Pesticide Registration Process in Brazil
Guest Author: Flavio Hirata, partner at AllierBrasil, a pesticide registration consulting firm. Email: flavio.hirata@uol.com.br
22 June 2024, Brazil: Brazil is the most attractive pesticide market in the world. Few companies have more than 70% of the market share. One of the reasons for this is because that, for several decades, pesticide registration was extremely expensive and used to take a very long time. However, since the regulation of equivalency was approved, 20 years ago, more players started accessing the market, specially manufacturers from China and India. Nevertheless, the competition has become tough all over the world, so more and more companies are trying to access the Brazilian market.
Part I: Technical Product Based on Equivalency
This is the first one in a series of articles to explain briefly the pesticide registration steps in Brazil.
There are three Ministries (or agencies) in charge of pesticide registration in Brazil. It is evaluated by Anvisa (health), Ibama (environmental) and MAPA (agriculture). The last is responsible for issuing the registration certificate.
Each of the Ministries makes its evaluation and, when it is finalized, it will inform the other Ministries. If any of the Ministries rejects the evaluation, MAPA will publish it at the Official Gazzete, the same as when it is approved.
The first step in elaborating a dossier is to define a manufacturer legally established with due licenses and permits. The registration dossier should be prepared using samples from the manufacturer. In the registration request, the manufacturer information should be described in the dossier.
For the registration of a technical product based on equivalency (a chemical product that has a reference product, ie., the active ingredient was already evaluated and approved by MAPA), the registrant should submit the same dossier to the three ministries, within five working days.
Registrants should pay fees in advance to Anvisa and Ibama prior to the submission, BRL 317.21 to BRL 3,172.10, depending on the registrant revenue category (checklist and evaluation) and BRL 865.58 (check-list), respectively. After the submission, an additional fee of BRL 60.680,25 (evaluation) should be paid to Ibama. No fee to MAPA is demanded.
Once the registration dossier is submitted, MAPA is in charge of the evaluation. It will compare chemical equivalency based on five-batches and P&C studies, manufacturing process and impurity profile. In addition, MAPA will request an operation license from the manufacturer, product registration in the country, quality control of 20 batches and composition declaration from the manufacturer.
In the event the equivalency is not proven with such data, the evaluation will go to Tier II, which has Anvisa in charge. Anvisa will evaluate the toxicological parameters and thus will request a structure-activity relationship report, three mutagenicity studies, and maybe some acute toxicological studies, depending on the impurity profile of the five batches.
However, as it takes 4 years or more until a registration is in fact in evaluation, the tested samples of the five-batches study should have already expired. In this case, the registrant should perform a one-batch analysis with a sample that has a similar impurity profile to the batches.
In general, the time for evaluation in Tier II takes 6 to 12 months. In some cases, it could be faster, taking 2 to 3 months.
If the equivalency is not proven in Tier II, the evaluation will move to Tier III. For this, the registrant should present full toxicological and environmental dossiers.
It is important to highlight that registration takes a long time, and during the registration process there should happen regulation changes and submitted dossiers should be updated according to the new regulation. This could delay much more the time for evaluation.
All study reports should be performed under GLP from an international accredited laboratory. In Brazil, there are several laboratories working with pesticides, with fees starting from US$ 30,000 or even less.
Choosing a contracted laboratory demands special attention. Time for conclusion, compliance with regulations, commitment to keep tested samples until they expire, and replying to queries from authorities are some of the points to take into consideration when choosing a laboratory. Checking the records and history of the laboratory may minimize such problems in the future.
It often happens that the same technical product dossier is applied for registration by different registrants. In this case, if the registration with the same dossier was already approved, authorities will check whether the dossier is the same, and if confirmed, registration will be approved within a couple of months.
In addition, if there are different registration requests with the same dossier when the first registration goes for evaluation, all others will be evaluated at the same time, regardless of when they were submitted.
Once the technical product registration is approved, it can be a source to formulate products, upon formal request by the interested company. This procedure is very fast.
In 2023, MAPA approved 190 technical product registrations, out of which 179 were technical products based on equivalency.
To know more about pesticide registration in Brazil, AllierBrasil organizes seminars and exhibitions in Brazil, India and China.
15th Brasil AgrochemShow: August 13-14th, in São Paulo, Brazil. Lecture “Pesticide Registration: Time, Lawsuit, New Law”, by Flavio Hirata
21st Forum AllierBrasil: November, in New Delhi, India
22nd Forum AllierBrasil: November, in Nanjing, China
AllierBrasil is a consulting firm focused on pesticide registration in Brazil since 2004. In 2023, out of all approved registrations under the name of consulting firms, almost 40% were approved by AllierBrasil.
Also Read: Best Agrolife Ltd Announces Launch of New Insecticide ‘Nemagen’
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