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Declaring concentrations under Annex VIII to CLP Regulation

Declaring concentrations under Annex VIII to CLP Regulation

Annex VIII to the CLP Regulation has provisions on the information provided on the concentration of mixture components (substances or mixture in mixtures). Different provisions apply to hazardous components considered of major concern and to other hazardous components and components not classified as hazardous. This distinction is defined in section 3.4 of Part B of Annex VIII. The submitter is required to provide the concentration or concentration range of each component according to the hazard class.

Other hazardous components and components not classified as hazardous

The concentration of components classified for other hazard classes or components not classified as hazardous should be expressed as concentration ranges in descending order by mass or volume, in accordance with Table 2 in Part B of Annex VIII (Table 2 below).

Alternatively, the exact concentration may be provided. Where the exact concentration is higher than 1 %, the upper and lower limits of the concentration bands may be rounded to a maximum of one decimal. Where the exact concentration is lower than or equal to 1 %, a maximum of two decimals may be used.

All identified mixture components classified as hazardous on the basis of their health or physical effects need to be included in the submission, even if present in concentrations below 0.1 %, unless they are demonstrated to be irrelevant for emergency health response and preventative measures.

Table 2: Concentration ranges applicable to other hazardous components and components not classified as hazardous (substances or MiMs)

Concentration range of component contained in the mixture (%) Maximum width of concentration range to be used in the submission
≥ 25 - < 100 20 % units
≥ 10 - < 25 10 % units
≥ 1 - < 10 3 % units
> 0 - < 1 1 % units


When reporting a concentration range that overlaps two band widths, you must provide a range according to the lower maximum width allowed, see the examples below:

Exact concentration Concentration range width used Example range Allowed
11 % 10 % 10-20 %
11 % 2 % 10-12 %
11% 10 % 6-16 % X
11% 3 % 9.5-12.5 %

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