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Brazil introduces REACH style chemical management law
Time：
2024-11-01
The Brazilian Senate has passed a chemical management bill similar to REACH, aimed at establishing a national list of chemical substances and strengthening regulation to reduce harm to health and the environment. The bill specifies registration requirements and exemption clauses, establishes a risk assessment framework, and clarifies legal enforcement measures. The government plans to establish a complete registration information system within three years.
On October 15, 2024, the Brazilian Senate passed a chemical management bill similar to REACH - Act 6120 of 2019, which aims to establish a national list of chemical substances, conduct comprehensive assessments and risk control of chemical substances used, produced, or imported domestically, in order to minimize adverse effects on human health and the environment.
Legislative background
Improper management of chemical substances can lead to serious environmental and health problems. Therefore, the Brazilian government proposed this bill with the aim of establishing a national list of chemical substances, strengthening the regulation of chemical substances, and ensuring the safety of the public and the environment. The promotion of this bill was inspired by the international chemical management framework REACH.
Chemical registration
The bill stipulates that all chemical substances produced or imported in Brazil with an annual production or import volume of 1 ton must be registered in the national chemical substance system before their manufacturing or import activities begin.
The registration information should include the following:
·Identification data of chemical substance producers or importers;
·Annual production and import volume of chemical substances;
·Identification information of chemical substances, including CAS number;
·The content of the Chemical Safety Data Sheet (SDS) that complies with GHS, including recommended uses and hazard classification;
·Risk assessment and analysis of chemical substances based on recommended uses.
For chemical substances that have already been registered in the national chemical substance list, if they are planned for new uses or if there are changes in relevant data, they should also be re registered before March 31 of the following year for updating.
Exemption clause
The bill explicitly exempts the following specific chemical substances from registration requirements:
1. Radioactive material;
2. Substances under development;
3. Substances specifically used for research;
4. Unsolved intermediates;
5. Materials used for national defense;
6. Residue;
7. Substances under customs supervision without any processing or conversion;
8. Substances in temporary storage, free trade zones, and transportation processes;
9. Substances produced by unintentional chemical reactions during the storage of other substances, as well as substances produced by exposure of other substances to environmental factors;
10. Substances used as food, food additives, spices, and drugs
11. Substances that exist in nature and have not been chemically modified
12. Substances used solely as components of tobacco;
13. Metal alloys;
14. Explosives and their accessories;
15. Cosmetics;
Risk assessment and management
The bill also establishes a framework for assessing chemical risks, where substances on the list will be selected and prioritized for risk assessment, and corresponding risk management measures will be developed. The priority assessment of materials will be based on the following criteria:
Persistence, bioaccumulation, and toxicity in the environment;
-Carcinogenicity;
-Mutagenicity;
-Reproductive toxicity;
-Endocrine disruptor;
-Exposure to humans or the environment: including potential exposure levels, production or export quantities, etc;
-Included in certain international agreements or conventions in which Brazil participates
Legal Enforcement
Violations of this law, such as failing to register chemical substances in the national list as required, providing false information, etc., will face administrative penalties. The government will also establish a Chemical Substance Assessment Committee responsible for risk assessment and management recommendations for chemical substances.
Future prospects
This bill shall come into effect from the date of its publication. The government plans to formulate implementation rules within 180 days after the official release of the law, and plans to establish a complete registration information system within three years. This marks an important step for Brazil in chemical safety management, not only protecting public health and the environment, but also enhancing Brazil's competitiveness and image in the international market.
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