On November 23, 2022, Bill PL 6120/2019 was approved by the Commission of Economic Development, Industry, Trade, and Commercial Services (CDEICS) of the Brazilian Chamber of Deputies and has been submitted to the Commission on Constitution, Justice and Citizenship (CCJS) for further review. If the Bill successfully passes the review, it will act as the Brazilian REACH Regulation. Domestic enterprises involved in exporting chemicals to Brazil should pay close attention to the Bill.
Under the Bill, Brazil will establish a national inventory of chemical substances, in which a batch of priority chemical substances will be selected for risk assessments. A batch of chemicals subject to authorization will also be screened out. If the Bill becomes law, Brazil will become the third country in South America to set up chemical management rules, after Chile and Colombia.
The following substances are exempted from Bill PL 6120/2019:
- Radioactive substances;
- Chemical substances under development or specifically for research use with a prescribed quantity;
- Non-isolated intermediates, impurities, contaminants, and chemicals resulting from unintentional chemical reactions, including those generated during storage or due to environmental factors;
- Chemical substances, mixtures, and articles under customs control, which are temporarily stored in free zones or free warehouses with the purpose of being exported again, or are in transit;
- Narcotic drugs, psychotropic drugs, and immunosuppressive agents that are stipulated by specific laws;
- Substances that are exclusively used as ingredients of tobacco and derivatives;
- Metallic alloys in the form of plates, sheets, strips, billets, ingots, beams, and other similar items for structural purposes;
- Explosives and their accessories;
- Products that are regulated by specific laws and regulations:
- Pesticides and related products, premix, and technique products;
- Pharmaceuticals and medical gases;
- Cosmetics, toiletries, and perfumes;
- Products for veterinary uses;
- Manufacturing technologies of food, food additives, and accessories;
- Products used for animal feed;
- Fertilizers, inoculants, and correctives;
- Wood preservatives; and
- Environmental restoration agents.
- The following substances, except those that have been chemically modified or are composed of or contain substances harmful to health or the environment according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS):
- Ores and their concentrates, and other rocks and minerals, including components for manufacturing coal, coke, crude oil, natural gas, liquefied natural gas, natural gas condensate, gas, and mineral;
- Natural substances;
- Fats, essence oils, and fixed oils extracted by the method of grinding, pressing, or bleeding, even if purified, as long as they yield a product with the same characteristics as the original product; and
- Glass and ceramics.
Mixtures and polymers of low concern are not required to make declarations while polymers of non-low concern are required to do so. Chemical substances that are manufactured, used, or stored in Brazil in volumes of over one ton per year (t/a) (average amount over the last three years) are required to make declarations, for the establishment of a chemical inventory.
Declarations must include the following information:
- The identification data of manufacturers and importers specified in regulations;
- The exact identification of chemical substances including names and CAS numbers (if they exist) issued by the Chemical Abstracts Service (CAS) or the International Union of Pure and Applied Chemistry (IUPAC);
- The annual production and import amount of chemical substances;
- Recommended uses of chemical substances; and
- Hazard classifications made under GHS and Brazilian current regulation.
Any change to the above information must be submitted before March 31, of the following year.
Registration of New Chemical Substances
Once the chemical inventory is published, substances that are not listed in the inventory shall be identified as new chemical substances. Registration dossiers must be submitted and risk assessments carried out on the new chemical substances prior to manufacture or use. Currently, specific data requirements have not been determined yet.
Priority chemical substances must be selected based on the following criteria:
- Persistence in the environment;
- Bioaccumulation in the environment;
- Toxicity in the environment;
- Carcinogenicity, mutagenicity, and reproductive toxicity;
- Endocrine disruptor characteristics based on scientific evidence;
- Hazards equal to human and environmental exposure; and
- Substances bound to an international agreement, treaty, or convention of which Brazil is a party or is included in an international alert.
It is worth mentioning that manufacturers based outside of Brazil are permitted to entrust an only representative (OR) to fulfill regulatory obligations.
According to statistics released by the Brazilian Chemical Industry Association, the total import amount of chemicals in Brazil reached $71.4 billion dollars between June 2021 and May 2022, with a year-on-year growth of 16.5%; and the export of chemicals totaled $16.4 billion with a year-on-year growth of 13.4%. The trade deficit in the last 12 months reached $55 billion, hitting a historical high.
CIRS Group will continue to focus on the updates of Brazil REACH and share relevant information in a timely manner.
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