“The time for approval of a registration, from the submission of the application to the completion of the evaluation, is too long, and can exceed 10 years…”
Flávio Hirata, agronomist (ESALQ-USP), expert in pesticide registration and partner at AllierBrasil.
AllierBrasil is a consultancy dedicated to agribusiness, focusing on product registration and development of technical-commercial partnerships. For over 25 years, AllierBrasil has been enabling pesticide companies to enter the Brazilian market.
Flávio Hirata, partner at AllierBrasil flavio.hirata@uol.com.br
652 pesticide registrations were approved in 2022. This is the seventh consecutive year with record approvals. There were 3709 registrations between 2013 and 2022. In 2023, 231 registrations have already been approved. Even so, the demand for registrations of “newer products” is far from being met.
The time for approval of a registration, from the submission of the application to the completion of the evaluation, is too long, and can exceed 10 years.
The expression “newer products” does not necessarily mean products still under patent or data protection, but products that are interesting to the market. The approval of registrations today considered unattractive happens because the processes were initiated a long time ago.
According to a survey performed by AllierBrasil, the time it takes to approve a registration depends on the type of product. Biological products have priority for evaluation. Regarding the 273 chemical formulated products (new formulated product; formulated product; formulated product based on equivalent technical grade product) approved in 2022, the average time for approval was 5.8 years, and for 47.68% of these products the time was 6 years or more to be registered. In addition, several of these approvals were the subject of legal action against the bodies responsible for the assessments.
If the 57 evaluations of chemical formulated products approved through legal action against Anvisa are disregarded, the average time for approval increases to 6.5 years. Of the 180 approved registration processes that followed the regular queue for analysis, the time to approval was 6 years or more for 60.56% of the products.
In the case of formulated products based on equivalent technical grade products (FP/ETP), also called generics, for 52.38% of the 168 registrations approved in 2022, the time for approval was 6 years or more. If the 53 products approved through legal action against Anvisa are excluded, which are 115 products, for 73.04% of these the time for approval was 6 years or more.
Time for registration approval of Chemical Formulated Products (CFP)
(1) Registration processes that followed the regular queue and those that were subject to legal action to expedite toxicological evaluation.
(2) Registration processes without taking legal action to expedite toxicological evaluation.
Sources: Anvisa, Ministry of Agriculture and Livestock; adapted by AllierBrasil
In another survey elaborated by AllierBrasil, on registration approvals in 2021, it was observed that 60% of FP/ETP (1) registrations required 5 years or more for approval, compared to 59.07% in 2022. This means that there has been no variation in the time taken for approvals of this type of product over the last two years.
Formulated chemical products
(1) Registration processes that followed the regular queue and those that were subject to legal action to expedite toxicological evaluation.
(2) Registration processes without taking legal action to expedite toxicological evaluation.
(3) Registration processes subject to legal action to expedite toxicological evaluation.
Sources: Anvisa, Ministry of Agriculture and Livestock; adapted by AllierBrasil
To anticipate toxicological evaluation and registration approval, applicant companies are increasingly filing lawsuits in the face of administrative delays against the agencies responsible for product registration. According to another survey performed by AllierBrasil, in 2022, 59 evaluations were granted by Anvisa and 48 by Ibama, which were the subject of lawsuits.
Regarding the registrations of Equivalent Technical Grade Products (ETPs), the 10 most approved active ingredients in 2022, out of a total of 58, represent 47.6% of the registered ETPs, with emphasis on flumioxazin, with 8.12%, and prothioconazole, with 7.38%. Some of these active ingredients have more than 40 approved technical product registrations. Others have little prospect of market access, either because their factories have closed, or because of re-evaluation by regulatory agencies, for example.
Active ingredients of Equivalent Technical Grade Products (ETP) approved in 2022
Sources: Ministry of Agriculture and Livestock; adapted by AllierBrasil
All steps of pesticide registration and maintenance are costly, and even unpredictable in certain cases. Re-evaluations of active ingredients prevent new registrations with the active ingredients under re-evaluation, depending on the responsible body. Indirectly, this procedure serves as market protection for players who already have approved registrations. After the registration is approved, there are the state registries, where each state has its own legislation and which may differ significantly from the federal legislation.
This and other topics will be presented during the lecture “Pesticide Registration” at the 14th Brazil AgrochemShow, on August 14 and 15 at Expo Center Norte, in São Paulo, Brazil.