14 November 2026, Brasília, BR: Brazil’s health regulatory agency ANVISA has abolished SIPTOX, the simplified procedure companies used to reuse previously accepted toxicological data when registering new pesticide products or amending existing ones. The change took effect on November 6, 2026, the date Resolution RDC No. 1,047 was published in the Diário Oficial da União, Edition 209, Section 1, Page 102.
The resolution, dated November 5, 2026 and signed by ANVISA director-president Leandro Pinheiro Safatle, revokes Resolution RDC No. 184 of October 17, 2017, which had created SIPTOX, short for Sistema de Peticionamento da Toxicologia (Toxicology Petitioning System). ANVISA’s governing board, the Diretoria Colegiada, voted to end the simplified procedure at a meeting held on October 29, 2026. The new resolution states that extinguishing the simplified procedure extinguishes SIPTOX as a system in its own right.
What the simplified procedure allowed
Under the 2017 rule, a company seeking to register a new technical product, premix, pesticide, related product or wood preservative could rely on toxicological data from a case ANVISA had already evaluated in a different registration, rather than submitting a complete data package of its own. That option is now gone entirely. Companies that relied on the simplified route must move their records into ANVISA’s Sispa platform, the Sistema Unificado de Informação, Petição e Avaliação Eletrônica (Unified System for Electronic Information, Petitioning and Electronic Evaluation), following migration guidelines ANVISA will issue separately.
Transition rules differ by filing status
The resolution sets different rules depending on where a company’s filing stood when the change took effect. Applications still pending are now evaluated under whichever current rules apply to that type of product, and companies must submit the full study package those rules require without waiting for ANVISA to request it; this does not change any other requirement ANVISA applies during its review.
Toxicological evaluations already approved under the simplified procedure remain valid on the terms originally granted. However, the holder of that approval must obtain a signed Carta de Cessão de Dados Técnicos de Estudos Toxicológicos, a Letter of Assignment of Toxicological Study Data, from the company that owns the original underlying studies. The letter authorizes continued use and reference to that data before ANVISA, the Ministry of Agriculture and Livestock, and IBAMA, and must be filed by whichever comes first: migration of the record into Sispa, or the next request to change the registration after approval. Both companies sign the letter through their legal representatives, and once signed, the resolution says the two registration processes have no further technical, documentary or regulatory dependency on each other, beyond the data-use authorization itself.
Companies that no longer want to keep a registration obtained through the simplified procedure can request withdrawal through ANVISA’s Solicita system, using subject code 5075, Desistência de petição/processo a pedido (Withdrawal of petition or process upon request). That withdrawal request must include proof that a corresponding cancellation request was already filed with the body that granted the underlying pesticide registration, typically the Ministry of Agriculture and Livestock.
Failure to meet these requirements carries a direct consequence under the resolution: ANVISA may refuse a pending petition outright, or cancel a toxicological evaluation already granted under the simplified procedure.
Global Agriculture is an independent international media platform covering agri-business, policy, technology, and sustainability. For editorial collaborations, thought leadership, and strategic communications, write to pr@global-agriculture.com
