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Chile Moves Towards Recognising Pesticide Registrations Authorised in the EU and the United States

A regulatory opportunity for companies with plant protection products already authorised in reference markets

Chile has established a procedure that may, under specific conditions, recognise the assessment process of technical-grade active substances previously authorised by the US EPA or by the competent authorities of the European Union.

In addition, Chile’s Servicio Agrícola y Ganadero —SAG— has considered extending this approach to certain formulated products. Such a development could facilitate market access for plant protection products that have already undergone demanding regulatory assessments in recognised reference markets.

What does the current Chilean framework allow?

SAG Exempt Resolution No. 7,128/2022 introduced a specific procedure for requesting recognition of the registration or authorisation process of technical-grade active substances authorised in the United States or the European Union.

This system does not provide automatic authorisation, nor does it remove SAG’s assessment powers. However, it may allow part of the conventional dossier to be supported by official documentation issued by the relevant foreign regulatory authority.

Depending on where the authorisation was granted, this documentation may include:

Letters and certificates issued by the US EPA.
Official European approval documents.
Assessment or renewal reports.
Information concerning the identity, composition and manufacture of the active substance.
Evidence that the authorisation remains valid.

To use this route, the active substance and the submitted documentation must meet the conditions established under Chilean legislation.

The potential next step: recognition of formulated products

The possible extension of this system to formulated products is particularly relevant for companies already marketing pesticides in the European Union or the United States.

Should such a route be approved, eligible products might be able to rely on part of the assessment performed in their original market. This could reduce unnecessary duplication and improve the planning of registration projects in Chile.

Nevertheless, applicants would need to demonstrate a clear correspondence between the product submitted in Chile and the product authorised in the reference market. The assessment could include aspects such as:

Qualitative and quantitative composition.
Manufacturer and manufacturing origin.
Authorisation status of the active substance.
Co-formulants included in the formulation.
The procedure under which the original authorisation was granted.
Available studies, certificates and regulatory assessment reports.
Information required for the label and safety data sheet.

An EU or US authorisation may therefore provide an important advantage, but it does not automatically guarantee that a product will be eligible for registration in Chile.

Which companies could benefit?

This route may be particularly relevant for:

European or US manufacturers planning to enter Chile.
Companies with active substances already authorised by the US EPA or in the EU.
Authorisation holders whose formulated products are supported by complete dossiers.
Chilean distributors seeking to introduce international products.
Companies planning to expand their presence in Latin America.

The opportunity must be assessed individually for each product. A preliminary review can identify potential obstacles before the application begins and prevent resources from being invested in an unsuitable regulatory strategy.

How to prepare for pesticide registration in Chile

Interested companies can begin by reviewing their portfolios and classifying products according to their potential eligibility.

The first steps should include:

Confirming that the authorisation of the active substance or formulated product remains valid.
Identifying the procedure under which the authorisation was granted.
Comparing the authorised formulation with the formulation intended for Chile.
Checking the availability of assessment reports and official certificates.
Analysing potential differences in composition, manufacturing origin or co-formulants.
Defining the regulatory strategy before preparing the dossier.

This initial assessment helps determine whether the recognition procedure may be applicable and what additional documentation could be required.

Turn an existing authorisation into a market opportunity

Chile may offer an attractive opportunity for companies whose plant protection products have already been assessed in the European Union or the United States. However, taking advantage of this potential route requires a correct interpretation of the regulatory framework, a detailed eligibility assessment and consistent, traceable documentation.

At Sun Chemicals Services, we support you throughout the entire process of entering the Chilean market. We assess the regulatory feasibility of your active substances and formulated products, review the available documentation, identify potential obstacles before the dossier is submitted, and define the most efficient registration strategy for each product.

Our objective is to help you reduce risks, avoid unnecessary delays, and make the most of the regulatory assessments previously obtained in the European Union or the United States.