What changed

PR_COD_1amCom

Follow up to the European Parliament legislative resolution on the Proposal for a directive of the European Parliament and of the Council amending Directive 2011/65/EU of the European Parliament and of the Council as regards the re-attribution of scientific and technical tasks to the European Chemicals Agency

Symbols for procedures

1. Rapporteur: Dimitris TSIODRAS (EPP / GR)

* Consultation procedure

2. References: 2023/0454(COD) / A10-0019/2025 / P10_TA(2025)236

*** Consent procedure

3. Date of adoption of the resolution: 21 October 2025

***I Ordinary legislative procedure (first reading)

4. Legal basis: Treaty on the Functioning of the European Union, Article 114

***II Ordinary legislative procedure (second reading)

5. Competent Parliamentary Committee: Committee on Environment, Climate and Food Safety (ENVI)

***III Ordinary legislative procedure (third reading)

6. Commission's position: accepts all amendments.

(The type of procedure depends on the legal basis proposed by the draft act.)

Amendments to a draft act

Amendments by Parliament set out in two columns

Deletions are indicated in bold italics in the left-hand column. Replacements are indicated in bold italics in both columns. New text is indicated in bold italics in the right-hand column.

The first and second lines of the header of each amendment identify the relevant part of the draft act under consideration. If an amendment pertains to an existing act that the draft act is seeking to amend, the amendment heading includes a third line identifying the existing act and a fourth line identifying the provision in that act that Parliament wishes to amend.

Amendments by Parliament in the form of a consolidated text

New text is highlighted in bold italics. Deletions are indicated using either the ▌symbol or strikeout. Replacements are indicated by highlighting the new text in bold italics and by deleting or striking out the text that has been replaced.

By way of exception, purely technical changes made by the drafting departments in preparing the final text are not highlighted.

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

on the proposal for a directive of the European Parliament and of the Council amending Directive 2011/65/EU of the European Parliament and of the Council as regards the re-attribution of scientific and technical tasks to the European Chemicals Agency

(COM(2023)0781 – C90448/2023 – 2023/0454(COD))

(Ordinary legislative procedure: first reading)

– having regard to the Commission proposal to Parliament and the Council (COM(2023)0781),

– 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 (C90448/2023),

– 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 Rule 60 of its Rules of Procedure,

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

– 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 directive

Recital 8

Text proposed by the Commission

Amendment

(8) For amending procedural provisions under Directive 2011/65/EU, a transitional period of 12 months is necessary to allow for appropriate resource and task allocation for the European Chemicals Agency. That timeframe is considered sufficient to allow potential applicants or Member States to adjust to the modified procedural steps under that Directive.

(8) For amending procedural provisions under Directive 2011/65/EU, a transitional period of 24 months is necessary to allow for appropriate resource and task allocation for the European Chemicals Agency. That timeframe is considered sufficient to allow potential applicants or Member States to adjust to the modified procedural steps under that Directive.

Or. en

Justification

ECHA needs a longer transitional period than the 12 months' period set out in the Commission's legal proposal. This is particularly important since no resources (neither financial nor posts) are currently planned to be provided to ECHA until the legal text is adopted and enters into force, and the Agency will have in principle to wait until then to start preparing, incl. recruiting/training new dedicated staff and adapting our processes, guidance and tools, for being able to receive and process regulatory submissions.

Amendment 2

Proposal for a directive

Article 2 – paragraph 1

Text proposed by the Commission

Amendment

The provisions under this Directive shall be applicable from [OJ: 12 months after the publication of this Directive].

The provisions under this Directive shall be applicable from [OJ: 24 months after the publication of this Directive].

Or. en

Justification

ECHA will need a longer transitional period than the initial 12 months' period set out in the legal proposal. This is particularly important since no resources (neither financial nor posts) are currently planned to be provided to ECHA until the legal text is adopted and enters into force, and the Agency will have in principle to wait until then to start preparing, incl. recruiting/training new dedicated staff and adapting our processes, guidance and tools, for being able to receive and process regulatory submissions.

EXPLANATORY STATEMENT

In general, the Rapporteur considers that ECHA needs a Basic Regulation to ensure it is fit for the future and can deliver EU goals and ambitions on chemical safety, protecting health and the environment and supporting competitiveness. To ensure simplification and flexibility, the basic regulation should provide ECHA with the possibility to have one single budget line for its EU contribution and the possibility to build up a reserve fund from fees.

The Rapporteur considers that the reattribution of scientific and technical tasks will have a significant impact on ECHA. A restructuring of the work of the Agency will be necessary to ensure that its Committees can cope with the increased workload without compromising the quality, punctuality and the timeliness of their work.

In this context, new structures – committees or working groups – are likely to be considered in order the Agency to cope effectively with the new tasks. In addition, the reinforcement of the existing ones (the Risk Assessment Committee and the Committee for Socio-Economic Analysis) is needed.

Beyond the need for additional budget and staffing, the setup as well as the organisation of the work need to be considered. With no clarity on the future structure of the Agency’s scientific committees it is impossible to conclude on whether the proposed resources will be sufficient for the Agency to manage the increased workload.

The adoption of a proposal for an ECHA Basic Regulation is very important, as it will allow the Agency to smoothly and efficiently integrate the new tasks.

In this regards, the Rapporteur proposes a longer transitional period than the current 12 months set out in the legal proposal. This is particularly important since no financial and human resources are currently planned to be provided to ECHA until the legal text is adopted and enters into force.

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:

Entity and/or person

CEFIC

COSMETICS EUROPE

EFPIA

SFEE (Hellenic Association of Pharmaceutical Companies)

BASF

EFEO

ECHA

L'Oréal group in Europe

AnimalhealthEurope

ClientEarth

European Environmental Bureau (EEB)

FuelsEurope

EFSA

EEA

EMA

Croplife Europe

DOW

AESPG

AISE

SMEunited

DUCC (Downstream Users of Chemicals Co-ordination group)

SEVAS (Association of the Greek Industry of Detergents and Soaps)

Eurometaux

Eurocolour

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.