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. 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

• 21 CFR Part 73 color additives exempt from certification, 4-1-2023 edition

Update history

The five most recent substantive edits to this page, classified major (evidence or structure moved), correction (a published value or statement was wrong and has been fixed), or minor (narrative rewritten without changing the underlying evidence). Each description is derived from what the edit did to this page; the linked commit is the authoritative record, routine regeneration passes are excluded, and the full version history lives in git. When DOI minting comes online (see schema docs), each entry below will also link to a version-pinned DataCite DOI.