print this page
The Euratom Basic Safety Standards - Aims and Scope

This paper was presented to the UK Nuclear Free Local Authorities annual conference in Caernarfon, Wales, on 15 October 1998 by two European Commission officals - Stephen Kaiser, EC, DG XI/C/1 and Augustin Janssens, EC, DG XI/C/1

Introduction

The Euratom Basic Safety Standards for the radiological protection of workers and the general public against the dangers arising from exposure to ionizing radiation were laid down in Directive 96/29/Euratom adopted by the Council in May 1996 and are now due to be implemented in national legislation by May 2000.

The establishment of the Basic Safety Standards is the key activity of the Radiation Protection unit of DG XI/C/1 in Luxembourg and is an obligation for the Commission as laid down in Article 30 of the Euratom Treaty.

Other activities pertain to environmental radioactivity and relate directly to the Euratom Treaty under the terms of Articles 35, 36 and 37. Another major piece of legislation concerns radiation protection arrangements in medical applications which have been worked out separately from the Basic Safety Standards and which were adopted in June last year.

In addition, important activities resulted from the Chernobyl accident in terms of information to the public, early exchange of information , radioactivity in foodstuffs, mutual assistance in the case of radiological emergencies and also in the field of education, training and information.

Basic Safety Standards

The obligation to establish uniform safety standards is laid down in Article 2.b of the Euratom Treaty and further specified in Chapter III, Health and Safety. The first standards were already laid down in 1959, very soon after the signature of the Euratom Treaty in 1957. They have evolved over the past 40 years as scientific knowledge on the effects of ionizing radiation has improved and in this context it is important to refer to the internationally recognised work of the ICRP.

Another major reason for the repeated revisions of the Basic Safety Standards is to take into account practical experience with operational radiation protection. Throughout these 40 years there has been a continued trend to strengthen regulatory control of radiation exposure.

Procedure

The procedure by which the Basic Safety Standards are established is laid down in the Treaty itself. The Commission receives guidance from a group of experts established under Article 31 of the Treaty which then gives rise to a Commission proposal for a Directive or revised Directive. This is submitted first to the Economic and Social Committee. Upon incorporation of all or part of the observations of this Committee, the proposal is published in the Official Journal and forwarded to Council and to the European Parliament.

The European Parliament then proposes amendments to the Commission proposal which are examined by the Commission and taken up as a whole or in part in a revised Commission proposal which is again submitted to the Council. In the end, under the terms of the Euratom Treaty, it is the Council who decides and the Directive is ultimately adopted by a qualified majority at Council. Subsequently, the Directives need to be transposed in national legislation.

For the new Directive an implementation period of 4 years has been laid down in the Directive. Draft legislation is submitted to the Commission under the terms of the procedure laid down in Article 33. The Commission gives an opinion on draft legislation in order to make sure that it is in conformity with the standards.

Radiation protection principles

In order to understand fully the overall philosophy of the radiation protection standards it is important to be aware of the three major general principles underlying radiation protection. The principle of justification of practices implies that the detriment from exposure should be justified by the benefit resulting from the practice and thus requiring that no frivolous applications of ionizing radiation be permitted.

The cornerstone of radiation philosophy, however, is the principle of optimisation of protection which is translated into the principle that doses should be as low as reasonably achievable taking social and economic considerations into account. Finally, the principle of dose limitation ensures an equitable distribution of individual benefits and detriment.

These basic principles all reflect the basic working hypothesis in radiation protection, that there is no safe level of radiation. The radiation detriment is a stochastic effect, which means that the detriment, for instance radiation-induced cancer, is never certain to occur but has a certain probability of occurrence which is assumed to be proportional to the radiation exposure. So there is no safe level of radiation and this is reflected by the strict regulatory control of practices involving ionising radiation.

Extended scope of the Standards

An important new feature of the 1996 Basic Safety Standards is that in line with ICRP guidance, a clear distinction is now made between, on the one hand, practices, i.e. human activities that can increase the exposure of individuals to radiation from a source, and on the other hand intervention situations, i.e. human activities that aim at preventing or decreasing the exposure of individuals to radiation from sources which are not part of a practice or which are out of control. ICRP has introduced this fundamental distinction between practices and intervention in its 1990 Recommendations (Publication 60).

In the Basic Safety Standards a further distinction is made between practices and work activities, the latter involving the presence of natural radiation sources. The 1980 Directive also pertained to practices even if this terminology was not yet introduced at that time and considered both natural and artificial sources but lacked specific operational provisions for natural radiation sources. Intervention situations are now dealt with much more explicitly than before both for radiological emergencies and in the case of lasting radioactivity or contamination resulting from past practices or work activities, which is an important extension of the previous protective arrangements in the event of an accident laid down in the 1980 Directive.

Natural radiation sources

The extension of the scope of the Directive to include natural radiation sources is very important. In Title VII, consideration is given both to cosmic radiation sources as far as air-crew exposure is concerned and to terrestrial natural radiation sources, including exposure to radon gas in the workplace and exposure of the population or workers resulting from work activities involving ores or residues containing enhanced levels of natural radioactivity.

The Directive prescribes that for each work activity declared by the Member Stateís competent authorities to be of concern, the Member State shall require the setting up of appropriate means for monitoring exposure and, as necessary, implement corrective measures pursuant to Title IX, that means the application of the general principles for intervention situations and, as appropriate, the application of all or part of Titles III up to VIII which lay down the radiation protection requirements pertaining to practices.

Intervention

Title IX dealing with intervention situations addresses in the first place the possible occurrence of radiological emergencies and, secondly, lasting exposures resulting either from radiological emergencies (e.g. land contaminated as a result of accidental releases), as a result of past or old practices or work activities which were not subject to a level of regulatory control which would be acceptable today. The basic principles of intervention are similar to those for practices but are worded differently.

The justification principle now reads that the harm and cost of intervention should be justified in terms of the averted or avoided exposure resulting from the intervention situation. The intervention is justified if the net benefit is positive. The optimisation of radiation protection pertains to the form, scale and duration of the intervention. Dose limits do not apply. Intervention down to the limits may, in certain cases, cause excessive harm to the individual by comparison to the averted radiation detriment. Indicative intervention levels however need to be laid down by competent authorities for different types of counter-measures.

The new Directive is much more explicit in its requirements for emergency planning in connection with practices within or outside Member Statesí territories. The competent authorities are required to establish and test intervention plans in relation to such emergencies, to establish intervention levels taking into account the general principles for intervention, to ensure the training of intervention teams and to seek co-operation with other Member States both for the co-ordination of intervention plans and in the case of an actual emergency.

Dose limits and regulatory control

In addition to the extension of the scope of the Directive, the system of dose limitation and the regime of regulatory control have been considerably strengthened.

The dose limit for workers is 50 mSv effective dose for one year but in addition, on average, 100 mSv over a period of 5 years or, in practice 20 mSv per year (Member States may decide on an annual amount). This compares to a single effective dose limit of 50 mSv per year for workers in the 1980 Directive, so the reduction in practice down to 20 mSv is more restrictive.

For the population the dose limit has been reduced to 1 mSv per year (exceptionally more than 1 mSv may occur as long as the average over 5 years remains less than 1 mSv). The dose limit to members of the public was 5 mSv per year so we have now a five-fold decrease.

Finally the regulatory control of practices has been considerably strengthened through the requirements of reporting of all practices and the explicit requirement of prior authorisation for a list of identified practices including the whole of the nuclear fuel cycle. Particularly important is the explicit requirement of prior authorisation for the disposal, recycling or reuse of materials containing radioactive substances arising from practices which themselves are subject to reporting or prior authorisation.

Practices need to be reported except if quantities or concentrations of activity per unit mass are below exemption values. In terms of activity concentration, for instance, we now have a nuclide-specific list of exempt activity concentrations which is in general much more restrictive than the single value of 100 Bq/g laid down in the 1980 Directive for artificial sources and 500 Bq/g for natural radiation sources. Exemption can also be granted in a number of other cases (sealed sources or electrical apparatus) if the dose rate is less than 1 µSv per hour, at a distance of 0.1 m.

The exemption values have been established on the basis of general basic criteria which have been laid down in Annex I of the Directive together with the exemption values. Individual risks involved in the exempted practices are required to be below concern, as well as the collective impact expressed in terms of collective doses. It is presumed that these basic criteria are met without further considerations if annual individual doses are about 10 µSv which is 1% of the dose limit or less than 1% of the average level of exposure to natural radiation sources. There is a further requirement that collective dose should be less than 1 man Sv.

We now have a range of nuclide-specific activity concentration values, most of which are lower than the exempt activity concentration in the 1980 Directive, at least for the most toxic radionuclides that matter such as Caesium-137, Cobalt-60 or Plutonium-239. For other radionuclides, in particular for the beta-emitters, much higher exempt activity concentrations are now permitted, reflecting simply the fact that there is very little risk involved in their use. The assessment of specific exposure pathways for each radionuclide depending on its radioactive and chemical properties has indeed given rise to a very broad range of nuclide-specific activity concentrations. The same applies to the exempt total activities for which there were only four radiotoxicity classes in the 1980 Directive.

Conclusions

The Commission has ensured through repeated updates of the Basic Safety Standards over more than forty years a continuous improvement of the protection of the health of workers and members of the public against the dangers arising from exposure to ionizing radiation.

The new Directive adopted in 1996 is an important milestone in this process since it ensures the extension of radiation protection requirements to natural radiation sources. In addition, more detailed requirements have been included for planning and intervention in relation to radiological emergencies.

The dose limits for exposed workers and members of the public have been substantially reduced. Regulatory control of practices has been strengthened through more explicit requirements for prior authorisation, in particular with regard to the disposal of radioactive waste, and through a more coherent approach to the setting of exemption criteria.