On December 29th, 2022, the Modernization of Cosmetics Regulation Act (MoCRA) was approved, which is the first major amendment to Chapter VI of the Federal Food, Drug and Cosmetic Act (FDCA) dating back to 1938.
It will come into effect on December 29th, 2023 and provides for the introduction of new obligations that companies selling cosmetic products in the United States will have to comply with.
The most important aspects introduced by MoCRA include:
• Introduction of the US Responsible Person, whose name appears on the label of cosmetic products
• Recall of cosmetic products from the market (introduction of the traceability principle)
• Allergen labeling
• Mandatory GMP regulation
• Registration of facilities (located in the USA or abroad) which must be renewed every two years
• Product registration
• Reporting of adverse effects (which introduce cosmetovigilance procedures)
• Safety Substantiation (which introduces the concept of safety assessment)
| KEY PROVISIONS | 2024 | 2025 |
| Advers Events Reporting | x | |
| GMP | x | |
| Registration and Product Listing | x | |
| Safety Substantiation | x | |
| Labelling of Fragrance Allergens | x | |
| Labelling – Contatct Information | x | |
| Labelling – Professional Use | x | |
| Mandatory Recall Authority | x | |
| Testing Method Absestos | x | |
| PFAS |