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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). Fuente

Resumen del lado de fábrica; prevalece el texto oficial; no constituye asesoramiento legal.

Autoridad
Brazilian Health Regulatory Agency (ANVISA)
Regulación principal
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)
Vigente
2022-10-03
Entrada al mercado
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.
Persona 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.
Ficha de seguridad
Safety/efficacy dossier (formula, specifications, stability, microbiology, safety assessment and, for registered products, efficacy data) kept by the holder and submitted for registration.
Etiquetado
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.
Pruebas en animales
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.
Listas de ingredientes
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.
Notas
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.
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巴西 · ANVISA cosmetic ingredient restrictions and positive lists
Texto oficial
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

Cambios 2025–2026

  1. Brazil issues RDC 1.029/2026 and 1.030/2026 ingredient lists after 2025 bans

    ANVISA's new Mercosur-harmonised restricted list (part 1, 24-month adaptation) and prohibited list (12-month adaptation) follow RDC 995/2025's TPO and DMPT ban in force 2025-11-03 and Law 15.183/2025's animal-testing ban from 2025-07-31; consultation 1.399/2026 on the second restricted-list tranche ran until 8 September 2026. Fuente

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).

Fuente: 123456

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