FDA Draft Lead in Cosmetic Lip Products and Externally Applied Cosmetics Recommended Maximum Level
标准简介
Draft Lead in Cosmetic Lip Products and Externally Applied Cosmetics Recommended Maximum Level[附网盘链接]是Food And Drug Administration发布的FDA标准，适用于U.S。标准截图
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标准文档说明
标准文档类型为Draft Lead in Cosmetic Lip Products and Externally Applied Cosmetics Recommended Maximum Level[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
Draft-Not for Implementation Lead in Cosmetic Lip Products and Externally Applied Cosmetics: 1
Recommended Maximum Level Guidance for Industry This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration's (FDA or we) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page. I. Introduction This guidance provides a recommended maximum level of 10 parts per million (ppm) for lead as an impurity in cosmetic lip products and externally applied cosmetics that are marketed in the United States. FDA (or “we”) has concluded that a recommended maximum level of 10 ppm for lead as an impurity in cosmetic lip products and externally applied cosmetics would not pose a health risk. We consider the recommended maximum lead level to be achievable with the use of good manufacturing practices and to be consistent with the 10 ppm maximum lead level for similar products recommended by other countries. For additional discussion of the scientific and legal background and rationale underlying this recommended level, see “Supporting Document for Recommended Maximum Lead Level in Cosmetic Lip Products and Externally Applied Cosmetics” (http://www.fda.gov/Cosmetics/GuidanceRegulation/GuidanceDocuments/ucm517327.htm). The issuance of this guidance supports our effort to limit human exposure to lead in finished FDA-regulated cosmetic products by educating new manufacturers who wish to enter the market and encouraging current manufacturers to continue to follow or improve on voluntary good manufacturing practices that limit trace amounts of lead as an impurity. This guidance applies to cosmetic lip products (such as lipsticks, lip glosses, and lip liners) and externally applied cosmetics (such as eye shadows, blushes, shampoos, and body lotions) marketed in the United 2
States. This guidance does not apply to topically applied products that are classified as drugs or to hair dyes that contain lead acetate as an ingredient. 1
This guidance has been prepared by the Office of Cosmetics and Colors in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration. 2
Cosmetic lip products are applied to the mucous membrane and therefore are not considered externally applied cosmetics (See 21 CFR 70.3(v)). 3
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