The US Food and Drug Administration (FDA) recently announced its plans to delay the enforcement of the cosmetic product facility registration and product listing requirements under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) by 6 months to allow all businesses sufficient time to comply.
The new deadline for facility registration and product listing is July 1, 2024.
The MoCRA is the most recent and significant expansion of the Federal Food, Drug, and Cosmetic (FD&C) Act passed in 1938 and aims to enhance the safety of cosmetic products that consumers use daily.
The MoRA requires all cosmetic product manufacturers and processors to:
- Register facilities, update information within 60 days of changes, and renew registration every two years.
- Designate responsible persons who must list each marketed cosmetic product with the FDA, including ingredients, and provide annual updates
“Responsible person means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act.”
Exemptions to the MoCRA facility registration and product listing requirements include small businesses with gross annual sales in the U.S. from cosmetic products totaling less than $1M per year over the past three years.
However, such exemptions do not apply to facilities that manufacture or process, or responsible persons for, the following cosmetic products:
- Cosmetics that come into contact with the mucus membrane of the eye or eyeball
- Injectable products
- Products that are intended for internal use
- Products that are intended to alter appearance for more than 24 hours under customary or usual conditions of use and removal by the consumer is not part of such conditions of use
Electronic registration is encouraged to ensure efficiency and timeliness. The FDA has announced that electronic submission, technical assistance documents, and paper submission forms will be available by early December 2023.
Woodland provides specialized solutions to the Personal Care and Chemicals & Polymers Supply Chain. Our team of dedicated experts is ready to offer customized solutions to meet your specific requirements. Should you have any questions on your global cosmetics supply chain, please contact us here.
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