MoCRA USA FDA
L
The Personal Care Products Safety Act, S. 2100 so called Fenstein Bill
on going since 2013- revamped by Fenstein 2021- submitted to Senate in 06/2021
Modernization of Cosmetic Regulation Act of 2022 (MoCRA) -> old version 1938
MoCRA passed House December : enacted on 29th, 2022
MoCRA amends Chapter VI of the Federal Food, Drug, and Cosmetic Act (FDCA) to include new provisions for cosmetic products
Feinstein bill replaced by the MOCRA see Subtitle E (p.3498)
While MoCRA does not include a premarket approval requirement for cosmetics, it does create new obligations for the cosmetics industry
Main Changes
•FACILITY REGISTRATION
: 29/12/23 existing facility
•PRODUCT
LISTING – 23/12/2023 existing product
•ADEQUATE SUBSTANTIATION OF
SAFETY
•LABELING : FRAFRANCE ALLERGENS –
2024 consultation period
•ADVERSE EVENT REPORTING AND
RECORDKEEPING
•GOOD MANUFACTURING PRACTICES
•SUSPENSIONS AND MANDATORY RECALLS
•EXEMPTIONS
•PFAS
•TALC
• ANIMAL TESTING
•PREEMPTION