“35% of generic formulated product registrations approved in 2022 went through lawsuits…”
Flavio Hirata is a partner at the agribusiness consultancy AllierBrasil, an agronomist graduated at Esalq/USP and an expert in pesticide registration.
AllierBrasil is a pesticide registration consultancy, which organizes technical-commercial visits, exhibitions and lectures on agribusiness and registration in India, China and Brazil with the aim of promoting Brazilian agriculture.
Flavio Hirata, partner at AllierBrasil flavio.hirata@uol.com.br
In Brazil, the largest and most attractive pesticide market in the world, product registration process is quite slow and complex, and may take more than 12 years to evaluate generic formulated products (Formulated Products based on Equivalent Technical Products).
Some measures were adopted by the regulatory agencies in charge for pesticide registration to speed up evaluations. Among these, there is Anvisa’s Toxicology Petition System – Siptox, launched in October 2017, in which there were few adherences by registrant companies, and until now it is reason of registration rejections. Very recently, from 09/29/2023, another measure was the Joint Ordinance SDA MAPA – IBAMA – ANVISA No. 3, is still under discussion by agencies. Furthermore, Bill No. 1459/2022, also called the Pesticide Bill, which has been pending and discussed in the Legislature for more than 20 years, was forwarded by the Federal Senate for presidential sanction, and could be approved in 2023, if there would not have any vetoes.
According to a survey elaborated by AllierBrasil (2023), of the 168 registrations of generic Formulated Products approved in 2022, 52.38% demanded 6 years or more for approval. This time for approval has remained stable for the last four years, being much longer in years before that.
Notes:
FP Chemical: Chemical Formulated Product
FP/ETP): Chemical Formulated Product based on Equivalent Technical Product
Sources: Anvisa, Ibama, MAPA; adapted by AllierBrasil
The levels of pest and disease control can vary more quickly than the time for pesticide registration approvals, mainly due to the development of resistance in the biological targets against the molecules that are used. In a market worth US$ 20 billion per year, a delay in a product launch can be crucial for a company’s success or failure.
For this reason, 2022 had a record number of approvals of pesticide registration evaluations through court decision. Of the 168 registrations of Formulated Products based on Equivalent Technical Products, 60 were result of lawsuits, that is, more than a third of the approvals. Highlights to Rainbow (13.4%), Iharabras (13.4%), Adama (7.5%), Perterra (7.5%) and Syncrom (7.5%), which together totaled 49.3 % of the lawsuits, or 33 processes among 67.
Sources: Anvisa, Ibama, MAPA, Mazza & Manente de Almeida Advogados; adapted by AllierBrasil
The registration of Equivalent Formulated Products represented 90% of lawsuits, or 60 of the 67; 24 mixtures of active ingredients versus 43 of stand-alone products, with a total of 27 active ingredients. No lawsuit of technical products was identified in 2022.
“In a market worth US$ 20 billion per year, a delay in a product launch can be crucial for a company’s success or failure”
The majority of the lawsuits had Anvisa and Ibama as defendants, 71.79%, while, for only Anvisa or Ibama, the percentage was 28.21% of the actions. The survey did not include lawsuits against the Ministry of Agriculture.
Pesticide registration of products approved through lawsuits in 2022
| Type | Brand Name (Registration No.) | Registrant | Agency | Product |
|---|---|---|---|---|
| FP | DORAI MAX (322) | IHARABRAS | Ibama | Amicarbazone 50 + diquat dibromide 373.5 g/L SC |
| FP | XEQUE MATE HT (422) | IHARABRAS | Anvisa | Glyphosate - potassium salt 720 g/L SL |
| FP/ETP | ARQUERO (722) | ADAMA | Anvisa | Acetamiprid 375 + bifenthrin 165 g/L SC |
| FP/ETP | ADVER 240 SC (1522) | TECNOMYL | Anvisa | Chlorfenapyr 240 g/L SC |
| FP/ETP | CROPPER (1622) | ADAMA | Anvisa, Ibama | Prothioconazole 31.5 + fluxapyroxad 22.5 + mancozeb 440 g/L OD |
| FP | BURNER (2522) | IHARABRAS | Anvisa, Ibama | Diquat dibromide 373.5 + flumioxazin 25 g/L SC |
| FP/ETP | FORASTEIRO (4422) | ADAMA | Anvisa, Ibama | 2,4-D 322 + fluroxypyr-meptyl 92.2 + picloram 64 g/L EC |
| FP/ETP | UPL 1014 FP (4822) | UPL | Anvisa | Acephate 850 + bifenthrin 30 g/kg WG |
| FP/ETP | WINOUT XTRA (5922) | RAINBOW | Anvisa, Ibama | Fluazinam 800 g/kg WG |
| FP/ETP | AMICARBAZONE NORTOX (6222) | NORTOX | Anvisa | Amicarbazone 700 g/kg WG |
| FP/ETP | GARROTEBR (6322) | OURO FINO | Anvisa, Ibama | Fluroxypyr-meptyl 115.3 + picloram 143.4 g/L ME |
| FP/ETP | COFENRIN (6922) | RAINBOW | Anvisa | Bifenthrin 400 g/L EC |
| FP/ETP | WIKING 600 WG (7122) | CROPCHEM | Anvisa | Metsulfuron-methyl 600 g/kg WG |
| FP/ETP | VIGORBR (7422) | OURO FINO | Ibama | Imidacloprid 600 g/L FS |
| FP/ETP | ARBUST (8822) | OURO FINO | Anvisa, Ibama | Triclopyr-butotyl 667 g/L EC |
| FP/ETP | JUMBO BR (8622) | ADAMA | Anvisa, Ibama | Sulfentrazone 360 + tebuthiuron 450 g/kg WG |
| FP/ETP | CHLOROTHALONIL C 720 SC PERTERRA (9622) | PERTERRA | Anvisa, Ibama | Chlorothalonil 720 g/L SC |
| FP/ETP | SONDA HT (10122) | IHARABRAS | Anvisa, Ibama | Terbuthylazine 500 g/L SC |
| FP | TARGA MAX HT (10222) | IHARABRAS | Anvisa, Ibama | Quizalofop-P-ethyl 100 g/L EC |
| FP/ETP | BORDALO PRO (10722) | TRADECORP | Anvisa, Ibama | Lufenurom 50 + profenofos 500 g/L EC |
| FP/ETP | KANPAI (11722) | IHARABRAS | Anvisa, Ibama | Acetamiprid 200 + lambda-cyhalothrin 250 g/L OD |
| FP/ETP | TRICLOPIR 667 EC PERTERRA (11922) | PERTERRA | Anvisa, Ibama | Triclopyr-butotyl 667 g/L EC |
| FP/ETP | SUNGAIN XTRA (12222) | RAINBOW | Anvisa, Ibama | Flumioxazin 800 g/kg WG |
| FP/ETP | CROPPER BR (12722) | ADAMA | Anvisa, Ibama | Prothioconazole 31.5 + fluxapyroxad 22.5 + mancozeb 440 g/L OD |
| FP | SHODAN (12822) | IHARABRAS | Ibama | Flumioxazin 60 + sulfentrazone 450 g/L |
| FP/ETP | OSBAR DUO (13222) | CROPCHEM | Anvisa, Ibama | Flumioxazin 100 + imazethapyr 212 g/L SC |
| FP/ETP | LONGAR 480 EC (13322) | SUMITOMO | Anvisa | Triclopyr-butotyl 667.32 g/L EC |
| FP/ETP | ACARIGEN (13622) | TECNOMYL | Anvisa | Abamectin 18 g/L EC |
| FP/ETP | EDDUS EC (14022) | SYNGENTA | Anvisa | S-metolachlor 517.83 + fomesafen 119.54 g/L EC |
| FP | PRIMACY (16022) | IHARABRAS | Anvisa, Ibama | Amicarbazone 250 + sulfentrazone 250 g/L SC |
| FP/ETP | THUMB-TACK NORTOX (16322) | NORTOX | Anvisa | Acetamiprid 100 + bifenthrin 67 g/L SL |
| FP/ETP | RICEPAL (16422) | RAINBOW | Ibama | Propanil 800 g/kg WG |
| FP/ETP | GEMPOX (18022) | SYNCROM | Anvisa, Ibama | Glufosinate-ammonium 850 g/kg SG |
| FP/ETP | TRICLOMAX (18122) | RAINBOW | Anvisa | Triclopyr-butotyl 667 g/L EC |
| FP/ETP | LANFOR PRO (19022) | ALBAUGH | Anvisa, Ibama | Azoxystrobin 400 + cyproconazole 160 g/L SC |
| FP/ETP | BRAULTRA 720 SC (19122) | CAC | Anvisa, Ibama | Chlorothalonil 720 g/L SC |
| FP/ETP | CLETHODIM R 240 EC PERTERRA (20922) | PERTERRA | Ibama | Clethodim 240 g/L EC |
| FP/ETP | TANREK 500 SC (21322) | AVGUST | Ibama | Imidacloprid 500 g/L SC |
| FP/ETP | EQUINOX (21722) | ROTAM | Anvisa | S-metolachlor 480 + sulfentrazone 128 g/L EC |
| FP/ETP | AUG 134 (22422) | AVGUST | Ibama | Imidacloprid 500 g/L SC |
| FP/ETP | SENSUS (22622) | OURO FINO | Anvisa, Ibama | Clomazone 250 + sulfentrazone 100 g/L OD |
| FP/ETP | CROPCARE SC (22922) | CROPCHEM | Anvisa, Ibama | Azoxystrobin 125 + tebuconazole 240 g/L SC |
| FP/ETP | POTENZA SINON PLUS 36 EC (23222) | SINON | Anvisa | Abamectin 36 g/L EC |
| FP/ETP | FLUAZINAM 800 WG PERTERRA (23422) | PERTERRA | Ibama | Fluazinam 800 g/kg WG |
| FP/ETP | VALLEX (23522) | TECNOMYL | Anvisa, Ibama | Pyriproxyfen 100 g/L EC |
| FP/ETP | TRIPLEC (23722) | TECNOMYL | Anvisa, Ibama | Trinexapac-ethyl 250 g/L EC |
| FP/ETP | VERACE (24322) | ALTA | Anvisa, Ibama | Flumioxazin 500 g/L SC |
| FP/ETP | DOMADO 200 SL (24422) | SYNCROM | Anvisa, Ibama | Glufosinate-ammonium 200 g/L SL |
| FP/ETP | AGROSBAN (24522) | SYNCROM | Anvisa, Ibama | Chlorpyrifos 480 g/L EC |
| FP/ETP | CROPSHIELD (24822) | SYNCROM | Anvisa, Ibama | Chlorothalonil 825 g/kg WG |
| FP/ETP | GHALOR (25922) | ALBAUGH | Anvisa, Ibama | 2,4-D diethanolamine salt 442.8 + 2,4-D-dimethylamine 361.2 g/L SL |
| FP/ETP | DIQUATE NORTOX (26122) | NORTOX | Anvisa | Diquat dibromide 373.5 g/L SL |
| FP/ETP | DIQUAT VANON 200 SL (26222) | SYNCROM | Anvisa | Diquat dibromide 374 g/L SL |
| FP/ETP | LANDRIN (27622) | LANDRIN | Anvisa, Ibama | Fipronil 0.02 + indoxacarb 0.24 g/kg RB |
| FP/ETP | GLUFOSINATO 200 SL PERTERRA (28722) | PERTERRA | Anvisa, Ibama | Glufosinate-ammonium 200 g/L SL |
| FP/ETP | GRASIDIM FULL (23922) | RAINBOW | Anvisa, Ibama | Clethodim 360 g/L EC |
| NFP | STRIKE (29522) | IHARABRAS | Ibama | Metamifop 300 g/L EC |
| FP/ETP | AZOXYSTROBIN+CYPROCONAZOLE+OXICLORETO DE COBRE SC ALBAUGH 01 (29722) | ALBAUGH | Anvisa, Ibama | Azoxystrobin 110 + cyproconazole 80 + copper oxychloride 436.8 g/L SC |
| FP/ETP | BOKSIA 300 WG (30422) | CROPCHEM | Anvisa, Ibama | Indoxacarb 300 g/kg WG |
| FP/ETP | PROTERRA 200 SL (31122) | ALLIERBRASIL | Anvisa, Ibama | Glufosinate-ammonium 200 g/L SL |
| FP/ETP | GLINT FULL (31222) | RAINBOW | Anvisa, Ibama | Haloxyfop-P-methyl 540 g/L EC |
| FP/ETP | ALON (31422) | GLOBACHEM | Anvisa, Ibama | Bifenthrin 120 + lufenurom 140 g/L SC |
| FP/ETP | METOMY (31522) | RAINBOW | Anvisa, Ibama | Methomyl 900 g/kg SP |
| FP/ETP | HDB 276 (32122) | HELM | Anvisa, Ibama | Chlorothalonil 750 + tebuconazole 60 g/L SC |
| FP/ETP | MEDEIRO WG (32822) | TRADECORP | Anvisa | Fosetyl 800 g/kg WG |
| FP/ETP | TRACKING 720 WG (33522) | ALLIERBRASIL | Ibama | Glyphosate 792.5 g/kg WG |
| FP/ETP | METRARO (34122) | RAINBOW | Anvisa | S-metolachlor 960 g/L EC |
Notes:
FP: Chemical Formulated Product
NFP: New Chemical Formulated Product
FP/ETP: Chemical Formulated Product based on Equivalent Technical Product
Sources: Anvisa, Ibama, MAPA, Mazza & Manente de Almeida Advogados; adapted by AllierBrasil
According to the report “Lawsuits, Decisions by Federal Court – 2022”, unpublished, elaborated by AllierBrasil and Mazza & Manente de Almeida Advogados, not all lawsuits are successful, especially in the case of the granting of injunctions by the Judiciary. Some Courts have a greater number of approvals, while the need for appeals to a second instance are more frequent in others.
In the same survey elaborated by AllierBrasil (2023), when comparing the time for registration approvals “without lawsuits” versus “with lawsuits”, it is possible to demonstrate that lawsuits reduce significantly the time for pesticide registration approval.
Notes:
(1) Pesticide registration processes that followed a regular queue and processes that underwent legal action/lawsuits to speed up toxicological and environmental evaluations (all of the processes)
(2) Pesticide registration processes that did not resort to lawsuits to speed up toxicological and environmental evaluations
Sources: Anvisa, Ibama, MAPA; adapted by AllierBrasil
The increase of lawsuits continues in 2023. For 2024, the Joint Ordinance No. 3 may speed up pesticide evaluations, but its procedures are still under discussion by the authorities. In regards to the much-discussed Pesticide Bill, it is still too early to predict whether the project will reduce the time for registration, even if it is sanctioned in whole, without any vetoes.
This and other topics related to agribusiness, environment, biologicals, will be subject of lectures at the 2nd Agrochemical Tradeshow São Paulo 2024 organized by AllierBrasil.
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