Safety Assessment of Cosmetics in Europe

Abstract

This volume of Current Problems in Dermatology presents the reader with a portrait of the scientifi c background of the complex process of safety assessment of cosmetics as well as information on European cosmetic legislation. A practical approach to the search for toxicity data on cosmetic ingredients and a compilation of the legally required technical dossier of a fi nished cosmetic product as well as an in-depth analysis of the safety assessment of cosmetic ingredients performed at the EU level by the Scientifi c Committee on Consumer Products (SCCP) are available. The current status of 3R alternatives to animal testing and the extent to which they are implemented by the cosmetic industry and considered by the SCCP in the risk assessment process is discussed. As such, guidance is provided in relation to the manifold challenges cosmetic safety assessors are faced with in the current EU regulatory setting. In this valuable handbook, qualifi ed cosmetic safety assessors, suppliers of raw materials, dermatologists and pharmacists, toxicologists as well as EU offi cials and administrators dealing with cosmetics will fi nd relevant information on the European cosmetic legislation, the compilation of cosmetic technical dossiers, toxicological database searches, and the availability and use of alternative methods in the fi eld of cosmetics.

Current Status of Healthy Human Skin Models: Can Histone Deacetylase Inhibitors Potentially Improve the Present Replacement Models?

“…Only a few exceptions existed, ending March 2013 [73]. All these events have triggered increased attention on 3R alternative methods, in particular in regulatory toxicity testing [74,75,76,77,78]. For local toxicity, in vitro skin models are of major interest [79].…”

Advances in the analysis of non-allowed pharmacologically active substances in cosmetic products

“…The compilation of the above points is commonly referred to as a cosmetic's Technical Information File (TIF) or Product Information File (PIF) [7].…”

“…the Cosmetics Directive by EU and USA FDCA cosmetic acts to ensure the safety of cosmetics and by a strong commitment by manufacturers to utilize the best science and latest available research data to assure the safety of a cosmetic product before it is placed on the market [6,7].…”

A critique of the EC’s expert (draft) reports on the status of alternatives for cosmetics testing to meet the 2013 deadline

“…the experts in this chapter failed to consider the ttC approach and did not quantitatively assess the validity of in vivo or in vitro or in silico methods. Much of the chapter was devoted to describing qualitatively the various in vivo methods available, ignoring the fact that for cosmetics ingredients only the developmental toxicity guideline (OeCD tG 414) tends to be used (Rogiers and Pauwels, 2008).…”

“…the use of these tests should be viewed in the context of the poor predictivity of the animal test and the fact that these tests are not always considered mandatory -due, in part, to the low exposure of humans to individual cosmetic ingredients. those companies that voluntarily undertake reproductive toxicity tests usually only do the developmental toxicity test (Rogiers and Pauwels, 2008), which the eSt may effectively replace. In addition, the threshold of toxicological concern (ttC) approach has demonstrated feasibility for reproduction end points for chemicals generally (Bernauer et al, 2008) and may also be used in certain cases when exposure is low.…”