Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is a new set of regulations that standardizes how cosmetic organizations conduct business and maintain the safety of cosmetic products within a Regulatory framework. In the draft regulation, the enforcement deadline for facility registration is December 29, 2023. There are two (02) different deadlines for new facilities and existing facilities.
Here's what you need to know about MoCRA facility registration:
Mandatory Facility Registration
According to Section 607 of MoCRA, facility registration, and product listings are now mandatory. This is regardless of whether your facility is located in the US or internationally. If your facility manufactures or processes cosmetic products for the US, you must register your facility with the US FDA. Existing facilities have one (01) year to comply with facility registration, while new facilities must register within 60 days from when they start production of cosmetic products or by February 27, 2024, whichever is later. All registrations must be renewed biennially.
Contract manufacturers are subject to registration for their facility.
Changes to Facility (Amendment to Registration)
Any changes to your facility must be reported within 60 days, and the facility registration must be updated accordingly.
MoCRA will now pre-empt all state or local laws that differ from the USFDA on product listings, adverse event reporting, facility registrations, records, GMP, recalls, or safety substantiation.
Separate from the facility registration requirement, MoCRA also mandates the submission of cosmetic product listings. The Responsible Person (RP) is required to either submit these product listings to the USFDA or ensure that product listings are submitted. Although the US FDA Direct (Product listing and facility registration portal) is in the development stage, it is important to note that under the FD&C Act, specific information is required for facility registration. The information includes details about the owner/operator, facility, contact information, registration number (if applicable), brand names, product categories, and submission type. You also have the option to provide additional data, such as the parent company and DUNS number. It is crucial to submit this information with an attestation of accuracy to register your facility with the USFDA.
In brief, MoCRA facility registration is obligatory for all US cosmetic product manufacturers by February 27, 2024. Registration renewals are required every two (02) years. Partnering with experienced Regulatory service providers like Freyr simplifies entering the US cosmetic market and addressing MoCRA facility registration challenges. Consult Freyr experts for assistance in navigating the complex US cosmetic Regulatory landscape.