3.4. Concentration and concentration ranges of the mixture components
Submitters shall provide the information laid down in Sections 3.4.1 and 3.4.2 with regard to the concentration of the mixture components, identified in accordance with Section 3.3.
3.4.1. Hazardous components of major concern for emergency health response and preventative measures
When mixture components are classified in accordance with this Regulation for at least one of the hazard categories listed below, their concentration in the mixture shall be expressed as exact percentages, in descending order by mass or volume.
As an alternative to providing concentrations as exact percentages, a range of percentages may be submitted in accordance with Table 1.
Table 1
Concentration ranges applicable to hazardous components of major concern for emergency health response
|
Concentration range of the hazardous component contained in the mixture (%) |
Maximum width of the concentration range to be used in the submission |
|
≥ 25 – < 100 |
5 % units |
|
≥ 10 – < 25 |
3 % units |
|
≥ 1 – < 10 |
1 % units |
|
≥ 0,1 – < 1 |
0,3 % units |
|
> 0 – < 0,1 |
0,1 % units |
3.4.2. Other hazardous components and components not classified as hazardous
The concentration of the hazardous components in the mixture that are not classified for any of the hazard categories listed in Section 3.4.1 and of the identified components not classified as hazardous shall be expressed, in accordance with Table 2, as ranges of percentages in descending order by mass or volume. As an alternative, exact percentages may be provided.
Table 2
Concentration ranges applicable to other hazardous components and components not classified as hazardous
|
Concentration range of the component contained in the mixture (%) |
Maximum width of the concentration range to be used in the submission |
|
≥ 25 – < 100 |
20 % units |
|
≥ 10 – < 25 |
10 % units |
|
≥ 1 – < 10 |
3 % units |
|
> 0 – < 1 |
1 % units |
By way of derogation from the first subparagraph, for perfume components in a group submission that are not classified or only classified for skin sensitisation Category 1, 1A or 1B or aspiration toxicity, submitters shall not be required to provide information on their concentration.