Chile REACH 2027: Which Products Are Actually Covered?

Registration under Chile REACH rolls onto hazardous substances in industrial mixtures next year – from February through August 2027.

Not every hazardous substance in scope — and not every mixture, either.

Chile’s Decree 57/2019 exempts a long list of product categories already governed by their own rules: pharmaceuticals, food and animal feed, cosmetics, hazardous waste, medical devices, fertilizers, and several others — though raw materials and additives used to make some of these products can still fall back into scope.

For substances in imported mixtures specifically, inclusion isn’t automatic. Two conditions both have to be met — a risk to health and the environment and a concentration above specific hazard-based thresholds — before notification is triggered.

And the mixture itself has to be classified as industrial under Chile’s own definitions — professional and consumer-use mixtures are treated differently.

That combination of exemptions, thresholds, and mixture classification is where scope errors are most likely: assuming a product is covered when it is not or missing that it is.

AMBIENTELEGAL handles Chile substance registrations from start to finish. Companies unsure whether the 2027 phase applies are welcome to get in touch.

Brazil REACH: What Next and When

Brazil’s major chemical framework measure, Law 15.022/2024 – known widely as Brazil REACH – still lacks the implementing decree that would make many provisions fully operational. Last word is that the latest version of that draft is still circulating in the legal departments of the Executive Branch agencies. Brazil watchers and newsletter readers know that the current Presidential elections could impact the future of this important chemical regulatory system.

This tense moment in the next step for Brazil REACH got extra energy when CONAMA (Brazil’s Environmental Council) just adopted a motion proposed by an NGO that urges the federal government to adopt the regulation and the rest of the scaffolding needed for the new framework chemical management system. Keep in mind, though, that a motion is a recommendation and does not bind the government or companies.

The motion basically urges the government to:

• publish the decree implementing Law 15.022/2024 (Brazil REACH)
• publish the pending decree on the country’s national emergency response system for hazardous product (ENP2R2)
• create a new National Chemical Substances Agency to coordinate implementation and support the new chemical committees called for in Law 15.022/2024
• have greater coordination among CONAMA, the National Commission on Chemical Safety (Conasq), and other bodies responsible for chemical management in implementing the Global Framework on Chemicals (GFC) in Brazil.

Key Takeaway:

CONAMA, like many in industry and civil society, is pressing for the decree and the committees which the chemical framework needs before it can operate fully. The question is whether the government can get the decree published before the end of the President’s current term (which ends on January 1, 2027). All eyes on Brazil.

Brazil: ANVISA Moves to Make Its Regulatory Sandbox Permanent

Brazil’s health authority (ANVISA) continues its run of rule-making innovation. The “regulatory sandbox” concept that we have reported on in the past now takes form. The government just posted a draft Collegiate Board Resolution (RDC) for public comment that would set permanent rules for how ANVISA runs experimental regulatory environments.

What Is It?

This draft RDC creates general rules for the ANVISA sandbox, a mechanism for supervised testing of innovative products and services subject to health surveillance. Projects test under temporary regulatory flexibility, within limits set in advance. Comments are open from October 13 to December 11, 2026.

How It Would Work

Participation is by selection. ANVISA would run experimental cycles through specific calls that set scope, eligibility, number of participants, and objectives. Selected projects sign an Experimental Regulatory Flexibility Protocol and receive a Temporary Authorization.

Health rules stay in force except those expressly relaxed for the specific project, and requirements on health protection, quality, safety, and efficacy remain. ANVISA would monitor projects throughout and can suspend or cancel an authorization for noncompliance or significant health risks.

Completing the sandbox creates no vested right. It does not guarantee registration, final authorization, or validation of the tested model. The evidence produced informs future regulatory decisions.

Cannabis Sandbox

The draft also amends RDC 1,014/2026 to bring the existing medical cannabis sandbox into the new general model.

Key Takeaway

The draft turns the sandbox from a series of pilots into a standing framework. ANVISA points to emerging technologies, digital health, medical devices, advanced therapies, artificial intelligence, and new service models as the likely users. For cosmetics and household product companies, the practical value is in future calls, such as the point-of-sale personalization pilot, where temporary flexibility could be used to test products that do not fit current rules like cosmetic foundation colors custom blended on the spot. Companies planning to apply should comment now, since eligibility criteria and the limits on flexibility will shape what future calls can offer.

Link to Draft:

https://anexosportal.datalegis.net/arquivos/1933649.pdf

Brazil: Critical Minerals in a Critical Election

As reported, countries across Latin America are making moves to take more control of their critical mineral reserves and supply chains. Nowhere is the issue hotter in the region than Brazil. The new Critical Minerals Law (Law 15.506/2026), as we covered a few weeks back, calls for Brazil to build a state-guided system around its reserves, with financing, tax credits, mandatory traceability, and government screening of key transactions.

What the Law Does

The law creates the National Policy on Critical and Strategic Minerals and a National Council for the Industrialization of Critical and Strategic Minerals (CIMCE). Its elements point in one direction: more state involvement in who owns, finances, and supplies these resources. Two matter most for compliance:

· Screening of transactions:

The government must approve changes of corporate control of mineral rights holders, significant foreign participation or access to strategic geological information, international supply contracts that could affect economic or geopolitical security, and sale, assignment, or encumbrance of mineral titles. Under the implementing decree, the council decides case by case and can also open a review on its own initiative.

· Mandatory spending:

Companies in research, mining, and processing of these minerals must apply a share of operating revenue net of taxes to R&D and to a guarantee fund for six years after regulation, then at least a certain percent to R&D. Failing to apply the R&D funds carries a fine of 150% of the unapplied amount.

The rest of the framework is incentives and traceability: a guarantee fund with up to R$2 billion of federal capital, tax credits of up to 20% of processing spending from 2030 to 2034, and a mandatory supply chain traceability system.

What Comes Next

The council’s structure was set by decree the same day as the law, but it still has to be formally installed within 90 days (around December 15). Most of the substance remains open: which substances count as critical or strategic, how screening will work in practice, and how the traceability system and contributions will be built.

The Election Factor

The law, the decree, and the first appointments to the council all came from the current administration, but the presidential term ends January 1, 2027, and the council’s government seats follow whoever governs. Some of the pending decisions may be settled in the weeks before the term ends, and the rest will fall to whoever takes office. Companies face two uncertainties: what the rules will say and who will issue them.

Key Takeaway

Companies with mineral rights or supply contracts should track CIMCE’s first decisions, starting with the list of substances and the screening procedure. That procedure will shape how change of control, foreign investment, and long-term supply contracts are structured. As the U.S. and China both rush to secure and protect critical mineral supplies for the AI, space, and technology race, Brazil and its vast reserves of rare earth minerals will be center stage in this tense election year.

Links:

Law 15.506/2026: https://www.gov.br/mme/pt-br/acesso-a-informacao/legislacao/leis/lei-n-15-506-2026.pdf Decree 13.118/2026: https://www.planalto.gov.br/ccivil_03/_ato2023-2026/2026/decreto/d13118.htm Portaria 1.043/2026: https://www.in.gov.br/web/dou/-/portaria-n-1.043-de-16-de-setembro-de-2026-732098019

Mexico: Imports Still Getting Harder

Importing into Mexico is still getting harder, but companies just got some breathing room on one of the two biggest new documentation requirements.

🔹 Mandatory electronic customs valuation filings.

Mexico is moving the customs valuation declaration (Manifestación de Valor) from a paper process to mandatory electronic filing through VUCEM. Under the new system, companies will be required to submit the valuation declaration and supporting documentation electronically before customs clearance can proceed.

The September 30, 2026 deadline has now been postponed again, and this time implementation is phased in by customs regime:

➡️November 1, 2026: Processing, transformation, or repair in a bonded facility

➡️November 15, 2026: Strategic bonded facilities

➡️December 1, 2026: Customs transit

➡️December 15, 2026: Fiscal deposit

➡️January 1, 2027: Temporary imports, including applicable IMMEX operations

➡️January 15, 2027: Definitive imports

Until October 31, importers can keep using the current process. Companies importing under more than one regime may face more than one deadline.

The schedule comes from an advance version of SAT’s Third Resolution of Modifications to the 2026 General Rules on Foreign Commerce, posted ahead of Official Gazette publication.

🔹 Greater customs broker liability.

Under Article 54 of Mexico’s Customs Law, brokers are personally responsible for the accuracy of customs declarations, and they are still asking for studies, certificates of analysis, and other support before certifying tariff classifications that went unquestioned for years.

Together, these changes increase documentation requirements, strengthen customs oversight, and require closer coordination between trade compliance, procurement, finance, and logistics teams.

Key Takeaway: The extension buys time, not relief. Identify which customs regimes you use, map your deadlines, and align valuation and classification data across your teams now. The deadline has moved. The direction of customs enforcement has not.

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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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