如果该物质用于欧洲经济区的化妆品中，注册人何时可以调整 REACH 下的信息要求？

如果该物质用于欧洲经济区的化妆品中，注册人何时可以调整 REACH 下的信息要求？

When can an adaptation of the information requirements under REACH be exercised by a Registrant, in case the substance is used in cosmetic products in the EEA?

一般而言，如果物质在欧洲经济区 (EEA) 仅用于化妆品法规范围内的化妆品，且无需进行测试即可满足 REACH 中关于工人暴露评估的要求，则可调整（“豁免”）人体健康终点测试。预计在两种主要情况下可适用基于化妆品的豁免。如果进口产品属于化妆品法规 (EC No 1223/2009) 的范围内，且自进口之日起未在欧洲经济区 (EEA) 进行进一步加工或重新包装，则可基于不存在相关工人暴露，申请调整人体健康终点动物测试要求；在其他情况下，您可以通过证明该物质在生命周期的所有阶段（除用作化妆品外，即制造、配制和/或包装阶段）均在严格控制的条件下处理，来申请调整信息要求。在任何情况下，您都应提供申请豁免的合理理由。基于化妆品的豁免情形说明 [PDF]

In general, testing for human health endpoints can be adapted (‘waived'), if the substance is used in the EEA exclusively in cosmetic products falling within the scope of the Cosmetics Regulation, and if the testing would not be necessary to fulfil the REACH requirements for the assessment of worker exposure. Two main scenarios are foreseen where cosmetics-based waiving could be applied.  In cases where imported products fall within the scope of the Cosmetics Regulation (EC No 1223/2009) and which, from the time of import, are neither further processed nor repackaged inside the EEA, an adaptation of animal testing requirements for human health endpoints can be sought, based on the absence of relevant worker exposure;   In other cases, you may be able to seek an adaptation of an information requirement by demonstrating that the substance is handled under strictly controlled conditions during all stages of the life-cycle, other than the use as a cosmetic product (i.e. manufacture, formulation and/or packaging stage).   In all circumstances, you shall provide a reasoned justification for requesting the waiver. Illustration of cosmetics-based waiving scenarios [PDF]