[en] The recently published Council Directive 2013/59/Euratom ('new European Basic Safety Standards', EU BSS) modernises and consolidates the European radiation protection legislation by taking into account the latest scientific knowledge, technological progress and experience with implementing the current legislation and by merging five existing Directives into a single piece of legislation. The new European BSS repeal previous European legislation on which the national systems for radiation protection in medicine of the 28 European Union (EU) Member States are based, including the 96/29/Euratom 'BSS' and the 97/43/ Euratom 'Medical Exposure' Directives. While most of the elements of the previous legislation have been kept, there are several legal changes that will have important influence over the regulation and practice in the field all over Europe-these include, among others: (i) strengthening the implementation of the justification principle and expanding it to medically exposed asymptomatic individuals, (ii) more attention to interventional radiology, (iii) new requirements for dose recording and reporting, (iv) increased role of the medical physics expert in imaging, (v) new set of requirements for preventing and following up on accidents and (vi) new set of requirements for procedures where radiological equipment is used on people for non-medical purposes (nonmedical imaging exposure). The EU Member States have to enforce the new EU BSS before January 2018 and bring into force the laws, regulations and administrative provisions necessary to comply with it. The European Commission has certain legal obligations and powers to verify the compliance of the national measures with the EU laws and, wherever necessary, issue recommendations to, or open infringement cases against, national governments. In order to ensure timely and coordinated implementation of the new European legal requirements for radiation protection, the Commission is launching several actions including promotion and dissemination activities, exchange and discussion forums and provision of guidance. These actions will be based on previous experiences and will rely on the results of recent and ongoing EU-funded projects. Important stakeholders including the Euratom Article 31 Group, the association of the Heads of European Radiological protection Competent Authorities (HERCA) and different European professional and specialty organisations will be involved. (authors)

[en] The European Union has a positive record of addressing radiation protection of patients, including specific Euratom legislation in 1984 and 1997, guidance, research and stakeholder involvement. Today we experience a rapid development of medical technology and doses from medical exposure are increasing. Accidents in radiotherapy, although rare, cause unnecessary suffering of patients. The Commission is undertaking a series of initiatives to address these challenges. Communication COM(2010)4231 from August 2010 provides an overview of the challenges and the associated Community action and proposes a long-term perspective. A proposal for amendment of Euratom legislation is underway. Further action is taking shape in order to strengthen regulatory supervision, raise awareness and safety culture, etc. (authors)

[en] The European Union has a long and successful history of legislating in the area of radiation protection of the public, workers and individuals submitted to medical exposure, the first Euratom “Basic Safety Standards” (BSS) adopted in 1959 and subsequently updated and supplemented with other Directives. The recent revision of this legislation aims to update it in the light of the latest knowledge and experience and to simplify it by consolidating the current legal acts into one Directive. The draft of the revised Euratom BSS Directive has been approved by the group of scientific experts under Euratom Treaty Article 31 and is currently undergoing the European Commission’s procedures. This draft contains several new or amended provisions relating to protection of medical staff, among them: (i) a streamlining of the annual dose limit provisions, (ii) enhancing the use of dose constraints in optimization of protection, and (iii) ensuring better recording and transfer of occupational dose data including in cases of trans-border movement of workers. The Community action to radiation protection of workers is not restricted to passing relevant legislation but also includes ‘soft action’ as issuing guidance, supporting research and stakeholders’ involvement, etc. In August 2010 the Commission issued a Communication to the Council and the European Parliament dealing with the issues in the medical uses of ionizing radiation, including those relating to radiation protection of medical staff.