The cosmetic world is often perceived as the land of luxury, in which science fails to play
any part. This is, however, not justified since several aspects of the development of cosmetic
products require significant scientific input.Multiple research groups are involved
in the formulation of innovative cosmetic products in the quest for new galenic forms on
the macro- or nano-scale and/or in the objective assessment of the efficacy of cosmetic
products. In addition and most importantly, cosmetic products are not allowed to be
placed on themarket unless their safety for the consumer has been scientifically proven.
Whereas the safety standards for cosmetic products vary between different parts of the
globe, it is generally agreed upon that Europe has put in place a relatively stringent regulatory
framework to ensure cosmetic safety, in which the development of validated alternative
methods plays a key role. It is a real challenge for industry, academia and
regulatory bodies to maintain, under these conditions, the standards for cosmetic safety
high. This book, therefore, solely focuses on the challenging subject of safety assessment
of cosmetics in the current European regulatory framework and does not cover the interesting
topics of cosmetic product development and claimsubstantiation.
Cosmetic safety evaluation appears to be a complex process, which in first instance
requires knowledge of the extensive web of Directives, Regulations and Recommendations
intended to ensure the free movement and safe use of these products. Of
most relevance is the Cosmetic Products Directive (76/768/EEC), laying down the
principal rules for marketing and labelling cosmetic products in the EU. One of its
major provisions is that every cosmetic product on the EU market is considered to be
safe for use. In order to substantiate this, a specific set of technical data must be
assembled and made readily accessible to the competent authorities of the EU
Member States. This data set is more commonly referred to as a cosmetic product’s
technical information file or TIF.