мтр удобрения пестициды гербициды

Brazil may stop importing, start exporting agrochemicals

Through investments and regulatory improvements, Brazil could “stop being an importer of products and can become an exporter.” This statement was made by agronomist Fábio Kagi, who is the manager of regulatory affairs at the Brazilian National Union of Vegetal Defense Products Industry (Sindiveg).

However, Kagi stressed when discussing local production, the fair and free offer of products manufactured abroad is not being debated, stating, “It is just a reasoning about the permanence in the market and the growth of companies already in Brazil, as well as about offering an incentive for foreign investors in terms of guaranteeing legal security when investing in country’s industrial parks.”

In addition to stimulating national industrialization, Sindiveg “considers ensuring reliability and lessening of deadlines related to analyzing and standardizing the criteria for assessing claims to be of paramount importance, as well as the adoption of regulatory optimization measures, along with transparency, isonomy and decision-making by federal bodies,” he added.

CURRENT LEGISLATION

Kagi, who is also a specialist in strategic and economic project management, noted Brazilian legislation stipulates pesticides can only be produced, marketed and used with prior registration at specific federal agencies.

“This same law deals with research, experimentation, packaging and labeling, transport, storage, commercial advertising, the destination of waste and the packaging, classification, control and inspection of products. As Brazil is a signatory to several international treaties, the process of obtaining registration and conducting tests is in line with what has been adopted in the member countries of the Organization for Economic Cooperation and Development (OECD), an entity that currently has 38 members countries,” he said.

To register an agrochemical in Brazil, the interested party must submit an application to the Ministry of Agriculture, Livestock, and Supply (Mapa), the National Health Surveillance Agency (Anvisa), and the Brazilian Institute for the Environment and Renewable Natural Resources (Ibama), containing data defined by legislation for each type of claim.

“By analyzing the test results, government agencies will decide whether the product has acceptable risks to human health and the environment, as well as whether it has agronomic efficiency and practicability. If one of the bodies understands that the product is not suitable for registration, the claim will be dismissed. If the claim is approved by the three bodies, it is incumbent upon the Ministry to issue the registration certificate. For chemical products, in addition to the registration of the formulated product, the one that will be marketed, the interested party must obtain the registration of a technical product, or one intended for industrial use with a high purity content, which will be used in the composition of the formulated product,” he explained.

In addition, he stressed Brazil uses the so-called equivalence criterion adopted by OECD member countries, which does not require the presentation of a complete dossier of all requests for the registration of technical products involving these nations, as well as tests of efficacy and residues in formulated products that use equivalent technical products, popularly known as “generics.”

“And the process does not stop there. To be sold, a product still needs to be registered in Brazilian states. This registration process is not accounted for by federal legislation, but instead under state legislation in almost all units of the federation,” he added.

According to data prepared by Spark Consulting Strategy for the National Union of Vegetal Defense Products Industry (Sindiveg) based on information provided by the Ministry, the registration process of a chemical product in Brazil takes around 5.7 years in cases of equivalents, and 7.7 years for asset-based products not yet registered in the country. The registration of biologicals will be obtained, on average, one year after the submission of the claim.

THE FUTURE OF AGROCHEMISTRY IN BRAZIL

“If the current scenario is not the most favorable in terms of the time needed to obtain records, the projection of a future scenario is even more worrying for equivalent products. Despite the increasing pace of analysis, which went from a level of 180 registrations granted since 2016 to approximately 500 in 2021, the queues have increased even more in recent years,” Kagi pointed out.

In 2020 alone, 1,083 registrations were requested. In 2021, from January to August, there were 576. However, only 493 and 351 claims, respectively, were granted during these periods. “Therefore, as the submission of claims cannot be controlled by any government agency, and since it is the right of an interested party to request registration provided fees are paid and proper documents are submitted, the registration scenario in Brazil is becoming more and more chaotic,” he said.

According to Kagi, over the last few years, relevant bodies have adopted measures to increase the speed of analysis of claims without the loss of regulatory quality, stating, “One of these is prioritizing the analysis of registration requests by meeting certain criteria, such as the indication for crops and pests considered of greater economic importance for Brazil.”

“Sindiveg considers industrialization, both manufacturing and formulation in Brazilian territory to be one of the criteria for setting priorities in the next list. Brazil is a major importer of pesticides, with a trade balance deficit in the agrochemical sector of around US$5 billion in 2019. In the same year, industries also operated with an average idleness rate of 61%, in terms of capacity production of formulated products,” further added.

“This is a delicate situation that must first be corrected with the simplification of the registration process for the export of products based on active ingredients and components already registered in Brazil, established by the recently published Decree 10.833/2021, which should encourage the development of a formulation industrial park and reduce the country’s vulnerability,” Kagi said in conclusion.

 

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