“…the involvement of a 4th Institution in the registration process is being demanded, the Federal Court…”
Flávio Hirata, agronomist (ESALQ-USP), expert in pesticide registration and partner at AllierBrasil.
AllierBrasil is a consulting firm dedicated to agribusiness, focused on product registration and development of technical-commercial partnerships. For over 25 years, AllierBrasil has enabled pesticide companies to enter the Brazilian market.
Product registration is the main barrier to accessing the pesticide market in Brazil.
According to Decree No. 4074, the time for evaluation of a pesticide registration should be within 120 days after registration request submission. This period, however, was changed to 24 months by Decree No. 10833, from October 7th, 2021. Regardless the period established by law, the actual time necessary may exceed 10 years.
Considering this long time, lawsuits against the governmental bodies involved in the registration process, Anvisa, Ibama and Mapa, have been increasing in recent years.
At Anvisa, the number of toxicological evaluation deferrals in compliance with court decision of formulated chemical products almost tripled in four years. From 2019 to 2022, 167 deferrals of toxicological evaluations of formulated chemical products were through court decisions. In 2022, there were 61 deferrals of toxicological evaluations of formulated products, against 21 in 2019, according to a survey performed by AllierBrasil.
Deferrals of toxicological evaluations (formulated chemical products)
in compliance with court decisions
Number of deferrals (*)
(*) partial, AllierBrasil
Source: Anvisa, adapted by AllierBrasil
According to the report “Pesticide Registration versus Court Decisions” from AllierBrasil, lawsuits can be against one, two or all three of the agencies responsible for pesticide registration. In 2022, 39 formulated chemical products had their registrations approved through court decisions against Anvisa + Ibama, 18 only against Anvisa and 10 only against Ibama.
Deferrals via court decision (*)
Registrations approved in 2022
(formulated chemical products)
Anvisa + Ibama
(*) partial, AllierBrasil
Sources: Anvisa and Ibama, adapted by AllierBrasil
In that same report, the companies that most resorted to court decisions were Rainbow and Iharabras, both with nine registration approvals via lawsuit each.
Those numbers show that, because of the long time taken to approve pesticide registrations, the involvement of a 4th Institution in the registration process is being demanded, the Federal Court.
Furthermore, it should always be considered that the evaluation for registration purposes requires great caution, given that those are chemical products applied in the environment, used in agriculture, for food production.
This and other issues will be presented during the lecture “Pesticide Registration” at the 14th Brasil AgrochemShow, on August 14th and 15th at Expo Center Norte, in São Paulo, Brazil.