Basic information
Outline of the system
The importation of genetically modified propagation material is regulated by Resolution No. 1.523 of 2001, which establishes rules for the entry and introduction into the environment of living modified plant propagation organisms in a confined manner.
Materials entering Chile are classified as follows:
- Materials "with a history" of being released into the country.
- Materials "with no history" of being released into the country.
It should be noted that genetically modified materials "with a history" of being released may be subject to the provisions of Article 9 of Resolution No. 1.523 of 2001, which indicates that biosecurity measures may be partially or totally waived if they have been waived in the country of origin of the modified organism; if the latter has completed periods of biosecurity crop quarantine in Chile and the national background is suitable for adopting such a decision; and provided that the risk analysis allows the adoption of the decision, without prejudice to the possibility of re-establishing biosecurity measures if supervening circumstances so require. The above shall not apply when Chile is a place of origin of the species to which the modified organism belongs.
Within these two classifications (with a history and with no history), the Service has established the following categories:
- Materials without delegated responsibility (SRD).
- Materials with delegated responsibility (CRD).
Product coverage
The licence is intended for living modified plant propagation organisms.
Nature of licensing
Automatic
If Automatic, administrative purpose
Non-Automatic
If Non-Automatic, description of the notified Non-Automatic Licensing regime
Products under restriction as to the quantity or value of imports
The licence is intended to serve as an authorization procedure for the introduction into the environment of genetically modified propagation material in a confined manner, based on a case by case risk analysis process that makes it possible to conclude that the introduction of the material will have no adverse effects on the environment.
Questions for products under restriction as to the quantity or value of imports
Not applicable.
The system applies to products originating from which country?
The system applies to all goods entering the country, irrespective of their origin.
Expected duration of licensing procedure
Legal requirements
Is the licensing statutorily required?
The laws and regulations under which the licensing is maintained are:
- Exempt Resolution No. 1.523 of 2001, which establishes rules for the entry and introduction into the environment of living modified plant propagation organisms in a confined manner.
- Resolution No. 6.183 of 2018, which establishes standard time frames for the entry and introduction into the environment of living modified plant propagation organisms in a confined manner.
- Resolution No. 3.928 of 2015, which creates a technical committee on genetically modified organisms.
- Information and submission: SAG Agricultural Protection Division (Av. Bulnes 140, piso 3, Santiago) or at the relevant SAG sectoral office.
Does the legislation leave designation of products to be subject to licensing to administrative discretion?
Is it possible for the government to abolish the system without legislative approval?
Eligibility of applicants
Is there a system of registration of persons or firms permitted to engage in importation?
What persons or firms are eligible to apply for a licence?
Eligibility is granted to natural or legal persons working in the seed sector, biotechnology developers, research centres and universities that are registered in the GMO Seed Authorization Portal (https://ovvm.sag.gob.cl/empresaadd.asp).
Is there a registration fee?
Is there a published list of authorized importers?
Contact point for information on eligibility
Ministry/Authority
Address
Telephone
Fax
E-mail address
Website
Contact officer
Submission of an application
Administrative body(ies) for submission of an application
Documentation requirements
What information is required in applications?
To request authorization to import genetically modified propagation material, the user must submit to the SAG:
1. The importation request form generated by the GMO Seed Authorization System.
2. Depending on the characteristics of the material to be imported, the complementary information form will be:
(a) With no history:
(i) Importation request form for transgenic plant material for propagation (must be submitted through the GMO Seed Authorization System, available at https://ovvm.sag.gob.cl/empresaadd.asp).
(ii) C5- Incorporation of maintenance event in the GMO Seed Authorization System (F-PA-VIB-BIO-002).
(iii) Supplementary information for evaluating the release into the environment of a genetically modified plant without prior authorization (F-PA-VIB-BIO-001).
(iv) Extract of request for publication in the Official Journal (F-PA-VIB-BIO-004).
*The forms in points 2, 3 and 4 can be found at https://www.sag.gob.cl/ambitos-de-accion/importacion-de-organismos-veget...
(b) With a history:
(i) Importation request form for transgenic plant material for propagation (must be submitted through the GMO Seed Authorization System).
(ii) User guide to generate the importation request form.
The forms in points 2 and 3 can be found at https://www.sag.gob.cl/ambitos-de-accion/importacion-de-organismos-veget...
What documents is the importer required to supply with the application?
Window of submission of an application
How far in advance of importation must application for a licence be made?
Are there any limitations as to the period of the year during which application for licence can be made? If so, explain
There are no limitations as to the period of the year during which the licence may be requested.
Issuing the license
Can a licence be granted immediately on request?
It is not possible for a licence to be granted immediately.
Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence
Given that the process involves the consideration of a series of prior reports, the authorization procedure for the confined sowing of GMOs takes 45 working days for modified organisms the entry of which is requested for the first time, and 20 working days if entry has previously been requested.
Which administrative body is responsible for approving application of licences?
Licence applications are considered only by the Agriculture and Livestock Service.
Must the applications be passed on to other organs for visa, note or approval?
Are there any other conditions attached to the issue of a licence?
The importation of modified plant material for propagation must also comply with the phytosanitary requirements established by the SAG in each case.
Fees and other administrative charges
Is there any licensing fee or administrative charge?
For the evaluation and background check:
- Applications for genetically modified propagation materials without prior authorization: 33.6 standard hours (one standard hour is equivalent to 0.5 monthly tax units (UTM), in accordance with Decree-Law No. 142 of 1990).
- Applications for genetically modified propagation materials authorized in previous cases: 7.8 standard hours (one standard hour is equivalent to 0.5 UTM, in accordance with Decree Law No. 142 of 1990).
What is the amount of the fee or charge?
Is there any deposit or advance payment required associated with the issue of licences?
There are no additional charges to the one mentioned in point 33.
Amount or rate?
Is it refundable?
What is the period of retention?
What is the purpose of this requirement?
Refusal of an application
Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria?
The application may be refused if the SAG determines that the entry of GMOs could pose a risk to the environment.
Are the reasons for any refusal given to applicants?
Have applicants a right of appeal in the event of refusal to issue a licence?
If so, to what bodies and under what procedures?
Importation
Are there any limitations as to the period of year during which importation may be made?
What documents are required upon actual importation?
Actual importation requires:
- Paying the evaluation and background check fee.
- In the case of modified material that is being imported for the first time, publishing an extract of the application submitted to the SAG in the Official Journal, subject to the authorization of the SAG.
- Having a history of previous releases in other countries, if new material is to be imported.
- In the case of material developed abroad, identifying the person legally and technically responsible (experienced professional designated by the company who is familiar with the subject).
Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
Not applicable.
Conditions of licensing
What is the period of validity of a licence? Can the validity be extended? How?
The application makes it possible to obtain:
- A decision issued on a case-by-case basis, authorizing importation until 31 December of the same calendar year. In duly justified cases, it is possible to request an extension of the deadline.
- A decision on release into the environment that establishes the biosecurity measures (pursuant to Resolution No. 1.523/2001) with which the GMO must comply in each case. This decision may be valid for more than one season.
Is there any penalty for the non-utilization of a licence or a portion of a licence?
Not applicable.
Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
Licences are not transferable between importers, given that their issue is based on a case by case risk analysis process.
Foreign Exchange
Is foreign exchange automatically provided by the banking authorities for goods to be imported?
Not applicable.
Is a licence required as a condition to obtaining foreign exchange?
Not applicable.
Is foreign exchange always available to cover licences issued?
Not applicable.
What formalities must be fulfilled for obtaining the foreign exchange?
Not applicable.