Cosmetics Compliance in South America: ANVISA, Invima, COFEPRIS

On February 16, 2026, more than a hundred nail gel and semi-permanent polish products became illegal to sell anywhere in the Andean Community. Colombia's Invima had cancelled 136 Mandatory Sanitary Notifications (NSO) through Resolution 2026007526, automatically triggered 60 days after the bloc's Resolution 2548 of 2025 banned the photoinitiator TPO and the accelerant DMPT for reproductive toxicity and carcinogenicity risks. Five weeks later, on the other side of the continent, Brazil's ANVISA published RE 1.146 cancelling the registrations of more than 500 nail products containing the same two substances, the tail end of a ban it had approved on its own, RDC 995/2025, four months before the Andean bloc acted.

Two regional blocs, two national health agencies, one chemical pair, and two different timelines for the same underlying safety concern: that is the operating reality for any cosmetics compliance team covering South America in 2026. Brazil and Argentina answer to Mercosur, Colombia answers to the Andean Community alongside Bolivia, Ecuador and Peru, and Chile and Mexico run entirely independent national systems with no supranational layer at all. A single ingredient ban can arrive on five different dates depending on which country's shelf it is sitting on.

Which regulators actually govern cosmetics compliance across South America?

There is no continental cosmetics authority. Brazil's ANVISA, through its General Management of Cosmetics (GGCOS), regulates under Resolution RDC 907/2024, which consolidated and replaced RDC 752/2022, RDC 841/2023 and Article 13 of RDC 814/2023 when it took effect on September 23, 2024. Argentina's ANMAT applies the same Mercosur technical regulations domestically once it incorporates them by disposición. Colombia's Invima administers the Andean Community's Decision 833, in force since March 1, 2021, alongside Bolivia, Ecuador and Peru. Chile's Instituto de Salud Pública (ISP) runs its own system under Decreto Supremo 239/02, tied to neither bloc. Mexico's COFEPRIS, whose cosmetics rules are grounded in the General Health Law and a set of Normas Oficiales Mexicanas, is not part of either South American trade bloc at all.

The practical consequence is that a company selling the same formulation in Brazil, Colombia, Chile and Mexico is dealing with four different legal instruments, three different notification codes, and no single point of ingredient truth. A ban decided in Brussels or Brasília does not become law anywhere else in the region automatically.

How did the TPO and DMPT bans expose two different enforcement speeds?

Brazil moved first and moved nationally. ANVISA's board approved RDC 995/2025 on October 29, 2025, prohibiting the manufacture, import and new registration of any cosmetic containing TPO or DMPT immediately, giving companies 90 days to stop selling existing stock. When that window closed in late January 2026, ANVISA proceeded to cancel the registrations of the affected products, formalizing the list of over 500 items in RE 1.146, published and confirmed between March 26 and 31, 2026.

The Andean Community moved as a bloc and moved slower on paper, but its mechanism was harsher once triggered. Resolution 2548 of 2025, published in the Gaceta Oficial of the Cartagena Agreement on December 15, 2025, gave member states 60 calendar days for an automatic NSO cancellation, with no discretion to extend. Colombia's Invima executed that cancellation via Resolution 2026007526 dated February 17, 2026, and the commercialization cutoff, including exhausting existing stock, took effect the day before, February 16, 2026, publicly announced March 4 and 5, 2026 with the full 136-product list. Mercosur's own bloc-wide version, GMC Resolution 27/2025, published November 12, 2025, set a later internal deadline: member states had until May 3, 2026 to incorporate it into national law, with a further 60 days after each country's incorporation before compliance was required, a schedule Brazil had effectively already outrun with its own earlier national rule.

What does Brazil's Grade I and Grade II system actually require?

RDC 949/2024 sorts every cosmetic, personal hygiene product and perfume into one of two risk grades, and the grade determines the entire pathway. Grade I products, generic soaps, basic shampoos, perfumes and nail polish among them, only need a prior notification filed with GGCOS through the Solicita/Datavisa platform, carry no pre-market technical review, and stay valid for 5 years. Grade II products, including sunscreens, hair straighteners, anti-dandruff formulas and topical insect repellents under Article 34 of RDC 907/2024, require a full dossier with stability and safety data, an average review time of around 120 days, and a 10-year validity once granted.

The list of what a company must screen for keeps moving. RDC 1030/2026, published June 15, 2026, amended the prohibited substances Annex to RDC 529/2021 and internalized Mercosur's GMC Resolution 07/25, giving companies 12 months from publication to adapt already-registered products, extended to 18 months specifically for formulations containing the fragrance allergens butylphenyl methylpropional or hydroxyisohexyl 3-cyclohexene carboxaldehyde, the same two substances the EU restricted under Regulation (EU) 2025/877.

Why does Mexico's cosmetics regime look so different from the rest of the region?

Mexico skips product-level pre-market approval almost entirely. COFEPRIS does not require sanitary registration for the large majority of cosmetics before they reach the market; instead, the binding obligation is a Notice of Operation (Aviso de Funcionamiento) filed once through the DIGIPRIS platform under procedure code COFEPRIS-05-018, using the company's e.firma, before manufacturing, importing or distributing begins. Any change to the establishment's address, ownership or activity must be reported within 30 calendar days under the related COFEPRIS-05-019 procedure.

What actually stops shipments at the Mexican border is labeling, not registration. NOM-141-SSA1/SCFI-2012 mandates that every prepackaged cosmetic carry Spanish-language labeling with the product name, net content, batch number, country of origin, importer's name, address and RFC tax ID, and a full INCI ingredient list in descending order of concentration, while NOM-259-SSA1-2022 sets the Good Manufacturing Practice standard manufacturers must be able to demonstrate on request. A missing importer RFC or an English-only warning statement is a far more common cause of customs detention in Mexico than any ingredient dispute.

What should a team entering Colombia or Chile expect operationally?

Colombia's Invima operates entirely inside the Andean Community's harmonized system, so an NSO issued in Colombia, Bolivia, Ecuador or Peru is recognized across all four countries from a company's second country of sale onward, and stays valid for 7 years under Decision 833. Decision 944, in force since December 17, 2025, rewrote Article 9 of that Decision to simplify what technical substantiation an applicant must submit, but it did not touch the labeling rules, which still fall back to the older Decision 516 pending a dedicated Andean labeling regulation that has not yet been issued.

Chile sits outside both blocs entirely. The ISP authorizes cosmetics under Decreto Supremo 239/02 through its GICONA online system, issuing either a notification (for low-risk hygiene and odor products) or a full registration depending on category, both valid for 5 years. The ISP has also been notably active on enforcement against the informal market, publicly naming unauthorized sellers on social media and e-commerce sites and directing consumers to its public registry at registrosanitario.ispch.gob.cl to verify a product before purchase, a level of retail-facing enforcement that has no real equivalent in Brazil or Mexico's frameworks.

What should a compliance team do next?

The TPO and DMPT episode is a useful test case because it shows the region will keep producing near-simultaneous but not identical deadlines: a bloc-wide ban, a national ban that moves faster than the bloc, and a formal cancellation notice that can land with only weeks of public notice. Building a single South America cosmetics calendar means tracking ANVISA's RDC pipeline, ANMAT's incorporation disposiciones, Invima's NSO cancellations under Andean Community resolutions, ISP's GICONA-based authorizations, and COFEPRIS's NOM updates as five separate, asynchronous feeds, not one.

Obsidian tracks each of these sources directly, so a team does not have to manually check five agency portals to catch the next ingredient cancellation before it hits a shelf. Setting up per-jurisdiction monitoring flags a new RDC, a Mercosur GMC resolution, or an Andean Community NSO cancellation the moment it publishes, rather than weeks later through a trade association email. The AI companion can answer a direct question about a specific country's current ingredient restrictions straight from Obsidian's verified regulatory database, and teams running their own compliance tooling can pull the same underlying data through the MCP integration. Given how differently Brazil, the Andean Community, Chile and Mexico have each handled the same ingredient risk this year, the safer assumption for 2027 planning is that South America will keep moving as five separate regulatory clocks, not one.