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 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.
In addition to the requirements under relevant regulation, this document ("Guidance on the safety assessment of nanomaterials in cosmetics") is intended to provide guidance for the safety evaluation of nanomaterials to be used as cosmetic ingredients, and as per the Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation (SCCS/1416/11 or more recent version). As nanomaterials may have certain properties, interactions with biological systems, and/or effects that are different from conventional or bulk ingredients, this guidance has highlighted them for consideration when testing and reporting data for nanomaterials. In this sense, it addresses what information must be provided by industry to the Commission in order to perform the risk assessment of nanomaterials intended for use in cosmetics.