Outline of the system
Importation of enriched, fissile or radioactive materials and ionizing radiation generating sources. Supreme Decree No. 323 establishes the conditions and procedures governing the licensing of civilian entities to carry out activities related to enriched, fissile or radioactive materials and ionizing radiation generating sources. The importation of radioactive material, nuclear material or radiation generators may not take place without prior authorization granted by the Chilean Nuclear Energy Commission (CCHEN). Supreme Decree No. 133 of the Ministry of Health (Official Journal of 23 August 1984) approves regulations on authorizations for radioactive facilities or ionizing radiation generating equipment, personnel working in such facilities or operating such equipment and other related activities.
The import licence or authorization issued by the CCHEN covers: importation of radioactive material, importation of nuclear material, importation of equipment containing radioactive material and importation of equipment not containing radioactive material, but which generates radiation.
Nature of licensing
If Automatic, administrative purpose
If Non-Automatic, description of the notified Non-Automatic Licensing regime
Products under restriction as to the quantity or value of imports
The licensing procedure is not intended to restrict the quantity or value of imports.
Questions for products under restriction as to the quantity or value of imports
The system applies to products originating from which country?
Originating in and coming from all countries. Nuclear material is only imported from countries that have signed an agreement on safeguards with the International Atomic Energy Agency (IAEA).
Expected duration of licensing procedure
Is the licensing statutorily required?
The laws and regulations under which the licensing is maintained are as follows:
Law No. 16.319, Law No. 18.302;
Supreme Decree No. 323 of 1974 of the Ministry of the Economy;
Supreme Decree No. 133 of 1984 of the Ministry of Health;
Supreme Decree No. 12 of 1985 of the Ministry of Mining.
Licensing is statutorily required. The legislation clearly states which products are to be subjected to licensing. It is not possible for the Government to abolish the system without legislative approval.
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?
All authorized persons, firms and institutions are eligible to apply for import licences.
Is there a registration fee?
Is there a published list of authorized importers?
Contact point for information on eligibility
Submission of an application
Administrative body(ies) for submission of an application
What information is required in applications?
Information required in the application: Identity of exporter, identity of importer, identity of end users and characteristics of the goods.
Documents to be supplied with the application: Transport package certificate, radioactive material certificate, pro forma invoice.
(a) General information:
Information regarding the owner operator: name, tax identification number (RUT), address, municipality, telephone numbers, firm's email address, and name, RUT, email address and telephone number of the legal representative.
Information regarding the recipient operator: must be the owner operator, otherwise transfer authorization is required.
Information regarding the manufacturer or supplier: firm's name, address, telephone number.
Information regarding the intermediary: firm's name, email address, telephone number (where applicable).
Indicate facility of use: particle accelerators, irradiation facility, radiotherapy, high radiotoxicity laboratory, gammagraphy and industrial radiography, in accordance with Supreme Decree No. 133, Title 3, Article 7, first paragraph. Research, mining, laboratory, industrial or other.
Material to be imported: refers to sealed and unsealed radioactive material, nuclear material, and equipment containing radioactive material and generating ionizing radiation.
Mode of importation: single or annual (put frequency in annual).
Physical state of radioactive material or nuclear material (solid liquid gaseous).
(b) Technical information:
Radioactive material activity certificate (decay table): Verify the make, model and series or code, radionuclide, source activity and date.
For used sealed sources, the owner must provide a leak test certificate.
Material certificate (decay table): nuclear material, activity and date.
Make, model and series or code, for equipment with shielding of nuclear material or percentage of alloys.
Verify the country of origin, which must be under safeguards.
Weight of nuclear material (uranium, thorium or plutonium),
Equipment: may be equipment containing radioactive material or ionizing radiation generating equipment.
Equipment background, such as the operating manual or other document indicating the characteristics of the equipment, as follows:
Equipment containing radioactive material: make, model, series, nominal capacity in Bq or Ci and radioisotope.
Radiation generator: make, model, series and rated capacity in mA and kV.
For used equipment, the owner must indicate the length of use and report on the state of the equipment.
(ii)Pro forma invoice: These documents may also be called international quotation, purchase order or supplier's quotation. However, they must all contain the same information, and the following must be checked:
Radionuclide, activity and date of radioactive material or nuclear material.
Material to be imported: radioactive material nuclear material equipment containing radioactive material ionizing radiation generators
Physical state of radioactive material or nuclear material (solid liquid gaseous).
Verify manufacturer or supplier information.
(c) Owner operator: For the importation of any of the materials, the owner operator must comply with the following:
Importation of radioactive material: must have an authorized storage facility and authorized associated equipment, where applicable.
Importation of nuclear material: must have an authorized storage facility and verify that it is under safeguards control.
Importation of equipment containing radioactive material: must have an authorized storage facility.
Importation of radiation generating equipment: depends on the type of facility:
Medical area: The owner operator shall require authorization for the construction of the unit (shielded irradiation room).
Industrial area: The owner operator shall be required to indicate the storage location, which must be in a secure, locked location. (It should be noted that according to the conditions and requirements of the import authorization, the owner operator must request authorization to operate the equipment within 40 days of receipt. Alternatively, the owner operator may first apply for construction authorization to assess the calculation report, dose rates, operating conditions, among others, and subsequently apply for operating authorization).
(d) Intermediary: The firm that undertakes the import formalities, but which is not listed as the owner operator. If the firm transports the material, it must supply transport authorization.
(e) Distributors: The owner operator firm that imports and subsequently markets the material to one or more operators.
Must have an authorized storage facility.
Transfer authorization application. (Optional, it may also apply for transfer authorization once the material is in the authorized facility of the owner operator).
List of customers, stating to which firms it will distribute the material.
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?
Applications for a licence must be made 38 days prior to importation.
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 applications for a licence may be made.
Issuing the license
Can a licence be granted immediately on request?
A licence cannot be granted immediately.
Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence
Licences cannot be obtained within a shorter time limit.
Which administrative body is responsible for approving application of licences?
Consideration of licence applications is effected by a single administrative organ.
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?
Fees and other administrative charges
Is there any licensing fee or administrative charge?
What is the amount of the fee or charge?
Fees amount to 2.6 development units (UF).
Is there any deposit or advance payment required associated with the issue of licences?
Fees must be paid when the application is submitted.
Amount or rate?
Is it refundable?
In the event of refusal of the application, the fee will be refunded.
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?
An application for a licence is only refused on the grounds of failure to meet the requirements.
Are the reasons for any refusal given to applicants?
The refusal is based on a reasoned decision, of which the applicant is notified.
Have applicants a right of appeal in the event of refusal to issue a licence?
If an application is refused, the applicant has a right of appeal pursuant to Law No. 19.880.
If so, to what bodies and under what procedures?
Are there any limitations as to the period of year during which importation may be made?
What documents are required upon actual importation?
The following documents are required upon actual importation:
Transport package certificate
Radioactive material certificate
Pro forma invoice
Authorization to transport radioactive material
Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
Conditions of licensing
What is the period of validity of a licence? Can the validity be extended? How?
For single importation it is valid for a period of three months. For multiple importation it is valid for one year. No type of licence is renewable.
Is there any penalty for the non-utilization of a licence or a portion of a licence?
There is no penalty for the non utilization of a licence or a portion of a licence.
Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
Licences are not transferable between importers.
Is foreign exchange automatically provided by the banking authorities for goods to be imported?
Is a licence required as a condition to obtaining foreign exchange?
Is foreign exchange always available to cover licences issued?
What formalities must be fulfilled for obtaining the foreign exchange?