COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT Accompanying the document COUNCIL DIRECTIVE laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation
Date: 2012-05-30
Institutions: European Commission
Subjects: consumer protection, environmental protection, health control, in-service training, ionising radiation, medical diagnosis, occupational health, safety standard, technical standard, worker information

EUROPEAN COMMISSION 

Brussels, 30.5.2012  
SWD(2012) 137 final 

3 

COMMISSION STAFF WORKING DOCUMENT 

IMPACT ASSESSMENT 

Accompanying the document 

COUNCIL DIRECTIVE 

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

{COM(2012) 242 final} 
{SWD(2012) 138 final} 

EN 

   EN 

 
 
 
 
  
 
ANNEX VIII (D) WORLDWIDE TRENDS IN NUMBER OF MONITORED WORKERS 
AND  IN  COLLECTIVE  EFFECTIVE  DOSES  AND  EFFECTIVE  DOSES  TO 
MONITORED WORKERS (UNSCEAR Report 2008) 

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ANNEX VIII (E) 

EXPOSURE TO IONISING RADIATION FOR WORKERS IN NORM INDUSTRIES 
(case study) 

FRANCE, Bilan 2008 de la surveillance de travailleurs exposés aux rayonnements ionisants en 
France (Institute de Radioprotection et de Sûreté Nucléaire) 

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 ANNEX IX RADON 

(A) Annual Averaged Indoor Radon Concentration 

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ANNEX IX (B) 

Radon in Dwellings 

Finland1 

Sweden2 

United Kingdom3 

Housing stock 

1 700 000 

4 500 000 

27 000 000 

Average radon 
concentrations  

Estimated number of 
dwellings at or above 
200 Bq/m3  

Percentage of 
dwellings at or above 
200 Bq/m3 

96 

108 

20 

 200 000 

 450 000 

 100 000 

12 

10 

< 1 

1 Recommendations for radon in dwellings in the Nordic countries, 2009, see Nordic 
radiation protection authorities' websites, e.g. www.ssm.se 

2 Recommendations for radon in dwellings in the Nordic countries, 2009  

3 Radon and Public Health, Report prepared by the Subgroup on Radon Epidemiology of 
the independent Advisory Group on Ionising Radiation. Advisory Group to Health and 
Protection Agency, UK, 2009 

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ANNEX X  

(A) Graded Approach to Regulatory Control 

The  concept  of  a  graded  approach  to  regulatory  control  was  developed  some  ten  years  ago  by 
NEA’s Committee on Radiation Protection and Public Health (CRPPH). CRPPH advocated that, 
in  addition  to  the  concept  of  optimisation  of  radiation  protection,  the  efficiency  of  regulatory 
control  could  benefit  from  a  similar  approach.  Hence  regulatory  authorities  would  concentrate 
their  supervision  on  those  situations  which  represent  a  higher  risk  of  exposure  and  on  those 
where regulatory intervention is instrumental in reducing overall exposures. The BSS Directive 
from 1996 already gives indication that as an exception to the rule MS may specify that practices 
shall not require 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".  This  opportunity  given  by  the  Directive  has  been  used  to  little 
extend, because the requirement is very vague. Given that proper implementation of the graded 
approach would reduce the administrative burden to the businesses, it is important to clarify and 
enforce the use of this concept.  

In this respect it is necessary to improve the requirements on regulatory control, on the one hand 
by  making  the  list  of  practices  submitted  to  authorisation  more  precise,  and  on  the  other  hand 
introducing list of practices that can be submitted to lighter regimes like registration (a two-tier 
approach replacing the current concept of "prior authorisation" (Article 4 of the BSS). Article 3 
of  the  BSS  Directive  96/29  requires  all  practices  to  report  the  conduct  of  a  practice  involving 
ionising radiation or radioactive substances. Practices may be exempted from the requirement to 
report if certain values, called exemption levels, are not exceeded. There are exemption values for 
the total activity as well as for activity concentrations.  These exemption values are laid down in 
the  Directive  (on  the  basis  of  a  European  study  published  in  our  radiation  protection  series: 
RP65)  and  uniformly  transposed  in  national  legislation.  The  Euratom  values  were  also 
incorporated in the International Basic Safety Standards of 1996. Later, IAEA adopted a Safety 
Guide  (RS-G-1.7)  laying  down  a  different  set  of  radionuclide-specific  values  (in  general  lower 
than those in RP65). As part of the graded approach it is envisaged to make explicit provision for 
exemption of specific practices, for specific radionuclides, as long as the exemption criteria laid 
down in the Directive are complied with (essentially that doses should be lower than 1% of the 
dose  limit).  The  current  Directive,  again,  does  not  rule  out  this  possibility  but  it  is  very  vague 
("MS's may exempt further practices …"). 

A  second  important  aspect  of  the  “graded  approach”  relates  to  the  release  of  materials  arising 
from  within  a  regulated  practice.  In  the  absence  of  any  criteria  all  such  materials  should  be 
regarded as radioactive waste. Taking into account the huge volume of materials arising from the 

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dismantling  of  decommissioned  nuclear  power  plants,  this  would  be  at  a  tremendous  cost  and 
there  would  be  a  shortage  of  disposal  sites.  Most  of  this  material  has  in  fact  no  or  very  little 
radioactivity,  so  it  could  be  cleared  from  regulatory  control.  The  concept  of  "clearance",  for 
materials  with  no  or  very  little  contamination,  for  instance  steel  or  building  rubble,  is  very 
important in this context. In the current BSS Directive the application of the concept of clearance 
was left to national authorities, being merely required to take Community guidance into account 
(as was later published in the Radiation Protection Series). Harmonisation of clearance levels for 
materials resulting from dismantling has therefore become a crucial issue, both within the EU as 
internationally.  In  the  international  guidance  (IAEA  RS-G_1.7)  and  draft  new  standards  it  is 
envisaged  to  use  the  same  set  of  values  both  for  clearance  and  exemption  (with  the  lower 
numbers  taken  from  RS-G_1.7).  This  approach  could  be  incorporated  in  the  Euratom  BSS  as 
well. 

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