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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 (Text with EEA relevance)
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1.A substance that fulfils the criteria set out in Annex I for the following shall normally be subject to [F4mandatory] classification and labelling in accordance with Article 37 [F5or 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 [F6Regulation (EC) No 1107/2009 or Regulation (EC) No 528/2012] shall normally be subject to [F7mandatory] classification and labelling. For such substances, the procedures set out in Article 37 [F8or Article 37A], F9... 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 [F10mandatory] classification and labelling [F11requirement] in accordance with Article 37 [F12or Article 37A] may also be added to [F13the GB mandatory classification and labelling list] on a case-by-case basis, if justification is provided demonstrating the need for such action F14....
Textual Amendments
F3Word 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)
F4Word 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)
F5Words 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)
F6Words 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)
F7Word 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)
F8Words 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)
F9Words 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)
F10Word 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)
F11Word 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)
F12Words 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)
F13Words 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)
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
F15Art. 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)
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
[F18A1.Any opinion of the Agency referred to in Article 37 must specify the reasons for the opinion.]
1.Any opinion [F19of 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.
[F202.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.]
[F213.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
F17Words 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)
F18Art. 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)
F19Words 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)
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
F22Art. 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
This Chapter shall apply to:
substances subject to registration in accordance with Regulation (EC) No 1907/2006;
substances within the scope of Article 1 which meet the criteria for classification as hazardous and are placed on the market either on their own or in a mixture above the concentration limits specified in this Regulation F24..., where relevant, which results in the classification of the mixture as hazardous.
Textual Amendments
F24Words in Art. 39(b) 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. 38; 2020 c. 1, Sch. 5 para. 1(1)
1.Any manufacturer or importer, or group of manufacturers or importers (hereinafter referred to as ‘the notifier(s)’), who places on the market a substance referred to in Article 39, shall notify to the Agency the following information in order for it to be included in the [F25GB notification database] referred to in Article 42:
(a)the identity of the notifier(s) responsible for placing the substance or substances on the market as specified in section 1 of Annex VI to Regulation (EC) No 1907/2006;
(b)the identity of the substance or substances as specified in section 2.1 to 2.3.4 to Annex VI to Regulation (EC) No 1907/2006;
(c)the classification of the substance or substances in accordance with Article 13;
(d)where a substance has been classified in some but not all hazard classes or differentiations, an indication of whether this is due to lack of data, inconclusive data, or data which are conclusive although insufficient for classification;
(e)specific concentration limits or M-factors, where applicable, in accordance with Article 10 of this Regulation together with a justification using the relevant Parts of sections 1, 2 and 3 of Annex I to Regulation (EC) No 1907/2006;
(f)the label elements specified in points (d), (e) and (f) of Article 17(1) for the substance or substances together with any supplemental hazard statements for the substance, determined in accordance with Article 25(1).
The information referred to in (a) to (f) shall not be notified, if it has been submitted to the Agency as part of a registration pursuant to Regulation (EC) No 1907/2006, or if it has already been notified by that notifier [F26or has been notified before IP completion day to the European Chemicals Agency under Article 40 of Regulation (EC) 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures].
The notifier shall submit this information in the format specified [F27by the Agency].
2.The information listed in paragraph 1 shall be updated and notified to the Agency by the notifier(s) concerned when, pursuant to the review in Article 15(1), a decision to change the classification and labelling of the substance has been taken.
3.Substances placed on the market on or after 1 December 2010 shall be notified in accordance with paragraph 1 within one month after their placing on the market.
However, substances placed on the market before 1 December 2010 may be notified in accordance with paragraph 1 before that date.
Textual Amendments
F25Words in Art. 40(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. 39(a) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 10(a)); 2020 c. 1, Sch. 5 para. 1(1)
F26Words in Art. 40(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. 39(b) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 10(b)); 2020 c. 1, Sch. 5 para. 1(1)
Where the notification in Article 40(1) results in different entries on the [F28GB notification database] referred to in Article 42 for the same substance, the notifiers and registrants shall make every effort to come to an agreed entry to be included in the [F28GB notification database]. The notifiers shall inform the Agency accordingly.
Textual Amendments
F28Words in Art. 41 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. 40 (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 11); 2020 c. 1, Sch. 5 para. 1(1)
1.The Agency shall establish and maintain [F30 a database, (to be called “the GB notification database”)].
The information notified pursuant to Article 40(1) shall be included in the [F31GB notification database].
[F32Information in the GB notification database which corresponds to the information referred to in Article 38(1) is to be made publicly accessible by the Agency except where Article 38(3) applies to that information.]
2.The Agency shall update the [F33GB notification database] when it receives updated information in accordance with Article 40(2) or Article 41.
3.In addition to the information referred to in paragraph 1, the Agency shall, where applicable, include the following information in each entry:
[F34(a)whether in respect of the entry, there is mandatory classification and labelling by inclusion in the GB mandatory classification and labelling list;]
F35(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F36(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F37(d). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The information referred to in (a) shall be updated where a decision is taken in accordance with Article [F3837(4)(b) and Article 37A(8)].
Textual Amendments
F29Words in Art. 42 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. 41(a) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 12(a)); 2020 c. 1, Sch. 5 para. 1(1)
F30Words in Art. 42(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. 41(b)(i) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 12(a)); 2020 c. 1, Sch. 5 para. 1(1)
F31Words in Art. 42(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. 41(b)(ii) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 12(a)); 2020 c. 1, Sch. 5 para. 1(1)
F32Words in Art. 42(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. 41(b)(iii) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 12(a)); 2020 c. 1, Sch. 5 para. 1(1)
F33Words in Art. 42(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. 41(c) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 12(a)); 2020 c. 1, Sch. 5 para. 1(1)
F34Art. 42(3)(a) 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. 41(d)(i) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 12(a)); 2020 c. 1, Sch. 5 para. 1(1)
F35Art. 42(3)(b) 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. 41(d)(ii); 2020 c. 1, Sch. 5 para. 1(1)
F36Art. 42(3)(c) 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. 41(d)(ii); 2020 c. 1, Sch. 5 para. 1(1)
F37Art. 42(3)(d) 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. 41(d)(ii); 2020 c. 1, Sch. 5 para. 1(1)
F38Words in Art. 42(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. 41(e) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 12(b)); 2020 c. 1, Sch. 5 para. 1(1)
Textual Amendments
F23Title 5 Ch. 2 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. 37 (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 9(c)); 2020 c. 1, Sch. 5 para. 1(1)
Textual Amendments
F1Title 5 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. 30 (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 6(g)); 2020 c. 1, Sch. 5 para. 1(1)
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