Brazil's ANVISA Cosmetic Ingredient Rules Explained: RDC 529/2021 and the Lists Behind It

ANVISA, Brazil's health surveillance agency, does not regulate cosmetic ingredients through one master list. It uses a set of separate Resolução da Diretoria Colegiada (RDC) acts, each covering one function: substances that cannot be used at all, substances allowed as preservatives, substances allowed as UV filters, substances allowed as colorants, and a product-risk classification that decides which products need prior registration. This article walks through each piece, how they trace back to Mercosur, and where Brazil's rules differ from the EU's, using the site's own Brazilian records as evidence. The controlling text throughout is Portuguese; any English wording below, including in ANVISA's own translated titles, is a working aid, not the legal text.

RDC 529/2021: the prohibited-substances list

RDC 529/2021, published 4 August 2021, sets the list of substances that personal-hygiene products, cosmetics and perfumes may not contain in Brazil. It internalises Mercosur GMC Resolution No. 62/2014, as amended by GMC Resolution No. 37/2020 — Mercosur's technical regulation that Brazil, Argentina, Paraguay and Uruguay each turn into national law. At publication the list ran to roughly 1,400 entries.

RDC 529/2021 is not static. ANVISA consolidates amendments into it over time, and the most recent is RDC 1.030/2026, published 11 June 2026, which internalises Mercosur GMC Resolution No. 07/2025 and adds substances including the fragrance ingredients Lilial (Butylphenyl Methylpropional) and Lyral, boric acid and its borates, ketoconazole, and the polymers Polyurethane-18 and Polyurethane-19. Products already on the market get a 12-month compliance window from that publication date, except formulations containing Lilial or Lyral, which get 18 months, to 11 December 2027.

What the site's Brazilian records actually cover

cosingchecker.com/regulations/br/ currently publishes 1,387 Brazilian rules, confirmed live via /api/v1/jurisdictions/. Every one of those records traces to RDC 529/2021's consolidated annex, as amended through RDC 1.030/2026, and every one carries a prohibited status. That is a description of the site's data, not of Brazilian law: RDC 528/2021 (preservatives), RDC 600/2022 (UV filters) and RDC 628/2022 (colorants) are real, separate positive lists that also bind cosmetic formulators in Brazil, but they are not yet built out as individual per-substance records in this dataset. Checking a substance like triclosan against /api/v1/ingredients/38663-triclosan/jurisdictions/ returns entries for the EU, GB, Canada, New Zealand, ASEAN, South Korea and Australia, but no Brazil row — because triclosan sits on the RDC 528/2021 preservatives list, not the RDC 529/2021 prohibited list this dataset tracks. Absence of a Brazil record here means absence from this dataset, never permission under Brazilian law.

curl -s "https://cosingchecker.com/api/v1/jurisdictions/br/rules/?q=exceto"
# 56 of the 1,387 Brazilian records carry a conditional "except" clause
# rather than a flat ban — thresholds and product-type carve-outs that
# only show up by reading the full condition text, not the status field.

The positive lists: preservatives, UV filters and colorants

Alongside the prohibited list, three RDCs set out what may be used, and under what conditions, for three specific functions:

Each of these is a positive list: a substance not named on it may not be used for that function, regardless of whether it also appears, or does not appear, on the RDC 529/2021 prohibited list. A colorant absent from RDC 628/2022 is not automatically prohibited under RDC 529/2021 — it is simply not authorised for colouring use, which is a different legal question that this site's current Brazilian dataset does not yet answer substance-by-substance.

The Mercosur harmonisation behind the RDCs

Mercosur's Grupo Mercado Común (GMC) issues technical resolutions on cosmetics that bind member states only once each one internalises them domestically. Brazil does this through ANVISA's RDCs: RDC 529/2021 for GMC 62/2014 (amended by GMC 37/2020) on prohibited substances, RDC 600/2022 for GMC 44/2015 (amended by GMC 14/2021) on UV filters, and RDC 628/2022 for GMC 16/2012 on colorants. This matters for formulators working across the bloc: a change agreed at Mercosur level does not take effect in Brazil until ANVISA publishes the corresponding RDC, and the domestic instrument, not the Mercosur resolution, is what a Brazilian regulatory-affairs file should cite.

Grau 1 and Grau 2: the categories that gate registration, not the ban itself

RDC 752/2022, of 19 September 2022, sets the current classification. It revoked RDC 07/2015 and consolidated ANVISA's rules on classification, labelling, microbiological limits and market-entry procedures for personal-hygiene products, cosmetics and perfumes. Products are classed by the risk their use presents, Grau 1 or Grau 2; most reach the market through notification to ANVISA rather than a full registration review, and a defined list of product types in the resolution still has to be registered before sale. Read that list in RDC 752/2022 itself: it changed when RDC 07/2015 was replaced, and many summaries still online describe the superseded version.

Grau classification is a market-entry gate, not an ingredient rule: a substance banned under RDC 529/2021 is banned in a Grau 1 product exactly as it is in a Grau 2 one. What the classification changes is how much administrative scrutiny a finished product gets before sale, which is a separate compliance question from whether any individual ingredient is permitted.

How the Brazilian lists map onto the EU annexes

Structurally, Brazil's RDCs and the EU Cosmetics Regulation's annexes serve the same functions but are not the same instrument, and matching a CAS number across both does not mean matching conditions:

• RDC 529/2021 (prohibited) corresponds in role to EU Annex II (prohibited substances)
• RDC 528/2021 (preservatives) corresponds in role to EU Annex V (preservatives)
• RDC 600/2022 (UV filters) corresponds in role to EU Annex VI (UV filters)
• RDC 628/2022 (colorants) corresponds in role to EU Annex IV (colorants)
• The EU also runs Annex III (restricted substances allowed under conditions), which has no single one-to-one Brazilian counterpart in this dataset

Three worked examples of where Brazil and the EU diverge

The following are drawn directly from the site's Brazilian and EU records by CAS number, and checked against ANVISA's and the EU's own text.

Potassium bromate, CAS 7758-01-2, appears in EU Annex II with no qualifying text: a flat ban in all cosmetic products. The equivalent Brazilian RDC 529/2021 entry reads "Bromato de potássio, exceto em produtos para ondular cabelos, na concentração máxima de 10%" — prohibited, except in hair-waving products up to a 10% concentration. Same substance, same CAS number, a materially different scope of ban.

Dibutyl phthalate (DBP), CAS 84-74-2, is likewise an unqualified Annex II entry in the EU. Brazil's RDC 529/2021 record instead reads "Ftalato de dibutila, exceto em produtos para as unhas de uso adulto em concentração até 15%" — prohibited except in adult nail products up to 15%.

Benzyl butyl phthalate (BBP), CAS 85-68-7, is a third unqualified EU Annex II entry. Brazil's record narrows the ban to children's products outright and to adult products only "em concentração maior ou igual a 1%" — at concentrations of 1% or more — leaving a lower-concentration use in adult products outside this particular prohibition entry.

A useful contrast is safrole, CAS 94-59-7, where the two systems align almost word for word: both the EU Annex II entry and Brazil's RDC 529/2021 entry ban it except for normal levels occurring in natural essences, capped at 100 ppm in the finished product and 50 ppm in oral-hygiene products, with no safrole permitted in toothpaste made for children. Shared drafting history does not always produce shared thresholds, as the phthalates and potassium bromate show, but it sometimes does — which is why each substance needs checking on its own rather than assumed from a pattern.

Using this in practice

A record on cosingchecker.com/regulations/br/ is evidence that a named substance appears in ANVISA's consolidated text with a stated status and condition — it is not a compliance verdict, and it is not a substitute for reading the current RDC and its Mercosur basis in Portuguese, which remains the controlling text. cosingchecker.com/market-compare/ and cosingchecker.com/market-divergence/ let you line up the same CAS number across Brazil, the EU and other tracked markets side by side, which is the fastest way to spot a threshold or carve-out like the ones above before it surfaces as a labelling or export problem. Where the site has no Brazilian record for a substance, that means the substance is not on the prohibited list this dataset tracks — check the preservative, UV-filter or colorant RDCs directly, and check ANVISA's own consolidated text, before concluding anything about its status.

Sources

• Resolução RDC nº 529, de 04/08/2021 (ANVISA/Datalegis, official text) — https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&numeroAto=00000529&orgao=RDC%2FDC%2FANVISA%2FMS&tipo=RDC&valorAno=2021
• Anvisa revisa atos normativos da área de Cosméticos (RDC 528, 600, 628, 629, 630 and their Mercosur GMC basis) — https://www.gov.br/anvisa/pt-br/setorregulado/regularizacao/cosmeticos/informes/anvisa-revisa-atos-normativos-da-area-de-cosmeticos
• Anvisa atualiza listas de substâncias para uso em cosméticos (RDC 1.030/2026 and RDC 1.029/2026) — https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/anvisa-atualiza-listas-de-substancias-para-uso-em-cosmeticos
• Resolução da Diretoria Colegiada - RDC nº 7, de 10/02/2015 (revoked by RDC 752/2022) — https://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2015/rdc0007_10_02_2015.pdf
• Resolução da Diretoria Colegiada - RDC nº 752, de 19/09/2022 (current classification) — https://www.legisweb.com.br/legislacao/?id=449665
• Regulation (EC) No 1223/2009 on cosmetic products, consolidated text (Annexes II, IV, V, VI) — https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20240301
• cosingchecker.com API, live Brazilian jurisdiction data — https://cosingchecker.com/api/v1/jurisdictions/ and https://cosingchecker.com/api/v1/jurisdictions/br/rules/