Scope
RDC 628/2022 applies to coloring substances permitted for personal hygiene products, cosmetics, and perfumes in Brazil. HMI records the artificial organic-colorant impurity row that is directly expressible as elemental lead.
Exact limit and units
Article 5 sets lead, expressed as Pb, at not more than 20 ppm in artificial organic colorants. The structured register converts 20 ppm to 20,000 ug/kg. The same article also lists arsenic as As2O3 and a combined other-heavy-metals cap; those are gap-logged rather than converted into elemental species rows.
How tested
The excerpt does not prescribe a metal-specific analytical method. Article 7 requires insolubility testing for barium, strontium, and zirconium lakes, but that method statement is not a general Pb test method.
Enforcement posture
The list operates as a binding ANVISA positive-list and impurity specification for cosmetic colorants. Covered colorants must meet the listed impurity limits to be used in cosmetic products.
History of changes
RDC 628/2022 was published as an ANVISA resolution in 2022 and replaced older colorant-list provisions for cosmetics.
How it compares
The 20 ppm Pb colorant limit aligns with a common cosmetics-colorant impurity pattern also seen in India, ASEAN-derived cosmetic guidance, and other color-additive schedules. It is an ingredient-colorant limit, not a finished cosmetic Pb limit.
Sources
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.
| Commit | Date | Change | Description |
|---|---|---|---|
| a8052bb | 2026-08-09 | major | 1 source added; contamination-profile values revised; 7 sections added |