Brazil's health regulator Anvisa has abolished SIPTOX, the simplified system that let companies reuse toxicological data from earlier pesticide evaluations when applying for new registrations or post-registration changes, Global Agriculture reports. Resolution RDC No. 1,047, dated 5 November, was published in the official gazette on 6 November and took effect the same day.
The resolution revokes RDC No. 184/2017, which created SIPTOX nine years ago. Under it, companies registering technical-grade pesticides, pre-mixtures, formulated products, related products or wood preservatives could rely on toxicology studies already accepted for a comparable product instead of submitting a full dossier, a route meant to speed registration and avoid repeating animal and laboratory tests.
Pending applications lose the shortcut: companies must now submit the toxicology studies required under the rules for each product category, without waiting for a notice from Anvisa. Approvals already granted under the simplified route stay valid, but holders must send a letter authorising use of the original study data, in a model format, either when they migrate the file into Sispa, Brazil's unified electronic registration system, or at their first post-registration change, whichever comes first. Without it, a pending application can be rejected or an approval cancelled.
The change is part of the consolidation of registration into Sispa since Law 14,785 of 2023, which also aligned Brazil's pesticide classification with the UN Globally Harmonized System. Anvisa handles only the toxicology leg of registration; the Ministry of Agriculture and Livestock assesses agronomic efficacy and the environmental agency Ibama the environmental risk.
Brazil's pesticide market is the largest in Latin America by registration volume, and the rule affects both multinational originators and the growing number of domestic and Chinese-linked generic formulators seeking registrations there.
Photo: James Martins / Wikimedia Commons (CC BY 3.0)
Source: Global Agriculture
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