20 Feb MoCRA – the “biggest” cosmetic regulation change in the US
On 29 December 2022, President Biden signed into law the Consolidated Appropriations Act, 2023.
Modernization of Cosmetic Regulation. Act, “MoCRA”, is the first major update to the Food and Drug Administration's (FDA) cosmetics authorities since 1938 and introduces significant changes.
MOCRA'S KEY PROVISIONS
Sec. 605 Adverse Effect
Adverse effects caused by the use of the product must be reported to the FDA within 15 days. In addition, records must be kept for 6 years.
Sec. 606 Good Manufacturing Practice
The FDA will finalize its GMP standards to align them with the international ones. It is expected to be completed in 2025.
Sec. 607 Mandatory Facility Registration and Product Listing
Facilities must be registered within one year of MoCRA enactment and must be renewed every 2 years.
Responsible persons must register the products that they place on the market including the place of manufacture, contact, etc. This registration may include multiple cosmetic products with identical formulations, or formulations that differ only with respect to colors, fragrances or content. This registration must be done before December 2023 for what is on the market, or 120 days for new releases.
Sec. 608: Safety Substantiation
A responsible person must ensure and maintain records supporting that there is adequate substantiation of safety of the cosmetic product. Companies will be required to keep records to ensure products are safe.
Sec. 609 Labelling
MoCRA required the FDA to determine by regulation which fragrance allergens must be disclosed in cosmetic label. Cosmetic lable will be required to identify every fragrance allergen in a product. The labeling requirement will take effect at the end of 2024.
Sec. 3505 Talc
MoCRA also directs FDA to issue regulations to establish and require standardized testing methods for detecting and identifying asbestos in cosmetic products containing talc.
Sec. 3506 PFAs
MoCRA requires FDA to issue a public report, no later than three years after MoCRA is enacted, to assess the use of perfluoralkyl and polyfluoralky substances (PFAS) in cosmetic products.
Sec. 3209 y 3507 Animal testing
The need for Animal Testing to ensure the safety of cosmetics should be phased out with the exception of appropriate allowances. At the moment, there is no official ban on animal testing.
AT COSMEWAX, WE ARE EXPERTS IN COSMETIC REGULATION
Cosmewax advises its clients to apply the cosmetic legislation of their markets, develop the required documentation and implement the necessary quality tests.
Advice on applicable regulations
Our regulatory experts comply with packaging requirements and international regulations regarding ingredients applicable to your sales territory. In addition, our experts constantly monitor changes in regulations and adapt their recommendations accordingly, informing our clients immediately so that they stay up to date.