Agrochemical product registration is evaluated by three agencies in Brazil, ANVISA, IBAMA and Ministry of Agriculture (MAPA).
In 2019 IBAMA, the agency responsible for the environment has already completed 68 pesticide registration evaluations. Among these, there were 4 rejections, 6 filings and 58 approvals. The filings are generally due to the desistance of registrant companies. The rejections and filings totaled 15% of the registration applications that had their evaluations completed by IBAMA.
The sole approval from IBAMA does not permit the approval of the registration, considering that it also requires the approval of ANVISA and MAPA. After the approvals from ANVISA and IBAMA, the application will be evaluated by MAPA for completion, of which the approval may also be denied by the agency.
Meanwhile, the rejections published by ANVISA consist of 8 applications:
The reasons for the rejections are several. Particularly in relation to technical products based on copper, QUIMETAL COPPER OXYCHLORIDE TECHNICAL and TRADECORP COPPER HYDROXIDE TECHNICAL, these products are not classified as liable to registration, which may have caused the rejections. For inorganic copper and sulfur based products, only the formulated products can be registered.
Furthermore, the cancellations of the registration applications and registrations approved by MAPA complying with the requests of the registrant companies are frequent, totaling of 51 cancellations in 2019. The reasons for the cancellation requests are mainly due to lack of commercial interest, deactivated manufacturer, applications rejected in other agencies involved in the registration, and registrations in duplicate due to the merging/purchase of companies.
52 cancellations of registrations approved by MAPA registration applications and in 2019, by request of the registrant companies:
The product registration dynamics in Brazil has unique peculiarities in the world, such as its complexity. Despite the excess delay in the approvals and the high costs involved, it is not rare for companies sponsoring registrations to give up interest in the market and abandon the registration processes, and even abandon registrations that have been approved, as it occurs with processes/registrations of active ingredients like acephate, imidacloprid, glyphosate, sulfluramid, fipronil, thiamethoxam, among others.
The reasons for the rejections are among the topics to be addressed at the
15th Forum AllierBrasil in Nanjing, China, on May 28th.
From May 23rd to June 2nd, AllierBrasil is organizing a visit to the agrochemical plants in the provinces of Hebei, Jiangsu and Shandong, in China, with the purpose of identifying registration and business partners, in addition to providing in loco visit of the manufacturers who are actually producing.