Modernization of Cosmetics Regulation Act (MoCRA) in the United States: Key Changes

On December 29^th, 2022, a major amendment to cosmetics regulation in the United States was enacted, marking the most significant reform since 1938.

compliance, Cosmetics, FDA, GMP, MoCRA

The Modernization of Cosmetics Regulation Act (MoCRA) brings substantial implications for the cosmetics industry while strengthening the authority of the FDA (Food and Drug Administration). The regulatory requirements imposed by MoCRA are mandatory for establishments wishing to export cosmetics to the United States.

Implications of the MoCRA on Cosmetic Ingredients and Finished Products

MoCRA introduces essential changes in the American cosmetics industry. The most notable modifications include:

Detection of asbestos in products containing talc,
Examination of PFAS (per- and poly-fluoroalkyl substances),
Requirement to comply with Good Manufacturing Practices (GMP).

The reform also mandates adequate safety justification for each cosmetic product, allowing experts to determine necessary warnings on cosmetic labels.

Responsible Person

A key aspect of MoCRA is the requirement that a Responsible Person be appointed for each cosmetic product sold in the United States. This individual must ensure safety justification, manage adverse effects, maintain cosmetovigilance records, and properly label allergens. The Responsible Person must coordinate a market recall at the FDA’s request if necessary.

Company Registration and Cosmetic Product Listing

MoCRA also mandates registering all companies and cosmetic products in the U.S. market. A new portal, Cosmetics Direct, has replaced the former Voluntary Cosmetic Registration Portal (VCRP). The deadline for registering establishments and cosmetic products via the Cosmetics Direct portal has been extended from December 29th, 2023, to July 1st, 2024.

Every establishment involved in manufacturing, processing, or importing cosmetics intended for the U.S. must register and maintain updated records with the FDA. The Responsible Person must also maintain an annual list of their marketed cosmetics and share it with the FDA.

Labeling

Cosmetic labeling undergoes modifications under MoCRA. In addition to current mandatory elements, labels must include contact information for reporting adverse effects to the Responsible Person via a website. Cosmetics intended for professional use must be clearly labeled, and a complete list of ingredients, including allergens, must be displayed on the packaging according to regulations.

GxpManager Support

GxpManager can assist and simplify regulatory compliance by providing:

Quality management of manufactured products,
Multi-project/multi-site management,
Audit management with report publication,
Risk analysis with report dossier publication,
Multi-language Artworks management,
GMP compliance: traceability, safety, and compliance.

Using GxpManager, your company can prepare for potential future regulatory evolutions, such as the possible digitization of cosmetic product labeling. With our expertise in enterprise process digitalization and our agile application solutions, your business will be ahead of competitors and ready to adapt to regulatory changes quickly.