Regulation (EC) No 1272/2008 of the European Parliament and of the CouncilDangos y teitl llawn

CHAPTER 1 U.K. [F1 Establishing mandatory classification of substances]

Article 36 U.K. [F2 Mandatory] classification and labelling of substances

1. A substance that fulfils the criteria set out in Annex I for the following shall normally be subject to [F3 mandatory] classification and labelling in accordance with Article 37 [F4 or Article 37A]:

(a) respiratory sensitisation, category 1 (Annex I, section 3.4);

(b) germ cell mutagenicity, category 1A, 1B or 2 (Annex I, section 3.5);

(c) carcinogenicity, category 1A, 1B or 2 (Annex I, section 3.6);

(d) reproductive toxicity, category 1A, 1B or 2 (Annex I, section 3.7).

2. A substance that is an active substance in the meaning of [F5 Regulation (EC) No 1107/2009 or Regulation (EC) No 528/2012] shall normally be subject to [F6 mandatory] classification and labelling. For such substances, the procedures set out in Article 37 [F7 or Article 37A], F8 ... shall apply.

3. Where a substance fulfils the criteria for other hazard classes or differentiations than those referred to in paragraph 1 and does not fall under paragraph 2, a [F9 mandatory] classification and labelling [F10 requirement] in accordance with Article 37 [F11 or Article 37A] may also be added to [F12 the GB mandatory classification and labelling list] on a case-by-case basis, if justification is provided demonstrating the need for such action F13 ....

Textual Amendments

F2 Word in Art. 36 heading substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 32(a); 2020 c. 1, Sch. 5 para. 1(1)

F3 Word in Art. 36(1) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 32(b)(i); 2020 c. 1, Sch. 5 para. 1(1)

F4 Words in Art. 36(1) inserted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 32(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F5 Words in Art. 36(2) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 32(c)(i); 2020 c. 1, Sch. 5 para. 1(1)

F6 Word in Art. 36(2) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 32(c)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F7 Words in Art. 36(2) inserted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 32(c)(iii); 2020 c. 1, Sch. 5 para. 1(1)

F8 Words in Art. 36(2) omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 32(c)(iv); 2020 c. 1, Sch. 5 para. 1(1)

F9 Word in Art. 36(3) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 32(d)(i); 2020 c. 1, Sch. 5 para. 1(1)

F10 Word in Art. 36(3) inserted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 32(d)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F11 Words in Art. 36(3) inserted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 32(d)(iii); 2020 c. 1, Sch. 5 para. 1(1)

F12 Words in Art. 36(3) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 32(d)(iv) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 6(h)); 2020 c. 1, Sch. 5 para. 1(1)

F13 Words in Art. 36(3) omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 32(d)(v); 2020 c. 1, Sch. 5 para. 1(1)

[F14 Article 37 U.K. Procedure for mandatory classification and labelling where the EU Risk Assessment Committee publishes an opinion

1. This Article applies in relation to a substance—

(a) on which the Committee for Risk Assessment of the European Chemicals Agency (“the Committee”) publishes an opinion under Article 37(4) of the EU CLP Regulation on or after IP completion day, or

(b) on which the Committee has published an opinion under Article 37(4) of the EU CLP Regulation before IP completion day, but which has not, as at IP completion day, been included in Part 3 of Annex VI of the EU CLP Regulation.

2. Within 6 months of the publication of the Committee’s opinion, the Agency must publish a technical report on the Committee’s opinion.

3. Within 12 months of the publication by the Agency of the technical report, the Agency must publish its own opinion.

4. Where the Agency’s opinion recommends aligning with the Committee’s opinion that there should be a change—

(a) within 12 months of the publication of its opinion, the Agency must—

(i) submit a recommendation to the Secretary of State to give effect to the classification and labelling requirement set out in the Agency’s opinion, and

(ii) send a copy of that recommendation to the Devolved Authorities;

(b) within 3 months of the recommendation being submitted by the Agency, the Secretary of State must—

(i) decide whether to accept the recommendation;

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

(iii) where the decision referred to in paragraph (i) 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;

(iv) notify the Agency of the decision and details referred to in paragraphs (ii) and (iii);

(c) the Secretary of State’s functions under paragraph (b)(i) and (iii) are subject to the consent requirement in Article 53B;

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

5. Where the Agency’s opinion does not recommend aligning with the Committee’s opinion the Agency may produce a proposal under paragraph 2 of Article 37A for a new or revised mandatory classification and labelling requirement.]

Textual Amendments

F14 Art. 37 substituted (31.12.2020) by S.I. 2019/720, Sch. 2 para. 33 (as substituted 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. 7)

[F15 Article 37A U.K. 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

F15 Art. 37A inserted by S.I. 2019/720, Sch. 2 para. 34 (as substituted 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)

Article 38 U.K. Content of opinions and decisions for [F16 mandatory] classification and labelling in [F16 the GB mandatory classification and labelling list]; accessibility of information

[F17 A1. Any opinion of the Agency referred to in Article 37 must specify the reasons for the opinion.]

1. Any opinion [F18 of the Agency referred to in Article 37A] shall at least specify for each substance:

(a) the identity of the substance as specified in sections 2.1 to 2.3.4 of Annex VI to Regulation (EC) No 1907/2006;

(b) the classification of the substance referred to in Article 36, including a statement of reasons;

(c) the specific concentration limits or M-factors, where applicable;

(d) the label elements specified in points (d), (e) and (f) of Article 17(1) for the substance, together with any supplemental hazard statements for the substance, determined in accordance with Article 25(1);

(e) any other parameter enabling an assessment to be made of the health or environmental hazard of mixtures containing the hazardous substance in question or of substances containing such hazardous substances as identified impurities, additives and constituents, if relevant.

[F19 2. When making publicly available an opinion or a decision as referred to in Article 37 or Article 37A, the Agency must not publish any information in relation to which paragraph 3 applies.]

[F20 3. This paragraph applies to information which has been made available to the Agency in relation to which a person has submitted a justification, accepted by the Agency as valid, as to why publication of the information is potentially harmful to the commercial interests of that person or any other person.]

Textual Amendments

F16 Words in Art. 38 heading substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 35(a) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 9(a)); 2020 c. 1, Sch. 5 para. 1(1)

F17 Art. 38(A1) inserted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 35(b); 2020 c. 1, Sch. 5 para. 1(1)

F18 Words in Art. 38(1) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 35(c); 2020 c. 1, Sch. 5 para. 1(1)

F19 Art. 38(2) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 35(d); 2020 c. 1, Sch. 5 para. 1(1)

F20 Art. 38(3) inserted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 35(e); 2020 c. 1, Sch. 5 para. 1(1)

[F21 Article 38A U.K. GB mandatory classification and labelling list

The Agency must establish, maintain and publish electronically a list (to be called “the GB mandatory classification and labelling list”) of all the mandatory classifications and accompanying labelling requirements made by the Secretary of State in accordance with Article 37 and Article 37A.]

Textual Amendments

F21 Art. 38A inserted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 36 (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 9(b)); 2020 c. 1, Sch. 5 para. 1(1)

Textual Amendments

F1 Title 5 Ch. 1 heading substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 31; 2020 c. 1, Sch. 5 para. 1(1)