MoCRA Mastery: Navigating FDA Changes with Ease. Secure Your Spot with Eurofins Experts Today
What brands should know
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant expansion of FDA’s authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic (FD&C) Act was passed in 1938. This new law will help ensure the safety of cosmetic products many consumers use in the United States daily.
Per U.S. Food & Drug Administration (FDA) guidance, the Modernization of Cosmetics Regulation Act (MoCRA) registration requirements on facilities and product listing will be enforced as of July 1, 2024. All cosmetics and personal care end product producers must meet registration requirements. In addition, already enacted MoCRA regulations include rules for adverse event reporting and record keeping, Standard Operating Procedures for mandatory recalls, safety substantiation, and testing requirements for products containing talc. Not yet implemented is the creation of a list of fragrance allergens (due June 2024) by the FDA, as well as the adoption of rules for the labeling of fragrance allergen and contact information (due December 2024). Additionally, the FDA will finalize GMP rules and release their PFAS report by December 2025.
MoCRA compliance requirements
- Facility registration and product listing
- Labeling compliance
- Good Manufacturing Practice (GMP) requirements
- Adverse event reporting & record keeping
- Mandatory recall authority
- Safety substantiation
- Allergen labeling
- Labeling of fragrance allergens
- Testing methods for talc-containing cosmetics
- PFAS in cosmetic
Simplification and sequencing of this process is essential for companies to avoid delays or penalties in not meeting with MoCRA regulations.
How companies can register
Companies can register electronically or submit paper applications. Eurofins Cosmetics and Personal care has regulatory experts who can assist with compliance.
Why chose Eurofins Cosmetics and Personal Care as your MoCRA compliance partner?
As the world leader in certification, inspection and testing for the cosmetics and personal care industry, Eurofins offers consultation and testing solutions to help companies navigate the new regulatory environment enacted by MoCRA.
Some crucial ways we can help
- Safety testing & analysis
- Documentation & record-keeping
- Gap Analysis
- Quality control
- Regulatory compliance
- Customized testing plans
- Communication with regulatory authorities
- Training & education
- Updates on regulatory changes
- Development support
- Efficiency in submission
- Verification of labeling compliance
Our dedicated team is prepared to determine if you need to register your facility, perform additional product testing, designate a U.S. agent as well as advise on other areas for MoCRA compliance with the FDA.
Contact our team of experts today
For a summary of MoCRA regulations view FDA final guidance document here
