Index 
Texts adopted
Wednesday, 17 April 2019 - Strasbourg 
Drafting or amendment of the title of a resolution tabled to wind up a debate (interpretation of Rule 149a(2) of the Rules of Procedure)
 Political declaration for the establisment of a political group (interpretation of Rule 32(5), first subparagraph, second indent, of the Rules of Procedure)
 Protocol to the EC-Denmark Agreement on the criteria and mechanisms for establishing the State responsible for examining a request for asylum and 'Eurodac' ***
 Establishing Horizon Europe – laying down its rules for participation and dissemination ***I
 Programme implementing Horizon Europe***I
 Market surveillance and compliance of products ***I
 Promoting fairness and transparency for business users of online intermediation services ***I
 Better enforcement and modernisation of EU consumer protection rules ***I
 Transparency and sustainability of the EU risk assessment in the food chain ***I
 Supplementary protection certificate for medicinal products ***I
 Space programme of the Union and European Union Agency for the Space Programme ***I
 Digital Europe programme for the period 2021-2027 ***I
 Fiscalis programme for cooperation in the field of taxation ***I
 Programme for the Environment and Climate Action (LIFE) ***I
 Justice programme ***I
 Rights and values programme ***I
 Number of inter-parliamentary delegations, delegations to joint inter-parliamentary committees and delegations to parliamentary cooperation committees and multilateral Parliamentary Assemblies
 Adapting a number of legal acts providing for the use of the regulatory procedure with scrutiny to Articles 290 and 291 TFEU - part II ***I
 Adapting a number of legal acts providing for the use of the regulatory procedure with scrutiny to Articles 290 and 291 TFEU - part I ***I
 Adapting a number of legal acts in the area of Justice providing for the use of the regulatory procedure with scrutiny to Article 290 TFEU ***I
 Implementation and financing of the EU general budget for 2019 in relation to the UK's withdrawal from the Union ***
 EU-Russia agreement on cooperation in science and technology ***
 Amendment of the European Investment Bank’s Statute *
 European Border and Coast Guard ***I
 Visa Code ***I
 Conservation and control measures applicable in the Regulatory Area of the Northwest Atlantic Fisheries Organisation ***I
 Rules facilitating the use of financial and other information ***I
 European Cybersecurity Industrial, Technology and Research Competence Centre and Network of National Coordination Centres ***I
 Connecting Europe Facility ***I
 Tackling the dissemination of terrorist content online ***I

Drafting or amendment of the title of a resolution tabled to wind up a debate (interpretation of Rule 149a(2) of the Rules of Procedure)
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European Parliament decision of 17 April 2019 concerning the drafting or amendment of the title of a resolution tabled to wind up a debate (interpretation of Rule 149a(2) of the Rules of Procedure) (2019/2020(REG))
P8_TA-PROV(2019)0392

The European Parliament,

–  having regard to the letter of 3 April 2019 from the Chair of the Committee on Constitutional Affairs,

–  having regard to Rule 226 of its Rules of Procedure,

1.  Decides to append the following interpretation to Rule 149a(2) of the Rules of Procedure:"“The drafting or amendment of the title of a resolution tabled to wind up a debate under Rules 123, 128 or 135 does not constitute a change to the agenda, provided that the title remains within the scope of the subject being debated.”"

2.  Instructs its President to forward this decision to the Council and the Commission, for information.


Political declaration for the establisment of a political group (interpretation of Rule 32(5), first subparagraph, second indent, of the Rules of Procedure)
PDF 117kWORD 42k
European Parliament decision of 17 April 2019 concerning the political declaration for the establisment of a political group (interpretation of Rule 32(5), first subparagraph, second indent, of the Rules of Procedure) (2019/2019(REG))
P8_TA-PROV(2019)0393

The European Parliament,

–  having regard to the letter of 3 April 2019 from the Chair of the Committee on Constitutional Affairs,

–  having regard to Rule 226 of its Rules of Procedure,

1.  Decides to append the following interpretation to Rule 32(5), first subparagraph, second indent, of the Rules of Procedure:"“The political declaration of a group shall set out the values that the group stands for and the main political objectives which its members intend to pursue together in the framework of the exercise of their mandate. The declaration shall describe the common political orientation of the group in a substantial, distinctive and genuine way.”"

2.  Instructs its President to forward this decision to the Council and the Commission, for information.


Protocol to the EC-Denmark Agreement on the criteria and mechanisms for establishing the State responsible for examining a request for asylum and 'Eurodac' ***
PDF 128kWORD 42k
European Parliament legislative resolution of 17 April 2019 on the draft Council decision on the conclusion of the Protocol to the Agreement between the European Community and the Kingdom of Denmark on the criteria and mechanisms for establishing the State responsible for examining a request for asylum lodged in Denmark or any other Member State of the European Union and "Eurodac" for the comparison of fingerprints for the effective application of the Dublin Convention regarding access to Eurodac for law enforcement purposes (15822/2018 – C8-0151/2019 – 2018/0423(NLE))
P8_TA-PROV(2019)0394A8-0196/2019

(Consent)

The European Parliament,

–  having regard to the draft Council decision (15822/2018),

–  having regard to the draft Protocol to the Agreement between the European Community and the Kingdom of Denmark on the criteria and mechanisms for establishing the State responsible for examining a request for asylum lodged in Denmark or any other Member State of the European Union and "Eurodac" for the comparison of fingerprints for the effective application of the Dublin Convention regarding access to Eurodac for law enforcement purposes (15823/2018),

–  having regard to the request for consent submitted by the Council in accordance with Article 87(2)(a), Article 88(2), first subparagraph, point (a) and Article 218(6), second subparagraph, point (a) of the Treaty on the Functioning of the European Union (C8-0151/2019),

–  having regard to Rule 99(1) and (4) and Rule 108(7) of its Rules of Procedure,

–  having regard to the recommendation of the Committee on Civil Liberties, Justice and Home Affairs (A8-0196/2019),

1.  Gives its consent to conclusion of the protocol;

2.  Instructs its President to forward its position to the Council, the Commission and the governments and parliaments of the Kingdom of Denmark and of the other Member States.


Establishing Horizon Europe – laying down its rules for participation and dissemination ***I
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European Parliament legislative resolution of 17 April 2019 on the proposal for a regulation of the European Parliament and of the Council establishing Horizon Europe – the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination (COM(2018)0435 – C8-0252/2018 – 2018/0224(COD))
P8_TA(2019)0395A8-0401/2018

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Programme implementing Horizon Europe***I
PDF 557kWORD 226k
European Parliament legislative resolution of 17 April 2019 on the proposal for a decision of the European Parliament and of the Council on establishing the specific programme implementing Horizon Europe - the Framework Programme for Research and Innovation (COM(2018)0436 – C8-0253/2018 – 2018/0225(COD))
P8_TA(2019)0396A8-0410/2018

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Market surveillance and compliance of products ***I
PDF 385kWORD 120k
Resolution
Consolidated text
European Parliament legislative resolution of 17 April 2019 on the proposal for a regulation of the European Parliament and of the Council laying down rules and procedures for compliance with and enforcement of Union harmonisation legislation on products and amending Regulations (EU) No 305/2011, (EU) No 528/2012, (EU) 2016/424, (EU) 2016/425, (EU) 2016/426 and (EU) 2017/1369 of the European Parliament and of the Council, and Directives 2004/42/EC, 2009/48/EC, 2010/35/EU, 2013/29/EU, 2013/53/EU, 2014/28/EU, 2014/29/EU, 2014/30/EU, 2014/31/EU, 2014/32/EU, 2014/33/EU, 2014/34/EU, 2014/35/EU, 2014/53/EU, 2014/68/EU and 2014/90/EU of the European Parliament and of the Council (COM(2017)0795 – C8-0004/2018 – 2017/0353(COD))
P8_TA-PROV(2019)0397A8-0277/2018

(Ordinary legislative procedure: first reading)

The European Parliament,

–  having regard to the Commission proposal to Parliament and the Council (COM(2017)0795),

–  having regard to Article 294(2) and Articles 33, 114 and 207 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8‑0004/2018),

–  having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–  having regard to the reasoned opinion submitted, within the framework of Protocol No 2 on the application of the principles of subsidiarity and proportionality, by the Swedish Parliament, asserting that the draft legislative act does not comply with the principle of subsidiarity,

–  having regard to the opinion of the European Economic and Social Committee of 23 May 2018(1),

–  having regard to the provisional agreement approved by the committee responsible under Rule 69f(4) of its Rules of Procedure and the undertaking given by the Council representative by letter of 15 February 2019 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,

–  having regard to Rule 59 of its Rules of Procedure,

–  having regard to the report of the Committee on the Internal Market and Consumer Protection and the opinion of the Committee on the Environment, Public Health and Food Safety (A8-0277/2018),

1.  Adopts its position at first reading hereinafter set out;

2.  Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

3.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Position of the European Parliament adopted at first reading on 17 April 2019 with a view to the adoption of Regulation (EU) 2019/… of the European Parliament and of the Council on market surveillance and compliance of products and amending
Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011

P8_TC1-COD(2017)0353


(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 33 and 114 ▌thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee(2),

Acting in accordance with the ordinary legislative procedure(3),

Whereas:

(1)  In order to guarantee the free movement of products within the Union, it is necessary to ensure that products are compliant with Union harmonisation legislation and therefore fulfil requirements providing a high level of protection of public interests, such as health and safety in general, health and safety in the workplace, protection of consumers, protection of the environment, public security and protection of any other public interests protected by that legislation. Robust enforcement of these requirements is essential to the proper protection of these interests and to create the conditions in which fair competition in the Union market for goods can thrive. Rules are therefore necessary to ensure this enforcement, regardless of whether products are placed on the market via offline or online means and regardless of whether they are manufactured in the Union or not.

(2)  Union harmonisation legislation covers a large share of manufactured products. Non-compliant and unsafe products put citizens at risk, and might distort competition with economic operators selling compliant products within the Union.

(3)  Strengthening the single market for goods through further enhancing efforts to keep non-compliant products from being placed on the Union market was identified as a priority in the Communication from the Commission of 28 October 2015 entitled ‘Upgrading the Single Market: more opportunities for people and business’. This should be achieved by strengthening market surveillance, providing economic operators with clear, transparent and comprehensive rules, intensifying compliance controls and promoting closer cross-border cooperation among enforcement authorities, including through cooperation with customs authorities.

(4)  The framework for market surveillance established by this Regulation should complement and strengthen existing provisions in Union harmonisation legislation relating to the ensuring of compliance of products and the framework for cooperation with organisations representing economic operators or end users, the market surveillance of products and controls on those products entering the Union market. However, in accordance with the principle of lex specialis, this Regulation should apply only in so far as there are no specific provisions with the same objective, nature or effect in Union harmonisation legislation. The corresponding provisions of this Regulation should therefore not apply in the areas covered by such specific provisions, for instance those set out in Regulations (EC) No 1223/2009 (4), (EU) 2017/745 (5) and (EU) 2017/746 (6), including as regards the use of the European database on medical devices (EUDAMED), and (EU) 2018/858(7) of the European Parliament and of the Council.

(5)  Directive 2001/95/EC of the European Parliament and of the Council(8) lays down the general safety requirements for all consumer products and provides for specific obligations and powers of the Member States in relation to dangerous products as well as for the exchange of information to that effect through the Rapid Information Exchange System (RAPEX). Market surveillance authorities should have the possibility of taking the more specific measures available to them under that Directive. In order to achieve a higher level of safety for consumer products, the mechanisms for exchanges of information and rapid intervention situations provided for in Directive 2001/95/EC should be made more effective.

(6)  The provisions on market surveillance of this Regulation should cover products that are subject to the Union harmonisation legislation listed in ▌Annex I concerning manufactured products other than food, feed, medicinal products for human and veterinary use, living plants and animals, products of human origin and products of plants and animals relating directly to their future reproduction. This will ensure a uniform framework for market surveillance of those products at Union level and will help to increase the confidence of consumers and other end users in products placed on the Union market. If new Union harmonisation legislation is adopted in the future, it will be for that legislation to specify whether this Regulation is also to apply to that legislation.

(7)  Articles 15 to 29 of Regulation (EC) No 765/2008 of the European Parliament and of the Council(9) laying down the Community market surveillance framework and controls of products entering the Community market should be deleted and the respective provisions should be replaced by this Regulation. That framework includes the provisions on controls of products entering the Community market, in Articles 27, 28 and 29 of Regulation (EC) No 765/2008, which apply not only to products covered by the market surveillance framework, but to all products in so far as other Union law does not contain specific provisions relating to the organisation of controls on products entering the Union market. It is therefore necessary that the scope of the provisions of this Regulation with regard to products entering the Union market extend to all products.

(8)  In order to rationalise and simplify the overall legislative framework, while simultaneously pursuing the objectives of Better Regulation, the rules applicable to controls on products entering the Union market should be revised and integrated into a single legislative framework for controls on products at the Union’s external borders.

(9)  Responsibility for enforcing Union harmonisation legislation should lie with the Member States, and their market surveillance authorities should be required to ensure that the legislation is fully complied with. The Member States should, therefore, establish systematic approaches to ensure effectiveness of market surveillance and other enforcement activities. In this regard, the methodology and criteria for assessing risks should be further harmonised in all Member States in order to ensure a level playing field for all economic operators.

(10)  In order to assist market surveillance authorities to strengthen consistency in their activities related to the application of this Regulation, an effective peer review system should be established for those market surveillance authorities wishing to participate.

(11)  Certain definitions currently set out in Regulation (EC) No 765/2008 should be aligned with definitions set out in other Union legal acts and, where appropriate, reflect the architecture of modern supply chains. The definition of ‘manufacturer’ in this Regulation should not relieve manufacturers of any obligations they might have under Union harmonisation legislation where specific definitions of manufacturer are applied, which might cover any natural or legal person who modifies a product already placed on the market in such a way that compliance with the applicable Union harmonisation legislation might be affected and places it on the market, or any other natural or legal person who places a product on the market under its name or trade mark.

(12)  Economic operators throughout the entire supply chain should be expected to act responsibly and in full accordance with the legal requirements applicable when placing or making products available on the market, so as to ensure compliance with the Union harmonisation legislation on products. This Regulation should be without prejudice to the obligations corresponding to the roles of each of the economic operators in the supply and distribution process pursuant to specific provisions in Union harmonisation legislation, and the manufacturer should retain ultimate responsibility for compliance of the product with requirements in the Union harmonisation legislation.

(13)  The challenges of the global market and increasingly complex supply chains, as well as the increase of products that are offered for sale online to end users within the Union, call for the strengthening of enforcement measures, to ensure the safety of consumers. Furthermore, practical experience of market surveillance has shown that such supply chains sometimes involve economic operators whose novel form means that they do not fit easily into the traditional supply chains according to the existing legal framework. Such is the case, in particular, with fulfilment service providers, which perform many of the same functions as importers but which might not always correspond to the traditional definition of importer in Union law. In order to ensure that market surveillance authorities can carry out their responsibilities effectively and to avoid a gap in the enforcement system, it is appropriate to include fulfilment service providers within the list of economic operators against whom it is possible for market surveillance authorities to take enforcement measures. By including fulfilment service providers within the scope of this Regulation, market surveillance authorities will be better able to deal with new forms of economic activity in order to ensure the safety of consumers and the smooth functioning of the internal market, including where the economic operator acts both as an importer as regards certain products and as a fulfilment service provider as regards other products.

(14)  Modern supply chains encompass a wide variety of economic operators who should all be subject to enforcement of Union harmonisation legislation, while taking due consideration of their respective roles in the supply chain, and the extent to which they contribute to the making available of products on the Union market. Therefore, it is necessary to apply this Regulation to economic operators that are directly concerned by Union harmonisation legislation listed in Annex I to this Regulation, such as the producer of an article and the downstream user as defined in Regulation (EC) No 1907/2006 of the European Parliament and of the Council(10) and in Regulation (EC) No 1272/2008 of the European Parliament and of the Council (11), the installer as defined in Directive 2014/33/EU of the European Parliament and of the Council(12), the supplier as defined in Regulation (EC) No 1222/2009 of the European Parliament and of the Council(13) or the dealer as defined in Regulation (EU) 2017/1369 of the European Parliament and of the Council(14).

(15)  In the case of a product offered for sale online or through other means of distance sales, the product should be considered to have been made available on the market if the offer for sale is targeted at end users in the Union. In line with the applicable Union rules on private international law, a case-by-case analysis should be carried out in order to establish whether an offer is targeted at end users in the Union. An offer for sale should be considered to be targeted at end users in the Union if the relevant economic operator directs, by any means, its activities to a Member State. For the case-by-case analyses, relevant factors, such as the geographical areas to which dispatch is possible, the languages available, used for the offer or for ordering, or means of payment, need to be taken into consideration. In the case of online sales, the mere fact that the economic operators’ or the intermediaries’ website is accessible in the Member State in which the end user is established or domiciled is insufficient.

(16)  The development of e-commerce is also due, to a great extent, to the proliferation of information society service providers, usually through platforms and for remuneration, which offer intermediary services by storing third party content, without exercising control over that content, and therefore not acting on behalf of an economic operator. Removal of content regarding non-compliant products or, where this is not feasible, restricting access to non-compliant products offered through their services should be without prejudice to the rules laid down in Directive 2000/31/EC of the European Parliament and of the Council(15). In particular, no general obligation should be imposed on information society service providers to monitor the information which they transmit or store, nor should a general obligation be imposed upon them to actively seek facts or circumstances indicating illegal activity. Furthermore, hosting service providers should not be held liable as long as they do not have actual knowledge of illegal activity or information and are not aware of the facts or circumstances from which the illegal activity or information is apparent.

(17)  While this Regulation does not deal with the protection of intellectual property rights, it should nevertheless be borne in mind that often counterfeit products do not comply with the requirements set out in the Union harmonisation legislation, present risks to health and safety of end users, distort competition, endanger public interests and support other illegal activities. Therefore, Member States should continue taking effective measures to prevent counterfeit products from entering the Union market pursuant to Regulation (EU) No 608/2013 of the European Parliament and of the Council(16).

(18)  A fairer single market should ensure equal conditions for competition to all economic operators and protection against unfair competition. To this end, strengthened enforcement of Union harmonisation legislation on products is necessary. Good cooperation between manufacturers and the market surveillance authorities is a key element, allowing immediate intervention and corrective action in relation to the product. It is important that, for certain products, there should be an economic operator established in the Union so that market surveillance authorities have someone to whom requests can be addressed, including requests for information regarding a product’s compliance with Union harmonisation legislation, and who can cooperate with market surveillance authorities in making sure that immediate corrective action is taken to remedy instances of non-compliance. The economic operators who should perform those tasks are the manufacturer, or the importer when the manufacturer is not established in the Union, or an authorised representative mandated by the manufacturer for this purpose, or a fulfilment service provider established in the Union for products handled by it when no other economic operator is established in the Union.

(19)  The development of e-commerce poses certain challenges for market surveillance authorities with regard to the ensuring of compliance of products offered for sale online and the effective enforcement of Union harmonisation legislation. The number of economic operators offering products directly to consumers by electronic means is increasing. Therefore, economic operators with tasks regarding products subject to certain Union harmonisation legislation perform an essential role by providing market surveillance authorities with an interlocutor established in the Union, and by performing specific tasks in a timely manner to make sure that the products comply with the requirements of Union harmonisation legislation, for the benefit of consumers, other end users and businesses within the Union.

(20)  The obligations of the economic operator with tasks regarding products subject to certain Union harmonisation legislation should be without prejudice to existing obligations and responsibilities of manufacturer, importer and authorised representative under the relevant Union harmonisation legislation.

(21)  Obligations of this Regulation requiring an economic operator to be established in the Union in order to place products on the Union’s market should only apply to areas where the need for an economic operator to act as a liaison point with the market surveillance authorities has been identified, taking into account a risk-based approach, having regard to the principle of proportionality, and taking into account high level of protection of end users in the Union.

(22)  Moreover, those obligations should not apply where the specific requirements set out in certain legal acts on products achieve in effect the same result, namely Regulation (EC) No 648/2004 of the European Parliament and of the Council(17), Regulation (EC) No 1223/2009, Regulation (EU) No 167/2013 of the European Parliament and of the Council(18), Regulation (EU) No 168/2013 of the European Parliament and of the Council(19), Directive 2014/28/EU of the European Parliament and of the Council(20), Directive 2014/90/EU of the European Parliament and of the Council(21), Regulation (EU) 2016/1628 of the European Parliament and of the Council(22), Regulation (EU) 2017/745, Regulation (EU) 2017/746, Regulation (EU) 2017/1369 and Regulation (EU) 2018/858. Consideration should also be given to situations where potential risks or cases of non-compliance are low, or in which products are mainly traded through traditional supply chains, which is the case, for instance, for Directive 2014/33/EU, Regulation (EU) 2016/424/EU of the European Parliament and of the Council(23) and Directive 2010/35/EU of the European Parliament and of the Council(24).

(23)  Contact information of economic operators with tasks regarding products subject to certain Union harmonisation legislation should be indicated with the product in order to facilitate checks throughout the supply chain.

(24)  Economic operators should fully cooperate with market surveillance authorities and other competent authorities to ensure the smooth performance of market surveillance and to enable the authorities to perform their tasks. This includes, where requested by authorities, providing the contact information of the economic operators with tasks regarding products subject to certain Union harmonisation legislation where this information is available to them.

(25)  Economic operators should have easy access to high quality, comprehensive information. Since the single digital gateway established under Regulation (EU) 2018/1724 of the European Parliament and of the Council(25) provides for a single point of online access to information, it can be used in respect to providing relevant information on Union harmonisation legislation to economic operators. Nevertheless, Member States should put in place procedures for ensuring access to the Product Contact Points established under Regulation (EU) 2019/... of the European Parliament and of the Council(26)(27) in order to assist the economic operators in addressing properly their requests for information. Guidance on issues relating to technical specifications or harmonised standards or design of a specific product should not be part of the obligations of Member States when providing such information.

(26)  Market surveillance authorities might carry out joint activities with other authorities or organisations representing economic operators or end users, with a view to promoting compliance, identifying non-compliance, raising awareness and providing guidance on Union harmonisation legislation and with respect to specific categories of products, including those that are offered for sale online.

(27)  Member States should designate their own market surveillance authorities. This Regulation should not prevent Member States from choosing the competent authorities to carry out the market surveillance tasks. In order to facilitate administrative assistance and cooperation, Member States should also appoint a single liaison office. Single liaison offices should at least represent the coordinated position of the market surveillance authorities and the authorities in charge of the control on products entering the Union market.

(28)  E-commerce poses certain challenges for market surveillance authorities regarding the protection of the health and safety of end users from non-compliant products. Therefore, Member States should ensure their market surveillance is organised with the same effectiveness for products made available online as it is for products made available offline.

(29)  While performing market surveillance of products offered for sale online, market surveillance authorities are facing numerous difficulties, such as tracing products offered for sale online, identifying the responsible economic operators, or conducting risk-assessments or tests due to the lack of physical access to products. In addition to the requirements introduced by this Regulation, Member States are encouraged to use complementary guidance and best practices for market surveillance and for communication with businesses and consumers.

(30)  Special attention should be given to emerging technologies, taking into account that consumers are increasingly using connected devices in their daily lives. The Union regulatory framework should therefore address the new risks to ensure the safety of the end users.

(31)  In the age of constant development of digital technologies new solutions that could contribute to the effective market surveillance within the Union should be explored.

(32)  Market surveillance should be thorough and effective, to ensure that Union harmonisation legislation on products is applied correctly. Given that controls may represent a burden for economic operators, market surveillance authorities should organise and conduct inspection activities on a risk-based approach, taking the interests of those economic operators into account and limiting the said burden to what is necessary for the performance of efficient and effective controls. Furthermore, market surveillance should be performed with the same level of care by the competent authorities of the Member State irrespective of whether non-compliance of the given product is relevant on the territory of that Member State or is likely to have an impact on the market of another Member State. Uniform conditions for certain inspection activities carried out by the market surveillance authorities where products or categories of products present specific risks or seriously breach the applicable Union harmonisation legislation might be laid down by the Commission.

(33)  Market surveillance authorities, when performing their duties, are confronted with different shortcomings in terms of resources, coordination mechanisms, as well as powers with regard to non-compliant products. Such differences lead to fragmented enforcement of Union harmonisation legislation and to market surveillance being more rigorous in some Member States than in others, potentially compromising the level playing field among businesses and creating also potential imbalances in the level of product safety throughout the Union.

(34)  In order to ensure that the Union harmonisation legislation on products is correctly enforced, market surveillance authorities should have a common set of investigative and enforcement powers, allowing for enhanced cooperation between market surveillance authorities and more effective deterrence for economic operators that willingly infringe Union harmonisation legislation. Those powers should be sufficiently robust to tackle the enforcement challenges of Union harmonisation legislation, along with the challenges of e-commerce and the digital environment and to prevent economic operators from exploiting gaps in the enforcement system by relocating to Member States whose market surveillance authorities are not equipped to tackle unlawful practices. In particular, the powers should ensure that information and evidence can be exchanged between competent authorities so that enforcement can be undertaken equally in all Member States.

(35)  This Regulation should be without prejudice to the freedom of Member States to choose the enforcement system that they consider to be appropriate. Member States should be free to choose whether their market surveillance authorities can exercise investigation and enforcement directly under their own authority, by recourse to other public authorities or upon application to the competent courts.

(36)  Market surveillance authorities should be in a position to open investigations on their own initiative if they become aware of non-compliant products placed on the market.

(37)  Market surveillance authorities should have access to all necessary evidence, data and information relating to the subject matter of an investigation in order to determine whether applicable Union harmonisation legislation has been infringed, and in particular to identify the economic operator responsible, irrespective of who possesses the evidence, data or information in question and regardless of where it is located and of the format in which it is held. Market surveillance authorities should be able to request economic operators, including those in the digital value chain, to provide all the evidence, data and information necessary.

(38)  Market surveillance authorities should be able to carry out the necessary on-site inspections, and should have the power to enter any premises, land or means of transport, that the economic operator uses for purposes relating to its trade, business, craft or profession.

(39)  Market surveillance authorities should be able to require a representative or a relevant member of staff of the economic operator concerned to give explanations or provide facts, information or documents relating to the subject matter of the on-site inspection, and to record the answers given by that representative or relevant member of staff.

(40)  Market surveillance authorities should be able to check the compliance of products to be made available on the market with Union harmonisation legislation and to obtain evidence of non-compliance. They should, therefore, have the power to acquire products and, where the evidence cannot be obtained by other means, to purchase products under a cover identity.

(41)  In the digital environment in particular, market surveillance authorities should be able to bring non-compliance to an end quickly and effectively, notably where the economic operator selling the product conceals its identity or relocates within the Union or to a third country in order to avoid enforcement. In cases where there is a risk of serious and irreparable harm to end users due to non-compliance, market surveillance authorities should be able to take ▌measures, where duly justified and proportionate and where there are no other means available to prevent or mitigate such harm, including, where necessary, requiring the removal of content from the online interface or the display of a warning. When such a request is not observed, the relevant authority should have the power to require information society service providers to restrict access to the online interface. These measures should be taken in accordance with the principles laid down in Directive 2000/31/EC. ▌

(42)  The implementation of this Regulation and the exercise of powers in its application should also comply with other Union and national law, for example Directive 2000/31/EC, including with applicable procedural safeguards and principles of the fundamental rights. That implementation and that exercise of powers should also be proportionate and adequate in view of the nature and the overall actual or potential harm caused by the infringement. Competent authorities should take all facts and circumstances of the case into account and should choose the most appropriate measures, namely, those which are essential to address the infringement covered by this Regulation. Those measures should be proportionate, effective and dissuasive. Member States should remain free to set out conditions and limits for the exercise of the powers to fulfil duties in national law. Where, for example, in accordance with national law, prior authorisation to enter the premises of natural persons and legal persons is required from the judicial authority of the Member State concerned, the power to enter such premises should be used only after such prior authorisation has been obtained.

(43)  Market surveillance authorities act in the interest of economic operators, of end users, and of the public, to ensure that public interests covered by relevant Union harmonisation legislation on products are consistently preserved and protected through appropriate enforcement measures, and that compliance with such legislation is ensured across the supply chain through appropriate checks, taking into consideration the fact that administrative checks alone, in many cases, cannot replace physical and laboratory checks in order to verify the compliance of products with the relevant Union harmonisation legislation. Consequently, market surveillance authorities should ensure a high level of transparency while performing their activities and should make available to the public any information that they consider to be relevant in order to protect the interests of end users in the Union.

(44)  This Regulation should be without prejudice to the functioning of RAPEX in accordance with Directive 2001/95/EC ▌.

(45)  This Regulation should be without prejudice to the safeguard clause procedure provided for by sectoral Union harmonisation legislation, pursuant to Article 114(10) of the Treaty on the Functioning of the European Union. With a view to ensuring an equivalent level of protection throughout the Union, Member States are authorised to take ▌measures in relation to products presenting a risk to health and safety, or other aspects of public interest protection. They are also required to notify those measures to other Member States and the Commission, allowing the Commission to take a position on whether national measures that restrict the free movement of products with a view to ensuring the functioning of the internal market are justified.

(46)  The exchange of information between market surveillance authorities, and the use of evidence and investigation findings should respect the principle of confidentiality. Information should be handled in accordance with applicable national law, in order to ensure that investigations are not compromised and that the reputation of the economic operator is not prejudiced.

(47)  Where, for the purposes of this Regulation, it is necessary to process personal data, this should be carried out in accordance with Union law on the protection of personal data. Any processing of personal data under this Regulation is subject to Regulation (EU) 2016/679 of the European Parliament and of the Council(28) and Regulation (EU) 2018/1725 of the European Parliament and of the Council(29), as applicable.

(48)  To ensure the effectiveness and consistency of testing across the Union in the market surveillance framework with regard to specific products or a specific category or group of products or for specific risks related to a category or group of products, the Commission might designate testing facilities of its own or public testing facilities of a Member State as a Union testing facility. All Union testing facilities should be accredited in accordance with the requirements of Regulation (EC) No 765/2008. In order to avoid conflicts of interests, Union testing facilities should only provide services to market surveillance authorities, the Commission, the Union Product Compliance Network (the Network) and other government or intergovernmental entities.

(49)  Member States should ensure that adequate financial resources are always available for the appropriate staffing and equipping of the market surveillance authorities. Efficient market surveillance is demanding in terms of resources, and stable resources should be provided, at a level appropriate to the enforcement needs at any given moment. Member States should have the possibility to supplement public financing by reclaiming from the relevant economic operators the costs incurred when performing market surveillance in relation to products that were found to be non-compliant ▌.

(50)  Mechanisms for mutual assistance should be established, since it is imperative for the Union market for goods that the market surveillance authorities of the Member States cooperate with each other effectively. Authorities should act in good faith and, as a general principle, accept requests for mutual assistance, in particular those concerning access to EU declaration of conformity, declaration of performance and technical documentation.

(51)  It is appropriate that Member States designate the authorities responsible for applying the customs legislation and any other authorities in charge under national law of control on products entering the Union market.

(52)  An effective way to ensure that unsafe or non-compliant products are not placed on the Union market would be to detect such products before they are released for free circulation. ▌Authorities ▌in charge of the control on products entering the ▌Union market, have a complete overview of trade flows across the Union’s external borders, and should therefore be required to carry out adequate controls on a risk assessment basis, to contribute to a safer market place which ensures a high level of protection of public interests. It is for Member States to designate the specific authorities that are to be responsible for the appropriate documentary and, where necessary, physical or laboratory checks of products before those products are released for free circulation. A uniform enforcement of Union harmonisation legislation on products can only be achieved through systematic cooperation and exchange of information between market surveillance and other authorities designated as authorities in charge of the control on products entering the Union market. These authorities should receive well in advance from the market surveillance authorities all the necessary information concerning non-compliant products or information on economic operators where a higher risk of non-compliance has been identified. In turn, ▌authorities in charge of the control on products entering the customs territory of the Union should inform the market surveillance authorities in a timely manner of the release of products for free circulation, and the results of controls, where such information is relevant for the enforcement of Union harmonisation legislation on products. Furthermore, where the Commission becomes aware of a serious risk presented by an imported product, it should inform the Member States about that risk in order to ensure coordinated and more effective compliance and enforcement controls at the first points of entry to the Union.

(53)  Importers should be reminded that Articles 220, 254, 256, 257 and 258 of Regulation (EU) No 952/2013 of the European Parliament and of the Council(30) provide that products entering the Union market that require further processing in order to be in compliance with the applicable Union harmonisation legislation shall be placed under the appropriate customs procedure allowing such processing by the importer. Generally, the release for free circulation should not be deemed to be proof of conformity with Union law, since such a release does not necessarily include a complete check of compliance.

(54)  In order to use the EU Single Window environment for customs and therefore to optimise and unburden the data transfer between customs and market surveillance authorities, it is necessary to set up electronic interfaces that allow automatic data transfer. Customs and market surveillance authorities should contribute to determine the data to be transmitted. Additional burden for customs authorities should be limited and the interfaces should be highly automated and easy-to-use.

(55)  It is necessary to establish the Network, hosted by the Commission, aimed at structured coordination and cooperation between enforcement authorities of the Member States and the Commission, and at streamlining the practices of market surveillance within the Union that facilitate the implementation of joint enforcement activities by Member States, such as joint investigations. This administrative support structure should allow the pooling of resources and maintain a communication and information system between Member States and the Commission, thereby helping to strengthen enforcement of Union harmonisation legislation on products and to deter infringements. The involvement of administrative cooperation groups (ADCOs) in the Network should not preclude the involvement of other, similar, groups involved in administrative cooperation. The Commission should provide the necessary administrative and financial support to the Network.

(56)  There should be effective, speedy and accurate exchange of information among the Member States and the Commission. A number of existing tools, such as the information and communication system for market surveillance (ICSMS) and RAPEX enable coordination among market surveillance authorities in the Union. These tools, together with the interface permitting data transfer from ICSMS into RAPEX should be maintained and further developed in order to exploit their full potential and help to increase the level of cooperation and exchange of information between Member States and the Commission.

(57)  In that context, for the purpose of collecting information relating to the enforcement of Union harmonisation legislation on products, ICSMS should be upgraded and be accessible to the Commission, single liaison offices, ▌customs and market surveillance authorities ▌. Furthermore, an electronic interface should be developed to allow effective exchange of information between national ▌systems of customs and market surveillance authorities. With regard to the cases of mutual assistance requests the single liaison offices should give any support necessary for cooperation between the relevant authorities. Therefore, ICSMS should provide the functions enabling an automated indication to the single liaison offices when deadlines are not met. When sectoral legislation already provides for electronic systems for cooperation and data exchange, as is the case for example of EUDAMED for medical devices, those systems should be kept in use, when appropriate.

(58)  In general, ICSMS should be used to exchange information considered helpful for other market surveillance authorities. This might include checks undertaken in the context of market surveillance projects, regardless of the outcome of the tests. The amount of data to be entered in ICSMS should strike a balance between imposing too great a burden, when the efforts for entering the data would exceed the work involved in doing the actual checks, and being comprehensive enough to support greater efficiency and effectiveness on the side of the authorities. Thus, the data entered in ICSMS should also cover simpler checks than laboratory tests only. Nevertheless, there should be no need to include brief visual checks. As a guideline, checks which are individually documented should also be entered in ICSMS.

(59)  Member States are encouraged to use ICSMS for interactions between customs and market surveillance authorities as an alternative to the national systems. This should not replace the Community Risk Management System (CRMS) used by customs authorities. These two systems could work in parallel since they fulfil different, complementary roles, with ICSMS facilitating communication between customs and market surveillance authorities in order to allow for a smooth treatment of customs declarations in the scope of the product safety and compliance framework while CRMS is for customs common risk management and controls.

(60)  Injuries caused by non-compliant products are important information for market surveillance authorities. ICSMS should therefore provide for related data fields so that market surveillance authorities can enter readily available reports provided for in the course of their investigations, thus facilitating later statistical evaluations.

(61)  The Commission should be able to exchange market surveillance related information with regulatory authorities of third countries or international organisations within the framework of agreements concluded between the Union and third countries or international organisations, with a view to ensuring compliance of products prior to their export to the Union market.

(62)  In order to achieve a high degree of compliance with applicable Union harmonisation legislation on products while at the same time ensuring an effective resource-allocation and a cost-efficient control of products entering the Union market, the Commission should be able to approve specific pre-export control systems. Products falling under such approved systems might, as part of the risk assessment performed by authorities in charge of controls on products entering the Union market, benefit from a higher level of confidence than comparable products which have not been subject to a pre-export control.

(63)  The Commission should carry out an evaluation of this Regulation in light of the objective it pursues, and taking into consideration new technological, economic, commercial and legal developments. Pursuant to point 22 of the Interinstitutional Agreement of 13 April 2016 on Better Law Making(31), the evaluation, based on efficiency, effectiveness, relevance, coherence and value added, should provide the basis for impact assessments of options for further action, particularly as regards the scope of this Regulation, the application and enforcement of the provisions related to the tasks of economic operators placing products on the market, and the system of product-related pre-export controls.

(64)  The financial interests of the Union should be protected through proportionate measures throughout the expenditure cycle, including the prevention, detection and investigation of irregularities, the recovery of funds lost, wrongly paid or incorrectly used and, where appropriate, administrative and financial penalties.

(65)  The diversity of sanctions across the Union is one of the main reasons for inadequate deterrence and uneven protection. Rules on establishing sanctions, including monetary penalties, are a matter of national jurisdiction and should, therefore, be determined by national law. ▌

(66)  In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission in relation to: determining the uniform conditions for checks, criteria for determination of the frequency of checks and amount of samples to be checked in relation to certain products or categories of products, where specific risks or serious breaches of Union harmonisation legislation have been continuously identified; specifying the procedures for the designation of Union testing facilities ▌; laying down benchmarks and techniques for checks on the basis of common risk analysis at the Union level; specifying the details of statistical data covering controls performed by the designated authorities with respect to products subject to Union law; ▌specifying the details of implementation arrangements for the information and communication system and defining the data relating to the placing of products under the customs procedure ‘release for free circulation’ transmitted by customs authorities; and to the approval of specific systems of product-related pre-export controls and the withdrawal of such approvals▌. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council(32).

(67)  Since the objective of this Regulation, namely to improve the functioning of the internal market by strengthening the market surveillance of products covered by Union harmonisation legislation, cannot be sufficiently achieved by the Member States given the need for a very high degree of cooperation, interaction and coherent action of all of the competent authorities in all Member States, but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.

(68)  This Regulation respects fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union and present in the constitutional traditions of Member States. Accordingly, this Regulation should be interpreted and applied in accordance with those rights and principles, including those related to the freedom and pluralism of the media. In particular, this Regulation seeks to ensure full respect for consumer protection, the freedom to conduct a business, the freedom of expression and information, the right to property and the protection of personal data,

HAVE ADOPTED THIS REGULATION:

Chapter I

General provisions

Article 1

Subject matter

1.  The objective of this Regulation is to improve the functioning of the internal market by strengthening the market surveillance of products covered by the Union harmonisation legislation referred to in Article 2, with a view to ensuring that only compliant products that fulfil requirements providing a high level of protection of public interests, such as health and safety in general, health and safety in the workplace, the protection of consumers, the protection of the environment and public security and any other public interests protected by that legislation, are made available on the Union market.

2.  This Regulation lays down rules and procedures for economic operators regarding products subject to certain Union harmonisation legislation and establishes a framework for cooperation with economic operators.

3.   This Regulation also provides a framework for controls on ▌products entering the Union market.

Article 2

Scope

1.  This Regulation shall apply to ▌products that are subject to the Union harmonisation legislation listed in Annex I (‘Union harmonisation legislation’), in so far as there are no specific provisions with the same objective in the Union harmonisation legislation, which regulate in a more specific manner particular aspects of market surveillance and enforcement.

2.   Articles 25 to 28 shall apply to products covered by Union law in so far as there are no specific provisions relating to the organisation of controls on products entering the Union market in Union law.

3.  The application of this Regulation shall not prevent market surveillance authorities from taking more specific measures as provided for in Directive 2001/95/EC.

4.  This Regulation is without prejudice to Articles 12 to 15 of Directive 2000/31/EC.

Article 3

Definitions

For the purposes of this Regulation, the following definitions shall apply:

(1)  ‘making available on the market’ means any supply of a product for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;

(2)  ‘placing on the market’ means the first making available of a product on the Union market;

(3)  ‘market surveillance’ means the activities carried out and measures taken by market surveillance authorities to ensure that products comply with the requirements set out in the applicable Union harmonisation legislation and to ensure protection of the public interest covered by that legislation;

(4)  ‘market surveillance authority’ means an authority designated by a Member State under Article 10 as responsible for carrying out market surveillance ▌in the territory of that Member State;

(5)  ‘applicant authority’ means the market surveillance authority that makes a request for mutual assistance;

(6)  ‘requested authority’ means the market surveillance authority that receives a request for mutual assistance;

(7)  ‘non-compliance’ means any failure to comply with any requirement under the Union harmonisation legislation or under this Regulation;

(8)  ‘manufacturer’ means any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under its name or trademark;

(9)  ‘importer’ means any natural or legal person established within the Union who places a product from a third country on the Union market;

(10)  ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market;

(11)  ‘fulfilment service provider’ means any natural or legal person offering, in the course of commercial activity, at least two of the following services: warehousing, packaging, addressing and dispatching, without having ownership of the products involved, excluding postal services as defined in point 1 of Article 2 of Directive 97/67/EC of the European Parliament and of the Council(33), parcel delivery services as defined in point 2 of Article 2 of Regulation (EU) 2018/644 of the European Parliament and of the Council(34), and any other postal services or freight transport services;

(12)  'authorised representative' means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on its behalf in relation to specified tasks with regard to the manufacturer’s obligations under the relevant Union harmonisation legislation or under the requirements of this Regulation;

(13)  ‘economic operator’ means the manufacturer, the authorised representative, the importer, the distributor, the fulfilment service provider or any other natural or legal person who is subject to obligations in relation to the manufacture of products, making them available on the market or putting them into service in accordance with the relevant Union harmonisation legislation;

(14)  ‘information society service provider’ means a provider of a service as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535 of the European Parliament and of the Council(35);

(15)  ‘online interface’ means any software, including a website, part of a website or an application, that is operated by or on behalf of an economic operator, and which serves to give end users access to the economic operator’s products;

(16)  ‘corrective action’ means any action taken by an economic operator to bring any non-compliance to an end where required by a market surveillance authority or on the economic operator's own initiative;

(17)  ‘voluntary measure’ means a corrective action where not required by a market surveillance authority;

(18)  ‘risk’ means the combination of the probability of an occurrence of a hazard causing harm and the degree of severity of that harm;

(19)  ‘product presenting a risk’ means a product having the potential to affect adversely health and safety of persons in general, health and safety in the workplace, protection of consumers, the environment, public security and other public interests, protected by the applicable Union harmonisation legislation, to a degree which goes beyond that considered reasonable and acceptable in relation to its intended purpose or under the normal or reasonably foreseeable conditions of use of the product concerned, including the duration of use and, where applicable, its putting into service, installation and maintenance requirements;

(20)  ‘product presenting a serious risk’ means a product presenting a risk, for which, based on a risk assessment and taking into account the normal and foreseeable use of the product, the combination of the probability of occurrence of a hazard causing harm and the degree of severity of the harm is considered to require rapid intervention by the market surveillance authorities, including cases where the effects of the risk are not immediate ▌;

(21)  ‘end user’ means any natural or legal person residing or established in the Union, to whom a product has been made available either as a consumer outside of any trade, business, craft or profession or as a professional end user in the course of its industrial or professional activities;

(22)  ‘recall’ means any measure aimed at achieving the return of a product that has already been made available to the end user;

(23)  ‘withdrawal’ means any measure aimed at preventing a product in the supply chain from being made available on the market;

(24)  ‘customs authorities’ means customs authorities as defined in point 1 of Article 5 of Regulation (EU) No 952/2013;

(25)  ‘release for free circulation’ means the procedure laid down in Article 201 of Regulation (EU) No 952/2013;

(26)  ‘products entering the Union market’ means products from third countries intended to be placed on the Union market or intended for private use or consumption within the customs territory of the Union and placed under the customs procedure ‘release for free circulation’.

Chapter II

Tasks of economic operators

Article 4

Tasks of economic operators regarding products subject to certain Union harmonisation legislation

1.  Notwithstanding any obligations set out in applicable Union harmonisation legislation, a product subject to legislation referred to in paragraph 5 may be placed on the market only if there is an economic operator established in the Union who is responsible for the tasks set out in paragraph 3 in respect of that product.

2.  For the purposes of this Article, the economic operator referred to in paragraph 1 means any of the following:

(a)  a manufacturer established in the Union ▌;

(b)  an importer, where the manufacturer is not established in the Union;

(c)  an authorised representative who has a written mandate from the manufacturer designating the authorised representative to perform the tasks set out in paragraph 3 on the manufacturer's behalf;

(d)  a fulfilment service provider established in the Union with respect to the products it handles, where no other economic operator as mentioned in points (a), (b) and (c) is established in the Union.

3.  Without prejudice to any obligations of economic operators under the applicable Union harmonisation legislation, the economic operator referred to in paragraph 1 shall perform the following tasks:

(a)  if the Union harmonisation legislation applicable to the product provides for an EU declaration of conformity or declaration of performance and technical documentation, verifying that the EU declaration of conformity or declaration of performance and technical documentation have been drawn up, keeping the declaration of conformity or declaration of performance at the disposal of market surveillance authorities for the period required by that legislation and ensuring that the technical documentation can be made available to those authorities upon request;

(b)  further to a reasoned request from a market surveillance authority, providing that authority with all information and documentation necessary to demonstrate the conformity of the product in a language which can be easily understood by that authority;

(c)  when having reason to believe that a product in question presents a risk, informing the market surveillance authorities thereof;

(d)  cooperating with the market surveillance authorities, including following a reasoned request making sure that the immediate, necessary, corrective action is taken to remedy any case of non-compliance with the requirements set out in Union harmonisation legislation applicable to the product in question, or, if that is not possible, to mitigate the risks presented by that product, when required to do so by the market surveillance authorities or on its own initiative, where the economic operator referred to in paragraph 1 considers or has reason to believe that the product in question presents a risk.

4.  Without prejudice to the respective obligations of economic operators under the applicable Union harmonisation legislation, the name, registered trade name or registered trade mark, and contact details, including the postal address, of the economic operator referred to in paragraph 1 shall be indicated on ▌the product or on its packaging, the parcel or an accompanying document.

5.  This Article only applies in relation to products that are subject to Regulations (EU) No 305/2011(36), (EU) 2016/425(37) and (EU) 2016/426(38) of the European Parliament and of the Council, and Directives 2000/14/EC(39), 2006/42/EC(40), 2009/48/EC(41), 2009/125/EC(42), 2011/65/EU(43), 2013/29/EU(44), 2013/53/EU(45), 2014/29/EU(46), 2014/30/EU(47), 2014/31/EU(48), 2014/32/EU(49), 2014/34/EU(50), 2014/35/EU(51), 2014/53/EU(52) and 2014/68/EU(53) of the European Parliament and of the Council.

Article 5

Authorised representative

1.  For the purposes of point (c) of Article 4(2), the authorised representative shall be mandated by the manufacturer to perform the tasks listed in Article 4(3), notwithstanding any other tasks mandated under the relevant Union harmonisation legislation.

2.  The authorised representative shall perform the tasks specified in the mandate. It shall provide a copy of the mandate to the market surveillance authorities upon request, in an Union language determined by the market surveillance authority.

3.  Authorised representatives shall have the appropriate means to be able to fulfil their tasks.

Article 6

Distance sales

Products offered for sale online or through other means of distance sales shall be deemed to be made available on the market if the offer is targeted at end users in the Union. An offer for sale shall be considered to be targeted at end users in the Union if the relevant economic operator directs, by any means, its activities to a Member State.

Article 7

Obligation of cooperation

1.  Economic operators shall cooperate with market surveillance authorities regarding actions which could eliminate or mitigate risks that are presented by products made available on the market by those operators.

2.  Information society service providers shall cooperate with the market surveillance authorities, at the request of the market surveillance authorities and in specific cases, to facilitate any action taken to eliminate or, if that is not possible, to mitigate the risks presented by a product that is or was offered for sale online through their services.

Chapter III

Assistance to and cooperation with economic operators

Article 8

Information to economic operators

1.  The Commission, in accordance with Regulation (EU) 2018/1724, shall ensure that the Your Europe portal provides users with easy online access to information about the product requirements and rights, obligations and rules derived from the Union harmonisation legislation.

2.  Member States shall put in place procedures for providing economic operators, at their request and free of charge, with information with respect to the national transposition and implementation of Union harmonisation legislation applicable to products. For this purpose, Article 9(1), (4) and (5) of Regulation (EU) 2019/...(54) shall apply.

Article 9

Joint activities to promote compliance

1.  Market surveillance authorities may agree with other relevant authorities or with organisations representing economic operators or end users on the carrying out ▌of joint activities that have the aim of ▌promoting compliance, identifying non-compliance, raising awareness and providing guidance in relation to the Union harmonisation legislation with respect to specific categories of products, in particular categories of products that are often found to present a serious risk, including products offered for sale online.

2.  The market surveillance authority in question and the parties referred to in paragraph 1 shall ensure that the agreement on joint activities does not lead to unfair competition between economic operators and does not affect the objectivity, independence and impartiality of the parties.

3.  A market surveillance authority may use any information resulting from joint activities carried out as part of any investigation regarding non-compliance that it undertakes.

4.  The market surveillance authority in question shall make the agreement on joint activities, including the names of the parties involved, available to the public and shall enter that agreement in the information and communication system referred to in Article 34. At the request of a Member State, the Network established under Article 29 shall assist in the drawing up of the agreement on joint activities.

Chapter IV

Organisation, activities and obligations of market surveillance authorities and the single liaison office

Article 10

Designation of market surveillance authorities and the single liaison office

1.  Member States shall organise and carry out market surveillance as provided for in this Regulation.

2.  For the purposes of paragraph 1 of this Article, each Member State shall designate one or more market surveillance authorities in its territory. Each Member State shall inform the Commission ▌and the other Member States of its market surveillance authorities ▌and the areas of competence of each of those authorities, using the information and communication system referred to in Article 34.

3.  Each Member State shall appoint a single liaison office.

4.  The single liaison office ▌shall at least be responsible for representing the coordinated position of the market surveillance authorities and the authorities designated under Article 25(1) and for communicating the national strategies as set out in Article 13. The single liaison office shall also assist in the cooperation between market surveillance authorities in different Member States, as set out in Chapter VI.

5.  In order to carry out market surveillance of products made available online and offline with the same effectiveness for all distribution channels, Member States shall ensure that their market surveillance authorities and single liaison office have the necessary resources, including sufficient budgetary and other resources, such as a sufficient number of competent personnel, expertise, procedures and other arrangements for the proper performance of their duties.

6.  Where there is more than one market surveillance authority in their territory, Member States shall ensure that the respective duties of those authorities are clearly defined and that appropriate communication and coordination mechanisms are established to enable those authorities to collaborate closely and exercise their duties effectively.

Article 11

Activities of market surveillance authorities

1.  Market surveillance authorities shall conduct their activities in order to ensure the following:

(a)  effective ▌market surveillance within their territory of products made available online and offline with respect to ▌products that are subject to ▌Union harmonisation legislation ▌;

(b)  ▌the taking by economic operators of appropriate and proportionate corrective action in relation to compliance with that legislation and this Regulation;

(c)  the taking of appropriate and proportionate measures where the economic operator fails to take corrective action.

2.  Market surveillance authorities shall exercise their powers and carry out their duties independently, impartially and without bias.

3.  Market surveillance authorities, as part of their activities set out in paragraph 1 of this Article, shall perform appropriate checks on the characteristics of products on an adequate scale, by means of documentary checks and, where appropriate, physical and laboratory checks based on adequate samples, prioritising their resources and actions to ensure effective market surveillance and taking into account the national market surveillance strategy referred to in Article 13.

In deciding on which checks to perform, on which types of products and on what scale, market surveillance authorities shall follow a risk-based approach taking into account the following factors:

(a)  possible hazards and non-compliance associated with the products and, where available, their occurrence on the market;

(b)  activities and operations under the control of the economic operator;

(c)  the economic operator's past record of non-compliance;

(d)  if relevant, the risk profiling performed by the authorities designated under Article 25(1);

(e)  consumer complaints and other information received from other authorities, economic operators, media and other sources that might indicate non-compliance.

4.  The Commission, after consulting the Network, may adopt implementing acts determining the uniform conditions of checks, criteria for determination of the frequency of checks and amount of samples to be checked in relation to certain products or categories of products, where specific risks or serious breaches of applicable Union harmonisation legislation have been continuously identified, in order to ensure high level of protection of health and safety or other public interests protected by that legislation. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 43(2).

5.  Where economic operators present test reports or certificates attesting the conformity of their products with Union harmonisation legislation issued by a conformity assessment body accredited in accordance with Regulation (EC) No 765/2008, market surveillance authorities shall take due account of those reports or certificates.

6.  Evidence that is used by a market surveillance authority in one Member State may be used as part of investigations to verify product compliance carried out by market surveillance authorities in another Member State, without any further formal requirements.

7.  Market surveillance authorities shall establish the following procedures in connection with products subject to the Union harmonisation legislation:

(a)  procedures for following up on complaints or reports on issues relating to risks or non-compliance;

(b)  procedures for verifying that the corrective action that was to be taken by economic operators has been taken.

8.  With a view to ensuring communication and coordination with their counterparts in other Member States, market surveillance authorities shall actively participate in administrative cooperation groups (ADCOs) as referred to in Article 30(2).

9.  Without prejudice to any Union safeguard procedure pursuant to the applicable Union harmonisation legislation, products that have been deemed to be non-compliant on the basis of a decision of a market surveillance authority in one Member State shall be presumed to be non-compliant by market surveillance authorities in other Member States, unless a relevant market surveillance authority in another Member State concluded the contrary on the basis of its own investigation, taking into account the input, if any, provided by an economic operator.

Article 12

Peer reviews

1.  Peer reviews shall be organised for market surveillance authorities wishing to participate in such reviews, in order to strengthen consistency in market surveillance activities in relation to the application of this Regulation.

2.  The Network shall develop the methodology and the rolling plan for peer reviews among participating market surveillance authorities. When establishing the methodology and the rolling plan, the Network shall take into consideration, at least, the number and the size of market surveillance authorities in the Member States, the number of personnel available and other resources for performing the peer review, and other relevant criteria.

3.  Peer reviews shall cover best practices developed by some market surveillance authorities which may be of benefit for other market surveillance authorities, and other relevant aspects related to the effectiveness of market surveillance activities.

4.  The outcome of the peer reviews shall be reported to the Network.

Article 13

National market surveillance strategies

1.  Each Member State shall draw up an overarching national market surveillance strategy, at least every four years. Each Member State shall draw up the first such strategy by ... [three years after the date of entry into force of this Regulation]. The national strategy shall promote a consistent, comprehensive and integrated approach to market surveillance and to the enforcement of Union harmonisation legislation within the territory of the Member State. When drawing up the national market surveillance strategy, all sectors covered by the Union harmonisation legislation and all stages of the product supply chain, including imports and digital supply chains, shall be considered. The priorities set out within the work programme of the Network may also be considered.

2.  The national market surveillance strategy shall include at least the following elements, when this does not compromise market surveillance activities:

(a)  the available information on the occurrence of non-compliant products, in particular taking into account the ▌checks and controls referred to in Articles 11(3) and 25(3), respectively, and, where applicable, market trends that may affect non-compliance rates for the categories of products, and possible threats and risks related to emerging technologies;

(b)  the areas identified by the Member States as priorities for the enforcement of Union harmonisation legislation;

(c)  the enforcement activities planned in order to reduce non-compliance in those areas identified as priorities, including, where relevant, the minimum control levels envisaged for categories of products which have significant levels of non-compliance;

(d)  an assessment of the cooperation with market surveillance authorities in other Member States, as referred to in Article 11(8) and Chapter VI.

3.  Member States shall communicate their national market surveillance strategy to the Commission and other Member States through the information and communication system referred to in Article 34. Each Member State shall publish a summary of its strategy.

Chapter V

Market surveillance powers and measures

Article 14

Powers of market surveillance authorities

1.  Member States shall confer on their market surveillance authorities the powers of market surveillance, investigation and enforcement necessary for the application of this Regulation and for the application of ▌Union harmonisation legislation ▌.

2.  Market surveillance authorities shall exercise the powers set out in this Article efficiently and effectively, in accordance with the principle of proportionality, to the extent that such exercise relates to the subject matter and the purpose of the measures and the nature and the overall actual or potential harm resulting from the instance of non-compliance. Powers shall be conferred and exercised in accordance with Union and national law, including the principles of the Charter of Fundamental Rights of the European Union, as well as with principles of national law relating to freedom of expression and the freedom and pluralism of the media, with applicable procedural safeguards and with the Union rules on data protection, in particular Regulation (EU) 2016/679.

3.  When conferring powers under paragraph 1, ▌Member States may provide for the power to be exercisable in one of the following ways, as appropriate:

(a)  directly by the market surveillance authorities under their own authority;

(b)  by recourse to other public authorities in accordance with the division of powers and the institutional and administrative organisation of the Member State in question;

(c)  upon application to courts competent to grant the necessary decision to approve the exercise of that power, including, where appropriate, on appeal, if the application to grant the necessary decision was not successful.

4.  The powers conferred on market surveillance authorities under paragraph 1 shall include at least the following ▌:

(a)  the power to require economic operators to provide relevant documents, technical specifications, data or information on compliance and technical aspects of the product, including access to embedded software in so far as such access is necessary for the purpose of assessing the product’s compliance with applicable Union harmonisation legislation, in any form or format and irrespective of the medium of storage or the place where such documents, technical specifications, data or information are stored, and to take or obtain copies thereof;

(b)  the power to require economic operators to provide relevant information on the supply chain, on the details of the distribution network, on quantities of products on the market and on other product models that have the same technical characteristics as the product in question, where relevant for compliance with the applicable requirements under Union harmonisation legislation;

(c)  the power to require economic operators to provide relevant information required for the purpose of ascertaining the ownership of websites, where the information in question is related to the subject matter of the investigation;

(d)  the power to carry out unannounced on-site inspections and physical checks of products;

(e)  the power to enter any premises, land or means of transport that the economic operator in question uses for purposes related to the economic operator's trade, business, craft or profession, in order to identify non-compliance and to obtain evidence;

(f)  the power to start investigations ▌on market surveillance authorities' own initiative in order to identify non-compliances and bring them to an end;

(g)  the power to require economic operators to take appropriate action to bring an instance of non-compliance to an end or to eliminate the risk;

(h)  the power to take appropriate measures where an economic operator fails to take appropriate corrective action or where the non-compliance or the risk persists, including the power to prohibit or restrict the making available of a product on the market or to order that the product is withdrawn or recalled;

(i)  the power to impose penalties in accordance with Article 41;

(j)  the power to acquire product samples, including under a cover identity, to inspect those samples and to reverse-engineer them in order to identify non-compliance and to obtain evidence;

(k)  the power, where no other effective means are available to eliminate a serious risk:

(i)  to require the removal of content referring to the related products from an online interface or to require the explicit display of a warning to end users when they access an online interface; or

(ii)  where a request according to point (i) has not been complied with, to require information society service providers to restrict access to the online interface, including by requesting a relevant third party to implement such measures.

5.  Market surveillance authorities may use any information, document, finding, statement, or any intelligence as evidence for the purpose of their investigations, irrespective of the format in which and medium on which they are stored.

Article 15

Recovery of costs by market surveillance authorities

1.  Member States may authorise their market surveillance authorities to reclaim from the relevant economic operator the totality of the costs of their activities with respect to instances of non-compliance.

2.  The costs referred to in paragraph 1 of this Article may include the costs of carrying out testing, the costs of taking measures in accordance with Article 28(1) and (2), the costs of storage and the costs of activities relating to products that are found to be non-compliant and are subject to corrective action prior to their release for free circulation or their placing on the market.

Article 16

Market surveillance measures

1.   Market surveillance authorities shall take appropriate measures if a product subject to Union harmonisation legislation, when used in accordance with its intended purpose or under conditions which can be reasonably foreseen and when properly installed and maintained:

(a)  is liable to compromise the health or safety of users; or

(b)  does not conform to applicable Union harmonisation legislation.

2.  Where market surveillance authorities make findings referred to in point (a) or (b) of paragraph 1, they shall without delay require the relevant economic operator to take appropriate and proportionate corrective action to bring the non-compliance to an end or to eliminate the risk within a period they specify.

3.  For the purposes of paragraph 2, the corrective action required to be taken by the economic operator may include, inter alia:

(a)  bringing the product into compliance, including by rectifying formal non-compliance as defined by the applicable Union harmonisation legislation, or by ensuring that the product no longer presents a risk;

(b)  preventing the product from being made available on the market;

(c)  withdrawing or recalling the product immediately and alerting the public to the risk presented;

(d)  destroying the product or otherwise rendering it inoperable;

(e)  affixing to the product suitable, clearly worded, easily comprehensible warnings of the risks that it might present, in the language or languages determined by the Member State in which the product is made available on the market;

(f)  setting prior conditions for making the product concerned available on the market;

(g)  alerting the end users at risk immediately and in an appropriate form, including by publication of special warnings in the language or languages determined by the Member State in which the product is made available on the market.

4.  Corrective actions referred to in points (e), (f) and (g) of paragraph 3 may only be required in cases where the product is liable to present a risk only in certain conditions or only to certain end users.

5.  If the economic operator fails to take corrective action referred to in paragraph 3 or where the non-compliance or the risk referred to in paragraph 1 persists, market surveillance authorities shall ensure that the product is withdrawn or recalled, or that its being made available on the market is prohibited or restricted, and that the public, the Commission and the other Member States are informed accordingly.

6.  The information to the Commission and the other Member States pursuant to paragraph 5 of this Article shall be communicated through the information and communication system referred to in Article 34. That communication of information shall also be deemed to fulfil notification requirements for the applicable safeguard procedures of Union harmonisation legislation.

7.  Where a national measure is considered to be justified in accordance with the applicable safeguard procedure, or where no market surveillance authority of another Member State concluded the contrary as referred to in Article 11(9), the competent market surveillance authorities in the other Member States shall take the necessary measures in respect of the non-compliant product and shall enter the relevant information in the information and communication system referred to in Article 34.

Article 17

Use of information, professional and commercial secrecy

Market surveillance authorities shall perform their activities with a high level of transparency and shall make available to the public any information that they consider to be relevant in order to protect the interests of end users. Market surveillance authorities shall respect the principles of confidentiality and of professional and commercial secrecy and shall protect personal data in accordance with Union and national law ▌.

Article 18

Procedural rights of economic operators

1.  Any measure, decision or order taken or made by market surveillance authorities pursuant to Union harmonisation legislation or this Regulation ▌shall state the exact grounds on which it is based.

2.  Any such measure, decision or order shall be communicated without delay to the relevant economic operator, who shall at the same time be informed of the remedies available to it under the law of the Member State concerned and of the time limits to which those remedies are subject.

3.  Before a measure, decision or order referred to in paragraph 1 is taken or made, the economic operator concerned shall be given the opportunity to be heard within an appropriate period of not less than 10 working days, unless it is not possible to give the economic operator that opportunity because of the urgency of the measure, decision or order, based on health or safety requirements or other grounds relating to the public interests covered by the relevant Union harmonisation legislation.

If the measure, decision or order is taken or made without the economic operator being given the opportunity to be heard, the economic operator shall be given that opportunity as soon as possible thereafter and that measure, decision or order shall be reviewed promptly by the market surveillance authority.

Article 19

Products presenting a serious risk

1.  Market surveillance authorities shall ensure that products presenting a serious risk are withdrawn or recalled, where there is no other effective means available to eliminate the serious risk, or that their being made available on the market is prohibited. Market surveillance authorities shall notify the Commission thereof immediately, in accordance with Article 20.

2.  A decision whether or not a product presents a serious risk shall be based on an appropriate risk assessment that takes account of the nature of the hazard and the likelihood of its occurrence. The feasibility of obtaining higher levels of safety and the availability of other products presenting a lesser degree of risk shall not constitute grounds for considering that a product presents a serious risk.

Article 20

Rapid Information Exchange System

1.  Where a market surveillance authority takes or intends to take a measure pursuant to Article 19 and considers that the reasons which prompted the measure or the effects of the measure go beyond the territory of its Member State, it shall immediately notify the Commission of that measure in accordance with paragraph 4 of this Article. The market surveillance authority shall also inform the Commission without delay of the modification or withdrawal of any such measure.

2.  If a product presenting a serious risk has been made available on the market, market surveillance authorities shall immediately notify the Commission of any voluntary measures taken and communicated to the market surveillance authority by an economic operator.

3.  The information provided in accordance with paragraphs 1 and 2 shall include all available details, in particular the data necessary for the identification of the product, the origin and the supply chain of the product, the risk related to the product, the nature and the duration of the national measure taken and any voluntary measures taken by economic operators.

4.  For the purposes of paragraphs 1, 2 and 3 of this Article, the Rapid Information Exchange System (RAPEX) provided for in Article 12 of Directive 2001/95/EC shall be used. Paragraphs 2, 3 and 4 of Article 12 of that Directive shall apply mutatis mutandis.

5.  The Commission shall provide and maintain a data interface between RAPEX and the information and communication system referred to in Article 34 so as to avoid double data entry.

Article 21

Union testing facilities

1.  The objective of the Union testing facilities is to contribute to enhancing laboratory capacity, as well as to ensuring the reliability and consistency of testing, for the purposes of market surveillance within the Union.

2.  For the purposes of paragraph 1, the Commission may designate a public testing facility of a Member State as a Union testing facility for specific categories of products or for specific risks related to a category of products.

The Commission may also designate one of its own testing facilities as a Union testing facility for specific categories of products or for specific risks related to a category of products, or for products for which testing capacity is missing or is not sufficient.

3.   Union testing facilities shall be accredited in accordance with Regulation (EC) No 765/2008.

4.  The designation of Union testing facilities shall not affect the freedom of market surveillance authorities, the Network and the Commission to choose testing facilities for the purpose of their activities.

5.  Designated Union testing facilities shall provide their services solely to market surveillance authorities, the Network, the Commission and other government or intergovernmental entities.

6.  Union testing facilities shall, within the area of their competence, perform the following activities:

(a)  carry out testing of products at the request of market surveillance authorities, the Network or the Commission;

(b)  provide independent technical or scientific advice at the request of the Network;

(c)  develop new techniques and methods of analysis.

7.  The activities referred to in paragraph 6 of this Article shall be remunerated and may be financed by the Union in accordance with Article 36(2).

8.  Union testing facilities may receive financing by the Union in accordance with Article 36(2) in order to increase their testing capacity or to create new testing capacity for specific categories of products or for specific risks related to a category of products for which the testing capacity is missing or is insufficient.

9.  The Commission shall adopt implementing acts specifying the procedures for the designation of Union testing facilities. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 43(2).

Chapter VI

Cross-border mutual assistance

Article 22

Mutual Assistance

1.  There shall be efficient cooperation and exchange of information among the market surveillance authorities of the Member States, and between market surveillance authorities and the Commission and the relevant Union agencies.

2.  When a market surveillance authority is unable to conclude its investigation because of its inability to access certain information, despite having made all appropriate efforts to obtain that information, it may submit a reasoned request to the market surveillance authority of another Member State where access to this information can be enforced. In this case the requested authority shall supply to the applicant authority without delay, and in any event within 30 days, any information that the requested authority considers to be relevant in order to establish whether a product is non-compliant.

3.  The requested authority shall undertake appropriate investigations or take any other measures that are appropriate in order to gather the requested information. Where necessary, those investigations shall be carried out with the assistance of other market surveillance authorities.

4.  The applicant authority shall remain responsible for any investigation that it has initiated, unless the requested authority agrees to take over responsibility.

5.  In duly justified cases, a requested authority may refuse to comply with a request for information under paragraph 2 where:

(a)  the applicant authority has not sufficiently substantiated that the requested information is necessary in order to establish non-compliance;

(b)  the requested authority demonstrates reasonable grounds showing that complying with the request would substantially impair the execution of its own activities.

Article 23

Requests for enforcement measures

1.  Where bringing non-compliance with regard to a product to an end requires measures within the jurisdiction of another Member State and where such measures do not result from the requirements of Article 16(7), an applicant authority may submit a duly reasoned request for enforcement measures to a requested authority in that other Member State.

2.  The requested authority shall without delay take all appropriate and necessary enforcement measures using the powers conferred on it under this Regulation in order to bring the instance of non-compliance to an end by exercising the powers laid down in Article 14 and any additional powers granted to it under national law.

3.  The requested authority shall ▌inform ▌the applicant authority about the measures referred to in paragraph 2 that have been taken or which are intended to be taken.

A requested authority may refuse to comply with a request for enforcement measures in any of the following situations:

(a)  the requested authority concludes that the applicant authority has not provided sufficient information;

(b)  the requested authority considers that the request is contrary to Union harmonisation legislation;

(c)  the requested authority demonstrates reasonable grounds showing that complying with the request would substantially impair the execution of its own activities.

Article 24

Procedure for mutual assistance requests

1.  Before submitting a request under Article 22 or 23, the applicant authority shall endeavour to carry out all reasonable possible investigations.

2.  When submitting a request under Article 22 or 23, the applicant authority shall provide all available information in order to enable the requested authority to fulfil the request, including any necessary evidence obtainable only in the Member State of the applicant authority.

3.  Requests ▌under Articles 22 and 23 and all communication related to them shall be made using electronic standard forms by means of the information and communication system referred to in Article 34.

4.  Communication shall take place directly between the involved market surveillance authorities or through the single liaison offices of the Member States concerned.

5.  The languages to be used for requests ▌under Articles 22 and 23 and for all communication linked to them shall be agreed upon by the market surveillance authorities concerned.

6.  Where no agreement about the languages to be used can be reached between the market surveillance authorities concerned, the requests ▌under Articles 22 and 23 shall be sent in the official language of the Member State of the applicant authority, and the replies to such requests shall be sent in the official language of the Member State of the requested authority. In such case, the applicant authority and the requested authority shall arrange for the translation of the requests, replies or other documents that it receives from the other authority.

7.  The information and communication system referred to in Article 34 shall provide structured information on mutual assistance cases to the single liaison offices involved. Using this information, single liaison offices shall provide any support that is necessary to facilitate assistance.

Chapter VII

Products entering the Union market

Article 25

Controls on products entering the Union market

1.  Member States shall designate customs authorities, one or more market surveillance authorities or any other authority in their territory as the authorities in charge of the control on products entering the Union market.

Each Member State shall inform the Commission and the other Member States of the authorities designated under the first subparagraph and of their areas of competence through the information and communication system referred to in Article 34.

2.  The authorities designated under paragraph 1 shall have the necessary powers and resources for the proper performance of their tasks as referred to in that paragraph.

3.  Products subject to Union ▌law that are to be placed under the customs procedure ‘release for free circulation’ shall be subject to controls performed by the authorities designated under paragraph 1 of this Article. They shall perform those controls on the basis of risk analysis in accordance with Articles 46 and 47 of Regulation (EU) No 952/2013 and, where relevant, on the basis of risk-based approach as referred to in the second subparagraph of Article 11(3) of this Regulation.

4.  Risk-related information shall be exchanged between:

(a)  the authorities designated under paragraph 1 of this Article in accordance with Article 47(2) of Regulation (EU) No 952/2013; and

(b)  customs authorities in accordance with Article 46(5) of Regulation (EU) No 952/2013.

Where, in relation to products subject to Union ▌law that are either in temporary storage or placed under a customs procedure other than ‘release for free circulation’, customs authorities at the first point of entry have reason to believe that those products are not compliant with applicable Union law or present a risk, they shall transmit all relevant information to the competent customs office of destination.

5.  Market surveillance authorities shall provide authorities designated under paragraph 1 with information on categories of products or the identity of economic operators where a higher risk of non-compliance has been identified.

6.  By 31 March of each year, Member States shall submit to the Commission detailed statistical data covering controls performed by the authorities designated under paragraph 1 with respect to products subject to Union law during the previous calendar year. The statistical data shall cover the number of interventions in the field of controls on such products with regard to product safety and compliance.

The Commission shall draw up a report by 30 June of each year, containing the information provided by the Member States for the previous calendar year and an analysis of the data submitted. The report shall be published in the information and communication system referred to in Article 34.

7.  Where the Commission becomes aware of a serious risk presented ▌by products subject to Union ▌law that are imported from a third country, it shall recommend to the Member State concerned to take appropriate market surveillance measures.

8.  The Commission, after consulting the Network, may adopt implementing acts laying down benchmarks and techniques for checks on the basis of common risk analysis on the Union level, in order to ensure a consistent enforcement of Union law, to strengthen the controls on products entering the Union market and to ensure an effective and uniform level of such controls. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 43(2).

9.  The Commission shall adopt implementing acts further specifying the details of the data to be submitted ▌under paragraph 6 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 43(2).

Article 26

Suspension of release for free circulation

1.  Authorities designated under Article 25(1) shall suspend the release of a product for free circulation if in the course of controls pursuant to Article 25(3), it is established that:

(a)  the product is not accompanied by the documentation required by the Union ▌law applicable to it or there is a reasonable doubt as to the authenticity, accuracy or completeness of such documentation;

(b)  the product is not marked or labelled in accordance with the Union ▌law applicable to it;

(c)  the product bears a CE marking or other marking required by the Union ▌law applicable to it which has been affixed in a false or misleading manner;

(d)  the name, registered trade name or registered trade mark and the contact details, including the postal address, of an economic operator with tasks regarding the product subject to certain Union harmonisation legislation is not indicated or identifiable in accordance with Article 4(4); or

(e)  for any other reason, when there is cause to believe that the product does not comply with the Union law applicable to it ▌or that it presents a serious risk to health, safety, the environment or any other public interest referred to in Article 1.

2.  Authorities designated under Article 25(1) shall immediately notify the market surveillance authorities of any suspension of release referred to in paragraph 1 of this Article.

3.  Where the market surveillance authorities have reasonable grounds to believe that a product does not comply with the Union law applicable to it or presents a serious risk, they shall request the authorities designated under Article 25(1) to suspend the process for its release for free circulation.

4.  Notifications under paragraph 2 and requests under paragraph 3 of this Article may take place by means of the information and communication system referred to in Article 34, including through the use of electronic interfaces between this system and systems used by customs authorities, when they are available.

Article 27

Release for free circulation

Where the release of a product for free circulation ▌has been suspended in accordance with Article 26, that product shall be released for free circulation where all the other requirements and formalities relating to such a release have been fulfilled and where either of the following conditions is satisfied:

(a)  within four working days of the suspension, the authorities designated under Article 25(1) have not been requested by the market surveillance authorities to maintain the suspension;

(b)  the authorities designated under Article 25(1) have been informed by the market surveillance authorities of its approval for release for free circulation.

The release for free circulation shall not be deemed to be proof of conformity with Union law.

Article 28

Refusal to release for free circulation

1.  Where the market surveillance authorities conclude that a product presents a serious risk, they shall take measures to prohibit the placing of the product on the market and shall require the authorities designated under Article 25(1) not to release it for free circulation. They shall also require these authorities to include the following notice in the customs data-processing system, and, where appropriate, on the commercial invoice accompanying the product and on any other relevant accompanying document ▌:"

‘Dangerous product – release for free circulation not authorised – Regulation (EU) 2019/... (55)’.

"

Market surveillance authorities shall immediately enter that information in the information and communication system referred to in Article 34.

2.  Where market surveillance authorities conclude that a product may not be placed on the market since it does not comply with the Union ▌law applicable to it, they shall take measures to prohibit the placing of the product on the market and shall require the authorities designated under Article 25(1) not to release it for free circulation. They shall also require those authorities to include the following notice in the customs data-processing system, and, where appropriate, on the commercial invoice accompanying the product and on any other relevant accompanying document ▌:"

‘Product not in conformity – release for free circulation not authorised – Regulation (EU) 2019/... (56) .’

"

Market surveillance authorities shall immediately enter that information in the information and communication system referred to in Article 34.

3.  Where the product referred to in paragraph 1 or 2 is subsequently declared for a customs procedure other than release for free circulation and provided that the market surveillance authorities do not object, the notice required by paragraph 1 or 2 shall also be included, under the same conditions as required by paragraph 1 or 2, in the documents used in connection with that procedure.

4.  Authorities designated under Article 25(1) may destroy or otherwise render inoperable a product which presents a risk to the health and safety of end users where the authority in question considers that it is necessary and proportionate to do so. The cost of such measure shall be borne by the natural or legal person declaring the product for free circulation.

Articles 197 and 198 ▌of Regulation (EU) No 952/2013 shall apply accordingly.

Chapter VIII

Coordinated enforcement and international cooperation

Article 29

Union Product Compliance Network

1.   A Union Product Compliance Network (‘the Network’) is hereby established.

2.  The purpose of the Network is to serve as a platform for structured coordination and cooperation between enforcement authorities of the Member States and the Commission, and to streamline the practices of market surveillance within the Union, thereby making market surveillance more effective.

Article 30

Composition and functioning of the ▌Network

1.  The Network shall be composed of representatives from each Member State, including a representative of each single liaison office referred to in Article 10 and an optional national expert, the chairs of ADCOs, and representatives from the Commission.

2.  Separate or joint ADCOs shall be established for the uniform application of Union harmonisation legislation. ADCOs shall be composed of representatives of the national market surveillance authorities and, if appropriate, representatives of the single liaison offices.

ADCOs meetings are intended only for representatives of market surveillance authorities and the Commission.

Relevant stakeholders, such as organisations representing the interests at Union level of industry, small and medium-sized enterprises (SMEs), consumers, testing laboratories, standardisation and conformity assessment bodies, may be invited to attend the ADCOs meetings depending on the subject matter of discussion.

3.  The Commission shall support and encourage cooperation between market surveillance authorities through the Network and participate in the meetings of the Network, its sub-groups and the ADCOs.

4.  The Network shall meet at regular intervals and, where necessary, at the reasoned request of the Commission or a Member State.

5.  The Network may establish standing or temporary sub-groups dealing with specific questions and tasks.

6.  The Network may invite experts and other third parties, including the organisations representing the interests of industry, SMEs, consumers, testing laboratories, standardisation and conformity assessment bodies at Union level, to attend meetings as observers or to provide written contributions.

7.  The Network shall use its best endeavours to reach consensus. Decisions taken by the Network shall be legally non-binding recommendations.

8.  The Network shall establish its own rules of procedure.

Article 31

Role and tasks of the Network

1.  In carrying out the tasks set out in paragraph 2, the Network shall address general, horizontal issues of market surveillance with a view to facilitating the cooperation among single liaison offices, as well as the Commission.

2.  The Network shall have the following tasks:

(a)  to prepare, adopt and monitor the implementation of its work programme;

(b)  to facilitate the identification of common priorities for market surveillance activities and the exchange of information across sectors on evaluations of products, including risk assessment, test methods and results, recent scientific developments and new technologies, emerging risks and other aspects relevant to control activities and on the implementation of national market surveillance strategies and activities;

(c)  to coordinate ADCOs and their activities;

(d)  to organise cross-sector joint market surveillance and testing projects and define their priorities;

(e)  to exchange expertise and best practices, in particular regarding the implementation of national market surveillance strategies;

(f)  to facilitate the organisation of training programmes and exchanges of personnel;

(g)  in collaboration with the Commission, to organise information campaigns and voluntary mutual visit programmes between market surveillance authorities;

(h)  to discuss questions arising from cross-border mutual assistance mechanisms;

(i)  to contribute to the development of guidance to ensure the effective and uniform application of this Regulation;

(j)  to propose the financing of activities referred to in Article 36;

(k)  to contribute to uniform administrative practices with regard to market surveillance in the Member States;

(l)  to provide advice and assist the Commission with issues related to the further development of RAPEX and the information and communication system referred to in Article 34;

(m)  to promote the cooperation and exchange of expertise and best practices between market surveillance authorities and authorities in charge of controls at the Union’s external borders;

(n)  to promote and facilitate collaboration with other relevant networks and groups, with a view to explore possibilities for using new technologies for the purposes of market surveillance and traceability of products;

(o)  to evaluate regularly the national market surveillance strategies, the first such evaluation taking place by ... [5 years after entry into force of this Regulation];

(p)  to take up any other issues in activities within the remit of the Network, with the aim of contributing to the effective functioning of market surveillance within the Union.

Article 32

Role and tasks of administrative cooperation groups

1.  In carrying out the tasks set out in paragraph 2, ADCOs shall address specific matters related to market surveillance and sector specific issues.

2.  ADCOs shall have the following tasks:

(a)  to facilitate the uniform application of Union harmonisation legislation within their area of competence with a view to increasing the efficiency of market surveillance throughout the internal market;

(b)  to promote communication between market surveillance authorities and the Network and develop mutual confidence between market surveillance authorities;

(c)  to establish and coordinate common projects, such as cross-border joint market surveillance activities;

(d)  to develop common practices and methodologies for effective market surveillance;

(e)  to inform each other of national market surveillance methods and activities and to develop and promote best practices;

(f)  to identify issues of shared interest relating to market surveillance and suggest common approaches to be adopted;

(g)  to facilitate sector-specific evaluations of products, including risk assessments, test methods and results, recent scientific developments and other aspects relevant to control activities.

Article 33

Role and tasks of the Commission

1.  The Commission shall have the following tasks:

(a)  to assist the Network, its sub-groups, and the ADCOs by means of an executive secretariat that provides technical and logistic support;

(b)  to keep and make available to the single liaison offices and ADCO chairs an updated list of ADCO chairs, including their contact information;

(c)  to assist the Network in preparing and monitoring its work programme;

(d)  to support the functioning of the Product Contact Points having duties assigned by Member States in relation to Union harmonisation legislation;

(e)  to determine, in consultation with the Network, the need for additional testing capacity and to propose solutions for that purpose, in accordance with Article 21;

(f)  to apply the instruments of international cooperation referred to in Article 35;

(g)  to provide support for the establishment of separate or joint ADCOs;

(h)  to develop and maintain the information and communication system referred to in Article 34, including the interface ▌referred to in Article 34(7), as well as the interface with national market surveillance databases, and provide information to the public by means of that system;

(i)  to assist the Network to perform preliminary or ancillary work in connection with the implementation of market surveillance activities linked to the application of Union harmonisation legislation, such as studies, programmes, evaluations, ▌comparative analyses, mutual joint visits and visit programmes, exchange of personnel, research work, ▌laboratory work, proficiency testing, inter-laboratory tests and conformity assessment work ▌;

(j)  to prepare and assist in the implementation of Union market surveillance campaigns and similar activities;

(k)  to organise joint market surveillance and testing projects, and common training programmes, to facilitate exchanges of personnel between market surveillance authorities and, where appropriate, with the market surveillance authorities of third countries or with international organisations, and to organise information campaigns and voluntary mutual visit programmes between market surveillance authorities;

(l)  to carry out activities under programmes of technical assistance, cooperation with third countries and the promotion and enhancement of Union market surveillance policies and systems among interested parties at Union and international level;

(m)  to facilitate technical or scientific expertise for the purpose of implementing market surveillance administrative cooperation;

(n)  to examine, ▌at the request of the Network or on its own initiative, any question covering the application of this Regulation and issue guidelines, recommendations and best practices in order to encourage consistent application of this Regulation ▌.

Article 34

Information and communication system

1.  The Commission shall further develop and maintain an information and communication system for the collection, processing and storage of information, in a structured form, on issues relating to the enforcement of Union harmonisation legislation, with the aim of improving the sharing of data among Member States, including for the purpose of requests for information, providing a comprehensive overview of market surveillance activities, results and trends. The Commission, market surveillance authorities, single liaison offices, and authorities designated under Article 25(1) shall have access to that system. The Commission shall develop and maintain the public user interface of this system, where key information for end-users about market surveillance activities shall be provided.

2.  The Commission shall further develop and maintain electronic interfaces between the system referred to in paragraph 1 and national market surveillance systems.

3.  Single liaison offices shall enter the following information in the information and communication system:

(a)  the identity of the market surveillance authorities in their Member State and areas of competence of those authorities pursuant to Article 10(2);

(b)  the identity of the authorities designated under Article 25(1) ;

(c)  the national market surveillance strategy drawn up by their Member State under Article 13 and the results from the review and assessment of the market surveillance strategy.

4.  Market surveillance authorities shall enter into the information and communication system ▌in relation to products made available on the market for which an in-depth check of compliance has been carried out, without prejudice to Article 12 of Directive 2001/95/EC and Article 20 of this Regulation, and where applicable, in relation to products entering the Union market for which the process for the release for free circulation has been suspended in accordance with Article 26 of this Regulation, in their territory, the following information concerning:

(a)  measures according to Article 16(5) taken by that market surveillance authority;

(b)  reports of testing carried out by them;

(c)  corrective action taken by economic operators concerned;

(d)  readily available reports on injuries caused by the product in question;

(e)  any objection raised by a Member State in accordance with the applicable safeguard procedure in the Union harmonisation legislation applicable to the product and any subsequent follow-up;

(f)  where available, failures by authorised representatives to comply with Article 5(2);

(g)  where available, failures by manufacturers to comply with Article 5(1).

5.  Where market surveillance authorities consider it useful, they may enter into the information and communication system any additional information related to the checks they perform and results of testing carried out by them or at their request.

6.  Where relevant for the enforcement of Union harmonisation legislation and for the purpose of minimising risk ▌, customs authorities shall extract from national customs systems ▌information ▌on products placed under the customs procedure ‘release for free circulation’ ▌related to the enforcement of Union harmonisation legislation and transmit it to the information and communication system.

7.  The Commission shall develop an electronic interface to enable the transmission of data between national customs systems and the information and communication system. This interface shall be in place within four years from the date of adoption of the relevant implementing act referred to in paragraph 8.

8.  The Commission shall adopt implementing acts specifying the details of implementation arrangements for paragraphs 1 to 7 of this Article, and in particular the data processing to be applied on data collected in accordance with paragraph 1 of this Article, and defining the data to be transmitted in accordance with paragraphs 6 and 7 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 43(2).

Article 35

International cooperation

1.  In order to improve the efficiency of market surveillance in the Union, the Commission may cooperate with and exchange ▌market surveillance related information with regulatory authorities of third countries or international organisations within the framework of agreements concluded between the Union and third countries or international organisations. Any such agreements shall be based on reciprocity, include provisions on confidentiality corresponding to those applicable in the Union, and ensure that any exchange of information is in accordance with applicable Union law.

2.  ▌The cooperation or exchange of information may relate, inter alia, to the following:

(a)  risk assessment methods used and the results of product-testing;

(b)  coordinated product recalls or other similar actions;

(c)  the measures taken by market surveillance authorities under Article 16.

3.  The Commission may approve a specific system of product-related pre-export control carried out by a third country on products immediately prior to their export into the Union in order to verify that those products satisfy the requirements of the Union harmonisation legislation applicable to them. The approval may be granted in respect of one or more products, in respect of one or more categories of products or in respect of products or categories of products manufactured by certain manufacturers.

4.  The Commission shall produce and maintain a list of those products or categories of products with regard to which approval has been granted as referred to in paragraph 3 and shall make this list available to the public.

5.  Approval may only be granted to a third country under paragraph 3 if following conditions are satisfied:

(a)  the third country possesses an efficient verification system of the compliance of products exported to the Union, and the controls carried out in that third country are sufficiently effective and efficient to replace or reduce import controls;

(b)  audits within the Union and, if relevant, in the third country demonstrate that products exported from that third country to the Union satisfy the requirements set out in Union harmonisation legislation.

6.  Where such an approval has been granted, the risk assessment applied to import controls for those products or categories of products entering the Union market, referred to in paragraph 3, shall include the granted approvals.

▌Authorities designated under Article 25(1) may however carry out controls on those products or categories of products entering the Union market, including in order to ensure that the pre-export controls carried out by the third country are effective to determine compliance with Union harmonisation legislation.

7.  The approval referred to in paragraph 3 shall specify the competent authority of the third country under whose responsibility the pre-export controls are to be performed and that competent authority shall be the counterpart for all contacts with the Union.

8.  The competent authority, referred to in paragraph 7, shall ensure the official verification of the products prior to their entry into the Union.

9.  Where controls on products entering the Union market referred to in paragraph 3 of this Article reveal significant non-compliance, the market surveillance authorities shall notify immediately the Commission through the information and communication system referred to in Article 34 and adapt the level of controls on such products.

10.  The Commission shall adopt implementing acts approving each specific system of product-related pre-export controls, referred to in paragraph 3 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 43(2).

11.  The Commission shall regularly monitor the correct functioning of the approval granted under paragraph 3 of this Article. The Commission shall adopt implementing acts withdrawing that approval where it is revealed that the products entering the Union market do not comply with Union harmonisation legislation in a significant number of instances. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 43(2). The Commission shall immediately inform the third country concerned thereof.

12.  The system of product-related pre-export control shall be evaluated in accordance with Article 42(4).

Chapter IX

Financial provisions

Article 36

Financing activities

1.  The Union shall finance performance of the tasks of the Network referred to in Article 31 and the peer reviews referred to in Article 12.

2.  The Union may finance the following activities in relation to the application of this Regulation:

(a)  the functioning of the Product Contact Points ▌;

(b)  the establishment and functioning of Union testing facilities referred to in Article 21;

(c)  the development of instruments of international cooperation referred to in Article 35;

(d)  the drawing up and updating of contributions to guidelines on market surveillance;

(e)  the making available to the Commission of technical or scientific expertise for the purpose of assisting the Commission in its implementation of market surveillance administrative cooperation;

(f)  the implementation of national market surveillance strategies referred to in Article 13;

(g)   Member States' and Union market surveillance campaigns and associated activities, including resources and equipment, IT tools and training;

(h)  the performance of preliminary or ancillary work in connection with market surveillance activities related to the application of Union harmonisation legislation, such as studies, programmes, evaluations, guidelines, comparative analyses, mutual joint visits and visit programmes, exchange of personnel, research work, training activities, laboratory work, proficiency testing, inter-laboratory tests and conformity assessment work;

(i)  activities carried out under programmes providing technical assistance, cooperation with third countries and the promotion and enhancement of Union market surveillance policies and systems amongst interested parties at Union and international level.

3.  The Union shall finance the electronic interface referred to in Article 34(7), including the development of the information and communication system referred to in Article 34 to enable it to receive automatic flows of electronic data from the national customs systems. ▌

4.  The Union shall finance the electronic interfaces referred to in Article 34(2) enabling the exchange of data between the information and communication system referred to in Article 34 and the national market surveillance systems.

5.  The Union's financial assistance with respect to the activities in support of this Regulation shall be implemented in accordance with Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council(57), either directly, or by entrusting budget implementation tasks to the entities listed in point (c) of Article 62(1) of that Regulation.

6.  The appropriations allocated to activities referred to in this Regulation shall be determined each year by the budgetary authority within the limits of the financial framework in force.

7.  The appropriations determined by the budgetary authority for the financing of market surveillance activities may also cover expenses relating to preparatory work, monitoring, control, audit and evaluation activities which are required for the management of the activities set out in this Regulation and for the achievement of their objectives. These expenses shall include the costs of conducting studies, arranging meetings of experts, information and communication activities, including corporate communication of the political priorities of the Union in so far as they are related to the general objectives of market surveillance activities, expenses linked to information technology networks focusing on information processing and exchange together with all other related technical and administrative assistance expenses incurred by the Commission.

Article 37

Protection of the financial interests of the Union

1.  The Commission shall take appropriate measures to ensure that, when activities financed under this Regulation are implemented, the financial interests of the Union are protected by the application of preventive measures against fraud, corruption and any other illegal activities, by effective controls and, if irregularities are detected, by the recovery of the amounts wrongly paid and, where appropriate, by effective, proportionate and dissuasive administrative and financial penalties.

2.  The Commission or its representatives and the Court of Auditors shall have the power of audit, on the basis of documents and of on-the-spot inspections, over all grant beneficiaries, contractors and subcontractors who have received Union funds under this Regulation.

3.  The European Anti-Fraud Office (OLAF) may carry out investigations, including on-the-spot controls and inspections, in accordance with the provisions and procedures laid down in Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council(58) and Council Regulation (Euratom, EC) No 2185/96(59) with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union in connection with a grant agreement or grant decision or a contract funded under this Regulation.

4.  Without prejudice to paragraphs 1, 2 and 3, cooperation agreements with third countries and with international organisations, contracts, grant agreements and grant decisions resulting from the implementation of this Regulation shall contain provisions expressly empowering the Commission, the Court of Auditors and OLAF to conduct such audits and investigations, in accordance with their respective competences.

Chapter X

Amendments

Article 38

Amendments to Directive 2004/42/EC

Articles 6 and 7 of Directive 2004/42/EC of the European Parliament and of the Council(60) are deleted.

Article 39

Amendments to Regulation (EC) No 765/2008

1.  Regulation (EC) No 765/2008 is amended as follows:

(1)  the title is replaced by the following: "

“Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and repealing Regulation (EEC) No 339/93”;

"

(2)  in Article 1, paragraphs 2 and 3 are deleted;

(3)  in Article 2, points 1, 2, 14, 15, 17, 18 and 19 are deleted;

(4)  Chapter III, containing Articles 15 to 29, is deleted;

(5)  paragraph 1 of Article 32 is amended as follows:

(a)  point (c) is replaced by the following:"

“(c) the drawing up and updating of contributions to guidelines in the fields of accreditation, notification to the Commission of conformity assessment bodies and conformity assessment;”;

"

(b)  points (d) and (e) are deleted;

(c)  points (f) and (g) are replaced by the following:"

“(f) the performance of preliminary or ancillary work in connection with the implementation of the conformity assessment, metrology and accreditation activities linked to the implementation of Community legislation, such as studies, programmes, evaluations, guidelines, comparative analyses, mutual joint visits, research work, the development and maintenance of databases, training activities, laboratory work, proficiency testing, inter-laboratory tests and conformity assessment work;

   (g) activities carried out under programmes of technical assistance, cooperation with third countries and the promotion and enhancement of European conformity assessment and accreditation policies and systems among interested parties in the Community and at international level.”.

"

2.  References to the deleted provisions of Regulation (EC) No 765/2008 shall be construed as references to the provisions of this Regulation and shall be read in accordance with the correlation table in Annex III to this Regulation.

Article 40

Amendments to Regulation (EU) No 305/2011

In Article 56(1) of Regulation (EU) No 305/2011, the first subparagraph is replaced by the following:"

“1. Where the market surveillance authorities of one Member State have sufficient reason to believe that a construction product covered by a harmonised standard or for which a European Technical Assessment has been issued does not achieve the declared performance and presents a risk for the fulfilment of the basic requirements for construction works covered by this Regulation, they shall carry out an evaluation in relation to the product concerned covering the respective requirements laid down by this Regulation. The relevant economic operators shall cooperate as necessary with the market surveillance authorities.”.

"

Chapter XI

Final provisions

Article 41

Penalties

1.  The Member States shall lay down the rules on penalties applicable to infringements of this Regulation and of Union harmonisation legislation listed in Annex II that impose obligations on economic operators ▌and shall take all measures necessary to ensure that they are implemented in accordance with national law.

2.  The penalties provided for shall be effective, proportionate and dissuasive.

3.   The Member States shall, by ... [27 months after the date of entry into force of this Regulation], notify those provisions to the Commission, where they have not previously been notified, and shall notify it, without delay, of any subsequent amendment affecting them.

Article 42

Evaluation, review and guidelines

1.   By 31 December 2026 and every five years thereafter, the Commission shall ▌carry out an evaluation of this Regulation in light of the objectives that it pursues and shall present a report thereon to the European Parliament, to the Council and to the European Economic and Social Committee.

2.  The report shall assess whether this Regulation achieved its objective, in particular with regard to reducing the number of non-compliant products on the Union market, ensuring effective and efficient enforcement of Union harmonisation legislation within the Union, improving cooperation between competent authorities and strengthening the controls on products entering the Union market, while taking into account the impact on business and in particular on SMEs. In addition, the evaluation shall also assess the scope of this Regulation, the effectiveness of the peer review system and of the market surveillance activities that receive Union financing in the light of the requirements of Union policies and law and the possibilities to further improve the cooperation between the market surveillance authorities and customs authorities.

3.  By ... [four years after the date of entry into force of this Regulation], the Commission shall prepare an evaluation report on the implementation of Article 4. The report shall in particular evaluate the scope of that Article, its effects and its costs and benefits. The report shall be accompanied, where appropriate, by a legislative proposal.

4.  Within four years after the first approval of a specific system of product-related pre-export control referred to in Article 35(3), the Commission shall carry out an evaluation of its effects and cost efficiency.

5.  In order to facilitate the implementation of this Regulation, the Commission shall draw up guidelines for the practical implementation of Article 4 for the purposes of market surveillance authorities and economic operators.

Article 43

Committee procedure

1.  The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

2.  Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act in respect of the implementing powers referred to in Article 11(4), Article 21(9), Article 25(8), Article 35(10) and Article 35(11) of this Regulation, and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply.

Article 44

Entry into force and application

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from ... [two years after the date of entry into force of this Regulation]. However, Articles 29, 30, 31, 32, 33 and 36 shall apply from 1 January 2021.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at ...,

For the European Parliament For the Council

The President The President

ANNEX I

List of Union harmonisation legislation

1.  Council Directive 69/493/EEC of 15 December 1969 on the approximation of the laws of the Member States relating to crystal glass (OJ L 326, 29.12.1969, p. 36);

2.  Council Directive 70/157/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the permissible sound level and the exhaust system of motor vehicles (OJ L 42, 23.2.1970, p. 16);

3.  Council Directive 75/107/EEC of 19 December 1974 on the approximation of the laws of the Member States relating to bottles used as measuring containers (OJ L 42, 15.2.1975, p. 14);

4.  Council Directive 75/324/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to aerosol dispensers (OJ L 147, 9.6.1975, p. 40);

5.  Council Directive 76/211/EEC of 20 January 1976 on the approximation of the laws of the Member States relating to the making-up by weight or by volume of certain pre-packaged products (OJ L 46, 21.2.1976, p. 1);

6.  Council Directive 80/181/EEC of 20 December 1979 on the approximation of the laws of the Member States relating to units of measurement and on the repeal of Directive 71/354/EEC (OJ L 39, 15.2.1980, p. 40);

7.  Council Directive 92/42/EEC of 21 May 1992 on efficiency requirements for new hot-water boilers fired with liquid or gaseous fuels (OJ L 167, 22.6.1992, p. 17);

8.  Directive 94/11/EC of the European Parliament and of the Council of 23 March 1994 on the approximation of the laws, regulations and administrative provisions of the Member States relating to labelling of the materials used in the main components of footwear for sale to the consumer (OJ L 100, 19.4.1994, p. 37);

9.  European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste (OJ L 365, 31.12.1994, p. 10);

10.  Directive 98/70/EC of the European Parliament and of the Council of 13 October 1998 relating to the quality of petrol and diesel fuels and amending Council Directive 93/12/EEC (OJ L 350, 28.12.1998, p. 58);

11.  Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331, 7.12.1998, p. 1);12. Directive 2000/14/EC of the European Parliament and of the Council of 8 May 2000 on the approximation of the laws of the Member States relating to the noise emission in the environment by equipment for use outdoors (OJ L 162, 3.7.2000, p. 1);

13.  Directive 2000/53/EC of the European Parliament and of the Council of 18 September 2000 on end-of-life vehicles (OJ L 269, 21.10.2000, p. 34);

14.  Regulation (EC) No 2003/2003 of the European Parliament and of the Council of 13 October 2003 relating to fertilisers (OJ L 304, 21.11.2003, p. 1);

15.  Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents (OJ L 104, 8.4.2004, p. 1);

16.  Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants and amending Directive 79/117/EEC (OJ L 158, 30.4.2004, p. 7);

17.  Directive 2004/42/CE of the European Parliament and of the Council of 21 April 2004 on the limitation of emissions of volatile organic compounds due to the use of organic solvents in certain paints and varnishes and vehicle refinishing products and amending Directive 1999/13/EC (OJ L 143, 30.4.2004, p. 87);

18.  Directive 2005/64/EC of the European Parliament and of the Council of 26 October 2005 on the type-approval of motor vehicles with regard to their reusability, recyclability and recoverability and amending Council Directive 70/156/EEC (OJ L 310, 25.11.2005, p. 10);

19.  Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (OJ L 157, 9.6.2006, p. 24);

20.  Directive 2006/40/EC of the European Parliament and of the Council of 17 May 2006 relating to emissions from air conditioning systems in motor vehicles and amending Council Directive 70/156/EEC (OJ L 161, 14.6.2006, p. 12);

21.  Directive 2006/66/EC of the European Parliament and of the Council of 6 September 2006 on batteries and accumulators and waste batteries and accumulators and repealing Directive 91/157/EEC (OJ L 266, 26.9.2006, p. 1);

22.  Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1);

23.  Regulation (EC) No 715/2007 of the European Parliament and of the Council of 20 June 2007 on type approval of motor vehicles with respect to emissions from light passenger and commercial vehicles (Euro 5 and Euro 6) and on access to vehicle repair and maintenance information (OJ L 171, 29.6.2007, p. 1);

24.  Directive 2007/45/EC of the European Parliament and of the Council of 5 September 2007 laying down rules on nominal quantities for pre-packed products, repealing Council Directives 75/106/EEC and 80/232/EEC, and amending Council Directive 76/211/EEC (OJ L 247, 21.9.2007, p. 17);

25.  Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1);

26.  Regulation (EC) No 78/2009 of the European Parliament and of the Council of 14 January 2009 on the type-approval of motor vehicles with regard to the protection of pedestrians and other vulnerable road users, amending Directive 2007/46/EC and repealing Directives 2003/102/EC and 2005/66/EC (OJ L 35, 4.2.2009, p. 1);

27.  Regulation (EC) No 79/2009 of the European Parliament and of the Council of 14 January 2009 on type-approval of hydrogen-powered motor vehicles, and amending Directive 2007/46/EC (OJ L 35, 4.2.2009, p. 32);

28.  Directive 2009/34/EC of the European Parliament and of the Council of 23 April 2009 relating to common provisions for both measuring instruments and methods of metrological control (OJ L 106, 28.4.2009, p. 7);

29.  Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (OJ L 170, 30.6.2009, p. 1);

30.  Regulation (EC) No 595/2009 of the European Parliament and of the Council of 18 June 2009 on type-approval of motor vehicles and engines with respect to emissions from heavy duty vehicles (Euro VI) and on access to vehicle repair and maintenance information and amending Regulation (EC) No 715/2007 and Directive 2007/46/EC and repealing Directives 80/1269/EEC, 2005/55/EC and 2005/78/EC (OJ L 188, 18.7.2009, p. 1);

31.  Regulation (EC) No 661/2009 of the European Parliament and of the Council of 13 July 2009 concerning type-approval requirements for the general safety of motor vehicles, their trailers and systems, components and separate technical units intended therefor (OJ L 200, 31.7.2009, p. 1);

32.  Directive 2009/125/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for the setting of ecodesign requirements for energy- related products (OJ L 285, 31.10.2009, p. 10);

33.  Regulation (EC) No 1005/2009 of the European Parliament and of the Council of 16 September 2009 on substances that deplete the ozone layer (OJ L 286, 31.10.2009, p. 1);

34.  Regulation (EC) No 1222/2009 of the European Parliament and of the Council of 25 November 2009 on the labelling of tyres with respect to fuel efficiency and other essential parameters (OJ L 342, 22.12.2009, p. 46);

35.  Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59);

36.  Regulation (EC) No 66/2010 of the European Parliament and of the Council of 25 November 2009 on the EU Ecolabel (OJ L 27, 30.1.2010, p. 1);

37.  Directive 2010/35/EU of the European Parliament and of the Council of 16 June 2010 on transportable pressure equipment and repealing Council Directives 76/767/EEC, 84/525/EEC, 84/526/EEC, 84/527/EEC and 1999/36/EC (OJ L 165, 30.6.2010, p. 1);

38.  Regulation (EU) No 305/2011 of the European Parliament and of the Council of 9 March 2011 laying down harmonised conditions for the marketing of construction products and repealing Council Directive 89/106/EEC (OJ L 88, 4.4.2011, p. 5);

39.  Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (OJ L 174, 1.7.2011, p. 88);

40.  Regulation (EU) No 1007/2011 of the European Parliament and of the Council of 27 September 2011 on textile fibre names and related labelling and marking of the fibre composition of textile products and repealing Council Directive 73/44/EEC and Directives 96/73/EC and 2008/121/EC of the European Parliament and of the Council (OJ L 272, 18.10.2011, p. 1);

41.  Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1);

42.  Directive 2012/19/EU of the European Parliament and of the Council of 4 July 2012 on waste electrical and electronic equipment (WEEE) (OJ L 197, 24.7.2012, p. 38);

43.  Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 February 2013 on the approval and market surveillance of agricultural and forestry vehicles (OJ L 60, 2.3.2013, p. 1);

44.  Regulation (EU) No 168/2013 of the European Parliament and of the Council of 15 January 2013 on the approval and market surveillance of two- or three-wheel vehicles and quadricycles (OJ L 60, 2.3.2013, p. 52);

45.  Directive 2013/29/EU of the European Parliament and of the Council of 12 June 2013 on the harmonisation of the laws of the Member States relating to the making available on the market of pyrotechnic articles (OJ L 178, 28.6.2013, p. 27);

46.  Directive 2013/53/EU of the European Parliament and of the Council of 20 November 2013 on recreational craft and personal watercraft and repealing Directive 94/25/EC (OJ L 354, 28.12.2013, p. 90);

47.  Directive 2014/28/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market and supervision of explosives for civil uses (OJ L 96, 29.3.2014, p. 1);

48.  Directive 2014/29/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of simple pressure vessels (OJ L 96, 29.3.2014, p. 45);

49.  Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to electromagnetic compatibility (OJ L 96, 29.3.2014, p. 79);

50.  Directive 2014/31/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of non-automatic weighing instruments (OJ L 96, 29.3.2014, p. 107);

51.  Directive 2014/32/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of measuring instruments (OJ L 96, 29.3.2014, p. 149);

52.  Directive 2014/33/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to lifts and safety components for lifts (OJ L 96, 29.3.2014, p. 251);

53.  Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres (OJ L 96, 29.3.2014, p. 309);

54.  Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits (OJ L 96, 29.3.2014, p. 357);

55.  Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC (OJ L 127, 29.4.2014, p. 1);

56.  Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC (OJ L 153, 22.5.2014, p.  62);

57.  Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of pressure equipment (OJ L 189, 27.6.2014, p. 164);

58.  Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on marine equipment and repealing Council Directive 96/98/EC (OJ L 257, 28.8.2014, p. 146);

59.  Regulation (EU) No 517/2014 of the European Parliament and of the Council of 16 April 2014 on fluorinated greenhouse gases and repealing Regulation (EC) No 842/2006 (OJ L 150, 20.5.2014, p. 195);

60.  Regulation (EU) No 540/2014 of the European Parliament and of the Council of 16 April 2014 on the sound level of motor vehicles and of replacement silencing systems, and amending Directive 2007/46/EC and repealing Directive 70/157/EEC (OJ L 158, 27.5.2014, p. 131);

61.  Regulation (EU) 2016/424 of the European Parliament and of the Council of 9 March 2016 on cableway installations and repealing Directive 2000/9/EC (OJ L 81, 31.3.2016, p. 1);

62.  Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (OJ L 81, 31.3.2016, p. 51);

63.  Regulation (EU) 2016/426 of the European Parliament and of the Council of 9 March 2016 on appliances burning gaseous fuels and repealing Directive 2009/142/EC (OJ L 81, 31.3.2016, p. 99);

64.  Regulation (EU) 2016/1628 of the European Parliament and of the Council of 14 September 2016 on requirements relating to gaseous and particulate pollutant emission limits and type-approval for internal combustion engines for non-road mobile machinery, amending Regulations (EU) No 1024/2012 and (EU) No 167/2013, and amending and repealing Directive 97/68/EC (OJ L 252, 16.9.2016, p. 53);

65.  Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1);

66.  Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176);

67.  Regulation (EU) 2017/852 of the European Parliament and of the Council on mercury, and repealing Regulation (EC) No 1102/2008 (OJ L 137, 24.5.2017, p. 1);

68.  Regulation (EU) 2017/1369 of the European Parliament and of the Council of 4 July 2017 setting a framework for energy labelling and repealing Directive 2010/30/EU (OJ L 198, 28.7.2017, p. 1);

69.  Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC (OJ L 151, 14.6.2018, p. 1);

70.  Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in the field of civil aviation and establishing a European Union Aviation Safety Agency, and amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the European Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the European Parliament and of the Council and Council Regulation (EEC) No 3922/91 (OJ L 212, 22.8.2018, p. 1), in so far as the design, production and placing on the market of aircrafts referred to in points (a) and (b) of Article 2(1) thereof, where it concerns unmanned aircraft and their engines, propellers, parts and equipment to control them remotely, are concerned.

ANNEX II

List of Union harmonisation legislation without provisions on penalties

1.  Council Directive 69/493/EEC of 15 December 1969 on the approximation of the laws of the Member States relating to crystal glass (OJ L 326, 29.12.1969, p. 36);

2.  Council Directive 70/157/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the permissible sound level and the exhaust system of motor vehicles (OJ L 42, 23.2.1970, p. 16);

3.  Council Directive 75/107/EEC of 19 December 1974 on the approximation of the laws of the Member States relating to bottles used as measuring containers (OJ L 42, 15.2.1975, p. 14);

4.  Council Directive 75/324/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to aerosol dispensers (OJ L 147, 9.6.1975, p. 40);

5.  Council Directive 76/211/EEC of 20 January 1976 on the approximation of the laws of the Member States relating to the making-up by weight or by volume of certain pre-packaged products (OJ L 46, 21.2.1976, p. 1);

6.  Council Directive 92/42/EEC of 21 May 1992 on efficiency requirements for new hot-water boilers fired with liquid or gaseous fuels (OJ L 167, 22.6.1992, p. 17);

7.  Directive 94/11/EC of the European Parliament and of the Council of 23 March 1994 on the approximation of the laws, regulations and administrative provisions of the Member States relating to labelling of the materials used in the main components of footwear for sale to the consumer (OJ L 100, 19.4.1994, p. 37);

8.  European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste (OJ L 365, 31.12.1994, p. 10);

9.  Directive 2000/14/EC of the European Parliament and of the Council of 8 May 2000 on the approximation of the laws of the Member States relating to the noise emission in the environment by equipment for use outdoors (OJ L 162, 3.7.2000, p. 1);

10.  Directive 2000/53/EC of the European Parliament and of the Council of 18 September 2000 on end-of life vehicles (OJ L 269, 21.10.2000, p. 34);

11.  Directive 2005/64/EC of the European Parliament and of the Council of 26 October 2005 on the type-approval of motor vehicles with regard to their reusability, recyclability and recoverability and amending Council Directive 70/156/EEC (OJ L 310, 25.11.2005, p. 10);

12.  Directive 2006/40/EC of the European Parliament and of the Council of 17 May 2006 relating to emissions from air conditioning systems in motor vehicles and amending Council Directive 70/156/EEC (OJ L 161, 14.6.2006, p. 12);

13.  Directive 2007/45/EC of the European Parliament and of the Council of 5 September 2007 laying down rules on nominal quantities for pre-packed products, repealing Council Directives 75/106/EEC and 80/232/EEC, and amending Council Directive 76/211/EEC (OJ L 247, 21.9.2007, p. 17);

14.  Regulation (EC) No 1222/2009 of the European Parliament and of the Council of 25 November 2009 on the labelling of tyres with respect to fuel efficiency and other essential parameters (OJ L 342, 22.12.2009, p. 46);

15.  Directive 2010/35/EU of the European Parliament and of the Council of 16 June 2010 on transportable pressure equipment and repealing Council Directives 76/767/EEC, 84/525/EEC, 84/526/EEC, 84/527/EEC and 1999/36/EC (OJ L 165, 30.6.2010, p. 1);

16.  Regulation (EU) No 305/2011 of the European Parliament and of the Council of 9 March 2011 laying down harmonised conditions for the marketing of construction products and repealing Council Directive 89/106/EEC (OJ L 88, 4.4.2011, p. 5);

17.  Regulation (EU) No 1007/2011 of the European Parliament and of the Council of 27 September 2011 on textile fibre names and related labelling and marking of the fibre composition of textile products and repealing Council Directive 73/44/EEC and Directives 96/73/EC and 2008/121/EC of the European Parliament and of the Council (OJ L 272, 18.10.2011, p. 1);

18.  Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on marine equipment and repealing Council Directive 96/98/EC (OJ L 257, 28.8.2014, p. 146);

19.  Regulation (EU) No 540/2014 of the European Parliament and of the Council of 16 April 2014 on the sound level of motor vehicles and of replacement silencing systems, and amending Directive 2007/46/EC and repealing Directive 70/157/EEC (OJ L 158, 27.5.2014, p. 131).

ANNEX III

Correlation table

Regulation (EC) No 765/2008

This Regulation

Article 1(2)

Article 1(1)

Article 1(3)

Article 1(3)

Article 2, point 1

Article 3, point 1

Article 2, point 2

Article 3, point 2

Article 2, point 14

Article 3, point 22

Article 2, point 15

Article 3, point 23

Article 2, point 17

Article 3, point 3

Article 2, point 18

Article 3, point 4

Article 2, point 19

Article 3, point 25

Article 15(1) and (2)

Article 2(1)

Article 15(3)

Article 2(3)

Article 15(4)

-

Article 15(5)

Article 2(2)

Article 16(1)

Article 10(1)

Article 16(2)

Article 16(5)

Article 16(3)

-

Article 16(4)

—  

Article 17(1)

Article 10(2)

Article 17(2)

Article 34(1), last sentence and Article 34(3), point (a)

Article 18(1)

Article 10(6)

Article 18(2), point (a)

Article 11(7), point (a)

Article 18(2), point (b)

-

Article 18(2), point (c)

Article 11(7), point (b)

Article 18(2), point (d)

-

Article 18(3)

Articles 10(5) and 14(1)

Article 18(4)

Article 14(2)

Article 18(5)

Article 13

Article 18(6)

Article 31(2), point (o)

Article 19(1), first subparagraph

Article 11(3)

Article 19(1), second subparagraph

Article 14(4), points (a), (b), (e) and (j)

Article 19(1), third subparagraph

Article 11(5)

Article 19(2)

Article 16(3), point (g)

Article 19(3)

Article 18(2)

Article 19(4)

Article 11(2)

Article 19(5)

Article 17

Article 20(1)

Article 19(1)

Article 20(2)

Article 19(2)

Article 21(1)

Article 18(1)

Article 21(2)

Article 18(2)

Article 21(3)

Article 18(3)

Article 21(4)

-

Article 22(1)

Article 20(1)

Article 22(2)

Article 20(2)

Article 22(3)

Article 20(3)

Article 22(4)

Article 20(4)

Article 23(1) and (3)

Article 34(1)

Article 23(2)

Article 34(4)

Article 24(1)

Article 22(1)

Article 24(2)

Article 22(2) to (5)

Article 24(3)

-

Article 24(4)

-

Article 25(1)

-

Article 25(2), point (a)

Article 31(2), point (f) and Article 33(1), points (i) and (k)

Article 25(2), point (b)

Article 31(2), points (g) and (m) and Article 33(1), points (i) and (k)

Article 25(3)

-

Article 26

-

Article 27(1), first sentence

Article 25(2)

Article 27(1), second sentence

Article 25(3)

Article 27(2)

Article 25(4)

Article 27(3), first subparagraph

Article 26(1)

Article 27(3), second subparagraph

Article 26(2)

Article 27(4)

-

Article 27(5)

-

Article 28(1)

Article 27, first paragraph, point (a)

Article 28(2)

Article 27, first paragraph, point (b)

Article 29(1)

Article 28(1)

Article 29(2)

Article 28(2)

Article 29(3)

Article 28(3)

Article 29(4)

Article 28(4)

Article 29(5)

Article 25(5)

Article 32(1), point (d)

-

Article 32(1), point (e)

Article 36(2), point (e)

(1) OJ C 283, 10.8.2018, p. 19.
(2)OJ C 283, 10.8.2018, p. 19.
(3) Position of the European Parliament of 17 April 2019.
(4)Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59).
(5)Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).
(6)Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176).
(7) Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC (OJ L 151, 14.6.2018, p. 1).
(8)Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (OJ L 11, 15.1.2002, p. 4).
(9) Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30).
(10) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).
(11) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).
(12) Directive 2014/33/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to lifts and safety components for lifts (OJ L 96, 29.3.2014, p. 251).
(13) Regulation (EC) No 1222/2009 of the European Parliament and of the Council of 25 November 2009 on the labelling of tyres with respect to fuel efficiency and other essential parameters (OJ L 342, 22.12.2009, p. 46).
(14) Regulation (EU) 2017/1369 of the European Parliament and of the Council of 4 July 2017 setting a framework for energy labelling and repealing Directive 2010/30/EU (OJ L 198, 28.7.2017, p. 1).
(15)Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market (Directive on electronic commerce) (OJ L 178, 17.7.2000, p. 1).
(16) Regulation (EU) No 608/2013 of the European Parliament and of the Council of 12 June 2013 concerning customs enforcement of intellectual property rights and repealing Council Regulation (EC) No 1383/2003 (OJ L 181, 29.6.2013, p. 15).
(17) Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents (OJ L 104, 8.4.2004, p. 1).
(18) Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 February 2013 on the approval and market surveillance of agricultural and forestry vehicles (OJ L 60, 2.3.2013, p. 1).
(19) Regulation (EU) No 168/2013 of the European Parliament and of the Council of 15 January 2013 on the approval and market surveillance of two- or three-wheel vehicles and quadricycles (OJ L 60, 2.3.2013, p. 52).
(20) Directive 2014/28/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market and supervision of explosives for civil uses (OJ L 96, 29.3.2014, p. 1).
(21) Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on marine equipment and repealing Council Directive 96/98/EC (OJ L 257, 28.8.2014, p. 146).
(22) Regulation (EU) 2016/1628 of the European Parliament and of the Council of 14 September 2016 on requirements relating to gaseous and particulate pollutant emission limits and type-approval for internal combustion engines for non-road mobile machinery, amending Regulations (EU) No 1024/2012 and (EU) No 167/2013, and amending and repealing Directive 97/68/EC (OJ L 252, 16.9.2016, p. 53).
(23) Regulation (EU) 2016/424 of the European Parliament and of the Council of 9 March 2016 on cableway installations and repealing Directive 2000/9/EC (OJ L 81, 31.3.2016, p. 1).
(24) Directive 2010/35/EU of the European Parliament and of the Council of 16 June 2010 on transportable pressure equipment and repealing Council Directives 76/767/EEC, 84/525/EEC, 84/526/EEC, 84/527/EEC and 1999/36/EC (OJ L 165, 30.6.2010, p. 1).
(25) Regulation (EU) 2018/1724 of the European Parliament and of the Council of 2 October 2018 establishing a single digital gateway to provide access to information, to procedures and to assistance and problem-solving services and amending Regulation (EU) No 1024/2012 (OJ L 295, 21.11.2018, p. 1).
(26) Regulation (EU) 2019/... of the European Parliament and of the Council of ... on the mutual recognition of goods lawfully marketed in another Member State and repealing Regulation (EC) No 764/2008 (OJ L ...).
(27)+OJ: please insert the number in the text, and the number, the date and the publication reference of the document in PE-CONS 70/18 - COD 2017/0354 in the footnote.
(28)Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).
(29)Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).
(30)Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (OJ L 269, 10.10.2013, p. 1).
(31)OJ L 123, 12.5.2016, p. 1.
(32)Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
(33) Directive 97/67/EC of the European Parliament and of the Council of 15 December 1997 on common rules for the development of the internal market of Community postal services and the improvement of quality of service (OJ L 15, 21.1.1998, p. 14).
(34) Regulation (EU) 2018/644 of the European Parliament and of the Council of 18 April 2018 on cross-border parcel delivery services (OJ L 112, 2.5.2018, p. 19).
(35) Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1).
(36) Regulation (EU) No 305/2011 of the European Parliament and of the Council of 9 March 2011 laying down harmonised conditions for the marketing of construction products and repealing Council Directive 89/106/EEC (OJ L 88, 4.4.2011, p. 5).
(37) Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (OJ L 81, 31.3.2016, p. 51).
(38) Regulation (EU) 2016/426 of the European Parliament and of the Council of 9 March 2016 on appliances burning gaseous fuels and repealing Directive 2009/142/EC (OJ L 81, 31.3.2016, p. 99).
(39) Directive 2000/14/EC of the European Parliament and of the Council of 8 May 2000 on the approximation of the laws of the Member States relating to the noise emission in the environment by equipment for use outdoors (OJ L 162, 3.7.2000, p. 1).
(40) Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (OJ L 157, 9.6.2006, p. 24).
(41) Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (OJ L 170, 30.6.2009, p. 1).
(42) Directive 2009/125/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for the setting of ecodesign requirements for energy- related products (OJ L 285, 31.10.2009, p. 10).
(43) Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (OJ L 174, 1.7.2011, p. 88).
(44) Directive 2013/29/EU of the European Parliament and of the Council of 12 June 2013 on the harmonisation of the laws of the Member States relating to the making available on the market of pyrotechnic articles (OJ L 178, 28.6.2013, p. 27).
(45) Directive 2013/53/EU of the European Parliament and of the Council of 20 November 2013 on recreational craft and personal watercraft and repealing Directive 94/25/EC (OJ L 354, 28.12.2013, p. 90).
(46) Directive 2014/29/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of simple pressure vessels (OJ L 96, 29.3.2014, p. 45).
(47) Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to electromagnetic compatibility (OJ L 96, 29.3.2014, p. 79).
(48) Directive 2014/31/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of non-automatic weighing instruments (OJ L 96, 29.3.2014, p. 107).
(49) Directive 2014/32/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of measuring instruments (OJ L 96, 29.3.2014, p. 149).
(50) Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres (OJ L 96, 29.3.2014, p. 309).
(51) Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits (OJ L 96, 29.3.2014, p. 357).
(52) Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC (OJ L 153, 22.5.2014, p. 62)
(53) Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of pressure equipment (OJ L 189, 27.6.2014, p. 164).
(54)+OJ: please insert the number in the text of the document in PE-CONS 70/18 - COD 2017/0354.
(55)+OJ: please insert the number of the document in PE-CONS 45/19 - COD 2017/0353.
(56)+OJ: please insert the number of the document in PE-CONS 45/19 - COD 2017/0353.
(57)Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1).
(58)Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1).
(59)Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities' financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p.2).
(60)Directive 2004/42/EC of the European Parliament and of the Council of 21 April 2004 on the limitation of emissions of volatile organic compounds due to the use of organic solvents in certain paints and varnishes and vehicle refinishing products and amending Directive 1999/13/EC (OJ L 143, 30. 4.2004, p. 87).


Promoting fairness and transparency for business users of online intermediation services ***I
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Resolution
Consolidated text
European Parliament legislative resolution of 17 April 2019 on the proposal for a regulation of the European Parliament and of the Council on promoting fairness and transparency for business users of online intermediation services (COM(2018)0238 – C8-0165/2018 – 2018/0112(COD))
P8_TA-PROV(2019)0398A8-0444/2018

(Ordinary legislative procedure: first reading)

The European Parliament,

–  having regard to the Commission proposal to Parliament and the Council (COM(2018)0238),

–  having regard to Article 294(2) and Article 114 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8‑0165/2018),

–  having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–  having regard to the opinion of the European Economic and Social Committee of 19 September 2018(1),

–  after consulting the Committee of the Regions,

–  having regard to the provisional agreement approved by the committee responsible under Rule 69f(4) of its Rules of Procedure and the undertaking given by the Council representative by letter of 20 February 2019 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,

–  having regard to Rule 59 of its Rules of Procedure,

–  having regard to the report of the Committee on the Internal Market and Consumer Protection and the opinions of the Committee on Legal Affairs, the Committee on Industry, Research and Energy and the Committee on Transport and Tourism (A8-0444/2018),

1.  Adopts its position at first reading hereinafter set out;

2.  Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

3.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Position of the European Parliament adopted at first reading on 17 April 2019 with a view to the adoption of Regulation (EU) 2019/… of the European Parliament and of the Council on promoting fairness and transparency for business users of online intermediation services

P8_TC1-COD(2018)0112


(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee(2),

After consulting the Committee of the Regions,

Acting in accordance with the ordinary legislative procedure(3),

Whereas:

(1)  Online intermediation services are key enablers of entrepreneurship and new business models, trade and innovation, which can also improve consumer welfare and which are increasingly used by both the private and public sectors. They offer access to new markets and commercial opportunities allowing undertakings to exploit the benefits of the internal market. They ▌ allow consumers in the Union to exploit those benefits, in particular by increasing their choice of goods and services, as well as by contributing to offering competitive pricing online, but they also raise challenges that need to be addressed in order to ensure legal certainty.

(2)  Online intermediation services can be crucial for the commercial success of undertakings who use such services to reach consumers. To fully exploit the benefits of the online platform economy, it is therefore important that undertakings can trust online intermediation services with which they enter into commercial relationships. This is important mainly because the growing intermediation of transactions through online intermediation services, fuelled by strong data-driven indirect network effects, leads to an increased dependence of such business users, particularly micro, small and medium-sized enterprises (SMEs), on those services in order for them to reach consumers. Given that increasing dependence, the providers of those services often have superior bargaining power, which enables them to, in effect, behave unilaterally in a way that can be unfair and that can be harmful to the legitimate interests of their businesses users and, indirectly, also of consumers in the Union. For instance, they might unilaterally impose on business users practices which grossly deviate from good commercial conduct, or are contrary to good faith and fair dealing. This Regulation addresses such potential frictions in the online platform economy.

(3)  Consumers have embraced the use of online intermediation services. A competitive, fair, and transparent online ecosystem where companies behave responsibly is also essential for consumer welfare. Ensuring the transparency of, and trust in, the online platform economy in business-to-business relations could also indirectly help to improve consumer trust in the online platform economy. Direct impacts of the development of the online platform economy on consumers are, however, addressed by other Union law, especially the consumer acquis.

(4)  Similarly, online search engines can be important sources of Internet traffic for undertakings which offer goods or services to consumers through websites and can therefore significantly affect the commercial success of such corporate website users offering their goods or services online in the internal market. In this regard, the ranking of websites by providers of online search engines, including of those websites through which corporate website users offer their goods and services to consumers, has an important impact on consumer choice and the commercial success of those corporate website users. Even in the absence of a contractual relationship with corporate website users, providers of online search engines can therefore, in effect, behave unilaterally in a way that can be unfair and that can be harmful to the legitimate interests of corporate website users and, indirectly, also of consumers in the Union.

(5)  The nature of the relationship between providers of online intermediation services and business users might also lead to situations in which business users often have limited possibilities to seek redress where unilateral actions of the providers of those services lead to a dispute. In many cases, those providers do not offer accessible and effective internal complaint-handling systems. Existing alternative out-of-court dispute settlement mechanisms can also be ineffective for a variety of reasons, including a lack of specialised mediators and business users' fear of retaliation.

(6)  Online intermediation services and online search engines, as well as the ▌ transactions facilitated by those services, have an intrinsic cross-border potential and are of particular importance for the proper functioning of the Union's internal market in today's economy. The potentially unfair and harmful commercial practices of certain providers of those services, and the lack of effective redress mechanisms, hamper the full realisation of that potential and negatively affect the proper functioning of the internal market. ▌

(7)  A targeted set of mandatory rules should be established at Union level to ensure a fair, predictable, sustainable and trusted online business environment within the internal market. In particular, business users of online intermediation services should be afforded appropriate transparency, as well as effective redress possibilities, throughout the Union in order to facilitate cross-border business within the Union and thereby improve the proper functioning of the internal market and to address possible emerging fragmentation in the specific areas covered by this Regulation.

(8)  ▌ Those rules should also provide for appropriate incentives to promote fairness and transparency, especially as regards the ranking of corporate website users in the search results generated by online search engines. At the same time, those rules should recognise and safeguard the important innovation potential of the wider online platform economy and allow for healthy competition leading to increased consumer choice. It is appropriate to clarify that this Regulation should not affect national civil law, in particular contract law, such as the rules on the validity, formation, effects or termination of a contract, in so far as the national civil law rules are in conformity with Union law and to the extent that the relevant aspects are not covered by this Regulation. Member States should remain free to apply national laws which prohibit or sanction unilateral conduct or unfair commercial practices to the extent that the relevant aspects are not covered by this Regulation.

(9)  Since online intermediation services and online search engines typically have a global dimension, this Regulation should apply to providers of those services regardless of whether they are established in a Member State or outside the Union, provided that two cumulative conditions are met. Firstly, the business users or corporate website users should be established in the Union. Secondly, the business users or corporate website users should, through the provision of those services, offer their goods or services to consumers located in the Union at least for part of the transaction. In order to determine whether business users or corporate website users are offering goods or services to consumers located in the Union, it is necessary to ascertain whether it is apparent that the business users or corporate website users direct their activities to consumers located in one or more Member States. This criterion should be interpreted in accordance with the relevant case law of the Court of Justice of the European Union on point (c) of Article 17(1) of Regulation (EC) No 1215/2012 of the European Parliament and of the Council(4) and point (b) of Article 6(1) of Regulation (EC) No 593/2008 of the European Parliament and of the Council(5). Such consumers should be located in the Union, but do not need to have their place of residence in the Union nor have the nationality of any Member State. Accordingly, this Regulation should not apply where business users or corporate websites users are not established in the Union or where they are established in the Union but where they use online intermediation services or online search engines to offer goods or services exclusively to consumers located outside the Union or to persons who are not consumers. Furthermore, this Regulation should apply irrespective of the law otherwise applicable to a contract.

(10)  A wide variety of business-to-consumer ▌ relations are intermediated online by providers operating multi-sided services that are essentially based on the same ecosystem-building business model. In order to capture the relevant services, online intermediation services should be defined in a precise and technologically-neutral manner. In particular, the services should consist of information society services, which are characterised by the fact that they aim to facilitate the initiating of direct transactions between business users and consumers, irrespective of whether the transactions are ultimately concluded online, on the online portal of the provider of online intermediation services in question or that of the business user, ▌ offline or in fact not at all, meaning that there should be no requirement for any contractual relationship between the business users and consumers as a precondition for online intermediation services falling within the scope of this Regulation. The mere inclusion of a service of a marginal character only should not be seen as making the aim of a website or service the facilitation of transactions within the meaning of online intermediation services. In addition, the services should be provided on the basis of contractual relationships between the providers and business users which offer goods or services to consumers. Such a contractual relationship should be deemed to exist where both parties concerned express their intention to be bound in an unequivocal ▌ manner on a durable medium, without an express written agreement necessarily being required.

(11)  Examples of online intermediation services covered by this Regulation should consequently include online e-commerce market places, including collaborative ones on which business users are active, online software applications services, such as application stores, and online social media services, irrespective of the technology used to provide such services. In this sense, online intermediation services could also be provided by means of voice assistant technology. It should also not be relevant whether those transactions between business users and consumers involve any monetary payment or whether they are concluded in part offline. However, this Regulation should not apply to peer-to-peer online intermediation services without the presence of business users, pure business-to-business online intermediation services which are not offered to consumers, online advertising tools and online advertising exchanges which are not provided with the aim of facilitating the initiation of direct transactions and which do not involve a contractual relationship with consumers. For the same reason, search engine optimisation software services as well as services which revolve around advertising-blocking software should not be covered by this Regulation. Technological functionalities and interfaces that merely connect hardware and applications should not be covered by this Regulation, as they normally do not fulfil the requirements for online intermediation services. However, such functionalities or interfaces can be directly connected or ancillary to certain online intermediation services and where this is the case, the relevant providers of online intermediation services should be subject to transparency requirements related to differentiated treatment based on these functionalities and interfaces. This Regulation should also not apply to online payment services, since they do not themselves meet the applicable requirements but are rather inherently auxiliary to the transaction for the supply of goods and services to the consumers concerned.

(12)  In line with the relevant case-law of the Court of Justice of the European Union and in the light of the fact that the dependent position of business users has been observed principally in respect of online intermediation services that serve as a gateway to consumers in the form of natural persons, the notion of consumer used to delineate the scope of this Regulation should be understood as referring solely to natural persons, where they are acting for purposes which are outside their trade, business, craft or profession.

(13)  Considering the quick pace of innovation, the definition of online search engine used in this Regulation should be technology-neutral. In particular, the definition should be understood to also encompass voice requests.

(14)  Providers of online intermediation services tend to use pre-formulated terms and conditions and in order to effectively protect business users where needed, this Regulation should apply where the terms and conditions of a contractual relationship, regardless of their name or form, are unilaterally determined by the provider of online intermediation services. Whether the terms and conditions were unilaterally determined should be evaluated case by case on the basis of an overall assessment. For that overall assessment, the relative size of the parties concerned, the fact that a negotiation took place, or that certain provisions thereof might have been subject to such a negotiation and determined together by the relevant provider and business user should not, in itself, be decisive. In addition, the obligation for providers of online intermediation services to make their terms and conditions easily available to business users, including in the pre-contractual stage of their commercial relationship, means that business users will not be deprived of the transparency resulting from this Regulation as a result of them being in any way able to successfully negotiate.

(15)  To ensure that the general terms and conditions of a contractual relationship enable business users to determine the commercial conditions for the use, termination and suspension of online intermediation services, and to achieve predictability regarding their business relationship, those terms and conditions should be drafted in plain and intelligible language ▌. Terms and conditions should not be considered to have been drafted in plain and intelligible language where they are vague, unspecific or lack detail on important commercial issues and thus fail to give business users a reasonable degree of predictability on the most important aspects of the contractual relationship. Moreover, misleading language should not be considered to be plain and intelligible.

(16)  In order to ensure that business users have sufficient clarity regarding where, and to whom, their goods or services are being marketed , providers of online intermediation services should ensure, towards their business users, the transparency of any additional distribution channels and potential affiliate programmes that they might use to market those goods or services. Additional channels and affiliate programmes should be understood in a technologically neutral manner but could, inter alia, include other websites, apps or other online intermediation services used to market the goods or services offered by the business user.

(17)  The ownership and control of intellectual property rights online can have significant economic importance for both the providers of online intermediation services and their business users. To ensure clarity and transparency for business users and for their better understanding, providers of online intermediation services should within their terms and conditions include general, or more detailed, information if they so wish, regarding the overall effects, if any, of those terms and conditions on the ownership and control of intellectual property rights of the business user. Such information could, inter alia, include information such as the general usage of logos, trademarks or brand names.

(18)  Ensuring transparency in the general terms and conditions can be essential to promoting sustainable business relationships and to preventing unfair behaviour to the detriment of business users. Providers of online intermediation services should therefore also ensure that the terms and conditions are easily available at all stages of the commercial relationship, including to prospective business users at the pre-contractual phase, and that any changes to those terms are notified on a durable medium to business users concerned within a set notice period which is reasonable and proportionate in light of the specific circumstances and which is at least 15 days. Proportionate longer notice periods of more than 15 days should be given where the proposed changes to the terms and conditions require business users to make technical or commercial adaptations in order to comply with the change, for example by requiring them to make significant technical adjustments to their goods or services. That notice period should not apply where, and to the extent that, it is waived in an unambiguous manner by the business user concerned or where, and to the extent that, the need to implement the change without respecting the notice period stems from a legal or regulatory obligation incumbent on the service provider under Union or national law. However, proposed editorial changes should not be covered by the term ‘change’ in as far as they do not alter the content or meaning of terms and conditions. The requirement of notifying proposed changes on a durable medium should enable business users to review effectively these changes at a later stage. Business users should be entitled to terminate their contract within 15 days from the receipt of the notice of any change, unless a shorter period applies to the contract, for example as resulting from national civil law.

(19)  In general, submitting new goods or services, including software applications, to the online intermediation services should be considered to be clear affirmative action, resulting in the waiving, by the business user, of the notice period required for changes to the terms and conditions. However, in cases where the reasonable and proportionate notice period is longer than 15 days because the changes to the terms and conditions require the business user to make significant technical adjustments to its goods or services, the notice period should not be considered to be automatically waived where the business user submits new goods and services. The provider of online intermediation services should expect the changes to terms and conditions to require the business user to make significant technical adjustments where, for example, entire features of the online intermediation services that business users had access to are removed or added, or where business users might need to adapt their goods or reprogramme their services to be able to continue to operate through the online intermediation services.

(20)  In order to protect business users and to provide legal certainty for both sides, non-compliant terms and conditions should be null and void, that is, deemed to have never existed, with effects erga omnes and ex tunc. This should however only concern the specific provisions of the terms and conditions which are not compliant. The remaining provisions should remain valid and enforceable, in as far as they can be severed from the non-compliant provisions. Sudden changes to existing terms and conditions may significantly disrupt business users' operations. In order to limit such negative effects on business users, and to discourage such behaviour, changes made in contravention of the obligation to provide a set notice period should therefore be null and void, that is, deemed to have never existed, with effects erga omnes and ex tunc.

(21)  In order to ensure that business users can fully exploit the commercial opportunities offered by online intermediation services, providers of these services should not completely prevent their business users from featuring their trading identity as part of their offering or presence on the relevant online intermediation services. However, this prohibition of interference should not be understood as a right for business users to unilaterally determine the presentation of their offering or presence on the relevant online intermediation services.

(22)  A provider of online intermediation services can have legitimate reasons to decide to restrict, suspend or terminate the provision of its services ▌ to a given business user, including by delisting individual goods or services of a given business user or effectively removing search results. Short of being suspended, providers of online intermediation services can also restrict individual listings of business users; for example, through their demotion or by negatively affecting a business user’s appearance (‘dimming’) which can include lowering its ranking. However, given that such decisions can significantly affect the interests of the business user concerned, they should be provided, prior to or at the time of the restriction or suspension taking effect, with a statement of reasons for that decision on a durable medium. To minimise the negative impact of such decisions on business users, providers of online intermediation services should also allow an opportunity to clarify the facts that led to that decision in the framework of the internal complaint-handling process, which will help the business user, where this is possible, to re-establish compliance. In addition, where the provider of online intermediation services revokes the decision to restrict, suspend or terminate, for example because the decision was made in error or the infringement of terms and conditions that led to this decision was not committed in bad faith and has been remedied in a satisfactory manner, the provider should reinstate the business user concerned without undue delay, including providing the business user with any access to personal or other data, or both, available prior to the decision. The statement of reasons regarding the decision to restrict, suspend or terminate the provision of online intermediation services should allow business users to ascertain whether there is scope to challenge the decision, thereby improving the possibilities for business users to seek effective redress where necessary. ▌The statement of reasons should identify the ▌ grounds for the decision, based on the grounds that the provider had set out in advance in its terms and conditions, and refer in a proportionate manner to the relevant specific circumstances, including third party notifications, that led to that decision. However, a provider of online intermediation services should not be required to provide a statement of reasons for restrictions, suspensions or terminations insofar as it would infringe a legal or regulatory obligation. Furthermore, a statement of reasons should not be required where a provider of online intermediation services can demonstrate that the business user concerned has repeatedly infringed the applicable terms and conditions, resulting in termination of the provision of the whole of the online intermediation services in question.

(23)  The termination of the whole of the online intermediation services and the related deletion of data provided for the use of, or generated through, the provision of online intermediation services represent a loss of essential information which could have a significant impact on business users and could also impair their ability to properly exercise other rights granted to them by this Regulation. Therefore, the provider of online intermediation services should provide the business user concerned with a statement of reasons on a durable medium, at least 30 days before the termination of the provision of the whole of its online intermediation services enters into effect. However, in cases where a legal or regulatory obligation requires a provider of online intermediation services to terminate the provision of the whole of its online intermediation services to a given business user, this notice period should not apply. Equally, the notice period of 30 days should not apply where a provider of online intermediation services invokes rights of termination under national law in compliance with Union law which allow immediate termination where, taking into account all the circumstances of the specific case and weighing the interests of both parties, it cannot reasonably be expected to continue the contractual relationship until the agreed end or until the expiry of a notice period. Finally, the notice period of 30 days should not apply where a provider of online intermediation services can demonstrate a repeated infringement of terms and conditions. The various exceptions to the 30-day notice period can in particular arise in connection with illicit or inappropriate content, the safety of a good or service, counterfeiting, fraud, malware, spam, data breaches, other cybersecurity risks or suitability of the good or service to minors. In order to ensure proportionality, providers of online intermediation services should, where reasonable and technically feasible, delist only individual goods or services of a business user. Termination of the whole of the online intermediation services constitutes the most severe measure.

(24)  The ranking of goods and services by the providers of online intermediation services has an important impact on consumer choice and, consequently, on the commercial success of the business users offering those goods and services to consumers. Ranking refers to the relative prominence of the offers of business users or relevance given to search results as presented, organised or communicated by providers of online intermediation services or by providers of online search engines, resulting from the use of algorithmic sequencing, rating or review mechanisms, visual highlights, or other saliency tools, or combinations thereof. Predictability entails that providers of online intermediation services determine ranking in a non-arbitrary manner. Providers should therefore outline the main parameters determining ranking beforehand, in order to improve predictability for business users, to allow them to better understand the functioning of the ranking mechanism and to enable them to compare the ranking practices of various providers. The specific design of this transparency obligation is important for business users as it implies the identification of a limited set of parameters that are most relevant out of a possibly much larger number of parameters that have some impact on ranking. This reasoned description should help business users to improve the presentation of their goods and services, or some inherent characteristics of those goods or services. The notion of main parameter should be understood to refer to any general criteria, processes, specific signals incorporated into algorithms or other adjustment or demotion mechanisms used in connection with the ranking. ▌

(25)  The description of the main parameters determining ranking should also include an explanation of any possibility for business users to actively influence ranking against remuneration, as well as an explanation of the relative effects thereof. Remuneration could, in this respect, refer to payments made with the main or sole aim to improve ranking, as well as indirect remuneration in the form of the acceptance by a business user of additional obligations of any kind which may have this as its practical effect, such as the use of services that are ancillary or of any premium features. The content of the description, including the number and type of main parameters, can accordingly vary strongly depending on the specific online intermediation services , but should provide business users with an adequate understanding of how the ranking mechanism takes account of the characteristics of the actual goods or services offered by the business user, and their relevance to the consumers of the specific online intermediation services. The indicators used for measuring the quality of goods or services of business users, the use of editors and their ability to influence the ranking of those goods or services, the amplitude of the impact of remuneration on ranking as well as elements that do not or only remotely relate to the good or service itself, such as presentational features of the online offer, could be examples of main parameters that, when included in a general description of the ranking mechanism in plain and intelligible language, should assist business users in obtaining the required adequate understanding of its functioning.

(26)  Similarly, the ranking of websites by the providers of online search engines, notably of those websites through which undertakings offer goods and services to consumers, has an important impact on consumer choice and the commercial success of corporate website users. Providers of online search engines should therefore provide a description of the main parameters determining the ranking of all indexed websites and the relative importance of those main parameters as opposed to other parameters, including those of corporate website users as well as other websites. In addition to the characteristics of the goods and services and their relevance for consumers, this description should in the case of online search engines also allow corporate website users to obtain an adequate understanding of whether, and if so how and to what extent, certain design characteristics of the website used, such as their optimisation for display on mobile telecommunications devices, is taken into account. It should also include an explanation of any possibility for corporate website users to actively influence ranking against remuneration, as well as an explanation of the relative effects thereof. In the absence of a contractual relationship between providers of online search engines and corporate website users, that description should be available to the public in an obvious and easily accessible location on the relevant online search engine. Areas of websites that require users to log in or register should not be understood as easily and publicly available in this sense. To ensure predictability for corporate website users, the description should also be kept up to date, including the possibility that any changes to the main parameters should be made easily identifiable. The existence of an up-to-date description of the main parameters would also benefit users other than corporate website users of the online search engine. In some cases, providers of online search engines can decide to influence the ranking in a specific case or delist a particular website from a ranking based on a third-party notification. Unlike providers of online intermediation services, providers of online search engines cannot, due to the lack of any contractual relationship between the parties, be expected to notify a corporate website user directly of a change in ranking order or a delisting due to a third party notification. Nevertheless, a corporate website user should be able to inspect the contents of the notification that has led to the change in ranking order in a specific case or to delisting of a particular website, by investigating the contents of the notification such as in a publicly accessible online database. That would help to mitigate potential abuses, by competitors, of notifications that could lead to delisting.

(27)  Providers of online intermediation services or of online search engines should not be required to disclose the detailed functioning of their ranking mechanisms, including algorithms, under this Regulation. Their ability to act against bad faith manipulation of ranking by third parties, including in the interest of consumers, should equally not be impaired. A general description of the main ranking parameters should safeguard those interests, while providing business users and corporate website users with an adequate understanding of the functioning of ranking in the context of their use of specific online intermediation services or online search engines. To ensure that the objective of this Regulation is achieved, consideration of the commercial interests of providers of online intermediation services or online search engines should, therefore, never lead to a refusal to disclose the main parameters determining ranking. In this regard, whilst this Regulation is without prejudice to Directive (EU) 2016/943 of the European Parliament and of the Council(6), the description given should at least be based on actual data on the relevance of the ranking parameters used.

(28)  The Commission should develop guidelines to assist providers of online intermediation services and providers of online search engines in applying the ranking transparency requirements laid down by this Regulation. This effort should help to optimise the manner in which the main parameters determining ranking are identified and presented to business users and corporate website users.

(29)   Ancillary goods and services should be understood as goods and services offered to the consumer immediately prior to the completion of a transaction initiated on online intermediation services to complement the primary good or service being offered by the business user. Ancillary goods and services refer to products that typically depend on, and are directly related to, the primary good or service in order to function. Therefore, the term should exclude goods and services that are merely being sold in addition to the primary good or service in question rather than being complementary in their nature. Examples of ancillary services include repair services for a specific good or financial products such as car rental insurance offered so as to complement the specific goods or services being offered by the business user. Likewise, ancillary goods might include goods that complement the specific product being offered by the business user by constituting an upgrade or a customisation tool linked to that specific product. Providers of online intermediation services offering goods or services to consumers that are ancillary to a good or service sold by a business user, using their online intermediation services, should set out in their terms and conditions a description of the type of ancillary goods and services being offered. Such a description should be available in the terms and conditions regardless of whether the ancillary good or service is being provided by the provider of online intermediation services itself or by a third party. Such a description should be comprehensive enough to allow a business user to understand whether any good or service is being sold as ancillary to the business user’s good or service. The description should not necessarily include the specific good or service, but rather the type of product being offered as complementary to the primary product of the business user. Furthermore, this description should in all circumstances include whether and under what conditions a business user is allowed to offer its own ancillary good or service in addition to the primary good or service that it is offering through the online intermediation services.

(30)  Where a provider of online intermediation services itself offers certain goods or services to consumers through its own online intermediation services, or does so through a business user which it controls, that provider might compete directly with other business users of its online intermediation services which are not controlled by the provider, which might give the provider an economic incentive and the ability to use its control over the online intermediation services to provide technical or economic advantages to its own offering, or those offered through a business user which it controls, which it could deny to competing business users. Such behaviour could undermine fair competition and restrict consumer choice. In such situations, in particular, it is important that the provider of online intermediation services acts in a transparent manner and provides an appropriate description of, and sets out the considerations for any differentiated treatment, whether through legal, commercial or technical means, such as functionalities involving operating systems that it might give in respect of goods or services it offers itself compared to those offered by business users. To ensure proportionality, this obligation should apply at the level of the overall online intermediation services, rather than at the level of individual goods or services offered through those services.

(31)  Where a provider of an online search engine itself offers certain goods or services to consumers through its own online search engine, or does so through a corporate website user which it controls, that provider might compete directly with other corporate website users of its online search engine which are not controlled by the provider. In such situations, in particular, it is important that the provider of the online search engine acts in a transparent manner and provides a description of any differentiated treatment, whether through legal, commercial or technical means, that it might give in respect of goods or services it offers itself or through a corporate website user which it controls, compared to those offered by competing corporate website users. To ensure proportionality, this obligation should apply at the level of the overall online search engine, rather than at the level of individual goods or services offered through those services.

(32)  Specific contractual terms should be addressed in this Regulation, in particular in situations of imbalances in bargaining power, in order to ensure that contractual relations are conducted in good faith and on the basis of fair dealing. Predictability and transparency require that business users are given a real opportunity to become acquainted with changes to terms and conditions, which should therefore not be imposed with retroactive effect unless they are based on a legal or regulatory obligation or are beneficial to those business users. Business users should in addition be offered clarity as to the conditions under which their contractual relationship with providers of online intermediation services can be terminated. Providers of online intermediation services should ensure that the conditions for termination are always proportionate and can be exercised without undue difficulty. Finally, business users should be fully informed of any access that providers of online intermediation services maintain, after the expiry of the contract, to the information that business users provide or generate in the context of their use of online intermediation services.

(33)  The ability to access and use data, including personal data, can enable important value creation in the online platform economy, both generally as well as for the business users and online intermediation services involved. Accordingly, it is important that providers of online intermediation services provide business users with a clear description of the scope, nature and conditions of their access to and use of certain categories of data. The description should be proportionate and might refer to general access conditions, rather than an exhaustive identification of actual data, or categories of data. However, identification of and specific access conditions to certain types of actual data that might be highly relevant to the business users could also be included in the description. Such data could include ratings and reviews accumulated by business users on the online intermediation services. Altogether, the description should ▌enable business users to understand whether they can use the data to enhance value creation, including by possibly retaining third-party data services. ▌

(34)  In the same vein, it is important for business users to understand whether the provider shares with third parties any data which has been generated through the use of the intermediation service by the business user . Business users should in particular be made aware of any sharing of data with third parties that occurs for purposes which are not necessary for the proper functioning of the online intermediation services; for example where the provider monetises data under commercial considerations. To allow business users to fully exercise available rights to influence such data sharing, providers of online intermediation services should also be explicit about possibilities to opt out from the data sharing where they exist under their contractual relationship with the business user.

(35)  Those requirements should not be understood as any obligation for providers of online intermediation services to either disseminate or not to disseminate personal or non-personal data to their business users. However, transparency measures could contribute to increased data sharing and enhance, as a key source of innovation and growth, the aims to create a common European data space. Processing of personal data should comply with the Union legal framework on the protection of natural persons with regard to the processing of personal data, and on respect for private life and the protection of personal data in electronic communications, in particular Regulation (EU) 2016/679 (7), Directive (EU) 2016/680(8) and Directive 2002/58/EC(9) of the European Parliament and of the Council.

(36)  Providers of online intermediation services might in certain cases restrict in their terms and conditions the ability of business users to offer goods or services to consumers under more favourable conditions through other means than through those online intermediation services. In those cases, the providers concerned should set out the grounds for doing so, in particular with reference to the main economic, commercial or legal considerations for the restrictions. This transparency obligation should however not be understood as affecting the assessment of the legality of such restrictions under other acts of Union law or the law of Member States that is in accordance with Union law, including in the areas of competition and unfair commercial practices, and the application of such laws.

(37)  In order to enable business users, including those whose use of the relevant online intermediation services might have been restricted, suspended or terminated, to have access to immediate, suitable and effective possibilities of redress, providers of online intermediation services should provide for an internal complaint-handling system. That internal complaint-handling system should be based on principles of transparency and equal treatment applied to equivalent situations, aimed at ensuring that a significant proportion of complaints can be solved bilaterally by the provider of online intermediation services and the relevant business user in a reasonable period of time. The providers of online intermediation services might maintain in force during the duration of the complaint the decision that they have taken. Any attempt to reach an agreement through the internal complaint handling-process does not affect the rights of providers of online intermediation services or business users to initiate judicial proceedings at any time during or after the internal complaint-handling process. In addition, providers of online intermediation services should publish and, at least annually, verify information on the functioning and effectiveness of their internal complaint-handling system to help business users to understand the main types of issues that can arise in the context of the provision of different online intermediation services and the possibility of reaching a quick and effective bilateral resolution.

(38)  The requirements of this Regulation regarding the internal complaint-handling systems aim to allow providers of online intermediation services a reasonable degree of flexibility when operating those systems and addressing individual complaints, so as to minimise any administrative burden. In addition, the internal complaint-handling systems should allow providers of online intermediation services to address, where necessary, in a proportionate manner any use in bad faith which certain business users might seek to make of those systems. ▌ In light of the costs of setting up and operating such systems, it is appropriate to exempt from those obligations any providers of online intermediation services which constitute small enterprises, in line with the relevant provisions of Commission Recommendation 2003/361/EC(10). The consolidation rules laid down in that Recommendation ensure that any circumvention is prevented. That exemption should not affect the right of such enterprises to set up, on a voluntary basis, an internal complaint-handling system that complies with the criteria set out in this Regulation.

(39)  The use of the word ‘internal’ should not be understood as preventing the delegation of an internal complaint-handling system to an external service provider or other corporate structure, as long as such a provider or other corporate structure has full authority and the ability to ensure compliance of the internal complaint-handling system with the requirements in this Regulation.

(40)  Mediation can offer providers of online intermediation services and their business users a means to resolve disputes in a satisfactory manner, without having to use judicial proceedings which can be lengthy and costly. Therefore, providers of online intermediation services should facilitate mediation by, in particular, identifying at least two public or private mediators with which they are willing to engage. The aim of requiring the identification of a minimum number of mediators is to safeguard the mediators’ neutrality. Mediators which provide their services from a location outside the Union should only be identified where it is guaranteed that the use of those services does not in any way deprive the business users concerned of any legal protection offered to them under Union law or the law of the Member States, including the requirements of this Regulation and the applicable law regarding protection of personal data and trade secrets. In order to be accessible, fair, and as swift, efficient and effective as possible, those mediators should meet certain set criteria. Nonetheless, providers of online intermediation services and their business users should remain free to jointly identify any mediator of their choice after a dispute has arisen between them. In line with Directive 2008/52/EC of the European Parliament and of the Council(11), the mediation provided for in this Regulation should be a voluntary process in the sense that the parties are themselves in charge of the process and can start and terminate it at any time. Notwithstanding its voluntary nature, providers of online intermediation services should examine in good faith requests to engage in the mediation provided for in this Regulation.

(41)  Providers of online intermediation services should bear a reasonable proportion of the total costs of the mediation, taking into account all relevant elements of the case at hand. To that end, the mediator should suggest which proportion is reasonable in the individual case. ▌ In light of the costs and of the administrative burden associated with the necessity to identify mediators in terms and conditions, it is appropriate to exempt from that obligation any providers of online intermediation services which are small enterprises, in line with the relevant provisions of Recommendation 2003/361/EC. The consolidation rules laid down in that Recommendation ensure that any circumvention of that obligation is prevented. Nevertheless, this should not affect the right of such enterprises to identify mediators in their terms and conditions that comply with the criteria set out in this Regulation.

(42)  Since the providers of online intermediation services should always be required to identify mediators with which they are willing to engage, and should be obliged to engage in good faith throughout any mediation attempts conducted pursuant to this Regulation, these obligations should be established in a way that prevents abuse of the mediation system by business users. Business users should also be obliged to engage in mediation in good faith. Providers of online intermediation services should not be obliged to engage in mediation where a business user brings proceedings on a subject in relation to which that business user has previously brought proceedings seeking mediation and the mediator has determined in that case that the business user has not acted in good faith. Providers of online intermediation services should also not be obliged to engage in mediation with business users who have made repeated unsuccessful mediation attempts. These exceptional situations should not limit the business user’s ability to submit a case to mediation where, as determined by the mediator, the subject matter of the mediation is not related to the previous cases.

(43)  In order to facilitate the settlement of disputes relating to the provision of online intermediation services using mediation in the Union, the Commission should, in close cooperation with the Member States, encourage the setting up of specialised mediation organisations, which are currently lacking. The involvement of mediators having specialist knowledge of online intermediation services as well as of the specific industry sectors within which those services are provided should add to the confidence both parties have in the mediation process and should increase the likelihood of that process leading to a swift, just and satisfactory outcome.

(44)  Various factors, such as limited financial means, a fear of retaliation and exclusive choice of law and forum provisions in terms and conditions, can limit the effectiveness of existing judicial redress possibilities, particularly those which require business users or corporate website users to act individually and identifiably. To ensure the effective application of this Regulation, organisations, associations representing business users or corporate website users, as well as certain public bodies set up in Member States, should be granted the possibility to take action before national courts in accordance with national law, including national procedural requirements. Such action before national courts should aim to stop or prohibit infringements of the rules set out in this Regulation and to prevent future damage that could undermine sustainable business relationships in the online platform economy. In order to ensure that such organisations or associations exercise that right effectively and in an appropriate manner, they should meet certain criteria. In particular, they must be properly established according to the law of a Member State, be of a non-profit making character and pursue their objectives on a sustained basis. Those requirements should prevent any ad hoc establishment of organisations or associations for the purpose of a specific action or specific actions, or for the sake of making profits. Furthermore, it should be ensured that there is no undue influence by any third party providers of financing on decision-making by those organisations or associations. In order to avoid a conflict of interest, organisations or associations representing business users or corporate website users should, in particular, be prevented from being subject to undue influence from any providers of online intermediation services or of any online search engines. The full and public disclosure of information on membership and source of financing should facilitate national courts in assessing whether these eligibility criteria are met. Considering the particular status of the relevant public bodies in Member States where such bodies have been set up, it should only be required that those have been specifically charged, in accordance with the relevant rules of national law, with bringing such actions either in the collective interest of the parties concerned or in the general interest, without there being a need to apply those criteria to such public bodies. Any such actions should in no way affect the rights of the business users and corporate website users to take judicial action on an individual basis.

(45)  The identity of organisations, associations and public bodies which, in the view of the Member States, should be qualified to bring an action under this Regulation, should be communicated to the Commission. In the course of such a communication, Member States should make specific reference to the relevant national provisions according to which the organisation, association or public body was established and, where appropriate, refer to the relevant public register in which the organisation or association is registered. This additional option of a designation by Member States should provide for a certain level of legal certainty and predictability that business users and corporate website users can rely on. At the same time, it aims at making judicial procedures more efficient and shorter, which seems appropriate in this context. The Commission should ensure the publication of a list of those organisations, associations and public bodies in the Official Journal of the European Union. Inclusion on that list should serve as refutable proof of the legal capacity of the organisation, association or public body bringing the action. Where there are any concerns regarding a designation, the Member State which designated an organisation, association or public body should investigate those concerns. Organisations, associations and public bodies that are not designated by a Member State should have the possibility to bring an action before national courts subject to examination of legal capacity according to the criteria set out in this Regulation.

(46)  Member States should be required to ensure adequate and effective enforcement of this Regulation. Different enforcement systems already exist in Member States, and they should not be obliged to set up new national enforcement bodies. Member States should have the option to entrust existing authorities, including courts, with the enforcement of this Regulation. This Regulation should not oblige Member States to provide for ex officio enforcement or to impose fines.

(47)  The Commission should continuously monitor the application of this Regulation in close cooperation with the Member States. In this context, the Commission should aim to establish a broad information exchange network by leveraging relevant expert bodies, centres of excellence as well as the Observatory on the Online Platform Economy. Member States should, upon request, provide any relevant information they have in this context to the Commission. Finally, this exercise should benefit from the overall enhanced transparency in commercial relations between business users and providers of online intermediation services and between corporate website users and online search engines that this Regulation aims to achieve. In order to carry out its monitoring and review duties effectively under this Regulation, the Commission should endeavour to gather information from providers of online intermediation services. Providers of online intermediation services should cooperate in good faith in facilitating the gathering of such data, where applicable.

(48)  Codes of conduct, drawn up either by the service providers concerned or by organisations or associations representing them, can contribute to the proper application of this Regulation and should therefore be encouraged. When drawing up such codes of conduct, in consultation with all relevant stakeholders, account should be taken of the specific features of the sectors concerned as well as of the specific characteristics of SMEs. Such codes of conduct should be worded in an objective and non-discriminatory way.

(49)  The Commission should periodically evaluate this Regulation and closely monitor its effects on the online platform economy, in particular with a view to determining the need for amendments in light of relevant technological or commercial developments. This evaluation should include the effects on business users which might result from the general use of exclusive choice of law and forum provisions in terms and conditions which are unilaterally determined by the provider of online intermediation services. In order to obtain a broad view of developments in the sector, the evaluation should take into account the experiences of Member States and relevant stakeholders. The group of experts for the Observatory on the Online Platform Economy established in accordance with the Commission Decision C(2018)2393 has a key role in informing the evaluation of this Regulation by the Commission. The Commission should therefore duly consider the opinions and reports presented to it by the group. Following the evaluation, the Commission should take appropriate measures. Further measures, including of a legislative nature, may be appropriate if and where the provisions established in this Regulation prove to be insufficient to adequately address imbalances and unfair commercial practices persisting in the sector.

(50)  When providing the information required under this Regulation, account should be taken as much as possible of the particular needs of persons with disabilities, in line with the objectives of the United Nations Convention on the Rights of Persons with Disabilities(12).

(51)  Since the objective of this Regulation, namely to ensure a fair, predictable, sustainable and trusted online business environment within the internal market, cannot be sufficiently achieved by the Member States, but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.

(52)  This Regulation seeks to ensure full respect for the right to an effective remedy and to a fair trial as laid down in Article 47 of the Charter of Fundamental Rights of the European Union and promote the application of the freedom to conduct a business as laid down in Article 16 of the Charter,

HAVE ADOPTED THIS REGULATION:

Article 1

Subject-matter and scope

1.  The purpose of this Regulation is to contribute to the proper functioning of the internal market by laying down rules to ensure that business users of online intermediation services and corporate website users in relation to online search engines are granted appropriate transparency, fairness and effective redress possibilities.

2.  This Regulation shall apply to online intermediation services and online search engines provided, or offered to be provided, to business users and corporate website users, respectively, that have their place of establishment or residence in the Union and that, through those online intermediation services or online search engines, offer goods or services to consumers located in the Union, irrespective of the place of establishment or residence of the providers of those services and irrespective of the law otherwise applicable.

3.  This Regulation shall not apply to online payment services or to online advertising tools or online advertising exchanges, which are not provided with the aim of the facilitating the initiation of direct transactions and which do not involve a contractual relationship with consumers.

4.  This Regulation shall be without prejudice to national rules which, in conformity with Union law, prohibit or sanction unilateral conduct or unfair commercial practices, to the extent that the relevant aspects are not covered by this Regulation. This Regulation shall not affect national civil law, in particular contract law, such as the rules on the validity, formation, effects or termination of a contract, in so far as the national civil law rules are in conformity with Union law, and to the extent that the relevant aspects are not covered by this Regulation.

5.  This Regulation shall be without prejudice to Union law, in particular Union law applicable in the areas of judicial cooperation in civil matters, competition, data protection, trade secrets protection, consumer protection, electronic commerce and financial services.

Article 2

Definitions

For the purposes of this Regulation, the following definitions apply:

(1)  'business user' means any private individual acting in a commercial or professional capacity who, or any legal person which, through online intermediation services offers goods or services to consumers for purposes relating to its trade, business, craft or profession;

(2)  'online intermediation services' means services which meet all of the following requirements:

(a)  they constitute information society services within the meaning of point (b) of Article 1(1) of Directive (EU) ▌2015/1535 of the European Parliament and of the Council(13);

(b)  they allow business users to offer goods or services to consumers, with a view to facilitating the initiating of direct transactions between those business users and consumers, irrespective of where those transactions are ultimately concluded;

(c)  they are provided to business users on the basis of contractual relationships between ▌ the provider of those services and ▌ business users which offer goods or services to consumers;

(3)  'provider of online intermediation services' means any natural or legal person which provides, or which offers to provide, online intermediation services to business users;

(4)  'consumer' means any natural person who is acting for purposes which are outside this person's trade, business, craft or profession;

(5)  'online search engine' means a digital service that allows users to input queries in order to perform searches of, in principle, all websites, or all websites in a particular language, on the basis of a query on any subject in the form of a keyword, voice request, phrase or other input, and returns results in any format in which information related to the requested content can be found;

(6)  'provider of online search engine' means any natural or legal person which provides, or which offers to provide, online search engines to consumers;

(7)  'corporate website user' means any natural or legal person which uses an online interface, meaning any software, including a website or a part thereof and applications, including mobile applications, to offer goods or services to consumers for purposes relating to its trade, business, craft or profession;

(8)  'ranking' means the relative prominence given to the goods or services offered ▌ through online intermediation services, or the relevance given to search results by online search engines, as presented, organised or communicated ▌ by the providers of online intermediation services or by providers of online search engines, respectively, irrespective of the technological means used for such presentation, organisation or communication;

(9)  'control' means ownership of, or the ability to exercise decisive influence over, an undertaking, within the meaning of Article 3(2) of Council Regulation (EC) No 139/2004(14);

(10)  'terms and conditions' means all terms and conditions or specifications, irrespective of their name or form, which govern the contractual relationship between the provider of online intermediation services and its business users and are unilaterally determined by the provider of online intermediation services, that unilateral determination being evaluated on the basis of an overall assessment, for which the relative size of the parties concerned, the fact that a negotiation took place, or that certain provisions thereof might have been subject to such a negotiation and determined together by the relevant provider and business user is not, in itself, decisive;

(11)  'ancillary goods and services' means goods and services offered to the consumer prior to the completion of a transaction initiated on the online intermediation services in addition to and complementary to the primary good or service offered by the business user through the online intermediation services;

(12)  ‘mediation’ means any structured process as defined in point (a) of Article 3 of Directive 2008/52/EC ▌;

(13)  ‘durable medium’ means any instrument which enables business users to store information addressed personally to them in a way accessible for future reference and for a period of time adequate for the purposes of the information and allows the unchanged reproduction of the information stored.

Article 3

Terms and conditions

1.  Providers of online intermediation services shall ensure that their terms and conditions:

(a)  are drafted in plain and intelligible language;

(b)  are easily available to business users at all stages of their commercial relationship with the provider of online intermediation services, including in the pre-contractual stage;

(c)  set out the ▌ grounds for decisions to suspend or terminate or impose any other kind of restriction upon, in whole or in part, the provision of their online intermediation services to business users;

(d)  include information on any additional distribution channels and potential affiliate programmes through which providers of online intermediation services might market goods and services offered by business users;

(e)  include general information regarding the effects of the terms and conditions on the ownership and control of intellectual property rights of business users.

2.  Providers of online intermediation services shall notify, on a durable medium, to the business users concerned any proposed changes of their terms and conditions.

The proposed changes shall not be implemented before the expiry of a notice period which is reasonable and proportionate to the nature and extent of the envisaged changes and to their consequences for the business user concerned. That notice period shall be at least 15 days from the date on which the provider of online intermediation services notifies the business users concerned about the proposed changes. Providers of online intermediation services shall grant longer notice periods when this is necessary to allow business users to make technical or commercial adaptations to comply with the changes.

The business user concerned shall have the right to terminate the contract with the provider of online intermediation services before the expiry of the notice period. Such termination shall take effect within 15 days from the receipt of the notice pursuant to the first subparagraph, unless a shorter period applies to the contract.

The business user concerned may, either by means of a written statement or a clear affirmative action, waive the notice period referred to in the second subparagraph at any moment from the receipt of the notice pursuant to the first subparagraph.

During the notice period, submitting new goods or services to the online intermediation services shall be considered clear affirmative action to waive the notice period, except in cases where the reasonable and proportionate notice period is longer than 15 days because the changes to the terms and conditions require the business user to make significant technical adjustments to its goods or services. In such cases, the notice period shall not be considered automatically to be waived where the business user submits new goods and services.

3.  Terms and conditions, or specific provisions thereof, which do not comply with the requirements of paragraph 1, as well as changes to terms and conditions implemented by a provider of online intermediation services contrary to the provisions of paragraph 2 shall be null and void.

4.  The notice period set out in the second subparagraph of paragraph 2 shall not apply where a provider of online intermediation services:

(a)   is subject to a legal or regulatory obligation which requires it to change its terms and conditions in a manner which does not allow it to respect the notice period referred to in the second subparagraph of paragraph 2;

(b)  has exceptionally to change its terms and conditions to address an unforeseen and imminent danger related to defending the online intermediation services, consumers or business users from fraud, malware, spam, data breaches or other cybersecurity risks.

5.  Providers of online intermediation services shall ensure that the identity of the business user providing the goods or services on the online intermediation services is clearly visible.

Article 4

Restriction, suspension and termination

1.  Where a provider of online intermediation services decides to restrict or suspend ▌ the provision of its online intermediation services to a given business user in relation to individual goods or services offered by that business user, it shall provide the business user concerned, prior to or at the time of the restriction or suspension taking effect, with a statement of reasons for that decision on a durable medium.

2.  Where a provider of online intermediation services decides to terminate the provision of the whole of its online intermediation services to a given business user, it shall provide the business user concerned, at least 30 days prior to the termination taking effect, with a statement of reasons for that decision on a durable medium.

3.  In the case of restriction, suspension or termination, the provider of online intermediation services shall give the business user the opportunity to clarify the facts and circumstances in the framework of the internal complaint-handling process referred to in Article 11. Where the restriction, suspension or termination is revoked by the provider of online intermediation services, it shall reinstate the business user without undue delay, including providing the business user with any access to personal or other data, or both, that resulted from its use of the relevant online intermediation services prior to the restriction, suspension or termination having taken effect.

4.  The notice period in paragraph 2 shall not apply where a provider of online intermediation services:

(a)  is subject to a legal or regulatory obligation which requires it to terminate the provision of the whole of its online intermediation services to a given business user in a manner which does not allow it to respect that notice period, or

(b)  exercises a right of termination under an imperative reason pursuant to national law which is in compliance with Union law;

(c)  can demonstrate that the business user concerned has repeatedly infringed the applicable terms and conditions, resulting in the termination of the provision of the whole of the online intermediation services in question.

In cases where the notice period in paragraph 2 does not apply, the provider of online intermediation services shall provide the business user concerned, without undue delay, with a statement of reasons for that decision on a durable medium.

5.  The statement of reasons referred to in paragraphs 1, and 2 and in the second subparagraph of paragraph 4 shall contain a reference to the specific facts or circumstances, including contents of third party notifications, that led to the decision of the provider of online intermediation services, as well as a reference to the applicable grounds for that decision referred to in point (c) of Article 3(1).

A provider of online intermediation services does not have to provide a statement of reasons where it is subject to a legal or regulatory obligation not to provide the specific facts or circumstances or the reference to the applicable ground or grounds, or where a provider of online intermediation services can demonstrate that the business user concerned has repeatedly infringed the applicable terms and conditions, resulting in termination of the provision of the whole of the online intermediation services in question.

Article 5

Ranking

1.  Providers of online intermediation services shall set out in their terms and conditions the main parameters determining ranking and the reasons for the relative importance of those main parameters as opposed to other parameters.

2.  Providers of online search engines shall set out ▌ the main parameters, which individually or collectively are most significant in determining ranking and the relative importance of those main parameters, by providing an easily and publicly available description, drafted in plain and intelligible language, on the online search engines of those providers. They shall keep that description up to date.

3.  Where the main parameters include the possibility to influence ranking against any direct or indirect remuneration paid by business users or corporate website users to the respective provider, that provider shall also set out a description of those possibilities and of the effects of such remuneration on ranking in accordance with the requirements set out in paragraphs 1 and 2.

4.  Where a provider of an online search engine has altered the ranking order in a specific case or delisted a particular website following a third party notification, the provider shall offer the possibility for the corporate website user to inspect the contents of the notification.

5.  The descriptions referred to in paragraphs 1, 2 and 3 shall be sufficient to enable the business users or corporate website users to obtain an adequate understanding of whether, and if so how and to what extent, the ranking mechanism takes account of the following:

(a)  the characteristics of the goods and services offered to consumers through the online intermediation services or the online search engine;

(b)  the relevance of those characteristics for those consumers;

(c)  as regards online search engines, the design characteristics of the website used by corporate website users.

6.  Providers of online intermediation services and providers of online search engines shall, when complying with the requirements of this Article, not be required to disclose algorithms or any information that, with reasonable certainty, would result in the enabling of deception of consumers or consumer harm through the manipulation of search results. This Article shall be without prejudice to Directive (EU) 2016/943.

7.  To facilitate the compliance of providers of online intermediation services and providers of online search engines with and the enforcement of the requirements of this Article, the Commission shall accompany the transparency requirements set out in this Article with guidelines.

Article 6

Ancillary goods and services

Where ancillary goods and services, including financial products, are offered to consumers through the online intermediation services, either by the provider of online intermediation services or by third parties, the provider of online intermediation services shall set out in its terms and conditions a description of the type of ancillary goods and services offered and a description of whether and under which conditions the business user is also allowed to offer its own ancillary goods and services through the online intermediation services.

Article 7

Differentiated treatment

1.  Providers of online intermediation services shall include in their terms and conditions a description of any differentiated treatment which they give, or might give, in relation to goods or services offered to consumers through those online intermediation services by, on the one hand, either that provider itself or any business users which that provider controls and, on the other hand, other business users. That description shall refer to the main economic, commercial or legal considerations for such differentiated treatment.

2.  Providers of online search engines shall set out a description of any differentiated treatment which they give, or might give, in relation to goods or services offered to consumers through those online search engines by, on the one hand, either that provider itself or any corporate website users which that provider controls and, on the other hand, other corporate website users.

3.  The descriptions referred to in paragraphs 1 and 2 shall cover in particular, where applicable, any differentiated treatment through specific measures taken by, or the behaviour of, the provider of online intermediation services or the provider of the online search engine relating to any of the following:

(a)  access that the provider, or that the business users or corporate website users which that provider controls, may have to any personal data or other data, or both, which business users, corporate website users or consumers provide for the use of the online intermediation services or the online search engines concerned or which are generated through the provision of those services;

(b)  ranking or other settings applied by the provider that influence consumer access to goods or services offered through those online intermediation services by other business users or through those online search engines by other corporate website users;

(c)  any direct or indirect remuneration charged for the use of the online intermediation services or online search engines concerned;

(d)  access to, ▌ conditions for, or any direct or indirect remuneration charged for the use of services or functionalities, or technical interfaces, that are relevant to the business user or the corporate website user and that are directly connected or ancillary to utilising the online intermediation services or online search engines concerned.

Article 8

Specific contractual terms

In order to ensure that contractual relations between providers of online intermediation services and business users are conducted in good faith and based on fair dealing, providers of online intermediation services shall:

(a)  not impose retroactive changes to terms and conditions, except when they are required to respect a legal or regulatory obligation or when the retroactive changes are beneficial for the business users;

(b)  ensure that their terms and conditions include information on the conditions under which business users can terminate the contractual relationship with the provider of online intermediation services; and

(c)  include in their terms and conditions a description of the technical and contractual access, or absence thereof, to the information provided or generated by the business user, which they maintain after the expiry of the contract between the provider of online intermediation services and the business user.

Article 9

Access to data

1.  Providers of online intermediation services shall include in their terms and conditions a description of the technical and contractual access, or absence thereof, of business users to any personal data or other data, or both, which business users or consumers provide for the use of the online intermediation services concerned or which are generated through the provision of those services.

2.  Through the description referred to in paragraph 1, providers of online intermediation services shall adequately inform business users in particular of the following:

(a)  whether the provider of online intermediation services has access to personal data or other data, or both, which business users or consumers provide for the use of those services or which are generated through the provision of those services, and if so, to which categories of such data and under what conditions;

(b)  whether a business user has access to personal data or other data, or both, provided by that business user in connection to the business user's use of the online intermediation services concerned or generated through the provision of those services to that business user and the consumers of the business user's goods or services, and if so, to which categories of such data and under what conditions;

(c)  in addition to point (b), whether a business user has access to personal data or other data, or both, including in aggregated form, provided by or generated through the provision of the online intermediation services to all of the business users and consumers thereof, and if so, to which categories of such data and under what conditions; and

(d)  whether any data under point (a) is provided to third parties, along with, where the provision of such data to third parties is not necessary for the proper functioning of the online intermediation services, information specifying the purpose of such data sharing, as well as possibilities for business users to opt out from that data sharing.

3.  This Article shall be without prejudice to the application of Regulation (EU) 2016/679, Directive (EU) 2016/680 and Directive 2002/58/EC.

Article 10

Restrictions to offer different conditions through other means

1.  Where, in the provision of their services, providers of online intermediation services restrict the ability of business users to offer the same goods and services to consumers under different conditions through other means than through those services, they shall include the grounds for that restriction in their terms and conditions and make those grounds easily available to the public. Those grounds shall include the main economic, commercial or legal considerations for those restrictions.

2.  The obligation set out in paragraph 1 shall not affect any prohibitions or limitations in respect of the imposition of such restrictions that result from the application of other acts of Union law or the law of Member States that is in accordance with Union law and to which the providers of online intermediation services are subject.

Article 11

Internal complaint-handling system

1.  Providers of online intermediation services shall provide for an internal system for handling the complaints of business users.

That internal complaint-handling system shall be easily accessible and free of charge for business users and shall ensure handling within a reasonable time frame. It shall be based on the principles of transparency and equal treatment applied to equivalent situations, and treating complaints in a manner which is proportionate to their importance and complexity. It shall allow business users to lodge complaints directly with the provider concerned regarding any of the following issues:

(a)  alleged non-compliance by that provider with any ▌ obligations laid down in this Regulation which ▌ affects the business user lodging the complaint (“the complainant”);

(b)  technological issues which relate directly to the provision of online intermediation services, and which ▌ affect the complainant ▌;

(c)  measures taken by, or behaviour of, that provider which relate directly to the provision of the online intermediation services, and which ▌ affect the complainant ▌.

2.  As part of their internal complaint-handling system, providers of online intermediation services shall:

(a)  duly consider complaints lodged and the follow-up which they may need to give to the complaint in order to adequately address the issue raised ▌;

(b)  process complaints swiftly and effectively, taking into account the importance and complexity of the issue raised;

(c)  communicate to the complainant the outcome of the internal complaint-handling process, in an individualised manner and drafted in plain and intelligible language.

3.  Providers of online intermediation services shall provide in their terms and conditions all relevant information relating to the access to and functioning of their internal complaint-handling system.

4.  Providers of online intermediation services shall ▌ establish and make easily available to the public information on the functioning and effectiveness of their internal complaint-handling system. They shall verify the information at least annually and where significant changes are needed, they shall update that information.

That information shall include the total number of complaints lodged, the main types of complaints, the average time period needed to process the complaints and aggregated information regarding the outcome of the complaints.

5.  The provisions of this Article shall not apply to providers of online intermediation services that are small enterprises within the meaning of the Annex to Recommendation 2003/361/EC▌.

Article 12

Mediation

1.  Providers of online intermediation services shall identify in their terms and conditions two or more mediators with which they are willing to engage to attempt to reach an agreement with business users on the settlement, out of court, of any disputes between the provider and the business user arising in relation to the provision of the online intermediation services concerned, including complaints that could not be resolved by means of the internal complaint-handling system referred to in Article 11.

Providers of online intermediation services may only identify mediators providing their mediation services from a location outside the Union where it is ensured that the business users concerned are not effectively deprived of the benefit of any legal safeguards laid down in Union law or the law of the Member States as a consequence of the mediators providing those services from outside the Union.

2.  The mediators referred to in paragraph 1 shall meet the following requirements:

(a)  they are impartial and independent;

(b)  their mediation services are affordable for ▌ business users of the online intermediation services concerned;

(c)  they are capable of providing their mediation services in the language of the terms and conditions which govern the contractual relationship between the provider of online intermediation services and the business user concerned;

(d)  they are easily accessible either physically in the place of establishment or residence of the business user, or remotely using communication technologies;

(e)  they are capable of providing their mediation services without undue delay;

(f)  they have a sufficient understanding of general business-to-business commercial relations, allowing them to contribute effectively to the attempt to settle the disputes.

3.  Notwithstanding the voluntary nature of mediation, providers of online intermediation services and business users shall engage in good faith throughout any mediation attempts conducted pursuant to this Article.

4.  Providers of online intermediation services shall bear a reasonable proportion of the total costs of mediation in each individual case. A reasonable proportion of those total costs shall be determined, on the basis of a suggestion by the mediator, by taking into account all relevant elements of the case at hand, in particular the relative merits of the claims of the parties to the dispute, the conduct of the parties, as well as the size and financial strength of the parties relative to one another. ▌

5.  Any attempt to reach an agreement through mediation on the settlement of a dispute in accordance with this Article shall not affect the rights of the providers of online intermediation services and of the business users concerned to initiate judicial proceedings at any time before, during or after the mediation process.

6.  If requested by a business user, before entering into or during mediation, the provider of online intermediation services shall make available, to the business user, information on the functioning and effectiveness of mediation related to its activities.

7.  The obligation set out in paragraph 1 shall not apply to providers of online intermediation services that are small enterprises within the meaning of the Annex to Recommendation 2003/361/EC.

Article 13

Specialised mediators

The Commission shall, in close cooperation with the Member States, encourage providers of online intermediation services as well as organisations and associations representing them to, individually or jointly, set up one or more organisations providing mediation services which meet the requirements specified in Article 12(2), for the specific purpose of facilitating the out-of-court settlement of disputes with business users arising in relation to the provision of those services, taking particular account of the cross-border nature of online intermediation services.

Article 14

Judicial proceedings by representative organisations or associations and by public bodies

1.  Organisations and associations that have a legitimate interest in representing business users or in representing corporate website users, as well as public bodies set up in Member States, shall have the right to take action before competent national courts in the Union, in accordance with the rules of the law of the Member State where the action is brought, to stop or prohibit any non-compliance by providers of online intermediation services or by providers of online search engines, with the relevant requirements laid down in this Regulation.

2.  The Commission shall encourage Member States to exchange best practices and information with other Member States, based on registries of unlawful acts which have been subject to injunction orders before national courts, where such registries are set up by relevant public bodies or authorities.

3.  Organisations or associations shall have the right referred to in paragraph 1 only where ▌ they meet all of the following requirements:

(a)  they are properly established in accordance with the law of a Member State;

(b)  they pursue objectives that are in the collective interest of the group of business users or corporate website users that they represent on a sustained basis;

(c)  they are of a non-profit making character;

(d)  their decision-making is not unduly influenced by any third party providers of financing, in particular by providers of online intermediation services or of online search engines.

To this end, organisations or associations shall fully and publicly disclose information on their membership and source of financing.

4.  In Member States where ▌ public bodies have been set up, those public bodies shall have the right referred to in paragraph 1, where they are charged with defending the collective interests of business users or corporate website users or with ensuring compliance with the requirements laid down in this Regulation, in accordance with the national law of the Member State concerned.

5.  Member States may designate:

(a)  organisations or associations established in their Member State that meet at least the requirements of paragraph 3 at the request of those organisations or associations;

(b)  public bodies set up in their Member State that meet the requirements of paragraph 4

that are granted the right referred to in paragraph 1. Member States shall communicate to the Commission the name and purpose of any such designated organisations, associations or public bodies.

6.  The Commission shall draw up a list of the organisations, associations and public bodies designated in accordance with paragraph 5. That list shall specify the purpose of those organisations, associations and public bodies. That list shall be published in the Official Journal of the European Union. Changes to the list shall be published without delay and, in any event, an updated list shall be drawn up and published every six months.

7.  The court shall accept the list referred to in paragraph 6 as proof of the legal capacity of the organisation, association or public body, without prejudice to the court’s right to examine whether the purpose of the claimant justifies its taking action in a specific case.

8.  If a Member State or the Commission raises concerns regarding the compliance, by an organisation or association, with the criteria laid down in paragraph 3, or, by a public body, with the criteria laid down in paragraph 4, the Member State that designated that organisation, association or public body in accordance with paragraph 5 shall investigate the concerns and, where appropriate, revoke the designation if one or more of the criteria are not complied with.

9.  The right referred to in paragraph 1 shall be without prejudice to the rights of business users and corporate website users to start any action before competent national courts, in accordance with the rules of the law of the Member State where the action is brought, which is based on individual rights and aims to stop any non-compliance, by providers of online intermediation services or providers of online search engines, with the relevant requirements laid down in this Regulation.

Article 15

Enforcement

1.  Each Member State shall ensure adequate and effective enforcement of this Regulation.

2.  Member States shall lay down the rules setting out the measures applicable to infringements of this Regulation and shall ensure that they are implemented. The measures provided for shall be effective, proportionate and dissuasive.

Article 16

Monitoring

The Commission, in close cooperation with Member States, shall closely monitor the impact of this Regulation on relationships between online intermediation services and their business users and between online search engines and corporate website users. To this end, the Commission shall gather relevant information to monitor changes in these relationships, including by carrying out relevant studies. Member States shall assist the Commission by providing, upon request, any relevant information gathered including about specific cases. The Commission may, for the purpose of this Article and Article 18, seek to gather information from providers of online intermediation services.

Article 17

Codes of conduct

1.  The Commission shall encourage the drawing up of codes of conduct by providers of online intermediation services and by organisations and associations representing them, together with business users, including SMEs and their representative organisations, that are intended to contribute to the proper application of this Regulation, taking account of the specific features of the various sectors in which online intermediation services are provided, as well as of the specific characteristics of SMEs.

2.  The Commission shall encourage providers of online search engines and organisations and associations representing them to draw up codes of conduct that are specifically intended to contribute to the proper application of Article 5 ▌.

3.  The Commission shall encourage the providers of online intermediation services to adopt and implement sector-specific codes of conduct, where such sector-specific codes of conduct exist and are widely used.

Article 18

Review

1.  By ... [18 months after the date of application of this Regulation], and subsequently every three years, the Commission shall evaluate this Regulation and report to the European Parliament, the Council and the European Economic and Social Committee.

2.  The first evaluation of this Regulation shall be carried out, in particular, with a view to the following:

(a)   assessing the compliance with, and impact on the online platform economy of, the obligations laid down in Articles 3 to 10;

(b)  assessing the impact and effectiveness of any established codes of conduct to improve fairness and transparency;

(c)  investigating further the problems caused by the dependence of business users on online intermediation services, and problems caused by unfair commercial practices by providers of online intermediation services, and to determine further to which extent those practices continue to be widespread;

(d)  investigating whether the competition between goods or services offered by a business user and goods or services offered or controlled by a provider of online intermediation services constitutes fair competition and whether providers of online intermediation services misuse privileged data in this regard;

(e)  assessing the effect of this Regulation on any possible imbalances in the relationships between providers of operating systems and their business users;

(f)  assessing whether the scope of the Regulation, especially as regards the definition of ‘business user’, is suitable in that it does not encourage bogus self-employment.

The first and subsequent evaluations shall establish whether additional rules, including regarding enforcement, may be required to ensure a fair, predictable, sustainable and trusted online business environment within the internal market. Following the evaluations, the Commission shall take appropriate measures, which may include legislative proposals.

3.  Member States shall provide any relevant information they have that the Commission may require for the purposes of drawing up the report referred to in paragraph 1.

4.  In carrying out the evaluation of this Regulation, the Commission shall take into account inter alia, the opinions and reports presented to it by the group of experts for the Observatory on the Online Platform Economy. It shall also take into account the content and functioning of any codes of conduct referred to in Article 17, where appropriate.

Article 19

Entry into force and application

1.  This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

2.  It shall apply from ... [twelve months after the date of its publication].

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at ...,

For the European Parliament For the Council

The President The President

(1) OJ C 440, 6.12.2018, p. 177.
(2)OJ C 440, 6.12.2018, p. 177.
(3) Position of the European Parliament of 17 April 2019.
(4) Regulation (EU) No 1215/2012 of the European Parliament and of the Council of 12 December 2012 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters, (OJ L 351, 20.12.2012, p. 1).
(5) Regulation (EC) No 593/2008 of the European Parliament and of the Council of 17 June 2008 on the law applicable to contractual obligations (Rome I), (OJ L 177, 4.7.2008, p. 6).
(6)Directive (EU) 2016/943 of the European Parliament and of the Council of 8 June 2016 on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure (OJ L 157, 15.6.2016, p. 1).
(7)Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).
(8) Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, and on the free movement of such data, and repealing Council Framework Decision 2008/977/JHA (OJ L 119, 4.5.2016, p. 89).
(9) Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications) (OJ L 201, 31.7.2002, p. 37).
(10)Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p36).
(11) Directive 2008/52/EC of the European Parliament and of the Council of 21 May 2008 on certain aspects of mediation in civil and commercial matters (OJ L 136, 24.5.2008, p. 3).
(12)Council Decision 2010/48/EC of 26 November 2009 concerning the conclusion, by the European Community, of the United Nations Convention on the Rights of Persons with Disabilities (OJ L 23, 27.1.2010, p.37.).
(13)Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1).
(14)Council Regulation (EC) No 139/2004 of 20 January 2004 on the control of concentrations between undertakings (the EC Merger Regulation) (OJ L 24, 29.1.2004, p. 1).


Better enforcement and modernisation of EU consumer protection rules ***I
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Resolution
Consolidated text
European Parliament legislative resolution of 17 April 2019 on the proposal for a directive of the European Parliament and of the Council amending Council Directive 93/13/EEC of 5 April 1993, Directive 98/6/EC of the European Parliament and of the Council, Directive 2005/29/EC of the European Parliament and of the Council and Directive 2011/83/EU of the European Parliament and of the Council as regards better enforcement and modernisation of EU consumer protection rules (COM(2018)0185 – C8-0143/2018 – 2018/0090(COD))
P8_TA-PROV(2019)0399A8-0029/2019

(Ordinary legislative procedure: first reading)

The European Parliament,

–  having regard to the Commission proposal to Parliament and the Council (COM(2018)0185),

–  having regard to Article 294(2) and Article 114 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8‑0143/2018),

–  having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–  having regard to the reasoned opinions submitted, within the framework of Protocol No 2 on the application of the principles of subsidiarity and proportionality, by the Austrian Federal Council and the Swedish Parliament, asserting that the draft legislative act does not comply with the principle of subsidiarity,

–  having regard to the opinion of the European Economic and Social Committee of 20 September 2018(1),

–  having regard to the provisional agreement approved by the committee responsible under Rule 69f(4) of its Rules of Procedure and the undertaking given by the Council representative by letter of 29 March 2019 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,

–  having regard to Rule 59 of its Rules of Procedure,

–  having regard to the report of the Committee on the Internal Market and Consumer Protection (A8-0029/2019),

1.  Adopts its position at first reading hereinafter set out;

2.  Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

3.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Position of the European Parliament adopted at first reading on 17 April 2019 with a view to the adoption of Directive (EU) 2019/… of the European Parliament and of the Council amending Council Directive 93/13/EEC ▌, Directive 98/6/EC of the European Parliament and of the Council, Directive 2005/29/EC of the European Parliament and of the Council and Directive 2011/83/EU of the European Parliament and of the Council as regards better enforcement and modernisation of EU consumer protection rules(2)

P8_TC1-COD(2018)0090


(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee(3),

Acting in accordance with the ordinary legislative procedure(4),

Whereas:

(1)  Article 169(1) and point (a) of Article 169(2) of the Treaty on the Functioning of the European Union (TFEU) provide that the Union is to contribute to the attainment of a high level of consumer protection through measures adopted pursuant to Article 114 TFEU. Article 38 of the Charter of Fundamental Rights of the European Union provides that Union policies are to ensure a high level of consumer protection.

(2)  Consumer protection legislation should be applied effectively throughout the Union. Yet, the comprehensive Fitness Check of consumer and marketing law directives carried out by the Commission in 2016 and 2017 in the framework of the Regulatory Fitness and Performance (REFIT) programme concluded that the effectiveness of the Union consumer legislation is compromised by lack of awareness both among traders and consumers and as a consequence existing means of redress could be more often taken advantage of.

(3)  The Union has already taken a number of measures to improve awareness among consumers, traders and legal practitioners about consumer rights and to improve enforcement of consumer rights and consumer redress. However, there are remaining gaps ▌ in national laws regarding truly effective and proportionate penalties to deter and sanction intra-Union infringements, insufficient individual remedies for consumers harmed by breaches of national legislation transposing Directive 2005/29/EC(5) and shortcomings of the injunctions procedure under Directive 2009/22/EC(6). Revision of the injunctions procedure should be addressed by a separate instrument amending and replacing Directive 2009/22/EC.

(4)  Directives 98/6/EC(7), 2005/29/EC and 2011/83/EU(8) include requirements for Member States to provide for effective, proportionate and dissuasive penalties to address infringements of national provisions transposing these directives. Furthermore, Article 21 of Regulation (EU) 2017/2394(9) on consumer protection cooperation (CPC) requires Member States to take enforcement measures, including imposition of penalties, in an effective, efficient and coordinated manner to bring about the cessation or prohibition of widespread infringements or widespread infringements with a Union dimension.

(5)  Current national rules on penalties differ significantly across the Union. In particular not all Member States ensure that effective, proportionate and dissuasive fines can be imposed on infringing traders for widespread infringements or widespread infringements with a Union dimension. Therefore, the existing rules on penalties of Directives 98/6/EC, 2005/29/EC and 2011/83/EU should be improved and at the same time new rules on penalties in Directive 93/13/EEC(10) should be introduced.

(6)   It should remain a matter for the Member States to choose the type of penalties to be imposed and to lay down in their national law the relevant procedures to impose penalties in the event of infringements of the Directives amended by this Directive.

(7)  To facilitate more consistent application of penalties, in particular in intra-Union infringements, widespread infringements and widespread infringements with a Union dimension referred to in Regulation (EU) 2017/2394, common non-exhaustive and indicative criteria should be introduced for the application of penalties. These criteria should include, for example the nature, gravity, scale and duration of the infringement, and any redress provided by the trader to consumers for the harm caused ▌. Repeated infringements by the same perpetrator shows a propensity to commit such infringements and is therefore a significant indication of the gravity of the conduct and, accordingly, of the need to increase the level of the penalty to achieve effective deterrence. The ▌financial benefits gained, or losses avoided, due to the infringement should be taken into account, if the relevant data are available. Other aggravating or mitigating factors applicable to the circumstances of the case may also be taken into account.

(8)  These common non-exhaustive and indicative criteria for the application of penalties may not be relevant in deciding on penalties regarding every infringement, in particular regarding non-serious infringements. Member States should also take account of other general principles of law applicable to the imposition of penalties, such as the principle of non bis in idem.

(9)  In accordance with Article 21 of Regulation (EU) 2017/2394 Member States' competent authorities concerned by the coordinated action are to take within their jurisdiction all necessary enforcement measures against the trader responsible for the widespread infringement or the widespread infringement with a Union dimension to bring about the cessation or prohibition of that infringement. Where appropriate, they are to impose penalties, such as fines or periodic penalty payments, on the trader responsible for the widespread infringement or the widespread infringement with a Union dimension. Enforcement measures are to be taken in an effective, efficient and coordinated manner to bring about the cessation or prohibition of the widespread infringement or the widespread infringement with a Union dimension. The competent authorities concerned by the coordinated action are to seek to take enforcement measures simultaneously in the Member States concerned by that infringement.

(10)  To ensure that Member State authorities can impose effective, proportionate and dissuasive penalties in relation to widespread infringements of consumer law and to widespread infringements with a Union dimension that are subject to coordinated investigation and enforcement in accordance with Regulation (EU) 2017/2394, fines should be introduced as an element of penalties for such infringements. In order to ensure deterrence of the fines, Member States should set in their national law the maximum fine for such infringements at a level that is at least 4% of the trader's annual turnover in the Member State or Member States concerned. Trader in certain cases can also be a group of companies.

(11)  As laid down in Articles 9 and 10 of Regulation (EU) 2017/2394, when imposing penalties due regard should be given, as appropriate, to the nature, gravity and duration of the infringement in question. The imposition of penalties should be proportionate and should comply with Union and national law, including with applicable procedural safeguards, and with the principles of the Charter of Fundamental Rights of the European Union. Finally, the penalties adopted should be appropriate to the nature and the overall actual or potential harm of the infringement of Union laws that protect consumers’ interests. The power to impose penalties is to be exercised either directly by competent authorities under their own authority, or, where appropriate, by recourse to other competent authorities or other public authorities, or by instructing designated bodies, if applicable, or by application to courts competent to grant the necessary decision, including, where appropriate, by appeal, if the application to grant the necessary decision is not successful.

(12)  Where, as a result of the coordination mechanism under Regulation (EU) 2017/2394, a single national competent authority within the meaning of that Regulation imposes a fine on the trader responsible for the widespread infringement or the widespread infringement with a Union dimension, it should be able to impose a fine at least 4 % of the trader’s annual turnover in all Member States concerned by the coordinated enforcement action.

(13)  Member States should not be prevented from maintaining or introducing in their national law higher maximum turnover-based fines for widespread infringements and widespread infringements with a Union dimension of consumer law, as defined in Regulation (EU) 2017/2394. It should also be possible for Member States to base such fines on trader’s worldwide turnover, or to extend the rules on fines to other infringements not covered by provisions of this Directive related to Article 21 of Regulation (EU) 2017/2394. Moreover, in cases where no information on trader’s annual turnover is available, Member States should not be prevented from maintaining or introducing other rules providing for fines. The requirement to set the fine at a level of not less than 4 % of the trader's turnover should not apply to any additional rules of the Member States on periodic penalty payments, such as daily fines, for non-compliance with any decision, order, interim measure, trader's commitment or other measure with the aim of stopping the infringement.

(14)  Rules on penalties should be provided in Directive 93/13/EEC with a view to strengthening its deterrent effect. Member States are free to decide on the administrative or judicial procedure of application of penalties for the breaches of Directive 93/13/EEC. In particular, administrative authorities or national courts could impose penalties when establishing the unfair character of contractual clauses, including on the basis of legal proceedings initiated by an administrative authority. The penalties could also be applied by national courts or administrative authorities when the trader uses contractual terms which are expressly defined as unfair in all circumstances according to the national law as well as when the trader uses contractual term which has been found unfair by a final binding decision. Member States could decide that administrative authorities also have the right to establish the unfair character of contractual clauses. National courts or administrative authorities could also apply the penalty through the same decision by which unfairness of contractual terms is established. It is also for Member States to lay down the appropriate mechanisms of coordination of any actions at domestic level regarding individual redress and penalties.

(15)  When allocating revenues from fines ▌, Member States should consider enhancing the protection of the general interest of consumers as well as other protected public interests. ▌

(16)  Member States should ensure that remedies are available for consumers harmed by unfair commercial practices in order to eliminate all the effects of those unfair practices. A clear framework for individual remedies would facilitate private enforcement. The consumer should have access to compensation for damages and, where relevant, price reduction or contract termination, in a proportionate and effective manner. Member States should not be prevented from maintaining or introducing rights to other remedies such as repair or replacement for consumers harmed by unfair commercial practices in order to ensure full removal of the effects of such practices. Member States should not be prevented from determining conditions for the application and effects of remedies for consumers. When applying the remedies, the gravity and nature of the unfair commercial practice, damages suffered by the consumer and other relevant circumstances, such as the trader's misconduct or the infringement of the contract, could be taken into account, where appropriate.

(17)  The Fitness Check of consumer and marketing law directives and the parallel evaluation of Directive 2011/83/EU also identified a number of areas where the existing consumer protection rules should be modernised ▌. In the context of continuous development of digital tools constant adjustment of consumer protection legislation is necessary.

(18)  Higher ranking or any prominent placement of commercial offers within online search results made by the providers of online search functionality has an important impact on consumers.

(19)  Ranking refers to the relative prominence of the offers of traders or relevance given to search results as presented, organised or communicated by providers of online search functionality, including resulting from the use of algorithmic sequencing, rating or review mechanisms, visual highlights, or other saliency tools, or combinations thereof.

(20)  In this regard, a new item should be added to Annex I of Directive 2005/29/EC in order to make it clear that practices where a trader provides information to a consumer in the form of search results in response to the consumer’s online search query without disclosing paid advertising or payment specifically for achieving higher ranking of products within the search results should be prohibited. When a trader has directly or indirectly paid the provider of the online search functionality for a higher ranking of a product within the search results, the provider of the online search functionality should inform consumers thereof in a concise, easy and intelligible form. Indirect payment could be in the form of the acceptance by a trader of additional obligations towards the provider of the online search functionality of any kind which have higher ranking as its specific effect. The indirect payment could consist of increased commision per transaction as well as different compensation schemes that specifically lead to higher ranking. Payments for general services, such as listing fees or membership subscriptions, which address a broad range of functionalities offered by the provider of the online search functionality to the trader should not be considered as a payment for specifically achieving higher ranking of products, provided that such payments are not dedicated to achieving higher ranking. Online search functionality can be provided by different types of online traders, including intermediaries, such as online market places, search engines and comparison websites.

(21)  Transparency requirements with regard to the main parameters of ranking are also regulated by Regulation (EU) 2019/... of the European Parliament and of the Council(11)(12) on promoting fairness and transparency for business users of online intermediation services. The transparency requirements under Regulation (EU) 2019/...(13)+ covers a broad range of online intermediaries, including online marketplaces, but they only apply between traders and online intermediaries. Similar requirements should therefore be introduced in Directive 2005/29/EC to ensure adequate transparency towards the consumers, except in the case of providers of online search engines which are already required by the Regulation (EU) 2019/...++ to set out the main parameters, which individually or collectively are most significant in determining ranking and the relative importance of those main parameters, by providing an easily and publicly available description, drafted in plain and intelligible language on the online search engines of those providers.

(22)  Traders enabling consumers to search for goods and services, such as travel, accommodation and leisure activities, offered by different traders or by consumers should inform consumers about the default main parameters determining ranking of offers presented to the consumer as a result of the search query and their relative importance as opposed to other parameters. This information should be succinct and made easily, prominently and directly available. Parameters determining the ranking mean any general criteria, processes, specific signals incorporated into algorithms or other adjustment or demotion mechanisms used in connection with the ranking.

(23)  The information requirement regarding the main parameters of ranking is without prejudice to Directive (EU) 2016/943(14). Traders should not be required to disclose the detailed functioning of their ranking mechanisms, including algorithms. Traders should provide a general description of the main ranking parameters that explains the main default parameters used by the trader and their relative importance as opposed to other parameters, however it does not have to be presented in a customized manner for each individual search query.

(24)  When products are offered to consumers in online marketplaces, both the online marketplace and the third party supplier are involved in the provision of the pre-contractual information required by Directive 2011/83/EU. As a result, consumers using the online marketplace may not clearly understand who their contractual partners are and how their rights and obligations are affected.

(25)  Online marketplaces should be defined for the purposes of Directive 2011/83/EU in a similar manner as in Regulation (EU) 524/2013(15) and Directive 2016/1148/EU(16). However, the definition should be updated and rendered more technologically neutral in order to cover new technologies. It is therefore appropriate to refer, instead of a 'website', to the software, including a website, part of a website or an application that is operated by or on behalf of the trader, in accordance with the notion of an 'online interface' as provided by Regulation (EU) 2017/2394 and Regulation (EU) 2018/302(17).

(26)  Specific transparency requirements for online marketplaces should therefore be provided in Directive 2005/29/EU and Directive 2011/83/EU to inform consumers using online marketplaces about the main parameters determining ranking of offers, and whether they enter into a contract with a trader or a non-trader (such as another consumer) ▌ .

(27)  Online marketplaces should inform the consumers whether the third party offering goods, services or digital content is a trader or non-trader, on the basis of a declaration by the third party to the online marketplace. When the third party offering the goods, services or digital content declares its status as non-trader, online marketplaces should provide a short statement that the consumer rights stemming from Union consumer protection legislation do not apply to the contract concluded. Furthermore, consumers should be informed how the obligations related to the contract are shared between the third party offering the goods, services or digital content and the provider of the online market place. The information should be provided in a clear and comprehensible manner and not only through a reference in the standard Terms and Conditions or similar contractual document. The information requirements for online marketplaces should be proportionate and need to strike a balance between a high level of consumer protection and the competitiveness of online marketplaces. Online marketplaces should not be required to list specific consumer rights when informing consumers about their applicability or non-applicability. This is without prejudice to the consumer information requirements provided in Directive 2011/83/EU, in particular Article 6(1). The information to be provided about the responsibility for ensuring consumer rights depends on the contractual arrangements between the online marketplace and the relevant third party traders. Online marketplace may refer to the third party trader as being solely responsible for ensuring consumer rights or describe its specific responsibilities where it assumes the responsibility for certain aspects of the contract, for example, delivery or the exercise of the right of withdrawal.

(28)  In accordance with Article 15(1) of Directive 2000/31/EC(18), online marketplaces should not be required to verify the legal status of third party suppliers. Instead, the online marketplace should require third party suppliers of products on the online marketplace to indicate their status as traders or non-traders for the purposes of consumer law and to provide this information to the online marketplace.

(29)  Taking into account the rapid technological developments concerning online marketplaces and the need to ensure a higher level of consumer protection, Member States should be able to adopt or maintain specific additional measures for that purpose. Such provisions should be proportionate, non-discriminatory and without prejudice to Directive 2003/31/EC.

(30)  The definitions of digital content and digital services in Directive 2011/83/EU should be aligned to those in the Directive (EU) 2019/... of the European Parliament and of the Council(19)(20). Digital content covered by the Directive (EU) 2019/...(21)+ covers single act of supply, a series of individual acts of supply, or continuous supply over a period of time. The element of continuous supply should not necessarily require a long-term supply. Cases such as web-streaming of video clips should be considered continuous supply over a period of time, regardless of the actual duration of the audio-visual file. It may therefore be difficult to distinguish between certain types of digital content and digital services, since both can involve continuous supply by the trader over the duration of the contract ▌. Examples of digital services are video and audio sharing services and other file hosting, word processing or games offered in the cloud, cloud storage, webmail, social media and cloud applications. The continuous involvement of the service provider justifies the application of the rules on the right of withdrawal provided in Directive 2011/83/EU that effectively allow the consumer to test the service and decide, during the 14-day period from the conclusion of the contract, whether to keep it or not. ▌Contracts for the supply of digital content which is not supplied on a tangible medium are characterised by a single act of supply to the consumer a specific piece or pieces of digital content, such as specific music or video files. They remain subject to the exception from the right of withdrawal in Article 16(m), which provides that the consumer loses the right of withdrawal when the performance of the contract is started, such as download or streaming of the ▌content, subject to consumer’s prior express consent to begin the performance during the right of withdrawal period and acknowledgement that he thereby lost his right. In case of doubt, as to whether the contract is a service contract or contract for digital content which is not supplied on a tangible medium, the right of withdrawal rules for services should be applied.

(31)  Digital content and digital services are often supplied online under contracts where the consumer does not pay a price but provides personal data to the trader. Directive 2011/83/EU already applies to contracts for the supply of digital content which is not supplied on a tangible medium (i.e. supply of online digital content) regardless of whether the consumer pays a price in money or provides personal data. In contrast, Directive 2011/83/EU only applies to service contracts, including contracts for digital services, under which the consumer pays or undertakes to pay a price. Consequently, that Directive does not apply to contracts for digital services under which the consumer provides personal data to the trader without paying a price. Given their similarities and the interchangeability of paid digital services and digital services provided in exchange for personal data, they should be subject to the same rules under Directive 2011/83/EU.

(32)  Consistency should be ensured between the scope of application of Directive 2011/83/EU and the Directive (EU) 2019/...(22), which applies to contracts for the supply of digital content or digital services under which the consumer provides or undertakes to provide personal data to the trader.

(33)  Therefore, the scope of Directive 2011/83/EU should be extended to cover also contracts under which the trader supplies or undertakes to supply a digital service to the consumer, and the consumer provides or undertakes to provide personal data. Similar to contracts for the supply of digital content which is not supplied on a tangible medium, the Directive should apply whenever the consumer provides or undertakes to provide personal data to the trader, except where the personal data provided by the consumer is exclusively processed by the trader for supplying the digital content or digital service, and the trader does not process this data for any other purpose. Any processing of personal data should comply with Regulation (EU) 2016/679.

(34)  In order to ensure full alignment with Directive (EU) 2019/...(23), where digital content and digital services are not supplied in exchange for a price, Directive 2011/83/EU should also not apply to situations where the trader collects personal data ▌for the sole purpose of meeting legal requirements to which the trader is subject. Such situations could include cases where the registration of the consumer is required by applicable laws for security and identification purposes ▌.

(35)  Directive 2011/83/EU should also not apply to situations where the trader only collects metadata, such as information concerning the consumer’s device or the browsing history ▌, except where this situation is considered a contract under national law. It should also not apply to situations where the consumer, without having concluded a contract with the trader, is exposed to advertisements exclusively in order to gain access to digital content or a digital service. However, Member States should remain free to extend the application of the rules of Directive 2011/83/EU to such situations or to otherwise regulate such situations which are excluded from the scope of that Directive.

(36)  The notion of functionality should refer to the ways in which digital content or a digital service can be used. For instance, the absence or presence of any technical restrictions such as protection via Digital Rights Management or region coding may have an impact on the possibility of the digital content or digital service to perform all its functions having regard to its purpose. The notion of interoperability describes whether and to what extent digital content or a digital service is able to function with hardware or software different from the ones with which digital content or services of the same type are normally used. The successful functioning would include, for instance, the ability of the digital content or digital service to exchange information with such other software or hardware and to use the information exchanged. The notion of compatibility is defined in Directive (EU) 2019/...(24).

(37)  Article 7(3) and Article 8(8) of Directive 2011/83/EU require traders, for off-premises and distance contracts respectively, to obtain the consumer’s prior express consent to begin performance before the expiry of the right of withdrawal period. Article 14(4)(a) provides for a contractual sanction when this requirement is not fulfilled by the trader, namely, the consumer does not have to pay for the services provided. The requirement to obtain consumer’s express consent is accordingly only relevant for services, including digital services, which are provided against the payment of the price. It is therefore necessary to amend Article 7(3) and Article 8(8) to the effect that the requirement for traders to obtain the consumer’s prior consent only applies to service contracts that place the consumer under an obligation to pay.

(38)  Article 16(m) of Directive 2011/83/EU provides for an exception to the right of withdrawal in respect of digital content that is not supplied on a tangible medium if the consumer has given prior consent to begin the performance before the expiry of the right of withdrawal period and acknowledged that he thereby loses the right of withdrawal. Article 14(4)(b) of Directive 2011/83/EU provides for a contractual sanction when this requirement is not fulfilled by the trader, namely, the consumer does not have to pay for the digital content consumed. The requirement to obtain consumer’s express consent and acknowledgment is accordingly only relevant for digital content, which is provided against the payment of the price. It is therefore necessary to amend Article 16(m) to the effect that the requirement for traders to obtain the consumer’s prior consent and acknowledgment only applies to contracts that place the consumer under an obligation to pay.

(39)  Article 7(4) of Directive 2005/29/EC sets out information requirements for the 'invitation to purchase' a product at a specific price. These information requirements apply already at the advertising stage, whilst Directive 2011/83/EU imposes the same and other, more detailed information requirements at the later pre-contractual stage (i.e. just before the consumer enters into a contract). Consequently, traders may be required to provide the same information in advertising (e.g. an online ad on a media website) and at the pre-contractual stage (e.g. on the pages of their online web-shops).

(40)  The information requirements under Article 7(4) of Directive 2005/29/EC include informing the consumer about the trader’s complaint handling policy. The Fitness Check findings show that this information is most relevant at the pre-contractual stage, which is governed by Directive 2011/83/EU. The requirement to provide this information in invitations to purchase at the advertising stage under Directive 2005/29/EC should therefore be deleted.

(41)  Article 6(1)(h) of Directive 2011/83/EU requires traders to provide consumers with pre-contractual information about the right of withdrawal, including the model withdrawal form set out in Annex I(B) of the Directive. Article 8(4) of Directive 2011/83/EU provides for simpler pre-contractual information requirements if the contract is concluded through a means of distance communication which allows limited space or time to display the information, such as over the telephone, via voice operated shopping assistants or by SMS. The mandatory pre-contractual information requirements to be provided on or through that particular means of distance communisation include information regarding the right of withdrawal as referred to in point (h) of Article 6(1). Accordingly, they include also the provision of the model withdrawal form set out in Annex I(B) of the Directive. However, the provision of the withdrawal form is impossible when contract is concluded by means such as telephone or voice operated shopping assistant and it may not be technically feasible in a user-friendly way on other means of distance communication covered by Article 8(4). It is therefore appropriate to exclude the provision of the model withdrawal form from the information that traders have to provide in any case on or through the particular means of distance communisation used for the conclusion of the contract under Article 8(4) of Directive 2011/83/EU.

(42)  Article 16(a) of Directive 2011/83/EU provides for an exception from the right of withdrawal regarding service contracts that have been fully performed if the performance has begun with the consumer’s prior express consent and with the acknowledgement that he will lose the right of withdrawal once the contract has been fully performed by the trader. In contrast, Article 7(3) and 8(8) of Directive 2011/83/EU, which deal with the trader’s obligations in situations where the performance of the contract is begun before the expiry of the right of withdrawal period, only require traders to obtain consumer’s prior express consent but not acknowledgment that the right of withdrawal will be lost when the performance is completed. To ensure consistency between the above-mentioned legal provisions, it is necessary to add an obligation in Articles 7(3) and 8(8) of Directive 2011/83/EU for the trader also to obtain the acknowledgement from the consumer that the right of withdrawal will be lost when the performance is completed. In addition, the wording of Article 16(a) should be adjusted to the changes to Article 7(3) and Article 8(8) whereby the requirement for traders to obtain the consumer’s prior consent only applies to service contracts that place the consumer under an obligation to pay. However, Member States should be given the option not to apply the requirement to obtain the acknowledgment from the consumer that the right of withdrawal will be lost when the performance is completed to service contracts where the consumer has specifically requested a visit from the trader for the purpose of carrying out repairs. Point (c) of Article 16 of Directive 2011/83/EU provides for an exception from the right of withdrawal in case of the supply of goods made to the consumer's specifications or clearly personalised. This exception covers, for example, the manufacturing and installation of customised furniture at the consumer's home when provided under a single sales contract.

(43)  The exception from the right of withdrawal provided in Article 16(b) of Directive 2011/83/EU, should also be considered to apply to contracts for individual deliveries of non-network energy, because its price is dependent on fluctuations in the commodity markets or energy markets which cannot be controlled by the trader and which may occur within the withdrawal period.

(44)  Article 14(4) of Directive 2011/83/EU stipulates the conditions under which, in the event of exercising the right of withdrawal, the consumer does not bear the cost for the performance of services, supply of public utilities and supply of digital content which is not supplied on a tangible medium. When any of those conditions is met, the consumer does not have to pay the price of the service, public utilities or digital content received before the exercise of the right of withdrawal. As regards digital content, one of these non-cumulative conditions under Article 14(4)(b)(iii) is a failure to provide the contract confirmation including confirmation of the consumer’s prior express consent to begin the performance of the contract before the expiry of the right of withdrawal period and acknowledgement that the right of withdrawal is lost as a result. However, this condition is not included among the conditions for the loss of the right of withdrawal in Article 16(m), creating uncertainty as to the possibility for consumer to invoke Article 14(4)(b)(iii) when the other two conditions provided in Article 14(4)(b) are met and the right of withdrawal is lost according to Article 16(m) as a result. The condition provided in Article 14(4)(b)(iii) should therefore be added to Article 16(m) to enable the consumer to exercise the right of withdrawal when it is not met and accordingly claim the rights provided in Article 14(4).

(45)  Traders may personalise the price of their offers for specific consumers or specific categories of consumers based on automated decision making and profiling of consumer behaviour allowing traders to assess the consumer's purchasing power. Consumers should therefore be clearly informed when the price presented to them is personalised on the basis of an automated decision, so that they would take into account the potential risks in their decision-making. Consequently, a specific information requirement should be added to Directive 2011/83/EU to inform the consumer when the price is personalised based on automated decision-making. This information requirement should not apply to techniques such as 'dynamic' or 'real-time' pricing that involves changing the price in a highly flexible and quick manner in response to market demands when it does not involve personalisation based on automated decision making. This information requirement is without prejudice to Regulation (EU) 2016/679 of the European Parliament and of the Council(25), which provides, inter alia, for the right of the individual not to be subjected to automated individual decision making, including profiling.

(46)  Considering technological developments, it is necessary to remove the reference to fax number from the list of the means of communication in Article 6(1)(c) of Directive 2011/83/EU since fax is rarely used and largely obsolete.

(47)  Consumers increasingly rely on consumer reviews and recommendations when they make purchasing decisions. Therefore, when traders provide access to consumer reviews of products, they should inform whether processes or procedures are in place to ensure that the published reviews originate from consumers who have purchased or used the products. If such processes or procedures are in place, these should provide information on how the checks are made and provide clear information to consumers on how reviews are processed, for example, if all reviews, either positive or negative, are posted or whether these reviews have been sponsored or influenced by a contractual relationship with a trader. Moreover, it should therefore be considered as an unfair commercial practice to mislead consumers by using statements according to which reviews of a product are submitted by consumers who have actually used or purchased the product when no reasonable and proportionate steps have been taken to ensure that they originate from such consumers. Such steps could include for instance technical means to verify the reliability of the person posting a review, requesting information to verify that the consumer has actually purchased or used the product.

(48)  The provisions addressing consumer reviews and endorsements are without prejudice to the common and legitimate advertising practice of making exaggerated statements or statements which are not meant to be taken literally.

(49)  Traders should also be prohibited from publishing fake consumer reviews and endorsements, such as ‘likes’ on social media, or commissioning others to do so in order to promote their products, as well as from manipulating consumer reviews and endorsements, such as publishing only positive reviews and deleting the negative ones. Such may also occur through the extrapolation of social endorsements when a user’s positive interaction with certain online content is linked or transferred to different but related content, creating the appearance that that user also takes a positive stance towards the related content.

(50)  Traders should be prohibited from reselling to consumers tickets to cultural and sports events that they have acquired by using software such as 'bots' enabling them to buy tickets in excess of the technical limits imposed by the primary ticket seller or to bypass any other technical means put in place by the primary seller to ensure accessibility of tickets for all individuals. This specific prohibition is without prejudice to any other national measures that Member States can take to protect the legitimate interests of consumers and to secure cultural policy and broad access of all individuals to cultural and sports events, such as regulating the resale price of the tickets.

(51)  Article 16 of the Charter of Fundamental Rights of the EU guarantees the freedom to conduct a business in accordance with Union law and national laws and practices. However, marketing across Member States of goods as being identical when, in reality, they have a significantly different composition or characteristics may mislead consumers and cause them to take a transactional decision that they would not have taken otherwise.

(52)  Such a practice can therefore be qualified as contrary to Directive 2005/29/EC based on a case by case assessment of relevant elements. In order to facilitate the application of existing law by Member States' consumer and food authorities, guidance on the application of current EU rules to situations of dual quality of food ▌was provided in the Commission Notice of 26.9.2017 'on the application of EU food and consumer protection law to issues of Dual Quality of products – The specific case of food'.(26) In this context, the Commission's Joint Research Centre has presented a common approach to the comparative testing of food ▌(27).

(53)  However, the enforcement experience has shown that it may be unclear to consumers, traders and national competent authorities which commercial practices could be contrary to the Directive 2005/29/EC in the absence of an explicit provision. Therefore, Directive 2005/29/EC should be amended to ensure legal certainty both for traders and enforcement authorities by addressing explicitly the marketing of a good as being identical to a good marketed in ▌other Member States, where that good has significantly different composition or characteristics. Competent authorities should assess and address on a case- by-case basis such practices according to the provisions of the Directive. In undertaking its assessment the competent authority should take into account whether such differentiation is easily identifiable by consumers, a trader's right to adapt goods of the same brand for different geographical markets due to legitimate and objective factors, such as national legislation, availability or seasonality of raw materials ▌or voluntary strategies to improve access to healthy and nutritious food as well as the traders' right to offer goods of the same brand in packages of different weight or volume in different geographical markets. The competent authorities should assess whether such differentiation is easily identifiable by consumers by looking at the availability and adequacy of information. It is important that consumers are informed about the differentiation of goods due to legitimate and objective factors. Traders should be free to provide such information in different ways that allow consumers to access the necessary information. Alternatives to providing information on the label of goods should generally be preferred by traders. The relevant Union sectorial rules and rules on free movement of goods should be respected.

(54)  While off-premises sales constitute a legitimate and well-established sales channel, like sales at a trader's business premises and distance–selling, some particularly aggressive or misleading marketing or selling practices in the context of visits to the consumer's home ▌or ▌excursions as referred to in Article 2(8) of Directive 2011/83/EU can put consumers under pressure to make purchases of goods or services they would not otherwise buy and/or purchases at excessive prices, often involving immediate payment. Such practices often target elderly or other vulnerable consumers. Some Member States consider those practices undesirable and deem it necessary to restrict certain forms and aspects of off-premises sales within the meaning of Directive 2011/83/EU, such as aggressive and misleading marketing or selling of a product in the context of unsolicited visits to a consumer's home or ▌excursions. Where such restrictions are taken on grounds other than consumer protection, such as public interest or the respect for consumers’ private life protected by Article 7 of the Charter of Fundamental Rights of the EU, they fall outside the scope of Directive 2005/29/EC.

(55)  In accordance with the principle of subsidiarity and in order to facilitate enforcement, it should therefore be clarified that Directive 2005/29/EC is without prejudice to Member States' freedom to enact national provisions to further protect the legitimate interests of consumers against unfair commercial practices in the context of unsolicited visits at their private home by a trader in order to offer or sell products or excursions organised by a trader with the aim or effect of promoting or selling products to consumers where such provisions are justified on grounds of consumer protection. Any such provisions should be proportionate and non-discriminatory and should not prohibit these sales channels as such. National provisions enacted by Member States could, for example, define time of the day when visits to consumers’ homes without their express request are not allowed or prohibit such visits when the consumer has visibly indicated that such visits are not acceptable or prescribe the payment procedure. Furthermore, such provisions could lay down more protective rules in the areas harmonised by Directive 2011/83/EU. Directive 2011/83/EU should therefore be amended to allow Member States to adopt national measures to provide a longer period for the right of withdrawal and to derogate from specific exceptions from the right of withdrawal. Member States should be required to notify any national provisions adopted in this regard to the Commission so that the Commission can make this information available to all interested parties and monitor the proportionate nature and legality of those measures.

(56)  When it comes to aggressive and misleading practices in the context of events organised at places other than trader’s premises, Directive 2005/29/EC is without prejudice to any conditions of establishment or of authorisation regimes that Member States can impose on traders. Furthermore, Directive 2005/29/EC is without prejudice to national contract law, and in particular to the rules on validity, formation or effect of a contract. Aggressive and misleading practices in the context of events organised at places other than trader’s premises can be prohibited subject to a case-by-case assessment according to Articles 5 to 9 of the Directive 2005/29/EC. In addition, Annex I of Directive 2005/29/EC contains a general prohibition of practices where the trader creates the impression that he is not acting for purposes relating to his profession, and practices that create the impression that the consumer cannot leave the premises until a contract is formed. The Commission should assess whether the current rules provide adequate level of protection of consumers and tools for Member States to effectively address such practices.

(57)  Therefore, this Directive should not affect national law in the area of contract law for contract law aspects that are not regulated by this Directive. Therefore, this Directive should be without prejudice to national law regulating for instance the conclusion or the validity of a contract in cases such as lack of consent or unauthorised commercial activity.

(58)  In order to ensure that citizens have access to up-to-date information on their Union consumer rights and redress, the online entry point to be developed by the Commission should be user-friendly, mobile responsive, easily accessible and usable by all, including persons with disabilities (‘design for all’), as far as possible.

(59)  In accordance with the Joint Political Declaration of 28 September 2011 of Member States and the Commission on explanatory documents(28), Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments. With regard to this Directive, the legislator considers the transmission of such documents to be justified.

(60)  Since the objectives of this Directive of better enforcement and modernisation of the consumer protection legislation cannot be sufficiently achieved by the Member States but can rather, by reason of the Union-wide character of the problem, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives,

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Amendments to Directive 2005/29/EC

Directive 2005/29/EC is amended as follows:

(1)  Article 2, paragraph 1 is amended as follows:

(a)  point (c) is replaced by the following:"

“(c) 'product' means any good or service including immovable properties, digital service and digital content, as well as rights and obligations;”;

"

(b)  the following points are added:"

“(m) 'ranking' means the relative prominence given to products, as presented, organised or communicated by the trader, irrespective of the technological means used for such presentation, organisation or communication;

   (n) ‘online marketplace’ means a service which allows consumers to conclude distance contracts with other traders or consumers using software, including a website, part of a website or an application that is operated by or on behalf of the trader.”;

"

(2)  in Article 3, paragraphs 5 and 6 are replaced by the following: ▌"

“5. This Directive does not prevent Member States from adopting provisions to protect the legitimate interests of consumers with regard to aggressive or misleading marketing or selling practices in the context of unsolicited visits by a trader to a consumer's home or ▌excursions organised by a trader with the aim or effect of promoting or selling products to consumers. ▌Such provisions shall be proportionate, non-discriminatory and justified on grounds of consumer protection.

6.   Member States shall notify the Commission without delay of any national provisions applied on the basis of paragraph 5 as well as of any subsequent changes. The Commission shall make this information easily accessible to consumers and traders on a dedicated website.”;

"

(3)  in Article 6(2), the following point is added:"

(c) any marketing of a good, in one Member State, as being identical to a good marketed in ▌other Member States, while that good has significantly different composition or characteristics, unless justified by legitimate and objective factors.”;

"

(4)   ▌ Article 7 ▌is amended as follows:

(a)  paragraph 4 is amended as follows:

(i)  point (d) is replaced by the following:"

(d) the arrangements for payment, delivery and performance, if they depart from the requirements of professional diligence;”;

"

(ii)  the following point is added:"

“(f) for products offered on online marketplaces, whether the third party offering the products is a trader or not, on the basis of the declaration of that third party to the online marketplace.”;

"

(b)  the following paragraph is inserted:"

“4a. When providing consumers with the possibility to search for products offered by different traders or by consumers on the basis of a query in the form of a keyword, phrase or other input, irrespective of where transactions may be ultimately concluded, general information made available in a specific section of the online interface that is directly and easily accessible from the page where the query results are presented on the main parameters determining ranking of products presented to the consumer as a result of the search query and the relative importance of those parameters as opposed to other parameters shall be regarded as material. This paragraph does not apply to providers of online search engines as defined in Regulation (EU) 2019/...*(29).

__________________

* Regulation (EU) 2019/... of the European Parliament and of the Council of ...(OJ ...).”;

"

(c)  the following paragraph is added:"

“6. Where a trader provides access to consumer reviews of products, information about whether and how the trader ensures that the published reviews originate from consumers who have purchased or used the product shall be regarded as material.”;

"

(5)  the following Article  ▌ is inserted:"

“Article 11a

Redress

1.  ▌Consumers harmed by unfair commercial practices, shall have access to proportionate and effective remedies, including compensation for damages suffered by the consumer and, where relevant, price reduction or the termination of contract. Member States may determine the conditions for the application and effects of those remedies. Member States may take into account, where appropriate, the gravity and nature of the unfair commercial practice, damages suffered by the consumer and other relevant circumstances.

2.  Those remedies shall be without prejudice to the application of other remedies available to consumers under Union or national law.”;

"

(6)  Article 13 is replaced by the following:"

“Article 13

Penalties

1.  Member States shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all necessary measures to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive.

2.  Member States shall ensure that ▌the following non-exhaustive and indicative criteria are taken into account for the imposition of penalties, where appropriate:

   (a) the nature, gravity, scale and duration ▌of the infringement;

   (b) any action taken by the trader to mitigate or remedy the damage suffered by consumers;

   (c) any previous infringements by the trader;
   (d) the financial benefits gained or losses avoided by the trader due to the infringement, if the relevant data are available;
   (e) penalties imposed on the trader for the same infringement in other Member States in cross-border cases where the information about such penalties is available through the mechanism established by the Regulation (EU) 2017/2394;
   (f) any other aggravating or mitigating factor applicable to the circumstances of the case.

3.  Member States shall ensure that when penalties are to be imposed in accordance with Article 21 of Regulation (EU) 2017/2394, they include either the possibility to impose fines through administrative procedures or to initiate legal proceedings for the imposition of fines, or both, the maximum amount of which shall be at least 4 % of the trader's annual turnover in the Member State or Member States concerned. Without prejudice to that Regulation, for national constitutional reasons, Member States may restrict the imposition of fines to:

   (a) infringements of Articles 6, 7, 8, 9 and of Annex I; and
   (b) a trader's continued use of a commercial practice that has been deemed unfair by the competent national authority or court when the infringement is not covered by point (a).

4.  For cases where a fine is to be imposed in accordance with paragraph 3, but the information on the trader’s annual turnover is not available, Member States shall introduce the possibility to impose fines, the maximum amount of which shall be at least 2 million EUR.

5.  Member States shall notify their rules on penalties to the Commission by ... [date for the transposition of this amending Directive] and shall notify it without delay of any subsequent amendment affecting them.”;

"

(7)  ▌ Annex I is amended as follows:

(a)  the following point is inserted:"

“11a. Providing search results in response to a consumer’s online search query without clearly disclosing any paid advertisement or payment specifically for achieving higher ranking of products within the search results.”;

"

(b)  the following points are inserted:"

“23a. Reselling events tickets to consumers if the trader acquired them by using automated means to circumvent any imposed limit on the number of tickets that a person can buy or any other rules applicable to the purchase of tickets.

23b.  Stating that reviews of a product are submitted by consumers who have actually used or purchased the product without taking reasonable and proportionate steps to check that they originate from such consumers.

23c.  Submitting or commissioning another legal or natural person to submit false consumer reviews or endorsements, or misrepresenting consumer reviews or social endorsements, in order to promote products.”.

"

Article 2

Amendments to Directive 2011/83/EU

Directive 2011/83/EU is amended as follows:

(1)  Article 2 is amended as follows:

(a)  point 3 is replaced by the following:"

“(3) ‘goods’ means goods as defined in point (5) of Article 2 of Directive (EU) 2019/ ... of the European Parliament and of the Council*(30);

__________________

* Directive (EU) 2019/ ... of the European Parliament and of the Council of ... (OJ …).”;

"

(b)   the following point ▌is inserted:"

“(4a) ‘personal data’ means personal data as defined in point (1) of Article 4 ▌of Regulation (EU) 2016/679;";

"

(c)   points (5) and (6) are replaced by the following:"

(5)sales contract’ means any contract under which the trader transfers or undertakes to transfer ownership of goods to the consumer, including any contract having as its object both goods and services;

   (6) ‘service contract’ means any contract other than a sales contract under which the trader supplies or undertakes to supply a service, including a digital service to the consumer ▌;”;

"

(d)   point (11) is replaced by the following:"

“(11) ‘digital content’ means digital content as defined in point of (1) of Article 2 of Directive (EU) 2019/... of the European Parliament and of the Council*(31);”;

__________________

* Directive (EU) 2019/... of the European Parliament and of the Council of ... (OJ …).”;

"

(e)   the following points are added:"

“ ▌ (16) ‘digital service’ means digital service as defined in point of (2) of Article 2 of Directive (EU) 2019/...(32)+;

   (17) ‘online marketplace’ means a service ▌which allows consumers to conclude distance contracts with other traders or consumers using software, including a website, part of a website or an application that is operated by or on behalf of the trader;
   (18) 'provider of online marketplace' means any service provider which provides online marketplace to consumers;

   (19) ‘compatibility’ means compatibility as defined in point (10) of Article 2 of Directive (EU) 2019/...(33);
   (20) ‘functionality’ means functionality as defined in point (11) of Article 2 of Directive (EU) 2019/...+;
   (21) ‘interoperability’ means interoperability as defined in point (12) of Article 2 of Directive (EU) 2019/...+.”;

"

(2)  Article 3 is amended as follows:

(a)  paragraph 1 is replaced by the following:"

“1. This Directive shall apply, under the conditions and to the extent set out in its provisions, to any contract concluded between a trader and a consumer where the consumer pays or undertakes to pay the price thereof. It shall apply to contracts for the supply of water, gas, electricity or district heating, including by public providers, to the extent that these commodities are provided on a contractual basis.”;

"

(b)  the following paragraph is inserted:"

“1a. This Directive shall also apply where the trader supplies or undertakes to supply digital content which is not supplied on tangible medium or a digital service to the consumer and the consumer provides or undertakes to provide personal data to the trader, except where the personal data provided by the consumer is exclusively processed by the trader for supplying the digital content which is not supplied on tangible medium or digital service in accordance with this Directive or for the trader to comply with legal requirements to which the trader is subject, and the trader does not process this data for any other purpose.”;

"

(c)  paragraph 3 is amended as follows:

(i)  point (k) is replaced by the following:"

“(k) for passenger transport services, with the exception of Article 8(2) and Articles 19, 21 and 22;”;

"

(ii)  the following point is added:"

“(n) for any goods sold by way of execution or otherwise by authority of law.”;

"

(3)  in ▌Article 5, paragraph 1 is amended as follows:

(a)  point (e) is replaced by the following:"

“(e) in addition to a reminder of the existence of the legal guarantee of conformity for goods, digital content and digital services, the existence and the conditions of after-sales services and commercial guarantees, where applicable;”;

"

(b)  points (g) and (h) are replaced by the following:"

(g) where applicable, the functionality, including applicable technical protection measures, of goods with digital elements, digital content and digital services;

   (h) where applicable, any relevant compatibility and interoperability of goods with digital elements, digital content and digital services ▌ that the trader is aware of or can reasonably be expected to have been aware of.”;

"

(4)  ▌Article 6 is amended as follows:

(a)  paragraph 1 is amended as follows:

(i)  point (c) is replaced by the following:"

(c) the geographical address at which the trader is established as well as the trader’s telephone number and e-mail address. In addition, where the trader provides other means of online communication which guarantee that the consumer can keep any written correspondence, including the date and time of such correspondence, with the trader on a durable medium, the information shall also include details of those other means. All these means of communication provided by the trader shall enable the consumer to contact the trader quickly and communicate with him efficiently. Where applicable, the trader shall also provide the geographical address and identity of the trader on whose behalf he is acting.”;

"

(ii)  the following point is inserted:"

“(ea) where applicable, that the price was personalised on the basis of automated decision making;”;

"

(iii)  point (l) is replaced by the following:"

“(l) a reminder of the existence of a legal guarantee of conformity for goods, digital content and digital services;”;

"

(iv)  points (r) and (s) are replaced by the following:"

(r) where applicable, the functionality, including applicable technical protection measures, of goods with digital elements, digital content and digital services;

   (s) where applicable, any relevant compatibility and interoperability of goods with digital elements, digital content and digital services ▌that the trader is aware of or can reasonably be expected to have been aware of.”;

"

(b)  paragraph 4 is replaced by the following:"

“4. The information referred to in points (h), (i) and (j) of paragraph 1 may be provided by means of the model instructions on withdrawal set out in Annex I(A). The trader shall have fulfilled the information requirements laid down in points (h), (i) and (j) of paragraph 1 if he has supplied these instructions to the consumer, correctly filled in. The references to the withdrawal period of 14 days in the model instructions on withdrawal set out in Annex I(A) shall be replaced by references to a withdrawal period of 30 days in cases where Member States have adopted rules in accordance with Article 9(1a).”;

"

(5)  the following Article ▌is inserted:"

Article 6a

Additional specific information requirements for contracts concluded on online marketplaces

1.  Before a consumer is bound by a distance contract, or any corresponding offer, on an online marketplace, the provider of online marketplace shall, without prejudice to the provisions of Directive 2005/29/EC, provide the following information in a clear and comprehensible manner and in a way appropriate to the means of distance communication:

   (a) general information made available in a specific section of the online interface that is directly and easily accessible from the page where the offers are presented on the main parameters determining ranking, as defined in point (m) of Article 2(1) of Directive 2005/29/EC , of offers presented to the consumer as result of the search query and the relative importance of those parameters as opposed to other parameters;
   (b) whether the third party offering the goods, services or digital content is a trader or not, on the basis of the declaration of that third party to the online marketplace;
   (c) where the third party offering the goods, services or digital content is not a trader, that the consumer rights stemming from Union consumer legislation do not apply ▌to the contract ▌; ▌
   (d) where applicable, how the obligations related to the contract are shared between the third party offering the goods, services or digital content and the provider of the online marketplace. This information shall be without prejudice to the responsibility that the online marketplace or trader may have in relation to the contract under other Union or national law.

2.  Without prejudice to Directive 2000/31/EC, this Article does not prevent Member States from imposing additional information requirements for the online marketplaces. Such provisions shall be proportionate, non-discriminatory and justified on grounds of consumer protection.”;

"

(6)   in Article 7, paragraph 3 is replaced by the following:"

3. Where a consumer wants the performance of services, or the supply of water, gas or electricity, where they are not put up for sale in a limited volume or set quantity, or of district heating to begin during the withdrawal period provided for in Article 9(2), and the contract places the consumer under an obligation to pay, the trader shall require that the consumer makes such an express request on a durable medium. The trader shall also request the consumer to acknowledge that once the contract has been fully performed by the trader, the consumer will no longer have the right of withdrawal.”;

"

(7)  Article 8 is amended as follows:

(a)  paragraph 4 is replaced by the following:"

4. If the contract is concluded through a means of distance communication which allows limited space or time to display the information, the trader shall provide, on or through that particular means prior to the conclusion of such a contract, at least the pre-contractual information regarding the main characteristics of the goods or services, the identity of the trader, the total price, the right of withdrawal, the duration of the contract and, if the contract is of indeterminate duration, the conditions for terminating the contract, as referred to, respectively, in points (a), (b), (e), (h) and (o) of Article 6(1) except the model withdrawal form set out in Annex I(B) referred to in point (h). The other information referred to in Article 6(1), including the withdrawal form shall be provided by the trader to the consumer in an appropriate way in accordance with paragraph 1 of this Article.”;

"

(b)  paragraph 8 is replaced by the following:"

8. Where a consumer wants the performance of services, or the supply of water, gas or electricity, where they are not put up for sale in a limited volume or set quantity, or of district heating, to begin during the withdrawal period provided for in Article 9(2), and the contract places the consumer under an obligation to pay, the trader shall require that the consumer make an express request. The trader shall also request the consumer to acknowledge that once the contract has been fully performed by the trader, the consumer will no longer have the right of withdrawal.”;

"

(8)  Article 9 is amended as follows

(a)  the following paragraph is inserted:"

“1a. Member States may adopt rules in accordance with which the withdrawal period of 14 days referred to in paragraph 1 is extended to 30 days for contracts concluded in the context of unsolicited visits by a trader to consumer's home or excursions organised by a trader with the aim or effect of promoting or selling products to consumers for the purpose of protecting legitimate interests of consumers with regard to aggressive or misleading marketing or selling practices. Such rules shall be proportionate, non-discriminatory and justified on grounds of consumer protection.”;

"

(b)  in paragraph 2, the introductory part is replaced by the folowwing:"

“2. Without prejudice to Article 10, the withdrawal period referred to in paragraph 1 of this Article shall expire after 14 days, or 30 days in cases where Member States have adopted rules in accordance with paragraph 1a of this Article, from:”;

"

(9)  in Article 10, paragraph 2 is replaced by the following:"

“2. If the trader has provided the consumer with the information provided for in paragraph 1 of this Article within 12 months from the day referred to in Article 9(2), the withdrawal period shall expire 14 days or 30 days in cases where Member States have adopted rules in accordance with Article 9(1a) after the day upon which the consumer receives that information.”;

"

(10)  in Article 13 the following paragraphs are added:"

4. In respect of personal data of the consumer, the trader shall comply with the obligations applicable under Regulation (EU) 2016/679.

5.  The trader shall refrain from using any content, other than personal data, which was provided or created by the consumer when using the digital content or digital service supplied by the trader, except where such content:

   (a) has no utility outside the context of the digital content or digital service supplied by the trader;
   (b) only relates to the consumer’s activity when using the digital content or digital service supplied by the trader;
   (c) has been aggregated with other data by the trader and cannot be disaggregated or only with disproportionate efforts; or
   (d) has been generated jointly by the consumer and others, and other consumers are able to continue to make use of the content.

6.  Except in the situations referred to in points (a), (b) or (c) of paragraph 5, the trader shall, at the request of the consumer, make available to the consumer any content other than personal data, which was provided or created by the consumer when using the digital content or digital service supplied by the trader.

7.  The consumer shall be entitled to retrieve that digital content free of charge, without hindrance from the trader, within a reasonable time and in a commonly used and machine-readable format.

8.  In the event of withdrawal from the contract, the trader may prevent any further use of the digital content or digital service by the consumer, in particular by making the digital content or digital service inaccessible to the consumer or disabling the user account of the consumer, without prejudice to paragraph 6.”;

"

(11)  Article 14 is amended as follows:

(a)  the following paragraph is inserted:"

“2a. In the event of withdrawal from the contract, the consumer shall refrain from using the digital content or digital service and from making it available to third parties.”;

"

(b)  in paragraph 4, point (b)(i) is replaced by the following:"

“(i) the consumer has not given his prior express consent to the beginning of the performance before the end of the 14-day or 30-day period referred to in Article 9;”;

"

(12)  Article 16 is amended as follows:

(a)  point (a) is replaced by the following:"

(a) service contracts after the service has been fully performed and, if the contract places the consumer under an obligation to pay if the performance has begun with the consumer’s prior express consent, and with the acknowledgement that he will lose his right of withdrawal once the contract has been fully performed by the trader;”;

"

(b)  point (m) is replaced by the following:"

(m) contracts for the supply of digital content which is not supplied on tangible medium if the performance has begun and, if the contract places the consumer under an obligation to pay, where:

   (i) the consumer has provided prior express consent to begin the performance during the right of withdrawal period;
   (ii) the consumer has provided acknowledgement that he thereby loses his right of withdrawal; and
   (iii) the trader has provided confirmation in accordance with Article 7(2) or Article 8(7).”;

"

(c)  the following paragraphs are added:"

“Member States may derogate from the exceptions from the right of wihdrawal set out in points (a), (b), (c) and (e) of paragraph 1 for contracts concluded in the context of unsolicited visists by a trader to consumer's home or excursions organised by a trader with the aim or effect of promoting or selling products to consumers for the purpose of protecting legitimate interests of consumers with regard to aggressive or misleading marketing or selling practices. Such provisions shall be proportionate, non-discriminatory and justified on grounds of consumer protection.

Member States may provide that the consumer loses the right of withdrawal in case of service contracts after the service has been fully performed and where the consumer has specifically requested a visit from the trader for the purpose of carrying out repairs, if the performance has begun with the consumer’s prior express consent, if the contract places the consumer under an obligation to pay.”;

"

(13)  Article 24 is replaced by the following:"

“Article 24

Penalties

1.  Member States shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all necessary measures to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive.

2.  Member States shall ensure that ▌the following non-exhaustive and indicative criteria are taken into account for the imposition of penalties, where appropriate:

   (a) the nature, gravity, scale and duration ▌of the infringement;

   (b) any action taken by the trader to mitigate or remedy the damage suffered by consumers;

   (c) any previous infringements by the trader;
   (d) the financial benefits gained or losses avoided by the trader due to the infringement, if the relevant data are available;
   (e) penalties imposed on the trader for the same infringement in other Member States in cross-border cases where the information about such penalties is available through the mechanism established by the Regulation (EU) 2017/2394;
   (f) any other aggravating or mitigating factor applicable to the circumstances of the case.

3.  Member States shall ensure that when penalties are to be imposed in accordance with Article 21 of Regulation (EU) 2017/2394, they include either the possibility to impose fines through administrative procedures or to initiate legal proceedings for the imposition of fines, or both, the maximum amount of which shall be at least 4 % of the trader's annual turnover in the Member State or Member States concerned.

4.  For cases where a fine is to be imposed in accordance with paragraph 3, but the information on the trader’s annual turnover is not available, Member States shall introduce the possibility to impose fines, the maximum amount of which shall be at least 2 million EUR.

5.  Member States shall notify their rules on penalties to the Commission by ... [date for the transposition of this amending Directive] and shall notify it without delay of any subsequent amendment affecting them.”;

"

(14)  in Article 29, paragraph 1 is replaced by the following:"

“1. Where a Member State makes use of any of the regulatory choices referred to in Article 3(4), Article 6(7), Article 6(8), Article 7(4), Article 8(6), Article 9(1a), Article 9(3) and the second subparagraph of Article 16, it shall inform the Commission thereof by ... [the date of transposition provided in Article 5 of this amending Directive], as well as of any subsequent changes.”;

"

(15)  Annex I is amended as follows:

(a)  point A is amended as follows:

(i)  the third paragraph ▌under "Right of withdrawal" is replaced by the following:"

“To exercise the right of withdrawal, you must inform us [2] of your decision to withdraw from this contract by an unequivocal statement (e.g. a letter sent by post or e‑mail). You may use the attached model withdrawal form, but it is not obligatory. [3]”;

"

(ii)  point 2 under "Instructions for completion" is replaced by the following:"

“ [2.] Insert your name, geographical address, your telephone number and e‑mail address.”;

"

(b)  in point B, the first indent is replaced by the following:"

“To [here the trader’s name, geographical address and ▌ e‑mail address are to be inserted by the trader]:”.

"

Article 3

Amendments to Directive 93/13/EC

Directive 93/13/EEC is amended as follows:

The following Article  ▌ is inserted:"

Article 8b

1.  Member States shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all necessary measures to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive.

2.  Member States may restrict such penalties to situations where the contractual terms are expressly defined as unfair in all circumstances in national law or where a seller or supplier continues to use contractual terms that have been established as unfair in a final decision taken in accordance with Article 7(2).

3.  Member States shall ensure that ▌the following non-exhaustive and indicative criteria are taken into account for the imposition of penalties, where appropriate:

   (a) the nature, gravity, scale and duration ▌of the infringement;

   (b) any action taken by the seller or supplier to mitigate or remedy the damage suffered by consumers;

   (c) any previous infringements by the seller or supplier;
   (d) the financial benefits gained or losses avoided by the seller or supplier due to the infringement, if the relevant data are available;
   (e) penalties imposed on the seller or supplier for the same infringement in other Member States in cross-border cases where the information about such penalties is available through the mechanism established by Regulation (EU) 2017/2394;
   (f) any other aggravating or mitigating factor applicable to the circumstances of the case.

4.  Without prejudice to paragraph 2, Member States shall ensure that when penalties are to be imposed in accordance with Article 21 of Regulation (EU) 2017/2394, they include either the possibility to impose fines through administrative procedures or to initiate legal proceedings for the imposition of fines, or both, the maximum amount of which shall be at least 4 % of the seller’s or supplier’s annual turnover in the Member State or Member States concerned.

5.  For cases where a fine is to be imposed in accordance with paragraph 4, but the information on the seller’s or supplier’s annual turnover is not available, Member States shall introduce the possibility to impose fines, the maximum amount of which shall be at least 2 million EUR.

6.  Member States shall notify their rules on penalties to the Commission by ... [date for the transposition of this amending Directive] and shall notify it without delay of any subsequent amendment affecting them..

"

Article 4

Amendments to Directive 98/6/EC

Directive 98/6/EC is amended as follows:

(a)  the following Article is inserted:"

“Article 6a

1.  Any announcement of price reduction shall indicate the prior price applied by the trader for a determined period of time prior to the application of the price reduction.

2.  Prior price shall mean the lowest price applied by the trader during a period of time which may not be shorter than one month prior to the application of the price reduction.

3.  Member States may provide for different rules for goods which are liable to deteriorate or expire rapidly.

4.  Where the product has been on the market for less than 30 days, Member States may also provide for shorter period of time than the period specified in paragraph 2.

5.  Member States may provide that when the price reduction is progressively increased, the prior price is the price without price reduction before the first application of the price reduction.”;

"

(b)   Article 8 is replaced by the following:"

Article 8

1.  Member States shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all necessary measures to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive.

2.  Member States shall ensure that ▌the following non-exhaustive and indicative criteria are taken into account for the imposition of penalties, where appropriate:

   (a) the nature, gravity, scale and duration ▌of the infringement;

   (b) any action taken by the trader to mitigate or remedy the damage suffered by consumers;

   (c) any previous infringements by the trader;
   (d) the financial benefits gained or losses avoided by the trader due to the infringement, if the relevant data are available;
   (e) penalties imposed on the trader for the same infringement in other Member States in cross-border cases where the information about such penalties is available through the mechanism established by the Regulation (EU) 2017/2394;
   (f) any other aggravating or mitigating factor applicable to the circumstances of the case.

3.  Member States shall notify their rules on penalties to the Commission by ... [date for the transposition of this amending Directive] and shall notify it without delay of any subsequent amendment affecting them..

"

Article 5

Information on Consumer rights

The Commission shall ensure that citizens seeking information on their consumer rights or out-of-court dispute resolution benefit from an online entry point, through the single digital gateway established by Regulation (EU)2018/1724 of the European Parliament and of the Council (34) enabling them to:

(a)  access up-to-date information about their Union consumer rights in a clear, understandable and easily accessible way; and

(b)  submit a complaint through the Online Dispute Resolution platform established under Regulation (EU) No 524/2013 of the European Parliament and of the Council(35) and to the competent European Consumer Centre, depending on the parties involved.

Article 6

Reporting by the Commission and review

By ... [2 years after the date of application], the Commission shall submit a report on the application of this Directive to the European Parliament and to the Council. That report shall include in particular an assessment of the provisions of this Directive regarding:

(a)  events organised at places other than trader’s business premises; and

(b)  cases of goods marketed as identical but having significantly different composition or characteristics, including whether those cases should be subject to more stringent requirements, including prohibition in Annex I of Directive 2005/29/EC and whether more detailed provisions on information about the differentiation of goods are necessary.

This report shall be accompanied, where necessary, by a legislative proposal.

Article 7

Transposition

1.  Member States shall adopt and publish, by ... [24 months after adoption at the latest], the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions.

They shall apply those provisions from ... [6 months after transposition deadline].

When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

2.  Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 8

Entry into force

This Directive shall enter into force on the twentieth day following its publication in the Official Journal of the European Union.

Article 9

Addressees

This Directive is addressed to the Member States.

Done at ...,

For the European Parliament For the Council

The President The President

(1) OJ C 440, 6.12.2018, p. 66.
(2)*TEXT HAS NOT YET UNDERGONE LEGAL-LINGUISTIC FINALISATION.
(3)OJ C 440, 6.12.2018, p. 66.
(4) Position of the European Parliament of 17 April 2019.
(5)Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005 concerning unfair business-to-consumer commercial practices in the internal market and amending Council Directive 84/450/EEC, Directives 97/7/EC, 98/27/EC and 2002/65/EC of the European Parliament and of the Council and Regulation (EC) No 2006/2004 of the European Parliament and of the Council (OJ L 149, 11.6.2005, p. 22).
(6)Directive 2009/22/EC of the European Parliament and of the Council of 23 April 2009 on injunctions for the protection of consumers' interests (OJ L 110, 1.5.2009, p. 30).
(7)Directive 98/6/EC of the European Parliament and of the Council of 16 February 1998 on consumer protection in the indication of the prices of products offered to consumers (OJ L 80, 18.3.1998, p. 27).
(8)Directive 2011/83/EU of the European Parliament and of the Council of 25 October 2011 on consumer rights, amending Council Directive 93/13/EEC and Directive 1999/44/EC of the European Parliament and of the Council and repealing Council Directive 85/577/EEC and Directive 97/7/EC of the European Parliament and of the Council (OJ L 304, 22.11.2011, p. 64).
(9)Regulation (EU) 2017/2394 of the European Parliament and of the Council of 12 December 2017 on cooperation between national authorities responsible for the enforcement of consumer protection laws and repealing Regulation (EC) No 2006/2004 (OJ L 345, 27.12.2017, p. 1).
(10)Council Directive 93/13/EEC of 5 April 1993 on unfair terms in consumer contracts (OJ L 95, 21.4.1993, p. 29).
(11) Regulation (EU) 2019/... of the European Parliament and of the Council of ... (OJ ...).
(12)+ OJ: Please insert in the text the serial number of the Regulation contained in document PE-CONS No/YY (2018/0112(COD)) and insert the number, date, title and OJ reference of that Directive in the footnote.
(13)++ OJ: Please insert in the text the serial number of the Regulation contained in document PE-CONS No/YY (2018/0112(COD)).
(14) Directive (EU) 2016/943 of the European Parliament and of the Council of 8 June 2016 on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure (OJ L 157, 15.6.2016, p. 1 ).
(15)Regulation (EU) No 524/2013 of the European Parliament and of the Council of 21 May 2013 on online dispute resolution for consumer disputes and amending Regulation (EC) No 2006/2004 and Directive 2009/22/EC (Regulation on consumer ODR) (OJ L 165, 18.6.2013, p. 1).
(16)Directive (EU) 2016/1148 of the European Parliament and of the Council of 6 July 2016 concerning measures for a high common level of security of network and information systems across the Union (OJ L 194, 19.7.2016, p. 1).
(17)Regulation (EU) 2018/302 of the European Parliament and of the Council of 28 February 2018 on addressing unjustified geo-blocking and other forms of discrimination based on customers' nationality, place of residence or place of establishment within the internal market and amending Regulations (EC) No 2006/2004 and (EU) 2017/2394 and Directive 2009/22/EC (OJ L 60 I, 2.3.2018, p. 1).
(18)Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market ('Directive on electronic commerce') (OJ L 178, 17.7.2000, p. 1).
(19) Directive (EU) 2019/... of the European Parliament and of the Council of ... (OJ ...).
(20)+ OJ: Please insert in the text the serial number of the Directive contained in document PE-CONS 26/19 (2015/0287(COD)) and insert the number, date, title and OJ reference of that Directive in the footnote.
(21)++ OJ: Please insert in the text the serial number of the Directive contained in document PE-CONS 26/19 (2015/0287(COD)).
(22)+ OJ: Please insert in the text the serial number of the Directive contained in document PE-CONS 26/19 (2015/0287(COD)).
(23)+ OJ: Please insert in the text the serial number of the Directive contained in document PE-CONS 26/19 (2015/0287(COD)).
(24)+ OJ: Please insert in the text the serial number of the Directive contained in document PE-CONS 26/19 (2015/0287(COD)).
(25)Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).
(26)C(2017)6532.
(27)https://ec.europa.eu/jrc/sites/jrcsh/files/eu_harmonised_testing_methodology__framework_for_selecting_and_testing_of_food_products_to_assess_quality_related_characteristics.pdf
(28)OJ C 369, 17.12.2011, p. 14.
(29)+ OJ: Please insert in the text the serial number of the Regulation contained in document PE-CONS No/YY (2018/0112(COD)) and insert the number, date, title and OJ reference of that Regulation in the footnote.
(30)+ OJ: Please insert in the text the number of the Directive contained in document PE-CONS 27/19 (2015/0288(COD)) and insert the number, date, title and OJ reference of that Directive in the footnote.
(31)+ OJ: Please insert in the text the serial number of the Directive contained in document PE-CONS 26/19 (2015/0287(COD)) and insert the number, date, title and OJ reference of that Directive in the footnote.
(32)++ OJ: Please insert in the text the serial number of the Directive contained in document PE-CONS 26/19 (2015/0287(COD)).
(33)+ OJ: Please insert in the text the serial number of the Directive contained in document PE-CONS 26/19 (2015/0287(COD)).
(34) Regulation (EU) 2018/1724 of the European Parliament and of the Council of 2 October 2018 establishing a single digital gateway to provide access to information, to procedures and to assistance and problem-solving services and amending Regulation (EU) No 1024/2012 (OJ L 295, 21.11.2018, p. 1).
(35) Regulation (EU) No 524/2013 of the European Parliament and of the Council of 21 May 2013 on online dispute resolution for consumer disputes and amending Regulation (EC) No 2006/2004 and Directive 2009/22/EC (Regulation on consumer ODR) (OJ L 165, 18.6.2013, p. 1).


Transparency and sustainability of the EU risk assessment in the food chain ***I
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Resolution
Consolidated text
European Parliament legislative resolution of 17 April 2019 on the proposal for a Regulation of the European Parliament and of the Council on the transparency and sustainability of the EU risk assessment in the food chain amending Regulation (EC) No 178/2002 [on general food law], Directive 2001/18/EC [on the deliberate release into the environment of GMOs], Regulation (EC) No 1829/2003 [on GM food and feed], Regulation (EC) No 1831/2003 [on feed additives], Regulation (EC) No 2065/2003 [on smoke flavourings], Regulation (EC) No 1935/2004 [on food contact materials], Regulation (EC) No 1331/2008 [on the common authorisation procedure for food additives, food enzymes and food flavourings], Regulation (EC) No 1107/2009 [on plant protection products] and Regulation (EU) No 2015/2283 [on novel foods] (COM(2018)0179 – C8-0144/2018 – 2018/0088(COD)
P8_TA-PROV(2019)0400A8-0417/2018

(Ordinary legislative procedure: first reading)

The European Parliament,

–  having regard to the Commission proposal to Parliament and the Council (COM(2018)0179),

–  having regard to Article 294(2) and Articles 43, 114 and 168(4)(b) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8-0144/2018),

–  having regard to the opinion of the Committee on Legal Affairs on the proposed legal basis,

–  having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–  having regard to the opinion of the European Economic and Social Committee of 19 September 2018(1),

–  having regard to the opinion of the Committee of the Regions of 10 October 2018(2),

–  having regard to the provisional agreement approved by the committee responsible under Rule 69f(4) of its Rules of Procedure and the undertaking given by the Council representative by letter of 15 February 2019 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,

–  having regard to Rules 59 and 39 of its Rules of Procedure,

–  having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinions of the Committee on Fisheries and the Committee on Legal Affairs (A8-0417/2018),

1.  Adopts its position at first reading hereinafter set out(3);

2.  Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

3.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Position of the European Parliament adopted at first reading on 17 April 2019 with a view to the adoption of Regulation (EU) 2019/… of the European Parliament and of the Council on the transparency and sustainability of the EU risk assessment in the food chain and amending Regulations (EC) No 178/2002, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 2065/2003, (EC) No 1935/2004, (EC) No 1331/2008, (EC) No 1107/2009, (EU) 2015/2283 and Directive 2001/18/EC

P8_TC1-COD(2018)0088


(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 43(2), Article 114 and Article 168(4)(b) thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee(4),

Having regard to the opinion of the Committee of the Regions(5),

Acting in accordance with the ordinary legislative procedure(6),

Whereas:

(1)  Regulation (EC) No 178/2002 of the European Parliament and of the Council(7) lays down the general principles and requirements of food law, so as to form a common basis for measures governing food law at both Union and national level. It provides, inter alia, that food law is to be based on risk analysis, except where this is not appropriate to the circumstances or the nature of the measure.

(2)  Regulation (EC) No 178/2002 defines risk analysis as a process consisting of three interconnected components: risk assessment, risk management, and risk communication. For the purposes of risk assessment at Union level, it establishes the European Food Safety Authority (the ‘Authority’), as the responsible Union risk assessment body in matters relating to food and feed safety.

(3)  Risk communication is an essential part of the risk analysis process. ▌ The REFIT evaluation of the general food law (Regulation (EC) No 178/2002) of 2018 ('Fitness Check of the General Food Law') found that risk communication is not considered to be effective enough overall. This has an impact on consumers’ confidence in the outcome of the risk analysis process.

(4)  It is necessary, therefore, to ensure transparent, continuous and inclusive risk communication throughout the risk analysis, involving Union and national risk assessors and risk managers. Such risk communication should strengthen citizens' trust that the risk analysis is underpinned by the objective of ensuring a high level of protection of human health and consumers' interests. That risk communication should also be capable of contributing to a participatory and open dialogue between all interested parties in order to ensure that the prevalence of the public interest, and accuracy, comprehensiveness, transparency, consistency and accountability are taken into account in the risk analysis process.

(5)  Risk communication should place particular emphasis ▌ on explaining in an accurate, clear, comprehensive, coherent, appropriate and timely manner not only risk assessment findings themselves but also how such findings are used to help inform risk management decisions along with other legitimate factors, where relevant. Information should be provided on how risk management decisions were reached and on the factors, other than the results of the risk assessment, which were considered by the risk managers, as well as how those factors were weighed up against each other.

(6)  Given the ambiguity in the public perception of the difference between hazard and risk, risk communication should endeavour to clarify that distinction and thereby ensure that such distinction is better understood by the general public.

(7)  Where there are reasonable grounds to suspect that a food or feed may present a risk for human or animal health due to non-compliance resulting from intentional violations of applicable Union law perpetrated through fraudulent or deceptive practices, public authorities, identifying to the fullest extent possible the products concerned and the risk that they may present, should inform the public accordingly as soon as possible.

(8)  It is necessary to establish general objectives and principles of risk communication, taking into account the respective roles of risk assessors and managers, while guaranteeing their independence.

(9)  On the basis of the▌ general objectives and principles, a general plan on risk communication should be established in close cooperation with the Authority and Member States, and following relevant public consultations. That general plan should promote an integrated risk communication framework for all risk assessors and risk managers at Union and national level on all matters relating to the food chain. It should also allow for the necessary flexibility and should not deal with situations specifically covered by the general plan for crisis management.

(10)  The general plan on risk communication should identify the key factors to be taken into account when considering the type and level of risk communication activities needed, such as the different levels of risk, the nature of the risk and its potential impact on human health, animal health and, where relevant, the environment, who and what are directly or indirectly affected by the risk, the levels of ▌ exposure to a hazard, the level of urgency and the ability to control risk, and other factors that influence risk perception, including the ▌ applicable legal framework and relevant market context.

(11)  The general plan on risk communication should also identify the tools and channels to be used and should establish appropriate mechanisms of coordination and cooperation between the risk assessors and risk managers at Union and national level involved in the risk analysis process, in particular where several Union agencies provide scientific outputs on the same or on related subject matters, to ensure coherent risk communication and an open dialogue amongst all interested parties.

(12)  Transparency of the risk assessment process contributes to greater legitimacy of the Authority being acquired in the eyes of the consumers and general public in the pursuit of its mission, increases their confidence in its work and ensures that the Authority is more accountable to the Union citizens in a democratic system. It is therefore essential to strengthen the confidence of the general public and other interested parties in the risk analysis underpinning the relevant Union law, and in particular in the risk assessment, including the transparency thereof as well as the organisation, functioning and independence of the Authority.

(13)  It is appropriate to increase the role of Member States as well as the effort and engagement of all parties involved in the Management Board of the Authority (the ‘Management Board’).

(14)  Experience shows that the role of the Management Board is focused on administrative and financial aspects and does not impact on the independence of the scientific work performed by the Authority. It is thus appropriate to include representatives of all Member States, of the European Parliament and of the Commission as well as of civil society and industry organisations in the Management Board, ▌while providing that those representatives should have experience and expertise not only in the fields of food chain law and policy, including risk assessment, but also in the fields of managerial, administrative, financial and legal matters and ensuring that they act independently in the public interest.

(15)  The members of the Management Board should be selected and appointed in such a way as to secure the highest standards of competence and the broadest range of relevant experience available.

(16)  The Fitness Check of the General Food Law identified certain shortcomings in the long-term capability of the Authority to maintain its high-level expertise. In particular, there has been a decrease in the number of candidates applying to be members of the Authority’s Scientific Panels. The system has thus to be strengthened and Member States should take a more active role to ensure that a sufficient pool of experts is available to meet the needs of the Union risk assessment system in terms of high level of scientific expertise, independence and multidisciplinary expertise.

(17)  To preserve the independence of the risk assessment from risk management and from other interests at Union level, it is appropriate that the selection by the Authority’s Executive Director and the appointment by the Management Board of the members of the Authority’s Scientific Committee and Scientific Panels ▌be based on strict criteria ensuring the excellence and independence of the experts while ensuring the required multidisciplinary expertise for each Scientific Panel. It is essential to that end that the Executive Director, whose function is to defend the Authority’s interests and in particular the independence of its expertise, have a role in the selection ▌ of those scientific experts. The Management Board should endeavour to ensure, to the largest extent possible, that experts appointed as members of the Scientific Panels are scientists who are also actively conducting research, and publishing their research findings in peer-reviewed scientific journals, provided that they comply with the strict criteria of excellence and independence. Proper financial compensation of the experts should be ensured. Further measures should also be put in place to ensure that scientific experts have the means to act independently.

(18)  It is essential to ensure the efficient operation of the Authority and to improve the sustainability of its expertise. It is therefore necessary to strengthen the support provided by the Authority and the Member States to the work of the Scientific Committee and the Scientific Panels. In particular, the Authority should organise the preparatory work supporting the tasks of the Scientific Panels, including by requesting the Authority’s staff or national scientific organisations networking with the Authority to draft preparatory scientific opinions to be peer-reviewed and adopted by those Scientific Panels. That should be without prejudice to the independence of the Authority’s scientific assessments.

(19)  Authorisation procedures are based on the principle that it is for the applicant or the notifier to prove that the subject matter of an application or notification complies with Union ▌ requirements. That principle is based on the premise that human health, animal health and, where relevant, the environment are better protected where the burden of proof is on the applicant or the notifier since it has to prove that the subject matter of its application or notification is safe prior to its placing on the market, instead of the public authorities having to prove that that subject matter is unsafe in order to be able to ban it from the market. ▌In accordance with that principle and the applicable regulatory requirements, in support of applications or notifications under Union sectoral ▌ law, applicants or notifiers are required to submit relevant studies, including tests, to demonstrate the safety and, in some cases, the efficacy of a subject matter.

(20)  Union law provides for the content of applications and notifications. It is essential that the application or notification ▌submitted to the Authority for its risk assessment meet the applicable specifications to ensure the best quality scientific assessment by the Authority. Applicants or notifiers and in particular small and medium-sized enterprises do not always have a clear understanding of those specifications. It is thus appropriate that, where the Authority may be requested to provide a scientific output, it should provide advice to a potential applicant or notifier upon request, before an application or notification is formally submitted. Such pre-submission advice should relate to the rules applicable to, and the content required for, an application or notification and should not address the design of the studies to be submitted, as that remains the applicant’s responsibility. ▌

(21)  Where the Authority may be requested to provide a scientific output, it should have knowledge ▌ of all studies performed by an applicant with a view to supporting an application ▌ under Union ▌ law. To that end, it is necessary and appropriate that, when business operators commission or carry out studies with a view to submitting an application or notification, they notify those studies to the Authority. The obligation to notify such studies should also apply to the laboratories and other testing facilities carrying them out. Information about the notified studies should be made public only once a corresponding application ▌ has been made public in accordance with the applicable rules on transparency. In order to ensure effective implementation of that obligation, it is appropriate to provide for certain procedural consequences in the event of non-compliance . The Authority should, in that context, lay down practical arrangements to implement that obligation, including procedures for requesting and making public the justifications for the non-compliance.

(22)  In accordance with Directive 2010/63/EU of the European Parliament and of the Council(8), tests on animals should be replaced, reduced or refined. Therefore, within the scope of this Regulation, duplication of animal testing should be avoided, where possible.

(23)  In the case of applications or notifications to request the renewal of an authorisation or an approval, the authorised or approved substance or product has already been on the market for several years. Experience and knowledge therefore already exist with regard to that substance or product. Where the Authority may be requested to provide a scientific output, it is ▌ appropriate for studies planned for supporting requests for renewals, including information on the proposed design, that have been notified by the applicant or the notifier to the Authority, to be submitted for consultation of third parties. The Authority should systematically provide advice to the applicants or to the notifiers on the content of the intended renewal application or notifications, as well as on the design of studies, taking into account the comments received.

(24)  There are certain public concerns about the Authority’s assessment in the area of authorisation procedures being primarily based on industry studies. It is of utmost importance that the Authority carry out searches in scientific literature to be able to consider other data and studies existing on the subject matter submitted to its assessment. In order to provide an additional level of guarantee to ensure that the Authority can have access to all relevant scientific data and studies available on a subject matter of an application or a notification for an authorisation or a renewal of an authorisation or an approval, it is appropriate to provide for consultation of third parties in order to identify whether other relevant scientific data or studies are available. To increase the effectiveness of the consultation, the consultation should take place immediately after the studies submitted by industry included in an application or a notification are made public, under the applicable transparency rules. Where there is a risk that the results of a public consultation cannot be given proper consideration because of the applicable deadlines, it is appropriate to provide for a limited extension of those deadlines.

(25)  Food safety is a sensitive matter of prime interest for all Union citizens. While maintaining the principle that the burden to prove compliance with Union requirements is on the industry, it is important to establish an additional verification tool, namely the commissioning of additional studies with the objective of verifying evidence used in the context of risk assessment to address specific cases of high societal importance where there are serious controversies or conflicting results . Considering that those verification studies would be financed from the Union budget and that the use of this exceptional verification tool should remain proportionate, the Commission, taking into account the views expressed by the European Parliament and by Member States, should be responsible for triggering the commissioning of such verification studies. Account should be taken of the fact that in some specific cases the verification studies commissioned may need to have a wider scope than the evidence at stake, for example, in cases where new scientific developments become available.

(26)  The Fitness Check of the General Food Law demonstrated that, although the Authority has made considerable progress in terms of transparency, the risk assessment process, especially in the context of authorisation procedures covering the food chain, is not always perceived as fully transparent. That is also partly due to the different transparency and confidentiality rules that are laid down in Regulation (EC) No 178/2002 and in other Union sectoral legislative acts ▌. The interplay among those acts can have an impact on the acceptance of the risk assessment by the general public.

(27)  The European citizens’ initiative entitled 'Ban glyphosate and protect people and the environment from toxic pesticides' further confirmed concerns regarding transparency with respect to studies commissioned by the industry and submitted in authorisation ▌ procedures.

(28)  It is therefore necessary to strengthen the transparency of the risk assessment in a proactive manner. All scientific data and information supporting requests for authorisations or for approvals under Union ▌ law as well as other requests for scientific output should be made publicly available in a proactive manner and be easily accessible as early as possible in the risk assessment process. However, such disclosure to the public should be without prejudice to any rules concerning intellectual property rights or to any provisions of Union ▌ law protecting the investment made by innovators in gathering the information and data supporting relevant applications or notifications. It should be ensured that such disclosure to the public is not considered to be permission for further uses or exploitation, without jeopardising the proactive character of disclosure to the public and the easy public access to the disclosed data and information.

(29)  To ensure the transparency of the risk assessment, a summary of the pre-submission advice should be made public only once a corresponding application or notification has been made public in accordance with the applicable rules on transparency.

(30)  Where the opinion of the Authority is requested in relation to applications or notifications submitted under Union ▌ law, and having regard to its obligation to ensure public access to all supporting information with respect to the provision of its scientific outputs, the Authority should have responsibility for assessing confidentiality requests.

(31)  To determine what level of proactive disclosure to the public strikes the appropriate balance, the relevant rights of the public to transparency in the risk assessment process, should be weighed up against the rights of ▌ applicants or notifiers, taking into account the objectives of Regulation (EC) No 178/2002.

(32)  With respect to the application or notification procedures provided for in Union ▌ law, experience gained so far has shown that certain items of information are generally considered sensitive and should remain confidential across the different sectoral ▌ procedures. It is therefore appropriate to lay down in Regulation (EC) No 178/2002 a horizontal list of items of information whose disclosure, as demonstrated by the applicant or the notifier, will potentially harm the commercial interests concerned to a significant degree and which should not therefore be disclosed to the public . Those items should include the manufacturing and production process, including the method and innovative aspects thereof, as well as technical and industrial specifications, such as impurities, inherent to that process other than information which is relevant to the assessment of safety. Only in very limited and exceptional circumstances relating to foreseeable health effects or, where an environmental assessment is required under Union sectoral law, to environmental effects, or where relevant authorities have identified urgent needs to protect human health, animal health or the environment, should such information be disclosed.

(33)  For the purposes of clarity and to increase legal certainty, it is necessary to set out the specific procedural requirements to be followed by an applicant or by a notifier in respect of a request for information submitted to support an application or a notification under Union ▌ law to be treated in a confidential manner.

(34)  It is also necessary to set out specific requirements with respect to the protection and confidentiality of personal data for the purposes of the transparency of the risk assessment process, taking into account Regulations (EU) 2018/1725(9) and (EU) 2016/679(10) of the European Parliament and of the Council. Accordingly, no personal data should be made publicly available under this Regulation, unless it is necessary and proportionate for the purposes of ensuring the transparency, independence and the reliability of the risk assessment process, while preventing conflicts of interests. In particular, for the purpose of ensuring the transparency and to avoid conflicts of interest, it is necessary to publish the names of the participants and observers in certain meetings of the Authority.

(35)  For the purpose of increased transparency and in order to ensure that requests for scientific outputs received by the Authority are processed in an effective manner, standard data formats should be developed.

(36)  Having regard to the fact that the Authority would be required to store scientific data, including confidential and personal data, it is necessary to ensure that such storage is carried out in accordance with a high level of security.

(37)  Furthermore, in order to assess the effectiveness and efficiency of the different legal provisions applicable to the Authority, it is also appropriate to provide for a Commission evaluation of the Authority ▌. That evaluation should, in particular, review the procedures for selecting the members of Scientific Committee and Scientific Panels, for their degree of transparency, cost-effectiveness, and suitability to ensure independence and competence, and to prevent conflicts of interests.

(38)  Studies, including tests, submitted by business operators in support of applications ▌ usually comply with internationally recognised principles, which provide a uniform basis for their quality in particular in terms of reproducibility of results. However, issues of compliance with the applicable standards, such as those set by Directive 2004/10/EC of the European Parliament and of the Council(11) or those developed by the International Organization for Standardization, may arise in some cases and this is why international and national systems are in place to verify such compliance. It is therefore appropriate for the Commission to carry out fact-finding missions to assess the application by laboratories and other testing facilities of the relevant standards for carrying out tests and studies submitted to the Authority as part of an application. Those fact-finding missions would allow the Commission to identify, and to aim at correcting, possible weaknesses in the systems and non-compliance and to provide an additional level of guarantees to reassure the general public on the quality of studies. Based on the conclusions of such fact-finding missions, the Commission could propose appropriate legislative measures aimed at improving compliance with the relevant standards.

(39)  In order to ensure consistency with the proposed adaptations in Regulation (EC) No 178/2002, provisions relating to public access and the protection of confidential information in, Regulations (EC) No 1829/2003(12), (EC) No 1831/2003 (13),(EC) No 2065/2003(14), (EC) No 1935/2004(15), (EC) No 1331/2008(16), (EC) No 1107/2009(17), (EU) 2015/2283(18) and in Directive 2001/18/EC(19) of the European Parliament and of the Council should be amended.

(40)  To ensure that sectoral specificities with respect to confidential information are taken into account, it is necessary to weigh up the relevant rights of the public to transparency in the risk assessment process ▌ against the rights of ▌ applicants or of notifiers, taking into account the specific objectives of sectoral Union law as well as experience gained. Accordingly, it is necessary to make specific amendments to Regulations (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 1935/2004, (EC) No 1331/2008, (EC) No 1107/2009, (EU) 2015/2283 and Directive 2001/18/EC in order to provide for additional confidential items to those set out in Regulation (EC) No 178/2002.

(41)  The rights on access to documents enshrined in Regulation (EC) No 1049/2001 of the European Parliament and of the Council(20) and, where environmental information is concerned, the rights enshrined in Regulation (EC) No 1367/2006(21) and Directive 2003/4/EC(22) of the European Parliament and of the Council are unaffected by this Regulation. The rights provided by those acts should not in any manner be limited by the provisions on proactive dissemination laid down in this Regulation and the relevant assessment of confidentiality request.

(42)  In order to ensure uniform conditions for the implementation of Regulation (EC) No 178/2002 with regard to the adoption of a general plan for risk communication and the adoption of standard data formats, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council(23).

(43)  In order to enable the Commission, Member States, the Authority and the business operators to adapt to the new requirements set by this Regulation while ensuring that the Authority continues its smooth operation, it is necessary to provide for transitional measures for the application of this Regulation.

(44)  Since the appointment of the members of the Scientific Committee and Scientific Panels depends on the entry in function of the new Management Board, it is necessary to provide for specific transitional provisions allowing a prolongation of the current term of office of the members of the Scientific Committee and Scientific Panels.

(45)  The European Data Protection Supervisor was consulted in accordance with Article 28(2) of Regulation (EC) No 45/2001 of the European Parliament and of the Council(24),

HAVE ADOPTED THIS REGULATION:

Article 1

Amendments to Regulation (EC) No 178/2002

Regulation (EC) No 178/2002 is amended as follows:

(1)  in Article 6, the following paragraph is added:"

"4. Risk communication shall fulfil the objectives and respect the general principles set out in Articles 8a and 8b.";

"

(2)  in Chapter II, the following Section is inserted:"

"SECTION 1a

RISK COMMUNICATION

Article 8a

Objectives of risk communication

Taking into account the respective roles of risk assessors and risk managers, risk communication shall pursue the following objectives:

   (a) raise awareness and understanding of the specific issues under consideration, including in cases of divergences in scientific assessment, during the entire risk analysis process;
   (b) ensure consistency, transparency and clarity in formulating risk management recommendations and decisions;
   (c) provide a sound basis, including, where appropriate, a scientific basis, for understanding risk management decisions;
   (d) improve the overall effectiveness and efficiency of the risk analysis;
   (e) foster public understanding of the risk analysis, including of the respective tasks and responsibilities of risk assessors and risk managers to enhance confidence in its outcome;
   (f) ensure appropriate involvement of consumers, feed and food businesses, the academic community and all other interested parties; ▌
   (g) ensure appropriate and transparent exchange of information with interested parties in relation to risks associated with the ▌ food chain;
   (h) ensure the provision of information to consumers about risk prevention strategies; and
   (i) contribute to the fight against the dissemination of false information and the sources thereof.

Article 8b

General principles of risk communication

Taking into account the respective roles of risk assessors and risk managers, risk communication shall:

   (a) ensure that accurate and all appropriate ▌ information is ▌ exchanged in an interactive and timely manner with all interested parties, based on the principles of transparency, openness, and responsiveness;
   (b) provide transparent information at each stage of the risk analysis process from the framing of requests for scientific advice to the provision of risk assessment and the adoption of risk management decisions, including information on how risk management decisions were reached and which factors were considered;
   (c) take into account risk perceptions of all interested parties;
   (d) facilitate understanding and dialogue amongst all interested parties; and
   (e) be clear and accessible, including to those not directly involved in the process or not having a scientific background, while duly respecting the applicable legal provisions on confidentiality and protection of personal data.

Article 8c

General plan for risk communication

1.  The Commission shall adopt, by means of implementing acts, a general plan for risk communication in order to achieve the ▌ objectives set out in Article 8a, in accordance with the general principles set out in Article 8b. The Commission shall keep that general plan updated, taking into account technical and scientific progress and experience gained. Those implementing acts shall be adopted in accordance with the procedure referred to in Article 58(2). When preparing those implementing acts, the Commission shall consult the Authority.

2.  The general plan for risk communication shall promote an integrated risk communication framework to be followed both by the risk assessors and the risk managers in a coherent and systematic manner both at Union and national level. It shall:

   (a) identify the key factors that need to be taken into account when considering the type and level of risk communication activities needed;
   (b) identify the different types and levels of risk communication activities, and the appropriate main tools and channels to be used for risk communication purposes, taking into account the needs of relevant target audience groups; ▌
   (c) establish appropriate mechanisms of coordination and cooperation in order to strengthen coherence of risk communication amongst risk assessors and risk managers; and
   (d) establish appropriate mechanisms to ensure an open dialogue amongst consumers, food and feed businesses, the academic community and all other interested parties, and their appropriate involvement.";

"

(3)  in Article 22(7), the second subparagraph is replaced by the following:"

"It shall act in close cooperation with the competent bodies in the Member States that carry out similar tasks to those of the Authority and, where appropriate, with the relevant Union agencies.";

"

(4)  Article 25 is amended as follows:

(a)  paragraph 1 is replaced by the following:"

"1. Each Member State shall nominate a member and an alternate member as its representatives to the Management Board. The members and alternate members thus nominated shall be appointed by the Council and have the right to vote.";

"

(b)  the following paragraphs are inserted:"

"1a. In addition to members and alternate members referred to in paragraph 1, the Management Board shall include:

   (a) two members and two alternate members appointed by the Commission as its representatives, with the right to vote;
   (b) two members appointed by the European Parliament, with the right to vote;
   (c) four members and four alternate members with the right to vote as representatives of civil society and food chain interests, namely one member and one alternate member from consumer organisations, one member and one alternate member from environmental non-governmental organisations, one member and one alternate member from farmers organisations, and one member and one alternate member from industry organisations.

The members and alternate members referred to in point (c) of the first subparagraph shall be appointed by the Council in consultation with the European Parliament on the basis of a list which shall be drawn up by the Commission and sent to the Council. The list shall include more names than there are posts to be filled. The list drawn up by the Commission shall be forwarded to the European Parliament by the Council, together with the relevant background documents. As quickly as possible and at the latest within three months of the receipt of that list, the European Parliament may submit its views for consideration to the Council which shall then appoint those members.

1b.  The members and the alternate members of the Management Board shall be nominated and appointed on the basis of their relevant experience and expertise in the field of food chain law and policy, including risk assessment, whilst ensuring that there is relevant expertise in the fields of managerial, administrative, financial and legal matters within the Management Board.";

"

(c)  paragraph 2 is replaced by the following:"

"2. The term of office of members and alternate members shall be four years and may be renewed. However, the ▌ term of office of the members and alternate members referred to in point (c) of the first subparagraph of paragraph 1a may be renewed only once.";

"

(d)  in paragraph 5, the second subparagraph is replaced by the following:"

"Unless otherwise provided, the Management Board shall act by a majority of its members. Alternate members shall represent the members in their absence and vote on their behalf.";

"

(5)  Article 28 is amended as follows:

(a)  paragraph 5 is replaced by the following:"

"5. The members of the Scientific Committee who are not members of the Scientific Panels and the ▌ members of the Scientific Panels shall be appointed by the Management Board, acting upon a proposal from the Executive Director, for a five-year term of office, which may be renewed, following publication of a call for expression of interest in the Official Journal of the European Union, in relevant leading scientific publications and on the Authority’s website. The Authority shall publish such a call for expression of interest after having informed the Member States about the necessary criteria and fields of expertise.

The Member States shall:

   (a) publish the call for expression of interest on the websites of their competent authorities and of their competent bodies which undertake tasks similar to those of the Authority;
   (b) inform relevant scientific organisations located on their territory;
   (c) encourage potential candidates to apply; and
   (d) take any other appropriate measures to support the call for expression of interest.";

"

(b)  the following paragraphs are inserted:"

"5a. The members of the Scientific Committee who are not members of Scientific Panels and the members of the Scientific Panels shall be selected and appointed ▌ in accordance with the following procedure:

   (a) on the basis of the applications received to a call for expression of interest, the Executive Director shall draw up a draft list of suitable candidates including at least twice the number of candidates necessary to fill the posts in the Scientific Committee and the Scientific Panels and send the draft list to the Management Board, indicating the specific multidisciplinary expertise needed in each Scientific Panel;
   (b) on the basis of that draft list, the Management Board shall appoint the members of the Scientific Committee who are not members of the Scientific Panels and the members of the Scientific Panels and draw up the reserve list of candidates for the scientific Committee and the Scientific Panels;

   (c) the ▌ selection procedure and the appointments of the members of the Scientific Committee who are not members of the Scientific Panels and the members of the Scientific Panels shall be made on the basis of the following criteria:
   (i) a high level of scientific expertise;
   (ii) independence and absence of conflict of interests in accordance with Article 37(2) and the Authority’s independence policy and implementation of that policy in respect of the members of the Scientific Panels;
   (iii) meeting the needs for the specific multi-disciplinary expertise of the Scientific Panel to which they will be appointed and the applicable language regime;
   (d) where candidates have equivalent scientific expertise, the Management Board shall ensure that the broadest possible geographical distribution is achieved in the ▌ appointments.

5b.  When the Authority identifies that specific expertise is missing in one or several Scientific Panels, the Executive Director shall propose ▌ to the Management Board, in accordance with the procedure laid down in paragraphs 5 and 5a, the appointment of additional members of the relevant Scientific Panels.

5c.  The Management Board shall adopt, on the basis of a proposal of the Executive Director, rules on the detailed organisation and timing of the procedures set up in paragraphs 5a and 5b.

5d.  ▌Member States and employers of the members of the Scientific Committee and of the Scientific Panels shall refrain from giving those members, or the external experts participating in the working groups of the Scientific Committee or the Scientific Panels, any instruction which is incompatible with the individual tasks of those members and experts, or with the tasks, responsibilities and independence of the Authority.

5e.  ▌The Authority shall support the tasks of the Scientific Committee and Scientific Panels by organising their work, in particular the preparatory work to be undertaken by the Authority’s staff or by designated national scientific organisations referred to in Article 36, including by organising the possibility for preparing scientific opinions to be peer-reviewed by the Scientific Panels before they adopt them.

5f.  Each Scientific Panel shall include a maximum of 21 members.

5g.  Members of Scientific Panels shall have access to comprehensive training on the risk assessment.";

"

(c)  in paragraph 9, point (b) is replaced by the following:"

"(b) the number of members in each Scientific Panel but no more than the maximum number provided for in paragraph 5f.";

"

(6)  the following Articles are inserted:"

"Article 32a

Pre-submission advice

1.  Where Union law contains provisions for the Authority to provide a scientific output, including a scientific opinion, the staff of the Authority shall, at the request of a potential applicant or notifier, provide advice on the rules applicable to, and the content required for, the application or notification, prior to its submission. Such advice provided by the staff of the Authority shall be without prejudice and non-committal as to any subsequent assessment of applications or notifications by the Scientific Panels. The staff of the Authority providing the advice shall not be involved in any preparatory scientific or technical work that is directly or indirectly relevant to the application or notification that is the subject of the advice.

2.  The Authority shall publish general guidance on its website regarding the rules applicable to, and the content required for, applications and notifications, including, where appropriate, general guidance on the design of required studies.

Article 32b

Notification of studies

1.  The Authority shall establish and manage a database of studies commissioned or carried out by business operators to support an application or notification in relation to which Union law contains provisions for the Authority to provide a scientific output, including a scientific opinion.

2.  For the purposes of paragraph 1, business operators shall, without delay, notify the Authority of the title and the scope of any study commissioned or carried out by them to support an application or a notification, as well as the laboratory or testing facility carrying out that study, and its starting and planned completion dates.

3.  For the purposes of paragraph 1, laboratories and other testing facilities located in the Union shall also, without delay, notify the Authority of the title and the scope of any study commissioned by business operators and carried out by such laboratories or other testing facilities to support an application or a notification, its starting and planned completion dates, as well as the name of the business operator who commissioned such a study.

This paragraph shall also apply, mutatis mutandis, to laboratories and other testing facilities located in third countries insofar as set out in relevant agreements and arrangements with those third countries, including as referred to in Article 49.

4.  An application or notification shall not be considered valid or admissible where it is supported by studies that have not been previously notified in accordance with paragraph 2 or 3, unless the applicant or notifier provides a valid justification for the non-notification of such studies.

Where studies have not been previously notified in accordance with paragraph 2 or 3, and where a valid justification has not been provided, an application or notification may be re-submitted, provided that the applicant or notifier notifies to the Authority those studies, in particular their title and their scope, the laboratory or testing facility carrying them out as well as their starting and planned completion dates.

The assessment of the validity or the admissibility of such re-submitted application or notification shall commence six months after the notification of the studies pursuant to the second subparagraph.

5.  An application or notification shall not be considered valid or admissible, where studies that have previously been notified in accordance with paragraph 2 or 3 are not included in the application or notification, unless the applicant or notifier provides a valid justification for the non-inclusion of such studies.

Where the studies which have previously been notified in accordance with paragraph 2 or 3 were not included in the application or notification, and where a valid justification has not been provided, an application or notification may be resubmitted, provided that the applicant or notifier submits all the studies that were notified in accordance with paragraph 2 or 3.

The assessment of the validity or admissibility of such re-submitted application or notification shall commence six months after the submission of the studies pursuant to the second subparagraph.

6.  Where the Authority detects, during its risk assessment, that studies notified in accordance with paragraph 2 or 3 are not included in the corresponding application or notification in full, and in the absence of a valid justification of the applicant or notifier to that effect, the applicable time limits within which the Authority is required to deliver its scientific output shall be suspended. That suspension shall end six months after the submission of all data of those studies.

7.  The Authority shall make public the notified information only in cases where it received a corresponding application or notification and after the Authority has decided on the disclosure of the accompanying studies in accordance with Articles 38 to 39e.

8.  The Authority shall lay down ▌ the practical arrangements for implementing the provisions of this Article, including arrangements for requesting and making public the valid justifications in the cases referred to in paragraphs 4, 5 and 6. Those arrangements shall ▌be in accordance with this Regulation and other relevant Union ▌law.

Article 32c

Consultation of third parties

1.  Where the relevant Union law provides that an approval or an authorisation, including by means of a notification, may be renewed, the potential applicant or notifier for the renewal shall notify the Authority of the studies it intends to perform for that purpose, including information on how the various studies are to be carried out to ensure compliance with regulatory requirements. Following such notification of studies, the Authority shall launch a consultation of stakeholders and the public on the intended studies for renewal, including on the proposed design of studies. Taking into account the received comments from the stakeholders and the public which are relevant for the risk assessment of the intended renewal, the Authority shall provide advice on the content of the intended renewal application or notification, as well as on the design of the studies. The advice provided by the Authority shall be without prejudice and non-committal as to the subsequent assessment of the applications or notifications for renewal by the Scientific Panels.

2.  The Authority shall consult stakeholders and the public on the basis of the non-confidential version of the application or notification made public by the Authority in accordance with Articles 38 to 39e, and immediately after such disclosure to the public, in order to identify whether other relevant scientific data or studies are available on the subject matter concerned by the application or notification. In duly justified cases, where there is a risk that the results of the public consultation performed in accordance with this paragraph cannot be given proper consideration because of the applicable time limits within which the Authority is required to deliver its scientific output, those time limits may be extended for a maximum period of seven weeks. This paragraph is without prejudice to the Authority's obligations under Article 33 and does not apply to the submission of any supplementary information by the applicants or notifiers during the risk assessment process.

3.  The Authority shall lay down ▌ the practical arrangements for implementing the procedures referred to in this Article and Article 32a.

Article 32d

Verification studies

Without prejudice to the obligation on applicants ▌ to demonstrate the safety of a subject matter submitted to a system of authorisation, the Commission, in exceptional circumstances of serious controversies or conflicting results, may request the Authority to commission scientific studies with the objective of verifying evidence used in its risk assessment process. The studies commissioned may have a wider scope than the evidence subject to verification.";

"

(7)  Article 38 is amended as follows:

(a)  Paragraph 1 is replaced by the following:"

"1. The Authority shall carry out its activities with a high level of transparency. It shall in particular make public:

   (a) agendas, participant lists and minutes of the Management Board, the Advisory Forum, the Scientific Committee and the Scientific Panels and their working groups;
   (b) all its scientific outputs, including the opinions of the Scientific Committee and the Scientific Panels after adoption, minority opinions and results of consultations performed during the risk assessment process always being included;
   (c) scientific data, studies and other information supporting applications ▌, including supplementary information supplied by applicants, as well as other scientific data and information supporting requests from the European Parliament, the Commission and the Member States for a scientific output, including a scientific opinion, taking into account the protection of confidential information and the protection of personal data in accordance with Articles 39 to 39e;
   (d) the information on which its scientific outputs, including scientific opinions are based, taking into account the protection of confidential information and the protection of personal data in accordance with Articles 39 to 39e;
   (e) the annual declarations of interest made by the members of the Management Board, the Executive Director and the members of the Advisory Forum, the Scientific Committee and the Scientific Panels, as well as the members of the working groups, and the declarations of interest made in relation to items on the agendas of meetings;
   (f) its scientific studies in accordance with Articles 32 and 32d;
   (g) the annual report of its activities;
   (h) requests from the European Parliament, from the Commission or from a Member State for scientific opinions which have been refused or modified and the justifications for the refusal or modification ▌;
   (i) a summary of the advice provided ▌ to potential applicants at pre-submission phase pursuant to Articles 32a and 32c.

Information referred to in the first subparagraph shall be made public without delay, with the exception of the information referred to in point (c) thereof, as far as applications are concerned, and in point (i) thereof, which shall be made public without delay once an application has been considered valid or admissible.

The information referred to in the second subparagraph shall be made public in a dedicated section of the Authority’s website. That dedicated section shall be publicly available and easily accessible. That information shall be available to be downloaded, printed and searched through in an electronic format.";

"

(b)  the following paragraph is inserted:"

"1a. The disclosure of the information referred to in points (c), (d) and (i) of the first subparagraph of paragraph 1 ▌ to the public shall be without prejudice to:

   (a) ▌ any existing rules concerning intellectual property rights which set out limitations on certain uses of the disclosed documents or their content; and
   (b) any provisions set out in Union ▌ law protecting the investment made by innovators in gathering the information and data supporting relevant applications for authorisations (‘data exclusivity rules’).

The disclosure to the public of the information referred to in point (c) of the first subparagraph of paragraph 1 shall not be considered to be explicit or implicit permission or licence for the relevant data and information and their content to be used, reproduced, or otherwise exploited in breach of any intellectual property right or data exclusivity rules, and the Union shall not be responsible for its use by third parties. The Authority shall ensure that clear undertakings or signed statements are given to that effect by those who access the relevant information prior to its disclosure.";

"

(c)  paragraph 3 is replaced by the following:"

"3. The Authority shall lay down ▌ the practical arrangements for implementing the transparency rules referred to in paragraphs 1, 1a and 2 of this Article, taking into account Articles 39 to 39g and 41.";

"

(8)  Article 39 is replaced by the following:"

"Article 39

Confidentiality

1.  By way of derogation from Article 38, the Authority shall not make public any information for which confidential treatment has been requested under the conditions laid down in this Article.

2.  Upon the request of an applicant, the Authority may grant confidential treatment only with respect to the following items of information where the disclosure of such information is demonstrated by the applicant to potentially harm its interests to a significant degree:

   (a) the manufacturing or production process, including the method and innovative aspects thereof, as well as other technical and industrial specifications inherent to that process or method, except for information which is relevant to the assessment of safety;
   (b) commercial links between a producer or importer and the applicant or the authorisation holder, where applicable;
   (c) commercial information revealing sourcing, market shares or business strategy of the applicant; and
   (d) quantitative composition of the subject matter of the request, except for information which is relevant to the assessment of safety.

3.  The list of information referred to in paragraph 2 shall be without prejudice to any sectoral Union ▌ law.

4.  Notwithstanding paragraphs 2 and 3:

   (a) where urgent action is essential to protect human health, animal health or the environment, such as in emergency situations, the Authority may disclose the information referred to in paragraphs 2 and 3 ▌;
   (b) information which forms part of conclusions of scientific outputs, including scientific opinions, delivered by the Authority and which relate to foreseeable ▌ effects on human health, animal health or the environment, shall nevertheless be made public.";

"

(9)  the following Articles are inserted:"

"Article 39a

Confidentiality request

1.  When submitting an application ▌, supporting scientific data and other supplementary information in accordance with Union ▌ law, the applicant may request certain parts of the information submitted to be treated as confidential in accordance with Article 39(2) and (3). Such request shall be accompanied by verifiable justification that demonstrates how making public the information concerned significantly harms the interests concerned in accordance with Article 39(2) and (3).

2.  Where an applicant submits a request for confidentiality, it shall provide a non-confidential version and a confidential version of the information submitted in accordance with standard data formats, where they exist, pursuant to Article 39f. The non-confidential version shall not include the information the applicant deems confidential on the basis of Article 39(2) and (3) and shall indicate the places where such information has been deleted. The confidential version shall contain all information submitted, including information the applicant deems confidential. Information requested to be treated as confidential in the confidential version shall be clearly marked. The applicant shall clearly indicate the grounds on the basis of which confidentiality is requested for the different pieces of information.

Article 39b

Decision on confidentiality

1.  The Authority shall:

   (a) make public ▌ the non-confidential version of the application as submitted by the applicant without delay once that application has been considered valid or admissible;
   (b) proceed, without delay, to a concrete and individual examination of the confidentiality request in accordance with this Article;
   (c) inform the applicant in writing of its intention to disclose information and the reasons for that, before the Authority formally takes a decision on the confidentiality request. If the applicant disagrees with the assessment of the Authority, the applicant may state its views or withdraw its application within two weeks of the date on which it was notified of the Authority’s position;
   (d) adopt a reasoned decision on the confidentiality request, taking into account the observations of the applicant, within 10 weeks of the date of receipt of the confidentiality request with respect to applications and without delay in the case of supplementary data and information; notify the applicant of its decision and provide information on the right to submit a confirmatory application in accordance with paragraph 2;, and inform the Commission and the Member States, where appropriate, of its decision; and
   (e) make public any additional data and information for which the confidentiality request has not been accepted as justified at the earliest two weeks after the notification of its decision to the applicant has taken place pursuant to point (d).

2.  Within two weeks of the notification of the Authority's decision on the confidentiality request to the applicant pursuant to paragraph 1, the applicant may submit a confirmatory application asking the Authority to reconsider its decision. The confirmatory application shall have suspensive effect. The Authority shall examine the grounds for the confirmatory application and shall adopt a reasoned decision on that confirmatory application. It shall notify the applicant of that decision within three weeks of submitting the confirmatory application and shall include in that notification information on the available remedies, namely an action before the Court of Justice of the European Union (the ‘Court of Justice’) against the Authority pursuant to paragraph 3. The Authority shall make public any additional data and information for which the confidentiality request has not been accepted by the Authority as justified, at the earliest two weeks after the notification of the Authority's reasoned decision on the confirmatory application to the applicant has taken place pursuant to this paragraph.

3.  Decisions taken by the Authority pursuant to this Article may be subject to an action before the Court of Justice, under the conditions laid down in Articles 263 and 278 of the Treaty on the Functioning of the European Union (TFEU) respectively.

Article 39c

Review of confidentiality

Before the Authority issues its scientific outputs, including scientific opinions, it shall review whether information that has been previously accepted as confidential may nevertheless be made public in accordance with point (b) of Article 39(4). Should that be the case, the Authority shall follow the procedure laid down in Article 39b, which shall apply mutatis mutandis.

Article 39d

Obligations with regard to confidentiality

1.  The Authority shall make available, upon request, to the Commission and the Member States all information in its possession relating to an application ▌ or to a request by the European Parliament, by the Commission or by the Member States for a scientific output, including a scientific opinion, unless otherwise indicated in Union ▌ law.

2.  The Commission and the Member States shall take the necessary measures so that information received by them under Union ▌ law for which confidential treatment has been requested is not made public until a decision on the confidentiality request has been taken by the Authority and has become final. The Commission and the Member States shall also take the necessary measures so that information for which confidential treatment has been accepted by the Authority is not made public.

3.  If an applicant ▌ withdraws or has withdrawn an application, the Authority, the Commission and the Member States shall respect the confidentiality of ▌ information as granted by the Authority in accordance with Articles 39 to 39e. The application shall be considered withdrawn as of the moment the written request to that effect is received by the competent body that had received the original application. Where the withdrawal of the application takes place before a final decision on the ▌ confidentiality request has been adopted by the Authority pursuant to, where appropriate, Article 39b(1) or (2), the Commission, the Member States and the Authority, shall not make public the information for which confidentiality has been requested.

4.  Members of the Management Board, the Executive Director, members of the Scientific Committee and Scientific Panels as well as external experts participating in their working groups, members of the Advisory Forum and members of the staff of the Authority, even after their duties have ceased, shall be subject to the requirements of the obligation of professional secrecy pursuant to Article 339 TFEU.

5.  The Authority shall lay down in consultation with the Commission the practical arrangements for implementing the confidentiality rules laid down in Articles 39, 39a, 39b, 39e and in this Article, including arrangements concerning the submission and treatment of confidentiality requests with respect to information to be made public under Article 38, and taking into account Articles 39f and 39g. As regards Article 39b(2), the Authority shall ensure that appropriate separation of tasks is applied for the assessment of confirmatory applications.

Article 39e

Protection of personal data

1.  With respect to requests for scientific outputs, including scientific opinions under Union ▌ law, the Authority shall always make public:

   (a) the name and address of the applicant;
   (b) the names of authors of published or publicly available studies supporting such requests; and
   (c) the names of all participants and observers in meetings of the Scientific Committee and the Scientific Panels, their working groups and any other ad hoc group meeting on the subject matter.

2.  Notwithstanding paragraph 1, disclosure of names and addresses of natural persons involved in testing on vertebrate animals or in obtaining toxicological information shall be deemed to significantly harm the privacy and the integrity of those natural persons and shall not be made publicly available unless otherwise specified in Regulations (EU) 2016/679(25) and (EU) 2018/1725(26) of the European Parliament and of the Council.

3.  Regulations (EU) 2016/679 and (EU) 2018/1725 shall apply to the processing of personal data carried out pursuant to this Regulation. Any personal data made public pursuant to Article 38 of this Regulation and this Article shall only be used to ensure the transparency of the risk assessment under this Regulation and shall not be further processed in a manner that is incompatible with these purposes, in accordance with point (b) of Article 5(1) of Regulation (EU) 2016/679 and point (b) of Article 4(1) of Regulation (EU) 2018/1725, as the case may be.

Article 39f

Standard data formats

1.  For the purposes of point (c) of Article 38(1) and in order to ensure the efficient processing of requests to the Authority for a scientific output, standard data formats ▌ shall be adopted in accordance with paragraph 2 of this Article to allow documents to be submitted, searched, copied and printed, while ensuring compliance with regulatory requirements set out in Union ▌ law. Those ▌ standard data formats ▌ shall:

   (a) not be based on proprietary standards;
   (b) ensure interoperability with existing data submission approaches to the extent possible;
   (c) be user-friendly and adapted for the use by small and medium-sized enterprises.

2.  For the adoption of standard data formats referred to in paragraph 1 ▌, the following procedure shall be followed:

   (a) the Authority shall draw up draft standard data formats ▌ for the purposes of the different authorisation procedures ▌ and relevant requests for a scientific output by the European Parliament, by the Commission and by the Member States;
   (b) the Commission shall, taking into account the applicable requirements in the different authorisation procedures and other legal frameworks and following any necessary adaptations, adopt, by means of implementing acts, standard data formats ▌. Those implementing acts shall be adopted in accordance with the procedure referred to in Article 58(2);
   (c) the Authority shall make the standard data formats ▌, as adopted, available on its website;
   (d) where standard data formats ▌ have been adopted pursuant to this Article, applications as well as requests for a scientific output, including a scientific opinion by the European Parliament, by the Commission and by the Member States ▌, shall only be submitted in accordance with those standard data formats.

Article 39g

Information systems

The information systems operated by the Authority to store its data, including confidential and personal data shall be designed in a way that guarantees that any access to it is fully auditable and that the highest standards of security appropriate to the security risks at stake are attained, taking into account Articles 39 to 39f. ▌";

"

(10)  in Article 40(3), the second subparagraph is replaced by the following:"

"The Authority shall make public all scientific outputs including the scientific opinions issued by it and supporting scientific data and other information in accordance with Articles 38 to 39e.";

"

(11)  Article 41 is amended as follows ▌:

(a)  paragraph 1 is replaced by the following:"

"1. Notwithstanding the rules on confidentiality provided for in Articles 39 to 39d of this Regulation, Regulation (EC) No 1049/2001 of the European Parliament and of the Council* shall apply to documents held by the Authority.

Where environmental information is concerned, ▌ Regulation (EC) No 1367/2006 of the European Parliament and of the Council** shall also apply. Directive 2003/4/EC of the European Parliament and of the Council*** shall apply to environmental information held by Member States, notwithstanding the rules on confidentiality provided for in Articles 39 to 39d of this Regulation.

--------------------------------------

* Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43).

** Regulation (EC) No 1367/2006 of the European Parliament and of the Council of 6 September 2006 on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to Community institutions and bodies (OJ L 264, 25.9.2006, p. 13).

*** Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information and repealing Council Directive 90/313/EEC (OJ L 41, 14.2.2003, p. 26).";

"

(b)  paragraph 2 is replaced by the following:"

"2. The Management Board shall adopt the practical arrangements for implementing Regulation (EC) No 1049/2001 and Articles 6 and 7 of Regulation (EC) No 1367/2006by … six months after the date of entry into force of this amending Regulation, ensuring as wide access as possible to documents in its possession.";

"

(12)  Article 61 is replaced by the following:"

"Article 61

Review clause

1.  The Commission shall ensure the regular review of the application of this Regulation.

2.  By …five years after the date of application of this amending Regulation, and every five years thereafter, the Commission shall evaluate the Authority’s performance in relation to its objectives, mandate, tasks, procedures and location, in accordance with Commission guidelines. That evaluation shall also cover the impact of Article 32a on the functioning of the Authority with particular attention to the relevant workload and mobilisation of staff, and to any shifts in the allocation of the Authority’s resources that may have taken place, at the expense of activities of public interest. That evaluation shall address the possible need to modify the mandate of the Authority, and the financial implications of any such modification.

3.  In the evaluation referred to in paragraph 2, the Commission shall also evaluate whether the organisational framework of the Authority needs to be further updated with regard to decisions on requests for confidentiality and confirmatory applications, namely by setting up a specific Board of Appeal or by other appropriate means.

4.  Where the Commission considers that the continued operation of the Authority is no longer justified with regard to its assigned objectives, mandate and tasks, it may propose that the relevant provisions of this Regulation be amended accordingly or repealed.

5.  The Commission shall report to the European Parliament, to the Council and to the Management Board on the findings of its reviews and evaluations under this Article. Those findings shall be made public.";

"

(13)  the following Article is inserted:"

"Article 61a

Fact-finding missions

▌ Commission experts shall perform fact-finding missions in Member States to assess the application, by laboratories and by other testing facilities, of the relevant standards for carrying out tests and studies submitted to the Authority as part of an application, as well as compliance with the notification obligation set out in Article 32b(3), by …four years after the date of application of this amending Regulation. By that date, Commission experts shall also perform fact-finding missions to assess the application of those standards by laboratories and other testing facilities located in third countries insofar as set out in relevant agreements and arrangements with those third countries, including as referred to in Article 49.

Non-compliance identified during those fact-finding missions shall be brought to the attention of the Commission, Member States, the Authority as well as the assessed laboratories and other testing facilities. The Commission, the Authority and Member States shall ensure the appropriate follow-up to such identified non-compliance.

The outcome of these fact-finding missions shall be presented in an overview report. On the basis of that report, the Commission shall submit a legislative proposal, if appropriate, as regards, in particular, any necessary control procedures, including audits.".

"

Article 2

Amendments to Regulation (EC) No 1829/2003

Regulation (EC) No 1829/2003 is amended as follows:

(1)  in Article 5, paragraph 3 is amended as follows:

(a)  the introductory wording is replaced by the following:"

"The application shall be submitted in accordance with standard data formats, where they exist pursuant to Article 39f of Regulation (EC) No 178/2002, and shall be accompanied by the following:";

"

(b)  point (l) is replaced by the following:"

"(l) an identification of the parts of the application and any other supplementary information that the applicant requests to be treated as confidential, accompanied by verifiable justification, pursuant to Article 30 of this Regulation and Article 39 of Regulation (EC) No 178/2002;";

"

(c)  the following point is added:"

"(m) a summary of the dossier in a standardised form.";

"

(2)  in Article 6, paragraph 7 is replaced by the following:"

"7. The Authority, in accordance with Article 38(1) of Regulation (EC) No 178/2002, shall make its opinion public, after deletion of any information identified as confidential in accordance with Articles 39 to 39e of Regulation (EC) No 178/2002 and Article 30 of this Regulation. The public may make comments to the Commission within 30 days of such publication.";

"

(3)  in Article 10, paragraph 1 is replaced by the following:"

"1. On its own initiative or following a request from the Commission or from a Member State, the Authority shall issue an opinion on whether an authorisation for a product referred to in Article 3(1) of this Regulation still meets the conditions set out in this Regulation. It shall forthwith transmit that opinion to the Commission, Member States and the authorisation-holder. The Authority, in accordance with Article 38(1) of Regulation (EC) No 178/2002, shall make its opinion public, after deletion of any information identified as confidential in accordance with Articles 39 to 39e of Regulation (EC) No 178/2002 and Article 30 of this Regulation. The public may make comments to the Commission within 30 days of such publication.";

"

(4)  in Article 11(2), the introductory wording is replaced by the following:"

"2. The application shall be submitted in accordance with standard data formats, where they exist pursuant to Article 39f of Regulation (EC) No 178/2002, and accompanied by the following:";

"

(5)  in Article 17, paragraph 3 is amended as follows:

(a)  the introductory wording is replaced by the following:"

"The application shall be submitted in accordance with standard data formats, where they exist pursuant to Article 39f of Regulation (EC) No 178/2002, and accompanied by the following:";

"

(b)  point (l) is replaced by the following:"

"(l) an identification of the parts of the application and any other supplementary information that the applicant requests to be treated as confidential, accompanied by verifiable justification, pursuant to Article 30 of this Regulation and Articles 39 to 39e of Regulation (EC) No 178/2002;";

"

(c)  the following point is added:"

"(m) a summary of the dossier in a standardised form.";

"

(6)  in Article 18, paragraph 7 is replaced by the following:"

"7. The Authority shall, in accordance with Article 38(1) of Regulation (EC) No 178/2002, make its opinion public, after the deletion of any information identified as confidential in accordance with Articles 39 to 39e of Regulation (EC) No 178/2002 and Article 30 of this Regulation. The public may make comments to the Commission within 30 days of such publication.";

"

(7)  in Article 22, paragraph 1 is replaced by the following:"

"1. On its own initiative or following a request from the Commission or from a Member State, the Authority shall issue an opinion on whether an authorisation for a product referred to in Article 15(1) still meets the conditions set out in this Regulation. It shall forthwith transmit that opinion to the Commission, Member States and the authorisation-holder. The Authority, in accordance with Article 38(1) of Regulation (EC) No 178/2002, shall make its opinion public, after deletion of any information identified as confidential in accordance with Articles 39 to 39eof Regulation (EC) No 178/2002 and Article 30 of this Regulation. The public may make comments to the Commission within 30 days of such publication.";

"

(8)  in Article 23(2), the introductory wording is replaced by the following:"

"2. The application shall be submitted in accordance with standard data formats, where they exist pursuant to Article 39f of Regulation (EC) No 178/2002, and accompanied by the following:";

"

(9)  in Article 29, paragraphs 1 and 2 are replaced by the following:"

"1. The Authority shall make public the application for authorisation, relevant supporting information and any supplementary information supplied by the applicant, as well as its scientific opinions and opinions from the competent authorities referred to in Article 4 of Directive 2001/18/EC, in accordance with Articles 38 to 39e ▌of Regulation (EC) No 178/2002 and taking into account Article 30 of this Regulation.

2.  The Authority shall apply Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents* when handling applications for access to documents held by the Authority.

--------------------------------------

* Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43).";

"

(10)  Article 30 is replaced by the following:"

"Article 30

Confidentiality

1.  In accordance with the conditions and the procedures laid down in Articles 39 to 39e of Regulation (EC) No 178/2002 and this Article:

   (a) the applicant may submit a request to treat certain parts of the information submitted under this Regulation as confidential, accompanied by verifiable justification; and
   (b) the Authority shall assess the confidentiality request submitted by the applicant.

2.  In addition to the items of information referred to in points (a), (b) and (c) of Article 39(2) of Regulation (EC) No 178/2002 and pursuant to Article 39(3) thereof, the Authority may also grant confidential treatment with respect to the following information, where the disclosure of such information is demonstrated by the applicant to potentially harm its interests to a significant degree:

   (a) DNA sequence information, except for sequences used for the purpose of detection, identification and quantification of the transformation event; and
   (b) breeding patterns and strategies.

3.  The use of the detection methods and the reproduction of the reference materials, provided under Articles 5(3) and 17(3) for the purpose of applying this Regulation to GMOs, food or feed to which an application refers, shall not be restricted by the exercise of intellectual property rights or otherwise.

4.  This Article is without prejudice to Article 41 of Regulation (EC) No 178/2002.".

"

Article 3

Amendments to Regulation (EC) No 1831/2003

Regulation (EC) No 1831/2003 is amended as follows:

(1)  Article 7 is amended as follows:

(a)  paragraph 1 is replaced by the following:"

"1. An application for an authorisation as provided for in Article 4 of this Regulation shall be sent to the Commission, in accordance with standard data formats, where they exist pursuant to Article 39f of Regulation (EC) No 178/2002, which shall apply mutatis mutandis. The Commission shall without delay inform the Member States and forward the application to the European Food Safety Authority (hereinafter referred to as the ‘Authority’).";

"

(b)  in paragraph 2, point (c) is replaced by the following:"

"(c) make public ▌the application and any information supplied by the applicant, in accordance with Article 18.";

"

(2)  Article 18 is replaced by the following:"

"Article 18

Transparency and confidentiality

1.  The Authority shall make public the application for authorisation, relevant supporting information and any supplementary information supplied by the applicant, as well as its scientific opinions, in accordance with Articles 38 to 39e ▌of Regulation (EC) No 178/2002, which shall apply mutatis mutandis.

2.  In accordance with the conditions and the procedures laid down in Articles 39 to 39e of Regulation (EC) No 178/2002 and in this Article, the applicant may submit a request to treat certain parts of the information submitted under this Regulation as confidential, accompanied by verifiable justification. The Authority shall assess the confidentiality request submitted by the applicant.

3.  In addition to the items of information referred to in Article 39(2) of Regulation (EC) No 178/2002 and pursuant to Article 39(3) thereof, the Authority may also grant confidential treatment with respect to the following items of information, where the disclosure of such information is demonstrated by the applicant to potentially harm its interests to a significant degree:

   (a) the study plan for studies demonstrating the efficacy of a feed additive in terms of the aims of its intended use as defined in Article 6(1) of, and Annex I to, this Regulation; and
   (b) specifications of the impurities of the active substance and the relevant methods of analysis developed internally by the applicant, except for impurities that may have adverse effects on animal health, human health, or the environment.

4.  This Article is without prejudice to Article 41 of Regulation (EC) No 178/2002.".

"

Article 4

Amendments to Regulation (EC) No 2065/2003

Regulation (EC) No 2065/2003 is amended as follows:

(1)  Article 7 is amended as follows:

(a)  in paragraph 2, point (c) is replaced by the following:"

"(c) The Authority shall:

   (i) inform without delay the Commission and the other Member States of the application and shall make the application and any supplementary information supplied by the applicant available to them; and
   (ii) make public ▌ the application, relevant supporting information and any supplementary information supplied by the applicant, in accordance with Articles 14 and 15.";

"

(b)  paragraph 4 is replaced by the following:"

"4. The Authority shall publish detailed guidance, following the agreement with the Commission, concerning the preparation and the submission of the application, referred to in paragraph 1 of this Article, taking into account standard data formats, where they exist in accordance with Article 39f of Regulation (EC) No 178/2002.";

"

(2)  in Article 14, paragraph 1 is replaced by the following:"

"1. The Authority shall make public the application for authorisation, relevant supporting information and any supplementary information supplied by the applicant as well as its scientific opinions, in accordance with Articles 38 to 39e ▌of Regulation (EC) No 178/2002.";

"

(3)  Article 15 is replaced by the following:"

"Article 15

Confidentiality

1.  In accordance with the conditions and the procedures laid down in Articles 39 to 39e of Regulation (EC) No 178/2002:

   (a) the applicant may submit a request to treat certain parts of the information submitted under this Regulation as confidential, accompanied by verifiable justification; and
   (b) the Authority shall assess the confidentiality request submitted by the applicant.

2.  This Article is without prejudice to Article 41 of Regulation (EC) No 178/2002.".

"

Article 5

Amendments to Regulation (EC) No 1935/2004

Regulation (EC) No 1935/2004 is amended as follows:

(1)  Article 9 is amended as follows:

(a)  in paragraph 1, point (c) is replaced by the following:"

"(c) the Authority shall without delay:

   (i) inform the Commission and the other Member States of the application and shall make the application and any supplementary information supplied by the applicant available to them; and
   (ii) make public ▌ the application, relevant supporting information and any supplementary information supplied by the applicant, in accordance with Articles 19 and 20.";

"

(b)  paragraph 2 is replaced by the following:"

"2. The Authority shall publish detailed guidelines, following the agreement with the Commission, concerning the preparation and the submission of the application, taking into account standard data formats, where they exist in accordance with Article 39f of Regulation (EC) No 178/2002, which shall apply mutatis mutandis.";

"

(2)  in Article 19, paragraph 1 is replaced by the following:"

"1. The Authority shall make public the application for authorisation, relevant supporting information and any supplementary information supplied by the applicant, as well as its scientific opinions, in accordance with Articles 38 to 39e ▌ of Regulation (EC) No 178/2002, which shall apply mutatis mutandis and with Article 20 of this Regulation.";

"

(3)  Article 20 is replaced by the following:"

"Article 20

Confidentiality

1.  In accordance with the conditions and the procedures laid down in Articles 39 to 39e of Regulation (EC) No 178/2002 and in this Article:

   (a) the applicant may submit a request to treat certain parts of the information submitted under this Regulation as confidential, accompanied by verifiable justification; and
   (b) the Authority shall assess the confidentiality request submitted by the applicant.

2.  In addition to the items of information referred to in Article 39(2) of Regulation (EC) No 178/2002 and pursuant to Article 39(3) thereof, the Authority may also grant confidential treatment with respect to the following items of information, where the disclosure of such information is demonstrated by the applicant to potentially harm its interests to a significant degree:

   (a) any information provided in detailed descriptions of starting substances and mixtures used to manufacture the substance subject to the authorisation, the composition of mixtures, materials or articles in which the applicant intends to use that substance, the manufacturing methods of those mixtures, materials or articles, impurities, and migration testing results, except for information which is relevant to the assessment of safety;
   (b) the trademark under which the substance shall be marketed as well as the tradename of the mixtures, material or articles in which it shall be used, where applicable; and
   (c) any other information deemed confidential within the specific procedural rules referred to in point (n) of Article 5(1) of this Regulation.

3.  This Article is without prejudice to Article 41 of Regulation (EC) No 178/2002.".

"

Article 6

Amendments to Regulation (EC) No 1331/2008

Regulation (EC) No 1331/2008 is amended as follows:

(1)  in Article 6, the following paragraph is added:"

"5. The Authority shall make public ▌ the additional information supplied by the applicant in accordance with Articles 11 and 12.";

"

(2)  Article 11 is replaced by the following:"

"Article 11

Transparency

Where the Commission requests the opinion of the Authority in accordance with Article 3(2) of this Regulation, the Authority shall make public without delay the application for authorisation, relevant supporting information and any supplementary information supplied by the applicant, as well as its scientific opinions, in accordance with Articles 38 to 39e ▌ of Regulation (EC) No 178/2002. The Authority shall also make public any request for its opinion as well as any extension of period pursuant to Article 6(1) of this Regulation.";

"

(3)  Article 12 is replaced by the following:"

"Article 12

Confidentiality

1.  The applicant may submit a request to treat certain parts of the information submitted under this Regulation be as confidential, accompanied by verifiable justification, upon submission of the application.

2.  Where an opinion by the Authority is required in accordance with Article 3(2) of this Regulation, the Authority shall assess the confidentiality request submitted by the applicant, in accordance with Articles 39 to 39e of Regulation (EC) No 178/2002.

3.  In addition to the items of information referred to in Article 39(2) of Regulation (EC) No 178/2002 and pursuant to Article 39(3) thereof, the Authority may also grant confidential treatment with respect to the following items of information, where the disclosure of such information is demonstrated by the applicant to potentially harm its interests to a significant degree:

   (a) where applicable, information provided in detailed descriptions of starting substances and starting preparations and on how they are used to manufacture the substance subject to the authorisation, and detailed information on the nature and composition of the materials or products in which the applicant intends to use the substance subject to the authorisation, except for information which is relevant to the assessment of safety;
   (b) where applicable, detailed analytical information on the variability and stability of individual production batches of the substance subject to the authorisation, except for information which is relevant to the assessment of safety.

4.  Where an opinion by the Authority is not required in accordance with Article 3(2) of this Regulation, the Commission shall assess the confidentiality request submitted by the applicant. Articles 39, 39a and 39d of Regulation (EC) No 178/2002 and paragraph 3 of this Article shall apply mutatis mutandis.

5.  This Article is without prejudice to Article 41 of Regulation (EC) No 178/2002.".

"

Article 7

Amendments to Regulation (EC) No 1107/2009

Regulation (EC) No 1107/2009 is amended as follows:

(1)  Article 7 is amended as follows:

(a)  in paragraph 1, the first subparagraph is replaced by the following:"

"▌ An application for the approval of an active substance or for an amendment to the conditions of an approval shall be submitted by the producer of the active substance to a Member State (the ‘rapporteur Member State’), together with a summary and a complete dossier as provided for in Article 8(1) and (2) of this Regulation or a scientifically reasoned justification for not providing certain parts of those dossiers, demonstrating that the active substance fulfils the approval criteria provided for in Article 4 of this Regulation. The application shall be submitted in accordance with standard data formats, where they exist pursuant to Article 39f of Regulation (EC) No 178/2002, which shall apply mutatis mutandis.";

"

(b)  paragraph 3 is replaced by the following:"

"3. When submitting the application, the applicant may submit a request, pursuant to Article 63, to treat certain information, including certain parts of the dossier, to be as confidential and shall physically separate that information.

Member States shall assess the confidentiality requests. After consultation with the Authority, the rapporteur Member States shall decide what information is to be treated as confidential, in accordance with Article 63.

The Authority, following consultations with the Member States, shall lay down practical arrangements to ensure the consistency of those assessments.";

"

(2)  Article 10 is replaced by the following:"

"Article 10

Public access to the dossiers

The Authority shall without delay make the dossiers referred to in Article 8, including any supplementary information supplied by the applicant, available to the public, with the exception of any information to which the rapporteur Member State has granted confidential treatment ▌ pursuant to Article 63.";

"

(3)  In Article 15, paragraph 1 is replaced by the following:"

"1. The application provided for in Article 14 of this Regulation shall be submitted by a producer of the active substance to a Member State, with a copy to the Commission, to the other Member States and to the Authority, no later than three years before the expiry of the approval. The application shall be submitted in accordance with standard data formats, where they exist pursuant to Article 39f of Regulation (EC) No 178/2002, which shall apply mutatis mutandis.";

"

(4)  Article 16 is replaced by the following:"

"Article 16

Public access to the information for renewal

The Authority shall assess, without delay, any request for confidentiality and make available to the public the information provided by the applicant under Article 15 as well as any other supplementary information submitted by the applicant, except for information in respect of which confidential treatment has been requested and granted by the Authority pursuant to Article 63.

The Authority, following consultations with the Member States, shall lay down practical arrangements to ensure the consistency of those assessments.";

"

(5)  in Article 63, paragraphs 1, 2 and 3 are replaced by the following:"

"1. An applicant may submit a request to treat certain parts of the information submitted under this Regulation as confidential, accompanied by verifiable justification.

2.  Confidential treatment may be granted only with respect to the ▌ following items of information, where the disclosure of such information is demonstrated by the applicant to potentially harm its interests to a significant degree:

   (a) information referred to in Article 39(2) of Regulation (EC) No 178/2002;
   (b) the specification of impurity of the active substance and the related methods of analysis for impurities in the active substance as manufactured, except for the impurities that are considered to be toxicologically, ecotoxicologically or environmentally relevant and the related methods of analysis for such impurities;
   (c) results of production batches of the active substance including impurities; and
   (d) information on the complete composition of a plant protection product.

2a.  Where the Authority assesses confidentiality requests under this Regulation, the conditions and the procedures laid down in Articles 39 to 39e of Regulation (EC) No 178/2002 and paragraph 2 of this Article shall apply.

2b.  Where Member States assess confidentiality requests under this Regulation, the following requirements and procedures apply:

   (a) confidentiality treatment may only be granted with respect to information listed in paragraph 2;
   (b) where the Member State has decided which information is to be treated as confidential, it shall inform the applicant of its decision;
   (c) Member States, the Commission and the Authority shall take the necessary measures so that information for which confidential treatment has been granted is not made public;
   (d) Article 39e of Regulation (EC) No 178/2002 shall also apply mutatis mutandis;
   (e) notwithstanding paragraph 2 and points (c) and (d) of this paragraph:
   (i) where urgent action is essential to protect human health, animal health or the environment, such as in emergency situations, the Member State may disclose the information referred to in paragraph 2;
   (ii) information which forms part of the conclusions of the scientific outputs delivered by the Authority and which relate to foreseeable effects on human health, animal health or the environment shall nevertheless be made public. In that case, Article 39c of Regulation (EC) No 178/2002 shall apply;
   (f) if the applicant withdraws or has withdrawn an application, Member States, the Commission and the Authority shall respect the confidentiality as granted in accordance with this Article. Where the withdrawal of the application takes place before the Member State has decided on the relevant confidentiality request, Member States, the Commission and the Authority shall not make public the information for which confidentiality has been requested.

3.  This Article is without prejudice to Directive 2003/4/EC* and Regulations (EC) No 1049/2001** and (EC) No 1367/2006*** of the European Parliament and of the Council.

--------------------------------------

* Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information and repealing Council Directive 90/313/EEC (OJ L 41, 14.2.2003, p. 26).

** Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43).

*** Regulation (EC) No 1367/2006 of the European Parliament and of the Council of 6 September 2006 on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to Community institutions and bodies (OJ L 264, 25.9.2006, p. 13).".

"

Article 8

Amendments to Regulation (EU) 2015/2283

Regulation (EU) 2015/2283 is amended as follows:

(1)  Article 10 is amended as follows:

(a)  paragraph 1 is replaced by the following:"

"1. The procedure for authorising the placing on the market within the Union of a novel food and updating of the Union list provided for in Article 9 of this Regulation shall start either on the Commission’s initiative or following an application to the Commission by an applicant, in accordance with standard data formats, where they exist pursuant to Article 39f of Regulation (EC) No 178/2002. The Commission shall make the application available to the Member States without delay. The Commission shall make a summary of the application, based on the information referred to in points (a), (b) and (e) of paragraph 2 of this Article, publicly available.";

"

(b)  paragraph 3 is replaced by the following:"

"3. Where the Commission requests an opinion from the European Food Safety Authority (the ‘Authority’), the Authority shall make public ▌ the application in accordance with Article 23 and shall give its opinion as to whether the update is liable to have an effect on human health.";

"

(2)  ▌ in Article 15, paragraph 2 is replaced by the following:"

"2. Within four months from the date on which a valid notification is forwarded by the Commission in accordance with paragraph 1 of this Article, a Member State or the Authority may submit to the Commission duly reasoned safety objections to the placing on the market within the Union of the traditional food concerned. Where the Authority submits duly reasoned safety objections, it shall make public, without delay, the notification, pursuant to Article 23, which shall apply mutatis mutandis.";

"

(3)  Article 16 is amended as follows:

(a)  in the first paragraph, the following sentence is added :"

"The application shall be submitted in accordance with standard data formats, where they exist pursuant to Article 39f of Regulation (EC) No 178/2002.";

"

(b)  in the second paragraph, the following sentence is added:"

"The Authority shall make public ▌ the application, relevant supporting information and any supplementary information supplied by the applicant in accordance with Article 23.";

"

(4)  Article 23 is replaced by the following:"

"Article 23

Transparency and confidentiality

1.  Where the Commission requests the opinion of the Authority in accordance with Article 10(3) and Article 16 of this Regulation, the Authority shall make public the application for authorisation, relevant supporting information and any supplementary information supplied by the applicant, as well as its scientific opinions, in accordance with Articles 38 to 39e ▌ of Regulation (EC) No 178/2002 and with this Article.

2.  The applicant may submit a request to treat certain parts of the information submitted under this Regulation as confidential, accompanied by verifiable justification, upon submission of the application.

3.  Where the Commission requests the opinion of the Authority in accordance with Article 10(3) and Article 16 of this Regulation, the Authority shall assess the confidentiality request submitted by the applicant, in accordance with Articles 39 to 39e of Regulation (EC) No 178/2002.

4.  In addition to the items of information referred to in Article 39(2) of Regulation (EC) No 178/2002 and pursuant to Article 39(3) thereof, the Authority may also grant confidential treatment with respect to the following items of information, where the disclosure of such information is demonstrated by the applicant to potentially harm its interests to a significant degree:

   (a) where applicable, information provided in detailed descriptions of starting substances and starting preparations and on how they are used to manufacture the novel food subject to the authorisation, and detailed information on the nature and composition of the specific foods or food categories in which the applicant intends to use that novel food, except for information which is relevant to the assessment of safety;
   (b) where applicable, detailed analytical information on the variability and stability of individual production batches, except for information which is relevant to the assessment of safety.

5.  Where the Commission does not request the Authority’s opinion pursuant to Articles 10 and 16 of this Regulation, the Commission shall assess the confidentiality request submitted by the applicant. Articles 39, 39a and 39d of Regulation (EC) No 178/2002 and paragraph 4 of this Article shall apply mutatis mutandis.

6.  This Article is without prejudice to Article 41 of Regulation (EC) No 178/2002.".

"

Article 9

Amendments to Directive 2001/18/EC

Directive 2001/18/EC is amended as follows:

(1)  in Article 6, the following paragraph is inserted:"

"2a. The notification referred to in paragraph 1 shall be submitted in accordance with standard data formats, where they exist under Union law.";

"

(2)  in Article 13, the following paragraph is inserted:"

"2a. The notification referred to in paragraph 1 shall be submitted in accordance with standard data formats, where they exist under Union law.";

"

(3)  Article 25 is replaced by the following:"

"Article 25

Confidentiality

1.  The notifier ▌may submit a request to the competent authority to treat certain parts of the information submitted under this Directive as confidential, accompanied by verifiable justification, in accordance with paragraphs 3 and 6.

2.  The competent authority shall assess the confidentiality request submitted by the notifier ▌.

3.  Upon request of a notifier, the competent authority may grant confidential treatment only with respect to the ▌following items of information, upon verifiable justification, where the disclosure of such information is demonstrated by the notifier to potentially harm its interests to a significant degree:

   (a) items of information referred to in points (a), (b) and (c) of Article 39(2) of Regulation (EC) No 178/2002;
   (b) DNA sequence information, except for sequences used for the purpose of detection, identification and quantification of the transformation event; and
   (c) breeding patterns and strategies.

4.  The competent authority shall, after consultation with the notifier, decide which information is to be treated as confidential and shall inform the notifier of its decision.

5.  Member States, the Commission and the relevant Scientific Committee(s) shall take the necessary measures to ensure that confidential information notified or exchanged under this Directive is not made public.

6.  The relevant provisions of Articles 39e and 41 of Regulation (EC) No 178/2002 shall also apply mutatis mutandis.

7.  Notwithstanding paragraphs 3, 5 and 6 of this Article:

   (a) where urgent action is essential to protect human health, animal health or the environment, such as in emergency situations, the competent authority may disclose the information referred to in paragraph 3; and
   (b) information which forms part of the conclusions of the scientific outputs delivered by the relevant Scientific Committee(s) or the conclusions of the assessment reports and which relate to foreseeable effects on human health, animal health or the environment shall nevertheless be made public. In that case Article 39c of Regulation (EC) No 178/2002 shall apply.

8.  In the event of a withdrawal of the notification by the notifier, Member States, the Commission and the relevant Scientific Committee(s) shall respect the confidentiality as granted by the competent authority in accordance with this Article. Where the withdrawal of the notification takes place before the competent authority has decided on the relevant confidentiality request, Member States, the Commission and the relevant Scientific Committee(s) shall not make public the information for which confidentiality has been requested.";

"

(4)  in Article 28, the following paragraph is added:"

"4. Where the relevant Scientific Committee is consulted in accordance with paragraph 1 of this Article, it shall make public without delay the notification ▌ , relevant supporting information and any supplementary information supplied by the notifier ▌, as well as its scientific opinions, with the exception of any information to which the competent authority has granted confidential treatment in accordance with Article ▌25.".

"

Article 10

Transitional measures

1.  This Regulation shall not apply to applications ▌ under Union ▌ law as well as requests for scientific outputs submitted to the Authority before … [18 months after the date of entry into force of this Regulation].

2.  The term of office of the members of the Management Board of the Authority (the ‘Management Board’) who are in office on 30 June 2022, shall expire on that date. Notwithstanding the dates of application referred to in Article 11, the procedure for nomination and appointment of members to the Management Board set out in point 4 of Article 1 shall apply for the purposes of allowing the members appointed under those rules to start their term of office on 1 July 2022.

3.  Notwithstanding the dates of application referred to in Article 11, the term of office of the members of the Scientific Committee and of the Scientific Panels who are in office on 30 June 2021, shall be prolonged until the members of that Scientific Committee and those Scientific Panels appointed according to the selection and appointment procedure laid down in point 5 of Article 1 start their term of office.

Article 11

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from … [18 months after the date of entry into force of this Regulation].

However, points 4 and 5 of Article 1 shall apply from 1 July 2022.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at …,

For the European Parliament For the Council

The President The President

(1) OJ C 440, 6.12.2018, p. 158.
(2) OJ C 461, 21.12.2018, p. 225.
(3) This position replaces the amendments adopted on 11 December 2018 (Texts adopted, P8_TA(2018)0489).
(4)OJ C 440, 6.12.2018, p. 158.
(5)OJ C 461, 21.12.2018, p. 225.
(6) Position of the European Parliament of 17 April 2019.
(7)Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).
(8)Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).
(9)Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).
(10)Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).
(11)Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (OJ L 50, 20.2.2004, p. 44).
(12)Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (OJ L 268, 18.10.2003, p. 1).
(13)Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (OJ L 268, 18.10.2003, p. 29).
(14)Regulation (EC) No 2065/2003 of the European Parliament and of the Council of 10 November 2003 on smoke flavourings used or intended for use in or on foods (OJ L 309, 26.11.2003, p. 1).
(15)Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4).
(16)Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (OJ L 354, 31.12.2008, p. 1).
(17)Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1).
(18)Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (OJ L 327, 11.12.2015, p. 1).
(19)Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1).
(20)Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43).
(21)Regulation (EC) No 1367/2006 of the European Parliament and of the Council of 6 September 2006 on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to Community institutions and bodies (OJ L 264, 25.9.2006, p. 13).
(22)Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information and repealing Council Directive 90/313/EE (OJ L 41, 14.2.2003, p. 26).
(23)Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
(24)Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1).
(25)Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data and repealing Directive 95/46/EC (General Data Protection Regulation), (OJ L 119, 4.5.2016, p. 1).
(26)Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).


Supplementary protection certificate for medicinal products ***I
PDF 275kWORD 87k
Resolution
Consolidated text
European Parliament legislative resolution of 17 April 2019 on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products (COM(2018)0317 – C8-0217/2018 – 2018/0161(COD))
P8_TA-PROV(2019)0401A8-0039/2019

(Ordinary legislative procedure: first reading)

The European Parliament,

–  having regard to the Commission proposal to Parliament and the Council (COM(2018)0317),

–  having regard to Article 294(2) and Article 114 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8-0217/2018),

–  having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–  having regard to the opinion of the European Economic and Social Committee of 19 September 2018(1),

–  having regard to the provisional agreement approved by the committee responsible under Rule 69f(4) of its Rules of Procedure and the undertaking given by the Council representative by letter of 20 February 2019 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,

–  having regard to Rule 59 of its Rules of Procedure,

–  having regard to the report of the Committee on Legal Affairs and also the opinions of the Committee on International Trade and the Committee on the Environment, Public Health and Food Safety (A8-0039/2019),

1.  Adopts its position at first reading hereinafter set out;

2.  Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

3.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Position of the European Parliament adopted at first reading on 17 April 2019 with a view to the adoption of Regulation (EU) 2019/… of the European Parliament and of the Council amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products

P8_TC1-COD(2018)0161


(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee(2),

Acting in accordance with the ordinary legislative procedure(3),

Whereas:

(1)  Regulation (EC) No 469/2009 of the European Parliament and of the Council(4) provides that any product protected by a patent in the territory of a Member State and subject, prior to being placed on the market as a medicinal product, to an administrative authorisation procedure as laid down in Directive 2001/82/EC(5) or 2001/83/EC(6) of the European Parliament and of the Council, may, under the terms and conditions provided for in that Regulation, be the subject of a supplementary protection certificate (‘certificate’).

(2)  By providing for a period of supplementary protection, Regulation (EC) No 469/2009 seeks to promote, within the Union, the research and innovation that is necessary to develop medicinal products, and to contribute to preventing the relocation of pharmaceutical research outside the Union to countries that might offer greater protection.

(3)  Since the adoption in 1992 of the predecessor to Regulation (EC) No 469/2009, markets have evolved significantly and there has been huge growth in the making of generics and especially of biosimilars, and in the making of their active ingredients, in particular in ▌ countries outside the Union (‘third countries’) in which protection does not exist or has expired.

(4)  The absence in Regulation (EC) No 469/2009 of any exception to the protection conferred by the certificate has had the unintended consequence of preventing makers of generics and biosimilars established in the Union from making generics and biosimilars in the Union, even for the ▌ purpose of export to third-country markets in which ▌ protection does not exist or has expired. Likewise, makers are prevented from making generics and biosimilars for the purpose of storing them for a limited period before the expiry of the certificate. Those circumstances make it more difficult for those makers, in contrast to makers located in third countries where protection does not exist or has expired, to enter the Union market immediately after expiry of the certificate, given that they are not in a position to build up production capacity for the purpose of export or for the purpose of entering the market of a Member State until the protection provided by that certificate has expired.

(5)  Those circumstances put makers of generics and biosimilars established in the Union at a significant competitive disadvantage in comparison with makers based in third countries that offer less or no protection. The Union should strike a balance between restoring a level playing field between those makers and ensuring that the essence of the exclusive rights of holders of certificates (‘certificate holders’) is guaranteed in relation to the Union market.

(6)  Without intervention, the viability of makers of generics and biosimilars established in the Union could be threatened, with consequences for the Union’s pharmaceutical industrial base as a whole. That situation could affect the fully effective functioning of the internal market through the loss of potential new business opportunities for makers of generics and biosimilars, thereby possibly diminishing related investments and hampering job creation within the Union.

(7)  The timely entry of generics and biosimilars into the Union market is important, particularly in order to increase competition, to reduce prices and to ensure that national healthcare systems are sustainable and that patients in the Union have better access to affordable medicines. The importance of such timely entry was underlined by the Council in its conclusions of 17 June 2016 on strengthening the balance in the pharmaceutical systems in the Union and its Member States. Regulation (EC) No 469/2009 should, therefore, be amended so as to allow the making of generics and biosimilars for export and storing, while bearing in mind that intellectual property rights remain one of the cornerstones of innovation, competitiveness and growth in the internal market.

(8)  The aim of this Regulation is to promote the competitiveness of the Union, thereby enhancing growth and job creation in the internal market and contributing to a wider supply of products under uniform conditions, by allowing makers of generics and biosimilars established in the Union to make in the Union products, or medicinal products containing those products, for the purpose of export to third-country markets in which protection does not exist or has expired, thereby also helping those makers to compete effectively in those third-country markets. This Regulation should also allow such makers to make and store products, or medicinal products containing those products, in a Member State for a defined period pending the expiry of the certificate, for the purpose of entering the market of any Member State upon expiry of the corresponding certificate, thereby helping those makers to compete effectively in the Union immediately after protection has expired (‘EU day-one entry’). This Regulation should also complement the efforts of the Union’s trade policy to ensure open markets for makers of products, or medicinal products containing those products, established in the Union. Over time, this Regulation should benefit the entire pharmaceutical sector in the Union, by allowing all players, including newcomers, to reap the benefits of the new opportunities opening up in the fast-changing global pharmaceutical market. Furthermore, the general interest of the Union would be promoted given that, by reinforcing Union-based supply chains for medicines and by allowing storing with a view to entry into the Union market upon expiry of the certificate, medicines would become more accessible to patients in the Union after the expiry of the ▌ certificate.

(9)  In those specific and limited circumstances, and in order to create a level playing field between makers established in the Union and third-country makers, it is appropriate to provide for an exception to the protection conferred by a ▌ certificate so as to allow the making of a product, or a medicinal product containing that product, for the purpose of export to third countries or of storing, and any related acts in the Union strictly necessary for that making or for the actual export or the actual storing, where such acts would otherwise require the consent of a certificate holder (‘related acts’). For instance, such related acts could include: possessing; offering to supply; supplying; importing; using or synthesising an active ingredient for the purpose of making a medicinal product;▌ or temporary storing or advertising for the exclusive purpose of export to third-country destinations. That exception should also apply to related acts performed by third parties who are in a contractual relationship with the maker.

(10)  The exception should apply to a product, or a medicinal product containing that product, protected by a certificate. It should cover the making of the product protected by a certificate in the territory of a Member State and the making of the medicinal product containing that product.

(11)  The exception should not cover placing a product, or a medicinal product containing that product, which is made for the ▌ purpose of export to third countries or of storing with a view to EU day-one entry, on the market of a Member State where a ▌ certificate is in force, either directly or indirectly after export, nor should it cover re-importation of such a product, or medicinal product containing that product, into the market of a Member State in which a certificate is in force. Moreover, it should not cover any act or activity carried out for the purpose of import of ▌products, or ▌ medicinal products containing those products, into the Union merely for the purposes of repackaging and re-exporting. In addition, the exception should not cover any storing of products, or medicinal products containing those products, for any purposes other than those set out in this Regulation.

(12)  By limiting the scope of the exception to making for the purpose of export outside the Union or to making for the purpose of storing, and to acts strictly necessary for such making or for the actual export or the actual storing, the exception provided for in this Regulation should not ▌ conflict with the normal exploitation of the product, or the medicinal product containing that product, in the Member State in which the certificate is in force, namely with the core exclusive right of the certificate holder to make that product for the purpose of placing it on the Union market during the term of the certificate. In addition, that exception should not unreasonably prejudice the legitimate interests of the certificate holder, whilst taking account of the legitimate interests of third parties.

(13)  Effective and proportionate safeguards should apply in relation to the exception in order to increase transparency, to help the holder of a ▌certificate ▌enforce its protection in the Union and check compliance with the conditions set out in this Regulation, and to reduce the risk of illicit diversion onto the Union market during the term of the certificate.

(14)  This Regulation should impose an information obligation on the maker, namely the person established in the Union, on whose behalf the making of a product, or a medicinal product containing that product, for the ▌ purpose of export or storing, is carried out. It is possible that the maker directly carries out the making. That information obligation should consist of requiring the maker to provide certain information to the competent industrial property office, or another designated authority, which granted the ▌ certificate (“the authority") in the Member State where the making is to take place. A standard form for notification should be provided for this purpose. The information should be provided before the making of a product, or a medicinal product containing that product, starts for the first time in that Member State, or before any related act prior to that making, whichever is the earlier. The information should be updated as and when appropriate. The making of a product, or a medicinal product containing that product, and the related acts, including those performed in Member States other than the one of making in cases where the product is also protected by a certificate in those other Member States, should only fall within the scope of the exception where the maker has sent the notification to the authority of the Member State of making, and where the maker has informed the holder of the certificate granted in that Member State. Where making takes place in more than one Member State, a notification should be required in each of those Member States. In the interests of transparency, the authority should be required to publish, as soon as possible, the information received, together with the date of notification of that information. Member States should be allowed to require that notifications, and updates to notifications, be subject to the payment of a one-off fee. That fee should be set at a level which does not exceed the administrative cost of processing notifications and updates.

(15)  The maker should also inform the certificate holder, through appropriate and documented means, of the intention to make a product, or a medicinal product containing that product, pursuant to the exception, by providing the certificate holder with the same information as notified to the authority. That information should be limited to what is necessary and appropriate for the certificate holder to assess whether the rights conferred by the certificate are being respected, and should not include confidential or commercially sensitive information. The standard form for notification could also be used to inform the certificate holder, and the information provided should be updated as and when appropriate.

(16)  With regard to related acts, if any, prior to the making of a product, or a medicinal product containing that product, the notification should indicate the name of the Member State in which the first related act which would otherwise require the consent of a certificate holder is to take place, as that information is relevant for the timing of the notification.

(17)  If a local marketing authorisation, or the equivalent of such authorisation, in a specific third country, for a given medicinal product, is published after the authority is notified, the notification should be promptly updated to include the reference number of that marketing authorisation, or the equivalent of such authorisation, as soon as it is publicly available. If the reference number of that marketing authorisation, or the equivalent of such authorisation, is pending publication, the maker should be required to provide, in the notification, that reference number as soon as it is publicly available.

(18)  For reasons of proportionality, failure to comply with the requirement regarding a third country should only affect exports to that country, and exports to that country should thus not benefit from the exception provided for in this Regulation. It should be the responsibility of the maker established in the Union to verify that protection does not exist or has expired in a country of export, or whether that protection is subject to any limitations or exemptions in that country.

(19)  A notification to the authority and the corresponding information to the certificate holder could be provided during the period between the date of entry into force of this Regulation and the date on which the exception provided for in this Regulation becomes applicable for the relevant certificate.

(20)  This Regulation should impose certain due diligence requirements on the maker as a condition to use the exception. The maker should be required to inform persons within its supply chain in the Union, including the exporter and the person carrying out the storing, through appropriate and documented means, in particular contractual means, that the product, or the medicinal product containing that product, is covered by the exception provided for in this Regulation and that the making is intended for the ▌ purpose of export or storing. A maker who fails to comply with those due diligence requirements should not benefit from the exception, nor should any third party performing a related act in the Member State of making or in a different Member State in which a certificate conferring protection for the product is in force. The holder of the relevant certificate would therefore be entitled to enforce its rights under the certificate, while having due regard to the general obligation, provided for in Directive 2004/48/EC of the European Parliament and of the Council(7), not to engage in abusive litigation.

(21)   This Regulation should impose labelling requirements on the maker in respect of products, or medicinal products containing those products, to be exported, in order to facilitate, by means of a logo, identification of such products or such medicinal products as being exclusively intended for the purpose of export to third countries. Making for the purpose of export and related acts should only fall within the scope of the exception if the product, or the medicinal product containing that product, is labelled in the manner provided for in this Regulation. That labelling obligation should be without prejudice to labelling requirements of third countries.

(22)  Any act not covered by the exception provided for in this Regulation should remain within the scope of the protection conferred by a ▌certificate. Any diversion onto the Union market, during the term of the certificate, of any product, or any medicinal product containing that product, made under the exception, should remain prohibited.

(23)  This Regulation is without prejudice to other intellectual property rights that could protect other aspects of a product, or a medicinal product containing that product. This Regulation does not affect the application of Union acts that aim to prevent infringements, and facilitate enforcement, of intellectual property rights, including Directive 2004/48/EC and Regulation (EU) No 608/2013 of the European Parliament and of the Council(8).

(24)  This Regulation does not affect the rules on the unique identifier, provided for in Directive 2001/83/EC. The maker should ensure that any medicinal product made for the purpose of export, pursuant to this Regulation, does not bear an active unique identifier within the meaning of Commission Delegated Regulation (EU) 2016/161(9). However, under that Delegated Regulation, the requirement to carry such an active unique identifier applies to medicinal products intended to be placed on the market of a Member State upon expiry of the corresponding certificate.

(25)  This Regulation does not affect the application of Directives 2001/82/EC and 2001/83/EC, in particular the requirements relating to the manufacturing authorisation of medicinal products made for export. This includes compliance with the principles and guidelines of good manufacturing practices for medicinal products and using only active substances which have been manufactured in accordance with good manufacturing practices for active substances and distributed in accordance with good distribution practices for active substances.

(26)  ▌To safeguard the rights of certificate holders, the exception provided for in this Regulation should not apply to a certificate that has already taken effect at the date of entry into force of this Regulation. In order to ensure that the rights of certificate holders are not excessively restricted, the exception should apply to certificates that are applied for on or after the date of entry into force of this Regulation. Given that a certificate takes effect at the end of the lawful term of the basic patent, which can be a relatively long time after the date of filing of the application for the certificate, and in order to achieve the aim of this Regulation, it is justified that this Regulation also cover, over a certain period of time, a certificate that was applied for before the date of entry into force of this Regulation, but has not yet taken effect before that date, irrespective of whether or not that certificate was granted before that date. The exception should apply, therefore, from [1 July 2022](10) to a certificate that takes effect from the date of entry into force of this Regulation. The concept of ‘certain period of time’ for each individual certificate that takes effect after the date of entry into force of this Regulation should ensure that the exception is applied, on a progressive basis, to such a certificate, depending on the date on which it takes effect and on its duration. Such application of the exception would allow the holder of a certificate that has been granted, but that has not yet taken effect by the date of the entry into force of this Regulation, a reasonable period of transition to adapt to the changed legal context, while at the same time ensuring that makers of generics and biosimilars can benefit effectively, without excessive delay, from the exception.

(27)  Typically, an applicant for a certificate files an application at approximately the same date in each Member State of filing. However, due to differences in national procedures for the examination of applications, the date of grant of the certificate might vary significantly from one Member State to another, thereby creating disparities in the legal situation of the applicant in the Member States in which the certificate was applied for. Introducing the exception on the basis of the date of the filing of the application for a certificate would therefore promote uniformity and limit the risk of disparities.

(28)  The Commission should carry out a regular evaluation of this Regulation. Pursuant to the Interinstitutional Agreement of 13 April 2016 on Better Law-Making(11), that evaluation should be based on the five criteria of effectiveness, efficiency, relevance, coherence and added value and should provide the basis for impact assessments of possible further measures. That evaluation should take into account, on the one hand, exports to outside the Union, and on the other, the effects of storing on the swifter entry of generics and especially biosimilars into markets in the Union as soon as possible after a certificate expires. Such regular evaluation should also address the effects of this Regulation on the making of generics and biosimilars in the Union by makers of generics and biosimilars established in the Union. In that context, it would be important to ascertain whether making that was previously taking place outside of the Union would be moved to within Union territory. In particular, that evaluation should review the effectiveness of the exception in the light of the aim to restore a global level playing field for makers of generics and biosimilars in the Union ▌. It should also study the impact of the exception on research and production of innovative medicines in the Union by certificate holders ▌ and consider the balance between the different interests at stake, in particular as regards public health, public expenditure and, in this context, access to medicines within the Union. It should also study whether the period provided for as regards the making of generics and biosimilars for the purpose of storing is sufficient to achieve the objective of EU day-one entry, including its effects on public health.

(29)  Since the objective of this Regulation, namely to promote the competitiveness of the Union, in a manner that creates a level playing field for makers of generics and biosimilars in relation to their competitors in third-country markets in which protection does not exist or has expired, by laying down rules enabling the making of ▌ a product, or a medicinal product containing that product, during the term of the corresponding certificate, and also by providing for certain information, labelling and due diligence obligations for makers that use those rules, cannot be sufficiently achieved by the Member States but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.

(30)  This Regulation respects fundamental rights and observes the principles recognised by the Charter of Fundamental Rights of the European Union (“the Charter”). In particular, this Regulation seeks to ensure full respect for the right to property and the right to health care set out respectively in Articles 17 and 35 of the Charter. This Regulation should maintain the core rights of the ▌certificate, by limiting the exception provided for in this Regulation to the making of a product, or a medicinal product containing that product, only for the purpose of export outside the Union or for the purpose of storing for a limited period of time with a view to entry into the Union market upon expiry of the protection, and to the acts strictly necessary for such making or for the actual export or the actual storing. In the light of those fundamental rights and principles, the exception provided for in this Regulation does not go beyond what is necessary and appropriate in the light of the overall objective of this Regulation, which is to promote the competitiveness of the Union by avoiding relocation and allowing makers of generics and biosimilars established in the Union to compete, on the one hand, on fast-growing global markets where protection does not exist or has already expired, and on the other, on the Union market upon expiry of the certificate. Indeed, it is necessary to benefit from the positive economic effects arising from the exception, as otherwise the Union would risk substantially weakening its position as a hub for pharmaceutical development and manufacturing. It is therefore appropriate to introduce that exception in order to increase the competitive position of makers of generics and biosimilars established in the Union in third countries whose markets are in any event open to competition, whilst leaving the scope and duration of the protection granted by the certificate in the Union untouched. The appropriateness of the measure is further ensured by providing for appropriate safeguards regulating the use of the exception. This Regulation should allow sufficient time for public authorities to put in place the necessary arrangements to receive and publish notifications,

HAVE ADOPTED THIS REGULATION:

Article 1

Amendment of Regulation (EC) No 469/2009

Regulation (EC) No 469/2009 is amended as follows:

(1)   in Article 1, the following point is added:"

‘(f) ‘maker’ means the person, established in the Union, on whose behalf the making of a product, or a medicinal product containing that product, for the purpose of export to third countries or for the purpose of storing, is carried out;’

"

(2)  ▌ Article 5 is replaced by the following:"

Article 5

Effects of the certificate

1.  Subject to the provisions of Article 4, the certificate shall confer the same rights as conferred by the basic patent and shall be subject to the same limitations and the same obligations.

2.  By way of derogation from paragraph 1, the certificate referred to in paragraph 1 shall not confer protection against certain acts which would otherwise require the consent of the holder of the certificate (‘the certificate holder’), if the following conditions are met:

   (a) the acts comprise:
   (i) the making of a product, or a medicinal product containing that product, for the ▌ purpose of export to third countries; or
   (ii) any related act that is strictly necessary for the making, in the Union, referred to in point (i), or for the actual export; or
   (iii) the making, no earlier than six months before the expiry of the certificate, of a product, or a medicinal product containing that product, for the purpose of storing it in the Member State of making, in order to place that product, or a medicinal product containing that product, on the market of Member States after the expiry of the corresponding certificate; or
   (iv) any related act that is strictly necessary for the making, in the Union, referred to in point (iii), or for the actual storing, provided that such related act is carried out no earlier than six months before the expiry of the certificate.
   (b) the maker, through appropriate and documented means, notifies the authority referred to in Article 9(1) in the Member State in which that making is to take place, and informs the certificate holder, of the information listed in paragraph 5 no later than three months before the start date of the making in that Member State, or no later than three months before the first related act, prior to that making, that would otherwise be prohibited by the protection conferred by a certificate, whichever is the earlier;
   (c) if the information listed in paragraph 5 changes, the maker notifies the authority referred to in Article 9(1) and informs the certificate holder, before those changes take effect;
   (d) in the case of products, or medicinal products containing those products, made for the purpose of export to third countries, the maker ensures that a logo, in the form set out in Annex -I, is affixed to the outer packaging of the product, or the medicinal product containing that product, referred to in point (a)(i) of this paragraph, and, where feasible, to its immediate packaging;
   (e) the maker complies with paragraph 9 of this Article and, if applicable, with Article 12(2).

3.  The exception referred to in paragraph 2 shall not apply to any act or activity carried out for the import of products, or medicinal products containing those products, into the Union merely for the purpose of repackaging, re-exporting or storing.

4.  The information provided to the certificate holder for the purposes of points (b) and (c) of paragraph 2 shall be used exclusively for the purposes of verifying whether the requirements of this Regulation have been met and, where applicable, initiating legal proceedings for non-compliance.

5.  The information to be provided by the maker for the purposes of point (b) of paragraph 2 shall be as follows:

   (a) the name and address of the maker;
   (b) an indication of whether the making is for the purpose of export, for the purpose of storing, or for the purpose of both export and storing;
   (c) the Member State in which the making and, if applicable, also the storing is to take place, and the Member State in which the first related act, if any, prior to that making is to take place;
   (d) the number of the certificate granted in the ▌ Member State of making, and the number of the certificate granted in the Member State of the first related act, if any, prior to that making; and
   (e) for medicinal products to be exported to third countries, the reference number of the marketing authorisation, or the equivalent of such authorisation, in each third country of export, as soon as it is publicly available.

6.  For the purposes of notification to the authority under points (b) and (c) of paragraph 2, the maker shall use the standard form for notification contained in Annex -Ia.

7.  Failure to comply with the requirements of point (e) of paragraph 5 with regard to a third country shall only affect exports to that country, and those exports shall therefore not benefit from the exception.

8.  The maker shall ensure that medicinal products made pursuant to point (a)(i) of paragraph 2 do not bear an active unique identifier within the meaning of Commission Delegated Regulation (EU) 2016/161*.

9.  The maker shall ensure, through appropriate and documented means, that any person in a contractual relationship with the maker who performs acts falling under point (a) of paragraph 2 is fully informed and aware of the following:

   (a) that those acts are subject to paragraph 2;
   (b) that the placing on the market, import or re-import of the product, or the medicinal product containing that product, referred to in point (a)(i) of paragraph 2 or the placing on the market of the product, or the medicinal product containing that product, referred to in point (a)(iii) of paragraph 2 could infringe the certificate referred to in paragraph 2 where, and for as long as, that certificate applies.

10.  Paragraph 2 shall apply to certificates that are applied for on or after … [the date of entry into force of this amending Regulation].

Paragraph 2 shall also apply to certificates that have been applied for before … [the date of entry into force of this amending Regulation] and that take effect on or after that date. Paragraph 2 shall only apply to such certificates from [1 July 2022](12).

Paragraph 2 shall not apply to certificates that take effect before … [the date of entry into force of this amending Regulation].

_______________

* Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use (OJ L 32, 9.2.2016, p. 1).’;

"

(3)  in Article 11, the following paragraph is added:"

‘4. ‘The ▌ authority ▌ referred to in Article 9(1) shall publish, as soon as possible, the information listed in Article 5(5), together with the date of notification of that information. It shall also publish, as soon as possible, any changes to the information notified in accordance with point (c) of Article 5(2).’;

"

(4)  Article 12 is replaced by the following:"

‘Article 12

Fees

1.  Member States may require that the certificate be subject to the payment of annual fees.

2.  Member States may require that the notifications referred to in points (b) and (c) of Article 5(2) be subject to the payment of a fee.’;

"

(5)  the following Article is inserted:"

‘Article 21a

Evaluation

No later than five years after the date referred to in Article 5(10), and every five years thereafter, the Commission shall carry out an evaluation of Article 5(2) to (9) and Article 11 in order to assess whether the objectives of those provisions have been achieved, and present a report on the main findings to the European Parliament, the Council and the European Economic and Social Committee. In addition to evaluating the impact of the exception of making for the purpose of export, special account shall be taken of the effects of making for the purpose of storing in order to place that product, or a medicinal product containing that product, on the market of Member States after the expiry of the corresponding certificate on access to medicines and on public health expenditure, and of whether the waiver and in particular the period provided for in point (a)(iii) of Article 5(2) is sufficient to achieve the objectives referred to in Article 5, including public health.’;

"

(6)  Annex -I and -Ia as set out in the Annex to this Regulation are inserted▌.

Article 2

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at …,

For the European Parliament For the Council

The President The President

ANNEX

The following Annexes are inserted:

ANNEX -I

Logo

This logo shall appear in black and in such a size as to be sufficiently visible.

20190417-P8_TA-PROV(2019)0401_EN-p0000002.png

ANNEX -Ia

Standard form for notification pursuant to points (b) and (c) of Article 5(2)

Tick the appropriate box

 New notification

 Update of an existing notification

(a)  Name and address of the maker

(b)  Purpose of making

 Export

 Storing

 Export and storing

(c)  Member State in which making is to take place and Member State in which first related act (if any) prior to making is to take place

Member State of making

(Member State of first related act (if any))

(d)  Number of certificate granted in the Member State of making and number of certificate granted in Member State of first related act (if any) prior to making

Certificate of Member State of making

(Certificate of Member State of first related act (if any))

(e)  For medicinal products to be exported to third countries, reference number of marketing authorisation, or the equivalent of such authorisation, in each third country of export

".

(1) OJ C 440, 6.12.2018, p. 100.
(2) OJ C 440, 6.12.2018, p. 100.
(3) Position of the European Parliament of 17 April 2019.
(4)Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (OJ L 152, 16.6.2009, p. 1).
(5)Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1). Directive 2001/82/EC is repealed and replaced, with effect from 28 January 2022, by Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (OJ L 4, 7.1.2019, p. 43).
(6)Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p.67).
(7) Directive 2004/48/EC of the European Parliament and of the Council of 29 April 2004 on the enforcement of intellectual property rights (OJ L 157, 30.4.2004, p. 45).
(8)Regulation (EU) No 608/2013 of the European Parliament and of the Council of 12 June 2013 concerning customs enforcement of intellectual property rights and repealing Council Regulation (EC) No 1383/2003 (OJ L 181, 29.6.2013, p. 15).
(9) Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use (OJ L 32, 9.2.2016, p. 1).
(10)+ OJ: date to be replaced by the date corresponding to three years from date of entry into force of this amending Regulation.
(11)OJ L 123, 12.5.2016, p. 1.
(12)+ OJ: date to be replaced by the date corresponding to three years from date of entry into force of this amending Regulation.


Space programme of the Union and European Union Agency for the Space Programme ***I
PDF 509kWORD 180k
European Parliament legislative resolution of 17 April 2019 on the proposal for a regulation of the European Parliament and of the Council establishing the space programme of the Union and the European Union Agency for the Space Programme and repealing Regulations (EU) No 912/2010, (EU) No 1285/2013, (EU) No 377/2014 and Decision 541/2014/EU (COM(2018)0447 – C8-0258/2018 – 2018/0236(COD))
P8_TA(2019)0402A8-0405/2018

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Digital Europe programme for the period 2021-2027 ***I
PDF 299kWORD 116k
European Parliament legislative resolution of 17 April 2019 on the proposal for a regulation of the European Parliament and of the Council establishing the Digital Europe programme for the period 2021-2027 (COM(2018)0434 – C8-0256/2018 – 2018/0227(COD))
P8_TA(2019)0403A8-0408/2018

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Fiscalis programme for cooperation in the field of taxation ***I
PDF 231kWORD 73k
European Parliament legislative resolution of 17 April 2019 on the proposal for a regulation of the European Parliament and of the Council establishing the ‘Fiscalis’ programme for cooperation in the field of taxation (COM(2018)0443 – C8-0260/2018 – 2018/0233(COD))
P8_TA(2019)0404A8-0421/2018

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Programme for the Environment and Climate Action (LIFE) ***I
PDF 309kWORD 119k
European Parliament legislative resolution of 17 April 2019 on the proposal for a regulation of the European Parliament and of the Council establishing a Programme for the Environment and Climate Action (LIFE) and repealing Regulation (EU) No 1293/2013 (COM(2018)0385 - C8-0249/2018 – 2018/0209(COD))
P8_TA(2019)0405A8-0397/2018

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Justice programme ***I
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European Parliament legislative resolution of 17 April 2019 on the proposal for a regulation of the European Parliament and of the Council establishing the Justice programme (COM(2018)0384 – C8-0235/2018 – 2018/0208(COD))
P8_TA(2019)0406A8-0068/2019

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Rights and values programme ***I
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European Parliament legislative resolution of 17 April 2019 on the proposal for a regulation of the European Parliament and of the Council establishing the Rights and Values programme (COM(2018)0383 – C8-0234/2018 – 2018/0207(COD))
P8_TA(2019)0407A8-0468/2018

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Number of inter-parliamentary delegations, delegations to joint inter-parliamentary committees and delegations to parliamentary cooperation committees and multilateral Parliamentary Assemblies
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European Parliament decision of 17 April 2019 on the number of interparliamentary delegations, delegations to joint parliamentary committees and delegations to parliamentary cooperation committees and to multilateral parliamentary assemblies (2019/2698(RSO))
P8_TA-PROV(2019)0408B8-0240/2019

The European Parliament,

–  having regard to the proposal from the Conference of Presidents,

–  having regard to the association, cooperation and other agreements concluded by the European Union with third countries,

–  having regard to Rules 212 and 214 of its Rules of Procedure,

A.  anxious to strengthen parliamentary democracy by pursuing continuous interparliamentary dialogue;

1.  Decides on the number of the interparliamentary delegations and their regional groupings as follows:

   (a) Europe, Western Balkans and Turkey

Delegations to the:

   EU-North Macedonia Joint Parliamentary Committee
   EU-Turkey Joint Parliamentary Committee

Delegation for Northern cooperation and for relations with Switzerland and Norway and to the EU-Iceland Joint Parliamentary Committee and the European Economic Area (EEA) Joint Parliamentary Committee

Delegation to the EU-Serbia Stabilisation and Association Parliamentary Committee

Delegation to the EU-Albania Stabilisation and Association Parliamentary Committee

Delegation to the EU-Montenegro Stabilisation and Association Parliamentary Committee

Delegation for relations with Bosnia and Herzegovina and Kosovo

   (b) Russia and the Eastern Partnership states

Delegation to the EU-Russia Parliamentary Cooperation Committee

Delegation to the EU-Ukraine Parliamentary Association Committee

Delegation to the EU-Moldova Parliamentary Association Committee

Delegation for relations with Belarus

Delegation to the EU-Armenia Parliamentary Partnership Committee, the EU-Azerbaijan Parliamentary Cooperation Committee and the EU-Georgia Parliamentary Association Committee

   (c) Maghreb, Mashreq, Israel and Palestine

Delegations for relations with:

   Israel
   Palestine
   the Maghreb countries and the Arab Maghreb Union, including the EU-Morocco, EU-Tunisia and EU-Algeria Joint Parliamentary Committees
   the Mashreq countries
   (d) The Arab Peninsula, Iraq and Iran

Delegations for relations with:

   the Arab Peninsula
   Iraq
   Iran
   (e) The Americas

Delegations for relations with:

   the United States
   Canada
   the Federative Republic of Brazil
   the countries of Central America
   the countries of the Andean Community
   Mercosur

Delegation to the EU-Mexico Joint Parliamentary Committee

Delegation to the EU-Chile Joint Parliamentary Committee

Delegation to the Cariforum — EU Parliamentary Committee

   (f) Asia/Pacific

Delegations for relations with:

   Japan
   the People’s Republic of China
   India
   Afghanistan
   the countries of South Asia
   the countries of Southeast Asia and the Association of Southeast Asian Nations (ASEAN)
   the Korean Peninsula
   Australia and New Zealand

Delegation to the EU-Kazakhstan, EU-Kyrgyzstan, EU-Uzbekistan and EU-Tajikistan Parliamentary Cooperation Committees, and for relations with Turkmenistan and Mongolia

   (g) Africa

Delegations for relations with:

   South Africa
   the Pan-African Parliament
   (h) Multilateral assemblies

Delegation to the ACP-EU Joint Parliamentary Assembly

Delegation to the Parliamentary Assembly of the Union for the Mediterranean

Delegation to the Euro-Latin American Parliamentary Assembly

Delegation to the Euronest Parliamentary Assembly

Delegation for relations with the NATO Parliamentary Assembly;

2.  Decides that the membership of parliamentary committees created on the basis of the Economic Partnership Agreement (EPA) shall be drawn exclusively from the Committee on International Trade and the Committee on Development – ensuring the maintenance of the leading role of the Committee on International Trade as the committee responsible – and that they should actively coordinate their work with the ACP-EU Joint Parliamentary Assembly;

3.  Decides that the membership of the Parliamentary Assembly of the Union for the Mediterranean, the Euro-Latin American Parliamentary Assembly and the Euronest Parliamentary Assembly shall be drawn exclusively from the bilateral or sub-regional delegations covered by each Assembly;

4.  Decides that the membership of the Delegation for relations with the NATO Parliamentary Assembly shall be drawn exclusively from the Subcommittee on Security and Defence;

5.  Decides that the Conference of Delegation Chairs should draw up a draft six-monthly calendar of activities following a consultation with the Committees on Foreign Affairs, on Development and on International Trade. It should be drafted in close cooperation with the Conference of Committee Chairs’ six-month calendar of committee delegations, also taking into account the yearly work programme of the Democracy Support and Election Coordination Group (DEG), in order to ensure a consistent approach. This joint draft six-monthly calendar of activities shall then be submitted for adoption to the Conference of Presidents. The Conference of Presidents may modify the proposed draft calendar with a view to responding to political events and to ensuring coherence of all Parliament’s external activities;

6.  Recalls that only official delegations, duly authorised by the Conference of Presidents, are permitted to carry out activities on behalf of the European Parliament and to represent its position;

7.  Decides that the political groups and non-attached Members shall appoint permanent substitutes to serve on each type of delegation and that the number of those substitutes may not exceed the number of full members representing the groups or non-attached Members;

8.  Decides that full members of standing interparliamentary delegations shall be entitled to participate in interparliamentary meetings outside Parliament’s places of work. If a full member is unable to travel, he or she may be replaced by one of the permanent substitute members or, if the substitute member is not available, by a member of the interparliamentary assembly covering this delegation, nominated by the political group to which the full member belongs. If a member of the interparliamentary assembly covering this delegation is not available, members of the Committee on Foreign Affairs, the Committee on Development and the Committee on International Trade could be entitled to participate;

9.  Considers that prior to an interparliamentary meeting with the counterpart (SAPC, JPC, PAC, PCC, IPM, etc.), or prior to any given outgoing delegation, close consultation should take place with the relevant committee(s) on possible political topics or legislative scrutiny issues that the delegation should address in meetings with the counterparts of the country concerned;

10.  Will endeavour to ensure in practice that one or more committee rapporteurs or chairs may likewise take part in the proceedings of delegations, joint interparliamentary committees, parliamentary cooperation committees and multilateral parliamentary assemblies, and decides that the President, on the joint request of the delegation and committee chairs concerned, shall authorise missions of this type;

11.  Decides that this decision will enter into force at the first part-session of the ninth parliamentary term;

12.  Instructs its President to forward this decision to the Council, the Commission and the European External Action Service.


Adapting a number of legal acts providing for the use of the regulatory procedure with scrutiny to Articles 290 and 291 TFEU - part II ***I
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European Parliament legislative resolution of 17 April 2019 on the proposal for a regulation of the European Parliament and of the Council adapting a number of legal acts providing for the use of the regulatory procedure with scrutiny to Articles 290 and 291 of the Treaty on the Functioning of the European Union (COM(2016)0799 – C8-0148/2019 – 2016/0400B(COD))
P8_TA-PROV(2019)0409A8-0190/2019

(Ordinary legislative procedure: first reading)

The European Parliament,

–  having regard to the Commission proposal to Parliament and the Council (COM(2016)0799),

–  having regard to Article 294(2) and Article 33, Article 43(2), Article 53(1), Article 62, Article 64(2), Article 91, Article 100(2), Article 114, Article 153(2)(b), Article 168(4) (a), Article 168(4)(b), Article 172, Article 192(1), Article 207, Article 214(3), and Article 338(1) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8‑0148/2019),

–  having regard to the opinion of the Committee on Legal Affairs on the proposed legal basis,

–  having regard to Article 294(3) and Article 43(2), Article 53(1), Article 62, Article 91, Article 100(2), Article 114, Article 153(2)(b), Article 168(4) (a), Article 168(4)(b), Article 192(1) and Article 338(1) of the Treaty on the Functioning of the European Union,

–  having regard to the opinion of the European Economic and Social Committee of 1 June 2017(1),

–  having regard to the opinion of the Committee of the Regions of 1 December 2017(2),

–  having regard to the letters of the Committee on Employment and Social Affairs, the Committee on the Environment, Public Health and Food Safety, the Committee on Industry, Research and Energy and the Committee on the Internal Market and Consumer Protection,

–  having regard to the decision by the Conference of Presidents of 7 March 2019 to authorise the Committee on Legal Affairs to split the above-mentioned Commission proposal and to draw up two separate legislative reports on the basis thereof,

–  having regard to the report of the Committee on Legal Affairs (A8-0020/2018),

–  having regard to Rules 59 and 39 of its Rules of Procedure,

–  having regard to the report of the Committee on Legal Affairs and also the opinions and position in the form of amendments of the Committee on Economic and Monetary Affairs, the Committee on the Environment, Public Health and Food Safety, the Committee on Transport and Tourism and the Committee on Agriculture and Rural Development (A8-0190/2019),

1.  Adopts its position at first reading hereinafter set out;

2.  Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

3.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Text proposed by the Commission   Amendment
Amendment 1
Proposal for a regulation
Citation 2
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 33, Article 43(2), Article 53(1), Article 62, Article 64(2), Article 91, Article 100(2), Article 114, Article 153(2)(b), Article 168(4) (a), Article 168(4)(b), Article 172, Article 192(1), Article 207, Article 214(3), and Article 338(1) thereof,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 43(2), Article 53(1), Article 62, Article 91, Article 100(2), Article 114, Article 153(2)(b), Article 168(4)(a), Article 168(4)(b), Article 192(1) and Article 338(1) thereof,
Amendment 2
Proposal for a regulation
Recital 1
(1)  The Treaty of Lisbon introduced a distinction between powers delegated to the Commission to adopt non-legislative acts of general application to supplement or amend certain non-essential elements of a legislative act (delegated acts), and the powers conferred upon the Commission to adopt acts to ensure uniform conditions for implementing legally binding Union acts (implementing acts).
(1)  The Treaty of Lisbon has substantially modified the legal framework governing the powers conferred on the Commission by the legislator, introducing a clear distinction between powers delegated to the Commission to adopt non-legislative acts of general application to supplement or amend certain non-essential elements of a legislative act (delegated acts), and the powers conferred upon the Commission to adopt acts to ensure uniform conditions for implementing legally binding Union acts (implementing acts).
Amendment 3
Proposal for a regulation
Recital 8 a (new)
(8a)   Bundling and presenting empowerments that are not closely linked with each other within a single delegated act of the Commission impedes the exercise of Parliament's right of scrutiny, as it is forced to simply accept or refuse the entire delegated act, which leaves no room to express an opinion on each empowerment individually.
Amendment 4
Proposal for a regulation
Annex I – Part I – point 1 – paragraph 2 – point 1
Directive 2009/31/EC
Article 29 – paragraph 1
The Commission is empowered to adopt delegated acts in accordance with Article 29a amending the Annexes.
The Commission is empowered to adopt delegated acts in accordance with Article 29a amending the Annexes to this Directive in order to adapt to technical and scientific progress.
Amendment 5
Proposal for a regulation
Annex I – Part I – point 1 – paragraph 2 – point 2
Directive 2009/31/EC
Article 29a – paragraph 2
2.  The power to adopt delegated acts referred to in Article 29 shall be conferred on the Commission for an indeterminate period of time from [date of entry into force of this Omnibus].
2.  The power to adopt delegated acts referred to in Article 29 shall be conferred on the Commission for a period of five years from ... [date of entry into force of this amending Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Amendment 6
Proposal for a regulation
Annex I – Part I – point 1 – paragraph 2 – point 3
Directive 2009/31/EC
Article 30
(3)   Article 30 is deleted.
(3)  Article 30 is replaced by the following:
“Article 30
Committee procedure
1.  The Commission shall be assisted by the Climate Change Committee established by Article 26 of Regulation (EU) No 525/2013 of the European Parliament and of the Council*. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011 of the European Parliament and of the Council**.
2.  Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.”
___________________
* Regulation (EU) No 525/2013 of the European Parliament and of the Council of 21 May 2013 on a mechanism for monitoring and reporting greenhouse gas emissions and for reporting other information at national and Union level relevant to climate change and repealing Decision No 280/2004/EC (OJ L 165, 18.6.2013, p. 13).
**Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
Amendment 7
Proposal for a regulation
Annex I – Part I – point 2
[...]
deleted
Amendment 8
Proposal for a regulation
Annex I – Part I – point 3 – paragraph 3 – point 1
Regulation (EC) No 1005/2009
Article 7 – paragraph 2 – subparagraph 2
“The Commission is empowered to adopt delegated acts in accordance with Article 24a concerning the form and content of the label to be used.”
“The Commission is empowered to adopt delegated acts in accordance with Article 24a to supplement this Regulation by establishing rules concerning the form and content of the label to be used.”
Amendment 9
Proposal for a regulation
Annex I – Part I – point 3 – paragraph 3 – point 2 – point a
Regulation (EC) No 1005/2009
Article 8 – paragraph 3 – subparagraph 2
“The Commission is empowered to adopt delegated acts in accordance with Article 24a concerning the form and content of the label to be used.”
“The Commission is empowered to adopt delegated acts in accordance with Article 24a to supplement this Regulation by establishing rules concerning the form and content of the label to be used.”
Amendment 10
Proposal for a regulation
Annex I – Part I – point 3 – paragraph 3 – point 3 – point a
Regulation (EC) No 1005/2009
Article 10 – paragraph 3 – subparagraph 2
The Commission is empowered to adopt delegated acts in accordance with Article 24a concerning the form and content of the label to be used.
The Commission is empowered to adopt delegated acts in accordance with Article 24a to supplement this Regulation by establishing rules concerning the form and content of the label to be used.
Amendment 11
Proposal for a regulation
Annex I – Part I – point 3 – paragraph 3 – point 3 – point b
Regulation (EC) No 1005/2009
Article 10 – paragraph 6 – subparagraph 3
The Commission is empowered to adopt delegated acts in accordance with Article 24a concerning a mechanism for the allocation of quotas to producers and importers.
The Commission is empowered to adopt delegated acts in accordance with Article 24a to supplement this Regulation by establishing rules concerning a mechanism for the allocation of quotas to producers and importers.
Amendment 12
Proposal for a regulation
Annex I – Part I – point 3 – paragraph 3 – point 6
Regulation (EC) No 1005/2009
Article 19 – paragraph 1
"The Commission is empowered to adopt delegated acts in accordance with Article 24a concerning additional measures for the monitoring of controlled substances or new substances and of products and equipment containing or relying on controlled substances placed under temporary storage, customs warehousing or free zone procedure or in transit through the customs territory of the Union and subsequently re-exported, on the basis of an evaluation of the potential risks of illegal trade linked to such movements, taking into account the environmental benefits and socio-economic impacts of such measures.”
"The Commission is empowered to adopt delegated acts in accordance with Article 24a to supplement this Regulation by establishing rules concerning additional measures for the monitoring of controlled substances or new substances and of products and equipment containing or relying on controlled substances placed under temporary storage, customs warehousing or free zone procedure or in transit through the customs territory of the Union and subsequently re-exported, on the basis of an evaluation of the potential risks of illegal trade linked to such movements, taking into account the environmental benefits and socio-economic impacts of such measures.”
Amendment 13
Proposal for a regulation
Annex I – Part I – point 3 – paragraph 3 – point 7
Regulation (EC) No 1005/2009
Article 20 – paragraph 2
“2. The Commission is empowered to adopt delegated acts in accordance with Article 24a concerning the rules, in line with decisions taken by the Parties, applicable to the release for free circulation in the Union of products and equipment imported from any State not party to the Protocol which were produced using controlled substances but do not contain substances which can be positively identified as controlled substances. The identification of such products and equipment shall comply with periodical technical advice given to the Parties.”
“2. The Commission is empowered to adopt delegated acts in accordance with Article 24a to supplement this Regulation by establishing the rules, in line with decisions taken by the Parties, applicable to the release for free circulation in the Union of products and equipment imported from any State not party to the Protocol which were produced using controlled substances but do not contain substances which can be positively identified as controlled substances. The identification of such products and equipment shall comply with periodical technical advice given to the Parties.”
Amendment 14
Proposal for a regulation
Annex I – Part I – point 3 – paragraph 3 – point 8 – point b
Regulation (EC) No 1005/2009
Article 22 – paragraph 4 – subparagraph 2
The Commission is empowered to adopt delegated acts in accordance with Article 24a concerning a list of products and equipment, in line with decisions taken by the Parties, for which the recovery of controlled substances or destruction of products and equipment without prior recovery of controlled substances shall be considered technically and economically feasible, specifying, if appropriate, the technologies to be applied.
The Commission is empowered to adopt delegated acts in accordance with Article 24a to supplement this Regulation by establishing rules concerning a list of products and equipment, in line with decisions taken by the Parties, for which the recovery of controlled substances or destruction of products and equipment without prior recovery of controlled substances shall be considered technically and economically feasible, specifying, if appropriate, the technologies to be applied.
Amendment 15
Proposal for a regulation
Annex I – Part I – point 3 – paragraph 3 – point 8 – point c
Regulation (EC) No 1005/2009
Article 22 – paragraph 5 – subparagraphs 2 and 3
“The Commission shall evaluate the measures taken by the Member States and is empowered to adopt delegated acts in accordance with Article 24a concerning those minimum qualification requirements, in the light of that evaluation and of technical and other relevant information.”
“The Commission shall evaluate the measures taken by the Member States and is empowered to adopt delegated acts in accordance with Article 24a to supplement this Regulation by establishing rules concerning those minimum qualification requirements, in the light of that evaluation and of technical and other relevant information.”
Amendment 16
Proposal for a regulation
Annex I – Part I – point 3 – paragraph 3 – point 9 – point a – point i
Regulation (EC) No 1005/2009
Article 23 – paragraph 4 – subparagraph 1
“Member States shall define the minimum qualification requirements for the personnel carrying out activities referred to in paragraph 2. In the light of an evaluation of those measures taken by the Member States and of technical and other relevant information, the Commission is empowered to adopt delegated acts in accordance with Article 24a concerning the harmonisation of those minimum qualification requirements.”
“Member States shall define the minimum qualification requirements for the personnel carrying out activities referred to in paragraph 2. In the light of an evaluation of those measures taken by the Member States and of technical and other relevant information, the Commission is empowered to adopt delegated acts in accordance with Article 24a to supplement this Regulation by establishing rules concerning the harmonisation of those minimum qualification requirements.”
Amendment 17
Proposal for a regulation
Annex I – Part I – point 3 – paragraph 3 – point 9 – point b
Regulation (EC) No 1005/2009
Article 23 – paragraph 7
“7. The Commission is empowered to adopt delegated acts in accordance with Article 24a establishing a list of technologies or practices to be used by undertakings to prevent and minimise any leakage and emissions of controlled substances.”
“7. The Commission is empowered to adopt delegated acts in accordance with Article 24a to supplement this Regulation by establishing a list of technologies or practices to be used by undertakings to prevent and minimise any leakage and emissions of controlled substances.”
Amendment 18
Proposal for a regulation
Annex I – Part I – point 3 – paragraph 3 – point 11
Regulation (EC) No 1005/2009
Article 24a – paragraph 2
2.  The power to adopt delegated acts referred to in Article 7(2), Article 8(3) and (5), Article 10(3) and (6), Article 13(2), Article 18(9), Article 19, Article 20(2), Article 22(3), (4) and (5), Article 23(4) and (7), Article 24(2) and (3), Article 26(3) and Article 27(10) shall be conferred on the Commission for an indeterminate period of time from [date of entry into force of this Omnibus].
2.  The power to adopt delegated acts referred to in Article 7(2), Article 8(3) and (5), Article 10(3) and (6), Article 13(2), Article 18(9), Article 19, Article 20(2), Article 22(3), (4) and (5), Article 23(4) and (7), Article 24(2) and (3), Article 26(3) and Article 27(10) shall be conferred on the Commission for a period of five years from ... [date of entry into force of this amending Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Amendment 19
Proposal for a regulation
Annex I – Part I – point 3 – paragraph 3 – point 14
Regulation (EC) No 1005/2009
Article 27 – paragraph 10
“10. The Commission is empowered to adopt delegated acts in accordance with Article 24a concerning amendments to the reporting requirements laid down in paragraphs 1 to 7 of this Article in order to meet the commitments under the Protocol or to facilitate their application.”
“10. The Commission is empowered to adopt delegated acts in accordance with Article 24a to amend the reporting requirements laid down in paragraphs 1to 7 of this Article in order to meet the commitments under the Protocol or to facilitate their application.”
Amendment 20
Proposal for a regulation
Annex I – Part II – point 4 – paragraph 2 – point 1
Directive 2002/58/EC
Article 4 – paragraph 5
“5. The Commission is empowered to adopt delegated acts in accordance with Article 14b, concerning the circumstances, format and procedures applicable to the information and notification requirements referred to in paragraphs 2, 3 and 4 of this Article, following consultation with the European Network and Information Security Agency (ENISA), the Working Party on the Protection of Individuals with regard to the Processing of Personal Data established by Article 29 of Directive 95/46/EC and the European Data Protection Supervisor.”
“5. The Commission is empowered to adopt delegated acts in accordance with Article 14b to supplement this Directive in respect of the circumstances, format and procedures applicable to the information and notification requirements referred to in paragraphs 2, 3 and 4 of this Article, following consultation with the European Network and Information Security Agency (ENISA), the Working Party on the Protection of Individuals with regard to the Processing of Personal Data established by Article 29 of Directive 95/46/EC and the European Data Protection Supervisor.”
Amendment 21
Proposal for a regulation
Annex I – Part II – point 4 – paragraph 2 – point 3
Directive 2002/58/EC
Article 14b – paragraph 2
2.  The power to adopt delegated acts referred to in Article 4(5) shall be conferred on the Commission for an indeterminate period of time from [from the date of entry into force of this Omnibus].
2.  The power to adopt delegated acts referred to in Article 4(5) shall be conferred on the Commission for a period of five years from ... [date of entry into force of this amending Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Amendment 22
Proposal for a regulation
Annex I – Part IV – point 8 – paragraph 2 – point 3
Directive 89/391/EEC
Article 17b – paragraph 2
2.  The power to adopt delegated acts referred to in Article 16a shall be conferred on the Commission for an indeterminate period of time from [date of entry into force of this Omnibus].
2.  The power to adopt delegated acts referred to in Article 16a shall be conferred on the Commission for a period of five years from ... [date of entry into force of this amending Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Amendment 23
Proposal for a regulation
Annex I – Part IV – point 16 – paragraph 2 – point 2
Directive 92/91/EEC
Article 11a – paragraph 2
2.  The power to adopt delegated acts referred to in 11 shall be conferred on the Commission for an indeterminate period of time from [date of entry into force of this Omnibus].
2.  The power to adopt delegated acts referred to in Article 11 shall be conferred on the Commission for a period of five years from ... [date of entry into force of this amending Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Amendment 24
Proposal for a regulation
Annex I – Part IV – point 17 – paragraph 2 – point 2
Directive 92/104/EEC
Article 11a – paragraph 2
2.  The power to adopt delegated acts referred to in Article 11 shall be conferred on the Commission for an indeterminate period of time from [date of entry into force of this Omnibus].
2.  The power to adopt delegated acts referred to in Article 11 shall be conferred on the Commission for a period of five years from ...[date of entry into force of this amending Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Amendment 25
Proposal for a regulation
Annex I – Part IV – point 18 – paragraph 2 – point 2
Directive 93/103/EC
Article 12a – paragraph 2
2.  The power to adopt delegated acts referred to in Article 12 shall be conferred on the Commission for an indeterminate period of time from [date of entry into force of this Omnibus].
2.  The power to adopt delegated acts referred to in Article 12 shall be conferred on the Commission for a period of five years from ... [date of entry into force of this amending Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Amendment 26
Proposal for a regulation
Annex I – Part IV – point 21 – paragraph 2 – point 2
Directive 1999/92/EC
Article 10a – paragraph 2
2.  The power to adopt delegated acts referred to in Article 10 shall be conferred on the Commission for an indeterminate period of time from [date of entry into force of this Omnibus].
2.  The power to adopt delegated acts referred to in Article 10 shall be conferred on the Commission for a period of five years from ... [date of entry into force of this amending Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Amendment 27
Proposal for a regulation
Annex I – Part IV – point 22 – paragraph 2 – point 2
Directive 2000/54/EC
Article 19a – paragraph 2
2.  The power to adopt delegated acts referred to in Article 19 shall be conferred on the Commission for an indeterminate period of time from [date of entry into force of this Omnibus].
2.  The power to adopt delegated acts referred to in Article 19 shall be conferred on the Commission for a period of five years from ... [date of entry into force of this amending Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Amendment 28
Proposal for a regulation
Annex I – Part IV – point 27 – paragraph 2 – point 2
Directive 2009/104/EC
Article 11a – paragraph 2
2.  The power to adopt delegated acts referred to in Article 11 shall be conferred on the Commission for an indeterminate period of time from [date of entry into force of this Omnibus].
2.  The power to adopt delegated acts referred to in Article 11 shall be conferred on the Commission for a period of five years from ... [date of entry into force of this amending Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Amendment 29
Proposal for a regulation
Annex I – Part V – point 29 – paragraph 2 – point 1
Directive 2009/73/EC
Article 6 – paragraph 4
“4. The Commission is empowered to adopt delegated acts in accordance with Article 50a establishing Guidelines for regional cooperation in a spirit of solidarity.”
“4. The Commission is empowered to adopt delegated acts in accordance with Article 50a to supplement this Directive by establishing Guidelines for regional cooperation in a spirit of solidarity.”
Amendment 30
Proposal for a regulation
Annex I – Part V – point 29 – paragraph 2 – point 2
Directive 2009/73/EC
Article 11 – paragraph 10
“10. The Commission is empowered to adopt delegated acts in accordance with Article 50a establishing Guidelines setting out the details of the procedure to be followed for the application of this Article.”
“10. The Commission is empowered to adopt delegated acts in accordance with Article 50a to supplement this Directive by establishing Guidelines setting out the details of the procedure to be followed for the application of this Article.”
Amendment 31
Proposal for a regulation
Annex I – Part V – point 29 – paragraph 2 – point 3
Directive 2009/73/EC
Article 15 – paragraph 3
“3. The Commission is empowered to adopt delegated acts in accordance with Article 50a establishing Guidelines to ensure full and effective compliance of the transmission system owner and of the storage system operator with paragraph 2 of this Article.”
“3. The Commission is empowered to adopt delegated acts in accordance with Article 50a to supplement this Directive by establishing Guidelines to ensure full and effective compliance of the transmission system owner and of the storage system operator with paragraph 2 of this Article.”
Amendment 32
Proposal for a regulation
Annex I – Part V – point 29 – paragraph 2 – point 4
Directive 2009/73/EC
Article 36 – paragraph 10
“10. The Commission is empowered to adopt delegated acts in accordance with Article 50a establishing Guidelines for the application of the conditions laid down in paragraph 1 of this Article and setting out the procedure to be followed for the application of paragraphs 3, 6, 8 and 9 of this Article.”
“10. The Commission is empowered to adopt delegated acts in accordance with Article 50a to supplement this Directive by establishing Guidelines for the application of the conditions laid down in paragraph 1 of this Article and setting out the procedure to be followed for the application of paragraphs 3, 6, 8 and 9 of this Article.”
Amendment 33
Proposal for a regulation
Annex I – Part V – point 29 – paragraph 2 – point 5
Directive 2009/73/EC
Article 42 – paragraph 5
“5. The Commission is empowered to adopt delegated acts in accordance with Article 50a establishing Guidelines on the extent of the duties of the regulatory authorities to cooperate with each other and with the Agency.”
“5. The Commission is empowered to adopt delegated acts in accordance with Article 50a to supplement this Directive by establishing Guidelines on the extent of the duties of the regulatory authorities to cooperate with each other and with the Agency.”
Amendment 34
Proposal for a regulation
Annex I – Part V – point 29 – paragraph 2 – point 6
Directive 2009/73/EC
Article 43 – paragraph 9
“9. The Commission is empowered to adopt delegated acts in accordance with Article 50a establishing Guidelines setting out the details of the procedure to be followed by the regulatory authorities, the Agency and the Commission as regards the compliance of decisions taken by regulatory authorities with the Guidelines referred to in this Article.”
“9. The Commission is empowered to adopt delegated acts in accordance with Article 50a to supplement this Directive by establishing Guidelines setting out the details of the procedure to be followed by the regulatory authorities, the Agency and the Commission as regards the compliance of decisions taken by regulatory authorities with the Guidelines referred to in this Article.”
Amendment 35
Proposal for a regulation
Annex I – Part V – point 29 – paragraph 2 – point 7
Directive 2009/73/EC
Article 44 – paragraph 4
“4. The Commission is empowered to adopt delegated acts in accordance with Article 50a establishing Guidelines which specify the methods and arrangements for record keeping as well as the form and content of the data that shall be kept.”
“4. The Commission is empowered to adopt delegated acts in accordance with Article 50a to supplement this Directive by establishing Guidelines which specify the methods and arrangements for record keeping as well as the form and content of the data that shall be kept.”
Amendment 36
Proposal for a regulation
Annex I – Part V – point 29 – paragraph 2 – point 8
Directive 2009/73/EC
Article 50a – paragraph 2
2.  The power to adopt delegated acts referred to in Article 6(4), Article 11(10), Article 15(3), Article 36(10), Article 42(5), Article 43(9) and Article44(4) shall be conferred on the Commission for an indeterminate period of time from [date of entry into force of this Omnibus].
2.  The power to adopt delegated acts referred to in Article 6(4), Article 11(10), Article 15(3), Article 36(10), Article 42(5), Article 43(9) and Article 44(4) shall be conferred on the Commission for a period of five years from ... [date of entry into force of this amending Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Amendment 37
Proposal for a regulation
Annex I – Part V – point 30 – paragraph 2 – point 1
Regulation (EC) No 715/2009
Article 3 – paragraph 5
“5. The Commission is empowered to adopt delegated acts in accordance with Article 27a establishing Guidelines setting out the details of the procedure to be followed for the application of paragraphs 1 and 2 of this Article.”
“5. The Commission is empowered to adopt delegated acts in accordance with Article 27a to supplement this Regulation by establishing Guidelines setting out the details of the procedure to be followed for the application of paragraphs 1 and 2 of this Article.”
Amendment 38
Proposal for a regulation
Annex I – Part V – point 30 – paragraph 2 – point 2
Regulation (EC) No 715/2009
Article 6 – paragraph 11 – subparagraph 2
“Where the Commission proposes to adopt a network code on its own initiative, the Commission shall consult the Agency, the ENTSO for Gas and all relevant stakeholders in regard to the draft network code during a period of no less than two months. The Commission is empowered to adopt delegated acts in accordance with Article 27a adopting such network codes.”
“Where the Commission proposes to adopt a network code on its own initiative, the Commission shall consult the Agency, the ENTSO for Gas and all relevant stakeholders in regard to the draft network code during a period of no less than two months. The Commission is empowered to adopt delegated acts in accordance with Article 27a to supplement this Regulation by adopting such network codes.”
Amendment 39
Proposal for a regulation
Annex I – Part V – point 30 – paragraph 2 – point 4
Regulation (EC) No 715/2009
Article 12 – paragraph 3 – subparagraph 1
“For the purposes of achieving the goals set out in paragraphs 1 and 2 of this Article, the Commission is empowered to adopt delegated acts in accordance with Article 27a determining the geographical area covered by each regional cooperation structure, taking into account existing regional cooperation structures. For that purpose, the Commission shall consult the Agency and the ENTSO for Gas.”
“For the purposes of achieving the goals set out in paragraphs 1 and 2 of this Article, the Commission is empowered to adopt delegated acts in accordance with Article 27a to supplement this Regulation by determining the geographical area covered by each regional cooperation structure, taking into account existing regional cooperation structures. For that purpose, the Commission shall consult the Agency and the ENTSO for Gas.”
Amendment 40
Proposal for a regulation
Annex I – Part V – point 30 – paragraph 2 – point 5
Regulation (EC) No 715/2009
Article 23 – paragraph 2 – subparagraph 2
“The Commission is empowered to adopt delegated acts in accordance with Article 27a establishing Guidelines on the issues listed in paragraph 1 of this Article and amending the Guidelines referred to in points (a), (b) and (c) thereof.”
“The Commission is empowered to adopt delegated acts in accordance with Article 27a to supplement this Regulation by establishing Guidelines on the issues listed in paragraph 1 of this Article and to amend the Guidelines referred to in points (a), (b) and (c) thereof.”
Amendment 41
Proposal for a regulation
Annex I – Part V – point 30 – paragraph 2 – point 6
Regulation (EC) No 715/2009
Article 27a – paragraph 2
2.  The power to adopt delegated acts referred to in Article 3(5), Article 6(11), Article 7(3), Article 12(3) and Article 23(2) shall be conferred on the Commission for an indeterminate period of time from [date of entry into force of this Omnibus].
2.  The power to adopt delegated acts referred to in Article 3(5), Article 6(11), Article 7(3), Article 12(3) and Article 23(2) shall be conferred on the Commission for a period of five years from ... [date of entry into force of this amending Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Amendment 42
Proposal for a regulation
Annex I – Part VI – point 32 – paragraph 2 – point 6
Directive 91/271/EEC
Article 17a – paragraph 2
2.  The power to adopt delegated acts referred to in Article 3(2), Article 4(3), Article 5(3), Article 11(2) and Article 12(3) shall be conferred on the Commission for an indeterminate period of time from [date of entry into force of this Omnibus].
2.  The power to adopt delegated acts referred to in Article 3(2), Article 4(3), Article 5(3), Article 11(2) and Article 12(3) shall be conferred on the Commission for a period of five years from ... [date of entry into force of this amending Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Amendment 43
Proposal for a regulation
Annex I – Part VI – point 33 – paragraph 2 – point 2
Directive 91/676/EEC
Article 8a – paragraph 2
2.  The power to adopt delegated acts referred to in Article 8 shall be conferred on the Commission for an indeterminate period of time from [date of entry into force of this Omnibus].
2.  The power to adopt delegated acts referred to in Article 8 shall be conferred on the Commission for a period of five years from ... [date of entry into force of this amending Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Amendment 44
Proposal for a regulation
Annex I – Part VI – point 35 – paragraph 2 – point 1
Directive 96/59/EC
Article 10 – paragraph 2 – introductory part
2.  The Commission is empowered to adopt delegated acts in accordance with Article 10b:
2.  The Commission is empowered to adopt delegated acts in accordance with Article 10b to supplement this Directive for the following purposes:
Amendment 45
Proposal for a regulation
Annex I – Part VI – point 35 – paragraph 2 – point 3
Directive 96/59/EC
Article 10b – paragraph 2
2.  The power to adopt delegated acts referred to in Article 10(2) shall be conferred on the Commission for an indeterminate period of time from [date of entry into force of this Omnibus].
2.  The power to adopt delegated acts referred to in Article 10(2) shall be conferred on the Commission for a period of five years from ... [date of entry into force of this amending Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Amendment 46
Proposal for a regulation
Annex I – Part VI – point 36 – paragraph 4 – point 2
Directive 98/83/EC
Article 11a – paragraph 2
2.  The power to adopt delegated acts referred to in Article 11(2) shall be conferred on the Commission for an indeterminate period of time from [date of entry into force of this Omnibus].
2.  The power to adopt delegated acts referred to in Article 11(2) shall be conferred on the Commission for a period of five years from ... [date of entry into force of this amending Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Amendment 47
Proposal for a regulation
Annex I – Part VI – point 37 – paragraph 3 – point 2
Directive 2000/53/EC
Article 5 – paragraph 5 – subparagraph 2
The Commission is empowered to adopt delegated acts in accordance with Article 9a concerning minimum requirements for the certificate of destruction.;
The Commission is empowered to adopt delegated acts in accordance with Article 9a to supplement this Directive by establishing minimum requirements for the certificate of destruction.
Amendment 48
Proposal for a regulation
Annex I – Part VI – point 37 – paragraph 3 – point 4
Directive 2000/53/EC
Article 7 – paragraph 2 – subparagraph 3
“The Commission is empowered to adopt delegated acts in accordance with Article 9a concerning the detailed rules necessary to control compliance of Member States with the targets set out in the first subparagraph. When preparing such rules, the Commission shall take into account all relevant factors, inter alia, the availability of data and the issue of exports and imports of end-of-life vehicles.”
“The Commission is empowered to adopt delegated acts in accordance with Article 9a to supplement this Directive by establishing the detailed rules necessary to control compliance of Member States with the targets set out in the first subparagraph. When preparing such rules, the Commission shall take into account all relevant factors, inter alia, the availability of data and the issue of exports and imports of end-of-life vehicles.”
Amendment 49
Proposal for a regulation
Annex I – Part VI – point 37 – paragraph 3 – point 5
Directive 2000/53/EC
Article 8 – paragraph 2
“2. The Commission is empowered to adopt delegated acts in accordance with Article 9a concerning the standards referred to in paragraph 1. When preparing such standards, the Commission shall take account of the work going on in this area in the relevant international forums and contribute to this work as appropriate.”
“2. The Commission is empowered to adopt delegated acts in accordance with Article 9a to supplement this Directive by establishing the standards referred to in paragraph 1. When preparing such standards, the Commission shall take account of the work going on in this area in the relevant international forums and contribute to this work as appropriate.”
Amendment 50
Proposal for a regulation
Annex I – Part VI – point 37 – paragraph 3 – point 6
Directive 2000/53/EC
Article 9a – paragraph 2
2.  The power to adopt delegated acts referred to in Article 4(2)(b), Article 5(5), Article 6(6), Article 7(2) and Article 8(2) shall be conferred on the Commission for an indeterminate period of time from [date of entry into force of this Omnibus].
2.  The power to adopt delegated acts referred to in point (b) of Article 4(2), Article 5(5), Article 6(6), Article 7(2) and Article 8(2) shall be conferred on the Commission for a period of five years from ... [date of entry into force of this amending Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Amendment 51
Proposal for a regulation
Annex I – Part VI – point 38 – paragraph 3 – point 1
Directive 2000/60/EC
Article 8 – paragraph 3
“3. The Commission is empowered to adopt delegated acts in accordance with Article 20a laying down technical specifications and standardised methods for analysis and monitoring of water status.”
“3. The Commission is empowered to adopt delegated acts in accordance with Article 20a to supplement this Directive by laying down technical specifications and standardised methods for analysis and monitoring of water status.”
Amendment 52
Proposal for a regulation
Annex I – Part VI – point 38 – paragraph 3 – point 3
Directive 2000/60/EC
Article 20a – paragraph 2
2.  The power to adopt delegated acts referred to in Article 8(3), in the first subparagraph of Article 20(1) and in Annex V, paragraph 1.4.1, point (ix), shall be conferred on the Commission for an indeterminate period of time from [date of entry into force of this Omnibus].
2.  The power to adopt delegated acts referred to in Article 8(3), in the first subparagraph of Article 20(1) and in Annex V, paragraph 1.4.1, point (ix), shall be conferred on the Commission for a period of five years from ... [date of entry into force of this amending Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Amendment 53
Proposal for a regulation
Annex I – Part VI – point 38 – paragraph 3 – point 5
Directive 2000/60/EC
Annex V – paragraph 1.4.1 – point ix
“(ix) The Commission is empowered to adopt delegated acts in accordance with Article 20a setting out the results of the intercalibration exercise and establishing the values of the Member State monitoring system classifications in accordance with points (i) to (viii). It shall be published within six months of the completion of the intercalibration exercise.”
“(ix) The Commission is empowered to adopt delegated acts in accordance with Article 20a to supplement this Directive by setting out the results of the intercalibration exercise and by establishing the values of the Member State monitoring system classifications in accordance with points (i) to (viii). They shall be published within six months of the completion of the intercalibration exercise.”
Amendment 54
Proposal for a regulation
Annex I – Part VI – point 41 – paragraph 2 – point 2
Directive 2004/107/EC
Article 5a – paragraph 2
2.  The power to adopt delegated acts referred to in Article 4(15) shall be conferred on the Commission for an indeterminate period of time from [date of entry into force of this Omnibus].
2.  The power to adopt delegated acts referred to in Article 4(15) shall be conferred on the Commission for a period of five years from ... [date of entry into force of this amending Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Amendment 55
Proposal for a regulation
Annex I – Part VI – point 42 – paragraph 3 – point 1
Directive 2006/7/EC
Article 15 – paragraph 2 – point a
(a)  specifying the EN/ISO standard on the equivalence of microbiological methods for the purposes of Article 3(9);
(a)  to supplement this Directive by specifying the EN/ISO standard on the equivalence of microbiological methods for the purposes of Article 3(9);
Amendment 56
Proposal for a regulation
Annex I – Part VI – point 42 – paragraph 3 – point 1
Directive 2006/7/EC
Article 15 – paragraph 2 – point b
(b)  amending Annex I, where necessary in the light of scientific and technical progress, as regards the methods of analysis for the parameters set out in that Annex;
(b)  to amend Annex I, where necessary in the light of scientific and technical progress, as regards the methods of analysis for the parameters set out in that Annex;
Amendment 57
Proposal for a regulation
Annex I – Part VI – point 42 – paragraph 3 – point 1
Directive 2006/7/EC
Article 15 – paragraph 2 – point c
(c)  amending Annex V where necessary in the light of scientific and technical progress.;
(c)  to amend Annex V where necessary in the light of scientific and technical progress.
Amendment 58
Proposal for a regulation
Annex I – Part VI – point 42 – paragraph 3 – point 2
Directive 2006/7/EC
Article 15a – paragraph 2
2.  The power to adopt delegated acts referred to in Article 15(2) shall be conferred on the Commission for an indeterminate period of time from [date of entry into force of this Omnibus].
2.  The power to adopt delegated acts referred to in Article 15(2) shall be conferred on the Commission for a period of five years from ... [date of entry into force of this amending Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Amendment 59
Proposal for a regulation
Annex I – Part VI – point 43 – paragraph 3 – point 1
Directive 2006/21/EC
Article 22 – paragraph 2 – subparagraph 1 – introductory part
2.  The Commission is empowered to adopt delegated acts in accordance with Article 22a necessary for the following:
2.  The Commission is empowered to adopt delegated acts in accordance with Article 22a to supplement this Directive for the following purposes:
Amendment 60
Proposal for a regulation
Annex I – Part VI – point 43 – paragraph 3 – point 1
Directive 2006/21/EC
Article 22 – paragraph 2 – subparagraph 1 – point a
(a)  the elaboration of the technical requirements for the purposes of Article 13(6), including technical requirements relating to the definition of weak acid dissociable cyanide and its measurement method;
(a)  to elaborate the technical requirements for the purposes of Article 13(6), including technical requirements relating to the definition of weak acid dissociable cyanide and its measurement method;
Amendment 61
Proposal for a regulation
Annex I – Part VI – point 43 – paragraph 3 – point 1
Directive 2006/21/EC
Article 22 – paragraph 2 – subparagraph 1 – point b
(b)  the completion of the technical requirements for waste characterisation contained in Annex II;
(b)  to complete the technical requirements for waste characterisation contained in Annex II;
Amendment 62
Proposal for a regulation
Annex I – Part VI – point 43 – paragraph 3 – point 1
Directive 2006/21/EC
Article 22 – paragraph 2 – subparagraph 1 – point c
(c)  the interpretation of the definition contained in point 3 of Article 3;
(c)  to provide an interpretation of the definition contained in point 3 of Article 3;
Amendment 63
Proposal for a regulation
Annex I – Part VI – point 43 – paragraph 3 – point 1
Directive 2006/21/EC
Article 22 – paragraph 2 – subparagraph 1 – point d
(d)  the definition of the criteria for the classification of waste facilities in accordance with Annex III;
(d)  to define the criteria for the classification of waste facilities in accordance with Annex III;
Amendment 64
Proposal for a regulation
Annex I – Part VI – point 43 – paragraph 3 – point 1
Directive 2006/21/EC
Article 22 – paragraph 2 – subparagraph 1 – point e
(e)  the determination of any harmonised standards for sampling and analysis methods needed for the technical implementation of this Directive.
(e)  to determine any harmonised standards for sampling and analysis methods needed for the technical implementation of this Directive.
Amendment 65
Proposal for a regulation
Annex I – Part VI – point 43 – paragraph 3 – point 2
Directive 2006/21/EC
Article 22a – paragraph 2
2.  The power to adopt delegated acts referred to in Article 22(2) and (3) shall be conferred on the Commission for an indeterminate period of time from [date of entry into force of this Omnibus].
2.  The power to adopt delegated acts referred to in Article 22(2) and (3) shall be conferred on the Commission for a period of five years from ... [date of entry into force of this amending Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Amendment 66
Proposal for a regulation
Annex I – Part VI – point 44 – paragraph 2 – point 2
Directive 2006/118/EC
Article 8a – paragraph 2
2.  The power to adopt delegated acts referred to in Article 8 shall be conferred on the Commission for an indeterminate period of time from [date of entry into force of this Omnibus].
2.  The power to adopt delegated acts referred to in Article 8 shall be conferred on the Commission for a period of five years from ... [date of entry into force of this amending Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Amendment 67
Proposal for a regulation
Annex I – Part VI – point 46 – paragraph 3 – point 2
Directive 2007/2/EC
Article 7 – paragraph 1
“1. The Commission is empowered to adopt delegated acts in accordance with Article 21a laying down technical arrangements for the interoperability and, where practicable, harmonisation of spatial data sets and services. Relevant user requirements, existing initiatives and international standards for the harmonisation of spatial data sets, as well as feasibility and cost-benefit considerations shall be taken into account in the development of those arrangements.”
“1. The Commission is empowered to adopt delegated acts in accordance with Article 21a to supplement this Directive by laying down technical arrangements for the interoperability and, where practicable, harmonisation of spatial data sets and services. Relevant user requirements, existing initiatives and international standards for the harmonisation of spatial data sets, as well as feasibility and cost-benefit considerations shall be taken into account in the development of those arrangements.”
Amendment 68
Proposal for a regulation
Annex I – Part VI – point 46 – paragraph 3 – point 3
Directive 2007/2/EC
Article 16 – paragraph 1 – introductory part
The Commission is empowered to adopt delegated acts in accordance with Article 21a concerning rules, laying down, in particular, the following to supplement this Chapter:
The Commission is empowered to adopt delegated acts in accordance with Article 21a to supplement this Directive by laying down, in particular, the following:
Amendment 69
Proposal for a regulation
Annex I – Part VI – point 46 – paragraph 3 – point 4
Directive 2007/2/EC
Article 17 – paragraph 8 – subparagraph 2
The Commission is empowered to adopt delegated acts in accordance with Article 21a laying down rules governing those conditions. Those rules shall fully respect the principles set out in paragraphs 1, 2 and 3 of this Article.;
The Commission is empowered to adopt delegated acts in accordance with Article 21a to supplement this Directive by laying down rules governing those conditions. Those rules shall fully respect the principles set out in paragraphs 1, 2 and 3 of this Article.
Amendment 70
Proposal for a regulation
Annex I – Part VI – point 46 – paragraph 3 – point 5
Directive 2007/2/EC
Article 21a – paragraph 2
2.  The power to adopt delegated acts referred to in Article 4(7), Article 7(1), Article 16 and Article 17(8) shall be conferred on the Commission for an indeterminate period of time from [date of entry into force of this Omnibus].
2.  The power to adopt delegated acts referred to in Article 4(7), Article 7(1), Article 16 and Article 17(8) shall be conferred on the Commission for a period of five years from ... [date of entry into force of this amending Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Amendment 71
Proposal for a regulation
Annex I – Part VI – point 47 – paragraph 2 – point 2
Directive 2007/60/EC
Article 11a – paragraph 2
2.  The power to adopt delegated acts referred to in Article 11(2) shall be conferred on the Commission for an indeterminate period of time from [date of entry into force of this Omnibus].
2.  The power to adopt delegated acts referred to in Article 11(2) shall be conferred on the Commission for a period of five years from ... [date of entry into force of this amending Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Amendment 72
Proposal for a regulation
Annex I – Part VI – point 48 – paragraph 2 – point 2
Directive 2008/50/EC
Article 28a – paragraph 2
2.  The power to adopt delegated acts referred to in Article 28(1) shall be conferred on the Commission for an indeterminate period of time from [date of entry into force of this Omnibus].
2.  The power to adopt delegated acts referred to in Article 28(1) shall be conferred on the Commission for a period of five years from ... [date of entry into force of this amending Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Amendment 73
Proposal for a regulation
Annex I – Part VI – point 49 – paragraph 2 – point 1
Directive 2008/56/EC
Article 9 – paragraph 3 – subparagraph 1
The Commission is empowered to adopt delegated acts in accordance with Article 24a laying down, by 15 July 2010, criteria and methodological standards to be used by the Member States, on the basis of Annexes I and III, in such a way as to ensure consistency and to allow for comparison between marine regions or sub-regions of the extent to which good environmental status is being achieved.
The Commission is empowered to adopt delegated acts in accordance with Article 24a to supplement this Directive by laying down, by 15 July 2010, criteria and methodological standards to be used by the Member States, on the basis of Annexes I and III, in such a way as to ensure consistency and to allow for comparison between marine regions or sub-regions of the extent to which good environmental status is being achieved.
Amendment 74
Proposal for a regulation
Annex I – Part VI – point 49 – paragraph 2 – point 2
Directive 2008/56/EC
Article 11 – paragraph 4
“4. The Commission is empowered to adopt delegated acts in accordance with Article 24a laying down specifications and standardised methods for monitoring and assessment, which take into account existing commitments and ensure comparability between monitoring and assessment results.”
“4. The Commission is empowered to adopt delegated acts in accordance with Article 24a to supplement this Directive by laying down specifications and standardised methods for monitoring and assessment, which take into account existing commitments and ensure comparability between monitoring and assessment results.”
Amendment 75
Proposal for a regulation
Annex I – Part VI – point 49 – paragraph 2 – point 4
Directive 2008/56/EC
Article 24a – paragraph 2
2.  The power to adopt delegated acts referred to in Article 9(3), Article 11(4) and Article 24(1) shall be conferred on the Commission for an indeterminate period of time from [date of entry into force of this Omnibus].
2.  The power to adopt delegated acts referred to in Article 9(3), Article 11(4) and Article 24(1) shall be conferred on the Commission for a period of five years from ... [date of entry into force of this amending Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Amendment 76
Proposal for a regulation
Annex I – Part VI – point 52 – paragraph 2 – point 2
Directive 2009/147/EC
Article 15a – paragraph 2
2.  The power to adopt delegated acts referred to in Article 15 shall be conferred on the Commission for an indeterminate period of time from [date of entry into force of this Omnibus].
2.  The power to adopt delegated acts referred to in Article 15 shall be conferred on the Commission for a period of five years from ... [date of entry into force of this amending Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Amendment 77
Proposal for a regulation
Annex I – Part VI – point 53 – paragraph 1
In order to update Regulation (EC) No 1221/2009 and to establish evaluation procedures, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission to amend the Annexes to that Regulation and to supplement it with procedures for carrying out the peer evaluation of the EMAS Competent Bodies. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement on Better Law-Making of 13 April 2016. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.
In order to update Regulation (EC) No 1221/2009 and to establish evaluation procedures, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission to amend the Annexes to that Regulation and to supplement it with procedures for carrying out the peer evaluation of the EMAS Competent Bodies and to provide sectoral reference documents as well as guidance documents referring to registration of organisations and to harmonisation procedures. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.
Amendment 78
Proposal for a regulation
Annex I – Part VI – point 53 – paragraph 2
In order to ensure uniform conditions for the implementation of Regulation (EC) No 1221/2009 implementing powers should be conferred on the Commission concerning the harmonisation of certain procedures and in relation to sectoral reference documents. Those powers should be exercised in accordance with Regulation (EU) No 182/2011.
deleted
Amendment 79
Proposal for a regulation
Annex I – Part VI – point 53 – paragraph 3 – point 1
Regulation (EC) No 1221/2009
Article 16 – paragraph 4 – subparagraph 1
Guidance documents referring to harmonisation procedures approved by the Forum of Competent Bodies shall be adopted by the Commission by means of implementing acts. Those implementing acts shall be adopted in accordance with the procedure referred to in Article 49(2).
The Commission is empowered to adopt delegated acts in accordance with Article 48a to supplement this Regulation by establishing guidance documents on the harmonisation procedures approved by the Forum of Competent Bodies.
Amendment 80
Proposal for a regulation
Annex I – Part VI – point 53 – paragraph 3 – point 2
Regulation (EC) No 1221/2009
Article 17 – paragraph 3
“3. The Commission is empowered to adopt delegated acts in accordance with Article 48a concerning the procedures for carrying out the peer evaluation of the EMAS Competent Bodies, including appropriate appeals procedures against decisions taken as a result of the peer evaluation.”
“3. The Commission is empowered to adopt delegated acts in accordance with Article 48a to supplement this Regulation by establishing the procedures for carrying out the peer evaluation of the EMAS Competent Bodies, including appropriate appeals procedures against decisions taken as a result of the peer evaluation.”
Amendment 81
Proposal for a regulation
Annex I – Part VI – point 53 – paragraph 3 – point 3
Regulation (EC) No 1221/2009
Article 30 – paragraph 6 – subparagraph 1
The Commission shall adopt guidance documents referring to harmonisation procedures approved by the Forum of the Accreditation and Licensing Bodies by means of implementing acts. Those implementing acts shall be adopted in accordance with the procedure referred to in Article 49(2).
The Commission is empowered to adopt delegated acts in accordance with Article 48a to supplement this Regulation by establishing guidance documents on the harmonisation procedures approved by the Forum of the Accreditation and Licensing Bodies.
Amendment 82
Proposal for a regulation
Annex I – Part VI – point 53 – paragraph 3 – point 4
Regulation (EC) No 1221/2009
Article 46 – paragraph 6
“6. The Commission shall adopt the sectoral reference documents referred to in paragraph 1 and the guide referred to in paragraph 4 by means of implementing acts in accordance with the procedure referred to in Article 49(2).”
“6. The Commission is empowered to adopt delegated acts in accordance with Article 48a to supplement this Regulation by adopting the sectoral reference documents referred to in paragraph 1 and the guide referred to in paragraph 4.”
Amendment 83
Proposal for a regulation
Annex I – Part VI – point 53 – paragraph 3 – point 6
Regulation (EC) No 1221/2009
Article 48a
“Article 48a
“Article 48a
Exercise of the delegation
Exercise of the delegation
1.  The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
1.  The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
2.  The power to adopt delegated acts referred to in Article 17(3) and Article 48 shall be conferred on the Commission for an indeterminate period of time from [date of entry into force of this Omnibus].
2.  The power to adopt delegated acts referred to in Article 16(4), Article 17(3), Article 30(6), Article 46(6) and Article 48 shall be conferred on the Commission for a period of five years from ... [date of entry into force of this amending Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
3.  The delegation of power referred to in Article 17(3) and Article 48 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
3.  The delegation of power referred to in Article 16(4), Article 17(3), Article 30(6), Article 46(6) and Article 48 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
4.  Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement on Better Law-Making of 13 April 2016*.
4.  Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making *.
5.  As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
5.  As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
6.  A delegated act adopted pursuant to Article 17(3) and Article 48 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
6.  A delegated act adopted pursuant to Article 16(4), Article 17(3), Article 30(6), Article 46(6) and Article 48 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
_______________
_______________
* OJ L 123, 12.5.2016, p. 1.”
* OJ L 123, 12.5.2016, p. 1.”
Amendment 84
Proposal for a regulation
Annex I – Part VI – point 54 – paragraph 4 – point 1 – point b
Regulation (EC) No 66/2010
Article 6 – paragraph 7 – subparagraph 1
For specific categories of goods containing substances referred to in paragraph 6, and only in the event that it is not technically feasible to substitute them as such, or via the use of alternative materials or designs, or in the case of products which have a significantly higher overall environment performance compared with other goods of the same category, the Commission is empowered to adopt delegated acts in accordance with Article 15a granting derogations from paragraph 6 of this Article.
For specific categories of goods containing substances referred to in paragraph 6,and only in the event that it is not technically feasible to substitute them as such, or via the use of alternative materials or designs, or in the case of products which have a significantly higher overall environment performance compared with other goods of the same category, the Commission is empowered to adopt delegated acts in accordance with Article 15a to supplement this Regulation by laying down measures granting derogations from paragraph 6 of this Article.
Amendment 85
Proposal for a regulation
Annex I – Part VI – point 54 – paragraph 4 – point 2
Regulation (EC) No 66/2010
Article 8 – paragraph 2 – subparagraph 1
The Commission is empowered to adopt delegated acts in accordance with Article 15a laying down, no later than nine months after consulting the EUEB, measures to establish specific EU Ecolabel criteria for each product group. These measures shall be published in the Official Journal of the European Union.
The Commission is empowered to adopt delegated acts in accordance with Article 15a to supplement this Regulation by laying down, no later than nine months after consulting the EUEB, measures to establish specific EU Ecolabel criteria for each product group. These measures shall be published in the Official Journal of the European Union.
Amendment 86
Proposal for a regulation
Annex I – Part VI – point 54 – paragraph 4 – point 4
Regulation (EC) No 66/2010
Article 15a – paragraph 2
2.  The power to adopt delegated acts referred to in Article 6(7), Article 8(2) and Article 15 shall be conferred on the Commission for an indeterminate period of time from [date of entry into force of this Omnibus].
2.  The power to adopt delegated acts referred to in Article 6(7), Article 8(2) and Article 15 shall be conferred on the Commission for a period of five years from ... [date of entry into force of this amending Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Amendment 87
Proposal for a regulation
Annex I – Part VII – point 55 – paragraph 3 – point 1
Regulation (EEC) No 3924/91
Article 2 – paragraph 6
“6. The Commission is empowered to adopt delegated acts in accordance with Article 9a updating the Prodcom list and the information actually collected for each heading.”
“6. The Commission is empowered to adopt delegated acts in accordance with Article 9a to supplement this Regulation by updating the Prodcom list and the information actually collected for each heading.”
Amendment 88
Proposal for a regulation
Annex I – Part VII – point 55 – paragraph 3 – point 2
Regulation (EEC) No 3924/91
Article 3 – paragraph 5
“5. The Commission is empowered to adopt delegated acts in accordance with Article 9a concerning detailed rules for applying paragraph 3 of this Article, including for the adjustment to technical progress.”
“5. The Commission is empowered to adopt delegated acts in accordance with Article 9a to supplement this Regulation by adopting detailed rules for applying paragraph 3 of this Article, including for the adjustment to technical progress.”
Amendment 89
Proposal for a regulation
Annex I – Part VII – point 55 – paragraph 3 – point 3
Regulation (EEC) No 3924/91
Article 4 – paragraph 2
However, for certain headings in the Prodcom list, the Commission is empowered to adopt delegated acts in accordance with Article 9a providing that monthly or quarterly surveys are to be conducted.
However, for certain headings in the Prodcom list, the Commission is empowered to adopt delegated acts in accordance with Article 9a to supplement this Regulation by providing that monthly or quarterly surveys are to be conducted.
Amendment 90
Proposal for a regulation
Annex I – Part VII – point 55 – paragraph 3 – point 4
Regulation (EEC) No 3924/91
Article 5 – paragraph 1
“1. The required information shall be collected by the Member States using survey questionnaires the content of which shall comply with the arrangements defined by the Commission. The Commission is empowered to adopt delegated acts in accordance with Article 9a concerning those arrangements.”
“1. The required information shall be collected by the Member States using survey questionnaires the content of which shall comply with the arrangements defined by the Commission. The Commission is empowered to adopt delegated acts in accordance with Article 9a to supplement this Regulation by defining those arrangements.”
Amendment 91
Proposal for a regulation
Annex I – Part VII – point 55 – paragraph 3 – point 5
Regulation (EEC) No 3924/91
Article 6 – paragraph 1
The Commission is empowered to adopt delegated acts in accordance with Article 9a concerning the detailed rules in accordance with which Member States shall process the completed questionnaires referred to in Article 5(1) or the information from other sources referred to in Article 5(3).;
The Commission is empowered to adopt delegated acts in accordance with Article 9a to supplement this Regulation by defining detailed rules in accordance with which Member States shall process the completed questionnaires referred to in Article 5(1) or the information from other sources referred to in Article 5(3).
Amendment 92
Proposal for a regulation
Annex I – Part VII – point 55 – paragraph 3 – point 6
Regulation (EEC) No 3924/91
Article 9a – paragraph 2
2.  The power to adopt delegated acts referred to in Article 2(6), Article 3(5), Article 4, Article 5(1) and Article 6 shall be conferred on the Commission for an indeterminate period of time from [date of entry into force of this Omnibus].
2.  The power to adopt delegated acts referred to in Article 2(6), Article 3(5), Article 4, Article 5(1) and Article 6 shall be conferred on the Commission for a period of five years from ... [date of entry into force of this amending Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Amendment 93
Proposal for a regulation
Annex I – Part VII – point 56 – paragraph 2 – point 1
Regulation (EEC) No 696/93
Article 6 – paragraph 1
The Commission is empowered to adopt delegated acts in accordance with Article 6a amending in particular the statistical units of the production system, the criteria used and the definitions specified in the Annex in order to adapt them to economic and technical developments.;
The Commission is empowered to adopt delegated acts in accordance with Article 6a amending the statistical units of the production system, the criteria used and the definitions specified in the Annex in order to adapt them to economic and technical developments.
Amendment 94
Proposal for a regulation
Annex I – Part VII – point 56 – paragraph 2 – point 2
Regulation (EEC) No 696/93
Article 6a – paragraph 2
2.  The power to adopt delegated acts referred to in Article 6 shall be conferred on the Commission for an indeterminate period of time from [date of entry into force of this Omnibus].
2.  The power to adopt delegated acts referred to in Article 6 shall be conferred on the Commission for a period of five years from ... [date of entry into force of this amending Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Amendment 95
Proposal for a regulation
Annex I – Part VII – point 57 – paragraph 1 – indent 4
—  supplement that Regulation with the criteria for the measurement of quality;
—  supplement that Regulation with the criteria for the measurement of quality of the variables;
Amendment 96
Proposal for a regulation
Annex I – Part VII – point 57 – paragraph 4 – point 2 – introductory part
(2)  in Article 4(2), the second subparagraph is replaced by the following:
(2)  in point (d) of the first subparagraph of Article 4(2), the second subparagraph is replaced by the following:
Amendment 97
Proposal for a regulation
Annex I – Part VII – point 57 – paragraph 4 – point 2
Regulation (EC) No 1165/98
Article 4 – paragraph 2 – subparagraph 1 – point d – subparagraph 2
The details of the schemes referred to in the first subparagraph shall be as specified in the Annexes. The Commission is empowered to adopt delegated acts in accordance with Article 18a concerning their approval and application.;
The details of the schemes referred to in the first subparagraph shall be as specified in the Annexes. The Commission is empowered to adopt delegated acts in accordance with Article 18a to supplement this Regulation by further specifying their approval and application.
Amendment 98
Proposal for a regulation
Annex I – Part VII – point 57 – paragraph 4 – point 3
Regulation (EC) No 1165/98
Article 10 – paragraph 5
“5. The Commission is empowered to adopt delegated acts in accordance with Article 18a concerning the criteria for the measurement of quality.”
“5. The Commission is empowered to adopt delegated acts in accordance with Article 18a to supplement this Regulation by specifying the criteria for the measurement of quality of the variables.”
Amendment 99
Proposal for a regulation
Annex I – Part VII – point 57 – paragraph 4 – point 4 a (new)
Regulation (EC) No 1165/98
Article 18 – paragraph 3
(4a)  in Article 18, paragraph 3 is deleted;
Amendment 100
Proposal for a regulation
Annex I – Part VII – point 57 – paragraph 4 – point 5
Regulation (EC) No 1165/98
Article 18a – paragraph 2
2.  The power to adopt delegated acts referred to in Article 3(3), Article 4(2), Article 10, Annex A points (a), (b) 3, (c) 2, (c) 10, (d) 2, (f) 8 and 9, Annex B points (b) 4 and (d) 2, Annex C points (b) 2, (d) 2 and (g) 2 and Annex D points (b) 2 and (d) 2. shall be conferred on the Commission for an indeterminate period of time [from the entry into force of this Omnibus].
2.  The power to adopt delegated acts referred to in Article 3(3), the second subparagraph of point (d) of the first subparagraph of Article 4(2), Article 10(5), points (a), (b) 3, (c) 2, (c) 10, (d) 2, (f) 8 and 9 of Annex A, points (b) 4 and (d) 2 of Annex B, points (b) 2, (d) 2 and (g) 2 of Annex C and points (b) 2 and (d) 2 of Annex D shall be conferred on the Commission for a period of five years from ...[date of entry into force of this amending Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Amendment 101
Proposal for a regulation
Annex I – Part VII – point 57 – paragraph 4 – point 5
Regulation (EC) No 1165/98
Article 18a – paragraph 3
3.  The delegation of power referred to in Article 3(3), Article 4(2), Article 10, Annex A points (a), (b) 3, (c) 2, (c) 10, (d) 2, (f) 8 and 9, Annex B points (b) 4 and (d) 2, Annex C points (b) 2, (d) 2 and (g) 2 and Annex D points (b) 2 and (d) 2 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
3.  The delegation of power referred to in Article 3(3), the second subparagraph of point (d) of the first subparagraph of Article 4(2), Article 10(5), points (a), (b) 3, (c) 2, (c) 10, (d) 2, (f) 8 and 9 of Annex A, points (b) 4 and (d) 2 of Annex B, points (b) 2, (d) 2 and (g) 2 of Annex C and points (b) 2 and (d) 2 of Annex D may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
Amendment 102
Proposal for a regulation
Annex I – Part VII – point 57 – paragraph 4 – point 5
Regulation (EC) No 1165/98
Article 18a – paragraph 6
6.  A delegated act adopted pursuant to Article 3(3), Article 4(2), Article 10, Annex A points (a), (b) 3, (c) 2, (c) 10, (d) 2, (f) 8 and 9, Annex B points (b) 4 and (d) 2, Annex C points (b) 2, (d) 2 and (g) 2 and Annex D points (b) 2 and (d) 2 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
6.  A delegated act adopted pursuant to Article 3(3), the second subparagraph of point (d) of the first subparagraph of Article 4(2), Article 10(5), points (a), (b) 3, (c) 2, (c) 10, (d) 2, (f) 8 and 9 of Annex A, points (b) 4 and (d) 2 of Annex B, points (b) 2, (d) 2 and (g) 2 of Annex C and points (b) 2 and (d) 2 of Annex D shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of three months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by three months at the initiative of the European Parliament or of the Council.
Amendment 103
Proposal for a regulation
Annex I – Part VII – point 57 – paragraph 4 – point 6 – point ii
Regulation (EC) No 1165/98
Annex A – point b – point 3
“3. The Commission is empowered to adopt delegated acts in accordance with Article 18a concerning the use of other observation units.”
“3. The Commission is empowered to adopt delegated acts in accordance with Article 18a to supplement this Regulation by providing for the possibility to use other observation units.”
Amendment 104
Proposal for a regulation
Annex I – Part VII – point 57 – paragraph 4 – point 6 – point iii
Regulation (EC) No 1165/98
Annex A – point c – point 2
“2. The information on output prices for non-domestic markets (No 312) and import prices (No 340) may be compiled using unit values for products originating from foreign trade or other sources only if there is no significant deterioration in quality compared to specific price information. The Commission is empowered to adopt delegated acts in accordance with Article 18a concerning the conditions for assuring the necessary data quality.”
“2. The information on output prices for non-domestic markets (No 312) and import prices (No 340) may be compiled using unit values for products originating from foreign trade or other sources only if there is no significant deterioration in quality compared to specific price information. The Commission is empowered to adopt delegated acts in accordance with Article 18a to supplement this Regulation by determining the conditions for assuring the necessary data quality.”
Amendment 105
Proposal for a regulation
Annex I – Part VII – point 57 – paragraph 4 – point 6 – point vi
Regulation (EC) No 1165/98
Annex A – point d – point 2
“2. In addition, the production variable (No 110) and the hours-worked variable (No 220) are to be transmitted in working-day adjusted form. Wherever other variables show working-day effects, Member States may also transmit those variables in working-day adjusted form. The Commission is empowered to adopt delegated acts in accordance with Article 18a concerning the amendment of the list of variables to be transmitted in working-day adjusted form.”
“2. In addition, the production variable (No 110) and the hours-worked variable (No 220) are to be transmitted in working-day adjusted form. Wherever other variables show working-day effects, Member States may also transmit those variables in working-day adjusted form. The Commission is empowered to adopt delegated acts in accordance with Article 18a amending the list of variables to be transmitted in working-day adjusted form.”
Amendment 106
Proposal for a regulation
Annex I – Part VII – point 57 – paragraph 4 – point 6 – point vii
Regulation (EC) No 1165/98
Annex A – point f – point 8
“8. For the import price variable (No 340), the Commission is empowered to adopt delegated acts in accordance with Article 18a concerning the determination of the terms for applying a European sample scheme as defined in point (d) of the first subparagraph of Article 4(2).”
“8. For the import price variable (No 340), the Commission is empowered to adopt delegated acts in accordance with Article 18a to supplement that Regulation by determining the terms for applying a European sample scheme as defined in point (d) of the first subparagraph of Article 4(2).”
Amendment 107
Proposal for a regulation
Annex I – Part VII – point 57 – paragraph 4 – point 6 – point viii
Regulation (EC) No 1165/98
Annex A – point f – point 9
“9. The variables on the non-domestic markets (Nos 122 and 312) are to be transmitted according to the distinction into euro-zone and non-euro- zone. The distinction is to be applied to the total industry defined as NACE Rev. 2 Sections B to E, the MIGs, the Section (1 letter) and Division 2-digit level of NACE Rev. 2. The information on NACE Rev. 2 D and E is not required for variable 122. In addition, the import price variable (No 340) is to be transmitted according to the distinction into euro-zone and non-euro-zone. The distinction is to be applied to the total industry defined as CPA Sections B to E, the MIGs, the Section (1 letter) and Division 2-digit level of CPA. For the distinction into the euro-zone and non-euro-zone, the Commission is empowered to adopt delegated acts in accordance with Article 18a concerning the determination of the terms for applying European sample schemes as defined in point (d) of the first subparagraph of Article 4(2). The European sample scheme may limit the scope of the import price variable to the import of products from non-euro-zone countries. The distinction into the euro-zone and non- euro-zone for the variables 122, 312 and 340 does not need to be transmitted by those Member States that have not adopted the euro as their currency.”
“9. The variables on the non-domestic markets (Nos 122 and 312) are to be transmitted according to the distinction into euro-area and non-euro-area. The distinction is to be applied to the total industry defined as NACE Rev. 2 Sections B to E, the MIGs, the Section (1 letter) and Division 2-digit level of NACE Rev. 2. The information on NACE Rev. 2 D and E is not required for variable 122. In addition, the import price variable (No 340) is to be transmitted according to the distinction into euro-area and non-euro-area. The distinction is to be applied to the total industry defined as CPA Sections B to E, the MIGs, the Section (1 letter) and Division 2-digit level of CPA. For the distinction into the euro-area and non-euro-area, the Commission is empowered to adopt delegated acts in accordance with Article 18a to supplement this Regulation by determining the terms for applying European sample schemes as defined in point (d) of the first subparagraph of Article 4(2). The European sample scheme may limit the scope of the import price variable to the import of products from non-euro-area countries. The distinction into the euro-area and non- euro-area for the variables 122, 312 and 340 does not need to be transmitted by those Member States that have not adopted the euro as their currency.”
Amendment 108
Proposal for a regulation
Annex I – Part VII – point 57 – paragraph 4 – point 7 – point i
Regulation (EC) No 1165/98
Annex B – point b – point 4
“4. The Commission is empowered to adopt delegated acts in accordance with Article 18a concerning the use of other observation units.”
“4. The Commission is empowered to adopt delegated acts in accordance with Article 18a to supplement this Regulation by providing for the possibility to use other observation units.”
Amendment 109
Proposal for a regulation
Annex I – Part VII – point 57 – paragraph 4 – point 7 – point iv
Regulation (EC) No 1165/98
Annex B – point d – point 2 – subparagraph 2
Wherever other variables show working-day effects, Member States may also transmit those variables in working-day adjusted form. The Commission is empowered to adopt delegated acts in accordance with Article 18a concerning the amendment of the list of variables to be transmitted in working-day adjusted form.
Wherever other variables show working-day effects, Member States may also transmit those variables in working-day adjusted form. The Commission is empowered to adopt delegated acts in accordance with Article 18a amending the list of variables to be transmitted in working-day adjusted form.
Amendment 110
Proposal for a regulation
Annex I – Part VII – point 57 – paragraph 4 – point 8 – point i
Regulation (EC) No 1165/98
Annex C – point b – point 2
“2. The Commission is empowered to adopt delegated acts in accordance with Article 18a concerning the use of other observation units.”
“2. The Commission is empowered to adopt delegated acts in accordance with Article 18a to supplement this Regulation by providing for the possibility to use other observation units.”
(The reference in the header relating to the annex (“Annex I – Part VII – point 57 – paragraph 4 – point 8 – point i“) corresponds to “Annex I – Part VII – point 57 – paragraph 4 – point 9 – point i“of the Commission’s proposal. This discrepancy is caused by the incorrect numbering (Annex I, Part VII, point 57, paragraph 4, point 8 is missing) in the Commission’s proposal.)
Amendment 111
Proposal for a regulation
Annex I – Part VII – point 57 – paragraph 4 – point 8 – point iii
Regulation (EC) No 1165/98
Annex C – point c – point 4
(iii)  in point (c) 4., the last paragraph is deleted;
(iii)  in point (c)4, the third subparagraph is deleted;
(The reference in the header relating to the annex (“Annex I – Part VII – point 57 – paragraph 4 – point 8 – point iii“) corresponds to “Annex I – Part VII – point 57 – paragraph 4 – point 9 – point iii“of the Commission’s proposal. This discrepancy is caused by the incorrect numbering (Annex I, Part VII, point 57, paragraph 4, point 8 is missing) in the Commission’s proposal.)
Amendment 112
Proposal for a regulation
Annex I – Part VII – point 57 – paragraph 4 – point 8 – point iv
Regulation (EC) No 1165/98
Annex C – point d – point 2
“2. The turnover variable (No 120) and the volume of sales variable (No 123) are also to be transmitted in a working-day adjusted form. Wherever other variables show working-day effects, Member States may also transmit those variables in working-day adjusted form. The Commission is empowered to adopt delegated acts in accordance with Article 18a concerning the amendment of the list of variables to be transmitted in working-day adjusted form.”
“2. The turnover variable (No 120) and the volume of sales variable (No 123) are also to be transmitted in a working-day adjusted form. Wherever other variables show working-day effects, Member States may also transmit those variables in working-day adjusted form. The Commission is empowered to adopt delegated acts in accordance with Article 18a amending the list of variables to be transmitted in working-day adjusted form.”
(The reference in the header relating to the annex (“Annex I – Part VII – point 57 – paragraph 4 – point 8 – point iv“) corresponds to “Annex I – Part VII – point 57 – paragraph 4 – point 9 – point iv“of the Commission’s proposal. This discrepancy is caused by the incorrect numbering (Annex I, Part VII, point 57, paragraph 4, point 8 is missing) in the Commission’s proposal.)
Amendment 113
Proposal for a regulation
Annex I – Part VII – point 57 – paragraph 4 – point 8 – point v
Regulation (EC) No 1165/98
Annex C – point g – point 2
“2. The variables shall be transmitted for turnover (No 120) and the deflator of sales/volume of sales (No 330/123) within one month for the level of detail specified in paragraph 3 under heading (f) of this Annex. Member States may choose to participate for the turnover and deflator of sales/ volume of sales variables No 120 and 330/123 with contributions according to the allocation of a European sample scheme as defined in point (d) of the first subparagraph of Article 4(2). The Commission is empowered to adopt delegated acts in accordance with Article 18a concerning the terms of the allocation of a European sample scheme.”
“2. The variables shall be transmitted for turnover (No 120) and the deflator of sales/volume of sales (No 330/123) within one month for the level of detail specified in paragraph 3 under heading (f) of this Annex. Member States may choose to participate for the turnover and deflator of sales/ volume of sales variables No 120 and 330/123 with contributions according to the allocation of a European sample scheme as defined in point (d) of the first subparagraph of Article 4(2). The Commission is empowered to adopt delegated acts in accordance with Article 18a to supplement this Regulation by determining the terms of the allocation of a European sample scheme.”
(The reference in the header relating to the annex (“Annex I – Part VII – point 57 – paragraph 4 – point 8 – point v“) corresponds to “Annex I – Part VII – point 57 – paragraph 4 – point 9 – point v“of the Commission’s proposal. This discrepancy is caused by the incorrect numbering (Annex I, Part VII, point 57, paragraph 4, point 8 is missing) in the Commission’s proposal.)
Amendment 114
Proposal for a regulation
Annex I – Part VII – point 57 – paragraph 4 – point 9 – point i
Regulation (EC) No 1165/98
Annex D – point b – point 2
“2. The Commission is empowered to adopt delegated acts in accordance with Article 18a concerning the use of other observation units.”
“2. The Commission is empowered to adopt delegated acts in accordance with Article 18a to supplement this Regulation by providing for the possibility to use other observation units.”
(The reference in the header relating to the annex (“Annex I – Part VII – point 57 – paragraph 4 – point 9 – point i“) corresponds to “Annex I – Part VII – point 57 – paragraph 4 – point 10 – point i“of the Commission’s proposal. This discrepancy is caused by the incorrect numbering (Annex I, Part VII, point 57, paragraph 4, point 8 is missing) in the Commission’s proposal.)
Amendment 115
Proposal for a regulation
Annex I – Part VII – point 57 – paragraph 4 – point 9 – point iv
Regulation (EC) No 1165/98
Annex D – point d – point 2
“2. The turnover variable (No 120) is also to be transmitted in working-day adjusted form. Wherever other variables show working-day effects, Member States may also transmit those variables in working-day adjusted form. The Commission is empowered to adopt delegated acts in accordance with Article 18a concerning the amendment of the list of variables to be transmitted in working-day adjusted form may be amended by the Commission.
“2. The turnover variable (No 120) is also to be transmitted in working-day adjusted form. Wherever other variables show working-day effects, Member States may also transmit those variables in working-day adjusted form. The Commission is empowered to adopt delegated acts in accordance with Article 18a amending the list of variables to be transmitted in working-day adjusted form”;
(The reference in the header relating to the annex (“Annex I – Part VII – point 57 – paragraph 4 – point 9 – point iv“) corresponds to “Annex I – Part VII – point 57 – paragraph 4 – point 10 – point iv“of the Commission’s proposal. This discrepancy is caused by the incorrect numbering (Annex I, Part VII, point 57, paragraph 4, point 8 is missing) in the Commission’s proposal.)
Amendment 116
Proposal for a regulation
Annex I – Part VII – point 58 – paragraph 1
In order to adapt Regulation (EC) No 530/1999 with a view to taking account of economic and technical changes, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission to supplement that Regulation with the definition and breakdown of the information to be provided and the quality evaluation criteria. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement on Better Law-Making of 13 April 2016. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.
In order to adapt Regulation (EC) No 530/1999 with a view to taking account of economic and technical changes, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission to supplement that Regulation with the definition and breakdown of the information to be provided and the criteria for quality evaluation of the statistics. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.
Amendment 117
Proposal for a regulation
Annex I – Part VII – point 58 – paragraph 3 – point 1
Regulation (EC) No 530/1999
Article 6 – paragraph 3
“3. The Commission is empowered to adopt delegated acts in accordance with Article 10a concerning the definition and breakdown of the information to be provided under paragraphs 1 and 2 of this Article. These delegated acts shall be adopted for each reference period at least nine months before the beginning of the reference period.”
“3. The Commission is empowered to adopt delegated acts in accordance with Article 10a to supplement this Regulation by specifying the definition and breakdown of the information to be provided under paragraphs 1 and 2 of this Article. These delegated acts shall be adopted for each reference period at least nine months before the beginning of the reference period.”
Amendment 118
Proposal for a regulation
Annex I – Part VII – point 58 – paragraph 3 – point 3
Regulation (EC) No 530/1999
Article 10 – paragraph 3
“3. The Commission is empowered to adopt delegated acts in accordance with Article 10a concerning the quality evaluation criteria. Those delegated acts shall be adopted for each reference period at least nine months before the beginning of the reference period.”
“3. The Commission is empowered to adopt delegated acts in accordance with Article 10a to supplement this Regulation by specifying the criteria for quality evaluation of the statistics. Those delegated acts shall be adopted for each reference period at least nine months before the beginning of the reference period.”
Amendment 119
Proposal for a regulation
Annex I – Part VII – point 58 – paragraph 3 – point 4
Regulation (EC) No 530/1999
Article 10a – paragraph 2
2.  The power to adopt delegated acts referred to in Article 6(3) and Article 10(3) shall be conferred on the Commission for an indeterminate period of time from [date of entry into force of this Omnibus].
2.  The power to adopt delegated acts referred to in Article 6(3) and Article 10(3) shall be conferred on the Commission for a period of five years from ... [date of entry into force of this amending Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Amendment 120
Proposal for a regulation
Annex I – Part VII – point 58 – paragraph 3 – point 4
Regulation (EC) No 530/1999
Article 10a – paragraph 6
6.  A delegated act adopted pursuant to Article 6(3) and Article 10(3) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
6.  A delegated act adopted pursuant to Article 6(3) and Article 10(3) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of three months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by three months at the initiative of the European Parliament or of the Council.
Amendment 121
Proposal for a regulation
Annex I – Part VII – point 59 – paragraph 4
In order to ensure uniform conditions for the implementation of Regulation (EC) No 2150/2002 concerning the production of results, the appropriate format for the transmission of results and the contents of the quality reports implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011.
In order to ensure uniform conditions for the implementation of Regulation (EC) No 2150/2002 concerning the production of results, the appropriate format for the transmission of results and the structure and detailed arrangements of the quality reports implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011.
Amendment 122
Proposal for a regulation
Annex I – Part VII – point 59 – paragraph 5 – point 1
Regulation (EC) No 2150/2002
Article 1 – paragraph 5
“5. The Commission is empowered to adopt delegated acts in accordance with Article 5b concerning the establishment of a table of equivalence between the statistical nomenclature of Annex III to this Regulation and the list of waste established by Commission Decision 2000/532/EC.*
“5. The Commission is empowered to adopt delegated acts in accordance with Article 5b to supplement this Regulation by establishing a table of equivalence between the statistical nomenclature of Annex III to this Regulation and the list of waste established by Commission Decision 2000/532/EC.*
____________________
____________________
* Commission Decision of 3 May 2000 replacing Decision 94/3/EC establishing a list of wastes pursuant to Article 1(a) of Council Directive 75/442/EEC on waste and Council Decision 94/904/EC establishing a list of hazardous waste pursuant to Article 1(4) of Council Directive 91/689/EEC on hazardous waste (OJ L 226, 6.9.2000, p. 3).”
* Commission Decision of 3 May 2000 replacing Decision 94/3/EC establishing a list of wastes pursuant to Article 1(a) of Council Directive 75/442/EEC on waste and Council Decision 94/904/EC establishing a list of hazardous waste pursuant to Article 1(4) of Council Directive 91/689/EEC on hazardous waste (OJ L 226, 6.9.2000, p. 3).”
Amendment 123
Proposal for a regulation
Annex I – Part VII – point 59 – paragraph 5 – point 2 – point a
Regulation (EC) No 2150/2002
Article 3 – paragraph 1 – subparagraph 2
“The Commission is empowered to adopt delegated acts in accordance with Article 5b concerning the definition the quality and accuracy conditions.”
“The Commission is empowered to adopt delegated acts in accordance with Article 5b to supplement this Regulation by defining the quality and accuracy conditions.”
Amendment 124
Proposal for a regulation
Annex I – Part VII – point 59 – paragraph 5 – point 4
Regulation (EC) No 2150/2002
Article 5a – paragraph 1
The Commission is empowered to adopt delegated acts in accordance with Article 5b concerning the adjustment to economic and technical developments in the collection and statistical processing of data, as well as the processing and the transmission of results and the adaptation of the specifications listed in the Annexes.
The Commission is empowered to adopt delegated acts in accordance with Article 5b to amend this Regulation by adjusting it to economic and technical developments in the collection and statistical processing of data, as well as the processing and the transmission of results and by adapting the specifications listed in the Annexes.
Amendment 125
Proposal for a regulation
Annex I – Part VII – point 59 – paragraph 5 – point 4
Regulation (EC) No 2150/2002
Article 5b – paragraph 2
2.  The power to adopt delegated acts referred to in Article 1(5), Article 3(1) and (4) and Article 5a, shall be conferred on the Commission for an indeterminate period of time from [[date of entry into force of this Omnibus].
2.  The power to adopt delegated acts referred to in Article 1(5), Article 3(1) and (4), and Article 5a, shall be conferred on the Commission for a period of five years from ... [date of entry into force of this amending Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Amendment 126
Proposal for a regulation
Annex I – Part VII – point 59 – paragraph 5 – point 5
Regulation (EC) No 2150/2002
Article 6 – paragraph 1 – point c
(c)  the contents of the quality reports as referred to in Section 7 of Annex I and Section 7 of Annex II.
(c)  the structure and detailed arrangements of the quality reports as referred to in Section 7 of Annex I and Section 7 of Annex II.
Amendment 127
Proposal for a regulation
Annex I – Part VII – point 60 – paragraph 3 – point 2
Regulation (EC) No 437/2003
Article 5 – paragraph 2
The Commission is empowered to adopt delegated acts in accordance with Article 10a concerning the establishment of other standards of accuracy.
The Commission is empowered to adopt delegated acts in accordance with Article 10a to supplement this Regulation by establishing other standards of accuracy.
Amendment 128
Proposal for a regulation
Annex I – Part VII – point 60 – paragraph 3 – point 5
Regulation (EC) No 437/2003
Article 10a – paragraph 2
2.  The power to adopt delegated acts referred to in Article 3(1) and Article 5 shall be conferred on the Commission for an indeterminate period of time from [date of entry into force of this Omnibus].
2.  The power to adopt delegated acts referred to in Article 3(1) and Article 5 shall be conferred on the Commission for a period of five years from ... [date of entry into force of this amending Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Amendment 129
Proposal for a regulation
Annex I – Part VII – point 61 – paragraph 1 – indent 3 a (new)
—  supplement that Regulation by adopting measures regarding the provision of the data pursuant to the results of the feasibility studies.
Amendment 130
Proposal for a regulation
Annex I – Part VII – point 61 – paragraph 3
In order to ensure uniform conditions for the implementation of Regulation (EC) No 450/2003 concerning the content of the quality report, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011.
In order to ensure uniform conditions for the implementation of Regulation (EC) No 450/2003 concerning the structure and detailed arrangements for the quality report, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011.
Amendment 131
Proposal for a regulation
Annex I – Part VII – point 61 – paragraph 4 – point 1
Regulation (EC) No 450/2003
Article 2 – paragraph 4
“4. The Commission is empowered to adopt delegated acts in accordance with Article 11a concerning amendments to redefine the technical specification of the index and revise the weighting structure.”
“4. The Commission is empowered to adopt delegated acts in accordance with Article 11a amending the Annex to redefine the technical specification of the index and revise the weighting structure.”
Amendment 132
Proposal for a regulation
Annex I – Part VII – point 61 – paragraph 4 – point 2
Regulation (EC) No 450/2003
Article 3 – paragraph 2
“2. The Commission is empowered to adopt delegated acts in accordance with Article 11a concerning the amendments for the inclusion of economic activities defined by NACE Rev.2 sections O to S in the scope of this Regulation, taking into account the feasibility studies defined in Article 10.”
“2. The Commission is empowered to adopt delegated acts in accordance with Article 11a amending this Regulation as regards the inclusion of economic activities defined by NACE Rev.2 sections O to S in the scope of this Regulation, taking into account the feasibility studies provided for in Article 10.”
Amendment 133
Proposal for a regulation
Annex I – Part VII – point 61 – paragraph 4 – point 3
Regulation (EC) No 450/2003
Article 4 – paragraph 1 – subparagraph 1
Taking account of contributions to total employment and to labour costs at Union and national levels, the Commission is empowered to adopt delegated acts in accordance with Article 11a concerning the identification of the economic activities defined by NACE Rev. 2 sections and by further disaggregations, not beyond the level of NACE Rev. 2 divisions (2-digit level) or groupings of divisions in which the data shall be broken down taking account of economic and social developments.
Taking account of contributions to total employment and to labour costs at Union and national levels, the Commission is empowered to adopt delegated acts in accordance with Article 11a to supplement this Regulation as regards the breakdown by economic activities defined by NACE Rev. 2 sections and by further disaggregations, not beyond the level of NACE Rev. 2 divisions (2-digit level) or groupings of divisions in which the data shall be broken down taking account of economic and social developments.
Amendment 134
Proposal for a regulation
Annex I – Part VII – point 61 – paragraph 4 – point 3
Regulation (EC) No 450/2003
Article 4 – paragraph 2 – subparagraph 2
The Commission is empowered to adopt delegated acts in accordance with Article 11a concerning the determination of these economic activities, taking into account the feasibility studies defined in Article 10.
The Commission is empowered to adopt delegated acts in accordance with Article 11a to supplement this Regulation by determining these economic activities, taking into account the feasibility studies provided for in Article 10.
Amendment 135
Proposal for a regulation
Annex I – Part VII – point 61 – paragraph 4 – point 3
Regulation (EC) No 450/2003
Article 4 – paragraph 3
“3. The Commission is empowered to adopt delegated acts in accordance with Article 11a concerning the establishment of the methodology for chaining the index.”
“3. The Commission is empowered to adopt delegated acts in accordance with Article 11a to supplement this Regulation by establishing the methodology for chaining the index.”
Amendment 136
Proposal for a regulation
Annex I – Part VII – point 61 – paragraph 4 – point 4
Regulation (EC) No 450/2003
Article 8 – paragraph 1
“1. The Commission is empowered to adopt delegated acts in accordance with Article 11a concerning the definition of separate quality criteria. The current data and back data transmitted shall satisfy these quality criteria.”
“1. The Commission is empowered to adopt delegated acts in accordance with Article 11a to supplement this Regulation by defining separate quality criteria. The current data and back data transmitted shall satisfy these quality criteria.”
Amendment 137
Proposal for a regulation
Annex I – Part VII – point 61 – paragraph 4 – point 4
Regulation (EC) No 450/2003
Article 8 – paragraph 2
“2. The Member States shall provide annual quality reports to the Commission, beginning in 2003. The content of the reports shall be defined by the Commission by means of implementing act. Those implementing acts shall be adopted in accordance with the procedure referred to in Article 12(2).”
“2. The Member States shall provide annual quality reports to the Commission, beginning in 2003. The structure and detailed arrangements for the reports shall be defined by the Commission by means of implementing acts. Those implementing acts shall be adopted in accordance with the procedure referred to in Article 12(2).”
Amendment 138
Proposal for a regulation
Annex I – Part VII – point 61 – paragraph 4 – point 4 a (new)
Regulation (EC) No 450/2003
Article 9
(4a)  Article 9 is deleted.
Amendment 139
Proposal for a regulation
Annex I – Part VII – point 61 – paragraph 4 – point 5 – point a
Regulation (EC) No 450/2003
Article 10 – paragraph 5
“5. The Commission shall adopt measures pursuant to the results of the feasibility studies by means of implementing act. Those implementing acts shall be adopted in accordance with the procedure referred to in Article 12(2). Those measures shall respect the principle of cost-effectiveness, as defined in Article 2 of Regulation (EC) No 223/2009, including the minimisation of the burden on respondents.”
“5. The Commission is empowered to adopt delegated acts in accordance with Article 11a to supplement this Regulation concerning the provision of the data referred to in paragraph 2 of this Article pursuant to the results of the feasibility studies referred to in this Article. Those delegated acts shall respect the principle of cost-effectiveness, as defined in Article 2 of Regulation (EC) No 223/2009, including the minimisation of the burden on respondents.”
Amendment 140
Proposal for a regulation
Annex I – Part VII – point 61 – paragraph 4 – point 7
Regulation (EC) No 450/2003
Article 11a – paragraph 2
2.  The power to adopt delegated acts referred to in Article 2(4), Article 3(2) and Article 4 shall be conferred on the Commission for an indeterminate period of time from [date of entry into force of this omnibus].
2.  The power to adopt delegated acts referred to in Article 2(4), Article 3(2), Article 4(1), (2) and (3), Article 8(1) and Article 10(5) shall be conferred on the Commission for a period of five years from ... [date of entry into force of this amending Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Amendment 141
Proposal for a regulation
Annex I – Part VII – point 61 – paragraph 4 – point 7
Regulation (EC) No 450/2003
Article 11a – paragraph 3
3.  The delegation of power referred to in Article 2(4), Article 3(2) and Article 4 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
3.  The delegation of power referred to in Article 2(4), Article 3(2), Article 4(1), (2) and (3), Article 8(1) and Article 10(5) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
Amendment 142
Proposal for a regulation
Annex I – Part VII – point 61 – paragraph 4 – point 7
Regulation (EC) No 450/2003
Article 11a – paragraph 6
6.  A delegated act adopted pursuant to Article 2(4), Article 3(2) and Article 4 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
6.  A delegated act adopted pursuant to Article 2(4), Article 3(2), Article 4(1), (2) and (3), Article 8(1) and Article 10(5) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of three months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by three months at the initiative of the European Parliament or of the Council.
Amendment 143
Proposal for a regulation
Annex I – Part VI – point 62 – paragraph 3 – point 2
Regulation (EC) No 808/2004
Article 8a – paragraph 2
2.  The power to adopt delegated acts referred to in Article 8(1) shall be conferred on the Commission for an indeterminate period of time from [date of entry into force of this Omnibus].
2.  The power to adopt delegated acts referred to in Article 8(1) shall be conferred on the Commission for a period of five years from ... [date of entry into force of this amending Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Amendment 144
Proposal for a regulation
Annex I – Part VII – point 63 – paragraph 1 – indent 2
—  amend that Regulation to adapt the proportion of the Union total;
—  amend that Regulation to adjust the proportion of the Union total;
Amendment 145
Proposal for a regulation
Annex I – Part VII – point 63 – paragraph 3 – point 1 – point a
Regulation (EC) No 1161/2005
Article 2 – paragraph 2
“2. The Commission is empowered to adopt delegated acts in accordance with Article 7a concerning the timetable for the transmission of items P.1, P.2, D.42, D.43, D.44, D.45, and B.4G, and any decision to require a breakdown of the transactions listed in the Annex by counterPart sector. Any such decision shall only be adopted after the Commission has reported to the European Parliament and the Council on the implementation of this Regulation pursuant to Article 9.”
“2. The Commission is empowered to adopt delegated acts in accordance with Article 7a to supplement this Regulation by specifying the timetable for the transmission of items P.1, P.2, D.42, D.43, D.44, D.45, and B.4G, and by requiring a breakdown of the transactions listed in the Annex by counterpart sector. Any such delegated act shall only be adopted after the Commission has reported to the European Parliament and the Council on the implementation of this Regulation pursuant to Article 9.”
Amendment 146
Proposal for a regulation
Annex I – Part VII – point 63 – paragraph 3 – point 1 – point b a (new)
Regulation (EC) No 1161/2005
Article 2 – paragraph 5
(ba)  paragraph 5 is deleted;
Amendment 147
Proposal for a regulation
Annex I – Part VII – point 63 – paragraph 3 – point 2
Regulation (EC) No 1161/2005
Article 3 – paragraph 3
“3. The Commission is empowered to adopt delegated acts in accordance with Article 7a amending paragraph 1 of this Article as regards the proportion of the Union total."
“3. The Commission is empowered to adopt delegated acts in accordance with Article 7a amending paragraph 1 of this Article to adjust the proportion (1%) of the Union total."
Amendment 148
Proposal for a regulation
Annex I – Part VII – point 63 – paragraph 3 – point 3
Regulation (EC) No 1161/2005
Article 6 – paragraph 1 – subparagraph 1
“The Commission is empowered to adopt delegated acts in accordance with Article 7a concerning the adoption of common quality standards.”
“The Commission is empowered to adopt delegated acts in accordance with Article 7a to supplement this Regulation by establishing common quality standars.”
Amendment 149
Proposal for a regulation
Annex I – Part VII – point 63 – paragraph 3 – point 4
Regulation (EC) No 1161/2005
Article 7a – paragraph 2
2.  The power to adopt delegated acts referred to in Article 2(2) and (4), Article 3(3) and Article 6(1) shall be conferred on the Commission for an indeterminate period of time from [date of entry into force of this Omnibus].
2.  The power to adopt delegated acts referred to in Article 2(2) and (4), Article 3(3) and Article 6(1) shall be conferred on the Commission for a period of five years from ... [date of entry into force of this amending Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Amendment 150
Proposal for a regulation
Annex I – Part VII – point 63 – paragraph 3 – point 4
Regulation (EC) No 1161/2005
Article 7a – paragraph 6
6.  A delegated act adopted pursuant to Article 2(2) and (4), Article 3(3) and Article 6(1) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
6.  A delegated act adopted pursuant to Article 2(2) and (4), Article 3(3) and Article 6(1) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of three months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by three months at the initiative of the European Parliament or of the Council.
Amendment 151
Proposal for a regulation
Annex I – Part VII – point 64 – paragraph 4 – point 1
Regulation (EC) No 1552/2005
Article 5 – paragraph 2 – subparagraph 2
In addition, the Commission is empowered to adopt delegated acts in accordance with Article 13a concerning the extension of that definition, if such extension would substantially enhance the representativeness and the quality of the result of the survey in the Member States concerned.;
In addition, the Commission is empowered to adopt delegated acts in accordance with Article 13a to supplement this Regulation by adopting the extension of that definition, if such extension would substantially enhance the representativeness and the quality of the result of the survey in the Member States concerned.
Amendment 152
Proposal for a regulation
Annex I – Part VII – point 64 – paragraph 4 – point 2
Regulation (EC) No 1552/2005
Article 7 – paragraph 3
“3. The Commission is empowered to adopt delegated acts in accordance with Article 13a determining the sampling and precision requirements, the sample sizes needed to meet those requirements, and the detailed specifications of the NACE Rev. 2 and size categories into which the results can be broken down.”
“3. The Commission is empowered to adopt delegated acts in accordance with Article 13a to supplement this Regulation by determining the sampling and precision requirements, the sample sizes needed to meet those requirements, and the detailed specifications of the NACE Rev. 2 and size categories into which the results can be broken down.”
Amendment 153
Proposal for a regulation
Annex I – Part VII – point 64 – paragraph 4 – point 3
Regulation (EC) No 1552/2005
Article 8 – paragraph 2
“2.  The Commission is empowered to adopt delegated acts in accordance with Article 13a concerning the specific data to be collected with respect to training and non-training enterprises and to the different forms of vocational training.”
“2.  The Commission is empowered to adopt delegated acts in accordance with Article 13a to supplement this Regulation by establishing the specific data to be collected with respect to training and non-training enterprises and to the different forms of vocational training.”
Amendment 154
Proposal for a regulation
Annex I – Part VII – point 64 – paragraph 4 – point 4 – point a
Regulation (EC) No 1552/2005
Article 9 – paragraph 4
“4. The Commission is empowered to adopt delegated acts in accordance with Article 13a concerning the quality requirements for the data to be collected and transmitted for European statistics on vocational training in enterprises, and any measures necessary for assessing or improving the quality of the data.”
“4. The Commission is empowered to adopt delegated acts in accordance with Article 13a to supplement this Regulation by establishing the quality requirements for the data to be collected and transmitted for European statistics on vocational training in enterprises, and by adopting any measures necessary for assessing or improving the quality of the data.”
Amendment 155
Proposal for a regulation
Annex I – Part VII – point 64 – paragraph 4 – point 4 – point b
Regulation (EC) No 1552/2005
Article 9 – paragraph 5
“5. The Commission shall determine the structure of the quality reports referred to in paragraph 2 by means of implementing act. Those implementing acts shall be adopted in accordance with the procedure referred to in Article 14(2).”
“5. When drawing up the quality reports referred to in paragraph 2, Member States shall comply with the quality requirements and any other measure established pursuant to paragraph 4. In order to assess the quality of the data transmitted, they shall use the format determined by the Commission by means of implementing acts. Those implementing acts shall be adopted in accordance with the procedure referred to in Article 14(2).”
Amendment 156
Proposal for a regulation
Annex I – Part VII – point 64 – paragraph 4 – point 5
Regulation (EC) No 1552/2005
Article 10 – paragraph 2
“2. The Commission is empowered to adopt delegated acts in accordance with Article 13a concerning the determination of the first reference year for which the data are to be collected.”
“2. The Commission is empowered to adopt delegated acts in accordance with Article 13a to supplement this Regulation by determining the first reference year for which the data are to be collected.”
Amendment 157
Proposal for a regulation
Annex I – Part VII – point 64 – paragraph 4 – point 7
Regulation (EC) No 1552/2005
Article 13a – paragraph 2
2.  The power to adopt delegated acts referred to in Article 5(2), Article 7(3), Article 8(2), Article 9(4), Article 10(2) and Article 13 shall be conferred on the Commission for an indeterminate period of time from [date of entry into force of this Omnibus].
2.  The power to adopt delegated acts referred to in Article 5(2), Article 7(3), Article 8(2), Article 9(4), Article 10(2) and Article 13 shall be conferred on the Commission for a period of five years from ... [date of entry into force of this amending Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Amendment 158
Proposal for a regulation
Annex I – Part VII – point 66 – paragraph 2 – point 2
Regulation (EC) No 458/2007
Article 7 – paragraph 3 – subparagraph 1
The Commission is empowered to adopt delegated acts in accordance with Article 7a establishing the first year for which full data shall be collected, and adopting measures relating to the detailed classification of data covered and the definitions to be used.
The Commission is empowered to adopt delegated acts in accordance with Article 7a to supplement this Regulation by establishing the first year for which full data shall be collected, and by adopting measures relating to the detailed classification of data covered and the definitions to be used.
Amendment 159
Proposal for a regulation
Annex I – Part VII – point 66 – paragraph 2 – point 3
Regulation (EC) No 458/2007
Article 7a – paragraph 2
2.  The power to adopt delegated acts referred to in Article 7(3) and Annex I, point 1.1.2.4. shall be conferred on the Commission for an indeterminate period of time from [date of entry into force of this Omnibus].
2.  The power to adopt delegated acts referred to in Article 7(3) and Annex I, point 1.1.2.4. shall be conferred on the Commission for a period of five years from ... [date of entry into force of this amending Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Amendment 160
Proposal for a regulation
Annex I – Part VII – point 67 – paragraph 1
In order to adapt Regulation (EC) No 716/2007 to economic and technical developments the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission to amend the definitions in Annexes I and II and the level of detail in Annex III and to supplement that Regulation with measures concerning inward and outward statistics on foreign affiliates.
In order to adapt Regulation (EC) No 716/2007 to economic and technical developments the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission to amend the definitions in Annexes I and II and the level of detail in Annex III and to supplement that Regulation with measures concerning inward and outward statistics on foreign affiliates and common quality standards.
Amendment 161
Proposal for a regulation
Annex I – Part VII – point 67 – paragraph 4 – point 2
Regulation (EC) No 716/2007
Article 5 – paragraph 4 – subparagraph 1
The Commission is empowered to adopt delegated acts in accordance with Article 9a concerning the necessary measures for inward and outward statistics on foreign affiliates, on the basis of the conclusions of the pilot studies.
The Commission is empowered to adopt delegated acts in accordance with Article 9a to supplement this Regulation by determining the necessary measures for inward and outward statistics on foreign affiliates, on the basis of the conclusions of the pilot studies.
Amendment 162
Proposal for a regulation
Annex I – Part VII – point 67 – paragraph 4 – point 3
Regulation (EC) No 716/2007
Article 6 – paragraph 3
“3. The Commission is empowered to adopt delegated acts in accordance with Article 9a concerning common quality standards.”
“3. The Commission is empowered to adopt delegated acts in accordance with Article 9a to supplement this Regulation by establishing the common quality standards