Abstract：
EU cosmetic ingredients are governed by two regulations that conflict. Regulation EC 1223/2009, the Cosmetic Regulation, bans in vivo (animal) testing for cosmetic product safety assessments, including both final products and ingredients. At the same time, the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation can impose in vivo testing of those same ingredients under its chemical testing requirements. Here, we examined REACH dossiers for chemicals for which the only reported use is cosmetics to determine the extent of new in vivo testing caused by REACH. We found the REACH database has 3,206 chemical dossiers with cosmetics as a reported use. Of these, 419 report cosmetics as the only use, and 63 of these have in vivo tests completed after the Cosmetic Regulation ban on in vivo testing. Registrants largely used alternative, non-animal methods to evaluate ingredients for REACH, but some still conducted new in vivo tests to comply with REACH requirements for toxicity data and worker safety assessments. In some cases, ECHA, the agency that evaluates REACH dossiers, rejected registrants’ alternative methods as insufficient and required new in vivo tests. As ECHA continues to evaluate dossiers, more requests for in vivo tests are likely. REACH tests on cosmetic ingredients appear only as “industrial chemicals legislation” tests in EU reports. Given the importance to consumers and the cosmetic industry of having cosmetics free of animal testing, the public should be made aware of REACH testing until the conflict between the regulations is resolved.
摘要：
欧盟化妆品成分受两项相互冲突的法规管辖。法规EC1223/2009，化妆品法规，化妆品安全评估的体内（动物）测试禁令，包括最终产品和成分。同时,注册,评价,化学品授权和限制（REACH）法规可以根据其化学测试要求对这些相同成分进行体内测试。这里,我们检查了REACH档案中唯一报告使用的化学品是化妆品，以确定REACH引起的新体内测试的程度。我们发现REACH数据库有3,206个化学档案，其中有化妆品作为报告的用途。其中,419报告化妆品是唯一的用途，其中63个在化妆品法规禁止体内测试后完成了体内测试。注册人主要使用替代方案，评估REACH成分的非动物方法，但一些人仍在进行新的体内测试，以符合REACH对毒性数据和工人安全评估的要求。在某些情况下,ECHA,评估REACH档案的机构，拒绝注册人的替代方法不足，需要新的体内测试。随着ECHA继续评估档案，可能会有更多的体内测试要求。在欧盟报告中，化妆品成分的REACH测试仅作为“工业化学品立法”测试出现。鉴于化妆品不经过动物试验对消费者和化妆品行业的重要性，公众应该意识到REACH测试，直到法规之间的冲突得到解决。
