Chile & Colombia: Upcoming REACH-Related Reporting and Re-Notification Deadlines

While much of the current attention in the region is focused on Brazil’s REACH-inspired framework, existing compliance obligations in countries such as Chile and Colombia continue to require active management.

In particular, upcoming reporting and re-notification deadlines may affect companies that have already completed initial registrations but must now maintain or update those records.

Colombia (INSQUI)

All substances registered in the INSQUI inventory in 2025 are subject to annual maintenance reporting requirements in 2026.

This includes:

• Reporting manufacture and import volumes for the 2025 calendar year
• Ensuring alignment between importers and the designated REE (Foreign Representative), where applicable

Deadline: September 30, 2026

Chile

For hazardous industrial substances (“pure” substances) registered in 2024, companies are required to complete a re-notification process.

This includes:

• Submission of updated volume data covering the previous two years

Deadline: August 30, 2026

Practical considerations

These obligations are part of the ongoing lifecycle management of chemical registrations in both jurisdictions.

In practice, companies may encounter challenges such as:

• Ensuring accurate volume tracking across multiple importers or business units
• Aligning roles and responsibilities between local entities and foreign representatives
• Identifying substances that fall within scope for re-notification

Additionally, companies that did not complete original registrations on time may still face compliance exposure, as obligations may continue to apply or require remediation.

Takeaway

REACH-type frameworks in Latin America extend beyond initial registration. Ongoing reporting and re-notification requirements are becoming a routine part of compliance and require structured internal processes to manage effectively

Brazil REACH: The Organizational Challenge Behind Compliance

Recent discussions with companies preparing for Brazil’s REACH-inspired chemical framework are highlighting a consistent pattern.

While regulatory interpretation is an important component, the most significant effort is often not legal or technical — it is organizational.

Understanding substance flows

A central challenge is developing visibility over how substances and volumes enter Brazil across the business.

This typically requires answering questions such as:

• Which substances ultimately enter Brazil through mixtures or finished products?
• In what volumes are those substances imported?
• Through which affiliates, distributors, or third parties do they enter the market?
• Which entity holds the compliance obligation under the framework?

These questions are not always straightforward, particularly in companies with complex supply chains or decentralized operations.

An organizational, not just regulatory, exercise

In many cases, the effort required to answer these questions goes beyond regulatory analysis.

It involves:

• Mapping supply chains across multiple entities and jurisdictions
• Coordinating data between regulatory, procurement, and commercial teams
• Establishing internal ownership and accountability for compliance activities

As a result, preparation for Brazil REACH is often driven by internal alignment and data visibility rather than interpretation of the regulation itself.

Emerging focus areas

Companies are increasingly focusing on:

• Building internal inventories of substances and volumes
• Improving traceability of substances within mixtures
• Clarifying roles between importers, affiliates, and third parties

Takeaway

Preparation for Brazil’s REACH framework is as much an organizational exercise as it is a regulatory one. Companies that establish early visibility over substance flows and internal responsibilities are better positioned to manage upcoming obligations efficiently.

From EU Signal to Regional Enforcement: CMR Bans in Latin America

Colombia has now taken concrete enforcement action following the Andean Community (CAN) ban on CMR substances in cosmetics, underscoring how quickly regional measures are moving from policy to market impact.

In February 2026, INVIMA cancelled 136 sanitary notifications (NSOs) for semi-permanent nail products containing TPO and DMPT, substances classified for their carcinogenic, reproductive toxicity, and sensitization risks. As a result, these products can no longer be commercialized in Colombia—or across the Andean region—and no sell-through of existing inventory is permitted. The cancellations were triggered automatically after the 60-day compliance window established under CAN Resolution 2548 (December 2025).

What stands out is not just the restriction itself, but the speed and coordination:

• The original safety signal originated in the EU (September 2025)
• Regional adoption followed via the Andean Community (December 2025)
• Market enforcement actions—like Colombia’s NSO cancellations—are now happening within weeks

This pattern is consistent with what we’ve seen across the region:

• Brazil and Chile moving quickly on recalls (continuing even to now) and bans
• Central American authorities amplifying EU safety alerts
• Multiple countries taking aligned action on the same substances within short timeframes

Taken together, this is no longer a series of isolated national decisions—it is a regional regulatory response, closely tracking EU hazard classifications and translating them into enforceable measures at speed.

For companies, the implications are practical. Actions taken abroad are now rapidly cascading into Latin America, often with short transition periods, limited sell-off options, and immediate commercial impact. That dynamic can affect inventory planning, product formulation decisions, and the timing of market access across multiple countries at once.

In other words, what starts as a regulatory signal in one jurisdiction is increasingly becoming a near-simultaneous operational issue across the region.

Brazil Biomethane: Implications for Gas Buyers

Despite the move away from Paris Agreement commitments in the US and even the EU, Brazil has continued to move forward with its plans for decarbonization.  The country is building out the regulatory infrastructure to make it a reality.  As the requirements come online, business in Brazil will be impacted.

The latest addition is Brazil’s National Agency of Petroleum, Natural Gas and Biofuels (ANP) Resolutions 995 and 996, establishing the regulatory framework for biomethane targets under the National Decarbonization Program for natural gas, created by Law No. 14.993/2024.

The rules introduce mandatory annual biomethane targets for natural gas producers and importers, supported by a certificate system—the Biomethane Guarantee of Origin Certificate (CGOB)—which allows companies to demonstrate compliance through verified biomethane volumes or tradable certificates.

Resolution 996 sets up the infrastructure behind the certificates (certification, verification, registry, and traceability), while Resolution 995 defines who must comply and how targets are enforced.

While this framework does not directly regulate most industrial companies, it is a relevant development for those with exposure to natural gas markets. In practice, it may influence:

• Gas pricing and contract structures as compliance costs are passed through
• Availability of biomethane or “green gas” sourcing options
• Longer-term decarbonization pathways tied to fuel use

For now, this sits more as a market and supply chain signal than a direct compliance obligation, but one that may become more relevant as decarbonization expectations continue to expand.

Chile Textile EPR: Broad Scope, Fast Track, Open Questions

Latin American countries across the board are fans of Extended Producer Responsibility.  From Mexico to South America, many products – and increasing all packaging – are covered by requirements for producers, importers, and merchants to take responsibility for their end-of-life products.  Textiles, however, have not been among the covered products – until now.  Chile has become the first country in the region to move forward with Extended Producer Responsibility (EPR) for textiles, marking the next phase in the expansion of its circular economy framework.  (Keep eyes out for Brazil to be the next mover in this trend.)

A resolution published in March 2026 formally initiates the process to develop binding collection and recycling targets for textiles under Chile’s EPR Law (Law 20.920). This follows the 2025 decision to classify textiles as a priority product, bringing the sector into a regime where producers are responsible for the end-of-life management of what they place on the market.

Scope is intentionally broad. For preliminary purposes, “textiles” are defined to include all products composed mainly of textile fibers, regardless of manufacturing stage or composition. The draft categories capture:

• Clothing (formal, casual, sports, workwear)
• Home textiles (e.g., sheets, towels, curtains, cushions, mattresses)
• Footwear primarily made of textile materials
• Accessories and other textile goods (e.g., bags, hats, gloves, belts)

Importantly, the scope applies regardless of end use (consumer or professional) and includes second-hand products when placed on the market for the first time—a signal that resale and circular models will also sit within the compliance perimeter.

What this means in practice:

• Companies that manufacture, import, or sell textiles under their own brand will fall within scope
• They will be required to organize and finance the collection, recycling, or recovery of textile waste
• Specific targets, reporting obligations, and system requirements will be defined in a forthcoming decree
• A formal rulemaking process is now underway, including stakeholder consultation and technical design

This is still an early-stage step—but an important one. Under Chile’s EPR framework, once the targets decree is finalized, obligations become operational and enforceable, typically requiring companies to join or create compliance schemes and rethink how products are managed at end of life.

What stands out is the pace of development. Textiles were only added as a priority product in 2025, and within months Chile has moved into the decree development phase—faster than the rollout seen for earlier EPR categories.

At the same time, there is some uncertainty tied to the change in administration, with a new president taking office on March 11, 2026. Recent signals indicate a pause on several pending regulatory matters under review by the Comptroller General (Contraloría), including the long-awaited EPR decree for electric and electronic equipment. While there has been no formal indication that the textiles process will slow, the full impact of the transition is not yet clear.

For companies in apparel, retail, and related supply chains, the implications are tangible. The breadth of scope and upcoming targets can influence cost structures, product design choices, reverse logistics, and how quickly new requirements need to be operationalized.

In short, Chile is moving textiles into the same regulatory category as packaging and electronics—turning post-consumer waste into a managed, financed responsibility of the producer.

Link to Resolution:

https://www.diariooficial.interior.gob.cl/publicaciones/2026/03/10/44396/01/2779727.pdf

Chemical Precursors: A Quiet Market Access Risk in Latin America

If you sell any type of chemical product – from inks to hobby glue, cosmetics to paints – then the concept of chemical precursor controls is nothing new to you.  Recent updates in Argentina and Honduras highlight how this typically technical issue is becoming a more immediate market access and compliance consideration across Latin America.

In Argentina, Decree 128/2026 expanded the national control framework under RENPRE by adding 56 substances already commonly regulated in other jurisdictions, while also introducing clearer sanction structures and updated infraction categories. The direction is not just more substances, but more defined enforcement and accountability.

In Honduras, ARSA has issued an updated list of controlled substances, replacing the 2025 version and reinforcing alignment with UN conventions and regional models. At the same time, the update makes the system more operational in practice:

• Controls applied across the full lifecycle (import, storage, transport, use, disposal)
• More explicit treatment of mixtures, concentration thresholds, and finished products
• Continued emphasis on authorizations, traceability, and recurring reporting

Importantly, this is not a new regulatory structure—but a tightening of how it works day-to-day, with clearer expectations and fewer gray areas.

What these updates illustrate is that, while precursor control remains highly country-specific in its details—from exemptions to thresholds to licensing steps—the practical burden is increasing.

For companies, the impact is often felt in routine operations:

• Delays or blocks at import if classifications or permits are not aligned
• Reclassification of products or mixtures that were previously out of scope
• Additional documentation and reporting tied to substances that are widely used in industrial processes

These are not headline regulatory changes—but they can directly affect timing, cost, and continuity of supply if not picked up early.

In that sense, precursor control is shifting from a static compliance requirement to a more active operational risk, particularly for companies moving chemicals, intermediates, or formulated products across multiple countries in the region.

Link to Argentina publication:

https://www.boletinoficial.gob.ar/detalleAviso/primera/339043/20260304

Link to Honduras publication:

https://arsateca.arsa.hn/c-arsa-003-v4

Chile Expands Medical Device Controls to High-Risk Products

Chile continues to expand its medical device regulatory framework with a new decree incorporating a broad set of medical devices and in vitro diagnostic devices into the sanitary control regime under Article 111 of the Health Code.

The update brings a wide range of higher-risk devices into formal oversight, including:

• Cardiovascular implants (e.g., stents, valves, pacemakers)
• Diagnostic tests (HPV, respiratory viruses, pregnancy tests)
• Imaging and treatment equipment (CT scanners, radiotherapy, nuclear medicine)
• Critical care devices (ventilators, dialysis equipment)
• Certain software used in medical imaging and oncology

What changes in practice: These devices will now require verification of conformity (i.e., sanitary registration) before they can be manufactured, imported, or commercialized in Chile. This includes demonstrating compliance with recognized international standards (ISO, IEC) covering safety, quality management, and risk management.

The approach is risk-based and phased:

• Higher-risk devices (Classes III and IV) are prioritized
• Implementation timelines range from 24 to 36 months, depending on the product
• Voluntary registration can begin earlier, ahead of full enforcement

Notably, Chile is relying heavily on international standards and principles (ISO-based frameworks) as the basis for compliance, reflecting a continued move toward globally aligned device regulation.

Another practical point: there are currently no accredited third-party bodies in Chile to perform conformity assessments, meaning the national authority (ISP) will play a central role—at least initially—in reviewing and approving these devices.

Overall, this is part of Chile’s gradual shift toward a more structured, risk-based medical device regime, moving beyond partial oversight toward a system where higher-risk products are subject to formal, standardized pre-market controls.

Link to rule:

https://www.diariooficial.interior.gob.cl/publicaciones/2026/03/19/44404/01/2781436.pdf

Brazil Revises Rules for Wearable and Textile Repellents

In a country plagued by mosquito-borne illnesses like dengue, chikungunya, and zika, repellents are serious business.  Brazil’s health authority (Anvisa) has updated how it classifies personal insect-repellent products, reflecting the rise of new formats such as wearable and textile-based technologies.

The revision moves away from the previous approach, which broadly treated these products as environmental disinfectants (saneantes), and instead introduces a use- and exposure-based classification.

What’s new:

• Products designed to protect the human body directly (e.g., bracelets, patches, clothing with repellent properties) are now classified as cosmetics
• Products intended to act in the surrounding environment (e.g., treated fabrics, certain accessories) remain classified as sanitizers (saneantes)

This shift is meant to better reflect how these products are actually used and how they interact with people, while also aligning regulation with emerging technologies and international approaches.

Notably, Anvisa highlights that many of these formats—especially wearables—do not yet have a history of registration in Brazil, meaning companies may face additional scrutiny on safety and efficacy data, particularly for new technologies.

Overall, the update provides greater clarity for product classification, while signaling that innovative formats will be evaluated closely as the market evolves.

Link to technical note:

Nota Técnica 35/2026/SEI/CRCOS/GGCOS/DIRE3/ANVISA

Chile & Colombia REACH

If your company sells chemicals into Latin America, this question always comes up:“Do we need to do anything for Chile or Colombia REACH?”

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