Holidays and Holy Days

International business still stops for major holidays and religious celebrations. This week – February 17 – 20 – is an unusual convergence of important dates across broad swaths of the world.

In Latin America, business will stop in Brazil and some Caribbean countries for the celebration of Carnaval.

In Asia, Lunar New Year will be celebrated on and around February 17.

Muslims around the world will also begin Ramadan on February 17.

And finally, the United States is celebrating a federal holiday on February 16 known as “President’s Day.”

To all my friends all over the world on holiday, enjoy!

Business will be here when you get back.

Guatemala:  Game-Changing Regulation for Pharmaceuticals, Chemical Precursors, Pesticides, Cosmetics, Cleaners, Personal Care, and More

Guatemala is proposing a sea change in regulation of a broad gamut of final products and chemical precursors, shifting from border inspection of products to a pre-market authorization system where companies must present technical files, labeling and conformity certificates before they can import or sell.

The proposed regulation – which would repeal the existing standards – is deceptively titled Regulation for Health Control of Pharmaceutical and Related Products.”  Don’t be fooled.

Covered products & substances

• Pharmaceutical products
• Narcotics, psychotropic substances, and chemical precursors
• Pesticides for Household Use
• Pesticides for Professional Use (of chemical and biological origin)
• Repellents
• Raw materials for pesticides & repellents
• Machines and accessories for their production
• Cosmetics & Personal Care Products
• Medical Devices & Medical Supplies
• Cleaning Products
• Laboratory Reagents
• Dental products
• Facilities that produce and market them

What are the “Related Products”?

This broad category is really where the most impact will be felt. Per the Draft, “related products subject to control” include cosmetics and personal care products, cleaners and hospital hygiene products, medical and surgical supplies and medical devices, laboratory reagents for in vitro diagnostic use, and dental products and equipment, pesticides for domestic use, pesticides for professional use, and repellents.

Product Registration

All aspects of bringing these covered products to market are addressed in the major reform.  It is here that the reform really takes place.  Currently, the existing regulations are fragmented by product type, and compliance is usually checked after import or during inspection.  Under the Draft, compliance becomes a question of market access.  The proposed unified framework for multiple product categories requires mandatory technical documentation file, conformity assessment (certificates/test reports), traceability, and labeling.  Authorities now evaluate the evidence, not just the product.

Next Steps

The Draft was posted to the WTO for consultation among member nations. Even once adopted, this significant change will require new regulatory infrastructure. The Draft would provide government agencies 18 months from adoption to modify and rectify existing regulations to fit the new model.

Link to Draft:

https://members.wto.org/crnattachments/2026/TBT/GTM/26_00839_00_s.pdf

Brazil: Enforcement for Consumer Products including Cosmetics

Each year as part of the national Carnaval holidays, Brazil’s regulatory agencies, including the health authorities at ANVISA, carry out different inspection and enforcement actions to ensure popular consumer products don’t pose a risk to public health and safety.

This year, the aptly named “Tô de Olho na Folia” enforcement operation (translation: “I’ve got my eye on the party”) targeted product safety across retail channels in Salvador, São Paulo and the Federal District.  The numbers are impressive – authorities checked ~23,500 products across 64 businesses. ANVISA alone inspected 1,035 items and identified irregularities in over half of them..

Product Scope

The joint operation (with Inmetro, MAPA and law-enforcement agencies) covered high-traffic consumer goods typically sold during Carnaval, including:

• Alcoholic beverages (authenticity, labeling and registration)
• Cosmetics, especially hair styling pastes and pomades
• Tobacco-related items and prohibited vapes (e-cigarettes)
• Condoms and health-regulated products
• Costumes, accessories (masks, glasses, tiaras) and toys

Key compliance findings

Authorities noted:

• Missing regulatory registration or manufacturer identification
• Irregular or fraudulent labeling
• Lack of origin traceability
• Improper storage conditions
• Sale of prohibited products (e-cigarettes)

Across the agencies involved, the government identified almost 1,000 “irregularities” leading to 126 seizures and 124 product destructions.  Six stores received citations, and multiple fines were issued.

The operation highlights Brazil’s coordinated market-surveillance model — combining consumer education with enforcement.  Holidays don’t imply that the agencies have lowered their guard.

Brazil RoHS:  Moving Toward Adoption

The long-awaited Brazilian version of the EU’s Restriction of Hazardous Substances in electrical and electronic products continues its move toward adoption.

In late January, a technical committee within the Brazilian National Environmental Council (CONAMA) voted to adopt the version as revised following the public comment period in 2025.  Importantly, that vote cleared the way for the proposal to move to the Technical Committee for Legal Affairs for consideration.  This next committee will be the final stop before the draft moves to the plenary of CONAMA for a vote.  After that, the proposal can be sent for final publication.  Minor revisions can still – and likely will – occur as the proposal makes it down the final stretch.

Nonetheless, we don’t expect any major revisions in the text at this point.

It’s worth getting familiar with the latest version.

Link to current Draft Brazil RoHS:

https://conama.mma.gov.br/index.php?option=com_sisconama&task=documento.download&id=27033

LATAM REACH: Where are we now?

Followers know that Latin American countries have moved far ahead in adopting framework chemical regulations that are inspired in part by EU REACH, in part by Canada’s CMP or US TSCA.  Despite the international precedents, each country has enacted laws different enough that companies need to drill down into each scheme to determine applicability to their product portfolio and ompliance obligatiosn to retain market access.

Let’s take a look at where we are now on these schemes:

· CHILE

Chile opted for four phased-in registration (called “notification”) deadlines for covered substances:

• Hazardous industrial substances: 2024
• Hazardous non-industrial substances: 2025
• Hazardous substances in industrial mixtures: 2027
• Hazardous substances in non-industrial mixtures: 2029

The country already published first national inventories for the “pure” hazardous substances (industrial and non-industrial).

In 2026, companies that registered their hazardous industrial substances in 2024 will need to re-notify before August 30, 2026.

Companies that have not met those deadlines need to register as “new” substances.

Details and inventories are available at the official portal:

https://plataformasqi.mma.gob.cl

· COLOMBIA

All substances were subject to registration by the May 2025 deadline. The government has released a series of innovative dashboards that serve as the first national inventory.

All substances registered in 2025 will need to file their annual update through the registration system by September 30, 2026, reporting on the volumes imported or manufactured in calendar year 2025.

Substances that missed the deadline – or are newly imported into or manufactured in the country – still need to register.  The full details on what is a “new” substance are expected in the upcoming regulation on risk assessments, expected later this year.

Link to dashboards/inventory:

https://insqui.sical.gov.co/BI/tableros_insqui.html

· BRAZIL

Brazil “REACH” became law in November 2024 after ten years in development.

The implementing regulation is under consideration by government after a speedy development in the multistakeholder CONASQ group.

Companies will have three years to register their substances in the new online portal once the government has created that IT system.

The law gives the government until November 2027 to develop that IT infrastructure – and companies would be able to start registering from that time until the initial period closes three years later (i.e., November 2030).

The implementing regulation is expected at any time.

The country is working with consultants on the development of the IT infrastructure for registration.

· PERU

The country adopted its national REACH-inspired law, including wholesale adoption of the GHS, in 2023.  The system needs an implementing regulation to be get off the ground.  The government has worked assiduously on it – including reviewing some 1,000 comments received during its extended public consultation in 2024.  Due to political instability in 2025, the publication of the regulation is quite delayed.

We expect it to be published later this year.

Colombia: Tax on Single-Use Plastics Enforceable

With Resolution 000005, the Colombian tax authority (DIAN) has defined the how the national tax on single-use plastics will be enforced. As a reminder, the tax applies broadly to essentially all plastic containers and packaging.

The regulation establishes the operational procedure to declare, calculate and pay the tax upon import of the packaging or containers.  In practical terms, the plastic tax is no longer a legal concept… it is now a daily compliance task.

What changes for companies?

• Plastic packaging traceability becomes mandatory
• Customs declarations must incorporate material-level data
• ERP and supply chain processes require adaptation
• Tax, sustainability and logistics teams must work together

This is more than just about a new tax.  This SUP regulation is a transformation in how companies understand EPR, packaging responsibility, and environmental accountability.

Organizations that treat this as only a tax issue will struggle.  This is data and operations challenge as well.

Sustainability regulation is now an operational obligation.

Link to DIAN Resolution:

https://www.dian.gov.co/normatividad/Normatividad/Resoluci%C3%B3n%20000005%20de%2009-02-2026.pdf/44369/01/2761803.pdfcodigo=5350651&fecha=01/07/2014#gsc.tab=01/16/44350/01/2749490.pdf

LatAm “REACH” is now in reach

Check out AMBIENTELEGAL ACADEMY — designed for professionals who need clarity, not theory.

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• Crash Course on Colombia “REACH”
• Crash Course on Chile “REACH”

📌 Essential regulatory documents — translated into English so you save time and avoid misinterpretation:

• Brazil “REACH” Law
• Colombia “REACH” Registration Instruction Guides
• Chile “REACH” Registration Instruction Guides

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