Introduction

Latin America has been actively advancing chemical management regulations to ensure compliance with international standards and protect public health and the environment. We provide a detailed overview of the chemical management frameworks in Colombia, Chile, Brazil, Peru, Argentina, and Mexico, including corporate obligations, notification requirements, and exemption scopes.

Overview of Chemical Management in Latin America

Unlike regions with harmonized regulations—like the EU's REACH—Latin America features a patchwork of national chemical control laws. These vary widely in scope, structure, and enforcement. However, the trend across the region is clear: governments are moving toward greater oversight of chemical substances through national inventories, registration requirements, and risk assessment systems.

Let’s take a closer look at some of the key national regulations:

Colombian REACH

In November 2021, Colombia issued Decree No. 1630, known as the Comprehensive Management Regulation for Industrial Chemicals. This regulation established the National Chemical Inventory and Notification List and introduced an Integrated Management Mechanism for industrial chemicals classified under the GHS (Globally Harmonized System of Classification and Labelling of Chemicals).

Notification Scope

Applies to hazardous substances for industrial use and hazardous components in mixtures produced or imported in quantities of 100 kg or more annually.

Notification Entities

• Local manufacturers

• Local Importers

• Foreign Exclusive Representatives (REE): submit CBI

Notification Information

• Manufacturer/importer identity

• Annual production/import quantity

• Substance details (e.g., CAS Number)

• GHS hazard classification and risk assessment

• Substance use

• Annual updates are mandatory.

Exemption Scope

Includes pharmaceuticals, cosmetics, UVCB substances, impurities, articles, natural substances, by-products, and polymers.

Foreign Exclusive Representative (REE)

The REE acts on behalf of foreign manufacturers to submit confidential business information (CBI) such as CAS Numbers and substance names. The REE must be a Colombian entity or individual.

Chile REACH

In February 2021, Chile promulgated Decree 57/2019, instituting standardized regulatory management for the registration and subsequent risk assessment of hazardous substances. Currently, Chile has advanced to the second phase of its chemical governance framework, focusing on the registration of non-industrial existing substances and industrial new substances.

Notification Scope

• substance either on its own or in mixture

• import/produce ≥ 1t/y

• classified as hazardous according to GHS

Notification Entities

• Local manufacturers

• Local Importers

Notification Information

• Manufacturer/importer identity

• Annual production/import tonnage

• CAS Number, IUPAC Nomenclature, and common name

• GHS hazard classification

• Substance use and SDS

• Updates are required every two years.

Notification Timeline

Exemption Scope

Includes nuclear substances, cosmetics, pesticides, hazardous waste, and substances used exclusively for research.

Brazilian Chemical Management Regulations

Taking effect in November 2024, Law 15.022/2024 aims to establish the National Inventory of Chemical Substances and control the risks of manufacturing, importing, and using chemicals in Brazil with a view to reducing adverse health and environmental effects.

Notification Scope

• Substance either on its own or in a mixture

• import/produce ≥ 1t/y

• polymer (excl. PLC/monomer/stabilizer)

• UVCB as single chemical

Notification Entities

• Local manufacturers

• Local importers

• Only Representatives (OR)

Notification Information

• Manufacturer/importer identity

• Annual production/import tonnage range

• CAS Number or IUPAC Nomenclature

• GHS hazard classification

• Recommended use

• Updates are required by March 31 of the following year.

Exemption Scope

Includes radioactive substances, research chemicals, non-isolated intermediates, cosmetics, pesticides, and polymers of low concern.

Only Representative (OR)

The OR must be a Brazilian entity with the capacity to manage notifications and compliance on behalf of foreign manufacturers.

Peru REACH

In May 2023, Peru enacted Decree 1570/2023, which mandates the creation of the National Chemical Substances Inventory (RENASQ), prioritizes risk assessment protocols for hazardous substances, and enforces compliance with the Globally Harmonized System (GHS).

A draft supplementary regulation was released in July 2024, introduces

• “Foreign Exclusive Representative” and “Technical Support”

• pre-classified inventory covering over 4,000 chemicals

• hazard classification, labeling, and Safety Data Sheet (SDS) assessments

Notification Scope

Applies to substances/substance components in mixtures produced or imported in Peru (no tonnage threshold specified for now).

Notification Entities

• Local manufacturers

• Local importers

• Foreign Exclusive Representatives: submit CB

Timeline Development

Pre-evaluation

The pre-evaluation is the first step of chemical compliance, which is the Hazard classification, labeling, and SDS review.

Information requirements:

• Identification of entity

• substance identity

• Use

• SDS& label

• Technical report

• Request for CBI protection

Timeline for Pre-evaluation

Substance Notification

The substance notification is the second step of chemical compliance, which requires

• Substance: production/import volume

• Substance components: production/import volume of the previous year, substance identity, use, and hazard classification

Annual updates by February 15.

Exemption Scope

Includes radioactive substances, customs-regulated substances, natural substances, cosmetics, and pesticides.

Argentina REACH

Argentina's Bill 2846-S/2022 outlines a phased implementation plan for chemical notification and risk management. Resolution 504/2022 established a National List of Restricted and Prohibited Chemicals. 

Notification Scope

Applies to substances and substance components in mixtures produced/imported in quantities exceeding 1 ton annually over the past three years. 

Notification Entities

• Local manufacturers

• Local importers

Notification Information

Manufacturer/importer identity

Annual production/import tonnage

CAS Number and SDS

Annual updates are required.

Exemption Scope

Includes research chemicals, radioactive substances, natural substances, and unmodified minerals.

Mexico REACH

Mexico currently lacks a unified chemical management regulation. In 2019, the General Health Council (CGS) proposed the Comprehensive National Policy for Chemical Management, but progress has been delayed.

Services We Offer

• Compliance Analysis Services: Tailored solutions for regulatory compliance in Latin America.

• Notification Agency and Technical Support: Assistance with chemical notifications and technical documentation.

• Regulatory Consulting and Training: Expert guidance on chemical management regulations.

• SDS and Labeling Services: Development of compliant safety data sheets and labels.

To learn more about how to ensure compliance across Latin America, contact REACH24H’s team of regulatory experts today.