On October 15, 2024, Brazil's Senate approved Bill No. 6120 of 2019, a REACH-like chemical management bill aimed at establishing a national registry of chemical substances. This bill mandates a comprehensive assessment and risk control of chemicals used, produced, or imported within the country to minimize adverse impacts on human health and the environment.
Legislative Background
Improper management of chemicals can lead to serious environmental and health issues. Therefore, the Brazilian government introduced this bill to strengthen the regulation of chemical substances by creating a national chemical registry, ensuring the safety of the public and the environment. The bill was developed by the international chemical management framework, REACH.
Chemical Registration
The bill requires that all chemicals produced or imported in Brazil, with an annual production or import quantity of one ton or more, must be registered in the national registry of chemical substances before manufacturing or import activities commence.
The registration must include the following information:
- Identification data of the chemical producer or importer;
- Annual production and import quantities of the chemical;
- Identification information of the chemical, including its CAS number;
- Content of the Safety Data Sheet (SDS) compliant with GHS, including recommended uses and hazard classification;
- Risk assessment analysis studies conducted according to recommended uses.
For chemicals already registered in the national registry, if there are plans for new uses or changes in relevant data, re-registration must be completed by March 31 of the following year to update the information.
Exemptions
The bill exempts certain chemicals from the registration requirement:
- Radioactive substances;
- Substances under development;
- Substances exclusively for research purposes;
- Non-isolated intermediates;
- Substances used for defense purposes;
- Residues;
- Substances under customs supervision without any processing or transformation;
- Substances in temporary storage, free trade zones, or in transit;
- Substances produced unintentionally during the storage of other substances or due to exposure of other substances to environmental factors;
- Substances used as food, food additives, flavorings, or pharmaceuticals;
- Substances that exist in nature and have not been chemically modified;
- Substances used solely as components of tobacco;
- Metal alloys;
- Explosives and their accessories;
- Cosmetics.
Risk Assessment and Management
The bill also 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, quantities produced or exported, etc.;
- Inclusion in certain international agreements or conventions that Brazil is a part of.
Legal Enforcement
Violations of the provisions, such as failure to register chemicals in the national list or providing false information, will result in administrative penalties. A Chemical Substance Assessment Committee will also be established to oversee the risk assessment and management recommendations for chemicals.
Future Outlook
The bill will take effect from the date of its publication. The government plans to start developing implementation regulations within 180 days of the bill's official publication and aims to establish a complete registration information system within three years. This marks a significant step for Brazil in managing chemical safety, protecting public health and the environment, and enhancing Brazil's competitiveness and image in the international market.
