Abstract:
REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) is a European Union regulation that aims to protect human health and the environment from the risks posed by chemicals. Article 25 clearly states that: \"[i]n order to avoid animal testing, testing on vertebrate animals for the purposes of this Regulation shall be undertaken only as a last resort.\" In practice, however, the standard information requirements under REACH are still primarily filled using animal studies. This paper presents examples illustrating that animal testing is not always undertaken only as a last resort. Six over-arching issues have been identified which contribute to this: (1) non-acceptance of existing animal or non-animal data, (2) non-acceptance of read-across, (3) inflexible administrative processes, (4) redundancy of testing, (5) testing despite animal welfare concerns and (6) testing for cosmetic-only ingredients. We, members of the Animal-Free Safety Assessment (AFSA) Collaboration, who work together to accelerate the global adoption of non-animal approaches for chemical safety assessment, herein propose several recommendations intended to aid the European Commission, the European Chemicals Agency and registrants to protect human health and the environment while avoiding unnecessary animal tests - truly upholding the last resort requirement in REACH.
摘要:
REACH(注册,评价,化学品的授权和限制)是欧盟的一项法规,旨在保护人类健康和环境免受化学品带来的风险。第25条明确规定:“为了避免动物试验,就本规例而言,对脊椎动物的测试只能作为最后手段进行。“在实践中,然而,REACH下的标准信息要求仍然主要使用动物研究来满足。本文提供了一些例子,说明动物试验并不总是作为最后的手段进行。已经确定了六个主要问题,这些问题促成了这一点:(1)不接受现有的动物或非动物数据,(2)不接受读取,(3)行政程序不灵活,(4)冗余测试,(5)尽管有动物福利问题,但仍进行测试;(6)仅对化妆品成分进行测试。我们,无动物安全评估(AFSA)合作组织成员,他们共同努力,加速全球采用非动物方法进行化学品安全评估,本文提出了几项旨在帮助欧盟委员会的建议,欧洲化学品管理局和注册人保护人类健康和环境,同时避免不必要的动物试验-真正坚持REACH的最后手段要求。