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). ソース
工場側の概要です。正式な原文が優先されます。法的助言ではありません。
- 主管機関
- Brazilian Health Regulatory Agency (ANVISA)
- 主要規制
- 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)
- 有効
- 2022-10-03
- 市場参入
- 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.
- 責任者
- 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.
- 安全性ファイル
- Safety/efficacy dossier (formula, specifications, stability, microbiology, safety assessment and, for registered products, efficacy data) kept by the holder and submitted for registration.
- ラベリング
- 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.
- 動物実験
- 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.
- 成分表
- 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.
- 備考
- 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.
- この在庫をこちらで確認
- 巴西 · ANVISA cosmetic ingredient restrictions and positive lists
- 公式文書
- 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
2025〜2026年の変遷
- 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. ソース
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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