The Modernization of Cosmetics Regulation Act (MoCRA) has reshaped the cosmetics industry in the United States, introducing stricter FDA oversight and compliance requirements. One of the most critical obligations is facility registration, a cornerstone measure designed to strengthen transparency, consumer safety, and accountability across the cosmetics supply chain.
Why Facility Registration Matters
Under MoCRA, all facilities engaged in the manufacture or processing of finished cosmetic products must be registered with the U.S. Food and Drug Administration (FDA). This registration ensures that the FDA has visibility over where cosmetics are produced, enabling more efficient inspections and regulatory oversight.
Key obligations include:
- Facilities must register through the FDA Direct Notification Portal.
- Registrations must be updated every two years.
- The process requires detailed company and facility information, including categories of cosmetic products manufactured.
By registering, companies demonstrate their commitment to safety and compliance, while also protecting their business against potential enforcement actions.
Who Needs to Register?
MoCRA’s facility registration applies specifically to establishments producing finished cosmetic products. However, certain operations are exempt, including:
- Warehouses and distribution hubs
- Labeling and packaging centers
- Ingredient manufacturers
- Research and product development facilities
This targeted requirement ensures that responsibility lies with the businesses directly accountable for final product safety and quality.
What Information Is Required?
To complete the registration process, cosmetic manufacturers must provide:
- Company and facility details
- Product categories produced in the facility
- Registration numbers of manufactured products
- Access to safety substantiation documentation for authorities upon request
How CE.way Supports Facility Registration
Navigating MoCRA’s regulatory framework can be complex, particularly for international companies entering the U.S. market. At CE.way, we make the process simple by offering:
- Facility registration and renewal support
- FDA-compliant product listings
- Assistance with maintaining safety substantiation documentation
- Full MoCRA compliance packages, including Responsible Person services and product safety reviews
By partnering with CE.way, cosmetic companies gain peace of mind knowing their facilities are properly registered and fully compliant with FDA requirements.
Build Consumer Trust Through Compliance
Facility registration is more than just a legal obligation—it is an opportunity for cosmetic companies to demonstrate accountability and reinforce consumer trust. With CE.way’s expertise, brands can meet every requirement under MoCRA while focusing on growth in the competitive U.S. market.
👉 Contact CE.way today to learn how our team can help you handle facility registration, FDA product listing, and complete MoCRA compliance.
