EUROPEAN COMMISSION 
Brussels, 29.9.2011 
SEC(2011) 1099 final 
  
COMMISSION STAFF WORKING PAPER 
EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT 
Accompanying the document 
COUNCIL DIRECTIVE 
laying down basic safety standards for protection against the dangers arising from 
expsoure to ionising radiation 
{COM(2011) 593 final} 
{SEC(2011) 1098 final}  
 
EN 2   EN 1. Problem definition 
1.1. Introduction 
Exposure to ionising radiation re sults in a health detriment. In normal situations doses are 
very low so that there is no clinically observabl e tissue effect, but there still is a possible late 
effect, cancer in particular. It is assumed that any exposure, how ever small, can be the cause 
of cancer later in life. This calls for a speci fic approach in radia tion protection, which has 
been established for many decades by th e International Commission on Radiological 
Protection (ICRP).  
The need to protect health as  well as the environment has b een recognised in the Euratom 
Treaty (1957) and there are spec ific provisions laid down in Ch apter III, Health and Safety, 
addressing these concerns. Article 31 of the Treat y calls for uniform Basi c Safety Standards to 
be established.  
Article 31 of the Euratom Treaty also lays down the procedure for the establishment of these 
Standards, in particular that the Commission shall seek the opinion of a Group of Experts 
("Article 31 Experts"). In ge neral, new legislation is drafted jointly by the Commission 
services and the Experts.  
The Community legislation has always followed the recommenda tions of ICRP. This highly 
respected scientific organisati on has recently issued new guidan ce on the system of protection 
(Publication 103, 2007) reflecting la test scientific findings on ra diation risks and defining the 
system of radiological protection.  
1.2. Problem definition 
The current system to protect workers and the public from the effects of ionising radiation 
does not respond to the latest scientific findings an d new societal and technological 
developments.  
In detail: 
– Health protection of workers and the public  does not respond to latest scientific 
progress 
– Protection of workers in NORM industries and in specific professional groups such 
as Outside Workers and interventional radiologists is insufficient 
– Health protection of patients and the public  does not respond to latest advances in 
technologies 
– Health protection of the public from na tural radiation sources is insufficient 
– The risk of ionising radiation for non-human s species, or the environment as a whole, 
is not explicitly addressed, contrary to international recommendations 
– The current legal framework for ra diation protection is too complex. 
 
EN 3   EN In the light of these developments the Comm ission undertook a comprehensive review of the 
Community radiation protection le gislation and asked the "Artic le 31 Experts"  to provide 
guidance on this matter. In February 2010, the Experts issued an opinion on the possible revision of Community le gislation, on the basis of  a draft Directive.  
2. Subsidiarity 
According to Article 2(b) of the Euratom Treaty "…the Community shall, as provided in this 
Treaty ….establish uniform safety  standards to protect the he alth of workers and of the 
general public and ensure that they are applie d". Accordingly, in the Treaty's preamble, the 
Member States declare that they are "resolved to create the conditions necessary for the development of a strong nuclear industry" and also "anxious to create conditions of safety 
necessary to eliminate hazards to the life and health of the public". The Community is 
mandated to "establish uniform sa fety standards to protect the health of workers and of the 
general public and ensure that they are applie d." Therefore, the comp etence of the European 
Atomic Energy Community (EAEC) to regulate in the field of heal th protection against 
ionizing radiation is explicitly recognised by the Euratom Treaty. 
The exclusive nature of the Euratom Commun ity's legislative power s under Articles 30 and 
31 of the Euratom Treaty does not in principle require the application of the principle of 
subsidiarity. On the other hand these Article s require the Commission to seek for its 
legislative proposals the opinion of a Group of Experts nominated by the Euratom Scientific 
and Technical Committee and working as inde pendent experts for the benefit of the 
Community.  
3. Main policy objectives 
The general objective of the initiative is to en sure a high level of protection of workers, 
members of the public and patients against the health detriment caused by exposure to 
ionising radiation, as well as to protect the environment. 
This general objective is translat ed into four specific objectives: 
1. to introduce the necessary subject matter amen dments in order to respond to the latest 
scientific data and operational experience, 
2. to clarify the requirements and to ensure  coherence within th e body of Community 
legislation, 
3. to ensure coherence with the intern ational standards and recommendations, 
4. to cover the whole range of exposure s ituations and categories of exposure. 
4. Policy options 
After thorough analysis of different soluti ons to the identified problem areas, and 
consideration of different solutio ns in terms of the extent of  simplification, update and scope 
of the legislation, the following options  were chosen for further assessment: 
Option 1: Maintaining the stat us quo of existing legislation, 
 
EN 4   EN Option 2: Revision of Basic Safety Standards and Medical Directive, 
Option 3: Revision and consolidation of Basic Safety Standards and Medical Directive, and 
integration of the Outside Workers Directive, the Public Information Directive and the High 
Activity Sealed Sources Directive, 
Option 4: Revision of the Basi c Safety Standards Directive a nd broadening the scope to cover 
public exposure to natural radiation, 
Option 5: Revision of the Basi c Safety Standards Directive a nd broadening the scope to cover 
protection of non-human species, 
Option 6: Revision and consolidation of the Ba sic Safety Standards Directive and Medical 
Directive, integration of the Outside Workers Directive, the Public Information Directive and the High Activity Sealed Sources Directive and broadening the scope to cover public 
exposure to natural radiation and protection of non-human species. 
5. Assessment of impacts 
5.1. Option 1: Maintaining the stat us-quo of existing legislation 
This option obviously does not fully meet the speci fic objectives of this  initiative. The Basic 
Safety Standards Directive adopted in 1996 was a guarantee for adequate protection of 
workers and members of the public, in the same way as the Medical Directive in 1997 was a 
milestone in the protection of patients. Howeve r, science and society have evolved since, 
operational experience has shown a need for updating certain requirements, technological 
developments challenge the adequateness of the existing legislation and there are new societal 
expectations with regard to the coherent management of na tural and man-made radiation 
sources as well as with regard to the protection of the environment.  
Within this option an analysis was made to what extent the international Basic Safety 
Standards (IBSS) could fill the gap. The IBSS have a different purpose, however: they are 
non-binding and have a lower level of ambition in view of their application by developing countries. In the light of the Community's obligations in the Tr eaty, corresponding new 
national law should be based on Community legislation. 
5.2. Option 2: Amendment of the main affected Directives 
This option considers how the two main pieces of  legislation could be amended separately in 
the light of operational experi ence and new developments. The amendments could address 
most of the identified problems: 
A) In the Basic Safety Standards Directive: 
– introduction of the new ICRP methodology for the assessment of doses, and reduction of 
the organ dose limit for the lens-of-the-eye; 
– a coherent approach to the management of  NORM (i.e. naturally occurring radioactive 
material) industries; 
 
EN 5   EN – a graded approach to regulatory control, co mmensurate with the effectiveness of such 
oversight, including uniform clearance levels  (e.g. for materials arising from the 
dismantling of decommissione d nuclear installations); 
B) In the Medical Directive: – strengthened requirements for th e protection of patients as well as on risk assessment, 
reporting and response to accidental expos ures especially in radiotherapy; 
– a new approach to " medico-legal exposures " to allow for the grow ing use of devices for 
security screening, now regarded as public exposures under the Ba sic Safety Standards 
Directive. 
The above amendments would have an important impact within the following areas: 
• Economic impact:
 While it is not possible at this stage to make a quantified economic 
assessment, NORM industries will benefit fr om the harmonisation of the requirements 
between Member States. The introduction of  uniform clearance levels may in addition 
have a considerable impact on reducing the co st of dismantling of nuc lear installations; 
• Social and health impact : The social impact relates to providing adequate protection to 
workers in NORM industries. The health imp act will be most notable with regard to 
medical exposures, in particular to prev ent that frequent CT-scans of young patients 
would show up through an increased cancer  incidence many years later. Specific 
professional groups (for instance cardiologists)  will benefit from the reduction of the dose 
limit to the lens-of-the-eye and a void the occurrence of cataract. 
• Regulatory burden:  While the principle of Optimisation of protection, calling for doses to 
be "As Low As Reasonably Achievable" (ALA RA), taking social and economic factors 
into account, is very instrumental in ensu ring a proper cost-benefit balance of operational 
radiation protection, the new concept of a “g raded approach” extends this principle to 
enhance the effectiveness of regulatory oversig ht and reduce the administrative burden to 
industries. 
5.3. Option 3: Revision and consolidation of  Basic Safety Standards and Medical 
Directive, and integration of the Outside Workers Directive, the Public Information 
Directive and the High Activity Sealed Sources Directive. 
This option offers a revision of the BSS Directive, extending the requirements to medical 
exposure, public information, outside worker s exposure and high-activ ity sealed sources. 
Within this policy the BSS Directive 96/29 and th e related legislative ac ts would merge. This 
option relies on non-legislative measures for solv ing the problems related to the protection 
from natural radiation sources and the risks of  ionising radiation to non-human species. In 
addition to the changes considered in opti on 2, this option would include the following 
amendments: 
• harmonisation of the definition of High Ac tivity Sealed Sources (HASS) with the 
international standards; 
 
EN 6   EN • specific requirements for the protection of Ou tside Workers with a clear definition of the 
responsibilities of their employer and of the undertakings conducting the practices in 
which they are exposed; 
• requirements for informing the public before and in case of an emergency, within the 
overall revised scope for the management  of emergency exposure situations. 
Merging the five Directives would be a majo r achievement in terms of the coherence of 
Community legislation. The rest ructuring required to accommodate  this broader scope of the 
BSS Directive would further benefit to the clar ity of the text and to  better operational 
implementation of the requirements. While option 3 conserves the economic, social and 
health benefits of option 2, and increases the impact in some of these aspects for instance through better protection and enhanced mobility of outside workers, the main benefit of option 3 lies with the simplification of Commu nity legislation and corresponding reduction of 
the regulatory burden, both in term s of transposition in national law and in operational terms. 
Guidance on establishment of national action plan s for reducing the risks from indoor radon 
exposure will again draw the atte ntion of the Member States to this problem and possible 
actions for solving it. However this action will have added value only if Member States follow the proposed advice, which in the absenc e of binding requirements is probably not the 
case. 
5.4. Option 4: Revision of the Basic Safety St andards Directive and broadening the scope 
to cover public exposure to natural radiation  
The new recommendations of ICRP allow a more  coherent management of exposures to 
natural radiation sources, defining reference levels  for indoor radon concentrations and for 
external exposure from building materials. 
As underlined by WHO, the health impact of  binding requirements for radon in dwellings 
should be very important. Member States will be required to establish a comprehensive and 
transparent Action Plan, adjusted to national need s and to the geological features of different 
regions. The implementation and enforcemen t of the national Action Plan are the 
responsibility of member States. 
Harmonised requirements on building materials will permit further stan dardisation under the 
EC Construction Products legislation (Council Di rective 89/106/EEC). This will however also 
represent a cost to the industry. While consum ers and the building professions will benefit 
from the monitoring and labelling of the material s, the administrative burden to the industry 
will be kept to a minimum by the proper choice of the reference level  and through the list of 
types of materials deemed to be of concern. 
5.5. Option 5: Revision of the Basic Safety St andards Directive and broadening the scope 
to cover protection of non-human species  
ICRP now offers a methodology for the assessment of exposure to biota. The incorporation of 
relevant requirements in the Euratom BSS (as well as in the new international BSS) allows Member States to incorporate this in nationa l environmental policies, in a way which is 
coherent with current approaches to heal th protection against ionizing radiation. The 
environmental impact of this expanded scope of Community legislati on should be essentially 
 
EN 7   EN in terms of a better understanding of the absenc e of any impact in norm al situations, and the 
prevention of environmental damage in case of a nuclear accident. 
The requirements for the protecti on of the environment are not ve ry demanding at this stage. 
In addition to the methodology for the assessment  of exposures to bi ota (Publication 108), 
ICRP will provide guidance on the application of  a radiation protection system in 2011-2012. 
So there would still be time, before adopti on of the Directive by th e Council, to include 
harmonised criteria on this basis. The Article  31 Experts therefore recommended to include 
the requirements already now in the Commissi on proposal, rather than  adding another piece 
of legislation a few years later,  which would be contrary to th e simplification policy of the 
Commission. 
5.6. Option 6: Revision and consolidation of th e Basic Safety Standards Directive, the 
Medical Directive and integration of the Outside Workers Directive, the Public 
Information Directive and the High Activ ity Sealed Sources Directive, and 
broadening the scope to cover public exposur e to natural radiati on and protection of 
non-human species 
This option includes all the elements of Option 3. The revision of the Basic Safety Standards 
includes all identified issues, and broadens th e scope to include the whole range of exposure 
situations, including indoor public exposure to  radon and to building materials, and all 
categories of human and non-human exposures. 
6. Comparison of the options 
The different options have been compared on the basis of their effectiveness, efficiency and 
their coherence with other legi slation. Option 1 partia lly satisfies the general objective of the 
action. It is included as a ba seline scenario for the comparis on of the other options. Option 2 
fully responds to the first objective and impr oves to some extent the coherence of Euratom 
radiation protection legislation an d is also coherent with intern ational standards, thus meeting 
three of the specific objectives. Option 3 fully meets the objective of co herence and clarity. It 
also meets the Commission's policy of simplification. 
Options 4 and 5 fully meet the objective of coherence with international recommendations. 
These options broaden the scope of current legislation and this may imply a certain 
administrative and economic cost. Option 6 combines Options 4 and 5, thus covering, 
together, the whole range of i ssues in radiation protection. Option 6 consolidates also all 
legislation in the same way as Option 3. In co nclusion, with Option 6 all the objectives are 
reached effectively through a set of efficient meas ures. It is also the option which offers the 
best possible coherence with other legislati on. Summary comparison table is given in Annex 
1. 
7. Monitoring and evaluation 
Under Article 33 of the Euratom Treaty, Member States will submit draft legislation and 
administrative provisions to the Commission so that it can ensure the harmonisation of the 
approaches. The correct transpos ition of the Directive in national law will be a key indicator 
for its success in terms of clarity and simplification.  
 
EN 8   EN Annex 1 Summary of the comparison of options 2 to 6 
Impact Option 2 Option 3 Option 4 Option 5 Option 6 
Economic  (+) (+) (+) (+) (+) 
Functioning of the internal market (+) (+) (+) (+) (+) 
Administrative burden on 
businesses (+) (+) (+)(-) 
 (+) 
(-) (+)(-) 
Regulatory authorities (-) (+) (-) (-) (+)(--) 
Environment  (+) (+) (+) (++) (++) 
Protection of the environment (+) (+) (+) (++) (++) 
Social and Health (+) (++) (++) (+) (++) 
Health and safety at work (+) (++) (+) (+) (++) 
Mobility of workers and experts (+) (+)  (+) (+) (+) 
Protection of patients (+) (+)   (+) 
Protection of the public (+) (+) (++) (+) (++) 
Coherence and clarity of 
legislation (+) (++) (+) 
 (+) (++) 
International coherence (+) (+) (+) (+) (++) 
Overall impact + ++ ++ + +++