Chile’s Broadest REACH Category Yet Starts February 2027
Chile’s REACH-inspired system under Decree 57/2019 hits its broadest category yet in 2027: substances in industrial mixtures. Not professional or consumer use — industrial only.
Notification (Chile’s term for registration) runs February through August 2027.
What triggers the 2027 obligation?
A substance in an industrial mixture classified as hazardous under GHS, present at 1 ton/year or more. Within that, notification in 2027 applies only to substances in imported industrial mixtures that (a) present risks to health or the environment and (b) exceed the applicable cut-off concentration values.
This is a narrower test than any hazardous substance in any mixture — but getting the classification and cut-off analysis right matters, since it determines whether you’re in scope at all.
How do you notify?
For this next range of substances, the Chilean importer will use the email option in place for now: a downloadable Excel form is completed and submitted by email along with the applicable SDS — which must be GHS-compliant under Chile’s adoption of the standard.
Brazil: Artisanal Cosmetics Have Easier Path to Market
Brazil’s health regulator (ANVISA) continues to be at the forefront of regulatory innovation. In addition to the regulatory sandbox for product innovation, the regulator has shown flexibility now toward traditional and small-scale producers of certain cosmetics, personal hygiene, and perfume products. The draft regulations we reported on last fall are now final: RDC 1.045/2026 and IN 474/2026. The rules go into effect 60 days after their October 5, 2026 publication.
The Flexibility
The big news here is that qualifying products need no registration or notification with ANVISA, and producers need no company operating authorization (AFE). Where local health authorities require a sanitary license, it is issued automatically, with inspection only afterward. Responsibility for safety and compliance rests entirely with the producer, and no technical manager is needed. Shelf life is capped at 12 months. These rules are quite different from the complex pathway for bringing standard cosmetics to market.
Who Qualifies
The light touch regulatory regime is not meant to apply broadly. To qualify, a producer and products must meet all the criteria: Production must be predominantly manual, small scale, and fully controlled by the producer from formulation to labeling. Outsourcing any step is prohibited. Automated machinery and salaried workers dedicated to serial production are excluded. Repackaging, dilution, or relabeling of industrial products, and simple assembly of kits, do not qualify. Products must be low risk, with simple formulations, and may not be applied to eyes or mucous membranes or intended for babies, children, pregnant women, or the elderly. Companies and producers outside these limits remain under the standard industrial regime.
Product Groups and Claims
The IN lists seven groups that qualify for the artisanal category: alcohol-based perfumery, room fragrances, solid bath products, solid soaps, solid shampoos and conditioners, body oils and butters, and stick deodorants without aluminum salts. Liquid soaps, bath gels, lotions, and creams are excluded because of microbiological risk. For each artisanal group, the IN sets permitted claims, prohibited claims, and mandatory warnings. Antibacterial, antiperspirant, therapeutic, anti-aging, and sun protection claims are barred where relevant, and room fragrances cannot claim to purify air or repel insects.
Other Requirements
Ingredients must still comply with ANVISA’s lists of prohibited, restricted, preservative, and colorant substances. Producers must follow basic hygiene and facility rules, check final product quality before sale, handle consumer complaints, and keep complaint records. Labels must carry the product name, ingredients, producer identification and contact, manufacture and expiry dates, production address, net quantity, IN warnings, and the statement “PRODUTO ARTESANAL.”
Sales must be through the producer’s own stores, websites, social media, and marketplaces, craft fairs, or door-to-door sales direct to consumers. Family members and helpers may sell on the producer’s behalf.
Key Takeaway:
Industry will not be able to use this new regulatory pathway. It’s clearly designed for small handmade producers, and the scope tests are strict. Instead, industry should take note of ANVISA’s regulatory flexibility – and also understand that even for artisanal products the same ingredient restrictions still apply. In theory the “PRODUTO ARTESANAL” label will make the category visible to consumers and regulators – and differentiate it from industrialized products.
Links:
RDC 1.045/2026: https://www.in.gov.br/web/dou/-/resolucao-da-diretoria-colegiada-anvisa-n-1.045-de-2-de-outubro-de-2026-736303961
IN 474/2026: https://www.in.gov.br/en/web/dou/-/instrucao-normativa-anvisa-n-474-de-2-de-outubro-de-2026-736288471
Brazil: Enforcement Just Got Its Own Page
Latin American countries are notably active on regulation, but from the outside it can seem that those rules are not always enforced. As we have reported many times, enforcement actions happen across product categories in every country all the time, but they rarely make the news. Check out our coverage on Mexico’s COFEPRIS pulling over 31,000 digital ads as part of escalating e-commerce enforcement. Now, Brazil’s health regulator (ANVISA) has taken a step to make that enforcement more visible, for everything from pharmaceuticals to cleaning products and cosmetics.
The Enforcement Site
ANVISA launched a dedicated enforcement page on its portal that aggregates information on product inspection and market surveillance. The agency describes enforcement as one of its main tools for verifying conformity of products and services under health surveillance. The page is aimed at citizens, health professionals, the National Health Surveillance System (SNVS), as well as the regulated sector.
What Is on the Page
The main content includes enforcement actions, a search tool for irregular products, and a notification and search function for theft, robbery, and loss of products. There are separate sections for medicines and vaccines, cosmetics, health products, and household cleaners (saneantes), along with links on aesthetics safety and food supplements and a repository of enforcement news.
The page also lists Epinet, an ANVISA initiative that uses artificial intelligence to monitor online advertising of products subject to health surveillance. ANVISA says the page will be updated continuously and will work as a repository for clarifying enforcement questions.
Key Takeaway:
This is not a story about new product requirements or sanctions. Instead, the news here is the shift in enforcement from scattered notices to a searchable official public record organized by product category. Companies with products in these categories should expect irregular product listings and enforcement actions to be easier for regulators, customers, and competitors to find. Epinet also signals that online advertising and claims will be monitored systematically, which matters for cosmetics and household cleaner marketing in particular. Regulatory affairs teams should review the category sections that apply to their portfolios.
Link to ANVISA enforcement page:
https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao
Brazil: New National EPR Program
Circular Economy and Extended Producer Responsibility are two related concepts that are baked into policies in countries across Latin America at this point. Brazil might be seen as a regional leader in EPR and other progressive waste strategies, going all the way back to its 2010 modern waste law. However, since then, a patchwork of systems has emerged, including product-specific decrees, government/industry agreements (terms of commitment), and complex federal, state, and even municipal laws covering the same companies and end of life products.
The national government is trying to take steps to unify and coordinate EPR, known locally as reverse logistics. Last week, we reported on the National Reverse Logistics System (SISREV-BR), and now the government has posted for public comment a draft National Reverse Logistics Program (PNLR).
What is it?
First, the PNLR is a planning program and not a new set of obligations for industry. It is a coordination document seeking to optimize infrastructure, gain scale, and create synergy among reverse logistics systems. It covers products already subject to EPR obligations, including packaging, electronics, tires, batteries, oils, agrochemicals, and medicines. Targets will be imported from instruments in force when the program is published.
What comes next?
The draft lists actions that point to coming regulations:
Enforcement: a CONAMA enforcement resolution, enablement rules with enforcement mechanisms for managing entities in unregulated sectors, and a revision of the packaging managing entity rule.
Unified Decree: a single Reverse Logistics Decree consolidating the framework.
Economic instruments: a review of recycling certificates, environmental fees, and deposit-return schemes abroad, and improvement of reverse logistics credit instruments.
Tax: coordination with the National Council of Fiscal Policy (CONFAZ) on interstate tax treatment of recyclable flows.
Data and coverage: SISREV-BR and an interoperability environment, a consolidated annual balance of results against targets, and mapping of territorial gaps in system coverage.
Key Takeaway:
This draft will not create any new duties, but it outlines the next steps: tighter managing entity oversight, a consolidated decree, and possible new economic instruments. Companies with reverse logistics obligations should take advantage of this opportunity to shape the future of their regulated environment. Comments are accepted through October 28, 2026 on the Brasil Participativo platform.
Link:
https://brasilparticipativo.presidencia.gov.br/processes/pnlrre de 2026
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Tracking Brazil’s new chemical management law? Visit www.BrazilREACH.comfor plain-English guidance on Law 15.022/2024, including what an Only Representative structure means in practice.
Questions about how any of this applies to your business? Reach out directly at mowen@ambientelegal.comto talk about how we can help your business succeed in Latin America.
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