With the implementation of the Modernization of Cosmetics Regulation Act (MoCRA) in the United States, cosmetic manufacturers operating globally must reassess their compliance strategies. While adherence to European Union (EU) and United Kingdom (UK) cosmetic regulations provides a strong foundation, MoCRA introduces distinct regulatory obligations that require targeted adjustments.

This article outlines the key areas of convergence and divergence between EU/UK frameworks and MoCRA, offering guidance for brands seeking seamless market access across jurisdictions.

Regulatory Convergence: Areas of Alignment

1. Safety Substantiation

Under EU Regulation (EC) No 1223/2009 and the UK Cosmetics Regulation, cosmetic products must undergo a comprehensive safety assessment documented in a Cosmetic Product Safety Report (CPSR). MoCRA similarly mandates safety substantiation, and CPSRs are generally accepted as valid evidence, provided they include toxicological profiles, exposure assessments, and margin of safety calculations.

2. Ingredient Restrictions

The EU maintains a robust list of prohibited and restricted substances, with over 1,600 ingredients banned due to safety concerns. While the U.S. historically maintained a more permissive stance, MoCRA signals a shift toward stricter ingredient oversight, particularly at the state level (e.g., California’s bans on formaldehyde, parabens, and PFAS). Products compliant with EU/UK ingredient standards are likely to meet or exceed MoCRA’s safety expectations.

3. Fragrance Allergen Disclosure

EU Regulation 2023/1545 expands the list of mandatory fragrance allergen disclosures from 26 to 82 substances, with defined thresholds for leave-on and rinse-off products. MoCRA is expected to introduce a similar requirement via a proposed rule in January 2025, aligning both regions in their pursuit of label transparency and consumer safety.

Regulatory Divergence: MoCRA-Specific Requirements

1. Facility Registration

MoCRA mandates that all domestic and foreign facilities engaged in the manufacture or processing of cosmetic products for the U.S. market must register with the Food and Drug Administration (FDA). Registrations must be renewed biennially, and failure to comply may result in enforcement actions.

2. Product Listing

Each cosmetic product must be listed on the FDA Cosmetics Direct portal, including details such as product name, ingredients, and associated facility. Listings must be updated annually, ensuring traceability and regulatory oversight.

3. Adverse Event Reporting

MoCRA introduces mandatory reporting of serious adverse events, including hospitalizations, infections, and significant allergic reactions. Reports must be submitted within 15 business days, and manufacturers are required to maintain records for a minimum of six years.

4. Mandatory Recalls

The FDA now possesses the authority to mandate recalls of cosmetic products deemed unsafe or misbranded. This represents a significant shift from the previously voluntary recall system and underscores the importance of robust quality assurance protocols.

5. Good Manufacturing Practices (GMPs)

MoCRA will enforce cosmetic GMPs, with a proposed rule expected in October 2025. While EU GMP standards (e.g., ISO 22716) may serve as a reference, U.S.-specific requirements will necessitate procedural alignment and documentation updates.

6. U.S. Agent Requirement

Foreign manufacturers must designate a U.S. Agent responsible for liaising with the FDA. This agent serves as the primary point of contact for regulatory communications, inspections, and compliance inquiries

Conclusion

While EU and UK compliance provides a robust framework for product safety and transparency, MoCRA introduces additional regulatory dimensions that must be addressed independently. Brands seeking to operate in the U.S. market must proactively adapt to MoCRA’s requirements to ensure uninterrupted distribution and regulatory integrity.

For organizations navigating MoCRA for the first time, collaboration with regulatory consultants and legal experts is strongly recommended to mitigate risks and streamline compliance.