Text · Comparison of two versions
Changes from report parliamentary committee draft to plenary report
ENVI-PR-781186 → A-10-2026-0093
- From
- ENVI-PR-781186 report parliamentary committee draft of 17 Dec 2025
- To
- A-10-2026-0093 Plenary report of 16 Apr 2026
- Changes
- 59 changes to the text
- Paragraphs
- +98 added · −136 removed · 21 changed
More facts (3)
- Dossier
- 2025/0207(COD)
- Title (from)
- 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
- Title (to)
- 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
AI: What changed, in short Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
The report expands the Agency's tasks to include groups of substances, occupational health, and non-animal approaches, and adds provisions for scientific opinions from Parliament or member states.1456 It establishes an Assembly of accredited stakeholders and a permanent cross-agency task force, replacing a Forum and adding detailed governance rules.3121343 It strengthens conflict-of-interest rules, independence requirements, and transparency for committees and the Management Board.14151617 It adds provisions on financial reserve, fees revision, and budget assessments, and requires the Commission to report on evaluation findings.4184056 The other changes are formal or wording: updated references, punctuation, and explanatory notes.2112021
The notes class 42 changes as substance, 12 as formal, 5 as wording only.
Changes that matter, 59
Changes to the text in document order — the ones the change notes describe. Cover page, renumbering and punctuation-only edits are left out (see “Every difference”); changes to citations and references stay in and are marked as formal in the notes.
Change 1
ChangedRecital 9: (9) The Agency should continue to contribute to the implementation and enforcement of Union legislation and policies related to the hazards, risks, safe use, and environmental sustainability of chemical substances,substances and groups thereof, mixtures and articles in order to achieve a high level of protection of human health and the environment, including the protection of vulnerable groups, the efficient functioning of the internal market and coherence and consistency in chemicals management across the Union, while enhancing competitiveness and innovation, taking into account the specific needs of small and medium-sized enterprises to safeguard and promotingfurther alternativesenhance tooccupational health standards and promoting non-animal approaches.approaches and emerging methodologies. By achieving its objectives and tasks, the Agency will contribute to the full implementation of the objectives of the Treaties and, in particular, pursuant to Article 191(2) TFEU, that environmental policy is to be based on the precautionary principle and on the principles that preventive action should be taken, that environmental damage should as a priority be rectified at source and that the polluter should pay.
AI: Note on change 1 · substance Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Expands the Agency's contribution to include groups of substances, safeguarding occupational health standards and promoting non-animal approaches and emerging methodologies.
Change 2
RemovedThis wording is more consistent with other wording used across chemicals legislation (REACH, OSOA, ...)
AddedRecital 10 a (new): (10a) To reinforce the capacity and contribute to the work of the competent authorities of Member States, the Agency should be able to second officials and other servants in its employment, in the interest of the service and in accordance with Article 37 of the Staff Regulations of Regulation No 31 (EEC), 11 (EAEC)1a and Article 51 of the Conditions of Employment of Other Servants of Regulation No 31 (EEC), 11 (EAEC), to the competent authorities of the Member States or to other public bodies entrusted with tasks related to the Agency’s mandate. / 1a Regulation No 31 (EEC), 11 (EAEC), laying down the Staff Regulations of Officials and the Conditions of Employment of Other Servants of the European Economic Community and the European Atomic Energy Community (OJ 45 14.6.1962, p. 1385, ELI: http://data.europa.eu/eli/reg/1962/31(1)/oj).
RemovedRecital 10 a (new): (10a) To reinforce the capacity and contribute to the work of the competent authorities of Member States, the Agency should be able to second officials and other servants in its employment, in the interest of the service and in accordance with Article 37 of Regulation No 31(EEC), 11 (EAEC)1a, to the competent authorities of the Member States or to other public bodies entrusted with tasks related to the Agency’s mandate, for example to help Member States meet their obligations to appoint committee members and thus ensure that the Agency has the number of committee members and experts it needs to do its work properly. / 1a Regulation No 31 (EEC), 11 (EAEC), laying down the Staff Regulations of Officials and the Conditions of Employment of Other Servants of the European Economic Community and the European Atomic Energy Community (OJ P 045 14.6.1962, p. 1385, ELI: http://data.europa.eu/eli/reg/1962/31(1)/oj).
RemovedTo perform its tasks and mission the Agency relies heavily on financial and human resources in the Member States in particular for scientific experts. Some Member States may have less resources or competences in the field of chemicals. Where appropriate, the Agency should be able to use to possibility offered by Article 37 of the Staff Regulation to contribute to the capacity building of the expertise of those Member States for example to help them meet their obligations to appoint committee members and thus ensure that the agency has the number of committee members and experts it needs to do its work properly.
AI: Note on change 2 · substance Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Adds a recital allowing the Agency to second staff to member state authorities, while removing an earlier version that specified helping member states appoint committee members.
Change 3
RemovedMoved to a new recital.
AddedRecital 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.
RemovedRecital 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.
AddedRecital 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.
RemovedConsidering the crucial nature of transparency and efficiency for the Agency, this deserves a separated recital. This recital is based on recital 95 of REACH with modification to give it a more horizontal meaning.
AddedRecital 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.
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RemovedRecital 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 amend a request providing justification for that refusal or amendment and on the basis of predetermined criteria.
AddedRecital 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.
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.
AddedRecital 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.
RemovedRecital 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, without compromising the independence of the Committees and their working groups.
AddedRecital 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.
RemovedRecital 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, each Member State should nominate two members for RAC and SEAC respectively and should 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 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.
AddedRecital 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.
RemovedRecital 21 a (new): (21a) The Agency should set up a Forum for accreditedstakeholders which should aim to structure and reinforce the relationship with all stakeholders, and allow the members of that forum to contribute to the tasks of the Agency.
AddedRecital 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.
RemovedECHA has had a long standing practice of interaction and exchange with stakeholders and civil society in general, in particular via its accredited stakeholders. The proposal for a Basic Regulation is the opportunity to institutionalise this practice to structure and reinforce the relationship with all stakeholders, and allow its members to contribute to the tasks of the Agency.
RemovedRecital 21 b (new): (21b) In order to enhance scientific cooperation and support the Agency’s work, it is necessary to promote the networking of organisations 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 competent organisations designated by the Member States should be drawn up, enabling these organisations to assist the Agency with tasks such as preparatory work for scientific opinions, data collection, and the identification of emerging risks. The Commission is empowered to adopt delegated acts to establish the criteria for the inclusion of organisations on this list, the quality requirements, and the financial rules governing any financial support that may be provided.
AI: Note on change 3 · substance Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Adds recitals on the Agency's credibility, independence, conflict-of-interest rules, scientific opinions from Parliament or member states, and an Assembly of accredited stakeholders, replacing a Forum.
Change 4
RemovedRecital 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 and other hazardous chemicals and in the development of scientific methods, notably non-animal approaches, to assess hazards of chemicals as well as risks and socio-economic impacts of their use. In particular, the Agency should assist and contribute to the 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.
AddedRecital 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…
RemovedSubstitution effort should not be limited to the most harmful substances. This amendment also outlines research on exposome as one of the key priorities to which the Agency should contribute.
AddedRecital 26: deleted / (deleted)
RemovedRecital 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 between 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), established in 2023, has proved to be a successful initiative to strengthen transdisciplinary cooperation among 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 approach, such as exposome. The Agencies composing the task force should outline a common vision and objectives for that task force, working toward a more permanent and established form of transdisciplinary cooperation between the Union agencies. They should be able to plan coordinated actions and to broaden the scope of their cooperati…
AddedRecital 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.
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RemovedArticle 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 generate data on chemicals, and communicate on those matters.
AddedRecital 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…
RemovedThe 'One Substance One Assessment' package tasks ECHA to collect data on the environmental sustainability of chemicals (Article 13 of the Common Data Platform on Chemicals), this needs to be reflected in the objectives and tasks of the Agency.
AddedRecital 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).
RemovedArticle 4 – paragraph 2 – subparagraph 1: In the fulfilment of its objectives, the Agency shall aim to 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 ensure 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 the development and use of non-animal approaches.
AddedArticle 3 – paragraph 1: The Agency shall have its seat in Helsinki, Finland. / (deleted)
RemovedThe first and foremost objective of the agency should remain the ensuring a high level of protection of health and the environment. A particular attention should be given to vulnerable groups in alignment with the text adopted in the OSOA Package (Proposal on the re-attribution of scientific and technical tasks and improving cooperation among Union agencies in the area of chemicals). It is also key to base the objectives of this Regulation in alignment with the general principles of the Treaties regarding protection of health and the environment.
AddedArticle 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.
RemovedArticle 4 – paragraph 2 – subparagraph 1 a (new): As a body based on scientific and technical expertise, the Agency shall also contribute to ensuring that Union policy on chemicals is based on the principles enshrined in Article 191(2) TFEU.
AddedArticle 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.
AI: Note on change 4 · substance Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Adds recitals on a financial reserve, a permanent cross-agency task force, and budget assessment; removes a recital on research and innovation; rephrases recitals on substitution and research.
Change 5
ChangedThe first andArticle foremost4 objective– ofparagraph the5 agency– shouldpoint remainb: the(b) ensuringprovide atechnical highand levelscientific ofsupport, protectionguidance, ofIT healthtools and thedigital environment.infrastructure Afor particularthe attentiondevelopment, shouldimplementation beand givenenforcement toof vulnerablethis groupsRegulation inand alignmentsectoral withUnion thelegislation texttaking adoptedinto inaccount the OSOAobjectives Packageof (Proposalensuring ona thehigh re-attributionlevel of scientificprotection andof technicalhuman taskshealth and improving cooperation among Union agencies in the area of chemicals). It is alsoenvironment, keyoccupational tohealth basestandards, the objectives of thisspecific Regulationneeds inof alignmentSMEs withand the general principlesrequirement of thereplacing Treatiesanimal regardingtesting protectionwith ofnon-animal healthapproaches andwhere thescientifically environment.possible;
AI: Note on change 5 · substance Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Replaces a deleted paragraph on objectives with a new Article 4(5)(b) that adds technical support for digital infrastructure and occupational health standards.
Change 6
RemovedArticle 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 health and the environment, the specific needs of SMEs and the goal of replacing animal testing with non-animal approaches where scientifically possible;
RemovedProtection of health and the environment should remain the principal compass of the Agency, together with contributing to the competitiveness of the industry and replacing animal testing.
AI: Note on change 6 · substance Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Drops a paragraph that required the Agency to provide technical support for implementation and enforcement, including IT tools and digital infrastructure.
Change 7
RemovedThe role of the Agency as a point of reference must also go hand in hand with strong rules regarding the prevention of conflict of interests.
AddedArticle 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;
AI: Note on change 7 · substance Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Adds a task for the Agency to provide scientific opinions and technical assistance upon request from the European Parliament or a member state.
Change 8
ChangedArticle 4 – paragraph 5 – point k ab (new): (ka) foster expertise in non-animal approaches(kb) throughprovide annual training for staff and committee members, and share knowledge with all stakeholders.
AI: Note on change 8 · substance Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Changes a new task from fostering expertise in non-animal approaches through annual training to providing annual training for staff and committee members and sharing knowledge with stakeholders.
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Change 9
RemovedTasks and objectives of the Agency should reflect the objectives of the Chemicals Strategy for Sustainability to move away from animal testing.
AddedArticle 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.
AI: Note on change 9 · substance Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Adds a requirement to publicly list requests for opinions and their status on the Agency's website.
Change 10
ChangedArticle 5 – paragraph 1 – point c: (c) a Committee for Risk Assessment (‘RAC’), which shall be responsible for preparing opinions of the Agency relating to riskshazards and hazardsrisks of chemicals to human health or the environment;
AI: Note on change 10 · wording only Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Reorders 'risks and hazards' to 'hazards and risks' in the description of RAC's responsibilities.
Change 11
RemovedThis Wording better reflects the tasks of RAC which is to prepare opinions of ECHA related to the risks of substances to human health and the environment but also examine the proposals for harmonised classification and labelling and give an opinion on the proposed harmonised classification of substances.
AI: Note on change 11 · formal Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Removes an explanatory note about RAC's tasks.
Change 12
RemovedAs part of its task, SEAC is mandated to give opinion not only relating to the socio-economic impact of possible legislative measures on substances on their own, but also on substances in a mixture or in an article, the broader term 'chemicals' is meant to encompass all of these possibilities.
AddedArticle 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;
AI: Note on change 12 · substance Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Adds an Assembly of accredited stakeholders to the Agency's structure, replacing a previously proposed Forum.
Change 13
ChangedArticle 5 – paragraph 1 – point hi: (i) a (new):Secretariat, (ha)which ashall Forumwork ofunder accreditedthe stakeholders,leadership asof establishedthe inExecutive ArticleDirector 41a,and whichundertake shallthe aimwork torequired structureof andthe reinforceAgency thein relationshipaccordance with allsectoral stakeholders,Union legislation, provide technical, scientific and allowadministrative itssupport, memberscapacity tobuilding contributeand training, to the tasksCommittees ofand the Agency;Forum, and ensure appropriate coordination between them;
AI: Note on change 13 · substance Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Replaces the Secretariat's task of supporting the Forum with supporting the Assembly of accredited stakeholders.
Change 14
RemovedECHA has had a long standing practice of interaction and exchange with stakeholders and civil society in general, in particular via its accredited stakeholders. The proposal for a Basic Regulation is the opportunity to institutionalise this practice to structure and reinforce the relationship with all stakeholders, and allow its members to contribute to the tasks of the Agency.
AddedArticle 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.
RemovedArticle 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 and capacity building and training to the Committees and the Forum, and ensure appropriate coordination between them;
AddedArticle 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.
RemovedThis draft report introduces several proposals in order to reinforce the capacity building and training role of ECHA, such as training staff and experts on non-animal approaches. This should therefore be reflected in the tasks of the Secretariat.
AddedArticle 6 – paragraph 3 – point b: (b) trade unions, including occupational health and safety;
AI: Note on change 14 · substance Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Adds two independent persons appointed by the European Parliament to the Management Board with voting rights, and adds trade unions as interested parties.
Change 15
ChangedArticle 6 – paragraph 13 – point c: (c) two independent personsd appointeda by(new): the(da) Europeannon-animal Parliament.approaches;
AI: Note on change 15 · substance Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Adds a new point (da) in Article 6(3) for non-animal approaches, replacing a previous point that had no content.
Change 16
RemovedAlignment with current REACH wording.
AddedArticle 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.
AI: Note on change 16 · substance Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Adds requirements for Management Board members' qualifications, gender balance, and exclusion of committee members.
Change 17
ChangedArticle 6 – paragraph 2:4 2.a The(new): representatives4a. Members of the Member States, theManagement representativesBoard ofshall thebe Commissionnominated and independent persons appointed by the European Parliament shallin haveaccordance votingwith rights.the Therules personson representingconflicts interestedof parties,interest appointedadopted by the Commission,Management shallBoard notpursuant haveto votingArticle rights.9(1), point (e).
AI: Note on change 17 · substance Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Adds a provision that Management Board members are appointed in accordance with conflict-of-interest rules.
Change 18
RemovedAlignment with current REACH wording.
AddedArticle 6 – paragraph 6: 6. Members of the Management Board shall act exclusively in the interests of the Agency and of the Union.
RemovedArticle 6 – paragraph 3 – point d a (new): (da) occupational health and safety;
AddedArticle 9 – paragraph 1 – point s: (s) adopt the rules of procedure of the Committees, the Forum, and the Assembly of stakeholders;
RemovedAs this Regulation integrates the task for RAC to provide 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, relevant expertise should be integrated in the management board.
AddedArticle 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;
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RemovedArticle 6 – paragraph 3 – point d b (new): (db) non-animal approaches.
RemovedTasks and objectives of the Management Board should reflect the objectives of the Chemicals Strategy for Sustainability to move away from animal testing.
RemovedArticle 6 – paragraph 4 a (new): 4a. All parties nominating and appointing members of the Management Board shall refrain from nominating or appointing any person as a member of the Management Board 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.
RemovedThis amendment aims at strengthening the provisions to avoid conflict of interests for members of the Management Board.
RemovedArticle 6 – paragraph 6: 6. Members of the Management Board shall act exclusively in the interests of the Agency and the Union.
RemovedMembers of the management should not only act in the interests of the Agency but also in the interest of all citizens of the Union.
RemovedArticle 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;
RemovedThe draft proposal deletes Art 118(1) REACH which is the legal basis for ECHA to apply the ATD Regulation (Regulation 1049/2001) to documents that ECHA holds. However, the proposal does not have an equivalent provision setting out such a clear legal basis, unlike the founding regulations of the other Agencies (see e.g. Article 41 Regulation 178/2002). It only has a provision saying the Management Board will adopt implementing rules for the ATD Regulation. The ATD Regulation as such does not apply to ECHA; it only applies to the Commission, Council and EP documents. To ensure proper transparency considering Article 15 TFEU, we propose to create in the Basic Regulation an equivalent to Article 118(1) of REACH in a new article which should be cross-referenced here.
RemovedArticle 10 – paragraph 1: 1. The Management Board shall act by a two-thirds majority of all its members with voting rights.
RemovedEditorial
AI: Note on change 18 · substance Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Adds provisions on Management Board members acting in the Agency's interest, adopting rules for committees and the Assembly, and adopting arrangements for access to documents.
Change 19
RemovedThe Commission's proposal would give a de facto veto power to the Commission in case of second reading on those matters. We propose instead that the two-thirds majority set in paragraph 1 of this article should apply in all cases.
AddedArticle 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.
AI: Note on change 19 · substance Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Adds a requirement for the Executive Director to report to Parliament or Council on task performance.
Change 20
ChangedArticle 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;
AI: Note on change 20 · wording only Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Adds 'of' before 'the independence' in a list of Executive Director duties.
Change 21
RemovedArticle 4(4) provides that the Agency should serve as a point of reference by virtue of the independence of its assessments and opinions, this needs to be reflected in the tasks and responsibilities of the Executive Director.
AI: Note on change 21 · formal Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Removes an explanatory note about the Agency's role as a point of reference.
Change 22
RemovedArticle 45 is not about resolving potential divergence of opinions between bodies within the Agency, but with other Union bodies. A new item is added to address this specific case.
AddedArticle 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;
AI: Note on change 22 · substance Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Adds a duty for the Executive Director to ensure coordination with other Union bodies on scientific opinion divergence.
Change 23
ChangedArticle 12 – paragraph 5 – point eh a (new): (ea)(ha) ensure appropriate and timely coordinationresponse withto otherreports Unionof bodiesattempts withto regardexert pressure or attempts of undue influence made pursuant to potentialArticle divergence19(3a); a record of scientificall opinionthose reports and responses shall be included in accordancethe annual activity report referred to in point (q) of this paragraph; with Articleanonymisation 45;of those who have reported;
AI: Note on change 23 · substance Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Adds a duty for the Executive Director to respond to reports of pressure or undue influence and include records in the annual activity report.
Change 24
RemovedItem added to address the specific case of resolving potential divergence of scientific opinion between the Agency and other Union bodies.
AddedArticle 12 – paragraph 5 – point p a (new): (pa) appoint the Agency's representative to the task force as referred to in Article 44;
RemovedArticle 12 – paragraph 5 – point h a (new): (ha) ensure appropriate and timely response to reports of attempts of pressure or 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;
AddedArticle 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.
RemovedThis report introduces a new provision in Article 19 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. Hence, the Executive Director should be tasked to responding to and reporting on these potential cases.
RemovedArticle 12 – paragraph 5 – point p a (new): (pa) appoint the Agency's representative to the task force referred to in Article 44;
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RemovedAs this report proposes in Article 44 to perpetuate and institutionalise the current cross-agency One Health task, the role of the Executive Director to appoint its representative to the Task Force should be reflected in this Article.
AI: Note on change 24 · substance Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Adds duties for the Executive Director to appoint the Agency's representative to the task force and ensure a psychologically healthy workplace.
Change 25
RemovedEditorial
AddedArticle 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.
RemovedArticle 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, provide technical and scientific support for steps to improve cooperation between the Union, the 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 sound management of chemicals in developing countries.
AddedArticle 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.
RemovedArticle 77(3)(b) of REACH provides the possibility for RAC at the Executive Director's request, to provide provide 'technical and scientific support for steps to improve cooperation between the Community, its 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 sound management of chemicals in developing countries'. This mandate should not be limited to matters related under REACH but should be available for all tasks performed by ECHA, and for all Committees, regardless of the legislation from which it is emanating. Therefore, this possibility is now included in this article, and Article 77(3)(b) of REACH is deleted (see AM to Article 48)
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.
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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.
AI: Note on change 25 · substance Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Adds tasks for committees to provide technical support for international cooperation and to issue opinions on other safety aspects, and allows Parliament or member states to request opinions.
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.
AI: Note on change 26 · substance Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Adds a provision that each member state appoints one member to BPC and may appoint an alternate.
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.
AI: Note on change 27 · substance Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Changes the Agency's assistance to member states from identifying candidates to helping them identify candidates, with the obligation remaining with 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.
AI: Note on change 28 · substance Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Adds a requirement for the SCCS candidate list to include at least twice the number of candidates needed.
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.
AI: Note on change 29 · formal Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Removes an explanatory note about nanomaterials expertise.
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).
AI: Note on change 30 · substance Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Adds a requirement for SCCS members to have independence and no conflicts of interest, and specifies the SCCS shall have 20 members.
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.
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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.
AI: Note on change 31 · substance Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Changes the requirement for member states to provide resources and support to committee members, and clarifies independence and coordination duties.
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.
AI: Note on change 32 · formal Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Fixes punctuation in Article 15(2) and removes a paragraph on Secretariat support.
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.
AI: Note on change 33 · substance Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Adds a requirement for committee rules of procedure to be made publicly available.
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,
AI: Note on change 34 · substance Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Adds a requirement for detailed summaries of committee meetings to be made public.
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.
AI: Note on change 35 · wording only Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Rephrases the requirement to keep a list of experts up-to-date.
Change 36
RemovedSimilarly to the requirements for Committee members, qualifications of experts should also be made public.
AI: Note on change 36 · formal Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Removes an explanatory note about qualifications of experts.
Change 37
RemovedEditorial
AI: Note on change 37 · formal Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Removes an editorial note.
Change 38
RemovedThe adoption phase seems to be missing from the original proposal.
AI: Note on change 38 · formal Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Removes an explanatory note about the adoption phase.
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.
AI: Note on change 39 · formal Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Removes an explanatory note about transparency of experts.
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;
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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;
RemovedArticle 25 – paragraph 4: 4. The Commission shall adopt implementing acts determining the procedures of the Board of Appeal and its Registry. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 47(2).
AddedArticle 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)
RemovedArticle 27 – paragraph 1 – introductory part: 1. By the end of each year, based on a draft proposal by the Executive Director, the Management Board shall endorse a draft single programming document containing the following:
AddedArticle 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.
RemovedEditorial
AddedArticle 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.
RemovedArticle 27 – paragraph 1 – point d a (new): (da) an assessment of the adequacy of its financial and human resources to carry out its current and upcoming tasks;
AddedArticle 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.
RemovedArticle 27 – paragraph 1 – point d b (new): (db) a strategy for the mobilisation of members and experts, and the expected needs and expenses resulting from the financial support referred to in Article 35(2a) and Article 41b.
AddedArticle 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.
RemovedArticle 29 – paragraph 4: 4. The expenditure of the Agency shall include staff remuneration, administrative and infrastructure expenses, and operational expenditure, and expenses resulting from contracts entered into with third parties or resulting from the financial support referred to in Article 35(2a) and Article 41b.
AddedArticle 35 – title: Seconded national experts and other staff seconded in the interest of the service
RemovedArticle 29 – paragraph 6: 6. The Commission may review the conditions for the reserve set out in paragraph 5 taking into account fluctuations in the Agency's revenues from fees and charges over successive years, and is empowered to adopt delegated acts in accordance with Article 46(1) to amend paragraph 5 on the basis of such review, where appropriate.
AddedArticle 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.
RemovedIn case where important fluctuations in the Agency's fee revenues over successive years are observed, the Commission should take that factor into account to adapt the maximum percentage of the total actual amount realised in the year N-1 of the Agency’s revenues from the fees and charges to this fluctuation.
AddedArticle 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.
RemovedArticle 35 – title: Seconded national experts and other staff seconded in the interests of the service
AddedArticle 37 – paragraph 2: 2. For all regulatory, scientific and technical information held by the Agency concerning the safety of substances on their own, in mixtures or in articles and not covered by Article 37a(1) shall apply, without prejudice to specific provisions in Union legislation on disclosure of information.
RemovedArticle 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 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 affect the independence of the staff concerned and shall be subject to appropriate safeguards concerning conflicts of interest and confidentiality.
AddedArticle 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).
RemovedTo reinforce the capacity and contribute to the work of Member States Competent Authorities, the Agency should be able to second officials and other servants in its employment, in particular scientific experts, in the interest of the service and in accordance with Article 37 of the Staff Regulations of Officials of the European Union and the Conditions of Employment of Other Servants, to temporarily assign or second them to the competent authorities of the Member States or to other public bodies entrusted with tasks related to the Agency’s mandate, for example to help Member States meet their obligations to appoint committee members and thus ensure that the agency has the number of committee members and experts it needs to do its work properly.
RemovedArticle 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 interests of the service as referred to in paragraph 2a shall take place.
RemovedArticle 37 a (new): Article 37a / Access to documents / 1. Notwithstanding the rules on confidentiality provided for in sectoral Union legislation, Regulation (EC) No 1049/2001 of the European Parliament and of the Council1a shall apply to documents held by the Agency. / Where environmental information is concerned, Regulation (EC) No 1367/2006 of the European Parliament and of the Council1b shall also apply. Directive 2003/4/EC of the European Parliament and of the Council shall apply to environmental information held by Member States, notwithstanding the rules on confidentiality provided for in sectoral Union legislation. / 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 by ...[OP please insert: 6 months from the date of entry into force of this Regulation], ensuring as wide access as possible to documents in its possession. / 3. Decisions taken by the Agency pursuant to Article 8 of Regulation (EC) No 1049/2001 may form 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 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43, ELI: http://data.europa.eu/eli/reg/2001/1049/oj). / 1b Regulation (EC) No 1367/2006 of the European …
RemovedThe draft proposal deletes Art 118(1) REACH which is the legal basis for ECHA to apply the ATD Regulation (Regulation 1049/2001) to documents that ECHA holds. However, the proposal does not have an equivalent provision setting out such a clear legal basis, unlike the founding regulations of the other Agencies (see e.g. Article 41 Regulation 178/2002). It only has a provision saying the Management Board will adopt implementing rules for the ATD Regulation. The ATD Regulation as such does not apply to ECHA; it only applies to the Commission, Council and EP documents. To ensure proper transparency considering Article 15 TFEU, we propose to create in the Basic Regulation an equivalent to Article 118(1) of REACH.
AI: Note on change 40 · substance Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Adds a duty for members to report attempts of pressure or undue influence, and adds requirements for programming documents, fees, and a reserve.
Change 41
RemovedThis is the only instance where the proposal refers to 'external' experts, to avoid confusion this amendment aims to align the wording with the rest of the text by referring only to 'experts'.
AddedArticle 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.
RemovedArticle 41 a (new): Article 41a / Forum of accredited stakeholders / 1. For the purpose of Article 41, the Agency shall establish and coordinate a Forum of accredited stakeholders. / 2. All stakeholders invited to attend meetings of the Agency as referred to in Article 15(1) shall be members of the Forum of accredited stakeholders. The Executive Director or a representative of the Executive Director shall be entitled to attend all the meetings of the Forum of accredited stakeholders. The Forum of accredited stakeholders shall be chaired by a representative of the Agency. A list of Agency accredited stakeholders shall be made public on the Agency's website. / 3. The Forum of accredited stakeholders shall aim to structure and reinforce the relationship with all stakeholders, and allow its members to contribute to the tasks of the Agency in accordance with its rules of procedure. / 4. The Forum of accredited stakeholders shall draft a proposal for its own rules of procedure for adoption by the Management Board.
AddedArticle 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…
RemovedECHA has had a long standing practice of interaction and exchange with stakeholders and civil society in general, in particular via its accredited stakeholders. The proposal for a Basic Regulation is the opportunity to institutionalise this practice to structure and reinforce the relationship with all stakeholders, and allow its members to contribute to the tasks of the Agency.
AddedArticle 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).
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RemovedArticle 41 b (new): Article 41b / Networking of organisations operating in the areas of competence of the Agency / 1. The Agency shall promote the European networking of organisations 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, the exchange of expertise and best practices in the areas of competence of the Agency. / 2. The Management Board, acting on a proposal from the Executive Director, shall draw up a list, to be made public, of competent organisations designated by the Member States which may assist the Agency, either individually or in networks, with its tasks. The Agency may entrust to those organisations 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. / 3. The Commission is empowered to adopt delegated acts in accordance with Article 46 in order to supplement this Regulation by establishing the criteria for the inclusion of an organisation on the list of competent organisations designated by the Member States, the arrangements for setting out harmonised quality requirements and the financial rules governing any financial support. / The Commission shall adopt implementing acts for the application of …
AddedArticle 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.
RemovedArticle 42 – paragraph 1: 1. In so far as is necessary to achieve the objectives set out in this Regulation and sectoral Union legislation, and without prejudice to the respective competences of Member States and the institutions of the Union, the Agency may cooperate with the competent authorities of third countries and with international organisations that have entered into agreements with the Union to that effect.
RemovedEditorial
RemovedArticle 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 by safer and more sustainable alternative substances and technologies and in the development 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 Council . In particular, the Agency shall assist and contribute to the research on the links between exposure to hazardous chemicals and negative impacts on health in the field of exposomics. / 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
RemovedSubstitution effort should not be limited to the most harmful substances. This amendment also aligns the proposal with the data generation tasks allocated to the Agency under OSOA and also outline research on exposome as one of the key priorities to which the Agency should contribute.
RemovedArticle 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.
RemovedAs the central actor on chemical knowledge and expertise in the Union, the ECHA is in a key position to identify further scientific research and regulatory needs in this field, to help building strong partnership and collaboration between regulators and researchers and connecting the latest scientific discoveries with regulatory practices. The Agency should therefore contribute to this debate by publishing an annual report outlining its recommendations on knowledge and data gaps in terms of regulatory and fundamental science needs in any field within its competence.
AI: Note on change 41 · substance Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Adds articles establishing an Assembly of accredited stakeholders and networking of national authorities, and expands the Agency's research and substitution tasks.
Change 42
RemovedStrengthened collaboration between EU 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 EU research funding, and facilitating engagement with ongoing research and innovation projects. The cross-agency One Health task force between ECHA, EFSA, EAM, ECDC and EEA, established in 2023, has proved to be a successful initiative to strengthen transdisciplinary cooperation among five EU 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 this initiative will 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 approach, such as exposome.
AI: Note on change 42 · formal Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Removes an explanatory note about cross-agency cooperation.
Change 43
RemovedStrengthened collaboration between EU 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 EU research funding, and facilitating engagement with ongoing research and innovation projects. The cross-agency One Health task force between ECHA, EFSA, EAM, ECDC and EEA, established in 2023, has proved to be a successful initiative to strengthen transdisciplinary cooperation among five EU 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 this initiative will 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 approach, such as exposome.
AddedArticle 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.
AI: Note on change 43 · substance Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Adds a permanent task force with the Agency, EFSA, EMA, ECDC, EEA, and EU-OSHA.
Change 44
ChangedArticle 44 – paragraph 1 bc (new): 1b. A1c. permanentThe task force (theshall 'taskfocus force')on iscross-sectoral establishedissues withthat thecan Agency,benefit EFSA,from EMA,a ECDCOne Health and EEA.exposome approach. The task force shall build on existing mechanisms of cooperation, maximising synergies and avoiding duplication.
AI: Note on change 44 · substance Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Specifies the task force's focus on cross-sectoral One Health and exposome issues, building on existing mechanisms.
Change 45
RemovedStrengthened collaboration between EU 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 EU research funding, and facilitating engagement with ongoing research and innovation projects. The cross-agency One Health task force between ECHA, EFSA, EAM, ECDC and EEA, established in 2023, has proved to be a successful initiative to strengthen transdisciplinary cooperation among five EU 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 this initiative will 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 approach, such as exposome.
AddedArticle 44 – paragraph 1 d (new): 1d. The Agency shall coordinate the work of the task force for 12 months after the task force is established. The coordination and chairing of the work of the taskforce, including leading the coordination of the task force meetings and activities shall rotate among the agencies every 12 months thereafter in accordance with its framework for action referred to in paragraph 1l.
AI: Note on change 45 · substance Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Adds provisions for the Agency to coordinate the task force for 12 months and rotate coordination annually.
Change 46
ChangedArticle 44 – paragraph 1 ce (new): 1c.1e. The task force aimsshall toconsist addof valuestaff byfrom buildingeach onagency existingreferred mechanismsto in paragraph 1b. The Executive Director of cooperation,each maximisingagency synergiesshall andappoint avoidinga duplication.representative Theto the task force primarilyand focusesthe onrepresentatives cross-sectoralshall issuesreport thatto cantheir benefitrespective Executive Directors on progress. A representative from athe OneCommission Healthshall be invited to participate in the meetings of the task force to ensure close cooperation between the task force and exposomethe approach.Commission.
AI: Note on change 46 · substance Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Adds details on task force composition, representatives, and Commission participation.
Change 47
RemovedStrengthened collaboration between EU 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 EU research funding, and facilitating engagement with ongoing research and innovation projects. The cross-agency One Health task force between ECHA, EFSA, EAM, ECDC and EEA, established in 2023, has proved to be a successful initiative to strengthen transdisciplinary cooperation among five EU 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 this initiative will 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 approach, such as exposome.
AddedArticle 44 – paragraph 1 f (new): 1f. Each agency referred to in paragraph 1b shall establish a focal point within that agency to coordinate its respective input to joint activities and convey the position of that agency on strategic matters. Each focal point shall keep its own management and interagency mechanisms informed of relevant developments under the task force.
RemovedArticle 44 – paragraph 1 d (new): 1d. The Agency shall coordinate the work of the task force for 12 months after the task force is established. The coordination of the work of the task force shall rotate among the agencies every 12 months thereafter in accordance with its framework for action referred to in paragraph 1l. The agency that acts as the rotating chair shall lead the coordination of the task force meetings and activities.
RemovedStrengthened collaboration between EU 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 EU research funding, and facilitating engagement with ongoing research and innovation projects. The cross-agency One Health task force between ECHA, EFSA, EAM, ECDC and EEA, established in 2023, has proved to be a successful initiative to strengthen transdisciplinary cooperation among five EU 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 this initiative will 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 approach, such as exposome.
RemovedArticle 44 – paragraph 1 e (new): 1e. The task force shall consist of senior officers from each agency referred in paragraph 1b. The Executive Director of each agency shall appoint a representative to the task force and the representatives shall report to their respective Executive Directors on progress. A representative from the Commission shall be invited to participate in the meetings of the task force to ensure close cooperation between the task force and the Commission.
RemovedStrengthened collaboration between EU 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 EU research funding, and facilitating engagement with ongoing research and innovation projects. The cross-agency One Health task force between ECHA, EFSA, EAM, ECDC and EEA, established in 2023, has proved to be a successful initiative to strengthen transdisciplinary cooperation among five EU 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 this initiative will 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 approach, such as exposome.
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RemovedArticle 44 – paragraph 1 f (new): 1f. Each agency referred to in paragraph 1b shall establish a focal point within each agency to coordinate the respective inputs to joint activities and convey the position of the agency on strategic matters. Each focal point shall keep their own management and interagency mechanisms informed of relevant developments under the task force.
RemovedStrengthened collaboration between EU 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 EU research funding, and facilitating engagement with ongoing research and innovation projects. The cross-agency One Health task force between ECHA, EFSA, EAM, ECDC and EEA, established in 2023, has proved to be a successful initiative to strengthen transdisciplinary cooperation among five EU 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 this initiative will 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 approach, such as exposome.
AI: Note on change 47 · substance Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Adds a requirement for each agency to establish a focal point for the task force.
Change 48
RemovedStrengthened collaboration between EU 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 EU research funding, and facilitating engagement with ongoing research and innovation projects. The cross-agency One Health task force between ECHA, EFSA, EAM, ECDC and EEA, established in 2023, has proved to be a successful initiative to strengthen transdisciplinary cooperation among five EU 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 this initiative will 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 approach, such as exposome.
AddedArticle 44 – paragraph 1 h (new): 1h. Observers and external experts may attend meetings of the task force as and when required, in agreement with the members of the task force.
AI: Note on change 48 · substance Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Adds a provision allowing observers and external experts to attend task force meetings.
Change 49
ChangedArticle 44 – paragraph 1 hi (new): 1h.1i. ExternalThe adtask hocforce membersshall andnot observersact as a decision-making body. The task force may attendpropose meetingsrecommendations for action to the senior management of the agencies. Representatives of each agency in the task force asshall have an advisory role to the Executive Directors and whensenior required,management inof agreementits own agency and shall engage with the membersCommission ofand theother taskstakeholders force.for input and advice, as appropriate.
AI: Note on change 49 · substance Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Clarifies the task force's advisory role and prohibits it from being a decision-making body.
Change 50
RemovedStrengthened collaboration between EU 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 EU research funding, and facilitating engagement with ongoing research and innovation projects. The cross-agency One Health task force between ECHA, EFSA, EAM, ECDC and EEA, established in 2023, has proved to be a successful initiative to strengthen transdisciplinary cooperation among five EU 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 this initiative will 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 approach, such as exposome.
AddedArticle 44 – paragraph 1 j (new): 1j. The task force shall meet at least six times a year, with at least one annual physical meeting of a more strategic nature. Ad hoc meetings may be organised, as needed.
RemovedArticle 44 – paragraph 1 i (new): 1i. The task force shall liaise with on-going inter-agency groups and activities and may establish dedicated working groups to support the activities of the task force.
AddedArticle 44 – paragraph 1 k (new): 1k. By 31 December each year, members of the task force shall draw up and endorse an annual framework for action describing a plan for the joint One Health and exposome work of the agencies referred to in paragraph 1b. / The framework for action shall include objectives to be pursued by the task force, concrete actions and outcomes to achieve them, and an approximate timeline for the implementation of such actions, and shall be built around the following objectives with regards to One Health and exposome: / (a) facilitate strategic coordination in its implementation; / (b) promote research coordination; / (c) enhance capacity building; / (d) strengthen communication and stakeholders' engagement; / (e) support the development of joint partnerships.
RemovedStrengthened collaboration between EU 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 EU research funding, and facilitating engagement with ongoing research and innovation projects. The cross-agency One Health task force between ECHA, EFSA, EAM, ECDC and EEA, established in 2023, has proved to be a successful initiative to strengthen transdisciplinary cooperation among five EU 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 this initiative will 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 approach, such as exposome.
AddedArticle 44 – paragraph 1 l (new): 1l. The framework for action referred to in paragraph 1l shall be consistent with the respective mandates of each agency and shall not hinder their statutory activities.
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RemovedArticle 44 – paragraph 1 j (new): 1j. The task force shall not act as a decision-making body. The task force may propose recommendations for action to the senior management of the agencies. Representatives of each agency in the task force shall have an advisory role to the Executive Directors and senior management of its own agency and shall engage with the Commission and other stakeholders for input and advice, as appropriate.
RemovedStrengthened collaboration between EU 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 EU research funding, and facilitating engagement with ongoing research and innovation projects. The cross-agency One Health task force between ECHA, EFSA, EAM, ECDC and EEA, established in 2023, has proved to be a successful initiative to strengthen transdisciplinary cooperation among five EU 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 this initiative will 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 approach, such as exposome.
RemovedArticle 44 – paragraph 1 k (new): 1k. The task force shall meet at least six times a year, with at least one annual physical meeting of a more strategic nature. Ad hoc meetings may be organised, as needed.
RemovedStrengthened collaboration between EU 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 EU research funding, and facilitating engagement with ongoing research and innovation projects. The cross-agency One Health task force between ECHA, EFSA, EAM, ECDC and EEA, established in 2023, has proved to be a successful initiative to strengthen transdisciplinary cooperation among five EU 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 this initiative will 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 approach, such as exposome.
RemovedArticle 44 – paragraph 1 l (new): 1l. By the end of each year, members of the task force shall draw up and endorse an annual framework for action describing a plan for the joint One Health and exposome work of the agencies referred to in paragraph 1b. / The framework for action shall include objectives to be pursued by the task force, concrete actions and outcomes to achieve them, and an approximate timeline for the implementation of such actions, and shall be built around the following objectives: / (a) facilitate strategic coordination in the implementation of the One Health and exposome approach; / (b) promote research coordination and One Health and exposome-driven agenda setting; / (c) enhance capacity building on One Health and exposome; / (d) strengthen One Health and exposome communication and stakeholders' engagement; / (e) support the development of partnerships through joint One Health and exposome activities.
RemovedStrengthened collaboration between EU 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 EU research funding, and facilitating engagement with ongoing research and innovation projects. The cross-agency One Health task force between ECHA, EFSA, EAM, ECDC and EEA, established in 2023, has proved to be a successful initiative to strengthen transdisciplinary cooperation among five EU 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 this initiative will 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 approach, such as exposome.
RemovedArticle 44 – paragraph 1 m (new): 1m. The framework for action referred to in paragraph 1l shall be consistent with the respective mandates of each agency and shall not hinder their statutory activities.
RemovedStrengthened collaboration between EU 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 EU research funding, and facilitating engagement with ongoing research and innovation projects. The cross-agency One Health task force between ECHA, EFSA, EAM, ECDC and EEA, established in 2023, has proved to be a successful initiative to strengthen transdisciplinary cooperation among five EU 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 this initiative will 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 approach, such as exposome.
AI: Note on change 50 · substance Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Adds provisions on task force meeting frequency and annual framework for action.
Change 51
RemovedAlignment with 'One Substance One Assessment'
AI: Note on change 51 · formal Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Removes an explanatory note about alignment with 'One Substance One Assessment'.
Change 52
RemovedThe agreement between co-legislators on the "Proposal on the reattribution of scientific and technical tasks and improving cooperation among Union agencies in the area of chemicals" amended the General Food Law with this wording, the ECHA Basic Regulation should therefore be aligned with the provisions on resolving divergent opinions between agencies.
AddedArticle 46: deleted / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted)
AI: Note on change 52 · formal Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Deletes Article 46 on delegated acts.
Change 53
ChangedArticle 48 – paragraph 1 – point 3: (3) in Article 77, paragraph 1, and paragraph 3, pointpoints (b), and (c), are deleted;
AI: Note on change 53 · substance Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Extends the deletion in REACH Article 77 to include points (b) and (c) of paragraph 3.
Change 54
RemovedArticle 77(3)(b) of REACH provides the possibility for RAC at the Executive Director's request, to provide 'technical and scientific support for steps to improve cooperation between the Community, its 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 sound management of chemicals in developing countries'. This mandate should not be limited to matters regulated under REACH but should be available for all tasks performed by ECHA, regardless of the legislation from which they are emanating. Therefore, this possibility is now included in Article 13 of this proposal to make it a horizontal provision.
RemovedArticle 48 – paragraph 1 – point 6: deleted
AI: Note on change 54 · formal Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Removes an explanatory note about REACH Article 77(3)(b).
Change 55
ChangedArticle 54 – paragraph 2: 2. The evaluation shall address the possible need to modify the mandate of the Agency, and the financial implications of any such modification. The evaluation shall also assess the functioning of the Committees and whether it would be warrantedappropriate to align or adapt the rules forArticles membership14 and functioning15 of thethis Committees.Regulation.
AI: Note on change 55 · wording only Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Changes 'warranted' to 'appropriate' and rephrases the evaluation of committee rules.
Change 56
RemovedSCCS has been incorporated into ECHA but the proposal keeps its particular rules and structure intact. BPC members are not independent from their government, whereas members of RAC and SEAC are. While there is no express reasons to change this approach in this draft report, experience might show in the future that rules should be aligned or adapted for the Committees.
AddedArticle 54 – paragraph 3: 3. The Commission shall report to the European Parliament, to the Council, and to the Management Board on the findings of the evaluation. An action plan and a timetable shall be included, if appropriate. The Commission shall, where appropriate, submit a legislative proposal to the European Parliament and to the Council. The findings of the evaluation shall be made public by the Commission.
RemovedArticle 54 – paragraph 3: 3. The Commission shall report to the European Parliament, to the Council, and to the Management Board on the findings of the evaluation. An action plan and a timetable shall be included, if appropriate, and the Commission may propose a legislative proposal, where appropriate. The findings of the evaluation shall be made public by the Commission.
AI: Note on change 56 · substance Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Adds a requirement for the Commission to report evaluation findings to the Management Board and make them public.
Change 57 under “EXPLANATORY STATEMENT”
ChangedThird, the Basic Regulation must ensure more robust governance of ECHA’s resources. I have therefore proposed that the Agency carry out regular assessments of the adequacy between its mandate and its financial and human resources, ensuring that each expansion of tasks is matched with appropriate capacity. These assessments should directly inform the preparation of the annual budget so that political ambition and operational reality are aligned. My report also proposes that ECHA should be able to temporarily assign staff to other institutions, or finance staff or projects in other institutions, such as Member states bodies, in order to reinforce the capacity and contribute to the work of Member States Competent Authorities on tasks related to the Agency’s mandate and their capacity to appoint committee members and experts ECHA needs to mobilize to achieve its goals.mandate.
AI: Note on change 57 · wording only Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Shortens an explanatory statement about staff secondment, removing reference to appointing committee members.
Change 58 under “EXPLANATORY STATEMENT”
ChangedAnother major priority is to strengthen the cooperation between EU agencies working on health, food safety, environment and chemicals. Stakeholders and agencies themselves have repeatedly called for more coherence, shared data and better anticipatory capacity. Building on the very positive experience of the Cross-Agency One Health Task Force, my amendments propose to make this collaboration permanent through a structured and durable task force bringing together ECHA, EFSA, EMA, ECDCECDC, EEA, and EEA.EU-OSHA. This framework will help develop joint actions, share methodologies and support a common scientific agenda for chemicals safety. It is a concrete step towards a more integrated, transdisciplinary and efficient EU chemicals governance.
AI: Note on change 58 · substance Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Adds EEA and EU-OSHA to the list of agencies in the task force in the explanatory statement.
Change 59 under “EXPLANATORY STATEMENT”
AddedBUDGETARY ASSESSMENT OF THE COMMITTEE ON BUDGETS
Addedfor the Committee on the Environment, Climate and Food Safety
Addedon 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
AddedRapporteur for budgetary assessment: Hélder Sousa Silva
AddedThe Committee on Budgets has carried out a budgetary assessment of the proposal under Rule 58 of the Rules of Procedure and has reached the following conclusions:
AddedThe Committee on Budgets,
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AddedA. whereas this proposal is aimed at strengthening the governance of the European Chemicals Agency (‘the Agency’), while enabling it to effectively perform the tasks assigned to it under existing legislation and allowing its mandate to evolve in line with new responsibilities arising from adopted or forthcoming initiatives;
AddedB. whereas the Agency is partially self-financed, with sources of income deriving from three different regulations; whereas this has required the establishment of three separate budgets and staffing plans, leading to operational inflexibility and a significant administrative burden; whereas the fees received by the Agency are highly volatile and non-linear in terms of amount and timing, mainly as a result of their one-off nature and their dependence on the strategic decisions of chemicals industry players;
AddedC. whereas the Joint Statement of Parliament, the Council and the Commission of 19 July 2012 on decentralised agencies was signed by the three institutions after the creation of the Agency;
AddedD. whereas in 2025, fees charged to industry accounted for around 30 % of the Agency’s general revenues, with fees charged under the REACH Regulation and the CLP Regulation representing the largest share of those fees;
AddedE. whereas revenues from REACH fees are extremely difficult to forecast, as they are usually one-off and there is a reduction of up to 95 % for small and medium-sized enterprises;
AddedF. whereas the Agency currently operates under a universal budgeting model, whereby revenues derived from fees charged to the chemicals industry and the balancing contribution from the EU are not segregated, possibly creating cross-subsidisation between the two;
Added1. Insists that the resources allocated to the Agency must be in line with the tasks entrusted to it, and notes that, at this stage, the proposal appears to provide sufficient financial and human resources for the planned changes, since the proposal’s estimated financial impact for the remaining period of the current multiannual financial framework (MFF) is limited to EUR 0.577 million in staff expenditure as operational appropriations under Heading 1, and an estimated EUR 2.956 million in administrative appropriations for the post-2027 MFF;
Added2. Stresses that, should additional responsibilities be granted to the Agency in the course of the negotiations, the financial implications will need to be assessed and the legislative financial and digital statement accompanying the proposal will have to be revised accordingly, in order to ensure that the financial and human resources allocated by the legislative proposal match the tasks entrusted to the Agency;
Added3. Reiterates that any new tasks entrusted to decentralised agencies should be financed through fresh appropriations, and that redeployments from other programmes and priorities should be limited and examined with due care;
Added4. Welcomes the abolition of the requirement for segregated budgets and their grouping into a single budget line for the EU budget contribution to the Agency, which simplifies the Agency’s budgeting model, enhances transparency and allows for year-on-year comparison, taking into consideration the additional tasks attributed to the Agency;
Added5. Welcomes the abolition of the requirement for segregated staffing plans, which removes operational impediments that affect the management of human resources, thus allowing the Agency to better adjust staff allocations in the light of its workload and improving its productivity;
Added6. Underlines the importance of regularly assessing the level of fees in the light of changes in costs, in line with Commission Delegated Regulation (EU) 2019/715;
Added7. Considers that, given the volatility of the revenues received by the Agency from fees and charges, the creation of a reserve for the Agency promotes the long-term sustainability of its financial model, increases its resilience to possible future crises and protects the financial interests of the EU’s budget and taxpayers; affirms that the creation of a reserve for the Agency makes it, at present, an exception among partially self-funded EU decentralised agencies, and requires close monitoring of the Agency’s operations as well as assessment in the near future;
Added8. Determines that the proposal is compatible with the MFF, the system of own resources, the Interinstitutional Agreement of 16 December 2020 and the budgetary principles laid down in the Financial Regulation.
AI: Note on change 59 · substance Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Adds a budgetary assessment section with conclusions on resources, fees, and the reserve.
Sources & citation
Where the facts on this page come from, and how to cite it.
- Data source
- Licensed CC BY 4.0.
- Retrieved
- 25 September 2026
Cite as
European Parliament (2026). “Changes between ENVI-PR-781186 and A-10-2026-0093”. Text, 16 April 2026. from ENVI-PR-781186, to A-10-2026-0093, reference 2025/0207(COD). EU Parl Watch Research. https://news.eu-parl.st-solutions.dev/texts/ENVI-PR-781186/compare/A-10-2026-0093 (retrieved 25 September 2026). Data: European Parliament Open Data, https://data.europarl.europa.eu/ (CC BY 4.0).
BibTeX
@misc{epw-text-2026-04-16,
author = {{European Parliament}},
title = {{Changes between ENVI-PR-781186 and A-10-2026-0093}},
year = {2026},
date = {2026-04-16},
howpublished = {\url{https://news.eu-parl.st-solutions.dev/texts/ENVI-PR-781186/compare/A-10-2026-0093}},
url = {https://news.eu-parl.st-solutions.dev/texts/ENVI-PR-781186/compare/A-10-2026-0093},
urldate = {2026-09-25},
publisher = {EU Parl Watch Research},
note = {Text. from ENVI-PR-781186, to A-10-2026-0093, reference 2025/0207(COD). Data: European Parliament Open Data (CC BY 4.0)}
}