Article 10 Concentration limits and M-factors for classification of substances and mixtures

United Kingdom

Specific concentration limits and generic concentration limits are limits assigned to a substance indicating a threshold at or above which the presence of that substance in another substance or in a mixture as an identified impurity, additive or individual constituent leads to the classification of the substance or mixture as hazardous.

Specific concentration limits shall be set by the manufacturer, importer or downstream user where adequate and reliable scientific information shows that the hazard of a substance is evident when the substance is present at a level below the concentrations set for any hazard class in Part 2 of Annex I or below the generic concentration limits set for any hazard class in Parts 3, 4 and 5 of Annex I.

In exceptional circumstances specific concentration limits may be set by the manufacturer, importer or downstream user where he has adequate, reliable and conclusive scientific information that a hazard of a substance classified as hazardous is not evident at a level above the concentrations set for the relevant hazard class in Part 2 of Annex I or above the generic concentration limits set for the relevant hazard class in Parts 3, 4 and 5 of that Annex.

M-factors for substances classified as hazardous to the aquatic environment, acute category 1 or chronic category 1, shall be established by manufacturers, importers and downstream users.

Notwithstanding paragraph 1, specific concentration limits shall not be set for F1mandatory hazard classes or differentiations for substances included in the GB mandatory classification and labelling list.

Notwithstanding paragraph 2, M-factors shall not be set for F2mandatory hazard classes or differentiations for substances included in the GB mandatory classification and labelling list for which an M-factor is given in that Part.

However, where an M-factor is not given in F3the GB mandatory classification and labelling list for substances classified as hazardous to the aquatic environment, acute category 1 or chronic category 1, an M-factor based on available data for the substance shall be set by the manufacturer, importer or downstream user. When a mixture including the substance is classified by the manufacturer, importer or downstream user using the summation method, this M-factor shall be used.

F45.

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Specific concentration limits set in accordance with paragraph 1 shall take precedence over the concentrations in the relevant sections of Part 2 of Annex I or the generic concentration limits for classification in the relevant sections of Parts 3, 4 and 5 of Annex I.

The Agency shall provide further guidance for the application of paragraphs 1 and 2.

Annotations

Textual amendments

F1: Words in Art. 10(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. 17(a) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 6(a)); 2020 c. 1, Sch. 5 para. 1(1)
F2: Words in Art. 10(4) 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. 17(b)(i) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 6(a)); 2020 c. 1, Sch. 5 para. 1(1)
F3: Words in Art. 10(4) 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. 17(b)(ii) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 6(a)); 2020 c. 1, Sch. 5 para. 1(1)
F4: Art. 10(5) 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(4)