Recently, agricultural chemical registration expert, Allier Brasil partner, and agronomist Flavio Hirata pointed out that Brazil's pesticide registration process is one of the strictest regulations in the world, evaluated by three departments and may take up to 10 years or more.
Ibama (Brazilian Institute of Environment and Renewable Natural Resources) evaluates the registration of pharmaceutical products, technical products containing new active ingredients, and non agricultural use products. During the period from 2019 to 2022, Ibama reviewed the registration of 927 chemical agents, of which 733 were approved by PPA (79.07%), 169 were filed (18.23%), and 25 were rejected (2.69%). Hirata stated that the number of rejected registrations is statistically insignificant, but closely related to companies that have failed to register.
Once Ibama approves the assessment, the registered company should pay the PPA maintenance fee based on the environmental level. According to the environmental level, the annual fee to be paid is 1638.82 US dollars (8669.38 reals) or 3823.41 US dollars (20225.84 reals). The cost for Class I and Class II products is $3823.41, while the cost for Class III and Class IV products is $1638,82. According to the approved quantity and their respective environmental levels, the amount of PPA maintenance fee to be paid by the six companies that obtain the most licenses from 2019 to 2022 is 2211280.55 US dollars (11159239.54 Reais).
Calculate the required PPA maintenance fees for all companies, and the amount payable from 2019 to 2022 is 5801610.66 US dollars (29247460.04 Brazilian real). Hirata believes that PPA does not represent registration approval or reflect the number of registrations approved by MAPA, and still requires approval from Anvisa (Toxicological Assessment Report), which may take several years. Approval of MAPA is necessary, and there are also cases where registration is refused by Anvisa, which could result in the loss of all registration processes and fees paid in Ibama (inventory, evaluation, and PPA). But the most crucial thing is that the evaluation of each institution does not match the time required to complete the registration process.
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