Cosmetic Compliance in United States and Canada
North American cosmetic compliance: US MoCRA safety substantiation with the state-level provisions, and Canadian Health Canada notification under the Cosmetic Regulations. Prepared by the assessor who signs our EU and UK CPSRs.
Regulatory framework
- Regulator
- FDA (United States); Health Canada (Canada)
- Primary regulation
- Modernization of Cosmetics Regulation Act 2022 and FDA 21 CFR Parts 700 to 740 (US); Food and Drugs Act and Cosmetic Regulations C.R.C., c. 869 (Canada)
- Notification
- FDA facility registration and product listing (US); Cosmetic Notification Form (Canada)
- Region
- Americas
The United States and Canada operate separate frameworks, and both diverge from the EU and UK. We prepare for each from the same evidence base that underpins our European work.
United States
The Modernization of Cosmetics Regulation Act 2022 brought US cosmetics under a federal safety regime for the first time. It requires registration of manufacturing facilities with the FDA, product listing, adequate substantiation of safety, adverse event recordkeeping and reporting, and a responsible person, within FDA 21 CFR Parts 700 to 740. The technical centre of compliance is a MoCRA Toxicological Risk Assessment, which we prepare as a fixed-fee engagement. Several states impose their own obligations on top of the federal requirement, and our assessment addresses California (Proposition 65, the Safe Cosmetics Act and the Toxic-Free Cosmetics Act), Washington, New York and Minnesota.
Canada
Canadian cosmetics are governed by the Food and Drugs Act and the Cosmetic Regulations (C.R.C., c. 869), administered by Health Canada. We prepare the Cosmetic Notification Form, review every ingredient against the Health Canada Cosmetic Ingredient Hotlist, and provide a written compliance report.
Lead and heavy metals
In the United States, FDA draft guidance from December 2016 recommends no more than 10 ppm lead in lip products and externally applied cosmetics. Washington State law bans lead at 1 ppm or above from 1 January 2025. Its interim policy accepts up to 2 ppm in general cosmetics and 5 ppm in colour cosmetics and clay masks while the state writes a permanent rule. In Canada, Health Canada guidance treats lead above 10 ppm as technically avoidable. Our lead limits page sets these figures beside those of other markets, each with a link to its primary source, and our heavy metals testing service reports results against them.
Our services for United States and Canada
FDA MoCRA
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.
Learn more →CPSR
From £70 · 2 to 3 days
The Cosmetic Product Safety Report is the safety assessment required under Article 10 and Annex I of Regulation (EC) No 1223/2009 before a cosmetic product may be placed on the UK or EU market. Prepared and signed by a qualified safety assessor.
Learn more →Global Markets
Cosmetic regulatory documentation for markets beyond the EU and UK: Canada, Australia, New Zealand, ASEAN, the GCC and Latin America, prepared from the same evidence base by the assessor who signs our CPSRs.
Learn more →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 as a fixed-fee engagement, 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.
What is the lead limit for cosmetics in the United States?
At federal level, FDA draft guidance from December 2016 recommends no more than 10 ppm lead as an impurity in lip products and externally applied cosmetics, and the guidance does not bind companies. In Washington State, the Toxic-Free Cosmetics Act bans lead at 1 ppm or above from 1 January 2025. An interim policy there accepts up to 2 ppm in general cosmetics and 5 ppm in colour cosmetics and clay masks while the state writes a permanent rule.
What are the lead limits for cosmetics in Canada, Latin America and India?
Health Canada guidance from July 2012 treats lead above 10 ppm in a cosmetic as technically avoidable. In the MERCOSUR countries, artificial organic colourants may carry up to 20 ppm lead, and Brazil applies this through ANVISA RDC 628 of 2022. India's Cosmetics Rules 2020 allow up to 20 ppm lead in the permitted colours. The MERCOSUR and Indian limits apply to the colourant, with no figure for the finished product.