Declaring concentrations under Annex VIII to CLP Regulation

Nested Applications

Declaring concentrations under Annex VIII to CLP Regulation

Declaring concentrations

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.

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Changes in composition

Changes in composition and the effect on the UFI

When declaring the exact concentration of a mixture component, changes in the exact value are allowed within certain limits without there being a need to submit an update and create a new UFI.

Allowed variations are listed in Table 4 following the second amendment of Annex VIII (Table 4 below). If the new concentration exceeds the allowed variation, an update is required and a new UFI has to be created. If the original submission for the mixture was done according to a concentration range, the new composition must comply with the original concentration range. An update and a new UFI is otherwise required. This table therefore applies only to submissions made according to the exact concentration.

Table 4: Variations in component concentration requiring a submission update

Exact concentration of component contained in the mixture (%)	Variation (±) in initial component concentration requiring a submission update
> 25 - ≤ 100	5 %
> 10 - ≤ 25	10 %
> 2.5 - ≤ 10	20 %
≤ 2.5	30 %

Poison Centres