No C 350/20 Official Journal of the European Communities 31. 12. 80 
Proposal for a Council Directive laying down basic measures for the radiation protection of 
persons undergoing medical examinations or treatment 
(Submitted by the Commission to the Council on 18 December 1980) 
THE COUNCIL OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty establishing the European 
Atomic Energy Community, and in particular Article 31 
thereof, 
Having regard to the proposal from the Commission, 
drawn up after obtaining the opinion of a group of 
persons appointed by the Scientific and Technical 
Committee, 
Having regard to the opinion of the European 
Parliament, 
Having regard to the opinion of the Economic and Social 
Committee, 
Whereas the Council has adopted a Directive laying 
down the basic safety standards for the health protection 
of the general public and workers against the dangers of 
ionizing radiation; 
Whereas the standards also relate to problems of 
radiation protection connected with the use of ionizing 
radiation for diagnostic and therapeutic purposes; 
Whereas, on the one hand, apart from natural 
background radiation, medical exposure to radiation is 
at present by far the major source of exposure to ionizing 
radiation; whereas this problem has been repeatedly 
reviewed by the World Health Organization, the United 
Nations Scientific Committee on the Effects of Atomic 
Radiation and the International Commission on 
Radiological Protection, which have already 
recommended measures with a view to preventing 
excessive medical exposure; 
Whereas, on the other hand, ionizing radiation has 
enabled very great progress to be made in the diagnostic, 
therapeutic and preventive aspects of medicine and 
whereas, moreover, new techniques are • under 
development, notably in nuclear medicine, high energy 
therapy and the use of computer-controlled tomography; 
whereas, although it is certainly not desired to raise 
objections to the proper use of ionizing radiation for 
legitimate reasons and under good radiation protection 
conditions, it is nevertheless important to eliminate 
unnecessary radiation exposures; 
Whereas measures which make it possible to increase 
significantly the radiation protection of patients and of 
the general public in no way jeopardize the benefits -
whether diagnostic, preventive or therapeutic -
obtainable from radiation; whereas, on the contrary, 
measures which avoid inappropriate or excessive 
radiation exposure improve the quality and effectiveness 
of medical uses of radiation; Whereas it must be recognized also that the number of 
radiological installations and the variety of uses of 
ionizing radiation are increasing; whereas any resultant 
unjustified increase in public exposure must be 
prevented; 
Whereas given the growing use of ionizing radiation and 
the proliferation of techniques, it is necessary to ensure 
that users have the necessary competence and experience 
to avoid inappropriate uses of these techniques; whereas 
any unnecessary proliferation of radiological installations 
must be avoided; 
Whereas it is therefore appropriate that other provisions 
be enacted to complement those contained in the 
abovementioned Directive, laying down suitable 
measures relating to the radiation protection of patients, 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
Member States shall take all appropriate measures to 
ensure that radiological procedures are carried out under 
the responsibility of doctors or dentists engaged in 
radiology, who have a recognized competence in 
radiation protection and who have received an adequate 
training in radiation protection which is approved by the 
administrative authority and which is appropriate to the 
techniques used in medical and dental diagnostic 
radiology, in radiotherapy or in nuclear medicine. 
Assistants shall receive instruction in the techniques 
applied and in suitable radiation protection procedures; 
they shall receive training appropriate to their work. 
Article 2 
(a) No radiological examination shall be carried out for 
preventive purposes without medical indication. 
(b) Individual or collective preventive radiological 
examinations shall be carried out only if they are 
biologically, clinically or epidemiologically justified. 
(c) Radiological examinations carried out at the request 
of insurance companies shall depend on a previous 
medical decision. Such examinations may be refused 
by the individuals concerned. 
(d) Direct fluoroscopic examinations without the use of 
image intensification shall be carried out only when 
justified by exceptional circumstances. 
31. 12. 80 Official Journal of the European Communities No C 350/21 
Article 3 
Member States shall take the steps necessary to ensure 
that doctors or dentists engaged in radiology referred to 
in Article 1 have acquired adequate and effective training 
in radiation protection. 
Training facilities shall also be available for doctors or 
dentists engaged in radiology already authorized to use 
ionizing radiation but who have not acquired the 
necessary competence in radiation protection. 
Article 4 criteria of acceptability for radiological installations, 
without prejudice to the Community provisions on 
harmonization relating to medical electroradiological 
equipment. 
All installations in use shall be kept under appropriate 
surveillance in regard to procedures relevant to 
radiological protection. 
Member States shall implement the necessary measures 
with a view to improving inadequate or defective 
features of installations subject to such surveillance. In 
extreme cases Member States may require that certain 
installations be removed from service. 
The doctors or dentists engaged in radiology and 
assistants referred to in Article 1 and 3 shall make the 
necessary arrangements to ensure that exposures 
permitted for diagnostic purposes are kept under control 
and as low as reasonably achievable. 
Article 5 
(a) Member States shall set up a system allowing any 
practitioner who may be consulted to ascertain what 
previous radiological examinations a patient has 
undergone. 
(b) Appropriate measures shall ensure that existing 
radiological information or records can be made 
available quickly and without complex formalities to 
other medical or dental practitioners treating the 
patient. Article 7 
Member States shall determine the actual requirements 
of the population with a view to optimizing the 
use of sophisticated departments of radiotherapy, 
radiodiagnosis and nuclear medicine. A trained specialist 
in medical physics shall be at any time available to such 
departments. 
Article 8 
Member States shall take the steps necessary for 
compliance with this Directive before 1 February 1983. 
Member State shall inform the Commission of provisions 
they have made to comply with this Directive. 
Article 6 
Member States shall draw up an inventory of medical 
and dental radiological equipment and shall establish Article 9 
This Directive is addressed to the Member States. 
Proposal for 
I. a Council Directive amending Directives Nos 69/169/EEC and 78/1035/EEC - tax-free 
allowances applied in international travel and to imports of goods in small consignments 
of a non-commercial character: third countries 
a third Council Directive amending Directive No 74/651/EEC on the tax reliefs to be 
allowed on the importation of goods in small consignments of a non-commercial character 
within the Community 
(Submitted by the Commission to the Council on 18 December 1980)