Brazilian health regulator Anvisa discontinues SIPTOX, requiring companies to update pending applications and provide additional documentation for previously approved evaluations.
Anvisa has discontinued SIPTOX, a system used to simplify toxicological evaluations required for pesticide registrations in Brazil. The decision, established under Resolution RDC No. 1,047 of November 5th, 2026, was published in the Official Gazette of Brazil on November 6th.
Under the previous rules, companies could rely on toxicological data from previously evaluated products to support new pesticide registration applications and post-registration amendments, reducing the need to submit separate studies. This simplified procedure was established under RDC No. 184/2017 and covered technical-grade products, premixes, formulated pesticides, related products and wood preservatives.
With the termination of SIPTOX, applications still awaiting evaluation must comply with Brazil’s current regulatory requirements. Companies must submit the toxicological studies required for each product category without waiting for a formal notification from Anvisa.
For companies that have already obtained favorable toxicological evaluations through SIPTOX, existing approvals will remain valid. However, they must submit a Letter of Authorization to Use Toxicological Study Data when transferring their applications to SISPA, Brazil’s Unified Electronic Information, Petitioning and Evaluation System, or when requesting their first post-registration amendment, whichever occurs first.
The letter must formally authorize the use of toxicological studies from the original application, allowing the company holding the simplified approval to continue referencing those data for regulatory purposes.
Failure to comply with the new requirements may result in rejection of an application or cancellation of a previously granted toxicological evaluation approval, as provided by the resolution. Companies that no longer intend to maintain their registrations must formally request withdrawal through Anvisa’s Solicita electronic system.
The regulation took effect on November 6th, 2026. The changes affect companies operating in Brazil’s pesticide market, particularly those relying on previously evaluated toxicological data to obtain or maintain product registrations.
Source: Official Gazette of Brazil – RDC No. 1,047, dated 11/5/26, published on 11/6/26 (Anvisa).
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