Cosmetic Compliance in South America

Selling cosmetics in South America

South America has no single regulator. A product faces one of three frameworks depending on where it is sold, and in every case it must comply with the rules of the country of sale rather than the region in the abstract. Brazil stands on its own. Argentina, Uruguay and Paraguay share the Mercosur framework. Colombia, Peru, Ecuador and Bolivia share the Andean Community framework. Chile sits outside both. The encouraging point for a brand already assessed for Europe is that the regional frameworks draw on the same scientific basis as EU law, so the existing dossier carries much of the weight.

Brazil

Brazil is regulated by ANVISA, the Agência Nacional de Vigilância Sanitária. Resolution RDC 907/2024, in force from 2025, consolidates the framework, and RDC 949/2024 sets the risk classification. Grade 1 products (lower risk, such as shampoo and soap) require only notification and may be sold once notified; Grade 2 products require full registration with safety, efficacy and stability data and may be sold only after ANVISA approval. RDC 907/2024 lists nine product groups that always require registration, among them sunscreens, hair straightening and waving products, antiseptic hand gels and insect repellents.

A foreign manufacturer cannot hold a registration directly. It must appoint a Brazilian legal representative or importer that holds an ANVISA company operating authorisation (the Autorização de Funcionamento, or AFE), and imports clear through the SISCOMEX system. Labelling is in Portuguese, and a cosmetovigilance system is required under RDC 894/2024.

The Mercosur bloc: Argentina, Uruguay and Paraguay

Mercosur sets common rules through GMC Resolutions, which take effect simultaneously across the member states under the Ouro Preto Protocol. Resolution GMC 110/94 established the risk classification (Grade I lower risk, Grade II higher risk), and Resolution GMC 18/23 is the updated classification regulation now being incorporated nationally. In Argentina the regulator is ANMAT, the Administración Nacional de Medicamentos, Alimentos y Tecnología Médica, which administers notification through its TAD platform and places particular weight on Good Manufacturing Practice and stability data. Labelling is in Spanish, to GMC Resolution 36/04.

The Andean Community: Colombia, Peru, Ecuador and Bolivia

The Andean Community operates a genuinely regional system. Cosmetics require a Mandatory Sanitary Notification (Notificación Sanitaria Obligatoria, NSO) under Decision 833, which replaced Decision 516 and entered into force in 2020. The notification is made by a Responsible Person established in the first country of sale, is valid for seven years, and is then recognised in the other member states. In Colombia the competent authority is INVIMA. Decision 833 expressly takes the EU directives and regulations as reference for its ingredient lists, which keeps it close to an EU dossier.

Chile

Chile is outside both blocs. Cosmetics are regulated by the Instituto de Salud Pública (ISP) under Supreme Decree No. 239, on a registration basis.

How Oxford Biosciences helps

For a product already assessed for the EU or UK, the task is rarely to rebuild the science. It is to map the existing safety evidence onto each national requirement, prepare the country-specific documentation in Portuguese or Spanish, and work with the local representative each market requires. South American engagements are quoted on application.