Brazil Introduces a New Method to Assess Toxicity in Cleaning Products

Anvisa (Agência Nacional de Vigilância Sanitária de Brasil) has published a manual establishing a new procedure for calculating the estimated acute oral toxicity in cleaning products, replacing the traditional in vivo test with a safer and more transparent method.

The Brazilian health authority Anvisa has taken an important step toward regulatory modernization with the release of the Manual for Calculating Estimated Acute Oral Toxicity (ETA). This document provides companies with detailed guidance on applying the quantitative ETA method as an alternative to the traditional LD50 test, reducing the need for animal testing and promoting more ethical and efficient processes.

The manual, which outlines the technical requirements of Resolution RDC 989/2025, is aligned with the recommendations of the Globally Harmonized System (GHS) and the World Health Organization (WHO). Its goal is to standardize calculations, documentation, and result presentation, improving the quality of submissions to Anvisa and increasing transparency in risk communication.

However, the document clarifies that there are exceptions where the experimental LD50 test remains mandatory, such as for disinfectant products (RDC 682/2022) and paints or varnishes with disinfectant properties (RDC 847/2024). This clarification provides legal certainty and predictability for companies operating in the sector.

With this initiative, Anvisa aims to reduce review times, increase regulatory efficiency, and strengthen public health protection, ensuring that hazard information is clear and accessible to all stakeholders.

At Siam, we work to make regulatory adaptation simple and secure, offering personalized solutions that guarantee legal compliance.

The full manual can be consulted at the official source.

In addition, this development is complemented by the Brazilian standard NBR 14725, which regulates the classification, labeling, and safety data sheets of chemical products.