Regulation (EU) 2025/2457 of the European Parliament and of the Council of 26 November 2025 amending Regulations (EC) No 178/2002, (EC) No 401/2009, (EU) 2017/745 and (EU) 2019/1021 as regards the reattribution of scientific and technical tasks and improving cooperation among Union agencies in the area of chemicals (Text with EEA relevance)

• CELEX: Regulation (EU) 2025/2457
• Articles: 5

Article 1 Amendments to Regulation (EC) No 178/2002

Regulation (EC) No 178/2002 is amended as follows:

(1)

in Article 23, the following point is added:

‘(m)

to cooperate with the competent bodies in the Member States that carry out similar tasks to those of the Authority and with other scientific bodies established under Union law, in particular the European Chemicals Agency, the European Medicines Agency and the European Environment Agency, on the provision of relevant scientific opinions, on the exchange of data and information, including the potential establishment of related data formats and controlled vocabularies to facilitate such an exchange, and on the development of scientific methodologies for the assessment of chemicals.’

;

(2)

in Article 27(4), point (b) is replaced by the following:

‘(b)

in those circumstances identified in Article 30(2), where the Authority and a national body are obliged to cooperate;’

;

(3)

Article 30 is replaced by the following:

‘Article 30

Diverging scientific opinions

1.   The Authority shall take the necessary and appropriate measures to monitor and identify at an early stage any potential source of divergence between its scientific opinions and the scientific opinions issued by other bodies carrying out similar tasks.

2.   Where the Authority identifies a potential source of divergence as referred to in paragraph 1, it shall contact the other body in order to ensure that all relevant scientific or technical information is shared and to identify potentially contentious scientific or technical issues.

The Authority and the other body shall cooperate to resolve any divergence, taking into consideration the objective of a high level of protection of health and the environment. If the Authority and the other body are not able to resolve the divergence, they shall draw up a joint report. The report shall clearly outline the contentious scientific issues, identify any relevant uncertainties in the data and give the underlying reasons for the divergence of opinions, including reasons related to methodological differences. The report shall be made publicly available.

Where the other body is a Union agency or a scientific committee, the Authority shall also present the joint report to the Commission.

3.   Where relevant, and where the divergence concerns conflicting scientific opinions of the Authority and another Union body on whether a substance fulfils the criteria laid out in Annex I to Regulation (EC) No 1272/2008 of the European Parliament and of the Council  ( *1 ) , the Commission may request the European Chemicals Agency to prepare a proposal for the harmonised classification and labelling of substances and, where appropriate, specific concentration limits, M-factors or acute toxicity estimates, or a proposal for the revision of such classification and labelling of substances, and, where appropriate, for the revision of such limits, factors or estimates in accordance with the procedure laid down in Article 37 of Regulation (EC) No 1272/2008. The Authority and the other Union body shall cooperate with the European Chemicals Agency in preparing that proposal.

( *1 )   Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 ( OJ L 353, 31.12.2008, p. 1 , ELI: http://data.europa.eu/eli/reg/2008/1272/oj ).’."

Article 2 Amendments to Regulation (EC) No 401/2009

Regulation (EC) No 401/2009 is amended as follows:

(1)

in Article 2, the following point is added:

‘(p)

to develop assessment methodologies relating to chemicals in the fields falling within its mandate.’

;

(2)

Article 15 is amended as follows:

(a)

paragraph 1 is replaced by the following:

‘1.   The Agency shall actively seek the cooperation of the Commission, other Union bodies and programmes, in particular the Joint Research Centre, the Statistical Office of the Union (Eurostat), the European Chemicals Agency, the European Food Safety Authority, the European Medicines Agency and the Union’s environmental research and development programmes.

Cooperation with the Joint Research Centre shall include in particular the tasks set out in Annex I, Part A.

Coordination with Eurostat and the statistical programme of the Union shall follow in particular the guidelines outlined in Annex I, Part B.

Cooperation with the European Chemicals Agency, the European Food Safety Authority and the European Medicines Agency shall relate to the exchange of data and information on chemicals, including the possible establishment of related data formats and controlled vocabularies to facilitate such an exchange, and to the development of scientific methodologies for the assessment of chemicals.’

;

(b)

paragraph 4 is replaced by the following:

‘4.   The cooperation referred to in paragraphs 1, 2 and 3 shall take account, inter alia, of the need to enhance coherence and synergies and to avoid any duplication of effort.’.

Article 3 Amendments to Regulation (EU) 2017/745

Annex I to Regulation (EU) 2017/745 is amended as follows:

(1)

in Section 10.4.1, point (b) is replaced by the following:

‘(b)

substances which are classified as endocrine disruptors for human health, of Category 1, in accordance with Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council  ( *2 ) and substances having endocrine-disrupting properties for which there is scientific evidence of probable serious effects to human health and which are identified in accordance with the procedure set out in Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council  ( *3 ) or substances having endocrine-disrupting properties relevant to human health identified in accordance with Regulation (EU) No 528/2012 of the European Parliament and the Council  ( *4 ) .

( *2 )   Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 ( OJ L 353, 31.12.2008, p. 1 , ELI: http://data.europa.eu/eli/reg/2008/1272/oj )."

( *3 )   Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC ( OJ L 396, 30.12.2006, p. 1 , ELI: http://data.europa.eu/eli/reg/2006/1907/oj )."

( *4 )   Regulation (EU) No 528/2012 of the European Parliament and the Council of 22 May 2012 concerning the making available on the market of and use of biocidal products ( OJ L 167, 27.6.2012, p. 1 , ELI: http://data.europa.eu/eli/reg/2012/528/oj ).’;"

(2)

in Section 10.4.2, point (d) is replaced by the following:

‘(d)

where applicable and available, the latest relevant guidelines in accordance with Sections 10.4.3 and 10.4.4’

;

(3)

Section 10.4.3 is replaced by the following:

‘10.4.3.   Guidelines on phthalates

When deemed appropriate based on the latest scientific evidence, but at least every 5 years, the Commission shall request the European Chemicals Agency (ECHA) to prepare and update guidelines on the benefit-risk assessment of the presence of phthalates which belong to either of the groups of substances referred to in Section 10.4.1, points (a) and (b). The benefit-risk assessment shall consider the intended purpose and context of the use of the device, as well as any available alternative substances and alternative materials, designs or medical treatments.

When appropriate or when requested by the Commission, the ECHA shall consult the Committee for Risk Assessment and the Committee for Socio-economic Analysis.’

;

(4)

Section 10.4.4 is replaced by the following:

‘10.4.4.   Guidelines on other CMR and endocrine-disrupting substances

In addition to the guidelines referred to in Section 10.4.3, the Commission shall request the ECHA to prepare such guidelines for other substances referred to in Section 10.4.1, points (a) and (b), where appropriate. Such guidelines shall be prepared in accordance with the process described in Section 10.4.3.’.

Article 4 Amendments to Regulation (EU) 2019/1021

Regulation (EU) 2019/1021 is amended as follows:

(1)

Article 8 is amended as follows:

(a)

in paragraph 1, the following point is added:

‘(i)

upon request by the Commission, draw up and submit a report within 12 months of the request on the impacts on human health and on the environment and socioeconomic impacts of introducing or amending concentration limit values specified in Annex IV or V.’

;

(b)

the following paragraph is inserted:

‘1a.   The report referred to in paragraph 1, point (i), shall contain the following information:

(a)

information on the impacts on human health and on the environment of waste consisting of, containing or contaminated with POPs, including impacts on waste management;

(b)

information on concentrations and mass flows of POPs in relevant waste streams and on waste treatment and treatment capacities;

(c)

an analysis of the impacts of the different concentration limit values considered in drawing up the report;

(d)

a reasoned proposal for concentration limit values to be introduced in Annex IV and, as appropriate, in Annex V.

The Agency shall, as soon as it receives the request referred to in paragraph 1, point (i), publish on its website a notice that a report on a possible amendment of Annex IV or V will be prepared. The notice shall also invite all interested parties, including waste operators and users of recycled materials, to submit comments within 8 weeks. The Agency shall publish those comments on its website.

At the latest 9 months following the submission of the report referred to in paragraph 1, point (i), of this Article, the Committee for Socioeconomic Analysis of the Agency, set up pursuant to Article 76(1), point (d), of Regulation (EC) No 1907/2006, shall adopt an opinion on the report and on the concentration limit values proposed therein. For that purpose Article 87 of Regulation (EC) No 1907/2006 shall apply mutatis mutandis .

The Agency shall then submit the report and the opinion of the Committee for Socioeconomic Analysis on the concentration limit values to the Commission without delay.’

;

(2)

in Article 13, paragraph 2 is replaced by the following:

‘2.   Where a Member State shares the information referred to in paragraph 1, point (e), with the European Environmental Agency (the “EEA”), that Member State shall indicate that in the report and, in doing so, shall be deemed to have fulfilled its reporting obligations under that point.

Where the information referred to in paragraph 1, point (e), is contained in the report of a Member State provided to the Agency, the Agency shall transmit the information to the EEA for compiling, storing and sharing that information.’

;

(3)

in Article 15, paragraph 2 is replaced by the following:

‘2.   The Commission is empowered to adopt delegated acts in accordance with Article 18, in order to amend Annexes IV and V to adapt them to the changes to the list of substances set out in Annexes I, II or III or to modify existing entries in Annex IV and V to adapt them to scientific and technical progress, including developments in waste treatment and decontamination technologies or new scientific information regarding health and environmental impacts associated with the presence of a substance in waste.’

;

(4)

Article 18 is amended as follows:

(a)

the first sentence of paragraph 2 is replaced by the following:

‘The power to adopt delegated acts referred to in Article 4(3), Article 10(2) and Article 15 shall be conferred on the Commission for a period of five years from 1 January 2026.’

;

(b)

the first sentence of paragraph 3 is replaced by the following:

‘The delegation of power referred to in Article 4(3), Article 10(2) and Article 15 may be revoked at any time by the European Parliament or by the Council.’

;

(c)

paragraph 6 is replaced by the following:

‘A delegated act adopted pursuant to Article 4(3), Article 10(2) or Article 15 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.’

;

(5)

the following article is inserted:

‘Article 21b

Review

Taking due account of any regulatory developments concerning the status of the resources and of the governance of the scientific committees of the European Chemicals Agency, the Commission shall monitor the situation regarding the tasks, workload and remit of the scientific committees, and, where appropriate, present a legislative proposal to amend this Regulation accordingly.’

;

(6)

Annex IV, table 1, is amended as follows:

(a)

in row 4, the text in the fourth column is replaced by the following:

‘

1 500 mg/kg

By 30 December 2027, the Commission shall review that concentration limit and shall, where appropriate, adopt a delegated act in accordance with Article 15(2) to lower that value.’

;

(b)

in row 11, the text in the fourth column is replaced by the following:

‘5 μg/kg ( 2 )

By 30 December 2027, the Commission shall review that concentration limit and shall, where appropriate, adopt a delegated act in accordance with Article 15(2) to lower that value.’

;

(c)

in row 26, the text in the fourth column is replaced by the following:

‘500 mg/kg

By 30 December 2027, the Commission shall review that concentration limit and shall, where appropriate, adopt a delegated act in accordance with Article 15(2) to lower that value to not higher than 200 mg/kg.’

;

(d)

in row 29, the text in the fourth column is replaced by the following:

‘1 mg/kg (PFOA and its salts),

40 mg/kg (sum of PFOA-related compounds)

By 30 December 2027, the Commission shall review that concentration limit and shall, where appropriate, adopt a delegated act in accordance with Article 15(2) to lower that value.’

;

(e)

in row 30, the text in the fourth column is replaced by the following:

‘1 mg/kg (PFHxS and its salts),

40 mg/kg (sum of PFHxS-related compounds)

By 30 December 2027, the Commission shall review that concentration limit and shall, where appropriate, adopt a delegated act in accordance with Article 15(2) to lower that value.’.

Article 5 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 .