Can the European Union’s Specific Concentration Limits for Skin Sensitization be used in the United States and Canada

9 April, 2019

The European Union (EU) has adopted a Specific Concentration Limit (SCL) for numerous chemicals that are considered potent skin sensitizers. Under the EU’s Classification, Labeling and Packaging (CLP) of substances and mixtures guidance, extreme sensitizers can have an SCL that is lower than the generic concentration limit (GCL) for sub-category 1A. Values for the concentration may be set at 0.001% or an individual value based on reliable data. Therefore, a mixture may be classified as sensitizing if it contains a sensitizing substance at a concentration of at least one tenth of the generic/specific classification limit. This policy of adopting SCLs for potent sensitizers is not common in the United States or Canada. This poster presents relevant sections of the US and Canadian regulations and/or guidance documents that show when concentrations other than the GCL may be adopted for classification in the US and Canada. This poster also illustrates the value of a weight-of-evidence approach in the determination of a chemical’s classification. Companies should develop their own best practices and recognize the importance of consistently executed these internal best practices with strong documentation.

Kathrine Sullivan

SCHC Spring Meeting 2019 Las Vegas


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