Regul Toxicol Pharmacol. 2021 Dec;127:105052. doi: 10.1016/j.yrtph.2021.105052. Epub 2021 Oct 13.
The "SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation, 11 th Revision" (SCCS/1628/21) contains relevant and updated information on the different aspects of testing and safety evaluation of cosmetic substances in Europe. The emphasis is on cosmetic ingredients for which a concern has been expressed for human health. Indirectly, the Guidance also provides some advice on the safety of finished products. A general aim is to improve harmonised compliance with the current cosmetic EU legislation, Regulation (EC) No 1223/2009, for which animal testing and marketing bans fully apply from 2013 onwards. This means that no in vivo testing of ingredients or finished products is allowed in Europe for the purpose of cosmetics. For this reason, the SCCS has closely followed the progress made in regard to the development and validation of alternative replacement methods, also referred to as new approach methodology (NAM). The "SCCS Notes of Guidance" are regularly revised and updated in order to incorporate progress made and experience gained over time, in particular on the use of NAMs, and the new methods and data that became available since previous revision (SCCS/1602/18) formed the basis of the current (11 th) Revision.
《化妆品成分测试和安全性评价指导原则注释,第 11 修订版》(SCCS/1628/21)包含了欧洲化妆品物质测试和安全性评价不同方面的相关和更新信息。重点是对人类健康表示关注的化妆品成分。间接地,该指导原则也为成品的安全性提供了一些建议。总的目标是提高对现行化妆品欧盟法规(EC)No 1223/2009 的协调一致遵守,该法规自 2013 年起全面适用动物测试和市场禁令。这意味着,出于化妆品目的,在欧洲不得对成分或成品进行体内测试。出于这个原因,SCCS 一直密切关注替代方法(也称为新方法学)的开发和验证方面的进展。《SCCS 指导原则注释》定期修订和更新,以纳入随着时间的推移取得的进展和经验,特别是关于替代方法的使用,以及自上次修订(SCCS/1602/18)以来新出现的方法和数据,这些构成了当前(第 11 修订版)的基础。