Correlation of In Vitro / In Vivo Human Data for Consumer Product Safety

消费品安全的体外/体内人体数据关联

• 批准号: 103602
• 金额: $ 48.71万
• 依托单位: XCELLR8 LIMITED
• 依托单位国家: 英国
• 项目类别: Collaborative R&D
• 财政年份: 2017
• 资助国家: 英国
• 起止时间: 2017 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=103602
• 关键词: Correlation; Vitro; Vivo; Human; Data

The EU ban on animal testing for cosmetics came into full effect on 11 March 2013 and was the culmination of several decades of campaigning with huge public support. This progress is now under threat by the EU REACH regulation, which still requires animal tests where there are no validated alternatives available. In addition, industry guidelines issued by other international organisations such as the Scientific Committee on Consumer Safety (SCCS) still advocate animal testing for the approval of new key ingredients such as preservatives and UV filters. This contradictory stance has resulted in a seemingly insurmountable barrier to gaining approval for new, innovative ingredients. These regulatory clashes present the UK / EU cosmetics industry with an enormous dilemma and places the future of the industry under significant threat, stifling innovation, as well as the supply of established ingredients. Non-animal replacement tests, which are both scientifically advanced and ethically sound, are urgently needed. The project will deliver several new and improved human-based in vitro and in vivo tests for cosmetic safety, circumventing the need for animal testing. The project partners will explore the feasibility of developing replacement tests for acute toxicity and repeat-dose toxicity that are scientifically relevant and sufficiently robust and reproducible for (ultimate) adoption as OECD Test Guidelines, in addition to improving a current non-regulatory test for mildness, for the purpose of claim support for innovative cosmetic ingredients.

2013年3月11日，欧盟禁止化妆品动物试验的禁令全面生效，这是数十年来获得公众支持的运动的高潮。这一进展现在受到欧盟REACH法规的威胁，该法规仍然要求在没有经过验证的替代品的情况下进行动物试验。此外，消费者安全科学委员会（SCCS）等其他国际组织发布的行业指南仍然提倡动物测试，以批准新的关键成分，如防腐剂和紫外线过滤剂。这种矛盾的立场导致了一个似乎不可逾越的障碍，以获得批准的新的，创新的成分。这些监管冲突给英国/欧盟化妆品行业带来了巨大的困境，并将该行业的未来置于重大威胁之下，扼杀了创新以及既定成分的供应。迫切需要科学上先进、道德上健全的非动物替代试验。该项目将提供几种新的和改进的基于人体的体外和体内化妆品安全性测试，避免了动物测试的需要。项目合作伙伴将探索开发急性毒性和重复剂量毒性替代测试的可行性，这些测试具有科学相关性，并且具有足够的鲁棒性和可重复性，以（最终）采用为OECD测试指南，此外还将改进当前的非监管温和性测试，以支持创新化妆品成分。