Reference source : SAG (Servicio Agrícola y Ganadero)
Chile’s Agricultural and Livestock Service (SAG) has published a draft resolution proposing significant amendments to the country’s pesticide regulatory framework, updating two rules dating back to 2014 and 2018. The proposal would modify Resolution No. 9,074 of 2018, which governs the authorisation of microbial pesticides, and Resolution No. 1,557 of 2014, which sets out general requirements for pesticide approval. According to SAG, the changes are intended to modernise the system, introduce new types of special authorisations and align Chile’s rules more closely with international regulatory practices.
One of the most substantial elements of the draft concerns microbial pesticides. SAG proposes to introduce additional authorisation pathways for both microorganisms used as active substances and formulated microbial products. These include approvals based on full identity schemes, authorisations for products identical to those already approved in Chile, and special authorisations based on recognition of registrations or active substance approvals granted in the United States or the European Union. The proposal also formally incorporates special authorisations for pesticides used in minor crops, organic agriculture, natural ecosystems, export-only products, analytical standards and experimental samples.The draft clarifies how products derived from microbial fermentation should be assessed, distinguishing between low-concern natural extracts and extracts of higher regulatory concern, and specifies which technical dossiers must be submitted in each case.
The proposal also updates Resolution No. 1,557 of 2014 to reflect regulatory developments introduced in recent years for semio-chemicals and low-concern natural extracts. New definitions would be added, including “active substance component” for semio-chemicals and “significant impurities”, defined as impurities present at levels equal to or above 1 g/kg. SAG says these changes are intended to harmonise terminology and assessment approaches across synthetic pesticides, natural products and biologically derived substances.
A central feature of the draft is the expansion and clarification of rules allowing Chile to recognise pesticide active substances authorised in the United States or the European Union. Under the proposal, applicants would need to demonstrate that both the active substance and the formulated product are manufactured or produced at the same sites authorised in those jurisdictions and are in use in at least one US state or EU member country. However, the draft makes clear that recognition is not automatic. If an active substance authorised abroad is subject to regulatory concern, prohibition or data insufficiency, SAG would retain the right to carry out a prior assessment and reject the application. Certain products, such as plant-incorporated protectants and genetically modified organisms, would be excluded from this recognition pathway.
The draft introduces new documentation requirements for products intended for export, including official certification from destination countries confirming authorisation or ongoing approval processes. Transport labelling requirements for microbial active substances are also expanded. In addition, the proposal updates technical data requirements, including new parameters such as corrosivity and other formulation-specific properties.
Reflecting Chile’s broader digital transformation of public administration, the draft formally incorporates the use of advanced electronic signatures in pesticide authorisation procedures. It sets out detailed rules for submitting digitally signed domestic documents and recognising electronic signatures and apostilled documents issued abroad. The changes are designed to improve traceability, legal certainty and administrative efficiency, while maintaining safeguards for public health, agriculture and the environment.
If adopted, the proposed amendments would enter into force on the date of their publication in Chile’s Official Gazette.
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