MoCRA facility registration is a fundamental compliance requirement for cosmetic manufacturers under the Modernization of Cosmetics Regulation Act. We help companies adapt to this new regulatory reality by ensuring their manufacturing facilities meet FDA registration obligations accurately, efficiently, and in full alignment with U.S. law.
MoCRA marks the most substantial reform of U.S. cosmetic regulation in decades. Its primary objective is to increase FDA oversight, enhance consumer safety, and improve transparency across the cosmetics supply chain. Facility registration plays a central role in achieving these goals by allowing the FDA to identify where cosmetic products are manufactured and to respond quickly in case of safety concerns.
Scope of Facility Registration Requirements
Under MoCRA, facilities engaged in the manufacture or processing of finished cosmetic products intended for the U.S. market must be registered with the FDA through the FDA Direct notification portal. This obligation applies to both domestic and foreign manufacturers supplying cosmetic products to the United States.
Facility registration must be renewed every two years, and manufacturers are responsible for maintaining accurate, current information. Any failure to register or update registration data may result in compliance gaps that expose companies to regulatory scrutiny or enforcement actions.
It is equally important to understand which facilities are excluded. Warehouses, labeling and packaging centers, distribution facilities, ingredient manufacturers, and research or product development sites are not subject to MoCRA facility registration. Correctly determining regulatory scope helps companies avoid unnecessary filings while remaining fully compliant.
Regulatory Expectations Beyond Registration
Facility registration under MoCRA goes beyond submitting basic company details. Manufacturers must be prepared to demonstrate that product safety substantiation documentation is maintained and readily accessible to authorities. While safety data is not submitted as part of the registration itself, MoCRA empowers the FDA to request this documentation at any time.
Additionally, registered facilities must be able to identify the cosmetic product categories manufactured on site and reference the relevant product registration numbers. This strengthens traceability and supports effective regulatory oversight.
Risk Management and Compliance Strategy
From a compliance perspective, MoCRA facility registration should be viewed as part of a broader regulatory strategy rather than a standalone administrative task. Ongoing monitoring, timely updates, and internal compliance processes are essential to maintaining regulatory readiness. Companies that proactively manage these obligations significantly reduce the risk of operational disruptions or market access limitations.
Our Role in MoCRA Compliance
We support cosmetic manufacturers with MoCRA facility registration as a standalone service or as part of integrated compliance packages. Our services also extend to product listings, regulatory updates, formula review, product safety substantiation, U.S. Responsible Person support, and monitoring of U.S. state cosmetics legislation.
By combining regulatory expertise with hands-on implementation support, we help companies translate MoCRA requirements into practical compliance actions.
About CE.way
We are CE.way, an international regulatory consultancy focused on cosmetic compliance in the U.S., EU, and global markets. Our team works closely with manufacturers and brand owners to ensure regulatory obligations are met efficiently, accurately, and in line with evolving legislation. We emphasize clarity, accountability, and long-term compliance planning.
To secure FDA compliance and protect U.S. market access, our MoCRA facility registration services provide cosmetic manufacturers with the regulatory confidence they need in an increasingly controlled regulatory environment.
