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October 7, 2011

EC Requests Guidance on Safety Assessment of Nanomaterials in Cosmetics

Lynn L. Bergeson

The European Commission (EC) has asked the Scientific Committee on Consumer Safety (SCCS) to prepare a guidance document on the safety assessment of nanomaterials in cosmetics. In its request for guidance, the EC notes that a number of documents provide general guidance on the health risk assessment of manufactured nanomaterials, but experience with the assessment of specific substances is limited. The guidance, which is due February 2012, should address the essential elements that would be required in a manufactured nanomaterial safety dossier (i.e., physicochemical characterization, toxicological evaluation, exposure assessment). According to the EC, the guidance will facilitate the submission of safety dossiers at present, as well as assist in the implementation of the provisions of Article 16 of the Cosmetics Regulation (EC) No. 1223/2009/, “which will impose strict conditions and timelines for the notification and the assessment of cosmetic products containing nanomaterials on the responsible persons and the SCCS respectively, starting on January 2013.”

The EC specifically requests guidance on:

  1. The essential elements that must form part of safety dossiers for the assessment of nanomaterials in cosmetic products, based on the data requirements for the pre-market notification listed in Article 16 of Regulation (EC) No. 1223/2009, i.e. taking into account points 3a to 3f of Article 16 (identification of the nanomaterial, specification, quantity, toxicological profile, safety data, and exposure).
  2. The possibility to develop criteria and conditions that would allow the safety assessment of nanomaterials on a category-based approach rather than on a case-by-case basis.
  3. The suitability of alternative methods already validated for the assessment of conventional chemical substances for the assessment of nanomaterials in light of the current (as of 2009) ban on animal testing in the European Union.
  4. The set of attributes unique to manufactured nanomaterials that will need to be addressed by newly developed and/or newly validated alternative methods for the testing of toxicological end points for which there will be a ban on the testing on animals after March 2013.