Basic safety standards for protection against the dangers arising from exposure to ionising radiation

Purpose of the directive: Parliament specified that the draft directive must aim to establish the basic safety standards for the protection of the health of workers, general public, patients and other individuals subject to medical exposure against the dangers arising from ionising radiation for the purpose of guaranteeing a uniform threshold level of protection in Member States, without barring Member States from maintaining or establishing higher basic safety standards than set out in the Directive.

The latter also set out requirements for the control of the safety and security of radioactive sources and the provisions of mandatory information in an emergency exposure situation.

Scope: Parliament made a series of amendments to the scope of the proposal so that the Directive might apply to any planned, existing, accidental or emergency exposure situation which involves a risk from exposure to ionising radiation with regard to the health protection of workers, members of the public, or patients and other individuals subject to medical exposure or with regard to the protection of the environment.

New provisions were introduced on: i) disposal of radioactive material and temporary or final radioactive waste storage; ii) practices exposing workers to cosmic radiation, including the operation of aircraft and spacecraft as well as frequent flying. On the other hand, the plenary rejected the amendment proposed by its competent committee providing for awareness-raising regarding the potential risks of cosmic radiation on citizens who flew frequently.

Members specified that occupational exposure means exposure of workers, including employees and self-employed as well as trainees and volunteers, incurred in the course of their work as well as apprentices aged 16 years or over.

Medical devices: in the area of medical exposure, Parliament proposed to prevent duplication of work in connection with medical devices which gave off ionising radiation, and considered that these medical devices should be dealt with under the Medical Devices Directive (93/42/EEC), which already lays down comprehensive monitoring and supervisory arrangements.

With regard to testing of medical equipment, Parliament specified that in performing such testing, Member States must comply with the Commission guidelines (in particular RP162)1 and European and international standards currently applicable to medical radiological equipment (IECTC62 on Electrical equipment in medical practice, IAEA Standards, ICRP Guidelines).

Contrary to the amendments made by its competent committee, Parliament retained the Commission’s proposals on interventional radiology.

Protection of the environment against ionising radiation: the draft directive stated that the presence of radioactive substances in the environment has consequences for the health of the general public. In addition to direct environmental exposure pathways, the aim was to protect the environment as a whole, including the exposure of biota, within a comprehensive and coherent overall framework. However, Parliament felt that more resources should go to examining in detail the impact that ionising radiation has on both mankind and the environment. Accordingly, Members deleted the corresponding provisions.

Minimum requirement: Parliament asked Member States to establish legal requirements and an appropriate regime of regulatory control which, for all exposure situations reflect a system of radiation protection based on up-to-date, robust scientific evidence, following principles of justification, optimisation, dose limitation and reparation for damages. For each of these principles, new provisions were added in order to limit as much as possible the risk of exposure.

With regard specifically to:

• dose limitation, Parliament required that the sum of doses received by a member of the public from all regulated radiation sources and all existing anthropic exposure situations must not exceed the dose limits laid down for public exposure. The sum of doses to an exposed worker from all regulated radiation sources must not exceed the dose limits laid down for occupational exposure. These dose limits will not apply to medical exposures;
• reparation for damages, Parliament required the establishment of a mechanism which guarantees reparation for all physical damage and personal injury likely to be caused by an emergency at the installation before authorising the construction of a nuclear installation or renewing its operating licence.

Organisational measures to minimise the risk of exposure: Parliament proposed to strengthen the provision enabling better regulation of the procedures regarding exposure for workers so as to minimize risk as much as possible. The text provides for other measures regarding training and organisation.

Information for the public and the limit of a dose: Members feel that the public should be better informed of the risks and doses to which it is exposed. The values chosen for the dose constraints must be published, so that any member of the public can check that he or she has not received, as a result of aggregate planned and existing anthropic exposure situations, a dose in excess of the legal limit (this being 1mSv per year.)

There are also provisions regarding informing the public in emergency situations. In such cases, Member States must publish all information necessary for an assessment of the situation and its development – in particular weather data and forecasts, air movements and ground deposits, ambient dose rates and contamination levels of critical foodstuffs

Member States must ensure that members of the public likely to be affected in the event of an emergency are given information about the health protection measures applicable to them and about the action they should take in the event of such an emergency. This shall concern, at the very least, people living within 50km of an installation at risk.

Stakeholders: Parliament required that Member States ensure that all stakeholders, in particular the persons likely to be affected by the health impact of the practice, whether in normal operating circumstances or in an emergency, were involved in the decision-making process. That involvement must be arranged sufficiently far ahead of the deadline for a decision so that alternative solutions could be properly studied. This type of provisions also applied to revision of the relevant legislation.

Penalties: Parliament stated that Member States must prohibit and sanction the addition of radioactive substances in the production of foodstuffs, toys, personal ornaments and cosmetics, and, more generally, in consumer goods, and must prohibit the import or export of such products.

Monitoring by Member States: there are new provisions strengthening the level of monitoring for non-medical imaging exposure. In addition, Member States must specify the information that the undertaking is required to provide in order to enable the competent authority to assess the levels of exposure of members of the public and workers and the radiological risks, in normal and emergency situations. 

Stricter provisions: should a Member State plan to adopt standards stricter than those laid down by this Directive, it must inform the Commission and the other Member States accordingly.

Annexes: lastly, Parliament amended the annexes to the proposal to correspond to the amendments in the body of the text.