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Laws and regulations

FDA suggests maximum lead levels in lip cosmetics

The U.S. Food and Drug Administration (FDA) has issued a new draft guidance [1] proposing to limit lead levels to 10 ppm in cosmetic lip products (such as lipsticks, lip glosses, and lip liners) and externally applied cosmetics (such as eye shadows, blushes, shampoos, and body lotions).

Based on exposure assessment, FDA has concluded that a recommended maximum level of 10 ppm would not pose a health risk. However, considering that lead is a chemical element for which toxicity in humans has been well documented, the agency highlights that cosmetics manufacturers should “follow or continue to follow manufacturing practices that allow them to achieve levels of lead lower than 10 ppm whenever feasible.

Actually, lead may be find as an impurity in very low concentrations in some cosmetics. FDA surveys indicate that levels of lead in the cosmetic lip products and externally applied cosmetics are for the most part well below 10 ppm, the level that is considered as not posing a health risk. However, FDA explains that “’a small number” of products currently available on the market have lead levels that exceed this limit. The agency also notes that such a limit is already enforced in several markets, such as Canada and the European Union.

FDA therefore explains the issuance of this guidance should be readily achievable by manufacturers that source their ingredients appropriately and use good manufacturing practices while supporting the agency’s effort to limit human exposure to lead 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.

The comment period for this proposal opened on December 22, 2016. To ensure that the agency considers all comments on this draft guidance before it begins work on the final version, it is recommended to submit either electronic or written comments by February 21, 2017.

Submit electronic comments on http://www.regulations.gov to docket number FDA-2014-D-2275

Submit written comments to:

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852, USA

All comments should be identified with the docket number FDA-2014-D-2275.

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