RADIATION PROTECTION 1. The Euratom Treaty

The Treaty establishing the European Atomic Energy Community, the so-called Euratom Treaty [1], gives to the European Union the normative and executive legal power in the field of peaceful use of nuclear energy.

Chapter III of the Treaty, entitled Health and Safety, delegates the direct and exclusive legal competence in radiation protection related legislative initiatives to the European Union. Articles 30 to 39 provide the relevant obligations for the Union and the Member States in order to fulfil their liabilities. Article 30 stipulates that the Union shall lay down basic safety standards for the protection of the health of workers and the general public against the dangers from ionizing radiation (Section 2.2). In this context, the EU basic safety standards are to express maximum permissible doses compatible with adequate safety, maximum permissible levels of exposure and cont-amination and the fundamentals governing the health surveillance of workers.

Articles 31 and 32 describe the legal pathway for the establishment of any radiation protection legislation, the EU Basic Safety Standards in particular. Article 33 obliges the Member States to lay down appropriate national laws, regulations or administra-tive actions to ensure compliance with the EU Basic Safety Standards. Furthermore, Member States have to communicate any draft provision applicable, and the Commission may issue recommendations with regard to such provisions.

2.2. The EU Basic Safety Standards

Article 161 of the Euratom Treaty describes the legal instruments available to the Union in order to carry out its tasks. From the beginning in 1959, the Union has chosen the directive as the most appropriate legal instrument for the adoption of the EU Basic Safety Standards. The directive is addressed to the Member States, which are consequently obliged to transpose this European law into national legislation. The directive is binding on the Member States as to the result to be achieved.

The directive is the only legal instrument of the Union which takes into account the different legislative structures of the individual Member States and which leaves them the necessary legislative and administrative freedom for the transposition of European legislative acts.

The centrepiece of the European radiation protection policy is the Basic Safety Standards for the Protection of the Health of Workers and the General Public against the Dangers from Ionizing Radiation [2]. First issued in 1959, the Basic Safety Standards have been regularly adopted and revised, taking into account the most recent scientific developments and findings. With the Como Agreement, it was agreed by Euratom, the International Commission on Radiological Protection (ICRP) and the

IAEA-CN-7WB2.7 1 1 1

International Commission on Radiation Units and Measurements (ICRU) that the EU Basic Safety Standards will mirror the scientific recommendations issued by these two important international organizations in radiation protection.

After the publication of the 1990 Recommendations of the ICRP [3], in applica-tion of Article 32 of the Euratom Treaty, the European Commission took the initiative and drafted, in consultation with the group of experts under Article 31, the most recent Basic Safety Standards. On 13 May 1996 the 15 Member States of the European Council unanimously adopted this directive [1], which must be implemented before 13 May 2000; consequently the directive now in force will be inoperative as of this date.

There are major changes in the obligations provided by the new directive. In the context of this International Conference, those articles providing the legal basis for the activities of the Member States and the Commission concerning the safety of radi-ation sources and security of radioactive material will be highlighted.

The new directive changes the scope of application in two important points. It no longer applies to activities involving a hazard from ionizing radiation. Instead, it now applies to practices, which are human activities increasing radiation exposures, and it applies to interventions, which are activities foreseen to decrease and prevent radiation exposures. In this way, it enlarges the scope and the legal margin of the directive.

The redefinition of the scope of the directive also includes new requirements for reporting and authorization, such as for import and export into and from the Union.

In relation to illicit traffic, this modification of Article 2 is of importance.

Import and export are now legally treated in the same way as transport, holding, use, etc. Import and export must undergo the system of prior notification and authoriza-tion, even if there is no physical possession of the material in question. In relation to the prevention of illicit practices, this is an important step forward towards harmo-nization of EU Member States' legislation.

The revision of the system of prior notification and authorization created some confusion in the public because of misinterpretations and misunderstandings between the radiation protection specialists, the mass media and politicians. The Member States' authorities now have two systems of laying down the appropriate regulations to handle the use of radioactive substances.

Reporting of the intention to carry out any practice involving ionizing radiation is compulsory.

Exempted from the system of notification are those practices in which the radio-activity involved is below values given in Annex I of the Directive. Article 3 and Annex I describe the circumstances under which competent authorities may exempt prior notifi-cation. The specifications given in Annex I say that under exceptional circumstances, and subject to specified conditions, Member States' authorities may deviate from the values of the quantities and the activity concentrations given in Table A therein.

Also exempted from prior reporting and authorization is the use of electrical equipment which emits ionizing radiation below limits given in Article 3 and practices permitted in accordance with special conditions laid down in national legislation.

These are mainly cases involving negligible risks of exposure to human beings.

The next section of the EU Basic Safety Standards deals with clearance of radioactive substances. Disposal, recycling or reuse of materials containing radioactive substances is subject to prior authorization, in particular when these materials originate from authorized practices.

Such materials may be released from the scope of the directive in cases where the quantities of the involved radioactivity are below the clearance levels, which must be established by national authorities in application of the criteria given in Annex I of the directive.

Article 3 also states that those activities involving materials contaminated as a result of authorized releases need not be reported.

Within the context of this Conference, other important changes in the obliga-tion of the directive are the reducobliga-tion of annual radiaobliga-tion dose limits for workers and the general public. The directive follows the recommendation of the ICRP [4] with respect to setting the annual dose limit for workers to 100 mSv, averaged over five consecutive years. But in view of the different possibilities of interpretation and of managing the averaging over a long period, the directive entitles the Member States to decide on annual dose limits.

In this context, the general principle of justification of practices must be seen in different views. The justification of practices is in the competence of the Member States' authorities, except for those practices directly prohibited by Article 5 of the directive.

The general principle of justification can also be seen in the light of the topics of this Conference. Practices may be not justified when the safety of the sources or the security of radioactive material cannot be guaranteed by the user.

New practices involving radiation sources or radioactive materials must always be seen in the context of the balance between economic and social benefits and the risks of possible health detriments.

One of the major challenges of the Commission's activities is to work towards a uniform adoption of European radiation protection legislation with the view to establishing within the European Union a harmonized and synchronized system of radiation protection for workers and the general public.

2.3. Shipment of radioactive substances

The Council regulation concerning the shipment of radiactive substances [5]

supplements the Basic Safety Standards directive and closes gaps between other existing European legislation concerning the transport of dangerous goods.

IAEA-CN-70/B2.7 113

The regulation seemed to be the most appropriate legal instrument in relation to the problems of shipments within the European Union, because the regulation says explicitly that the authorization, supervision and control of shipments of radioactive substances should not be discriminatory. The regulation specifies that directly existing provisions for shipments under Chapter VII of the Euratom Treaty, entitled Safeguards, are not affected, nor are those under the Convention on the Physical Protection of Nuclear Material [6]. The Union therefore considered that sufficient control is already exercised on nuclear material and radioactive substances likely to play a role in nuclear proliferation. This is notably the case for those provisions requesting advance notification of those States through which the nuclear material is expected to transit.

One major point of the regulation is the mutual notification of the competent authorities involved in shipments of radioactive substances. This was the major gap to be closed, because all the operations and conditions associated with the movement of radioactive materials, such as the design, manufacture, maintenance and preparation of packages and their dispatch, handling, routing, storage during transport and recep-tion or delivery, are dealt with by the European Union legislarecep-tion on transport [7].

In 1984 and 1989, communications from the Commission on the transport of radioactive materials in the European Union [8, 9], together with reports on that subject from a special working group [10], were established and transmitted to the Council and the Parliament. A third report has been finished recently [11], and on the basis of this the Commission may identify possible actions in the field, taking into account the activities ongoing within the IAEA.

The regulation has to be seen independently, because it deals with radiation protection, which is the subject of Chapter III of the Euratom Treaty, and it must be applied independently from other European legislation.

2.4. Radiation sources

The competence of the European Union in relation to radiation sources is distributed over a number of legal instruments. On one side, European legislation lays down provisions for the production and placing on the market of such sources. On the other side, provisions are issued regulating all activities from first use until final disposal. Above all, these different regulatory steps have to be seen in the light of radiation protection. Therefore, the respective provisions of the Basic Safety Standards have to be adopted by the Member States' authorities in conjunction with the adoption of other European legislation.

2.4.1. Active sources

The manufacturing of active radiation sources is mainly regulated by interna-tional standards on electrical equipment. The Internainterna-tional Organization for

Standardization (ISO), the International Electrotechnical Commission (IEC) and the European Standardization Commission lay down general standards for electrical equip-ment subsequently specified by the national standardization organizations such as the Association frangaise de normalisation (AFNOR), the Deutsches Institut fur Normung (DIN) or the Osterreichische Normungsinstitut (ONorm). Within the European Union, these standards are mandatory because of the obligation of the Member States' author-ities to comply with the directive on Low Voltage Equipment [12]. This is the result of the earlier mentioned flexibility of the Member States in transposing directives.

The directive on Low Voltage Equipment and the directive on medical devices [13] require the establishment of a quality assurance and control regime during man-ufacturing, installation and testing of any equipment emitting ionizing radiation. The directives require further quality assurance measures for equipment used in the med-ical sector, such as acceptance tests, status tests and constancy tests.

For the use of the equipment as mentioned above, prior notification and autho-rization are compulsory. It is the only competence of the Member States' authorities to lay down requirements and obligations for the operators of such equipment. The national regulations on the use of equipment emitting ionizing radiation are based on the Basic Safety Standards directive or on the Medical Exposure directive [14]. Both directives require the training and education of workers and the presence of a quali-fied expert in radiation protection.

Furthermore, the directive on the Health and Safety of Workers [15], established under Article 118a of the EEC Treaty, requires that Member States pay particular attention to encouraging improvements, especially in the working environment as regards the health and safety of workers. Member States must set as their objective the harmonization of conditions in this area, but in cases of contradictory disposi-tions, the Euratom directives are given priority.

2.4.2. Passive sources

For passive sources, manufacturing is also regulated under the provisions of the Basic Safety Standard directive because this is an activity involving radioactive substances.

In respect of the safety of sealed sources, the Member States transposed their obligations into national legislation through the creation of national standards and norms based on standards laid down by international organizations. The same goes for quality assurance.

However, the authorization of activities using sealed radiation sources must follow different priorities. Reports on accidents arising from the use of radiation sources have shown that routine, daily use of radioactive sources has resulted in many cases in care-less manipulations and subsequently in accidents. The aspects of physical protection became more important, particularly in relation to illicit traffic. Training and education,

IAEA-CN-70/B2.7 115

in combination with the presence of a qualified expert, is an essential requirement of the Basic Safety Standards directive in order to prevent such unacceptable events.

It is in the competence of the Member States to lay down provisions for the safe manufacturing, handling, use, transport and final disposal of radiation sources. This includes requirements for physical protection and notification procedures in case of loss or theft.

2.5. Radioactive substances

The field of application of radioactive substances in industry, research and medicine is of vast variety. It is extremely difficult to cover the large number of different radioactive substances by single national regulations adopting the Basic Safety Standards directive.

In order to get a clear picture of the situation, the Radiation Protection Division (since February 1997 known as the Radiation Protection Unit) initiated and published in 1993 a study on consumer goods containing radioactive substances [16]. When reviewing the actual situation and observing the developments, it can be seen that Member States' authorities tend to apply the general principle of justification more frequently and more strictly.

Radioactive substances can be separated into two major categories. In one category are substances which are used in different applications for their chemical or physical properties but which also emit ionizing radiation. In the other category are substances enriched with natural or artificial isotopes and which are used because of their radiological properties. In this context, residues from the dismantling of nuclear installations and contaminated metal scrap should be mentioned.

Because of the unsolved problem of the final disposal of radioactive substances, it is the intention of the Commission to take the steps necessary to motivate the Member States' authorities to reduce authorizations for the import, manufacturing, placing on the market and use of the latter category.

The reduction of the exception levels and the concept of clearance as provided by the new Basic Safety Standards directive can be seen as an important step forward in this direction.

2.6. Legal consequences

Article 192 of the Euratom Treaty obliges the Member States to take all appro-priate measures, whether general or particular, to ensure fulfilment of the obligations arising from the Treaty or resulting from actions taken by the institutions of the Union. The Member States must facilitate the achievement of the Union's tasks.

Within the EU, there is still a long way to go towards harmonization of the different national legislation laying down the juridical consequences for jeopardizing

regulations based on the obligations given by the Basic Safety Standards directive.

Similar offences against regulations in the radiation protection area are prosecuted very differently. In some countries, violation is prosecuted as a minor administrative offence and fined between 5 and 50 000 ECU. Other countries punish similar violations by imprisonment between 6 months and 20 years. Ireland even foresees imprisonment for life for causing health detriments.

3. ILLICIT TRAFFIC