COMMISSION STAFF WORKING PAPER SUMMARY OF THE IMPACT ASSESSMENT
Date: 2011-08-30
Institutions: European Commission
Subjects: centralisation of information, documentary reference recording, environmental risk prevention, ionising radiation, occupational safety, radioactive materials, transport licence, transport of dangerous goods, transport safety

EUROPEAN COMMISSION 

Brussels, 30.8.2011 
SEC(2011) 1005 final 

COMMISSION STAFF WORKING PAPER 

SUMMARY OF THE IMPACT ASSESSMENT  

Accompanying the document 

Proposal for a COUNCIL REGULATION 

establishing a Community system for registration of carriers of radioactive materials 

{COM(2011) 518 final} 
{SEC(2011) 1006 final} 

 
 
 
 
  
 
 
TABLE OF CONTENTS 

1. 

2. 

3. 

4. 

4.1. 

4.2. 

4.3. 

Problem definition:....................................................................................................... 2 

Analysis of Subsidiarity ............................................................................................... 3 

Objectives of EU initiative........................................................................................... 3 

Policy options............................................................................................................... 4 

Baseline scenario: No policy changes/business as usual ............................................. 4 

Option 1: Commission Recommendation to harmonise implementation of existing 
law; Website with access to legislation........................................................................ 4 

Option 2: Regulation with harmonised rules and more efficient role of the Competent 
Authorities.................................................................................................................... 5 

4.4. 

Option 3: Regulation with a new EU Agency as central Competent Authority .......... 5 

5. 

5.1. 

5.2. 

5.3. 

Assessment of impacts ................................................................................................. 5 

Baseline scenario: No policy changes/business as usual ............................................. 5 

Option 1: Commission Recommendation to harmonise implementation of existing 
law; Website with access to legislation........................................................................ 5 

Option 2: Regulation with harmonised rules and more efficient role of the Competent 
Authorities.................................................................................................................... 6 

5.4. 

Option 3: Regulation with a new EU Agency as central Competent Authority .......... 6 

6. 

7. 

Comparison of options ................................................................................................. 6 

Monitoring and evaluation ........................................................................................... 7 

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1. 

PROBLEM DEFINITION:  

Radioactive  materials  are  used  in  many  applications  that  help  us  in  our  daily  lives,  ranging 
from  healthcare,  research,  industrial  manufacturing  and  agriculture  to  electric  power 
generation.  Radioactive  material  (RAM)  is  shipped  in  packages  varying  from  small  boxes 
with tiny amounts of  radiopharmaceuticals for healthcare use to heavy steel containers with 
spent  nuclear  fuel  and  vitrified  waste  from  the  nuclear  fuel  cycle,  both  of  which  are  highly 
radioactive materials. 

It  is  estimated  that  2.5  million  RAM  packages  are  shipped  annually  across  the  EU,  which 
represents about 2% of all dangerous goods packages. Most (nearly 90%) of these packages 
contain relatively small quantities of RAM. 

Barriers to smooth operation of TRAM in Europe 

Causes 

Effects 

Complex regulatory framework 

Non-compliance 

Differing requirements between Member States 

Delays and denials of shipments 

Need for multiple licenses and training sessions 

Barriers to entry 

Administrative burden 

Risks for supply to medical patients 

Limitations to controls and inspections 

Additional costs 

Stakeholders  involved  in  the  transport  of  radioactive  materials  (TRAM)  have  repeatedly 
voiced  their  concern  about  barriers  to  the  smooth  functioning  of  TRAM  activities  in 
Europe.  They  complain  about  a  complex  regulatory  framework,  differing  requirements 
between Member States, the multitude of licences, approvals and training courses needed for 
transports involving more than one Member State, the high administrative burden and the lack 
of  controls  and  inspections.  These  elements  lead  to  non-compliance,  denials  and  delays  of 
shipments,  barriers  to  entry  (in  particular  for  small  and  medium-sized  companies),  risks  for 
the supply to medical patients and ultimately higher than necessary costs. These drivers and 
effects have been summarised in picture above: 

Given  the  nature  of  RAM,  its  handling,  use  and  transport  in  the  public  domain,  adequate 
attention  is  required  in  order  to  protect  the  public  and  workers  exposed  to  RAM  and  to 
prevent  any  releases  to  the  environment.  The  existing  legislation,  which  ranges  from  non-
binding  international  regulations,  binding  modal  rules  and  Community  law  to  national  law, 
results  in  a  level  of  control  and  supervision  that  is  more  intensive  than  for  other  classes  of 
dangerous  goods.  The  complete  set  of  rules  is  multi-layered,  which  makes  it  very  complex, 
although the main objective of safety is attained (over the past decades there has never been a 
transport  incident  that  has  caused  significant  radiological  damage  to  persons  or  the 
environment). 

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In  addition,  there  are  major  differences  between  Member  States  in  terms  of  procedures, 
assessments,  administrative  requirements  and  application  formats,  which  are  not  related  to 
safety. 

Increasingly,  the  transport  of  radioactive  materials  is  becoming  a  case  for  specialised  large 
carriers. As a result of the complexity of the regulatory framework and the high costs that are 
associated  with  compliance  with  the  regulations,  this  does  indeed  create  barriers  to  market 
entry  for  new  (and  especially  small  and  medium-sized)  carriers.  Due  to  their  specialisation, 
the  remaining  established  carriers,  in  addition  to  benefitting  from  the  reduced  competition, 
appear to be able to run TRAM without major difficulties.  

Radioactive  materials  are  widely  used  in  hospitals,  most  commonly  for  the  purposes  of 
diagnosis and treatment. Problems with the transport of radioactive materials might have an 
impact on the treatment of patients, especially in the case of last-minute shipments of short-
lived medical radioactive materials. 

The  main  issue  with  TRAM,  when  compared  to  other  classes  of  dangerous  goods,  is  the 
existence  of  differing  administrative  requirements  when  implementing  the  Basic  Safety 
Standards  Directive  96/29/Euratom.  By  defining  transport  as  one  of  the  "practices  which 
involve  a  risk  from  ionizing  radiation",  the  Directive  requires  Member  States  to  establish  a 
"reporting"  system  (requirement  to  submit  a  document  to  the  competent  authority  to  notify 
their  intention  to  carry  out  a  practice),  while  still  allowing  them  to  impose  prior 
"authorization" (a permission granted in a document by the competent authority to carry out a 
practice,  on  application,  or  granted  by  national  legislation).  This  enables  the  competent 
authorities to check more closely whether the standards contained in that Directive are being 
respected. 

2. 

ANALYSIS OF SUBSIDIARITY 

EU  action  is  justified  under  Title  II  Chapter  3  of  the  Euratom  Treaty,  which  provides  the 
Community  with  the  powers  to  set  basic  standards  of  radiation  protection  and  their 
implementation. At the same time, this EU action in a growing market for transport services 
would  harmonise  and  effectively  tackle  the  particular  problems  relating  to  trans-boundary 
shipments which require a multitude of licences and approvals, and thereby create real added 
value. 

Indeed,  EU  action  can  successfully  help  to  harmonise  and  simplify  rules  in  the  Community 
and to increase transparency, while continuing to guarantee a high level of safety. 

3. 

OBJECTIVES OF THE EU INITIATIVE 

The general objectives of TRAM policy are directly linked to the fundamental objectives of 
EU policy, as applied in this particular field, i.e. 

•  to  ensure  and  maintain  adequate  safety  standards  in  order  to  protect  the  public  and  the 

environment during transports of radioactive materials and 

•  to aim at a European single market for services for the transport of radioactive materials.  

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Considering  the  specificities  and  relatively  low  number  of  transports  involving  fissile 
materials,  the  main  problems  concern  radiopharmaceutical  isotopes.  Hence,  the  specific 
objectives of the proposed Community action should be:  

•  to guarantee the safety and health protection of citizens during the transport of radioactive 

materials in the territory of the EU, 

•  to help remove obstacles to the internal market in this sector, 

•  to  increase  transparency  in  TRAM  legislation,  allowing  carriers  and  users  to  find  the 

information needed and identify the authorities involved easily, 

•  to create the appropriate legislative and organisational conditions to ensure delivery in time 
and  in  good  conditions  of  the  life-saving  radioisotopes  that  are  essential  for  trials  and 
therapy treatments for a large number of diseases. 

Finally, operational objectives are related to the specific outputs of Community action: 

•  to apply internationally accepted regulations so as to make repetitive Member States rules 

obsolete, 

•  to allow carriers to transport materials in the Community without the need for additional 

administrative procedures for registration or licences in other Member States, 

•  to  establish  national  Contact  Points  guiding  carriers  to  the  relevant  information  and 

authorities, 

•  to  abandon  notification  requirements  for  individual  transports  for  radioactive  materials  – 

apart from fissile and high-consequence radioactive materials. 

4. 

POLICY OPTIONS 

In order to maintain the safety of TRAM activities, simplify legislation, increase transparency 
and  eliminate  barriers  to  a  functioning  internal  market,  and  after  comparing  different 
experiences in transport sectors as well as the available legal instruments, four options have 
been evaluated. 

4.1. 

Baseline scenario: No policy changes/business as usual 

Under this option, the scope and content of the existing EU legislation on TRAM would be 
kept in its present format. Member States would be in a position to continue setting their own 
administrative requirements for registering carriers of radioactive materials.  

4.2. 

Option  1:  Commission  Recommendation  to  harmonise  implementation  of 
existing law; website with access to legislation 

Under this option, the Commission would make available a central website giving access to 
the  different  Competent  Authorities,  the  legal  framework  and  the  forms  necessary  in  the 
different  Member  States.  In  addition,  a  Commission  Recommendation  would  interpret  the 
applicable  rules  of  Directive  96/29  with  a  view  to  harmonising  implementation  and,  in 

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particular,  to  urging  the  Member  States  to  recognise,  where  necessary,  the  licences  and 
registrations issued by other Member States. 

4.3. 

Option  2:  Regulation  with  harmonised  rules  and  the  Competent  Authorities 
playing a more efficient role 

A Regulation would go one step further – by proposing directly applicable harmonised rules 
such as a common registration system for carriers which does away with the different systems 
used  in  the  Member  States  for  reporting  and  authorization  and  giving  carriers  access  to  the 
EU27 transport market in one "slimmed-down" procedure, while adopting a graded approach. 
To allow for  the  necessary exchange of data,  the  Commission would set up a  secure online 
registration system.  

4.4. 

Option 3: Regulation with a new EU agency as central Competent Authority 

Going beyond option 2, while ensuring safe standards and completing the internal market, an 
EU  agency  as  central  Competent  Authority  would  oversee  all  transport  of  radioactive 
materials  in  the  European  Union  and  issue  the  licences  and  approvals  needed,  thereby 
replacing  existing  procedures  in  the  Member  States,  in  a  manner  similar  to  the  European 
Aviation Safety Agency based in Cologne. 

5. 

ASSESSMENT OF IMPACTS 

Although  the  options  analysed  by  ECORYS  -  the  independent  experts  who  carried  out  a 
supporting  study  for  the  Commission  -  seem  to  have  a  rather  modest  impact  from  a  global 
viewpoint, this impact does matter to such a small sector. The impacts are categorised in five 
groups,  namely:  Public  sector  expenses  and  fees,  Regulatory  effects,  Transport,  Safety  and 
environment, and Social impacts.  

Small and medium-sized companies are expected to benefit in proportion to the total savings 
achieved under these options: the higher the savings in total, the higher the savings for these 
enterprises that nowadays are often effectively blocked out of the market. 

5.1. 

Baseline scenario: No policy changes/business as usual 

The absence of any serious accidents in the past shows that the current legal framework does 
ensure  safe  transport  operations.  The  current  inconsistencies  in  legislation  and  the  high 
administrative costs are likely to remain – potentially leading to reduced competition, barriers 
to  entry  and  risks  to  the  supply  of  radioisotopes  in  the  medical  field.  The  varying  legal 
regimes  in  the  Member  States  would  continue  to  exist  and  transporters  would  continue  to 
suffer the burden described above. 

5.2. 

Option  1:  Commission  Recommendation  to  harmonise  implementation  of 
existing law; Website with access to legislation 

As  a  Recommendation  on  how  to  interpret  rules  laid  down  in  Directives  is  not  binding  in 
nature, differences between Member States are likely to persist. Users, carriers and producers 
can  expect  variations  between  those  countries  that  have  implemented  the  Recommendation 
and  those  that  have  not.  ECORYS  estimated  the  savings  at  €  1.9  million  per  year  over  the 
baseline scenario. 

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Increasing transparency by making all information available at one central point, in addition 
to the Recommendation, could increase the impact while creating only a negligible strain on 
Commission resources. 

This option does not guarantee the reduction of the burden on the part of users, carriers and 
producers  to  the  extent  possible.  At  the  same  time,  the  internal  market  is  unlikely  to  be 
completed.  

5.3. 

Option  2:  Regulation  with  harmonised  rules  and  a  more  efficient  role  for  the 
Competent Authorities  

By providing, among others, for the mutual recognition of licences for carriers, a Regulation 
would lead to savings of € 13.6 million per year  over the baseline scenario. Such an approach 
would  reduce  the  bureaucratic  burden  on  carriers,  users  and  producers,  while  freeing  up 
resources in authorities, which could then be used , at least partially, for compliance checks, 
the lack of which has been identified as one of the problems mentioned above.  

Because  a  Regulation  is  binding,  this  option  will  be  effective  in  helping  to  attain  the 
objectives  -  i.e.  to  simplify  the  system,  introduce  transparency  and  eliminate  barriers  to  a 
functioning internal market, while maintaining a high level of safety. 

5.4. 

Option 3: Regulation with a new EU Agency as central Competent Authority 

This  option  combines  the  advantages  of  a  Regulation  with  a  central  and  harmonised 
implementation of rules through a central Competent Authority as EU agency. Savings could 
reach € 13 million annually. 

An EU Agency in conjunction with a Regulation will ultimately reduce the complexity of the 
framework  by  harmonising  it.  Furthermore,  according  to  the  stakeholders,  the  number  of 
denials  and  delays  would  decrease.  The  biggest  possible  reduction  is  related  to  the 
administrative  burden  because  of  the  simplified  regulatory  framework.  On  the  other  hand, 
running an EU Agency costs additional money, which is clearly seen in the high costs for this 
policy option.  

Given  the  nature  of  the  measures  included  in  this  option,  the  objectives  are  achievable, 
although  a  certain  doubt  may  persist  as  to  whether  this  option  complies  fully  with  the 
subsidiarity principle and with the current restrained approach concerning new agencies. 

6. 

COMPARISON OF OPTIONS 

The following comparative table summarises the impact of the options: 

Calculated expected total 
impact (in million € p.a.) 

Safety and environment 

Social impacts 

Transparency, access to 

COMPARATIVE TABLE OF EFFECTS 
Policy options 

Baseline  Recommendation 

Regulation 

EU Agency 

1,9 

+ 

+ 

6 

13,6 

+ 

+ 

+ 

13 

+ 

+ 

+ 

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information improved 

Subsidiarity 

+ 

+ 

+ 

- 

With  regard  to  the  stated  objectives,  a  central  European  Competent  Authority  (option  3) 
appears to be a very effective solution. However, the high costs involved with setting up such 
an  agency  completely  negate  these  advantages  compared  to  option  2.  In  addition,  such  an 
initiative is unlikely to succeed, due to opposition of the Member States, the lengthy process 
needed to establish such an agency and concerns about subsidiarity.  

Against this background, a Regulation making use of the national Competent Authorities 
(option 2), which in addition leads to the highest estimated savings of all of the options, is 
clearly the preferred option. By simplifying parts of the existing legislation, harmonising its 
implementation  and  providing  for  recognition  of  licences,  this  option  is  effective,  feasible 
and acceptable.  

Under  certain  circumstances,  this  option  could  be  complemented  by  setting  up  the  website 
contained in option 1 with information on the different Competent Authorities, the respective 
national legal framework and the necessary forms.  

The preferred option strikes a careful balance between effective protection of workers and the 
public during TRAM operations, the legitimate interests of the stakeholders involved and the 
interests  of  Member  States.  Above  all,  the  preferred  option  is  the  minimum  necessary  to 
effectively achieve the objectives, while keeping the costs within reasonable limits.  

7. 

MONITORING AND EVALUATION 

Following  the  preferred  option  by  making  use  of  a  Regulation  reduces  the  need  for 
monitoring implementation in the Member States, as a Regulation would apply immediately 
throughout  the  EU.  Nevertheless,  the  proposed  change  should  also  be  evaluated  against  the 
objectives defined above. 

DG Energy proposes to follow the expert advice received and to evaluate the effects of this 
Regulation two years after it has entered into force. This interim evaluation could reveal any 
difficulties and bottlenecks to be resolved. After this initial evaluation, it might be useful to 
revisit the issue at five-year intervals to monitor what barriers to the smooth operation of the 
transport of radioactive materials in the European Union may still exist.  

Use  could  be  made  in  this  context  of  the  expert  group,  which  might  be  needed  in  order  to 
advise the Commission on the administrative requirements under the proposed instrument. 

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