“In 2023, the number of registration approvals through court decision fell…”
Flavio Hirata is a partner at AllierBrasil, with a degree in agronomy from Esalq/USP, and a specialist in pesticide registration.
AllierBrasil is a pesticide registration consulting firm that organizes technical-commercial visits, exhibitions and lectures in India, China and Brazil with the aim of promoting Brazilian agriculture.
Flavio Hirata, partner at AllierBrasil
In 2023, 555 pesticide registrations were approved in Brazil, which represented a 15% drop when compared to 2022, after seven consecutive years of record approvals. Even so, the number of approvals is the 3rd highest in the historical series. So far (July 31st), in 2024, 220 registrations of formulated products and 80 of technical products were granted, totaling 300 approvals.
Pesticide Registration Approvals (2015 to 2024)
On the other hand, in the past 5 years, 516 registrations were cancelled, while 2,737 registrations were approved. Cancellations represent 18.8% of the approvals in the period. In 2023, 177 registrations were cancelled, which is a record when compared to the average of the previous 5 years, with an increase of 41.8% from 2019 to 2023.
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Pesticide Registration Cancellations (2019 to 2023) |
|||||
| Year | 2019 | 2020 | 2021 | 2022 | 2023 |
| Cancellation request by registrant | 73 | 43 | 50 | 41 | 89 |
| Cancellation | 1 | 26 | 17 | 88 | 88 |
| Total | 74 | 69 | 67 | 129 | 177 |
Brazil is the largest and most attractive pesticide market in the world, compatible with the size of its agriculture, but the product registration process is slow, and a registration approval can take more than 10 years.
According to the most recent publication by the Ministry of Agriculture regarding the approval of pesticide registrations (Federal Official Gazette of Brazil, Act No. 32, of July 18th, 2024), of the 50 approved registrations of formulated chemical products, the average time for approval was 5.14 years. Some processes took 12 years for approval, and 15% (9 products) took at least 8 years.
Year of Approved Registration Protocols
|
Total |
Until 2015 | 2016 | 2017 | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 |
| 50 | 5 | 8 | 1 | 9 | 5 | 9 | 13 | 0 | 0 |
0 |
Source: Federal Official Gazette of Brazil, Act No. 32, of July 18th, 2024, Ministry of Agriculture.
Time Necessary to Register Pesticide Products
| Total | 6 years or + | 5 years or + | ||
| Approvals | % | Approvals | % | |
| 50 | 20 | 40 | 25 | 50 |
Source: Federal Official Gazette of Brazil, Act No. 32, of July 18th, 2024, Ministry of Agriculture.
In 2023, of the 215 approved generic Formulated Products (FPs) registrations, 61.86% took 5 years or more for approval, and 49.30% took 6 years or more, according to a survey prepared by AllierBrasil (2024).
This time is already considered excessive. Furthermore, the situation is much more critical if we disregard the effects of court decisions against the agencies involved in the registration of pesticides (mainly Anvisa and Ibama). These actions aim to speed up the evaluations and, ultimately, the registration.
150 generic FPs registration processes followed the normal procedures, without legal action. In this case, 80% of the products took 5 years or more to obtain registration, and 65.33% took 6 years or more.
Taking into account the generic FPs that were the subject of court decisions, the situation is very different: only 18.46% took 5 years or more, and 12.3% took 6 years or more. In 2023, 65 generic FP registrations were approved through court decisions against at least one of the regulatory agencies (Anvisa and/or Ibama), representing 30.02% of the total registrations in this category.
According to official data, in 2023 the number of registration approvals through court decisions decreased when compared to 2022. It is important to note that this data is partial, given that many of the court decisions are not published and/or the legal proceedings are under judicial secrecy.
The complete data on this subject is the subject of the lecture “Registration of Pesticides: “Time, Court Decisions and the New Pesticides Law”, to be given by the author, at the 15th Brasil AgrochemShow, at Expo Center Norte, on August 13th and 14th.
To participate in the event, it is necessary to donate basic food hampers to the charity institution Crê-Ser.
For more information: brasil@agrochemshow.com.br
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