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Specific concentration limits in SDS

Posted Date:2025/4/22

Article 10(1) Specific concentration limits and generic concentration limits are limits assigned to a substance indicating a threshold at or above which the presence of that substance in another substance or in a mixture as an identified impurity, additive or individual constituent leads to the classification of the substance or mixture as hazardous.

Specific concentration limits shall be set by the manufacturer, importer or downstream user where adequate and reliable scientific information shows that the hazard of a substance is evident when the substance is present at a level below the concentrations set for any hazard class in Part 2 of Annex I or below the generic concentration limits set for any hazard class in Parts 3, 4 and 5 of Annex I.

In exceptional circumstances specific concentration limits may be set by the manufacturer, importer or downstream user where he has adequate, reliable and conclusive scientific information that a hazard of a substance classified as hazardous is not evident at a level above the concentrations set for the relevant hazard class in Part 2 of Annex I or above the generic concentration limits set for the relevant hazard class in Parts 3, 4 and 5 of that Annex.

The specific concentration limit (SCL) concept allows a fine tuning of the contribution of certain hazardous substances to the classification of mixtures based on the potency of the substances, as well as a classification of other substances containing these substances as impurities, additives or individual constituents. The SCL concept is generally only applicable to health hazards. For physical hazards, classification must normally be established on the basis of test data for the respective mixture, where applicable.

The procedure of derivation of SCLs is different for every health hazard class and therefore guidance on how to set SCLs is provided in the respective chapters of the different health hazard

classes.

SCLs should take precedence over the generic concentration limits (GCLs) given in the relevant health hazard sections of Annex I to CLP. In case specific concentration limits have been set in Annex VI to CLP, these must be applied. Moreover, manufacturers, importers or downstream users may not set their own SCLs for hazards subject to harmonised classifications in Annex VI to CLP.

However, if a hazard class is not included in Annex VI and adequate and reliable data exist showing a hazard below the GCL, SCLs must be set by a manufacturer, importer or downstream user in accordance with CLP and be available in the C&L Inventory. SCLs should be communicated via the SDS.