On April 9, 2026, the Brazilian Institute of Environment and Renewable Natural Resources (IBAMA) published in the Federal Official Gazette (Diário Oficial da União – DOU) the Notice #26804432/2026‑Gabin, dated April 2, 2026, announcing the opening of a public consultation on a proposal for a new Normative Instruction, which fully revises the current framework for environmental assessment for purposes of registration, amendment of registration, reanalysis and environmental assessment of agrochemicals, environmental control products and related items, currently regulated by Ordinance #84/1996. The initiative seeks to align the regulatory framework with the changes introduced by Statute #14,785/2023 (Agrochemicals Statute), as well as to incorporate scientific and methodological advances in the environmental analysis of these products.

With respect to the environmental assessment for purposes of product registration, the draft sets out the procedure based on a structured set of information and studies to be submitted by registration applicants, including ecotoxicological data and data on environmental fate and behavior. The text establishes the stages of environmental risk assessment—hazard identification to the environment, exposure assessment, and risk characterization—and defines criteria for classification and categorization according to environmental risk, as well as for the possible imposition of mitigation measures. It also regulates aspects such as the format and content of the regulatory dossier, rules for the acceptance of studies and tests, and the circumstances under which IBAMA may request additional information.

In the context of environmental reevaluation, IBAMA’s proposal provides for the reassessment of active ingredients based on new scientific evidence, monitoring data, or indications of previously unidentified risks. The draft describes the conditions for initiating such processes, the stages of technical analysis, and the possible resulting regulatory measures, which may include the maintenance, amendment, or cancellation of registrations, as well as the imposition of use restrictions and additional risk mitigation measures.

It is important to note that the text also establishes the application of the one‑year protection period, supposedly provided for in Article 4(III) of Law #10,603/2002 (Brazilian Regulatory Data Protection Law) to new data required as a result of environmental reevaluation. However, this provision is incorrect.

Such protection period – notably short – does not appear proportionate to the significant effort undertaken by companies in generating this regulatory data required from IBAMA during environmental reevaluations and does not align with the rationale enshrined in Law #10,603/2002, according to which the greater the technical and scientific investment involved in producing the information, the longer the corresponding data protection period should be. Moreover, the very wording of the legal provision of Article 4(III) of Law #10,603/2002, does not support this interpretation, as it expressly refers to “new data required after the granting of the registration” (singular), whereas data produced in the context of a reevaluation are, as a rule, intended to support multiple registrations (plural).

The possible establishment by IBAMA of a regulatory data protection period may also give rise to controversy regarding the competence of the authorities involved to regulate the matter, particularly in light of the position of the Ministry of Agriculture and Livestock (MAPA), which maintains that this subject falls within its jurisdiction, considering its statutory role as coordinator of registration and reevaluation procedures.

With respect to the environmental reevaluation procedure as well, it should also be noted that the procedure described in the draft largely mirrors the provisions set forth in the Agrochemicals Statute, especially regarding the conclusion of the procedure, with IBAMA forwarding its conclusions to MAPA so that the Ministry may adopt the appropriate mitigation measures (cf. Article 31 of the Agrochemicals Statute). However, in an arguably contradictory manner, IBAMA also expressly provides for the possibility of reassessing, at any time, the results of the environmental assessment and the classification of the Environmental Hazard Potential (PPA) of products whose active ingredient is under reevaluation, allowing such products to be maintained, amended, suspended, or cancelled. This provision leads to an overlap of competences, insofar as the draft both reproduces the Agrochemicals Statute’s allocation of regulatory measures to MAPA at the conclusion of the reevaluation procedure and, at the same time, grants IBAMA broad and ongoing powers to intervene in previously approved uses, without clear legal support.

This is not the only aspect in which the draft may give rise to discussion regarding the delineation of competences among the authorities involved in the reevaluation process. The text also provides that IBAMA is empowered to adopt precautionary measures related to uses approved based on the results of the environmental assessment and the PPA classification of products under reevaluation, with the aim of minimizing environmental risks, until the conclusion of the respective reevaluation procedure. However, the temporal framework thus established—namely, “until the conclusion of the reevaluation”—could create a loophole allowing such precautionary measures to be adopted already at the final stage of the procedure, even where IBAMA has already completed the technical assessment within its remit and MAPA is in the process of adopting the regulatory measures resulting from the environmental reevaluation, pursuant to Article 31 of the Agrochemicals Statute and Article 19, sole paragraph, of Decree #4,074/2002.

The proposal also includes provisions on post‑registration monitoring and follow‑up, including the collection and analysis of environmental data and the possibility of revising conditions of use over time. These data are integrated into enforcement activities and may support both registration‑related decisions and reevaluation processes, within IBAMA’s statutory powers.

Finally, the draft also refers to the need to safeguard confidential data and protected information, observing, where applicable, the data protection periods and conditions established under Law #10,603/2002.

Parties interested in contributing to the proposal must submit their comments through the “Brasil Participativo” platform, using gov.br credentials. Contributions may be made directly to specific provisions of the draft regulatory text, with the possibility of attaching supporting technical documents. The procedure is structured in an interactive manner, allowing for comments on individual provisions of the draft.

The deadline for submitting contributions remains open until June 8, 2026, and participation is open to any interested parties, including companies, associations, academia, and civil society. This represents a relevant opportunity to influence the consolidation of the new regulatory framework for the environmental assessment of agrochemicals in Brazil, with potential direct impacts on registration processes, environmental reevaluation, and regulatory compliance.

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