Last update 22.10.2019
To protect the population against the dangers of ionising radiation and to safeguard human health and the environment from radioactive sources to the greatest extent possible, certain professional and/or commercial activities that involve acquiring, holding, using or transporting radioactive materials or X-ray equipment are subject to prior authorisation.
The establishments concerned are divided into 4 classes (I, II, III and IV). The classification is based on the specific nature of the radioactive materials in question, and the potential risks involved in using them.
The requirement to apply for authorisation, and the conditions to be satisfied, depend on the criteria defined for each class of material.
Under the terms of the transition period that has been put in place: permits issued under the former legislation shall remain valid until their expiry date. Permits with no expiry date shall be valid until 1 August 2022.
Who is concerned
Class I, II and III establishments must hold a permit.
Establishments are categorised as Class I if:
- they use one or more particle accelerators whose operation requires a non-negligible degree of organisation in terms of the management of radioactive waste or radionuclide production, or if they manufacture such accelerators;
- they use X-ray generators producing energies in excess of 1 megaelectronvolt for industrial sterilisation purposes;
- they use or store radioactive nuclides whose activity, for at least one individual source, is greater than the D-value by a factor of 1000;
- they produce radioactive substances or manufacture radioactive sources for sale;
- they treat and condition radioactive waste;
- they use accelerators or sealed radioactive sources for the purpose of external radiotherapy or brachytherapy.
Establishments are categorised as Class II if:
- they use or store radionuclides and the activity of an individual source or substance is greater than or equal to 1000 times the exemption value;
- they perform industrial radiography, unless they use equipment operated from a purpose-designed booth;
- they collect and temporarily store radioactive waste;
- they have one or more facilities where:
- fissile materials are used or stored;
- radiation exposure is used for medical purposes, with the exception of dental X-ray equipment without 3D imaging capabilities;
- X-ray machines or any other electron accelerator device is used, whose components operate with a potential difference greater than 300 kilovolts (kV);
- radioactive substances are intentionally added for the purpose of producing and manufacturing consumer products, medicine and medical devices, and the importation of such products;
- human beings are exposed to radiation for non-medical imaging purposes;
- particle accelerators and neutron-generating electrical devices are present.
Establishments are categorised as Class III if:
- they use or store significant quantities of radionuclides and the activity of any individual source or substance is:
- equal to the exemption value; or
- between 1 and 1000 times the exemption value;
- they use X-ray machines or any other electron accelerating device whose components operate with a potential difference that is less than or equal to 300 kV, with the exception of electrical devices operating at a potential difference that is less than or equal to 30 kV, provided that, during normal operation, the do not generate a dose rate greater than 0.5 microsieverts per hour at any point within 0.1 metres of their accessible surface;
- they use or store naturally radioactive substances whose activity concentration is greater than or equal to 100 becquerels per gram. This concentration corresponds to parent nuclides in equilibrium with the daughter nuclides;
- they use dental X-ray machines without 3D imaging capabilities.
Establishments are categorised as Class IV if:
- they use or store significant quantities of radionuclides, and the activity of any individual source or substance is less than the exemption value, but exceeds 1/100 of the exemption value;
- they use of store naturally radioactive substances whose activity concentration is between 1 and 100 becquerels per gram. This concentration corresponds to parent nuclides in equilibrium with the daughter nuclides.
The establishments in question are generally of the following types:
- medical (e.g. hospitals and veterinary clinics that operate devices used for radiodiagnosis and/or radiotherapy purposes);
- industrial (e.g. that operate devices for non-destructive testing purposes);
- scientific (e.g. research laboratories that use radioactive tracers);
- administrative (e.g. baggage checks);
- military (e.g. that operate tanks fitted with depleted uranium armour).
Human activities involving the use of materials contaminated by radioactivity from authorised emissions or liberated materials are exempt from the requirement to obtain a permit and notify the relevant authorities.
Any establishment engaging in a justified practice which belongs to Class III or IV may be exempted from the requirement to obtain a permit and/or notify the relevant authorities by ministerial decision, if:
- the practice entails a very limited risk of human exposure and does not require case-by-case assessment;
- it has been established that the effective annual dose received by a member of the public is less than 10 microsieverts;
- the practice does not involve medical exposure.
If the establishment's activity does not belong to any of classes I to IV, then the establishment is automatically exempted from the requirement to obtain a permit and notify the relevant authorities.
All establishments are advised to consult with the Radiation Protection Division (Division de la Radioprotection) prior to acquiring any source of radiation.
Class I, II and III establishments must obtain their permit prior to acquiring, holding or using radioactive sources.
Class IV establishments must notify the Health Directorate (Direction de la santé) of their practices at least 15 days before engaging in them.
To obtain and keep their permit, the establishments must pay a fee before 1 June each year.
The fee amounts to:
- EUR 1,000 for Class I establishments;
- EUR 500 for Class II establishments; or
- EUR 200 for Class III establishments.
The fee is to be paid by direct deposit or wire transfer to the account held by the Registration Duties, Estates and VAT Authority (Administration de l’enregistrement, des domaines et de la TVA). When making the payment, the applicant must specify their identity and the purpose of the deposit or transfer (the reference is sent to permit holders by post at the start of the year).
Account holder: Administration de l’enregistrement, des domaines et de la TVA
Account number: IBAN LU13 1111 0011 4679 0000 (Swift code: CCPLLULL)
Proof of payment must be sent to the National Health Directorate.
The establishment is also required to pay:
- any assessment fees incurred for the purpose of processing the application and auditing the establishment, if the National Health Directorate decides to enlist the help of an outside expert to assess the permit application;
- any costs incurred for the acceptance and the inspection of the establishment;
- any costs incurred for the purpose of conducting assessments and analyses in connection with an operational accident or incident;
- any costs incurred in connection with the discontinuation of a practice.
How to proceed
Filing an application
For each class I, II and III, there is a corresponding application procedure of varying length.
For Class I and II establishments
The permit application must be filed with the Ministry of Health. The application will be handled administratively by the Director for Health.
For Class III establishments
The permit application must be filed with the National Health Directorate.
For Class IV establishments
Class IV establishments are exempted from the requirement to apply for a permit, but are nevertheless required to notify the National Health Directorate of any listed practices at least 15 days prior to commencing said practices.
Class IV establishments are not required to apply for a permit: they merely need to notify the National Health Directorate of the existence of the establishment and any listed practices within 15 days of commencing operations.
When an establishment engages in practices which qualify it for 2 or more classes, it is held to belong to the highest-ranked class.
Supporting documents and information to be disclosed
It should be noted that, if it deems it relevant, the National Health Directorate can request further information and/or additional documents to process the application.
Documents and information for Class I, II and III establishments
The information required for a permit application is as follows:
- the company or business name, and its corporate, administrative and operational headquarters;
- the nature and purpose of the establishment;
- the nature, characteristics and intensity of the radiation emitted;
- the specifications of the devices, equipment and installations used;
- the physical and chemical state and quantity of the radioactive substances in question;
- the intended use of the devices, equipment, installations or substances;
- the site where the devices, equipment, installations or substances will be produced, stored or used;
- a risk analysis report, describing:
- workforce and public exposure in the course of normal operations;
- the applicable dose constraints;
- the protective or security measures recommended for the devices, equipment, installations, substances and sites;
- how the radioactive sources are processed once they have been decommissioned or become unusable;
- a written commitment provided by the supplier of the radioactive source, or any other specialised establishment, to recover the radioactive source once it has been decommissioned;
- the first name, surname, contact details and radioprotection qualifications of the person in charge of radioprotection and, where applicable, their deputy;
- the radioprotection qualifications of the staff in charge of the production, distribution, use, maintenance or monitoring of the substances and the devices capable of producing ionising radiation;
- the anticipated number of persons liable to be exposed to radiation from the source in the course of their professional duties;
- the draft civil liability insurance policy, notably covering:
- the use of ionising radiation sources;
- in the case of high-activity sources: the risks linked to safe management and recycling of the sources in the event of their decommissioning, including in the event of insolvency or cessation of the establishment;
- the number/identifier of the land registry parcel on which the equipment is being used, along with a map of the installations and the premises where they are located. This map must also show all premises situated within a radius of less than 20 metres from the premises containing the radioactive sources, as well as the purpose of such premises;
- the proposed measures for managing and evacuating any radioactive waste, including waste produced during the operation and decommissioning of the installation, and notably:
- an agreement in principle given by a radioactive waste management centre, attesting that the centre is capable of handling the type and quantity of waste in question;
- detailed studies showing that, for the intended practice, radioactive waste production is at the lowest level that it is reasonably possible to achieve in terms both of activity and volume;
- details regarding the different categories of waste and, for each category, the maximum volume and weight of waste or products to be evacuated, warehoused or transported, per month and per year;
- the nature and concentration of the radioactive substances contained in the different categories of waste or in the products to be evacuated, warehoused or transported, as well as their level of radioactivity, radiotoxicity and critical mass, and an estimation of the amount of heat released during the time that they are stored;
- details regarding the treatment and on-site conditioning of any solid waste.
Further information and documents for Class I and II establishment
For Class I and II establishments, the following are also required:
- extracts from the internal intervention plan for dealing with different types of radiological emergency situations;
- the assessment of a radioprotection expert, or of the person in charge of radioprotection, if that person satisfies the conditions enabling them to provide the establishment with advice in radioprotection matters;
- for facilities that manage radioactive waste:
- a demonstration of the safety measures covering the commissioning, operation, dismantling and, where applicable, closure and post-closure decommissioning, of any permanent storage facilities;
- integrated management systems, including a quality guarantee in which the safety of the entire radioactive waste management process is appropriately prioritised;
- a demonstration of adequate financial and human resources.
Class I establishments, as well as Class II establishments that handle high activity sources, are also required to include a risk assessment report describing:
- the mechanisms that could lead to accidental or unintentional exposure;
- insofar as possible, an assessment of the likelihood and degree of accidental/unintentional exposure;
- an assessment of the quality and scope of physical protection and radioprotection measures.
Required documents and information for Class IV establishments:
Notification of a practice by Class IV establishments must be accompanied by the following supporting documents and information:
- the company or business name, and its corporate, administrative and operational headquarters;
- a certificate specifying the characteristics of the radiation source;
- a declaration of what is done with the radiation source once it has been used;
- the first name, surname and contact details of the person in charge of managing the radiation source.
Application processing time
Note that if documents are missing from the application, the acknowledgement of receipt sent to the applicant will specify a deadline for providing them.
Processing times are given in calendar days.
For Class I establishments
The Director of the National Health Directorate will acknowledge receipt of the file as soon as possible, before forwarding it to the communal authorities of any communes whose boundaries are within 200 metres of the radiation source.
If required by the information disclosed, the National Health Directorate may pass the file on to external experts for their opinion. In that case, the fees incurred are borne by the applicant.
The file is then passed to the communal authorities of the affected communes, who must, within 10 days of receiving it, display it for 15 days in their town halls and on the site of the future establishment. The file may be viewed by all interested parties.
Once the display period has expired, observations are recorded and a report drawn up.
The entire file is sent back to the National Health Directorate no later than 45 days after the application is received.
Thereafter, within 15 days, and based on the advice of the National Health Directorate, the Minister of Health will return a decision setting the conditions for granting the permit.
The Minister of Health's reasoned decision will then be forwarded to:
- the applicant;
- the mayors of the communes in which the file was displayed for public viewing;
- the Inspectorate of Labour and Mines.
Anyone who had submitted their observations will also be informed of the decision by registered letter.
The Minister of Health's decision must be published for public viewing in the town hall concerned for a period of 40 days.
For Class II or III establishments
The reasoned decision returned by the Minister of Health (Class II) or by the National Health Directorate (Class III) will be forwarded to:
- the applicant;
- the Inspectorate of Labour and Mines.
Validity of the permit
Permits for Class I, Class II and Class III establishments are granted for at least one year and no more than 10 years.
The permit will be deemed invalid if:
- the establishment is closed;
- the establishment specifically foregoes the permit;
- the permit expires;
- the practice is no longer covered by civil liability insurance;
- the fee has not been paid;
- the conditions for obtaining the permit have not been satisfied (permits may specify certain conditions, such as: liabilities, minimum level of training for staff, minimum criteria concerning the source's performance, work procedures that must be observed, requirements applicable to emergency procedures and communications, maintenance of equipment, etc.).
It should be noted that permits will be denied if there is no justification for the use of a radioactive source as part of the activity.
An establishment's permit will be suspended or revoked by the Minister, either in full or in part, if the establishment:
- cannot guarantee the independence of the radioprotection expert engaged to assess the production and operational services;
- fails to appoint a person in charge of radioprotection, does not provide that officer with the necessary resources to carry out their duties, or appoints a person to the role who does not have the requisite training;
- allows people to work within the exposure zone who do not have the requisite training;
- fails to ensure that the workers in question are provided with the necessary information;
- fails to satisfy one or more of the conditions for obtaining the permit;
- eliminates, recycles or reuses radioactive substances without the proper authorisation;
- fails to consult a radioprotection expert on matters regarding:
- the assessment and inspection of protective devices and measuring instruments;
- prior critical assessment of installation plans;
- acceptance testing;
- periodic checks of the effectiveness of protective devices and techniques;
- the periodic calibration of measuring instruments and periodic checks to ensure that they are working properly and being used correctly;
- fails to comply with all legal and regulatory obligations;
- has not taken optimisation measures.
However, before suspending or revoking their permit, the Minister will grant the establishment a grace period – of no more than 6 months – to comply with the legal requirements.
The total duration of the suspension measures may not exceed 2 years. The suspension will be lifted when the shortcoming has been rectified. However, if the shortcoming has not been rectified within the grace period granted by the Minister, the permit will be revoked.
It must be noted that if the permit is granted to implement a number of practices, the suspension or partial revocation will apply only to those practices which are not implemented in accordance with the law.
Renewal of the permit
Permit renewal applications must be sent:
- by registered mail, if no elements of the practice have changed;
- on a new application, if the application involves new elements.
If the permit is denied, suspended or revoked, an administrative appeal may be lodged against the decree within 3 months of notification thereof.
Once the permit has been issued, any new or modified practices authorised by that permit may only be implemented after:
- the establishment has had an appropriate acceptance test performed on the radiation sources and the facilities;
- the National Health Directorate has been informed that the results of the acceptance test are compliant.
The establishment must keep registers of all highly radioactive sources under its responsibility. Such registers must also mention the location and, where applicable, all transfers of such sources.
In particular, the information recorded in these registers must include:
- the nature of the radionuclides in question;
- the activity at the time when the product was first released onto the market, or when the establishment acquired the radioactive source;
- the type of source.
Any establishment which sells, transfers, distributes, installs, transforms or transports a device or material that is likely to emit ionising radiation must ensure that the receiving party has complied with the applicable regulatory provisions regarding the storage, use or transformation of the device or material in question.
Any establishment that implements practices without prior authorisation may be charged with a criminal offence.
Alteration of the object of the permit / cessation of activity
Any plans to modify the object of the permit must be submitted for authorisation in accordance with the application procedure for the class to which the establishment will belong after the said modification.
If the National Health Directorate judges that the modification does not increase the risk level, it may authorise it under the Class III permit scheme.
Any cessation of activity must be reported to the National Health Directorate. The establishment is responsible for arranging the removal or reuse of the radiation sources, and for ensuring that the facility and site are free of contamination.