Brazil Reach Regulation for Various Sectors
Prior to November 13, 2024, the country regulated chemicals through sector-specific legislation covering pharmaceuticals, cosmetics, pesticides, sanitizing products, and explosives. However, on November 13, 2024, President Lula sanctioned Law 15.022/24 (formerly known as Bill 6120/19), which addresses a long-standing gap in Brazil's chemical regulatory framework.
Draft Chemical Law (Law 15.022/24)
Law 15.022/24 requires 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 most important aspects of Law 15.022/24 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 law 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
- Radioactive Substances
- Residuals
The draft law mainly applies to industrial chemical substances above 1 TPA. According to the Article 3 of the 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
- Residuals
- Explosives
Law 15.022/24 creates a National Inventory of Chemical Substances to consolidate information on chemicals produced and manufactured in Brazil. Furthermore, the law would requires 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 date the IT system becomes functional. 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.
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.
Law 15.022/24 makes the seventh version of the 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.
Law 15.022/24 requires 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.
Companies and natural persons must comply with transportation regulations and the Brazilian Federal Police registry and authorization.
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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