21 CFR Part 700
The section of the US Code of Federal Regulations containing FDA regulations specific to cosmetic products, including prohibited ingredients, required warning statements, and labeling requirements. Parts 700-740 collectively govern cosmetics.
Title 21 of the Code of Federal Regulations (CFR), Parts 700 through 740 contains the FDA's regulatory requirements for cosmetics. These regulations implement the statutory authority granted by the FD&C Act and MoCRA.
Part 700 covers general provisions including prohibited and restricted ingredients. For example, 21 CFR 700.11 prohibits bithionol, 700.13 prohibits mercury compounds (with limited exceptions), 700.14 prohibits vinyl chloride as an ingredient or propellant, 700.15 prohibits zirconium-containing complexes in aerosol cosmetics, 700.16 prohibits chloroform as an ingredient, 700.18 prohibits chlorofluorocarbon propellants, and 700.23 prohibits methylene chloride.
Part 701 addresses labeling requirements including ingredient declaration (using INCI names in descending order of predominance), warning statements, and fair packaging requirements. Part 710 covers voluntary cosmetic registration (now mandatory under MoCRA), and Part 720 covers voluntary product listing (also now mandatory).
The CFR is updated annually and published by the Government Publishing Office. FDA periodically amends these parts through notice-and-comment rulemaking, and MoCRA has triggered significant new rulemaking expected to update these sections through 2026.
Related Terms
Federal Food, Drug, and Cosmetic Act (FD&C Act)
The foundational US law (21 U.S.C. ch. 9) granting the FDA authority to oversee the safety of food, drugs, medical devices, and cosmetics. MoCRA (2022) amended the FD&C Act to significantly expand FDA's cosmetics oversight.
OrganizationFood and Drug Administration (FDA)
The US federal agency within the Department of Health and Human Services responsible for regulating cosmetics, food, drugs, medical devices, and other products. Under MoCRA, the FDA has expanded authority over cosmetics including facility registration, product listing, and mandatory recall power.
RegulationModernization of Cosmetics Regulation Act (MoCRA)
A US federal law (Public Law 117-328, Title XXXV) signed on December 29, 2022, that gives the FDA new authority over cosmetics including mandatory facility registration, product listing, adverse event reporting, safety substantiation, and recall authority.
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