US FDA Draft Guidance Recommends a Maximum Level for Lead in Cosmetics
SAFEGUARDS | Cosmetics, Personal Care & Household NO. 023/17
The US FDA has issued draft guidance to recommend a tolerance limit of no more than 10ppm of lead as impurity in cosmetic lip products and externally applied cosmetic products, including eye shadows, blushes, compact powders, shampoos, and body lotions.
In December 2016, the United States Food and Drug Administration (US FDA) issued draft guidance to recommend a tolerance limit of no more than 10 ppm of lead (Pb) as impurity in cosmetic lip products and externally applied cosmetic products. These include eye shadows, blushes, compact powders, shampoos, and body lotions.
Between 2007 and 2013 a number of surveys and testing exercises were conducted on the impurity content of Pb. Based on the results of the surveys and an exposure assessment, the US FDA has concluded that cosmetic products complying with its recommended limit for Pb would not pose a health risk to consumers. The US FDA believes that with the use of good manufacturing practices the limit is achievable.
Currently, the US FDA does not regulate the level of Pb in finished cosmetic products under the Federal Food, Drug, and Cosmetic Act and Fair Packaging and Labeling Act, but instead restricts the purity of colorants. With the issue of this non-binding recommendation, the authority encourages manufacturers of lipsticks and other cosmetic products to achieve levels of lead lower than 10 ppm whenever feasible. This guidance does not apply to topically applied products which are classified as drugs, or to hair dyes that contain lead acetate as an ingredient.
It is crucial for all cosmetic, personal care and household products to be safe, effective and stable. SGS provides testing, inspection, auditing and consulting services to manufacturers, distributors and importers to ensure a high level of product quality in every area. Our state of the art laboratories offer custom-made solutions for chemical, biophysical, microbiological, stability and biological aspects. We also have extensive capabilities in performance testing, claim support studies and consumer panels. Our testing is conducted according to customer specific or recognized standard methods, some of which were developed by SGS. Our cosmetic safety assessors and other technical experts can support customers by making sure new products comply with regulatory requirements.
Draft Guidance for Industry: Lead in Cosmetic Lip Products and Externally Applied Cosmetics: Recommended Maximum Level 
FDA's Testing of Cosmetics for Arsenic, Cadmium, Chromium, Cobalt, Lead, Mercury, and Nickel Content 
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