Navigating Chemical Regulations in Latin America: What Global Companies Need to Know

Introduction

As global chemical regulations become increasingly stringent, Latin America is emerging as a key region with evolving chemical compliance frameworks. Countries such as Chile, Colombia, Brazil, Argentina, Peru, and Mexico are introducing or updating legislation to manage industrial chemicals and protect human health and the environment.

Understanding and complying with chemical regulations in Latin America is crucial for manufacturers, importers, and exporters aiming to enter or operate within these markets. Here’s what you need to know.

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:

Brazil: National Chemical Management Law Coming into Force

Brazil’s Law No.15, 022 lays the foundation for a national chemical inventory and risk-based prioritization system. Registration will be required for substances (including those in mixtures) produced or imported ≥ 1 ton per year over the past three years.

Key elements:

• Includes foreign manufacturers via a designated Only Representative (OR).
• Excludes low-concern polymers
• Transition period: 3 years from law enactment (November 14, 2024).

Broad exemptions cover pharmaceuticals, cosmetics, food products, natural minerals, explosives, and more.

Chile: Building a National Inventory and Registration System

Chile’s chemical regulation efforts have accelerated with the enactment of Decree No. 57 in 2021 and the release of a risk assessment draft regulation in 2024. A national industrial chemical inventory has been established, and companies must register hazardous substances or components of mixtures ≥ 1 ton per year.

Key requirements:

• Registration must include CAS numbers, hazard classifications, and Safety Data Sheets (SDS).
• Registration data must be updated every two years.
• New substances not listed in the inventory require registration and supporting toxicological data.
• Deadline for registration of non-industrial substance: August 30, 2025.

Exemptions include: cosmetics, pharmaceuticals, food additives, fertilizers, and substances used exclusively in scientific research.

Colombia: Integrated Chemical Substance Management

Colombia’s Decree 1630/2021 introduced a robust framework for industrial chemicals, including the creation of a national inventory and mandatory registration for substances ≥ 100 kg/year.

Notable features:

• Applies to foreign manufacturers represented by a local Exclusive Representative (REE).
• Registration data must be updated annually.
• Deadline for registration: May 30, 2025.

Exemptions include: cosmetics, pharmaceuticals, polymers, natural substances, and intermediates.

Argentina: Gradual Implementation of a Risk-Based Framework

Argentina is implementing a phased chemical management system under draft Bill 2846-S/2022 and Resolution 504/2022, which introduces substance registration and a national restriction list.

Applies to: producers/importers of substances or mixtures ≥ 1 ton/year over the past three years.

Requirements include: hazard classifications, SDS, and annual updates.

Exemptions: substances used in research, defense, cosmetics, pharmaceuticals, food, and naturally occurring substances without chemical modification.

Peru: Laying the Groundwork for National Control

Peru’s Law No. 1570 established a national chemical management system in 2023. Although detailed requirements are pending, the law mandates:

• Development of a national chemical inventory (RENASQ).
• Registration and risk assessment of all substances or mixtures manufactured/imported into Peru.
• Implementation of the GHS (Globally Harmonized System).

Exemptions include: non-commercial substances, natural minerals, medical products, and agricultural chemicals.

Mexico: Awaiting Unified Legislation

Currently, Mexico does not have a unified chemical management regulation. While a National Policy on Chemical Management was proposed in 2019, its legislative process has stalled.

However, companies must still comply with sector-specific regulations under multiple government bodies for pharmaceuticals, cosmetics, pesticides, and food additives.

How REACH24H Can Help

Successfully navigating the regulatory landscape across Latin America can be challenging due to the complexity and diversity of national laws. REACH24H Consulting Group offers tailored services to support chemical compliance in the region, including:

• Regulatory Analysis & Compliance Strategy
  In-depth assessments to identify regulatory obligations and risk areas.
• Registration Agent Services & Technical Support
  Acting as Only Representative (OR) or REE, managing local submissions, data collection, and communications with authorities.
• Training & Regulatory Consultation
  Webinars, workshops, and customized consulting on LATAM chemical regulations.
• SDS & Label Preparation
  Preparation of GHS-compliant Safety Data Sheets and product labels in Spanish or Portuguese.

Final Thoughts

Latin America is becoming an increasingly regulated region for the chemical industry. Whether you’re a multinational chemical supplier or a local distributor, staying ahead of evolving requirements is essential to ensuring smooth market access, avoiding penalties, and protecting your brand.

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