On September 26, 2023, the Commission on Constitution, Justice and Citizenship (CCJC) in Brazil published PL 6120/2019 which has been submitted to the Senate for further review.
PL 6120/2019 proposes to set up a national chemical inventory as a national database to collect the information on chemicals imported or manufactured in Brazil with hazard characteristics. If PL 6120/2019 is approved, Brazil will be the four country in South America to establish chemical management regulations, following Peru, Chile, and Colombia.
The following substances are exempted from Bill PL 6120/2019:
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Radioactive substances |
Chemicals under development |
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Chemicals specifically used for research use |
Non-isolated intermediates |
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Chemicals used for national defense |
Residuals |
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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 |
Substances unintentionally produced during storage due to environmental factors such as air, light, humidity, microorganisms, etc. |
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Products that are regulated by specific laws and regulations: |
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): |
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Narcotic drugs, psychotropic drugs, and immuno-suppressive agents |
Substances that are exclusively used as ingredients of tobacco and derivatives |
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Metallic alloys in the form of plates, sheets, strips, billets, ingots, beams, and other similar items for structural purposes |
Explosives and their accessories |
Substance declaration:
Chemicals or its mixtures manufactured or imported in volumes of over 1t/a (average amount over the last three years) are required to make declarations. Polymers are required to make declarations in volumes of or over 1t/a. Specific chemicals may be subject to a declaration threshold of less than 1t/a. Mixtures, articles, polymers of low concern are not subject to make declarations.
Declarations must include the following information:
- The identification data of manufacturers and importers specified in regulations;
- The annual production and import amount of chemical substances;
- The exact identification of chemicals including names and CAS number (if they exist) issued by the Chemical Abstracts Service (CAS) or the International Union of Pure and Applied Chemistry (IUPAC);
- Hazard classifications made under GHS and Brazilian current regulation; and
- Recommended uses of chemical substances.
Any change to the above information must be submitted before March 31, of the following year.
Generally, the information submitted to the National Chemical Inventory will be made public. However, in accordance with Article 31 of the Freedom of Information Act, personal information will be protected. Industrial or commercial trade secrets will be treated as confidential, and manufacturers or importers may request protection for the identity and CAS number of chemicals for a maximum period of 5 years.
Registration of new chemical substances:
If a chemical is listed in the Inventory, those not included are considered new chemical substances. Manufacturers or importers must register any new chemicals or mixtures produced or imported annually in quantities equal to or exceeding 1 ton, in accordance with the declaration requirements mentioned above. Manufacturers or importers shall provide additional information for new chemicals if they meet the priority assessment criteria as follows:
Risk assessment:
Chemicals under priority risk assessment must be selected based on the following criteria:
- Persistence and environmental toxicity;
- Bio-accumulation and environmental toxicity;
- Persistence,bio-accumulation and environmental toxicity;
- 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.
Chemicals that do not meet the aforementioned criteria but may have a severe impact on human health or the environment will be under priority risk assessment. The Brazilian government will establish the Chemical Substance Assessment Technical Committee and the Chemical Substance Review Committee. The Chemical Substance Assessment Technical Committee will propose recommendations for chemicals to undergo priority risk assessment based on technical evidence, which will be submitted to the Chemical Substance Review Committee. The Chemical Substance Review Committee will regularly publish its work plan for chemical substance risk assessments. To support the risk assessment, the Chemical Substance Review Committee will utilize information and research results provided by recognized organizations in domestic and international. Manufacturers and importers may be required to provide information, research, and SDS. According to the regulations, the deadline for manufacturers and importers to submit information and additional research is 120 days. It is important to note that the regulation specifies that animal testing should be considered as the last resort for determining the hazard of chemical substances and should only be used when all alternative methods have been exhausted.
Risk management measures:
Based on the risk management of chemicals, the Deliberative Committee on Chemical Substances of Brazil may take one or more of the following measures:
- Improve information dissemination and promotional strategies related to chemicals;
- Manufacturers and importers are required to formulate and implement risk management plans to reduce risks;
- Labels and SDS of chemicals, mixtures, or products shall be adjusted (where applicable);
- Concentration limits for chemicals in mixtures or products shall be specified;
- The production, import, export, trade, and use of chemicals shall be restricted;
- Authorization management for the production and import of chemicals; and
- Prohibition of the production, import, export, trade, and use of chemicals.
Manufacturers and importers of chemicals subject to risk management measures may be required to regularly provide information to the National Chemicals Inventory. The specific frequency and content of information will be determined by the Chemical Substance Review Committee.
PL 6120/2019 also introduced “representante exclusivo” (similar to Only Representative in the EU) for foreign manufacturers. This allows Brazilian entities to act as representatives for foreign manufacturers, assuming all responsibilities and obligations on their behalf within the Brazil.
To implement the national chemical inventory in an effective way, the Brazilian government shall formulate regulations related to the management of chemicals within 180 days after the promulgation of PL 6120/2019 and computer systems shall be developed or adjusted within 3 years.
Comments:
Statistics from Brazilian Chemical Industries Association show that chemical imports in Brazil reached $5.1 billion this year by July with an import volume of 5 million tons. This brings the highest import value record this year, and it marks a 50% surge compared to the 3.3 million tons imported in February. The approval of PL 6120/2019 means a lot to the chemical industry development in Brazil and its international standing, which also underscores the importance of keeping consistent with international standards and regulations, making a crucial step in its modernization. CIRS will stay focus on the development of in Brazilian regulations on chemicals and update in a timely manner.
