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REACH regulation officially implemented in Brazil!
Time：
2024-11-20
The REACH regulation in Brazil has come into effect, requiring the registration of non exempt chemicals with an annual production or import exceeding 1 ton. Exemption clauses include radioactive substances, etc. Foreign manufacturers may hire local entities as representatives. Related companies have a buffer period of 3-6 years to prepare for declaration, and Brazil will continue to issue supplementary regulations.
On November 15, 2024, according to the official Brazilian gazette, the Brazilian REACH regulation Law 15.022 officially came into effect. Thus, Brazil will become the largest country in Latin America to implement unified management of chemicals.
According to the regulations, for non exempt chemicals with an annual production or import volume exceeding 1 ton, manufacturers and importers must complete registration in the newly established registration system. This move aims to prioritize the identification and attention to chemicals, conduct risk assessments, and ultimately take risk management measures.
1、 Implementation timeline of regulations
Within 3 years after the announcement of the regulations, the Brazilian government will develop a chemical declaration system;
Within 3 years after the official opening of the system, relevant enterprises should make declarations as required to form a national chemical list.
Substances not listed in the existing chemical inventory are considered new substances and require new substance declaration.
2、 Declaration object
In the past three years, the production/import of substances or components in mixtures exceeding 1 ton per year;
Polymers other than low attention polymers (excluding monomers and additives that maintain polymer stability).
3、 Declaration subject
Producers within Brazil;
Importers within Brazil;
The sole representative (OR) designated by the Brazilian overseas manufacturer.
4、 Exemption clause
The bill explicitly exempts the following specific chemical substances from registration requirements:
1. Radioactive substances;
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;
5、 Registration Information
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.
6、 OR represents
The new regulations allow foreign manufacturers to hire local entities as their representatives, making it the first truly EU like "sole representative" in the region. For foreign chemical manufacturers, this OR style choice will have more advantages than other emerging systems in Chile, Colombia, and Peru. This will have a significant impact on the compliance requirements and market strategies of chemical companies exporting to Brazil.
7、 Subsequent development
The Brazilian government will establish a working group at the next meeting of the National Chemicals Committee (CONASQ) based on the new regulations to develop detailed implementation drafts and issue relevant supplementary regulations within 180 days.
Starting from November 15, 2024, relevant companies will have a buffer period of 3-6 years.
Remind companies in the Brazilian market to prepare their declaration in advance and screen for substances that require compliance. We will also continue to monitor the latest developments in Brazilian regulations and update progress in a timely manner.
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