Regulatory compliance · EU → BR
ANVISA closes SIPTOX: pesticide files move to the ordinary route
Nov 9, 2026 · 5 min read
In short
ANVISA's RDC 1,047/2026 took effect on 6 November 2026, revoked RDC 184/2017 and closed SIPTOX. Pending toxicological evaluation files submitted under the old simplified procedure will now be assessed under the current rules for their product category, and holders must submit the required studies without waiting for an ANVISA notice. Evaluations already approved remain valid, but their holders must provide a technical-data assignment letter when the file migrates to Sispa or at the first post-registration change, whichever comes first. Failure to meet the transition requirements can lead to denial of a pending petition or cancellation of an approved toxicological evaluation. The change applies to files that used the former simplified route, not to every pesticide registration in Brazil.
Brazil has closed the SIPTOX simplified route for pesticide toxicology files. RDC 1,047/2026 came into force when it was published on 6 November, revoked RDC 184/2017 and ended the dedicated electronic system. The immediate question is not whether every pesticide registration must start again. It is whether a Brazilian file was submitted or approved under that former simplified procedure, because those are the files now subject to the transition rules.
The old route covered technical products, premixes, pesticides, related products and wood preservatives whose qualitative and quantitative composition and formulation matched a matrix petition. It allowed a simplified petition to rely on the matrix file within defined limits. The new resolution removes that parallel route. It does not invalidate toxicological evaluations already approved, but it separates the next steps for cases still awaiting review from those that have already received a favourable evaluation.
For a pending simplified petition, ANVISA will now apply the legislation currently in force for the relevant product category. The company must submit the studies and technical documents required by those rules from the date of publication, without waiting for a prior request from ANVISA. The agency may still raise further requirements during review. In practice, the holder should compare the existing file with the current ordinary dossier now, identify evidence gaps and decide who owns each missing study before the review reaches it.
For an evaluation already approved under RDC 184/2017, the approval remains valid in the terms originally granted. The holder must, however, present the technical-data assignment letter in the model attached to RDC 1,047/2026 when the process migrates to Sispa or with the first post-registration change, whichever happens first. The letter is signed by the holder of the matrix petition and the holder of the simplified petition, authorises use and reference to the underlying studies before ANVISA, MAPA and IBAMA, and formally removes the prior technical and documentary dependency between the files.
The practical work belongs to the Brazilian registration holder, but an EU developer may control the studies and signatures that make the transition possible. Build an inventory of affected process numbers, classify each as pending or approved, confirm who holds the matrix data, prepare the assignment letter where needed and map any current-study gap before the next Sispa migration or post-registration filing. A company abandoning a file must use the specified Solicita withdrawal route and provide evidence of its cancellation request to the registering authority. An Opportunity Scan can map the local holder, data owner and regulatory sequence before a missing document puts the Brazilian route at risk.
Business intelligence, not legal or tax advice.