Changes from report parliamentary committee draft to plenary report

RemovedArticle 13 – paragraph 2 b (new): 2b. The European Parliament or a Member State may request the Agency to issue a scientific opinion on matters falling within the competence of the Agency.

RemovedThis is a possibility that is given to the European Parliament or a Member State for EFSA in the General Food Law. This should be mirrored in the ECHA Basic Regulation.

Article 13 – paragraph 3: 3. The number of scientific opinions to be delivered pursuant to paragraph 2 and the timelines for their provision shall be decided between the Commission and the Agency on an annual basis.

Change 26

RemovedClarification that this paragraph does not apply to the possibility of requesting a committee opinion by the Executive Director.

AddedArticle 14 – paragraph 4: 4. Each Member State shall appoint one member to BPC and may appoint one alternate member to BPC. BPC members shall be appointed on the basis of their role and experience in performing the tasks assigned to BPC.

Change 27

ChangedArticle 14 – paragraph 4 a (new): 4a. At the request of a Member State, the Agency shall assist that Member State with the identificationto ofidentify possible satisfactory candidates for nomination by that Member State pursuant to paragraphs 1, 21 and 3.2. The obligation to nominate a candidate shall however remain with the Member States.

Change 28

RemovedSome Member States sometimes have had difficulty in the past to find candidates with an adequate profile. The Agency should be able, at their request, to help them identify experts with the proper qualification.

AddedArticle 14 – paragraph 5 – subparagraph 1: The members of SCCS shall be selected and appointed by the Management Board from a list of suitable candidates drawn up by the Executive Director. The list shall be drawn up on the basis of applications received following a call for expression of interest launched by the Agency and shall aim to include at least twice the number of candidates necessary to fill the posts in the SCCS and for each field of expertise.

Article 14 – paragraph 5 – subparagraph 2 – point a – point iv a (new): (iva) safety assessment of nanomaterials;

Change 29

RemovedNanomaterials are specifically regulated under Article 16 of the Cosmetics Regulation to ensure a high level of protection of human health shall be ensured as this type of material my present specific hazards and risks. A high level of scientific expertise and experience in the field of nanomaterials should therefore be one of the criteria for the nomination of members of the SCCS.

Article 14 – paragraph 5 – subparagraph 2 – point a – point v: (v) non-animal approaches, and emerging methodologies, including new approach methodologies and in vitro/ or in silico techniques;

Change 30

RemovedThis wording is more consistent with other wording used across chemicals legislation (REACH, OSOA, ...)

AddedArticle 14 – paragraph 5 – subparagraph 2 – point b: (b) independence and absence of conflicts of interest, in compliance with rules adopted pursuant to Article 9(1), point (e).

RemovedArticle 14 – paragraph 5 a (new): 5a. Member States shall refrain from nominating or appointing any person as a member of any of the Committees where, on the basis of an analysis there are reasonable grounds to believe that a conflict of interest exists or may arise in relation to that person. / The Management Board shall not proceed with the appointment of any person as a member of any of the Committees where such reasonable grounds exist.

AddedArticle 14 – paragraph 5 – subparagraph 3: The SCCS shall consist of 20 members and shall aim to include at least two members for each field of expertise represented.

RemovedThis amendment aims at strengthening the provisions to avoid conflict of interests for Committee members.

AddedArticle 14 – paragraph 5 a (new): 5a. Members of the Committees shall be nominated and appointed in accordance with the rules on conflicts of interest adopted by the Management Board pursuant to Article 9(1), point (e).

Article 14 – paragraph 6: 6. All Committees shall have a broad range of relevant expertise among their members. The Committees may co-opt additional members chosen on the basis of their specific competence and taking into account geographical diversity. The maximum number of co-opted members for the Committees shall be set and adjusted by the Management Board on the basis of a proposal from the Executive Director, taking into account the workload of the committees, the type of expertise needed and the availability of financial resources.

Article 14 – paragraph 7 a (new): 7a. Co-opted members, experts, advisers and stakeholders shall not have voting rights.

Change 31

RemovedThis is already the case in the Rules of Procedure of the different Committees, this amendment is meant to ensure this is a horizontal provision.

AddedArticle 14 – paragraph 9: 9. Member States shall provide adequate scientific and technical resources and administrative support to those members of the committees that they have nominated or appointed allowing their effective participation and shall facilitate the activities of the committees and their working groups.

RemovedArticle 14 – paragraph 9: 9. Member States shall provide adequate scientific and technical resources, and administrative support to those members of the Committees that they have nominated or appointed and shall facilitate their effective participation in the activities of the Committees and their working groups.

AddedArticle 14 – paragraph 10: 10. The members of RAC, SEAC and SCCS shall be independent and they shall neither seek nor take instructions from any government or other institution, body, office or entity. Those members and members of MSC and BPC shall act in the public interest and in the interest of the Union. They shall refrain from any action incompatible with their duties or the performance of their tasks.

RemovedArticle 14 – paragraph 10: 10. The members of RAC, SEAC and SCCS shall be independent and they shall neither seek nor take instructions from any government or other institution, body, office or entity. The members of MSC and BPC shall act in the public interest and in the interest of the Union. They shall refrain from any action incompatible with their duties or the performance of their tasks.

AddedArticle 14 – paragraph 12: 12. The members of the MSC, and the BPC that are appointed by a Member State shall ensure that there is appropriate coordination between the work in the Committees and the work in their Member State competent authorities.

RemovedArticle 14 – paragraph 12: 12. The members of the Committees that are nominated or appointed by a Member State shall ensure that there is appropriate coordination between the work in the Committees and the work in their Member State competent authorities.

Article 14 – paragraph 15: 15. The member concerned, or that person’s employer as referred to in paragraph 14, shall be remunerated by the Agency in accordance with the financial arrangements established by the Management Board following a positive opinion by the Commission. The list of tasks for which remuneration may be paid shall be established by the Management Board following a positive opinion of the Commission. Where the member concerned fails to fulfil any of those tasks, the Executive Director may withhold remuneration.

Change 32

RemovedEditorial

AddedArticle 15 – paragraph 2: 2. When preparing an opinion, the Committees shall use their best endeavours to reach a consensus among their members. The opinion shall include the grounds for the position of the committee. If a consensus cannot be reached, the opinion shall consist of the position of the majority of the members, the minority positions and the grounds for the respective majority and minority positions. The opinion shall be made publicly available on the Agency's website.

RemovedArticle 15 – paragraph 2: 2. When preparing an opinion, the Committees shall use their best endeavours to reach a consensus among their members. The opinion shall include the grounds for the position of the committee. If a consensus cannot be reached, the opinion shall consist of the position of the majority of the members the minority positions and the grounds for the respective majority and minority positions. The opinion shall be made publicly available on the Agency's website.

RemovedArticle 15 – paragraph 3: 3. The Secretariat shall provide scientific and administrative support to the technical and scientific work of the Committees and the Forum.

Article 15 – paragraph 4: 4. Each Committee shall draft a proposal for their own rules of procedure, which shall be prepared for adoption by the Executive Director and then adopted by the Management Board. When preparing the rules of procedure of RAC, SEAC and SCCS, the Executive Director shall consult the representatives of the Commission in the Management Board.

Change 33

RemovedThe Commission's proposal would give a de facto veto power to the Commission for the adoption of the rules of procedure of the Committees. We propose instead that the representatives of the Commission in the management board should only be consulted on the matter.

AddedArticle 15 – paragraph 5: 5. The rules of procedure of each Committee shall lay down the procedures for replacing and co-opting members, for the creation and organisation of working groups and for delegating certain tasks to such working groups, if applicable. The adoption of opinions shall not be delegated to those working groups. The rules of procedure shall also establish a procedure for the urgent adoption of opinions and the management of conflicts of interest. The rules of procedure shall be made publicly available on the Agency's website.

Change 34

ChangedArticle 15 – paragraph 5: 5. The6 rulesa of(new): procedure6a. ofFor eachall Committee shall lay down themeetings proceduresdetailed forsummaries replacingshall andbe co-optingmade members,available forto the creation and organisation of working groups and forpublic delegatingin certaindue taskstime, to such working groups, if applicable. The rules of procedure shall also establish a procedure forallow the urgent adoption ofpublic opinionsto andfollow the management of conflicts of interest. The rules of procedure shall beprogress made publiclyon availabledossiers onand theother Agency'sitems website.discussed,

Change 35

ChangedArticle 16 – paragraph 4: 4. The Agency shall keep a list of experts up-to-date, which shall include the experts referred to in Article 16(1) and other experts identified directly by the Agency as well as theirthe qualifications.qualifications of those experts.

Change 36

RemovedSimilarly to the requirements for Committee members, qualifications of experts should also be made public.

Article 16 – paragraph 5: 5. The provisions on independence in Article 14(10), on contractual arrangements in Article 14(14) and on the financial arrangements for remuneration in Article 14(15) shall apply mutatis mutandis to any expert serving in a working group of the Committees or of the Forum or performing any other task for the Agency.

Change 37

RemovedEditorial

Article 17 – paragraph 5: 5. The Forum shall draft a proposal for its own rules of procedure to be adopted by the Management Board. The rules of procedure shall lay down the procedures for appointing and replacing the Chairperson, for replacing members and for delegating certain tasks to working groups.

Change 38

RemovedThe adoption phase seems to be missing from the original proposal.

Article 19 – paragraph 1: 1. The membership of the Committees and of the Forum and the list of experts referred to in Article 16(4) shall be published by the Executive Director on the Agency’s website. Individual members and experts may request that their names not be made public if they believe that such publication could place them at risk. The Executive Director shall decide whether to agree to such requests. When an appointment of a member is published, the professional qualifications of that member shall also be published.

Change 39

RemovedFor reason of transparency, the name of experts available to serve in a working group of the Committees should also be made public. This amendment also provide that experts may also request anonymity, if they believe that the publication of their name may place them at risk.

Article 19 – paragraph 3: 3. At each meeting, the members of the Management Board, the Executive Director, chairpersons and members of the Committees and the Forum and any participating experts and advisers shall declare any additional interests which could be considered prejudicial to the members’ obligations pursuant to Article 14(10) with respect to any points on the agenda. A person that has declared such interests shall not participate in voting on the relevant point.

Change 40

RemovedAlignment with Article 37 of the General Food Law. This obligation of transparency should also apply to advisers

AddedArticle 19 – paragraph 3 a (new): 3a. Members of the Management Board, chairpersons and members of the Committees and the Forum and any participating experts and advisers shall report without delay to the Executive Director any attempts to exert pressure or attempts of undue influence of which they are the target.

RemovedArticle 19 – paragraph 3 a (new): 3a. Members of the Management Board, chairpersons and members of the Committees and the Forum and any participating experts and advisers shall report without delay to the Executive Director any attempts of pressure or undue influence of which they are the target.

AddedArticle 27 – paragraph 1 – introductory part: By the end of each year, based on a proposal by the Executive Director, the Management Board shall endorse a draft single programming document containing the following:

RemovedThis paragraph aims to introduce a new provision for Members of the Management Board, chairpersons and members of the Committees and the Forum and any participating experts and advisers to report without delay any attempts of pressure or undue influence they would be the target of to the Executive Director. This is key that the Executive Director is aware of such attempts and take measures to address them without delay to ensure the independence of the Agency, and prevent further pressure.

AddedArticle 27 – paragraph 1 – point d a (new): (da) an assessment of the adequacy of the Agency’s financial and human resources to carry out its current and upcoming tasks;

RemovedArticle 20 – paragraph 5: 5. The Commission shall adopt implementing acts determining the qualifications required for the members of the Board of Appeal in the field of chemical safety, natural sciences and regulatory and judicial procedures as set out in paragraph 3. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 47(2).

AddedArticle 27 – paragraph 1 – point d b (new): (db) a strategy on the effective use of members and experts referred to in Article 14(6), and Articles 16 and 35 respectively;

RemovedArticle 24 – paragraph 2: 2. The appeal, together with the statements of the grounds thereof, shall be filed in writing to the Agency within three months of the notification of the decision to the person concerned, or in the absence of such notification, of the day on which the decision became known to the person concerned, unless otherwise provided for in sectoral Union legislation.

AddedArticle 27 – paragraph 1 – point d c (new): (dc) a strategy on the expected needs and expenses resulting from secondment pursuant to Article 35(2a) and on any decision to grant financial support to national authorities, agencies and research institutes for the implementation of certain tasks within the meaning of Article 41b.

RemovedEditorial

AddedArticle 29 – paragraph 4 a (new): 4a. Fees and charges levied under Union sectoral legislation shall be set at a level sufficient to cover the costs of the services provided in accordance with that legislation.

RemovedArticle 24 – paragraph 3: 3. A fee may be payable by persons bringing an appeal against a decision of the Agency, where that is set out in sectoral Union legislation.

AddedArticle 29 – paragraph 4 b (new): 4b. Within the limits of the budget adopted in accordance with Union budgetary rules, the Agency shall determine the internal allocation of financial resources across its activities and tasks, in line with its mandate and programming documents.

RemovedEditorial

AddedArticle 29 – paragraph 5 – point a: (a) the Agency shall make contributions to the reserve solely from end-of-year budget results within the meaning of Article 99(4) of Delegated Regulation (EU) 2019/715, where those results are positive and stemming from fee and charges revenues collected that are higher than the budgeted amounts in the last amended budget approved by the Agency Management Board in a given year;