“With easier registration and importation, a greater supply of products is expected in the generic market, which will likely result in lower costs…”
Laura Beatriz Ruiz is the manager and founder of R&D Agro Consultant – Argentina and ONE MORE – Uruguay; she has a degree in Biological Sciences from UBA – CONICET; she is a specialist in agrochemical regulatory affairs and a member of the Bioinputs Standardization Committee.
Ruiz has 20 years of experience in agrochemical regulatory affairs.
Laura Ruiz, founder R&D Agro Consultant – Argentina
AgriBrasilis – What changes does the new pesticide law bring?
Laura Ruiz – The new regulation 458/2025, which will come into force on November 3rd, 2025, introduces changes compared to the current one, which will help speed up the pesticide registration and import process. The most important changes are:
I. The import and registration process will be facilitated for those products (active ingredients and formulations) that have a registration certificate in countries with Regulatory Convergence, i.e., countries with an equivalence system for pesticide registration such as Argentina. These countries are: Canada, the US, the European Union, Great Britain and Northern Ireland, New Zealand, Australia, and Brazil.
II. Another process that will be simplified is the registration of production plants, reduced to the submission of a declaration of composition containing all the plants used for their manufacture.
III. “Export Only” registration is not covered. This does not significantly affect manufacturers, as Argentina is not a major exporter of agrochemicals, but it could have been maintained.
IV. Samples will not be required for registration; only the analytical standard will be requested if SENASA decides to inspect the imported cargo or the product being marketed.
V. The Globally Harmonized System of Classification and Labeling of Chemicals (GHS) classification is adopted.
AgriBrasilis – In practical terms, what benefits does this law bring to the market?
Laura Ruiz – With easier registration and importation, a greater supply of products is expected in the generic market, which will likely result in lower costs. As for new molecules, which are also favored in the registration process, it will be possible to introduce products based on new technologies, many of which are more efficient and environmentally friendly. On the other hand, local production may be affected, as it will be difficult to compete on price due to high government taxes and labor costs
“Registrations do not expire. SENASA has the authority to reevaluate or cancel a product when a toxicity problem is identified … ”
AgriBrasilis – What are the requirements, costs, and deadlines for the approval of each type of product?
Laura Ruiz – The new regulation establishes that the evaluation of dossiers will be carried out within 180 days from the date of submission. Currently, an active ingredient takes between 4 and 5 years to be approved.
SENASA has not yet published the fees that will apply under the new regulation.
As for requirements, in Argentina technical products are registered by equivalence, following FAO guidelines. However, not all the requirements necessary to complete the submission of the different modalities provided for in the new standard have been published yet.
AgriBrasilis – After approval of the registration at the federal level, is it mandatory to register the product in each province and pay fees?
Laura Ruiz – No, the registration is federal. Some provinces may have special regulations, such as restrictions on the use of certain pesticides or requirements for agronomic prescriptions.
AgriBrasilis – Do registrations have an expiration date? Are approved products subject to reevaluation? What are the criteria?
Laura Ruiz – Registrations do not expire. SENASA has the authority to reevaluate or cancel a product when a toxicity problem is identified that poses a health risk, epidemiological issues, quality issues, or even when the product no longer has the support of the foreign registration used for its approval in Argentina due to regulatory convergence.
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