The Code of Federal Regulations (CFR) is a comprehensive codification of the general and permanent rules issued by U.S. federal government agencies. It is organized into 50 titles, each addressing a broad regulatory area. Title 21 CFR, dedicated to the Food and Drug Administration (FDA), provides detailed regulatory guidance under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Each CFR title is revised annually, with updates to Title 21 typically released around April 1st. Over the years, Title 21 has undergone frequent updates to align with changes in laws, advancements in cosmetic, food and drug regulations, and evolving industry practices. The latest updates to Title 21 CFR were released on December 6, 2024.
Key regulations in Title 21 CFR applicable to cosmetics include:
21 CFR Part 1 - General Enforcement Regulations
21 CFR Part 2 - General Administrative Rulings and Decisions
21 CFR Part 20 - Public Information
21 CFR Part 250 Section 250.250 - Requirements for Drugs and Cosmetics -- Hexachlorophene
21 CFR Part 700 Subpart A (Section 700.3) - Cosmetics -- General Provisions
21 CFR Part 700 Subpart B (Sections 700.11 Through 700.35) - Requirements for Specific Cosmetic Products
21 CFR Part 701 Subpart A - (Sections 701.1 Through 701.9) Cosmetic Labeling -- General Provisions
21 CFR Part 701 Subpart B - (Sections 701.10 Through 701.19) Package Form
21 CFR Part 701 Subpart C - (Sections 701.20 through 701.30) Labeling of Specific Ingredients
21 CFR Part 710 - Voluntary Registration of Cosmetic Product Establishments
21 CFR Part 720 - Voluntary Filing of Cosmetic Product Ingredient and Cosmetic Raw Material Composition Statements
21 CFR Part 740 - Cosmetic Product Warning Statements
21 CFR 73, Subpart C - Color Additives Listed for Use in Cosmetics: Exempt from Certification
21 CFR 74, Subpart C - Color Additives Listed for Use in Cosmetics: Subject to Certification
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