“…the long time for pesticide registration approval inhibits competition and discourages investments…”
Flavio Hirata, is partner at AllierBrasil, agronomist from Esalq/USP, MBA, and specialist in pesticide registration.
Email flavio.hirata@uol.com.br
Wechat FlavioHirata
Whatsapp +55 11 993304717
AllierBrasil is a consulting firm focused on pesticide registration. It has been promoting Brazilian agribusiness for over 25 years through exhibitions, lectures, seminars and technical-commercial visits in India, China and Brazil.
In the past 40 years, the Brazilian pesticide market has been developed following the growth of its agriculture, which occurred both in terms of planted area and increased yields. Since then, pesticide registration has been the most important non-tariff barrier to market access. This has been the main restriction for companies trying to enter the market, where only a few companies hold more than 70% of the market share.
Market access has another very important link, which is distribution. It is a dynamic market, sensitive to supply, exchange rate fluctuation, purchase/sale prices, payment terms, credit, supply, etc.
Furthermore, for the product to reach legally the farmer, the registration is mandatory in Brazil. Meanwhile, the figures in the illegal market are alarming. According to Luciano Stremel Barros, president of the Institute for Economic and Social Development of Borders – Idesf, “the smuggling and diversion of products, including pesticides, represent annual losses of approximately US$ 3.58 billion by the industries and local sales”.
In 2002, registration of equivalent pesticides was regulated by the Decree No. 4074, from January 4th. This was one of the main milestones which allowed more companies to access the market.
Analyzing the history of approvals to obtain pesticide registration, the key for market access.
From 2000 to 2005, the number of approved pesticide registrations was less than 100 per year, with an average of 83 registrations/year.
Pesticide registration approvals from 2000 to 2005
| Type of Registration | 2000 | 2001 | 2002 | 2003 | 2004 | 2005 |
| Technical Product | 20 | 23 | 13 | 19 | 9 | 23 |
| New Technical Product | 9 | 11 | 5 | 9 | 6 | 5 |
| Formulated Product | 38 | 54 | 23 | 40 | 54 | 48 |
| New Formulated Product | 13 | 14 | 6 | 4 | 11 | 5 |
| Others | 2 | 13 | 6 | 5 | 4 | 8 |
| Total | 82 | 115 | 53 | 77 | 84 | 89 |
Source: Ministry of Agriculture of Brazil, adapted by AllierBrasil
At that time, few companies in the country took the initiative to register a broad portfolio of products. The pioneers were Consagro, through AllierBrasil’s consulting services, and Volcano.
In 2006, the first registrations of equivalent technical products were approved, and, in 2007, 79 registrations of equivalent formulated products were approved. Registrations of equivalent products were evaluated and approved in approximately 8 to 18 months.
While these approvals were given in short time, other factors slowed down the registration process disproportionately, such as the Experimental Use Permit (RET), mandatory for sample import and testing. Approval of a RET used to demand 12 to 24 months, which was the same time, or even up to twice as long, for an evaluation/approval of an equivalent pesticide registration.
Laboratory costs were another factor, ranging from US$ 60,000 to US$ 80,000 for formulated product and technical product, respectively. This amount represents much more than double what is currently charged by laboratories in the country.
From 2007 to 2009, were approved 213 registrations of Equivalent Formulated Product (EFP), in an average of 71 registrations/year. However, from 2010 to 2016 there was a drastic drop in the number of approvals, with an average of 43 approvals/year.
Pesticide registration approvals from 2006 to 2016
| Type of Registration | 2006 | 2007 | 2008 | 2009 | 2010 | 2011 | 2012 | 2013 | 2014 | 2015 | 2016 |
| Technical Product | 26 | 2 | 3 | 4 | 2 | 0 | 0 | 1 | 0 | 0 | 1 |
| New Technical Product | 5 | 2 | 6 | 4 | 0 | 1 | 1 | 2 | 5 | 2 | 1 |
| Equivalent Technical Product | 7 | 50 | 45 | 28 | 35 | 60 | 64 | 45 | 79 | 46 | 160 |
| Formulated Product | 56 | 57 | 57 | 30 | 26 | 32 | 10 | 18 | 16 | 12 | 19 |
| New Formulated Product | 7 | 5 | 5 | 7 | 1 | 1 | 1 | 3 | 7 | 1 | 10 |
| Equivalent Formulated Product | 0 | 79 | 72 | 62 | 34 | 36 | 75 | 30 | 33 | 47 | 46 |
| Others | 8 | 7 | 3 | 2 | 6 | 16 | 17 | 11 | 8 | 31 | 40 |
| Total | 109 | 202 | 191 | 137 | 104 | 146 | 168 | 110 | 148 | 139 | 277 |
Source: Ministry of Agriculture of Brazil, adapted by AllierBrasil
This situation reversed after 2017, when the number of approvals more than doubled when compared to previous years. 177 equivalent technical products and 131 equivalent formulated products were approved in 2017.
Pesticide registration approvals from 2017 to 2023
| Type of Registration | 2017 | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 |
| Technical Product | 0 | 0 | 1 | 3 | 1 | 0 | 0 |
| New Technical Product | 5 | 2 | 3 | 5 | 7 | 8 | 11 |
| Equivalent Technical Product | 177 | 193 | 268 | 162 | 182 | 271 | 179 |
| Formulated Product | 36 | 48 | 36 | 69 | 60 | 34 | 36 |
| New Formulated Product | 9 | 4 | 19 | 10 | 12 | 35 | 24 |
| Equivalent Formulated Product | 131 | 148 | 104 | 147 | 207 | 168 | 215 |
| Others | 46 | 54 | 43 | 97 | 93 | 136 | 90 |
| Total | 404 | 449 | 474 | 493 | 562 | 652 | 555 |
Source: Ministry of Agriculture of Brazil, adapted by AllierBrasil
Several other markets have characteristics similar to those of the agrochemicals market, which means they are “dynamic markets, sensitive to several factors such as supply, exchange rate fluctuation, purchase/sale price, payment terms, credit, supply”. However, pesticide market has a differential: product registration. The time for registration approval can exceed 10 years, making access to the market extremely difficult or even impossible.
In order to shorten the time for registration process evaluating and to access the market faster, companies are taking legal actions against the agencies responsible for evaluations, which are Anvisa, Ibama and the Ministry of Agriculture. This is possible once the legislation stipulates a maximum period to conclude evaluations. For equivalent formulated products and equivalent technical products, the deadline is up to 12 months, in accordance with Law No. 14785, from December 27th, 2023, known as the Pesticides Law.
According to surveys carried out by AllierBrasil, 30.23% of registration approvals of equivalent formulated products in 2023 was in compliance with court decisions. In 2022, it was 35.71%.
Pesticide registration does not guarantee market access, nor the longevity of the company’s operations. For instance, the registrations held by Consagro and Volcano ended up incorporated by other players.
On one hand, the Pesticides Law establishes 12 months to conclude pesticide registration evaluation, on the other hand it also establishes that “once the registration is approved… the registration holder will have up to two years to start production and commercialization of the product, under penalty of registration”. In other words, the registration is approved with an “expiry date”.
It is important to emphasize the need for extreme caution when evaluating products that will be sprayed over crops. Pesticides must pose fewer risks and impacts to the environment and human health. That being said, the long time for pesticide registration approval inhibits competition and discourages investments in Brazil.
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