Pesticide Registration Steps in Brazil - Part I: Technical Product Based on Equivalency

“This is the first one in a series of articles with the objective of explaining briefly the pesticide registration steps in Brazil…”

Flavio Hirata is a partner at AllierBrasil, an agribusiness consulting firm, with a degree in agronomic engineering from Esalq/USP, and a specialist in pesticide registration.

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 manufactures 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.

This is the first one in a series of articles with the objective of explaining 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 one is responsible for issuing the registration certificate.





Each of the Ministries makes its own 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 Gazette, 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 (1), the registrant should submit the same dossier to the three ministries, within five working days.

(1) chemical product which has a reference product, ie., the active ingredient was already evaluated and approved by MAPA. 

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 (check list 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 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 of 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 contracted laboratory demands special attention. Time for conclusion, compliance with regulations, commitment to keep tested sample until it expires, 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 registrations 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 formulated 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, Japan 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, New Delhi, India

22nd Forum AllierBrasil: November, Osaka, Japan

22rd Forum AllierBrasil: November, 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, 40% were approved by AllierBrasil.