Resources/MoCRA Safety Substantiation: US Cosmetic Requirements
MoCRA Safety Substantiation: US Cosmetic Requirements
Disclaimer: The information provided in this guide is for educational and regulatory context purposes only and does not constitute formal legal advice. Compliance requirements can vary based on formulation, regional authority updates, and specific product claims. Consult a certified regulatory affairs professional or specialized legal counsel for official filings.
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) significantly altered the US regulatory landscape for cosmetics by introducing a mandatory requirement for safety substantiation. Under MoCRA, the "responsible person" for a cosmetic product must ensure that there is adequate safety substantiation for the product and maintain records supporting that substantiation. This shifts the burden from a post-market enforcement model to a pre-market assurance requirement.
US FDA and MoCRA Framework
MoCRA defines "adequate safety substantiation" as tests or studies, research, or other evidence or information that is sufficient to determine that a cosmetic product is safe for its intended use. The responsible person, typically the manufacturer, packer, or distributor whose name appears on the label, bears the primary obligation for this substantiation. While the US FDA does not "approve" cosmetic products before market entry, MoCRA empowers the agency to request safety records and take action if substantiation is deemed inadequate.
- Product safety assessments by qualified experts.
- Toxicological data for individual ingredients.
- Stability testing results.
- Microbiological testing results.
- Human repeat insult patch tests (HRIPT) for skin sensitization.