Procedure : 2018/0088(COD)
Document stages in plenary
Document selected : A8-0417/2018

Texts tabled :

A8-0417/2018

Debates :

PV 10/12/2018 - 15
CRE 10/12/2018 - 15

Votes :

PV 11/12/2018 - 5.7
CRE 11/12/2018 - 5.7

Texts adopted :

P8_TA(2018)0489

REPORT     ***I
PDF 1386kWORD 240k
29 November 2018
PE 623.765v03-00 A8-0417/2018

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))

Committee on the Environment, Public Health and Food Safety

Rapporteur: Renate Sommer

ERRATA/ADDENDA
DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION
 EXPLANATORY STATEMENT
 OPINION of the Committee on Fisheries
 OPINION of the Committee on Legal Affairs
 PROCEDURE – COMMITTEE RESPONSIBLE
 FINAL VOTE BY ROLL CALL IN COMMITTEE RESPONSIBLE

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.

 

_______________

 

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