Editorial 38(5):MasterEditorial.qxd.qxd
Editorial 38(5):MasterEditorial.qxd.qxd
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社论 38(5):MasterEditorial.qxd.qxd
DOI：
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发表时间：
2010
期刊：
影响因子：
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通讯作者：
M. Valverde
中科院分区：
文献类型：
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作者：
Laura Aibar;M. T. Aguilar;A. Puertas;M. Valverde
就替代方案报告草案进行了公众咨询（非动物）化妆品测试方法：1报告草稿由利益攸关方提名的五个专家组编写，要求世卫组织就与建立五种人类健康替代测试方法有关的科学和技术问题提供广泛和客观的情况，（相关）影响属于2013年欧盟化妆品指令禁止销售的最后期限。还打算在可能的情况下，在报告草案中包含对实现完全取代动物试验以达到相应终点所需时间的科学估计。此次咨询的背景是欧盟化妆品指令第7修正案，即指令76/768/EEC，该指令要求从2013年3月11日起，禁止销售含有在动物身上进行重复剂量毒性测试的成分的化妆品（包括皮肤致敏性和致癌性）、生殖毒性和毒代动力学。其中每一个都解决了一个特定的人类健康（相关）影响。2011年，欧盟委员会必须向欧洲议会和理事会通报非动物方法预计在2013年达到的状况。当然，这一活动对于欧洲公众和动物福利运动来说是一个非常好的消息，他们期待着有一天不再需要牺牲动物进行化妆品测试。然而，仔细研究报告的五个章节草稿，就会发现，正如FRAME的Michael Balls和Richard Clothier在这一期的ATLA 3中所述，已经错过了为前进道路提出新想法的重要机会。或即将投入使用，并就如何在化妆品成分的监管测试中实施这些方法提供现实的观点。相比之下，五份报告草案是当前体内动物方法的清单，通常是经合组织试验指南（TG），以及目前可用的体外方法，其中提到了一些有望达到预验证的方法，如ECVAM所定义的。然而，关于如何将新的非动物方法整合到化妆品成分的特定测试策略中，目前还没有具体的建议。事实上，缺少了一个总论章节，该章节本可以总结五个章节草案中描述的非动物方法的现状，这些章节是关于个体人类健康影响的测试，以及如何将个体测试纳入涵盖所有五种健康影响的测试策略。从科学和动物福利的角度来看，这是不可接受的，因为消费者安全科学委员会发表的意见中已经提供了指导。（SCCS，前身为消费品科学委员会[SCCP]），4这表明，当预期大量口服摄入时，或当皮肤渗透数据表明大量全身吸收时，“可能需要提供关于毒物、致癌性和生殖毒性的资料”。由于迄今为止SCCS尚未提供更详细的信息，因此可以预期，五个专家组将提出关于最低体内测试要求的建议，以及如何开发和使用非动物方法来取代它们，或如何在五个人类健康相关终点的综合测试策略中将体内方法和非动物方法联合收割机结合起来。由于我在生殖毒理学领域工作了40年，在学术界和监管机构工作，在体内和体外方法的使用方面都有经验，我想重点谈谈关于生殖毒性的第5章草案。此外，我的关于怀孕和哺乳期药物治疗的书（德语）已经出版了第7版。它是德国、奥地利和瑞士产科医生和儿科医生关于这一主题的标准文本，最近已被翻译成英文和俄文。在1986年ATLA关于REACH测试要求的社论中，6我总结了生殖毒性领域的测试法规。生殖系统的复杂性和巨大的ATLA 38，339-343，2010年
ated a public consultation on the Draft Report on Alternative (Non-animal) Methods for Cosmetics Testing: Current Status and Future Prospects — 2010.1 The draft report was prepared by five groups of experts, nominated by stakeholders, who were asked to provide a broad and objective picture of the scientific and technical issues related to establishing alternative test methods for the five human health(-related) effects falling under the 2013 deadline for the marketing ban of the EU Cosmetics Directive. It was also intended that the draft report would contain, where possible, a science-based estimate of the time necessary to achieve full replacement of animal testing for the respective endpoints. The background to this consultation is the 7th Amendment to the EU Cosmetics Directive, Directive 76/768/EEC, which calls for a marketing ban, from 11 March 2013, on cosmetic products which contain ingredients tested in animals for repeated dose toxicity (including skin sensitisation and carcinogenicity), reproductive toxicity and toxicokinetics.2 The draft report consists of five individual chapters, each of which addresses one of the specific human health(-related) effects. In 2011, the Commission will have to inform the European Parliament and the Council about the status that non-animal methods will be expected to have reached by 2013. This activity is, of course, very good news for the general public in Europe and for the animal welfare movement, who are looking forward to the day on which animals will no longer have to be sacrificed for cosmetics testing. However, a close look at the five draft chapters of the report shows that an important opportunity to come up with new ideas for the way forward has been missed, as is outlined in the Comment by Michael Balls and Richard Clothier, from FRAME, in this issue of ATLA.3 This is most unfortunate, since the authors of the individual chapters had a chance to provide an inventory of alternative methods that are, or would soon be, ready for use, and to offer a realistic view on how to implement these methods in the regulatory testing of cosmetic ingredients. In contrast, the five draft reports are inventories of current in vivo animal methods, usually OECD Test Guide lines (TGs), and in vitro methods that are available today, with some mention of methods that show some promise of reaching readiness for prevalidation, as defined by ECVAM. However, there are no specific proposals on how the new non-animal methods could be integrated into a specific testing strategy for cosmetics ingredients. In fact, a general chapter is missing, which could have summarised the current status of the nonanimal methods that are described in the five draft chapters on testing for individual human health effects, and how to integrate the individual tests in a testing strategy covering all the five health effects. This is not acceptable, from both the scientific perspective and the animal welfare perspective, since guidance has been provided in opinions published by the Scientific Committee on Con sumer Safety (SCCS, formerly the Scientific Committee on Consumer Products [SCCP]) in recent years,4 which indicates that, when considerable oral intake is expected, or when dermal penetration data suggest a significant systemic absorption, information on toxicokinetics, carcinogenicity and reproductive toxicity “may become necessary”. Since no more-detailed information has been provided by the SCCS to date, one would expect that the five expert groups would have come up with proposals on the minimum testing requirements in vivo, and how to develop and use non-animal methods to replace them, or how to combine in vivo methods and non-animal methods in integrated testing strategies for the five human health-related endpoints. Since I have worked for the past 40 years in reproductive toxicology, in academia and as a regulator, with experience in the use of both in vivo and in vitro methods, I want to focus my remarks on draft Chapter 5, on reproductive toxicity. In addition, my book on drug treatment in pregnancy and lactation5 (in German) is in its 7th edition. It is the standard text on this topic for obstetricians and paediatricians in Germany, Austria and Switzerland, and it has recently been translated into English and Russian. In an editorial in ATLA in 1986 on REACH testing requirements,6 I summarised the testing regulations in the area of reproductive toxicity. The complexity of the reproductive system and the vast ATLA 38, 339–343, 2010 339