On September 11, 2025, during the 17th Annual Global Chemical Regulations Forum (CRAC 2025), REACH24H successfully hosted a closed-door meeting on Brazilian pesticide registration. José Victor Torres Alves Costa, Head of the Pesticide Department at the Brazilian Ministry of Agriculture (MAPA), was present to provide an in-depth interpretation of hot topics of concern to Chinese enterprises, such as new Brazilian pesticide registration regulations, review procedures, and data requirements, and to answer questions on-site. This article will summarize and analyze the key points of the meeting.

Interpretation of New Brazilian Pesticide Registration Regulations: Opportunities and Challenges

1. Cancellation of Registration If Not Sold Within Two Years: Optimizing Queues, Promoting Actual Production

New Brazilian regulations stipulate that if pesticide registration is approved but no sales activities are carried out within two years, the registration qualification will be canceled. José Victor Torres Alves Costa explained that this measure was not issued by the Ministry of Agriculture but was passed by the Brazilian Parliament, aiming to optimize the queuing process for obtaining certificates and help enterprises with actual sales intentions obtain certificates faster. Currently, this policy only applies to formulation products, not technical grade products. Statistics show that the proportion of enterprises that actually go into production after obtaining registration is about 40%–50%. MAPA has proposed to Parliament to extend this period to be more friendly to enterprises that fail to produce due to non-subjective reasons.

2. New Act No. 40: MAPA Unified Receipt of Data, Promoting Digital Management

The new Act No. 40, launched by Brazil in September, requires that all registration data be uniformly received by MAPA and then distributed to the review departments. José Victor Torres Alves Costa clarified that this move will not fundamentally affect the registration process, but mainly aims to promote the digitization of the registration process and improve management efficiency. MAPA will also hold follow-up meetings to solicit feedback from enterprises on the use of the SISPA electronic system to continuously optimize it.

3. RET Program for New Active Ingredients and Changes in Testing Institutions: Flexible but Rigorous

Regarding the RET (Simplified Registration Procedure) required for the registration of new active ingredients and their formulations, and the prior designation of local Brazilian testing institutions for field and residue trials, José Victor Torres Alves Costa pointed out that changes or additions are allowed as long as the proposed new or replacement institutions are legally established testing units in Brazil. However, enterprises must notify MAPA, ANVISA, and IBAMA in advance and submit detailed documentation explaining the changes to ensure compliance.

Registration Application Process and Related Requirements: Long Cycle, IBAMA as a Bottleneck

1. Registration Cycle from Technical Grade to Formulation and the Accelerating Effect of Litigation

The pesticide registration cycle in Brazil is relatively long. It is estimated that it takes about 6-7 years from technical grade registration to formulation registration completion. Enterprises can file a lawsuit after the statutory review period expires, and the review can usually be completed within 1–2 years after litigation, which has a certain accelerating effect on the review.

2. The Biggest Difficulty in Formulation Registration: IBAMA Review Process Needs Improvement

Currently, the biggest bottleneck in Brazilian formulation registration lies in the review process of IBAMA (Brazilian Institute of Environment and Renewable Natural Resources). José Victor Torres Alves Costa frankly stated that pesticide registration review is not IBAMA's primary responsibility, so review delays are common and improvements are slow. MAPA is actively promoting IBAMA to improve its review efficiency.

3. Brazilian Registration for Chinese Enterprises Without Domestic Certificates: Conditional Approval, but Sales Restrictions

Regarding the question of whether Chinese enterprises can obtain Brazilian technical grade registration without obtaining domestic ICAMA registration certificates and production licenses, José Victor Torres Alves Costa stated that even if Chinese enterprises have not yet obtained domestic certificates, they may still obtain a conditional Brazilian registration certificate. However, this certificate will only officially take effect after the enterprise obtains both domestic ICAMA certificates. During this period, the technical grade registration certificate cannot be authorized to others for use, and production is allowed, but sales are not. Sales activities must be based on possessing relevant registration and production licenses in both China and Brazil.

4. Identical Formulation Registration Application: Currently Shares Queue with Conventional Formulations

MAPA originally planned to open a separate queue for identical formulations to accelerate approval, but due to the small number of such applications currently, they still share the same queue with conventional formulations for now.

Registration Data and Review Requirements: Stricter Toxicology Review, Case-by-Case Analysis is Key

1. Toxicology Phase II Review: Focus on Impurity Information, Improved Efficiency

ANVISA (Brazilian National Health Surveillance Agency) has indeed strengthened its review of toxicology data, especially focusing on impurity information. However, José Victor Torres Alves Costa also emphasized that ANVISA's review efficiency is also improving simultaneously and does not affect the overall registration progress. Currently, there are no uniform standards for data supplementation, and case-by-case analysis is required based on specific substances and product situations.

2. Adjustment of Identical Technical Grade Registration Strategy: Product Differences Require Specific Analysis

Regarding the case of a 400 g/L formulation intended to apply for "identical technical grade" registration, if there are differences between the reference product and the newly registered product, it is very likely that equivalence cannot be determined. José Victor Torres Alves Costa suggested that enterprises adjust their registration strategy based on the new reference product and conduct specific analysis.

Practical Cases and Regulatory Trends: Transparency and Consistency Regulation in Parallel

1. Sumitomo Chemical's New Active Ingredient Epyrifenacil Registration Progress: MAPA Completed Review, Awaiting ANVISA and IBAMA

The registration of Sumitomo Chemical's new active ingredient Epyrifenacil is progressing smoothly. MAPA has completed the review of registration materials and data and has now handed it over to ANVISA and IBAMA. Approval is expected within a few months, with ANVISA's review possibly taking longer. However, given that the product has been registered in other countries, ANVISA will also refer to the review opinions of other countries, so the progress should not be too slow. Enterprises can follow the Brazilian Ministry of Agriculture website, where review progress is updated weekly, maintaining transparency.

2. Brazil Strengthens Consistency Regulation for Pesticides: 2,4-D and Glyphosate First, Enterprises Need to Pay Attention to Formulation Changes

Currently, Brazil only implements consistency regulation for 2,4-D and glyphosate products, with specific details not yet fully clarified and the next batch of regulated pesticides not yet determined. If enterprises are found to have quality problems, they will have the opportunity to explain first, but may face fines. José Victor Torres Alves Costa suggested that enterprises submit formulation change applications in advance to avoid regulatory risks.

Conclusion

This closed-door meeting provided valuable first-hand information on Brazilian pesticide registration for Chinese pesticide enterprises. Brazilian pesticide registration regulations are continuously being optimized, aiming to improve efficiency, but also accompanied by stricter supervision and longer review cycles. Enterprises need to pay close attention to new regulatory developments, especially the improvement of IBAMA's review efficiency and the expansion of the scope of future consistency regulation. In the application process, a thorough understanding of data requirements, flexible adjustment of registration strategies, and active communication with Brazilian regulatory authorities will be key to successfully obtaining Brazilian pesticide registration certificates.