1.Manufacturers, importers and downstream users of a substance shall identify the relevant available information for the purposes of determining whether the substance entails a physical, health or environmental hazard as set out in Annex I, and, in particular, the following:
(a)data generated in accordance with any of the methods referred to in Article 8(3);
(b)epidemiological data and experience on the effects on humans, such as occupational data and data from accident databases;
(c)any other information generated in accordance with section 1 of Annex XI to Regulation (EC) No 1907/2006;
(d)any new scientific information;
(e)any other information generated under internationally recognised chemical programmes.
The information shall relate to the forms or physical states in which the substance is placed on the market and in which it can reasonably be expected to be used.
2.Manufacturers, importers and downstream users shall examine the information referred to in paragraph 1 to ascertain whether it is adequate, reliable and scientifically valid for the purpose of the evaluation pursuant to Chapter 2 of this Title.
1.Manufacturers, importers and downstream users of a mixture shall identify the relevant available information on the mixture itself or the substances contained in it for the purposes of determining whether the mixture entails a physical, health or environmental hazard as set out in Annex I, and, in particular, the following:
(a)data generated in accordance with any of the methods referred to in Article 8(3) on the mixture itself or the substances contained in it;
(b)epidemiological data and experience on the effects on humans for the mixture itself or the substances contained in it, such as occupational data or data from accident databases;
(c)any other information generated in accordance with section 1 of Annex XI to Regulation (EC) No 1907/2006 for the mixture itself or the substances contained in it;
(d)any other information generated under internationally recognised chemical programmes for the mixture itself or the substances contained in it.
The information shall relate to the forms or physical states in which the mixture is placed on the market and, when relevant, in which it can reasonably be expected to be used.
2.Subject to paragraphs 3 and 4, where the information referred to in paragraph 1 is available for the mixture itself, and the manufacturer, importer or downstream user has ascertained that information to be adequate and reliable and where applicable, scientifically valid, that manufacturer, importer or downstream user shall use that information for the purposes of the evaluation pursuant to Chapter 2 of this Title.
3.For the evaluation of mixtures pursuant to Chapter 2 of this Title in relation to the ‘germ cell mutagenicity’, ‘carcinogenicity’ and ‘reproductive toxicity’ hazard classes referred to in sections 3.5.3.1, 3.6.3.1 and 3.7.3.1 of Annex I, the manufacturer, importer or downstream user shall only use the relevant available information referred to in paragraph 1 for the substances in the mixture.
Further, in cases where the available test data on the mixture itself demonstrate germ cell mutagenic, carcinogenic or toxic to reproduction effects which have not been identified from the information on the individual substances, those data shall also be taken into account.
4.For the evaluation of mixtures pursuant to Chapter 2 of this Title in relation to the ‘biodegradation and bioaccumulation’ properties within the ‘hazardous to the aquatic environment’ hazard class referred to in sections 4.1.2.8 and 4.1.2.9 of Annex I, the manufacturer, importer or downstream user shall only use the relevant available information referred to in paragraph 1 for the substances in the mixture.
5.Where no or inadequate test data on the mixture itself of the kind referred to in paragraph 1 are available, the manufacturer, importer or downstream user shall use other available information on individual substances and similar tested mixtures which may also be considered relevant for the purposes of determining whether the mixture is hazardous, provided that that manufacturer, importer or downstream user has ascertained that information to be adequate and reliable for the purpose of the evaluation pursuant to Article 9(4).
1.Where new tests are carried out for the purposes of this Regulation, tests on animals [F1to which the Animals (Scientific Procedures) Act 1986 applies] shall be undertaken only where no other alternatives, which provide adequate reliability and quality of data, are possible.
2.Tests on non-human primates shall be prohibited for the purposes of this Regulation.
3.Tests on humans shall not be performed for the purposes of this Regulation. Data obtained from other sources, such as clinical studies, can however be used for the purposes of this Regulation.
Textual Amendments
1.For the purposes of determining whether a substance or a mixture entails a health or environmental hazard as set out in Annex I to this Regulation, the manufacturer, importer or downstream user may, provided that he has exhausted all other means of generating information including by applying the rules provided for in section 1 of Annex XI to Regulation (EC) No 1907/2006, perform new tests.
2.For the purposes of determining whether a substance or a mixture entails any of the physical hazards referred to in Part 2 of Annex I, the manufacturer, importer or downstream user shall perform the tests required in that Part, unless there is adequate and reliable information already available.
3.The tests referred to in paragraph 1 shall be conducted in accordance with one of the following methods:
(a)the test methods referred to in Article 13(3) of Regulation (EC) No 1907/2006;
or
(b)sound scientific principles that are internationally recognised or methods validated according to international procedures.
4.Where the manufacturer, importer or downstream user carries out new ecotoxicological or toxicological tests and analyses, these shall be carried out in compliance with Article 13(4) of Regulation (EC) No 1907/2006.
5.Where new tests for physical hazards are carried out for the purposes of this Regulation, they shall be carried out, at the latest from 1 January 2014, in compliance with a relevant recognised quality system or by laboratories complying with a relevant recognised standard.
6.Tests that are carried out for the purposes of this Regulation shall be carried out on the substance or on the mixture in the form(s) or physical state(s) in which the substance or mixture is placed on the market and in which it can reasonably be expected to be used.
1.Manufacturers, importers and downstream users of a substance or a mixture shall evaluate the information identified in accordance with Chapter 1 of this Title by applying to it the criteria for classification for each hazard class or differentiation in Parts 2 to 5 of Annex I, so as to ascertain the hazards associated with the substance or mixture.
2.In evaluating available test data for a substance or a mixture which have been obtained from test methods other than those referred to in Article 8(3), manufacturers, importers and downstream users shall compare the test methods employed with those indicated in that Article in order to determine whether the use of those test methods affects the evaluation referred to in paragraph 1 of this Article.
3.Where the criteria cannot be applied directly to available identified information, manufacturers, importers and downstream users shall carry out an evaluation by applying a weight of evidence determination using expert judgement in accordance with section 1.1.1 of Annex I to this Regulation, weighing all available information having a bearing on the determination of the hazards of the substance or the mixture, and in accordance with section 1.2 of Annex XI to Regulation (EC) No 1907/2006.
4.Where only the information referred to in Article 6(5) is available, manufacturers, importers and downstream users shall apply the bridging principles referred to in section 1.1.3 and in each section of Parts 3 and 4 of Annex I for the purposes of the evaluation.
However, where that information permits the application neither of the bridging principles nor the principles for using expert judgement and weight of evidence determination as described in Part 1 of Annex I, manufacturers, importers and downstream users shall evaluate the information by applying the other method or methods described in each section of Parts 3 and 4 of Annex I.
5.When evaluating the available information for the purposes of classification, the manufacturers, importers and downstream users shall consider the forms or physical states in which the substance or mixture is placed on the market and in which it can reasonably be expected to be used.
1.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.
2.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.
3.Notwithstanding paragraph 1, specific concentration limits shall not be set for [F2mandatory] hazard classes or differentiations for substances included in [F2the GB mandatory classification and labelling list].
4.Notwithstanding paragraph 2, M-factors shall not be set for [F3mandatory] hazard classes or differentiations for substances included in [F3the 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 [F4the 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.
5.In setting the specific concentration limit or M-factor manufacturers, importers and downstream users shall take into account any specific concentration limits or M-factors for that substance which have been included in the [F5GB notification database].
6.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.
7.The Agency shall provide further guidance for the application of paragraphs 1 and 2.
Textual Amendments
F2Words 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)
F3Words 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)
F4Words 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)
F5Words in Art. 10(5) 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(c) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 6(a)); 2020 c. 1, Sch. 5 para. 1(1)
1.Where a substance contains another substance, itself classified as hazardous, whether in the form of an identified impurity, additive or individual constituent, this shall be taken into account for the purposes of classification, if the concentration of the identified impurity, additive or individual constituent is equal to, or greater than, the applicable cut-off value in accordance with paragraph 3.
2.Where a mixture contains a substance classified as hazardous, whether as a component or in the form of an identified impurity or additive, this information shall be taken into account for the purposes of classification, if the concentration of that substance is equal to or greater than its cut-off value in accordance with paragraph 3.
3.The cut-off value referred to in paragraphs 1 and 2 shall be determined as set out in section 1.1.2.2 of Annex I.
Where, as a result of the evaluation carried out pursuant to Article 9, the following properties or effects are identified, manufacturers, importers and downstream users shall take them into account for the purposes of classification:
adequate and reliable information demonstrates that in practice the physical hazards of a substance or a mixture differ from those shown by tests;
conclusive scientific experimental data show that the substance or mixture is not biologically available and those data have been ascertained to be adequate and reliable;
adequate and reliable scientific information demonstrates the potential occurrence of synergistic or antagonistic effects among the substances in a mixture for which the evaluation was decided on the basis of the information for the substances in the mixture.
If the evaluation undertaken pursuant to Article 9 and Article 12 shows that the hazards associated with the substance or mixture meet the criteria for classification in one or more hazard classes or differentiations in Parts 2 to 5 of Annex I, manufacturers, importers and downstream users shall classify the substance or mixture in relation to the relevant hazard class or classes or differentiations by assigning the following:
one or more hazard categories for each relevant hazard class or differentiation;
subject to Article 21, one or more hazard statements corresponding to each hazard category assigned in accordance with (a).
1.The classification of a mixture shall not be affected where the evaluation of the information indicates any of the following:
(a)that the substances in the mixture react slowly with atmospheric gases, in particular oxygen, carbon dioxide, water vapour, to form different substances at low concentration;
(b)that the substances in the mixture react very slowly with other substances in the mixture to form different substances at low concentration;
(c)that the substances in the mixture may self-polymerise to form oligomers or polymers, at low concentration.
2.A mixture need not be classified for explosive, oxidising, or flammable properties as referred to in Part 2 of Annex I provided that any of the following requirements are met:
(a)none of the substances in the mixture possesses any of those properties and, on the basis of the information available to the supplier, the mixture is unlikely to present hazards of this kind;
(b)in the event of a change in the composition of a mixture, scientific evidence indicates that an evaluation of the information on the mixture will not lead to a change in classification[F6.]
[F7((c)] F7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F6Substituted by Commission Regulation (EU) No 487/2013 of 8 May 2013 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (Text with EEA relevance).
F7Deleted by Commission Regulation (EU) No 487/2013 of 8 May 2013 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (Text with EEA relevance).
1.Manufacturers, importers and downstream users shall take all reasonable steps available to them to make themselves aware of new scientific or technical information that may affect the classification of the substances or mixtures they place on the market. When a manufacturer, importer or downstream user becomes aware of such information which he considers to be adequate and reliable, that manufacturer, importer or downstream user shall without undue delay carry out a new evaluation in accordance with this Chapter.
2.Where the manufacturer, importer or downstream user introduces a change to a mixture that has been classified as hazardous, that manufacturer, importer or downstream user shall carry out a new evaluation in accordance with this Chapter where the change is either of the following:
(a)a change in the composition of the initial concentration of one or more of the hazardous constituents in concentrations at or above the limits in Table 1.2 of Part 1 of Annex I;
(b)a change in the composition involving the substitution or addition of one or more constituents in concentrations at or above the cut-off value referred to in Article 11(3).
3.A new evaluation in accordance with paragraphs 1 and 2 shall not be required if there is valid scientific justification that this will not result in a change of classification.
4.Manufacturers, importers and downstream users shall adapt the classification of the substance or the mixture in accordance with the results of the new evaluation except where there are [F8mandatory] hazard classes or differentiations for substances included in [F8the GB mandatory classification and labelling list].
5.For paragraphs 1 to 4 of this Article, when the substance or mixture concerned is within the scope of [F9Regulation (EC) No 1107/2009 or Regulation (EC) No 528/2012], the requirements of those [F9Regulations] shall also apply.
Textual Amendments
F8Words in Art. 15(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. 18(a) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 6(b)); 2020 c. 1, Sch. 5 para. 1(1)
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Textual Amendments