COMMISSION STAFF WORKING PAPER EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT
Date: 2011-09-29
Institutions: European Commission
Subjects: health policy, impact study, ionising radiation, radiation protection, safety standard

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} 

 
 
 
 
  
 
1. 

Problem definition 

1.1. 

Introduction 

Exposure  to  ionising  radiation  results  in  a  health  detriment.  In  normal  situations  doses  are 
very low so that there is no clinically observable tissue effect, but there still is a possible late 
effect, cancer in particular. It is assumed that any exposure, however small, can be the cause 
of  cancer  later  in  life.  This  calls  for  a  specific  approach  in  radiation  protection,  which  has 
been  established  for  many  decades  by  the  International  Commission  on  Radiological 
Protection (ICRP).  

The  need  to  protect  health  as  well  as  the  environment  has  been  recognised  in  the  Euratom 
Treaty (1957) and there are specific provisions laid down in Chapter III, Health and Safety, 
addressing these concerns. Article 31 of the Treaty calls for uniform Basic 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  general,  new  legislation  is  drafted  jointly  by  the  Commission 
services and the Experts.  

The Community legislation has always followed the recommendations of ICRP. This highly 
respected scientific organisation has recently issued new guidance on the system of protection 
(Publication 103, 2007) reflecting latest scientific findings on radiation 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  and  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 natural radiation sources is insufficient 

The risk of ionising radiation for non-humans species, or the environment as a whole, 
is not explicitly addressed, contrary to international recommendations 

The current legal framework for radiation protection is too complex. 

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In the light of these developments the Commission undertook a comprehensive review of the 
Community  radiation  protection  legislation  and  asked  the  "Article  31  Experts"  to  provide 
guidance  on  this  matter.  In  February  2010,  the  Experts  issued  an  opinion  on  the  possible 
revision of Community legislation, 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  health  of  workers  and  of  the 
general  public  and  ensure  that  they  are  applied".  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  safety  standards  to  protect  the  health  of  workers  and  of  the 
general public and ensure that they are applied." Therefore, the competence of the European 
Atomic  Energy  Community  (EAEC)  to  regulate  in  the  field  of  health  protection  against 
ionizing radiation is explicitly recognised by the Euratom Treaty. 

The  exclusive  nature  of  the  Euratom  Community's  legislative  powers  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  Articles  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  independent  experts  for  the  benefit  of  the 
Community.  

3. 

Main policy objectives 

The  general  objective  of  the  initiative  is  to  ensure  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 translated into four specific objectives: 

1.  to  introduce  the  necessary  subject  matter  amendments  in  order  to  respond  to  the  latest 

scientific data and operational experience, 

2.  to  clarify  the  requirements  and  to  ensure  coherence  within  the  body  of  Community 

legislation, 

3.  to ensure coherence with the international standards and recommendations, 

4.  to cover the whole range of exposure situations and categories of exposure. 

4. 

Policy options 

After  thorough  analysis  of  different  solutions  to  the  identified  problem  areas,  and 
consideration of different solutions 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 status quo of existing legislation, 

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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 Basic Safety Standards Directive and broadening the scope to cover 
public exposure to natural radiation, 

Option 5: Revision of the Basic Safety Standards Directive and broadening the scope to cover 
protection of non-human species, 

Option  6:  Revision  and  consolidation  of  the  Basic  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 status-quo of existing legislation 

This option obviously does not fully meet the specific 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.  However,  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  natural  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  Treaty,  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  experience  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; 

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–  a  graded  approach  to  regulatory  control,  commensurate  with  the  effectiveness  of  such 
oversight,  including  uniform  clearance  levels  (e.g.  for  materials  arising  from  the 
dismantling of decommissioned nuclear installations); 

B) In the Medical Directive: 

–  strengthened  requirements  for  the  protection  of  patients  as  well  as  on  risk  assessment, 

reporting and response to accidental exposures especially in radiotherapy; 

–  a  new  approach  to  "medico-legal  exposures"  to  allow  for  the  growing  use  of  devices  for 
security  screening,  now  regarded  as  public  exposures  under  the  Basic  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  from  the  harmonisation  of  the  requirements 
between  Member  States.  The  introduction  of  uniform  clearance  levels  may  in  addition 
have a considerable impact on reducing the cost of dismantling of nuclear installations; 

•  Social  and  health  impact:  The  social  impact  relates  to  providing  adequate  protection  to 
workers  in  NORM  industries.  The  health  impact  will  be  most  notable  with  regard  to 
medical  exposures,  in  particular  to  prevent  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 avoid the occurrence of cataract. 

•  Regulatory burden: While the principle of Optimisation of protection, calling for doses to 
be  "As  Low  As  Reasonably  Achievable"  (ALARA),  taking  social  and  economic  factors 
into account, is very instrumental in ensuring a proper cost-benefit balance of operational 
radiation  protection,  the  new  concept  of  a  “graded  approach”  extends  this  principle  to 
enhance the effectiveness of regulatory oversight 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  workers  exposure  and  high-activity  sealed  sources. 
Within this policy the BSS Directive 96/29 and the related legislative acts would merge. This 
option  relies  on  non-legislative  measures  for  solving  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  option  2,  this  option  would  include  the  following 
amendments: 

•  harmonisation  of  the  definition  of  High  Activity  Sealed  Sources  (HASS)  with  the 

international standards; 

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•  specific requirements for the protection of Outside 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  major  achievement  in  terms  of  the  coherence  of 
Community legislation. The restructuring required to accommodate this broader scope of the 
BSS  Directive  would  further  benefit  to  the  clarity  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 Community legislation and corresponding reduction of 
the regulatory burden, both in terms of transposition in national law and in operational terms. 
Guidance on establishment of national action plans for reducing the risks from indoor radon 
exposure  will  again  draw  the  attention  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 absence of binding requirements is probably not the 
case. 

5.4. 

Option 4: Revision of the Basic Safety Standards 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 needs and to the geological features of different 
regions.  The  implementation  and  enforcement  of  the  national  Action  Plan  are  the 
responsibility of member States. 

Harmonised requirements on building materials will permit further standardisation under the 
EC Construction Products legislation (Council Directive 89/106/EEC). This will however also 
represent  a  cost  to  the  industry.  While  consumers  and  the  building  professions  will  benefit 
from the monitoring and labelling of the materials, 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 Standards 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  national  environmental  policies,  in  a  way  which  is 
coherent  with  current  approaches  to  health  protection  against  ionizing  radiation.  The 
environmental impact of this expanded scope of Community legislation should be essentially 

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in terms of a better understanding of the absence of any impact in normal situations, and the 
prevention of environmental damage in case of a nuclear accident. 

The requirements for the protection of the environment are not very demanding at this stage. 
In  addition  to  the  methodology  for  the  assessment  of  exposures  to  biota  (Publication  108), 
ICRP will provide guidance on the application of a radiation protection system in 2011-2012. 
So  there  would  still  be  time,  before  adoption  of  the  Directive  by  the  Council,  to  include 
harmonised  criteria on this  basis.  The  Article 31 Experts therefore recommended to include 
the requirements already now in the Commission proposal, rather than adding another piece 
of  legislation  a  few  years  later,  which  would  be  contrary  to  the  simplification  policy  of  the 
Commission. 

5.6. 

Option  6:  Revision  and  consolidation  of  the  Basic  Safety  Standards  Directive,  the 
Medical  Directive  and  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 

This option includes all the elements of Option 3. The revision of the Basic Safety Standards 
includes all identified issues, and broadens the 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 legislation. Option 1 partially satisfies the general objective of the 
action. It is included as a baseline scenario for the comparison of the other options. Option 2 
fully  responds  to  the  first  objective  and  improves  to  some  extent  the  coherence  of  Euratom 
radiation protection legislation and is also coherent with international standards, thus meeting 
three of the specific objectives. Option 3 fully meets the objective of coherence 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  issues  in  radiation  protection.  Option  6  consolidates  also  all 
legislation  in  the  same  way  as  Option  3.  In  conclusion, with Option 6 all the objectives are 
reached effectively through a set of efficient measures. It is also the option which offers the 
best possible coherence with other legislation. 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 transposition of the Directive in national law will be a key indicator 
for its success in terms of clarity and simplification.  

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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 
businesses 

burden 

on 

(+) 

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 
legislation 

and 

clarity 

of 

(+) 

(++) 

(+) 

(+) 

(+)(-) 

(-) 

(+) 

(+) 

(++) 

(+) 

(+) 

(++) 

(+) 

(+) 

(+) 

(+) 

(-) 

(-) 

(++) 

(++) 

(+) 

(+) 

(+) 

(+) 

(+) 

(+) 

(+) 

(+)(-) 

(+)(--) 

(++) 

(++) 

(++) 

(++) 

(+) 

(+) 

(++) 

(++) 

International coherence 

(+) 

(+) 

(+) 

(+) 

(++) 

Overall impact 

+ 

++ 

++ 

+ 

+++ 

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