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Posted: Oct 11, 2011
European Commission requests guidance on the safety assessment of nanomaterials in cosmetics
(Nanowerk News) The European Commission (EC) has asked the Scientific Committee on Consumer Safety (SCCS) to prepare a guidance document (pdf) on the safety assessment of nanomaterials in cosmetics.
On the basis of the evolving knowledge based on the health risk assessment of specific
manufactured nanomaterials, the Commission considers appropriate to request the SCCS to
develop guidance on the essential elements that would be required in a manufactured
nanomaterial safety dossier i.e. physicochemical characterisation; toxicological evaluation,
exposure assessment etc.
Terms of reference
On the basis of the present experience, the SCCS is requested to develop 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-bycase
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 EU.
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.
In elaborating this guidance, and taking into account the growing experience on the matter the
SCCS is asked to consider all available documentation on the subject such as the SCCP
scientific opinion on safety of nanomaterials in cosmetic products; the documents issued by
the OECD Working Party on Manufactured Nanomaterials; the EFSA scientific opinion on
guidance on risk assessment of the application of nanoscience and nanotechnologies in the
food and feed chain.
The document should be finalised before the end of the current SCCS term (February 2012).