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环境中的化妆品紫外线滤光剂——欧盟法规、科学和可能存在的知识空白的现状。

Cosmetic UV filters in the environment-state of the art in EU regulations, science and possible knowledge gaps.

机构信息

Regulatory Ecotoxicology Chemicals, BASF SE, Ludwigshafen, Germany.

Regulatory Toxicology & Ecotoxicology, BASF Services Europe GmbH, Berlin, Germany.

出版信息

Int J Cosmet Sci. 2023 Oct;45 Suppl 1:52-66. doi: 10.1111/ics.12898.

Abstract

OBJECTIVE

The aim of this work was to review the principals of environmental hazard and risk assessment (ERA) of cosmetic UV filters registered under EU REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals). Furthermore, effects as obtained from non-standardized testing methods and organisms from scientific literature were compared against the predicted no effect concentrations (PNECs) as derived based on standardized test methods for the various environmental compartments under REACH.

METHODS

The REACH dossiers at the ECHA webpage were screened for available information related to basic physico-chemical data (i.e. water solubility, octanol-water partitioning coefficient), PNECs and associated data (data basis, assessment factors (AFs)). Scientific literature was screened for available ecotoxicity data and the adverse effect levels were compared against the derived PNECs under REACH. Current approaches for environmental risk assessments of UV filters were evaluated for its applicability for a direct release scenario.

RESULTS

Under REACH, PNECs were derived for all hazardous UV filters. Although, PNECs were often derived for various environmental compartments (i.e. freshwater, marine water, sediment, soil), results from literature focused on aquatic data. Effects as observed within scientific literature matches in principle with the hazardous profile of the UV filters. Effects levels both on the acute and the chronic toxicity as retrieved from the non-standardized test organisms (literature) were above the derived PNECs under REACH. Currently, ERAs performed for cosmetic UV filters under REACH are solely tonnage driven and thus do not fully capture the use in sunscreens and associated leisure activities.

CONCLUSION

Existing EU REACH regulation is considered as sufficient to evaluate the environmental safety of UV filters used in sunscreens. To cover the direct release of UV filters due to various leisure activities into the aquatic freshwater and marine environment, an additional application-based ERA is considered necessary.

摘要

目的

本工作旨在综述欧盟 REACH 法规下注册的化妆品紫外线滤光剂的环境危害和风险评估(ERA)原则。此外,将非标准化测试方法和生物体获得的效果与基于标准化测试方法为各种环境介质下的 REACH 得出的预测无影响浓度(PNEC)进行比较。

方法

在 ECHA 网页上筛选 REACH 档案,以获取与基本物理化学数据(即水溶性、辛醇-水分配系数)、PNEC 及其相关数据(数据基础、评估因子(AFs))相关的可用信息。筛选科学文献,以获取可用的生态毒性数据,并将不良影响水平与 REACH 下得出的 PNEC 进行比较。还评估了目前紫外线滤光剂环境风险评估的方法,以评估其在直接释放情景下的适用性。

结果

根据 REACH,为所有危险紫外线滤光剂都推导了 PNEC。尽管 PNEC 通常是为各种环境介质(即淡水、海水、沉积物、土壤)推导的,但文献结果主要集中在水生数据上。文献中观察到的影响原则上与紫外线滤光剂的危险特征相符。从非标准化测试生物(文献)中检索到的急性和慢性毒性的影响水平均高于 REACH 下推导的 PNEC。目前,根据 REACH 对化妆品紫外线滤光剂进行的 ERA 主要是基于吨位,因此不能完全捕捉防晒霜和相关休闲活动中紫外线滤光剂的使用情况。

结论

现有的欧盟 REACH 法规被认为足以评估防晒霜中使用的紫外线滤光剂的环境安全性。为了涵盖由于各种休闲活动而直接向水生淡水和海洋环境释放紫外线滤光剂的情况,认为有必要进行额外的基于应用的 ERA。

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