Lawsuits Are a Powerful Tool to Access the Brazilian Pesticide Market

“…the involvement of a 4^th 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.

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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 7^th, 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

Year	Number of deferrals (*)
2019	21
2020	42
2021	43
2022	61
Total	167

(*) 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 (*)
Regulatory agency	Registrations approved in 2022 (formulated chemical products)
Anvisa + Ibama	39
Anvisa	18
Ibama	10
Total	67

(*) 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 4^th 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 14^th Brasil AgrochemShow, on August 14^th and 15^th at Expo Center Norte, in São Paulo, Brazil.