European Coalition to End Animal Experiments (ECEAE), London, UK.
ALTEX. 2011;28(2):131-48. doi: 10.14573/altex.2011.2.131.
The 7th Amendment to the EU's Cosmetic Directive (now recast as Regulation 1223/2009) bans the testing of cosmetic ingredients and products on animals, effective 2009. An extension until 2013 was granted, for marketing purposes only, for three endpoints: repeated dose, toxicokinetics, and reproductive toxicity. If the European Commission determines that alternatives for these endpoints are not likely to be available, it can propose a further extension. To this end, the Commission has instructed experts to produce reports on the status of alternatives for the 2013 deadline. We criticized the draft reports on a number of issues. First, the experts fell into the "high fidelity fallacy trap," i.e. asserting that full replication of the in vivo response, as opposed to high predictivity, is required before an animal test can be considered useful for regulatory purposes. Second, the experts' reports were incomplete, omitting various methods and failing to provide data on the validity, reliability, and applicability of all the methods discussed, regardless of whether the methods were in vivo, in vitro, or in silico. In this paper we provide a summary of our criticisms and provide some of the missing data in an alternative proposal for replacement of animal tests by 2013. It is our belief that use of the Threshold of Toxicological Concern (TTC) will be a useful method to mitigate much animal testing. Alternative approaches for carcinogenicity and skin sensitization could be considered sufficient in the very near future, even though these tests are not listed under the 2013 extension. For repeated dose, toxicokinetics, and reproductive toxicity a combination of in vitro methods may be able to provide appropriate protection for consumers, especially when viewed in the context of the poor predictivity of the animal models they replace. We hope the revised report will incorporate these comments, since a more thorough and positive review is required if the elimination of animal testing for cosmetics in Europe and beyond is to be achieved.
欧盟化妆品指令（现经重编为法规 1223/2009）的第 7 条修正案禁止在动物身上测试化妆品成分和产品，该禁令自 2009 年生效。出于营销目的，仅针对三个终点（重复剂量、毒代动力学和生殖毒性），批准了一项延长至 2013 年的延期。如果欧盟委员会确定这些终点的替代方法不太可能实现，则可以提出进一步的延期。为此，委员会指示专家就 2013 年最后期限的替代方法编写报告。我们在许多问题上对报告草稿提出了批评。首先，专家们陷入了“高保真谬误陷阱”，即断言在动物试验被认为对监管目的有用之前，需要完全复制体内反应，而不是高预测性。其次，专家报告不完整，遗漏了各种方法，并且没有提供关于所讨论的所有方法的有效性、可靠性和适用性的数据，无论这些方法是体内、体外还是计算机模拟。在本文中，我们总结了我们的批评意见，并在替代动物试验的提案中提供了一些缺失的数据，我们相信，使用毒理学关注阈值（TTC）将是减少大量动物试验的一种有用方法。在不久的将来，即使这些试验未列入 2013 年延期，致癌性和皮肤致敏性的替代方法也可以被认为是足够的。对于重复剂量、毒代动力学和生殖毒性，体外方法的组合可能能够为消费者提供适当的保护，特别是当从它们所替代的动物模型的低预测性角度来看时。我们希望修订后的报告将纳入这些意见，因为如果要在欧洲和其他地区消除化妆品的动物试验，就需要进行更全面和积极的审查。
