FDA MoCRA Compliance
From £395
US market entry under MoCRA: a MoCRA-compliant Toxicological Risk Assessment with the state-level provisions for California, Washington, New York and Minnesota, prepared by the same assessor who signs our EU and UK CPSRs.
- Safety substantiation under the Modernization of Cosmetics Regulation Act 2022
- Federal framework under FDA 21 CFR Parts 700 to 740: facility registration, product listing, adverse event reporting
- State provisions: California (Proposition 65, Safe Cosmetics Act, Toxic-Free Cosmetics Act), Washington, New York, Minnesota
- MoCRA Toxicological Risk Assessment from £395, signed by a Clinical Pharmacologist
- Prepared from the same evidence base as our EU and UK work, and available in multiple languages
The Modernization of Cosmetics Regulation Act 2022 (MoCRA) brought cosmetic products in the United States under a federal safety regime for the first time. It amended the Federal Food, Drug, and Cosmetic Act to require registration of manufacturing and processing facilities with the FDA, listing of each marketed product, adequate substantiation of safety, adverse event recordkeeping and reporting, and the identification of a responsible person. The federal requirements sit within FDA 21 CFR Parts 700 to 740.
The technical centre of MoCRA compliance is the substantiation of safety. Oxford Biosciences prepares a MoCRA-compliant Toxicological Risk Assessment, signed by the same Clinical Pharmacologist who signs our EU and UK CPSRs and worked from the same evidence base. The assessment is £395.
The state-level overlay
Federal compliance is not the whole picture. Several US states impose their own obligations, and a product that satisfies MoCRA can still fall short at state level. Our assessment addresses the provisions of California (Proposition 65, the California Safe Cosmetics Act, and the California Toxic-Free Cosmetics Act), the Washington Department of Ecology Chapter 173-337, New York Environmental Conservation Law Articles 35 and 37, and the Minnesota disclosure regime, so that the substantiation holds across the markets a brand actually sells into.
Where a product is also sold in the EU or UK, the US assessment is built alongside the existing CPSR rather than from scratch, and the documentation makes the points of convergence and divergence explicit. The assessment can be produced in multiple languages for brands filing across several jurisdictions.
Frequently asked questions
What is MoCRA?
MoCRA, the Modernization of Cosmetics Regulation Act 2022, is the first comprehensive federal cosmetics law in the United States. It amended the Federal Food, Drug, and Cosmetic Act to require registration of manufacturing facilities with the FDA, product listing, adequate substantiation of product safety, adverse event recordkeeping and reporting, and a named responsible person. Oxford Biosciences prepares the MoCRA-compliant Toxicological Risk Assessment that substantiates safety, with the relevant US state provisions addressed alongside it.
What is a MoCRA Toxicological Risk Assessment?
A MoCRA Toxicological Risk Assessment is the safety substantiation the Modernization of Cosmetics Regulation Act 2022 requires a US responsible person to hold. Oxford Biosciences prepares it for £395, covering the federal requirement together with the state-level provisions that apply in California (Proposition 65, the Safe Cosmetics Act and the Toxic-Free Cosmetics Act), Washington, New York and Minnesota. It is prepared and signed by the same Clinical Pharmacologist who signs our EU and UK CPSRs, and can be produced in multiple languages.