“The most critical, however, is the mismatch between the evaluations by agencies, and the long time taken to conclude the registration process.”
Flavio Hirata is an agronomist from Escola Superior de Agricultura Luiz de Queiroz – USP, expert in agrochemical registration, and partner at AllierBrasil.
AllierBrasil is the organizer of the events Forum AllierBrasil (São Paulo, Nanjing, Mumbai, Osaka), Agrochemical Tradeshow São Paulo and Brasil Agrochemshow, with the objective of promoting Brazilian agriculture and developing technical-commercial partnerships between foreign and local companies.
Flavio Hirata, partner at AllierBrasil
Pesticide registration in Brazil has one of the strictest laws in the world. Registration processes are evaluated by three ministries: Ibama, Anvisa and the Ministry of Agriculture (MAPA), responsible for evaluations related to health, environment, and agriculture, respectively. Only after approval by Ibama and Anvisa is MAPA able to complete the registration process, that, as from the beginning, can take 10 years or more.
Ibama evaluates registration of formulated products, technical products with new active ingredients and non-agricultural use products.
Between 2019 and 2022, Ibama analyzed 927 registration processes of chemical 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.
Chemical Formulated Products Evaluated by Ibama (2019 – 2022)
Source: Ibama
The six companies that had the most approvals represent 7.4% of the total 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 specialized 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%).
Source: Ibama
Highlight to the fact 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.
|
Registrant |
Notes |
|
AllierBrasil |
Brazilian consulting firm |
|
Rainbow |
Chinese |
|
Nortox |
Brazilian, leader in sales among companies with Brazilian capital |
|
Syngenta |
Chinese, leader in sales and market share |
|
Cropchem |
Brazilian |
| Adama |
Chinese |
Ibama classifies the PPA evaluations into four categories, according to the environment characteristics of the products.
|
Environmental Class |
|
I – Product Highly Dangerous to the Environment |
|
II – Product Very Dangerous to the Environment |
|
III – Product Dangerous to the Environment |
|
IV – Product Slightly Dangerous to the Environment |
Source: Ibama
Environmental Class of All Approved Chemical Formulated Products (2019 – 2022)
Source: Ibama
More than half of the approved evaluations, 58.25%, 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 small increase in approvals of products Class IV, Slightly Dangerous to the Environment.
Environmental Class of Deferred Evaluations of Chemical Formulated Products (2019 – 2022)
|
Environmental Class |
2019 | 2020 | 2021 | 2022 | TOTAL |
|
Class I |
6 | 1 | 3 | 6 | 16 |
|
Class II |
130 | 83 | 110 | 88 | 411 |
| Class III | 74 | 82 | 68 | 69 | 293 |
| Class IV | 0 | 3 | 4 | 6 | 13 |
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 (BRL 8,669.38) or US$ 3,823.41 (BRL 20,225.84), 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.
|
Environmental Class |
PPA |
|
I – Product Highly Dangerous to the Environment |
US$ 3,823.41 |
|
II – Product Very Dangerous to the Environment |
|
|
III – Product Dangerous to the Environment |
US$ 1,638.82 |
|
IV – Product Slightly Dangerous to the Environment |
Source: Ibama
The amounts owed to the PPA maintenance fee, according to number of approvals and their respective environmental classes, of the six companies that had the most approvals between 2019 and 2022, was US$ 2,211,280.55 (R$ 11,159,239.54).
PPAs Maintenance Fees of the Six Companies with the Most Approvals (US$)
|
Registration Holder |
Approval Year | 2019 | 2020 | 2021 | 2022 | TOTAL |
|
AllierBrasil |
Approved PPAs |
13 | 21 | 18 | 9 | 61 |
|
Maintenance fee – accumulated |
49,136.34 | 102,114.20 | 152,247.58 | 176,394.45 | 479,892.57 | |
|
Rainbow |
Approved PPAs |
30 | 10 | 9 | 9 | 58 |
|
Maintenance fee – accumulated |
101,207.85 | 112,214.45 | 130,269.88 | 164,635.24 | 508,327.42 | |
|
Nortox |
Approved PPAs |
12 | 15 | 19 | 11 | 57 |
|
Maintenance fee – accumulated |
52,802.21 | 74,622.77 | 123,300.57 | 153,996.63 | 404,722.17 | |
|
Syngenta |
Approved PPAs |
14 | 8 | 10 | 4 | 36 |
|
Maintenance fee – accumulated |
60,136.02 | 72,937.81 | 105,070.81 | 123,193.52 | 361,338.16 | |
|
Cropchem |
Approved PPAs |
6 | 6 | 10 | 10 | 32 |
|
Maintenance fee – accumulated |
30,800.77 | 40,396.25 | 63,257.95 | 91,837.21 | 226,292.18 | |
|
Adama |
Approved PPAs |
6 | 7 | 8 | 10 | 31 |
| Maintenance fee – accumulated | 27,867.66 | 39,835.65 | 61,649.53 | 101,355.21 | 230,708.06 |
Author’s notes: It was considered that PPAs remained active during the period, and that the registration processes and/or approved registrations remained under the same ownership.
Source: Ibama, AgriBrasilis, adapted by AllierBrasil.
Considering all approved PPAs from all companies, the amount due for maintenance fees reached US$ 5,801,610.66 (BRL 29,247,460.04), between 2019 and 2022.
PPAs Maintenance Fees of All Companies (US$)
|
Approval year |
2019 | 2020 | 2021 | 2022 | TOTAL |
|
Number of Approved PPAs |
210 | 169 | 185 | 169 | 733 |
| Maintenance Fee (year of approval) | 860,976.74 | 472,984.05 | 539,835.85 | 494,463.65 | 2,368,260.30 |
| Maintenance Fee (accumulated) | 860,976.74 | 1,131,673.05 | 1,621,119.01 | 2,187,841.85 | 5,801,610.66 |
Author’s notes: It was considered that the PPAs remained active during the period, and that the registration processes and/or approved registrations remained under the same ownership.
Source: Ibama, AgriBrasilis, adapted by AllierBrasil.
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, as well as the fees paid (checklist, evaluation and PPA) are lost. The most critical, however, is the mismatch between the evaluations by agencies, and the long time taken to conclude the registration process.