Modernization of Cosmetics Regulation Act of 2022 (MOCRA)
On December 29, 2022, the Modernization of Cosmetics Regulation Act of 2022 or MOCRA was passed. The amendments made by the MOCRA constitutes the first statutory change to the FDA's powers over cosmetics since 1938.
Many obligations have come into effect since December 29, 2023.
Registration :
Since July 1, 2024, the registration of cosmetic products and establishments is mandatory.
Regarding the registration of establishments , the elements to be provided are as follows:
- Name, address, email and telephone number of the establishment;
- All brand names of the products marketed;
- Product categories and responsible persons; and
- Contact details and email address of the US agent.
Neo Cosmetics has been registered. It is now entirely possible for our customers to register their products.
Regarding product registration , the following elements must be provided:
- Manufacturer's registration number;
- Name and contact information of the responsible person;
- Product name as mentioned on the label;
- Product category;
- Ingredients (including perfumes, flavors and colorings) 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:
The reform provides for an obligation to report adverse effects.
The responsible person is in charge of reporting adverse events in the USA:
- Submit adverse event reports to the FDA within 15 days of becoming aware of the event;
- Provide new medical information related to the adverse effect within 1 year of the initial report; and
- Report fragrance or flavoring ingredients that may have contributed to an adverse reaction within 30 days of FDA's request.
Labeling:
From December 29, 2024: All labels must include contact information for cosmetovigilance. Contact information for reporting adverse reactions must be present (address, telephone number, or email address).
- The term “Professional use” must be indicated for products intended for professional use.
- The FDA will have to identify the list of allergens to be included on labels. The list of allergens is not yet known. Initially scheduled for June 29, 2024, discussions have been postponed to October 2024.
PFAS:
The FDA is expected to evaluate the use and safety of PFAS in cosmetic products. The report is expected in December 2025.
TALC:
The FDA is expected to propose regulations to establish standardized testing methods for detecting asbestos in products containing talc.
The method for detecting asbestos in talc, initially planned for December 2023, was postponed until July 2024, but no regulations have been published on the subject yet.
Safety Information:
It will be necessary to identify who will be responsible for collecting and maintaining product safety documentation. The responsible person must keep records proving that the products are safe.
Good Manufacturing Practices
Publication of GMP for cosmetic product establishments scheduled for December 29, 2025
For more information, you can contact us by email: info.neo-cosmetique@fr
Source :
Cosmed Document: USA – MOCRA – Preparing for the next deadlines