On the 6 July, 2012, the SCCS released its Guidance on the safety assessment of nanomaterials in cosmetics. A sixty-two page document, which Clara Arranz Aceves, from the European Directorate General for Health and Consumers (DG Sanco), explained during the 10th Regulatory Convention of the Cosmetic Valley, in November 2012. The guidelines, and its instructions for use.
The Cosmetics Regulation requires that any cosmetic product containing nanomaterials shall be notified to the European Commission, six months prior to its placing on the market. Further to the notification, the cosmetic industry have also to provide the Commission with specific data about the risk assessment, which will be given the SCCS, if there is a doubt about the safety.
Within this frame, the SCCS was required to write a Guidance on the safety assessment of nanomaterials in cosmetics. This document is necessary, due to their specificity to ease the submission to the SCCS of the safety dossiers by the industry. Then, the SCCS has a six-month period for evaluation.
However, this sixty-two page document, endorsed by the Committee of experts during its 15th Plenary Meeting, on 26 and 27 June 2012, at once was perceived by the industry as very complex and difficult to implement, based on current scientific knowledge on nano-materials and on the available tests to assess their safety. Clara Arranz Aceves came to the 10th Regulatory Convention of the Cosmetic Valley, to provide the audience with her view on the main points.
The regulatory frame
Article 16 of the Regulation 1223/2009
This article lists the information …