Activities of Jytte GUTELAND related to 2018/0088(COD)
Legal basis opinions (0)
Amendments (47)
Amendment 77 #
Proposal for a regulation
Recital 4
Recital 4
(4) It is therefore necessary to ensure a comprehensive and, continuous and inclusive 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 coherenceprevalence of public interest, accuracy and consistency within the risk analysis process.
Amendment 79 #
Proposal for a regulation
Recital 5
Recital 5
(5) Particular emphasis should be placed on explaining in a coherent, appropriatlear, 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 83 #
Proposal for a regulation
Recital 8
Recital 8
(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 of 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 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 coherenteffective risk communication.
Amendment 106 #
Proposal for a regulation
Recital 14
Recital 14
(14) To preserve the independence of the risk assessment from risk management and from other interests at Union level, it is appropriate that the nominaselection 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 and to dedicate sufficient time to their risk assessment work for the Authority.
Amendment 108 #
Proposal for a regulation
Recital 15
Recital 15
(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 113 #
Proposal for a regulation
Recital 17
Recital 17
(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. By 36 months after the entry into force of this regulation, the Commission should evaluate the impact of these pre-submission meetings on the functioning of the Authority. It should particularly evaluate their impact on the allocation of the Authority’s resources and its independence.
Amendment 120 #
Proposal for a regulation
Recital 18
Recital 18
(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. 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.
Amendment 134 #
Proposal for a regulation
Recital 22
Recital 22
(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 resThis exceptional verification tool should remain proportionate and should not replace the application of the precautionary principle in the presence of scientific uncertainty. The Commission, the Member States and the European Parliament should have the ponssible for triggering theility to ask the Authority to 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 140 #
Proposal for a regulation
Recital 23
Recital 23
(23) TAs a Party to the Aarhus Convention, the Union has recognised that, in the field of environment, access to information and public participation in decision-making enhance the quality and the implementation of decisions, contribute to the 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. However, 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.
Amendment 152 #
Proposal for a regulation
Recital 27
Recital 27
(27) To determine what level of proactive disclosure strikes the appropriate balance, the relevant rights of the public toneed 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.
Amendment 163 #
Proposal for a regulation
Recital 33
Recital 33
(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 Commissionconduct an independent 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.
Amendment 166 #
Proposal for a regulation
Recital 36
Recital 36
(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 ,benefit from proactive disclosure of 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 exhaustive list of confidential items to those set out in Regulation (EC) No 178/2002. The new provisions on active dissemination laid down in this Regulation and the assessment of confidentiality request by the Authority shall not in any manner limit the scope of the rights given by Regulations 1049/2001 and 1367/2006. __________________ 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 171 #
Proposal for a regulation
Recital 37
Recital 37
(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 communicwith other stakeholders in 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. IThe general plan on risk communication shall 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 175 #
Proposal for a regulation
Recital 37 a (new)
Recital 37 a (new)
(37a) Provisions regarding what information should be made public are without prejudice to Regulation (EC) No 1049/2001, as well as national or Union law regarding public access to official documents.
Amendment 191 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8 a – point b
Article 8 a – point b
(b) promote consistency and transparency in formulating risk management options and recommendations;
Amendment 195 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8 a – point c
Article 8 a – point c
(c) provide a sound basis for understanding risk management decisions; including information on:
Amendment 198 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8 a – point c a (new)
Article 8 a – point c a (new)
(ca) the risk management options considered including, as appropriate, the possibility to adopt provisional measures within the meaning of Article 7 of this Regulation;
Amendment 199 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8 a – point c b (new)
Article 8 a – point c b (new)
(cb) the extent to which the various risk management options under consideration reflect the degree of uncertainty of the risk assessment, and the level of consumer and animal health and environmental protection each of these options would achieve;
Amendment 200 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8 a – point c c (new)
Article 8 a – point c c (new)
(cc) as foreseen under Article 6(3) of this Regulation, 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;
Amendment 204 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8 a – point e
Article 8 a – point e
(e) promote appropriatebalanced involvement of all interested parties, including economic operators of the food chain, consumer and other civil society organisations; and,
Amendment 206 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8 a – point f
Article 8 a – point f
(f) ensure appropriatequitable exchange of information with these interested parties in relation to risks associated with the agri- food chain.
Amendment 208 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8 b – point a
Article 8 b – point a
(a) ensure that accurate, appropriacomplete and timely information is interactively exchanged, including with all interested parties, based on the principles of transparency, openness, and responsiveness;
Amendment 219 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8 c – paragraph 2 – point b
Article 8 c – paragraph 2 – point b
(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, to ensure the balanced involvements of all interested parties including economic operators of the food chain, consumer and other civil society organisations;
Amendment 220 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8 c – paragraph 2 – point c
Article 8 c – paragraph 2 – point c
(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., including by systematically acknowledging and explaining, where they exist, divergences in scientific assessment or in the appreciation of the acceptable level of risk
Amendment 268 #
Proposal for a regulation
Article 1 – paragraph 1 – point 3 – point c
Article 1 – paragraph 1 – point 3 – point c
Regulation (EC) No 178/2002
Article 28 – paragraph 9 b
Article 28 – paragraph 9 b
“The number of members in each Scientific Panel within the maximum provided for in paragraph 5g.;f.”
Amendment 275 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32 a
Article 32 a
At the request of a potential applicant for a food law authorisation, the staff of the Authority shall adprovisde on the relevant provisions and the required content of the application for authorisationconsultation 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 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 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.
Amendment 280 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32 a – paragraph 1 a (new)
Article 32 a – paragraph 1 a (new)
Amendment 281 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32 a – paragraph 1 a (new)
Article 32 a – paragraph 1 a (new)
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 Authority’s resources, at the expense of activities of public interest.
Amendment 283 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32 b – paragraph 1
Article 32 b – paragraph 1
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 within the EU 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 295 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32 b – paragraph 4 a (new)
Article 32 b – paragraph 4 a (new)
4a. The Commission shall establish, as part of a delegated act, penalties for breaches of the notification obligation.
Amendment 337 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point a
Article 1 – paragraph 1 – point 5 – point a
Regulation (EC) No 178/2002
Article 38 – paragraph 1 – subparagraph 2
Article 38 – paragraph 1 – subparagraph 2
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 and as appropriate machine- readable format.
Amendment 357 #
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Regulation (EC) No 178/2002
Article 39 – paragraph 1
Article 39 – paragraph 1
1. By way of derogation from Article 38, the Authority shall not make public information for which confidential treatment has been requesgranted under the conditions laid down in this Article.
Amendment 360 #
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Regulation (EC) No 178/2002
Article 39 – paragraph 2 – introductory part
Article 39 – paragraph 2 – introductory part
2. The Authority may only accept to provide confidential treatment in relation to the following information, the disclosure of which may be deemed, upon verifiable justification, to significantly harm the interests concernedand provided that the request for confidential treatment demonstrates, with adequate and verifiable justification, that disclosure would specifically and significantly harm the commercial interest of the applicant:
Amendment 365 #
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Regulation (EC) No 178/2002
Article 39 – paragraph 2 – point 1
Article 39 – paragraph 2 – point 1
(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; provided that the applicant demonstrates that such method does not entail emissions in the environment and has no harmful impacts on health and environment;
Amendment 374 #
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Regulation (EC) No 178/2002
Article 39 – paragraph 2 – point 4
Article 39 – paragraph 2 – point 4
(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 381 #
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Regulation (EC) No 178/2002
Article 39 – paragraph 4 – point a
Article 39 – paragraph 4 – point a
(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; andor,
Amendment 424 #
Proposal for a regulation
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Regulation (EC) No 178/2002
Article 41 – paragraph 1
Article 41 – paragraph 1
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. Articles 38 to 39d of this Regulation shall apply without prejudice to the application of Regulation 1049/2001 and Regulation 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).
Amendment 434 #
Proposal for a regulation
Article 1 – paragraph 1 – point 11
Article 1 – paragraph 1 – point 11
Regulation (EC) No 178/2002
Article 61 – paragraph 2 a (new)
Article 61 – paragraph 2 a (new)
2a. The Management Board of the Authority shall examine the conclusions of the evaluation and issue to the Commission such recommendations as may be necessary regarding changes in the Authority.
Amendment 435 #
Proposal for a regulation
Article 1 – paragraph 1 – point 11
Article 1 – paragraph 1 – point 11
Regulation (EC) No 178/2002
Article 61 – paragraph 3
Article 61 – paragraph 3
Amendment 448 #
Proposal for a regulation
Article 2 – paragraph 1 – point 3
Article 2 – paragraph 1 – point 3
Directive 2001/18/EC
Article 25 – paragraph 2 a (new)
Article 25 – paragraph 2 a (new)
The provisions on active dissemination laid down in Article 24 and 25 of this Directive, and Article 38 and 39 of Regulation 178/2002, are without prejudice to the right of access to documents upon request set in Regulation 1049/2001 and 1367/2006.
Amendment 462 #
Proposal for a regulation
Article 3 – paragraph 1 – point 10
Article 3 – paragraph 1 – point 10
Regulation (EC) No 1829/2003
Article 30 – paragraph 4 a (new)
Article 30 – paragraph 4 a (new)
Amendment 472 #
Proposal for a regulation
Article 4 – paragraph 1 – point 2
Article 4 – paragraph 1 – point 2
Regulation (EC) No 1831/2003
Article 18 – paragraph 3 a (new)
Article 18 – paragraph 3 a (new)
3a. The provisions on active dissemination laid down in this Article, and in 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 1049/2001.
Amendment 480 #
Proposal for a regulation
Article 5 – paragraph 1 – point 3
Article 5 – paragraph 1 – point 3
Regulation (EC) No 2065/2003
Article 15 – paragraph 1 a (new)
Article 15 – paragraph 1 a (new)
1a. The provisions on active dissemination laid down in Articles 14 and 15 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 485 #
Proposal for a regulation
Article 6 – paragraph 1 – point 3
Article 6 – paragraph 1 – point 3
Regulation (EC) No 1935/2004
Article 20 – paragraph 2 a (new)
Article 20 – paragraph 2 a (new)
2a. The provisions on active dissemination laid down in Articles 19 and 20 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 501 #
Proposal for a regulation
Article 7 – paragraph 1 – point 3
Article 7 – paragraph 1 – point 3
Regulation (EC) No 1331/2008
Article 12 – paragraph 3 a (new)
Article 12 – paragraph 3 a (new)
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 523 #
Proposal for a regulation
Article 8 – paragraph 1 – point 5 a (new)
Article 8 – paragraph 1 – point 5 a (new)
Regulation (EC) No 1107/2009
Article 63 – paragraph 3a (new)
Article 63 – paragraph 3a (new)
(5a) in Article 63, the following paragraph is added after paragraph 3: “3a. The provisions on active dissemination laid down in Article 63 of this Regulation, and Article 38 and 39 of Regulation 178/2002, are without prejudice to the right of access to documents upon request set in Regulations (EC) No 1049/2001 and (EC) No 1367/2006.”
Amendment 534 #
Proposal for a regulation
Article 9 – paragraph 1 – point 4
Article 9 – paragraph 1 – point 4
Regulation (EC) No 2015/2283
Article 23 – paragraph 4 a (new)
Article 23 – paragraph 4 a (new)
4a. The provisions on active dissemination laid down in Article 23 of this Regulation, and Articles 38 and 39 of Regulation 178/2002, are without prejudice to the right of access to documents upon request set in Regulation (EC) No 1049/2001.