Modernization of Cosmetics Regulation Act of 2022 (MOCRA)
On December 29, 2022, the Modernization of Cosmetics Regulation Act of 2022, or MOCRA, was passed into law. The changes brought about by MOCRA constitute the first statutory modification of the FDA’s powers over cosmetics since 1938.
Numerous obligations have come into force since December 29, 2023.
Registration
Since July 1, 2024, registration of cosmetic products and establishments has been mandatory.
For the registration of establishments, the following information is required:
- Name, address, email, and telephone number of the establishment
- All brand names of products marketed
- Product categories and responsible persons
- Contact details and e-mail address of the US agent
Neo Cosmetic’s business registration has been completed. It is now possible for our customers to register their products.
For product registration, the following information is required:
- Manufacturer’s registration number
- Name and contact details of the person responsible
- Product name as stated on the label
- Product category
- Ingredients (including fragrances, flavors, and colorants) identified by their common or usual name
Failure to register may result in a mandatory recall of all products manufactured or processed in the establishment.
Cosmetovigilance
Under the new regulations, it is compulsory to report adverse reactions.
The person in charge is responsible for reporting adverse reactions to the USA:
- Submit adverse event reports to the FDA within 15 days of learning of the event
- Provide new medical evidence related to the adverse reaction for 1 year after the initial report
- Communicate fragrance or flavor ingredients that may have contributed to an adverse reaction within 30 days of FDA request
Labeling
From December 29, 2024, all labels must include cosmetovigilance contact information. Contact information for reporting adverse reactions must be present (address, telephone number, or e-mail contact).
- “Professional use” must be indicated for products intended for professional use
- The FDA will have to identify the list of allergens to be mentioned on labels. For the moment, the list of allergens is not yet known. Initially scheduled for June 29, 2024, discussions have been postponed until October 2024
PFAS
The FDA is to evaluate the use and safety of PFAS in cosmetic products. The report is expected in December 2025.
Talc
The FDA is to propose regulations to establish standardized test methods for detecting asbestos in talc-containing products. The method for detecting asbestos in talc, originally scheduled for December 2023, has been postponed to July 2024, but no regulations have been published on this subject as yet.
Safety Information
It will be necessary to identify who will be the person responsible for collecting and maintaining product safety documentation. The person responsible must keep records proving that the products are safe.
Good Manufacturing Practices (GMPs)
The publication of GMPs for cosmetics establishments is scheduled for December 29, 2025.
For further information, please contact us by e-mail: