Authorisation to hold, use or transport radioactive sources or X-ray devices

In order to protect the population against the dangers of ionising radiation and to ensure maximum protection for human health and the environment from radioactive sources, certain professional and/or commercial activities that involve the purchase, holding, use or transport of radioactive sources or X-ray equipment require an authorisation.

The businesses concerned are divided into 4 classes (I, II, III and IV). The classification is based on the specificities of radioactive material as well as on the importance of potential operational risks in the establishment concerned.

The need to apply for an authorisation and the conditions to be met depend on the criteria defined for each class of material.

Depending on the class of the business concerned, the competent authorities who grant the authorisation are the Government in council, the Minister of Health or the Director of Health.

Who is concerned

Establishments or businesses must hold an authorisation for:

  • the production, manufacture, storage, offer for sale, sale, the transfer in return for payment or free of charge of substances, appliances or installations capable of emitting ionising radiation, the transit, transport, import, export, use for commercial, industrial, scientific, medical or other purposes, for recycling and re-use of appliances, installations or substances capable of emitting ionising radiation;
  • the treatment, handling, storage, elimination and evacuation of radioactive substances and waste;
  • any other activity or practice that involves a risk due to ionising radiation emanating either from an artificial source, or from a natural source of radiation where natural radionuclides are or have been processed, due to their radioactive, fissile or fertile properties;
  • the use of electrical appliances that emit ionising radiation with elements operating with a difference in potential in excess of 5 kV;
  • professional activities that are not covered by any of the aforementioned activities, but which involve the presence of natural sources of radiation resulting in a significant increase in exposure for workers or the public, which must be taken into consideration in terms of radiation protection;
  • any intervention in a radiological emergency situation or long-term exposure resulting from a radiological emergency situation or from exercising a past or former professional activity.

The establishments concerned are generally of the following type:

  • medical (e.g. hospitals, veterinary clinics, with diagnostic and/or therapeutic radiology devices);
  • industrial (e.g. use of non-destructive testing equipment);
  • scientific (e.g. research laboratories using radioactive tracers);
  • administrative (e.g. baggage inspection);
  • military (e.g. tanks with depleted uranium armour).

Prerequisites

In order to prepare the application, the establishment or business concerned must compile and verify certain elements. In general it must:

  • have personnel with appropriate training and skills in the areas of radiation protection and nuclear engineering. These persons must have documented qualifications (for transporting dangerous goods by road, see the website of the Department of Transport of the Ministry of Sustainable Development and Infrastructure);
  • have third-party liability insurance covering the use of sources of ionising radiation and a written declaration from the supplier of the radioactive source committing him to take back the source when it is no longer in use.
It is recommended for each establishment planning to purchase a source of radiation to contact the Radiation Protection Division during the purchase programming phase.

How to proceed

Preparing the application

The information to be provided for an authorisation will vary depending on the type of radiation equipment, such as x-ray devices, sealed radioactive sources, open radioactive sources and high-activity sealed sources.

The various pieces of information required for a holding permit are:

  • a plan of the installations and premises containing the radioactive sources and those located less than 20 metres from these sources;
  • a map of the location and the characteristics (demography, seismology, hydrology, etc.) of the site with a 25 km radius for a class I establishment and an extract from the land register with a 100 metres radius for a class II establishment;
  • the proposed means and measures for management, purification and disposal of radioactive waste;
  • for establishments of class I or II: a safety report with the worst case scenarios that could happen and the solutions to prevent them from happening, such as defined by Grand-Ducal regulation.

For the information to be provided in the application, please refer to the Grand-ducal regulation of 21 July 2006 amending the Grand-ducal regulation of 14 December 2000 concerning protection of the population against the dangers of ionising radiation.

The administration can request additional information if they deem necessary.

Authorisation for establishments holding radioactive substances

For each class (I, II and III) there is an authorisation procedure. Class IV is exempt from any authorisation requirements but may require a declaration to the Radiation Protection Division (division de la radioprotection), depending on the type of material used during the acquisition phase.

For classes I, II and III, the authorisation procedure extends over a variable period of time that is depending on the highest class and the accuracy of the elements in the dossier. Authorisation may be refused if the use of a radioactive source is not justified for the activity concerned.

 

Where to send the application

Authority for administrative follow-up of the application

Authority granting the authorisation

Class I

Minister of Health (5 copies, 3 copies for neighbouring communes)

Director of Health

Government in council

Class II

Minister of Health (3 copies, 1 copy for neighbouring communes)

Director of Health

Minister of Health

Class III

Director of Health (2 copies)

Director of Health

Director of Health

The authorisation is notified to the parties involved in the application procedure. It takes the form of an authorisation order granted by the competent authority, defining the various conditions and procedures that are to be respected for traceability and safety purposes.

The protection measures and installations of establishments holding material in classes I, II and III are inspected for acceptance by the Radiation Protection Division.

The head of the establishment must notify the Director of Health of any extension or modification in the building associated with the radioactive material.

Any cessation of activity must be declared to the authority that granted the authorisation and which will define the health protection measures that shall ensure the management, disposal or re-use of the sources of radiation.

Operational obligations for the director of the establishment

Business directors are responsible for the assessment and application of the provisions in force relating to radiation protection of exposed workers and to implement the necessary measures in and around the establishment so as to optimise radiation protection, whatever the working conditions.

The Radiation Protection Division has developed 3 guides which enable the business directors to efficiently structure their responsibilities:

  • a guide for the assessment and identification of radiation risks in terms of type and magnitude;
  • a guide to set up radiation protection procedures, and;
  • a guide and advice for internal action plans with regard to radiation accidents.

The establishment must keep registers of all sources of highly radioactive substances under its responsibility, also mentioning their location and shipment. The radionuclides concerned must be recorded in these registers as well as the activity when first placed on the market or when the establishment acquired the source, as well as the type of source.

Authorisation for the transport of radioactive substances

The transport of radioactive material must comply with the provisions of the international conventions and regulations in force governing the transport of dangerous goods (for dangerous goods transported by road, see the website of the Department of Transport.

Transport authorisations must be sent in duplicate to the Minister of Health, who will instruct the Director of Health with the administrative follow-up of the application. For the information to be provided in the application, please refer to the Grand-ducal regulation of 21 July 2006 amending the Grand-ducal regulation of 14 December 2000 concerning protection of the population against the dangers of ionising radiation.

Transporters holding a general authorisation must inform the Director of Health every 3 months at the latest of any transport of radioactive substances during the past period, mentioning the date and address of any delivery, the nature and quantity of the materials transported, the precautions taken, and any incidents that occurred during transport.

Transport authorisations for radioactive material granted by Belgium or the Netherlands and which also concern Luxembourg, may be deemed valid (without further administrative formality) if they comply with the regulations in force, with the exception however of radioactive waste from nuclear plants.

A register concerning the transport of radioactive material must be kept available for the staff of the Director of Health.

Transport of radioactive material between European Community Member States is subject to a declaration.

Radioactive material transport authorisations are granted for a limited period of time only.

Costs and deadlines

The table below gives indicative time frames for each stage of the authorisation procedure with regard to the holding or transport of radioactive material.

The procedures may take more time depending on the calendar days.

Steps

Holding

Transport

Class I

Class II

Class III

Class I, II and III

Acknowledgement of receipt of the application

15 days

15 days

15 days

15 days

Transmission of the application to the administrations and organisations concerned for an opinion

Not specified

15 days

15 days

Not specified

Return of dossier with collected remarks

6 months

(12 months if remarks from foreign organisations)

45 days

(3 months if remarks from foreign organisations)

30 days

(2 months if remarks from foreign organisations)

30 days

(3 months if remarks from foreign organisations)

Posting of the application in the communes

At the latest 10 days after receipt and for a period of 15 days

At the latest 10 days after receipt and for a period of 15 days

Not applicable

Not applicable

Transmission of opinions following posting

45 days after receipt

45 days after receipt

Not applicable

Not applicable

Drafting of the order

2 months

15 days

15 days

15 days

Posting of the authorisation in the communes concerned (*)

40 days

40 days

Not applicable

Not applicable

(*) the authorisation will also be posted on the operating site for a class I establishment

The establishment is responsible for:

  • publication costs;

  • the cost for assessments concerning the investigation of the application and the verification of establishments;

  • the cost for acceptance and inspection of establishments;

  • the cost for investigation and analysis relating to an accident or an incident associated with the business.

Validity of the authorisation

Authorisations may be granted with no limitation on their duration or for a specified period. After 10 years of use, the sources must undergo a leak test, to be repeated every two years, and records kept available for the Radiation Protection Division.

The authorisation expires if:

  • the establishment is closed;
  • the establishment specifically waives the authorisation;
  • the validity of the authorisation expires;
  • the liability insurance has expired and is not renewed by its holder.

Forms / Online services

Autorisation de transiter des substances radioactives au Luxembourg

Les informations qui vous concernent recueillies sur ce formulaire font l’objet d’un traitement par l’administration concernée afin de mener à bien votre demande.

Ces informations sont conservées pour la durée nécessaire par l’administration à la réalisation de la finalité du traitement

Les destinataires de vos données sont les administrations compétentes dans le cadre du traitement de votre demande. Veuillez-vous adresser à l’administration concernée par votre demande pour connaître les destinataires des données figurant sur ce formulaire. Conformément au règlement (UE) 2016/679 relatif à la protection des personnes physiques à l'égard du traitement des données à caractère personnel et à la libre circulation de ces données, vous bénéficiez d’un droit d’accès, de rectification et le cas échéant d’effacement des informations vous concernant. Vous disposez également du droit de retirer votre consentement à tout moment.

En outre et excepté le cas où le traitement de vos données présente un caractère obligatoire, vous pouvez, pour des motifs légitimes, vous y opposer.

Si vous souhaitez exercer ces droits et/ou obtenir communication de vos informations, veuillez-vous adresser à l’administration concernée suivant les coordonnées indiquées dans le formulaire. Vous avez également la possibilité d’introduire une réclamation auprès de la Commission nationale pour la protection des données ayant son siège à 1 Avenue du Rock'n'Roll, L-4361 Esch-sur-Alzette.

En poursuivant votre démarche, vous acceptez que vos données personnelles soient traitées dans le cadre de votre demande.

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