Changes from plenary report to adopted text

Recital 11: (11) The structure of the Agency should be suitable for its tasks and should take into account the experience gained from the Agency’s functioning and performance since its establishment. It is essential to ensure that the Agency is equipped to perform its tasks with high scientific and technical capacities to ensure the highest possible quality.

Recital 11 a (new): (11a) The Agency should be central to ensuring that chemicals legislation and the decision-making processes and scientific basis underlying it have credibility with all stakeholders and the general public. The Agency should also play a pivotal role in coordinating communication around chemicals legislation and its implementation. Trust in the Agency by the Union institutions, the Member States, the general public and interested parties is therefore essential. For that reason, it is vital to ensure its independence, high scientific, technical and regulatory capacities, as well as transparency and efficiency. In addition, clear and effective rules should be established to prevent and manage conflicts of interest, and experts should not be appointed to Committees where reasonable concerns about conflicts of interest exist.

Recital 13: (13) The Management Board of the Agency should be entrusted with the necessary powers, in particular to appoint the Executive Director, the members of RAC and SEAC and of the Board of Appeal, and to adopt the consolidated annual activity report, the programming document, the annual budget, and the financial rules applicable to the Agency. The Commission, the European Parliament, and the Member States should be represented within the Management Board in order to effectively exercise oversight over it. In the interests of transparency, interested parties without voting rights should be appointed to the Management Board by the Commission and should represent a wide range of relevant fields of expertise.

Recital 15 a (new): (15a) The Agency's role as an independent scientific point of reference means that a scientific opinion can be requested not only by the Commission, but also by the European Parliament and the Member States. In order to ensure the manageability and consistency of the process of scientific advice, the Agency should be able to refuse or propose to amend a request, providing justification in the case of a refusal, on the basis of predetermined criteria.

Recital 16: (16) RAC has, provided scientific opinions on evaluations of Occupational Exposure Limits (‘OELs’), and other aspects relevant to occupational exposure to hazardous chemicals such as biological limit values for hazardous chemicals in the context of Article 3 of Council Directive 98/24/EC11 . Articles 16, 16a and 18a of Directive 2004/37/EC of the European Parliament and of the Council12 and Articles 18c and 22a of Directive 2009/148/EC of the European Parliament and of the Council13 on the basis of an ad hoc agreement between the Commission and the Agency in the past. Since this task has become customary and in order to consolidate that practice, this Regulation should establish that RAC should provide such opinions upon request from the Commission. In addition, RAC should, upon a request from the Commission, the European Parliament or the Member States provide scientific opinions on all other matters related to the hazards, risks and safe use of chemical 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.

Recital 18: (18) The Management Board should adopt the rules of procedure of RAC, SEAC, MSC, BPC and SCCS, including the procedural arrangements for the Committees’ working groups. In order for the Commission to exercise its oversight, the Commission representatives in the Management Board should be consulted by the Executive Director when preparing the rules of procedure of the RAC, SEAC and SCCS, maintaining the independence of the Committees and their working groups.

Recital 19: (19) The opinions of RAC and SEAC should be based on the broadest possible scientific and technical expertise available within the Union. To this end and to ensure that RAC and SEAC are fully operational, it is essential that each Member State nominates two members for RAC and SEAC respectively and be entitled to nominate up to two additional members. RAC, SEAC, BPC and SCCS should have the possibility to co-opt members and to rely on the services of experts, taking into account the workload, type of expertise needed, geographical balance and availability of financial resources. Committee members should reflect the expertise required for the proper fulfilment of the tasks allocated to the Agency. The Agency should be able to assist Member States in identifying relevant profiles for membership of the RAC, SEAC and BPC, where Member States so request.

Recital 21 a (new): (21a) The Agency should set up an Assembly of accredited stakeholders which should aim to reinforce the relationship with accredited stakeholders, and facilitate their contribution to the tasks of the Agency while ensuring a balanced representation between industry representatives and civil society representatives.

Recital 21 b (new): (21b) In order to enhance scientific cooperation and support the Agency’s work, it is necessary to promote the networking of national authorities, agencies and research institutes operating in areas of competence of the Agency’s mandate. This networking aims to foster the exchange of information, coordination of activities, and the development of joint projects, as well as the sharing of expertise and best practices. To achieve this, a list of national authorities, agencies and research institutes designated by the Member States should be drawn up, enabling those national authorities, agencies and research institutes to assist the Agency with tasks such as preparatory work for scientific opinions, data collection, and the identification of emerging risks.

Recital 23 a (new): (23a) Additional workload arising from an increase in tasks and responsibilities allocated to the Agency should be accompanied by the allocation of appropriate funding for staff and other necessary costs. As part of the draft single programming document, the Management Board should conduct an assessment of the adequacy of its financial and human resources to carry out its current and upcoming tasks.

Recital 25: (25) The Agency has experienced difficulties to accurately predict the income from fees and charges even with the most advanced statistical techniques due to the paucity of information on the drivers of demand from duty holders. The Agency commits to continuously improve its forecasting methods. This impacts the operations of the Agency and requires recurrent amendments to the budget by the Management Board. Therefore, the Agency should be allowed to create a reserve from the surplus of its revenues from fees and charges, subject to the conditions set out in this Regulation. This will allow the Agency to mitigate the consequences of large fluctuation in income from fees and charges. Specifically, the creation of such reserve will allow the Agency to increase the sustainability of its financing model without prejudice to the annual Union contribution and multiannual financial programming. The detailed rules on the parameters, the calculation and the operation of the reserve should be laid down in the Agency’s financial rules and should include the requirements set out in this Regulation. The calculation of the amount of the annual contribution to the reserve or of the amount made available from the reserve, to be included in the draft budget of the Agency, should follow a methodology mechanically applied by the Agency every year. The establishment of such a reserve for a partially self-financed EU agency operating under the universal budgetary model is a unique case and does n…

Recital 26: deleted / (deleted)

Recital 31: (31) The Agency should continue to play an active role in research and innovation, assisting Member States and the Commission in the promotion of substitution of the most harmful chemicals and other hazardous chemicals and groups thereof and in the development of scientific methods, notably non-animal approaches and emerging methodologies, to assess hazards of chemicals and groups of chemicals as well as risks and socio-economic impacts of their use. Where appropriate, the Agency should contribute to research on the links between exposure to hazardous chemicals and negative impacts on health in the field of exposomics, the integrated compilation of all the physical, chemical, biological and psychosocial factors, and their interactions, which have an impact on biology and health.

Recital 31 a (new): (31a) Strengthened collaboration between Union agencies can play a critical role by ensuring that scientific evidence is aligned, making knowledge more accessible to all relevant stakeholders, providing strategic direction to Union research funding, and facilitating engagement with ongoing research and innovation projects. The cross-agency One Health task force established in 2023 by the Agency, the European Food Safety Authority (EFSA), the European Medicines Agency (EMA), the European Centre for Disease Prevention and Control (ECDC) and the European Environment Agency (EEA), has proven to be a successful initiative to strengthen transdisciplinary cooperation among those five Union agencies in order to help them to better address challenges to human, animal, plant and environmental health and successfully contribute to the implementation of the One Health approach in Europe. As that initiative is to end in 2026, this Regulation should establish a more permanent and established form of transdisciplinary cooperation with a permanent task force aiming to build on the work of the One Health task force and to broaden the scope of its work to other approaches, such as exposome encompassing also the One System framework, providing for a holistic, systems-based approach towards environmental risk assessment of chemicals. EU-OSHA should also be included in this permanent framework. The agencies composing the task force should outline a common vision and objectives for that task force…

Recital 37 a (new): (37a) The implications of this Regulation for the Union budget have been assessed1a pursuant to Article 310(4) of the Treaty on the Functioning of the European Union. Sufficient financial and human resources should be provided for its implementation, while considering the impact of the financing on other Union programmes or policies and ensuring its compatibility with the multiannual financial framework, the system of own resources and the corresponding interinstitutional agreement, as well as with the budgetary principles laid down in Regulation (EU, Euratom) 2024/2509 of the European Parliament and of the Council1b. / 1a Pro memoria: Budgetary assessment of the European Parliament’s Committee on Budgets of (XX) 2026 on the proposal for a Regulation of the European Parliament and of the Council on the European Chemicals Agency and amending Regulations (EC) No 1907/2006, (EU) No 528/2012, (EU) No 649/2012 and (EU) 2019/1021 (COM(2025)0386). / 1b Regulation (EU, Euratom) 2024/2509 of the European Parliament and of the Council of 23 September 2024 on the financial rules applicable to the general budget of the Union (OJ L, 2024/2509, 26.9.2024, ELI: http://data.europa.eu/eli/reg/2024/2509/oj).

Article 3 – paragraph 1: The Agency shall have its seat in Helsinki, Finland. / (deleted)

Article 4 – paragraph 1: 1. The Agency shall contribute to the implementation and enforcement of Union legislation and policies related to the hazards, risks, safe use and environmental sustainability of chemical substances, mixtures and articles, provide scientific opinions and advice and independent information on all matters within that field, monitor emerging chemical risks and collect or generate data on chemicals, and communicate on those matters.

Article 4 – paragraph 2: 2. In the fulfilment of its objectives, the Agency shall contribute to ensuring a high level of protection of human health and the environment, including the protection of vulnerable groups. The Agency shall aim to deliver quality, coherence and consistency in chemicals assessment and management across the Union which is key to ensuring the free circulation of substances in the internal market, while contributing to enhancing the competitiveness and innovation, taking into account the specific needs of small and medium-sized enterprises (‘SMEs’) as defined in the Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises26 and promoting and strengthening expertise in the substitution of harmful chemicals and groups of harmful chemicals as well as the development, and use of non-animal approaches and emerging methodologies.

Article 4 – paragraph 5 – point b: (b) provide technical and scientific support, guidance, IT tools and digital infrastructure for the development, implementation and enforcement of this Regulation and sectoral Union legislation taking into account the objectives of ensuring a high level of protection of human health and the environment, occupational health standards, the specific needs of SMEs and the requirement of replacing animal testing with non-animal approaches where scientifically possible;

Article 4 – paragraph 5 – point g a (new): (ga) ensure that conflicts of interest are prevented or managed, so as to ensure its independence and credibility with stakeholders and the general public;

Article 4 – paragraph 5 – point k a (new): (ka) upon request from the European Parliament or a Member State, provide scientific opinions and technical assistance in a field falling within its competences;

Article 4 – paragraph 5 – point k b (new): (kb) provide annual training for staff and committee members, and share knowledge with all stakeholders.

Article 4 – paragraph 5 a (new): 5a. Requests received under paragraph 5, points (c), (d), (e), (k) and (ka), of this Article and under Article 13(2), point (b), as well as a regular update on their status shall be made publicly available on the Agency’s website.

Article 5 – paragraph 1 – point c: (c) a Committee for Risk Assessment (‘RAC’), which shall be responsible for preparing opinions of the Agency relating to hazards and risks of chemicals to human health or the environment;

Article 5 – paragraph 1 – point d: (d) a Committee for Socio-economic Analysis (‘SEAC’), which shall be responsible for preparing opinions of the Agency relating to the socio-economic impact of possible legislative measures on chemicals;

Article 5 – paragraph 1 – point h a (new): (ha) an Assembly of accredited stakeholders, as established in Article 41a, which shall aim to reinforce the relationship between accredited stakeholders and the Agency, and facilitate their contribution to the tasks of the Agency;

Article 5 – paragraph 1 – point i: (i) a Secretariat, which shall work under the leadership of the Executive Director and undertake the work required of the Agency in accordance with sectoral Union legislation, provide technical, scientific and administrative support, capacity building and training, to the Committees and the Forum, and ensure appropriate coordination between them;

Article 6 – paragraph 1 – point c: (c) two independent persons appointed by the European Parliament, those persons shall be independent in the performance of their duties and shall neither seek nor take instructions from any Union institution, body, office or agency, any government or from any other public or private body.

Article 6 – paragraph 2: 2. The representatives of the Member States, the representatives of the Commission and the independent persons appointed by the European Parliament shall have voting rights. The persons representing interested parties, appointed by the Commission, shall not have voting rights.

Article 6 – paragraph 3 – point b: (b) trade unions, including occupational health and safety;

Article 6 – paragraph 3 – point d a (new): (da) non-animal approaches;

Article 6 – paragraph 4: 4. Members of the Management Board shall be appointed on the basis of their knowledge and relevant experience in the field of chemical safety or regulation of chemicals, taking due regard of their relevant managerial, administrative and budgetary skills. In accordance with the principle of equal treatment of all genders, all parties nominating and appointing members of the Management Board shall aim to achieve gender balance on the Management Board. Members, alternates and observers of the Committees and the Forum or their working groups shall not be eligible to become members of the Management Board.

Article 6 – paragraph 4 a (new): 4a. Members of the Management Board 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 6 – paragraph 6: 6. Members of the Management Board shall act exclusively in the interests of the Agency and of the Union.

Article 9 – paragraph 1 – point s: (s) adopt the rules of procedure of the Committees, the Forum, and the Assembly of stakeholders;

Article 9 – paragraph 1 – point y: (y) adopt the practical arrangements for complying with Regulation (EC) No 1049/2001 of the European Parliament and of the Council28, including appeals or remedies necessary for reviewing a partial or full rejection of a confidentiality request as referred to in Article 37a;

Article 10 – paragraph 3: 3. In the event that the Commission raises serious concerns on a decision proposal presented to the Management Board on matters related to Commission Delegated Regulation (EU) 2019/71529 on the Framework financial regulation for decentralised regulatory agencies or to the Staff Regulations and the Conditions of Employment of Other Servants of Regulation No 31 (EEC), 11 (EAEC), the Management Board shall postpone the adoption of the decision. Within 15 days, the Management Board shall re-examine and adopt it, possibly amended, in second reading.

Article 12 – paragraph 3: 3. Without prejudice to the powers of the Commission and of the Management Board, the Executive Director shall be independent in the performance of their duties and shall neither seek nor take instructions from any Union institution, body, office or agency, nor from any government or from any other public and private body. The Executive Director shall report to the European Parliament or the Council on the performance of tasks under this Regulation when invited to do so by the respective institution.