Pesticides

What are pesticides?

The following products are considered pesticides in Brazil:

• Technical Product - product obtained directly from raw materials by chemical, physical or biological processes, intended to obtain formulated products or premixes and whose composition contains defined content of active ingredient and impurities, and may contain stabilizers and related products such as isomers. For industrial use only.
• Technical product by equivalence - technical products from different manufacturers or different manufacturing processes of the same manufacturer shall be considered equivalent if the assessment of the production process used, the profile of impurities and, where appropriate, the assessment of the toxicological / ecotoxicological profiles, meet the requirements establishes by the Food and Agriculture Organization (FAO).
• Pre-mixture - product obtained from a technical product, through chemical, physical or biological processes, exclusively destined to the preparation of formulated products. The pre-market approval of premixes is only necessary for those cases in which the premix is to be transported from one plant to another and is unnecessary if it is a step in the formulation process within the same plant.
• Formulated product - is defined by Decree 4.074/2002 as the pesticide or related product obtained from technical product or premix, by means of physical process, or directly from raw materials by means of physical, chemical or biological processes. Those, when destined to agricultural use, must be pre-approved by MAPA; when destined to domestic use, must be pre-approved by Anvisa; and when destined to other ecosystems (native forests, roads, rail and metro roads, electric station, etc) must be pre-approved by Ibama.
• Biological product - living organisms, naturally occurring or obtained by genetic manipulation, introduced into the environment for the control of a population or biological activities of another living organism considered to be harmful.
• Semiochemical product (Pheromones and Allelochemicals) – comprised of chemical substances that evoke behavioral and physiological responses in the receiving organisms and that are used with the purpose of detecting, monitoring and controlling a population or biological activity of living organisms. They are categorized depending on the action they cause, intra or interspecifically, as pheromones and allelochemicals, respectively.
• Biochemical product (hormones, growth regulators and enzymes) - naturally occurring chemicals with non-toxic mechanisms of action, without disease or pest control as promoters of chemical or biological processes, including hormones and regulators of growth; and enzymes.

Market authorizations

In accordance with to Law 7.802/1989, pesticides, their components and related products may only be produced, handled, imported, exported, marketed and used in the Brazilian territory if previously approved. These products must comply with the directives and requirements of federal agencies responsible for agriculture, health and environment sectors.

To obtain a pre-market approval in Brazil, the pesticide must be evaluated by three federal government bodies: the Ministry of Agriculture, Livestock and Food Supply (MAPA), the Brazilian Institute for the Environment and Renewable Natural Resources (Ibama), and Anvisa. These bodies perform independent evaluations.

It is Ibama’s competence to evaluate the pollutant potential of the product. To MAPA is assigned the responsibility of evaluating the efficiency and potential of use in agriculture. Anvisa performs the toxicological assessment, evaluating how toxic the product is to the population and under which conditions its use is safe.

The Government agency responsible for issuing pre-market approvals to pesticides for plant protection in Brazil is the Ministry of Agriculture, Livestock and Food Supply. For further information on pesticides for plant protection pre-market approval procedures, please see Decree 4.074/2002, or check the Manual of Procedures for Registration of Pesticides published by MAPA.

Pre-market approvals do not expire, but they might be cancelled in cases of toxicological reassessment, in the impossibility of solving irregularities, or when fraud is detected.

Special temporary authorizations for research and experimentation (RET) might be issued for those that wish to develop activities with pesticides (market authorization holders, researches and others). They are assigned the right to use a pesticide or component for specific purposes in research and experimentation, for a period of 3 years, renewable for an equal period.

Please note that it is not possible for foreign companies to make administrative arrangements for issuing market authorizations directly with Anvisa. Foreign companies shall have partner companies legally constituted in Brazil that will be legally responsible for the products imported to and distributed in the Brazilian territory.

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

According to Decree 4.074/2002, the Ministry of Health, through Anvisa, is responsible for:

• The evaluation and toxicological classification of pesticides, their components, and related products;
• The evaluation of pesticides and similar products intended for use in urban, industrial, domestic, public or collective environments, water treatment and use in public health campaigns, as of the efficiency of the product;
• The conduction of preliminary toxicological evaluation of pesticides, technical products, pre mixtures and related products, for research and experimentation;
• Establishing the re-entry interval in an environment treated with pesticides and related products;
• Monitoring the residues of pesticides and related products in products of animal origin.