Abstract：
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) amends the Food, Drug and Cosmetic Act (FDCA), elevating the standard of proof of safety (better known as a \"safety standard\") for cosmetics to the standard of a \"reasonable certainty … [of] … safe.\"a standard equal to that of food ingredients. The standards of the proof of safety differ for various classes of FDA-regulated product categories e.g., cosmetics, dietary supplements, food ingredients and food itself. This manuscript describes the various standards of proof, the essential differences between the standards, key elements required to achieve a particular standard and, compares the standards to more familiar legal terms such as \"a preponderance of the evidence\" or \"beyond reasonable doubt.\" The standards of proof for these product categories are also ranked according to increasing threshold for achievement of \"safe\" status. Lastly, this manuscript suggests how the requirements for the high standard of a \"reasonable certainty of safe\" (or \"reasonable certainty of no harm\") might be met.
摘要：
2022年化妆品监管法案现代化(MoCRA)修订了食品、药品和化妆品法案（FDCA）将化妆品的安全证明标准（更好地称为“安全标准”）提升到“合理的确定性...[的]...安全的标准。“相当于食品配料的标准。不同类别的FDA监管产品类别的安全证明标准不同，例如，化妆品,膳食补充剂，食物成分和食物本身。这份手稿描述了各种证明标准，标准之间的本质区别，达到特定标准所需的关键要素，将标准与更熟悉的法律术语进行比较，例如“证据的优势”或“排除合理怀疑”。“这些产品类别的证明标准也根据实现“安全”状态的不断提高的阈值进行排名。最后,该手稿建议如何满足“合理的安全确定性”（或“合理的无害确定性”）的高标准要求。
