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

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

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

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

(Ordinary legislative procedure: first reading)

The European Parliament,

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

– 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),

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

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

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

– having regard to the opinions of the Committee on Budgets,

– having regard to the opinions of the Committee on Agriculture and Rural Development,

– having regard to the report of the Committee on the Environment, Public Health and Food Safety (A100000/2024),

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

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

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

Amendment 1

Proposal for a regulation

Article 1 – paragraph 1 – point 2

Regulation (EC) No 178/2002

Article 30

Or. en

Justification

A clear incentive for all the bodies involved in the process to work towards resolving divergent views is still missing. Paragraph 4 (deleted in the new version by the Commission) is restored, in order to ensure that all the bodies involved in the process work together with a view to either resolving the divergence or preparing a joint document clarifying the contentious scientific issues. Plant protection products formulations are almost always manufactured for the common European market, not for individual Member states. This means divergence in opinions on co-formulants across Member states leads to fragmentation of the common market, single sourcing and supply chain risk.

Amendment 2

Proposal for a regulation

Article 1 – paragraph 1 – point 2

Regulation (EC) No 178/2002

Article 30 – paragraph 4 a (new)

Or. en

Justification

When it comes to procedures for authorisation of regulated products, specific legal deadlines apply. The difficulty resulted from this is how accommodate the necessary time for cooperation to resolve divergences within the specific deadlines given in the sectorial legislation. No time frame or allocation of extra time is prescribed for resolving divergences under Article 30(2). The proposed mechanism allows sufficient time to resolve this issues, and is inspired from Article 6 of Regulation 1331/2008.

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

Pursuant to Article 8 of Annex I to the Rules of Procedure, the rapporteur declares that he has received input from the following entities or persons in the preparation of the draft report:

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.