The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant reform of cosmetics law in recent U.S. history.
On August 7, the FDA published the Draft Registration of Cosmetic Facilities and Products in the United States, complying with the new requirements approved in December 2022 through the Modernization of the Cosmetic Act (MoCRA).
MoCRA: New regulation for cosmetics products in the USA
The new regulations on cosmetic products in the USA require that any person who owns or operates a facility dedicated to the manufacturing or processing of a cosmetic product for distribution in the United States, register said facility with the FDA.
In addition, MoCRA establishes the obligation to register all cosmetic products through a Responsible Person in the US. The former (and voluntary) VCRP registration program has been rescinded, invalidating all registrations submitted to date.
The FDA intends to launch the new e-filing portal in October 2023. As described, the FDA Establishment Identifier (FEI) will be used as the registration number for the draft guidance. installation required. Therefore, facility owners or operators will need to obtain an FEI number before submitting facility registration.
Remember that MoCRA gave new responsibilities to the FDA:
• Facility Registration: All existing facilities subject to the new FDA MoCRA regulations must register within one year (December 2023); this includes contract manufacturers. New facilities must also register within 60 days and must be renewed every two years as required by the FDA.
• Product Listing: The responsible person must list each cosmetic product marketed with the FDA, including the product ingredients, and provide updates annually. Each product created now requires the submission of a cosmetic product list detailing everything from ingredients, including fragrance or flavor, and the party responsible for the manufacturing facility and its location.
In addition to the information mentioned, the new guide establishes:
The legal requirement to submit cosmetic product facility records and product listings;
Who is responsible for making the presentations
What information to include in presentations
How to make presentations
When to make presentations
BELAB SERVICES LLC, located in Miami (Florida) lends all its knowledge to the service of companies to register their facilities and products in strict compliance with the new regulations, acting as Contact Agents (US Agent) and Responsible Person in the US (US Responsible Person) for its products and facilities.
For more information, please contact us consult@belabservices.com / info@belabservices.com
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