Article 36 Mandatory classification and labelling of substancesF12
United Kingdom
A substance that fulfils the criteria set out in Annex I for the following shall normally be subject to F1mandatory classification and labelling in accordance with Article 37 F2...:
respiratory sensitisation, category 1 (Annex I, section 3.4);
germ cell mutagenicity, category 1A, 1B or 2 (Annex I, section 3.5);
carcinogenicity, category 1A, 1B or 2 (Annex I, section 3.6);
reproductive toxicity, category 1A, 1B or 2 (Annex I, section 3.7).
A substance that is an active substance in the meaning of F3Regulation (EC) No 1107/2009 or Regulation (EC) No 528/2012 shall normally be subject to F4mandatory classification and labelling. For such substances, the procedures set out in Article 37 F5..., F6... shall apply.
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 F7mandatory classification and labelling F8requirement in accordance with Article 37 F9... may also be added to F10the GB mandatory classification and labelling list on a case-by-case basis, if justification is provided demonstrating the need for such action F11....
Annotations
Textual amendments
- F1
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)
- F2
Words in Art. 36(1) omitted (21.5.2026) by virtue of The Chemicals (Health and Safety) (Amendment, Consequential and Transitional Provision) Regulations 2026 (S.I. 2026/484), reg. 1(1), Sch. para. 1(7) (with reg. 3)
- F3
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)
- F4
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)
- F5
Words in Art. 36(2) omitted (21.5.2026) by virtue of The Chemicals (Health and Safety) (Amendment, Consequential and Transitional Provision) Regulations 2026 (S.I. 2026/484), reg. 1(1), Sch. para. 1(7) (with reg. 3)
- F6
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)
- F7
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)
- F8
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)
- F9
Words in Art. 36(3) omitted (21.5.2026) by virtue of The Chemicals (Health and Safety) (Amendment, Consequential and Transitional Provision) Regulations 2026 (S.I. 2026/484), reg. 1(1), Sch. para. 1(7) (with reg. 3)
- F10
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)
- F11
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)
- F12
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)
Notes on Title V
Textual amendments
- F1
Title 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)
- F2
Words in Title 5 heading omitted (21.5.2026) by virtue of The Chemicals (Health and Safety) (Amendment, Consequential and Transitional Provision) Regulations 2026 (S.I. 2026/484), reg. 1(1), Sch. para. 1(6)