On November 15, 2024, Brazilian Chemical Management Law No. 15. 022 officially came into effect, marking a significant step forward in the field of chemical regulation in Brazil.
According to the provisions of this regulation, manufacturers and importers must complete registration in a newly established registration system for non-exempt chemicals with an annual production or import volume exceeding one ton. This measure aims to prioritize the identification and focus on chemicals, conduct risk assessments, and ultimately implement risk management measures.
Implementation Timeline
The Brazilian government will publish a significant implementing regulation within 180 days to fill in the details left by the law, and a new registration system platform will be developed within three years. According to recent developments, they have already started working with consulting firms to create the new system and are expected to complete it earlier than the three-year deadline.
Once the registration system platform is officially established, companies will have three years to register their existing chemicals in the system to establish the Brazilian Chemical Substance Inventory. Therefore, the final registration deadline will extend beyond three years, up to six years.
OR System
The new regulation allows foreign manufacturers to hire local entities as their representatives, making it the first true "Only Representative" system similar to the European Union in the region. For foreign chemical manufacturers, this OR option will be more advantageous than other emerging systems in Chile, Colombia, and Peru. This will significantly impact the compliance requirements and market strategies of chemical companies exporting to Brazil.
Chemical Registration
The law stipulates that all chemicals produced or imported in Brazil, with an annual production or import volume reaching one ton, must be registered in the national chemical substance system before their manufacturing or import activities begin.
Registration information should include the following:
- Identification data of the chemical producer or importer;
- Annual production and import volume of the chemical;
- Identification information of the chemical, including CAS number;
- Content of the Chemical Safety Data Sheet (SDS) compliant with GHS, including recommended uses and hazard classification;
- Chemical risk assessment analysis study based on recommended uses.
For chemicals already registered in the national chemical substance list, if planned for new uses or if relevant data changes, they should also be re-registered by March 31 of the following year for updates.
Exemption Clauses
The law explicitly exempts the following specific chemicals from registration requirements:
- Radioactive substances;
- Substances under development;
- Substances exclusively used for research;
- Unseparated intermediates;
- Substances used for national defense;
- Residues;
- Substances under customs supervision that have not undergone any processing or transformation;
- Substances in temporary storage, free trade zones, or in transit;
- Substances unintentionally produced by chemical reactions during the storage of other substances, and substances produced due to other substances being exposed to environmental factors;
- Substances used as food, food additives, flavorings, or drugs;
- Substances that occur naturally and have not been chemically modified;
- Substances used only as components of tobacco;
- Metal alloys;
- Explosives and their accessories;
- Cosmetics.
ChemRadar will continue to monitor the developments of Brazilian REACH and provide the latest information on chemical regulations in South America and Latin America, as well as offer consulting, training, registration agency, and technical support services.
Further Information
