21 CFR Part 70 - Color Additives

What it says

Part 70 contains general provisions for color additives used in food, drugs, cosmetics and medical devices. A color additive generally must be listed by FDA for its intended use before it can be used, and some require batch certification by FDA. The part covers petitions, listing, certification and requirements for labeling of color additives.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• A colorant that is acceptable in one product type may not be listed for another.
• Certified colors are tested batch by batch by FDA before use, while exempt colors have separate conditions.
• Color additives must be declared in ingredient labeling as required.

What FDA inspectors look for

• Whether color additives used are listed for the intended use.
• Whether certified batches come with proper certification.
• Whether labeling declares color additives correctly.

Related regulations