食品药品监督管理局
欧洲联盟
医学
文档
敏化
光防护
环境卫生
业务
国际贸易
计算机科学
植物
生物
光合作用
程序设计语言
免疫学
作者
Molly N. Pantelic,Nikita Wong,Michael Kwa,Henry W. Lim
标识
DOI:10.1016/j.jaad.2022.11.039
摘要
Availability of new UV filters in the United States lags behind the European Union (EU), partly due to differing approval processes.To review available human safety data of all US- and EU-approved UV filters.Data from Food and Drug Administration and EU regulatory guidelines, federal governmental documentation, databases, reviews, and opinions for approval and ongoing safety evaluation were analyzed.Currently, there are 17 US UV filters and 29 EU UV filters (18 EU-approved only filters). Almost all US filters possessed sensitization data (94%, 16/17) with the majority (76%, 13/17) showing minimal skin sensitization. The minority of EU-approved only filters (33%, 6/18) possessed sensitization data, all showing no sensitization. Some filters possessed dermal absorption data (US: 76%, 13/17; EU: 44%, 8/18). Oxybenzone, octinoxate, octisalate, homosalate, and octocrylene, approved in the US and EU, were shown to have plasma levels exceeding the Food and Drug Administration exposure threshold.Proprietary manufacturer human data were unavailable.Many new UV filters are available in the EU, but not yet in the United States. Rigorous US and EU guidelines ensure that UV filters provide adequate photoprotection assuming consumers follow American Academy of Dermatology SPF (sun protection factor) and broad-spectrum recommendations. Human data are limited, but known human risks of sunscreen appear minimal.
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