欧盟就REACH和化妆品监管法规（CR）的冲突进行澄清

       2014年10月27日，欧洲化学品管理局（ECHA）就用于化妆品中的物质也需要在欧盟REACH法规下注册，但在某些特定情况下的注册不需要在动物身上进行新的实验，REACH和化妆品监管法规（CR）的冲突进行澄清。 

       应化妆品监管法案（Regulation (EC) No 1223/2009）的要求，当最终配方（包括其中的原料或者成品）进行了动物实验，该化妆产品禁止投放市场。然而，其中某些化学物质同时也需要在REACH法规的管理下进行注册。这就造成了一些不确定性，即是否进行动物实验，REACH和CR的规定相悖。

       欧盟委员会和ECHA联合起来，就CR市场禁令和REACH数据要求的关系做以下澄清：

       除为了评估工人暴露于某物质下所受到的风险以外，仅仅用在化妆品中的物质不需要为了满足REACH的数据要求而开展人类健康节点实验(毒理学节点)。暴露于化学物质下的工人包括：在工业场所生产或者使用化学物质的人员，在工作中会用到化妆产品的非专业人员（如美发师等）。

       如果某种物质含有多种用途，其中包括非化妆产品的用途，那么注册者允许在万不得已的情况下再进行动物实验。

       因此，CR监管范围下的实验要求和市场禁令则不会与为了满足REACH法规进行的生态毒理性评估和工人暴露评估、非化妆品用途的实验发生冲突。

       对仅用于化妆品用途的物质，注册时依旧需要提供REACH法规所要求的数据，但可以使用替代实验，例如QSAR，交叉参照，证据权重分析等。

原文：

Clarity on interface between REACH and the Cosmetics Regulation

Substances used in cosmetic products may need to be registered under REACH but, under certain circumstances registrants may not have to carry out new tests on animals. Answers to questions on the interface between REACH and the Cosmetics Regulation are available on ECHA's website. 

ECHA/NA/14/46 

Helsinki, 27 October 2014 – To meet the requirements of the new Cosmetics Regulation (Regulation (EC) No 1223/2009) cosmetic products are prohibited to be placed on the market where the final formulation, ingredients in a final formulation or a finished product, have been subject to animal testing. Those same chemical ingredients may, however, also need to be registered under REACH. This has created some uncertainty about whether testing on animals can take place in order to comply with REACH, or whether it should not, in order to comply with the Cosmetics Regulation.

The European Commission, in cooperation with ECHA, has now clarified the relationship between the marketing ban and the REACH information requirements as follows:

• Registrants of substances that are exclusively used in cosmetics may not perform animal testing to meet the information requirements of the REACH human health endpoints, with the exception of tests that are done to assess the risks to workers exposed to the substance. Workers in this context, refers to those involved in the production or handling of chemicals on an industrial site, not professional users using cosmetic products as part of their business (e.g. hairdressers).
• Registrants of substances that are used for a number of purposes, and not solely in cosmetics, are permitted to perform animal testing, as a last resort, for all human health endpoints.
• Registrants are permitted to perform animal testing, as a last resort, for all environmental endpoints.

Therefore, the testing and marketing bans in the Cosmetics Regulation do not apply to testing required for environmental endpoints, exposure of workers and non-cosmetic uses of substances under REACH.

    Registrants of substances registered exclusively for cosmetic use will still have to provide the required information under REACH wherever possible, by using alternatives to animal testing (such as computer modelling, read-across, weight of evidence etc.).