Changes from plenary report to adopted text

Article 12 – paragraph 5 – point d: (d) ensure the fulfilment of the time-limits laid down in sectoral Union legislation for the adoption of opinions by the Agency and by the Committees and of the independence of those opinions;

Article 12 – paragraph 5 – point e: (e) ensure appropriate and timely coordination between the different bodies within the Agency, including with regard to potential divergence between their scientific opinions;

Article 12 – paragraph 5 – point e a (new): (ea) ensure an appropriate and timely coordination with other Union bodies, including in relation to potential divergence of scientific opinion as referred to in Article 45;

Article 12 – paragraph 5 – point h a (new): (ha) ensure appropriate and timely response to reports of attempts to exert pressure or attempts of undue influence made pursuant to Article 19(3a); a record of all those reports and responses shall be included in the annual activity report referred to in point (q) of this paragraph; with anonymisation of those who have reported;

Article 12 – paragraph 5 – point p a (new): (pa) appoint the Agency's representative to the task force as referred to in Article 44;

Article 12 – paragraph 6 a (new): 6a. The Executive Director shall ensure a psychologically healthy workplace by giving due consideration to measures beneficial to mental health at work.

Article 13 – paragraph 2 – point b: (b) all other matters not already covered by paragraph 1 or paragraph 2(a), related to the hazards, risks and safe use of substances, on their own, in mixtures or in articles as defined in Article 3, paragraphs 1, 2 and 3 of Regulation (EC) No 1907/2006.

Article 13 – paragraph 2 a (new): 2a. In addition to the tasks referred to in paragraph 1, the Committees shall, at the Executive Director's request: / (a) provide technical and scientific support for steps to improve cooperation among the Union, Member States, international organisations and third countries on scientific and technical issues relating to the safety of substances, as well as active participation in technical assistance and capacity building activities on the sound management of chemicals in developing countries; / (b) draw up an opinion on any other aspects concerning the safety of substances on their own, in mixtures or in articles.

Article 13 – paragraph 2 b (new): 2b. The European Parliament or a Member State may submit a request to the Agency to issue a scientific opinion on matters falling within its competences. The request shall be accompanied by background information explaining the scientific issue to be addressed and the Union interest. / The Agency may refuse or propose amendments to a request for an opinion in consultation with the European Parliament or the Member State(s) that made the request. Justifications for the refusal shall be given to the European Parliament or the Member State(s) that made the request.

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.

Article 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.

Article 14 – paragraph 4 a (new): 4a. At the request of a Member State, the Agency shall assist that Member State to identify possible candidates for nomination by that Member State pursuant to paragraphs 1 and 2. The obligation to nominate a candidate shall however remain with the Member States.

Article 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;

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;

Article 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).

Article 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.

Article 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.

Article 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.

Article 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.

Article 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.

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.

Article 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.

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.

Article 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.

Article 15 – paragraph 6 a (new): 6a. For all Committee meetings detailed summaries shall be made available to the public in due time, to allow the public to follow the progress made on dossiers and other items discussed,

Article 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 the qualifications of those experts.

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.

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.

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.

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.

Article 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.

Article 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:

Article 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;

Article 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;

Article 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.

Article 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.

Article 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.

Article 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;

Article 29 – paragraph 5 – point b: (b) at any moment, the reserve included in the year N in the draft budget for the year N+1 shall not exceed 15% of the average of the total actual amount realised in the last five years of the Agency’s revenues from the fees and charges referred to in paragraph 3, point (b)

Article 29 – paragraph 5 – point c a (new): (ca) the Agency shall report annually, as part of its Annual Activity Report, on the reserve’s opening balance, inflows, outflows, and justifications.

Article 29 – paragraph 6: 6. The Commission shall present an assessment of the functioning of the reserve to the European Parliament and to the Council at the end of the fourth year of operation of the reserve. Where appropriate, the Commission shall present a legislative proposal to the European Parliament and to the Council with a view to adapting the reserve.

Article 30 – paragraph 2 a (new): 2a. The Agency shall monitor its costs and the Executive Director shall provide, in a timely manner as part of the Annual Activity Report delivered to the European Parliament, the Council, the Commission and the Court of Auditors, detailed and substantiated information on the costs to be covered by fees and charges that are within the scope of this Regulation.

Article 30 a (new): Article 30a / Revision of the fees / 1. No later than… [two years after the date of application of this Regulation] and every three year thereafter, the Commission shall evaluate the budgetary adequacy and adapt accordingly the fees payable to the Agency, notably with regard to ensuring that the revenue derived from the fees when combined with other sources of the Agency's revenue is sufficient to cover the cost of the services delivered. / 2. No later than two years after the [date of application of this Regulation] and every three year thereafter, the Commission shall report to the European Parliament and to the Council on the budgetary adequacy of the fees payable to the agency and on the coherence and consolidation of the fees.

Article 35 – title: Seconded national experts and other staff seconded in the interest of the service

Article 35 – paragraph 2 a (new): 2a. Officials and other servants employed by the Agency may, in the interest of the service and in accordance with Article 37 of the Staff Regulations of Regulation No 31 (EEC), 11 (EAEC) and Article 51 of the Conditions of Employment of Other Servants of Regulation No 31 (EEC), 11 (EAEC), be seconded to the competent authorities of the Member States or to other public bodies entrusted with tasks related to the Agency’s mandate. / Such secondment shall not impact on the capacity, tasks and work of the Agency and shall not affect the independence of the staff concerned and shall be subject to appropriate safeguards concerning conflicts of interest and confidentiality.

Article 35 – paragraph 2 b (new): 2b. The Management Board may adopt a decision laying down the conditions under which temporary assignments or secondments in the interest of the service as referred to in paragraph 2a shall take place.

Article 37 a (new): Article 37a / Access to documents / 1. Regulation (EC) No 1049/2001 and Regulation (EC) No 1367/2006 of the European Parliament and of the Council1a shall apply to documents held by the Agency. / 2. The Management Board shall adopt the practical arrangements for implementing Regulation (EC) No 1049/2001 and Articles 6 and 7 of Regulation (EC) No 1367/2006, ensuring access that is as wide as possible to documents in its possession. / 3. Decisions taken by the Agency pursuant to Article 8 of Regulation (EC) No 1049/2001 may be the subject of a complaint to the Ombudsman or of an action before the Court of Justice, under the conditions laid down in Articles 228 and 263 TFEU, respectively. / 1a 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 Union institutions and bodies (OJ L 264, 25.9.2006, p. 13, ELI: http://data.europa.eu/eli/reg/2006/1367/oj).

Article 38 – paragraph 3: 3. Members of the Management Board, the Executive Director, members of the Committees, the Board of Appeal and the Forum, experts participating in working groups, and members of the staff of the Agency shall comply with the confidentiality requirements set out in Article 339 TFEU, even after their duties have ceased.

Article 41 a (new): Article 41a / Assembly of accredited stakeholders / 1. For the purpose of Article 41, the Agency shall establish and coordinate an Assembly of accredited stakeholders. (the ‘Assembly’). / 2. The Assembly shall aim to reinforce the relationship between accredited stakeholders and the Agency and facilitate their contribution to the tasks of the Agency / 3. The Executive Director or a representative of the Executive Director shall be entitled to attend all the meetings of the Assembly. The Assembly shall be chaired by a representative of the Agency. A list of Agency accredited stakeholders shall be made publicly available on the Agency's website. / 4. The Management Board shall draw up a list of the members of the Assembly that are selected among stakeholders referred to in Article 15(1) and ensure a balanced representation of industry representatives and civil society organisations among those members.

Article 41 b (new): Article 41b / Networking of national authorities, agencies and research institutes / 1. The Agency shall facilitate the networking of national authorities, agencies and research institutes operating in the areas of competence of the Agency. The aim of such networking is, in particular, to facilitate a scientific cooperation framework by the coordination of activities, the exchange of information, the development and implementation of joint projects, and the exchange of expertise and best practices in the areas of competence of the Agency. / 2. For the purpose of this Article, the Management Board, acting on a proposal from the Executive Director, shall draw up a list, to be made publicly available on the Agency’s website, of national authorities, agencies and research institutes referred to in paragraph 1 designated by the Member States which may assist the Agency, either individually or in networks, with its tasks. Without prejudice to the tasks entrusted to the Agency in sectoral legislation, the Agency may entrust to those national authorities, agencies and research institutes certain tasks, in particular preparatory work for scientific opinions, scientific and technical assistance, collection of data and identification of emerging risks. Some of those tasks may be eligible for financial support in accordance with paragraph 3. / 3. The Management Board shall adopt decisions to grant financial support to national authorities, agencies and research institutes on the list ref…

Article 43 – paragraph 1: 1. The Agency shall assist Member States and the Commission in promoting the substitution of the most harmful and other hazardous chemicals and groups thereof by safer and more sustainable alternative substances and technologies and in the development, regulatory acceptance, uptake and international validation of relevant scientific methodologies, including non-animal approaches, to assess hazards of chemicals as well as risks and socio-economic impacts of the use of chemicals. Such assistance shall include facilitation of information exchange, contribution to define data generation needs, as well as participation in and facilitation of relevant research, development, and innovation activities within the scope of the relevant Union sectoral legislation, including Regulation (EU) 2021/695 of the European Parliament and of the Council1a, and exposomics where appropriate. / 1a Regulation (EU) 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing Horizon Europe – the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013 (OJ L 170, 12.5.2021, p. 1, ELI: http://data.europa.eu/eli/reg/2021/695/oj).

Article 43 – paragraph 1 a (new): 1a. The Agency shall publish an annual report presenting its recommendations on knowledge and data gaps in terms of regulatory science and regulatory needs, as well as exploratory and fundamental science, in any field within its competence, taking into account emerging risks, and in close cooperation and permanent interaction with relevant Union and international bodies.

Article 44 – paragraph 1: 1. The Agency shall cooperate with other bodies established under Union law, including but not limited to the European Centre for Disease Prevention and Control (ECDC), the European Environment Agency (EEA), the European Food Safety Authority (EFSA), the European Medicines Agency (EMA) and the European Agency for Safety and Health at Work (EU-OSHA), on the provision of relevant scientific opinions, on the exchange of data and information, including the possible establishment of related data formats and controlled vocabularies to facilitate such an exchange, and on the development of scientific methodologies, including non-animal approaches, for the assessment of chemicals.

Article 44 – paragraph 1 a (new): 1a. The Agency shall ensure cooperation with the European Union Reference Laboratory for alternatives to animal testing (EURL ECVAM), in particular with regard to the development of scientific methodologies and training activities.

Article 44 – paragraph 1 b (new): 1b. A permanent task force (the 'task force') shall be established with the Agency, EFSA, EMA, ECDC, EEA, and EU-OSHA.

Article 44 – paragraph 1 c (new): 1c. The task force shall focus on cross-sectoral issues that can benefit from a One Health and exposome approach. The task force shall build on existing mechanisms of cooperation, maximising synergies and avoiding duplication.