JRC Guidelines for 1 - Selecting and/or validating analytical methods for cosmetics2 - Recommending standardization steps of analytical methods

摘要

The analysis of cosmetics constitutes a challenge mainly due to the large variety of ingredients and formulations, and to the complexity of cosmetic products, in particular due to huge matrix variability. In 2009, the European Commission issued a Regulation (Regulation (EC) N° 1223/2009 of the European Parliament and of the Council) establishing the requisites for cosmetic products and the responsibilities of the stakeholders. While the manufacturers' are responsible to ensure the safety of the products put on the market and for the selection of the most appropriate method to perform the production, the quality control, the storage and the shipment of their cosmetic products according to the ISO 22716 Standard, the Competent Authorities testing laboratories should ensure the analytical control of the products in the frame of the market surveillance. The Regulation (EC) N° 1223/2009 also establishes that "the sampling and analysis of cosmetic products shall be performed in a reliable and reproducible manner. In the absence of any applicable Community legislation, reliability and reproducibility shall be presumed if the method used is in accordance with the relevant harmonised standards, the references of which have been published in the Official Journal of the European Union". In this frame JRC-IRMM was requested by the CEN/TC 392 on cosmetics to provide advice and guidelines on an appropriate pattern for method validation to allow the analysis of cosmetic products in the frame of Art. 12 of Regulation (EC) No 1223/2009 of the European Parliament and of the Council. This document therefore describes an original and pragmatic approach not only for method validation in this frame but also for further standardisation if deemed necessary. Finally the document was discussed and endorsed by the three main stakeholders active in the field of cosmetics analysis, namely the PEMSAC AM (Platform of European Market Surveillance Authorities for Cosmetics Analytical Methods group), set by the European Commission, the Official Cosmetics Control Laboratories (OCCL) Network, Council of Europe - EDQM and the CEN/TC 392 'Cosmetics'. All three groups are composed of Member States Competent Authorities for control; the manufacturers' representatives are observer members of the CEN/TC 392.