Pesticides

What are pesticides?

According to Brazilian legislation, they are products and agents of physical or chemical processes, either isolated or mixed with biological agents. They are intended for use in the production, storage or processing of agricultural products; in pastures; or in the protection of planted forests. Their purpose is to alter the composition of flora or fauna in order to protect them from living beings considered harmful.

What are the types of pesticide registration?

Technical product – is a product obtained directly from raw materials by isolated physical or chemical processes, or mixed with biological agents, intended to produce formulated products or premixes. Its composition contains a defined amount of active ingredient and impurities, and it may contain stabilizers and related products, such as isomers. For industrial use only.

• Technical product by equivalence – is a technical product from different manufacturers or a technical product from the same manufacturer produced by different processes, which shall be considered equivalent if the production process, impurity profile and, where appropriate, toxicological/ecotoxicological profiles meet the requirements established by the Food and Agriculture Organization (FAO).
• Pre-mixture – is a product obtained from a technical product through isolated physical or chemical processes or mixed with biologicals, intended exclusively for the preparation of formulated products. Pre-market approval of premixes is only necessary if the premix is to be transported from one plant to another; it is not necessary if it is a step in the formulation process within the same plant.
• Plant protection product – is a pesticide, environmental control product or related product obtained from a technical product or premix through a physical process or directly from raw materials through physical or chemical processes alone or mixed with biologicals.

What are bioinsumos for phytosanitary use?

Bioinsumos for phytosanitary use are agricultural inputs developed from an active ingredient of natural/biological origin, which are considered biological active ingredients. These were previously known as biopesticides. They can be used in agricultural production, storage, and processing, and are presented as products with insecticidal, herbicidal, and microbiological and phytochemical nematicidal functions; as plant growth regulators, defoliants, and desiccants; as plant activators and protectors; as natural enemies; and as behavioural response pheromones.

The regulatory framework for biopesticides underwent legislative change with the publication of Law No. 15,070 on 23 December 2024. This law removes biopesticides used in agriculture to control pests and diseases from the pesticide regulatory framework, establishing new administrative procedures for granting registration to these products.

The law covers the production, import, export, registration, marketing, use, inspection, supervision, research, experimentation, packaging, labelling, advertising, transport, storage, fees, provision of services, and disposal of waste and packaging, as well as incentives for the production of bioinsecticides for phytosanitary, livestock, aquaculture, and forestry use.

Anvisa receives a toxicological dossier comprising information and studies that enable it to assess the following requirements: detailed taxonomic identification of the living organism; guarantee of the origin of the raw material; infectivity, toxicity and pathogenicity studies; acute and chronic studies; sensitization and dermal and ocular irritation studies; and compliance with good manufacturing practices and contaminant control in the production process of these products. The analysis of these requirements aims to classify the danger posed by products, i.e. to identify their potential to cause harm to human health.

The classification of substances is carried out in accordance with the Globally Harmonised System of Classification and Labelling of Chemicals (GHS), which is of fundamental importance for health and safety. It provides guidance on individual protection criteria for workers, as well as emergency measures in the event of accidents.

The toxicological analysis of Bioinsumos is highly specific and technically complex due to the variety of formulations and levels of technology and innovation involved. The results of the analysis are converted into information for users and the general public, such as label warnings, hazard classification and monographs on biological assets.

Market authorizations

In accordance with Law 14.785/2023, pesticides (commercial and technical products), environmental control products, their components, and related products may only be produced, searched for, imported, exported, marketed, or used if they have been previously authorized or registered by the federal body. These products must comply with the directives and requirements of the federal bodies responsible for the agricultural, health and environmental sectors.

In order to obtain pre-market approval in Brazil, pesticides must be evaluated by three federal government bodies: the Ministry of Agriculture, Livestock and Food Supply (MAPA), the Brazilian Institute of the Environment and Renewable Natural Resources (IBAMA) and the National Health Surveillance Agency (ANVISA). These bodies perform independent evaluations.

Ibama is responsible for evaluating the product's potential to pollute. Mapa is responsible for evaluating the product's efficiency and potential agricultural use. Anvisa is responsible for performing the toxicological assessment, evaluating how toxic the product is to the population and determining the conditions under which its use is safe.

The government body responsible for issuing pre-market approvals for pesticides used for plant protection in Brazil is the Ministry of Agriculture and Livestock and Food Supply.

Although pre-market approvals do not expire, they may be cancelled in cases of toxicological reassessment or if irregularities cannot be resolved. They may also be cancelled if fraud is detected.

Special temporary authorizations for research and experimentation (RET) may be granted to those wishing to conduct activities involving pesticides (market authorization holders, researchers, etc.). These authorizations grant the right to use a pesticide or component for specific research and experimental purposes for a period of three years, renewable for an equal period.

Please note that foreign companies cannot make administrative arrangements for the issuance of market authorizations directly with Anvisa. Foreign companies must have partner companies that are legally constituted in Brazil and that will be legally responsible for products imported into and distributed within Brazilian territory.

What is Anvisa’s role in the pre-market approval of pesticides?

The Ministry of Health, through Anvisa, is responsible for:

- establishing guidelines and requirements regarding the data and information that applicants must present for the registration of pesticides, their components, and related products;

- establishing guidelines and requirements aimed at minimizing the risks presented by pesticides, their components, and related products;

- performing the evaluation and toxicological classification of pesticides, their components and related products according to the Globally Harmonized System (GHS);

- establishing the re-entry interval in environments treated with pesticides and related products;

- establishing the maximum residue level (MRL) of pesticides permitted in foods of plant origin;

- establishing the labelling parameters for pesticides and related products;

- monitoring pesticide residues in foods of plant origin.

- promoting the re-evaluation of pesticide active ingredients, their components, and related products when international organizations specializing in health, food, or the environment – of which Brazil is a member, or with which it has signed agreements or conventions – issue warnings about risks, or recommend against the use of pesticides or similar substances.

Post-market monitoring

Anvisa is responsible for monitoring pesticide residues in food and is also in charge of the toxicological re-evaluation of active ingredients in pesticides. This monitoring is carried out through the Pesticide Residue Analysis in Food Programme (PARA), which aims to monitor pesticide residues in food of plant origin and identify and reduce the health risks arising from exposure to these substances through diet. The programme also assesses compliance with the maximum residue limit (MRL) established by Anvisa.

Since its establishment in 2001, the programme has collected over 45,000 food samples nationwide. It is part of the Brazilian Health Surveillance System (SNVS), which is coordinated by Anvisa and carried out by state and municipal health surveillance authorities, as well as the Central Public Health Laboratories (Lacen) and private reference laboratories.

PARA's sampling criteria are based on controls carried out in the United States through the Pesticide Data Programme (PDP) and in the European Union by the European Food Safety Authority (EFSA). Priority is given to foods most representative of the Brazilian population's diet. These are selected based on data from the Family Budget Survey conducted by the Brazilian Institute of Geography and Statistics (IBGE).

Samples are collected in locations where the population purchases food, in accordance with the Codex Alimentarius guidelines. Laboratory analyses follow ISO/IEC 17025 requirements, using internationally recognized and validated analytical methodologies.

Anvisa evaluates the results of the programme's analyses, mapping the distribution of pesticide residues in food in order to adopt mitigating measures when irregularities or health risks are identified. Consequently, Anvisa contributes to food safety by guiding production chains on non-conformities in their production processes and encouraging the adoption of Good Agricultural Practices (GAPs).

Re-evaluation of pesticides - registration review

Pesticides may only be used if they have been authorized and registered with a Federal Agency in accordance with Law No. 14,785 of 27 December 2023.

Anvisa is involved in the registration process and is responsible for assessing the potential impact on human health. Anvisa conducts comprehensive risk assessments to support the registration of pesticides and evaluates any subsequent changes through post-registration review processes.

There is no legal provision for the renewal or revalidation of pesticide registration in Brazil. Therefore, once granted, pesticide registration remains valid indefinitely. However, technical and scientific knowledge about these substances continues to evolve, and new risks – including, but not limited to, those related to dietary exposure – may be identified after the product has been registered.

According to Law No. 14.785/2023, when international organizations in the areas of health, food or the environment – of which Brazil is a member, or with which it has signed agreements or conventions – issue warnings about risks, or recommend against the use of pesticides or similar substances, the competent authority shall take steps to reassess the risks. This registration review must consider economic and phytosanitary aspects, as well as the availability of alternative products.

Re-evaluation is a regulatory tool used to review the registration of products that pose potential risks which were not identified at the time of initial registration.

At Anvisa, the re-evaluation process is regulated by RDC No. 221 of 28 March 2018. This establishes procedures for re-evaluation and sets out the criteria for selecting and prioritizing pesticide active substances for registration review.

Based on the findings of the re-evaluation, the authorities may decide to:

-          Maintain the active substance’s registration as is;

-          Maintain the active substance’s registration with the adoption of risk mitigation measures; or

-          Suspend or prohibit the active substance.

Which pesticide re-evaluations have been completed by Anvisa?

The table below shows the pesticide active substance re-evaluations completed by Anvisa since 2006, when the re-evaluation process was defined more clearly.

As a result of these reviews, several active substances have been restricted due to the identification of health hazards and risks, leading to the withdrawal of hundreds of products from the market.

What re-evaluations are currently underway at Anvisa?

International Forums

CCPR/Codex

Anvisa is responsible for establishing Maximum Residue Limits (MRLs) at a national level. Together with the Ministry of Agriculture and Livestock (MAPA), Anvisa is part of the Brazilian delegation that participates in the Codex Committee on Pesticide Residues (CCPR). 

The CCPR is a Codex Alimentarius committee responsible for setting MRL values for pesticides in specific foods or food groups within the Codex's remit, with the aim of safeguarding human health and facilitating international trade.

The Conferences of the Parties to the Basel, Rotterdam and Stockholm Conventions (BRS COPs)

Brazil has been a signatory to the Basel, Rotterdam and Stockholm Conventions (BRS) since 2005, when they became part of the Brazilian legal system. These three conventions deal with the environmentally sound management of chemicals used in various economic sectors and are interconnected in terms of the adoption of national policies aimed at protecting the environment and human health through the management of chemical waste, the control of international chemical trade and the elimination of the use of persistent organic pollutants. Due to this correlation, the COPs BRS are held simultaneously every two years and Anvisa plays an active role in the Brazilian delegation.