EU as regards the re-attribution of scientific and technical tasks to the European Chemicals Agency - Main contents

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dossier	COM(2023)781 - Amendment of Directive 2011/65/EU as regards the re-attribution of scientific and technical tasks to the European Chemicals ...
document	COM(2023)781
date	December 7, 2023

Article 1

Amendments to Directive 2011/65/EU

Directive 2011/65/EU is amended as follows:

(1) Article 5 is amended as follows:

(a) paragraphs 3 and 4 are replaced by the following:

‘3. An application for granting, renewing or revoking an exemption shall be made to the European Chemicals Agency set up pursuant to Article 75(1) of Regulation (EC) No 1907/2006 (‘the Agency’) in accordance with Annex V.

4. The Agency shall:

(a) acknowledge receipt of an application within 15 days of its receipt, stating the date of receipt of the application;

(b) verify that the application contains all the elements laid out in Annex V;

(c) if necessary, request the applicant to complete the application, and provide an appropriate deadline;

(d) make the application and any supplementary information supplied by the applicant available to Member States;

(e) make a summary of the application and a non-confidential version of the application as submitted by the applicant, as well as the date when the application is considered complete, available to the public on the Agency’s website;

(f) invite interested parties to submit information within 3 months of its publication on the Agency’s website.

Where the applicant does not complete the application with the missing elements identified by the Agency in compliance with Annex V within the deadline provided in accordance with the first subparagraph, point (c), the Agency may reject such application. The Agency shall establish and communicate to the applicant without undue delay the date when the application is considered complete.

Upon receipt of an application, the Agency shall notify the Commission of the application and keep it informed of any of the procedural steps under points (b) to (f).’;

(b) the following paragraph 4a is inserted after paragraph 4:

‘4a. The Agency shall, after verifying the completeness of the application, request the opinion of the Committee for Socio-economic Analysis, set up pursuant to Article 76(1), point (d) of Regulation (EC) No 1907/2006. It shall request the opinion of the Committee for Risk Assessment, set up pursuant to Article 76(1), point (c), of Regulation (EC) No 1907/2006, in the case of an application for a new exemption, or where otherwise considered appropriate.

The Committee for Socio-economic Analysis and, where relevant, the Committee for Risk Assessment:

(a) shall draw up draft opinions within 9 months of the date the application has been considered complete by the Agency under paragraph 4, point (b);

(b) shall assess whether the criteria in Article 5(1), point (a), are met and shall provide clear guidance to the Commission on granting, renewing or revoking an exemption;

(c) may request the applicant or third parties to submit, within a specified period, additional information;

(d) upon adopting the draft opinions, shall communicate those draft opinions to the applicant and shall allow the applicant the opportunity to comment within 4 weeks of the communication of the draft opinions to the applicant;

(e) shall adopt their final opinions, taking into account the comments from the applicant.

Each Committee shall take into account any information submitted by third parties in accordance with the second subparagraph, point (c).

The Agency shall send the final opinion(s) of the Committees to the Commission within 12 months from the date an application has been considered complete by the Agency.

The Agency shall identify which parts of its opinions and of any attachments thereto should be made publicly available on its website and shall make those parts publicly available on its website.

For the purpose of adopting opinions pursuant to this paragraph, Article 87 of Regulation (EC) No 1907/2006 shall apply mutatis mutandis.’;

(c) paragraph 8 is replaced by the following:

‘8. The Agency shall, in agreement with the Commission, provide a harmonised format for the applications referred to in paragraph 3 of this Article as well as comprehensive guidelines for such applications, taking into account the situation of SMEs. Any submission to the Agency shall be made using the format and the submission tools made available by the Agency.’;

(2) in Annex V, the following paragraph is added:

‘In cases referred to in the first paragraph, point (h), the applicant shall submit a non-confidential version of the application.’.

(3) Article 6 is amended as follows:

(a) in paragraph 1, the first subparagraph is replaced by the following:

‘With a view to achieving the objectives set out in Article 1 and taking account of the precautionary principle, a review, based on a thorough assessment, and an amendment of the list of restricted substances in Annex II shall be considered by the Commission periodically on its own initiative or following the submission of a restriction dossier prepared by a Member State containing the information referred to in paragraph 2.’;

(b) in paragraph 1, the fourth subparagraph is deleted.

(c) paragraph 2 is replaced by the following:

‘2. The review and amendment of the list of restricted substances in Annex II shall be based on restriction dossiers prepared by the Agency at the request of the Commission or prepared by a Member State.

The Agency or a Member State shall take into account any available information and any relevant risk assessment submitted for the purposes of other Union legislation covering the life cycle of the substance used in EEE, in particular the waste phase. To this end, other bodies established under Union law and carrying out a similar task shall, on request, provide information to the Agency or Member State concerned.

The restriction dossier shall comply with the requirements set out in Part II, point 3, of Annex XV to Regulation (EC) No 1907/2006 and shall, in addition, contain the following information:

(a) information on the use of the substance or the group of similar substances in EEE;

(b) information on detrimental effects and exposure in particular during waste EEE management operations.’

(4) the following Articles 6a, 6b and 6c are inserted:

‘Article 6a

Initiation of procedure for review and amendment of the list of restricted substances

1. Within 12 months of receipt of the request from the Commission referred to in Article 6(2), first subparagraph, the Agency shall prepare a restriction dossier conforming to the requirements referred to in Article 6(2), third subparagraph, and suggest restrictions in order to initiate the restriction process.

2. A Member State shall notify the Agency that it proposes to prepare a restriction dossier which conforms to the requirements referred to in Article 6(2), third subparagraph, within 12 months. If that dossier demonstrates that action on a Union-wide basis is necessary, beyond any measures already in place, the Member State shall submit it to the Agency in order to initiate the restriction process.

3. The Agency shall publish without delay the intention of the Commission or the Member State to initiate the process to review and amend the list of restricted substances in Annex II.

4. The Agency shall establish and maintain a list of substances for which a restriction dossier conforming to the requirements of Article 6(2) is planned or underway by either the Agency or a Member State for the purposes of a proposed restriction.

5. The Agency shall consult the Committee for Risk Assessment, set up pursuant to Article 76(1), point (c), of Regulation (EC) No 1907/2006, and the Committee for Socio-economic Analysis, set up pursuant to Article 76(1), point (d), of that Regulation. The Committees shall verify whether the restriction dossier submitted conforms to the requirements referred to in Article 6(2), third subparagraph.

Within 30 days of receipt of the restriction dossier, the respective Committee shall inform the Agency or the Member State proposing restrictions whether the dossier conforms to the requirements referred to in Article 6(2), third subparagraph. If the dossier does not conform to those requirements, the reasons shall be given to the Agency or the Member State in writing within 45 days of receipt of that dossier. The Agency or the Member State shall bring the dossier into conformity within 60 days of the date of receipt of the reasons from the Committees, otherwise the procedure under this Article shall be terminated.

6. Where the dossier meets the requirements referred to in Article 6(2), third subparagraph, the Agency shall make it publicly available without delay, clearly indicating the date of publication. The Agency shall invite all interested parties, including economic operators, recyclers, treatment operators, environmental organisations and employee and consumer associations to submit, individually or jointly, within 4 months from the date of the publication of the dossier, the following:

(a) comments on dossiers and the suggested restrictions;

(b) a socio-economic analysis including an analysis of alternatives, or information which can contribute to one of the suggested restrictions, examining the advantages and drawbacks of the proposed restrictions.

The analysis referred to in the first subparagraph, point (b), shall conform to the requirements in Annex XVI to Regulation (EC) No 1907/2006.

Article 6b

Opinion of the Agency’s Committees

1. Within 12 months from the date of publication referred to in Article 6a(6), the Committee for Risk Assessment shall adopt an opinion as to whether the restriction is appropriate in reducing the risk to human health or the environment, specifically by reference to the risks set out in Article 6(1), third subparagraph, based on its consideration of the relevant parts of the dossier. This opinion shall take account of the restriction dossier prepared by the Agency at the request of the Commission or by the Member State, and the views of interested parties referred to in Article 6a(6), point (a).

2. Within 15 months from the date of publication referred to in Article 6a(6), the Committee for Socio-economic Analysis, shall adopt an opinion on the proposed restrictions, based on its consideration of the relevant parts of the dossier and the socio-economic impact. Prior to that, it shall prepare a draft opinion on the suggested restrictions and on the related socio-economic impact, taking account any existing analysis or information according to Article 6a(6), point (b).

3. The Agency shall publish the draft opinion of the Committee for Socio-economic Analysis on its website without delay and invite interested parties to provide their comments on the draft opinion no later than 60 days from its publication.

4. The Committee for Socio-economic Analysis shall without delay adopt its opinion, taking into account where appropriate further comments received by the deadline set in paragraph 3. This opinion shall take into account the comments of interested parties submitted under Article 6a(6), point (a), and paragraph 3 of this Article.

5. Where the opinion of the Committee for Risk Assessment diverges significantly from the restrictions proposed, the Agency shall postpone the deadline for the opinion of the Committee responsible for Socio-economic Analysis by a maximum of 90 days.

6. For the purpose of adopting opinions pursuant to this article, Article 87 of Regulation (EC) No 1907/2006 shall apply mutatis mutandis.

Article 6c

Submission of an opinion to the Commission

1. The Agency shall submit to the Commission, without delay, the opinions of the Committees for Risk Assessment and Socio-economic Analysis on the restrictions suggested pursuant to Article 6b. Where the opinions of the Committees for Risk Assessment and Socio-economic Analysis diverge significantly from the restrictions suggested by the dossier, the Agency shall submit an explanatory note to the Commission providing a detailed explanation of the reasons for such differences. If one or both of the Committees do not adopt an opinion by the deadlines set in Article 6b(1) and (2) the Agency shall inform the Commission accordingly, stating the reasons.

2. The Agency shall publish the opinions of both Committees on its website without delay.

3. The Agency shall, on request, provide the Commission or Member State with all documents and evidence submitted to or considered by it.’;

Article 2

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

Article 3

This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Article 4

This Directive is addressed to the Member States.