Chemical safety assessments required under REACH (the European legislation on the Restriction, Evaluation, Authorisation and Restriction of Chemicals), include exposure assessments for all supported uses of a chemical, which must be justified against a derived no-effect level (DNEL). The DNEL established will depend on the point of departure selected and the various assessment factors (AFs) applied. With the first tier of REACH registrations, it seems that the multiplication of AFs is resulting in relatively low DNELs that are difficult to balance with conservative exposure estimations. ECETOC has reviewed recently available scientific data to update its previous guidance on AFs, which now includes examples of case studies (taken from documents of the Scientific Committee on Occupational Exposure Limits) comparing the default AFs provided in the REACH Guidance on information requirements and chemical safety assessment with those recommended by ECETOC.

[ECETOC Technical Report 110. Guidance on assessment factors to derive a DNEL. October 2010. The document can be obtained via on the website of the European Centre for Ecotoxicology and Toxicology of Chemicals.] {186748}

The above item was taken from the January 2011 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here for more details).

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