J Pharm Pharmacogn Res 2(Suppl. 1): S13, 2014
Special supplement with the abstract book of LATINFARMA 2013
CO 024: ALTERNATIVE METHODS IN THE SAFETY EVALUATION OF COSMETIC: EUROPEAN SITUATION
Vinardell MP.Dep. Fisiología, Facultad de Farmacia, Universitat de Barcelona, Av. Joan XXIII s/n 08028 Barcelona, Spain. E-mail: firstname.lastname@example.org
From July 11, 2013 onward, cosmetic products placed on the market of European Economic Area are obliged to comply with the new European cosmetics regulations, of which some provisions will be enforced before the above date. These new cosmetic requirements are released in the form of EU regulations in the 27 EU member states plus Norway, Iceland and Liechtenstein, and implemented as national law, unlike the EU directives which need converting into each domestic version. This Regulation will replace the old cosmetics directive of and the subsequent 67 amendments. The new regulation simplifies the cosmetic requirements of European Economic Area, making itself a single law, and eliminate ambiguities that may occur among the member states during the enforcement process.
The European Cosmetic Regulation indicates that all cosmetic products in the European Union should be safe for the human health in the normal use conditions. In Europe the safety of cosmetics is based on the safety evaluation of each individual ingredient. Currently, the safety of cosmetic products has to be assessed prior to release by a ‘suitably qualified’ person. The new regulations specify that the qualifications should be in toxicology and that the assessment should follow a particular protocol.
Cosmetics in general, do not induce severe problems to health, but this is not synonymous of innocuous. All the substances that should represent any serious health risk are listed in the annexes of the Regulation, including forbidden products, with restrictions, colorants, preservatives and UV filter. In these cases, the responsible of safe evaluation is the European Commission through the Directorate General for Health and Consumers (DG SANCO), the safety evaluation performed by the Scientific Committee on Cosmetic Safety (SCCS). This evaluation is based on the data of the dossiers submitted by industry. The SCCS publishes an opinion that appears in the open DG SANCO web.
The European Directive on Cosmetic 2003/15/EC established since March 2009 a ban to use animals in the safety evaluation of cosmetic ingredients.
In practice, the safety evaluations of the SCCS are based on old studies done with animals and prior to the ban and recently on in vitro studies.
In this talk the percentage of in vitro methods evaluated by the SCCS since 2009 will be presented. One of the difficulties relative to the use of in vitro methods is the lack of validated ones. The most used in vitro methods presented in the dossiers are the studies of dermal absorption, mutagenicity and genotoxicity and in a less extents studies of eye irritation and dermal irritation.