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
Ringkasan sisi pabrik; teks resmi berlaku; bukan nasihat hukum.
- Otoritas
- Brazilian Health Regulatory Agency (ANVISA)
- Regulasi utama
- 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)
- Berlaku
- 2022-10-03
- Masuk pasar
- 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.
- Orang yang bertanggung jawab
- 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.
- Dokumen keamanan
- Safety/efficacy dossier (formula, specifications, stability, microbiology, safety assessment and, for registered products, efficacy data) kept by the holder and submitted for registration.
- Pelabelan
- 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.
- Pengujian pada hewan
- 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.
- Daftar bahan
- 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.
- Catatan
- 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.
- Cari inventaris ini di sini
- 巴西 · ANVISA cosmetic ingredient restrictions and positive lists
- Teks resmi
- 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
Perubahan 2025–2026
- Brazil issues RDC 1.029/2026 and 1.030/2026 ingredient lists after 2025 bans
Daftar pembatasan baru ANVISA yang diselaraskan Mercosur (bagian 1, adaptasi 24 bulan) dan daftar larangan (adaptasi 12 bulan) mengikuti larangan TPO dan DMPT RDC 995/2025 yang berlaku 2025-11-03 dan larangan pengujian pada hewan Undang-Undang 15.183/2025 mulai 2025-07-31; konsultasi 1.399/2026 tentang tranche kedua daftar pembatasan berlangsung hingga 8 September 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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Entering Brazil? Send the product type and we reply with the factory-side document list and lead time. Kirim pertanyaan