Exporting Cosmetics to Brazil: ANVISA Notification, AFE and DUIMP

How ANVISA classifies cosmetics: Grade 1, Grade 2, notification or registration

ANVISA (Agência Nacional de Vigilância Sanitária) regulates personal hygiene products, cosmetics and perfumes (produtos de higiene pessoal, cosméticos e perfumes, HPPC). The main rule is RDC 907/2024, in force since its publication on 23 September 2024. It replaced RDC 752/2022 and was amended by RDC 949/2024, which rewrote Annex I, the list of product groups. Products are Grade 1 (Grau 1), needing a lower degree of surveillance, or Grade 2 (Grau 2), needing more, depending on where they are applied, who uses them, the formula and the claims. A Grade 1 product becomes Grade 2 if it claims, for example, use by pregnant women or infants, sensitive or acne-prone skin, sun protection, tanning, anti-dandruff or antiseptic action, or if it colours hair. Products for children are Grade 2.

The grade sets the data the company must hold; the procedure depends on the product group. Article 34 lists the groups that need registration (registro): ANVISA assesses them before sale and publishes the registration in the Diário Oficial da União (DOU). Every other group, Grade 1 or Grade 2, is exempt from registration and is notified (comunicação prévia): the product may be sold once it appears on ANVISA's portal. Registrations are valid for 10 years; for notified products the holder declares every 10 years that it still sells the product. Groups that need registration:

• Sunscreen (protetor solar), including children's sunscreen, and bronzer (bronzeador).
• Products to straighten hair, to straighten and dye hair, or to wave hair; RDC 906/2024 sets extra rules for them.
• Insect repellents, including children's repellents.
• Antiseptic hand gel.
• Hair pomades for fixing or styling, which ANVISA analyses before sale under the temporary rules of RDC 814/2023.
• Timing: the gov.br service pages estimate up to 3 calendar days for a notification and about 150 calendar days for a registration.

Only a Brazilian company with an AFE can hold the notification

ANVISA states that foreign companies cannot obtain marketing authorizations directly; they must partner with a company legally established in Brazil, which becomes the legal holder (titular) and answers for the product. For imported products, Article 38 of RDC 907/2024 requires the holder to have an ANVISA operating authorization (Autorização de Funcionamento de Empresa, AFE) to import that product class and a licence from the state or municipal health authority. Importing and distributing cosmetics need an AFE under RDC 16/2014; retail sale does not. The holder's legal representative and technical responsible sign a statement of responsibility (Termo de Responsabilidade), and the holder's name, CNPJ and AFE number go on the label.

Since 7 April 2025 new notifications are filed in ANVISA's Solicita system (Datavisa), which replaced the older SGAS system (RDC 951/2024, amended by RDC 965/2025). The applicant needs a CNPJ registered with ANVISA and a security manager linked to a gov.br account, which a foreign brand does not have. The holder can be your distributor or a separate regulatory company that holds the notifications for you and authorizes the import. Agree in writing who holds each notification and what happens if you change partner, and plan for a new partner having to notify the products again in its own name.

The holder files, or keeps on file, a technical dossier that the brand normally supplies: the qualitative and quantitative formula with INCI names and the function of each ingredient, specifications of the finished product and raw materials, stability, safety and efficacy data, the manufacturing process, the lot coding system and label artwork; a registration of an imported product also needs a copy of the original formula. A consularized or apostilled free sale certificate is not required (Article 10), and ANVISA does not require GMP certification for cosmetics, although it expects good manufacturing practice.

Ingredient lists, the 2026 updates and the animal testing ban

Brazil's ingredient lists take over MERCOSUR technical regulations and change when MERCOSUR updates them. The prohibited list is RDC 529/2021. RDC 1.030/2026, published on 15 June 2026, takes over MERCOSUR GMC Resolution 07/25: it adds 13 substances, changes some entries and moves 4 to the restricted list. Products already on the market have 12 months to comply, or 18 months for butylphenyl methylpropional (lilial) and hydroxyisohexyl 3-cyclohexene carboxaldehyde (lyral). RDC 1.029/2026, which takes over GMC Resolution 06/25 and replaces the restricted list of RDC 530/2021, was republished with its annex on 25 June 2026 and gives 24 months. The positive lists are RDC 528/2021 for preservatives, RDC 628/2022 for colorants and RDC 600/2022 for UV filters. A public consultation on the second part of the restricted list (Consulta Pública 1.399/2026) closed on 8 September 2026, so expect further changes. Check every formula against the Brazilian lists, not only against your home market's rules.

Law 15.183/2025 of 30 July 2025, in force since its publication on 31 July 2025, amended Law 11.794/2008 to ban the use of live vertebrate animals in tests of personal hygiene products, cosmetics and perfumes, and of ingredients made only for them. Animal test data generated after that date cannot be used to authorize the sale of such products or ingredients, unless it was obtained to meet non-cosmetic regulation in Brazil or abroad; the company must prove that purpose on request. Products relying on new animal data may not claim "not tested on animals" or "cruelty free", and products tested before the law may still be sold. The law gave the authorities two years to recognize alternative methods.

Labels in Brazilian Portuguese

Article 20 of RDC 907/2024 requires the mandatory label information to be legible in Brazilian Portuguese; INCI names, product names and brands may stay as they are. Article 13 splits the items between the container (primary packaging) and the outer pack (secondary packaging); if there is no outer pack, everything goes on the container (Article 14). If the container is too small, instructions and warnings may go on a leaflet or inside the outer pack, with a reference such as "Ver folheto".

• Container: product name, brand, product group if not clear from the name, batch number, and warnings and restrictions of use where they apply.
• Outer pack: product name, brand, product group, content, ingredients by INCI name, country of origin, expiry date, warnings, the holder's company name, CNPJ and AFE number, the ANVISA process number, and consumer contact details (phone, email or website).
• Container or outer pack: instructions for use where needed; hair and beard fixing products need detailed use instructions, including the quantity to apply.
• Composition in Portuguese (RDC 898/2024): the ingredients must also be listed in Portuguese, under the heading "Composição (português)" or "Ingredientes (português)", printed or through a QR code or website link, using ANVISA's INCI translation panel. This has applied to products made from 1 November 2023.
• Stickers: missing items may be added with a label applied at origin or in Brazil before sale (Article 21). Imported products may not claim therapeutic action or carry prohibited or unproven claims in any language; such text must be covered before sale (Article 22).

The importer: RADAR, product catalogue, DUIMP and ANVISA's check

The importer needs a CNPJ and Siscomex habilitação, known as RADAR, under IN RFB 1.984/2020. Listed companies and state companies use the expressa type, without limits. Other companies are limitada, with import ceilings of USD 50,000 or USD 150,000 per six-month period depending on their estimated financial capacity, or ilimitada, without limits. Check that your partner's ceiling covers your orders.

Brazil has moved imports from the old Siscomex import declaration (DI) and import licence (LI) to the Portal Único. The importer registers each product in the Catálogo de Produtos, with a full description in Portuguese, the NCM and ANVISA attributes such as the notification or registration number, and registers the foreign manufacturer and exporter as foreign operators (operadores estrangeiros) with name, address and, where available, a tax identification number (TIN). The DUIMP (Declaração Única de Importação) takes its product data from the catalogue. ANVISA says the DUIMP has been mandatory since 27 April 2026 for many imports that need its consent; some operations still use the DI or LI under the Siscomex switch-off schedule, last updated in September 2026.

ANVISA's control of imports is set by RDC 977/2025, in force since 9 June 2025. Depending on the operation, its consent comes through an LPCO (licence, permit, certificate or other document) requested in the Portal Único, or through a sanitary check (conferência sanitária) of the DUIMP, which may be documentary or physical. Products must be notified or registered before they are imported for sale (RDC 81/2008), and ANVISA says complete, consistent data is decisive for quick release. The commercial invoice (fatura comercial) and packing list must therefore match the catalogue and DUIMP. Under Article 557 of the Regulamento Aduaneiro the invoice shows the exporter and importer, a description in Portuguese, English, French or Spanish, marks and numbers, packages, gross and net weights, countries of origin, acquisition and provenance, unit and total prices, freight and other costs, payment terms and currency, and the Incoterm; it must be signed by the exporter, and a digital signature is accepted.

NCM codes, import taxes and origin

Brazil classifies goods in the 8-digit Mercosur Common Nomenclature (NCM), built on the HS. Most cosmetics fall in heading 3303 (perfumes and toilet waters), 3304 (beauty, make-up and skin care preparations, including sunscreens), 3305 (hair preparations), 3306 (oral hygiene) or 3307 (shaving preparations, deodorants, bath preparations). The import duty (II) comes from the MERCOSUR Common External Tariff (TEC) with Brazil's own exceptions; common lines such as 3303.00.20 (colognes), 3304.10.00 (lip make-up) and 3304.99.10 (creams and lotions) pay 16.2% of the customs value, which includes freight and insurance. IPI varies by NCM in the TIPI table, for example 7.8% for 3303.00.20 and 14.3% for 3304.99.10. PIS/PASEP-Importação and COFINS-Importação on headings 33.03 to 33.07 are 3.52% and 16.48% (Law 10.865/2004, Article 8 § 2, as amended by Law 13.137/2015). The importer's state charges ICMS at rates that vary by state, and some states set higher rates for perfumes and cosmetics. Triplicate's landed cost calculator gives a first estimate; get the final figure from the importer's customs broker.

Tax reform: under Complementary Law 214/2025, the new CBS and IBS have been shown on invoices since 1 January 2026 in a test year, and taxpayers who meet the reporting obligations do not pay them. Collection starts in 2027 for CBS and in 2029 for IBS, which replace PIS/COFINS and, step by step, ICMS and ISS; the transition ends in 2033. Ask your importer how its prices will change.

Origin: Brazil has no trade agreement with Korea, Japan, China or the US (MERCOSUR–Korea talks have not produced one), so their goods pay the full II whatever the certificate of origin says; still show the true origin on the invoice. EU-origin goods can claim the EU–Mercosur Interim Trade Agreement, provisionally applied since 1 May 2026, with a statement on origin; many cuts are phased, so check the rate for your NCM. India's preferential trade agreement with MERCOSUR, in force since June 2009, covers only about 450 products. Goods originating in Argentina, Paraguay or Uruguay can enter with MERCOSUR preference on a MERCOSUR certificate of origin.