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  • Writer's pictureDaniel Jiménez

The draft of the MoCRA Product and Facility Registration has been published

On August 7th, the FDA released the draft of the cosmetic product and facility registration in the United States, in compliance with the new requirements approved in December 2023 under the Modernization of the Cosmetic Act (MoCRA).

The new cosmetic product regulations in the USA mandate that anyone who owns or operates a facility engaged in the manufacturing or processing of a cosmetic product for their distribution in the United States must register each facility in the FDA. Additionally, MoCRA mandates the mandatory registration of all cosmetic products through an US Responsible Person. The old (and voluntary) VCRP registration program has been invalidated, rendering all registrations submitted to date null and void.

The FDA intends to launch the new electronic submission portal in October 2023. As described in the MoCRA Draft Guidance, the FDA Establishment Identifier (FEI) will be used as the required facility registration number. Therefore, facility owners or operators must obtain an FEI number before submitting the facility registration.

Remember that MoCRA has conferred new responsibilities upon the FDA:

• Facility Registration: All existing facilities subject to the new FDA MoCRA regulations must register within one year (by December 2023), including contract manufacturers. New facilities must also register within 60 days and renew every two years as required by the FDA.

• Product Listing: The Responsible Person must list every cosmetic product marketed with the FDA, including product ingredients, and provide updates annually. Each newly created product now requires the submission of a cosmetic product list detailing everything from ingredients, including fragrance or flavor, to the responsible party for manufacturing facilities and their location.

In addition to the mentioned information, the new MoCRA Draft Guidance specifies:

  • The legal requirement to submit cosmetic product facility records and product listings.

  • Who is responsible for making the submissions.

  • What information to include in the submissions.

  • How to make the submissions.

  • When to make the submissions.

BELAB SERVICES LLC, located in Miami, Florida, offers its expertise to companies for registering their facilities and products in strict compliance with the new regulations, acting as an US Agents and US Responsible Person for their products and facilities in the USA.

For more information, please contact us at:

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