It was adopted by the SCCS during its plenary session last December 12, 2013. With this Memorandum, experts are sending a key message to the industry: send us better safety dossiers with more exhaustive and relevant data on nanomaterials. This will make everyone gain time and ensure correct and transparent evaluation. Here is the whole text.
Memorandum on “Relevance, Adequacy and Quality of Data in Safety Dossiers on Nanomaterials”
1. Preamble
Nanotechnologies open new perspectives for useful innovation in cosmetics. However, manufactured nanomaterials may also have certain properties, interactions with biological systems, and/or effects that are different from conventional ingredients in insoluble bulk form with larger characteristic particle size. In the EU, the use of nanomaterials in cosmetic products is specifically covered under the Cosmetics Regulation (Regulation (EC) No 1223/2009). The Regulation provides a definition of nanomaterial, as well as a mechanism for notification, labelling, and safety evaluation of cosmetic products containing nanomaterials.
The risk assessment of specific nano substances is currently limited, and the ongoing risk assessments being carried out by the European Commission’s Scientific Committee on Consumer Safety (SCCS) on manufactured nanomaterials represent the first examples in the EU and worldwide with regulatory implications. This ongoing work has made possible the identification of a number of issues and questions regarding the types of information and data unique to nanomaterials that must form part of submissions of safety dossiers. These aspects have been detailed in the SCCS Guidance on the Safety Assessment of Nanomaterials in Cosmetics (SCCS/1484/12) to enable a consistency and, to the extent …
