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影响化妆品成分安全数据可用性的欧盟法规。

EU legislations affecting safety data availability of cosmetic ingredients.

作者信息

Pauwels Marleen, Rogiers Vera

机构信息

Department of Toxicology, Dermato-Cosmetology and Pharmacognosy, Vrije Universiteit Brussel, Laarbeeklaan 103, B-1090 Brussels, Belgium.

出版信息

Regul Toxicol Pharmacol. 2007 Dec;49(3):308-15. doi: 10.1016/j.yrtph.2007.08.009. Epub 2007 Aug 29.

Abstract

With the introduction of the 6th and 7th Amendments (OJ L151, 32-37, 23 June 1993; OJ L066, 26-35, 11 March 2003) to the Cosmetic Products Directive (OJ L262, 169-200, 27 September 1976), imposing a testing and marketing ban on cosmetic products tested on animals, the retrieval of toxicological data on individual ingredients became of greater need. Since the majority of cosmetic ingredients are used for many other purposes than their cosmetic function, they fall under the scope of more than one EU Directive. An overview is given of EU legislation that could potentially affect the availability and interpretation of cosmetic safety data. It will become clear that, although cosmetics are regulated by a specific so-called "vertical" legislation, "horizontal" influences from other products' legislations play a role since they determine the type and amount of data that theoretically could be found on the specific substances they regulate. This knowledge is necessary while performing extended searches in databases and becomes indispensable when initiating negotiations with manufacturers or suppliers for obtaining the safety data required.

摘要

随着对《化妆品指令》(《官方公报》L262,169 - 200,1976年9月27日)引入第六和第七修正案(《官方公报》L151,32 - 37,1993年6月23日;《官方公报》L066,26 - 35,2003年3月11日),对在动物身上进行过测试的化妆品实施测试和销售禁令,获取关于单个成分的毒理学数据变得更加必要。由于大多数化妆品成分的用途除了其化妆品功能外还有许多其他用途,它们属于不止一项欧盟指令的范围。本文概述了可能会影响化妆品安全数据的可得性和解释的欧盟法规。将会清楚的是,尽管化妆品受特定的所谓“纵向”法规监管,但来自其他产品法规的“横向”影响也发挥作用,因为它们决定了理论上可以在其所监管的特定物质上找到的数据类型和数量。在数据库中进行广泛搜索时,这些知识是必要的,而在与制造商或供应商开始谈判以获取所需安全数据时,这些知识就变得不可或缺。

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