“Considering all current 5,432 pesticide approved registrations (MAPA), the due amount of PPAs’ maintenance fees in 2023 is US$ 15,248,458.34…”
Flavio Hirata is an agronomist from Escola Superior de Agricultura “Luiz de Queiroz” – USP, pesticide registration expert and partner at AllierBrasil.
AllierBrasil organizes technical-commercial visits, exhibitions and lectures related to Brazilian agribusiness, environment and pesticide registrations in India, China and Brazil, with the objective of promoting Brazilian agriculture.
Brazilian pesticide market is the most attractive in the world. With state-of-the-art agriculture, 73.7 million cultivated hectares, fertile soils and almost always favorable climatic conditions, the demand for inputs is high. In the case of pesticides, sales reached US$ 20 billion in 2022 (considering end-user level).
Pesticide registration is a very controversial matter. For this reason, it is important to clarify relevant topics on the subject. Registration is still the biggest bottleneck for market access. Even with a record number of registration approvals over the past 6-7 years, the demand for newer products is far from being met. This is explained by the long time for evaluation and approval. This process can exceed 12 years, considering the time for approval of the technical product and its respective formulated product. For example, registrations of formulated products approved in 2022 were requested as far as 5-7 years in the past.
Pesticide registration process is assessed by three ministries: Ibama, Anvisa and the Ministry of Agriculture (MAPA), responsible for assessments related to health, environment and agriculture, respectively. MAPA can only grant the registration of a product after the favorable conclusion of the other involved agencies.
At the conclusion of the evaluation, Anvisa issues the Toxicological Assessment Report (IAT), while Ibama issues the Environmental Hazard Potential Assessment (PPA).
Technical products are evaluated jointly (three ministries), while formulated products are evaluated independently by Ibama and Anvisa. Often the evaluation is concluded by one agency, while in another agency the evaluation may still take several years to be concluded. This mismatch generates high costs for companies, since as soon as the PPA is issued, the applicant companies should pay the maintenance fee, even if the registration has not yet been approved by MAPA. That is, the PPA maintenance fee does not consider that the product cannot even be used or sold in the country.
PPA fee, that should be paid every year, varies from US$ 1,669.21 to US$ 3,894.30, according to the environmental class defined by Ibama. For Class I and II products, the due amount is US$ 3,894.30, while for Class II and IV products, the amount is US$ 1,669.21 (US$ 1.00 ~ BRL 5.19).
Payment is due for the calendar year, meaning that the fee is charged in full regardless of the month in which PPA was approved.
|I – Product Highly Dangerous to the Environment||US$ 3,894.30|
|II – Product Very Dangerous to the Environment|
|III – Product Dangerous to the Environment||US$ 1,669.21|
|IV – Product Slightly Dangerous to the Environment|
Considering the risk these products have of causing damages to the environment, it is pertinent that the companies should be responsible for the costs related to PPA maintenance.
However, it’s controversial that the payment should be compulsory for processes of registrations that have not been approved yet, because those products cannot be sold. Take, for example, the case of products based on the active ingredient imidacloprid. Since the publication of the Regulation of the environmental reassessment of the active ingredient by Ibama, until its conclusion, no process for registering a formulated product has been considered suitable for evaluation by Ibama. In this way, companies that had an approved registration of a technical product, as well as the related formulated product in the queue waiting for evaluation, were prevented from obtaining registration for more than 10 years, until the environmental reassessment would be concluded, without being exempt of PPA maintenance fee payment of the technical product during the period, in an amount of US$ 1,669.21 every year.
Considering all current 5,432 pesticide approved registrations (MAPA), the due amount of PPAs’ maintenance fees in 2023 is US$ 15,248,458.34 (BRL 79,195,981.04).
|Environmental Class||Pesticide Registrations in 2023 (MAPA)|
|I – Product Highly Dangerous to the Environment||182||10,818,372.94|
|II – Product Very Dangerous to the Environment||2.596|
|I + II||2.778|
|III – Product Dangerous to the Environment||1.970||4,430,085.40|
|IV – Product Slightly Dangerous to the Environment||684|
|III + IV||2.654|
Sources: Ibama, MAPA, Agrofit, AgriBrasilis, adapted by AllierBrasil.
Note: It was not considered “non-agricultural” pesticide use products, as Ibama is in charge of those registrations.
Additionally, other government fees are required at the time of filing the registration request.
Fees for the Registration of Pesticides (Chemical Product)
|Evaluation (technical product)||Ibama||11,683.43|
|Evaluation (formulated product)||Ibama||6,119.92|
|Evaluation (“clone” formulated product)||Ibama||1,112.81|
|Evaluation||Anvisa (1)||30.73 to 610.77|
Sources: Ibama, Anvisa, adapted by AllierBrasil.
Note: (1) according to the company’s revenue; (2) exchange rate US$ 1.00 ~ BRL 5.19.
Pesticide registration fees are extremely high, especially when the product cannot be sold. These, along with the long term for registration approvals, are the main reasons why a significant number of companies fail to access the Brazilian market, drastically restricting competition.