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 - Main contents

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dossier	COM(2023)783 - Amendment of Regulations (EC) No 178/2002, (EC) No 401/2009, (EU) 2017/745 and (EU) 2019/1021 of the European Parliament and ...
document	COM(2023)783
date	December 7, 2023

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 (m) is added:

‘(m) to cooperate with the competent bodies in the Member States that carry out similar tasks to those of the Authority 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 on the provision of relevant scientific opinions, on the exchange of data and information, including the possible 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. 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, it shall contact the body concerned in order to ensure that all relevant scientific or technical information is shared and in order to identify the potentially contentious scientific or technical issues.

The Authority and the body concerned shall cooperate to resolve the divergence. If the Authority and the body concerned are not able to resolve the divergence, they shall draw up a joint report. The report shall clearly outline the contentious scientific issues and identify the relevant uncertainties in the data and be made publicly available.

Where the body concerned is a Union agency or a scientific committee, the Authority shall 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 or agency on whether a substance fulfils the criteria laid out in Annex I of Regulation (EC) No 1272/2008 of the European Parliament and of the Council ⁵⁴, the Commission may request the European Chemicals Agency to prepare a proposal for harmonised classification and labelling of substances and, where appropriate, specific concentration limits, M-factors or acute toxicity estimates, or a proposal for revision thereof following the procedure laid out in Article 37 of Regulation (EC) No 1272/2008. The Authority and the Union body or agency concerned shall co-operate with the European Chemicals Agency in developing that proposal.’.

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 (p) is added:

‘(p) to develop assessment methodologies related to chemicals in the fields falling within its mission.’;

2. in Article 15, the following paragraph 5 is added:

‘5. The Agency shall cooperate with other scientific bodies established under Union law, notably the European Chemicals Agency, the European Food Safety Authority, and the European Medicines Agency, on 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 on the development of scientific methodologies for the assessment of chemicals.’.

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 identified 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 ⁵⁵ 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 or substances having endocrine disrupting properties relevant to human health identified in accordance with Regulation (EU) No 528/2012.’

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 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, 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

The Commission shall request ECHA to prepare guidelines as referred to in Section 10.4.3. and following the process described therein also for other substances referred to in Section 10.4.1., points (a) and (b), where appropriate.’.

Article 4

Amendments to Regulation (EU) 2019/1021

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

1. Article 8(1) is amended as follows:

a. the following point (i) is added:

‘(i) upon request from the Commission, and within 12 months from that request, draw up and provide a report on the human health, environmental and socio-economic impacts of introducing or modifying concentration limit values specified in Annex IV or V.’

2. Article 8(1a) is added:

‘1a. The report referred to in Article 8(1), point (i), shall contain the following information:

a. as appropriate, information on human health and environmental impacts 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;

d. a duly motivated 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 the first subparagraph, point (i), publish on its website a notice that a report on a possible amendment of Annex IV or V will be prepared inviting 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 that report, the Committee for Socio-economic 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 the purpose of adopting an opinion on the report, Article 87 of Regulation (EC) No 1907/2006 shall apply mutatis mutandis.

The Agency shall submit the report and the opinion of the Committee for the Socio-economic 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, that Member State shall indicate that in the report and the Member State shall be considered 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 European Environmental Agency 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, to amend Annexes IV and V to adapt them to the changes to the list of substances set out in the Annexes to the Convention or the Protocol or to adapt them to scientific and technical progress.’

4. Article 18 is amended as follows:

a. The first sentence of paragraph 2 is replaced by the following:

‘2. The power to adopt delegated acts referred to in Articles 4(3), 10(2) and 15 shall be conferred on the Commission for a period of five years from 15 July 2019.’.

b. The first sentence of paragraph 3 is replaced by the following:

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

c. Paragraph 6 is replaced by the following:

‘6. A delegated act adopted pursuant to Articles 4(3), 10(2) and 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.’.

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.