11 November 2026, Brasília, BR: Brazil’s health regulator Anvisa has eliminated SIPTOX, the simplified system companies used to reuse toxicological data from earlier pesticide evaluations when filing new registration requests or post-registration changes. The change comes through Resolution RDC No. 1,047, dated November 5, and published in the official gazette on November 6, taking effect the same day.
The new resolution revokes RDC No. 184/2017, the rule that created SIPTOX nine years ago. Under that earlier system, companies seeking to register technical-grade pesticides, pre-mixtures, formulated products, related products or wood preservatives could lean on toxicological studies already accepted for a comparable product, rather than resubmitting a full technical dossier each time. The simplified path was meant to speed up registration while avoiding duplicate animal and laboratory testing.
What companies must do now
For applications still waiting on a decision, the new rule removes the shortcut entirely. Companies must submit the toxicological studies required under the regulation that currently applies to each product category, and they no longer need to wait for a formal notice from Anvisa before doing so. In practice, this shifts the burden onto applicants to track which requirements apply to their pending filings rather than relying on the agency to prompt them.
Processes that were already evaluated favorably under the old simplified procedure keep their validity, but holders of those approvals face a new administrative step. They must submit a letter authorizing the use of the original toxicological study data, using a model format set out in the new resolution. That letter becomes due at one of two points, whichever comes first: when the company migrates its process into Sispa, Brazil’s unified electronic system for registration petitions and evaluations, or when it files its first post-registration change request for that product. Failing to provide the letter can result in a pending application being rejected or an existing toxicological approval being cancelled.
Companies that decide they no longer want to maintain a given registration can withdraw it through Anvisa’s existing Solicita petition system rather than let it lapse into non-compliance.
Context: a system seven years in the making
The move sits alongside other changes to Brazil’s pesticide regulatory architecture introduced since 2023, when Law 14,785 established Sispa and brought Brazilian pesticide classification in line with the United Nations’ Globally Harmonized System for chemical hazard labeling. A separate resolution, RDC 950/2024, had already begun adjusting procedures around that transition, and the elimination of SIPTOX is being presented as part of the same broader consolidation of registration processes into Sispa.
Anvisa shares pesticide registration authority in Brazil with the Ministry of Agriculture and Livestock, which evaluates agronomic efficacy, and the Brazilian Institute of Environment and Renewable Natural Resources, which handles environmental risk. Anvisa’s toxicological evaluation is one leg of that three-agency process, and SIPTOX had applied only to the toxicology dossier, not to the agronomic or environmental reviews.
The resolution does not specify a grace period beyond the letter-of-authorization deadlines described above, and it does not retroactively cancel approvals that were already granted. Industry groups tracking the change have advised registration holders to review the full text of RDC 1,047/2026 individually, since the letter requirement and its trigger points apply differently depending on whether a company’s process is still pending or already approved.
Brazil’s pesticide market is the largest in Latin America by registration volume, and changes to toxicological evaluation procedures affect both multinational originators and the growing number of domestic and Chinese-linked generic formulators seeking registrations in the country.
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