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Toxicological assessment and chemical legislation

REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals – Regulation (EC) No 1907/2006) is the cornerstone of the European Chemical Legislation. REACH requires all manufacturers, importers, or downstream users to assess the hazards and potential risks presented by chemical substances (e.g. surfactants) based on scientific data.

Risk assessments, as stipulated by REACH, aim to define the threshold levels accepted as safe when consumers and workers are exposed to a chemical. For the derivation of such threshold levels, safety factors need to be applied to account for the uncertainty associated with existing non-specific data. Non-specific data in this context means that data may not be available for the required time period, species or route of administration.

Default safety factors proposed for regulatory purposes are deemed to be highly conservative. This specially affects substances with widespread use as surfactants. Hence, from an industry point of view, there is a need for robust safety factors based on the probabilistic analysis of scientific data.