What changed

5.3.2024

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

Mr Pascal Canfin

on the 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) No 2019/1021 as regards the re-attribution of scientific and technical tasks and improving cooperation among Union agencies in the area of chemicals

Chair

(COM(2023)0783 – C90447/2023 – 2023/0455(COD))

Committee on the Environment, Public Health and Food Safety

(Ordinary legislative procedure: first reading)

BRUSSELS

The European Parliament,

Subject: Opinion on the Commission proposals for a Regulation on the re-attribution of scientific and technical tasks and improving cooperation among Union agencies in the area of chemicals (2023/0455(COD)), for a Directive on the re-attribution of scientific and technical tasks to the European Chemicals Agency (2023/0454(COD)) and for a Regulation establishing a common data platform on chemicals 2023/0453(COD)

– having regard to the Commission proposal to Parliament and the Council (COM(2023)0783),

Dear Mr Chair,

– having regard to Article 294(2) and Article 114 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C90447/2023),

Under the procedures referred to above, at its meeting on 04 March 2024 the Committee on Budgets’ adopted an opinion in the form of a letter and mandated me to convey the position set out below.

– having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

Background to the proposal

– having regard to the opinion of the European Economic and Social Committee of 20 March 2024,

The general objectives of the three legislative proposals which form the so-called ‘one substance, one assessment' package, are to streamline the assessments of chemicals across EU legislation, to strengthen the knowledge base on chemicals and to ensure early detection and action on emerging chemical risks.

– having regard to Rules 60 of its Rules of Procedure,

Under this package tasks will be reallocated between four EU agencies (ECHA, EEA, EFSA and EMA) and a Common Data Platform on chemicals held by the agencies will be established, ensuring coherent and transparent safety assessments of chemicals used in products such as medical devices, toys, food, pesticides and biocides.

– having regard to the report of the Committee on the Environment, Climate and Food Safety (A10-0020/2025),

According to the legislative financial statement accompanying the proposals, the package will require an additional budget of roughly EUR 33 million until 2027, 18 additional Temporary Agents and 23 additional contractual agents by 2027 for the four agencies.

1. Adopts its position at first reading hereinafter set out;

Most of the additionnal budget will be offset from the LIFE programme.

2. Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

Position of the Committee on Budgets

3. Instructs its President to forward its position to the Council, the Commission and the national parliaments.

The BUDG committee is of the general opinion that entrusting new tasks to decentralised agencies should be financed from fresh resources and should not lead to reduce programmes even if in the same policy area, in this case environment and health. Redeployments from the LIFE programme should be limited and examined with due care, especially in view of the several reinforcements received in the annual budgetary procedure following a strong push from the Parliament. In this context, it is important to recall that for the partially self-finances agencies, the costs incurred as a result of the provision of a service shall be charged in full to the clients receiving such service.

Amendment 1

In the framework of our cooperation agreement, we stay ready to provide the ENVI Committee with technical support throughout the process with a view to assessing the budgetary impact of any decisions of the co-legislators and prevent further carve-outs from the LIFE programme ensuring that the redeployments do not go beyond the absolutely necessary and to also ensure an optimised mix of fees and Union Budget.

Proposal for a regulation

Yours sincerely,

Recital 8

Johan Van Overtveldt

Amendment 2

Proposal for a regulation

Recital 9

Amendment 3

Proposal for a regulation

Recital 14 a (new)

Amendment 4

Proposal for a regulation

Article 1 – paragraph 1 – point 2

Regulation (EC) No 178/2002

Article 30 – paragraph 2 – subparagraph 1

Amendment 5

Proposal for a regulation

Article 1 – paragraph 1 – point 2

Regulation (EC) No 178/2002

Article 30 – paragraph 2 – subparagraph 2

Amendment 6

Proposal for a regulation

Article 1 – paragraph 1 – point 2

Regulation (EC) No 178/2002

Article 30 – paragraph 3 a (new)

Amendment 7

Proposal for a regulation

Article 1 – paragraph 1 – point 2

Regulation (EC) No 178/2002

Article 3 – paragraph 3 b (new)

Amendment 8

Proposal for a regulation

Article 3 – paragraph 1 – point 1

Regulation (EU) 2017/745

Annex I – Section 10.4.1 – point b

Amendment 9

Proposal for a regulation

Article 4 – paragraph 1 – point 2

Regulation (EU) 2019/1021

Article 8 – paragraph 1a – subparagraph 1 – point a

Amendment 10

Proposal for a regulation

Article 4 – paragraph 1 – point 2

Regulation (EU) 2019/1021

Article 8 – paragraph 1a – subparagraph 2

Amendment 11

Proposal for a regulation

Article 4 – paragraph 1 – point 2

Regulation (EU) 2019/1021

Article 8 – paragraph 1a – subparagraph 3

Amendment 12

Proposal for a regulation

Article 4 – paragraph 1 – point 4

Regulation (EU) 2019/1021

Article 15 – paragraph 2

Amendment 13

Proposal for a regulation

Article 4 – paragraph 1 – point 4 a (new)

Regulation (EU) 2019/1021

Article 16 – paragraph 2 a (new)

Amendment 14

Proposal for a regulation

Article 4 – paragraph 1 – point 5 – point c

Regulation (EU) 2019/1021

Article 18 – paragraph 6

Amendment 15

Proposal for a regulation

Article 4 – paragraph 1 – point 5 – point c a (new)

Regulation (EU) 2019/1021

Annex IV – Table 1 – Row 5

Amendment 16

Proposal for a regulation

Article 4 – paragraph 1 – point 5 – point c b (new)

Regulation (EU) 2019/1021

Annex IV – Table 1 – Row 12

Amendment 17

Proposal for a regulation

Article 4 – paragraph 1 – point 5 – point c c (new)

Regulation (EU) 2019/1021

Annex IV – Table 1 – Row 27

Amendment 18

Proposal for a regulation

Article 4 – paragraph 1 – point 5 – point c d (new)

Regulation (EU) 2019/1021

Annex IV – Table 1 – Row 30

Amendment 19

Proposal for a regulation

Article 4 – paragraph 1 – point 5 – point c e (new)

Regulation (EU) 2019/1021

Annex IV – Table 1 – Row 31

EXPLANATORY STATEMENT

The Rapporteur considers that strengthening the knowledge base on chemicals, facilitates the exchange of data between regulatory bodies as well as their communication and coordination on regulatory action, while streamlining the assessment of chemicals, and ensuring early detection and action on emerging chemical risks.

The Rapporteur welcomes the Commission’s proposal and the proposed harmonisation of assessments, with the caveat that each of the agencies work under their individual mandates, and full harmonisation is not possible without alignment of the regulations. He considers that streamlining is needed, and data harmonisation could work for the benefit of EU citizens and industry.

The reassignment of scientific and technical tasks should not lead to all tasks being centralised primarily in one agency (e.g. ECHA). When it comes to the hazard assessment of substances, it would be understandable that ECHA would be more involved. However, the risk assessment of chemicals – especially in the context of specific applications or product groups – should still be carried out by the agencies that have already gained extensive experience in this field.

In the case of substantive divergence over scientific issues, the Rapporteur considers that all the bodies involved in the process should work either resolving the divergence or preparing a joint document clarifying the contentious scientific issues.

ANNEX: ENTITIES OR PERSONS FROM WHOM THE RAPPORTEUR HAS RECEIVED INPUT

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The list above is drawn up under the exclusive responsibility of the rapporteur.

Where natural persons are identified in the list by their name, by their function or by both, the rapporteur declares that he has submitted to the concerned natural persons the European Parliament's Data Protection Notice No 484 (https://www.europarl.europa.eu/data-protect/index.do), which sets out the conditions applicable to the processing of their personal data and the rights linked to that processing.

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