MOCRA regulations – New rules for importing and selling cosmetic products in the U.S.

The export of cosmetics to the U.S. is now subject to a new regulation that will go into effect on December 29, 2023: MOCRA - Modernization of Cosmetics Regulation Act.

The most significant change contained in the MOCRA regulation concerns the requirement of registration with the FDA for companies wishing to export cosmetic products to the U.S. market. The registration will also have to include the list of ingredients for the various cosmetic products sold in the U.S.

Other essential aspects of the new FDA regulation on the standardization of cosmetic products intended for the U.S. market are:

• Appointing a responsible person by the manufacturing company;
• Compliance with the production standards to be introduced by the FDA for the production of cosmetic products (GMP - Good Manufacturing Practice);
• Keeping records to substantiate the safety of the production process and the safety of ingredients used in the production of cosmetic products;
• Label declaration of any allergens in the cosmetic;
• Keeping records of the production process and problems that have arisen due to cosmetic use.

It should be pointed out that the FDA has not yet promulgated implementing regulations; for example, registration with the FDA for cosmetic companies has not yet been opened. Under MOCRA, the FDA must propose cosmetic GMP regulations by December 29, 2024, and issue a final rule by December 29, 2025. Good manufacturing practices for cosmetic products will need to be consistent with current FDA and international standards (such as ISO 22716, which, at present, is the benchmark GMP standard for cosmetic manufacturing).

ExportUSA helps companies with FDA compliance with cosmetic products under the new MOCRA regulations. Although the implementation part of the regulation has not yet been published, we can begin to help cosmetics manufacturers prepare for MOCRA's scheduled effective date of December 29, 2023, to ensure hassle-free importation of cosmetic products into America.