Risk Assessments

Risk assessments with science, precision and regulatory acceptance

We structure risk assessments that withstand the technical scrutiny of ANVISA, IBAMA and international bodies, with recognized methodologies and consistent data.

Poorly conducted risk assessments are costly

Risk assessments with inadequate methodology or insufficient data are the main cause of demands and rejections at ANVISA.

The new RDC 998/2025 made DAROC with AOEL and AAOEL mandatory, and many companies do not have in-house staff trained to carry out these unprecedented assessments in Brazil.

Environmental risk assessments that do not consider real scenarios and representative data result in unnecessary restrictions on the indications for use of the product.

How SmartTox solves

We carry out risk assessments with a complete scientific and regulatory approach. Our team is proficient in ANVISA, OECD, EFSA and EPA methodologies, and is an expert in reference tools such as the OPEX Calculator. We deliver assessments that structure predictable and defensible processes.

Detailed services

Occupational Risk (RDC 998/2025):

Complete assessment according to the new RDC 998/2025: determination of AOEL and AAOEL, exposure estimation via the avaliAR Calculator, risk characterization for operators, workers, residents and passers-by, and preparation of the DAROC.

Dietary Risk:

Acute and chronic dietary risk assessment according to RDC 295/2019, with calculation of IDMT and risk characterization compared to DRFA and IDA.

Environmental risk:

Analysis of the environmental fate and ecotoxicological impact of the active ingredient, with data on persistence, mobility, bioaccumulation and toxicity to non-target organisms.

Non-dietary exposure:

Estimation of non-dietary exposure for specific scenarios, including residues on surfaces, water and air, using internationally recognized methodologies.

Toxicological parameters:

Determination and review of toxicological reference parameters (NOAEL, LOAEL, POD, uncertainty factors) to support consistent risk assessments.

Why SmartTox

Experts in the OPEX Calculator (ProHuma Institute / ANVISA).

Complete knowledge of RDC 998/2025 (DAROC, AOEL, AAOEL).

ANVISA, OECD, EFSA and EPA methodologies.

Team with scientific publications in SBTox.