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Heavy Metal Index

US FDA 21 CFR Part 73 - color-additive metal specifications

Scope Part 73 covers color additives exempt from certification for foods, drugs, cosmetics, and medical devices.

Scope

Part 73 covers color additives exempt from certification for foods, drugs, cosmetics, and medical devices. HMI records direct metal not-more-than specifications from the local 4-1-2023 CFR edition.

Exact limit and units

The structured register contains direct Part 73 section-level rows for arsenic, lead, mercury, cadmium, chromium, nickel, antimony, tin, and aluminum where the source states a numeric not-more-than value. Values in ppm, p/m, or mg/kg are normalized to ug/kg; percent specifications are converted as percent by weight.

How tested

Part 73 sections usually state identity, specifications, uses, labeling, and exemption from certification. Some sections name specific determinations for lead or arsenic, but the extracted source does not provide one uniform analytical method for all rows.

Enforcement posture

Color additives must conform to their section specifications to be safely used under the listed conditions. Products outside the listed uses or specifications are not covered by the exemption.

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 are ingredient-level color-additive specifications, not finished-food, finished-drug, or finished-cosmetic contaminant limits. Cross-referenced sections are gap-logged rather than expanded without a relational CFR parser.

Sources

Update history

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