EUROPEAN COMMISSION
Brussels, 7 December 2023
COM(2023) 783 final
2023/0455(COD)
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
Amending Regulations (EC) No 178/2002, (EC) No 401/2009, (EU) 2017/745 and (EU) 2019/1021 of the European Parliament and of the Council as regards the re‑attribution of scientific and technical tasks and improving cooperation among Union agencies in the area of chemicals
(Text with EEA relevance)
{SWD(2023) 850 final}
1. Context of the proposal – Reasons for and objectives of the proposal
The European Union has developed a comprehensive regulatory framework for chemicals to ensure a high level of protection of human health and the environment while supporting the efficient functioning of the internal market and competitiveness of EU industry. The framework includes over 40 pieces of legislation covering production, placement on the market, emissions, safety of workers, consumer products, food and feed, and the environment.
The fitness check of the most relevant EU chemicals legislation concluded that the framework delivers the intended results but shows shortcomings in the consistency of safety assessments, the efficiency of the underlying technical and scientific work, and the consistency of transparency rules. Tasks are currently carried out by different bodies (ECHA, EFSA, EEA, EMA, scientific committees, expert groups, Commission departments and contractors), leading to inconsistent outcomes, inefficient use of resources and unnecessary costs.
Building on the fitness check, the Commission, in the context of the European Green Deal, committed to a Chemicals Strategy for Sustainability and to the ‘one substance, one assessment’ approach to improve efficiency, effectiveness, coherence and transparency of safety assessments across EU legislation.
Key actions:
- Re‑attribute scientific and technical work on chemicals to European agencies (including ECHA’s Scientific Committee on Health, Environmental and Emerging Risks and the Scientific Committee on Consumer Safety).
- Ensure clear attribution of responsibilities and good cooperation among the agencies.
The Council and the European Parliament have welcomed the initiative.
2. Legal basis, subsidiarity and proportionality
Legal basis: Articles 43, 114, 207, 168(4)(c) and 192(1) TFEU. The regulation amends four existing regulations, each with its own legal basis.
Subsidiarity: The re‑attribution of tasks cannot be achieved by Member States alone; it requires EU‑level action.
Proportionality: The measures do not go beyond what is necessary to achieve the objectives.
3. Results of ex‑post evaluations, stakeholder consultations and impact assessments
- The 2019 fitness check identified weaknesses and opportunities for streamlining technical and scientific work through EU agencies.
- A call for evidence (15 March 2022 – 12 April 2022) received 65 submissions, with strong support for the ‘one substance, one assessment’ approach.
- Stakeholder consultations and expert group meetings confirmed the need for clear attribution of tasks and adequate resources.
- The proposal will not impose significant costs on businesses; the main impact is on the resources of the agencies.
4. Budgetary implications
The annexed financial statement shows the additional resources required for ECHA, EEA, EFSA and EMA to carry out the re‑attributed tasks. The increase in agency contributions will be offset by reductions in the LIFE programme.
5. Other elements
- Implementation will be monitored as part of the regular evaluation of the agencies’ performance.
- The proposal contains specific amendments to the four regulations:
Article 1 – Amendments to Regulation (EC) No 178/2002
- Adds a new point (m) in Article 23 on cooperation and data exchange among EFSA, ECHA, EMA and EEA.
- Replaces Article 30 with provisions on monitoring and resolving diverging scientific opinions, including possible involvement of ECHA for harmonised classification and labelling.
Article 2 – Amendments to Regulation (EC) No 401/2009
- Adds point (p) in Article 2 on development of assessment methodologies.
- Adds paragraph 5 in Article 15 on cooperation and data exchange with ECHA, EFSA and EMA.
Article 3 – Amendments to Regulation (EU) 2017/745 (Medical Devices)
- Updates Annex I to include guidelines on phthalates and other CMR/endocrine‑disrupting substances, with a mandate for ECHA to prepare and update them.
Article 4 – Amendments to Regulation (EU) 2019/1021 (POPs)
- Adds a reporting obligation for the Commission to request ECHA to produce a report on the impacts of modifying concentration limit values (within 12 months of request).
- Introduces delegated acts for adapting Annexes IV and V.
Article 6 – Entry into force
- The regulation shall enter into force on the twentieth day following its publication in the Official Journal of the EU.
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 43, 114, 168(4)(c), 192(1) and 207 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee, Having regard to the opinion of the Committee of the Regions, Acting in accordance with the ordinary legislative procedure, Whereas: (1) The European Green Deal sets a high ambition for a toxic‑free environment and zero pollution. The Chemicals Strategy for Sustainability introduces the ‘one substance, one assessment’ approach. (2) To achieve this, scientific and technical work on chemicals needs to be consolidated in the relevant Union agencies and cooperation among agencies must be strengthened. (3) Re‑attributing certain existing scientific and technical tasks to ECHA and allocating new tasks will improve the quality, consistency and transparency of chemical assessments. ... Article 1** Amendments to Regulation (EC) No 178/2002 (1) In Article 23, the following point (m) is added: ‘(m) to cooperate with the competent bodies in the Member States that carry out similar tasks … and to cooperate with other scientific bodies established under Union law, notably the European Chemicals Agency, the European Medicines Agency, and the European Environment Agency …’; (2) Article 30 is replaced by the following: ‘Article 30 – Diverging scientific opinions …’ (full text as in original).
Article 2 Amendments to Regulation (EC) No 401/2009 (1) In Article 2, point (p) is added: ‘(p) to develop assessment methodologies related to chemicals in the fields falling within its mission.’; (2) In Article 15, paragraph 5 is added: ‘5. The Agency shall cooperate with other scientific bodies … notably the European Chemicals Agency, the European Food Safety Authority, and the European Medicines Agency …’.
Article 3 Amendments to Regulation (EU) 2017/745 – Annex I (1) Section 10.4.1 (b) is replaced … (2) Section 10.4.2 (d) is replaced … (3) Section 10.4.3 is replaced … (4) Section 10.4.4 is replaced …
Article 4 Amendments to Regulation (EU) 2019/1021 (1) Article 8(1) is amended … (2) Article 8(1a) is added … (3) Article 13 (2) is replaced … (4) Article 15 (2) is replaced … (5) Article 18 is amended …
Article 6 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
European Commission, Directorate‑General for Environment, Brussels, Belgium.
This is a cleaned version of the official proposal document CELEX 52023PC0783.