Proposal for a COUNCIL DIRECTIVE laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation
Date: 2011-09-29
Institutions: European Commission
Subjects: apparatus based on the use of rays, carcinogenic substance, environmental impact, health risk, ionising radiation, nuclear accident, nuclear medicine, occupational safety, radiation protection, radioactive pollution, safety standard

EUROPEAN COMMISSION 

Brussels, 29.9.2011 
COM(2011) 593 final 

2011/0254 (NLE) 

Proposal for a 

COUNCIL DIRECTIVE 

laying down basic safety standards for protection against the dangers arising from 
exposure to ionising radiation 

Draft presented under Article 31 Euratom Treaty for the opinion of the European 
Economic and Social Committee 
{SEC(2011) 1098 final} 
{SEC(2011) 1099 final} 

 
 
  
 
EXPLANATORY MEMORANDUM 

1. Context 

1.1. Background and objectives 

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  there  is  no  dose  threshold  for  this  effect:  any 
exposure, however small, can be the cause of cancer later in life. It is further assumed that the 
probability of occurrence of a late effect is proportional to the dose. This calls for a specific 
approach in radiation protection based on the three principles of justification, optimisation and 
dose  limitation,  which  are  the  cornerstones  of  the  system  of  protection  established  many 
decades ago by the International Commission on Radiological Protection (ICRP).  

Euratom  legislation  has  always  followed  the  recommendations  of  the  ICRP.  This  highly 
respected scientific organisation has recently issued new guidance on the system of radiation 
protection (Publication 103, 2007). While preserving the three pillars of the system, the ICRP 
sets out in more detail the application of the principles throughout any exposure situation and 
irrespective  whether  the  source  of  radiation  is  man-made  or  natural.  Radiation  protection 
indeed covers not only exposures resulting from the operation of radiation sources (planned 
exposure  situations),  but  also  emergency  exposure  situations,  for  instance  resulting  from  a 
nuclear  accident,  and  a  range  of  other  situations,  in  particular  those  involving  exposure  to 
natural  radiation  sources,  termed  ‘existing  exposure  situations’.  The  ICRP  has  also  updated 
the methodology for assessment of the effective dose as well as the application of dose limits, 
in the light of the latest scientific information. 

A  large  proportion  of  workers  in  industries  processing  naturally  occurring  radioactive 
materials (NORM) receive doses above the dose limit for members of the public, but still do 
not  benefit  from  protection  as  occupationally  exposed  workers.  This  anomaly  is  not 
sustainable, so the ICRP’s new Recommendations aim to integrate natural radiation sources 
within  the  overall  system.  Already  in  1996,  the  current  Euratom  legislation1  had  introduced 
requirements for work activities involving natural radiation sources. These were put together 
in  a  separate  Title  rather  than  being  integrated  within  the  overall  radiation  protection 
framework.  In  addition,  maximum  flexibility  was  offered  to  Member  States  to  decide  for 
instance  which  NORM  industries  were  of  concern.  This  has  led  to  wide  differences  in 
controlling NORM industries and in protecting workers in these industries. This situation is 
not compatible with Euratom’s role in setting uniform standards.  

Exposure  to  indoor  radon,  a  natural  radioactive  noble  gas  entering  dwellings  from  the  soil 
below,  is  far  more  important  than  exposure  from  any  other  radiation  source.  Recent 
epidemiological studies have confirmed that lung cancer may be caused by exposure to radon, 
and  WHO2  now  ranks  this  as  a  major  health  issue3.  Exposure  to  radon  in  dwellings  was 
addressed  in  1990  in  a  Commission  Recommendation.  The  confirmed  causation  of  lung 

1 

2 
3 

Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection 
of the health of workers and the general public against the dangers arising from ionising radiation, OJ 
L 159, 29.6.1996, p. 1. 
World Health Organisation. 
WHO Handbook on indoor radon, World Health Organisation, 2009, ISBN 978 92 4 154767. 

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cancer  by  exposure  to  radon  calls  for  strengthening  radon  mitigation  policies  in  Europe 
through  binding  requirements.  Radioactivity  in  building  materials  has  been  included  in  the 
Construction  Products  Directive4,  but  this  has  still  not  led  to  any  corresponding  standards 
being  adopted  by  the  European  Committee  for  Standardisation  (CEN).  The  revision  of  the 
Basic Safety Standards (BSS) Directive will not only address the recycling of residues from 
NORM industries into building materials, but also ensure coherent and harmonised protection 
against other building materials with enhanced levels of radioactivity. 

In  addition  to  the  health  protection  of  people,  the  ICRP  radiation  protection  system  now 
addresses the protection of biota against exposure to ionising radiation. While it is generally 
assumed that the exposure of biota does not call for additional measures, this assumption now 
needs  to  be  demonstrated  through  compliance  with  criteria  and  on  the  basis  of  an  agreed 
methodology.  

There  is  a  significant  body  of  Euratom  legislation  addressing  different  radiation  protection 
issues defined as basic safety standards in the Euratom Treaty. As these issues have developed 
over a long period of time, there are inevitably quite a few inconsistencies between different 
acts and also obsolete references as a result of updated legislation. These inconsistencies need 
to  be  resolved,  in  line  with  the  Commission’s  policy  for  simplification  of  European 
legislation. 

The problem can be summarised as follows:  

– 

– 

– 

Scientific progress is not fully reflected in present legislation; 

There are inconsistencies between the existing pieces of legislation; 

The scope of the present legislation does not fully cover natural radiation sources or 
the protection of the environment.  

This translates into four specific objectives: 

– 

– 

– 

– 

to  introduce  the  necessary  subject-matter  amendments  in  order  to  respond  to  the 
latest scientific data and operational experience, 

to  clarify  the  requirements  and  to  ensure  coherence  within  the  body  of  European 
legislation, 

to ensure coherence with the international recommendations, 

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

1.2. 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 

4 

Council Directive 89/106/EEC, Annex 1, states that ‘the construction work must be designed and built 
in  such  a  way  that  it  will  not  be  a  threat  to  the  hygiene  or  health  of  the  occupants  or  neighbours,  in 
particular as a result of … the presence of dangerous particles or gases in the air [or] the emission of 
dangerous radiation’. 

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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’. Euratom 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, Euratom’s competence to regulate in the field of 
health protection against ionising radiation is explicitly recognised by the Euratom Treaty. 

The exclusive nature of Euratom’s legislative powers under Articles 30 and 31 of the Euratom 
Treaty  does  not  in  principle  require  the  application  of  the  principle  of  subsidiarity.  These 
Articles require the Commission to seek for its legislative proposals the opinion of a Group of 
Experts designated by the Euratom Scientific and Technical Committee. 

1.3. Current legislation 

Following  the  entry  into  force  of  the  Euratom  Treaty,  a  comprehensive  set  of  legislation 
establishing basic safety standards has been enacted on the basis of Article 31 of the Treaty. 

The  main  pillar  of  that  legislation  is  Council  Directive  96/29/Euratom  laying  down  basic 
safety standards for the protection of the health of workers and the general public against the 
dangers arising from ionising radiation (Euratom BSS Directive). Further legislation based on 
Article 31 of the Euratom Treaty comprises: 

-  Council  Decision  87/600/Euratom  of  14  December  1987  on  Community  arrangements  for 
early exchange of information in the event of a radiological emergency; 

-  Council  Regulation  3954/87/Euratom  of  22  December  1987  laying  down  maximum 
permitted  levels  of  radioactive  contamination of  foodstuffs  and  of  feedingstuffs  following  a 
nuclear accident or any other case of radiological emergency and the related legislative acts, 
Commission Regulation 944/89/Euratom of 12 April 1989 laying down maximum permitted 
levels  of  radioactive  contamination  in  minor  foodstuffs  following  a  nuclear  accident  or  any 
other  case  of  radiological  emergency,  and  Commission  Regulation  770/90/Euratom  of  29 
March  1990  laying  down  maximum  permitted  levels  of  radioactive  contamination  of 
feedingstuffs following a nuclear accident or any other case of radiological emergency5; 

-  Council  Directive  89/618/Euratom  of  27  November  1989  on  informing  the  general  public 
about  health  protection  measures  to  be  applied  and  steps  to  be  taken  in  the  event  of  a 
radiological emergency (Public Information Directive); 

- Commission Recommendation 90/143/Euratom of 21 February 1990 on the protection of the 
public against indoor exposure to radon; 

-  Council  Directive  90/641/Euratom  of  4  December  1990  on  the  operational  protection  of 
outside workers exposed to the risk of ionising radiation during their activities in controlled 
areas (Outside Workers Directive); 

5 

These  acts  are  subject  to  recast  —  proposal  for  a  Council  Regulation  (EURATOM)  laying  down 
maximum permitted levels of radioactive contamination of foodstuffs and of feedingstuffs following a 
nuclear  accident  or  any other  case of  radiological  emergency  (recast), COM/2010/0184 final  —  CNS 
2010/009. 

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- Council Regulation 1493/93/Euratom of 8 June 1993 on shipments of radioactive substances 
between Member States; 

- Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against 
the  dangers  of  ionising  radiation  in  relation  to  medical  exposure,  repealing  Directive 
84/466/Euratom of 3 September 1984 (Medical Directive);  

- Commission Recommendation 2001/928/Euratom of 20 December 2001 on the protection of 
the public against exposure to radon in drinking water supplies; 

- Council Directive 2003/122/Euratom of 22 December 2003 on the control of high-activity 
sealed radioactive sources and orphan sources (HASS Directive); 

-  Council  Directive  2006/117  of  20  November  2006  on  the  supervision  and  control  of 
shipments of radioactive waste and spent fuel; 

- Council Directive 2009/71/Euratom of 25 June 2009 establishing a Community framework 
for the nuclear safety of nuclear installations. 

The BSS Directive have been regularly updated in 1962, 1966, 1976, 1980, 1984 and 1996, 
taking account of advances in scientific knowledge of the effects of ionising radiation in line 
with  the recommendations of  the ICRP and on the basis of operational experience. Medical 
exposures  have  been  included  in  specific  legislation  since  1984.  Specific  problem  areas  are 
covered  in  three  ‘associated  directives’  –  the  High-Activity  Sealed  Radioactive  Sources 
(HASS)  Directive,  the  Outside  Workers  Directive  and  the  Public  Information  Directive.  An 
analysis  of  the  legislation  enacted  under  Article  31  of  the  Euratom  Treaty  reveals  that  the 
Medical  Directive,  the  HASS  Directive,  the  Outside  Workers  Directive  and  the  Public 
Information  Directive  are  closely  linked  with  BSS  Directive  96/29,  in  that  they  develop 
further  the  requirements  of  the  BSS  Directive  or  refer  to  different  provisions  of  the  BSS 
Directive. For this reason the proposal for a new basic safety standard Directive will cover the 
subject matter and scope of these Directives. 

The  Commission  will  propose  separately  a  Directive  laying  down  requirements  for  the 
protection of the health of the general public with regard to radioactive substances in water 
intended  for  human  consumption  (COM(2011)385).  This  Euratom  Directive  will  replace  an 
existing  Directive  98/83/EC  with  regard  to  its  application  to  radioactive  substances  and 
complement  it  with  technical  annexes  on  sampling  frequencies,  methods  of  analysis  and 
detection levels. The substance matter of this Directive is such that it could be incorporated in 
a recast with the basic safety standards at an appropriate point in time. At this stage however, 
since  the  Directive  is  intended  to  merely  transpose  existing  requirements  under  EC  Treaty 
legislation, in such a way as to avoid any interpretation as to a possible change in substance, it 
is  considered  more  appropriate  not  to  incorporate  it at  this  stage  in  a  proposal  for  a  revised 
Basic  Safety  Standards  Directive.  In  addition,  at  the  time  the  Article  31  Group  of  Experts 
gave  its  opinion  on  the  revised  Basic  safety  standards  Directive,  there  was  still  discussion 
whether  a  Directive  on  radioactive  substances  in  water  intended  for  human  consumption 
should  be  based  on  Euratom  Treaty  or  EC  Treaty.  In  these  circumstances  it  was  decided  to 
proceed  with  the  proposal  for  a  revised  Basic  Safety  Standards  Directive  as  agreed  upon  in 
February 2010 by Article 31 Group of Experts. 

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The other legislation based on Article 31 of the Euratom Treaty, as discussed in the Impact 
Assessment  Report,  either  uses  a  different  instrument,  or  the  scope  is  essentially  outside 
radiation protection or the legislation is specific to certain types of installation. 

1.4. Simplification 

In  2005  the  European  Commission  published  ‘Implementing  the  Community  Lisbon 
programme:  A  strategy  for  the  simplification  of  the  regulatory  environment:  the  better 
regulation  initiative’  (COM/2005/535  final)  as a  response  to  the  European  Parliament’s  and 
Council’s  requests  to  simplify  EU  legislation  and  enhance  its  quality.  This  initiative  is  the 
basis  for  attempting  the  consolidation  of  the  five  Directives  mentioned  above.  It  is  neither 
feasible nor useful to recast these Directives with the other pieces of legislation under Title II, 
Chapter 3 of the Euratom Treaty. 

1.5. International context 

The  International  Basic  Safety  Standards  reflect  an  international  consensus  on  what 
constitutes a high level of safety for protecting people and the environment from the harmful 
effects  of  ionising  radiation.  They  are  approved  by  the  IAEA  Board  of  Governors  and  are 
non-binding in nature. The main document on radiation protection is Safety Standards No 115 
‘International  Basic  Safety  Standards  for  Protection  against  Ionising  Radiation  and  for  the 
Safety  of  Radiation  Sources’,  IAEA,  1996.  In  2006,  the  IAEA,  together  with  other 
international organisations (FAO, ILO, the NEA/OECD, PAHO and WHO), embarked upon 
the revision of Safety Standards No 115. This ongoing activity is also driven by the new ICRP 
Recommendations in Publication 103, published in 2007.  

The  European  Commission  has  cooperated  closely  with  the  IAEA  and  other  international 
organisations on the revision of the International Basic Safety Standards. However, it should 
be  emphasised  that  the  Euratom  Basic  Safety  Standards  Directive  is  not  a  means  to  confer 
legally  binding  status  on  the  international  requirements.  There  are  two  main  reasons  why 
referring to or incorporating the international BSS in European legislation is not feasible. On 
the  one  hand,  the  language  of  the  international  BSS  does  not  conform  to  EU  legal  drafting 
rules. The international requirements are also sometimes far too detailed and go beyond the 
idea of ‘basic’ standards in the Euratom Treaty. The requirements of the Euratom BSS also 
need to take into account internal market rules. On the other hand, the international BSS allow 
for  the  fact  that  countries  throughout  the  world,  with  different  levels  of  regulatory  and 
technological infrastructure, must be able to comply with them.  The  European legislation is 
more ambitious. Euratom is bound by the Treaty to establish uniform basic safety standards. 
Incorporating the international BSS in a European act is hence not only difficult, but would 
also be at odds with the major role played by Euratom since 1959 and the significant body of 
legislation  that  has  already  been  built  up.  Nevertheless,  the  Commission  pursues  the  largest 
possible coherence between Euratom and international standards, and envisages the eventual 
sponsorship of the latter on behalf of Euratom. 

2. Consultation of interested parties and impact assessment 

2.1. Interested parties 

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The  Commission  (DG  ENER)  has  initiated  and  supported  several  projects  and  studies  on 
specific radiation protection issues, the results of which have been published in the Radiation 
Protection Series of the European Commission6. The various projects, studies and conferences 
identify  challenges  to  the  implementation  of  the  current  radiation  protection  legislation  and 
problem areas that are not sufficiently covered by the current system of protection.  

In  2009,  the  Commission  launched  a  consultation  on  a  ‘proposal  for  new  requirements  on 
natural  radiation  sources  in  the  Basic  Safety  Standards  Directive’.  The  Working  Party 
‘Natural Sources’ of the Article 31 Group of Experts proposed a comprehensive approach to 
the  regulation  of  NORM  industries,  radon  and  building  materials.  This  document  was 
published  on  the  Commission  website  and  was  also  highlighted  on  the  EANNORM  website7. 
The consultation ran from 02 February 2009 to 20 April 2009.  

The revision of the Euratom Basic Safety Standards has benefited from continuous interaction 
with  two  organisations  representing  major  stakeholders,  namely  the  Heads  of  European 
Radiological  Protection  Competent  Authorities  (HERCA)  and  the  International  Radiation 
Protection  Association  (IRPA).  An  outline  of  the  revision  of  the  BSS  was  presented  to 
HERCA at meetings in December 2008 and 2009 as well as in June 2010. The response of the 
radiation  protection  authorities  was  positive,  and  HERCA  did  not  raise  any  important  issue 
calling for changes in the approach. The revision has been presented at the International IRPA 
Congress (Buenos Aires 2008) and at European congresses organised by IRPA (Brasov, 2006, 
Helsinki 2010) as well as at annual meetings of the European IRPA societies. The European 
IRPA branch has set up a working party to collect input from their societies on the ongoing 
revision of both the international and Euratom BSS. There was also regular contact with the 
European  Atomic  Forum  (FORATOM)  which  represents  the  stakeholders  from  the  nuclear 
industry. 

The  key  interaction  with  stakeholders  is  through  the  Article  31  Group  of  Experts,  i.e.  the 
experts to be consulted under Article 31 of the Euratom Treaty. In February 2010, the Group 
of Experts issued an opinion on the possible revision of European legislation in the form of a 
draft Directive. This text is the fruit of intensive work by the working parties of the Group of 
Experts,  taking  into  account  the  studies  conducted  by  the  Commission  as  well  as  other 
sources of information (conferences, networks). 

The draft proposed by the Commission is to a large extent the same as the draft on which the 
Article 31 Group of Experts' Opinion was based. Only some editorial corrections have been 
made and a few definitions added. The Experts left it for the Commission to decide whether 
the  definition  of  HASS  sources  should  remain  the  same  as  in  the  current  Directive 
2003/122/Euratom  or  whether  the  definition  should  be  aligned  with  the  IAEA  Code  of 
Conduct on the safety and security of radioactive sources. The Commission has opted for the 
latter.  

In its Opinion the Article 31 Group of Experts also suggests maintaining the text of Article 54 
of Directive 96/29/Euratom, which allows Member States to opt out from the uniform Basic 
Safety Standards and introduce stricter dose limits to reflect possible new scientific findings 

6 

7 

Publications  in  the  Radiation  Protection  Series  of  the  European  Commission  can  be  found  at 
http://ec.europa.eu/energy/nuclear/radiation_protection/publications_en.htm. 
The result of the consultation can be found on the website of the European ALARA network for NORM 
industries (EANNORM), under http://www.ean-norm.net/lenya/ean_norm/live/news.html. 

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after the adoption of the directive. This would jeopardise the implementation of the Euratom 
Treaty which requires establishment of uniform standards. The proposed text of the directive 
therefore  does  not  include  such  clause.  In  its  judgement  of  25  November  1992  in  the  case 
Commission  of  the  European  Communities  v  Kingdom  of  Belgium  (Case  C-376/908),  the 
Court stated that 'in the absence of an express provision to the contrary, the Directive must be 
interpreted as allowing the Member States to set, …, stricter dose limits'. In this respect, an 
explicit statement on the uniformity of the standards has been introduced in the proposed text 
of the revised Basic Safety Standards Directive. 

2.2. Impact assessment 

A comprehensive impact assessment was made to evaluate the possible options for reaching 
the objectives: 

1. 

2. 

3. 

4. 

to bring the health protection of workers, the public and patients in line with latest 
scientific data and operational experience, 

to streamline existing EU legislation in the field of radiation protection, 

to ensure coherence with international standards and recommendations, 

to  cover  the  whole  range  of  exposure  situations,  including  exposure  to  natural 
radiation sources at home, as well as the protection of the environment. 

In  the  light  of  these  objectives,  the  impact  assessment  report  considers  a  broad  range  of 
options  both  with  regard  to  the  extent  of  the  consolidation  with  other  legislation  and  with 
regard to scope and substance of the incorporated legislation: 

Option 1: Maintaining the status quo of existing legislation. 

Option  2: Revision of Basic  Safety Standards and Medical Directive.  This option  envisages 
changes  in  the  two  Directives  with  the  aim  to  align  them  with  the  latest  ICRP 
recommendations and with the advance of the scientific knowledge. 

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.  Non-legislative  measures  will  address  natural  radiation 
issues  and  the  protection  of  non-human  species.  This  option  offers  a  revision  of  the  Basic 
Safety  Standards  Directive  by  extending  the  requirements  to  medical  exposure,  public 
information,  outside  workers  exposure  and  high-activity  sealed  sources.  Within  this  policy 
option,  the  BSS  Directive  96/29  and  the  related  legislative  acts  (Medical  Directive 
90/641/Euratom,  HASS  Directive 
97/43/Euratom,  Outside  Workers  Directive 
2003/122/Euratom, 
89/618/Euratom,  Commission 
Public 
Recommendation 90/143/Euratom) will merge and the requirements of BSS Directive and of 
Medical  Directive  will  at  the  same  time  be  upgraded  to  the  latest  scientific  knowledge  and 
regulatory experience. 

Information  Directive 

8 

European Court reports 1992 Page I-06153 

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Option 4: Revision of the Basic Safety Standards Directive and broadening the scope to cover 
exposure  to  natural  radiation  at  home.  With  this  option,  a  comprehensive  approach  to  the 
management  of  exposures  due  to  natural  radiation  sources  will  be  incorporated  within  the 
overall set of requirements of the Euratom BSS. The requirements will reflect the distinction 
between  planned  and  existing  exposure  situations,  as  made  in  ICRP  Publication 103.  While 
occupational exposure to natural radiation sources (as well as public exposure from residues 
or effluents from NORM industries) is already considered in Options 1 to 3, the exposures to 
natural radiation sources that will explicitly be incorporated relate to public exposure in the 
domestic environment. 

Option 5: Revision of the Basic Safety Standards Directive and broadening the scope to cover 
protection  of  non-human  species.  The  subject  matter  and  general  purpose  of  the  BSS 
Directive  96/29/Euratom  is  the  health  protection  of  the  population  and  workers  against 
dangers  of  ionising  radiation.  This  Directive  applies  to  the  protection  of  the  human 
environment, but only as a pathway from environmental sources to the exposure of man. In 
line  with  the  new  ICRP  Recommendations,  it  will  be  complemented  with  specific 
consideration  of  the  exposure of biota in the environment as a  whole.  The  aim  would  be  to 
require Member States to consider suitable protection of non-human species in their radiation 
protection legislation. 

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.  This  option  includes  all 
the elements of Option 3 (revision of the Basic Safety Standards Directive and integration of 
the other four Directives). 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. 

The effectiveness of the proposed options is assessed towards the objectives, the efficiency of 
the  additional  requirements  in  terms  of  their  health  and  environmental  impact,  economic 
benefit and administrative cost, and the coherence of the Directive with overall Euratom and 
EU legislation. The amendments to the Basic Safety Standards and to the Medical Directive 
will have an important impact in the following areas: 

-  Social  and  health  impact:  The  social  impact  relates  to  providing  adequate  protection  to 
workers  in  NORM  industries.  The  health  impact  will  be  most  noticeable  with  regard  to 
medical  exposures,  in  particular  in  preventing  unnecessarily  frequent  or  high-dose 
radiological  examinations  (for  instance  CT  scans)  of  patients  leading  to  increased  cancer 
incidence in future. Specific professional groups (for instance cardiologists) will benefit from 
the reduction of the dose limit for the lens of the eye and avoid contracting radiation-induced 
cataract. 

-  Economic  impact:  While  it  is  not  possible  at  this  stage  to  make  a  quantified  economic 
assessment,  NORM  industries  will  benefit  from  the  harmonisation  of  requirements  between 
Member States. 

- Administrative cost: While the principle of protection optimisation, calling for doses to be 
‘as low as reasonably achievable’ (ALARA), taking social and economic factors into account, 

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is  key  to  ensuring  a  proper  cost-benefit  balance  in  operational  radiation  protection,  the  new 
concept  of  a  ‘graded  approach’  extends  this  principle  to  enhance  the  effectiveness  of 
regulatory oversight and reduce the administrative cost to industries. 

Additional amendments introduced in the three other Directives are the following: 

- harmonisation of the definition of high-activity sealed radioactive sources (HASS) with the 
international standards; 

-  specific  requirements  for  the  protection  of  outside  workers  with  a  clear  definition  of  the 
responsibilities  of  their  employers  and  the  undertakings  conducting  the  practices  in  which 
they are exposed; 

-  requirements  for  informing  the  public  before  and  during  an  emergency,  within  the  overall 
revised scope for the management of emergency exposure situations. 

Merging  the  five  Directives  is  a  major  achievement  in  terms  of  the  coherence  of  Euratom 
legislation.  The  restructuring  required  to  accommodate  this  broader  scope  of  the  BSS 
Directive  further 
text  and  ensures  better  operational 
implementation of the requirements.  

the  clarity  of 

improves 

the 

The broader scope of the new Directive entails further substantial amendments: 

With  regard  to  ‘existing  exposure  situations’,  reference  levels  are  given  for  indoor  radon 
concentrations  and  for  external  exposure  from  building  materials.  Member  States  will  be 
required to establish a comprehensive and transparent Radon Action Plan, adjusted to national 
needs  and  to  the  geological  features  of  different  regions.  Harmonised  requirements  for 
building  materials  will  permit  further  standardisation  under  the  Construction  Products 
Directive  (Council  Directive  89/106/EEC).  While  consumers  and  the  building  professions 
will  benefit  from  the  monitoring  and  labelling  of  materials,  the  administrative  burden  on 
industry  will  be  kept  to  a  minimum  by  the  proper  choice  of  reference  levels  and  the  list  of 
types of materials deemed to be of concern. 

Relevant requirements in the Euratom BSS for the protection of non-human species will allow 
Member  States  to  incorporate  this  in  national  environmental  policies,  in  a  way  which  is 
coherent  with  current  approaches  to  health  protection  against  ionising  radiation.  The 
environmental  impact  assessment  of  these  new  requirements  relates  essentially  to  the 
prevention  of  environmental  damage  in  case  of  an  accident.  For  the  normal  operation  of  an 
installation it is rather a demonstration that there is no impact to the environment. 

3. Legal elements of the proposal 

The recast of five Directives yields a voluminous single Directive, with over 100 articles and 
numerous  annexes.  In  view  of  the  extent  and  complexity  of  the  changes,  a  formal  recast 
procedure is not pursued. It is not possible to point to each and every element of the proposal. 
The following sections give a summary description of the main features of each chapter. 

3.1. Chapter I: Subject matter and scope 

This chapter defines the scope of the new Directive (general purpose of the Directive across 
different  categories  of  exposure  and  different  exposure  situations  and  specific  purposes 

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resulting from integration of the requirements for high-activity sealed radioactive sources and 
for  public  information,  and  the  exclusion  of  non-controllable  exposures).  The  scope  is 
broadened  to  include  the  exposure  of  space  crew  to  cosmic  radiation,  domestic  exposure  to 
radon gas in indoor air, external exposure to gamma radiation from building materials, and the 
protection of the environment beyond environmental pathways leading to human exposure.  

3.2. Chapter II: Definitions 

This chapter includes all definitions given in the earlier Directives, with some adjustments to 
resolve  inconsistencies  as  well  as  to  adjust  to  the  new  terminology  introduced  in  ICRP 
Publication 103 and in the draft International Basic Safety Standards. 

3.3. Chapter III: System of radiation protection 

This title includes the general principles of radiation protection: justification, optimisation and 
dose limitation. It explains the more prominent role of dose constraints and reference levels in 
the process of optimisation, with Annex I giving the bands of reference levels proposed by the 
ICRP  for  existing  and  emergency  exposure  situations.  The  dose  limits  are  not  modified, 
except  for  a  uniform  definition  of  the  annual  occupational  dose  limit  (no  averaging  over  5 
years) and a lower organ dose limit for the lens of the eye, as recommended by the ICRP. The 
new Directive  no  longer includes the  technical  measurements  entering  into the definition of 
the effective dose and other factors entering into the assessment of doses, but refers to ICRP 
Publication 103 for this purpose. In addition, the Directive no longer includes the long lists of 
radionuclide-specific dose coefficients (doses per unit intake by ingestion or inhalation), but 
will  refer  to  a  forthcoming  consolidated  publication  of  the  ICRP  which  can  be  downloaded 
free of charge. 

3.4. Chapter IV: Requirements for radiation protection education, training and information 

This chapter brings together the miscellaneous requirements governing education and training 
in the different Directives and includes provisions for recognition of the ‘Radiation Protection 
Expert’ and ‘Medical Physics Expert’. 

3.5. Chapter V: Justification and regulatory control of practices 

The  application  of  the  principle  of  justification  remains  a  national  responsibility.  Specific 
attention is given to the justification of practices involving the deliberate exposure of humans 
for non-medical imaging (e.g. security screening in airports). 

The  regime  for  regulatory  control  is  now  presented  as  a  three-tier  system  (notification, 
registration,  licensing),  replacing  the  earlier  two-tier  system  of  reporting  and  ‘prior 
authorisation’. A more detailed list of which types of practice are subject to either registration 
or licensing is given. As part of the concept of a ‘graded approach’ to regulatory control, there 
is  explicit  provision  for  the  specific  exemption  of  practices  (from  notification  and  from 
authorisation)  at  national  level.  The  default  values  for  exemption  on  the  basis  of  activity 
concentrations  are  now  taken  from  IAEA  Safety  Guide  RS-G-1.7.  The  same  default  values 
apply  to  release  from  regulatory  control  (clearance  levels),  but  allow  for  specific  values  in 
European guidance. Member States will be allowed to keep default clearance levels in current 
national  legislation,  and  to  keep  the  existing  exemption  values  for  moderate  amounts  of 
material. Details of exemption criteria and exemption and clearance levels are given in Annex 
VI. 

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This chapter also includes more precise requirements on the information to be provided with a 
licence application (the issuing of discharge authorisations for radioactive airborne or liquid 
effluent is covered in Chapter VIII). 

3.6. Chapter VI: Protection of workers, apprentices and students 

This  title  includes,  with  little  amendment,  the  provisions  on  occupational  exposure  in 
Directive  96/29/Euratom.  It  also  includes  the  specific  requirements  in  the  Outside  Workers 
Directive, and introduces a clear allocation of responsibilities between the employer and the 
undertaking  where  the  practice  is  conducted.  The  data  system  for  individual  radiological 
monitoring of exposed workers and the minimum set of data to be communicated for outside 
workers has been updated in the light of recommendations by HERCA. 

No  distinction  is  made  between  the  management  of  occupational  exposures  in  NORM 
industries and other practices, but the former will benefit from a graded regulatory approach 
on the basis of prevailing exposures and their potential to increase with time. 

This  chapter  now  covers  occupational  exposure  in  all  exposure  situations,  which  provides 
more explicit protection for emergency workers as well as for workers exposed to high levels 
of indoor radon in their workplace. 

3.7. Chapter VII: Protection of patients and other individuals subjected to medical exposure 

This chapter includes the  relevant  requirements from the Medical Directive,  but strengthens 
them, in particular with regard to: 

- the application of the justification principle; 

- information to patients on the health risks and benefits; 

- information on doses; 

- diagnostic reference levels; 

- involvement of the Medical Physics Expert; 

- prevention of accidental and unintended medical exposures. 

3.8. Chapter VIII: Protection of members of the public 

This  chapter  includes  the  public  exposure  requirements  in  Directive  96/29/Euratom,  with 
more explicit consideration of the issuing of discharge authorisations for radioactive effluent 
(also with reference to Commission Recommendation 2004/2/Euratom). 

The  section  on  emergency  exposure  situations  includes  the  requirements  of  the  Public 
Information Directive. 

The  section  on  existing  exposure  situations  addresses  indoor  exposure  to  radon,  with  a 
somewhat  lower  maximum  reference  level  for  existing  dwellings  than  in  Commission 
Recommendation  90/143/Euratom,  in  line  with  ICRP  and  WHO  recommendations.  It  also 
includes  requirements  for  the  classification  of  building  materials  on  the  basis  of  a 

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radioactivity index and a uniform reference level for the annual dose resulting from residence 
in a building constructed with such materials. 

3.9. Chapter IX: Protection of the environment 

This  chapter,  in  line  with  the  broader  scope  of  the  Directive  as  in  the  International  Basic 
Safety  Standards,  aims  to  provide  a  means  to  demonstrate  compliance  with  environmental 
criteria.  While  the  ICRP  has  published  a  methodology  for  dose  assessment  for  biota,  a 
publication on the application of criteria is still awaited. Pending such further guidance, it is 
up to national authorities to assess the doses to representative animals and plants in terms of 
protection of the ecosystem. 

Appropriate  technical  measures  also  need  to  be  taken  to  avoid  the  environmental 
consequences  of  an  accidental  release  and  to  monitor  existing  levels  of  radioactivity  in  the 
environment, from the perspectives of both environmental protection and human health. 

3.10. Chapter X: Requirements for regulatory control 

This  chapter  includes  all  the  responsibilities  of  the  regulatory  authorities  in  all  exposure 
situations. A clear structure is provided by the following sections: 

- Institutional infrastructure; 

-  Control  of  sealed  radioactive  sources  (with Annexes  II,  XII,  XIII,  XIV,  XV  incorporating 
different aspects of the Directive on High-Activity Sealed Radioactive Sources); 

- Orphan sources (with new requirements with regard to metal contamination); 

-  Emergency  exposure  situations  (establishment  of  an  emergency  management  system  and 
international  cooperation,  while requirements  for  the  protection  of  workers  and  members  of 
the  public  in  an  emergency  exposure  situation  are  addressed  in  Chapters  V  and  VIII, 
respectively); 

- Existing exposure situations (general provisions for the management of contaminated areas, 
radon action plan); 

- System of enforcement (inspection programme and response to deficiencies). 

The  first  section  on  ‘institutional  infrastructure’  calls  for  a  clear  definition  of  the 
responsibilities  of  different  authorities.  The  Commission  is  to  receive  periodically  updated 
information  and  publish  this  in  the  Official  Journal.  This  section  also  defines  the 
responsibilities of the ‘Radiation Protection Expert’, the ‘Radiation Protection Officer’ (in the 
current  BSS  these  concepts  were  merged  within  the  function  of  ‘Qualified  Expert’)  and  the 
‘Medical Physics Expert’. 

3.11. Chapter XI: Final provisions  

The transposition of the new Directive into national law should not require a major legislative 
effort, so a 2-year transposition deadline is deemed sufficient. Specific new features, such as 
the protection of the environment, can be transposed later. 

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In  line  with  the  Euratom  Treaty,  the  Basic  Standards  are  to  be  uniformly  applied  in  the 
Member States, though without prejudice to those requirements for which flexibility is clear 
from the wording of the text. However, dose limits, default exemption values, the reference 
level  for  building  materials,  etc.  are  explicitly  intended  for  uniform  transposition  and 
application. 

4. Budgetary implications 

There are no implications for the EU budget. 

2011/0254 (NLE) 

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Proposal for a 

COUNCIL DIRECTIVE 

laying down basic safety standards for protection against the dangers arising from 
exposure to ionising radiation 

Draft presented under Article 31 Euratom Treaty for the opinion of the European 
Economic and Social Committee 

THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  establishing  the  European  Atomic  Energy  Community,  and  in 
particular Articles 31 and 32 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  from  among 
scientific  experts  in  the  Member  States,  and  after  having  consulted  the  European  Economic 
and Social Committee, 

Having regard to the opinion of the European Economic and Social Committee, 

Having regard to the opinion of the European Parliament, 

Whereas: 

(1) 

(2) 

Article 2(b) of the Treaty provides for the establishment of uniform safety standards to 
protect  the  health  of  workers  and  the  general  public  and  Article  30  of  the  Treaty 
defines  ‘basic  standards’  for  the  health  protection  of  workers  and  the  general  public 
against the dangers arising from ionising radiations. 

In order to perform its task, the Community laid down basic standards for the first time 
in 1959 pursuant to Article 218 of the Treaty by means of the Directives of 2 February 
1959 laying down the basic standards for the protection of the health of workers and 
the general public against the dangers arising from ionising radiation9. The Directives 
have  been  revised  several  times,  most  recently  in  1996  by  Council  Directive 
96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection 
of  the  health  of  workers  and  the  general  public  against  the  dangers  arising  from 
ionising radiation10 which repealed the earlier Directives. 

(3) 

Directive 96/29/Euratom establishes the basic safety standards. The provisions of that 
Directive apply to normal and  emergency situations and have been supplemented by 
more specific legislation. 

9 
10 

OJ 11, 20.2.1959, p. 221. 
OJ L 159, 29.6.1996, p. 1 

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15 

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(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals 
against the dangers of ionising radiation in relation to medical exposure and repealing 
Directive 84/466/Euratom 11, Council Directive 89/618/Euratom of 27 November 1989 
on  informing  the  general  public  about  health  protection  measures  to  be  applied  and 
steps  to  be  taken  in  the  event  of  a  radiological  emergency12,  Council  Directive 
90/641/Euratom of 4 December 1990 on the operational protection of outside workers 
exposed to the risk of ionising radiation during their activities in controlled areas13 and 
Council  Directive  2003/122/Euratom  of  22  December  2003  on  the  control  of  high-
activity  sealed  radioactive  sources  and  orphan  sources14  cover  different  specific 
aspects complementary to Directive 96/29/Euratom. 

Over time, definitions used in that legislation have evolved and been adjusted to the 
specific  scope,  however  many  requirements  laid  down  therein  fit  in  the  original 
context  at  the  time  of  adoption  of  that  legislation  but  cannot  be  extended  for  use  in 
Directive 96/29//Euratom. 

The  Group  of  Experts  appointed  by  the  Scientific  and  Technical  Committee  has 
advised that the basic safety standards, established according to Articles 30 and 31 of 
Euratom  Treaty  should  take  into  account  the  new  recommendations  of  the 
International  Commission  on  Radiological  Protection  (ICRP),  in  particular  those  in 
Publication 103 (2007)15, and should be revised in the light of new scientific evidence 
and operational experience.  

The provisions of this Directive should follow the situation based approach introduced 
by  ICRP  Publication  103  and  distinguish  between  existing,  planned  and  emergency 
exposure  situations.  Taking  into  account  this  new  framework  the  Directive  should 
cover  all  exposure  situations  and  all  categories  of  exposure,  namely  occupational, 
public and medical exposures. 

A  new  methodology  introduced  by  ICRP  to  calculate  doses  based  on  the  latest 
knowledge on radiation risks should also be taken into account in this Directive. 

The  current  annual  dose  limits  for  occupational  and  public  exposure  are  maintained. 
However, there should be no further need for averaging over 5 years, except in special 
circumstances specified in national legislation. 

(10)  New scientific information on tissue effects calls for the optimisation principle to be 
applied  to  organ  doses  as  well,  where  appropriate,  in  order  to  keep  doses  as  low  as 
reasonably  achievable.  The  directive  should  also  follow  new  ICRP  guidance  on  the 
organ dose limit for the lens of the eye in occupational exposure. 

(11) 

Industries  processing  naturally  occurring  radioactive  material  extracted  from  the 
earth’s  crust  subject  workers  and,  if  material  is  released  into  the  environment,  the 
public to increased radiation exposure. 

11 
12 
13 
14 
15 

OJ L 180, 9.7.1997, p. 22. 
OJ L 357, 7.12.1989, p. 31. 
OJ L 349, 13.12.1990, p. 21. 
OJ L 346, 31.12.2003, p. 57. 
The 2007 Recommendations of the International Commission on Radiological Protection 

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16 

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(12)  Protection against natural radiation sources, rather than being addressed separately in a 
specific title, should be fully integrated within the overall requirements. In particular, 
industries processing materials containing naturally occurring radionuclides should be 
managed within the same regulatory framework as other practices. 

(13)  The new requirements on radioactivity in building materials should allow for the free 

circulation of building materials. 

(14)  Recent  epidemiological  findings  from  residential  studies  demonstrate  a  lung  cancer 
risk  from  exposure  to  indoor  radon  at  levels  of  the  order  of  100  Bq  m-3.  The  new 
concept of exposure situations allows the provisions of Commission Recommendation 
90/143/Euratom on the protection of the public against indoor exposure to radon16 to 
be  incorporated  in  the  binding  requirements  of  the  Basic  Safety  Standards  while 
leaving enough flexibility for implementation. 

(15)  The exposure of aircrew to cosmic radiation should be managed as a planned exposure 
situation.  The  operation  of  spacecraft  should  come  under  the  scope  of  this  Directive 
and should be managed as a specially authorised exposure. 

(16)  The  health  protection  of  the  general  public  allows  for  the  presence  of  radioactive 
substances in the environment. In addition to direct environmental exposure pathways, 
consideration  should  be  given  to  the  protection  of  the  environment  as  a  whole, 
including  the  exposure  of  biota,  within  a  comprehensive  and  coherent  overall 
framework. As far as a mankind is part of its environment, this policy benefits to long 
term health protection.  

(17) 

In the medical area, important technological and scientific developments have led to a 
notable  increase  in  the  exposure  of  patients.  In  this  respect,  the  Directive  should 
emphasise  the  need  for  justification  of  medical  exposure,  including  the  exposure  of 
asymptomatic  individuals,  and  should  strengthen  the  requirements  concerning 
information  to  be  provided  to  patients,  the  recording  and  reporting  of  doses  from 
medical procedures, the use of diagnostic reference levels and the availability of dose-
indicating devices. 

(18)  Accidental  and  unintended  medical  exposures  are  a  source  of  continuing  concern. 
Their prevention and follow-up, should they occur, need to be fully addressed. In this 
respect,  the  role  of  quality  assurance  programmes,  including  risk  analysis  in 
radiotherapy, to avoid such incidents should be emphasised, and recording, reporting, 
analysis and corrective action should be required in such cases. 

(19)  The  so-called  ‘medico-legal’  exposures  introduced  in  Directive  97/43/Euratom  have 
now  been  clearly  identified  as  the  deliberate  exposure  of  individuals  for  other  than 
medical  purposes,  or  ‘non-medical  imaging  exposures’.  Such  practices  need  to  be 
placed under appropriate regulatory control and should be justified in a similar way as 
for medical exposures. However, a different approach is needed on the one hand for 
procedures  implemented  by  medical  staff  using  medical  equipment  and  on  the  other 
hand for procedures implemented by non-medical staff using non-medical equipment. 

16 

OJ L 80, 27.3.1990, p. 26. 

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17 

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In  general,  the  annual  dose  limits  and  corresponding  constraints  for  public  exposure 
should apply. 

(20)  Member States should be required to submit certain practices involving a hazard from 
ionising  radiation  to  a  system  of  regulatory  control  or  to  prohibit  certain  practices. 
Member States should benefit from the application of a graded approach to regulatory 
control,  which  should  be  commensurate  with  the  magnitude  and  likelihood  of 
exposures  resulting  from  the  practices,  and  commensurate  with  the  impact  that 
regulatory  control  may  have  in  reducing  such  exposures  or  improving  the  safety  of 
installations. 

(21)  There  is  benefit  in  having  the  same  activity  concentration  values  both  for  the 
exemption of practices from regulatory control and for the clearance of materials from 
regulated  practices.  After  a  comprehensive  review,  it  has  been  concluded  that  the 
values  recommended  in  IAEA  document  RS-G-1.717  can  be  used  both  as  default 
exemption values, replacing the activity concentration values laid down in Annex I to 
Directive  96/29/Euratom,  and  as  general  clearance  levels,  replacing  the  values 
recommended by the Commission in Radiation Protection No 12218. 

(22)  Member States may grant specific exemption from authorisation for certain practices 

involving activities above the exemption values. 

(23)  Specific  clearance  levels,  above  the  default  values  for  exemption  and  clearance,  as 
well  as  corresponding  Community  guidance19  remain  important  tools  for  the 
management  of  large  volumes  of  materials  arising  from  the  dismantling  of  licensed 
facilities. 

(24)  Member  States  should  ensure  that  outside  workers  receive  the  same  protection  as 
exposed  workers  employed  by  undertakings  performing  practices  with  radiation 
sources.  The  specific  arrangements  for  outside  workers  in  Directive  90/641/Euratom 
should be extended to cover work in supervised areas as well. 

(25)  With  regard  to  the  management  of  emergency  exposure  situations,  the  current 
approach  based  on  intervention  levels  should  be  replaced  by  a  more  comprehensive 
system  comprising  threat  analysis,  an  overall  emergency  management  system, 
emergency  response  plans  for  identified  threats,  and  pre-planned  strategies  for  the 
management of each postulated event. 

(26)  The  introduction  of  reference  levels  in  emergency  and  existing  exposure  situations 
allows  for  the  protection  of  the  individual  as  well  as  consideration  of  other  societal 
criteria  in  the  same  way  as  dose  limits  and  dose  constraints  for  planned  exposure 
situations. 

17 

18 

19 

IAEA 2004 Safety Standards Series RS-G-1.7 "Application of the Concepts of Exclusion, Exemption and Clearance". 
Radiation  Protection  122:  Practical  use  of  the  Concepts  of  the  Clearance  and  Exemption  —  Part  I,  Guidance  on  General 
Clearance Levels for Practices. 
Radiation  Protection  89:  Recommended  radiological  protection  criteria  for  the  recycling  of  metals  from  dismantling  of  nuclear 

installations,  Radiation  Protection  113:  Recommended  Radiological  Protection  Criteria  for  the  Clearance  of  Buildings  and 

Building Rubble from the Dismantling of Nuclear Installations, Radiation Protection 122: Practical Use of the Concepts of the 
Clearance and Exemption. 

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(27)  The  efficient  management  of  a  nuclear  emergency  with  cross-border  consequences 
calls  for  enhanced  cooperation  between  Member  States  in  emergency  planning  and 
response. 

(28)  The  International  Atomic  Energy  Agency 

the  World  Health 
Organisation,  the  Food  and  Agricultural  Organisation,  the  International  Labour 
Organisation,  the  Nuclear  Energy  Agency  of  the  Organisation  for  Economic 
Cooperation  and  Development,  and  the  Pan-American  Health  Organisation  are 
revising  the  International  Basic  Safety  Standards  in  the  light  of  the  ICRP’s  new 
Publication 103. 

together  with 

(29)  The roles and responsibilities of the national services and experts involved in ensuring 
that the technical and practical aspects of radiation protection are managed with a high 
level of competence need to be clarified. 

(30)  More  precise  requirements  should  be 

issuing  discharge 
authorisations  and  for  the  monitoring  of  discharges.  Commission  Recommendation 
2004/2/Euratom  of  18  December  2003  on  standardised  information  on  radioactive 
airborne and liquid discharges into the environment from nuclear power reactors and 
reprocessing  plants  in  normal  operation20introduced  standardised  information  for  the 
reporting of data on discharges from nuclear power plants and reprocessing facilities. 

introduced  for 

the 

(31)  No major changes need to be made to the most recent Directive on the control of high-
activity sealed radioactive sources and orphan sources (2003/122/Euratom), except to 
broaden some of the requirements to include any sealed radioactive source. However, 
there are still unresolved problems with orphan sources and there have been significant 
cases  of  contaminated  metal  being  imported  from  third  countries.  Accordingly,  a 
requirement should be introduced for the notification of incidents with orphan sources 
or  the  contamination  of  metal.  With  regard  to  international  security,  it  is  also 
important to harmonise the levels above which a source is regarded as a high-activity 
sealed source with those established by the IAEA. 

(32)  The basic safety standards established under the Euratom Treaty are meant to apply in 

a uniform way.  

(33)  Directive  96/29/Euratom  and 

the  complementary  Directives  89/618/Euratom, 
90/641/Euratom  96/29/Euratom,  97/43/Euratom  and  2003/122/Euratom  should  be 
repealed, 

20 

OJ L 2, 6.1.2004, p. 36 

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19 

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HAS ADOPTED THIS DIRECTIVE: 

CHAPTER I 

SUBJECT MATTER AND SCOPE 

1. 

2. 

3. 

4. 

5. 

1. 

Article 1  

Subject matter 

This Directive establishes the basic safety standards for the protection of the health 
of workers, general public, patients and other individuals subject to medical exposure 
against the dangers arising from ionising radiation for the purpose of their uniform 
implementation by Member States. 

This  Directive  applies  to  the  protection  of  the  environment  as  a  pathway  from 
radiation  sources  to  the  exposure  of  man,  complemented  where  appropriate  with 
specific consideration of the exposure of biota in the environment as a whole. 

This  Directive  sets  out  requirements  for  the  control  of  the  safety  and  security  of 
radioactive  sources  and  the  provisions  of  appropriate  information  in  an  emergency 
exposure situation.  

This Directive sets out requirements for the prevention of exposure of workers and 
members  of  the  public  to  ionising  radiation  arising  from  orphan  sources  and  from 
inadequate  control  of  high-activity  sealed  radioactive  sources  and  for 
the 
harmonisation  of  controls  in  place  in  the  Member  States  by  defining  specific 
requirements ensuring that each such source is kept under control. 

This  Directive  defines  at  Community  level  common  objectives  with  regard  to 
measures and procedures for informing the public for the purpose of improving the 
operational health protection provided in the event of an emergency. 

Article 2 

Scope 

This  Directive  applies  to  any  planned,  existing  or  emergency  exposure  situation 
which  involves  a  risk  from  exposure  to  ionising  radiation  which  cannot  be 
disregarded  from  the  radiation  protection  point  of  view  with  regard  to  the  health 
protection  of  workers,  members  of  the  public,  or  patients  and  other  individuals 
subject to medical exposure or with regard to the protection of the environment. 

2. 

This Directive applies to all practices involving radiation sources, namely: 

EN 

20 

   EN 

 
(a) 

(b) 

(c) 

(d) 

3. 

4. 

the  production,  processing,  handling,  use,  storage,  holding,  transport,  shipment, 
import to, and export from the Community and the disposal of radioactive material; 

the operation of electrical equipment emitting ionising radiation and the operation of 
any electrical equipment operating at a potential difference of more than 5 kV; 

practices  which  involve  the  presence  of  natural  radiation  sources  that  lead  to  a 
significant  increase  in  the  exposure  of  workers  or  members  of  the  public,  in 
particular: 

i) 

the operation of aircraft and spacecraft; 

ii) 

exposure to radon in workplaces; 

iii) 

the  activities  in  industries  processing  materials  with  naturally  occurring 

radionuclides, or activities related to such processing. 

any other practice specified by the Member State. 

This  Directive  applies  to  the  management  of  existing  exposure  situations,  in 
particular  the  exposure  of  the  public  to  indoor  radon,  the  external  exposure  from 
building materials and cases of lasting exposure resulting from the after-effects of an 
emergency or a past activity. 

This  Directive  applies  to  the  management  of  emergency  exposure  situations  to  the 
extent  that  these  are  deemed  to  warrant  intervention  to  protect  the  health  of  the 
public  or  workers  or  to  protect  the  environment;  potential  exposures  as  well  as 
emergency preparedness and planning are part of planned exposure situations. 

Article 3 

Exclusion from the scope 

This  Directive  shall  not  apply  to  radionuclides  naturally  contained  in  the  human  body,  to 
cosmic  radiation  prevailing  at  ground  level,  and  to  aboveground  exposure  to  radionuclides 
present in the undisturbed earth’s crust. 

CHAPTER II 

DEFINITIONS 

Article 4 

For  the  purpose  of  this  Directive,  the  following  terms  have  the  meaning  hereby 
assigned to them: 

EN 

21 

   EN 

 
(1)  Medical  exposure  means  exposure  incurred  by  patients  or  asymptomatic 
individuals as part of their own medical or dental diagnosis or treatment, and 
intended to benefit their health or well-being, as well as exposure incurred by 
carers and comforters and by volunteers in biomedical research; 

(2) Ionising  radiation  means  the  transfer  of  energy  in  the  form  of  particles  or 
electromagnetic waves of a wavelength of 100 nanometres or less (a frequency 
of 3x1015 Hertz or more) capable of producing ions directly or indirectly; 

(3) Emergency means a non-routine situation or event that necessitates prompt action 
primarily  to  mitigate  a  hazard or adverse consequences  for human health and 
safety, quality of life, property or the environment. This includes nuclear and 
radiological emergencies;  

(4) Emergency  exposure  situation  means  a  situation  of  exposure  due  to  any  sudden 
event  which  requires  urgent  decisions  to  be  taken  in  order  to  control  this 
situation; the event may result from an accident (whether or not envisaged as a 
potential exposure) or from a malicious act; 

(5) Exposure  means  the  act  of  exposing  or  condition  of  being  exposed  to  ionising 
radiation  emitted  outside  the  body  (external  exposure)  or  within  the  body 
(internal exposure); 

(6) Exposure  situation  means  a  situation  giving  rise  to  exposure,  including  the 
radiation  sources  and  the  activities  or  actions  which  may  affect  the  exposure 
from these radiation sources; 

(7) Members of the public mean individuals, subject to public exposure; 

(8) Radiation source means an entity that may cause radiation exposure — such as by 
emitting ionising radiation or by releasing radioactive material — and can be 
treated as a single entity for protection and safety purposes; 

(9) Radioactive source means a radiation source incorporating radioactive material for 

the purpose of utilising its radioactivity; 

(10)  Radioactive material means material incorporating radioactive substances; 

(11)  Orphan  source  means  a  sealed  source  which  is  neither  exempted  nor  under 
regulatory  control,  e.g.  because  it  has  never  been  under  regulatory  control  or 
because it has been abandoned, lost, misplaced, stolen or otherwise transferred 
without proper authorisation; 

(12)  Building  material  means  a  construction  product  which  is  produced  for 

incorporation in a permanent manner in a building; 

(13)  Disposal  means  the  emplacement  of  radioactive  waste  or  spent  fuel  in  an 

authorised facility without the intention of retrieval; 

EN 

22 

   EN 

 
(14)  Existing  exposure  situation  means  an  exposure  situation  that  already  exists 
when  a  decision  on  its  control  has  to  be  taken  and  which  does  not  call  or  no 
longer calls for urgent measures to be taken; 

(15)  Natural  radiation  source  means  sources  of  ionising  radiation  of  natural 

terrestrial or cosmic origin; 

(16)  Planned  exposure  situation  means  an  exposure  situation  that  arises  from  the 
planned operation or introduction of a radiation source or from activities which 
alter exposure pathways, so as to cause the exposure or potential exposure of 
people  or  the  environment.  Planned  exposure  situations  may  include  both 
normal exposures and potential exposures; 

(17)  Potential exposure means exposure that is not expected with certainty but may 
result from an event or sequence of events of a probabilistic nature, including 
equipment failures and operating errors. 

(18)  Radiation  protection  means  the  protection  of  people  from  harmful  effects  of 

exposure to ionising radiation, and the means for achieving this; 

(19)  Practice  means  any  activity  that  involves  the  operation  or  introduction  of 
radiation  sources  or  which  alters  exposure  pathways  and  is  managed  as  a 
planned exposure situation; 

(20)  Radon means the isotope Rn-222 and its progeny, as appropriate (exposure to 

radon means exposure to radon progeny); 

(21)  Storage  means  the  holding  of  radioactive  sources  or  radioactive  waste  in  a 
facility that provides adequate containment, with the intention of retrieval; 

(22)  Optimisation  means  a  forward-looking  iterative  process  to  establish  adequate 
protection  measures  taking  into  account  the  prevailing  circumstances,  the 
available  options,  and  the  nature  of  the  exposure  situation,  with  the  aim  of 
keeping  the  magnitude  and  likelihood  of  exposure  and  the  number  of  people 
exposed as low as reasonably achievable; 

(23)  Public exposure means exposure of individuals, excluding any occupational or 

medical exposure; 

(24)  Occupational  exposure  means  exposure  of  workers  incurred  in  the  course  of 

their work; 

(25)  Health  detriment  means  an  estimate  of  the  risk  of  reduction  in  length  and 
quality of life occurring in a population following exposure. This includes loss 
arising from tissue effects, cancer and severe genetic disorder; 

(26)  Effective dose (E) means the  sum of the weighted equivalent doses in all the 
tissues  and  organs  of  the  body  from  internal  and  external  irradiation.  It  is 
defined by the expression: 

EN 

23 

   EN 

 
∑∑
w
T

T

R

Dw
R

,
RT

E

=

∑

T

Hw
T

T

=

where 

DT,R is the absorbed dose averaged over tissue or organ T, due to radiation R, 

wR is the radiation weighting factor and 

wT is the tissue weighting factor for tissue or organ T. 

The  appropriate  wT  and  wR  values  are  specified  in  Publication  103  of  the 
International Commission on Radiological Protection. The unit for effective dose is 
the sievert; 

(27)  Dose limit: the value of the effective dose or the equivalent dose in a specified 
period which may not be exceeded for an individual. The dose limit applies to 
the sum of exposures from all authorised practices; 

(28)  Dose  constraint  means  a  constraint  set  as  a  prospective  upper  bound  of  an 
individual dose, used to define the range of options considered in the process of 
optimisation for a given radiation source in planned exposure situation;  

(29)  Equivalent dose (HT) means the absorbed dose, in tissue or organ T weighted 

for the type and quality of radiation R. It is given by: 

H

,
RT

=

Dw
R

,
RT

where 

– DT,R is the absorbed dose averaged over tissue or organ T, due to radiation R, 

– wR is the radiation weighting factor. 

When the radiation field is composed of types and energies with different values of 
wR, the total equivalent dose, HT, is given by: 

H

T

 ∑=

Dw
R

,
RT

R

The  appropriate  wR  values  are  specified  in  Publication  103  of  the  International 
Commission on Radiological Protection. The unit for equivalent dose is the sievert. 

(30)  Outside worker means any exposed worker of category A who is not employed 
by  the  undertaking  responsible  for  the  supervised  and  controlled  areas,  but 
performs activities in these areas, including trainees, apprentices and students; 

(31)  Undertaking  means  a  natural  or  legal  person  who  has  legal  responsibility  for 
carrying  out  a  practice  or  who  has  legal  responsibility  for  a  radiation  source 
(including  cases  where  the  owner  or  holder  of  a  radiation  source  does  not 
conduct related activities); 

EN 

24 

   EN 

 
 
 
 
 
 
 
(32)  Risk  constraint  means  a  constraint  set  as  a  restriction  on  the  individual  risk 
from a radiation source (risk in the sense of probability of health detriment due 
to a potential exposure, which is a function of the probability of an unintended 
event causing a dose and the probability of detriment due to that dose); 

(33)  Carers and comforters means individuals knowingly and willingly incurring an 
exposure to ionising radiation by helping, other than as part of their occupation, 
in  the  support  and  comfort  of  individuals  undergoing  or  having  undergone 
medical exposure; 

(34)  Reference  level  means  in  an  emergency  exposure  situation  or  in  an  existing 
exposure  situation,  the  level  of  dose  or  risk  above  which  it  is  judged 
inappropriate  to  allow  exposures  to  occur,  and  below  which  optimisation  of 
protection should continue to be implemented; 

(35)  Exposed  worker  means  person,  either  self-employed  or  working  under  an 
employer, and who is subject to exposure at work carried out within a practice 
regulated by this Directive and who is liable to receive doses exceeding one or 
other of the dose limits for public exposure; 

(36)  Sievert (Sv) means the special name of the unit of equivalent or effective dose. 

One sievert is equivalent to one joule per kilogram: 1 Sv = 1 J kg-1; 

(37)  Intake means the activities of radionuclides entering the body from the external 

environment; 

(38)  Apprentice  means  a  person  receiving  training  or  instruction  within  an 

undertaking with a view to exercising a specific skill. 

(39)  Committed  effective  dose  (E(τ))  means  the  sum  of  the  committed  organ  or 
tissue equivalent doses HT(τ) resulting from an intake, each multiplied by the 
appropriate tissue weighting factor wT. It is defined by: 

E

τ ∑=
)(

T

T Hw

T

)(
τ

In  specifying  E(τ),τ  is  given  in  the  number  of  years  over  which  the  integration  is 
made. For the purpose of complying with dose limits specified in this Directive, τ is 
a period of 50 years following intake for adults and up to age 70 for children. The 
unit for committed effective dose is the sievert; 

(40)  Medical  physics  expert  means  an  individual  having  the  knowledge,  training 
and  experience  to  act  or  give  advice  on  matters  relating  to  radiation  physics 
applied  to  medical  exposure,  whose  competence  to  act  is  recognised  by  the 
competent authorities; 

(41)  Occupational  health  service  means  a  health  professional  or  body  having 
competence  for  the  medical  surveillance  of  exposed  workers  and  whose 
capacity to act in that respect is recognised by the competent authorities; 

EN 

25 

   EN 

 
 
(42)  Radiation  protection  expert  means  an  individual  having  the  knowledge, 
training and experience needed to give radiation protection advice in order to 
ensure  the  effective  protection  of  individuals,  and  whose  capacity  to  act  is 
recognised by the competent authorities; 

(43)  High-activity  sealed  source  means  a  sealed  source  in  which  the  amount  of 

radioactive material exceeds the values laid down in Annex II; 

(44)  Emergency response plan means arrangements to plan for adequate response in 
the  event  of  an  emergency  exposure  situation  related  to  a  specific  facility  or 
activity on the basis of postulated events and related scenarios; 

(45)  Emergency worker means any person having a defined role as a worker in an 
emergency  and  who  might  be  exposed  while  taking  action  in  response  to  the 
emergency; 

(46)  Dosimetry  service  means  a  body  or  an  individual  having  the  competence  for 
calibration,  reading  or  interpretation  of  individual  monitoring  devices,  or  for 
measurement  of  radioactivity  in  the  human  body  or  in  biological  samples,  or 
for assessment of doses, whose capacity to act in this respect is recognised by 
the competent authorities; 

(47)  Emergency  management  system  means  legal  or  administrative  framework 
establishing  responsibilities  for  emergency  preparedness  and  response,  and 
arrangements  for  decision  making  in  the  event  of  an  emergency  exposure 
situation; 

(48)  Medical radiological means pertaining to radiodiagnostic and radiotherapeutic 
procedures,  and  interventional  radiology  or  other  planning  and  guiding 
radiology using ionising radiation; 

(49)  Practical  aspects  of  medical  exposure  procedures  means  the  physical  conduct 
of a medical exposure and any supporting aspects including handling and use 
of  medical  radiological  equipment,  and  the  assessment  of  technical  and 
physical parameters, including radiation doses, calibration and maintenance of 
equipment, preparation and administration of radio-pharmaceuticals, and image 
processing  as  carried  out  by,  among  others,  radiographers  and  technicians  in 
nuclear medicine and radiotherapy; 

(50)  Practitioner means a medical doctor, dentist or other health professional who is 
entitled  to  take  clinical  responsibility  for  an  individual  medical  exposure  in 
accordance with national requirements. 

(51)  Diagnostic  reference  levels  means  dose  levels  in  medical  radiodiagnostic  or 
interventional  radiology  practices,  or,  in  the  case  of  radio-pharmaceuticals, 
levels of activity, for typical examinations for groups of standard-sized patients 
or standard phantoms for broadly defined types of equipment;  

(52)  Activation means process through which a stable nuclide is transformed into a 
radionuclide  by  irradiating  with  particles  or  high-energy  photons  the  material 
in which it is contained; 

EN 

26 

   EN 

 
(53)  Radioactive  substance  means  any  substance  that  contains  one  or  more 
radionuclides the activity concentration of which cannot be disregarded as far 
as radiation protection is concerned; 

(54)  Non-medical imaging exposure means any deliberate exposure of humans for 
imaging purposes where the primary motivation for the exposure is not related 
to the health or well-being of the individual being exposed; 

(55)  Notification  means  submission  of  a  document  to  the  competent  authority  to 
notify the intention to carry out a practice within the scope of this Directive. 

(56)  Registration  means  permission  granted  in  a  document  by  the  competent 
authority,  or  granted  by  national  legislation,  to  carry  out  an  activity  in 
accordance with conditions laid down in national legislation; 

(57)  Consumer  product  means  a  device  or  manufactured  item  into  which 
radionuclides have deliberately been incorporated or produced by activation, or 
which generates ionising radiation, and which can be sold or made available to 
members of the public without special surveillance or regulatory control after 
sale; 

(58)  Accelerator  means  an  apparatus  or  installation  in  which  particles  are 
accelerated,  emitting  ionising  radiation  with  energy  higher  than  1  mega-
electron volt (MeV); 

(59)  Disused  sealed  source  means  a  sealed  source  which  is  no  longer  used  or 
intended to be used for the practice for which authorisation was granted; 

(60)  Inspection  means  an  investigation  by  any  competent  authority  to  verify 

compliance with national provisions; 

(61)  Radiation  generator  means  a  device  capable  of  generating  ionising  radiation, 
such  as  X  rays,  neutrons,  electrons  or  other  charged  particles,  which  may  be 
used for scientific, industrial or medical purposes; 

(62)  Radioactive  waste  means  radioactive  material  for  which  no  further  use  is 

foreseen. 

(63)  Quality assurance means all those planned and systematic actions necessary to 
provide  adequate  assurance  that  a  structure,  system,  component  or  procedure 
will perform satisfactorily in compliance with agreed standards. Quality control 
is a part of quality assurance; 

(64)  Licence means permission granted by the competent authority, on application, 
to  carry  out  a  practice  subject  to  conditions  laid  down  in  a  specific  licence 
document; 

(65)  Clearance  levels  means  values  established  by  the  competent  authority  or  in 
national  legislation,  and  expressed  in  terms  of  activity  concentrations,  at  or 
below  which  materials  arising  from  any  practice  subject  to  notification  or 
authorisation may be released from the requirements of this Directive.  

EN 

27 

   EN 

 
(66)  Supervised  area  means  an  area  subject  to  supervision  for  the  purpose  of 

protection against ionising radiation; 

(67)  Controlled  area  means  an  area  subject  to  special  rules  for  the  purpose  of 
protection  against  ionising  radiation  or  preventing  the  spread  of  radioactive 
contamination and to which access is controlled; 

(68)  Accidental exposure means an exposure of  individuals, other than emergency 

workers, as a result of an accident;  

(69)  Emergency occupational exposure means occupational exposure received in an 
emergency  exposure  situation  by  individuals  taking  action  to  mitigate  the 
consequences of the emergency;  

(70)  Health screening means a procedure using medical radiological installations for 

early diagnosis in population groups at risk; 

(71)  Radon-prone area means a geographic area or administrative region defined on 
the  basis  of  surveys  indicating  that  the  percentage  of  dwellings  expected  to 
exceed the national reference level is significantly higher than in other parts of 
the country;  

(72)  Medical  radiological  procedure  means  any  procedure  giving  rise  to  medical 

exposure; 

(73)  Referrer  means  a  medical  doctor,  dentist  or  other  health  professional  who  is 
entitled  to  refer  individuals  for  medical  radiological  procedures  to  a 
practitioner, in accordance with national requirements; 

(74)  Individual  detriment  means  clinically  observable  deleterious  effects  in 
individuals  or  their  descendants,  the  appearance  of  which  is  either  immediate 
or delayed and, in the latter case, implies a probability rather than a certainty of 
appearance; 

(75)  Interventional  radiology  means  the  use  of  X-ray  imaging  techniques,  in 
addition to those involving ultrasound or magnetic resonance imaging or other 
non-ionising  radiation  techniques,  to  introduce  and  guide  devices  in  the  body 
for diagnostic or treatment purposes;  

(76)  Radiodiagnostic  means  pertaining  to  in-vivo  diagnostic  nuclear  medicine, 
medical diagnostic radiology using ionising radiation, and dental radiology; 

(77)  Radiotherapeutic means pertaining to radiotherapy, including nuclear medicine 

for therapeutic purposes; 

(78)  Clinical  responsibility  means  responsibility  of  a  practitioner  for  individual 
medical  exposures,  notably:  justification;  optimisation;  clinical  evaluation  of 
the  outcome;  cooperation  with  other  specialists  and  staff,  as  appropriate, 
regarding  practical  aspects  of  medical  exposure  procedures;  obtaining 
information,  if  appropriate,  on  previous  examinations;  providing  existing 
medical  radiological  information  and/or  records  to  other  practitioners  and/or 

EN 

28 

   EN 

 
the  referrer,  as  required;  and  giving  information  on  the  risk  of  ionising 
radiation to patients and other individuals involved, as appropriate; 

(79)  Clinical  audit  means  a  systematic  examination  or  review  of  medical 
radiological  procedures  which  seeks  to  improve  the  quality  and  outcome  of 
patient care through structured review, whereby medical radiological practices, 
procedures and results are examined against agreed standards for good medical 
radiological procedures, with modification of practices where indicated and the 
application of new standards if necessary; 

(80)  Medical  radiological 

installation  means  a  facility  containing  medical 

radiological equipment; 

(81)  Unintended  exposure  means  medical  exposure  that  is  significantly  different 

from the medical exposure intended for a given purpose;  

(82)  Representative  person  means  an 

individual  receiving  a  dose 

that 

is 

representative of the more highly exposed individuals in the population; 

(83)  Radiation protection officer means an individual who is technically competent 
in  radiation  protection  matters  relevant  for  a  given  type  of  practice  and  is 
designated  by  the  undertaking  to  oversee  the  implementation  of  the  radiation 
protection arrangements of the undertaking; 

(84)  Remedial  measures  means  the  removal  of  a  source  or  the  reduction  of  its 
magnitude  (in  terms  of  activity  or  amount)  for  the  purposes  of  avoiding  or 
reducing doses that might otherwise be received in an existing exposure situation. 

(85)  Protective  measures  means  measures,  other  than  remedial  measures,  for  the 
purpose of avoiding or reducing doses that might otherwise be received in an 
emergency exposure situation or an existing exposure situation. 

(86)  Authorisation  means  the  granting  by  a  competent  authority  of  written 
permission  for  an  undertaking  to  perform  specified  activities  subject  to 
regulatory control in the form of registration or a licence; 

(87)  Sealed source means a radioactive source in which the radioactive material is 

permanently sealed in a capsule or closely bonded in a solid form; 

(88)  Supplier means any natural or legal person who supplies or makes available a 

sealed source; 

(89)  Source container means the containment of a sealed source, where this is not an 
integral part of the source but is meant for shielding the source during its use, 
transport, handling, etc. 

(90)  Thoron means the isotope Rn-220; 

(91)  Residual  dose  means  the  dose  expected  to  be  incurred  from  all  exposure 
pathways  after  protective  measures  have  been  fully  implemented,  or  where  a 
decision has been taken not to implement any protective measures; 

EN 

29 

   EN 

 
(92)  Absorbed dose (D) means the energy absorbed per unit mass 

D

=

dε
m
d

where 

 is the mean energy imparted by ionising radiation to the matter in a volume 

–  εd
element, 

– dm is the mass of the matter in this volume element. 

In this Directive, absorbed dose denotes the dose averaged over a tissue or an organ. 
The unit for absorbed dose is the gray. 

(93)  Gray  (Gy)  is  unit  of  absorbed  dose.  One  gray  is  equal  to  one  joule  per 

kilogram: 1Gy = 1 J kg-1; 

(94)  Activity  (A)  means  the  activity,  A,  of  an  amount  of  a  radionuclide  in  a 
particular energy state at a given time. It is the quotient of dN by dt, where dN 
is the expectation value of the number of spontaneous nuclear transitions from 
that energy state in the time interval dt: 

A

=

N
d
t
d

The unit of activity is the Becquerel; 

(95)  Becquerel (Bq) means the special name of the unit of activity. One Becquerel 

is equivalent to one nuclear transition per second: 1 Bq = 1 s-1; 

(96)  Committed  equivalent  dose  (H(τ))  means  the  integral  over  time  (τ)  of  the 
equivalent dose rate (in tissue or organ T) that will be received by an individual 
as a result of an intake. It is given by: 

H

T

)(
τ

=

t
0

τ
+
&
tH

d )(
t

∫

t
0

for an intake at time t0 where 

)(τTH&

is the relevant equivalent dose rate (in organ or tissue T) at time t, 

τ is the time over which the integration is performed. 

In specifying HT(τ), τ is given in years. When τ is not given, a period of 50 years is 
assumed for adults and up to age 70 for children. The unit for committed equivalent 
dose is the sievert; 

(97)  Normal  exposure  means  exposure  expected  to  occur  under  the  normal 
operating  conditions  of  a  facility  or  activity  (including  maintenance, 
inspection,  decommissioning),  including  possible  minor  mishaps  that  can  be 

EN 

30 

   EN 

 
 
 
 
kept  under  control,  i.e.  during  normal  operation  and  anticipated  operational 
occurrences; 

(98)  Projected  dose  means  the  dose  that  would  be  expected  to  be  incurred  if  no 

protective measures were to be taken; 

(99)  Quality  control  means  the  set  of  operations  (programming,  coordinating, 
implementing)  intended  to  maintain  or  to  improve  quality.  It  includes 
monitoring, evaluation and maintenance at required levels of all characteristics 
of performance of equipment that can be defined, measured, and controlled;  

(100) Response  strategy  means  a  set  of  different  protective  measures  to  respond  to 
postulated or actual events so as to manage an emergency exposure situation in 
accordance  with  the  stated  objectives.  Within  an  emergency  response  plan, 
response strategies are established for each postulated event and scenario; 

CHAPTER III 

SYSTEM OF RADIATION PROTECTION 

Article 5 

General principles 

Member  States  shall  establish  legal  requirements  and  an  appropriate  regime  of  regulatory 
control which, for all exposure situations reflect a system of radiation protection based on the 
principles of justification, optimisation and dose limitation: 

(a) 

(b) 

(c) 

Justification:  decisions  introducing  or  altering  a  radiation  source,  an  exposure 
pathway or actual exposures shall be justified in the sense that such decisions shall 
be taken with the intent to ensure that the individual or societal benefit resulting from 
them offsets the detriment that they may cause. 

Optimisation: in all exposure situations, radiation protection shall be optimised with 
the  aim  of  keeping  the  magnitude  and  likelihood  of  exposure  and  the  number  of 
individuals exposed as low as reasonably achievable, taking into account economic 
and  societal  factors,  whereby  optimisation  of  the  protection  of  individuals 
undergoing medical exposure shall be commensurate with the medical purpose of the 
exposure  as  described  in  Article  55.  This  principle  shall  be  applied  in  terms  of 
effective  dose  as  well  as  organ  doses,  as  a  precautionary  measure  to  allow  for 
uncertainties as to health detriment below the threshold, for deterministic effects. 

Dose  limitation:  in  planned  exposure  situations,  the  sum  of  doses  to  an  individual 
from  all  regulated  radiation  sources  may  not  exceed  the  dose  limits  laid  down  for 
occupational  exposure  or  public  exposure.  Dose  limits  shall  not  apply  to  medical 
exposures. 

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SECTION 1 

TOOLS FOR OPTIMISATION 

Article 6 

1. 

2. 

3. 

4. 

5. 

Dose constraints for occupational and public exposure 

For occupational exposure, the dose constraint shall be established as an operational 
tool  for  optimisation  by  the  undertaking  under  the  general  supervision  of  the 
competent  authorities.  In  the  case  of  outside  workers  the  dose  constraint  shall  be 
established in cooperation between the employer and the undertaking.  

For  public  exposure,  the  dose  constraint  shall  be  set  for  the  individual  dose  that 
members  of  the  public  receive  from  the  planned  operation  of  a  specified  radiation 
source. The competent authorities shall set the constraint so as to ensure compliance 
with the dose limit for the sum of doses to the same individual from all authorised 
practices. 

With regard to potential exposures, optimisation shall include adequate management 
of the safety and security of sources and facilities. Where appropriate risk constraints 
may be established. 

Dose  constraints  shall  be  established  in  terms  of  individual  effective  or  equivalent 
doses over a year or any other appropriate shorter time period.  

Where  dose  constraints  are  introduced  to  restrict  any  protracted  accumulated 
exposure, these shall be established in terms of annual effective doses or equivalent 
doses to an organ. 

Article 7 

Dose constraints for medical exposure 

Dose constraints shall not apply for the medical exposure of patients. 

For carers and comforters and for volunteers participating in medical and biomedical 
research  (for  whom  no  direct  medical  benefit  is  expected  from  the  exposure),  dose 
constraints shall be established in terms of the individual dose that is unlikely to be 
exceeded for the period of the examination, treatment or research project in question. 

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32 

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Article 8 

Reference levels  

Reference levels shall be established for emergency and existing exposure situations 
as a level of effective dose or organ dose above which it is judged inappropriate to 
allow exposures in emergency or existing exposure situations. Optimised protective 
strategies shall be planned and implemented with the objective of reducing individual 
doses below the reference levels. The values chosen for reference levels shall depend 
upon the type of exposure situation. Optimisation of protection shall give priority to 
exposures above the reference level. The choices  of reference levels shall take into 
account both radiological protection requirements and societal criteria. The choice of 
reference  levels  for  the  effective  dose  shall  take  into  account  the  three  bands  of 
reference levels set out in point 1 of Annex I. 

SECTION 2 

DOSE LIMITATION 

Article 9 

Age limit for exposed workers 

Subject to Article 12(2), persons under 18 years of age may not be assigned to any 
work which would result in their being exposed workers. 

Article 10 

Dose limits for occupational exposure 

1. 

2. 

(a) 

The  limit  on  the  effective  dose  for  occupational  exposure  shall  be  20  mSv  in  any 
single  year.  However,  in  special  circumstances  or  for  certain  exposure  situations 
specified  in  national  legislation,  a  higher  effective  dose  of  up  to  50  mSv  per  year 
may  be  authorised  in  a  single  year,  provided  that  the  average  dose  over  any  five 
consecutive years does not exceed 20 mSv per year. 

For  emergency  workers  a  higher  effective  dose  may  be  authorised,  in  accordance 
with Article 52.  

In addition to limits of effective dose laid down in paragraph 1, the following limits 
on equivalent dose shall apply: 

the limit on the equivalent dose for the lens of the eye shall be 20 mSv in a year or, 
where applicable, the same value as specified for the limit on effective dose; 

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33 

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(b) 

(c) 

1. 

the limit on the equivalent dose for the skin shall be 500 mSv in a year;, this limit 
shall  apply  to  the  dose  averaged  over  any  area  of  1  cm²,  regardless  of  the  area 
exposed; 

the limit on the equivalent dose for the hands, forearms, feet and ankles shall be 500 
mSv in a year. 

Article 11 

Protection of pregnant women 

As  soon  as  a  pregnant  woman  informs  the  undertaking  of  her  condition,  in 
accordance with national legislation or national practice, the protection of the unborn 
child  shall  be  comparable  with  that  provided  for  members  of  the  public.  The 
employment  conditions  for  the  pregnant  woman  shall  therefore  be  such  that  the 
equivalent dose to the unborn child is as low as reasonably achievable and unlikely 
to exceed 1 mSv during at least the remainder of the pregnancy. 

2. 

As  soon  as  a  breastfeeding  woman  informs  the  undertaking  of  her  condition,  she 
shall not be employed in work involving a significant risk of intake of radionuclides. 

Article 12 

Dose limits for apprentices and students 

1. 

2. 

(a) 

(b) 

(c) 

3. 

The dose limits for apprentices aged 18 years or over and students aged 18 years or 
over who, in the course of their studies, are obliged to work with radiation sources 
shall be the same as the dose limits for occupational exposure laid down in Article 
10. 

The limit on the effective dose for apprentices aged between 16 and 18 years and for 
students  aged  between  16  and  18  years  who,  in  the  course  of  their  studies,  are 
obliged to work with radiation sources shall be 6 mSv per year.  

In  addition  to  limits  of  effective  dose  laid  down  in  the  first  subparagraph,  the 
following limits on equivalent dose shall apply: 

the limit on the equivalent dose for the lens of the eye shall be 20 mSv in a year; 

the  limit  on  the  equivalent  dose  for  the  skin  shall  be  150  mSv  in  a  year,  averaged 
over any area of 1 cm², regardless of the area exposed; 

the limit on the equivalent dose for the hands, forearms, feet and ankles shall be 150 
mSv in a year. 

The dose limits for apprentices and students who are not subject to the provisions of 
paragraphs 1 and 2 shall be the same as the dose limits for members of the public as 
specified in Article 13. 

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34 

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Article 13 

Dose limits for public exposure 

(a) 

(b) 

(a) 

(b) 

The limit on the effective dose for public exposure shall be 1 mSv in a year.  

In addition to the dose limit referred to in the first subparagraph, the following limits 
on the equivalent dose shall apply: 

the limit on the equivalent dose for the lens of the eye shall be 15 mSv in a year; 

the limit on the equivalent dose for the skin shall be 50 mSv in a year, averaged over 
any 1 cm² area of skin, regardless of the area exposed. 

Article 14 

Estimation of the effective and equivalent dose 

For  the  estimation  of  effective  and  equivalent  doses,  the  following  values  and 
relationships shall be used:  

For external radiation, the values and relationships laid down in Publication 103 of 
the  International  Commission  on  Radiological  Protection  shall  be  used  to  estimate 
the effective and equivalent doses. 

For  internal  exposure  from  a  radionuclide  or  from  a  mixture  of  radionuclides,  the 
values  and  relationships  laid  down  in  Publication  103  of  the  International 
Commission  on  Radiological  Protection  and  the  ingestion  and  inhalation  dose 
coefficients  laid  down  in  Publication  72  of  the  International  Commission  on 
Radiological Protection shall be used to estimate the committed effective doses. 

CHAPTER IV 

REQUIREMENTS FOR RADIATION PROTECTION 
EDUCATION, TRAINING AND INFORMATION 

Article 15 

General responsibilities for the education, training and provision of information 

Member States shall establish an adequate legislative and administrative framework 
for providing appropriate radiation protection education, training and information to 
all individuals whose tasks require specific competences in radiation protection. The 

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35 

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training,  retraining  and  information  of  relevant  individuals  shall  be  repeated  at 
appropriate intervals and documented. 

Member  States  shall  establish  education,  training  and  retraining  to  allow  the 
recognition  of  radiation  protection  experts,  medical  physics  experts,  occupational 
health services, and dosimetry services.  

Article 16 

Training of exposed workers, apprentices and students and information provided to them 

1. 

(a) 

(b) 

(c) 

(d) 

2. 

3. 

4. 

Member  States  shall  require  the  undertaking  or  the  employer  to  inform  exposed 
workers, apprentices and students who are subject to occupational exposure on: 

the health risks involved in their work; 

the general radiation protection procedures and precautions to be taken, in particular 
those connected with the operational and working conditions of both the practice in 
general and each type of workstation or work to which they may be assigned; 

the emergency response plans and procedures; 

the  importance  of  complying  with  the  technical,  medical  and  administrative 
requirements; 

Member States shall require the undertaking or the employer to inform women on the 
importance  of  making  an  early  declaration  of  pregnancy  in  view  of  the  risks  of 
exposure  for  the  unborn  child  and  the  risk  of  contaminating  a  nursing  infant  after 
intake of radionuclides.  

Member  States  shall  require  that  the  undertaking  or  the  employer  provides 
appropriate  radiation  protection  training  and  information  programmes  for  their 
personnel. 

In  addition  to  the  information  and  training  in  the  field  of  radiation  protection  as 
specified  in  paragraphs  1,  2  and  3,  an  undertaking  responsible  for  high-activity 
sealed sources shall ensure that such training includes specific requirements for the 
safe  management  and  security  of  high-activity  sealed  sources  with  a  view  to 
preparing the relevant workers adequately for any events affecting their own safety 
or  the  radiation  protection  of  other  individuals.  The  information  and  training  shall 
place  particular  emphasis  on  the  necessary  safety  requirements  and  shall  contain 
specific information on the possible consequences of the loss of adequate control of 
high-activity sealed sources. 

EN 

36 

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Article 17 

Information and training of workers potentially exposed to orphan sources 

Member  States  shall  ensure  that  the  management  of  and  workers  in  installations 
where  orphan  sources  are  most  likely  to  be  found  or  processed,  in  particular  large 
metal  scrap  yards  and  major  metal  scrap  recycling  plants,  and  in  significant  nodal 
transit points, are: 

informed of the possibility that they may be confronted with a source; 

advised and trained in the visual detection of sources and their containers; 

informed of basic facts about ionising radiation and its effects; 

informed about detection systems; 

informed of and trained in the action to be taken on site in the event of the detection 
or suspected detection of a source. 

Article 18 

Information and training for emergency workers 

Member  States  shall  ensure  that  emergency  workers  and  any  other  persons  who 
might  be  involved  in  the  organisation  of  emergency  assistance  in  the  event  of  an 
emergency are given adequate and regularly updated information on the health risks 
their  intervention  might  involve  and  on  the  precautionary  measures  to  be  taken  in 
such  an  event.  This  information  shall  take  into  account  the  range  of  potential 
emergencies. 

As soon as an emergency occurs, the information referred to in paragraph 1 shall be 
supplemented appropriately, having regard to the specific circumstances. 

Member  States  shall  ensure  that  emergency  workers  receive  regular  training  as 
provided  for  in  the  emergency  management  system  set  out  in  Article  97.  Where 
appropriate, this training shall include practical exercises. 

Members  States  shall  ensure  that,  in  addition  to  the  emergency  response  training 
referred  to  in  paragraph  3  of  this  Article,  the  organisation  responsible  for  the 
protection  of  emergency  workers  as  referred  to  in  Article  30(1)(b)  provides  these 
workers with appropriate radiation protection training and information. 

(a) 

(b) 

(c) 

(d) 

(e) 

1. 

2. 

3. 

4. 

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37 

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Article 19 

Education, information and training in the field of medical exposure 

Member  States  shall  ensure  that  practitioners  and  the  individuals  involved  in  the 
practical  aspects  of  medical  exposure  procedures  have  adequate  education, 
information  and  theoretical  and  practical  training  for  the  purpose  of  medical 
radiological practices, as well as relevant competence in radiation protection. 

For  this  purpose  Member  States  shall  ensure  that  appropriate  curriculum  are 
established  and  shall  recognise  the  corresponding  diplomas,  certificates  or  formal 
qualifications. 

Individuals  undergoing  relevant  training  programmes  may  participate  in  practical 
aspects of medical exposure procedures as set out in Article 56(4). 

Member States shall ensure that continuing education and training after qualification 
is provided and, in the special case of the clinical use of new techniques, training is 
provided on these techniques and the relevant radiation protection requirements. 

Member  States  shall  ensure  that  mechanisms  are  in  place  for  the  timely 
dissemination  of  information  relevant  to  radiation  protection  for  medical  exposure 
regarding lessons learned from significant events. 

Member States shall ensure the introduction of a course on radiation protection in the 
basic curriculum of medical and dental schools. 

CHAPTER V 

JUSTIFICATION AND REGULATORY CONTROL OF 
PRACTICES 

Article 20 

Justification of practices 

Member  States  shall  ensure  that  new  types  of  practices  resulting  in  exposure  to 
ionising radiation are justified before being approved. 

Member  States  shall  list  the  approved  types  of  practices  in  legislation  or 
administrative acts. 

Existing types of practices shall be reviewed as to their justification whenever new 
and important evidence about their efficacy or potential consequences is acquired. 

1. 

2. 

3. 

4. 

5. 

1. 

2. 

3. 

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38 

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Article 21 

Justification of practices with apparatus or products emitting ionising radiation 

Member States shall require any undertaking intending to manufacture or import or 
export a new type of apparatus or product emitting ionising radiation to provide the 
competent  authorities  with  relevant  information  such  as  that  listed  in  Annex  III, 
Section  A,  in  order  to  enable  the  authorities,  on  the  basis  of  assessment  of 
information set out in Annex III, Section B, to decide whether the intended use of the 
apparatus or product can be justified.  

The competent authority shall share the information received according to paragraph 
1  with  the  competent  authorities  of  the  other  Member  States  to  allow  them  to  take 
their own decision on the justification of the intended use of the apparatus or product. 

The undertaking shall be informed on the decisions of the Member States' competent 
authorities within a period of 6 months. 

Article 22 

Prohibition of practices 

Member States shall prohibit the deliberate addition of radioactive substances in the 
production of foodstuffs, toys, personal ornaments and cosmetics, and shall prohibit 
the  import  or  export  of  such  products.  Without  prejudice  to  the  Directive 
1999/2/EC21 of the European Parliament and of the Council, practices involving the 
activation  of  material  resulting  in  an  increase  in  activity  in  the  associated  products 
shall be deemed not to be justified. 

Article 23 

Practices involving the deliberate exposure of humans for non-medical purposes 

Member States shall ensure the identification, by means of surveys or by any other 
appropriate means, of practices involving non-medical imaging exposure, as set out 
in Annex IV. 

Member  States  shall  ensure  that  special  attention  is  given  to  the  justification  of 
practices involving non-medical imaging exposure, in particular: 

all types of practices involving non-medical imaging exposure, as listed in Annex IV, 
shall be justified in advance before being generally accepted; 

1. 

2. 

3. 

1. 

2. 

(a) 

21 

OJ L 66, 13.3.1999, p.16. 

EN 

39 

   EN 

 
                                                 
(b) 

(c) 

(d) 

3. 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

each particular application of a generally accepted type of practice shall be justified 
in advance; 

all  individual  non-medical  imaging  exposure  procedures  as  listed  in  section  A  of 
Annex IV implemented by medical staff using medical radiological equipment shall 
be  justified  in  advance  taking  into  account  the  specific  objectives  of  the  procedure 
and the characteristics of the individual involved; 

the  general  and  particular  justification  of  practices  involving  non-medical  imaging 
exposure,  as  specified  in  (a)  and  (b),  shall  be  subject  to  periodic  review  by  the 
competent authority. 

Where  a  Member  State  has  determined  that  a  particular  practice  involving  non-
medical imaging exposure is justified it shall ensure that: 

each practice is subject to authorisation;  

requirements  for  the  practice,  including  criteria  for  individual  implementation,  are 
established  by  the  competent  authority,  in  cooperation  with  other  relevant  agencies 
and professional bodies as appropriate; 

dose constraints are established for each practice. Such shall be well below the dose 
limit  for  members  of  the  public,  including,  whenever  practicable,  for  procedures 
implemented by medical staff using medical equipment (section A in Annex IV); for 
other  practices  (section  B  in  Annex  IV),  the  dose  constraint  shall  satisfy  the 
requirements of Article 6(2); 

relevant  requirements  of  Chapter  VII,  including  those  for  equipment,  optimisation, 
responsibilities  and  special  protection  during  pregnancy,  are  met  for  procedures 
implemented by medical staff using medical radiological equipment; 

the  informed  consent  of  the  individual  to  be  exposed  is  sought,  allowing  for  cases 
where  the  law  enforcement  bodies  may  proceed  without  consent  according  to 
national legislation; 

where  the  exposure  is  routinely  carried  out  for  security  purposes  the  screened 
individuals  are  provided  with  a  choice  of  an  alternative  technique  which  does  not 
involve exposure to ionising radiation. 

Article 24 

Identification of practices involving naturally occurring radioactive material 

Member  States  shall  ensure  the  identification  of  practices  involving  naturally 
occurring radioactive material and leading to exposure of workers or members of the 
public which cannot be disregarded from a radiation protection point of view. Such 
identification  shall  be  carried  out  by  means  of  surveys  or  by  any  other  appropriate 
means taking into account industrial sectors listed in Annex V. 

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40 

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Article 25 

Notification 

1. 

(a) 

(b) 

(c) 

2. 

3. 

4. 

Member  States  shall  require  all  practices,  including  those  practices  identified  in 
accordance with Article 23, to be notified, except for justified practices involving the 
following: 

materials  containing  radioactive  substances  where  the  quantities  of  the  activity 
involved do not exceed in total the exemption values set out in Annex VI or higher 
values that, for specific applications, are authorised by the competent authorities and 
satisfy the general exemption and clearance criteria set out in Annex VI; or 

materials  containing  radioactive  substances,  provided  that  the  concentrations  of 
activity  per  unit  mass  do  not  exceed  the  exemption  values  set  out  in  Table  A  of 
Annex  VI,  or  higher  values  that,  for  specific  applications,  are  authorised  by  the 
competent authorities and satisfy the general exemption and clearance criteria set out 
in Annex VI; or 

any  cathode  ray  tube  intended  for  the  display  of  visual  images,  or  other  electrical 
apparatus  operating  at  a  potential  difference  not  exceeding  30  kV,  or  any  other 
apparatus or product which is of a type approved by the competent authorities of the 
Member State, provided that: 

(i) it does not cause, in normal operating conditions, a dose rate exceeding 1 µSv⋅h–1 
at a distance of 0.1 m from any accessible surface of the apparatus; and 

(ii) if it contains radioactive substances, these substances are embedded in a capsule 
or fixed to a solid holder; and  

(iii) conditions for disposal have been specified by the competent authorities. 

Member  States  may  exempt  further  types  of  practices  from  the  notification 
requirement subject to compliance with the general exemption criteria established in 
point  3  of  Annex  VI,  or  in  such  cases  where  an  assessment  of  the  optimisation  of 
protection shows that exemption is the best option. 

Practices  that  involve  naturally  occurring  radioactive  material,  identified  in 
accordance with Article 24, and produce or process residues which are known to be 
recycled  into  identified  building  materials  are  subject  to  notification  if  the  activity 
concentration  index  as  defined  in  Annex  VII  in  the  resulting  building  materials  is 
liable  to  exceed  1.  The  undertaking  shall  also  in  this  case  inform  the  user  of  the 
residue about the activity concentration of the residue. 

In  situations  identified  by  Member  States  where  there  is  concern  that  a  practice 
identified  in  accordance  with  Article  24  may  lead  to  the  presence  of  naturally 
occurring radionuclides in water liable to affect the quality of drinking water supplies 
or  affect  any  other  exposure  pathways,  so  as  to  be  of  concern  from  a  radiation 
protection  point  of  view,  the  competent  authority  may  require  that  the  practice  be 
subject to notification irrespective of the provisions of paragraph 1(b). 

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41 

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5. 

6. 

1. 

2. 

3. 

4. 

1. 

2. 

(a) 

(b) 

For  types  of  practices  subject  to  notification,  Member  States  shall  specify  the 
information to be provided by the undertaking so as to allow the competent authority 
to establish appropriate means of regulatory control. 

For  the  purpose of exemption  under paragraph  1(c), Member States shall exchange 
information  on  the  type  approvals  that  have  been  granted  and  on  the  underlying 
documentation  and  assessment.  Competent  authorities  shall  take  into  account  such 
information received, as well as applicable European and international standards, in 
making their own decisions with regard to the exemption of corresponding practices. 

Article 26 

Regulatory control 

Member States shall require any notified practice to be subject to regulatory control 
commensurate  with  the  magnitude  and  likelihood  of  exposures  resulting  from  the 
practice,  and  commensurate  with  the  impact  that  regulatory  control  may  have  in 
reducing such exposures or improving the safety of installations.  

Notified practices may be exempted from authorisation. 

In  the  case  of  moderate  amounts  of  material  as  specified  by  Member  States,  the 
activity  concentration  values  laid  down  in  Annex  VI,  Table  B,  column  2,  may  be 
used for the purpose of exemption. 

Notified practices which are not exempted shall be subject to authorisation through 
registration or licensing. 

Article 27 

Authorisation 

In  cases  where  a  limited  risk  of  exposure  does  not  necessitate  the  examination  of 
individual  cases  and  the  practice  is  undertaken  in  accordance  with  conditions  laid 
down  in  national  legislation,  competent  authorities  may  limit  regulatory  control  to 
registration of the practice and an appropriate frequency of inspections. 

Member States shall require licensing for the following practices: 

the operation and decommissioning of any facility of the nuclear fuel cycle and the 
exploitation and closure of uranium mining; 

the deliberate addition of radioactive substances  in the production and manufacture 
of consumer products or other products, including medicinal products, and the import 
or export of such products; 

(c) 

the manufacture, use or taking possession of a high-activity sealed source; 

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42 

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(d) 

(e) 

(f) 

3. 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

4. 

1. 

2. 

(a) 

(b) 

the  operation,  decommissioning  and  closure  of  any  facility  for  the  processing, 
storage or disposal of radioactive waste;  

practices in which workers are liable to receive an annual effective dose of more than 
6 mSv in normal operation and under normal working conditions; 

practices  discharging  significant  amounts  of  airborne  or  liquid  effluent  into  the 
environment. 

Member  States  shall  require  either  registration  or  licensing  of  the  following 
practices: 

the deliberate administration of radioactive substances to persons and, in so far as the 
radiation  protection  of  human  beings  is  concerned,  animals  for  the  purpose  of 
medical or veterinary diagnosis, treatment or research; 

the use of radiation generators or radioactive sources for industrial radiography, the 
processing  of  products  or  research,  and  the  use  of  accelerators,  except  electron 
microscopes; 

the use of radiation generators or radioactive sources for medical exposures; 

the manufacture and operation of electrical equipment emitting ionising radiation and 
operating at a potential difference of more than 30 kV, as well as the import or export 
of such equipment; 

practices in which workers are liable to receive an annual effective dose of more than 
1 mSv in normal operation and under normal working conditions; 

industries  involving  naturally  occurring  radioactive  material  identified  by  Member 
States as required in Article 24, and liable to lead to an effective dose to a member of 
the public equal to or exceeding 0.3 mSv per year. 

Member States may require registration or licensing for types of practices other than 
those listed in paragraphs 2 and 3. 

Article 28 

Authorisation procedure 

For authorisation purposes, Member States shall require the provision of information 
commensurate with the nature of the practice and the risks involved.  

The information referred to in paragraph 1 shall for the purpose of granting a license 
cover at least the following: 

responsibilities and organisational arrangements for protection and safety;  

staff competences, including information and training; 

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43 

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(c) 

(d) 

(e) 

(f) 

(g) 

(h) 

(i) 

(j) 

3. 

4. 

5. 

design features of the installation and radiation sources; 

anticipated occupational and public exposures in normal operation; 

safety assessment of the activities and the installation in order to: 

(i) identify ways in which potential exposures or accidental and unintended medical 
exposures could occur; 

(ii)  estimate,  to  the  extent  practicable,  the  probabilities  and  magnitude  of  potential 
exposures; 

(iii)  assess  the  quality  and  extent  of  protection  and  safety  provisions,  including 
engineering features as well as administrative procedures; 

(iv) define the operational limits and conditions of operation; 

emergency procedures and communication links; 

maintenance,  testing,  inspection  and  servicing  so  as  to  ensure  that  the  radiation 
source  and  the  installation  continue  to  meet  the  design  requirements,  operational 
limits and conditions of operation throughout their lifetime;  

management of radioactive waste and arrangements for the disposal of such waste in 
accordance with applicable regulatory requirements; 

management of disused sealed sources; 

quality assurance. 

A  licence  shall  include  specific  conditions  so  as  to  ensure  that  the  elements  of  the 
licence  are  legally  enforceable  or  to  impose  appropriate  restrictions  on  the 
operational  limits  or  conditions  of  operation.  The  conditions  shall  also  require  the 
formal, documented implementation of the principle of optimisation. 

Where  applicable,  a  licence  shall  include  a  discharge  authorisation  issued  in 
accordance with the requirements laid down in Chapter VIII for authorisation of the 
release of liquid or airborne radioactive effluent into the environment. 

Member States shall require the undertaking to promptly notify the occurrence of any 
significant event resulting or liable to result in the exposure of an individual beyond 
the operational limits or conditions of operation specified in licensing requirements 
with  regard  to  occupational  or  public  exposure  or  as  defined  by  the  authorities  for 
medical exposure. 

EN 

44 

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Article 29 

Release from regulatory control 

1. 

2. 

(a) 

(b) 

3. 

(a) 

(b) 

(c) 

4. 

The disposal, recycling or reuse of radioactive materials arising from any authorised 
practice is subject to authorisation. 

The materials for disposal, recycling or reuse may be released from the requirements 
of this Directive provided that the concentrations of activity per unit mass:  

do not exceed the values set out in Annex VI, part 1 of Table A; or 

comply  with  specific  clearance  levels  and  associated  requirements  for  specific 
materials or for materials originating from specific types of practices; these specific 
clearance levels, in addition to the general clearance levels referred to in (a), shall be 
established  by  the  national  competent  authority  following  the  general  exemption 
criteria set out in Annex VI and taking into account technical guidance provided by 
the Community. 

For  the  clearance  of  materials  containing  naturally  occurring  radionuclides,  the 
values  for  the  concentrations  of  activity  per  unit  mass  shall  be  those  laid  down  in 
Annex VI, part 2 of Table A. Nevertheless the following requirements shall apply: 

for practices subject to licensing as specified in Article 27(3)(f), the dose criteria for 
clearance of naturally occurring radionuclides shall be complied with; 

for other licensed practices, in particular those forming part of the nuclear fuel cycle, 
the  clearance  levels  shall  comply  with  the  dose  criteria  for  clearance  of  materials 
containing artificial radionuclides; 

for  authorised  practices  subject  to  notification  as  specified  under  Article  25(3),  the 
corresponding requirements for the placing on the market of building materials shall 
be complied with. 

The deliberate dilution of radioactive residues, other than the mixing of materials that 
takes place in normal operation when radioactivity is not a consideration, shall not be 
permitted. The competent authority may authorise in specific situations the mixing of 
radioactive  residues  containing  naturally  occurring  radioactive  material  with  other 
materials to promote the reuse and recycling of these materials and to reduce public 
exposure. 

EN 

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CHAPTER VI 

PROTECTION OF WORKERS, APPRENTICES AND 
STUDENTS 

Article 30 

Responsibilities 

1. 

(a) 

(b) 

(c) 

(d) 

2. 

The relevant requirements for occupational exposure in this Chapter and in Articles 
9, 10, 11 and 12, shall apply to the protection of workers in any exposure situation 
where their exposure at work or as the result of work is the legal responsibility of an 
undertaking or another legal person, including for instance: 

the employer of outside workers; 

the organisation responsible for the protection of emergency workers; 

the organisation responsible for the remediation of contaminated land, buildings and 
other constructions; 

the  employer  who  has  legal  responsibility  for  the  exposure  of  workers  to  radon  at 
work, in the situation specified in Article 53(4). 

The  responsibility  of  an  undertaking  for  occupational  exposure  shall  extend  to 
apprentices and students who in the course of their studies are obliged to work with 
radiation sources and to  individuals who  are self-employed or  work  on  a voluntary 
basis or for a charity organisation. 

3. 

The  undertaking  shall  be  responsible  for  assessing  and  implementing  arrangements 
for the radiation protection of exposed workers. 

Article 31 

Operational protection of workers 

The operational protection of exposed workers shall be based on: 

prior  evaluation  to  identify  the  nature  and  magnitude  of  the  radiological  risk  to 
exposed workers;  

implementation of the optimisation of radiation protection in all working conditions; 

classification of workers into different categories; 

(a) 

(b) 

(c) 

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(d) 

implementation  of  control  measures  and  monitoring  relating  to  the  different  areas 
and working conditions, including, where necessary, individual monitoring; 

(e) 

medical surveillance. 

Article 32 

Consultations with radiation protection expert 

Member States shall require the undertaking to consult a radiation protection expert 
on the examination and testing of protective devices and measuring instruments, in 
particular for: 

prior critical examination of plans for installations from the point of view of radiation 
protection; 

the  acceptance  into  service  of  new  or  modified  radiation  sources  from  the  point  of 
view of radiation protection; 

regular checking of the effectiveness of protective devices and techniques; 

regular  calibration  of  measuring  instruments  and  regular  checking  that  they  are 
serviceable and correctly used. 

Article 33 

Arrangements in workplaces 

For  the  purposes  of  radiation  protection,  arrangements  shall  be  made  as  regards  all 
workplaces where there is a possibility of exposure to ionising radiation in excess of 
an effective dose of 1 mSv per year or an equivalent dose of 15 mSv per year for the 
lens of the eye or 50 mSv per year for the skin and extremities. Such arrangements 
shall  be  appropriate  to  the  nature  of  the  installations  and  sources  and  to  the 
magnitude and nature of the risks. 

For  practices  involving  naturally  occurring  radioactive  material  where  the  effective 
dose to workers is liable to exceed 6 mSv per year, the requirements set out in this 
Chapter  shall  apply.  Where  the  effective  dose  to  workers  is  less  than  or  equal  to 
6 mSv per year the competent authorities shall at least require undertakings to keep 
exposures  under  review,  taking  into  account  the  potential  for  protection  to  be 
improved or the potential for doses to increase over time or as a result of changes in 
the process or the work arrangements. 

For undertakings operating aircraft where the effective dose to the crew from cosmic 
radiation is liable to exceed 6 mSv per year, the relevant requirements set out in this 
Chapter  shall  apply.  Where  the  effective  dose  to  the  crew  is  less  than  or  equal  to 
6 mSv per year and liable to be above 1 mSv per year, the competent authorities shall 
at least require undertakings to keep exposures under review, taking into account the 

(a) 

(b) 

(c) 

(d) 

1. 

2. 

3. 

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47 

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potential  for  doses  to  change  over  time  or  as  a  result  of  changes  in  the  work 
arrangements. The undertakings shall take appropriate measures, in particular: 

to assess the exposure of the crew concerned; 

to take into account the assessed exposure when organising working schedules with a 
view to reducing the doses of highly exposed crew; 

to  inform  the  workers  concerned  of  the  health  risks  their  work  involves  and  their 
individual dose. 

Article 34 

Classification of workplaces 

Arrangements  in  workplaces  shall  include  a  classification  of  workplaces  into 
different  areas,  where  appropriate,  on  the  basis  of  an  assessment  of  the  expected 
annual doses and the probability and magnitude of potential exposures. 

A  distinction  shall  be  made  between  controlled  areas  and  supervised  areas.  The 
competent authorities shall establish guidance on the classification of controlled and 
supervised areas with regard to particular circumstances. 

The  undertaking  shall  keep  under  review  the  working  conditions  in  controlled  and 
supervised areas. 

Article 35 

Requirements for controlled areas 

The minimum requirements for a controlled area shall be the following: 

The  controlled  area  shall  be  delineated  and  access  to  it  shall  be  restricted  to 
individuals  who  have  received  appropriate  instructions  and  shall  be  controlled  in 
accordance with written procedures provided by the undertaking. Wherever there is a 
significant  risk  of  the  spread  of  radioactive  contamination,  specific  arrangements 
shall  be  made,  including  for  the  access  and  exit  of  individuals  and  goods  and  for 
monitoring contamination within the controlled area and in the adjacent area. 

Taking into account the nature and extent of radiological risks in the controlled area, 
radiological  surveillance  of  the  working  environment  shall  be  organised  in 
accordance with the provisions of Article 37. 

Signs  indicating  the  type  of  area,  the  nature  of  the  sources  and  their  inherent  risks 
shall be displayed. 

Working instructions appropriate to the radiological risk associated with the sources 
and the operations involved shall be laid down. 

(a) 

(b) 

(c) 

1. 

2. 

3. 

1. 

(a) 

(b) 

(c) 

(d) 

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2. 

The  undertaking  shall  be  responsible  for  implementation  of  these  duties  following 
consultations with the radiation protection expert. 

Article 36 

Requirements for supervised areas 

The requirements for a supervised area shall be the following: 

taking into account the nature and extent of radiological risks in the supervised area, 
radiological  surveillance  of  the  working  environment  shall  be  organised  in 
accordance with the provisions of Article 37; 

signs  indicating  the  type  of  area,  the  nature  of  the  sources  and  their  inherent  risks 
shall be displayed; 

working instructions appropriate to the radiological risk associated with the sources 
and the operations involved shall be laid down. 

The  undertaking  shall  be  responsible  for  implementation  of  these  duties  following 
consultations with the radiation protection expert. 

Article 37 

Radiological surveillance of the working environment 

The  radiological  surveillance  of  the  working  environment  referred  to  in  Articles 
35(1)(b) and 36(1)(a) shall comprise, where appropriate: 

the  measurement  of  external  dose  rates,  indicating  the  nature  and  quality  of  the 
radiation in question; 

the  measurement  of  the  air  activity  concentration  and  the  surface  density  of 
contaminating radionuclides, indicating their nature and their physical and chemical 
states; 

the measurement of radon concentrations in the workplace. 

The results of these measurements shall be recorded and shall be used, if necessary, 
for estimating individual doses, as provided for in Articles 39. 

1. 

(a) 

(b) 

(c) 

2. 

1. 

(a) 

(b) 

(c) 

2. 

Article 38 

Categorisation of exposed workers 

1. 

For the purposes of monitoring and surveillance, a distinction shall be made between 
two categories of exposed workers: 

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49 

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(a) 

(b) 

2. 

3. 

1. 

2. 

3. 

category A: those exposed workers who are liable to receive an effective dose greater 
than 6 mSv per year or an equivalent dose greater than 15 mSv per year for the lens 
of the eye or greater than 150 mSv per year for skin and extremities; 

category B: those exposed workers who are not classified as category A workers. 

The  distinction  referred  to  in  paragraph  1  shall  be  made  prior  to  employment  for 
work  involving  exposure  and  shall  be  subject  to  regular  review  on  the  basis  of 
working conditions and medical surveillance. 

For  emergency  workers,  the  distinction  referred  to  in  paragraph  1  of  this  Article, 
where appropriate, shall have no effect on the requirements for monitoring set out in 
Articles 37, 39 – 43 as long as the workers are not involved in an actual emergency 
exposure situation. 

Article 39 

Individual monitoring 

Category  A  workers  shall  be  systematically  monitored  based  on  individual 
measurements performed by a dosimetry service. In cases where category A workers 
are liable to receive significant internal exposure or significant exposure of the lens 
of  the  eye  or  extremities  an  adequate  system  for  monitoring  shall  be  set  up.  The 
competent authority shall give special attention to the identification of such workers. 

Monitoring  for  category  B  workers  shall  be  at  least  sufficient  to  demonstrate  that 
such  workers  are  correctly  classified  in  category  B.  Member  States  may  require 
individual  monitoring  and  if  necessary  individual  measurements,  performed  by  a 
dosimetry service, for category B workers. 

In cases where individual measurements are impossible or inadequate, the individual 
monitoring  shall  be  based  on  an  estimate  arrived  at  either  from  individual 
measurements made on other exposed workers or from the results of the surveillance 
of the working environment provided for in Article 37. 

Article 40 

Monitoring in the case of accidental exposure 

In  the  case  of  accidental  exposure,  the  undertaking  in  collaboration  with  the 
dosimetry service shall assess the relevant doses and their distribution in the body. 

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Article 41 

Recording and reporting of results 

A  record  containing  the  results  of  individual  monitoring  shall  be  made  for  each 
exposed worker for whom such monitoring is performed. 

For the purposes of paragraph 1, the following information on exposed workers shall 
be retained: 

a record of the exposures measured or estimated, as the case may be, of individual 
doses pursuant to Articles 37, 40, 51,and 52; 

in the case of exposures as referred to in Articles 40 and 52, the reports relating to 
the circumstances and the action taken; 

the results of workplace monitoring used to assess individual doses where necessary. 

The information referred in paragraph 1 shall be retained during the period of their 
working life involving exposure to ionising radiation and afterwards until they have 
or  would  have  attained  the  age  of  75  years,  but  in  any  case  not  less  than  30  years 
after termination of the work involving exposure. 

Exposure as referred to in Articles 40, 51, and 52 shall be recorded separately in the 
dose record referred to in paragraph 1. 

Where  the  results  of  monitoring  are  used  for  the  management  of  planned  exposure 
situations,  appropriate  arrangements  shall  be  made  for  not  including  in  the  records 
exposures  attributed  to  an  existing  exposure  situation  namely  background  external 
radiation  or  radon  ingress  from  soil  in  the  case  of  industries  processing  naturally 
occurring radioactive material. 

Article 42 

Access to the results 

The Member States shall require that the results of the individual monitoring set out 
in Articles 39, 40 and 52 be: 

made available to the competent authorities, to the undertaking, and to the employer 
of outside workers; 

made available to the worker concerned in accordance with Article 43(1); 

submitted  to  the  occupational  health  services  in  order  for  them  to  interpret  the 
implications of the results for human health, as provided for in Article 44; 

submitted to the data system for individual radiological monitoring established by the 
Member State in accordance with paragraph 2. 

1. 

2. 

(a) 

(b) 

(c) 

3. 

4. 

5. 

1. 

(a) 

(b) 

(c) 

(d) 

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51 

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2. 

3. 

4. 

1. 

2. 

1. 

2. 

3. 

(a) 

Member  States  shall  determine  the  arrangements  under  which  the  results  of 
individual monitoring are conveyed. 

The data system for individual radiological monitoring shall communicate at least the 
data listed in Annex VIII, Section A.  

In  the  case  of  an  accidental  or  emergency  exposure,  the  results  of  individual 
monitoring shall be communicated without delay. 

Article 43 

Member States shall require workers to have access at their request to the results of 
their individual monitoring, including the results of measurements which may have 
been used in estimating these results, or to the results of the assessment of their doses 
made as a result of workplace measurements. 

Member  States  shall  facilitate 
the  exchange  among  competent  authorities, 
occupational  health  services,  radiation  protection  experts,  or  dosimetry  services 
within  the  Union  of  all  relevant  information  on  the  doses  previously  received  by  a 
worker  in  order  to  perform  the  medical  examination  prior  to  employment  or 
classification as a category A worker pursuant to Article 44 and to control the further 
exposure of workers. 

Article 44 

Medical surveillance of exposed workers 

The  medical  surveillance  of  exposed  workers  shall  be  based  on  the  principles  that 
govern occupational medicine generally. 

The  medical  surveillance  of  category  A  workers  shall  be  the  responsibility  of 
occupational health services. 

This  medical  surveillance  shall  allow  for  the  state  of  health  of  workers  under 
surveillance to be ascertained as regards their fitness for the tasks assigned to them. 
To  this  end,  the  occupational  health  services  shall  have  access  to  any  relevant 
information  they  require,  including  the  environmental  conditions  in  the  working 
premises. 

Medical surveillance shall include: 

A medical examination prior to employment or classification as a category A worker 
to  determine  the  worker’s  fitness  for  a  post  as  a  category  A  worker  for  which  the 
worker is being considered. 

(b) 

Periodic reviews of health. 

The state of health of all category A workers shall be reviewed at least once a year, 
in order to determine whether they remain fit to perform their duties. The nature of 

EN 

52 

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these  reviews,  which  can  be  performed  as  many  times  as  the  occupational  health 
services consider necessary, shall depend on the type of work and on the individual 
worker’s state of health. 

4. 

The  occupational  health  services  may  indicate  the  need  for  medical  surveillance  to 
continue after cessation of work for as long as they consider it necessary to safeguard 
the health of the person concerned. 

Article 45 

Medical classification 

The following medical classification shall be established with respect to fitness for work as a 
category A worker: 

(a) 

(b) 

(c) 

fit; 

fit, subject to certain conditions; 

unfit. 

Article 46 

Prohibition to employ or classify unfit workers 

No worker may be employed or classified for any period  in a specific post as a category A 
worker if medical surveillance establishes that the worker is unfit for that specific post. 

Article 47 

Medical records 

1. 

2. 

A medical record shall be opened for each category A worker and kept up to date so 
long as the worker remains a worker in that category. Thereafter, it shall be retained 
until the individual has or would have attained the age of 75 years, but in any case 
not  less  than  30  years  after  termination  of  the  work  involving  exposure  to  ionising 
radiation. 

The  medical  record  shall  include  information  regarding  the  nature  of  the 
employment,  the  results  of  the  medical  examinations  prior  to  employment  or 
classification as a category A worker, the periodic reviews of health and the record of 
doses required by Article 41. 

EN 

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Article 48 

Special medical surveillance 

In addition to the medical surveillance of exposed workers provided for in Article 44, 
provision  shall  be  made  for  any  further  action  considered  necessary  by  the 
occupational health services for the health protection of exposed individuals, such as 
further examinations, decontamination measures or urgent remedial treatment. 

Special  medical  surveillance  shall  be  performed  in  each  case  where  an  annual 
effective dose of 50 mSv in a year or any of the other dose limits laid down in Article 
10(2) has been exceeded. 

Subsequent exposure conditions shall be subject to the agreement of the occupational 
health services. 

Article 49 

Appeals 

Member  States  shall  lay  down  the  procedure  for  appeal  against  the  findings  and 
decisions made pursuant to Articles 45, 46 and 48. 

Article 50 

Protection of outside workers 

Member  States  shall  ensure  that  the  system  for  individual  radiological  monitoring 
affords  outside  workers  equivalent  protection  to  that  for  workers  employed  on  a 
permanent basis by the undertaking. 

The  undertaking  shall  be  responsible,  either  directly  or  through  contractual 
agreements with the employer of outside workers, for the operational aspects of the 
radiation protection of outside workers. 

In particular, the undertaking shall:  

check  that  the  outside  worker  concerned  has  been  passed  as  medically  fit  for  the 
activities to be assigned to the worker; 

ensure  that,  in  addition  to  the  basic  training  in  radiation  protection  referred  to  in 
Article 16, the outside worker has received specific training  in connection with the 
characteristics of both the controlled area and the activities; 

ensure that the outside worker has been issued with the necessary personal protective 
equipment; 

1. 

2. 

3. 

1. 

2. 

3. 

(a) 

(b) 

(c) 

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54 

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(d) 

(e) 

(f) 

4. 

(a) 

(b) 

(c) 

(d) 

5. 

1. 

(a) 

(b) 

ensure  that  the  outside  worker  receives  individual  exposure  monitoring  appropriate 
to the nature of the activities, and any operational dosimetric monitoring that may be 
necessary; 

ensure compliance with the system of protection as defined in Chapter III; 

ensure or take all appropriate steps to ensure that after every activity the radiological 
data from individual exposure monitoring of each outside worker within the meaning 
of Annex VIII, Section B, point 2, are recorded. 

Employers of outside workers shall, either directly or through contractual agreements 
with  the  undertaking,  ensure  that  the  radiation  protection  of  their  workers  is  in 
accordance with the relevant provisions of this Directive, in particular by: 

ensuring compliance with the system of protection as defined in Chapter III; 

providing the information and training in the field of radiation protection referred to 
in Article 16; 

guaranteeing  that  their  workers  are  subject  to  the  assessment  of  exposure  and 
medical surveillance under the conditions laid down in Articles 37, 39 to 48; 

ensuring that the radiological data from the individual exposure monitoring of each 
of their workers within the meaning of Annex VIII, Section B, point 1, are kept up to 
date in the data system for individual radiological monitoring  referred to in Article 
42(1)(d). 

All  outside  workers  shall  be  obliged  to  make  their  own  contribution  as  far  as 
practicable  towards  the  protection  to  be  afforded  to  them  by  the  radiological 
monitoring system referred to in paragraph 1. 

Article 51 

Specially authorised exposures 

In  exceptional  circumstances  evaluated  case  by  case,  excluding  emergencies,  the 
competent  authorities  may,  where  a  specific  operation  so  requires,  authorise 
individual occupational exposures of identified volunteer workers exceeding the dose 
limits set out in Article 10, provided that such exposures are limited in time, confined 
to  certain  working  areas  and  within  the  maximum  exposure  levels  defined  for  the 
particular case by the competent authorities. The following conditions shall be taken 
into account:  

only category A workers as defined in Article 38 may be subject to such exposures; 

apprentices,  students,  pregnant  women,  and,  if  there  is  a  risk  of  intake  of 
radionuclides, breastfeeding women shall be excluded from such exposures;  

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55 

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(c) 

(d) 

(e) 

2. 

3. 

1. 

2. 

3. 

the  undertaking  shall  carefully  justify  such  exposures  in  advance  and  thoroughly 
discuss  them  with  the  voluntary  workers,  their  representatives,  the  occupational 
health services or the radiation protection expert; 

information  about  the  risks  involved  and  the  precautions  to  be  taken  during  the 
operation shall be provided to the relevant workers in advance; 

all doses relating to such exposures shall be separately recorded in the medical record 
referred to in Article 47 and the individual record referred to in Article 41. 

The exceeding of dose limits as a result of specially authorised exposures shall not 
necessarily constitute a reason for excluding workers from their usual occupation or 
relocating them, without their agreement. 

The  exposure  of  space  crew  above  the  dose  limits  shall  be  managed  as  a  specially 
authorised exposure. 

Article 52 

Emergency occupational exposure 

Emergency response organisations shall ensure that no emergency worker undertakes 
actions resulting in doses in excess of 50 mSv, except in specific cases identified in 
the  national  emergency  plan.  In  such  cases,  appropriate  reference  levels  above  50 
mSv shall be defined. In exceptional situations, in order to save life, prevent severe 
radiation-induced  health  effects,  or  prevent  the  development  of  catastrophic 
conditions, a reference level above 100 mSv may be set. 

Emergency  response  organisations  shall  ensure  that  emergency  workers  who  are 
liable  to  undertake  actions  whereby  50  mSv  may  be  exceeded  are  volunteers  who 
have been clearly and comprehensively informed in advance of the associated health 
risks and the available protection measures. 

In  the  event  of  an  emergency  exposure,  Member  States  shall  require  radiological 
monitoring and medical surveillance of emergency workers. Individual monitoring or 
assessment  of  the  individual  doses  shall  be  carried  out  as  appropriate  to  the 
circumstances. 

Article 53 

Radon in workplaces 

1. 

Within  the  action  plan  referred  to  in  Article  103,  Member  States  shall  establish 
national reference levels for indoor radon concentrations. Such reference levels shall 
not exceed an annual average of 1 000 Bq m-3 for workplaces. 

EN 

56 

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2. 

3. 

4. 

Under the national action plan, Member States shall ensure that radon measurements 
are carried out in workplaces located on the ground floor or at basement level within 
radon-prone areas and in specific types of workplaces as identified in the action plan.  

Member  States  shall  require  undertakings  in  which  the  national  reference  level  for 
existing workplaces is exceeded to take appropriate action in order to reduce radon 
concentrations or exposures, in accordance with the principle of optimisation set out 
in Chapter III. 

Where  workplaces  or  specific  rooms  within  a  building  continue  to  exceed  the 
reference level despite the action taken in accordance with paragraph 3, the Member 
States  shall  manage  this  situation  as  a  planned  exposure  situation  and  apply  the 
relevant requirements for occupational exposure as specified in Article 31(d). 

CHAPTER VII 

PROTECTION OF PATIENTS AND OTHER INDIVIDUALS 
SUBJECTED TO MEDICAL EXPOSURE 

Article 54 

Justification 

1. 

(a) 

(b) 

(c) 

Medical  exposure  shall  show  a  sufficient  net  benefit,  weighing  the  total  potential 
diagnostic or therapeutic benefits it produces, including the direct benefits to health 
or  well-being  of  an  individual  and  the  benefits  to  society,  against  the  individual 
detriment  that  the  exposure  might  cause,  taking  into  account  the  efficacy,  benefits 
and risks of available alternative techniques having the same objective but involving 
no or less exposure to ionising radiation.  

Account  shall  also  be  taken  of  the  individual  detriment  from  the  exposure  of  the 
medical radiological staff and other individuals. 

In particular the following requirements shall be applied: 

all  new  types  of  practices  involving  medical  exposure  shall  be  justified  in  advance 
before being generally adopted; 

existing  types  of  practices  involving  medical  exposure  shall  be  reviewed  whenever 
new, important evidence about their efficacy or consequences is acquired; 

all individual medical exposures shall be justified in advance taking into account the 
specific objectives of the exposure and the characteristics of the individual involved. 

If  a  type  of  practice  involving  a  medical  exposure  is  not  justified  in  general,  a 
specific individual exposure of this type may be justified in special circumstances, to 
be evaluated on a case-by-case basis and documented. 

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2. 

3. 

4. 

5. 

The  referrer  and  the  practitioner  shall  seek,  where  practicable,  to  obtain  previous 
diagnostic  information  or  medical  records  relevant  to  the  planned  exposure  and 
consider these data to avoid unnecessary exposure. 

Medical  exposure  for  biomedical  and  medical  research  shall  be  examined  by  an 
ethics  committee,  set  up  in  accordance  with  national  procedures  and/or  by  the 
competent authorities; 

Specific justification for medical radiological procedures to be performed as part of a 
health  screening  programme  shall  be  carried  out  by  the  health  authority  in 
conjunction with appropriate professional bodies. 

The exposure of carers and comforters shall show a sufficient net benefit, taking into 
account the direct health benefits to a patient, the benefits to the carer / comforter and 
the detriment that the exposure might cause. 

Any medical radiological procedure on an asymptomatic individual, to be performed 
for the early detection of disease, shall be part of a health screening programme, or 
shall require specific documented justification for that individual by the practitioner, 
in  consultation  with  the  referrer,  following  guidelines  from  relevant  professional 
bodies and competent authorities. Special attention shall be given to the provision of 
information to the patients, as required by Article 56(3). 

6. 

If  an  exposure  cannot  be  justified  in  accordance  with  paragraphs  1-5,  it  shall  be 
prohibited. 

Article 55 

Optimisation 

1. 

All  doses  due  to  medical  exposure  for  radiodiagnostic  and  interventional  radiology 
purposes shall be kept as low as reasonably achievable consistent with obtaining the 
required imaging information, taking into account economic and social factors. 

For  all medical  exposure of  individuals for radiotherapeutic  purposes, exposures of 
target volumes shall be individually planned, taking into account that doses of non-
target  volumes  and  tissues  shall  be  as  low  as  reasonably  achievable  and  consistent 
with the intended radiotherapeutic purpose of the exposure. 

Member States shall ensure the establishment, regular review and use of diagnostic 
reference  levels  for  radiodiagnostic  examinations,  and  when  appropriate,  for 
interventional radiology procedures, and the availability of guidance for this purpose.  

Member States shall ensure that for each biomedical and medical research project: 

the individuals concerned participate voluntarily; 

these individuals are informed about the risks of exposure; 

2. 

3. 

(a) 

(b) 

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58 

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(c) 

(d) 

4. 

5. 

(a) 

(b) 

6. 

1. 

2. 

3. 

4. 

a dose constraint is established for individuals for whom no direct medical benefit is 
expected from exposure; 

in the case of patients who voluntarily accept to undergo an experimental diagnostic 
or  therapeutic  practice  and  who  are  expected  to  receive  a  diagnostic  or  therapeutic 
benefit  from  this  practice,  the  dose  levels  concerned  shall  be  considered  on  an 
individual basis by the practitioner and/or referrer. 

The optimisation shall include the selection of equipment, the consistent production 
of adequate diagnostic information or therapeutic outcomes, the practical aspects of 
medical  exposure  procedures,  quality  assurance,  and  the  assessment  and  evaluation 
of  patient  and  staff  doses  or  administered  activities,  taking  into  account  economic 
and social factors. 

Member States shall ensure that: 

dose constraints are established for the exposure of carers and comforters; 

appropriate guidance is established for the exposure of carers and comforters; 

Member  States  shall  ensure  that  in  the  case  of  a  patient  undergoing  treatment  or 
diagnosis  with  radionuclides,  the  practitioner  or  the  undertaking,  as  appropriate, 
provides  the  patient  or  legal  guardian  with  written  instructions  with  a  view  to 
restricting doses to persons in contact with the patient as far as reasonably achievable 
and providing information on the risks of ionising radiation. 

These  instructions  shall  be  handed  out  before  leaving  the  hospital  or  clinic  or  a 
similar institution. 

Article 56 

Responsibilities 

The  referrer  and  the  practitioner  shall  be  involved  in  the  justification  process  as 
specified by Member States. 

Member States shall ensure that any medical exposure takes place under the clinical 
responsibility of a practitioner. 

The  practitioner  shall  ensure  that  the  patient  or  legal  guardian  is  provided  with 
adequate information relating to the benefits and risks associated with the radiation 
dose from the medical exposure to enable informed consent. Similar information as 
well as relevant guidance in accordance with Article 55(5)(b) shall be given to carers 
and comforters. 

Practical  aspects  of  medical  exposure  procedures  may  be  delegated  by  the 
undertaking or the practitioner, as appropriate, to one or more individuals entitled to 
act in this respect in a recognised field of specialisation. 

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Article 57 

Procedures 

Written protocols for every type of standard medical radiological procedure shall be 
established for each equipment. 

Member States shall ensure that referral guidelines for medical imaging, taking into 
account the radiation doses, are available to the referrers. 

In  medical  radiological  practices,  a  medical  physics  expert  shall  be  appropriately 
involved,  the  level  of  involvement  being  commensurate  with  the  radiological  risk 
posed by the practice. In particular: 

in  radiotherapeutic  practices  other  than  standardised  therapeutic  nuclear  medicine 
practices, a medical physics expert shall be closely involved;  

in standardised therapeutical nuclear medicine practices as well as in radiodiagnostic 
and interventional radiology practices, a medical physics expert shall be involved; 

for  other  simple  radiodiagnostic  procedures,  a  medical  physics  expert  shall  be 
involved, as appropriate, for consultation and advice on matters relating to radiation 
protection concerning medical exposure. 

Clinical audits shall be carried out in accordance with national procedures. 

Member States shall ensure that appropriate local reviews are undertaken whenever 
diagnostic  reference  levels  are  consistently  exceeded  and  that  corrective  action  is 
taken where appropriate. 

Article 58 

Training 

Member States shall ensure that training and recognition requirements, as laid down 
in Articles 81, 15 and 19, are met for the practitioner, the medical physics expert and 
the individuals referred to in Article 56(4).  

Article 59 

Equipment 

Member  States  shall  take  such  steps  as  they  consider  necessary  with  a  view  to 
avoiding unnecessary proliferation of medical radiological equipment. 

Member States shall ensure that: 

1. 

2. 

3. 

(a) 

(b) 

(c) 

4. 

5. 

1. 

2. 

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60 

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(a) 

(b) 

(c) 

(d) 

3. 

4. 

5. 

1. 

(a) 

(b) 

(c) 

2. 

all medical radiological equipment in use is kept under strict surveillance regarding 
radiation protection; 

an  up-to-date  inventory  of  medical  radiological  equipment  for  each  medical 
radiological installation is available to the competent authorities; 

appropriate  quality  assurance  programmes  and  dose  or  administered  activity 
assessments are implemented by the undertaking; and 

acceptance  testing,  involving  the  medical  physics  expert,  is  carried  out  before  the 
first  use  of  the  equipment  for  clinical  purposes,  and  performance  testing  is  carried 
out thereafter on a regular basis, and after any major maintenance procedure. 

Competent  authorities  shall  take  steps  to  ensure  that  the  necessary  measures  are 
taken  by  the  undertaking  to  improve  inadequate  or  defective  features  of  medical 
radiological equipment. They shall also adopt specific criteria for the acceptability of 
equipment  in  order  to  indicate  when  appropriate  corrective  action  is  necessary, 
including, if appropriate, taking the equipment out of service. 

The  use  of  fluoroscopy  equipment  without  a  device  to  control  the  dose  rate,  or 
without an image intensifier or equivalent device, shall be prohibited.  

Any  equipment  used  for  interventional  radiology  and  computed  tomography  shall 
have  a  device  or  a  feature  informing  the  practitioner  of  the  quantity  of  radiation 
produced  by  the  equipment  during  the  medical  radiological  procedure.  Any  other 
medical radiodiagnostic equipment brought into use after this Directive has entered 
into force shall have such a device or a feature or equivalent means of determining 
the quantity of radiation produced. The radiation dose shall form part of the report on 
the examination. 

Article 60 

Special practices 

Member  States  shall  ensure  that  appropriate  medical  radiological  equipment, 
practical techniques and ancillary equipment are used for medical exposure 

of children; 

as part of a health screening programme; 

involving  high  doses  to  the  patient,  such  as  interventional  radiology,  computed 
tomography or radiotherapy. 

Special attention shall be given to quality assurance programmes and the assessment 
of dose or administered activity, as mentioned in Article 59(2)(c), for these practices. 

Member  States  shall  ensure  that  practitioners  and  those  individuals  referred  to  in 
Article  56(4)  who  perform  the  exposures  referred  to  in  paragraph  1  obtain 
appropriate training in these medical radiological practices as required by Article 19. 

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Article 61 

1. 

2. 

3. 

Special protection during pregnancy and breastfeeding 

In  the  case  of  a  woman  of  childbearing  age,  the  referrer  and  the  practitioner  shall 
inquire  as  specified  by  Member  States  whether  she  is  pregnant  or  breastfeeding,  if 
relevant. 

If  pregnancy  cannot  be  excluded,  depending  on  the  type  of  medical  exposure,  in 
particular  if  abdominal  and  pelvic  regions  are  involved,  special  attention  shall  be 
given  to  the  justification,  particularly  the  urgency,  and  to  the  optimisation  of  the 
medical exposure, taking into account the exposure both of the expectant mother and 
the unborn child. 

In the case of breastfeeding women, in nuclear medicine, depending on the type of 
medical examination or treatment, special attention shall be given to the justification, 
particularly the urgency, and to the optimisation of the medical exposure, taking into 
account the exposure both of the mother and the child. 

Without  prejudice  to  paragraphs  1  and  2,  Member  States  shall  take  measures  to 
increase the awareness of women to whom this Article applies, such as public notices 
in appropriate places. 

Article 62 

Accidental and unintended exposures 

Member States shall ensure that 

(a) 

(b) 

(c) 

(d) 

all  reasonable  steps  are  taken  to  minimise  the  probability  and  magnitude  of 
accidental  or  unintended  exposures  of  patients  from  all  medical  radiological 
procedures, taking into account economic and social factors; 

for  radiotherapeutic  practices  the  quality  assurance  programme  includes  a  study  of 
the risk of accidental or unintended exposures; 

for  all  medical  exposures  the  undertaking  implements  a  system  for  the  registration 
and  analysis  of  events  involving  or  potentially  involving  accidental  or  unintended 
exposures; 

the  undertaking  declares  as  soon  as  possible  to  the  competent  authorities  the 
occurrence of significant events as defined by the authorities, including the results of 
the  investigation  and  the  corrective  measures  to  avoid  such  events.  The  competent 
authorities shall share this information with the competent authorities for post-market 
surveillance  established  in  Council  Directive  93/42/EEC  concerning  medical 
devices; 

(e) 

arrangements are made to inform the referrer, the practitioner and the patient about 
an unintended or accidental exposure. 

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Article 63 

Estimates of population doses 

Member  States  shall  ensure  that  the  distribution  of  individual  dose  estimates  from  medical 
exposure is determined and shall take into account the age distribution and the gender of the 
exposed population. 

CHAPTER VIII 

PROTECTION OF MEMBERS OF THE PUBLIC 

SECTION 1 

PROTECTION OF THE MEMBERS OF THE PUBLIC IN NORMAL CIRCUMSTANCES 

Article 64 

Principles of protection of members of the public 

Member States shall create the conditions necessary to ensure the best possible protection of 
members of the public under the prevailing circumstances, based on the principles set out in 
Chapter III on the system of radiation protection and applying the requirements laid down in 
the present Chapter. 

Article 65 

Operational protection of members of the public 

1. 

(a) 

(b) 

The  operational  protection  of  members  of  the  public  in  normal  circumstances  from 
practices subject to licensing shall include all arrangements and surveys for detecting 
and eliminating factors which, in the course of any operation involving exposure to 
ionising  radiation,  are  liable  to  create  a  risk  of  exposure  for  the  members  of  the 
public which cannot be disregarded from the radiation protection point of view. Such 
protection shall include the following tasks: 

examination and approval of plans for installations involving an exposure risk, and of 
the proposed siting of such installations within the territory concerned, from the point 
of view of radiation protection; 

acceptance  into  service  of  new  installations  involving  an  exposure  risk,  subject  to 
radioactive 
adequate  protection  being  provided  against  any  exposure  or 

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63 

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contamination liable to extend beyond the perimeter, taking into account, if relevant, 
demographic, meteorological, geological, hydrological and ecological conditions; 

(c) 

examination and approval of plans for the discharge of radioactive effluents. 

2. 

(a) 

(b) 

(c) 

1. 

2. 

3. 

(a) 

(b) 

(c) 

These tasks shall be carried out in accordance with rules laid down by the competent 
authorities on the basis of the exposure risk involved. 

The competent authority shall establish authorised limits for discharging radioactive 
effluents. These discharge authorisations shall 

take into account the results of the optimisation of public exposure; 

reflect good practice in the operation of similar facilities; 

allow a margin for operational flexibility of a facility. 

Article 66 

Estimation of doses to the members of the public 

Member States shall, on the basis of the exposure risk involved, establish a system 
for  the  estimation  of  doses  to  members  of  the  public  from  planned  exposure 
situations.  

The  competent  authorities  shall  identify  practices  where  a  realistic  assessment  of 
doses  to  members  of  the  public  shall  be  carried  out.  For  other  practices  Member 
States may require only a screening assessment with generic data. 

For  the  realistic  assessment  of  doses  to  the  members  of  the  public,  the  competent 
authority shall: 

ensure  that  dose  estimates  for  practices  as  referred  to  in  Article  65  are  made  as 
realistic as possible for representative persons;  

decide  on  the  frequency  of  assessments  and  take  all  necessary  steps  to  identify  the 
representative person, taking into account the effective pathways for transmission of 
the radioactive substances; 

ensure,  taking  into  account  the  radiological  risks,  that  the  estimates  of  doses  to 
members of the public include: 

(i) assessment  of the doses due to external radiation, indicating, where appropriate, 

the quality of the radiation in question; 

(ii)  assessment  of  the  intake  of  radionuclides,  indicating  the  nature  of  the 
radionuclides  and,  where  necessary,  their  physical  and  chemical  states, 
these 
and  determination  of 
radionuclides; 

the  activity  and  concentrations  of 

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(iii)  assessment  of  the  doses  that  the  representative  person  is  liable  to  receive  and 
specification of the characteristics of the representative person; 

(d) 

require  records  to  be  kept  and  be  made  available  to  all  stakeholders  relating  to 
measurements  of  external  exposure,  estimates  of  intakes  of  radionuclides  and 
radioactive contamination, and the results of the assessment of the doses received by 
the representative person. 

Article 67 

Monitoring of radioactive discharges 

Member  States  shall  require  the  undertaking  responsible  for  practices  where  a 
discharge  authorisation  is  granted  to  monitor  appropriately  the  radioactive  airborne 
or liquid discharges into the environment and to report the results of this monitoring 
to the competent authority.  

Member States shall require any undertaking responsible for a nuclear power reactor 
or reprocessing plant to monitor discharges in normal operation in accordance with 
the  standardised  information  selected  for  monitoring  and  reporting  to  the  European 
Commission as laid down in Commission Recommendation 2004/2/Euratom22. 

Article 68 

Tasks for the undertakings 

Member States shall require the undertaking to carry out the following tasks: 

achieving and maintaining an optimal level of protection; 

checking the effectiveness and maintenance of technical devices; 

acceptance  into  service,  from  the  point  of  view  of  surveillance  of  radiation 
protection, of equipment and procedures for measuring and assessing, as appropriate, 
exposure  of  members  of  the  public  and  radioactive  contamination  of  the 
environment; 

regular  calibration  of  measuring  instruments  and  regular  checking  that  they  are 
serviceable and correctly used. 

Radiation protection experts and, as appropriate, radiation protection officers shall be 
involved in the performance of the tasks referred to in paragraph 1. 

1. 

2. 

1. 

(a) 

(b) 

(c) 

(d) 

2. 

22 

OJ L 2/36, 6.1.2000. 

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65 

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Article 69 

Environmental monitoring programme 

Member  States  shall  ensure 
programme is in place for estimating the exposure of members of the public. 

that  an  appropriate  environmental  monitoring 

SECTION 2 

EMERGENCY EXPOSURE SITUATIONS 

Article 70 

Emergency response 

1. 

2. 

3. 

(a) 

(b) 

(c) 

4. 

(a) 

(b) 

5. 

Member States shall require the undertaking responsible for a practice to notify the 
competent  authorities  immediately  of  any  emergency  occurring  in  its  facility  or 
related to its activities and to take all appropriate action to reduce the consequences. 

Member States shall ensure that, in the event of an emergency on its own territory, 
the  undertaking  makes  an  initial  provisional  assessment  of  the  circumstances  and 
consequences of the emergency and assists with protective measures. 

Member  States  shall  ensure  that  provision  is  made  for  protective  measures  with 
regard to: 

the  radiation  source,  to  reduce  or  stop  the  direct  radiation  and  emission  of 
radionuclides,  or  to  prevent  exposure  or  contamination  resulting  from  orphan 
sources; 

the environment, to reduce the transfer of radioactive substances to individuals; 

individuals, to reduce exposure. 

In  the  event  of  an  emergency  on  or  outside  its  territory,  the  Member  State  or  the 
emergency response authority shall require: 

the  organisation  of  appropriate  protective  measures,  taking  account  of  the  real 
characteristics  of  the  emergency  and  in  accordance  with  the  optimised  protection 
strategy as part of the emergency response plan, whereby the elements to be included 
in an emergency response plan are indicated in Section B of Annex IX; 

the  assessment  and  recording  of  the  consequences  of  the  emergency  and  of  the 
effectiveness of the protective measures. 

The  Member  State  or  the  emergency  response  authority  shall,  if  the  situation  so 
requires, ensure that provision is made to organise the medical treatment of victims. 

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Article 71 

Information to the members of the public likely to be affected in the event of an emergency 

1. 

2. 

3. 

4. 

1. 

2. 

1. 

(a) 

Member States shall ensure that the members of the public likely to be affected in the 
event  of  an  emergency  are  given  information  about  the  health  protection  measures 
applicable to it and about the action it should take in the event of such an emergency. 

The information supplied shall include at least the elements set out in Section A of 
Annex X. 

The information shall be communicated to the members of the public referred to in 
paragraph 1 without any request being made. 

Member States shall update the information and circulate it at regular intervals and 
whenever  significant  changes  take  place.  This  information  shall  be  permanently 
available to the public. 

Article 72 

Information to the members of the public actually affected in the event of an emergency 

Member  States  shall  ensure  that,  when  an  emergency  occurs,  the  members  of  the 
public actually affected is informed without delay of the facts of the emergency, the 
steps  to  be  taken  and,  as  appropriate,  the  health  protection  measures  applicable  to 
these members of the public. 

The information provided shall cover those points contained in Section B of Annex 
X which are relevant to the type of emergency. 

SECTION 3 

EXISTING EXPOSURE SITUATIONS 

Article 73 

Contaminated areas 

Strategies  for  managing  contaminated  areas  shall  include,  where  applicable,  the 
following: 

delineation of the affected regions and identification of the affected members of the 
public; 

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(b) 

(c) 

(d) 

(e) 

2. 

(a) 

(b) 

1. 

(a) 

(b) 

(c) 

2. 

(a) 

(b) 

3. 

consideration  of  the  need  for  and  extent  of  protective  measures  applied  to  the 
affected regions and members of the public; 

consideration of the  need  to  prevent  or control access to the affected regions, or to 
impose restrictions on living conditions in these regions; 

assessment of the exposure of different groups in the population and assessment of 
the means available to individuals for controlling their own exposure; 

objectives and long-term goals pursued by the strategy and corresponding reference 
levels. 

For  areas  with  long-lasting  residual  contamination  in  which  the  Member  State  has 
decided  to  allow  habitation  and  the  resumption  of  social  and  economic  activities, 
Member States shall ensure, in consultation with stakeholders, that arrangements are 
in  place,  as  necessary,  for  the  ongoing  control  of  exposure  with  the  aim  of 
establishing living conditions that can be considered as normal, including: 

establishment of reference levels consistent with day-to-day life; 

establishment of an infrastructure to support continuing self-help protective measures 
in the affected areas, such as information provision, advice and monitoring. 

Article 74 

Radon in dwellings and buildings with public access 

Within  the  action  plan  referred  to  in  Article  103,  Member  States  shall  establish 
national reference levels for indoor radon concentrations, which shall not exceed (as 
an annual average): 

200 Bq m-3 for new dwellings and new buildings with public access; 

300 Bq m-3 for existing dwellings; 

300  Bq  m-3  for  existing  buildings  with  public  access.  In  specific  cases  where  the 
occupancy time is low, a reference level of up to 1 000 Bq m-3 can be set.  

Under the national action plan, Member States shall 

take  action  to  identify  existing  dwellings  exceeding  the  reference  level  and  to 
encourage radon-reducing measures in existing dwellings where the reference levels 
are exceeded; 

ensure  that  radon  measurements  are  carried  out  in  buildings  with  public  access 
within radon-prone areas.  

Member States shall establish specific building codes to prevent radon ingress from 
the  soil  and,  as  specified  in  the  national  action  plan,  from  building  materials,  and 

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require compliance with such building codes, in particular in radon-prone areas, so as 
to avoid radon concentrations exceeding the reference level for new buildings. 

4. 

Member  States  shall  provide  local  and  national  information  on  prevailing  radon 
concentrations,  on  the  associated  health  risks  and  on  the  technical  means  available 
for reducing existing radon concentrations. 

Article 75 

Building materials 

1. 

(a) 

(b) 

2. 

(a) 

(b) 

3. 

4. 

5. 

The requirements in Article 75(2) to (6) shall apply to the following: 

building materials which are identified and listed by the relevant competent authority 
as being of concern from the radiation protection point of view, taking into account 
the  indicative  list  of  materials  set  out  in  Annex  XI  with  regard  to  their  emitted 
gamma radiation; or 

building materials which the authority has assessed to be of concern in the national 
action plan for radon, as specified in Article 103. 

For identified types of building materials, the industries placing such materials on the 
market  

shall determine the concentrations of the radionuclides specified in Annex VII; 

shall provide information to the competent authority on the results of measurements 
and the corresponding activity concentration index, as defined in Annex VII. 

The  competent  authority  shall  ensure  that identified  types  of  building  materials  are 
classified, as laid down in Annex VII, on the basis of their intended use and activity 
concentration index.  

Identified types of building materials which are not liable to give doses exceeding the 
reference  level  of  1  mSv  per  year  for  indoor  external  exposure  from  building 
materials,  in  excess  of  prevailing  outdoor  external  exposure,  shall  be  exempt  from 
requirements  at  national  level,  without  prejudice  to  Article  103.  Such  building 
materials  shall  nevertheless  be  further  monitored  to  ensure  that  the  activity 
concentration  continues  to  comply  with  this  reference  level.  Building  materials  of 
category  A  as  specified  in  Annex  VII  shall  be  exempt  from  any  restrictions  with 
regard to their placing on the market in the Union. 

For  identified  types  of  building  materials  which  are  liable  to  give  doses  exceeding 
the  reference  level  of  1  mSv  per  year  for  indoor  external  exposure  from  building 
materials,  in  excess  of  the  prevailing  outdoor  external  exposure,  the  competent 
authority shall decide on appropriate measures, ranging from registration and general 
application of relevant building codes to specific restrictions on the envisaged use of 
such materials. 

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6. 

Information on identified types of building materials, relevant to the implementation 
of building codes, including their radionuclide concentrations, activity concentration 
index and corresponding classification, shall be made available prior to their placing 
on the market. 

CHAPTER IX 

PROTECTION OF THE ENVIRONMENT 

Article 76 

Environmental criteria 

Member States shall include, in their legal framework for radiation protection and in 
particular  within  the  overall  system  of  human  health  protection,  provision  for  the 
radiation protection of non-human species in the environment. This legal framework 
shall introduce environmental criteria aiming to protect populations of vulnerable or 
representative  non-human  species  in  the  light  of  their  significance  as  part  of  the 
ecosystem.  Where  appropriate,  types  of  practices  shall  be  identified  for  which 
regulatory control is warranted in order to implement the requirements of this legal 
framework.  

Article 77 

Authorised limits on discharges 

Member  States’  competent  authorities,  when  establishing  authorised  limits  on 
discharges  of  radioactive  effluents,  in  accordance  with  Article  65(2),  shall  also 
ensure  adequate  protection  of  non-human  species.  For  this  purpose,  a  generic 
screening assessment may be conducted to provide assurance that the environmental 
criteria are met. 

Article 78 

Accidental releases 

Member States shall require  undertakings to take appropriate technical measures to 
avoid  significant  environmental  damage  in  the  event  of  an  accidental  release  or  to 
mitigate the extent of such damage. 

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Article 79 

Environmental monitoring 

When  establishing  environmental  monitoring  programmes,  or  requiring  such 
programmes  to  be  carried  out,  Member  States’  competent  authorities  shall  include 
representative non-human species, if necessary, and also environmental media which 
constitute a pathway of exposure for members of the public. 

CHAPTER X 

REQUIREMENTS FOR REGULATORY CONTROL 

SECTION 1 

INSTITUTIONAL INFRASTRUCTURE 

Article 80 

Competent authority 

1. 

2. 

3. 

4. 

5. 

Member  States  shall  designate  the  competent  authority  or  authorities  to  carry  out 
tasks in accordance with this Directive. 

Member  States  shall  forward  to  the  Commission  the  name  and  address  of  the 
competent authority or authorities and their respective areas of competence to ensure 
rapid communication with such authorities. 

Where  a  Member  State  has  more  than  one  competent  authority  for  the  control  of 
high-activity  sealed  sources  and  orphan  sources,  it  shall  designate  one  point  of 
contact for communication with the competent authorities of other Member States. 

Member  States  shall  forward  to  the  Commission  any  changes  to  the  information 
referred to in paragraphs 2 and 3. 

The  Commission  shall  communicate  the  information  referred  to  in  paragraphs  2,  3 
and  4  to  all  competent  authorities  and  shall  publish  it  periodically  in  the  Official 
Journal of the European Union, at intervals of no more than two years. 

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1. 

(a) 

(b) 

(c) 

(d) 

2. 

3. 

4. 

Article 81 

Recognition of services and experts 

Member States shall make the necessary arrangements for the recognition of: 

occupational health services; 

dosimetry services; 

radiation protection experts; 

medical physics experts. 

Member States shall ensure that the necessary arrangements are in place to ensure the 
continuity of expertise of these services and experts. 

Member States shall specify the recognition requirements and communicate them to 
the Commission together with the name and address of the competent authorities in 
charge  of  recognition.  Member  States  shall  communicate  any  changes  to  this 
information.  

Member  States  shall  specify  other  services  or  experts  requiring  particular  radiation 
protection  qualifications  and,  where  appropriate,  the  process  for  the  recognition  of 
such qualifications. 

The Commission shall make the information received in accordance with paragraph 
2 available to the Member States. 

Article 82 

Occupational health services 

Occupational health services shall perform medical surveillance of exposed workers 
with  regard  to  their  exposure  to  ionising  radiation  and  their  fitness  for  the  tasks 
assigned to them. 

Article 83 

Dosimetry services 

Dosimetry services shall determine the internal and external dose to exposed workers 
subject to individual monitoring in order to record the dose in cooperation with the 
undertaking and the occupational health service. Dosimetry services shall include the 
calibration,  reading  and  interpretation  of  individual  monitoring  devices,  and  the 
measurement of radioactivity in the human body and in biological samples. 

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Article 84 

Radiation protection expert 

The  radiation  protection  expert  shall,  on  the  basis  of  professional  judgment, 
measurements and assessments, give competent advice to the undertaking on matters 
relating to occupational exposure and public exposure.  

The  advice  of  the  radiation  protection  expert  shall  cover,  but  not  be  limited  to,  the 
following: 

plans  for  new  installations  and  the  acceptance  into  service  of  new  or  modified 
radiation  sources  in  relation  to  any  engineering  controls,  design  features,  safety 
features and warning devices relevant to radiation protection; 

the categorisation of controlled and supervised areas; 

the classification of workers; 

the content of workplace and individual monitoring programmes;  

the appropriate radiation monitoring instrumentation to be used; 

the appropriate methods of personal dosimetry; 

the optimisation and establishment of appropriate dose constraints, 

quality assurance; 

the environmental monitoring programme; 

radioactive waste disposal requirements; 

the arrangements for prevention of accidents and incidents; 

preparedness and response in emergency exposure situations; 

1. 

2. 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

(g) 

(h) 

(i) 

(j) 

(k) 

(l) 

(m) 

training and retraining programmes for exposed workers. 

3. 

Where appropriate, the task of the radiation protection expert may be carried out by a 
group of specialists who together have the necessary expertise. 

Article 85 

Medical physics expert 

1. 

Within the health care environment, the medical physics expert shall, as appropriate, 
act  or  give  specialist  advice  on  matters  relating  to  radiation  physics  as  applied  to 
medical exposure. 

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2. 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

1. 

2. 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

Depending on the medical radiological practice, the medical physics expert shall take 
responsibility  for  dosimetry,  including  physical  measurements  for  evaluation  of  the 
dose  delivered  to  the  patient,  give  advice  on  medical  radiological  equipment,  and 
contribute in particular to the following: 

optimisation of the radiation protection of patients and other individuals subjected to 
medical exposure, including the application and use of diagnostic reference levels; 

the  definition  and  performance  of  quality  assurance  of  the  medical  radiological 
equipment; 

the  preparation  of  technical  specifications  for  medical  radiological  equipment  and 
installation design; 

the  surveillance  of  the  medical  radiological  installations  with  regard  to  radiation 
protection; 

the selection of equipment required to perform radiation protection measurements; 

the training of practitioners and other staff in relevant aspects of radiation protection. 

Where  appropriate,  the  task  of  the  medical  physics  expert  may  be  carried  out  by  a 
medical physics service. 

Article 86 

Radiation protection officer 

Member  States  shall  decide  in  which  practices  the  designation  of  a  radiation 
protection  officer  is  necessary  to  perform  radiation  protection  tasks  within  an 
undertaking.  Member  States  shall  require  undertakings  to  provide  the  radiation 
protection officers with the means necessary for them to carry out their duties. The 
radiation protection officer shall report directly to the undertaking.  

Depending on the nature of the practice, the tasks of the radiation protection officer 
may include the following: 

ensuring that work with radiation is carried out in accordance with the requirements 
of any specified procedures or local rules; 

supervise implementation of the programme for workplace monitoring; 

maintaining adequate records of radioactive sources; 

carrying out periodic assessments of the condition of the relevant safety and warning 
systems; 

supervise implementation of the personal monitoring programme; 

supervise implementation of the health surveillance programme; 

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(g) 

(h) 

(i) 

(j) 

(k) 

providing new employees with an introduction to local rules and procedures; 

giving advice and comments on work plans; 

authorising work plans; 

providing reports to the local management;  

participating  in  the  arrangements  for  prevention,  preparedness  and  response  for 
emergency exposure situations; 

(l) 

liaising with the radiation protection expert. 

The  task  of  the  radiation  protection  officer  may  be  carried  out  by  a  radiation 
protection unit established within an undertaking. 

SECTION 2 

CONTROL OF SEALED SOURCES 

Article 87 

General requirements 

1. 

2. 

3. 

4. 

Member  States  shall  make  arrangements  for  keeping  adequate  control  of  sealed 
sources with regard to their location, use and disuse.  

Member  States  shall  require  the  undertaking  to  keep  records  of  all  such  sources 
under its responsibility, their location and their transfer. 

Member  States  shall  set  up  a  system  to  enable  them  to  be  adequately  informed  of 
individual transfers of sealed sources, where necessary, and in any event of transfers 
of high-activity sealed sources.  

Member States shall require each undertaking holding a sealed source to notify the 
competent  authority  promptly  of  any  loss,  theft  or  unauthorised  use  of  a  sealed 
source.  

Article 88 

Requirements for control of high-activity sealed sources 

Member States shall ensure that, before issuing authorisation for practices involving 
a high-activity sealed source:  

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(a) 

(b) 

(a) 

(b) 

(c) 

adequate  arrangements  have  been  made  for  the  safe  management  and  security  of 
sources,  including  when  they  become  disused  sources.  Such  arrangements  may 
provide  for  the  transfer  of  disused  sources  to  the  supplier  or  their  placement  in  a 
disposal  or  storage  facility  or  an  obligation  for  the  manufacturer  or  the  supplier  to 
receive them; 

adequate  provision,  by  way  of  a  financial  security  or  any  other  equivalent  means 
appropriate  for  the  source  in  question,  has  been  made  for  the  safe  management  of 
sources when they become disused sources, including the case where the undertaking 
becomes insolvent or ceases its activities. 

Article 89 

Specific requirements for licensing of high-activity sealed sources 

In addition to the general licensing requirements set out in Chapter V, Member States 
shall ensure that the licence for the manufacture, use or taking possession of a high-
activity sealed source includes: 

minimum  performance  criteria  for  the  source,  source  container  and  additional 
equipment; 

work procedures to be followed; 

adequate  management  of  disused  sources,  including  agreements  regarding  the 
transfer,  if  appropriate,  of  disused  sources  to  a  manufacturer,  a  supplier,  another 
authorised undertaking or a waste disposal or storage facility. 

Article 90 

Record keeping by the undertakings 

Member  States  shall  require  that  the  records  for  high-activity  sealed  sources  include  the 
information set out in Annex XII and that the undertaking provides the competent authorities 
with a copy of all or part of these records upon request and at least as set out in Annex XIII. 
The undertaking’s records shall be available for inspection by the competent authority. 

Article 91 

Record keeping by the competent authorities 

The competent authorities shall keep records of undertakings authorised to perform practices 
with  high-activity  sealed  sources  and  of  the  high-activity  sealed  sources  they  hold.  These 
records shall include the radionuclide involved, the activity at the time of manufacture or, if 
this activity is not known, the activity at the time of the first placing on the market or at the 

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time the undertaking acquired the source, and the type of source. The competent authorities 
shall keep the records up to date, taking transfers of the sources and other factors into account. 

1. 

2. 

1. 

2. 

3. 

Article 92 

Security of high-activity sealed sources 

The  undertaking  carrying  out  activities  involving  high  activity  sealed  sources  shall 
comply with requirements set out in Annex XIV. 

The manufacturer, the supplier, and each undertaking shall ensure that high-activity 
sealed  sources  and  containers  comply  with  the  requirements  for  identification  and 
marking as set out in Annex XV. 

SECTION 3 

ORPHAN SOURCES 

Article 93 

Detection of orphan sources 

Member States shall require any person encountering an orphan source to promptly 
notify the emergency organisation or the competent authority and to refrain from any 
further action on the source until these bodies have given appropriate instructions. 

Member  States  shall  make  arrangements  for  the  establishment  of  systems  to  detect 
orphan  sources  in  places  such  as  large  metal  scrap  yards  and  major  metal  scrap 
recycling  installations  where  orphan  sources  may  generally  be  encountered,  or  at 
significant nodal transit points, wherever appropriate, such as customs posts. 

Member  States  shall  ensure  that  specialised  technical  advice  and  assistance  is 
promptly made available to persons who work in the places referred to in paragraph 
2  and  who  are  not  normally  involved  in  operations  subject  to  radiation  protection 
requirements.  The  primary  aim  of  advice  and  assistance  shall  be  the  protection  of 
workers and members of the public from radiation and the safety of the source.  

Article 94 

Metal contamination 

Member  States  shall  require  that  a  metal  scrap  recycling  installation  promptly  notifies  the 
competent  authority  of  any  melting  of  an  orphan  source  and  shall  require  that  the 
contaminated metal not be further processed without authorisation by the competent authority. 

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Article 95 

Recovery, management and disposal of orphan sources 

1. 

2. 

Member States shall ensure that the competent authorities are prepared, or have made 
provision, including assignment of responsibilities, to recover orphan sources and to 
deal  with  emergencies  due  to  orphan  sources  and  have  drawn  up  appropriate 
response plans and measures. 

Member States shall ensure that campaigns are organised, as appropriate, to recover 
orphan sources left behind from past practices. 

The campaigns may include the financial participation of Member States in the costs 
of recovering, managing and disposing of the sources and may also include surveys 
of  historical  records  of  authorities,  such  as  customs,  and  of  undertakings,  such  as 
research institutes, material testing institutes or hospitals. 

Article 96 

Financial security for orphan sources 

Member  States  shall  ensure  that,  on  the  basis  of  arrangements  to  be  decided  by  Member 
States,  a  financial  security  system  or  other  equivalent  means  is  established  to  cover 
intervention  costs  relating  to  the  recovery  of  orphan  sources  and  which  may  result  from 
implementation of Article 95. 

SECTION 4 

EMERGENCY EXPOSURE SITUATIONS 

Article 97 

Emergency management system 

1. 

2. 

Member  States  shall  ensure  that  account  is  taken  of  the  fact  that  emergencies  may 
occur  on  their  territory  and  that  they  may  be  affected  by  emergencies  occurring 
outside  their  territory.  Member  States  shall  establish  an  emergency  management 
system and adequate administrative provisions to maintain such a system. 

The emergency management system shall be designed to be commensurate with the 
results  of  a  threat  assessment  and  to  be  able  to  respond  effectively  to  emergency 
exposure  situations  in  connection  with  practices  or  unforeseen  events,  including 
malevolent acts and the discovery of orphan sources. 

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3. 

1. 

2. 

3. 

4. 

1. 

2. 

3. 

The  emergency  management  system  shall  provide  for  the  establishment  of 
emergency response plans with the objective of avoiding deterministic effects in any 
individual  from  the  affected  members  of  the  public  and  reducing  the  risk  of 
stochastic effects, taking account of the general principles of radiation protection and 
the  reference  levels  referred  to  in  Chapter  III.  The  emergency  management  system 
shall include the elements listed in Section A of Annex IX. 

Article 98 

Emergency preparedness 

Member States shall ensure that emergency response plans are established in advance 
for the various types of emergencies identified by the threat assessment. 

Member States shall ensure that emergency response plans are tested, reviewed and 
revised at regular intervals. 

The  emergency  response  plans  shall,  where  appropriate,  incorporate  relevant 
elements of the emergency management system referred to in Article 97.  

The  emergency  response  plans  shall  include  the  elements  defined  in  Section  B  of 
Annex IX.  

Article 99 

International cooperation 

Member  States  shall  cooperate  with  other  Member  States  and  third  countries  in 
addressing  possible  emergencies  on  their  own  territory  which  may  affect  other 
Member  States  or  third  countries,  in  order  to  facilitate  the  organisation  of 
radiological protection in these Member States or third countries.  

Member  States  shall,  in  the  event  of  an  emergency  occurring  on  their  territory  or 
likely  to  have  radiological  consequences  on  its  territory,  establish  contact  to  obtain 
the cooperation of any other Member State or third country which may be involved. 

Member  States  shall  promptly  exchange  information  and  cooperate  with  other 
relevant  Member  States  or 
international 
organisations  regarding  the  loss,  removal,  theft  or  discovery  of  high-activity  sealed 
sources, other radioactive sources and radioactive material of concern and regarding 
related  follow-up  or  investigations,  without  prejudice  to  relevant  confidentiality 
requirements and relevant national legislation. 

third  countries  and  with  relevant 

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SECTION 5 

EXISTING EXPOSURE SITUATIONS 

Article 100 

Programmes on existing exposure situations 

1. 

2. 

(a) 

Member States shall ensure that programmes are established to identify and evaluate 
existing  exposure  situations  and  to  determine  which  occupational  and  public 
exposures are of concern from a radiation protection point of view.  

The requirements for existing exposure situations shall apply to: 

exposure due to contamination of areas by residual radioactive material from: 

(i) past activities that were never subject to regulatory control or were not regulated 

in accordance with the requirements laid down by this Directive; 

(ii) an emergency, after the emergency exposure situation has been declared ended, 

as provided for in the emergency management system; 

(iii)  residues  from  past  activities  for  which  the  undertaking  is  no  longer  legally 

accountable; 

(b) 

exposure to natural radiation sources, including: 

(i)  indoor  exposure  to  radon  and  thoron,  in  workplaces,  dwellings  and  other 

buildings; 

(ii) indoor external exposure from building materials; 

(c) 

exposure to commodities incorporating  

(i) radionuclides from contaminated areas specified in point (a), or  

(ii) naturally occurring radionuclides, in particular in foodstuffs, drinking water and 

building materials; 

(d) 

3. 

4. 

other  existing  exposure  situations  which  cannot  be  disregarded  from  a  radiation 
protection point of view. 

Member  States  may  decide,  having  regard  to  the  general  principle  of  justification, 
that an existing exposure situation warrants no consideration of protective measures. 

Existing exposure situations which are the legal responsibility of an undertaking and 
which are of concern from a radiation protection point of view shall be subject to the 
relevant requirements for planned exposure situations. 

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Article 101 

Establishment of strategies 

1. 

2. 

(a) 

(b) 

1. 

2. 

3. 

4. 

(a) 

(b) 

(c) 

(d) 

Member States shall arrange for the establishment of strategies to ensure that existing 
exposure situations are managed appropriately and that the resources made available 
for their management are commensurate with the risks and with the effectiveness of 
protective measures.  

The  competent  authority  charged  with  establishing  a  strategy  for  managing  an 
existing exposure situation shall ensure that the strategy contains:  

the objectives pursued by the strategy; 

appropriate  reference  levels,  taking  into  account  the  bands  of  reference  levels  laid 
down in Annex I. 

Article 102 

Implementation of strategies 

Member  States  shall  assign  responsibilities  to  a  competent  authority  for  the 
implementation  of  strategies  for  the  management  of  existing  exposures,  and,  as 
appropriate, to registrants, licensees and other parties involved in the implementation 
of  remedial  and  protective  measures,  and  shall  provide  as  appropriate  for  the 
involvement  of  stakeholders 
the  development  and 
implementation of strategies for managing exposures. 

in  decisions  regarding 

The  form,  scale  and  duration  of  all  protective  measures  considered  for 
implementation of a strategy shall be optimised.  

The  distribution  of  residual  doses  that  has  resulted  from  the  implementation  of  a 
strategy  shall  be  assessed.  Further  efforts  shall  be  considered  with  the  aim  of 
reducing any exposures that are still above the reference level. 

Throughout the implementation of a strategy, the competent authority shall regularly:  

evaluate the available remedial and protective measures for achieving the objectives 
and the efficiency of planned and implemented measures; 

provide  information  to  exposed  individuals  on  the  potential  health  risks  and  on  the 
available means for reducing their own exposure; 

provide guidance for the management of exposures at individual or local level; 

with regard to activities that involve naturally occurring radioactive material and are 
not managed as planned exposure situations, provide information to undertakings on 
appropriate  means  for  monitoring  concentrations  and  exposures  and  for  taking 
protective measures in the context of overall health and safety requirements. 

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1. 

2. 

1. 

2. 

3. 

4. 

5. 

Article 103 

Radon action plan 

Member States shall establish an action plan to manage long-term risks from radon 
exposures in dwellings, buildings with public access and workplaces for any source 
of radon ingress, whether from soil, building materials or water. The action plan shall 
take into account the issues set out in Annex XVI. 

Member  States  shall  forward  the  action  plan  and  information  on  any  identified 
radon-prone  areas  to  the  Commission.  Member  States  shall  update  the  action  plan 
and information on radon-prone areas on a regular basis. 

SECTION 6 

SYSTEM OF ENFORCEMENT 

Article 104 

Inspections 

Member  States  shall  establish  a  system  or  systems  of  inspection  to  enforce  the 
provisions  adopted  pursuant  to  this  Directive  and  to  initiate  surveillance  and 
corrective action wherever necessary. 

The  competent  authority  shall  establish  a  systematic  inspection  programme  taking 
into  account  the  potential  magnitude  and  nature  of  the  hazard  associated  with 
practices, a general assessment of radiation protection issues in the practices, and the 
state of compliance with the provisions adopted pursuant to this Directive.  

Member States shall ensure that the findings from each inspection are recorded and 
the reports communicated to the undertaking concerned. 

Member States shall make the inspection programme and the main findings from its 
implementation available to the public. 

The  competent  authority  shall  ensure  that  mechanisms  are  in  place  for  the  timely 
dissemination  to  relevant  parties,  including  manufacturers  and  suppliers  of  sources 
and,  where  appropriate,  international  organisations,  of  protection  and  safety 
information concerning lessons learned from inspections and from reported incidents 
and accidents and related findings. 

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Article 105 

Enforcement 

Member  States  shall  ensure  that  the  competent  authority  has  the  power  to  require  the 
undertaking to take action to remedy deficiencies and prevent their recurrence or to withdraw, 
where  appropriate,  authorisation  when  the  results  of  a  regulatory  inspection  or  another 
regulatory assessment indicate that the undertaking is not in compliance with the provisions 
adopted pursuant to this Directive. 

Article 106 

Penalties 

The Member States shall lay down the rules on penalties applicable to infringements  of the 
national provisions adopted pursuant to this Directive and shall take all measures necessary to 
ensure that they are implemented. The penalties provided for must be effective, proportionate 
and  dissuasive.  The  Member  States  shall  notify  those  provisions  to  the  Commission  by  the 
date specified in Article 107 at the latest and shall notify it without delay of any subsequent 
amendment affecting them. 

CHAPTER XI 

FINAL PROVISIONS 

Article 107 

Transposition 

1. 

2. 

3. 

Member  States  shall  bring  into  force  the  laws,  regulations  and  administrative 
provisions necessary to comply with this Directive by 00.00.0000 at the latest. The 
provisions laid down in Chapter IX with regard to the protection of the environment 
shall be transposed by 00.00.0000. 

When  Member  States  adopt  these  provisions,  they  shall  contain  a  reference  to  this 
Directive or shall be accompanied by such reference on the occasion of their official 
publication. Member States shall determine how such reference is to be made. 

Member  States  shall  communicate  to  the  Commission  the  text  of  the  provisions  of 
national law which they adopt in the field covered by this Directive and a correlation 
table between those provisions and this Directive. 

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Article 108 

Repeal 

Directives 
2003/122/Euratom shall be repealed with effect from 00.00.0000. 

89/618/Euratom, 

90/641/Euratom, 

96/29/Euratom, 

97/43/Euratom, 

Article 109 

Entry into force 

The Directive shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union. 

Article 110 

Addressees 

This Directive is addressed to the Member States. 

Done at Brussels, 

For the Council 
The President 

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ANNEX I 

Bands of reference levels for public exposure 

1. The optimisation of public exposures in emergency and existing exposure situations shall 
be based on a reference level to be established within the following bands, expressed in mSv 
effective dose (acute or annual): 

(a) 

(b) 

(c) 

greater than 20 and less or equal to 100  

greater than 1 and less or equal to 20  

1 or less.  

The choice of the reference level shall fulfil the conditions set out in points 2-5. 

2.  Without  prejudice  to  reference  levels  set  for  organ  doses,  reference  levels  expressed  in 
effective  doses  shall  be  set  in  the  range  of  1  to  20  mSv  per  year  for  existing  exposure 
situations and 20 to 100 mSv for emergency exposure situations. 

3.  In  specific  situations,  a  reference  level  below  ranges  referred  to  in  point  1  may  be 
considered, in particular: 

(a)  a  reference  level  below  20  mSv  may  be  set  in  an  emergency  exposure  situation  where 
appropriate protection can be provided without causing a disproportionate detriment from the 
corresponding countermeasures or an excessive cost; 

(b)  a  reference  level  below  1  mSv  per  year  may  be  set,  where  appropriate,  in  an  existing 
exposure situation for specific source-related exposures or pathways of exposure. 

4. For the transition from an emergency exposure situation to an existing exposure situation, 
appropriate  reference  levels  shall  be  set,  in  particular  upon  the  termination  of  long-term 
countermeasures such as relocation. 

5. The reference levels set shall take account of the features of prevailing situations as well as 
societal criteria, which may include the following: 

–  (a)  for  exposures  below  1  mSv  or  1  mSv  per  year,  general  information  on  the  level  of 

exposure, without specific consideration of individual exposures; 

–  (b)  in  the  range  up  to  20  mSv  or  20  mSv  per  year,  specific  information  to  enable 

individuals to manage their own exposure, if possible; 

–  (c) in the range up to 100 mSv or 100 mSv per year, assessment of individual doses and 

specific information on radiation risks and on available actions to reduce exposures. 

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ANNEX II 

Activity values defining high-activity sealed sources 

For radionuclides not listed in the table below, the relevant activity level is identical to the D-
value  defined  in  the  IAEA  publication  ‘Dangerous  quantities  of  radioactive  material  (D-
values)’, (EPR-D-VALUES 2006). 

Radionuclide 

Activity level (TBq) 

Am-241 

Am-241/Be 

Cf-252 

Cm-244 

Co-60 

Cs-137 

Gd-153 

Ir-192 

Pm-147 

Pu-238 

Pu-239/Be23 

Ra-226 

Se-75 

Sr-90 (Y-90) 

Tm-170 

Yb-169 

6× 10-2 

6× 10-2 

2× 10-2 

5× 10-2 

3 × 10-2 

1 × 10-1 

1 × 100 

8 × 10-2 

4× 101 

6 × 10-2 

6 × 10-2 

4 × 10-2 

2 × 10-1 

1 × 100 

2× 101 

3 × 10-1 

23 

The activity given is that of the alpha-emitting radionuclide 

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ANNEX III 

Placing on the market of apparatus or products 

A. Any undertaking intending to place on the market apparatus or products shall provide the 
competent authorities with all relevant information as to the: 

(1) 

(2) 

(3) 

(4) 

technical characteristics of the apparatus or product; 

in the case of apparatus containing radioactive substances, information on the means 
of fixation of the source in a holder and on shielding; 

dose rates at relevant distances for the use of the apparatus or product, including dose 
rates at a distance of 0.1 m from any accessible surface; 

intended use of the apparatus or product and information on the relative performance 
of the new apparatus or product compared to existing ones; 

(5) 

expected doses to regular users of the apparatus or product. 

B. The competent authorities shall assess the information, listed in Section A and in particular 
shall assess: 

(1) 

(2) 

(3) 

(4) 

(5) 

whether the performance of the apparatus or product justifies its intended use; 

whether  the  design  is  adequate  in  order  to  reduce  exposures  in  normal  use  and  the 
likelihood and consequences of misuse or accidental exposures; 

in  the  case  of  a  consumer  product,  whether  the  product  is  adequately  designed  to 
meet the exemption criteria and does not necessitate specific precautions for disposal 
when no longer in use; 

in the case of apparatus or products for use in practices exempted from authorisation, 
whether conditions for disposal are adequate; 

the  apparatus  or  product 

whether 
labelled  and  suitable 
documentation  is  provided  to  the  customer  with  instructions  for  proper  use  and 
disposal. 

is  appropriately 

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ANNEX IV 

Practices involving non-medical imaging exposure 

For the purposes of Article 23, the following list of practices involving non-medical imaging 
exposure shall be taken into account: 

A. Procedures implemented by medical staff using medical radiological equipment: 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

Radiological health assessment for employment purposes; 

Radiological health assessment for immigration purposes; 

Radiological health assessment for insurance purposes; 

Radiological health assessment for other purposes not intended to benefit the health 
and well-being of the exposed individual; 

Radiological  evaluation  of  the  physical  development  of  children  and  adolescents 
with a view to a career in sports, dancing, etc.; 

Radiological age assessment; 

Use of ionising radiation for the identification of concealed objects within the human 
body. 

B. Procedures implemented by non-medical staff using non-medical equipment:  

1. 

2. 

3. 

Use  of  ionising  radiation  for  detection  of  concealed  objects  on  or  attached  to  the 
human body; 

Use  of  ionising  radiation  for  detection  of  concealed  humans  as  part  of  cargo 
screening; 

Other practices involving the use of ionising radiation for legal or security purposes. 

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ANNEX V 

List of industrial practices involving naturally occurring radioactive material 

For  the  purposes  of  Article  24,  the  following  list  of  industrial  practices  involving  naturally 
occurring  radioactive  material,  including  relevant  secondary  processes,  shall  be  taken  into 
account: 

(1) 

(2) 

(3) 

(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

extraction of rare earths from monazite; 

production of thorium compounds and manufacture of thorium-containing products; 

processing of niobium/tantalum ore; 

oil and gas production; 

geothermal energy production; 

TiO2 pigment production; 

thermal phosphorus production; 

zircon and zirconium industry; 

production of phosphate fertilisers; 

(10) 

cement production, maintenance of clinker ovens; 

(11) 

coal-fired power plants, maintenance of boilers; 

(12) 

phosphoric acid production;  

(13) 

primary iron production;  

(14) 

tin/lead/copper smelting; 

(15) 

ground water filtration facilities; 

(16) 

mining of ores other than uranium ore. 

EN 

89 

   EN 

 
ANNEX VI 

Exemption and clearance criteria 

1. Exemption 

Practices may be exempted from requirements of this Directive either directly, on the basis of 
compliance  with  numerical  exemption  criteria  (activity  values  (Bq)  or  concentration  values 
(Bq g-1)) laid down in this Annex (section 2), or through a regulatory decision, on the basis of 
the information provided in conjunction with the notification of the practice and in line with 
general exemption criteria (section 3), to exempt the practice from further requirements. 

2. Exemption and clearance values 

The total activity values (Bq) for exemption apply to the total activity involved in a practice 
and are laid down in column 3 of Table B for artificial radionuclides and for some naturally 
occurring  radionuclides  used  in  consumer  products.  For  other  practices  involving  naturally 
occurring radionuclides, such values are in general not applicable.  
The  exempt  activity  concentration  values  (Bq  g-1)  for  the  materials  involved  in  the  practice 
are  laid  down  in  Table  A,  Part  1  for  artificial  radionuclides  and  in  Table  A,  Part  2  for 
naturally  occurring  radionuclides.  The  values  in  Table  A1,  Part  1  are  given  for  individual 
radionuclides,  where  applicable  including  short-lived  radionuclides  in  equilibrium  with  the 
parent  nuclide  as  indicated.  The  values  in  Table  A,  Part  2  apply  to  all  radionuclides  in  the 
decay  chain  of  U-238  or  Th-232,  but  for  segments  of  the  decay  chain  which  are  not  in 
equilibrium with the parent radionuclide higher values may be applied.  

The concentration values in Table A, Part 1 or in Table A, Part 2 also apply to the clearance 
of  solid  materials  for  re-use,  recycling,  conventional  disposal  or  incineration.  Higher  values 
may be defined for specific materials or specific pathways, taking Community guidance into 
account,  including  where  appropriate  additional  requirements  in  terms  of  surface  activity  or 
monitoring requirements.  

For  mixtures  of  artificial  radionuclides,  the  weighted  sum  of  nuclide-specific  activities  or 
concentrations  (for  various  radionuclides  contained  in  the  same  matrix)  divided  by  the 
corresponding exemption value shall be less than unity. Where appropriate this condition can 
be  verified  on  the  basis  of  best  estimates  of  the  composition  of  the  radionuclide  mix.  The 
values  in  Table  A,  Part  2  apply  individually  to  each  parent  nuclide.  Some  elements  in  the 
decay chain, e.g. Po-210 or Pb-210, may warrant the use of values significantly higher, by up 
to two orders of magnitude, taking Community guidance into account. 

The  values  in  Table  A,  Part  2  may  not  be  used  to  exempt  the  incorporation  into  building 
materials of residues from industries processing naturally occurring radioactive material. Such 
recycling of residues from identified industries shall be managed as an authorised practice or 
be  exempted  on  the  basis  of  the  general  exemption  criteria  laid  down  in  section  3.  For  this 
purpose, compliance of the sum of radionuclide concentrations with the appropriate value of 
the radionuclide index I for building materials as defined in Annex VII shall be verified. 

The  values  laid  down  in  Table  B,  column  3,  apply  to  the  total  inventory  of  radioactive 
substances held by a person or undertaking as part of a specific practice at any point in time. 
However, the regulatory authority may apply these values to smaller entities or packages, for 
instance  to  exempt  the  transport  or  storage  of  exempted  consumer  products,  if  the  general 
exemption criteria in section 3 are satisfied. 

3. General exemption and clearance criteria  

EN 

90 

   EN 

 
The general criteria for the exemption of notified practices or the clearance of materials from 
authorised practices are as follows: 

(a) the radiological risks to individuals caused by the practice are sufficiently low as to be of 
no regulatory concern; and 

(b) the type of practice has been determined to be justified; and 

(c) the practice is inherently safe. 

Practices  involving  small  amounts  of  radioactive  substances  or  low  activity  concentrations, 
comparable  to  the  exemption  values  laid  down  in  Tables  A,  Part  1  or  B,  and  in  general  all 
practices involving naturally occurring radionuclides are deemed to fulfil criterion (c).  

Practices  involving  amounts  of  radioactive  substances  or  activity  concentrations  below  the 
exemption values laid down in Table A, Part 1 or Table B automatically comply with criterion 
(a) without further consideration. This is also the case for the values in Table A, Part 2, with 
the  exception  of  the  recycling  of  residues  in  building  materials  or  the  case  of  specific 
exposure pathways, for instance drinking water. 

For  notified  practices  not  complying  with  these  values,  an  assessment  shall  be  made  of  the 
resulting  exposure  of  individuals.  For  compliance  with  the  general  criterion  (a),  it  shall  be 
demonstrated that the following dose criteria are met in all feasible circumstances:  

For artificial radionuclides: 

The effective dose expected to be incurred by an individual due to the exempted practice is of 
the order of 10 µSv or less in a year. 

For naturally occurring radionuclides: 

The dose increment, allowing for the prevailing background radiation from natural radiation 
sources, liable to be incurred by an individual due to the exempted practice is of the order of 
300 µSv or less in a year for members of the public and less than 1 mSv for workers.  

The assessment of doses to members of the public shall take into account not only pathways 
of exposure through airborne or liquid effluent, but also pathways resulting from the disposal 
or recycling of solid residues. 

EN 

91 

   EN 

 
TABLE A: 

Activity  concentration  values  for  exemption  or  clearance  of  materials  which  can  be 
applied by default to any amount and to any type of solid material. 

TABLE A Part 1: Artificial radionuclides

EN 

92 

   EN 

 
Radionuclide 

Activity 
concentration 
(Bq g-1) 

Radionuclide

Activity 
concentration 
(Bq g-1) 

Radionuclide 

Activity 
concentration 
(Bq g-1) 

100 

Mn-52m 

H-3 

Be-7 

C-14 

F-18 

Na-22 

Na-24 

Si-31 

P-32 

P-33 

S-35 

Cl-36 

Cl-38 

K-42 

K-43 

Ca-45 

Ca-47 

Sc-46 

Sc-47 

Sc-48 

V-48 

Cr-51 

Mn-51 

Mn-52 

Mn-53 

Mn-54 

Mn-56 

Fe-52a 

Fe-55 

Fe-59 

Co-55 

Co-56 

Co-57 

Co-58 

10 

100 

0.1 

10 

10 

1000 

1 

10 

0.1 

1 

1 

Ga-72 

Ge-71 

As-73 

As-74 

As-76 

As-77 

Se-75 

Br-82 

Rb-86 

Sr-85 

Sr-85m 

Co-58m 

10 000 

Sr-87m 

Co-60 

Co-60m 

Co-61 

Co-62m 

Ni-59 

Ni-63 

Ni-65 

Cu-64 

Zn-65 

Zn-69 

Zn-69ma 

0.1 

1000 

100 

10 

100 

100 

10 

100 

0.1 

1000 

10 

Sr-89 

Sr-90a 

Sr-91a 

Sr-92 

Y-90 

Y-91 

Y-91m 

Y-92 

Y-93 

Zr-93 

Zr-95a 

10 

1 

10 

0.1 

1 

1000 

1000 

1000 

100 

1 

10 

100 

10 

100 

10 

0.1 

100 

1 

1 

100 

10 

1 

10 

10000 

1000 

10 

10 

1000 

1 

1 

100 

1 

100 

100 

1000 

1 

10 

10 

1000 

100 

100 

100 

100 

10 

1 

EN 

93 

   EN 

 
Radionuclide 

Activity 
concentration 
(Bq g-1) 

Radionuclide

Activity 
concentration 
(Bq g-1) 

Radionuclide 

Activity 
concentration 
(Bq g-1) 

Zr-97a 

Nb-93m 

Nb-94 

Nb-95 

Nb-97a 

Nb-98 

Mo-90 

Mo-93 

Mo-99a 

Mo-101a 

Tc-96 

10 

10 

0.1 

1 

10 

10 

10 

10 

10 

10 

1 

Tc-96m 

1000 

Tc-97 

Tc-97m 

Tc-99 

Tc-99m 

Ru-97 

Ru-103a 

Ru-105a 

Ru-106a 

10 

100 

1 

100 

10 

1 

10 

0.1 

Pd-109a 

Ag-105 

Ag-110ma 

Ag-111 

Cd-109a 

Cd-115a 

Cd-115ma 

In-111 

In-113m 

In-114ma 

In-115m 

Sn-113a 

Sn-125 

Sb-122 

Sb-124 

Sb-125a 

Te-123m 

Te-125m 

Te-127 

Te-127ma 

Rh-103m 

10000 

Te-129 

Rh-105 

Pd-103a 

100 

1000 

Te-129ma 

Te-131 

100 

1 

0.1 

100 

1 

10 

100 

10 

100 

10 

100 

1 

10 

10 

1 

0.1 

1 

1000 

1000 

10 

100 

10 

100 

Te-131ma 

Te-132a 

Te-133 

Te-133m 

Te-134 

I-123 

I-125 

I-126 

I-129 

I-130 

I-131 

I-132 

I-133 

I-134 

I-135 

Cs-129 

Cs-131 

Cs-132 

Cs-134 

10 

1 

10 

10 

10 

100 

100 

10 

0.01 

10 

10 

10 

10 

10 

10 

10 

1000 

10 

0.1 

Cs-134m 

1000 

Cs-135 

Cs-136 

Cs-137a 

100 

1 

0.1 

EN 

94 

   EN 

 
Radionuclide 

Activity 
concentration 
(Bq g-1) 

Radionuclide

Activity 
concentration 
(Bq g-1) 

Radionuclide 

Activity 
concentration 
(Bq g-1) 

Cs-138 

Ba-131 

Ba-140 

La-140 

Ce-139 

Ce-141 

Ce-143 

Ce-144 

Pr-142 

Pr-143 

Nd-147 

Nd-149 

Pm-147 

Pm-149 

Sm-151 

Sm-153 

Eu-152 

Eu-152m 

Eu-154 

Eu-155 

Gd-153 

Gd-159 

Tb-160 

10 

10 

1 

1 

1 

100 

10 

10 

100 

1000 

100 

100 

1000 

1000 

1000 

100 

0.1 

100 

0.1 

1 

10 

100 

1 

Dy-165 

Dy-166 

Ho-166 

Er-169 

Er-171 

Tm-170 

1000 

Pt-191 

100 

100 

Pt-193m 

Pt-197 

1000 

Pt-197m 

100 

100 

Au-198 

Au-199 

Tm-171 

1000 

Hg-197 

Yb-175 

Lu-177 

Hf-181 

Ta-182 

W-181 

W-185 

W-187 

Re-186 

Re-188 

Os-185 

Os-191 

Os-191m 

Os-193 

Ir-190 

Ir-192 

Ir-194 

100 

100 

1 

0.1 

10 

1000 

10 

1000 

100 

1 

100 

1000 

100 

1 

1 

100 

Hg-197m 

Hg-203 

Tl-200 

Tl-201 

Tl-202 

Tl-204 

Pb-203 

Bi-206 

Bi-207 

Po-203 

Po-205 

Po-207 

At-211 

Ra-225 

Ra-227 

Th-226 

10 

1000 

1000 

100 

10 

100 

100 

100 

10 

10 

100 

10 

1 

10 

1 

0.1 

10 

10 

10 

1000 

10 

100 

1000 

EN 

95 

   EN 

 
Radionuclide 

Activity 
concentration 
(Bq g-1) 

Radionuclide

Activity 
concentration 
(Bq g-1) 

Radionuclide 

Activity 
concentration 
(Bq g-1) 

Th-229 

Pa-230 

Pa-233 

U-230 

U-231a 

U-232a 

U-233 

U-236 

U-237 

U-239 

U-240a 

Np-237a 

Np-239 

Np-240 

Pu-234 

Pu-235 

Pu-236 

Pu-237 

Pu-238 

Pu-239 

Pu-240 

Pu-241 

Pu-242 

0.1 

10 

10 

10 

100 

0.1 

1 

10 

100 

100 

100 

1 

100 

10 

100 

100 

1 

100 

0.1 

0.1 

0.1 

10 

0.1 

Pu-243 

Pu-244a 

Am-241 

0.1 

0.1 

1000 

Es-254a 

Es-254ma 

0.1 

10 

Fm-254 

10000 

Am-242 

1000 

Fm-255 

100 

Am-242ma 

Am-243a 

Cm-242 

Cm-243 

Cm-244 

Cm-245 

Cm-246 

Cm-247a 

Cm-248 

Bk-249 

Cf-246 

Cf-248 

Cf-249 

Cf-250 

Cf-251 

Cf-252 

Cf-253 

Cf-254 

Es-253 

0.1 

0.1 

10 

1 

1 

0.1 

0.1 

0.1 

0.1 

100 

1000 

1 

0.1 

1 

0.1 

1 

100 

1 

100 

EN 

96 

   EN 

 
Parent  radionuclides,  and  their  progeny  whose  dose  contributions  are  taken  into 
a 
account  in  the  dose  calculation  (thus  requiring  only  the  exemption  level  of  the  parent 
radionuclide to be considered), are listed in the following table: 

EN 

97 

   EN 

 
Te-127m 

Te-127 

Te-129m 

Te-129 

Te-131m 

Te-131 

Te132 

I-132 

Cs-137 

Ba-137m 

Ce-144 

Pr-144, Pr-144m 

U-232 

Th-228,  Ra-224,  Rn-220, 
Po-216,  Pb-212,  Bi-212, 
Tl-208 

U-240 

Np-240m, Np-240 

Np237 

Pa-233 

Pu-244 

U-240, Np-240m, Np-240 

Am-242m 

Np-238 

Am-243 

Np-239 

Cm-247 

Pu-243 

Es-254 

Bk-250 

Es-254m 

Fm-254 

Parent 
radionuclide 

Progeny 

Fe-52 

Mn-52m 

Zn-69m 

Zn-69 

Sr-90 

Sr-91 

Zr-95 

Zr-97 

Y-90 

Y-91m 

Nb-95 

Nb-97m, Nb-97 

Nb-97 

Nb-97m 

Mo-99 

Tc-99m 

Mo-101 

Tc-101 

Ru-103 

Rh-103m 

Ru-105 

Rh-105m 

Ru-106 

Rh-106 

Pd-103 

Rh-103m 

Pd-109 

Ag-109m 

Ag-110m 

Ag-110 

Cd-109 

Ag-109m 

Cd-115 

In-115m 

Cd-115m 

In-115m 

In-114m 

In-114 

Sn-113 

In-113m 

Parent 
radionuclide 

Progeny 

Sb-125 

Te-125m 

EN 

98 

   EN 

 
For  radionuclides  not  listed  in  Table  A,  Part  1  the  competent  authority  shall  assign 
appropriate  values  for  the  quantities  and  concentrations  of  activity  per  unit  mass  where  the 
need arises. Values thus assigned shall be complementary to those in Table A, Part 1.  

TABLE A Part 2: naturally occurring radionuclides 

Values for exemption or clearance for naturally occurring radionuclides in solid materials in 
secular equilibrium with their progeny: 

Natural radionuclides from the U-238 series 

Natural radionuclides from the Th-232 series 

K-40 

1 Bq g-1 
1 Bq g-1 
10 Bq g-1 

EN 

99 

   EN 

 
 
TABLE B: 

Total  activity  values  for  exemption  (column  3)  and  exemption  values  for  the  activity 
(column  2).
concentration 

in  moderate  amounts  of  any 

type  of  material 

EN 

100 

   EN 

 
Radionuclide 

Activity 
concentration 
(Bq g-1) 

Activity 
(Bq) 

Radionuclide 

Activity 
concentration 
(Bq g-1) 

Activity 
(Bq) 

H-3 

Be-7 

C-14 

O-15 

F-18 

Na-22 

Na-24 

Si-31 

P-32 

P-33 

S-35 

Cl-36 

Cl-38 

Ar-37 

Ar-41 

K-42 

K-43 

Ca-45 

Ca-47 

1 × 106 

1 × 109 

1 × 103 

1 × 107 

1 × 104 

1 × 107 

1 × 102 

1 × 109 

1 × 101 

1 × 106 

1 × 101 

1 × 106 

1 × 101 

1 × 105 

Sc-46 

Sc-47 

Sc-48 

V-48 

Cr-51 

Mn-51 

Mn-52 

1 × 101 

1 × 106 

1 × 102 

1 × 106 

1 × 101 

1 × 105 

1 × 101 

1 × 105 

1 × 103 

1 × 107 

1 × 101 

1 × 105 

1 × 101 

1 × 105 

1 × 103 

1 × 106 

Mn-52m 

1 × 101 

1 × 105 

1 × 103 

1 × 105 

1 × 105 

1 × 108 

1 × 105 

1 × 108 

1 × 104 

1 × 106 

1 × 101 

1 × 105 

1 × 106 

1 × 108 

1 × 102 

1 × 109 

1 × 102 

1 × 106 

1 × 101 

1 × 106 

Mn-53 

Mn-54 

Mn-56 

Fe-52 

Fe-55 

Fe-59 

Co-55 

Co-56 

Co-57 

Co-58 

1 × 104 

1 × 109 

1 × 101 

1 × 106 

1 × 101 

1 × 105 

1 × 101 

1 × 106 

1 × 104 

1 × 106 

1 × 101 

1 × 106 

1 × 101 

1 × 106 

1 × 101 

1 × 105 

1 × 102 

1 × 106 

1 × 101 

1 × 106 

1 × 104 

1 × 107 

Co-58m 

1 × 104 

1 × 107 

1 × 101 

1 × 106 

Co-60 

1 × 101 

1 × 105 

K-4024 

1 × 102 

1 × 106 

24 

Potassium salts in quantities less than 1000 
kg are exempted. 

Co-60m 

Co-61 

1 × 103 

1 × 106 

1 × 102 

1 × 106 

EN 

101 

   EN 

 
                                                 
Zn-69m 

1 × 102 

1 × 106 

Radionuclide 

Activity 
concentration 
(Bq g-1) 

Activity 
(Bq) 

Radionuclide 

Activity 
concentration 
(Bq g-1) 

Activity 
(Bq) 

Co-62m 

1 × 101 

1 × 105 

Kr-85 

1 × 105 

1 × 104 

1 × 104 

1 × 108 

Kr-85m 

1 × 103 

1 × 1010 

Ni-59 

Ni-63 

Ni-65 

Cu-64 

Zn-65 

Zn-69 

Ga-72 

Ge-71 

As-73 

As-74 

As-76 

As-77 

Se-75 

Br-82 

Kr-74 

Kr-76 

Kr-77 

Kr-79 

Kr-81 

1 × 105 

1 × 108 

1 × 101 

1 × 106 

1 × 102 

1 × 106 

1 × 101 

1 × 106 

1 × 104 

1 × 106 

1 × 101 

1 × 105 

1 × 104 

1 × 108 

1 × 103 

1 × 107 

1 × 101 

1 × 106 

1 × 102 

1 × 105 

1 × 103 

1 × 106 

Kr-87 

Kr-88 

Rb-86 

Sr-85 

Sr-85m 

Sr-87m 

Sr-89 

Sr-90b 

Sr-91 

Sr-92 

Y-90 

Y-91 

1 × 102 

1 × 109 

1 × 102 

1 × 109 

1 × 102 

1 × 105 

1 × 102 

1 × 106 

1 × 102 

1 × 107 

1 × 102 

1 × 106 

1 × 103 

1 × 106 

1 × 102 

1 × 104 

1 × 101 

1 × 105 

1 × 101 

1 × 106 

1 × 103 

1 × 105 

1 × 103 

1 × 106 

1 × 102 

1 × 106 

Y-91m 

1 × 102 

1 × 106 

1 × 101 

1 × 106 

1 × 102 

1 × 109 

1 × 102 

1 × 109 

1 × 102 

1 × 109 

1 × 103 

1 × 105 

Y-92 

Y-93 

Zr-93b 

Zr-95 

Zr-97b 

1 × 102 

1 × 105 

1 × 102 

1 × 105 

1 × 103 

1 × 107 

1 × 101 

1 × 106 

1 × 101 

1 × 105 

1 × 104 

1 × 107 

Nb-93m 

1 × 104 

1 × 107 

Kr-83m 

1 × 105 

1 × 1012 

Nb-94 

1 × 101 

1 × 106 

EN 

102 

   EN 

 
Radionuclide 

Activity 
concentration 
(Bq g-1) 

Activity 
(Bq) 

Radionuclide 

Activity 
concentration 
(Bq g-1) 

Activity 
(Bq) 

Nb-95 

Nb-97 

Nb-98 

Mo-90 

Mo-93 

Mo-99 

1 × 101 

1 × 106 

Ag-108m 

1 × 101 

1 × 106 

1 × 101 

1 × 106 

Ag-110m 

1 × 101 

1 × 106 

1 × 101 

1 × 105 

1 × 101 

1 × 106 

1 × 103 

1 × 108 

Ag-111 

Cd-109 

Cd-115 

1 × 103 

1 × 106 

1 × 104 

1 × 106 

1 × 102 

1 × 106 

1 × 102 

1 × 106 

Cd-115m 

1 × 103 

1 × 106 

Mo-101 

1 × 101 

1 × 106 

In-111 

1 × 102 

1 × 106 

Tc-96 

Tc-96m 

Tc-97 

Tc-97m 

Tc-99 

Tc-99m 

Ru-97 

Ru-103 

Ru-105 

1 × 101 

1 × 106 

1 × 103 

1 × 107 

1 × 103 

1 × 108 

1 × 103 

1 × 107 

1 × 104 

1 × 107 

1 × 102 

1 × 107 

1 × 102 

1 × 107 

1 × 102 

1 × 106 

In-113m 

In-114m 

In-115m 

Sn-113 

Sn-125 

Sb-122 

Sb-124 

Sb-125 

1 × 102 

1 × 106 

1 × 102 

1 × 106 

1 × 102 

1 × 106 

1 × 103 

1 × 107 

1 × 102 

1 × 105 

1 × 102 

1 × 104 

1 × 101 

1 × 106 

1 × 102 

1 × 106 

1 × 101 

1 × 106 

Te-123m 

1 × 102 

1 × 107 

Ru-106b 

1 × 102 

1 × 105 

Te-125m 

1 × 103 

1 × 107 

Rh-103m 

1 × 104 

1 × 108 

Te-127 

1 × 103 

1 × 106 

Rh-105 

Pd-103 

Pd-109 

Ag-105 

1 × 102 

1 × 107 

Te-127m 

1 × 103 

1 × 107 

1 × 103 

1 × 108 

Te-129 

1 × 102 

1 × 106 

1 × 103 

1 × 106 

Te-129m 

1 × 103 

1 × 106 

1 × 102 

1 × 106 

Te-131 

1 × 102 

1 × 105 

EN 

103 

   EN 

 
Radionuclide 

Activity 
concentration 
(Bq g-1) 

Activity 
(Bq) 

Radionuclide 

Activity 
concentration 
(Bq g-1) 

Activity 
(Bq) 

Te-131m 

1 × 101 

1 × 106 

Te-132 

Te-133 

1 × 102 

1 × 107 

1 × 101 

1 × 105 

Cs-134 

Cs-135 

Cs-136 

1 × 101 

1 × 104 

1 × 104 

1 × 107 

1 × 101 

1 × 105 

Te-133m 

1 × 101 

1 × 105 

Cs-137b 

1 × 101 

1 × 104 

Te-134 

1 × 101 

1 × 106 

1 × 102 

1 × 107 

Cs-138 

Ba-131 

1 × 101 

1 × 104 

1 × 102 

1 × 106 

I-123 

I-125 

I-126 

I-129 

I-130 

I-131 

I-132 

I-133 

I-134 

I-135 

1 × 103 

1 × 106 

Ba-140b 

1 × 101 

1 × 105 

1 × 102 

1 × 106 

1 × 102 

1 × 105 

1 × 101 

1 × 106 

1 × 102 

1 × 106 

La-140 

Ce-139 

Ce-141 

Ce-143 

1 × 101 

1 × 105 

1 × 102 

1 × 106 

1 × 102 

1 × 107 

1 × 102 

1 × 106 

1 × 101 

1 × 105 

Ce-144b 

1 × 102 

1 × 105 

1 × 101 

1 × 106 

1 × 101 

1 × 105 

1 × 101 

1 × 106 

Xe-131m 

1 × 104 

1 × 104 

Xe-133 

Xe-135 

Cs-129 

Cs-131 

Cs-132 

1 × 103 

1 × 104 

1 × 103 

1 × 1010 

1 × 102 

1 × 105 

1 × 103 

1 × 106 

1 × 101 

1 × 105 

Pr-142 

Pr-143 

Nd-147 

Nd-149 

Pm-147 

Pm-149 

Sm-151 

Sm-153 

Eu-152 

1 × 102 

1 × 105 

1 × 104 

1 × 106 

1 × 102 

1 × 106 

1 × 102 

1 × 106 

1 × 104 

1 × 107 

1 × 103 

1 × 106 

1 × 104 

1 × 108 

1 × 102 

1 × 106 

1 × 101 

1 × 106 

Cs-134m 

1 × 103 

1 × 105 

Eu-152m 

1 × 102 

1 × 106 

EN 

104 

   EN 

 
Radionuclide 

Activity 
concentration 
(Bq g-1) 

Activity 
(Bq) 

Radionuclide 

Activity 
concentration 
(Bq g-1) 

Activity 
(Bq) 

Eu-154 

Eu-155 

Gd-153 

Gd-159 

Tb-160 

Dy-165 

Dy-166 

Ho-166 

Er-169 

Er-171 

Tm-170 

Tm-171 

Yb-175 

Lu-177 

Hf-181 

Ta-182 

W-181 

W-185 

W-187 

Re-186 

Re-188 

Os-185 

1 × 101 

1 × 106 

Os-191 

1 × 102 

1 × 107 

1 × 102 

1 × 107 

Os-191m 

1 × 103 

1 × 107 

1 × 102 

1 × 107 

Os-193 

1 × 102 

1 × 106 

1 × 103 

1 × 106 

1 × 101 

1 × 106 

1 × 103 

1 × 106 

1 × 103 

1 × 106 

Ir-190 

Ir-192 

Ir-194 

Pt-191 

1 × 101 

1 × 106 

1 × 101 

1 × 104 

1 × 102 

1 × 105 

1 × 102 

1 × 106 

1 × 103 

1 × 105 

Pt-193m 

1 × 103 

1 × 107 

1 × 104 

1 × 107 

Pt-197 

1 × 103 

1 × 106 

1 × 102 

1 × 106 

Pt-197m 

1 × 102 

1 × 106 

1 × 103 

1 × 106 

1 × 104 

1 × 108 

1 × 103 

1 × 107 

Au-198 

Au-199 

Hg-197 

1 × 102 

1 × 106 

1 × 102 

1 × 106 

1 × 102 

1 × 107 

1 × 103 

1 × 107 

Hg-197m 

1 × 102 

1 × 106 

1 × 101 

1 × 106 

Hg-203 

1 × 102 

1 × 105 

1 × 101 

1 × 104 

1 × 103 

1 × 107 

1 × 104 

1 × 107 

1 × 102 

1 × 106 

1 × 103 

1 × 106 

1 × 102 

1 × 105 

1 × 101 

1 × 106 

Tl-200 

Tl-201 

Tl-202 

Tl-204 

Pb-203 

Pb-210b 

Pb-212b 

1 × 101 

1 × 106 

1 × 102 

1 × 106 

1 × 102 

1 × 106 

1 × 104 

1 × 104 

1 × 102 

1 × 106 

1 × 101 

1 × 104 

1 × 101 

1 × 105 

EN 

105 

   EN 

 
Radionuclide 

Activity 
concentration 
(Bq g-1) 

Activity 
(Bq) 

Radionuclide 

Activity 
concentration 
(Bq g-1) 

Activity 
(Bq) 

Bi-206 

Bi-207 

Bi-210 

1 × 101 

1 × 105 

1 × 101 

1 × 106 

Th-230 

Th-231 

1 × 100 

1 × 104 

1 × 103 

1 × 107 

1 × 103 

1 × 106 

Th-234b 

1 × 103 

1 × 105 

Bi-212b 

1 × 101 

1 × 105 

Po-203 

Po-205 

Po-207 

Po-210 

At-211 

Rn-220b 

Rn-222b 

Ra-223b 

Ra-224b 

Ra-225 

Ra-226b 

Ra-227 

Ra-228b 

Ac-228 

Th-226b 

Th-227 

Th-228b 

Th-229b 

1 × 101 

1 × 106 

1 × 101 

1 × 106 

1 × 101 

1 × 106 

1 × 101 

1 × 104 

Pa-230 

Pa-231 

Pa-233 

U-230 

U-231 

1 × 101 

1 × 106 

1 × 100 

1 × 103 

1 × 102 

1 × 107 

1 × 101 

1 × 105 

1 × 102 

1 × 107 

1 × 103 

1 × 107 

U-232b 

1 × 100 

1 × 103 

1 × 104 

1 × 107 

1 × 101 

1 × 108 

U-233 

U-234 

1 × 101 

1 × 104 

1 × 101 

1 × 104 

1 × 102 

1 × 105 

U-235b 

1 × 101 

1 × 104 

1 × 101 

1 × 105 

1 × 102 

1 × 105 

U-236 

U-237 

1 × 101 

1 × 104 

1 × 102 

1 × 106 

1 × 101 

1 × 104 

U-238b 

1 × 101 

1 × 104 

1 × 102 

1 × 106 

1 × 101 

1 × 105 

U-239 

U-240 

1 × 102 

1 × 106 

1 × 103 

1 × 107 

1 × 101 

1 × 106 

U-240b 

1 × 101 

1 × 106 

1 × 103 

1 × 107 

Np-237b 

1 × 100 

1 × 103 

1 × 101 

1 × 104 

1 × 100 

1 × 104 

1 x 100 

1 × 103 

Np-239 

Np-240 

Pu-234 

1 × 102 

1 × 107 

1 × 101 

1 × 106 

1 × 102 

1 × 107 

EN 

106 

   EN 

 
Radionuclide 

Activity 
concentration 
(Bq g-1) 

Activity 
(Bq) 

Radionuclide 

Activity 
concentration 
(Bq g-1) 

Activity 
(Bq) 

Pu-235 

Pu-236 

Pu-237 

Pu-238 

Pu-239 

Pu-240 

Pu-241 

Pu-242 

Pu-243 

Pu-244 

Am-241 

Am-242 

1 × 102 

1 × 107 

1 × 101 

1 × 104 

1 × 103 

1 × 107 

1 × 100 

1 × 104 

1 × 100 

1 × 104 

1 × 100 

1 × 103 

1 × 102 

1 × 105 

1 × 100 

1 × 104 

1 × 103 

1 × 107 

1 × 100 

1 × 104 

Cf-246 

Cf-248 

Cf-249 

Cf-250 

Cf-251 

Cf-252 

Cf-253 

Cf-254 

Es-253 

Es-254 

1 × 103 

1 × 106 

1 × 101 

1 × 104 

1 × 100 

1 × 103 

1 × 101 

1 × 104 

1 × 100 

1 × 103 

1 × 101 

1 × 104 

1 × 102 

1 × 105 

1 × 100 

1 × 103 

1 × 102 

1 × 105 

1 × 101 

1 × 104 

1 × 100 

1 × 104 

Es-254m 

1 × 102 

1 × 106 

Fm-254 

Fm-255 

1 × 104 

1 × 107 

1 × 103 

1 × 106 

1 × 103 

1 × 106 

Am-242mb 

1 × 100 

1 × 104 

Am-243b 

1 × 100 

1 × 103 

Cm-242 

Cm-243 

Cm-244 

Cm-245 

Cm-246 

Cm-247 

Cm-248 

Bk-249 

1 × 102 

1 × 105 

1 × 100 

1 × 104 

1 × 101 

1 × 104 

1 × 100 

1 × 103 

1 × 100 

1 × 103 

1 × 100 

1 × 104 

1 × 100 

1 × 103 

1 × 103 

1 × 106 

EN 

107 

   EN 

 
EN 

108 

   EN 

 
Parent  radionuclides,  and  their  progeny  whose  dose  contributions  are  taken  into 
b 
account  in  the  dose  calculation  (thus  requiring  only  the  exemption  level  of  the  parent 
radionuclide to be considered), are listed in the following: 

Sr-90 

Zr-93 

Zr-97 

Y-90 

Nb-93m 

Nb-97 

Ru-106 

Rh-106 

Ag-108m 

Ag-108 

Cs-137 

Ba-137m 

Ba-140 

La-140 

Ce-144 

Pr-144 

Pb-210 

Bi-210, Po-210 

Pb-212 

Bi-212, Tl-208 (0.36), Po-212 (0.64) 

Bi-212 

Tl-208 (0.36), Po-212 (0.64) 

Rn-220 

Po-216 

Rn-222 

Po-218, Pb-214, Bi-214, Po-214 

Ra-223 

Rn-219, Po-215, Pb-211, Bi-211, Tl-207 

Ra-224 

Rn-220, Po-216, Pb-212, Bi-212, Tl-208 (0.36), Po-212 (0.64) 

Ra-226 

Rn-222, Po-218, Pb-214, Bi-214, Po-214, Pb-210, Bi-210, Po-210 

Ra-228 

Ac-228 

Th-226 

Ra-222, Rn-218, Po-214 

Th-228 

Ra-224, Rn-220, Po-216, Pb-212, Bi-212, Tl-208 (0.36), Po-212 (0.64) 

Th-229 

Ra-225, Ac-225, Fr-221, At-217, Bi-213, Po-213, Pb-209 

Th-234 

Pa-234m 

EN 

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   EN 

 
U-230 

Th-226, Ra-222, Rn-218, Po-214 

U-232 

Th-228,  Ra-224,  Rn-220,  Po-216,  Pb-212,  Bi-212,  Tl-208  (0.36),  Po-212 
(0.64) 

U-235 

Th-231 

U-238 

Th-234, Pa-234m 

U-240 

Np-240m 

Np237 

Pa-233 

Am-242m 

Am-242 

Am-243 

Np-239 

EN 

110 

   EN 

 
ANNEX VII 

Definition and use of the activity concentration index for the gamma radiation emitted by 
building materials 

For  the  purposes  of  Article  75(2),  for  identified  types  of  building  materials,  the  activity 
concentrations of primordial radionuclides Ra-226, Th-232 (or its decay product Ra-228) and 
K-40 shall be determined.  

The activity concentration index I is given by the following formula: 

I = CRa226/300 Bq/kg + CTh232/200 Bq/kg+ CK40/3000 Bq/kg 

where  CRa226,  CTh232  and  CK40  are  the  activity  concentrations  in  Bq/kg  of  the  corresponding 
radionuclides in the building material.  

The index relates directly to the gamma radiation dose, in excess of typical outdoor exposure, 
in  a  building  constructed  from  a  specified  building  material.  It  applies  to  the  building 
material, not to its constituents. For application of the index to such constituents, in particular 
residues  from  industries  processing  naturally  occurring  radioactive  material  recycled  into 
building  materials  an  appropriate  partitioning  factor  needs  to  be  applied.  The  activity 
concentration  index  shall  be  used  as  a  screening  tool  for  identifying  materials  that  may  be 
exempted or subject to restrictions. For this purpose the activity concentration index I may be 
used  for  the  classification  of  the  materials  into  four  classes,  leading  to  two  categories  of 
building materials (A and B):  

Category (corresponding default dose) 

Use 

A (≤ 1 mSv) 

B (> 1 mSv) 

(1)  materials  used 
bulk amounts 

in 

A1 

I≤1 

(2) superficial and other 
materials  with  restricted 
use. 

A2 

I≤6 

B1 

I>1 

B2 

I>6 

The  division  of  materials  into  (1)  or  (2)  according  to  their  use  shall  be  based  on  national 
building codes. 

Where  appropriate,  actual  doses  for  comparison  with  the  reference  level  shall  be  assessed 
using  more  elaborate  models  which  may  also  take  into  account  the  background  outdoor 
external  exposure  from  local  prevailing  activity  concentrations  in  the  undisturbed  earth’s 
crust. 

EN 

111 

   EN 

 
 
ANNEX VIII 

Data system for individual radiological monitoring 

General Provisions  

The data system for individual radiological monitoring established by a Member State may be 
realised either as a centralised national network or as a national dose register. These networks 
or  registers  may  be  supplemented  by  the  issuance  of  individual  radiological  monitoring 
documents for every outside worker. 

1. Any data system of the Member States for individual radiological monitoring of exposed 
workers shall comprise the following sections: 

(a) 

(b) 

(c) 

particulars concerning the worker’s identity; 

particulars concerning the medical surveillance of the worker; 

particulars  concerning  the  undertaking  of  the  worker  and,  in  the  case  of  an  outside 
worker, the employer of the worker;  

(d) 

the results of the individual monitoring of the exposed worker. 

2.  The  competent  authorities  of  the  Member  States  shall  take  the  measures  necessary  to 
prevent  any  forgery  or  misuse  of,  or  illegal  tampering  with,  the  data  system  for  individual 
radiological monitoring. 

A: Data to be included in the data system for individual radiological monitoring 

3. Data on the worker’s identity shall include the worker’s  

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

surname;  

first name;  

sex; 

date of birth;  

nationality; and  

unique identification number. 

4. Data on the medical surveillance of the worker shall include  

(a) 

(b) 

(c) 

(d) 

the medical classification of the worker in accordance with Article 45 (fit; fit, subject 
to certain conditions; unfit); 

information on any restrictions on working with radiation; 

the date of the last periodic health review;  

the responsible occupational health service; and  

EN 

112 

   EN 

 
(e) 

the period of validity of the result.  

5. Data on the undertaking shall include the name, address and unique identification number 
of the undertaking.  

6. Data on the employment of the worker shall include: 

(a) 

(b) 

(c) 

the name, address and unique identification number of the employer; 

the starting date of employment; and  

the categorisation of the worker in accordance with Article 38.  

7. The results of the individual monitoring of the exposed worker shall include: 

(a) 

(b) 

the official dose record for the last 5 calendar years (year; effective dose in mSv; in 
the event of non-uniform exposure, dose-equivalent in the different parts of the body 
in mSv; and in the event of internal contamination, the committed dose in mSv); and 

the  official  dose  record  for  the  current  year  (period;  effective  dose  in  mSv;  in  the 
event of non-uniform exposure, dose-equivalent in the different parts of the body in 
mSv; and in the event of internal contamination, the committed dose in mSv). 

B: Data on outside workers to be supplied via the data system for individual radiological 
monitoring 

1.  Before  the  start  of  any  activity,  the  employer  of  the  outside  worker  shall  supply  the 
following data to the undertaking via the data system for individual radiological monitoring: 

(a) 

(b) 

(c) 

data on the employer of the outside worker in accordance with Section A, point 6; 

data on the medical surveillance of the outside worker in accordance with Section A, 
point 4; 

the results of the outside worker’s individual exposure monitoring in accordance with 
Section A, point 7. 

2. The following data shall be recorded or have been recorded by the undertaking in the data 
system for individual radiological monitoring after the end of any activity: 

(a) 

(b) 

(c) 

(d) 

the period covered by the activity; 

an  estimate  of  any  effective  dose  received  by  the  outside  worker  (operational  dose 
for the period covered by the activity); 

in  the  event  of  non-uniform  exposure,  an  estimate  of  the  dose-equivalent  in  the 
different parts of the body; 

in  the  event  of  internal  contamination,  an  estimate  of  the  intake  or  the  committed 
dose. 

C. Provisions concerning the individual radiological monitoring document 

1. 

Member States may decide to issue an individual radiological monitoring document 
for every outside worker.  

EN 

113 

   EN 

 
2. 

3. 

4. 

The document shall be non-transferable. 

Member  States  shall  take  the  measures  necessary  to  prevent  a  worker  from  being 
issued with more than one valid individual monitoring document at the same time. 

In  addition  to  the  information  required  in  Part  A  and  Part  B,  the  document  shall 
include the name and address of the issuing body and the issuing date. 

EN 

114 

   EN 

 
A. Elements to be included in an emergency management system 

ANNEX IX 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

9. 

Threat assessment; 

Clear allocation of the responsibilities of persons and organisations having a role in 
preparedness  and  response  arrangements,  including  establishment  and  coordination 
of  emergency  response  organisations  with  overall  responsibilities  in  managing 
emergency exposure situations and, where appropriate, creation of special teams for 
protective measures; 

Establishment of emergency response plans at national level, at local level and within 
installations; 

Reliable  communications  and  efficient  and  effective  arrangements  for  cooperation 
and coordination at the installation and local, national and international levels; 

Health protection of emergency workers; 

Education  and  training  of  emergency  workers  and  all  other  persons  with  duties  or 
responsibilities in emergency response, including regular exercises;  

Arrangements for individual monitoring of emergency workers and the recording of 
doses; 

Public information arrangements;  

Involvement of stakeholders;  

10. 

Transition from emergency response to recovery and remediation. 

B. Elements to be included in an emergency response plan 

For emergency preparedness: 

1. 

2. 

3. 

4. 

5. 

Reference levels, taking into account the criteria laid down in Annex I; 

Optimised protection strategies for members of the public who may be exposed, for 
different postulated events and related scenarios; 

Predefined generic criteria for particular protective measures, expressed in terms of 
projected and received doses;  

Default triggers or operational criteria such as observables and indicators of on-scene 
conditions; 

Arrangements for prompt coordination with the emergency response organisation in 
a neighbouring Member State or non-Member State, for facilities in the vicinity of a 
national border; 

EN 

115 

   EN 

 
6. 

Arrangements  for  the  emergency  response  plan  to  be  reviewed  and  revised  to  take 
account of changes or lessons learned from exercises and events. 

Arrangements shall be established in advance to revise these elements, as appropriate during 
an emergency exposure situation,  to accommodate the prevailing conditions as these evolve 
throughout the response. 

For emergency response: 

The  response  to  an  emergency  exposure  situation  shall  be  undertaken  through  the  timely 
implementation of preparedness arrangements, including but not limited to: 

1. 

2. 

3. 

4. 

Promptly implementing protective measures, if possible, before any exposure occurs; 

Assessing the effectiveness of strategies and implemented actions and adjusting them 
as appropriate to the prevailing situation;  

Comparing  the  expected  residual  doses  against  the  applicable  reference  level, 
focusing on those groups whose doses exceed the reference level; 

Implementing  further  protection  strategies,  as  necessary,  based  on  prevailing 
conditions and available information. 

EN 

116 

   EN 

 
ANNEX X 

A. Prior information to the members of the public likely to be affected by an emergency: 

1. 

2. 

3. 

4. 

Basic  facts  about  radioactivity  and  its  effects  on  human  beings  and  on  the 
environment; 

The various types of emergency covered and their consequences for the public and 
the environment; 

Emergency measures envisaged to alert, protect and assist the public in the event of 
an emergency; 

Appropriate  information  on  action  to  be  taken  by  the  public  in  the  event  of  an 
emergency. 

B.  Information  to  be  provided  to  the  affected  members  of  the  public  in  the  event  of  an 
emergency 

1. 

(a) 

On  the  basis  of  the  emergency  response  plan  previously  drawn  up  in  the  Member 
States, the members of the public actually affected in the event of an emergency shall 
rapidly and regularly receive: 

information  on  the  type  of  emergency  which  has  occurred  and,  where  possible,  its 
characteristics (e.g. its origin, extent and probable development); 

(b) 

advice on protection, which, depending on the type of emergency, may: 

i) 

cover the following: restrictions on the consumption of certain foodstuffs and 
water 
to  be  contaminated,  simple  rules  on  hygiene  and 
decontamination,  recommendations  to  stay  indoors,  distribution  and  use 
of protective substances, evacuation arrangements; 

likely 

ii) 

be  accompanied,  where  necessary,  by  special  warnings  for  certain  groups  of 

the members of the public; 

announcements  recommending  cooperation  with  instructions  or  requests  by  the 
competent authorities. 

If the emergency is preceded by a pre-alarm phase, the members of the public likely 
to  be  affected  shall  already  receive  information  and  advice  during  that  phase,  such 
as: 

an  invitation  to  the  members  of  the  public  concerned  to  tune  in  to  relevant 
communication channels; 

preparatory advice to establishments with particular collective responsibilities; 

recommendations to occupational groups particularly affected. 

(c) 

2. 

(a) 

(b) 

(c) 

EN 

117 

   EN 

 
3. 

This information and advice shall be supplemented, if time permits, by a reminder of 
the  basic  facts  about  radioactivity  and  its  effects  on  human  beings  and  on  the 
environment. 

EN 

118 

   EN 

 
ANNEX XI 

Indicative list of types of building materials considered for control measures with regard to 
their emitted gamma radiation 

1. 

(a) 

(b) 

Natural materials  

Alum-shale. 

Building materials or additives of natural igneous origin, such as:  

–  granite, 

–  gneiss; 

–  porphyries; 

–  syenite; 

–  basalt; 

–  tuff; 

–  pozzolana; 

–  lava. 

2. 

Materials  incorporating  residues  from  industries  processing  naturally  occurring 
radioactive material, such as: 

–  fly ash; 

–  phosphogypsum; 

–  phosphorus slag; 

–  tin slag; 

–  copper slag; 

–  red mud (residue from aluminium production); 

–  residues from steel production. 

EN 

119 

   EN 

 
ANNEX XII 
Information to be provided in the records for high activity sealed sources 

EN 

120 

EN 

 
  
1. HASS identification number

2. Identification of the authorised undertaking

3. Location of HASS (Use or storage) if not the same as in 2.

HASS)

Name:
Address:
Country:

Supplier □

User □

       Fixed use □          Storage □           Mobile use □

6. Operational controls of HASS

Manufacturer device number

Field of use:

4. Registration

Date of start of registration:
Date of transfer of registration to historic file:

7. HASS characteristic
Year of manufacture:
Radionuclide:
Аctivity at the date of manufacturing:

Activity reference date:
Manufacturer/Supplier*:

Name:
Аddress:

Country:

Name:
Address:
Country:
Manufacturer □

5. Authorisation

Number:
Date of issue:
Date of expiry:
8. Receipt of HASS

Date of receipt:
Receipt from

Name:
Address:
Country:
Manufacturer □
9. Transfer of HASS

Physical and chemical characteristics

Date of transfer:

Source type identification:

Transfer to

Supplier □

Another user □

Capsule identification:

ISO classificaton:
ANSI classificaton:
IAEA source category:

Neutron source:           Yes □        No □
    Neutron source target:
    Neutron flux:

Name:
Address:
Country:

       Authorisation number:
       Date of issue:
       Date of expiry:
Manufacturer □
Facility for long term storage and disposal □

Supplier □

Another user □

Date:
Date:
Date:
Date:

Date:
Date:
Date:
Date:
Date:

Date:
Date:
Date:
Date:
10. Further information

Loss □
Theft □
Finding:

Date:
Place:

Other information:

Date of loss:

Date of theft:

Yes □        No □

* Where the manufacturer of the source is establishd outside the Community, the name and address of the importer-supplier may be provided instead.

EN 

121 

EN 

 
  
 
ANNEX XIII 

Provision of data on high-activity sealed sources 

The undertaking shall provide the competent authority with an electronic or written copy of 
the  records  for  high-activity  sealed  sources,  referred  to  in  Article  90  and  covering  the 
information set out in Annex XII, as follows: 

1. 

2. 

3. 

4. 

5. 

without undue delay, at the time of the establishment of such records, which shall be 
as soon as possible after the source is acquired; 

at intervals, to be determined  by Member  States,  of  not  more  than  12  months  after 
the acquisition of the source; 

if the situation indicated on the information sheet has changed; 

without undue delay upon the closure of the records for a specific source when the 
undertaking  no  longer  holds  this  source,  whereby  the  name  of  the  undertaking  or 
waste  disposal  and  storage  facility  to  which  the  source  is  transferred  shall  be 
included; 

without  undue  delay  upon  the  closure  of  such  records  when  the  undertaking  no 
longer holds any sources. 

EN 

122 

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ANNEX XIV 

Requirements for undertakings responsible for a high-activity sealed source 

Each undertaking responsible for a high-activity sealed source shall: 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

(g) 

ensure  that  suitable  tests,  such  as  leak  tests  based  on  international  standards,  are 
undertaken regularly in order to check and maintain the integrity of each source; 

regularly  verify  at  specific  intervals,  which  may  be  determined  by  Member  States, 
that  each  source  and,  where  relevant,  the  equipment  containing  the  source  are  still 
present and in apparently good condition at their place of use or storage; 

ensure  that  each  fixed  and  mobile  source  is  subject  to  adequate  documented 
measures,  such  as  written  protocols  and  procedures,  aimed  at  preventing 
unauthorised access to or loss or theft of the source or its damage by fire; 

promptly  notify  the  competent  authority  of  any  loss,  theft  or  unauthorised  use  of  a 
source, arrange for a check on the integrity of each source after any event, including 
fire,  that  may  have  damaged  the  source,  and,  if  appropriate,  inform  the  competent 
authority thereof and of the measures taken; 

return  each  disused  source  to  the  supplier  or  place  it  in  a  facility  for  long  term 
storage and disposal or transfer it to another authorised undertaking unless otherwise 
agreed by the competent authority, without undue delay after termination of the use; 

ascertain that, before a transfer is made, the recipient holds appropriate authorisation. 

Promptly  notify  the  competent  authority  of  any  accident  or  incident  resulting  in 
unintentional exposure of a worker or a member of the public. 

EN 

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ANNEX XV 

Identification and marking of high-activity sealed sources 

The manufacturer or supplier shall ensure that: 

Each high-activity sealed source is identified by a unique number. This number shall 
be engraved or stamped on the source, where practicable. 

1. 

(a) 

The number shall also be engraved or stamped on the source container. If this is not feasible, 
or  in  the  case  of  reusable  transport  containers,  the  source  container  shall,  at  least,  bear 
information on the nature of the source. 

(b) 

2. 

3. 

The source container and, where practicable, the source are marked and labelled with 
an appropriate sign to warn people of the radiation hazard. 

The  manufacturer  shall  provide  a  photograph  of  each  manufactured  source  design 
type and a photograph of the typical source container. 

The undertaking shall ensure that each high-activity sealed source is accompanied by 
written information indicating that the source is identified and marked in compliance 
with point 1 and that the markings and labels referred to in point 1 remain legible. 
The information shall include photographs of the source, source container, transport 
packaging, device and equipment as appropriate. 

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ANNEX XVI 

Indicative list of items to be covered in the national action plan to manage long term risks 
from radon exposures  

1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

9. 

10. 

11. 

12. 

Strategy for conducting surveys of indoor radon concentrations, for the management 
of  measurement  data  (national  radon  database)  and  for  the  establishment  of  other 
parameters (soil and rock types, soil gas concentration, permeability and radium-226 
content of rock or soil). 

Available  data  and  criteria  used  for  the  delineation  of  radon-prone  areas  or  for  the 
identification of radon-prone buildings. 

Identification of types of buildings with public access and workplaces, e.g. schools, 
underground  workplaces  or  spas,  where  measurements  are  needed,  based  on  a  risk 
assessment including occupancy hours. 

The  basis  for  the  establishment  of  reference  levels  for  existing  dwellings, 
workplaces, buildings with public access and for new buildings. 

Assignment  of  responsibilities  (governmental  and  non-governmental),  coordination 
mechanisms and available resources for implementation of the action plan. 

Strategy for reducing radon exposure in dwellings, particularly in radon-prone areas. 

Strategy, including methods and tools, for preventing radon ingress in new buildings, 
including identification of building materials with significant radon exhalation. 

Schedules for audits and reviews of the action plan. 

Strategy for communication to increase public awareness and inform local decision 
makers of the risks of radon in relation to smoking. 

Where  appropriate,  guidance  on  methods  and  tools  for  measurements  and  remedial 
measures.  Criteria  for  the  accreditation  of  measurement  and  remediation  services 
shall also be considered. 

Where appropriate, provision of financial support for radon surveys and for remedial 
measures, in particular for private dwellings with very high radon concentrations. 

Long-term goals in terms of reducing lung cancer risk attributable to radon exposure 
(for smokers and non-smokers). 

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EN 

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