Pauwels Marleen, Rogiers Vera
Dermato-Cosmetology and Pharmacognosy, Department of Toxicology, Vrije Universiteit Brussel, Laarbeeklaan 103, B-1090 Brussels, Belgium.
Toxicol Lett. 2004 Jun 15;151(1):7-17. doi: 10.1016/j.toxlet.2004.01.026.
Council Directive 76/768/EEC, its seven amendments and 30 adaptations to technical progress form the basis of the cosmetic EU legislation today. There are actually four key principles for safety in the cosmetic legislation. (i) The full responsibility for the safety of cosmetics for human health is placed on the manufacturer, first importer in the EU or marketer. (ii) The safety evaluation of finished products is based on safety of individual ingredients, more specifically on their chemical structure, toxicological profile and their level of exposure. (iii) A compilation of information on each cosmetic product (dossier) must be kept readily available for inspection by the competent authorities of the Member State concerned. This information source, usually called a technical information file (TIF) or product information file/requirements (PIF(R)), contains, as the most important part, the safety assessment of the product undersigned by a competent safety assessor. (iv) The use of validated replacement alternative methods instead of animal testing forms the 4th key principle for safety of cosmetic products on the EU market. The 7th amendment imposes strict deadlines for the abolition of animal in vivo studies on cosmetic ingredients. These legal requirements induce a number of important challenges for the cosmetic industry and more specifically for the toxicologist involved as safety assessor.
欧盟理事会指令76/768/EEC及其七项修正案和30项技术进步适应性条款构成了当今欧盟化妆品法规的基础。实际上，化妆品法规中有四项关键安全原则。（i）化妆品对人体健康安全的全部责任由制造商、欧盟境内的第一进口商或经销商承担。（ii）成品的安全性评估基于单个成分的安全性，更具体地说是基于其化学结构、毒理学特征及其暴露水平。（iii）必须随时保留有关每个化妆品的信息汇编（档案），以供相关成员国的主管当局检查。这个信息源通常称为技术信息文件（TIF）或产品信息文件/要求（PIF(R)），其中最重要的部分包含由合格的安全评估员签署的产品安全评估。（iv）使用经过验证的替代方法而非动物试验，构成了欧盟市场上化妆品安全的第四项关键原则。第七项修正案对废除化妆品成分的动物体内研究规定了严格的期限。这些法律要求给化妆品行业，尤其是给作为安全评估员的毒理学家带来了一些重大挑战。
