C. LEFAURE Portoroz Workshop April 2002 The evolution of the system of radiological protection in the National regulations in the European Countries as of April 2002 C. LEFAURE Portoroz Workshop April 2002

ICRP 60 - 1990 European Directive - 1996 (96-29) International BSS 1997 Implemented in the regulations of: Belgium, Denmark, Finland, Germany, Italy, The Netherlands, Spain, Sweden, United Kingdom Norway, Switzerland Hungary, Lithuania, Slovak Republic Partially or nearly implemented in: Austria, France, Italy; Czeck Republic, Slovenia

JUSTIFICATION Member State shall ensure that all new classes or types of practice resulting in exposure to ionizing radiation are justified in advance of being first adopted or first approved by their economic, social or other benefits in relation to the health detriment they may cause. Existing classes or types of practice may be reviewed as to justification whenever new and important evidence about their efficacy or consequences is acquired. (Council Directive 96/29/EURATOM, General Principles, Article 6.1 and 6.2)

JUSTIFICATION (I) Previous situation: In most countries, all practices actually implemented were implicitly considered as justified. However, some practices or trades were explicitly named as unjustified and consequently forbidden in the national regulatory texts.  fluoroscopy for shoe-fitting (the Netherlands)  foodstuff, toys, cosmetic (Italy, Sweden, France)  lightening conductors (Italy, France) …

JUSTIFICATION (II) New situation: The justification principle appears now clearly into almost all national regulations. The wordings are quite similar to BSS ones. It deals with all "human activities" in Fr., Den., Neth., Nor.; with"practices" in Fin and Swed. or "new practices" in Aus., Be. and Sp. Its implementation is not obvious in the UK.

JUSTIFICATION (III) New situation: This is accompanied by a stronger control by authorities on activities involving radioactive substances. New tools for enforcing the principle:  lists of unjustified & justified practices (NL)  procedures for obtaining justification (Be,Sp, Slov…)  criteria for banning a practice

JUSTIFICATION (IV) New situation: The Netherlands: an ordinance will create a list of justified practices. If not on it = forbidden, up to approval after request with good arguments. Spain & Slovenia: the authority may propose to review justification of existing practices (new and important arguments) Switzerland: Any activity leading to effective dose ≤10 micro/Sv/year is justified

OPTIMISATION (I) « In the context of optimization (Member States shall ensure that) all exposures shall be kept as low as reasonably achievable, economic and social factors being taken into account » (Council Directive 96/29/ EURATOM, General Principles, Article 6.3)

OPTIMISATION (II) Previous situation: The optimisation principle was already stated in most of the national laws, albeit in general terms, often without any practical guidance (but UK). Consequently the application of optimisation (ALARA) was often quite limited.

OPTIMISATION (III) New situation: More precise wording referring explicitly to - economic and social factors in Belgium, France, the Netherlands, Spain and Sweden, or even - medical goals (Fr) - or critical event (Ukraine). Although in many cases the evolution of wording is not revolutionary, the optimisation principle has grown into a strict regulatory requirement.

OPTIMISATION (IV) New situation: Regulatory bodies have increasingly introduced guidance on how it should be applied in practice.  prior dose assessment (France, the Netherlands, Sweden, Finland, United Kingdom, Germany, Slovenia)  operational dosimetry & control (France, Sweden)  Workers information (Sweden)  Man Sievert values (CZ and Hungary)

OPTIMISATION (V) New situation: New Guides for NPP’s in Spain and Lithuania  ALARA responsibility assignments  components of an ALARA program  goals  work management  ALARA reviews (modification, design)  training  audit

OCCUPATIONAL DOSE LIMITS New Situation EC Directive 100 mSv/5 years OCCUPATIONAL DOSE LIMITS New Situation EC Directive 100 mSv/5 years 20mSv/ year

OCCUPATIONAL DOSE LIMITS Italy : 20 mSv/year + 100 mSv/10years Germany : 400 mSv worklife

DOSE LIMITS FOR THE PUBLIC EC Directive 1mSv/year  1 mSv a year in all countries  specified « for all sources » - Denmark, Finland  specified 0.3 dose constraint per site or sources - Germany, United Kingdom  specified 0.1 dose constraint per source in the Netherlands

CONCLUSION (I)  Implementation of European BSS or International BSS into European regulations (i.e. ICRP 60) not far to be achieved  All three principles will be applied across EU in a more consistent matter

 Practical guidance for ALARA implementation. CONCLUSION (II)  Justification is no more excluded from regulation, with tools for enforcing the principle.  Practical guidance for ALARA implementation.  Flexibility for setting effective dose limits.  Challenge : implementation into practice