The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019

[F1 34.   After Article 37 insert— U.K.

“Article 37A Procedure for mandatory classification and labelling of substances where Article 37(1) does not apply

1.   This Article—

(a) applies in relation to substances to which Article 37(1) does not apply;

(b) does not apply to manufacturers, importers or downstream users established in Northern Ireland who supply qualifying Northern Ireland goods directly to Great Britain.

2.— (1) The Agency may produce a proposal for a new or revised mandatory classification and labelling requirement and, where appropriate, specific concentration limits or M-factors.

(2) A competent authority may submit to the Agency a proposal for a new or revised mandatory classification and labelling requirement and, where appropriate, specific concentration limits or M-factors.

(3) A proposal under subparagraphs (1) or (2) must follow the format set out in Part 2 of Annex VI and must contain the relevant information provided for in Part 1 of Annex VI.

3.— (1) A manufacturer, importer or downstream user of a substance may submit to the Agency a proposal for a mandatory classification and labelling of that substance and, where appropriate, specific concentration limits or M-factors, where there is no entry in the GB mandatory classification and labelling list for such substance in relation to the hazard class or differentiation covered by that proposal;

(2) A manufacturer, importer or downstream user who has new information which may lead to a change of the mandatory classification and labelling elements of a substance in the GB mandatory classification and labelling list must submit a proposal to the Agency for a revised classification.

(3) A proposal under subparagraph (1) must follow the format set out in Part 2 of Annex VI and must contain the relevant information provided for in Part 1 of Annex VI.

(4) Where a proposal under subparagraph (1) concerns the mandatory classification and labelling of a substance in accordance with Article 36(3), it must be accompanied by a fee.

4.   Within 12 months of a proposal being received by or produced by the Agency, during which time the parties concerned must be given an opportunity to comment, the Agency must publish a technical report on the proposal.

5.   Within 6 months of publishing the technical report, the Agency must publish an opinion on the proposal.

6.   In exceptional circumstances, the 6 month time limit referred to in paragraph 5 may be extended to 12 months.

7.   Where the Agency considers that it is appropriate to recommend that a new or revised mandatory classification and labelling requirement is imposed, within 12 months of the opinion being published, the Agency must—

(a) submit a recommendation to the Secretary of State to give effect to the opinion, and

(b) send a copy of that recommendation to each of the Devolved Authorities.

8.— (1) Within 3 months of the recommendation being submitted by the Agency, the Secretary of State must—

(a) decide whether to accept the recommendation;

(b) publish that decision, together with reasons for the decision;

(c) where the decision referred to in paragraph (b) is to accept the recommendation, specify (alongside the decision and the reasons for the decision) the date from when any new or revised classification and labelling requirement must be complied with;

(d) notify the Agency of the decision and details referred to in paragraphs (b) and (c).

(2) The Secretary of State’s functions under subparagraphs (1)(a) and (c) are subject to the consent requirement in Article 53B.

9.   Within one month of the Secretary of State notifying the Agency of a decision in accordance with paragraph 8(d), the Agency must update the GB mandatory classification and labelling list accordingly, making clear the date from when any new or revised classification and labelling requirement must be complied with.”.]

Textual Amendments

F1 Sch. 2 para. 34 substituted (31.12.2020 immediately before IP completion day) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1567), reg. 1(2), Sch. 2 para. 8

Commencement Information

I1 Sch. 2 para. 34 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)