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3.2.: Mixtures
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 Part 3 of Annex VI to Regulation (EC) No 1272/2008;
(iii) if an M-factor has been given in Part 3 of Annex VI to Regulation (EC) No 1272/2008, 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) the specific concentration limits provided to the classification and labelling inventory established under Regulation (EC) No 1272/2008;
(v) the concentration limits set out in Annex II to Regulation (EC) No 1272/2008;
(vi) if an M-factor has been provided to the classification and labelling inventory established under Regulation (EC) No 1272/2008, 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.
(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 %.
For a mixture not meeting the criteria for classification in accordance with Regulation (EC) No 1272/2008, substances present in an individual concentration equal to or greater than the following concentrations shall be indicated, together with their concentration or concentration range:
(a) 1 % by weight in non-gaseous mixtures and 0,2 % by volume in gaseous mixtures for:
(i) substances which present a health or environmental hazard within the meaning of Regulation (EC) No 1272/2008; or
(ii) substances for which Union workplace exposure limits have been assigned;
(b) 0,1 % by weight for substances which are persistent, bioaccumulative and toxic in accordance with the criteria set out in Annex XIII, very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII, or included in the list established in accordance with Article 59(1) for reasons other than the hazards referred to in point (a).
For the substances indicated in subsection 3.2, the classification of the substance according to Regulation (EC) No 1272/2008, including the hazard class(es) and category code(s) as provided in Table 1.1 of Annex VI to that Regulation as well as the hazard statements which are assigned in accordance with their physical, human health and environmental hazards, shall be provided. The hazard statements do not need to be written out in full in this section; their codes shall be sufficient. In cases where they are not written out in full, reference shall be made to Section 16, where the full text of each relevant hazard statement shall be listed. If the substance does not meet the classification criteria, the reason for indicating the substance in subsection 3.2 shall be described, such as ‘non-classified vPvB substance’ or ‘substance with a Union workplace exposure limit’.
For the substances indicated in subsection 3.2 the name and, if available, the registration number, as assigned under Article 20(3) of this Regulation, shall be given.
Without affecting the obligations of downstream users laid down in Article 39 of this Regulation, the part of the registration number referring to the individual registrant of a joint submission may be omitted by the supplier of the mixture provided that:
(a) this supplier assumes the responsibility to provide the full registration number upon request for enforcement purposes or, if the full registration number is not available to him, to forward the request to his supplier, in line with point (b); and
(b) this supplier provides the full registration number to the Member State authority responsible for enforcement (hereinafter referred to as the enforcement authority) within seven days upon request, received either directly from the enforcement authority or forwarded by his recipient, or, if the full registration number is not available to him, this supplier shall forward the request to his supplier within seven days upon request and at the same time inform the enforcement authority thereof.
The EC number, if available, shall be given in accordance with Regulation (EC) No 1272/2008. The CAS number, if available, and the IUPAC name, if available, may also be given.
For substances indicated in this subsection by means of an alternative chemical name in accordance with Article 24 of Regulation (EC) No 1272/2008, the registration number, EC number and other precise chemical identifiers are not necessary.