Brazilian Ministry of Agriculture approved 4,216 generic pesticide registrations since 2006

″The implementation of equivalent product legislation in the early 2000s was widely celebrated by much of the agribusiness community. The main reason was that it enabled the entry of more companies offering generic products at more competitive prices″. This is the opinion of agronomic engineer from Esalq/USP, with MBA, Flavio Hirata, a partner at AllierBrasil. In this article below, the specialist in pesticide registration send more numbers and analysis. 

Since 2006, the Ministry of Agriculture has approved 4,216 generic products, of which 2,255 (53.49%) are technical products and 1,961 (46.51%) are formulated products.

Approved Generic Pesticide Registrations (2006 to 2024)*

Note: Technical Equivalent Product and Formulated Equivalent Product

Source: Ministry of Agriculture, adapted by AllierBrasil.

A few companies, however, account for the majority of approved registrations. Based on this data, it can generally be stated that there is a direct relationship between the number of approved registrations and revenue.

Source: Ministry of Agriculture, adapted by AllierBrasil. 

Among the companies with the most approved registrations, AllierBrasil (304 registrations), as a product registration consultancy, credits the revenue from product sales to its respective clients.

The others operate directly in the market through importation and distribution. Nortox (293 registrations), the largest national company in terms of revenue, has a factory for synthesizing technical products and a formulation plant. Following it are two foreign companies: Adama (237 registrations), now part of the Syngenta Group, with technical product synthesis factories and formulation plants both in Brazil and abroad; and Rainbow (218 registrations), a Chinese company with the highest revenue in the country. Finally, CropChem (175 registrations), a local company, has been in the market for over 20 years. 

However, the number of companies is much larger. To expand their product portfolios and offer a more complete range to their clients, companies without a wide range of registrations use ″import authorizations,″ which allow the importation of products directly from exporters using third-party registrations. This practice includes not only distributors but also retailers, cooperatives, and end users. On the other hand, companies holding registrations but lacking extensive distribution networks or credit lines offer their registrations so third parties can import and distribute. 

All of this reinforces the importance of product registration, which is the key to market access in Brazil and most countries. 

Of the total 6,484 registrations approved since 2000, the milestone of 500 registrations per year was surpassed in 2021, reaching over 650 in 2022 and 2024. In the five years from 2020 to 2024, 2,925 registrations were approved, accounting for 45.11% of the total.

Brazil approves 663 pesticide registrations in 2024

Finally, 2024 marked a record for pesticide registration approvals in Brazil, with 663 registrations approved, a 16.3% increase over the previous year. 

Approved Registrations (2020-2024)

Note: 

• Bio - Registration of Biological, Microbiological, Biochemical, Plant Extract, Growth Regulator, or Semiochemical Formulated Products with Class IV classification - Low Environmental Hazard Product, as assessed by Ibama, and Category 5 - Product Unlikely to Cause Acute Harm or Not Classified - Product Not Classified, according to Anvisa. 

• Bio/Org - Registration of Biological, Microbiological, Biochemical, Plant Extract, Growth Regulator, or Semiochemical Formulated Products for Organic Agriculture began with the legal provision in Decree No. 6,913, of July 23, 2009.

Source: Ministry of Agriculture and Livestock; adapted by AllierBrasil.

Despite the record numbers, only a few companies hold the majority of approvals. In 2024, 10 companies were responsible for 34.2% of the total approvals. Notably, AllierBrasil, Nortox, Rainbow, Adama, and Sumitomo together approved 174 registrations, or 26.24% of the total.

10 Companies Account for 34.2% of Pesticide Registrations in 2024 

Note: Registrations managed by consultancy firms under third-party ownership were not included.

Source: Ministry of Agriculture and Livestock; adapted by AllierBrasil. 

Comparing 2024 approvals with the historical data from 2006 to 2024, the same four companies topped both periods. Considering that an approved registration is the result of a long and costly process for market access, it can be concluded that these companies have consistently invested over the years to maintain and increase market share, competitiveness, and business longevity. 

The increase in the number of approvals in recent years was partly due to lawsuits aimed at expediting the evaluation process, with 30% to 35% of generic formulated product approvals resulting from judicial actions. This significant figure encourages more lawsuits to prevent ongoing processes from lagging too far behind competitors’ approvals, creating a vicious cycle. 

However, the primary factor for the increase in approvals has been specific actions—individual or joint—by the involved ministries. Positive results are already visible from the evaluations of equivalent technical products (generics) driven by MAPA, which recently added 15 technicians to its team, reducing the waiting time for analysis by over a year. Some regulations have been successfully implemented to simplify procedures and reduce bureaucratic hurdles, without compromising the rigor of technical assessments. 

In this context, there is great anticipation surrounding new procedures, particularly those related to Law No. 14,785, known as the Pesticides Law. This law establishes shorter deadlines for evaluation conclusions, cancellation of registrations for unmarketed products, risk assessment, strict fines, etc. Its regulation, which was supposed to be implemented within 12 months of its publication on December 27, 2023, is expected in the coming months.

(AllierBrasil is a consultancy specializing in product registration. For over 20 years, it has been promoting Brazilian agriculture both domestically and internationally.)

(Editing by Leonardo Gottems, reporter for AgroPages)