Brazil REACH Regulatory Compliance

On November 15, 2024, Brazilian Chemical Management Law No. 15. 022 (also known as Brazil REACH) was officially adopted, marking a significant step forward in the field of chemical regulations 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, 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 the recent developments, the Brazilian government has already started working with consulting firms to create the new system. It is expected that the system can be completed ahead of 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 be extended beyond three years, even up to six years.

Only Representatives

Brazil REACH allows foreign manufacturers to hire local entities as their representatives, making it the first true "Only Representative" system similar to that in the European Union. For foreign chemical manufacturers, this system will be more advantageous than that in Chile, Colombia, and Peru. The system will significantly impact the compliance requirements and market strategies of chemical companies exporting to Brazil.

Substance Registration

According to the requirements of Brazil REACH, all chemical substances manufactured in or imported into Brazil, with an annual production or import volume at or above one ton, must be registered via the national chemical substance system before manufacture or import.

The registration materials should include:

• 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; and
• Chemical risk assessment analysis study based on the recommended uses.

If the chemical substances have already registered under the national chemical substance list and new uses are planned or relevant data changes, they should also be re-registered by March 31, of the following year.

Exemptions

Brazil explicitly exempts the following substances from registration:

• Radioactive substances;
• Substances under development;
• Substances exclusively used for research;
• Non-isolated intermediates;
• Substances used for national defense;
• Residues;
• Substances under Customs supervision without any processing or transformation;
• Substances in temporary storage, in free trade zones, or in transit;
• Substances produced unintentionally during the storage of other substances or due to other substances being exposed to the environmental factors, including:
  • Air;
  • Sunlight;
  • Humidity; and
  • Microorganisms.
• Products supervised by other laws and regulations, including:
  • Food;
  • Manufacturing technology adjuvant;
  • Food additives;
  • Medicines, active pharmaceutical ingredients, gases, preparations for medical purposes, and substances intended for prevention, diagnosis and health treatments classified as medical devices;
  • Pesticide, its premixes and finished products;
  • Cosmetics, personal hygiene products and perfumes;
  • Disinfectants;
  • Substances used for veterinary purposes;
  • Animal feed;
  • Fertilizers, inoculants and correctives;
  • Wood preservatives; and
  • Environmental remediators.
• The following substances, unless they are chemically modified or consists of substances classified as hazardous to health or the environment according to the GHS system:
  • Ores and their concentrates, as well as other rocks and minerals, including coal and coke, crude oil, natural gas, liquefied petroleum gas, natural gas condensate and gases and components of mineral production processes;
  • Naturally occurred substances;
  • Fats, essential oils, fixed oils Fixed oils extracted by pressing, distillation, or extraction methods, which, even after purification, retain the same characteristics as the original product; and
  • Glass, enamel and ceramics.
• Narcotics, psychotropic drugs, and immunosuppressants;
• Substances used exclusively as tobacco ingredients and their derivatives;
• Metal alloys used for structural purposes, in forms such as sheets, strips, bars, profiles, ingots, beams, and other similar items; and
• Explosives and their accessories.

Risk Evaluation and Management

Brazil REACH establishes a framework for assessing chemical risks. Substances on the list will be prioritized for risk assessment, and appropriate risk management measures will be developed. Priority for substance assessment will be based on criteria such as:

• Persistence, bioaccumulation, and toxicity in the environment;
• Carcinogenicity;
• Mutagenicity;
• Reproductive toxicity;
• Endocrine disruption;
• Human or environmental exposure, including potential exposure levels, and quantities produced or exported; and
• Inclusion in certain international agreements or conventions that Brazil is a part of.

Our Services

• Brazil REACH pre-registration and full registration;
• Brazil REACH only representatives
• Brazil REACH consulting and training