Explainer

In Brazil, “Grau 2” Does Not Mean “Registered”

The claim

“Grau 2 means ANVISA registered the product and approved it.”

The short answer

Grau 1 and Grau 2 are a risk classification decided by what a product claims. Registro versus notificação is a separate axis. Only nine product groups need registration; most Grau 2 products, including ordinary permanent hair dye, are merely notified.

Evidence status

Settled

The Cosmetic Record · Published 2026-08-06 · Last checked 2026-08-06 · 20 sources · Corrections: none

1. One resolution, and when it came into force

Brazil puts cosmetics, personal-hygiene products and perfumes in one instrument. Since September 2024 that instrument is RDC nº 907, de 19 de setembro de 2024, which sets, in its own words, "a definição, a classificação, os requisitos técnicos para rotulagem e embalagem, os parâmetros para controle microbiológico, bem como os requisitos técnicos e procedimentos para a regularização de produtos de higiene pessoal, cosméticos e perfumes". Art. 51 revokes its predecessor RDC nº 752/2022, revokes RDC nº 841/2023, and revokes Art. 13 of RDC nº 814/2023.¹

Three months later RDC nº 949, de 12 de dezembro de 2024 amended it. That amendment is the one that matters here: it rewrote Art. 2, expanded the definitions in Art. 3, and replaced Anexo I outright with two lists — 71 Grau 1 product groups and 46 Grau 2 product groups. Its Art. 5, in the wording given by RDC nº 966, de 26 de fevereiro de 2025, reads "Esta Resolução entra em vigor em 7 de abril de 2025".²³

Two consequences follow immediately. Any page describing Brazilian cosmetic classification by reference to RDC 752/2022 is describing a revoked text,⁴ and any page reproducing Anexo I without RDC 949/2024 is reproducing a superseded annex. ANVISA's own consumer FAQ is in the first category: the page headed Conceitos e definições, last updated 05/04/2023, still defines both grades by reference to RDC 752/2022.⁶

2. A Mercosur transposition, not a purely national rulebook

The grade system is not Brazilian in origin, and Art. 2 says so:

Esta Resolução incorpora ao Ordenamento Jurídico Nacional as Resoluções GMC MERCOSUL nº 110/1994 "Definição de Produto Cosméticos", 48/2021 "Regulamento Técnico Mercosul sobre Rotulagem para Produtos de Higiene Pessoal, Cosméticos e Perfumes", 44/2018 "Requisitos Técnicos para Produtos de Higiene Pessoal, Cosméticos e Perfumes", 51/1998 "Parâmetros para Controle Microbiológico de Produtos de Higiene Pessoal, Cosméticos e Perfumes" e 18/2023 "Regulamento Técnico Mercosul sobre Classificação de Produtos de Higiene Pessoal, Cosméticos e Perfumes".

The classification rule is therefore a regional one, GMC 18/2023, which Brazil internalised through RDC 949/2024. The substance lists behave the same way: the permitted-preservative list internalises GMC 35/20, the prohibited list internalises GMC 62/14 as amended by GMC 37/20, and the restricted list in force since June 2026 internalises GMC 06/25.⁹¹⁰¹² A reader looking for "the Brazilian rule" is usually looking at a Mercosur text with a Brazilian number on it.

3. Grau 1 and Grau 2: a risk class defined by what the product claims

The two definitions sit at Art. 3, incisos XVII and XVIII. They are one sentence written twice, and the only difference is inicialmente menor against maior, plus which half of Anexo I the inciso points at. Note what does the sorting: the declared purpose of use. Brazil grades risk by what a product claims, which is the same lever the United States uses to decide whether a thing is a cosmetic or a drug at all.

XVII - produtos Grau 1: produtos de higiene pessoal, cosméticos e perfumes que cumprem com a definição adotada no inciso XVI deste artigo e que, por sua área de aplicação, público a que está destinado, condição específica de formulação ou impacto sanitário das finalidades de uso declaradas, requerem inicialmente menor grau de vigilância sanitária, conforme mencionado na lista indicativa "LISTA DE GRUPOS DE PRODUTOS DE GRAU 1" estabelecida no item "I" do Anexo I;

XVIII - produtos Grau 2: [...] requerem maior grau de vigilância sanitária, conforme mencionado na lista indicativa "LISTA DE GRUPOS DE PRODUTOS DE GRAU 2" estabelecida no item "II" do Anexo I;

Four things decide the grade: where the product is applied, who it is aimed at, a specific formulation condition, and "o impacto sanitário das finalidades de uso declaradas" — the health impact of the declared purposes. The last of those is the sentence on the pack. A grade is not a property of a molecule; it is a property of a claim, and Anexo I says so before it lists anything: item 1 provides that every product on the Grau 1 list is reclassified as Grau 2 the moment it declares one of eleven indications, among them "anticaspa" and "para tingimento, clareamento ou descoloração de cabelos e pelos corporais". The formula need not change.¹

The pairs are easy to read side by side. Item I nº 12, "Condicionador ou creme com enxágue ou enxaguatório capilar", is Grau 1. Item II nº 29 and nº 30, "Produtos capilares anticaspa com enxágue" and "sem enxágue", are Grau 2. The same rinse-off hair product changes grade because the label says anti-dandruff. Item II nº 33 is "Produtos destinados para pele sensível, desde que não se proclame como agente de tratamento" — a group whose very definition contains the limit of the claim that may be made. Item II nº 31 is everything "destinados ao público infantil", which is the audience criterion doing the work rather than the formula. Formulation can do it too: Art. 7 provides that a Grau 1 product must not contain the UV filters listed in RDC 600/2022, because their presence moves it up a grade.¹

4. Registro versus notificação is a different axis

Here is the whole of the registration list. It is nine groups:

I - bronzeador; II - gel antisséptico para as mãos; III - produto para alisar os cabelos; IV - produto para alisar e tingir os cabelos; V - produto para ondular os cabelos; VI - protetor solar; VII - protetor solar infantil; VIII - repelente de insetos; e IX - repelente de insetos infantil.

And everything else:

Os produtos dos grupos que não estão elencados no art. 34 desta Resolução são isentos de registro e estão sujeitos ao procedimento de comunicação prévia à Anvisa.

Compare the two lists and the answer falls out. Seven of the nine registered groups appear by name in Anexo I item II, the Grau 2 list — bronzeador at nº 7, protetor solar at nº 41, repelente de insetos at nº 42, the three hair-structure groups at nº 34, 35 and 38, and hand antiseptics at nº 22. The other two, protetor solar infantil and repelente de insetos infantil, reach Grau 2 by the audience route: nº 31 of the same list is "Produtos destinados ao público infantil", and item 1(a) of Anexo I moves any Grau 1 product into Grau 2 once it is declared for children. Registration is therefore a subset of Grau 2 — nine groups against forty-six. Grau 2 is the larger set, and it is not the set that gets examined.

Permanent hair colour is the cleanest worked example. Anexo I item II nº 45 is "Tintura capilar temporária, progressiva ou permanente" — Grau 2, the higher grade. It does not appear in Art. 34. The nearest entry is IV, "produto para alisar e tingir os cabelos", a product that straightens and colours. An ordinary box of permanent dye is notified, not registered, and no Brazilian official reads its dossier before it goes on sale.¹

5. Ten years, not five

English-language summaries routinely give the validity of a Brazilian cosmetic regularisation as five years. That number was correct once and is not correct now. The current text reads:

O registro tem validade por 10 (dez) anos, contados a partir do dia da sua publicação no Diário Oficial da União, podendo ser revalidado sucessivamente por igual período.

The five-year figure comes from the resolution two generations back, RDC nº 7, de 10 de fevereiro de 2015, whose Art. 22 read: "A regularização de produtos de higiene pessoal, cosméticos e perfumes Grau 1 e Grau 2 tem validade de 5 (cinco) anos e poderá ser revalidado por períodos iguais e sucessivos."⁵ That resolution was replaced by RDC 752/2022, which was replaced by RDC 907/2024. The ten-year term is not a 2024 novelty either: RDC 752/2022 already carried it, at its own Art. 40, in the same words the current Art. 40 uses, and that resolution took effect on 3 October 2022. Anything still citing the five-year period is citing a text revoked twice over and superseded on the point since 2022.⁴

The same 2015 resolution is, we think, where the "Grau 2 equals registered" shorthand was born. Its registration list was Anexo VIII, and Anexo VIII was headed "Produtos Grau 2 sujeitos a Registro" — Grau 2 products subject to registration. It ran to 23 items, most of them children's products: infant shampoo, infant conditioner, infant toothpaste, infant lip gloss, infant nail polish. A heading that named a subset was read as though it named the whole class, and the reading survived the annex. Of those 23 items, today's nine-group list keeps one child-specific entry — protetor solar infantil — and adds a second, repelente de insetos infantil; the shampoos, toothpastes and nail polishes are gone from it.⁵

6. Where Brazil keeps its annexes

The European Union puts its positive and negative lists in five annexes to one regulation — Annexes II to VI of Regulation (EC) No 1223/2009.¹⁷ Brazil puts them in six separate resolutions, cross-referenced from Art. 6 of RDC 907/2024: the actives permitted for straightening or waving hair (IN 220/2023), permitted UV filters (RDC 600/2022), permitted colourants (RDC 628/2022), permitted preservatives (RDC 528/2021), substances that may not be used at all (RDC 529/2021), and substances that may be used only under stated restrictions (RDC 530/2021, with RDC 645/2022).¹

Each moves on its own timetable, which is the practical cost of the design. IN 220/2023 revoked IN 124/2022 and took effect on 2 May 2023.⁷ The restricted-substances list was replaced in June 2026 by RDC nº 1.029, de 11 de junho de 2026, which internalises GMC 06/25, revokes RDC 530/2021 at its Art. 4 and gives products already regularised with ANVISA a 24-month adaptation period.¹² The preservative list runs to 60 numbered entries; the prohibited list runs to entry nº 1.419; the restricted list revoked in June ran to 105.⁹¹⁰¹¹ There is no single document to check, and no consolidated Brazilian equivalent of CELEX 02009R1223-20260501.

7. Labelling and the mandatory warnings

Art. 13 sets what must appear on the pack. On secondary packaging that includes the ingredients "utilizando a codificação de substâncias INCI", the "número do processo de regularização do produto", the holder's company authorisation (AFE) number, its CNPJ, the country of origin and the shelf life. The regularisation process number on the carton is the hook that makes §9 of this article possible.¹

Art. 24 then adds warnings for named product groups — aerosols, depilatories, antiperspirants, intimate-hygiene products, hair fixatives — and inciso II covers hair bleaches and colourants. Its first alínea is the line a Brazilian box of dye must carry:

a) "CUIDADO. Pode causar irritação na pele ou reação alérgica. Antes de usar, fazer a prova de toque" (descrever);

Note what this pairs with. A Brazilian hair colourant carries a mandated warning and a mandated self-test, and is notified rather than registered. The warning is the regulator's instrument here, not the dossier review.

8. Formaldehyde and escova progressiva

Products that alter hair structure are among the nine. RDC nº 906, de 19 de setembro de 2024 deals with them separately and its Art. 2 opens with one line: "Os produtos cosméticos para alisar ou ondular os cabelos sujeitam-se a registro." Its §1 closes the door: only products whose actives appear in IN 220/2023 may be registered, and §2 says applications that fail that test are refused. It revokes RDC 409/2020 and RDC 765/2022.⁸ The permitted actives are a closed list in IN 220/2023: thioglycolic acid and its salts, esters of thioglycolic acid, sodium or potassium hydroxide, lithium hydroxide, calcium hydroxide, inorganic sulfites and bisulfites, pyrogallol and thiolactic acid, each with a maximum concentration and, for several, a pH window and a professional-use restriction.⁷ Formaldehyde is not on that list.

ANVISA states the position for consumers in one word. Asked whether formol may be used to straighten hair, its FAQ answers: "Não. Tanto o formol quanto o glutaraldeído (devido à semelhança química com o formol) não podem ser utilizados como alisantes capilares."¹⁶ On 7 July 2025 the agency issued both a public alert on irregular straighteners and Informe de Segurança GGMON nº 03/2025, which records that adding formol to another product is a sanitary infraction and a crime hediondo under Art. 273 of the Penal Code, and that products containing formaldehyde and glyoxylic acid circulate through salons, informal markets and online platforms.¹⁴¹⁵

One boundary is where the Brazilian salon vocabulary and the regulation stop matching. ANVISA regulates products, not procedures. Its campaign page on straighteners, updated 27 April 2026, puts it in two sentences: "Procedimentos e métodos para alisamento capilar, como escovas inteligente, progressivas, BTOX, definitiva e de chocolate, não são regulamentados pela Anvisa. A Agência registra somente os produtos que serão utilizados." Salons are licensed by the local vigilância sanitária, not by ANVISA, and the straighteners FAQ says the same thing. What is regulated is each product in the bowl, and each of those must be registered, not merely notified.¹⁵¹⁶

The concentrations usually quoted alongside this — formol permitted at 0.2% as a preservative and 5% as a nail hardener — we could not confirm against any substance list currently in force, and the section below says exactly how far we got.

9. How to look a product up yourself

Art. 32 provides that "a regularização de produtos de higiene pessoal, cosméticos e perfumes é realizada por meio de procedimento eletrônico por meio do portal da Anvisa", and Art. 45 provides that failing to comply with the resolution cancels the regularisation and the cancellation is published on the agency's site.¹ The consumer-facing route runs through the process number that Art. 13 already requires on the carton. ANVISA's guidance page states it plainly: "Verifique se o produto está registrado na Anvisa, acessando o link: https://consultas.anvisa.gov.br/#/cosmeticos/registrados/", that the search needs "o número do processo, número de registro ou nome do produto, além do CNPJ da empresa detentora do registro", and — the useful part — "Dica: o número do processo sempre inicia com '25351'."¹⁶

Two limits on what that lookup tells you. A hit for a registered product means a file was examined and a decision published; a hit for a notified product means a filing exists. And the ten-year term at Art. 40 means the examination behind a current registration can be a decade old: a decision published today stands until 2036 unless ANVISA cancels it under Art. 45. A regularisation number is a fact about a process, not a verdict on the contents of the bottle in front of you.