Regulatory Support for Compliance with the Modernization of Cosmetics Regulation Act of 2022

On 29 December 2022, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)—included as part of the Consolidated Appropriations Act, 2023—came into effect, marking the first major change to the United States Cosmetics Regulation since 1938.

MoCRA has established new requirements for cosmetics companies wishing to market in the U.S. and has increased the FDA’s authority over the industry. The Act includes new requirements such as manufacturing site registration, documentation for safety substantiation, and labeling changes, among others.

Under the New Requirements in MoCRA, companies must: 

• Maintain robust safety dossiers - including testing and safety assessments that demonstrate with “reasonable certainty” that a cosmetics product is safe.
• Submit to the FDA annual cosmetics product listings - disclosing key product information (including ingredients and manufacturer information). This will no longer be voluntary. The listing must also include any fragrances, flavors, or colors within the product. Businesses must submit product listings for all existing products by December 2023 and must submit listings for new products within 120 days of entering the U.S. market.
• Submit to the FDA facility registrations – Every facility producing cosmetic products sold in the U.S., whether domestic or foreign, must register with FDA.
• Track and report adverse events associated with their cosmetics products - providing a point of contact for consumers to facilitate adverse event reporting is required.
• List fragrance allergens on product labels - The FDA will issue a regulation identifying these allergens by June 2024.
• Comply with Good Manufacturing Practices - following requirements established by the FDA for any facility that manufactures cosmetics.

For countries outside of the U.S., Intertek can act as a U.S. Agent. The U.S. Agent can help foreign facilities manage documents, record adverse events, communicate with FDA, and answer general questions while based in the U.S.

Intertek’s team of experts can assist companies around the world with MoCRA compliance efforts. We can provide guidance on site registration, labeling changes, and safety assessments, helping your company successfully market its cosmetics products in the U.S.

Our Services Include:

• Globally Compliant Cosmetic Safety Assessments 
• FDA Product Listing Services
• FDA Facility Registrations
• Prop 65 Exposure Assessments
• Product Registrations/Notifications 
• Global Label Reviews
• Microbiology & Stability Testing
• Clinical Testing
• Cosmetic Packaging Analysis
• Regulatory Support
• Literature Review & Data Collection