Control of high-activity sealed radioactive sources and orphan sources

Control of high-activity sealed radioactive sources and orphan sources

Outline of the Community (European Union) legislation about Control of high-activity sealed radioactive sources and orphan sources


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Control of high-activity sealed radioactive sources and orphan sources

Document or Iniciative

Council Directive 2003/122/Euratom of 22 December 2003 on the control of high-activity sealed radioactive sources and orphan sources [Official Journal L 346 of 31.12.2003].


Context: Sealed radioactive sources

A sealed radioactive source is a source containing radioactive substances designed to prevent any discharges of the substances, under normal conditions of use, and to rule out any possibility of contamination. Sealed radioactive sources are widely used in industry, medicine and research and are often small and mobile.

In this context, the Euratom Treaty (Title II, Chapter 3) lays down measures to protect the health of workers and the general public against the dangers arising from ionising radiation. Consequently there were already basic Community standards on this subject (Directive 96/29/Euratom) containing rules on high-activity sealed radioactive sources.

However, such radioactive sources are sometimes abandoned, lost, misplaced or removed without authorisation (in which case they are called “orphan sources”). Uncontrolled or “orphan” sources like this could be found by persons unaware of the risks which they pose.

Systems to control radioactive sources are already in place in several Member States, under basic Directive 96/29/Euratom. This follow-up Directive paves the way for tightening up and harmonising such controls.


This Directive applies to high-activity sealed radioactive sources. Sources are classified as “high-activity sources” on the basis of their radioactivity level. In technical terms, this Directive applies, in principle, to sealed sources causing a dose exceeding 1 mSv/h (millisievert per hour) at a distance of one metre. (The sievert is the unit for measuring the effective radiation dose.)


Directive 96/29/Euratom already required prior authorisation for certain practices, notably for the use of radioactive sources for industrial radiography, processing products, research or medical treatment.

Member States are under an obligation to introduce a prior authorisation system for any application involving a high-activity source. Before granting authorisation, the competent authorities must ensure that the user has made adequate arrangements to ensure not only safe use but also safe management of the sources once they are no longer used.

To this end, sources must be kept under control until they are transferred for recycling, re-use or disposal under controlled conditions. Care must also be taken to ensure that the persons responsible have, in particular, set aside adequate funds to finance this last stage.


One important point to note is that for the purposes of this Directive “transfer” means the shift of responsibility from one person to another and not the transport of the sources from one place to another.

Member States must set up a system to keep them adequately informed of each transfer of sources.


To guarantee safety, it is more efficient to target the controls by the authorities on the holder of the source (any natural or legal person who is responsible for a high- activity source) rather than on the sources themselves.

The new Directive proposes using a standard record sheet to be kept by holders of sources containing information on the holder of the source, the checks and tests carried out and all transfers of the source.

The holder must provide the competent authority with an electronic or written copy of the records at the time of establishment of the records, at regular intervals to be determined by the Member States or competent authorities, whenever the situation indicated on the record sheet changes, on the closure of the records for a specific source, on the closure of such records when the holder no longer holds any sources and, finally, whenever so requested by the competent authority.

Use of such standard record sheets will facilitate exchanges of information and make it easier for national or local authorities to keep records, if they wish.

Common requirements for holders

Holders of high-activity sources must:

  • ensure that leak tests are undertaken regularly in order to check the integrity of each high-activity source;
  • regularly verify that each high-activity source is still present and in apparently good condition at its place of use or of storage;
  • ensure that each fixed or mobile high-activity source is subject to adequate measures to prevent unauthorised access to or loss, theft or unauthorised use of the source;
  • promptly notify the competent authority of any loss, theft or unauthorised use of a high-activity source and of any event that may have damaged the source;
  • return each disused high-activity source to the supplier or place it in a recognised installation;
  • ascertain that, before a transfer is made, the recipient holds appropriate authorisation;
  • promptly notify the competent authority of any incident or accident resulting in unintentional exposure of a worker or a member of the public.

Identification and marking

Each source must be identified by a unique number. Sources must also be marked and labelled with an appropriate sign to warn people of the radiation hazard.

The holder must ensure that each high-activity source is accompanied by written information indicating that the source is identified and marked. The information must include photographs of the source, container, transport packaging, device and equipment as appropriate.

Training and information

Directive 96/29/Euratom requires the undertaking responsible for the source to train and inform the workers using it of the specific hazards and consequences.

Member States must provide encouragement to ensure that the management and workers in installations where orphan sources are most likely to be found or processed are:

  • informed of the possibility that they may be confronted with a source;
  • advised and trained in the visual detection of sources;
  • informed of basic facts about ionising radiation and its effects;
  • informed of and trained on the action to be taken on site in the event of the detection or suspected detection of a source.

Orphan sources

“Orphan source” means a high-activity source which is not under regulatory control, either because it has never been under regulatory control or because it has been abandoned, lost, misplaced, stolen or transferred without proper authorisation.

The objective of the Directive is to prevent orphan sources arising. The measures proposed include:

  • clear assignment of responsibilities between the various parties holding an orphan source;
  • establishment of specialised technical assistance or national contact points to provide prompt advice and assistance to persons who suspect the presence of an orphan source;
  • establishment of controls at places where orphan sources are most likely to be encountered such as large metal scrap yards and major scrap recycling installations;
  • organisation of campaigns to recover orphan sources or substances in danger of becoming orphan sources.

Financial security

Member States must ensure that a system of financial security is established or any other equivalent means to cover intervention costs relating to the recovery of orphan sources.

International cooperation and information exchange

The Directive places an obligation on each Member State to exchange information and cooperate with other States in the event of loss, removal, theft or discovery of high-activity sources.

Competent authority

Member States must designate the competent authority responsible for implementing the Directive. If they have more than one competent authority, they must designate a single contact point. The competent authorities must keep records of authorised holders, transfers and disposal of high-activity sources.


By 31 December 2010 at the latest Member States must report to the Commission on the experience gained in the implementation of this Directive.


Act Entry into force – Date of expiry Deadline for transposition in the Member States Official Journal
Directive 2003/122/Euratom 31.12.2003 31.12.2005


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