“From a regulatory point of view, the record of approvals does not reflect the complexity, slowness, high cost and legal uncertainty related to the pesticide registration process…”
Flavio Hirata is a partner at AllierBrasil, an agronomist from Esalq/USP, MBA, and a specialist in pesticide registration. AllierBrasil is a product registration consulting firm. It has been promoting Brazilian agriculture in Brazil and abroad. In 2024, it approved 45 registrations.
Flavio Hirata, partner at AllierBrasil
flavio.hirata@uol.com.br
www.allierbrasil.com.br
Whatsapp +55 11 993304717
Product registration is the key to access pesticide market in Brazil. 2024 was a record in number of approvals, with 663 registrations, which is 19.45% more than in 2023.
Another record was for Formulated Products Based on Equivalency approvals, also called “generic” formulated pesticides, with 327 new registrations.
Generic Formulated Product Approvals (2024)
Note: Registrations managed by consulting companies that are owned by third parties were not included.
Source: Ministry of Agriculture and Livestock; adapted by AllierBrasil.
The number of registrations approved in 2024 was higher, when compared to 2023, in the categories Equivalent Technical Product (+8.94%), Formulated Product for Organic Agriculture (+54.29%) and Generic Formulated Product (+52.09%).
Approved Registrations (2020-2024)
Notes*:
Bio – Registration of a Formulated Biological, Microbiological, Biochemical Product, Plant Extract, Growth Regulator or Semiochemical with classifications Class IV – Slightly Dangerous to the Environment, as evaluated by Ibama, and Category 5 – Product Unlikely to Cause Acute Harm or Product Without Classification, by Anvisa.
Bio/Org – Registration of a Formulated Biological, Microbiological, Biochemical Product, Plant Extract, Growth Regulator or Semiochemical, for Organic Agriculture, in accordance with Decree No. 6913, 07/23/2009.
Source: Ministry of Agriculture and Livestock; adapted by AllierBrasil.
Notably, the number of approved registrations has increased significantly, especially since 2017, when it reached 400 registration approvals for the first time.
Approved Pesticide Registrations in the Past 20 Years (2005-2024)
Source: Ministry of Agriculture and Livestock; adapted by AllierBrasil.
In regard to Generic Formulated Products, since 2008 there have been 1,882 approved registrations, which has allowed for a greater number of companies to access the market.
Generic Formulated Product Approvals (2005-2024)
Source: Ministry of Agriculture and Livestock; adapted by AllierBrasil.
Despite the large number of registrant companies, only 10 of them were granted with 49.43% of approvals in this product category over the last 15 years. Among these, the registration consulting firm AllierBrasil stands out with 9.1% of total approvals. Considering it is a registration consultancy, the company does not use registration to access the market. After approvals, registrations are generally transferred to the contractors or their agents, such as ADM, CHDS, Dinagro, Hailir, Max (Rudong), Solus, Wynca, Sinochem, Green Place, Hui Kwang, Hemani, CAC, among others, which will sell such products directly or through third parties.
1748 Generic Formulated Product Registration Approvals (2010-2024)
Note: Registrations managed by consulting companies under the ownership of third parties were not included.
Source: Ministry of Agriculture and Livestock; adapted by AllierBrasil.
Among the approvals of Generic Formulated Products, from 2020 to 2024, the most registered active ingredients were glyphosate, glufosinate, azoxystrobin, chlorothalonil, fipronil, imidacloprid, mancozeb, sulfentrazone, atrazine, 2,4-D.
Generic Formulated Product Approvals by Active Ingredient
Source: Ministry of Agriculture and Livestock; adapted by AllierBrasil.
Based on the official data, there is a large number of approved registrations of active ingredients with a considerable number of players in the market. This is due to the long time for evaluation and approval. In other words, when the registration is finally approved, the market may be saturated with competitors. There are also the cases where evaluations and registrations are approved in large numbers; however, many of these approvals may be of active ingredients to be banned. In 2021 and 2022, 11 registrations with the active ingredient carbendazim were approved, but the product was banned by Anvisa in August of 2022.
Even with the key to market access in hands, this record of approvals will not result in record in market access. As mentioned, many products or formulations are already obsolete when approved in saturated markets. So, companies rush to submit more registrations for products with higher competitive potential, creating a cycle in which not everyone will succeed.
To be successful, a combination of several elements is necessary, such as the right choices on active ingredient, supplier, people; speed and sense of urgency, etc. For those most eager to access the biggest market in the world, purchasing registrations is becoming a recurring alternative.
From a regulatory point of view, the record of approvals does not reflect the complexity, slowness, high cost and legal uncertainty related to the pesticide registration process. Even so, it is undeniable that current approval levels are much higher than those of previous years.
Pesticide registration, among other subjects, will be the topic of lectures at the Agrochemical TradeShow São Paulo, on April 16th and 17th, 2025.
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