3.2. Mixtures
The product identifier, the concentration or concentration ranges and the classifications shall be provided for at least all substances referred to in points 3.2.1 or 3.2.2. Suppliers of mixtures may choose to list in addition all substances in the mixture, including substances not meeting the criteria for classification. This information shall enable the recipient to identify readily the hazards of the substances in the mixture. The hazards of the mixture itself shall be given in section 2.
The concentrations of the substances in a mixture shall be described as either of the following:
exact percentages in descending order by mass or volume, if technically possible;
ranges of percentages in descending order by mass or volume, if technically possible.
When using a range of percentages, if the effects of the mixture as a whole are not available, the health and environmental hazards shall describe the effects of the highest concentration of each ingredient.
If the effects of the mixture as a whole are available, the classification determined from this information shall be included under section 2.
Where the use of an alternative chemical name is permitted in accordance with Article 24 of Regulation (EC) No 1272/2008, that name can be used.
3.2.1. For a mixture meeting the criteria for classification in accordance with Regulation (EC) No 1272/2008, the following substances (see also Table 1.1) shall be indicated, together with their concentration or concentration range in the mixture:
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:
the generic cut-off values set out in Table 1.1 of Annex I to Regulation (EC) No 1272/2008;
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) ≥ 1 %;
the specific concentration limits given in Part 3 of Annex VI to Regulation (EC) No 1272/2008;
if a 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;
the specific concentration limits provided to the classification and labelling inventory established under Regulation (EC) No 1272/2008;
one tenth of the specific concentration limit for a substance classified as skin sensitiser or respiratory sensitiser with a specific concentration limit;
the concentration limits set out in Annex II to Regulation (EC) No 1272/2008;
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;
substances for which there are Union workplace exposure limits which are not already included under point (a);
provided that the concentration of an individual substance is equal to or greater than 0,1 %, substances that meet any of the following criteria:
Table 1.1
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
|
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, categories 1A, 1B, 1C and category 2 |
≥ 1 |
|
Serious damage to eyes/eye irritation, category 1 and 2 |
≥ 1 |
|
Respiratory sensitiser category 1 or category 1B |
≥ 0,1 |
|
Respiratory sensitiser category 1A |
≥ 0,01 |
|
Skin sensitiser category 1 or category 1B |
≥ 0,1 |
|
Skin sensitiser category 1A |
≥ 0,01 |
|
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, 2 and 3 |
≥ 1 |
|
Specific target organ toxicity (STOT) – repeated exposure, category 1 and 2 |
≥ 1 |
|
Aspiration toxicity |
≥ 1 |
|
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 |
3.2.2. 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:
1 % by weight in non-gaseous mixtures and 0,2 % by volume in gaseous mixtures for:
substances which present a health or environmental hazard within the meaning of Regulation (EC) No 1272/2008; or
substances for which Union workplace exposure limits have been assigned;
0,1 % by weight for substances that meet any of the following criteria:
0,1 % of a substance classified as skin sensitiser category 1 or 1B, respiratory sensitiser category 1 or 1B, or carcinogenic category 2;
0,01 % of a substance classified as skin sensitiser category 1A or respiratory sensitiser category 1A;
one tenth of the specific concentration limit for a substance classified as skin sensitiser or respiratory sensitiser with a specific concentration limit;
0,1 % of a substance classified as toxic to reproduction categories 1A, 1B or 2, or with effects on or via lactation.
3.2.3. For the substances indicated in subsection 3.2:
3.2.4. 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:
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
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.