Pesticide registration in Brazil has one of the strictest laws in the world, points out agronomist Flavio Hirata, an expert in agrochemical registration and partner at AllierBrasil.
According to him, ″registration processes are evaluated by three ministries,″ which ″can take ten years or more.″
Ibama (Brazilian Institute of Environment and Renewable Natural Resources) evaluates the registration of formulated products, technical products with new active ingredients, and non-agricultural use products.
Chemical Formulated Products Evaluated by Ibama (2019 – 2022)
″Between 2019 and 2022, Ibama analyzed 927 registration processes of chemically formulated products, of which 733 PPAs were approved (79.07%), 169 filed (18.23%), and 25 rejected (2.69%). The number of rejected processes is statistically insignificant but very relevant for the company that lost its registration process,″ he highlights.
The six companies with the most approvals represent 7.4% of 81 companies and are responsible for 275 approvals (37.51%).
The company with the most approvals, 61 (8.32%), is AllierBrasil, a consulting firm specializing in pesticide registrations, representing several client companies, followed by Rainbow, of Chinese origin, with 58 (7.91%); Nortox, a Brazilian company, 57 (7.77%); Syngenta, leader in sales and of Chinese origin, 36 (4.91%); Cropchem, a Brazilian company, 32 (4.36%); Adama, of Chinese origin, 31 (4.22%), and the other 75 companies, 458 (62.48%).
″The highlight is that of the six companies that had the most approvals, three are of Chinese origin (Rainbow, Syngenta, and Adama), holding 18.6% of the approvals, while the two Brazilian companies, Nortox and Cropchem, hold 13.24% of approvals,″ Hirata pointed out.
More than half of the approved evaluations (58.25%), he said, are classified Classes I and II, Highly Dangerous to the Environment, and Very Dangerous to the Environment, respectively, and almost 40% are Class III. In the period portrayed, there was a slight increase in approvals of products Class IV, Slightly Dangerous to the Environment.
Once Ibama approves the evaluation, the registrant companies should pay the PPA maintenance fee according to the environmental class.
The fee amount to be paid every year is US$1,638.82 (BRL8,669.38) or US$3,823.41 (BRL20,225.84), according to the environmental class. For products Class I and II, the fee is US$3,823.41, while for Class II and IV products, is US$1.638,82.
The amounts owed to the PPA maintenance fee, according to the number of approvals and their respective environmental classes, of the six companies that had the most licences between 2019 and 2022, was US$2,211,280.55 (R$11,159,239.54).
Considering all approved PPAs from all companies, the amount due for maintenance fees reached US$5,801,610.66 (BRL29,247,460.04), between 2019 and 2022.
According to Hirata, ″PPA approval does not guarantee registration approval, nor does it reflect the number of registrations approved by MAPA. Approval by Anvisa (Toxicological Assessment Report) is still required and may take several more years. And after all that, MAPA’s approval is necessary.″
″It is important to point out that there are cases of rejection by Anvisa and, in this way, all the work carried out by Ibama and the fees paid (checklist, evaluation, and PPA) are lost. The most critical, however, is the mismatch between the evaluations by agencies and the time taken to conclude the registration process,″ he said in conclusion.
(Editing by Leonardo Gottems, reporter for AgroPages)