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Heavy Metal Index

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.

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

Update history

No substantive edit history is available in this build. The full commit record is available in git.