US FDA 21 CFR Part 74 - certified color-additive metal specifications

Scope

Part 74 covers color additives subject to certification for foods, drugs, cosmetics, and medical devices. HMI records direct section-level metal impurity specifications from the local 4-1-2023 CFR edition.

Exact limit and units

The structured register contains direct Part 74 rows for arsenic, lead, mercury, cadmium, and chromium where the local text states a numeric not-more-than value. Values in ppm, p/m, or mg/kg are normalized to ug/kg.

How tested

Part 74 works with FDA batch certification under part 80 and section-specific identity/specification provisions. The extracted rows preserve the section and color-additive context rather than generalizing one test method across the part.

Enforcement posture

Certified color additives must meet the section specifications and batch-certification requirements. A batch outside specification is not lawfully usable under the listed authorization.

History of changes

The local PDF is the 21 CFR Ch. I 4-1-2023 edition, generated from the CFR print text.

How it compares

These rows are ingredient-level certified-color-additive specifications, not finished-product contaminant limits. They are comparable to other cosmetic or food colorant impurity limits already carried in the register.

Sources

• 21 CFR Part 74 color additives subject to certification, 4-1-2023 edition

Update history

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