US FDA Issues Draft Guidance Recommending Maximum Limit for Lead in Cosmetics

The US FDA has issued draft guidance recommending a maximum limit of no more than 10ppm of lead as impurity in cosmetic lip products and externally applied cosmetic products.
( | Press Release | 2017-03-10 13:44:24 )
The United States Food and Drug Administration (US FDA) has published draft guidance recommending a maximum level of 10ppm for lead (Pb) as impurity in cosmetic products.

This new limit will apply to cosmetic lip products and externally applied cosmetics, including:

• Eye shadows
• Blushes
• Compact powders
• Shampoos
• Body lotions

Stakeholders should be aware that this guidance does not apply to:

• Topically applied products classified as drugs
• Hair dyes that contain lead acetate

The US FDA does not currently regulate the level of Pb in finished cosmetic products under the Federal Food, Drug, and Cosmetic Act and Fair Packaging and Labeling Act. Instead, it restricts the purity of colorants.

The publishing of this non-binding draft guidance, in December 2016, follows several surveys and testing exercises, carried out between 2007 and 2013. The results of these surveys, and an exposure assessment, have allowed the US FDA to conclude that cosmetic products complying with its recommended limit for Pb will not pose a health risk to consumers.

The US FDA hopes that, through the issuing of this non-binding recommendation, it can achieve the limit of 10ppm through the use of good manufacturing practices.

SGS Cosmetics & Personal Care Testing Services
SGS provides testing, inspection, auditing and consulting services to manufacturers, distributors and importers to ensure a high level of product quality in every area. A global network of state of the art laboratories offer custom-made solutions for chemical, biophysical, microbiological, stability and biological aspects. They have extensive capabilities in performance testing, claim support studies and consumer panels. SGS’s cosmetic safety assessors and technical experts can support customers by making sure new products comply with regulatory requirements. Learn more about SGS’s Cosmetics & Personal Care Testing Services (

SGS SafeGuardS keep you up to date with the latest news and developments in the consumer goods industry. Read the full US FDA Draft Guidance Recommends a Maximum Level for Lead in Cosmetics SafeGuardS. (

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For further information contact:

Queenie Tse
Senior Technical Service Executive
Cosmetics, Personal Care and Household (CPCH)
Tel: +852 2765 3672

About SGS
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 90,000 employees, SGS operates a network of over 2,000 offices and laboratories around the world.

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Ben Christie

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