Brazil Reach Regulation for Various Sectors
In Brazil, there are specific laws that apply to pharmaceutical products, cosmetics, pesticides, sanitizing products, and explosives. However, there is no law applicable to industrial chemicals. In October 2018, the National Chemicals Safety Commission along with the Ministry of Environment published a Draft Chemical Law (Bill 6120/2019) for the inventory, evaluation, and control of chemical substances. The draft law sets provisions for the creation of a National Inventory of Chemical Substances. It also makes GHS mandatory for industrial chemicals at the workplace.
Draft Chemical Law (Bill 6120/2019)
On 21 November 2019, the draft Chemical Law (Bill 6120/2019) was presented in the Chamber of Deputies. Bill 6120/2019 would require manufacturers, exporters, and importers of chemicals to report the volume of chemical substances annually produced and imported. Furthermore, Safety Data Sheets (SDSs) would have to prepared in accordance with GHS, including recommended uses, hazard classifications, and chemical risk assessment analysis studies for recommended uses. The draft law was approved by the Economic Development, Industry, Trade, and Commercial Services (CDEICS) on 23 November 2022. Now the measure is under consideration by the Commission on Constitution, Justice, and Citizenship (CCJC).
The most important aspects of Bill 6120/2019 are:
- The notification data requirements include substance identity, CAS number, recommended uses, safety data sheet, classification information, and risk assessment analysis for all substances in the Inventory.
- The bill adopts GHS as the mandatory classification system.
- Data related to hazard and risk are not confidential, but substance identity can be confidential in special circumstances.
- Chemicals of unknown or variable composition (UVBCs) must be registered as a single chemical.
- Candidate substances for prioritization include Carcinogenic, Mutagenic and Reprotoxic (CMR), Persistent, Bioaccumulative, and Toxic (PBT) and Endocrine Disruptors. In addition substances that are covered by international agreements or conventions can also be prioritized.
- Manufacturers, exporters, and importers of chemical substances are obliged to provide information to the National Inventory of Chemical Substances.
- Animal testing should be the last resort to determine the hazard of a chemical.
- Non-compliance of the law is subject to administrative sanctions.
- The government is responsible for setting up an Assessment Committee to assess the risks of the substances and recommend risk management measures.
The draft law, Bill 6120/2019, applies to industrial chemical substances on their own, in mixtures or in articles in volumes above 1 TPA. According to Article 3 of the draft law, the following chemical substances are out of scope as they are regulated by other specific laws and regulations:
- Pesticides
- Pharmaceuticals and medical gases
- Cosmetics, toiletries, and perfumes
- Disinfectants
- Products for veterinary uses
- Food and food additives
- Products used for animal feed
- Fertilizers
Ordinance No. 204/2022
Additionally, Ordinance No. 204/2022 came into force on 24 October 2022. Ordinance No. 204/2022 sets procedures for the control and supervision of chemicals and defines the chemicals subject to control by the Brazilian Federal Police. This entails the incorporation of requirements related to registration, licensing, and prior authorization as well as documents related to import and export, density declaration, and labelling. The chemicals listed under the Ordinance contains seven lists of chemicals in Annex 1 which are subjected to inspection.
The draft law mainly applies to industrial chemical substances above 1 TPA. According to the Article 3 of the draft law, the following chemical substances are out of scope.
- Radioactive substances
- Substances in development or solely for research
- Non-isolated intermediates
- Narcotic and psychotropic substances
- Pharmaceuticals
- Agrochemicals
- Cosmetics and personal hygiene products
- Food and food additives
Brazil does not have an approved national chemical inventory. A draft law, Bill 6120/2019, was approved by the Chamber of Deputies on 23 November 2022. Currently, Bill 6120/2019 is submitted to the Commission on Constitution, Justice, and Citizenship (CCJS) for further review. Bill 6120/2019 would create a National Inventory of Chemical Substances to consolidate information on chemicals produced and manufactured in Brazil. Furthermore, the draft law would require producers or importers of industrial chemical substances, in volumes over 1 Tonnes per Annum (TPA) (based on three years' average) to make declarations for the establishment of the chemical Inventory. The information that would need to be submitted to the Inventory includes:
- Company identification of the producer or importer
- Substance identity such as CAS name or IUPAC name as well as CAS number if available
- Annual volume produced or imported
- Recommended uses of the chemical substance
- Hazard classifications made under GHS and current Brazilian regulations
It is expected that the deadline for submitting the above information will be 3 years from the time a substance becomes available. For mixtures, each substance exceeding 1 TPA must be submitted separately. For polymers, only polymers that do not meet the criteria of a Polymer of Low Concern (PLC) must be submitted. Once the chemical inventory is published, substances that are not listed in the inventory shall be identified as new substances.
The following chemical substances are out of scope, i.e. they do not need to be submitted to the inventory.
- Radioactive substances
- Substances in development or specifically for research
- Non-isolated intermediates
- Chemical substance, mixtures, and articles under customs control
- Narcotic and psychotropic substances
- Substances exclusively used in tobacco
- Metallic alloys
- Explosives
- Residuals
Once the national existing chemical substance inventory has been finalized, chemical substances which are not listed will be regarded as new chemical substances. Manufacturers and importers of >=1t/y new chemical substances need to register those new substances by submitting additional studies and risk assesment report. Data requirements will increase with tonnage bands.
Certain existing chemical substances on the inventory will be selected for evaluation.
New substances and certain existing industrial chemicals on the inventory will be selected for hazard evaluation by Industrial Chemicals Assessment Technical Committee if they meet the following criteria:
- Persistent, bio-accumulative or toxic to the environment; or
- Carcinogenic, mutagenic or toxic to reproduction; or
- Endocrine disruptors, based on scientific evidence;
- There are relevant potential exposure to humans and the environment;
- Controlled by international treaties or conventions of which Brazil is a member or signatory.
Note: Industrial chemical substances which do not fulfill one or more of the criteria above but may give rise to a level of equivalent conern may also be subject to evaluation.
Producers and importers of >=1t/y industrial chemicals subject to evaluation will be required to submit certain information, studies, and safety data sheets to CONASQ to support risk assessment. Depending on the results of risk assessment, CONASQ may prohibit or restrict the production, import, trade or use of certain chemical substances.
If the regulation comes into force, the new law will make GHS mandatory for industrial chemicals at workplace.
The Brazilian Health Regulatory Agency (Anvisa) under the Ministry of Health is the authority that supervises the implementation of the GHS in the workplace and storage. The authority in charge of Ordinance No. 204/2022 is the Brazilian Federal Police.
Bill 6120/2019 will require that manufacturers, producers, and importers of industrial chemical substances, in an amount equal to or greater than 1 TPA, report the amount of chemical substances annually produced and imported as well as the contents of SDSs in accordance with GHS, including recommended uses, hazard classifications, and chemical risk. The Bill will also make it possible for foreign manufacturers/formulators to appoint an Only Representative for compliance purposes.
Manufacturers will need to comply with the Brazilian Regulatory Standard NR9 and NR15 which regulate and provide guidance on mandatory procedures related to occupational safety and health. Standard NR15 sets the tolerance limits for chemical agents in the workplace and Standard NR9 states the obligations of employers to have an Environmental Risk Prevention Program.
Companies and natural persons must comply with transportation regulations and the Brazilian Federal Police registry and authorization.
If a substance is listed in Annex I of Ordinance No. 204 of 21 October 2022, companies must register with the Federal Police to obtain the following documents:
- Cadastral Registration Certificate (CRC): the document that proves that the natural or legal person is duly registered with the Federal Police.
- Operating License Certificate (CLF): the document that proves that the legal entity is qualified to carry out a non-occasional activity with chemical products.
- Special Authorization (AE): the document that proves that the natural or legal person is authorized to carry out, eventually, activities with chemical products.
All the concerned bodies (traders, manufacturers, and transporting bodies) must have a Registration Certificate and an Operating License Certificate (CLF). The CLF must be renewed every year. A Special Authorization can be also granted under special circumstances stated in Annex II of Ordinance No. 204/2022. The Special Authorization is subject to:
- Registration approval
- Evaluation of the nature of the economic activity carried out by the applicant.
- Eventual use of the product
Importation and Exportation under Ordinance No. 204/2022
The Federal Police grants a prior authorization for the activities of import, export, or re-export of chemical products subject to mandatory administrative treatment in the official control systems. Prior Authorization must be requested with the following documents:
- Application contained in Annex III, for import processes
- Proforma invoice with the name of the product, quantity, concentration, density, value of the merchandise, in addition to the identification of the importer/exporter and the buyer, the manufacturer and available data related to transportation
- Bill of lading, when applicable
- Other documents that the Federal Police deem necessary for the analysis of the Prior Authorization request
For chemical products imported, exported, or re-exported in bulk, there will be a tolerance of up to 10% of the quantity previously authorized for shipment and, for other forms of presentation, there will be a tolerance of up to 5%.
The validity period of the Prior Authorization will be:
- Ninety days for importation, counted from the date of approval, extendable for an equal period.
- Ninety days for export or re-export, counted from the date of approval, extendable, successively, for an equal period.
There are no fees or penalties mentioned in Ordinance No. 204/2022.
The authorities involved in pesticide management in Brazil are the Ministry of Agriculture, Livestock and Supply (MAPA), the National Health Surveillance Agency (ANVISA) under the Ministry of Health (MS), and the Brazilian Institute of the Environment and Renewable Natural Resources (IBAMA) under the Ministry of Environment (MMA).
Law 7802 (Pesticide Law) established Brazil's current pesticide legislative framework, which governs pesticide research, experimentation, production, packaging, labelling, transportation, storage, marketing, commercial-advertising, utilization, import, export, waste and package disposal, registration, classification, and control. The role of each ministry is given below:
- The Ministry of Agriculture (Article 5): Evaluates the efficiency of agrochemicals, phytotoxicity of pesticides and resistance management.
- The Ministry of Health (Article 6): Toxicological Assessment, Monitor MRL and Pre-harvest Interval and Dietary Risk Evaluation.
- The Ministry of the Environment (Article 7): Checks environmental assessment and evaluation of environmental hazards.
- The applicant must submit the application and its attachments in triplicate to the above-mentioned federal agencies in the agriculture, health, and environmental sectors.
- The applicant must submit the application and its attachments in triplicate to the above-mentioned federal agencies in the agriculture, health, and environmental sectors. The registration authority will consider the effectiveness, toxicological, and environmental reviews conducted by the various authorities before deciding whether to accept the registration.
- When new health/environmental concerns are discovered, or when Brazil is alerted of new dangers by international health or environmental groups, or when a new pesticide with a better safety/efficacy profile is created to replace an existing pesticide, pesticide reevaluation is undertaken.
- The authorities may analyze the dossiers in the same way and decide whether to keep, change, or cancel them.
- The validity of product registration can be unlimited or canceled due to a negative result during aperiodic reevaluation, violation of government-imposed enterprise sanctions or breach of operating scope.
After Submission for the Registration:
1. Submission of the product registration will be reviewed by all the Authorities.
2. MAPA expresses an opinion on whether the proposed product is appropriate to reduce the Efficacy Evaluation, Phytotoxicity and Resistance Management risks.
3. In parallel, the ANVISA judge the Toxicological Assessment, MRL and Pre-harvest Interval and Dietary Risk Assessment of the product.
4. In addition, IBAMA views the Environmental Assessment Evaluation of Potential Environmental Hazards of the product.
5. After all the opinions are considered, the Brazil ministries then make a final decision, which needs to be supported by the Member States in comitology.
6. After the restriction enters into force, the substance is listed on the banned list and shall not be manufactured, placed on the market, or used.
Re-Registration: Technical product, pre-mixture, and formed product research and experimentation should get a special temporary registration (RET). For efficacy, toxicity, environment, residue, and chemical investigations, pesticides containing RET can be made or imported in small quantities. Agriculture products in the treated region are unfit for human consumption or animal feed. The RET can be given automatically by the registration authorities if a pesticide comprises active components that have already been registered in Brazil. The research and experiments are divided into three stages based on the condition, activity area, and study strategy.
When a product is intended to be further processed, the law does not require it to be labeled as a retail item. However, the exporter must provide all required information to the importer. The information provided by the exporter does not have to be on the product package (foodservice and industrial use packages), but it should be on the documentation that accompanies the items at the very least. The law does not need a specific document; therefore, it may be an invoice, a technical description sheet, or anything else.
Companies involved in the manufacturing, formulation, repackaging, exportation, importation, marketing, and application service of pesticides shall file the registration application. The registration can be categorized as product registration, special temporary registration (RET), component registration, and entity registration depending on the business stage, ingredient, and registration object (a.k.a. establishment registration).
Decree 7074 specifies the required material, label format, and layout, as well as the elements and text content of pesticide labels and product manuals. To indicate the product hazard to the user, a color band should be placed on the pesticide label. The color corresponds to the toxicological rating determined according to ANVISA's recommendations.
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