Brazil: Brazilian REACH regulation for chemicals finally adopted

On November 15, 2024, Brazil’s Chemical Management Law No. 15.022, commonly known as Brazil REACH, came into effect, representing a significant advancement in the country’s chemical regulatory landscape. This milestone followed the Senate’s approval of the legislation in October.

Under Brazil REACH, companies must:

Register chemical substances with the National Inventory if their annual production or import meets the one-ton threshold.
Provide data on hazard classifications, production volumes, and uses in compliance with the Globally Harmonized System (GHS) for chemical labeling.
Annually update records by March 31 to reflect changes in production or use.
Submit additional information for hazardous substances, including assessments of potential risks to human health or the environment.

Implementation Timeline

The Brazilian government is set to issue a detailed implementing regulation within 180 days, providing clarity on the law’s provisions. Additionally, a new registration platform is to be developed within three years. Collaborative efforts with consulting firms are already underway to ensure the system is operational ahead of schedule.

Once the registration platform is established, companies will have three years to register existing chemicals, effectively extending the registration deadline to six years from the platform’s launch.

Only Representative (OR) System

The regulation introduces a true “Only Representative” (OR) system, similar to the European Union’s framework. This allows foreign manufacturers to appoint local representatives, simplifying compliance and enhancing market access. Compared to similar systems in Chile, Colombia, and Peru, Brazil’s OR framework offers significant advantages for foreign chemical exporters.

Chemical Registration Requirements

All chemicals produced or imported in Brazil with annual volumes of one ton or more must be registered in the national chemical substance system before manufacturing or import begins. The required registration information includes:

Producer or importer identification data.
Annual production and import volumes.
Chemical identification details, including CAS numbers.
Safety Data Sheets (SDS) compliant with GHS, covering recommended uses and hazard classification.
Chemical risk assessments based on recommended uses.

Chemicals already listed in the national inventory must be re-registered by March 31 of the following year if new uses are planned or relevant data changes.

Exemptions

The law excludes the following substances from registration:

Radioactive substances.
Substances under development.
Substances exclusively for research.
Unseparated intermediates.
Substances for national defense.
Residues.
Substances under customs supervision without processing.
Substances in temporary storage, free trade zones, or transit.
Substances unintentionally produced during storage or due to environmental exposure.
Food, food additives, flavorings, or drugs.
Naturally occurring, unmodified substances.
Tobacco components.
Metal alloys.
Explosives and their accessories.
Cosmetics.

Alignment with Global Standards

Brazil REACH is heavily influenced by the EU REACH framework, emphasizing health and environmental safety, data transparency, and corporate accountability. By adopting the GHS system and prioritizing risk-based evaluations, the regulation aligns Brazil’s chemical management practices with international standards, facilitating global trade for Brazilian businesses.

To find out more about chemical compliance in Brazil and worldwide, please do not hesitate to contact the Product Compliance Institute.