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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.

Components of major concern

When mixture components are classified for at least one of the hazard categories listed below, their concentrations in a mixture should be expressed as exact percentages, in descending order by mass or volume:

  • acute toxicity, Category 1, 2 or 3;
  • specific target organ toxicity – single exposure, Category 1 or 2;
  • specific target organ toxicity – repeated exposure, Category 1 or 2;
  • skin corrosion, Category 1, 1A, 1B or 1C;
  • serious eye damage, Category 1.

As an alternative to providing a concentration as an exact percentage, a concentration range may be submitted in accordance with Table 1 in Part B of Annex VIII (Table 1 below).

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.

Table 1: Concentration ranges applicable to hazardous components of major concern for emergency health response (substances or MiMs)

Concentration range of component contained in the mixture (%) Maximum width of 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

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
26 % 5 % 25-30 %
26 % 1 % 25.5-26.5 %
26 % 5 % 23.5-28.5 % X
26 % 3 % 23.5-26.5 %

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