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