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The Modernization of Cosmetics Regulation Act (MoCRA) brings forth a significant directive for the cosmetics industry in the United States, mandating a comprehensive approach to regulatory compliance. One of the cornerstone requirements under this legislation is for cosmetic manufacturers to ensure their facilities are registered with the FDA. This step is pivotal in fostering transparency, safety, and accountability in the production and distribution of cosmetic products.
According to MoCRA, Cosmetic manufacturers must register their facilities with the FDA through FDA Direct notification portal, as well as ensuring that those registrations are updated every two years.
It’s important to note that this requirement specifically applies to establishments engaged in the production of finished cosmetic products. Warehouses, labelling and packaging centres, distribution hubs, companies involved in the production of preparations and ingredients, as well as research and product study centres, are exempt from this registration mandate.
CE.way can help with performing product listings and updates as individual services or part of our MOCRA compliance packages.
To complete the registration process the following information is required:
Company/facility details
Keeping safety substantiation documentation available to the authorities
Cosmetic product categories that are produced in the facility
Registration numbers of manufactured product
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