REPORT 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]

29.11.2018 - (COM(2018)0179 – C8-0144/2018 – 2018/0088(COD)) - ***I

Committee on the Environment, Public Health and Food Safety
Rapporteur: Renate Sommer

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

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))

(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 Rule 59 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;

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.

Amendment    1 Proposal for a regulation Citation 1
Draft legislative resolution	Amendment
Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 43, 114, and 168(4)(b) thereof,	Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 43, 114, 168(4)(b) and 192(1),
Justification
The authorisation to cultivate or to put into circulation genetically modified organisms, plants or animals as well as the authorisation of active substances of pesticides has considerable impacts on the natural environment and on human health; the protection of human health forms part of the EU environmental policy.
Amendment    2 Proposal for a regulation Recital 2 a (new)
Text proposed by the Commission	Amendment
	(2a)  Risk management, assessment and communication activities should be based on a thorough application of, inter alia, the precautionary principle.
Amendment    3 Proposal for a regulation Recital 4
Text proposed by the Commission	Amendment
(4)  It is therefore necessary to ensure a comprehensive and continuous risk communication process throughout risk analysis, involving Union and national risk assessors and risk managers. That process should be combined with an open dialogue between all interested parties to ensure the coherence and consistency within the risk analysis process.	(4)  It is therefore necessary to ensure a transparent, independent, continuous and inclusive risk communication process throughout risk analysis, involving Union and national risk assessors and risk managers. That process should regain citizens' trust that the whole process is underpinned by the objective of this Regulation, which is to ensure high level of human life and health and the protection of consumers' interests. That process should also be capable of contributing to a participatory and open dialogue between all interested parties particularly the public, to ensure prevalence of public interest only, accuracy, comprehensiveness, transparency, consistency, and accountability within the risk analysis process.
Justification
In order to win public's trust, any communication and marketing of the process, should have a real content which will concretely demonstrate and prove that the things have improved. Otherwise any change is doomed to failure.
Amendment    4 Proposal for a regulation Recital 4 a (new)
Text proposed by the Commission	Amendment
	(4a) On signing trade agreements, the Union needs to ensure that the food legislation of third-country partners is at least as protective of food safety as Union law, so as to guarantee consumer safety and prevent unfair competition with European products.
Amendment    5 Proposal for a regulation Recital 5
Text proposed by the Commission	Amendment
(5)  Particular emphasis should be placed on explaining in a coherent, appropriate and timely manner not only risk assessment findings themselves but also how these are utilized to help inform risk management decisions along with other legitimate factors, where relevant.	(5)  Particular emphasis should be placed on explaining in an accurate, clear, objective and timely manner not only risk assessment findings themselves but also how these are utilized to help inform risk management decisions along with other legitimate factors, where relevant.
Amendment    6 Proposal for a regulation Recital 5 a (new)
Text proposed by the Commission	Amendment
	(5a)  There is no definition of 'other legitimate factors' in the General Food Law in relation to its objective. This principle should always be applied on a case-by-case basis, but as there are no general guidelines on the application and interpretation of the principle, there is a lack of consistency in its application. The Commission should therefore draft general guidelines on the application of this principle.
Amendment    7 Proposal for a regulation Recital 6
Text proposed by the Commission	Amendment
(6)  To this effect, it is necessary to establish general objectives and principles of risk communication, taking into account the respective roles of risk assessors and managers.	(6)  To this effect, it is necessary to establish general objectives and principles of risk communication. In this connection, the respective roles of risk assessors and managers should be taken into account, while guaranteeing their independence.
Amendment    8 Proposal for a regulation Recital 8
Text proposed by the Commission	Amendment
(8)  The general plan should identify the key factors to be taken into account when risk communications’ activities are considered, such as the different levels of risk, the nature of the risk and its potential public health impact, who and what are directly or indirectly affected by the risk, the levels of risk exposure, the ability to control risk and other factors that influence risk perception including the level of urgency as well as the applicable legislative framework and relevant market context. The general plan should also identify the tools and channels to be used and should establish appropriate mechanisms to ensure coherent risk communication.	(8)  The general plan should lay down the practical arrangements for making available to the public the necessary information to achieve a high level of transparency in the risk management process. It should identify the key factors to be taken into account when risk communications’ activities are considered, such as the different levels of risk, the nature of the risk and its potential impact on public health, animal health and the environment, who and what are directly or indirectly affected by the risk, the levels of risk exposure, the ability to minimise or control risk and other factors that influence risk perception including the level of urgency as well as the applicable legislative framework and relevant market context. The general plan should also identify the tools and channels to be used and should establish appropriate mechanisms to ensure coherent risk communication.
Amendment    9 Proposal for a regulation Recital 9
Text proposed by the Commission	Amendment
(9)  Transparency of the risk assessment process contributes to the Authority acquiring greater legitimacy in the eyes of the consumers and general public in pursuing 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 maintain the confidence of the general public and other interested parties in the risk analysis process underpinning Union food law and in particular in the risk assessment, including the organisation and independence of the Authority and transparency.	(9)  Improving transparency of the risk assessment process would contribute to the Authority acquiring greater legitimacy in the eyes of the consumers and general public in pursuing its mission, increase their confidence in its work and ensure that the Authority is more accountable to the Union citizens in a democratic system. It is therefore essential to rebuild the confidence of the general public and other interested parties in the risk analysis process underpinning Union food law and in particular in the risk assessment, including the organisation, functioning and independence of the Authority and transparency.
Amendment    10 Proposal for a regulation Recital 10
Text proposed by the Commission	Amendment
(10)  It is appropriate to align the composition of the Management Board of the Authority to the Common Approach on decentralised agencies, in accordance with the Joint Statement of the European Parliament, the Council of the European Union and the European Commission on decentralised agencies of 201222 .	deleted
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22  https://europa.eu/european-union/sites/europaeu/files/docs/body/joint_statement_and_common_approach_2012_en.pdf.
Amendment    11 Proposal for a regulation Recital 11
Text proposed by the Commission	Amendment
(11)  Experience shows that the role of the Management Board of the Authority is focussed 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 in the Management Board of the Authority, while providing that those representatives should have experience in particular on risk assessment.	(11)  Experience shows that the role of the Management Board of the Authority is focussed 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, the Commission, the European Parliament, as well as civil society and industry associations in the Management Board of the Authority, while providing that those representatives should have experience in particular on risk assessment and that any conflict of interest is avoided.
Amendment    12 Proposal for a regulation Recital 12
Text proposed by the Commission	Amendment
(12)  The Management Board should be selected in such a way as to secure the highest standards of competence and a broad range of relevant experience available amongst the representatives of the Member States, the European Parliament and the Commission.	(12)  The Management Board should be selected in such a way as to secure the highest standards of competence and commitment to the protection of health and the environment and a broad range of relevant experience available amongst the representatives of the Member States, the European Parliament and the Commission.
Amendment    13 Proposal for a regulation Recital 13
Text proposed by the Commission	Amendment
(13)  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 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.	(13)  The Fitness Check of the General Food Law identified certain shortcomings in the long-term capacity of the Authority to maintain its high-level expertise through expert personnel. Moreover, there has been a decrease in the number of candidates applying to be members of the Scientific Panels, and the reason for this decline should be examined. Six Member States provide two thirds of the experts on the scientific panels. As the United Kingdom currently provides approximately 20% of the national experts, the problem will be further exacerbated with the withdrawal of the United Kingdom from the Union. In order to tackle this phenomenon more effectively, the system has thus to be strengthened and promoted, must encourage candidates to apply and Member States should support the dissemination of the Authority’s calls for expressions of interest for membership of the Scientific Panels and Scientific Committee, to ensure that a sufficient pool of independent experts is available, by undertaking support actions and using incentives and rewards to increase the level of participation and the degree of interest in seeking to engage in it.
Justification
Explanation of the causes of the Authority’s human resources problems.
Amendment    14 Proposal for a regulation Recital 14
Text proposed by the Commission	Amendment
(14)  To preserve the independence of the risk assessment from risk management and from other interests at Union level, it is appropriate that the nomination of the members of the Scientific Panels by the Member States, their selection by the Executive Director of the Authority and their appointment by the Management Board of the Authority are based on strict criteria ensuring the excellence and independence of the experts while ensuring the required multidisciplinary expertise for each Panel. It is also essential to this end that the Executive Director whose function is to defend EFSA’s interests and in particular the independence of its expertise has a role in the selection and appointment of those scientific experts. Further measures should also be put in place to ensure that scientific experts have the means to act independently.	(14)  To preserve the independence of the risk assessment from risk management and from other interests at Union level, it is appropriate that the nomination of the members of the Scientific Panels, their selection by the Executive Director of the Authority and their appointment by the Management Board of the Authority are based on strict criteria ensuring the excellence and independence of the experts while ensuring the required multidisciplinary expertise for each Panel. It is also essential to this end that the Executive Director, who is the legal representative of the Authority and whose function is to defend EFSA’s interests and to monitor its performance and in particular the independence of its expertise has a role in the selection and appointment of those scientific experts. Further measures, including proper financial compensation, should also be put in place to ensure that scientific experts have the means to act independently and to dedicate sufficient time to their risk assessment work for the Authority.
Amendment    15 Proposal for a regulation Recital 15
Text proposed by the Commission	Amendment
(15)  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 Authority’s Scientific Panels. In particular, the Authority should organise the preparatory work supporting the Panels’ tasks, 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 the Panels.	(15)  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 Authority’s Scientific Panels. In particular, the Authority should organise the preparatory work supporting the Panels’ tasks, 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 the Panels. This should be without prejudice to the independence of the Authority’s scientific assessments.
Amendment    16 Proposal for a regulation Recital 16
Text proposed by the Commission	Amendment
(16)  Authorisations procedures are based on the principle that it is for the applicant to prove that the subject matter of an authorisation procedure complies with Union safety requirements given the scientific knowledge in its possession. This principle is based on the premise that public health is better protected when the burden of proof is on the applicant since it has to prove that a particular subject matter is safe prior to its placing on the market, instead of the public authorities having to prove that a subject matter is unsafe in order to be able to ban it from the market. Moreover, public money should not be used to commission costly studies that will in the end help the industry to place a product on the market. According to this principle and in accordance with applicable regulatory requirements, in support of applications for an authorisation under Union sectoral food law applicants are required to submit relevant studies, including tests, to demonstrate the safety and in some cases the efficacy of a subject matter.	(16)  Authorisations procedures are based on the principle that it is for the applicant to prove that the subject matter of an authorisation procedure complies with Union safety requirements given the scientific knowledge in its possession. This principle is based on the premise that public health and the environment are better protected when the burden of proof is on the applicant since it has to prove that a particular subject matter is safe prior to its placing on the market, instead of the public authorities having to prove that a subject matter unsafe in order to be able to ban it from the market. Moreover, public money should not be used to commission costly studies that will in the end help the industry to place a product on the market. According to this principle and in accordance with applicable regulatory requirements, in support of applications for an authorisation under Union sectoral food law applicants are required to submit relevant studies, including tests, to demonstrate the safety and in some cases the efficacy of a subject matter.
Amendment    17 Proposal for a regulation Recital 16 a (new)
Text proposed by the Commission	Amendment
	(16a)  A comparison of Union agencies shows that the Authority needs up to 55 months for an authorisation procedure or five times longer than the European Medicines Agency (EMA). This discourages firms from investing in innovative products and reduces Union’s competitiveness in the long run. In addition, long authorisation procedures weaken confidence in the Authority. It is therefore urgently advisable to ensure the efficiency of the risk assessment by means of better human and financial resources.
Amendment    18 Proposal for a regulation Recital 17
Text proposed by the Commission	Amendment
(17)  Provisions exist on the content of applications for authorisations. It is essential that the application for authorisation submitted to the Authority for its risk assessment meets the applicable specifications to ensure the best quality scientific assessment by the Authority. Applicants and in particular small- and medium-sized enterprises do not always have a clear understanding of these specifications. It should be thus appropriate that the Authority provides advice to a potential applicant, upon request, on the applicable rules and the required content of an application for authorisation, before an application is formally submitted, while not entering into the design of the studies to be submitted that remain the applicant’s responsibility. To ensure the transparency of this process, the advice of the Authority should be made public.	(17)  Provisions exist on the content of applications for authorisations. It is essential that the application for authorisation submitted to the Authority for its risk assessment meets the applicable specifications to ensure the best quality scientific assessment by the Authority. Applicants and in particular small- and medium-sized enterprises do not always have a clear understanding of these specifications. It should be thus appropriate that the Authority provides advice to a potential applicant, upon request, on the applicable rules and the required content of an application for authorisation, before an application is formally submitted. By 36 months after the entry into force of this Regulation, the Commission should evaluate the impact of the general advice provided on the functioning of the Authority. In particular, the Commission should evaluate its impact on the allocation of the Authority's resources and on its independence.
Amendment    19 Proposal for a regulation Recital 18
Text proposed by the Commission	Amendment
(18)  The Authority should have knowledge of the subject matter of all studies performed by an applicant with a view to a future application for an authorisation under Union food law. To this end, it is necessary and appropriate that business operators commissioning the studies and laboratories carrying them out notify those studies to the Authority when commissioned. Information about the notified studies should be made public only once a corresponding application for authorisation has been made public in accordance with the applicable rules on transparency.	(18)  The Authority should have knowledge of the subject matter of all studies performed by an applicant with a view to a future application for an authorisation or renewal under Union food law. To this end, it is necessary and appropriate that business operators commissioning the studies and laboratories carrying them out notify those studies to the Authority when commissioned in the Union or beyond. Information about the notified studies should be made public only once a corresponding application for authorisation or renewal has been made public in accordance with the applicable rules on transparency.
Amendment    20 Proposal for a regulation Recital 20
Text proposed by the Commission	Amendment
(20)  There are certain public concerns about the Authority’s assessment in the area of authorisation being primarily based on industry studies. The Authority already makes 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 ensuring that the Authority can have access to all relevant scientific data and studies available on a subject matter of an authorisation procedure, it is appropriate to provide for a 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 when the studies submitted by industry included in an application for authorisation are made public, under the transparency rules of this Regulation.	(20)  There are certain public concerns about the Authority’s assessment in the area of authorisation being primarily based on industry studies. In the case of a new application for an authorisation or a renewal procedure, the Authority should always conduct searches in scientific literature to be able to consider other data and studies existing on the subject matter submitted to its assessment and, where necessary, demand additional studies. The Authority should provide public access to all relevant scientific literature on the matter, which it holds. In order to provide an additional level of guarantee ensuring that the Authority can have access to all relevant scientific data and studies available on a subject matter of an authorisation procedure, it is appropriate to provide for a 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 for authorisation have been made public, under the transparency rules of this Regulation.
Amendment    21 Proposal for a regulation Recital 21
Text proposed by the Commission	Amendment
(21)  Studies, including tests, submitted by business operators in support of applications for authorisations under Union sectoral food law 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 may arise in some cases and this is why national systems are in place to verify such compliance. It is appropriate to provide an additional level of guarantees to reassure the general public on the quality of studies and to lay down an enhanced auditing system whereby Member State controls on the implementation of those principles by the laboratories carrying out such studies and tests would be verified by the Commission.	(21)  Studies, including tests, submitted by business operators in support of applications for authorisations under Union sectoral food law should be based on scientific open literature or comply with internationally recognised standards and Good Laboratory Practice (GLP) 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 may arise in some cases and this is why national systems are in place to verify such compliance. It is appropriate to provide an additional level of guarantees to reassure the general public on the quality of studies and to lay down an enhanced auditing system whereby Member State or third country controls, in collaboration with the Commission’s Directorate for Health and Food Audits and Analysis on the implementation of those principles by the laboratories carrying out such studies and tests in the Union and in third countries would be verified by the Commission.
Amendment    22 Proposal for a regulation Recital 21 a (new)
Text proposed by the Commission	Amendment
	(21a)  Sufficient flexibility ought to be built into the process so that new insights into serious health adverse effects can be promptly taken into consideration, even when they are not specifically covered by regulatory data requirements.
Amendment    23 Proposal for a regulation Recital 22
Text proposed by the Commission	Amendment
(22)  Food safety is a sensitive matter of prime interest for all Union citizens. While maintaining the principle that the burden is on the industry to prove compliance with Union requirements, it is important to establish an additional verification tool to address specific cases of high societal importance where there is a controversy on safety issues, namely the commissioning of additional studies with the objective of verifying evidence used in the context of risk assessment. Considering that it would be financed by the Union budget and that the use of this exceptional verification tool should remain proportionate, the Commission should be responsible for triggering the commissioning of such verification studies. Account should be taken of the fact that in some specific cases the studies commissioned may need to have a wider scope than the evidence at stake (for example new scientific developments becoming available).	(22)  Food safety is a sensitive matter of prime interest for all Union citizens. While maintaining the principle that the burden is on the industry to prove compliance with Union requirements, it is important to establish an additional verification tool to address specific cases of high societal importance where there is a controversy on safety issues, namely the commissioning of additional studies with the objective of verifying evidence used in the context of risk assessment. Considering that it would be financed by the Union budget and that the use of this exceptional verification tool should remain proportionate, the Commission should, in case of divergent scientific findings, be responsible for triggering the commissioning of such verification studies. Account should be taken of the fact that in some specific cases the studies commissioned may need to have a wider scope than the evidence at stake in the risk assessment process (for example new scientific developments becoming available).
Amendment    24 Proposal for a regulation Recital 23 a (new)
Text proposed by the Commission	Amendment
	(23a)  The Aarhus Convention establishes a number of rights of the public with regard to the environment. The Aarhus Convention provides for the right of everyone to receive environmental information that is held by public authorities, the right to participate in environmental decision-making, and the right to review procedures to challenge public decisions that have been made without respecting the two aforementioned rights or environmental law in general.
Amendment    25 Proposal for a regulation Recital 24
Text proposed by the Commission	Amendment
(24)  The European Citizens’ Initiative “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 application23 .	(24)  As a Party to the Aarhus Convention, the Union has recognised that, in the field of the environment, improved access to information and public participation in decision-making enhance the quality and the implementation of decisions, contribute to public awareness of environmental issues, give the public the opportunity to express its concerns and enable public authorities to take due account of such concerns. The European Citizens’ Initiative “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 application23 .
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23 Communication from the Commission on the ECI “Ban glyphosate and protect people and the environment from toxic pesticides”, C(2017) 8414 final.	23 Communication from the Commission on the ECI “Ban glyphosate and protect people and the environment from toxic pesticides”, C(2017) 8414 final.
Amendment    26 Proposal for a regulation Recital 25 a (new)
Text proposed by the Commission	Amendment
	(25a)  Using the Board of Appeal of the European Chemicals Agency as its model, as set out in Articles 89 to 93 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council1a, an EFSA Board of Appeal should be established by means of delegated acts.
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	1a 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).
Amendment    27 Proposal for a regulation Recital 27
Text proposed by the Commission	Amendment
(27)  To determine what level of disclosure strikes the appropriate balance, the relevant rights of the public to transparency in the risk assessment process, should be weighted up against the rights of commercial applicants, taking into account the objectives of Regulation (EC) No 178/2002.	(27)  To determine what level of proactive disclosure strikes the appropriate balance, the need to ensure transparency in the risk assessment process, should be weighted up against the rights of commercial applicants, taking into account the objectives of Regulation (EC) No 178/2002 of a high level of protection of human life and health, the protection of consumers' interests, as well as the protection of animal health and welfare, plant health and the environment.
Justification
Wording of article 5(1) of Reg 178/2002.
Amendment    28 Proposal for a regulation Recital 27 a (new)
Text proposed by the Commission	Amendment
	(27a)  The provisions on active dissemination laid down in this Regulation are not meant to limit, in any manner, the scope of the rights provided for by Regulations (EC) No 1049/2001 and (EC) No 1367/2006.
Amendment    29 Proposal for a regulation Recital 30
Text proposed by the Commission	Amendment
(30)  It is also necessary to set out specific requirements with respect to the protection of personal data for the purposes of the transparency of the risk assessment process taking into account Regulation (EC) No 45/2001 of the European Parliament and of the Council24 and Regulation (EU) 2016/679 of the European Parliament and of the Council25 . 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.	(30)  It is also necessary to refer, for the protection and confidentiality of personal data for the purposes of the transparency of the risk assessment process, to Regulation (EC) No 45/2001 of the European Parliament and of the Council and Regulation (EU) 2016/679 of the European Parliament and of the Council25 . 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. For the purpose of ensuring the transparency, independence, sustainability and reliability of the risk assessment process, in particular to avoid conflicts of interest, it is considered necessary and proportionate to publish the names of any individual designated by the Authority to contribute to the Authority’s decision making process, including in the context of the adoption of guidance documents.
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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).	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).	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).
Amendment    30 Proposal for a regulation Recital 31
Text proposed by the Commission	Amendment
(31)  For the purposes 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 and software packages should be developed. In order to ensure uniform conditions for the implementation of Regulation (EC) No 178/2002 with regard to the adoption of standard data formats and software packages, 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 Council26.	(31)  For the purposes 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 and software packages should be developed. In order to ensure uniform and harmonised conditions for the implementation of Regulation (EC) No 178/2002 with regard to the adoption of standard data formats and software packages, 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 Council26.
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26 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).	26 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    31 Proposal for a regulation Recital 33
Text proposed by the Commission	Amendment
(33)  Furthermore, in order to assess the effectiveness and efficiency of the different provisions applying to the Authority, it is also appropriate to provide for a Commission evaluation of the Authority, in accordance with the Common Approach on Decentralised Agencies. The evaluation should, in particular, review the procedures for selecting the members of Scientific Committee and Panels, for their degree of transparency, cost-effectiveness, and suitability to ensure independence and competence, and to prevent conflicts of interests.	(33)  Furthermore, in order to assess the effectiveness and efficiency of the different provisions applying to the Authority, it is also appropriate to conduct an independent evaluation of the Authority. The evaluation should, in particular, review the procedures for selecting the members of Scientific Committee and Panels, for their degree of transparency, cost-effectiveness, and suitability to ensure independence and competence, and to prevent conflicts of interests.
Amendment    32 Proposal for a regulation Recital 33 a (new)
Text proposed by the Commission	Amendment
	(33a)  The Seventh European Environment Action Programme has prioritised the development and realisation of pathways to address the combined effects of chemicals on human health and the environment. Assessment of ‘cocktail effects’ requires a cross-sectoral approach, closer cooperation between monitoring agencies at European level and the formulation of suitable procedures.
Justification
This amendment seeks the adoption of a coordinated approach by all relevant sectors to the European chemicals evaluation process, giving EFSA a key role. In addition, it is important for those carrying out the evaluations to take account of cocktail effects also so that the appropriate management measures can be implemented.
Amendment    33 Proposal for a regulation Recital 35
Text proposed by the Commission	Amendment
(35)  For the purposes of ensuring transparency of the risk assessment process, it is also necessary to extend the scope of Regulation (EC) No 178/2002, currently limited to food law, to also cover applications for authorisations in the context of Regulation (EC) No 1831/2003 as regards feed additives, Regulation (EC) No 1935/2004 as regards food contact materials and Regulation (EC) No 1107/2009 as regards plant protection products.	(35)  For the purposes of ensuring the transparency and independence of the risk assessment process, it is also necessary to extend the scope of Regulation (EC) No 178/2002, currently limited to food law, to also cover applications for authorisations in the context of Regulation (EC) No 1831/2003 as regards feed additives, Regulation (EC) No 1935/2004 as regards food contact materials and Regulation (EC) No 1107/2009 as regards plant protection products.
Amendment    34 Proposal for a regulation Recital 36
Text proposed by the Commission	Amendment
(36)  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, including those flowing from the Aarhus Convention1, against the rights of commercial applicants, taking into account the specific objectives of sectoral Union legislation as well as experienced gained. Accordingly, it is necessary to amend Directive 2001/18/EC, Regulation (EC) No 1829/2003, Regulation (EC) No 1831/2003, Regulation (EC) No 1935/2004 and Regulation (EC) No 1107/2009 to provide for additional confidential items to those set out in Regulation (EC) No 178/2002.	(36)  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, including the right to benefit from proactive information related to the risk assessment process, against the rights of commercial applicants, taking into account the specific objectives of sectoral Union legislation as well as experienced gained. Accordingly, it is necessary to amend Directive 2001/18/EC, Regulation (EC) No 1829/2003, Regulation (EC) No 1831/2003, Regulation (EC) No 1935/2004 and Regulation (EC) No 1107/2009 to provide for additional confidential items to those set out in Regulation (EC) No 178/2002. The provisions on active dissemination laid down in this Regulation and the assessment of a confidentiality request by the Authority should not in any manner limit the scope of the rights provided by Regulations (EC) No 1049/2001 and (EC) No 1367/2006.
_____________________________
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).
Amendment    35 Proposal for a regulation Recital 36 a (new)
Text proposed by the Commission	Amendment
	(36a)  The Fitness Check of the General Food Law also highlighted a lack of transparency of the risk management process. There is a need to better inform the public on the risk management options under consideration, the level of protection to consumer and animal health and the environment that each of these options would achieve, as well as on the factors, other than the results of the risk assessment, which are taken into account by the risk managers, and how they are weighed up against each other in the decision-making process.
Amendment    36 Proposal for a regulation Recital 37
Text proposed by the Commission	Amendment
(37)  In order to further strengthen the link between risk assessors and risk managers at Union and national levels as well as the coherence and consistency of risk communication, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission to adopt a general plan on risk communication on matters covering the agri-food chain. It is of particular importance that the Commission carries 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.	(37)  In order to improve the interactive exchange of information, throughout the risk analysis process, amongst the risk assessors and risk managers at Union and national levels, as well as with other stakeholders of the food chain such as economic operators, consumer and other civil society organisations, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission to adopt a general plan on risk communication on matters covering the agri-food chain. The general plan on risk communication should lay down the practical arrangements for making available to the public the necessary information to achieve a high level of transparency of the risk management process. Therefore, it is of particular importance that the Commission carries 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.
Amendment    37 Proposal for a regulation Recital 37 a (new)
Text proposed by the Commission	Amendment
	(37a)  Provisions regarding what information should be made public should be without prejudice to Regulation (EC) No 1049/2001, as well as national or Union law regarding public access to official documents.
Amendment    38 Proposal for a regulation Recital 38
Text proposed by the Commission	Amendment
(38)  In order to enable the Authority and the business operators to adapt to the new requirements while ensuring that the Authority continues its smooth operation, it is necessary to provide for transitional measures for the application of this Regulation.	(38)  In order to enable the Authority, Member States, the Commission and the business operators to adapt to the new requirements while ensuring that the Authority continues its smooth operation, it is necessary to provide for transitional measures for the application of this Regulation.
Amendment    39 Proposal for a regulation Recital 39 a (new)
Text proposed by the Commission	Amendment
	(39a)  Since the amendments contained in this proposal serve to transfer far-reaching competencies for risk assessment and confidentiality checks to the Authority, a significant increase in the budget for the Authority pursuant to Annex 3 of the Commission’s proposal is necessary. The financing proposal is compatible with the current multiannual financial framework but may entail the use of special instruments as defined in Council Regulation (EU, Euratom) No 1311/2013. Should discussions between the European Parliament and the Member States on the Union budget not leave sufficient room for the necessary budgetary resources, then the Commission would have to propose an alternative financing proposal under a delegated act.
Justification
Given the impact of Brexit on the EU budget, the outcome of the negotiations on the multiannual financial framework is still completely uncertain. Should the Council of Ministers and the European Parliament not be able to agree on an appropriate budget for the EFSA, we would be saddling the Authority with a mandate that it could simply not carry out with the existing financial and human resources. The negotiations on the Commission proposal should also cover an alternative to take account of this eventuality.
Amendment    40 Proposal for a regulation Recital 40 a (new)
Text proposed by the Commission	Amendment
	(40a)  Recent food safety incidents have demonstrated the need to establish appropriate measures in emergency situations ensuring that all foods, whatever their type and origin, and all feed should be subject to common measures in the event of a serious risk to human health, animal health or the environment. This comprehensive approach to emergency food safety measures should enable effective action to be taken, avoiding artificial disparities in the treatment of any serious risk to food or feed through a harmonised joint food alerts management procedure.
Justification
Regulation (EC) No 178/2002 (Articles 50 to 54), establishes the RASFF, together with its basic provisions, scope and operation. Weaknesses were subsequently identified, requiring rectification through the adoption of Regulation (EU) No 16/2011, which did not include harmonised procedures to be followed by all MS or the necessary enhancement of the Commission’s powers for dealing with alerts. A joint, compulsory and enhanced procedure for managing food alerts is necessary.
Amendment    41 Proposal for a regulation Article 1 – paragraph – point -1 (new) Regulation (EC) No 178/2002 Article 6 – paragraph 2
Present text Amendment   (-1)  In Article 6, paragraph 2 is replaced as follows: 2.  Risk assessment shall be based on the available scientific evidence and undertaken in an independent, objective and transparent manner. “2.   "Risk assessment shall be based on all available scientific evidence and undertaken in an independent, objective and transparent manner."   (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)
Justification
On Glyphosate, the applicant submitted only 52% available scientific publications, along its own studies. Through the “Klimisch score” by the German Federal Institute for Risk Assessment, rapporteur for EFSA, most of these studies were classified of ‘limited value’, with little influence on the outcome of its assessment. That leads EFSA to grant greater weight to the applicant’s own studies. A rejection of peer-reviewed publications shouldn't be possible in a risk analysis.
Amendment    42 Proposal for a regulation Article 1 – paragraph 1 – point -1 a (new) Regulation (EC) No 178/2002 Article 7 – paragraph 1
Present text Amendment   (-1a)  In Article 7, paragraph 1 is replaced as follows: 1.  In specific circumstances where, following an assessment of available information, the possibility of harmful effects on health is identified but scientific uncertainty persists, provisional risk management measures necessary to ensure the high level of health protection chosen in the Community may be adopted, pending further scientific information for a more comprehensive risk assessment. "1.   In specific circumstances where, following an assessment of available information, the possibility of harmful effects on health is identified but scientific uncertainty persists, risk management measures necessary to ensure the high level of health protection chosen in the Community shall be adopted, pending further scientific information for a more comprehensive risk assessment."
Justification
add Shall" instead of may" In the Glyphosate file, the precautionary principle should have guided EFSA and COM in the decision making, as there was a “possibility of harmful effects on health is identified but scientific uncertainty persists”, according to Article 7. Instead of taking “provisional risk management measures” (Article 7), authorities seem to have applied “the doubt should benefit the substance”. Therefore, provisional risk management measures shall be taken when the pcp is applicable, and not "may" be taken
Amendment    43 Proposal for a regulation Article 1 – paragraph 1 – point 1 Regulation (EC) No 178/2002 Article 8a
Text proposed by the Commission Amendment Article 8a Article 8a Objectives of risk communication Objectives of risk communication Risk communication shall pursue the following objectives, while taking into account the respective roles of risk assessors and risk managers: Risk communication shall pursue the following objectives, while taking into account the respective roles of risk assessors and risk managers: (a)  promote awareness and understanding of the specific issues under consideration during the entire risk analysis process; (a)  promoting awareness and understanding of the specific issues under consideration during the entire risk analysis and management process; (b)  promote consistency and transparency in formulating risk management recommendations; (b)  promoting consistency, transparency and clarity in formulating risk management options, recommendations and decisions; (c)  provide a sound basis for understanding risk management decisions; (c)  providing a sound scientific basis for understanding risk management decisions; including information on:   (i)  how the risk management option chosen reflects the degree of uncertainty of the risk assessment, and the level of consumer and animal health and environmental protection it would achieve;   (ii)  as referred to in Article 6(3), the factors, other than the results of the risk assessment, which were considered by the risk managers, and how these factors were weighed up against each other; (d)  foster public understanding of the risk analysis process so as to enhance confidence in its outcome; (d)  fostering public understanding of the risk analysis process so as to enhance confidence in its outcome, including the provision of clear and consistent information regarding the respective tasks, powers and responsibilities of risk assessors and risk managers; (e)  promote appropriate involvement of all interested parties; and, (e)  promoting the balanced involvement of all interested parties, including economic operators of the food chain, consumers and other civil society organisations; (f)  ensure appropriate exchange of information with interested parties in relation to risks associated with the agri-food chain. (f)  ensuring a transparent and equitable exchange of information with the interested parties referred to in point (e) in relation to risks associated with the agri-food chain;   (fa)  informing consumers about risk prevention strategies; and   (fb)  combating the dissemination of false information and the sources thereof.
Amendment    44 Proposal for a regulation Article 1 – paragraph 1 – point 1 Regulation (EC) No 178/2002 Article 8b
Text proposed by the Commission Amendment Article 8b Article 8b General principles of risk communication General principles of risk communication Taking into account the respective roles of risk assessors and risk managers, risk communication shall: Taking into account the respective roles of risk assessors and risk managers, risk communication shall: (a)  ensure that accurate, appropriate and timely information is interactively exchanged, based on the principles of transparency, openness, and responsiveness; (a)  ensure that accurate, complete and timely information is interactively exchanged 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; (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; (c)  take into account risk perceptions; (c)  address risk perceptions; (d)  facilitate understanding and dialogue amongst all interested parties; and, (d)  facilitate understanding and dialogue amongst all interested parties; (e)  be accessible, including to those not directly involved in the process, while taking into account confidentiality and protection of personal data. (e)  be accessible, including to those not directly involved in the process, while taking into account confidentiality and protection of personal data; and   (ea)  formulate approaches to better communicate the difference between hazard and risk.
Amendment    45 Proposal for a regulation Article 1 – paragraph 1 – point 1 Regulation (EC) No 178/2002 Article 8c
Text proposed by the Commission Amendment Article 8c Article 8c General plan for risk communication General plan for risk communication 1.  The Commission, in close cooperation with the Authority, the Member States and following appropriate public consultations shall be empowered to adopt delegated acts in accordance with Article 57a establishing a general plan for risk communication on matters relating to the agri-food chain, taking into account the relevant objectives and general principles set out in Articles 8a and 8b. 1.  The Commission is empowered to adopt, in close cooperation with the Authority, the Member States and following appropriate public consultations, delegated acts in accordance with Article 57a which supplement this Regulation by establishing a general plan for risk communication on matters relating to the agri-food chain, taking into account the relevant objectives and general principles set out in Articles 8a and 8b. 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: 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 communications’ activities needed; (a)  identify the key factors that need to be taken into account when considering the type and level of risk communications’ activities needed; (b)  identify the appropriate main tools and channels to be used for risk communication purposes, taking into account the needs of relevant target audience groups; and, (b)  identify the appropriate main tools and channels to be used for risk communication purposes, taking into account the need to ensure the balanced involvement of all interested parties, including economic operators of the food chain, and consumer and other civil society organisations; (c)  establish appropriate mechanisms in order to strengthen coherence of risk communication amongst risk assessors and risk managers and ensure an open dialogue amongst all interested parties. (c)  establish appropriate mechanisms in order to strengthen coherence of risk communication amongst risk assessors and risk managers, including by systematically acknowledging and explaining divergences in scientific assessment or in the perception of the acceptable level of risk;   (ca)  lay down the practical arrangements and a timeline for making the information referred to in Article 55a(1) available to the public. 3.  The Commission shall adopt the general plan for risk communication within [two years from the date of application of this Regulation] and shall keep it updated, taking into account technical and scientific progress and experience gained."; 3.  The Commission shall adopt the general plan for risk communication within [two years from the date of application of this Regulation] and shall keep it updated, taking into account technical and scientific progress and experience gained.";
Amendment    46 Proposal for a regulation Article 1 – paragraph 1 – point 1 Regulation (EC) No 178/2002 Article 8d (new)
Text proposed by the Commission Amendment   Article 8d   Transparency of risk communication   1.  The Commission, the Authority and the Member States shall carry out their tasks as regards risk communication in relation to food law with a high level of transparency.   2.  The Commission may issue appropriate guidelines.
Amendment    47 Proposal for a regulation Article 1 – paragraph 1 – point 1 a (new) Regulation (EC) No 178/2002 Article 9
Present text Amendment   (1a)  Article 9 is replaced by the following: Article 9 "Article 9 Public consultation Public consultation There shall be open and transparent public consultation, directly or through representative bodies, during the preparation, evaluation and revision of food law, except where the urgency of the matter does not allow it. There shall be open and transparent public consultation, directly or through representative bodies, during the risk analysis, as well as during the preparation, evaluation and revision of food law, except where the urgency of the matter does not allow it."
Justification
add: "the risk analysis as well as during.." This amendment on the principle of transparency governing Regulation n°178/2002 is in line with Commission’s intention to reinforce transparency during the risk analysis process.
Amendment    48 Proposal for a regulation Article 1 – paragraph 1 – point 1 b (new) Regulation (EC) No 178/2002 Article 10
Present text Amendment   (1b)  Article 10 is replaced by the following: Article 10 “Article 10 Public information Public information Without prejudice to the applicable provisions of Community and national law on access to documents, where there are reasonable grounds to suspect that a food or feed may present a risk for human or animal health, then, depending on the nature, seriousness and extent of that risk, public authorities shall take appropriate steps to inform the general public of the nature of the risk to health, identifying to the fullest extent possible the food or feed, or type of food or feed, the risk that it may present, and the measures which are taken or about to be taken to prevent, reduce or eliminate that risk. 1.  Without prejudice to the applicable provisions of Community and national law on access to documents, where there are reasonable grounds to suspect that a food or feed may present a risk for human or animal health, then public authorities shall take appropriate and timely steps to inform the general public of the nature of the risk to health, identifying to the fullest extent possible the concerned products, the risk that they may present, and the measures which are taken or about to be taken to prevent, reduce or eliminate that risk. This paragraph shall also apply in case of suspected non-compliances resulting from possible intentional violations of applicable Union legislation perpetrated through fraudulent or deceptive practices.   2.  For the purpose of ensuring the uniform implementation of paragraph 1, the Commission shall adopt implementing acts on the modalities of its application by 12 months after the entry into force of this Regulation.”
Amendment    49 Proposal for a regulation Article 1 – paragraph 1 – point 1 c (new) Regulation (EC) No 178/2002 Article 22 – paragraph 7
Present text Amendment   (1c)  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 carrying out similar tasks to these of the Authority. “It shall act in cooperation with the other European Union evaluation agencies.”
Justification
This amendment is intended to facilitate EFSA's legal mandate and inter-agency coordination, given the need to take into account across the board all possible scenarios involving exposure of the public and the environment to chemicals.
Amendment    50 Proposal for a regulation Article 1 – paragraph 1 – point 1 d (new) Regulation (EC) No 178/2002 Article 23 – paragraph 1 – point b
Present text Amendment   (1d)  In the first paragraph of Article 23, point (b) is replaced by the following: (b)  to promote and coordinate the development of uniform risk assessment methodologies in the fields falling within its mission; “(b)  to promote and coordinate in a cross-cutting approach the development of uniform methods for risk assessment in the areas within its mission, in particular taking into account the “cocktail effects” of chemical substances which may have an impact on human health and the environment;”
Justification
This amendment seeks the adoption of a coordinated approach by all relevant sectors to the European chemicals evaluation process, giving EFSA a key role. In addition, it is important for those carrying out the evaluations to take account of cocktail effects also so that the appropriate management measures can be implemented.
Amendment    51 Proposal for a regulation Article 1 – paragraph 1 – point 2 – point b Regulation (EC) No 178/2002 Article 25 – paragraph 1a
Text proposed by the Commission Amendment 1a.  In addition to members and alternate members referred to in paragraph 1, the Management Board shall include: 1a.  In addition to members and alternate members referred to in paragraph 1, the Management Board shall include: (a)  two members and the alternate members appointed by the Commission and representing the Commission, with the right to vote. (a)  two members and the alternate members appointed by the Commission and representing the Commission, with the right to vote. (b)  one member appointed by the European Parliament, with the right to vote. (b)  two representatives appointed by the European Parliament, with the right to vote. (c)  four members with the right to vote representing civil society and food chain interests namely, one from consumers organisations, one from environmental non-governmental organisations, one from farmers organisations and one from industry organisations. Those members shall be appointed by the Council in consultation with the European Parliament on the basis of a list drawn up by the Commission which includes more names than there are posts to be filled. The list drawn up by the Commission shall be forwarded to the European Parliament, together with the relevant background documents. As quickly as possible and within three months of notification, the European Parliament may submit its views for consideration to the Council, which shall then appoint those members. (c)  six members with the right to vote representing civil society and food chain interests namely, one from consumers organisations, one from environmental non-governmental organisations, one from public health non-governmental organisations, one from farmers organisations, one from the agro-chemical organisations and one from food industry organisations. Those members shall be appointed by the Council in consultation with the European Parliament on the basis of a list drawn up by the Commission which includes more names than there are posts to be filled. The list drawn up by the Commission shall be forwarded to the European Parliament, together with the relevant background documents. As quickly as possible and within three months of notification, the European Parliament may submit its views for consideration to the Council, which shall then appoint those members.
Amendment    52 Proposal for a regulation Article 1 – paragraph 1 – point 2 – point c Regulation (EC) No 178/2002 Article 25 – paragraph 2
Text proposed by the Commission Amendment 2.  The term of office of members and alternate members shall be four years. However, the term of office of the members referred to in paragraph 1a (a) and (b) shall not be limited in duration. The term of office of the members referred to in paragraph 1a(c) may be renewable only once. 2.  The term of office of members referred to in point (b) of paragraph 1a shall be maximum 2,5 years. The term of office of the members referred to in points (a) and (c) of paragraph 1a shall be five years The term of office of the members referred to in point (c) of paragraph 1a may be renewable only once.
Amendment    53 Proposal for a regulation Article 1 – paragraph 1 – point 3 – points a and b Regulation (EC) No 178/2002 Article 28 – paragraphs 5 to 5g
Text proposed by the Commission Amendment 5.  The members of the Scientific Committee who are not members of Scientific Panels and the additional members referred to in paragraph 5b 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 renewable, following publication in the Official Journal of the European Union, in relevant leading scientific publications and on the Authority’s website of a call for expressions of interest.”, 5.  The members of the Scientific Committee who are not members of Scientific Panels and the members of the Scientific Panels shall be appointed by the Management Board for a renewable five year term of office in accordance with the following procedure: 5a.  The members of the Scientific Panels shall be appointed by the Management Board for a renewable five year term of office in accordance with the following procedure:   (a)  The Executive Director, after consulting the Management Board, shall send to the Member States the request for the specific multidisciplinary expertise needed in each Scientific Panel and shall indicate the number of experts to be nominated by the Member States. The Executive Director shall notify the Member States of the Authority’s independence policy and implementing rules applicable to Scientific Panels’ members. Member States shall launch a call for interest as a basis for their nominations. The Executive Director shall inform the Management Board of the requests sent to the Member States. (a)  The Executive Director, after consulting the Management Board, shall publish 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, and shall inform the Member States. The call shall lay down the specific multidisciplinary expertise needed in each Scientific Panel and shall indicate the number of experts required. (b)  Member States shall nominate experts with a view to collectively reach the number indicated by the Executive Director. Each Member State shall nominate at least 12 scientific experts. Member States may nominate nationals of other Member States. (b)  Member States shall ensure the broad dissemination of the call for expression of interest across the scientific community. They may also nominate experts for the fields indicated, provided that such nominations are made on the basis of a national call for expression of interest. (c)  On the basis of the nominations made by Member States, the Executive Director shall draw for each Scientific Panel a list of experts larger than the number of members to be appointed. The Executive Director may not draw up such a list where he/she can justify that the nominations received do not allow him, given the criteria for selection set up in point d) of this paragraph, to draw up a larger list. The Executive Director shall submit the list to the Management Board for appointment. (c)  On the basis of the applications and nominations received and in accordance with the Authority’s independence policy and implementing rules applicable to Scientific Panels’ members, the Executive Director shall draw for each Scientific Panel a list of experts larger than the number of members to be appointed. The Executive Director may not draw up such a list where he or she can justify that the applications and nominations received do not allow him or her, given the criteria for selection set up in point (d) of this paragraph, to draw up a larger list. The Executive Director shall submit the list to the Management Board for appointment. (d)  The nominations by the Member States, the selection by the Executive Director and the appointments by the Management Board shall be made on the basis of the following criteria: (d)  The nominations by the Member States, the selection by the Executive Director and the appointments by the Management Board shall be made on the basis of the following criteria: (i)  A high level of scientific expertise; (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 implementing rules on the independence of the Scientific Panels’ members; (ii)  Independence and absence of conflict of interests in accordance with Article 37(2) and the Authority’s independence policy and implementing rules on the independence of the Scientific Panels’ members; (iii)  Meeting the needs for the specific multi-disciplinary expertise of the Panel to which they will be appointed and the applicable language regime. (iii)  Meeting the needs for the specific multi-disciplinary expertise of the Panel to which they will be appointed and the applicable language regime. (e)  The Management Board shall ensure that the broadest possible geographical distribution is achieved in the final appointments. (e)  The Management Board shall ensure that the broadest possible geographical distribution is achieved in the final appointments. 5b.  When the Authority identifies that specific expertise is missing in a Panel or several Panels, the Executive Director shall propose additional members of the Panel(s) for appointment to the Management Board in accordance with the procedure laid down in paragraph 5. 5a.  When the Authority identifies that specific expertise is missing in a Panel or several Panels, the Executive Director shall propose additional members of the Panel(s) for appointment to the Management Board in accordance with the procedure laid down in paragraph 5. 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 of the present Article. 5b.  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 5 and 5a of the present Article. 5d.  The Member States shall put in place measures ensuring that the members of the Scientific Panels act independently and remain free from conflict of interests as provided for in Article 37(2) and the Authority’s internal measures. Member States shall ensure that the members of the Scientific Panels have the means to dedicate the necessary time and effort to contribute to the work of the Authority. Member States shall ensure that the members of the Scientific Panels do not receive any instruction at any national level and that their independent scientific contribution to the risk assessment system at Union level is recognised as a priority task for the protection of the safety of the food chain. 5c.  Members of the Scientific Panels shall act independently and remain free from conflict of interests as provided for in Article 37(2) and the Authority’s internal measures. They shall have the means to dedicate the necessary time and effort to contribute to the work of the Authority, shall not receive any instruction at any national level, and their independent scientific contribution to the risk assessment system at Union level shall be recognised as a priority task for the protection of the safety of the food chain. 5e.  Member States shall ensure that the public bodies employing those scientific experts and those having responsibility for the setting of priorities of the scientific bodies employing those experts implement the measures provided for in paragraph 5d. 5d.  As appropriate, Member States shall ensure that the public bodies employing those scientific experts and those having responsibility for the setting of priorities of the scientific bodies employing those experts implement the measures which are necessary to ensure that the conditions referred to in paragraph 5c are met. 5f.  The Authority shall support the tasks of the 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 the Article 36 including by organising the possibility for preparing scientific opinions to be peer-reviewed by the Panels before they adopt them. 5e.  The Authority shall support the tasks of the 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 the Article 36 including by organising the possibility for preparing scientific opinions to be peer-reviewed by the Panels before they adopt them. 5g.  Each Panel shall include a maximum of 21 members. 5f.  Each Panel shall include a maximum of 21 members.   5fa.  The Authority shall offer members of Panels comprehensive training on the risk assessment process.
Amendment    54 Proposal for a regulation Article 1 – paragraph 1 – point 3 – point c Regulation (EC) No 178/2002 Article 28 – paragraph 9 – point b
Text proposed by the Commission Amendment The number of members in each Scientific Panel within the maximum provided for in paragraph 5g.; (b) The number of members in each Scientific Panel within the maximum provided for in paragraph 5f.
Amendment    55 Proposal for a regulation Article 1 – paragraph 1 – point 3 – point c a (new) Regulation (EC) No 178/2002 Article 28 – paragraph 9 – point g a (new)
Text proposed by the Commission Amendment   (ca)  In Article 28(9), the following point is added:   (ga)  the possibility for applicants to address, in a maximum period of six months unless otherwise agreed with the Authority, and previous to the publication of the draft opinion of the Authority, critical areas of concern by new data.
Justification
During the process in which EFSA reviews a dossier, the agency may come across some critical areas of concern (which is in many cases related to a consideration related to lack of specific data) which are then reflected in its final Scientific Opinion. However, once these concerns are included in the final EFSA Opinion, the process does not allow applicants to address such concerns, even if in many cases these would be easily solved with specific already existing data.
Amendment    56 Proposal for a regulation Article 1 – paragraph 1 – point 3 a (new) Regulation (EC) No 178/2002 Article 29 – paragraph 6
Text proposed by the Commission Amendment   (3a)  The following sentence is added at the end of Article 29(6):   "They shall not allow a priori exclusion of certain scientific evidences, especially when these have been published after a peer-review process.";
Justification
In the Glyphosate file, the applicant submitted only 52% of available scientific publications, along its own studies. Most of these studies were classified of ‘limited value’, and hence had little influence on the outcome of its assessment. That methodological bias, led EFSA to grant greater weight to the applicant’s own studies. Quite on the contrary, CIRC was guided in its analysis by peer-reviewed publications only. Such a priori rejection of peer-reviewed publications should not be possible in a risk analysis guided by the precautionary principle, pursuant to Article 7.
Amendment    57 Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32a
Text proposed by the Commission Amendment At the request of a potential applicant for a food law authorisation, the staff of the Authority shall advise on the relevant provisions and the required content of the application for authorisation. The advice provided by the staff of the Authority shall be without prejudice and non-committal as to the subsequent assessment of applications for authorisation by the Scientific Panels. The Authority shall publish a guidance document that includes a list of questions and answers regarding the administrative and scientific requirements of an application for authorisation. At the request of a potential applicant for a food law authorisation, the Authority shall also offer consultation sessions to explain what information is required and how the various tests and studies necessary to prove the quality, safety and efficacy of the planned product are to be carried out. The advice provided by the Authority shall be without prejudice and non-committal as to the subsequent assessment of applications for authorisation by the Scientific Panels. The staff of the Authority providing the advice shall not be involved in any preparatory scientific work that is directly or indirectly relevant to the application that is the subject of the advice.   Within ... [36 months after the entry into force of the amending Regulation], the Commission shall assess the impact of this Article on the functioning of the Authority. Particular attention shall be paid to the additional workload and mobilisation of staff, and whether it has led to any shift in the allocation of the Authority’s resources, at the expense of activities of public interest.
Amendment    58 Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32b – paragraph 1
Text proposed by the Commission Amendment 1.  A Union register of studies commissioned by business operators to obtain an authorisation under Union food law is hereby established. Business operators shall notify, without delay, to the Authority the subject matter of any study commissioned to support a future application for an authorisation under Union food law. The register shall be managed by the Authority. 1.  A Union register of studies commissioned by business operators seeking to obtain an authorisation or renewal under Union food law is hereby established. Business operators shall notify, without delay, to the Authority the subject matter of any study commissioned in the Union and beyond to support a future application for an authorisation or renewal under Union food law. The register shall be managed by the Authority.
Amendment    59 Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32b – paragraph 1 a (new)
Text proposed by the Commission Amendment   1a.  Any studies commissioned shall take account of Directive 2010/63/EU on the protection of animals used for scientific purposes.
Amendment    60 Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32b – paragraph 2
Text proposed by the Commission Amendment 2.  The notification obligation under paragraph 1, also applies to Union laboratories carrying out those studies. 2.  The notification obligation under paragraph 1 also applies to any institution carrying out the studies, including laboratories, institutes or universities.
Amendment    61 Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32b – paragraph 2 a (new)
Text proposed by the Commission Amendment   2a.  Data from a test commissioned but not registered shall not be used in a risk assessment.
Justification
Provision that safeguards that the applicants won't make a cherry picking of the convenient for them research results, but all of them will be known and available allowing for a complete assessment.
Amendment    62 Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32b – paragraph 2 b (new)
Text proposed by the Commission Amendment   2b.  The subject matter shall not be authorised unless all data from all registered studies are submitted.
Amendment    63 Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32b – paragraph 3 a (new)
Text proposed by the Commission Amendment   3a.  Where the Authority requests and receives additional data by an applicant, this data is, marked as such, also added to the Union register and made available to the public.
Justification
This provision was added on recommendation of the Ombudsman, in order to avoid any public perception that the file is incomplete.
Amendment    64 Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32b – paragraph 4 a (new)
Text proposed by the Commission Amendment   4a.  The Commission shall adopt delegated acts in accordance with Article 57a supplementing this Regulation by establishing penalties for breaches of the notification obligation.
Amendment    65 Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32b – paragraph 4 b (new)
Text proposed by the Commission Amendment   4b.  This Article shall not be applicable to studies commissioned before ... [the date of entry into force of this amending Regulation].
Justification
The obligation to publish studies shall not have retroactive effect.
Amendment    66 Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32c – paragraph 1
Text proposed by the Commission Amendment 1.  Where Union food law provides that an authorisation may be renewed, the potential applicant for the renewal shall notify the Authority of the studies it intends to perform for that purpose. Following this notification, the Authority shall launch a consultation of stakeholders and the public on the intended studies for renewal and shall provide advice on the content of the intended renewal application taking into account the received comments. The advice provided by the Authority shall be without prejudice and non-committal as to the subsequent assessment of the applications for renewal of authorisation by the Scientific Panels. 1.  Where Union food law provides that an authorisation may be renewed, the potential applicant for the renewal shall notify the Authority of the studies it intends to perform for that purpose. Following this notification, the Authority shall launch a consultation of stakeholders and the public on the intended studies for renewal and shall provide advice on the content of the intended renewal application taking into account the received comments which are relevant for the risk assessment of the intended renewal. The advice provided by the Authority shall be without prejudice and non-committal as to the subsequent assessment of the applications for renewal of authorisation by the Scientific Panels.
Amendment    67 Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32c – paragraph 2
Text proposed by the Commission Amendment 2.  The Authority shall consult stakeholders and the public regarding the studies supporting applications for authorisation once they are made public by the Authority in accordance with Article 38 and Articles 39 to 39f in order to identify whether other relevant scientific data or studies are available on the subject matter concerned by the application for authorisation. This provision does not apply to the submission of any supplementary information by the applicants during the risk assessment process. 2.  The Authority shall, within two months, consult stakeholders and the public regarding the studies supporting applications for authorisation once they are made public by the Authority in accordance with Article 38 and Articles 39 to 39f in order to identify whether other relevant scientific data or studies that are based on independent peer-reviewed literature or have been carried out in accordance with international guidelines and Good Laboratory Practices (GLP) are available on the subject matter concerned by the application for authorisation, and are without prejudice to the Authority’s own obligations under Article 33. This provision does not apply to the submission of any supplementary information by the applicants during the risk assessment process.
Justification
The consultation period must be clearly defined in order to provide a clear structure for the overall duration of the authorisation process. Public consultation should not be seen as the panacea for good quality and exhaustive risk assessment. Indeed public consultations generally touch a very narrow audience. This responsibility lies with the EFSA. The rigorous identification of relevant scientific data should be done by the Authority itself, as laid down in Article 33. Public consultation should not exempt EFSA from this obligation.
Amendment    68 Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32d
Text proposed by the Commission Amendment The Commission experts shall perform controls, including audits, to obtain assurance that testing facilities comply with relevant standards for carrying out tests and studies submitted to the Authority as part of an application for an authorisation under Union food law. These controls shall be organised in cooperation with the competent authorities of the Member States. The Commission’s Directorate for Health and Food Audits and Analysis experts shall perform controls, including audits, to obtain assurance that testing facilities in the Union and in third countries comply with relevant standards for carrying out tests and studies submitted to the Authority as part of an application for an authorisation under Union food law. These controls shall be organised in cooperation with the competent authorities of the Member States or of the third countries concerned.
Amendment    69 Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32e
Text proposed by the Commission Amendment Without prejudice to the obligation of applicants for authorisations under food law to demonstrate the safety of a subject matter submitted to a system of authorisation, the Commission, in exceptional circumstances, 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. Without prejudice to the obligation of applicants for authorisations under food law to demonstrate the safety of a subject matter submitted to a system of authorisation, in the event of divergent scientific findings, the Commission 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 in the risk assessment process.
Amendment    70 Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32e – paragraph 1 a (new)
Text proposed by the Commission Amendment   Any studies commissioned shall take into account Directive 2010/63/EU on the protection of animals used for scientific purposes.
Amendment    71 Proposal for a regulation Article 1 – paragraph 1 – point 4 a (new) Regulation (EC) No 178/2002 Article 33 – paragraph 1 – point d a (new)
Text proposed by the Commission Amendment   (4a)  In Article 33(1), the following point is added:   “(da)  combinatorial and accumulated effects.”
Amendment    72 Proposal for a regulation Article 1 – paragraph 1 – point 5 – point a Regulation (EC) No 178/2002 Article 38 – paragraph 1 – introductory part
Text proposed by the Commission Amendment 1.  The Authority shall carry out its activities with a high level of transparency. It shall in particular make public without delay: 1.  The Authority shall carry out its activities with a high level of transparency in line with Regulation (EC) No 1367/2006 and without prejudice to Regulation (EC) No 1049/2001. It shall in particular make public without delay:
Amendment    73 Proposal for a regulation Article 1 – paragraph 1 – point 5 – point a Regulation (EC) No 178/2002 Article 38 – paragraph 1 – point a
Text proposed by the Commission Amendment (a)  agendas and minutes of the Scientific Committee and the Scientific Panels and their Working Groups; (a)  agendas, participants lists, and minutes of the Management Board, the Advisory Committee, the Scientific Committee and the Scientific Panels and their Working Groups;
Amendment    74 Proposal for a regulation Article 1 – paragraph 1 – point 5 – point a Regulation (EC) No 178/2002 Article 38 – paragraph 1 – point c
Text proposed by the Commission Amendment (c)  scientific data, studies and other information supporting applications for authorisation under Union food law, 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 protection of confidential information and protection of personal data in accordance with Articles 39 to 39f. (c)  scientific data, studies and other information supporting applications for authorisation under Union food law, 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 overriding public interest in disclosure and the protection of confidential information and protection of personal data in accordance with Articles 39 to 39f.
Amendment    75 Proposal for a regulation Article 1 – paragraph 1 – point 5 – point a Regulation (EC) No 178/2002 Article 38 – paragraph 1 – point d
Text proposed by the Commission Amendment (d)  the information on which its scientific outputs, including scientific opinions are based, taking into account protection of confidential data and protection of personal data in accordance with Articles 39 to 39f; (d)  the information on which its scientific outputs, including scientific opinions are based, taking into account the overriding public interest in disclosure and the protection of confidential data and protection of personal data in accordance with Articles 39 to 39f;
Amendment    76 Proposal for a regulation Article 1 – paragraph 1 – point 5 – point a Regulation (EC) No 178/2002 Article 38 – paragraph 1 – point h a (new)
Text proposed by the Commission Amendment   (ha)  information on the name of the applicant and the title of the application;
Amendment    77 Proposal for a regulation Article 1 – paragraph 1 – point 5 – point a Regulation (EC) No 178/2002 Article 38 – paragraph 1 – point i
Text proposed by the Commission Amendment (i)  advice provided by the Authority to potential applicants at pre-submission phase pursuant to Article 32a and 32c. (i)  the general advice provided by the Authority to potential applicants at pre-submission phase pursuant to Articles 32a and 32c.
Justification
In order to support the competitiveness and capacity for innovation of SMEs, it is essential for them to receive advice before they lodge an application. The crucial source of costs is often the studies required for the authorisation process. The advice should therefore also cover these aspects in order to avoid unnecessary or misdirected studies.
Amendment    78 Proposal for a regulation Article 1 – paragraph 1 – point 5 – point a Regulation (EC) No 178/2002 Article 38 – paragraph 1 – subparagraph 2
Text proposed by the Commission Amendment Those items referred to in the first subparagraph shall be made public on a dedicated section of the Authority’s website. That section shall be publicly available and easily accessible. The relevant items shall be available to download, print and search through in an electronic format. Those items referred to in the first subparagraph shall be made public on a dedicated section of the Authority’s website. That section shall be publicly available and easily accessible subject to clear undertakings recorded electronically by those accessing it and subject to measures and penalties which are effective, proportionate and dissuasive against any commercial use. The relevant items shall be available to download, print with a watermark for traceability and search through in an electronic format, which is machine-readable. Those measures shall focus on the commercial use of documents and their submission. Such measures shall be designed to protect effectively against commercial use of items referred to in the first subparagraph both within the Union and in third-countries.
Amendment    79 Proposal for a regulation Article 1 – paragraph 1 – point 5 – point b Regulation (EC) No 178/2002 Article 38 – paragraph 1a – subparagraph 1 – introductory part
Text proposed by the Commission Amendment 1a. The disclosure of the information mentioned in paragraph (1)(c) to the public shall be without prejudice: 1a. The disclosure of the information mentioned in points (c), (d) and (i) of paragraph 1 to the public shall be without prejudice:
Amendment    80 Proposal for a regulation Article 1 – paragraph 1 – point 5 – point b Regulation (EC) No 178/2002 Article 38 – paragraph 1a – subparagraph 1 – point a
Text proposed by the Commission Amendment (a)  to any intellectual property right which may exist over documents or their content; and, deleted
Justification
There is no reason to put the whole disclosure requirements with reservation as regards intellectual property rights (IPR). Moreover, there is no need to refer to IPR at this point: ‘Hard IPRs’, such as patents, copyrights or trademarks will already be protected under Article 38.1a (b). ‘Soft IPRs’ (trade secrets) will be covered by Article 39(2).
Amendment    81 Proposal for a regulation Article 1 – paragraph 1 – point 5 – point b Regulation (EC) No 178/2002 Article 38 – paragraph 1a – subparagraph 2
Text proposed by the Commission Amendment The disclosure to the public of the information mentioned in paragraph (1)(c) shall not be considered as an explicit or implicit permission or license for the relevant data and information and their content to be used, reproduced, or otherwise exploited and its use by third parties shall not engage the responsibility of the European Union. The disclosure to the public of the information mentioned in paragraph (1)(c) shall not be considered as an explicit or implicit permission or license for the relevant data and information and their content to be commercially used, reproduced, or otherwise exploited for commercial purposes. For the avoidance of doubt, the information published may be used for the purpose of public scrutiny of the results, including a better understanding of the potential adverse effects on health and the environment and its use by third parties for that purpose shall not engage the responsibility of the Union.
Amendment    82 Proposal for a regulation Article 1 – paragraph 1 – point 5 – point c a (new) Regulation (EC) No 178/2002 Article 38 – paragraph 3 a (new)
Text proposed by the Commission Amendment   (ca)  the following paragraph 3a is added:   “3a. This Article is without prejudice to Directive 2003/4/EC of the European Parliament and of the Council to Regulation (EC) No 1049/2001 and to Regulation (EC) No 1367/2006.”
Amendment    83 Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 1
Text proposed by the Commission Amendment 1.  By way of derogation from Article 38, the Authority shall not make public information for which confidential treatment has been requested under the conditions laid down in this Article. 1.  By way of derogation from Article 38 and without prejudice to Regulation (EC) No 1049/2001 and Directive 2003/4/EC and the general principle that the interests of public health always prevail over private interests, the Authority shall not make public information for which confidential treatment has been requested and granted in application of the conditions laid down in this Article.
Amendment    84 Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 2 – point 1
Text proposed by the Commission Amendment (1)  the method and other technical and industrial specifications relating to that method, used to manufacture or produce the subject matter of the request for a scientific output, including a scientific opinion; (1)  the method and other technical and industrial specifications relating to that method, used to manufacture or produce the subject matter of the request for a scientific output, including a scientific opinion, except when relevant to understanding the potential effects on health and the environment, and provided that the applicant demonstrates with verifiable justification that such method does not entail information about emissions in the environment and about impacts on health and environment;
Amendment    85 Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 2 – point 3
Text proposed by the Commission Amendment (3)  commercial information revealing sourcing, market shares or business strategy of the applicant; and (3)  commercial information revealing sourcing, innovative ideas for the product/substance, market shares or business strategy of the applicant;   (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)
Amendment    86 Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 2 – point 4
Text proposed by the Commission Amendment (4)  quantitative composition of the subject matter of the request for a scientific output, including a scientific opinion. (4)  quantitative composition of the subject matter of the request for a scientific output, including a scientific opinion, except when relevant to understanding the potential effects on health and the environment.
Amendment    87 Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 4 – point a
Text proposed by the Commission Amendment (a)  Where urgent action is essential to protect public health, animal health or the environment, such as in emergency situations, the Authority may disclose the information referred to paragraphs 2 and 3; and, (a)  Where urgent action is essential to protect public health, animal health or the environment, such as in emergency situations, the Authority may disclose the information referred to paragraphs 2 and 3; or,
Amendment    88 Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 4 – point b
Text proposed by the Commission Amendment (b)  information which forms part of conclusions of scientific outputs, including scientific opinions, delivered by the Authority and which relate to foreseeable health effects. (b)  information which forms part of conclusions of scientific outputs, including scientific opinions, delivered by the Authority and which relate to foreseeable effects on public health, animal health and the environment.
Amendment    89 Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 4 – point b a (new)
Text proposed by the Commission Amendment   (ba)  where an overriding public interest in disclosure exists.
Justification
This provision is, already today, included in the pesticides Regulation, and should not be abolished.
Amendment    90 Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 4 – point b b (new)
Text proposed by the Commission Amendment   (bb)  any information for which there is an overriding public interest in disclosure as per Article 4(2) of Regulation 1049/2001 and Article 6 of Regulation 1367/2006, in particular where the information relates to emissions into the environment.
Amendment    91 Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 4 a (new)
Text proposed by the Commission Amendment   4a.  This Article is without prejudice to Directive 2003/4/EC and Regulations (EC) No 1049/2001 and (EC) No 1367/2006.
Amendment    92 Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39a – paragraph 2
Text proposed by the Commission Amendment 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 be without the information the applicant deems confidential in accordance with paragraphs 2 and 3 of Article 39. 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. 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 edit, with black bars, the information, for which confidential treatment has been requested by the applicant in accordance with paragraph 2 and 3 of Article 39. The confidential version shall contain all information submitted, including information the applicant considers as confidential. Information requested to be treated as confidential in the confidential version shall be clearly marked. The applicant shall clearly indicate verifiable justifications and evidence on the basis of which confidentiality is requested for the different pieces of information.
Amendment    93 Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39b – paragraph 1 – subparagraph 1 – point c
Text proposed by the Commission Amendment (c)  inform the applicant in writing of its intention to disclose information and the reasons for it, before the Authority formally takes a decision on the confidentiality request. If the applicant disagrees with the assessment of the Authority it may state its views or withdraw its application within two weeks from the date on which it was notified of the Authority’s position. (c)  inform the applicant in writing of its intention to disclose information and the reasons for it, before the Authority formally takes a decision on the confidentiality request. If the applicant objects to the assessment of the Authority it may (1) state its views, (2) withdraw its application, or (3) request a review to the Authority’s Board of Appeal within four weeks from the date on which it was notified of the Authority’s position. The applicant may provide written notice to the Authority that it wishes to request a re-examination of the opinion to the Authority’s Board of Appeal. In that case the applicant shall forward to the Authority the detailed grounds for the request within 60 days after receipt of the opinion. Within 60 days after receipt of the grounds for the request, the Authority’s Board of Appeal shall re-examine its opinion;
Justification
Both EMA and EFSA has a Board of Appeal of some sort. This is to provide the applicant the possibility for a re-examination of the opinion. The Commission should, by means of a delegated act, set up this same possibility in EFSA.
Amendment    94 Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39b – paragraph 1 – subparagraph 1 – point d
Text proposed by the Commission Amendment (d)  adopt a reasoned decision on the confidentiality request taking into account the observations of the applicant within ten weeks from the date of receipt of the confidentiality request with respect to applications for authorisation and without undue delay in the case of supplementary data and information and notify the applicant and inform the Commission and the Member States, as appropriate, of its decision; and, (d)  adopt a reasoned decision on the confidentiality request taking into account the observations of the applicant within eight weeks from the date of receipt of the confidentiality request with respect to applications for authorisation and without undue delay in the case of supplementary data and information and notify the applicant and inform the Commission and the Member States, in every case, of its decision; and,
Amendment    95 Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39b – paragraph 1 – subparagraph 1 – point e
Text proposed by the Commission Amendment (e)  make public any additional data and information for which the confidentiality request has not been accepted as justified not earlier than two weeks after the notification of its decision to the applicant has taken place, pursuant to point (d). (e)  make public any additional data and information for which the confidentiality request has not been accepted as justified not earlier than four weeks after the notification of its decision to the applicant has taken place, pursuant to point (d).
Amendment    96 Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39b – paragraph 1 – subparagraph 2
Text proposed by the Commission Amendment Decisions taken by the Authority pursuant to this Article may be subject to an action before the Court of Justice of the European Union, under the conditions laid down in Articles 263 and 278 of the Treaty respectively. Decisions taken by the Authority pursuant to this Article may be subject to an action before the Authority’s Board of Appeal, which shall be established by the Commission by means of delegated acts. Those delegated acts shall be adopted in accordance with Article 57a of this Regulation. A submission of an appeal pursuant to this paragraph shall have suspensive effect. The applicant may provide written notice to the Authority that he wishes to request a re-examination of the opinion to the Authority’s Board of Appeal. In that case the applicant shall forward to the Authority the detailed grounds for the request within 60 days after receipt of the opinion. Within 60 days after receipt of the grounds for the request, the Authority’s Board of Appeal shall re-examine its opinion. In case of a contesting decision taken by the Authority’s Board of appeal, a case may be brought before the Court of Justice of the European Union under the conditions laid down in Article 263 of the Treaty.
Amendment    97 Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39d – paragraph 2
Text proposed by the Commission Amendment 2.  The Commission and the Member States shall take the necessary measures so that information received by them under Union food 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 definitive. 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. 2.  The Commission and the Member States shall take the necessary measures so that information received by them under Union food 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 definitive, except for when access to information is requested in accordance with Directive 2003/4/EC or national law on access to documents. 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, except for when access to information is requested in accordance with Directive 2003/4/EC or national law on access to documents.
Justification
Clarification needs to be made regarding when EFSA:s obligation to confidentiality decision applies, notably only when the authorities proactively publish information. When access to information is requested, an individual assessment must be made, even if the institution previously have decided on confidentiality.
Amendment    98 Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39d – paragraph 3
Text proposed by the Commission Amendment 3.  If an applicant in the context of an authorisation procedure withdraws or has withdrawn an application, the Authority, the Commission and the Member States shall respect the confidentiality of commercial and industrial information as accepted by the Authority in accordance with Articles 39to 39f. The application shall be considered withdrawn as of the moment the written request is received by the competent body that had received the original application. Where the withdrawal of the application takes place before the Authority has decided on the relevant confidentiality request, the Authority, the Commission and the Member States shall not make public the information for which confidentiality has been requested. 3.  If an applicant in the context of an authorisation procedure withdraws or has withdrawn an application, the Authority, the Commission and the Member States shall respect the confidentiality of commercial and industrial information as accepted by the Authority in accordance with Articles 39to 39f. The application shall be considered withdrawn as of the moment the written request is received by the competent body that had received the original application. The Authority shall not publish any information, confidential or non-confidential, should an applicant decide to withdraw its application.
Amendment    99 Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39e – paragraph 1 – point c
Text proposed by the Commission Amendment (c)  the names of all participants in meetings of the Scientific Committee and the Scientific Panels and their Working Groups. (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.
Amendment    100 Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39e – paragraph 2
Text proposed by the Commission Amendment 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 there is an overriding public interest. 2.  Notwithstanding paragraph 1, disclosure of names and addresses of natural persons involved in testing on vertebrate animals shall be deemed to significantly harm the privacy and the integrity of those natural persons and shall not be made publicly available, unless there is an overriding public interest.
Amendment    101 Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39f – paragraph 1
Text proposed by the Commission Amendment (1)  For the purposes of Article 38(1)(c) and in order to ensure the efficient processing of requests to the Authority for a scientific output, standard data formats and software packages shall be adopted to allow documents to be submitted, searched, copied and printed, while ensuring compliance with regulatory requirements set out in Union food law. These draft standard data formats and software packages shall not be based on proprietary standards and shall ensure interoperability with existing data submission approaches to the extent possible. (1)  For the purposes of Article 38(1)(c) and in order to ensure the efficient processing of requests to the Authority for a scientific output, standard data formats and software packages shall be adopted to allow documents to be submitted, searched, copied and printed, while ensuring compliance with regulatory requirements set out in Union food law and feasibility for small and medium-sized enterprises. These draft standard data formats and software packages shall not be based on proprietary standards and shall ensure interoperability with existing data submission approaches to the extent possible.
Justification
SMEs have limited technical possibilities. It should nonetheless also be possible for them to use the standard data formats without knowledge or possession of the latest software programmes.
Amendment    102 Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39f – paragraph 2 a (new)
Text proposed by the Commission Amendment   2a.  The standard data formats and software packages shall only apply to data generated after adoption of the implementing acts in accordance with point (b) of paragraph 2.
Amendment    103 Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39g – paragraph 1
Text proposed by the Commission Amendment The information systems operated by the Authority to store its data, including confidential and personal data shall be designed to a high level of security appropriate to the security risks at stake, taking into account Articles 39 to 39f of this Regulation. Access shall be based at the minimum on a system requiring two factor authentication or providing an equivalent level of security. The system shall ensure that any access to it is fully auditable. 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 the highest standards of security appropriate to the security risks at stake will be attained, taking into account Articles 39 to 39f of this Regulation. Access shall be based at the minimum on a system requiring two factor authentication or providing an equivalent level of security. The system shall ensure that any access to it is fully auditable.
Amendment    104 Proposal for a regulation Article 1 – paragraph 1 – point 9 Regulation (EC) No 178/2002 Article 41 – paragraph 1
Text proposed by the Commission Amendment Where environmental information is concerned, Articles 6 and Article 7 of Regulation (EC) No 1367/2006 of the European Parliament and of the Council39 shall also apply. The Authority shall ensure wide access to the documents, held by it. Where environmental information is concerned, Regulation (EC) No 1367/2006 of the European Parliament and of the Council39 shall also apply. Articles 38 to 39 of this Regulation shall apply without prejudice to the application of Regulations (EC) No 1049/2001 and (EC) No 1367/2006. __________________ __________________ 39 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). 39 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).
Amendment    105 Proposal for a regulation Article 1 – paragraph 1 – point 9 a (new) Regulation (EC) No 178/2002 Article 50 – paragraph 1
Present text Amendment   (9a)  In Article 50, paragraph 1 is replaced by the following: 1.   A rapid alert system for the notification of a direct or indirect risk to human health deriving from food or feed is hereby established as a network. It shall involve the Member States, the Commission and the Authority. The Member States, the Commission and the Authority shall each designate a contact point, which shall be a member of the network. The Commission shall be responsible for managing the network. “1.  A rapid alert system for the notification of a direct or indirect risk to human health deriving from food or feed is hereby established as a network. It shall involve the Member States, the Commission and the Authority. The Member States, the Commission and the Authority shall each designate a contact point, which shall be a member of the network.”
Amendment    106 Proposal for a regulation Article 1 – paragraph 1 – point 9 b (new) Regulation (EC) No 178/2002 Article 51 – paragraph 1 a (new)
Text proposed by the Commission Amendment   (9b)  In Article 51, the following paragraph is inserted:   “1a. The Commission shall adopt a delegated act in accordance with Article 57a to develop a harmonised food alert network management system between the Commission and the Member States.”
Justification
Regulation (EC) No 178/2002 (Articles 50 to 54), establishes the RASFF, together with its basic provisions, scope and operation. Weaknesses were subsequently identified, requiring rectification through the adoption of Regulation (EU) No 16/2011 which did not include harmonised procedures to be followed by all MS or the necessary enhancement of the Commission’s powers for dealing with alerts. A joint, compulsory and enhanced procedure for managing food alerts is necessary.
Amendment    107 Proposal for a regulation Article 1 – paragraph 1 – point 10 Regulation (EC) No 178/2002 Article 57a – paragraph 2
Text proposed by the Commission Amendment 2.  The powers to adopt delegated acts referred to in Article 8(c) shall be conferred upon the Commission for an indeterminate period of time from [date of entry into force of this Regulation]. 2.  The powers to adopt delegated acts referred to in Article 8(c), 32b(4a), subparagraph 2 of Article 39b(1) and Article 51(1a)shall be conferred upon the Commission for a period of five years from [date of entry into force of this Regulation].
Amendment    108 Proposal for a regulation Article 1 – paragraph 1 – point 11 Regulation (EC) No 178/2002 Article 61
Text proposed by the Commission Amendment Article 61 Article 61 Review clause Review clause 1.  The Commission shall ensure the regular review of the application of this Regulation. 1.  The Commission shall ensure the regular review of the application of this Regulation. 2.  Not later than five years after the date referred to in Article [entry into force of the Regulation amending the GFL], and every five years thereafter, the Commission shall assess the Authority’s performance in relation to its objectives, mandate, tasks, procedures and location, in accordance with Commission guidelines. The evaluation shall address the possible need to modify the mandate of the Authority, and the financial implications of any such modification. 2.  Not later than five years after the date referred to in Article [entry into force of the Regulation amending the GFL], and every five years thereafter, the Authority jointly with the Commission shall commission an independent external evaluation of their performance and achievements in relation to their objectives, mandates, tasks, procedures and locations. The evaluation shall be based on the Management Board’s work programme in agreement with the Commission. It shall assess the working practices and the impact of the Authority and address the possible need to modify the mandate of the Authority, including the financial implications of any such modification. It shall, furthermore, address the possible need to coordinate and dovetail the Authority’s activities more closely with those of the competent bodies in the Member States and other Union agencies. The evaluation shall take into account the views of the stakeholders, at both Union and national level.   2 a.  The Management Board shall examine the conclusions of the evaluation and issue recommendations to the Commission, which may concern changes in the Authority. 3.  Where the Commission considers that the continuation 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.   4.  The Commission shall report to the European Parliament, the Council and the Management Board on the evaluation findings. The findings of the evaluation shall be made public. 4.  The evaluations and recommendations referred to in paragraphs 2 and 2a shall be forwarded to the Commission, the Council, the European Parliament and the Management Board. The findings of the evaluation and the recommendations shall be made public.
Amendment    109 Proposal for a regulation Article 2 – paragraph 1 – point 2 a (new) Directive 2001/18/EC Article 24 – paragraph 2 a (new)
Text proposed by the Commission Amendment   (2a)  In Article 24, the following paragraph is added:   “2a.  The obligation to proactively disseminate the information set out in paragraph 1 of this Article, in line with Article 25 of this Directive, and in line with Articles 38 and 39 of Regulation (EC) No 178/2002, is without prejudice to the right of any natural or legal person to access documents upon request as set out in Regulations (EC) No 1049/2001 and (EC) No 1367/2006.”
Amendment    110 Proposal for a regulation Article 3 – paragraph 1 – point 9 Regulation (EC) No 1829/2003 Article 29 – paragraph 1
Text proposed by the Commission Amendment 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 Article 38, Articles 39 to 39f and Article 40 of Regulation (EC) No 178/2002 and taking into account Article 30 of this Regulation. 1.  The Authority shall make public the application for authorisation, relevant supporting information and any supplementary information supplied by the applicant, monitoring reports 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 Article 38, Articles 39 to 39f and Article 40 of Regulation (EC) No 178/2002 and taking into account Article 30 of this Regulation.
Justification
This provision is taken from the current Regulation 1829/2003, Article 29.
Amendment    111 Proposal for a regulation Article 3 – paragraph 1 – point 9 Regulation (EC) No 1829/2003 Article 29 – paragraph 1 a (new)
Text proposed by the Commission Amendment   1a.  The obligation to proactively disseminate the information set out in paragraph 1 of this Article, in line with Article 30 of this Regulation, and in line with Articles 38 and 39 of Regulation (EC) No 178/2002, is without prejudice to the right of any natural or legal person to access documents upon request as set out in Regulations (EC) No 1049/2001 and (EC) No 1367/2006.
Amendment    112 Proposal for a regulation Article 4 – paragraph 1 – point 1 a (new) Regulation (EC) No 1831/2003 Article 17 – paragraph 2 a (new)
Text proposed by the Commission Amendment   (1a)  In Article 17, the following paragraph is added:   “2a.  The obligation to proactively disseminate information set out in this Article and in line with Articles 38 and 39 of Regulation (EC) No 178/2002, is without prejudice to the right of any natural or legal person to access documents upon request as set out in Regulations (EC) No 1049/2001 and (EC) No 1367/2006.”
Amendment    113 Proposal for a regulation Article 4 – paragraph 1 – point 2 Regulation (EC) No 1831/2003 Article 18 – paragraph 3
Text proposed by the Commission Amendment 3.  In addition to Article 39(2) of Regulation (EC) No 178/2002 and pursuant to Article 39(3) of that Regulation, the Authority may also accept to provide confidential treatment to the following information, the disclosure of which may be deemed, upon verifiable justification, to significantly harm the interests concerned: deleted (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) 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.
Amendment    114 Proposal for a regulation Article 4 – paragraph 1 – point 2 Regulation (EC) No 1831/2003 Article 18 – paragraph 3 a (new)
Text proposed by the Commission Amendment   3a.  The Authority shall apply the principles of Regulation (EC) No 1049/2001 of the European Parliament and of the Council when handling applications for access to documents held by the Authority.
Amendment    115 Proposal for a regulation Article 4 – paragraph 1 – point 2 Regulation (EC) No 1831/2003 Article 18 – paragraph 3 b (new)
Text proposed by the Commission Amendment   3b.  The Member States, the Commission and the Authority shall keep confidential all the information identified as confidential under paragraph 2 except where it is appropriate for such information to be made public in order to protect human health, animal health or the environment. Member States shall handle applications for access to documents received under this Regulation in accordance with Article 5 of Regulation (EC) No 1049/2001.
Amendment    116 Proposal for a regulation Article 5 – paragraph 1 – point 2 Regulation (EC) No 2065/2003 Article 14 – paragraph 1 a (new)
Text proposed by the Commission Amendment   1a.  The obligation to proactively disseminate information set out in paragraph 1 of this Article, in line with Articles 38 and 39 of Regulation (EC) No 178/2002, is without prejudice to the right of any natural or legal person to access documents upon request as set out in Regulations (EC) No 1049/2001 and (EC) No 1367/2006.”
Amendment    117 Proposal for a regulation Article 6 – paragraph 1 – point 2 a (new) Regulation (EC) No 1935/2004 Article 19 – paragraph 2 a (new)
Text proposed by the Commission Amendment   (2a)  In Article 19, the following paragraph is added:   “2a.  The obligation to proactively disseminate information set out in paragraph 1 of this Article, including Article 20 of this Regulation, and Articles 38 and 39 of Regulation (EC) No 178/2002, is without prejudice to the right of any natural or legal person to access document upon request as set by Regulations (EC) No 1049/2001 and (EC) No 1367/2006.”
Amendment    118 Proposal for a regulation Article 6 – paragraph 1 – point 3 Regulation No 1935/2004 Article 20 – paragraph 2 – point a
Text proposed by the Commission Amendment (a)  any information provided in detailed descriptions of starting substances and preparations used to manufacture the substance subject to the authorisation, the composition of preparations, materials or articles in which the applicant intends to use this substance, the manufacturing methods of these preparations, materials or articles, impurities, and migration testing results; deleted
Amendment    119 Proposal for a regulation Article 6 – paragraph 1 – point 3 Regulation No 1935/2004 Article 20 – paragraph 2 – point b
Text proposed by the Commission Amendment (b)  the trademark under which the substance, shall be marketed as well as the tradename of the preparations, material or articles in which it shall be used, where applicable; and, deleted
Amendment    120 Proposal for a regulation Article 7 – paragraph 1 – point 2 Regulation (EC) No 1331/2008 Article 11
Text proposed by the Commission Amendment Where the Commission requests its opinion in accordance with Article 3(2) 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 Article 38, Articles 39to 39f and Article 40 of Regulation (EC) No 178/2002. It shall also make public any request for its opinion as well as any extension of period pursuant to Article 6(1) of this Regulation.”; 1.  Where the Commission requests its opinion in accordance with Article 3(2) 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 Article 38, Articles 39to 39f and Article 40 of Regulation (EC) No 178/2002. It shall also make public any request for its opinion as well as any extension of period pursuant to Article 6(1) of this Regulation.   1a.  The obligation to proactively disseminate information set out in paragraph 1 of this Article, in Article 12 of this Regulation and Articles 38 and 39 of Regulation (EC) No 178/2002, is without prejudice to the right of any natural or legal person to access document upon request as set by Regulations (EC) No 1049/2001 and (EC) No 1367/2006.
Amendment    121 Proposal for a regulation Article 7 – paragraph 1 – point 2 Regulation (EC) No 1331/2008 Article 11 – paragraph 1 b (new)
Text proposed by the Commission Amendment   1b.  The obligation to proactively disseminate information set out in paragraph 1 of this Article, in line with Article 12 of this Regulation and in line with Articles 38 and 39 of Regulation (EC) No 178/2002, is without prejudice to the right of any natural or legal person to access documents upon request as set out in Regulations (EC) No 1049/2001 and (EC) No 1367/2006.
Amendment    122 Proposal for a regulation Article 7 – paragraph 1 – point 3 Regulation (EC) No 1331/2008 Article 12 – paragraph 3 a (new)
Text proposed by the Commission Amendment   3a.  The provisions on active dissemination laid down in Articles 11 and 12 of this Regulation, and Articles 38 and 39 of Regulation (EC) No 178/2002, are without prejudice to the right of access to documents upon request set in Regulation (EC) No 1049/2001.
Amendment    123 Proposal for a regulation Article 8 – paragraph 1 – point 4 a (new) Regulation (EC) No 1107/2009 Article 23 – paragraph 1 – last sentence
Present text Amendment   (4a)  In Article 23, the last sentence of paragraph 1 is replaced by the following: For the purpose of this Regulation, an active substance which fulfils the criteria of a ‘foodstuff’ as defined in Article 2 of Regulation (EC) No 178/2002 shall be considered as a basic substance. “For the purpose of this Regulation, an active substance which fulfils the criteria of a ‘foodstuff’ as defined in Article 2 of Regulation (EC) No 178/2002 shall be considered as an approved basic substance.”
Justification
add: and “approved” This is an amendment of clarification, as many doubts remain on which substances may be considered as basic substances.
Amendment    124 Proposal for a regulation Article 8 – paragraph 1 – point 5 Regulation (EC) No 1107/2009 Article 63 – paragraph 1
Text proposed by the Commission Amendment 1.  In accordance with the conditions and the procedures laid down in Article 39 of Regulation (EC) No 178/2002 and this article, the applicant may request certain information submitted under this Regulation to be kept confidential, accompanied by verifiable justification. 1.  In accordance with the conditions and the procedures laid down in Article 39 of Regulation (EC) No 178/2002 and this Article, except for information that is considered toxicologically, ecotoxicologically or environmentally relevant, the applicant may request certain information submitted under this Regulation to be kept confidential, accompanied by adequate and verifiable justification. The justification shall include verifiable evidence to show that the disclosure of the information might undermine his commercial interests, or the protection of privacy and the integrity of the individual.
Justification
This is a clarification, this is provided for in Article 63 of Regulation 1107/2009.
Amendment    125 Proposal for a regulation Article 8 – paragraph 1 – point 5 Regulation (EC) No 1107/2009 Article 63 – paragraph 2
Text proposed by the Commission Amendment 2.  In addition to Article 39(2) of Regulation (EC) No 178/2002 and pursuant to Article 39(3), confidential treatment may be accepted with respect to the following information, the disclosure of which may be deemed, upon verifiable justification, to significantly harm the interests concerned: deleted (a)  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 these impurities;   (b)  results of production batches of the active substance including impurities; and,   (c)  information on the complete composition of a plant protection product.;
Amendment    126 Proposal for a regulation Article 8 – paragraph 1 – point 5 a (new) Regulation (EC) No 1107/2009 Article 63 – paragraph 3
Present text Amendment   (5a)  in Article 63, paragraph 3 is replaced by the following: 3.  This Article is without prejudice to Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information 3.  This Article is without prejudice to Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information and to Regulations (EC) No 1049/2001 and (EC) No 1367/2006.
Amendment    127 Proposal for a regulation Article 9 – paragraph 1 – point 1 – point a Regulation (EC) No 2015/2283 Article 10 – paragraph 1
Text proposed by the Commission Amendment 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. 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 and the summary of the application publicly available without delay.
Amendment    128 Proposal for a regulation Article 9 – paragraph 1 – point 4 Regulation (EC) No 2015/2283 Article 23 – paragraph 4 a (new)
Text proposed by the Commission Amendment   4a.  The provisions on active dissemination laid down in Article 23 of this Regulation, and Articles 38 and 39 of Regulation (EC) No 178/2002, are without prejudice to the right of access to documents upon request set in Regulation (EC) No 1049/2001.
Amendment    129 Proposal for a regulation Article 9 – paragraph 1 – point 4 Regulation (EC) No 2015/2283 Article 23 – paragraph 4 b (new)
Text proposed by the Commission Amendment   4b.  The Commission may, by means of implementing acts, adopt detailed rules on the implementation of paragraphs 1 to 4 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 30(3).
Justification
Regulation (EU) 2283/2015 foresaw in Article 23 (8) that the Commission may, by means of implementing acts, adopt detailed rules on the implementation of paragraphs 1 to 6. This is required because of the specificities of Novel Foos that can cover aspects that are new and not known today. This provision must remain.
Amendment    130 Proposal for a regulation Article 9 – paragraph 1 – point 4 a (new) Regulation (EU) No 2015/2283 Article 25 – paragraph 1 a (new)
Text proposed by the Commission Amendment   (4a)  In Article 25, the following paragraph is added:   “1a.  The obligation to proactively disseminate the information set out in this Regulation, in line with Articles 38 and 39 of Regulation (EC) No 178/2002, is without prejudice to the right of any natural or legal person to access documents upon request as set out in Regulations (EC) No 1049/2001 and (EC) No 1367/2006.”
Amendment    131 Proposal for a regulation Article 9 a (new)
Text proposed by the Commission	Amendment
	Article 9a
	Transparency of risk management
	1.  The Commission and the Member States shall carry out their risk management activities in the context of the legislative acts referred to in Articles 1 to 9 with a high level of transparency. They shall in particular make public without undue delay:
	(a)  at an early stage of the risk management process, any envisaged the draft risk management measures;
	(b)  the agendas and proceedings, detailed summary reports of meetings, and the draft measures, to be adopted, as appropriate, in the form of delegated or implementing acts, including the results and explanations of votes by individual Member States in committees within the meaning of Regulation (EU) No 182/20111a, including the appeal committees, which assist the Commission in the implementation of [Regulation (EC) No 178/2002, Directive 2001/18/EC, Regulation (EC) No 1829/2003, Regulation (EC) No 1831/2003, Regulation (EC) No 2065/2003, Regulation (EC) No 1935/2004, Regulation (EC) No 1331/2008, Regulation (EC) No 1107/2009 and Regulation No 2015/2283], where and in which the risk management measures are discussed and put to a vote; and
	(c)  the agendas and the detailed minutes of meetings of the Member States working groups in which the risk management measures are discussed;
	2.  For the purposes of paragraph 1, the Commission shall attach to each draft measure to be adopted on in accordance with Article 58 [of the GFL Regulation], Article 30 of Directive 2001/18/EC, Article 35 of Regulation (EC) No 1829/2003, Article 22 of Regulation (EC) No 1831/2003, Article 19 of Regulation (EC) No 2065/2003, Article 23 of Regulation (EC) 1935/2004, Article 14 of Regulation (EC) 1331/2008, Article 79 of Regulation (EC) No 1107/2009, and Articles 30 and 32 of Regulation EU (No) 2015/2283 an explanatory statement comprising:
	(a)  the reasons for and objectives of the measure;
	(b)  the justification of the measure taking into consideration both need and proportionality;
	(c)  the impact of the measure on public and animal health, the environment, on the society and on food manufacturers as indicated by the impact assessment; and
	(d)  the results of any public consultation, including pursuant to Article 9 [the GFL Regulation].
	_______________
	1a 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).

• [1]    Not yet published in the Official Journal.
• [2]    Not yet published in the Official Journal.

EXPLANATORY STATEMENT

1. Background

Following a number of serious food scandals, Regulation (EC) No 178/2002 established the independent European Food Safety Authority with responsibility for scientific risk assessment. Risk management is a matter for the Institutions of the Union, notably the Commission. Today, food safety in the Union is considered the best in the world. Through a Fitness Check, the Commission established that the Regulation met the objectives of ensuring a high level of food safety and harmonisation of the internal market.

Widespread scepticism with regard to GMOs and the associated herbicide glyphosate resulted in a public controversy regarding herbicides and pesticides in general, which gave rise to a citizens’ initiative. In view of the success of this citizens’ initiative, the Commission concluded that there was a need to improve public confidence in risk assessment and pledged to put forward a corresponding legislative proposal.

2. Commission proposal

In April 2018, the Commission submitted to Parliament and the Council a proposal for a recast of Regulation (EC) No 178/2002 comprising the following key points:

-  a tightening of the rules on transparency of the EFSA;

-  stricter rules to guarantee reliability, objectivity and independence of studies used by the EFSA in its risk assessment;

-  improvement of the functioning and governance of the EFSA;

-  greater involvement of the Member States;

-  making the EFSA more attractive to scientific experts;

-  a comprehensive and effective risk communication strategy, involving the Commission, Member States and the EFSA.

In the interests of coherence, eight legal acts relating to the sector are to be harmonised as regards transparency and confidentiality.

3. Rapporteur’s comments

In principle, your rapporteur welcomes the Commission's proposal for a regulation. The EFSA publishes a lot of information but it has to date not been legally obliged to do so. As result, the only way the public can gain access to information from the applications and studies submitted is by asserting the rights conferred under Regulation EC No 1049/2001 on public access to documents. A comparison with other EU agencies and the debate on the authorisation procedures for plant protection products show that the EFSA transparency rules are in need of revision. In addition, the EFSA is finding it increasingly difficult to find experts for the scientific panels.

The proposed amendments, however, are more likely to create new problems than solve existing ones. Moreover, the timing of the publication, the significant shortening of the consultation period and the absence of an impact assessment run counter to the Commission’s better law-making principles.

Your rapporteur is particularly critical of the following:

Lack of an impact assessment

Whereas the REFIT of the basic Regulation referred to the general principles of food law as well as to the rapid alert system and crisis management, the Commission is now proposing amendments to articles which were not covered by REFIT. The proposed transparency rules could seriously damage the innovative strength and competitiveness of the European food industry. It would have been appropriate to consider different options with regard to the time of publication of sensitive data from applications. It is equally hard to understand why the Commission chose not to carry out an impact assessment. Similarly, no impact assessments were carried out for the eight sectoral legislative acts.

The Commission provides for a significant increase (+80 %) in the EFSA’s budget. Should the European legislator, however, not be able to come to an agreement as regards the budget, then the Authority would not be able to fulfil its mandate in accordance with the revised regulation. An impact assessment with different funding models would also have been necessary in this connection.

Timing of the Commission proposal

The Commission essentially justified its proposal with the need to respond to the Citizens’ Initiative ‘Ban glyphosate and protect people and the environment from toxic pesticides’. In March 2018, the European Parliament set up a special committee (PEST) to look into the authorisation procedure and propose possible courses of action. The Commission ignored this process of democratic opinion forming and pre-empted its outcome.

By cutting the consultation period from the usual twelve weeks to eight, the Commission left the stakeholders scant time for consultation. Moreover, it was also only possible to react to general questions but not to the specific plans of the Commission. The publication of the Commission proposal shortly after the completion of the public consultation suggests that the draft regulation had already been finalised and that it was a consultation in name only.

Owing to time constraints in view of the 2019 European elections, there is hardly any possibility for the European Parliament to exercise due diligence and to obtain external expertise. Your rapporteur hopes that this was not the intention.

Rules on transparency

Unlike with the ECHA and EMA, which publish information and underlying studies in relation to applications simultaneously with their scientific opinions, the Commission proposes that in the authorisation procedures under food law such information be published already at the time of the submission of applications. This could, however, have far-reaching consequences for the competitiveness and innovative capacity of applicants. Competitors from third countries could tap into product ideas and realise them already whilst the European authorisation process is still on-going, particularly since innovations in the food sector cannot, as a rule, be protected by patents. The Commission proposal therefore puts important jobs in jeopardy. Moreover, the new rules could lead companies to transfer their research and development activities to third countries. In addition, such early publication might potentially expose the EFSA to public pressure.

As it is, in controversial cases, the EFSA already grants interested parties the opportunity to comment on the studies commissioned as part of a consultation following the publication of its draft scientific opinion. In the case of aspartame, for example, this consultation led to the EFSA reviewing its opinion.

Appointment of members of scientific panels

The involvement of the Member States in the appointment of members of scientific panels through the obligation to nominate numerous experts could result in political interference with the EFSA. Moreover, it is questionable whether all disciplines would be appropriately covered if each Member State issued its own call for expressions of interest. A constant exchange of information between Member States on the state of play in their search for experts would result in a further significant increase in the additional administrative burden, which is already enormous. It would therefore be appropriate to allow Member States to nominate experts but not to oblige them to do so. Ultimately, EFSA should draw up the lists of experts from as many Member States as possible and make the appointments on the basis of such lists.

4. Rapporteur’s amendments

Your rapporteur proposes to bring the EFSA rules on transparency into line with those of other agencies so that non-confidential information from applications, studies and consultation sessions are only made accessible when the EFSA publishes its scientific opinion and not at the time of the submission of the application. This is the only way to eliminate the theft of ideas. Information should only be published if an application is maintained.

The requirement for stringent transparency should also apply in the areas of risk management and risk communication. The Commission and Member States should be required to publish minutes of working group meetings and voting results in standing committees.

The audit obligation should also extend to laboratories in third countries commissioned by European companies to carry out studies. This should fall under the responsibility of the Commission’s Food and Veterinary Office (FVO).

Your rapporteur welcomes the involvement of stakeholder representatives in the EFSA Management Board, as is the case with the ECHA and EMA. However, in view of the broad range of products covered by Regulation 178/2002, your rapporteur considers it necessary to include not one but two representatives of industry (GMOs/plant protection products as well as foodstuffs/additives). This is also envisaged for non-governmental organisations (environment and consumer protection).

5. Conclusions

Regulation (EC) No 178/2002 on general food law is a success story. With it, the EU created the world’s highest food safety standards for its internal market. The Fitness Check of the basic Regulation confirmed this.

The structure and transparency of EFSA should be brought into line with those of other EU agencies. The Commission’s proposals, however, go well beyond the ECHA and EMA rules. This is just as hard to understand as the fact that the Commission intends to envelop the whole of the food sector with new rules liable to threaten the very survival of undertakings simply because of the public discourse on the authorisation procedure for a plant protection product and it intends to do so without the due impact assessment.

The Commission proposal also lacks precision. Many details are to be determined later in the Authority’s internal rules, making the evaluation of the proposals difficult. This is equally true for risk communication, which constitutes an important element if the EU is to restore public confidence in food safety.

OPINION of the Committee on Fisheries (11.10.2018)

for the Committee on the Environment, Public Health and Food Safety

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))

Rapporteur: Ricardo Serrão Santos

SHORT JUSTIFICATION

The rapporteur:

-  considers that it is crucial for EU citizens that the safety of food on the market is guaranteed and that high safety standards continue;

-  stresses the importance of the European Food Safety Authority (EFSA), particularly as a provider of scientific advice to the Commission, Parliament and the Member States;

-  takes a positive view of the Commission proposal to update the General Food Law (GFL) Regulation, particularly where it concerns the clarification of transparency rules for risk assessment and strengthening the guarantees of reliability, objectivity and independence of the studies that EFSA uses in its risk assessment;

-  believes that the conditions must be created under which EU citizens have full confidence in Union agencies and authorities like EFSA, and that this confidence can only be gained and maintained by applying transparent and clear rules and methodologies;

-  stresses that EFSA’s capacity must be increased if it is to achieve a high level of scientific expertise in all its areas of work;

-  believes that in a number of contexts, including the above context, decisions need to be based on the best available scientific knowledge and considers it important to increase EFSA’s capacity by hiring scientists known for their scientific panels;

-  stresses that a risk assessment can only be carried out quickly if a comprehensive and effective risk communication strategy, involving all the parties throughout the risk assessment process and maintaining an open dialogue, is in place;

-  is concerned that, in the Commission’s proposal, fishing, particularly aquaculture, is overlooked, and points out that fishery products are one of the most important and healthiest sources of animal protein, and that the EU is the biggest market for and consumer of such products in the world, and it currently imports 68% of them from third countries;

-  stresses the importance as a food source of fishery products, which were the subject of a scientific opinion, ‘Food from the Oceans’, presented by the Scientific Advice Mechanism’s High Level Group to the Commission in November 2017.

AMENDMENTS

The Committee on Fisheries calls on the Committee on the Environment, Public Health and Food Safety, as the committee responsible, to take into account the following amendments:

Amendment    1 Proposal for a regulation Recital 8 a (new)
Text proposed by the Commission	Amendment
	(8a)  No GMOs should be deliberately released into the environment or placed on the market, as or in products, in contravention of the precautionary principle and when there is no scientific knowledge of the implications for each of the areas concerned (the environment, health, biodiversity, etc.).
Amendment    2 Proposal for a regulation Recital 11
Text proposed by the Commission	Amendment
(11)  Experience shows that the role of the Management Board of the Authority is focussed 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 in the Management Board of the Authority, while providing that those representatives should have experience in particular on risk assessment.	(11)  Experience shows that the role of the Management Board of the Authority is focussed 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 as well as representatives of civil society and industry in the Management Board of the Authority, while providing that those representatives should have experience in particular on risk assessment.
Amendment    3 Proposal for a regulation Article 1 – paragraph 1 – point 1 Regulation (EC) No 178/2002 Article 8a – paragraph 1 – point b
Text proposed by the Commission Amendment (b)  promote consistency and transparency in formulating risk management recommendations; (b)  promote consistency, transparency and clarity in formulating risk management recommendations;
Amendment    4 Proposal for a regulation Article 1 – paragraph 1 – point 2 – point b Regulation (EC) No 178/2002 Article 25 – paragraph 1a – point a
Text proposed by the Commission Amendment a)  two members and the alternate members appointed by the Commission and representing the Commission, with the right to vote. a)  two members and two alternate members, appointed by the Commission and representing the Commission, with the right to vote.
Amendment    5 Proposal for a regulation Article 1 – paragraph 1 – point 2 – point b Regulation (EC) No 178/2002 Article 25 – paragraph 1a – point b
Text proposed by the Commission Amendment b)  one member appointed by the European Parliament, with the right to vote. b)  one member and one additional member, appointed by the European Parliament, with the right to vote.
Amendment    6 Proposal for a regulation Article 1 – paragraph 1 – point 2 – point b Regulation (EC) No 178/2002 Article 25 – paragraph 1a – point c
Text proposed by the Commission Amendment (c)  four members with the right to vote representing civil society and food chain interests namely, one from consumers organisations, one from environmental non-governmental organisations, one from farmers organisations and one from industry organisations. Those members shall be appointed by the Council in consultation with the European Parliament on the basis of a list drawn up by the Commission which includes more names than there are posts to be filled. The list drawn up by the Commission shall be forwarded to the European Parliament, together with the relevant background documents. As quickly as possible and within three months of notification, the European Parliament may submit its views for consideration to the Council, which shall then appoint those members. (c)  six members with the right to vote representing civil society and food chain interests namely, one from consumers organisations, one from environmental non-governmental organisations, one from farmers organisations, one from fisheries and aquaculture organisations, one from the agrochemical industry and one from the food industry. Those members shall be appointed by the Council in consultation with the European Parliament on the basis of a list drawn up by the Commission which includes more names than there are posts to be filled. The list drawn up by the Commission shall be forwarded to the European Parliament, together with the relevant background documents. As quickly as possible and within three months of notification, the European Parliament may submit its views for consideration to the Council, which shall then appoint those members.
Justification
The interests of producers in the field of GMOs and plant protection products, on the one hand, and those of producers of foodstuffs and additives, on the other, are different. Likewise agriculture and fisheries/aquaculture. The Board should also include a representative of fisheries and aquaculture organisations. The Board should therefore also include two separate representatives of industry.
Amendment    7 Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32d – paragraph 1
Text proposed by the Commission Amendment The Commission experts shall perform controls, including audits, to obtain assurance that testing facilities comply with relevant standards for carrying out tests and studies submitted to the Authority as part of an application for an authorisation under Union food law. These controls shall be organised in cooperation with the competent authorities of the Member States. The Commission's Food and Veterinary Office (FVO) experts shall perform controls, including audits, to obtain assurance that testing facilities in the Union and in third countries comply with relevant standards for carrying out tests and studies submitted to the Authority as part of an application for an authorisation under Union food law. These controls shall be organised in cooperation with the competent authorities of the Member States or of the third countries concerned.
Justification
The Food and Veterinary Office works to assure effective control systems and to evaluate compliance with EU standards within the EU, and in third countries exporting to the EU. This is done mainly through inspections carried out by the Food and Veterinary Office in the Member States and in third countries exporting to the EU.
Amendment    8 Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39e – paragraph 2
Text proposed by the Commission Amendment 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 there is an overriding public interest. 2.  Notwithstanding paragraph 1, disclosure of names and addresses of natural persons involved in testing 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 there is an overriding public interest.

PROCEDURE – COMMITTEE ASKED FOR OPINION

Title	Transparency and sustainability of the EU risk assessment in the food chain
References	COM(2018)0179 – C8-0144/2018 – 2018/0088(COD)
Committee responsible        Date announced in plenary	ENVI 28.5.2018
Opinion by        Date announced in plenary	PECH 28.5.2018
Rapporteur        Date appointed	Ricardo Serrão Santos 31.5.2018
Discussed in committee	20.6.2018	29.8.2018
Date adopted	9.10.2018
Result of final vote	+: –: 0:	21 1 0
Members present for the final vote	Marco Affronte, Clara Eugenia Aguilera García, Renata Briano, Alain Cadec, David Coburn, Richard Corbett, Diane Dodds, Linnéa Engström, João Ferreira, Sylvie Goddyn, Mike Hookem, Ian Hudghton, Carlos Iturgaiz, Werner Kuhn, António Marinho e Pinto, Barbara Matera, Gabriel Mato, Norica Nicolai, Liadh Ní Riada, Ulrike Rodust, Annie Schreijer-Pierik, Remo Sernagiotto, Ricardo Serrão Santos, Isabelle Thomas, Ruža Tomašić, Jarosław Wałęsa, Peter van Dalen
Substitutes present for the final vote	Izaskun Bilbao Barandica, José Blanco López, Nicola Caputo, Ole Christensen, Rosa D’Amato, Norbert Erdős, Giuseppe Ferrandino, John Flack, Elisabetta Gardini, Jens Gieseke, Anja Hazekamp, Maria Heubuch, Czesław Hoc, Yannick Jadot, France Jamet, Seán Kelly, Verónica Lope Fontagné, Linda McAvan, Francisco José Millán Mon, Ana Miranda, Nosheena Mobarik, Cláudia Monteiro de Aguiar, Rolandas Paksas, Maria Lidia Senra Rodríguez, Daciana Octavia Sârbu, Nils Torvalds
Substitutes under Rule 200(2) present for the final vote	Klaus Buchner

FINAL VOTE BY ROLL CALL IN COMMITTEE ASKED FOR OPINION

21	+
ALDE	António Marinho e Pinto, Norica Nicolai
ECR	Nosheena Mobarik, Remo Sernagiotto, Ruža Tomašić
EFDD	Rosa D'Amato
ENF	Sylvie Goddyn
PPE	Alain Cadec, Carlos Iturgaiz, Werner Kuhn, Gabriel Mato, Francisco José Millán Mon
S&D	Clara Eugenia Aguilera García, Renata Briano, Ole Christensen, Giuseppe Ferrandino, Ulrike Rodust, Ricardo Serrão Santos
VERTS/ALE	Marco Affronte, Klaus Buchner, Linnéa Engström

1	-
GUE/NGL	Anja Hazekamp

0	0

Key to symbols:

+  :  in favour

-  :  against

0  :  abstention

OPINION of the Committee on Legal Affairs (15.10.2018)

for the Committee on the Environment, Public Health and Food Safety

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))

Rapporteur for opinion: Pavel Svoboda

SHORT JUSTIFICATION

Assessing the proposal

This long awaited European Commission proposal for the disclosure of confidential industry studies used in the European Food Safety Authority’s (EFSA) risk assessments contains positive elements but fails to enable meaningful independent scrutiny of the data.

The proposal amends Regulation 178/2002 (hereafter the General Food Law (GFL)) and several related Regulations and Directives. The rapporteur considers that there are some positive changes in the proposal concerning transparency, however, he has also identified a number a provisions that need to be changed or strengthened in order to achieve what the European Commission intends on doing.

To that aim, the rapporteur has adopted a comprehensive stance, building on the Commission’s proposal in order to fully implement a much needed reform of the risk assessment process conducted by EFSA, thus allowing the EU as a whole to abide by the Aarhus Convention (Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters).

The two main features of the proposal, automatic and pro-active publication of data in a machine-readable format and the creation of a register of studies aimed at preventing industry cherry-picking of favourable studies, along with some minor changes with regard to risk communication, consultation of third parties, reform of the composition of EFSA’s management board are positive steps in the right direction.

The rapporteur considers however, that if the proposed industry authorisation for any publication and use of independent data cross checks is indeed to be mandated, the usefulness of these two provisions will be rather limited. Indeed, the proposal introduces a new provision stating that the disclosure of scientific data and studies regarding applications for authorisations under food law, authorisations for GMOs or additives in food, ‘shall be without prejudice to’ ‘any intellectual property right which may exist over documents or their content’. Furthermore, the proposal introduces a presumption with regard to categories of information that the disclosure of such information ‘may be deemed to significantly harm commercial interests’.

The impossibility of re-using the data without permission would compromise the possibility to reduce the overall number of toxicity studies, hinder the public scrutiny of the results, including a better understanding of the potential adverse effects on health and the environment. The peer review process that is essential to ensure the full effectiveness of the risk assessment conducted is essentially at risk.

Notwithstanding the changes with a positive effect on transparency in the proposal, the rapporteur deems necessary to amend the Commission’s proposal in order to maintain and expand the current level of transparency under European Union food law with regard to several categories of information, within the several directives that are amended under this proposal.

A real overhaul of the EU’s risk assessment in the food chain

The rapporteur does not consider that it is reasonable to “weigh up the relevant rights of the public to transparency in the risk assessment process, including those flowing from the Aarhus Convention, against the rights of commercial applicants” as stated in the European Commission’s proposal. Nor that the EU should grant more protection to commercial parties than the Aarhus legislation already provides for (implemented through Regulations 1049/2001 and 1367/2006). He is also firmly opposed to the use of the EU taxpayers money granted to EFSA to give advice to the private companies that are applicants.

The rapporteur aims to make transparency the rule and confidentiality the exception. The exceptions to the principle of transparency must be interpreted strictly to fully guarantee public and independent scrutiny. That translates into several amendments made to the GFL regulation.

Proposed amendments to the proposal within the sectorial regulations targeted are set to close the existing loopholes in the obligation to disclose information gathered when there is an “overriding public interest in disclosure” related to food safety. Then he considers appropriate to lay down in the GFL a horizontal and non-exhaustive list of information items which can never be kept secret.

AMENDMENTS

The Committee on Legal Affairs calls on the Committee on the Environment, Public Health and Food Safety, as the committee responsible, to take into account the following amendments:

Amendment    1 Proposal for a regulation Recital 2
Text proposed by the Commission	Amendment
(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. Risk communication is an essential part of the risk analysis process.	(2)  Regulation (EC) No 178/2002 defines “risk analysis” as a process consisting of three distinct but 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. Risk communication is an essential part of the risk analysis process and presupposes the interactive exchange of information and opinions throughout the risk analysis process as regards hazards and risks, risk-related factors and risk perceptions amongst risk assessors, risk managers, consumers, feed and food businesses, the academic community, including the explanation of risk assessment findings and the basis of risk management decisions.
Amendment    2 Proposal for a regulation Recital 3
Text proposed by the Commission	Amendment
(3)  The evaluation of Regulation (EC) No 178/200221 , (“Fitness Check of the General Food Law”), found that risk communication is overall, not considered to be effective enough, which has an impact on consumers’ confidence on the outcome of the risk analysis process.	(3)  The evaluation of Regulation (EC) No 178/200221 , (“Fitness Check of the General Food Law”), found that risk communication is overall, not considered to be effective enough, which can have a negative an impact on the outcome of the risk analysis process.
__________________	__________________
21 Commission Staff Working Document, “The REFIT evaluation of the General Food Law (Regulation (EC) No 178/2002)”, SWD(2018)38 final, dated 15.1.2018.	21 Commission Staff Working Document, “The REFIT evaluation of the General Food Law (Regulation (EC) No 178/2002)”, SWD(2018)38 final, dated 15.1.2018.
Amendment    3 Proposal for a regulation Recital 4
Text proposed by the Commission	Amendment
(4)  It is therefore necessary to ensure a comprehensive and continuous risk communication process throughout risk analysis, involving Union and national risk assessors and risk managers. That process should be combined with an open dialogue between all interested parties to ensure the coherence and consistency within the risk analysis process.	(4)  It is therefore necessary to ensure a comprehensive, transparent, independent and continuous risk communication process throughout risk analysis, involving Union and national risk assessors and risk managers. That process should be capable of contributing to a participatory and open dialogue between all interested parties to ensure prevalence of public interest only, accuracy, comprehensiveness, transparency and consistency of the risk analysis process.
Amendment    4 Proposal for a regulation Recital 5
Text proposed by the Commission	Amendment
(5)  Particular emphasis should be placed on explaining in a coherent, appropriate and timely manner not only risk assessment findings themselves but also how these are utilized to help inform risk management decisions along with other legitimate factors, where relevant.	(5)  Particular emphasis should be placed on explaining in an accurate, clear and timely manner not only risk assessment findings themselves but also how these are utilized to help inform risk management decisions along with other legitimate factors, where relevant.
Amendment    5 Proposal for a regulation Recital 6
Text proposed by the Commission	Amendment
(6)  To this effect, it is necessary to establish general objectives and principles of risk communication, taking into account the respective roles of risk assessors and managers.	(6)  To this effect, 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.
Amendment    6 Proposal for a regulation Recital 7
Text proposed by the Commission	Amendment
(7)  Based on these general objectives and principles, a general plan on risk communication should be established in close cooperation with the Authority and the Member States, and following relevant public consultations.	(7)  Based on these general objectives and principles, a general plan on risk communication in real time should be established in close cooperation with the Authority and the Member States, and following the organisation of the relevant public consultations.
Amendment    7 Proposal for a regulation Recital 8
Text proposed by the Commission	Amendment
(8)  The general plan should identify the key factors to be taken into account when risk communications’ activities are considered, such as the different levels of risk, the nature of the risk and its potential public health impact, who and what are directly or indirectly affected by the risk, the levels of risk exposure, the ability to control risk and other factors that influence risk perception including the level of urgency as well as the applicable legislative framework and relevant market context. The general plan should also identify the tools and channels to be used and should establish appropriate mechanisms to ensure coherent risk communication.	(8)  The general plan should identify the key factors to be taken into account when risk communications’ activities are considered, such as the different levels of hazard and risk, the nature of the hazard and its potential environmental and public health and environmental impacts, what groups of the population can directly or indirectly be affected by the risk, the levels of risk exposure, the ability to control exposure and risk, the ways of managing it and other factors that influence risk understanding including the level of urgency as well as the applicable legislative framework. The general plan should also identify the tools and channels to be used and should establish appropriate, exhaustive and expeditious mechanisms to ensure accurate risk communication.
Amendment    8 Proposal for a regulation Recital 10
Text proposed by the Commission	Amendment
(10)  It is appropriate to align the composition of the Management Board of the Authority to the Common Approach on decentralised agencies, in accordance with the Joint Statement of the European Parliament, the Council of the European Union and the European Commission on decentralised agencies of 201222.	(10)  It is appropriate to align the composition of the Management Board of the Authority to the Common Approach on decentralised agencies, in accordance with the Joint Statement of the European Parliament, the Council of the European Union and the European Commission on decentralised agencies of 201222, while also taking into account the withdrawal of the United Kingdom from the EU and the legal effects resulting therefrom.
_________________	_________________
22 https://europa.eu/european-union/sites/europaeu/files/docs/body/joint_statement_and_common_approach_2012_en.pdf.	22 https://europa.eu/european-union/sites/europaeu/files/docs/body/joint_statement_and_common_approach_2012_en.pdf.
Amendment    9 Proposal for a regulation Recital 11
Text proposed by the Commission	Amendment
(11)  Experience shows that the role of the Management Board of the Authority is focussed 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 in the Management Board of the Authority, while providing that those representatives should have experience in particular on risk assessment.	(11)  Experience shows that the role of the Management Board of the Authority is focussed 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, including representatives of civil society and industry, in the Management Board of the Authority, while providing that those representatives should have experience in particular in assessing and managing risks and problems and that they have no conflict of interest with the applicants.
Amendment    10 Proposal for a regulation Recital 12
Text proposed by the Commission	Amendment
(12)  The Management Board should be selected in such a way as to secure the highest standards of competence and a broad range of relevant experience available amongst the representatives of the Member States, the European Parliament and the Commission.	(12)  The Management Board should be selected in such a way as to secure the highest standards of competence and commitment to the protection of health and the environment and a broad range of relevant experience available amongst the representatives of the Member States, the European Parliament and the Commission.
Amendment    11 Proposal for a regulation Recital 13
Text proposed by the Commission	Amendment
(13)  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 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.	(13)  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 Scientific Panels. In order to tackle this phenomenon more effectively, the system has thus to be strengthened and promoted, and Member States should take a more active role to ensure that a sufficient pool of experts is available, by undertaking support actions and using incentives and rewards to increase the level of participation and the degree of interest in seeking to engage in it, to meet the needs of the Union risk assessment system in terms of high level of scientific expertise, independence and multidisciplinary expertise.
Amendment    12 Proposal for a regulation Recital 14
Text proposed by the Commission	Amendment
(14)  To preserve the independence of the risk assessment from risk management and from other interests at Union level, it is appropriate that the nomination of the members of the Scientific Panels by the Member States, their selection by the Executive Director of the Authority and their appointment by the Management Board of the Authority are based on strict criteria ensuring the excellence and independence of the experts while ensuring the required multidisciplinary expertise for each Panel. It is also essential to this end that the Executive Director whose function is to defend EFSA’s interests and in particular the independence of its expertise has a role in the selection and appointment of those scientific experts. Further measures should also be put in place to ensure that scientific experts have the means to act independently.	(14)  preserve the independence of the risk assessment from risk management and from vested private interests at Union level, it is appropriate that the nomination of the members of the Scientific Panels by the Member States, their selection by the Executive Director of the Authority and their appointment by the Management Board of the Authority are based on strict, transparent criteria ensuring the excellence and independence of the experts while ensuring the required multidisciplinary expertise for each Panel. It is also essential to this end that the Executive Director whose function is to safeguard EFSA’s accountability, and in particular the independence of its expertise, has a role in excluding scientific experts who oppose the publication of their name or who have conflicts of interest, from risk assessment. Adequate budgetary measures should be put in place to ensure that scientific experts have the means to act independently. To this effect, it is necessary to implement new and adequate budgetary measures.
Amendment    13 Proposal for a regulation Recital 16
Text proposed by the Commission	Amendment
(16)  Authorisations procedures are based on the principle that it is for the applicant to prove that the subject matter of an authorisation procedure complies with Union safety requirements given the scientific knowledge in its possession. This principle is based on the premise that public health is better protected when the burden of proof is on the applicant since it has to prove that a particular subject matter is safe prior to its placing on the market, instead of the public authorities having to prove that a subject matter is unsafe in order to be able to ban it from the market. Moreover, public money should not be used to commission costly studies that will in the end help the industry to place a product on the market. According to this principle and in accordance with applicable regulatory requirements, in support of applications for an authorisation under Union sectoral food law applicants are required to submit relevant studies, including tests, to demonstrate the safety and in some cases the efficacy of a subject matter.	(16)  Authorisations procedures are based on the principle that it is for the applicant to prove that the subject matter of an authorisation procedure complies with Union safety requirements given the scientific knowledge in its possession. This principle is based on the premise that public health and the environment are better protected when the burden of proof is on the applicant since it has to prove that a particular subject matter is safe prior to its placing on the market, instead of the public authorities having to prove that a subject matter unsafe in order to be able to ban it from the market. Moreover, public money should not be used to commission costly studies that will in the end help the industry to place a product on the market. According to this principle and in accordance with applicable regulatory requirements, in support of applications for an authorisation under Union sectoral food law applicants are required to submit relevant studies, including tests, to demonstrate the safety and in some cases the efficacy of a subject matter.
Amendment    14 Proposal for a regulation Recital 17
Text proposed by the Commission	Amendment
(17)  Provisions exist on the content of applications for authorisations. It is essential that the application for authorisation submitted to the Authority for its risk assessment meets the applicable specifications to ensure the best quality scientific assessment by the Authority. Applicants and in particular small- and medium-sized enterprises do not always have a clear understanding of these specifications. It should be thus appropriate that the Authority provides advice to a potential applicant, upon request, on the applicable rules and the required content of an application for authorisation, before an application is formally submitted, while not entering into the design of the studies to be submitted that remain the applicant’s responsibility. To ensure the transparency of this process, the advice of the Authority should be made public.	(17)  Provisions exist on the content of applications for authorisations. It is essential that the application for authorisation submitted to the Authority for its risk assessment meets the applicable specifications to ensure the best quality scientific assessment by the Authority. Applicants and in particular small- and medium-sized enterprises do not always have a clear understanding of these specifications. It should be thus appropriate that the Authority provides advice to a potential applicant, upon request, on the applicable rules and the required content of an application for authorisation, before an application is formally submitted, while not entering into the design of the studies to be submitted that remain the applicant’s responsibility. To ensure the transparency of this process and provide wide and non-discriminatory access to information, the advice of the Authority should be made public.
Amendment    15 Proposal for a regulation Recital 18
Text proposed by the Commission	Amendment
(18)  The Authority should have knowledge of the subject matter of all studies performed by an applicant with a view to a future application for an authorisation under Union food law. To this end, it is necessary and appropriate that business operators commissioning the studies and laboratories carrying them out notify those studies to the Authority when commissioned. Information about the notified studies should be made public only once a corresponding application for authorisation has been made public in accordance with the applicable rules on transparency.	(18)  The Authority should have knowledge of the subject matter of all studies performed by an applicant with a view to a future application for an authorisation under Union food law. To this end, it is necessary and appropriate that business operators commissioning the studies and laboratories carrying them out notify those studies to the Authority when commissioned. Information about the notified studies should be made public only once a corresponding application for authorisation or renewal has been submitted and the Authority has published its official scientific opinion.
Amendment    16 Proposal for a regulation Recital 20
Text proposed by the Commission	Amendment
(20)  There are certain public concerns about the Authority’s assessment in the area of authorisation being primarily based on industry studies. The Authority already makes 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 ensuring that the Authority can have access to all relevant scientific data and studies available on a subject matter of an authorisation procedure, it is appropriate to provide for a 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 when the studies submitted by industry included in an application for authorisation are made public, under the transparency rules of this Regulation.	(20)  There are public concerns about the Authority’s assessment in the area of authorisation being primarily based on industry studies. The Authority already makes 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 ensure that the Authority includes all relevant scientific data and studies available on a subject matter of an authorisation procedure, it is appropriate to provide for a public consultation, once a corresponding application for authorisation or renewal has been made public, in order to identify whether other relevant scientific data or studies are available.
Amendment    17 Proposal for a regulation Recital 21
Text proposed by the Commission	Amendment
(21)  Studies, including tests, submitted by business operators in support of applications for authorisations under Union sectoral food law 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 may arise in some cases and this is why national systems are in place to verify such compliance. It is appropriate to provide an additional level of guarantees to reassure the general public on the quality of studies and to lay down an enhanced auditing system whereby Member State controls on the implementation of those principles by the laboratories carrying out such studies and tests would be verified by the Commission.	(21)  Studies, including tests, submitted by business operators in support of applications for authorisations under Union sectoral food law usually refer to internationally recognised principles, which provide a uniform basis for their quality in particular in terms of reproducibility of results. However, non-compliance with the applicable standards may arise and this is why national systems are in place to verify such compliance. In order to ensure the quality of studies it is appropriate to enhance the auditing system whereby Member States control and ensure the implementation of those principles by the laboratories carrying out such studies and tests and whereby Member States’ controls are to be verified by the Commission.
Amendment    18 Proposal for a regulation Recital 21 a (new)
Text proposed by the Commission	Amendment
	(21 a)  Sufficient flexibility must be built into the process so that new insights into serious health adverse effects can be promptly taken into consideration, even when they are not specifically covered by regulatory data requirements.
Amendment    19 Proposal for a regulation Recital 22
Text proposed by the Commission	Amendment
(22)  Food safety is a sensitive matter of prime interest for all Union citizens. While maintaining the principle that the burden is on the industry to prove compliance with Union requirements, it is important to establish an additional verification tool to address specific cases of high societal importance where there is a controversy on safety issues, namely the commissioning of additional studies with the objective of verifying evidence used in the context of risk assessment. Considering that it would be financed by the Union budget and that the use of this exceptional verification tool should remain proportionate, the Commission should be responsible for triggering the commissioning of such verification studies. Account should be taken of the fact that in some specific cases the studies commissioned may need to have a wider scope than the evidence at stake (for example new scientific developments becoming available).	(22)  Food safety is a sensitive matter of prime interest for all Union citizens. While maintaining the principle that the burden is on the industry to prove compliance with Union requirements, it is important to establish an additional verification tool to address specific cases of high societal importance where there is a controversy on safety issues, namely the commissioning of additional studies with the objective of verifying evidence used in the context of risk assessment. Considering that it would be financed by the Union budget and that the use of this exceptional verification tool should remain proportionate, the Authority should be responsible for triggering the commissioning of such verification studies. Account should be taken of the fact that in some specific cases the studies commissioned may need to have a wider scope than the evidence at stake (for example new scientific developments becoming available).
Amendment    20 Proposal for a regulation Recital 23
Text proposed by the Commission	Amendment
(23)  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 agri-food chain, is not always perceived as fully transparent. This is also partly due to the different transparency and confidentiality rules that are laid down not only in Regulation (EC) No 178/2002 but also in other Union legislative acts covering the agri-food chain. Their interplay can impact on the acceptability of the risk assessment by the general public.	(23)  The Fitness Check of the General Food Law demonstrated that the Union has promoted a considerable number of measures to protect the quality and safety of food and products (Regulation (EC) No 2073/2005; Regulation (EC) No 853/2004; Regulation (EC) No 854/2004; and in particular Recital 12 of Directive 2009/128/EC) and, although the Authority has made considerable progress in terms of transparency, the risk assessment process, especially in the context of authorisation procedures covering the agri-food chain, is not yet fully transparent.
Amendment    21 Proposal for a regulation Recital 23 a (new)
Text proposed by the Commission	Amendment
	(23a)  The Aarhus Convention establishes a number of rights of the public with regard to the environment. The Convention provides for the right of everyone to receive environmental information that is held by public authorities, the right to participate in environmental decision-making, and the right to review procedures to challenge public decisions that have been made without respecting the two aforementioned rights or environmental law in general.
Amendment    22 Proposal for a regulation Recital 24
Text proposed by the Commission	Amendment
(24)  The European Citizens’ Initiative “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 application23 .	(24)  As a Party to the Aarhus Convention, the Union has recognized that, in the field of the environment, improved access to information and public participation in decision-making enhance the quality and the implementation of decisions, contribute to public awareness of environmental issues, give the public the opportunity to express its concerns and enable public authorities to take due account of such concerns. The European Citizens’ Initiative “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 application23 .
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23 Communication from the Commission on the ECI “Ban glyphosate and protect people and the environment from toxic pesticides”, C(2017) 8414 final.	23 Communication from the Commission on the ECI “Ban glyphosate and protect people and the environment from toxic pesticides”, C(2017) 8414 final.
Amendment    23 Proposal for a regulation Recital 25
Text proposed by the Commission	Amendment
(25)  It is therefore necessary to strengthen the transparency of the risk assessment process in a proactive manner. Public access to all scientific data and information supporting requests for authorisations under Union food law as well as other requests for scientific output should be ensured, as early as possible in the risk assessment process. However, this process should be without prejudice to existing intellectual property rights or to any provisions of Union food law protecting the investment made by innovators in gathering the information and data supporting relevant applications for authorisations.	(25)  To further the accountability and to regain public support for decisions of the Authority and in order to ensure the liability of the Authority, it is therefore necessary to strengthen the transparency and clarity of the risk assessment process in a proactive manner. In order to ensure public scrutiny, public access to all scientific data and information supporting requests for authorisations under Union food law as well as other requests for scientific output should be ensured, as early as possible in the risk assessment process.
Amendment    24 Proposal for a regulation Recital 27
Text proposed by the Commission	Amendment
(27)  To determine what level of disclosure strikes the appropriate balance, the relevant rights of the public to transparency in the risk assessment process, should be weighted up against the rights of commercial applicants, taking into account the objectives of Regulation (EC) No 178/2002.	(27)  The present Regulation intends to ensure transparency in the risk assessment process and give the fullest possible effect to the right of the public to transparency of information and access to documents of the Authority and is to be read in conjunction with Regulation No 1049/2001 and 1367/2006.
Amendment    25 Proposal for a regulation Recital 27 a (new)
Text proposed by the Commission	Amendment
	(27a)  The provisions on active dissemination laid down in this Regulation are not meant to limit, in any manner, the scope of the rights provided for by Regulation (EC) No 1049/2001 and (EC) No 1367/2006.
Amendment    26 Proposal for a regulation Recital 28
Text proposed by the Commission	Amendment
(28)  Accordingly and with respect to the procedures governing requests for authorisation procedures provided in Union food law, experience gained so far has shown that certain information items are generally considered sensitive and should remain confidential across the different sectoral authorisation procedures. It is appropriate to lay down in Regulation (EC) No 178/2002 a horizontal list of information items whose disclosure may be considered to significantly harm the commercial interests concerned and should not therefore be disclosed to the public, (“general horizontal list of confidential items”). Only in very limited and exceptional circumstances relating to foreseeable health effects and urgent needs to protect human health, animal health or the environment, such information should be disclosed.	(28)  Any information having a direct impact on health or the environment should therefore always be made public. It is appropriate to lay down, in Regulation (EC) No 178/2002, an exhaustive horizontal list of information items which may be kept confidential as they would significantly undermine the protection of commercial interest. However, it should only be possible for this information to be kept secret if the company opposing its dissemination can verifiably prove that the proactive disclosure of the information item would significantly undermine its commercial interests (“general horizontal list of confidential items”). The exceptions to the principle of transparency must be interpreted strictly. However, even if the disclosure of the information is considered to undermine the commercial interests of an economic operator, the information should, in case there is an overriding public interest in the disclosure, not be kept confidential as the interests of public health prevail over commercial interests. It is appropriate to lay down, in Regulation (EC)No178/2002, a horizontal exhaustive list of information items for which it should not be possible to keep them confidential, since they relate to circumstances where an overriding public interest in their disclosure is deemed to exist.
Amendment    27 Proposal for a regulation Recital 30
Text proposed by the Commission	Amendment
(30)  It is also necessary to set out specific requirements with respect to the protection of personal data for the purposes of the transparency of the risk assessment process taking into account Regulation (EC) No 45/2001 of the European Parliament and of the Council24 and Regulation (EU) 2016/679 of the European Parliament and of the Council25 . 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.	(30)  It is also necessary to refer, for the protection and confidentiality of personal data for the purposes of the transparency of the risk assessment process, to regulation (EC) No 45/2001 of the European Parliament and of the Council and Regulation (EU) 2016/679 of the European Parliament and of the Council25 . 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. For the purpose of ensuring the transparency, independence, sustainability and reliability of the risk assessment process, in particular to avoid conflicts of interest, it is considered necessary and proportionate to publish the names of any individual designated by the Authority to contribute to the Authority’s decision making process, including in the context of the adoption of guidance documents.
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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).	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).	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).
Amendment    28 Proposal for a regulation Recital 31
Text proposed by the Commission	Amendment
(31)  For the purposes 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 and software packages should be developed. In order to ensure uniform conditions for the implementation of Regulation (EC) No 178/2002 with regard to the adoption of standard data formats and software packages, 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 Council26.	(31)  For the purposes 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 and software packages should be developed. In order to ensure uniform and harmonised conditions for the implementation of Regulation (EC) No 178/2002 with regard to the adoption of standard data formats and software packages, 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 Council26.
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26 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).	26 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    29 Proposal for a regulation Recital 32
Text proposed by the Commission	Amendment
(32)  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.	(32)  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 a way that ensures complete security.
Amendment    30 Proposal for a regulation Recital 33
Text proposed by the Commission	Amendment
(33)  Furthermore, in order to assess the effectiveness and efficiency of the different provisions applying to the Authority, it is also appropriate to provide for a Commission evaluation of the Authority, in accordance with the Common Approach on Decentralised Agencies. The evaluation should, in particular, review the procedures for selecting the members of Scientific Committee and Panels, for their degree of transparency, cost-effectiveness, and suitability to ensure independence and competence, and to prevent conflicts of interests.	(33)  Furthermore, in order to assess the effectiveness and efficiency of the different provisions applying to the Authority, it is also appropriate to provide for a Commission evaluation of the Authority, in accordance with the Common Approach on Decentralised Agencies. The evaluation should, in particular, review the procedures for selecting the members of Scientific Committee and Panels, for their degree of transparency, cost-effectiveness, and suitability to ensure independence, vigilance and competence, and to prevent conflicts of interests.
Amendment    31 Proposal for a regulation Recital 35
Text proposed by the Commission	Amendment
(35)  For the purposes of ensuring transparency of the risk assessment process, it is also necessary to extend the scope of Regulation (EC) No 178/2002, currently limited to food law, to also cover applications for authorisations in the context of Regulation (EC) No 1831/2003 as regards feed additives, Regulation (EC) No 1935/2004 as regards food contact materials and Regulation (EC) No 1107/2009 as regards plant protection products.	(35)  For the purposes of ensuring the transparency and independence of the risk assessment process, it is also necessary to extend the scope of Regulation (EC) No 178/2002, currently limited to food law, to also cover applications for authorisations in the context of Regulation (EC) No 1831/2003 as regards feed additives, Regulation (EC) No 1935/2004 as regards food contact materials and Regulation (EC) No 1107/2009 as regards plant protection products.
Amendment    32 Proposal for a regulation Recital 36
Text proposed by the Commission	Amendment
(36)  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, including those flowing from the Aarhus Convention35, against the rights of commercial applicants, taking into account the specific objectives of sectoral Union legislation as well as experienced gained. Accordingly, it is necessary to amend Directive 2001/18/EC, Regulation (EC) No 1829/2003, Regulation (EC) No 1831/2003, Regulation (EC) No 1935/2004 and Regulation (EC) No 1107/2009 to provide for additional confidential items to those set out in Regulation (EC) No 178/2002.	(36)  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, including those flowing from the Aarhus Convention35, against the rights of commercial applicants, taking into account the specific objectives of sectoral Union legislation as well as experienced gained, while, however, bearing in mind that, where there are specific grounds for concern about public welfare and public health, public interest prevails over commercial interests. Accordingly, it is necessary to amend Directive 2001/18/EC, Regulation (EC) No 1829/2003, Regulation (EC) No 1831/2003, Regulation (EC) No 1935/2004 and Regulation (EC) No 1107/2009 to provide for additional confidential items to those set out in Regulation (EC) No 178/2002.
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35 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).	35 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).
Amendment    33 Proposal for a regulation Recital 37
Text proposed by the Commission	Amendment
(37)  In order to further strengthen the link between risk assessors and risk managers at Union and national levels as well as the coherence and consistency of risk communication, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission to adopt a general plan on risk communication on matters covering the agri-food chain. It is of particular importance that the Commission carries 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.	(37)  In order to safeguard the independence of the risk assessment and risk management stages at Union and national levels as well as the accuracy and consistency of risk communication, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission to adopt a general plan on risk communication on matters covering the agri-food chain. It is of particular importance that the Commission carries 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.
Amendment    34 Proposal for a regulation Recital 38
Text proposed by the Commission	Amendment
(38)  In order to enable the Authority and the business operators to adapt to the new requirements while ensuring that the Authority continues its smooth operation, it is necessary to provide for transitional measures for the application of this Regulation.	(38)  In order to enable the Authority, Member States, the Commission and the business operators to adapt to the new requirements while ensuring that the Authority continues its smooth operation, it is necessary to provide for transitional measures for the application of this Regulation.
Amendment    35 Proposal for a regulation Article 1 – paragraph 1 – point 1 Regulation (EC) No 178/2002 Article 8a – paragraph 1 – point a
Text proposed by the Commission Amendment (a)  promote awareness and understanding of the specific issues under consideration during the entire risk analysis process; (a)  promote transparency, clarity, awareness and understanding of the specific issues under consideration during the entire risk analysis and management processes;
Amendment    36 Proposal for a regulation Article 1 – paragraph 1 – point 1 Regulation (EC) No 178/2002 Article 8a – paragraph 1 – point b
Text proposed by the Commission Amendment (b)  promote consistency and transparency in formulating risk management recommendations; (b)  promote a high level of health and environmental protection, maximum reliability and transparency in formulating risk management recommendations;
Amendment    37 Proposal for a regulation Article 1 – paragraph 1 – point 1 Regulation (EC) No 178/2002 Article 8a – paragraph 1 – point c
Text proposed by the Commission Amendment c)  provide a sound basis for understanding risk management decisions; c)  provide a scientific basis for identifying the best decisions on risk management;
Amendment    38 Proposal for a regulation Article 1 – paragraph 1 – point 1 Regulation (EC) No 178/2002 Article 8a – paragraph 1 – point d
Text proposed by the Commission Amendment (d)  foster public understanding of the risk analysis process so as to enhance confidence in its outcome; (d)  foster public understanding of the risk analysis process so as to enhance accountability in its outcome, and restore consumer trust in the Union and its institutions;
Amendment    39 Proposal for a regulation Article 1 – paragraph 1 – point 1 Regulation (EC) No 178/2002 Article 8a – paragraph 1 – point f
Text proposed by the Commission Amendment (f)  ensure appropriate exchange of information with interested parties in relation to risks associated with the agri-food chain. (f)  ensure appropriate exchange of information with interested parties in relation to risks associated with the agri-food chain and strategies to avoid them.   (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)
Amendment    40 Proposal for a regulation Article 1 – paragraph 1 – point 1 Regulation (EC) No 178/2002 Article 8a – paragraph 1 – point f a (new)
Text proposed by the Commission Amendment   (fa) combat sources and dissemination of false and misleading information;
Amendment    41 Proposal for a regulation Article 1 – paragraph 1 – point 1 Regulation (EC) No 178/2002 Article 8b – paragraph 1 – point b
Text proposed by the Commission Amendment 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; b)  constantly provide up-to-date and 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;
Amendment    42 Proposal for a regulation Article 1 – paragraph 1 – point 1 Regulation (EC) No 178/2002 Article 8b – paragraph 1 – point c
Text proposed by the Commission Amendment c)  take into account risk perceptions; c)  take into account the level of risk, its possible consequences and risk perceptions;
Amendment    43 Proposal for a regulation Article 1 – paragraph 1 – point 1 Regulation (EC) No 178/2002 Article 8b – paragraph 1 – point d
Text proposed by the Commission Amendment d)  facilitate understanding and dialogue amongst all interested parties; and, d)  facilitate understanding, dialogue and cooperation amongst all interested parties, such as consumers and consumer associations, environmental groups, animal welfare organisations, health organisations, citizens’ associations, scientific research centres, trade unions and also cooperatives, associations of producers and farmers, representatives of small and medium-sized enterprises, and the research and innovation sectors; and,
Amendment    44 Proposal for a regulation Article 1 – paragraph 1 – point 1 Regulation (EC) No 178/2002 Article 8b – paragraph 1 – point e
Text proposed by the Commission Amendment (e)  be accessible, including to those not directly involved in the process, while taking into account confidentiality and protection of personal data. (e)  be accessible, including to those not directly involved in the process, while taking into account the protection of personal data.
Amendment    45 Proposal for a regulation Article 1 – paragraph 1 – point 1 Regulation (EC) No 178/2002 Article 8c – paragraph 2 – introductory part
Text proposed by the Commission Amendment 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: 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 an accurate and systematic manner both at Union and national level, while acknowledging diverging scientific opinions where they exist. It shall:
Amendment    46 Proposal for a regulation Article 1 – paragraph 1 – point 1 Regulation (EC) No 178/2002 Article 8c – paragraph 2 – point a
Text proposed by the Commission Amendment (a)  identify the key factors that need to be taken into account when considering the type and level of risk communications’ activities needed; (a)  identify the factors that need to be taken into account when considering the type and level of risk communications’ activities needed;
Amendment    47 Proposal for a regulation Article 1 – paragraph 1 – point 1 Regulation (EC) No 178/2002 Article 8c – paragraph 2 – point b
Text proposed by the Commission Amendment b)  identify the appropriate main tools and channels to be used for risk communication purposes, taking into account the needs of relevant target audience groups; and, b)  identify the appropriate main tools and channels (a clear, effective and accessible website) to be used for risk communication purposes, taking into account the specific needs of relevant target audience groups and in particular arranging for specific communication in situations in which emergencies are managed that might arise in the field of food or the environment, which presuppose an increase in dedicated communication tools and measures (helplines, a suitably identified section of the EFSA website, apps and specific information campaigns); and,
Amendment    48 Proposal for a regulation Article 1 – paragraph 1 – point 1 Regulation (EC) No 178/2002 Article 8c – paragraph 2 – point c
Text proposed by the Commission Amendment (c)  establish appropriate mechanisms in order to strengthen coherence of risk communication amongst risk assessors and risk managers and ensure an open dialogue amongst all interested parties. (c)  establish appropriate mechanisms in order to strengthen coherence of risk communication amongst risk assessors and risk managers and ensure an open dialogue and constant interaction amongst all interested parties, while acknowledging scientific divergent opinions where they exist.
Amendment    49 Proposal for a regulation Article 1 – paragraph 1 – point 2 – point b Regulation (EC) No 178/2002 Article 25 – paragraph 1a – point b
Text proposed by the Commission Amendment (b)  one member appointed by the European Parliament, with the right to vote. (b)  two members and two alternate members appointed by the European Parliament, with the right to vote.
Amendment    50 Proposal for a regulation Article 1 – paragraph 1 – point 2 – point b Regulation (EC) No 178/2002 Article 25 – paragraph 1a – point c
Text proposed by the Commission Amendment (c)  four members with the right to vote representing civil society and food chain interests namely, one from consumers organisations, one from environmental non-governmental organisations, one from farmers organisations and one from industry organisations. Those members shall be appointed by the Council in consultation with the European Parliament on the basis of a list drawn up by the Commission which includes more names than there are posts to be filled. The list drawn up by the Commission shall be forwarded to the European Parliament, together with the relevant background documents. As quickly as possible and within three months of notification, the European Parliament may submit its views for consideration to the Council, which shall then appoint those members. (c)  five members with the right to vote representing civil society and food chain workers interests namely, one from medical/health organisations, one from consumers organisations, one from environmental non-governmental organisations, one from farmers organisations and one from agrochemical or food industry organisations. Those members shall be appointed by the Council in consultation with the European Parliament on the basis of a list drawn up by the Commission which includes more names than there are posts to be filled. The list drawn up by the Commission shall be forwarded to the European Parliament, together with the relevant background documents. As quickly as possible and within three months of notification, the European Parliament may submit its views for consideration to the Council, which shall then appoint those members.
Amendment    51 Proposal for a regulation Article 1 – paragraph 1 – point 2 – point b Regulation (EC) No 178/2002 Article 25 – paragraph1b
Text proposed by the Commission Amendment 1b.  The members of the Management Board and where relevant, the alternate members shall be appointed taking into account high competence in the area of food safety risk assessment as well as competences in the food chain safety legislation and policy, and relevant managerial, administrative and budgetary/financial skills., 1b.  The members of the Management Board and where relevant, the alternate members shall be appointed taking into account high competence in the area of food safety risk assessment as well as competences in the food chain safety legislation and policy, and relevant managerial, administrative and budgetary/financial skills.”,
Justification
Alternate members are empowered to vote in place of full members, which means that they must have the same qualifications.
Amendment    52 Proposal for a regulation Article 1 – paragraph 1 – point 2 – point d Regulation (EC) No 178/2002 Article 25 – paragraph 5 – subparagraph 2
Text proposed by the Commission Amendment “Unless otherwise provided, the Management Board shall act by a majority of its members. Alternate members shall represent the member in his absence and vote on his behalf .”; “Unless otherwise provided, the Management Board shall act by a majority of its members. Alternate members shall represent the member in her or his absence and vote on her or his behalf .”;
Amendment    53 Proposal for a regulation Article 1 – paragraph 1 – point 3 – point b Regulation (EC) No 178/2002 Article 28 – paragraph 5a – point b
Text proposed by the Commission Amendment b)  Member States shall nominate experts with a view to collectively reach the number indicated by the Executive Director. Each Member State shall nominate at least 12 scientific experts. Member States may nominate nationals of other Member States. b)  Member States may nominate experts for the fields indicated on the basis of a call for expressions of interest. Member States may also nominate nationals of other Member States.
Amendment    54 Proposal for a regulation Article 1 – paragraph 1 – point 3 – point b Regulation (EC) No 178/2002 Article 28 – paragraph 5a – point c
Text proposed by the Commission Amendment (c)  On the basis of the nominations made by Member States, the Executive Director shall draw for each Scientific Panel a list of experts larger than the number of members to be appointed. The Executive Director may not draw up such a list where he/she can justify that the nominations received do not allow him, given the criteria for selection set up in point d) of this paragraph, to draw up a larger list. The Executive Director shall submit the list to the Management Board for appointment. (c)  On the basis of the nominations made by Member States on the basis of the expressions of interest, the Executive Director shall draw for each Scientific Panel a list of experts larger than the number of members to be appointed. The Executive Director may not draw up such a list where he/she can justify that the nominations received do not allow her/ him, given the criteria for selection set up in point d) of this paragraph, to draw up a larger list. The Executive Director shall submit the list to the Management Board for appointment.
Amendment    55 Proposal for a regulation Article 1 – paragraph 1 – point 3 – point b Regulation (EC) No 178/2002 Article 28 – paragraph 5a – point e
Text proposed by the Commission Amendment e)  The Management Board shall ensure that the broadest possible geographical distribution is achieved in the final appointments. e)  The Management Board shall ensure that the broadest, most comprehensive and most participatory possible geographical distribution is achieved in the final appointments.
Amendment    56 Proposal for a regulation Article 1 – paragraph 1 – point 3 – point b Regulation (EC) No 178/2002 Article 28 – paragraph 5d
Text proposed by the Commission Amendment 5d.  The Member States shall put in place measures ensuring that the members of the Scientific Panels act independently and remain free from conflict of interests as provided for in Article 37(2) and the Authority’s internal measures. Member States shall ensure that the members of the Scientific Panels have the means to dedicate the necessary time and effort to contribute to the work of the Authority. Member States shall ensure that the members of the Scientific Panels do not receive any instruction at any national level and that their independent scientific contribution to the risk assessment system at Union level is recognised as a priority task for the protection of the safety of the food chain. 5d.  The Member States shall put in place measures ensuring that the members of the Scientific Panels nominated by them act independently and remain free from conflict of interests as provided for in Article 37(2) and the Authority’s internal measures. Member States shall ensure that the members of the Scientific Panels have the means to dedicate the maximum time and effort which is necessary in order to contribute to the work of the Authority. Member States shall ensure that the members of the Scientific Panels do not receive any instruction and are not subject to pressure and influence at any national level and that their independent scientific contribution to the risk assessment system at Union level is perceived as a priority task for the protection of the safety of the food chain.
Amendment    57 Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32a – paragraph 1
Text proposed by the Commission Amendment At the request of a potential applicant for a food law authorisation, the staff of the Authority shall advise on the relevant provisions and the required content of the application for authorisation. The advice provided by the staff of the Authority shall be without prejudice and non-committal as to the subsequent assessment of applications for authorisation by the Scientific Panels. At the request of a potential applicant for a food law authorisation, the staff of the Authority may, in written form, advise on the relevant provisions and the required content of the application for authorisation. The staff of the Authority providing the advice referred to in the first sentence shall not be involved in any scientific work, including within the meaning of paragraph 5f of Article 28, that is directly or indirectly relevant to the application which is the subject of the advice. The advice provided by the staff of the Authority shall immediately be documented and published on the Authority’s website. It shall contribute to the development of a Frequently Asked Questions document with the purpose of developing more comprehensive guidelines for applicants and reducing the need for individual correspondence.   The advice provided shall be without prejudice and non-committal as to the subsequent assessment of applications for authorisation by the Scientific Panels. Within [36 months after the entry into force of this regulation], the Commission shall assess the impact of this article on the functioning of the Authority. Particular attention shall be paid to the additional workload and mobilisation of staff, and whether it has led to any shift in the allocation of the Autority’s resources at the expense of activities of public interest.
Amendment    58 Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32b – paragraph 3
Text proposed by the Commission Amendment 3.  The notified information shall be made public only in case a corresponding application for authorisation has been received and after the Authority has decided on the disclosure of the accompanying studies in accordance with Article 38 and Articles 39 to 39f. 3.  The notified information shall be made public if a corresponding application for authorisation has been received and after the Authority has decided on the disclosure of the accompanying studies and its scientific opinion in accordance with Article 38 and Articles 39 to 39f.
Amendment    59 Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32c – paragraph 2
Text proposed by the Commission Amendment 2.  The Authority shall consult stakeholders and the public regarding the studies supporting applications for authorisation once they are made public by the Authority in accordance with Article 38 and Articles 39 to 39f in order to identify whether other relevant scientific data or studies are available on the subject matter concerned by the application for authorisation. This provision does not apply to the submission of any supplementary information by the applicants during the risk assessment process. 2.  The Authority shall consult stakeholders and the public regarding the studies supporting applications for authorisation once they are made public by the Authority in accordance with Article 38 and Articles 39 to 39f in order to identify whether other relevant scientific data or studies are available on the subject matter concerned by the application for authorisation.
Amendment    60 Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32d – paragraph 1
Text proposed by the Commission Amendment The Commission experts shall perform controls, including audits, to obtain assurance that testing facilities comply with relevant standards for carrying out tests and studies submitted to the Authority as part of an application for an authorisation under Union food law. These controls shall be organised in cooperation with the competent authorities of the Member States. The Commission experts shall perform controls, including audits, to obtain assurance that testing facilities are independent, transparent and staffed by highly skilled persons and comply with relevant standards for carrying out tests and studies submitted to the Authority as part of an application for an authorisation under Union food law. These controls shall be organised in cooperation with the competent authorities of the Member States.
Amendment    61 Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32e – paragraph 1
Text proposed by the Commission Amendment Without prejudice to the obligation of applicants for authorisations under food law to demonstrate the safety of a subject matter submitted to a system of authorisation, the Commission, in exceptional circumstances, 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.; Without prejudice to the obligation of applicants for authorisations under food law to demonstrate the safety of a subject matter submitted to a system of authorisation, the Authority may, where scientific data and findings are in conflict with each other, commission scientific studies with the objective of verifying evidence used in its risk assessment process, with the aim of obtaining greater assurance about food or feed safety. The studies commissioned may have a wider scope than the evidence subject to verification.;
Amendment    62 Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32e – paragraph 1a (new)
Text proposed by the Commission Amendment   Any studies commissioned shall take into account Directive 2010/63/EU on the protection of animals used for scientific purposes.
Amendment    63 Proposal for a regulation Article 1 – paragraph 1 – point 5 – point a Regulation (EC) No 178/2002 Article 38 – paragraph 1 – subparagraph 1 – introductory part
Text proposed by the Commission Amendment The Authority shall carry out its activities with a high level of transparency. It shall in particular make public without delay: The Authority shall ensure a high level of transparency, in line with the Aarhus Convention and Regulation (EC) No 1367/2006, without prejudice to Regulation (EC) No 1049/2001, as well as in line with with Directive 2003/4/EC, providing for an active and systematic dissemination to the public of environmental information. It shall in particular make public without delay:
Amendment    64 Proposal for a regulation Article 1 – paragraph 1 – point 5 – point a Regulation (EC) No 178/2002 Article 38 – paragraph 1 – subparagraph 1 – point a
Text proposed by the Commission Amendment (a)  agendas and minutes of the Scientific Committee and the Scientific Panels and their Working Groups; (a)  agendas, participants lists, and minutes of the Scientific Committee and the Scientific Panels and their Working Groups;
Amendment    65 Proposal for a regulation Article 1 – paragraph 1 – point 5 – point а Regulation (EC) No 178/2002 Article 38 – paragraph 1 – subparagraph 1 – point c
Text proposed by the Commission Amendment c)  scientific data, studies and other information supporting applications for authorisation under Union food law, 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 protection of confidential information and protection of personal data in accordance with Articles 39 to 39f. deleted
Amendment    66 Proposal for a regulation Article 1 – paragraph 1 – point 5 – point а Regulation (EC) No 178/2002 Article 38 – paragraph 1 – subparagraph 1 – point d
Text proposed by the Commission Amendment d)  the information on which its scientific outputs, including scientific opinions are based, taking into account protection of confidential data and protection of personal data in accordance with Articles 39 to 39f; deleted
Amendment    67 Proposal for a regulation Article 1 – paragraph 1 – point 5 – point а Regulation (EC) No 178/2002 Article 38 – paragraph 1 – subparagraph 1 – point i
Text proposed by the Commission Amendment i)  advice provided by the Authority to potential applicants at pre-submission phase pursuant to Article 32a and 32c. deleted
Amendment    68 Proposal for a regulation Article 1 – paragraph 1 – point 5 – point а a (new) Regulation (EC) No 178/2002 Article 38 – paragraph -1a (new)
Text proposed by the Commission Amendment   (аа)  The following paragraph -1a is inserted:   (-1a) At the time of publication of its scientific opinion, the Authority shall also make the following public:   (а) scientific data, studies and other information supporting applications for authorisation under Union food law, 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, taking into account the protection of confidential information and the protection of personal data in accordance with Articles 39 to 39f.   b) the information on which its scientific outputs, including scientific opinions, are based, taking into account the protection of confidential data and the protection of personal data in accordance with Articles 39 to 39f;   c) information concerning the consultation sessions with applicants conducted by the Authority pursuant to Article 32a and 32c prior to their applications.
Amendment    69 Proposal for a regulation Article 1 – paragraph 1 – point 5 – point b Regulation (EC) No 178/2002 Article 38 – paragraph 1a – subparagraph 2
Text proposed by the Commission Amendment The disclosure to the public of the information mentioned in paragraph (1)(c) shall not be considered as an explicit or implicit permission or license for the relevant data and information and their content to be used, reproduced, or otherwise exploited and its use by third parties shall not engage the responsibility of the European Union. The disclosure to the public of the information mentioned in paragraph (1)(c) shall not be considered as an explicit or implicit permission or license for the relevant data and information and their content to be commercially used, reproduced, or otherwise exploited for commercial purposes. For the avoidance of doubt, the information published may be used for the purpose of public scrutiny of the results, including a better understanding of the potential adverse effects on health and the environment and its use by third parties for that purpose shall not engage the responsibility of the European Union.”
Amendment    70 Proposal for a regulation Article 1 – paragraph 1 – point 5 – point c a (new) Regulation (EC) No 178/2002 Article 38 – paragraph 3a
Text proposed by the Commission Amendment   (ca)  the following paragraph 3a is inserted:   3a. This Article is without prejudice to Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information, to Regulation (EC) No 1049/2001 and to Regulation (EC) No 1367/2006.
Amendment    71 Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 1
Text proposed by the Commission Amendment 1.  By way of derogation from Article 38, the Authority shall not make public information for which confidential treatment has been requested under the conditions laid down in this Article. 1.  By way of derogation from Article 38 and without prejudice to Regulation (EC) No 1049/2001 and Directive 2003/4/EC and the general principle that the interests of public health always prevail over private interests, the Authority shall not make public information for which confidential treatment has been requested and granted in application of the conditions laid down in this Article.
Amendment    72 Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 2 – point 2 a (new)
Text proposed by the Commission Amendment   (2a)  innovative commercial elements and models, formulae and products covered by patents the protection of which might be threatened by any failure to maintain confidentiality during the initial study request procedure, thus exposing the requester to damage and risks of market distortion and unfair competition
Amendment    73 Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 2 – point 3
Text proposed by the Commission Amendment (3)  commercial information revealing sourcing, market shares or business strategy of the applicant; and (3)  commercial information revealing sourcing, innovative ideas for the product/substance, market shares or business strategy of the applicant;   (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)
Amendment    74 Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 4 – point b
Text proposed by the Commission Amendment (b)  information which forms part of conclusions of scientific outputs, including scientific opinions, delivered by the Authority and which relate to foreseeable health effects.; (b)  information which forms part of conclusions of scientific outputs, including scientific opinions, delivered by the Authority which indicate risks of possible effects on, and threats to, public and animal health or the environment.;
Amendment    75 Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 4 a (new)
Text proposed by the Commission Amendment   4a.  This Article is without prejudice to Directive 2003/4/EC and Regulations (EC) No 1049/2001 and 1367/2006
Justification
This formulation is necessary for the benefit of transparency
Amendment    76 Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39a – paragraph 2
Text proposed by the Commission Amendment 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 be without the information the applicant deems confidential in accordance with paragraphs 2 and 3 of Article 39. 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. 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 edit, with black bars, the information for which the applicant requests confidential treatment in accordance with paragraphs 2 and 3 of Article 39. The confidential version shall contain all information submitted, including information the applicant considers confidential. Information requested to be treated as confidential in the confidential version shall be clearly marked. The applicant shall clearly indicate the verifiable justifications on the basis of which confidentiality is requested for each of the different pieces of information.
Amendment    77 Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39b – paragraph 1 – point c
Text proposed by the Commission Amendment (c)  inform the applicant in writing of its intention to disclose information and the reasons for it, before the Authority formally takes a decision on the confidentiality request. If the applicant disagrees with the assessment of the Authority it may state its views or withdraw its application within two weeks from the date on which it was notified of the Authority’s position. (c)  inform the applicant in writing of its intention to disclose information and the reasons for it, before the Authority formally takes a decision on the confidentiality request. If the applicant objects to the assessment of the Authority it may state its views or withdraw its application within two weeks from the date on which it was notified of the Authority’s position.
Amendment    78 Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39b – paragraph 1 – point d
Text proposed by the Commission Amendment (d)  adopt a reasoned decision on the confidentiality request taking into account the observations of the applicant within ten weeks from the date of receipt of the confidentiality request with respect to applications for authorisation and without undue delay in the case of supplementary data and information and notify the applicant and inform the Commission and the Member States, as appropriate, of its decision; and, (d)  adopt a reasoned decision on the confidentiality request taking into account the observations of the applicant within eight weeks from the date of receipt of the confidentiality request with respect to applications for authorisation and without undue delay in the case of supplementary data and information and notify the applicant and inform the Commission and the Member States, in every case, of its decision; and,
Amendment    79 Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39b – paragraph 1 – point e
Text proposed by the Commission Amendment (e)  make public any additional data and information for which the confidentiality request has not been accepted as justified not earlier than two weeks after the notification of its decision to the applicant has taken place, pursuant to point (d). (e)  make public any additional data and information for which the confidentiality request has not been accepted as justified not earlier than two weeks and no later than four weeks after the notification of its decision to the applicant has taken place, pursuant to point (d).
Amendment    80 Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39d – paragraph 2
Text proposed by the Commission Amendment 2.  The Commission and the Member States shall take the necessary measures so that information received by them under Union food 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 definitive. 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. 2.  The Commission and the Member States shall take the necessary measures so that information received by them under Union food law is not made public until a decision on the confidentiality request has been taken by the Authority and its scientific opinion has been published. 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.
Amendment    81 Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39d – paragraph 3
Text proposed by the Commission Amendment 3.  If an applicant in the context of an authorisation procedure withdraws or has withdrawn an application, the Authority, the Commission and the Member States shall respect the confidentiality of commercial and industrial information as accepted by the Authority in accordance with Articles 39to 39f. The application shall be considered withdrawn as of the moment the written request is received by the competent body that had received the original application. Where the withdrawal of the application takes place before the Authority has decided on the relevant confidentiality request, the Authority, the Commission and the Member States shall not make public the information for which confidentiality has been requested. 3.  If an applicant in the context of an authorisation procedure withdraws or has withdrawn an application, the Authority, the Commission and the Member States shall respect the confidentiality of commercial and industrial information as accepted by the Authority in accordance with Articles 39to 39f. The application shall be considered withdrawn as of the moment the written request is received by the competent body that had received the original application. Where the withdrawal of the application takes place before the Authority has decided on the relevant confidentiality request, the Authority, the Commission and the Member States shall not make public any information relating to the planned application.
Amendment    82 Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39e – paragraph 1 – point e
Text proposed by the Commission Amendment (a)  the name and address of the applicant; (a)  the name of the applicant;
Amendment    83 Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39e – paragraph 2
Text proposed by the Commission Amendment 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 there is an overriding public interest. 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, constituting a threat to their independence and autonomous judgement, and shall not be made publicly available, unless there is an overriding public interest.
Amendment    84 Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39g – paragraph 1
Text proposed by the Commission Amendment The information systems operated by the Authority to store its data, including confidential and personal data shall be designed to a high level of security appropriate to the security risks at stake, taking into account Articles 39 to 39f of this Regulation. Access shall be based at the minimum on a system requiring two factor authentication or providing an equivalent level of security. The system shall ensure that any access to it is fully auditable.; 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 the highest standards of security appropriate to the security risks at stake will be attained, taking into account Articles 39 to 39f of this Regulation. Access shall be based at the minimum on a system requiring two factor authentication or providing an equivalent level of security. The system shall ensure that any access to it is fully auditable.;
Amendment    85 Proposal for a regulation Article 1 – paragraph 1 – point 10 Regulation (EC) No 178/2002 Article 57a – paragraph 6
Text proposed by the Commission Amendment 6.  A delegated act adopted pursuant to Article 8(c) 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 8(c) 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 may be extended by two months at the initiative of the European Parliament or of the Council.;
Amendment    86 Proposal for a regulation Article 1 – paragraph 1 – point 11 Regulation (EC) No 178/2002 Article 61 – paragraph 2
Text proposed by the Commission Amendment 2.  Not later than five years after the date referred to in Article [entry into force of the Regulation amending the GFL], and every five years thereafter, the Commission shall assess the Authority’s performance in relation to its objectives, mandate, tasks, procedures and location, in accordance with Commission guidelines. The evaluation shall address the possible need to modify the mandate of the Authority, and the financial implications of any such modification. 2.  Not later than five years after the date referred to in Article [entry into force of the Regulation amending the GFL], and every five years thereafter, the Commission shall assess the Authority’s performance in relation to its objectives, mandate, tasks, procedures and location, in accordance with Commission guidelines. The evaluation shall address the possible need to modify the mandate of the Authority, and the financial implications of any such modification. Conversely, if the evaluation shows that the set objectives are being attained and the tasks assigned are being performed, the possibility to increase investment in order to secure more ambitious results shall be explored.
Amendment    87 Proposal for a regulation Article 1 – paragraph 1 – point 11 Regulation (EC) No 178/2002 Article 61 – paragraph 3
Text proposed by the Commission Amendment 3.  Where the Commission considers that the continuation 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. deleted
Amendment    88 Proposal for a regulation Article 1 – paragraph 1 – point 11 Regulation (EC) No 178/2002 Article 61 – paragraph 4
Text proposed by the Commission Amendment 4.  The Commission shall report to the European Parliament, the Council and the Management Board on the evaluation findings. The findings of the evaluation shall be made public. 4.  The evaluations and recommendations referred to in paragraphs 1 and 2 shall be forwarded to the Council and the European Parliament, and shall be made public.
Amendment    89 Proposal for a regulation Article 2 – paragraph 1 – point 2 a (new) Directive 2001/18/EC Article 24 – paragraph 3 a (new)
Text proposed by the Commission Amendment   (2a)  In Article 24, the following paragraph 3a is inserted:   “3a. The obligation to proactively disseminate the information set out in paragraph 1 of this Article, in line with Article 25, and in line with Articles 38 and 39 of Regulation (EC) No 178/2002, is without prejudice to the right of any natural or legal person to access documents upon request as set out in Regulation (EC) No 1049/2001 and Regulation (EC) No 1367/2006.”
Amendment    90 Proposal for a regulation Article 2 – paragraph 1 – point 4 Directive 2001/18/EC Article 28 – paragraph 4
Text proposed by the Commission Amendment 4.  Where the relevant Scientific Committee is consulted under paragraph 1, it shall make public the notification/application, relevant supporting information and any supplementary information supplied by the notifier/applicant, as well as its scientific opinions, in accordance with Article 38 and Articles 39 to 39f of Regulation (EC) No 178/2002, which shall apply mutatis mutandis, and Article 25 of this Directive.”. 4.  Where the relevant Scientific Committee is consulted under paragraph 1, it shall make public the notification/application, relevant supporting information and any supplementary information supplied by the notifier/applicant, at the same time as its scientific opinion, in accordance with Article 38 and Articles 39 to 39f of Regulation (EC) No 178/2002, which shall apply mutatis mutandis, and Article 25 of this Directive.
Amendment    91 Proposal for a regulation Article 3 – paragraph 1 – point 9 Regulation (EC) No 1829/2003 Article 29 – paragraph 1
Text proposed by the Commission Amendment 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 Article 38, Articles 39 to 39f and Article 40 of Regulation (EC) No 178/2002 and taking into account Article 30 of this Regulation. 1.  The Authority shall make public the application for authorisation, relevant supporting information and any supplementary information supplied by the applicant, at the same time as its scientific opinion and opinions from the competent authorities referred to in Article 4 of Directive 2001/18/EC, in accordance with Article 38, Articles 39 to 39f and Article 40 of Regulation (EC) No 178/2002 and taking into account Article 30 of this Regulation..
Amendment    92 Proposal for a regulation Article 3 – paragraph 1 – point 9 Regulation (EC) No 1829/2003 Article 29 – paragraph 1 a (new)
Text proposed by the Commission Amendment   1a.  The obligation to proactively disseminate the information set out in paragraph 1 of this Article, in line with Article 30, and in line with Articles 38 and 39 of Regulation (EC) No 178/2002, is without prejudice to the right of any natural or legal person to access documents upon request as set out in Regulation (EC) No 1049/2001 and Regulation (EC) No 1367/2006.
Amendment    93 Proposal for a regulation Article 3 – paragraph 1 – point 10 Regulation (EC) No 1829/2003 Article 30 – paragraph 2
Text proposed by the Commission Amendment 2.  In addition to Article 39(2) and pursuant to Article 39(3) of Regulation (EC) No 178/2002, the Authority may also accept to provide confidential treatment to the following information, the disclosure of which may be deemed, upon verifiable justification, to significantly harm the interests concerned: 2.  Information relating to the following shall not be considered confidential: (a) DNA sequence information, except for sequences used for the purpose of detection, identification and quantification of the transformation event; and, (a) name and composition of the GMO, food or feed referred to in Articles 3(1) and 15(1) and, where appropriate, indication of the substrate and the micro-organism; (b) breeding patterns and strategies. (b) general description of the GMO and the name and address of the authorisation-holder;   (c) physico-chemical and biological characteristics of the GMO, food or feed referred to in Articles 3(1) and 15(1);   (d) effects of the GMO, food or feed referred to in Articles 3(1) and 15(1) on human and animal health and on the environment;   (e) effects of the GMO, food or feed referred to in Articles 3(1) and 15(1) on the characteristics of animal products and its nutritional properties;   (f) methods for detection, including sampling and identification of the transformation event and, where applicable, for the detection and identification of the transformation event in the food or feed referred to in Articles 3(1) and 15(1);   (g) information on waste treatment and emergency response.
Justification
Paragraph 2 simply reinstates the current wording of Regulation 1829/2003. If the aim of the proposal is to strengthen transparency, then, instead of enlarging the list of information which can be kept confidential, the current provisions relating to information that can never be kept confidential must be kept.
Amendment    94 Proposal for a regulation Article 4 – paragraph 1 – point 1 – point b Regulation (EC) No 1831/2003 Article 7 – paragraph 2 – point c
Text proposed by the Commission Amendment c)  ensure public access to the application and any information supplied by the applicant, in accordance with Article 18.”; c)  ensure public access to the application and any information supplied by the applicant, and at the same time to its scientific opinion, in accordance with Article 18”;
Amendment    95 Proposal for a regulation Article 4 – paragraph 1 – point 1 a (new) Regulation (EC) No 1831/2003 Article 17 – paragraph 2 a (new)
Text proposed by the Commission Amendment   (1a)  In Article 17, the following paragraph 2a is inserted:   “2a. The obligation to proactively disseminate information set out in this Article and in line with Articles 38 and 39 of Regulation (EC) No 178/2002, is without prejudice to the right of any natural or legal person to access documents upon request as set out in Regulation (EC) No 1049/2001 and Regulation (EC) No 1367/2006.”
Amendment    96 Proposal for a regulation Article 4 – paragraph 1 – point 2 Regulation (EC) No 1831/2003 Article 18 – paragraph 1
Text proposed by the Commission Amendment 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 Article 38, Articles 39 to 39f and Article 40 of Regulation (EC) No 178/2002, which shall apply mutatis mutandis. 1.  The Authority shall make public the application for authorisation, relevant supporting information and any supplementary information supplied by the applicant, at the same time as its scientific opinion, in accordance with Article 38, Articles 39 to 39f and Article 40 of Regulation (EC) No 178/2002, which shall apply mutatis mutandis.
Amendment    97 Proposal for a regulation Article 4 – paragraph 1 – point 2 Regulation (EC) No 1831/2003 Article 18 – paragraph 3 a (new)
Text proposed by the Commission Amendment   3a.  The Authority shall apply the principles of 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.
Amendment    98 Proposal for a regulation Article 4 – paragraph 1 – point 2 Regulation (EC) No 1831/2003 Article 18 – paragraph 3 b (new)
Text proposed by the Commission Amendment   3b.  The Member States, the Commission and the Authority shall keep confidential all the information identified as confidential under paragraph 2 except where it is appropriate for such information to be made public in order to protect human health, animal health or the environment. Member States shall handle applications for access to documents received under this Regulation in accordance with Article 5 of Regulation (EC) No 1049/2001.”
Amendment    99 Proposal for a regulation Article 5 – paragraph 1 – point 1 – point а Regulation (EC) No 2065/2003 Article 7 – paragraph 2 – point c – point ii
Text proposed by the Commission Amendment ii)  ensure public access to the application, relevant supporting information and any supplementary information supplied by the applicant, in accordance with Articles 14 and 15.”; (ii)  ensure public access to the application, relevant supporting information and any supplementary information supplied by the applicant, when it publishes its scientific opinion, in accordance with Articles 14 and 15.
Amendment    100 Proposal for a regulation Article 5 – paragraph 1 – point 2 Regulation (EC) No 2065/2003 Article 14 – paragraph 1
Text proposed by the Commission Amendment 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 Article 38, Articles 39 to 39f and Article 40 of Regulation (EC) No 178/2002.; 1.  The Authority shall make public, at the same time as its scientific opinion, the application for authorisation, relevant supporting information and any supplementary information supplied by the applicant as well as its scientific opinions, in accordance with Article 38, Articles 39 to 39f and Article 40 of Regulation (EC) No 178/2002.;
Amendment    101 Proposal for a regulation Article 5 – paragraph 1 – point 2 a (new) Regulation (EC) No 2065/2003 Article 14 – paragraph 1 a (new)
Text proposed by the Commission Amendment   (2a)  In Article 14, the following paragraph 1a is inserted:   “1a. The obligation to proactively disseminate information set out in paragraph 1 of this Article, in line with Articles 38 and 39 of Regulation (EC) No 178/2002, is without prejudice to the right of any natural or legal person to access documents upon request as set out in Regulation (EC) No 1049/2001 and Regulation (EC) No 1367/2006.”
Amendment    102 Proposal for a regulation Article 5 – paragraph 1 – point 3 Regulation (EC) No 178/2002 Article 15 – paragraph 1 – point b
Text proposed by the Commission Amendment (b)  and, the Authority shall assess the confidentiality request submitted by the applicant. (b)  and, the Authority shall assess the confidentiality request submitted by the applicant and shall be required to respond - and provide the necessary justification - within two months of receipt of the application.
Amendment    103 Proposal for a regulation Article 6 – paragraph 1 – point 1 – point а Regulation (EC) No 1935/2004 Article 9 – paragraph 1 – point c – point ii
Text proposed by the Commission Amendment (ii)  ensure public access to the application, relevant supporting information and any supplementary information supplied by the applicant, in accordance with Articles 19 and 20; ii)  ensure public access to the application, relevant supporting information and any supplementary information supplied by the applicant, at the same time as to its scientific opinion, in accordance with Articles 19 and 20.
Amendment    104 Proposal for a regulation Article 6 – paragraph 1 – point 2 Regulation (EC) No 1935/2004 Article 19 – paragraph 1
Text proposed by the Commission Amendment 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 Article 38, Articles 39 to 39f and Article 40 of Regulation (EC) No 178/2002, which shall apply mutatis mutandis and Article 20 of this Regulation.”; 1.  The Authority shall make public the application for authorisation, relevant supporting information and any supplementary information supplied by the applicant, at the same time as its scientific opinion, in accordance with Article 38, Articles 39 to 39f and Article 40 of Regulation (EC) No 178/2002, which shall apply mutatis mutandis and Article 20 of this Regulation.”;
Amendment    105 Proposal for a regulation Article 6 – paragraph 1 – point 2 a (new) Regulation (EC) No 1935/2004 Article 19 – paragraph 2a (new)
Text proposed by the Commission Amendment   (2a)  in Article 19, the following paragraph 2a is inserted:   “2a. The obligation to proactively disseminate information set out in paragraph 1 is without prejudice to the right of any natural or legal person to access documents upon request as set out in Regulation (EC) No 1049/2001 and Regulation (EC) No 1367/2006.”
Amendment    106 Proposal for a regulation Article 7 – paragraph 1 – point 2 Regulation (EC) No 1331/2008 Article 11 – paragraph 1 a (new)
Text proposed by the Commission Amendment   The obligation to proactively disseminate information set out in paragraph 1 of this Article, in line with Article 12 and in line with Articles 38 and 39 of Regulation (EC) No 178/2002, is without prejudice to the right of any natural or legal person to access documents upon request as set out in Regulation (EC) No 1049/2001 and Regulation (EC) No 1367/2006.
Amendment    107 Proposal for a regulation Article 7 – paragraph 1 – point 3 Regulation (EC) No 1331/2008 Article 12 – paragraph 3 a (new)
Text proposed by the Commission Amendment   3a.  The Commission, the Authority and the Member States shall, in accordance with Regulation (EC) No 1049/2001, take the necessary measures to ensure appropriate confidentiality of the information received by them under this Regulation, except for information which must be made public if circumstances so require in order to protect human health, animal health or the environment.
Amendment    108 Proposal for a regulation Article 8 – paragraph 1 – point 5 a (new) Regulation (EC) No 1107/2009 Article 63 – paragraph 3
Present text Amendment   (5a)  in Article 63, paragraph 3 is replaced by the following: 3.  This Article is without prejudice to Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information 3.   This Article is without prejudice to Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information and to Regulation (EC) No 1049/2001 and Regulation (EC) No 1367/2006.
Amendment    109 Proposal for a regulation Article 9 – paragraph 1 – point 1 – point b Regulation (EC) No 2015/2283 Article 10 – paragraph 3
Text proposed by the Commission Amendment 3.  Where the Commission requests an opinion from, the European Food Safety Authority (‘the Authority’), the Authority shall ensure public access to 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.”; 3.  Where the Commission requests an opinion from the European Food Safety Authority (‘the Authority’), the Authority shall ensure public access to the application in accordance with Article 23 when it publishes its opinion as to the question of whether the update is liable to have an effect on human health.”;
Amendment    110 Proposal for a regulation Article 9 – paragraph 1 – point 3 – point b Regulation (EC) No 2015/2283 Article 16 – paragraph 2 – last sentence
Text proposed by the Commission Amendment The Authority shall ensure public access to the application, relevant supporting information and any supplementary information supplied by the applicant in accordance with Article 23.; The Authority shall ensure public access to the non-confidential elements of the application, and to the notification concerning safety concerns under Article 15, at the same time as it publishes its scientific opinion in accordance with Article 23.”;
Amendment    111 Proposal for a regulation Article 9 – paragraph 1 – point 4 Regulation (EC) No 2015/2283 Article 23 – paragraph 1
Text proposed by the Commission Amendment 1.  Where the Commission requests its opinion in accordance with Articles 10(3) and 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 Article 38, Articles 39 to 39f and Article 40 of Regulation (EC) No 178/2002 and with this Article. 1.  Where the Commission requests its opinion in accordance with Articles 10(3) and 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 Article 38, Articles 39 to 39f and Article 40 of Regulation (EC) No 178/2002 and with this Article, at the same time as it publishes its opinion concerning the application.
Amendment    112 Proposal for a regulation Article 9 – paragraph 1 – point 4 a (new) Regulation (EU) No 2015/2283 Article 25 – paragraph 1 a (new)
Text proposed by the Commission Amendment   (4a)  In Article 25, the following paragraph 1a is inserted:   “1a. The obligation to proactively disseminate the information set out in this Regulation, in line with Articles 38 and 39 of Regulation (EC) No 178/2002, is without prejudice to the right of any natural or legal person to access documents upon request as set out in Regulation (EC) No 1049/2001 and Regulation (EC) No 1367/2006.”

PROCEDURE – COMMITTEE ASKED FOR OPINION

Title	Transparency and sustainability of the EU risk assessment in the food chain
References	COM(2018)0179 – C8-0144/2018 – 2018/0088(COD)
Committee responsible Date announced in plenary	ENVI 28.5.2018
Opinion by Date announced in plenary	JURI 28.5.2018
Rapporteur Date appointed	Jiří Maštálka 23.4.2018
Discussed in committee	3.9.2018
Date adopted	10.10.2018
Result of final vote	+: –: 0:	12 5 6
Members present for the final vote	Max Andersson, Joëlle Bergeron, Jean-Marie Cavada, Kostas Chrysogonos, Mady Delvaux, Rosa Estaràs Ferragut, Enrico Gasbarra, Lidia Joanna Geringer de Oedenberg, Heidi Hautala, Sajjad Karim, Sylvia-Yvonne Kaufmann, Gilles Lebreton, António Marinho e Pinto, Pavel Svoboda, József Szájer, Axel Voss, Francis Zammit Dimech, Tadeusz Zwiefka
Substitutes present for the final vote	Geoffroy Didier, Pascal Durand, Angel Dzhambazki, Angelika Niebler, Virginie Rozière, Tiemo Wölken

FINAL VOTE BY ROLL CALL IN COMMITTEE ASKED FOR OPINION

12	+
ALDE	António Marinho e Pinto
ECR	Angel Dzhambazki, Sajjad Karim
PPE	Geoffroy Didier, Rosa Estaràs Ferragut, Angelika Niebler, József Szájer, Axel Voss, Francis Zammit Dimech, Tadeusz Zwiefka
S&D	Enrico Gasbarra, Virginie Rozière

5	-
GUE/NGL	Kostas Chrysogonos
S&D	Lidia Joanna Geringer de Oedenberg
VERTS/ALE	Max Andersson, Pascal Durand, Heidi Hautala

6	0
ALDE	Jean-Marie Cavada
EFDD	Joëlle Bergeron
ENF	Gilles Lebreton
S&D	Mady Delvaux, Sylvia-Yvonne Kaufmann, Tiemo Wölken

Key to symbols:

+  :  in favour

-  :  against

0  :  abstention

PROCEDURE – COMMITTEE RESPONSIBLE

Title	Transparency and sustainability of the EU risk assessment in the food chain
References	COM(2018)0179 – C8-0144/2018 – 2018/0088(COD)
Date submitted to Parliament	11.4.2018
Committee responsible        Date announced in plenary	ENVI 28.5.2018
Committees asked for opinions        Date announced in plenary	BUDG 28.5.2018	ITRE 28.5.2018	IMCO 28.5.2018	AGRI 28.5.2018
	PECH 28.5.2018	JURI 28.5.2018
Not delivering opinions        Date of decision	BUDG 23.4.2018	ITRE 24.4.2018	IMCO 19.6.2018
Rapporteurs        Date appointed	Renate Sommer 3.5.2018
Discussed in committee	30.8.2018
Date adopted	27.11.2018
Result of final vote	+: –: 0:	43 16 1
Members present for the final vote	Margrete Auken, Pilar Ayuso, Zoltán Balczó, Ivo Belet, Paul Brannen, Nessa Childers, Birgit Collin-Langen, Miriam Dalli, Seb Dance, Mark Demesmaeker, Stefan Eck, Bas Eickhout, Karl-Heinz Florenz, Elisabetta Gardini, Gerben-Jan Gerbrandy, Jens Gieseke, Julie Girling, Françoise Grossetête, Jytte Guteland, György Hölvényi, Anneli Jäätteenmäki, Karin Kadenbach, Kateřina Konečná, Urszula Krupa, Giovanni La Via, Jo Leinen, Peter Liese, Lukas Mandl, Jiří Maštálka, Valentinas Mazuronis, Joëlle Mélin, Susanne Melior, Rory Palmer, Massimo Paolucci, Piernicola Pedicini, Bolesław G. Piecha, John Procter, Julia Reid, Frédérique Ries, Michèle Rivasi, Annie Schreijer-Pierik, Davor Škrlec, Renate Sommer, Adina-Ioana Vălean, Jadwiga Wiśniewska
Substitutes present for the final vote	Nikos Androulakis, Christophe Hansen, Martin Häusling, Anja Hazekamp, Jan Huitema, Ulrike Müller, Alojz Peterle, Keith Taylor, Tiemo Wölken
Substitutes under Rule 200(2) present for the final vote	Martina Anderson, Edward Czesak, Jens Geier, Jude Kirton-Darling, Vladimír Maňka, Virginie Rozière
Date tabled	29.11.2018

FINAL VOTE BY ROLL CALL IN COMMITTEE RESPONSIBLE

43	+
ALDE	Gerben‑Jan Gerbrandy, Jan Huitema, Anneli Jäätteenmäki, Valentinas Mazuronis, Ulrike Müller, Frédérique Ries
ECR	Edward Czesak, Mark Demesmaeker, Urszula Krupa, Bolesław G. Piecha, John Procter, Jadwiga Wiśniewska
EFDD	Piernicola Pedicini
ENF	Joëlle Mélin
GUE/NGL	Martina Anderson, Stefan Eck, Anja Hazekamp, Kateřina Konečná, Jiří Maštálka
NI	Zoltán Balczó
PPE	Françoise Grossetête
S&D	Nikos Androulakis, Paul Brannen, Nessa Childers, Miriam Dalli, Seb Dance, Jens Geier, Jytte Guteland, Karin Kadenbach, Jude Kirton Darling, Jo Leinen, Vladimír Maňka, Susanne Melior, Rory Palmer, Massimo Paolucci, Virginie Rozière, Tiemo Wölken
Verts/ALE	Margrete Auken, Bas Eickhout, Martin Häusling, Michèle Rivasi, Davor Škrlec, Keith Taylor

16	-
PPE	Pilar Ayuso, Ivo Belet, Birgit Collin Langen, Karl Heinz Florenz, Elisabetta Gardini, Jens Gieseke, Julie Girling, Christophe Hansen, György Hölvényi, Giovanni La Via, Peter Liese, Lukas Mandl, Alojz Peterle, Annie Schreijer Pierik, Renate Sommer, Adina Ioana Vălean

1	0
EFDD	Julia Reid

Key to symbols:

+  :  in favour

-  :  against

0  :  abstention