Latin America · Brazil
What does it take to sell cosmetics in Brazil? Entry route, responsibility, labeling
Pre-market regularisation with ANVISA — electronic notification for most products and reg…; Responsible person: A Brazilian legal entity with ANVISA operating authorisatio…; Labeling: Portuguese labelling per RDC 752/2022 (name, INCI….
Latest change 2026-06-11 — RDC 1.030/2026 (new prohibited list internalising Mercosur GMC 07/25, 12-month adaptation) and RDC 1.029/2026 (restricted list part 1 per GMC 06/25, 24-month adaptation) were issued, following RDC 995/2025's TPO and DMPT ban (in force 2025-11-03) and Law 15.183/2025's animal-testing ban (2025-07-31). Source
Synthèse côté usine ; le texte officiel prévaut ; ne constitue pas un conseil juridique.
- Autorité
- Brazilian Health Regulatory Agency (ANVISA)
- Réglementation principale
- Lei nº 6.360/1976; RDC nº 752/2022 · Law No. 6.360/1976 on sanitary surveillance, implemented for cosmetics by RDC No. 752/2022 (classification, labelling, notification and registration)
- En vigueur
- 2022-10-03
- Introduction sur le marché
- Pre-market regularisation with ANVISA — electronic notification for most products and registration for higher-risk 'products subject to registration' (sunscreens, hair straighteners, repellents, hand sanitisers, children's products), filed by a Brazilian company holding an AFE.
- Personne responsable
- A Brazilian legal entity with ANVISA operating authorisation (AFE) and state licence must be the product holder (detentora) named on the label; foreign manufacturers need a local importer/holder.
- Dossier de sécurité
- Safety/efficacy dossier (formula, specifications, stability, microbiology, safety assessment and, for registered products, efficacy data) kept by the holder and submitted for registration.
- Étiquetage
- Portuguese labelling per RDC 752/2022 (name, INCI ingredients, holder and CNPJ, ANVISA notification/registration number, lot, validity, warnings, consumer service contact); no fragrance-allergen declaration requirement.
- Test animal
- Law No. 15.183 of 2025-07-31 bans testing of cosmetics, perfumes and hygiene products or their ingredients on live vertebrates, with narrow CONCEA exceptions.
- Liste des ingrédients
- RDC 529/2021 (prohibited substances) as amended by RDC 995/2025 and RDC 1.030/2026; RDC 1.029/2026 (restricted substances, part 1); separate Mercosur-harmonised RDCs list permitted preservatives, UV filters and colorants.
- Notes
- RDC 1.029/1.030 are dated 2026-06-11 with DOU publication reported as 2026-06-15, and RDC 1.029's annexes were still to be released; a public consultation (1.399/2026) on the second part of the restricted list ran 2026-07-08 to 2026-09-08.
- Consulter cet inventaire ici
- 巴西 · ANVISA cosmetic ingredient restrictions and positive lists
- Texte officiel
- https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&tipo=RDC&numeroAto=00000752&seqAto=000&valorAno=2022&orgao=RDC%2FDC%2FANVISA%2FMS&codTipo=&desItem=&desItemFim=&cod_menu=1696&cod_modulo=134&pesquisa=true
Modifications 2025–2026
- Brazil issues RDC 1.029/2026 and 1.030/2026 ingredient lists after 2025 bans
La nouvelle liste des substances restreintes harmonisée au sein du Mercosur par ANVISA (partie 1, adaptation sur 24 mois) et la liste des substances interdites (adaptation sur 12 mois) suivent l'interdiction du TPO et du DMPT par la RDC 995/2025 en vigueur depuis le 2025-11-03 ainsi que l'interdiction des tests sur les animaux par la loi 15.183/2025 effective depuis le 2025-07-31 ; la consultation publique n° 1.399/2026 sur la deuxième tranche de la liste des substances restreintes s'est achevée le 8 septembre 2026. Source
FAQ
Does Brazil require notification or registration before sale?
Pre-market regularisation with ANVISA — electronic notification for most products and registration for higher-risk 'products subject to registration' (sunscreens, hair straighteners, repellents, hand sanitisers, children's products), filed by a Brazilian company holding an AFE.
Is a local responsible person mandatory in Brazil?
A Brazilian legal entity with ANVISA operating authorisation (AFE) and state licence must be the product holder (detentora) named on the label; foreign manufacturers need a local importer/holder.
What are the labeling requirements in Brazil?
Portuguese labelling per RDC 752/2022 (name, INCI ingredients, holder and CNPJ, ANVISA notification/registration number, lot, validity, warnings, consumer service contact); no fragrance-allergen declaration requirement.
What changed recently in Brazil cosmetic regulation?
2026-06-11 RDC 1.030/2026 (new prohibited list internalising Mercosur GMC 07/25, 12-month adaptation) and RDC 1.029/2026 (restricted list part 1 per GMC 06/25, 24-month adaptation) were issued, following RDC 995/2025's TPO and DMPT ban (in force 2025-11-03) and Law 15.183/2025's animal-testing ban (2025-07-31).
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