In December 2025, the Brazilian Health Regulatory Agency (ANVISA) published Resolution RDC No. 1.006, marking a significant reform in the toxicological assessment requirements for Technical Grade Active Ingredient (TGAI) equivalence. Effective immediately, this resolution formally introduces a tiered toxicological assessment system based on impurity levels, shifting Brazil’s pesticide registration landscape from a traditional "one-size-fits-all" model to a more scientific, risk-based management era.

For agrochemical companies planning to enter or expand within the Brazilian market, this regulatory shift presents both an opportunity to accelerate registration and a new challenge regarding technical equivalence. Facing strict requirements such as the mandatory use of "at least three expert systems" and the submission of raw data, companies must now adopt highly specialized strategies to navigate the new landscape.

01. Core Change: Breaking Convention with "Tiered" Assessment

The most significant highlight of RDC No. 1.006 is the establishment of an assessment framework based on impurity concentration. ANVISA no longer demands comprehensive toxicological predictive assessments for all impurities. Instead, differentiated toxicological data requirements are now applied based on the specific proportion of new or increased impurities in the technical material.

Extremely Low Content (<0.1%): Generally, no mandatory QSAR prediction is required; submission of conclusive opinions based on existing data suffices.

· Low Content (0.1% - <0.3%): QSAR predictions are mandatory. Assessment must cover Mutagenicity, Carcinogenicity, and Skin/Respiratory Sensitization.

· Low-to-Medium Content (0.3% - <1.0%): In addition to the above, Reproductive Toxicity assessment is required.

· Medium-to-High Content (1.0% - <10%): Further adds assessments for Target Organ Toxicity, Eye and Skin Irritation, and Acute Oral Toxicity.

· High Content (≥10%): In addition to all the above endpoints, Inhalation Hazard assessment is required.

02. Technical Hurdles: Comprehensive Upgrade of QSAR Requirements

Beyond the changes in assessment endpoints, ANVISA has set unprecedentedly high standards for the quality and depth of QSAR reports. Companies must adhere to the following "hard indicators":

· Multi-System Verification: The regulation explicitly requires independent predictions using at least three different expert systems.

· Data Transparency: Submission of raw data is mandatory.

· Definitive Conclusions: Reports must provide a clear, conclusive evaluation of the toxicological relevance of the impurity relative to the active ingredient.

· New Documentation: All relevant applications must include a signed "Declaration of Toxicological Relevance of Impurities" (DRTI).

This implies that simple software outputs can no longer satisfy regulatory scrutiny. Companies now require deep toxicological expertise to scientifically interpret and integrate complex data generated by multiple systems.

03. REACH24H: Ensuring Precision Compliance and Market Access

The new regulation explicitly advises companies to "build or outsource capabilities for in silico toxicological assessments". REACH24H leverages extensive global pesticide regulatory experience and a specialized toxicology team to provide one-stop QSAR prediction and risk assessment services.

Our Solutions:

· Top-Tier Expert System Configuration: We utilize international authority QSAR software including Derek Nexus, Sarah Nexus, MultiCASE, OECD QSAR Toolbox, T.E.S.T. and so on, fully meeting ANVISA’s requirement for "at least three different expert systems."

· Senior Toxicology Team: Our experts are not only proficient in software operation but possess deep capabilities in toxicological mechanism analysis (Read-across, Weight of Evidence [WoE]). We provide professional interpretation of complex results and draft high-quality reports compliant with OECD guidelines and ANVISA requirements.

· Customized Compliance Strategy: We match precise "tiered assessment" solutions based on impurity concentrations. This prevents cost waste from over-testing while ensuring critical review points like "sensitization" and "reproductive toxicity" are rigorously met.

· Full-Process Support: From impurity profile analysis and QSAR report drafting to assisting with the DRTI declaration and responding to official review inquiries, we provide technical safeguards throughout the entire process.

If you are currently undergoing Brazilian TGAI equivalence applications or facing technical difficulties in impurity toxicological assessment, please contact REACH24H. With extensive experience in (Q)SAR services and a team of domain experts, REACH24H has successfully completed over 2,000 (Q)SAR projects across multiple jurisdictions, providing systemic solutions for global pesticide registration.