MoCRA facility registration represents one of the most important regulatory obligations introduced by the Modernization of Cosmetics Regulation Act (MoCRA) for cosmetic manufacturers operating in or exporting to the United States. We support companies in meeting FDA requirements efficiently, ensuring full compliance, transparency, and regulatory readiness under the new U.S. cosmetics framework.
MoCRA significantly strengthens FDA oversight of cosmetic products and manufacturing practices. One of its cornerstone requirements is mandatory facility registration with the FDA, designed to improve product traceability, consumer safety, and accountability across the cosmetics supply chain.
What Is Facility Registration Under MoCRA?
Under MoCRA, cosmetic manufacturers must register their facilities with the FDA using the FDA Direct notification portal. This obligation applies to establishments engaged in the manufacturing or processing of finished cosmetic products intended for sale in the U.S. market. Facility registrations must be renewed every two years, and companies are responsible for ensuring that all submitted information remains accurate and up to date.
The registration requirement is focused specifically on facilities involved in final product manufacturing. Warehouses, labeling and packaging centers, distribution facilities, ingredient manufacturers, research laboratories, and product development or testing centers are exempt from this obligation. Correctly identifying whether a facility falls within the scope of MoCRA is essential to avoid unnecessary filings or regulatory exposure.
Information Required for FDA Facility Registration
To complete MoCRA facility registration, companies must provide comprehensive and accurate information to the FDA. This includes company and facility identification details, the cosmetic product categories manufactured at the facility, and the registration numbers of cosmetic products produced on site.
In addition, manufacturers must ensure that product safety substantiation documentation is maintained and readily available for FDA inspection upon request. While safety data is not submitted during facility registration itself, MoCRA requires that manufacturers can demonstrate the safety of their products at any time.
Ongoing Compliance Responsibilities
Facility registration is not a one-time administrative task. Under MoCRA, manufacturers must actively manage regulatory compliance by updating facility registrations when required, renewing registrations every two years, and maintaining internal documentation systems that support FDA inspections and regulatory audits.
Failure to comply with MoCRA facility registration requirements may result in enforcement actions, regulatory delays, or restrictions on market access. Proactive compliance planning is therefore essential for companies operating in the U.S. cosmetics market.
How We Support MoCRA Compliance
We provide structured regulatory support for MoCRA compliance, including facility registration, product listings, and regulatory updates. Our services can be delivered as standalone support or as part of comprehensive MoCRA compliance packages, tailored to the size, structure, and regulatory exposure of each company.
In addition to facility registration, we assist with U.S. state cosmetics legislation monitoring, product safety substantiation, formula review, and U.S. Responsible Person support, ensuring a complete and coordinated approach to regulatory compliance.
About CE.way
We are CE.way, an international regulatory consultancy specializing in cosmetic compliance across the U.S., EU, and global markets. We work with cosmetic manufacturers, brand owners, and distributors to translate complex regulatory requirements into clear, actionable compliance strategies. Our team combines regulatory expertise with practical industry insight, helping companies meet FDA expectations efficiently and confidently.
For reliable regulatory guidance and end-to-end support, our MoCRA facility registration services help cosmetic manufacturers secure U.S. market access while staying fully compliant with evolving FDA regulations.
