Regulatory Support - Agrochemicals

Agrochemical registration with strategy, science and agility

From risk assessment to final protocol: we structure robust regulatory processes so that your product reaches the market with technical safety and without rework.

The regulatory complexity that delays your registrations

The registration of agrochemicals in Brazil involves three ministries (MAPA, IBAMA, ANVISA) with different technical requirements and unpredictable deadlines. An error in the dossier can mean months of delays.

With the new RDC 998/2025, occupational risk assessment now requires DAROC, AOEL and AAOEL, unprecedented parameters in Brazil. Unprepared companies face rejections and decisive deadlines already in force.

Drawing up the PATE requires in-depth knowledge of RDC 294/2019, and poorly structured documents result in cascading requirements that multiply costs and delay the entire pipeline.

How SmartTox solves

We conduct the entire agrochemical regulatory process with multidisciplinary expertise. Our team is familiar with all three regulatory spheres (ANVISA, MAPA, IBAMA), including the recently published RDC 998/2025 on occupational risk. We deliver consistent, strategic dossiers built for first-time approval.

Detailed services

Dietary Risk Assessment:

We conduct a complete acute and chronic dietary risk assessment in accordance with RDC 295/2019. We calculate IDMT, compare it with DRfA and IDA, and prepare the risk characterization with scientific rigor accepted by ANVISA.

Occupational Risk Assessment (RDC 998/2025):

Preparation of the DAROC in accordance with the new RDC 998/2025. We determine AOEL and AAOEL, estimate exposure for operators, workers, residents and bystanders using the avaliAR Calculator, and define mitigation measures for PPE and labeling.

Environmental Risk Assessment:

Integrated analysis of the environmental fate of the active ingredient: persistence, mobility, bioaccumulation and toxicity to non-target organisms. Technical support to meet IBAMA requirements with scientific consistency.

Meeting Technical Requirements:

Strategic response to ANVISA, IBAMA and MAPA requirements at all stages. Evaluation and strategy for Phase 2 requirements, with solid technical arguments that minimize review cycles.

PATE, DAROC, FLORA, DCIPA, Bula and Protocol:

Preparation of the PATE for New, Equivalent and Formulated Technical Products. Preparation of the DAROC in accordance with RDC 998/2025. Medical chart for ANVISA package leaflet, technical representation at ministries, process assembly and protocol, and request for prioritization for low toxicity products (Art. 15, RDC 294).

Why SmartTox

Full knowledge of RDC 294/2019, RDC 998/2025 and complementary regulations.

Team audited by ANVISA, MAPA, INMETRO/CGCRE and OECD.

International hub with strategic partners in 18+ countries.

First SmartTox Technical Congress on the regulation of agrochemicals and biologicals.