Selling skincare in Brazil and Mexico: ANVISA and COFEPRIS rules

Brazil and Mexico at a glance

The two largest Latin American markets regulate cosmetics in very different ways. Brazil runs a pre-market system: every product is notified or registered with the federal health regulator before it is sold. Mexico runs a mostly post-market system: there is no product file to submit, but the company, the factory standard and the label are all regulated, and COFEPRIS checks products already on the market.

Neither country lets a Korean manufacturer or a foreign brand hold the product directly. Your first decision for both markets is the same: which local company will be the importer and the legal holder, and what your contract says if you later change partners.

Brazil: how the ANVISA system works

ANVISA, Brazil's federal health regulator, groups skincare with toiletries and fragrances as "personal hygiene products, cosmetics and perfumes" (produtos de higiene pessoal, cosméticos e perfumes, often shortened to HPPC). The main rule today is ANVISA Resolution RDC 907 of 19 September 2024, published in the Diário Oficial da União on 20 September 2024. It covers the definition, the classification, labeling and packaging requirements, microbiological parameters and the procedures to regularize a product. ANVISA's 2026 technical notes cite RDC 907/2024 as the rule for regularization; some older ANVISA FAQ pages still cite its predecessor, RDC 752/2022, so you will see both numbers.

RDC 907/2024 defines these products as preparations of natural or synthetic substances for external use on the body (skin, hair, nails, lips, external genital organs, teeth and the mouth) whose only or main purpose is to clean, perfume, change the appearance of, correct body odor, protect or keep them in good condition. Anything that claims to treat a disease falls outside that definition and moves into the medicine rules.

Terms used below:

• Regularização: the general word for making a product legal to sell, either by notification or by registration.
• Notificação or comunicação prévia: the online prior notice for products exempt from registration. ANVISA does not evaluate the file before publication; the company answers for it.
• Registro: a full registration, reviewed by ANVISA and published in the Diário Oficial da União before sale.
• AFE (Autorização de Funcionamento de Empresa): ANVISA's operating authorization. A company needs it to make or import cosmetics.
• Responsável Técnico: the qualified technical responsible person at the Brazilian company who signs the product's responsibility statement.
• TFVS (Taxa de Fiscalização de Vigilância Sanitária): the sanitary surveillance fee paid for each petition by a federal payment slip (GRU).

Brazil: the AFE holder and the technical responsible

ANVISA's guidance is direct: to make or import cosmetics, a company needs an AFE. A Korean manufacturer cannot hold a Brazilian notification, and neither can a brand registered in the US, the UK or Korea. The product is held by a Brazilian company, called the holder (titular), which is usually your importer or distributor, or your own Brazilian subsidiary.

ANVISA lists the company steps in this order:

1. Local operating license

   The company first gets a Licença de Funcionamento (also called an alvará) from the state or municipal health surveillance office where it operates, for the activity of importing and storing cosmetics.

2. ANVISA company registration

   The company registers in ANVISA's systems, which links the legal representatives and users who will file petitions on its behalf.

3. Company size change, if needed

   The company declares its size (porte). This sets the value of the TFVS fees it pays, so micro and small companies should do it before filing.

4. AFE

   The company applies to ANVISA for the operating authorization for cosmetics. Only then can it notify or register products and import them.

The holder's Responsável Técnico and legal representative sign the Termo de Responsabilidade generated at the end of each electronic notification, and the company keeps it on file for health inspections. That signature is why a serious Brazilian holder will ask you for real data (formula, specifications, stability, microbiology, safety and efficacy support) before it notifies anything.

Brazil: Grade 1 and Grade 2 products

ANVISA classifies every product as Grade 1 or Grade 2, based on the probability of unwanted effects from improper use, the formulation, the purpose, the body area and the care needed in use.

• Grade 1: products with basic or elementary properties, where proof of the claims is not initially required and no detailed directions or restrictions are needed. Examples from ANVISA's indicative list: facial cleansing creams, lotions, gels and oils (except for acne-prone skin), facial toners (except for acne-prone skin), body creams and lotions with only moisturizing or refreshing purpose, hand and foot creams with only moisturizing purpose, mechanical exfoliating scrubs, makeup removers, and lip balm without sun protection.
• Grade 2: products with specific indications whose characteristics require proof of safety and/or efficacy, plus information, precautions, directions and restrictions of use. Examples from the same list: skin lightening products (clareador da pele), products for acne-prone skin, anti-wrinkle products, chemical peels, eye area products other than makeup and moisturizers, sunscreens and children's sunscreens, makeup with sun protection, lip protectors with SPF, anti-dandruff and anti-hair-loss shampoos and conditioners, hair dyes, and all children's products.

Grade 2 does not mean registration. This is the point most foreign brands miss. Under article 34 of RDC 907/2024, only these nine groups need a registration:

For a Grade 2 product that is only notified, the proof of safety and efficacy is not reviewed before sale, but it must exist in the holder's file and be shown on request. So a "reduces the look of wrinkles" serum still needs test data; it just does not wait for ANVISA approval.

Brazil: step by step to legal sale

The steps follow a 30 mL hyaluronic acid serum (Grade 1), a 30 mL brightening serum (Grade 2) and an SPF 50 sunscreen (registration), all made in Korea for a Brazilian importer.

1. Pick the Brazilian holder

   Confirm the importer has an AFE for cosmetics, a Responsável Técnico, and experience with the product type. Agree in writing who holds the notifications and what happens to them if you part ways.

2. Classify each product

   Use ANVISA's Grade 1 and Grade 2 lists and the article 34 list. The hyaluronic serum is Grade 1 notification, the brightening serum Grade 2 notification, the sunscreen a registration. The claims you plan to print decide the grade, so fix the claims before the file.

3. Check the formula against the Brazilian lists

   Every ingredient must comply with ANVISA's lists of prohibited and restricted substances, and every colorant, preservative and UV filter must be on the permitted lists (see the next section). A formula legal in Korea or the EU can still need a change.

4. Collect the technical file

   Formula, specifications, stability and packaging compatibility, microbiological results against ANVISA's parameters, and safety and efficacy support for Grade 2 claims. The sunscreen also needs SPF and UVA protection test reports for its registration file.

5. Write the Portuguese label

   The holder approves the Portuguese text, warnings and holder details. ANVISA asks for the label art (projeto de arte) in the regularization process. Leave room for the lot and expiry codes.

6. Notify or register

   Notifications are filed online in ANVISA's cosmetics system (SGAS). The system generates the GRU payment slip for the TFVS fee, and the online protocol is created automatically once payment is confirmed, which can take up to 72 hours. The product can be sold once the notification is published on ANVISA's portal. Registrations are filed in the Solicita system with the documents attached, reviewed by ANVISA and published in the Diário Oficial da União; the sunscreen can only be sold after that publication.

7. Import and clear

   The AFE holder imports the goods, with ANVISA's health control at the port or airport and customs clearance in Brazil. Ship only formulas and labels that match exactly what was notified or registered.

8. Keep it current

   Formula, label or shelf life changes are notified in SGAS (notified products) or filed as change petitions (registered products). Both notification and registration are valid for 10 years; for a notification, the holder declares interest in continuing in the last 6 months before it expires.

Timelines and fees. A notification can be published within days of payment when the file is complete. ANVISA does not publish a fixed review time for registrations, so ask your holder for its recent experience with sunscreens. TFVS fees depend on the petition type and the company's declared size; the system calculates them for each filing. As of October 2026 we do not quote a fee here because it varies by company size.

Brazil: ingredient lists and Mercosur

Brazil's ingredient lists are harmonized within Mercosur (Brazil, Argentina, Paraguay and Uruguay): ANVISA adopts the Mercosur resolutions into national RDCs. ANVISA's 2022 consolidation shows the pattern:

The practical rules for a Korean formula:

• Preservatives, colorants and UV filters work as positive lists. If one is not listed, it cannot be used, even if Korea or the EU allows it.
• The ingredient list uses INCI names. ANVISA publishes a translation base of INCI names into Portuguese for its systems, and new ingredients are added to its database by request.
• Microbiological limits are part of RDC 907/2024. Ask your manufacturer for batch microbiology results that state the method and limits.
• Mercosur harmonizes the lists, not the filings. A Brazilian notification does not let you sell in Argentina, Paraguay or Uruguay; each country has its own filing and local holder.

Brazil: labeling in Portuguese

ANVISA's labeling guidance lists the items that must appear on cosmetics labels, and Brazil's Consumer Defense Code requires product information in Portuguese. In practice the label shows:

• the product name and the group or type it belongs to, when the name does not make it clear;
• the brand;
• the manufacturer, importer and/or holder, with their address;
• directions for use, where needed;
• warnings and restrictions of use, including those required by specific rules (sunscreens, acids, children's products);
• the ingredients or composition;
• the lot, the expiry date (prazo de validade) and the content;
• the regularization details your holder confirms for that product.

Lot and expiry codes are not submitted to ANVISA; the label art shows where they go. The holder must keep every label version used for 2 years after the end of the product's shelf life, and ANVISA can suspend sales if a label it asks for cannot be produced. Changes to the name, holder, directions, warnings, ingredients or claims must be informed to ANVISA. The cross-market overview is in our label requirements by country guide.

Brazil: claims, whitening, acne and sunscreen

A cosmetic in Brazil cannot carry therapeutic indications. Three areas matter most for K-beauty lines:

• Whitening and dark spots. Skin lightening products are allowed as Grade 2 notified cosmetics with safety and efficacy support. But ANVISA's technical opinion (Parecer Técnico 1 of 28 July 2009) bans the words "mancha" (spot or stain) and "despigmentante" (depigmenting) in product names, labels, inserts and advertising, along with any other words or images that suggest the same, because a spot can be a sign of disease. "Uniformiza o tom" (evens the look of skin tone) or "ilumina" (brightens) is the cosmetic way to say it.
• Acne. "Produto para pele acneica" (for acne-prone skin) is a Grade 2 cosmetic. A claim to treat acne, kill bacteria or heal lesions makes it a medicine.
• Sunscreen. Sunscreen is a cosmetic in Brazil, unlike in the US, but it is one of the nine registration groups. RDC 629/2022 sets the protection, testing and labeling rules, and the UV filters must come from RDC 600/2022. Plan SPF and UVA tests to the methods ANVISA accepts before production.

Our cosmetic or drug guide compares these lines across markets, and the sunscreen regulation guide covers SPF and UVA testing.

Brazil: the 2025 animal testing law

Law 15.183 of 30 July 2025 amended Brazil's animal experimentation law (Law 11.794/2008) and the health surveillance law (Law 6.360/1976). It:

• bans the use of live vertebrate animals in tests of personal hygiene products, cosmetics and perfumes, including hazard, efficacy and safety tests, and of ingredients used only in those products;
• says animal test data generated after the law took effect cannot be used to authorize marketing, unless the test was done to meet a non-cosmetic rule in Brazil or abroad, which the company must prove on request;
• bars "not tested on animals" or "cruelty-free" type claims for products whose safety was established with new animal data;
• lets products and ingredients tested before the law stay on sale, and gives health authorities up to 2 years from publication to set up the alternative methods, monitoring and labeling rules.

For a Korean-made line this is rarely a problem: Korea's Cosmetics Act already bans animal testing of cosmetics, and KoreanOEM does not test on animals.

Brazil: post-market duties

• Cosmetovigilance. The holder must run a cosmetovigilance system in Brazil, record and report serious adverse events to ANVISA, document follow-up actions and keep records for 5 years. The current rule is reported as RDC 894/2024; confirm the reporting forms with your holder.
• Match the file. A registered product must match what ANVISA approved, and no change is allowed without prior authorization. A notified product must match its notification; changes are filed in SGAS.
• Label archive. Keep every label version for 2 years after the end of its shelf life.
• Renewal. Notifications and registrations last 10 years. A notification lapses if the holder does not declare interest in continuing in its last 6 months, and ANVISA can cancel it for non-compliance.

Our recalls and adverse events guide gives a full incident plan.

Mexico: how COFEPRIS regulates cosmetics

Mexico's General Health Law (Ley General de Salud) and its Regulation on the Sanitary Control of Products and Services set the framework, and COFEPRIS enforces it. A cosmetic is a product for external use on the body; a substance meant to be swallowed, inhaled, injected or implanted is not a cosmetic, as COFEPRIS's cosmetics page quotes from the law.

What Mexico does not have is a product registration for ordinary cosmetics. COFEPRIS's cosmetics page names one filing: the notice of operation (aviso de funcionamiento) for companies that sell cosmetics, submitted through its DIGIPRiS self-service platform. Specialist sources report the same: no pre-market product approval, with COFEPRIS checking products on the market. Instead, the obligations sit in four places:

Who is responsible. The Mexican company named on the label as importer or responsible party answers for the product. Specialist sources report that a foreign company sells through a Mexican local representative that handles all COFEPRIS communication and takes legal responsibility. The importer also needs to be registered in the tax authority's importers' register (Padrón de Importadores of the SAT), and imports normally clear through a licensed customs broker (agente aduanal). Ask the customs broker whether your tariff codes trigger any further health notice or permit at entry; the answer depends on the product.

Mexico: step by step to legal sale

The steps follow a niacinamide serum and an SPF 50 sunscreen made in Korea and sold by a Mexican importer on Mercado Libre and in stores.

1. Choose the importer

   The importer must be in the SAT importers' register, have its aviso de funcionamiento for cosmetics on file with COFEPRIS, and work to NOM-259-SSA1-2022. Agree who is named on the label and who handles complaints and recalls.

2. Check the formula

   Screen every ingredient against Mexico's agreement on prohibited and restricted substances. Preservatives, colorants and UV filters must be on the permitted lists. Mexico is often close to EU and US practice, but check each one.

3. Prove GMP

   NOM-259-SSA1-2022 applies to every establishment that processes or imports cosmetics sold in Mexico, and importers are reported to need proof that products were made under equivalent GMP. An ISO 22716 certificate copy from the manufacturer is the usual evidence.

4. Write the Spanish label

   Follow NOM-141 section by section (next section). The importer's name and address can be added in Mexico after customs clearance and before sale, which lets you ship one pack and sticker locally.

5. Check claims and advertising

   No medicinal-type or unverifiable claims on the pack. Advertising for cosmetics is reported to need a notice through DIGIPRiS, per brand, with the manufacturer, importer and distributor details.

6. Import and sell

   The customs broker clears the goods with the commercial invoice, packing list and origin documents. The importer keeps batch records, the COA and complaint records ready for a COFEPRIS inspection.

Timelines and fees. Because there is no product approval, Mexico is usually faster than Brazil: the time is in the importer setup and the label work. COFEPRIS fees for notices, where they apply, are set in Mexico's federal fees law and change each year; ask your importer for the current amount.

Mexico: NOM-141 labeling in Spanish

NOM-141-SSA1/SCFI-2012 (published 19 September 2012, in force 18 December 2012, modified on sunscreens in 2014) is the core Mexican rule. The main requirements:

• Language (5.1.1). All mandatory information in Spanish. Other languages may appear, but never in larger characters than the Spanish.
• Generic name (5.1.5.1). Every product shows its generic name (denominación genérica) from the norm's appendix, for example "crema facial" or "suero facial"; a specific name is optional.
• Responsible party (5.1.6.1). Name or business name and full address of the manufacturer or importer. For imported products this may be added in Mexico after customs clearance and before sale.
• Country of origin (5.1.6.2). "Hecho en Corea" or "Producto de Corea".
• Lot (5.1.7.1). A lot code that stays legible in normal use.
• Directions (5.1.8). Required for sun protection products, self-tanners, depilatories, dyes and others; "léase instructivo anexo" when they are on an insert.
• Net content (5.2). In metric units under the Mexican net content standards; the words "contenido neto" are optional.
• Ingredients (5.3.1 to 5.3.3). Introduced by the word "Ingredientes", in decreasing order, or above 1% in decreasing order followed by those at 1% or less in any order. INCI names are accepted. Fragrance can be named generically.
• Expiry (5.3.6). A date (at least month and year) is required only when the shelf life is 24 months or less.
• Warnings (5.3.7). Category warnings in Spanish, for example for sun protection products, ampoule formats ("no ingerible", "no inyectable"), aerosols and flammable products.
• Small packs (5.2.5, 5.3.5). Samples and very small items have reduced requirements, with the ingredient list allowed on the outer box, an insert or a tag.

More detail and other markets are in our label requirements by country and the INCI, PAO and claims guide.

Mexico: claims, sunscreen and advertising

• No medicinal claims. NOM-141 (5.1.9) bans unverifiable claims, medicinal-type effects and images that imply properties the product does not have. "Treats acne", "removes melasma" or "heals" pushes a product toward the medicine rules. "Helps reduce the look of blemishes" and "brightens the look of dull skin" stay cosmetic.
• Whitening. A lightening claim stays cosmetic only when it is about appearance and the ingredients sit within the substances agreement; anything presented as treating a pigmentation disorder belongs to the medicine rules. Keep the wording on appearance.
• Sunscreen (Appendix A). Sunscreen is a cosmetic in Mexico. It must protect against both UVB and UVA, with an SPF of at least 6 and UVA protection of at least one third of the SPF. The label states the SPF value and explains "FPS" or "SPF", gives a protection level, carries the sun warnings (avoid overexposure, keep babies and young children out of direct sun, stop if irritation appears, avoid the eyes) and states that no sunscreen gives 100% protection. "Bloqueador solar", "protección total" and "no need to reapply" are banned.
• Advertising. Cosmetic advertising may not attribute therapeutic properties or present a cosmetic as essential, and is reported to need a notice through DIGIPRiS per brand.
• Animal testing. Mexico amended its General Health Law to ban animal testing for cosmetics (reported; check the current text of the law with your importer). KoreanOEM does not test on animals.

Mexico: GMP, complaints and recalls

NOM-259-SSA1-2022 sets the minimum GMP for "the process and import of cosmetic products" and is mandatory for every establishment that processes and/or imports cosmetics sold in Mexico. For an importer the most relevant parts are:

• a written procedure for handling complaints, with special attention to toxic or allergenic effects (14.1.1);
• a recall procedure coordinated by authorized staff, and an obligation to inform the competent authorities when a recall could affect consumer health (14.3.3 and 14.3.5);
• records kept at least 1 year after the product's expiry or minimum durability date (16.2.2);
• supplier qualification, because materials can be approved on a supplier's quality certificate only when that supplier is qualified (9.3.3).

NOM-259 does not set up a separate adverse event filing like Brazil's cosmetovigilance rule, so ask your importer how it reports serious reactions and logs complaints for COFEPRIS inspections.

Chile, Colombia and the Andean countries

Other Latin American markets each have their own rules and local holder. Colombia, Ecuador, Peru and Bolivia follow Andean Community Decision 833, under which a local company files a mandatory sanitary notification (Notificación Sanitaria Obligatoria) with the national authority, such as INVIMA in Colombia, DIGEMID in Peru and ARCSA in Ecuador (reported). Chile regulates cosmetics through its public health institute (ISP) under Decree 239 of 2002 (reported). Argentina, Paraguay and Uruguay share the Mercosur ingredient lists with Brazil but run their own filings. For each of these, the documents from the manufacturer are close to Brazil's list: Certificate of Free Sale, formula information, specifications, COA, GMP certificate and label drafts. Check with the local company or the authority before you sell.

What the local company does and what we provide

The full list of shipment documents is in the export and import guide and export documents explained; duties are in the HS codes and duties guide, and shipping terms in Incoterms, LCL and customs brokers.

Frequently asked questions

How does ANVISA notification work in Brazil?

A Brazilian company with an ANVISA operating authorization (AFE) notifies each product online in ANVISA's cosmetics system, pays the TFVS fee, and can sell once the notification is published on ANVISA's portal. The notification is valid for 10 years, and the holder keeps the technical file and the signed responsibility statement for inspections.

What is the difference between Grade 1 and Grade 2 cosmetics in Brazil?

Grade 1 products have basic properties that need no initial proof, such as moisturizing creams and facial cleansers. Grade 2 products have specific indications that need proof of safety or efficacy, such as skin lightening, anti-wrinkle, acne-prone skin, sunscreen and children's products. Most Grade 2 products are still notified, not registered.

Which cosmetics need ANVISA registration?

Under article 34 of RDC 907/2024, nine groups need registration: tanning products, antiseptic hand gel, hair straightening products, hair straightening and coloring products, hair waving products, sunscreen, children's sunscreen, insect repellent and children's insect repellent. Registrations are published in the Diário Oficial da União and valid for 10 years.

Do I need a Brazilian company to sell skincare in Brazil?

Yes. ANVISA requires an operating authorization (AFE) to import cosmetics, and the product is held by that Brazilian company. Foreign brands usually work through an importer or distributor that holds the notifications, with a contract on transferring them if the partnership ends.

Does Mexico require cosmetics to be registered with COFEPRIS?

No product registration is required for ordinary cosmetics (reported, and COFEPRIS's cosmetics page lists only the notice of operation). The Mexican importer files an aviso de funcionamiento through DIGIPRiS, follows the GMP standard NOM-259-SSA1-2022 and labels products under NOM-141-SSA1/SCFI-2012.

What does NOM-141 require on a cosmetic label in Mexico?

Spanish text, the generic product name, the name and address of the manufacturer or importer, the country of origin such as "Hecho en Corea", a lot code, net content in metric units, the ingredient list introduced by "Ingredientes", directions and warnings where required, and an expiry date when the shelf life is 24 months or less.

Is sunscreen a cosmetic in Brazil and Mexico?

Yes in both. In Brazil it is a cosmetic that needs a full ANVISA registration under RDC 907/2024, with RDC 629/2022 and the UV filter list in RDC 600/2022. In Mexico it is a cosmetic that must protect against UVB and UVA, show the SPF, carry sun warnings and avoid claims such as "bloqueador solar" or "protección total".

Can I sell a skin whitening product in Brazil?

Yes, as a Grade 2 notified cosmetic with safety and efficacy support, within the ingredient limits. ANVISA bans the words "mancha" and "despigmentante" and any similar wording or images on cosmetic labels and advertising, so use appearance claims such as evening the look of skin tone.

Is animal testing banned for cosmetics in Brazil?

Yes. Law 15.183 of 30 July 2025 bans tests on live vertebrate animals for cosmetics, personal hygiene products, perfumes and ingredients used only in them, and bars new animal data from supporting marketing authorization unless it was generated for a non-cosmetic rule. Products tested before the law may stay on sale.

How do Chile, Colombia and the Andean countries handle cosmetics?

Colombia, Ecuador, Peru and Bolivia follow Andean Community Decision 833, with a mandatory sanitary notification filed by a local company with the national authority, and Chile's ISP regulates cosmetics under Decree 239 of 2002 (both reported). Each needs a local holder, so check the current rule with that company before you sell.

Sources

• ANVISA: Nota Técnica 35/2026 (cites RDC 907/2024 as the regularization rule and quotes its article 34 registration list)
• ANVISA: Cosméticos isentos de registro (notification steps, TFVS, 72-hour protocol, 10-year validity)
• ANVISA: Registro de cosméticos (AFE, Solicita, publication in the DOU, 10-year validity)
• ANVISA: Conceitos e definições (Grade 1 and Grade 2 definitions and lists)
• ANVISA: Rotulagem (mandatory label items, label art, 2-year label archive)
• ANVISA: Anvisa revisa atos normativos da área de Cosméticos (RDC 600, 628, 629, 630, 639 of 2022 and their Mercosur origin)
• ANVISA: Parecer Técnico 1 of 28 July 2009 (ban on "mancha" and "despigmentante")
• Presidência da República: Lei 15.183 of 30 July 2025 (animal testing ban for cosmetics)
• ANVISA: Autorização de Funcionamento (AFE)
• COFEPRIS: Productos cosméticos (definition, aviso de funcionamiento through DIGIPRiS) and COFEPRIS: disposiciones normativas for cosmetics
• Diario Oficial de la Federación: NOM-141-SSA1/SCFI-2012, labeling of prepackaged cosmetics
• Diario Oficial de la Federación: NOM-259-SSA1-2022, good manufacturing practices for cosmetics
• ChemLinked: Brazil cosmetic regulation (secondary: ingredient list RDCs, cosmetovigilance RDC 894/2024) and ChemLinked: Mexican cosmetic regulation (secondary: substances agreement, local representative, advertising notice)

Checked against these sources in October 2026. Rules and fees change; check with the authority or your importer before you sell.