31.12.85 Official Journal of the European Communities No C 347/9 
Communication from the Commission concerning the implementation of Council Directives 
80/836/Euratom of 15 July 1980 amending the Directives laying down the. basic safety 
standards for the health protection of the general public and workers against the dangers of 
ionizing radiation and 84/467/Euratom of 3 September 1984 amending Directive 80/836/ 
Euratom 
(85/C 347/03) 
In the context of the implementation of Council 
Directives 80/836/Euratom of 15 July 1980 amending 
the Directives laying down the basic safety standards for 
the health protection of the general public and workers 
against the dangers of ionizing radiation (') and 84/467/ 
Euratom of 3 September 1984 amending Directive 
80/836/Euratom (2), the Commission, having discussed 
the matter with scientific experts, wishes to communicate 
the following information: 
I. General Remarks 
1. The European Community is required by Article 30 
of the Treaty establishing the European Atomic Energy 
Community to lay down basic standards for the 
protection of people and workers against the dangers of 
ionizing radiation. These standards have been laid down 
in the form of Council Directives. Those Directives have 
always made use of the recommendations of the Inter­
national Commission on Radiological Protection (ICRP) 
and the International Commission on Radiation Units 
and Measurements (ICRU). 
2. The ICRP publications on which the Council 
Directives are based were written with a view to enabling 
the competent international organizations and national 
authorities to prepare legislatives texts. Seen in this light, 
ICRP Publication 26 does not modify the key principles 
of ICRP Publication 9, nor those of the 1976 Directive. 
The Council Directive of 1980, which takes into account 
the information available in Publication 26, should not 
require fundamental changes in the legislations of 
Member States. 
3. The basic principles of justification and 
optimization of exposures, which were formulated in 
ICRP Publication 26 and which are reproduced in Title 
III, Article 6 of the 1980 Directive, are clearly only of 
general value, something which must be taken into 
account when introducing them into national legislative 
and administrative provisions. The third principle (dose 
limits), for its part, can be transformed into national 
legislation in a binding form without restrictions. 
4. Changes introduced by the amended 1980 Directive 
also take into account the exposures of all parts of the 
body, not only of the so-called critical organs previously 
considered. Therefore the system is no less restrictive than previously, while the limits for parts of the body in 
the two systems are not comparable. 
5. The concept of effective dose equivalent which is a 
characteristic of the recommendations contained in 
ICRP Publication 26, is introduced in the 1980 
Directive. This concept is used in the case of partial body 
exposure. The aim is to define, for a given partial body 
exposure, a virtual equivalent whole body dose which 
would involve the same risk. Used by ICRP for 
determining the annual limits of intakes, the concept is 
not, however, always susceptible to direct application in 
routine surveillance. However, in the event of accidents, 
it may be useful to estimate the effective dose equivalent 
on the basis of data compiled in reconstituting the 
accident. 
6. Other changes in the standards are the result of the 
continuing process of evolution in the fields of 
radiobiology and metabolism. Most of these changes 
have influenced the material in the Annexes rather than 
in the Articles themselves. 
II. Comments on some Articles of the Directive (') 
a) TITLE I 
Definitions 
Article 1 
i) The definitions relate to terms used in the Directive. 
Where necessary, guidance on their interpretation is 
given below in the comments on the articles in 
question. 
ii) The word 'exposure' replaces the word 'irradiation', 
because the latter term is usually reserved for the 
intentional use of radiation for specific purposes. 
iii) The concept of 'radioactive contamination' is limited 
to the unwanted presence of any radioactive 
substance on a surface or within a material or a 
living organism. 'Radioactive substance' is, in the 
Directive, defined as any substance containing one or 
more radionuclides, the activity or concentration of 
which cannot be disregarded as far as radiation 
protection is concerned. 
(') OJ No L 246, 17. 9. 1980, p. 1. 
O OJ No L 265, 5. 10. 1984, p. 4. (3) Articles referred to in the document are those of the Council 
Directive of 15 July 1980. 
No C 347/10 Official Journal of the European Communities 31.12. 85 
i 
b) TITLE II 
Scope, reporting and authorization 
Article 2 
This article specifies the scope of the Directive. It is 
intended that the Directive should apply to all practices 
involving radioactive materials and to all equipment 
involving a hazard arising from ionizing radiation, such 
as X-ray equipment and accelerators, etc. It is not 
intended to apply to natural radioactivity other than in 
industrial and technical operations. For example, the 
Directive does not apply directly to radon in dwellings. 
Article 3 
This Article imposes a minimum requirement that 
activities which are not exempt (see Article 4) should be 
reported to the appropriate authority in the Member 
State. For certain activities the Member State is free to 
require prior authorization or not, but for the activities 
specified in Article 5 prior authorization is obligatory. 
Article 4 
The exemptions listed in this Article relate to the proc­
edures for notifications and prior authorization and 
permit the Member State to introduce corresponding 
exemptions nationally. The Article applies limits to the 
form and extent of such exemptions. Since exemptions 
apply to Articles 2 and 3 the exemptions applied by a 
Member State should be such that compliance with 
Articles other than these is not prejudiced, notably 
Articles 8 to 12. 
Article 5 
This Article specifies the types of activity for which 
Member States are obliged to require prior authorization 
(or prohibition). Additionally, the Article removes the 
power to make exemptions in relation to those activities, 
but the formal definition of a radioactive substance in 
Article 1 allows insignificant amounts or concentrations 
of radionuclides to be disregarded. 
c) TITLE III 
Limitation of doses for controllable exposures 
Article 6 
This Article sets out the basic principles of radiation 
protection and thus requires Member States to base their 
procedures on these principles. They are, however, written in fairly general terms and some flexibility is to 
be expected in the way in which they are applied by 
Member States. 
The justification (i.e. the first principle) of any type of 
activity is the duty of competent authority in Member 
States. Compliance with this principle is adequately 
demonstrated in respect of a type of activity by the 
existence or the laying down of regulations specifically 
concerning the type of activity. The second principle 
(optimization) requires that exposures shall be kept as 
low as reasonably achievable below the prescribed limits, 
economic and social factors being taken into account. 
Generally, in routine activities, optimization need not 
involve complex calculations. 
It is implicit in this requirement that the scientific 
considerations should be supplemented by economic and 
social factors. The techniques for judging the need for 
further reductions in exposure in the light of what is 
reasonable, are very diverse. They include for instance 
formal aids to decision-making, such as cost benefit 
analysis, etc. but they are more usually based on simple 
common-sense practices. If an improvement is easy to 
make and commits only few resources, it is sensible, and 
therefore reasonable, to make the improvement. If the 
improvement requires the major commitment of 
resources and produces only small reductions of 
exposure, it is likely to be unreasonable and therefore 
inappropriate. Because the procedures involve a 
combination of scientific, economic and social 
judgements, it is helpful to link them with the decision­
making procedures used in the Member States. 
The third principle requires that the individual doses 
shall not exceed specified limits. The dose limits are 
necessary to protect the most highly exposed individuals 
but they have to be complemented by the application of 
the second principle above. 
Article 8 
This Article establishes the limits for whole body 
exposure of workers. In practice, most situations 
exposing the whole body to highly penetrating radiation, 
such as gamma-rays, can be treated as if they caused a 
uniform distribution of dose throughout the body. In 
such cases it is an adequate approximation to refer to 
this as whole body exposure. For less uniform exposure 
of the body, or for radiations of low penetrating power, 
Article 9 is relevant. 
Article 9 
This Article introduces the effective dose equivalent. This 
quantity is not directly measurable and is intended 
primarily to permit the simple specification in summary 
31.12. 85 Official Journal of the European Communities No C 347/11 
form of any distribution of doses within the human body 
and thus of limits for any kind of distribution. In 
practice, it can be adequately assessed for control 
purposes by the use of quantities such as the readings of 
personal dosemeters or the amount of intakes of radio­
active substances. The limits for intakes are given in 
Annex III of the Directive, which also includes 
corresponding limits for concentrations of radioactive 
substance in the air breathed by workers over the whole 
of a working year. 
Compliance with the limits laid down for partial body 
exposures is evaluated from the results of individual 
dosemeters or in some cases from measurements carried 
out in the working environment. 
Article 12 
This Article deals with dose limits for members of the 
public, for whom personal monitoring is not required. 
Exposures are assessed from indirect estimations. The 
dose limits relate to any year and to individuals on any 
age. Since the doses actually received are not the same in 
all years and at all ages, the average annual dose over a 
lifetime is less than the dose in the year of highest dose. 
In practice, and bearing in mind the provisions of Article 
6, limiting the dose in that year by the requirements of 
Article 12 ensures an adequate limitation of the average 
annual dose over the whole lifetime. The Directive 
therefore contains no specific limit to be applied to the 
lifetime average dose. 
Much of the guidance given under Articles 8 and 9 is 
also relevant to Article 12. 
d) TITLE IV 
Secondary and derived limits 
Articles 14 to 17 
These Articles set out how derived limits, which 
correspond to the dose limits, can be used in practice. 
Their use is not obligatory and other limits authorized 
by the Member State in order to simplify procedures 
may be adopted, the only requirement being that such 
simplifications must not be less retrictive than is required 
by the dose limits in the Directive. 
The limits must be understood as follows: 
— as regards external exposure alone, exposure is usually 
presumed to be whole body exposure and no 
weighting is necessary. A distinction must be applied 
in respect of the different limits for the extremities, 
the skin and the lens of the eye. To translate 
absorbed dose into dose equivalent, in which the 
basic limits are expressed, the quality factors given in Annex II shall be taken into account. In practice, 
quality factors higher than 1 concern only neutrons 
and protons. 
Once a suitable conversion has been made, the limits 
for workers may be applied directly to the results 
obtained from individual dosemeters if these give 
estimates of the dose equivalent at depths of about 10 
mm and 0,07 mm in the body; the dose at 10 mm 
which can be regarded as a whole body dose shall 
remain below 50 mSv (5 rems) in a year; the dose at 
0,07 mm which can be regarded as a dose to the skin 
shall remain below 0,5 Sv (50 rems) in a year. In 
practice, compliance with these two limits will ensure 
compliance with the limits for the lens of the eye 
(150 mSv or 15 rems in a year); 
— as regards internal exposure alone, homogenous or 
otherwise, the dose limits set out in the Directive 
constitute a theoretical reference, but exposure is 
normally evaluated by reference to secondary limits 
constituted by the limits of annual intake indicated in 
Annex III. It should be noted that in the case of 
mixtures of radionuclides the rules which apply are 
defined in point 2 of this Annex. 
The annual intakes for workers are estimated on the 
bases of in vivo gamma measurements, excretion 
analysis, measurement of activities in air, as appro­
priate. They must be less than the corresponding 
annual limits of intakes indicated, for each radio­
nuclide, in Annex III. In the case of mixtures, the 
sum of the ratios of the annual intakes to the limits 
of annual intake must be less than unity. 
In the case of natural uranium and natural thorium 
the isotopes to take into consideration are only for: 
— uranium: the isotopes U-238, U-234 and U-235, 
— thorium: the isotopes Th-232 and Th-228. 
Apart from the case of natural uranium and U-238 
for which chemical toxicity has also to be taken into 
account, these limits for exposed workers may be 
deemed to be complied with if the annual average 
activity per unit volume measured in the working 
environment under consideration is less than the 
corresponding derived limit of concentration given in 
Annex III. 
For members of the public, the annual limits of 
intake by inhalation and ingestion, given in Annex 
III, may be deemed to be complied with if the annual 
average activities per unit volume measured in air, 
water and foodstuffs are less than the corresponding 
derived limits laid down by the competent authorities 
in the Member State on the basis of the data in this 
Annex account having been taken of the different 
pathways of transfer. 
No C 347/12 Official Journal of the European Communities 31.12.85 
The effective dose equivalent for members of the 
public is based on the same weighting factors for 
organs and tissues as those used for workers; 
— as regards combinations of external and internal 
exposure, the combination of the above-mentioned 
limits does not mean that the doses have to be added. 
In routine situations, an equation of the type shown 
in Annex IIGa) shall be used, the additional 
condition laid down in the Annex IIGb) for limiting 
the exposures of the lens of the eyes, of the skin and 
of the extremities having been taken into account, 
thus limiting the exposures to ensure that the limits 
referred to in Title III are complied with. 
f) TITLE VI 
Fundamental principles governing operational protection 
of exposed workers 
The Directive considers separately the classification of 
areas and that of workers because they are not exactly 
parallel, since the classification of areas does not take 
into consideration the time which workers spend in the 
area during the year and since conditions are rarely 
uniform throughout an entire area. 
Article 19 
The practical procedures for classifying working areas 
and exposed workers are intended to simplify working 
arrangements and to ensure that workers are aware both 
of their own status and of the likely conditions in their 
places of work. The procedures are particularly useful in 
protecting workers who do not work all the time in one 
single workplace, e.g. cleaners, maintenance workers and 
specialist advisers. 
Articles 20 to 22 
In working areas in which the doses are not liable to 
exceed one-tenth of the annual dose limits laid down for 
exposed workers, it is not necessary to adopt special 
radiation protection measures. In line with the ICRP 
recommendations, the Directive distinguishes between: — controlled areas, in which doses are liable to exceed 
three-tenths of the annual dose limits. Controlled 
areas must be delineated and, as a minimum 
requirement, access to them must be regulated with 
the aid of appropriate signs. Supplementary measures 
may have to be adopted depending on the nature of 
the working conditions and on the magnitude of the 
risk; 
— 'supervised areas', which are generally contiguous on 
the controlled areas and in which the exposure of 
workers is liable to exceed one-tenth of one of the 
annual limits of dose equivalent. There is no 
obligation to delineate these supervised areas or to 
signpost them, but appropriate measures must be 
adopted, in particular concerning environmental 
dosimetry, the marking of sources, and the use of 
intrinsically safe equipment. 
Articles 26 to 31 
Experience has shown that in the Member States of the 
European Community the average level of occupational 
exposure to ionizing radiation is low and that accidents 
are infrequent due to the laying down of provisions in 
compliance with the Euratom Safety Standards. It is the 
responsibility of the competent authorities in each 
Member State to define any limits above which the result 
of radiological monitoring is considered significant 
enough to warrant recording and keeping in the medical 
files or archives. 
Articles 35 
To protect medically confidential information, the only 
information in the medical record that has to be 
disclosed is the formal classification of the worker's 
fitness for work: 
— fit, 
— fit subject to certain conditions, 
— unfit. 
Communication from the Commission pursuant to Article 9 (9) of Council Regulation (EEC) 
No 3420/83 of 14 November 1983 
(85/C 347/04) 
By virtue of Article 9 (1) of Council Regulation (EEC) No 3420/83 of 14 November 1983 on 
import arrangements for products originating in State-trading countries, not liberalized at 
Community level ('), the Commission had adopted the following changes to the import 
arrangements applied in the Federal Republic of Germany, in Italy, in the Benelux countries, in 
Denmark and in Ireland with regard to certain State-trading countries with effect from 
20 December 1985. 
The quantitative restrictions on the release for free circulation in the Member States specified 
in the Annex, of the goods therein indicated, originating in the State-trading countries listed 
opposite each product, are hereby abolished. 
O OJ No L 346, 8. 12. 1983, p. 6.