Division 3.2.1 X1F1
United Kingdom
For a mixture meeting the criteria for classification in accordance with Regulation (EC) No 1272/2008, the following substances shall be indicated, together with their concentration or concentration range in the mixture:
- (a)
substances presenting a health or environmental hazard within the meaning of Regulation (EC) No 1272/2008, if those substances are present in concentrations equal to or greater than the lowest of any of the following:
- (ia)
the generic cut-off values set out in Table 1.1 of Annex I to Regulation (EC) No 1272/2008;
- (ib)
the generic concentration limits given in parts 3 to 5 of Annex I to Regulation (EC) No 1272/2008, taking into account the concentrations specified in the notes to certain tables in part 3 in relation to the obligation to make available a safety data sheet for the mixture upon request, and for aspiration hazard (Section 3.10 of Annex I to Regulation (EC) No 1272/2008) ≥ 10 %;
List of hazard classes, hazard categories and concentration limits for which a substance shall be listed as a substance in a mixture in subsection 3.2
1.1. Hazard class and category Concentration limit (%) Acute toxicity, category 1, 2 and 3 ≥ 0,1 Acute toxicity, category 4 ≥ 1 Skin corrosion/irritation, category 1, sub-categories 1A, 1B, 1C and category 2 ≥ 1 Serious damage to eyes/eye irritation, category 1 and 2 ≥ 1 Respiratory/skin sensitisation ≥ 0,1 Germ cell mutagenicity category 1A and 1B ≥ 0,1 Germ cell mutagenicity category 2 ≥ 1 Carcinogenicity category 1A, 1B and 2 ≥ 0,1 Reproductive toxicity, category 1A, 1B, 2 and effects on or via lactation ≥ 0,1 Specific target organ toxicity (STOT) — single exposure, category 1 and 2 ≥ 1 Specific target organ toxicity (STOT) — repeated exposure, category 1 and 2 ≥ 1 Aspiration hazard ≥ 10 Hazardous to the aquatic environment — Acute, category 1 ≥ 0,1 Hazardous to the aquatic environment — Chronic, category 1 ≥ 0,1 Hazardous to the aquatic environment — Chronic, category 2, 3 and 4 ≥ 1 Hazardous for the ozone layer ≥ 0,1 - (ii)
the specific concentration limits given in F2the GB mandatory classification and labelling list;
- (iii)
if an M-factor has been given in F3the GB mandatory classification and labelling list, the generic cut-off value in Table 1.1 of Annex I to that Regulation, adjusted using the calculation set out in Section 4.1 of Annex I to that Regulation;
- (iv)
F4...
- (v)
the concentration limits set out in Annex II to Regulation (EC) No 1272/2008;
- (vi)
F5...
- (ia)
- (b)
substances for which there are Union workplace exposure limits which are not already included under point (a);
- (c)
substances that are persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII, or substances included in the list established in accordance with Article 59(1) for reasons other than the hazards referred to in point (a), if the concentration of an individual substance is equal to or greater than 0,1 %.
Annotations
Textual amendments
- F1
- F2
Words in Annex 2 point 3.2.1(a)(ii) 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. 6(a) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 2(e)); 2020 c. 1, Sch. 5 para. 1(1)
- F3
Words in Annex 2 point 3.2.1(a)(iii) 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. 6(a) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 2(e)); 2020 c. 1, Sch. 5 para. 1(1)
- F4
Annex 2 point 3.2.1(a)(iv) 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. 2(3)
- F5
Annex 2 point 3.2.1(a)(vi) 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. 2(3)