Ionising radiation

Registration

An organisation that implements practices included in Part B of Annex I to Joint Ministerial Decision 45872/2019 “Regulatory control procedures for ionising radiation practices – recognition of services and experts” (Government Gazette 1103/B/03.04.2019), as amended by Joint Ministerial Decision 32083/2022 (Government Gazette 1552/B/4 April 2022), is subject to regulatory control through the registration procedure.

The procedure for issuing a registration certificate comprises the following 3 steps:

Step 1

Submit an initial application with the organisation’s identification details, including the details of the person designated as the point of contact with the EEAE.

Step 2

Submission of the radiation protection supervisor’s details. You can find detailed information on the requirements and supporting documents needed for the “Accreditation of services and experts” here.

Step 3

Submission of the information and supporting documents, as described in detail below for each practice.

Specifically for:

Organisations implementing the practices referred to in points 1–4 of Part B of Annex I shall submit the following:

  • a list of the types or categories of practices applied,
  • list of names and radiation protection training records for exposed workersof the organisation participating in the practical training, as well as the details of those in charge of the organisational units (of the organisation) where the practical training takes place,
  • a feasibility licence, where required by Ministerial Decision ΔΥΓ2/Γ.Π.οικ154949 (B’ 1918/10 December 2010), as currently in force,
  • design characteristics of the facility and a detailed list of the radiation sources it possesses, including, where applicable, the certificates for the radioactive sources,
  • a radiation protection and safety report containing the following:
  1. expected occupational and public exposure levels and radiation protection measures,
  2. a programme for the maintenance, testing and regular inspection of equipment and, in general, operating conditions,
  3. definition of operational limits, dose constraints and operating conditions,
  4. a study of shielding,
  5. regarding the management of disused sources, a solemn declaration by the organisation’s legal representative, stating that the organisation undertakes all appropriate administrative and financial measures for the safe management of radioactive sources at the end of their useful life, which ensure the return of the radioactive sources to the overseas supplier or their dispatch to an authorised radioactive material management facility abroad,
  6. where radioactive sources are used, management of the radioactive waste generated, measures for the final disposal of such waste, accident analysis and emergency procedures.

It should be noted that, in the case of industrial radiography practices falling under point 3 of Part B of Annex I and carried out in populated areas, the organisation shall submit to the EEEA a plan for the implementation of these practices and radiation protection measures for members of the public.

For the registration of practices involving naturally occurring radioactive materials pursuant to point 5 of Part B of Annex I, the organisation shall submit:

  • a radiation protection and safety report containing:
    1. a detailed description of the activities and facilities involving naturally occurring radioactive materials,
    2. an assessment of the expected occupational exposure, including exposure to radon, and public exposure,
    3. an analysis of accidents and measures to minimise the exposures referred to in sub-case (bb) above in accordance with the principle of optimisation, including dose limits,
    4. a personal dosimetry programme (if required) and workplace monitoring
  • emergency procedures.
  • waste management procedures and procedures for the final disposal, recycling or reuse of naturally occurring radioactive materials.
  • procedures for the further management and detailed analysis of exposures or potential exposures in the event of the removal of naturally occurring radioactive materials from the premises where the practice involving naturally occurring radioactive materials, or where responsibility for the materials is transferred from the organisation to another natural or legal person.

In the case of the employment of external workers, the employer of the external workers shall submit the following:

  • a nominal list and details of radiation protection training for external workers,
  • establishment of dose limits (in collaboration with the organisation where the external workers are expected to be employed),
  • an individual dosimetry programme, if required, and individual protection measures.

For the registration of shipments of radioactive materials referred to in point 7 of Part B of Annex I, the organisation shall submit the following:

  • details of the consignor and the consignee,
  • the date and method of transport of the radioactive materials,
  • a description of the radioactive materials to be transported,
  • a description of the transport containers and documented evidence of compliance of the transport container design with the EEAE guidelines,
  • a transport quality assurance programme, including operating procedures for normal transport conditions and guidelines for emergency preparedness and response.

Following an assessment of the information and supporting documents submitted, and in the event of a positive assessment, the EEAE shall issue the organisation with a certificate of registration, valid for ten (10) years, unless specific reasons require a shorter duration. In the case of a single consignment of Type A columni, radioactive material of low specific activity and a superficially contaminated object, the registration certificate is valid only for that single consignment and the total period of validity shall not exceed threethree (3) months.

To renew the registration, the organisation shall submit the necessary supporting documents to the EEAE, in accordance with applicable practices, no later than three (3) months before the expiry date of the registration certificate.

Amendment of a registration certificate

In the event that the conditions under which the registration certificate was issued change, the organisation shall submit an application for amendment to the EEAE, which shall include the updated supporting documents and information.

The EEAE checks compliance with the Radiation Protection Regulations and, in the event of a positive assessment, issues the organisation with a new registration certificate, valid for the remainder of the previous registration certificate’s validity period. If an inspection is carried out when a new certificate of registration is issued, the validity period of the new certificate may be ten years.

In the event of a change in the organisation’s ownership status accompanied by a change in tax registration number, applications for amendment* of the registration certificate must be submitted by the new and the current holder, a statutory declaration by the new holder confirming that the conditions under which the registration certificate was granted to the previous organisation remain unchanged, as well as the articles of association of the new organisation. In addition, an official document must be submitted evidencing the aforementioned change (e.g. a certificate of cessation of operations, revocation of a licence by a medical or dental association, a notarial deed, etc.). The new certificate, issued with a validity period equal to the remaining validity of the previous one, shall contain the details of the new organisation.

In the event of a change to the organisation’s details relating to registration (without a change to the Tax Identification Number), the organisation must submit to the EEAE an application to amend the registration certificate with the updated details, accompanied by a certificate of changes from the General Commercial Registry (GEMI) or, in the case of a public organisation, from the Government Gazette.

In the event of the cessation of a practice subject to registration, or the cessation of operations of the organisation implementing practices subject to registration, the organisation shall notify the EEAE accordingly.

Submission of applications and supporting documents

You may contact the EEAE or submit applications and the required supporting documents by email to adeies@eeae.gr. The supporting documents submitted must be digitally signed.

The fees for the authorisation of ionising radiation practices subject to registration are set out in point (c) of paragraph A of the schedule of fees for services provided by the EEAE (you can view here the fee schedule).

*Sample text for an application for amendment. 
I request the amendment of No. ………. (Reference number of registration certificate) decision of the EEAE from the aforementioned organisation to the organisation …….. (name) with Tax Identification Number ……”