From Simplification to Scrutiny: LATAM’s Regulatory Shift Explained
As regulatory frameworks in countries like Argentina and Costa Rica move toward modernization and international equivalence, producers can expect a more streamlined and transparent approach to agrifood health and safety standards. Photo: Adobe Stock
Several Latin American (LATAM) countries have implemented significant regulatory changes in recent years (2024 and 2025), aiming for harmonization with international standards, simplification of processes, and increased safety in the plant protection and bio-input sectors. Key nations that implemented these changes include Brazil, Argentina, Colombia, Costa Rica, Ecuador, and Mexico.
Brazil: Occupational Risk Assessment (ORA)
The publication of RDC 998/25 by ANVISA represents a watershed moment in the regulatory health and safety management of pesticides in Brazil. The mandatory nature of ORA unfolds in distinct and equally critical stages.
The first is the regulatory legacy. Since 2019, products that have undergone the toxicological reassessment process, such as 2,4-D, abamectin, thiram, and carbendazim, already carry the obligation to present this assessment. Any new registration request or inclusion of culture for these already established molecules mandatorily requires that risk studies be updated under the new and more rigorous criteria of RDC 998/25, including products in the queue and already registered, even those carried out in the past, within 12 months from June 1, 2026.
The second front is active monitoring. The new regulation establishes that, from June 1, 2026, all products that have an acceptable exposure level for the operator (AOEL) established in their monographs must present a risk assessment within 12 months. ANVISA will not publish an alert list or an official statement for each product. The responsibility for scouring the monographs, identifying which active ingredients already have their AOEL defined, and acting preventively falls entirely on the shoulders of the company holding the registration.
Finally, the third front is that of a future definition. For those assets that do not yet have an established ORA, ANVISA will initiate a task force, publishing proposed values through public consultations. These values will be primarily based on the guidelines of the European Food Safety Authority. Once the proposed value is published, the industry will have a very short period of only 60 days to accept it or to build a robust technical rebuttal. It is a microscopic window of opportunity that requires immediate scientific preparation, and after the completion and publication of the monograph, the company must present the risk assessment within 12 months.
An error in this process, a misinterpretation, or a weak submission can have catastrophic commercial consequences: from the imposition of severe restrictions in the product label to requirements for personal protective equipment that are impractical and challenging in the field to the drastic reduction of recommended crops and usage methods. Ultimately, what is at stake is not just the approval of a study or the completion of a spreadsheet, but the very competitiveness and market share of the product.
ANVISA’s RDC No. 1.006/2025 introduces complementary requirements to streamline the toxicological equivalence assessment of technical grade products containing increased or new impurities. The regulation mandates the submission of in-silico studies, toxicological studies, and the Declaration on the Toxicological Relevance of Impurities (DRTI) once the impurity profile equivalence review is completed and the dossier proceeds to toxicological evaluation.
In-silico studies must use three independent expert systems, include raw data, and cover specific toxicological endpoints according to impurity concentration tiers (≥0.1%, ≥0.3%, ≥1%, ≥10%), as detailed in Annex I. Toxicological testing is required when impurities reach defined thresholds, when genotoxicity results are positive, or when predictions indicate that an impurity may be more hazardous than the active ingredient. The DRTI (Annex II) formalizes the scientific justification for impurity relevance, requiring a tier-based identification of impurities and a final conclusion on whether any impurity increases the product’s hazard or affects toxicological equivalence.
Argentina: New Regulatory Framework and Globally Harmonized System
Argentina has implemented significant regulatory changes and started 2026 with modernized standards. The new regulatory framework established by the National Service for Agrifood Health and Quality Resolutions No. 458/2025 and No. 843/2025 came into effect on Jan. 5, encompassing chemical products and bio-inputs. It includes:
- Simplification and international equivalence: The import and registration process for those products (active ingredients and formulations) that have a registration certificate in countries with regulatory convergence, such as Australia, Brazil, Canada, U.S., and EU, among others, has been simplified.
- Simplification of production plant registration: Authorization for the operation of establishments/plant has also been simplified, based on sworn declarations.
- Deadline: The evaluation of dossiers will be carried out within 180 working days from the date of submission.
- International standards: There’s a mandatory adoption of the Globally Harmonized System (GHS) for labeling, with a three-year period for companies to adapt.
- Indefinite validity: Registrations now have indefinite validity.
- Product ban: Products banned in their countries of origin will be automatically excluded from the Argentinian registry.
Colombia: GHS Implementation
At the end of 2024, Resolution 20474/2024 came into effect, partially modifying ICA Resolution 75487/2020 and its Annex I, mainly regarding the implementation of the GHS Classification and new requirements for residue testing. The deadlines for GHS classification and labeling vary by hazard level. For IA (extremely hazardous) and IB (highly hazardous) products, the deadline expired in December 2024. For products classified as II (moderately hazardous) and III (slightly hazardous), the deadline is December 2026.
Regarding the preharvest period, specific changes were established in the methodology for the development of residue tests.
Costa Rica: Regulatory Renewal for Agrochemicals
Costa Rica is implementing a mandatory renewal process for all agrochemical registrations, as established by Decree No. 45007 — MAG, of April 24, 2025. The main objective of this measure is to ensure uniformity of all registrations in the country, overcoming the regulatory differences that existed in previous regulations. Starting this year, all existing registrations must be renewed by submitting updated technical information. The process will be phased, and the first stage will focus specifically on technical grade active ingredient products. The lists of molecules and the specific deadlines for submitting information have already been defined by the competent authorities. Failure to comply with the deadlines and requirements will result in the cancellation of both the technical grade active ingredient registration and the formulations associated with it.
Ecuador: Streamlining Pesticide Registration and Technical Cooperation
Ecuador seeks to optimize the registration process for plant protection products and bio-inputs in the country. The Agency for Plant Protection and Zoosanitary Regulation and Control (AGROCALIDAD) has established technical cooperation with the Inter-American Institute for Cooperation on Agriculture through Resolution No. 197/2024. The objective is to expedite the processing of registration requests, while maintaining existing technical requirements and guidelines. With the new procedure, it is expected to reduce the initial verification time (checklist) to 20 business days. The issuance of the registration certificate remains the sole responsibility of AGROCALIDAD.
Mexico: Simplification of Procedures
Mexico implemented changes through a Procedure Simplification Agreement and a Presidential Decree in 2025.
The Federal Commission for the Protection of Sanitary Risks issued a Procedure Simplification Measures Agreement in October 2025 that eliminated approximately 194 physical or redundant requirements to expedite sanitary registrations and authorizations for pesticides and plant nutrients. A 60% reduction in registration processing time is expected.
In September 2025, the Presidential Decree prohibited the import, production, storage, distribution, and sale of 35 pesticides considered highly hazardous. New lists of prohibitions are expected for 2026 and 2027.
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