SGS : US FDA Bans the Use of Lead Acetate in Cosmetics

The US FDA has banned the use of Lead Acetate in cosmetic products intended for hair color additives.

SAFEGUARDS | Cosmetics, Personal Care & Household NO. 005/19

The United States Food and Drug Administration (US FDA) has banned the use of Lead Acetate in cosmetic products intended for hair color additives.

In response to a petition dated February 24, 2017, and since current data no longer demonstrates the safety of the use of lead acetate as a color additive in hair dye, the US FDA is amending the color additive regulation. Lead Acetate is no longer allowed in cosmetic products intended for coloring hair. The rule is effective from December 3, 2018 and the industry has been granted a 12-month transition period, from the enforcement date, for reformulating products.

21 CFR 73.2396	Old Requirement	New Requirement
Lead Acetate	Authorized color additive in cosmetics intended for coloring hair on the scalp only, not to exceed 0.6 percent lead (weight/volume).	No longer authorized in cosmetics (hair dye) from December 3, 2018.

The cosmetic industry shall review the launch of hair products in the US and be prepared to reformulate within the transition period, if lead acetate is used as color additive. Source of Information:

1. Constituent Update - FDA to Repeal Color Additive Approval for the Use of Lead Acetate in Hair Dyes [1]
2. Final Rule - Termination of Listing of Color Additive Exempt from Certification; Lead Acetate [2]

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For enquiries, please contact:

Queenie TSE
Consumer and Retail
Cosmetics, Personal Care and Household (CPCH)
Senior Technical Service Executive
t: [phone] (ext 1672)

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