COMMISSION STAFF WORKING PAPER IMPACT ASSESSMENT
Date: 2011-08-30
Institutions: European Commission
Subjects: centralisation of information, cost-effectiveness analysis, 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) 1006 final 

COMMISSION STAFF WORKING PAPER 

IMPACT ASSESSMENT  

Accompanying document to the 

Proposal for a COUNCIL REGULATION 

establishing a Community system for Registration of carriers of radioactive materials 

{COM(2011) 518 final} 
{SEC(2011) 1005 final} 

 
 
 
 
  
 
 
TABLE OF CONTENTS 

1. 

1.1. 

1.2. 

1.3. 

Procedural issues and consultation of interested parties .............................................. 4 

Agenda Planning .......................................................................................................... 4 

Organisation and timing............................................................................................... 4 

Consultation and expertise ........................................................................................... 4 

1.3.1.  Stakeholder consultation .............................................................................................. 4 

1.3.2.  Public consultation ....................................................................................................... 6 

1.3.3.  Main results of the consultations.................................................................................. 6 

1.4. 

Impact Assessment Board ............................................................................................ 6 

2. 

2.1. 

2.2. 

Problem definition........................................................................................................ 7 

Background .................................................................................................................. 7 

Overview of the regulatory framework........................................................................ 9 

2.2.1. 

International rules....................................................................................................... 10 

2.2.1.1.  International regulations............................................................................................. 10 

2.2.1.2.  Modal Regulations ..................................................................................................... 10 

2.2.1.3.  International conventions, codes and agreements...................................................... 11 

2.2.2.  Community regulatory framework............................................................................. 11 

2.2.3.  National law ............................................................................................................... 13 

2.3. 

Causes for problems related to the transport of radioactive materials ....................... 14 

2.3.1.  Complex regulatory framework ................................................................................. 14 

2.3.2.  Requirements differ between Member States ............................................................ 15 

2.3.3.  Multiple transport licences and trainings needed for trans-boundary transports ....... 15 

2.3.4.  Administrative burden................................................................................................ 15 

2.3.5.  Limitations to controls and inspections...................................................................... 15 

2.4. 

Effects ........................................................................................................................ 15 

2.4.1.  Non-compliance ......................................................................................................... 15 

2.4.2.  Delays and denials of shipments ................................................................................ 16 

2.4.3.  Barriers to entry.......................................................................................................... 16 

2.4.4.  Risks for supply to medical patients .......................................................................... 17 

2.4.5.  Additional costs borne eventually by the society at large.......................................... 17 

EN 

2 

   EN 

 
2.5. 

Scope of an EU level initiative................................................................................... 17 

3. 

4. 

4.1. 

4.2. 

4.3. 

4.4. 

4.5. 

5. 

5.1. 

5.2. 

5.3. 

5.4. 

5.5. 

5.6. 

6. 

6.1. 

6.2. 

6.3. 

6.4. 

7. 

Objectives................................................................................................................... 18 

Policy options............................................................................................................. 19 

Baseline scenario: No policy changes/business as usual ........................................... 19 

Option 1: Commission Recommendation to harmonise implementation of existing 
law; Website with access to legislation...................................................................... 19 

Option 2: Regulation with harmonised rules and more efficient role of the Competent 
Authorities.................................................................................................................. 20 

Option 3: Regulation with a new EU Agency as central Competent Authority ........ 20 

Excluded option ......................................................................................................... 20 

Analysis of impact...................................................................................................... 20 

Types of impact and underlying assumptions............................................................ 21 

Baseline scenario........................................................................................................ 22 

Option 1: Commission Recommendation to harmonise implementation of existing 
law; Website with access to legislation...................................................................... 22 

Option 2: Regulation with harmonised rules and more efficient role of the Competent 
Authorities.................................................................................................................. 23 

Option 3: Regulation with a new EU Agency as central Competent Authority ........ 24 

Effects on small and medium-sized enterprises ......................................................... 24 

Comparing the options ............................................................................................... 25 

Summary of impacts .................................................................................................. 25 

Preferred option.......................................................................................................... 25 

Political feasibility and social acceptance.................................................................. 26 

Proportionality............................................................................................................ 26 

Monitoring and Evaluation ........................................................................................ 26 

Annex 1: Stakeholder consultation during the supporting study ............................................. 28 

Annex 2: Public consultation ................................................................................................... 31 

Annex 3: Impact calculations................................................................................................... 33 

EN 

3 

   EN 

 
1. 

PROCEDURAL ISSUES AND CONSULTATION OF INTERESTED PARTIES 

1.1. 

Agenda Planning 

The  recast  of  the  Community  regulatory  framework  regarding  transport  of 
radioactive material is included in the Commission's Legal and Work Programme as 
a  simplification  measure  and  was  registered  in  the  agenda  planning  by  the 
Directorate-General  (DG)  for  Energy  and  Transport  as  item  2008/TREN/005. 
Tabling  the  initial  proposal  in  2011  allowed  for  more  in-depth  consultation  while 
following the procedure foreseen in the Euratom Treaty. 

1.2. 

Organisation and timing 

The then-Directorate-General for Energy and Transport launched the preparations in 
late 2006 when a codification study to assess the Community regulatory framework 
regarding the transport of radioactive material was commissioned.1  

With a view to preparing this impact assessment report, ECORYS Nederland BV, a 
team  of  independent  consultants,  carried  out  a  supporting  study  between  October 
2007 and June 20082.  

The  Impact  Assessment  Steering  Group  (IASG)  including  representatives  of  DG 
Environment, the Secretariat General and four different directorates of the lead DG 
took up its work in October 2007 and met in January and June 2008 to discuss the 
work  progress.  Taking  onboard  the  results  of  the  codification  study  as  well  as  the 
appropriate  remarks  received  in  these  discussions  and  the  consultations  presented 
below, the supporting study was completed in October 2008. 

The  IASG  approved  the  draft  report  in  May  2009;  the  Impact  Assessment  Board 
approved  the  report  in  July  2009  (while  recommending  certain  improvements;  see 
1.4). 

1.3. 

Consultation and expertise 

1.3.1. 

Stakeholder consultation 

Four  main  groups  of  stakeholders  in  the  transport  of  radioactive  materials  were 
consulted for the supporting study: 

•  Competent  Authorities  (depending  on  the  situation  in  the  Member  State,  for 
example a ministry of health or transport, a national commission, institute, agency 
or state office); 

•  carriers, including standard carriers and those specialised in radioactive materials; 

1 

2 

Riskaudit  IRSN/GRS  International,  Study  on  the  Codification  of  the  European  Union  Regulatory 
Framework regarding the Transport of Radioactive Material, July 2007 
ECORYS Nederland BV, Impact Assessment of the Proposal for a Council Regulation on the Revision 
of the Regulatory Framework for TRAM Activities, August 2008 

EN 

4 

   EN 

 
                                                 
•  main  producers  of  radioactive  materials  in  Europe,  for  example  GE  Healthcare, 

Amersham, CISBIO, Advanced Accelerator Applications, Covedien; 

•  users such as hospitals, clinics and the European Association of Nuclear Medicine 

(EANM)3. 

The Competent Authorities are by nature authorities of the Member States whereas 
the  users,  carriers  and  producers  that  have  replied  to  the  questionnaire  are  private 
organisations.  

Of the 556 stakeholders approached, 64 have answered the questionnaire.  

Ten of the main stakeholders were interviewed (face-to face or by telephone) to get 
targeted information as well as specific input for impact evaluations. 

From  the  users  of  transport,  mainly  hospitals  and  medical  institutes  in  different 
countries  have  responded.  Also  the  large  producers  in  Europe  like  Advanced 
Accelerator  Applications  and  GE  Healthcare  have  replied.  Moreover,  the  main 
producer  of  technetium,  Covedien,  has  been  interviewed.  Airlines,  logistic  service 
providers  and,  of  course,  road  transport  companies  were  among  the  carriers  that 
replied. 

The Member States, via their members of the Standing Working Group for the safe 
transport of radioactive materials (SWG)4, were regularly informed and consulted by 
DG Energy and Transport at each step of the study by electronic communication and 
in plenary sessions of the SWG in December 2007, June 2008 and 2009. 

In addition and until June 2010, a sub-group of the SWG advised the Commission on 
the  administrative  procedures  of  the  proposed  initiative  after  the  Group  of  experts 
referred  to  in  Art.  31  of  the  Treaty  establishing  the  European  Atomic  Energy 
Community (Euratom) had given its green light to the principles of the proposal in 
their meeting of November 2009. 

3 
4 

EANM has further distributed the questionnaire among ca. 100 members) 
The  Standing  Working  Group  (SWG),  established  in  1982  following  a  request  of  the  European 
Parliament,  consists  of  national  experts  with  specific  competence  in  the  field  of  safe  transport  of 
radioactive materials. 

EN 

5 

   EN 

 
 
                                                 
1.3.2.  Public consultation 

As foreseen in the minimum standards for consultation5, the public was consulted via 
internet  ("Your  Voice  in  Europe")  from  10/12/2007  to  28/01/2008.  A  total  of  54 
answers were received. 

1.3.3.  Main results of the consultations 

The stakeholder consultation showed a need for harmonisation and simplification of 
existing rules providing for a level playing field across the European Union. Among 
others, the following issues were highlighted:  

•  High legislative burden; 

•  Administrative complexity; 

•  Lack of consistency and cooperation between Member States; 

•  High  costs  of  transport  licences  and  training  due  to  the  multitude  of  Member 

States; 

•  Barriers to entry for carriers, in particular small and medium-sized enterprises. 

Regarding  available  policy  options,  the  stakeholders  support  a  codification  of 
existing  rules.  They  are  generally  in  favour  of  adjusted  legislation  if  it  reduces  the 
legislative burden while diverging interests of the different groups lead to less clearer 
positions  on  specific  questions.  The  national  Competent  Authorities,  expectedly, 
refuse setting up a EU agency taking over their work (see Annex 1). 

The public consultation via internet, while certainly not of such a high quality as for 
example the follow-up telephone calls, did not bring very clear results, but included a 
call for action at EU level, in particular with regards to soft measures and increased 
transparency of the existing rules (see Annex 2). 

1.4. 

Impact Assessment Board 

The  Impact  Assessment  Board  reviewed  the  draft  report  on  1st  July  2009.  In  their 
opinion of 6 July 2009 the Board welcomed that the report provides a good overview 
of  the  existing  legislative  framework  and  a  clear  problem  definition  as  regards  the 
barriers  to  smooth  transport  operations  in  Europe.  In  addition,  the  Board 
recommended  improvements  on  the  description  of  the  scope  of  initiative,  certain 
aspects of the cost-benefit analysis, and the comparison of the options. 

As  agreed  during  the  Board  meeting,  this  report  has  been  revised  along  the  lines 
indicated. In particular, the scope of the initiative and the legal framework affected 
have been described in more detail in chapter 2.5 and the objectives adapted to this 
more concrete approach. Secondly, the underlying assumptions have been integrated 
into  the  main  body  of  the  text  and  the  results  of  the  cost-benefit  analysis  better 

5 

General  principles  and  minimum  standards  for  consultation  of  interested  parties  by  the  Commission, 
COM(2002)704 

EN 

6 

   EN 

 
                                                 
explained  in  chapter  5  and  Annex  3.  Thirdly,  chapter  6  on  the  comparison  of  the 
identified options has been edited to better clarify the criteria used and to identify the 
coherence  with  other  EU  legislation.  Due  to  the  social  and  political  concerns, 
political feasibility and social acceptance have been addressed as well. 

2. 

PROBLEM DEFINITION 

2.1. 

Background 

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. 

According  to  a  study  on  the  transport  of  radioactive  material  (TRAM)  in  Europe6 
over 1 million packages of RAM were transported annually at the beginning of the 
last decade within, to or from the EU, over land, water and by air. These packages 
represent  about  2%  of  all  dangerous  goods  packages.  Road  transport  is  the  most 
important transport mode for RAM shipments.  

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.7 

The packages for small quantities of RAM are either "Excepted packages" (for low-
activity  sources  and  materials;  15-30%  of  all  packages)  or  "Type  A  packages"  (for 
medium-activity  materials  for  industrial  and  medical  uses  and  able  to  withstand 
normal  transport  and  handling  conditions).  The  packages  used  in  the  nuclear  fuel 
cycle  are  mostly  large  and  heavy.  These  are  the  so-called  "Type  B  packages"  (for 
high  activity  materials  and  be  certified  to  withstand  severe  accident  conditions).  In 
France, for instance, a country with a fully developed nuclear programme, about 750 
Type  B  packages  containing  fuel  cycle  materials  are  transported  per  year,  that  is  a 
mere quarter percent of all transported radioactive packages.8 

Based on the registration data available from certain Member States, the Commission 
estimates that some 1000 to 2000 carriers active in the European Union. 

TRAM  traffic,  both  domestic  and  internationally,  varies  significantly  between 
countries (see figure below). Whether a country has a national nuclear programme, a 
major  producer  or  commercial  supplier  of  radioisotopes  for  medical,  scientific  and 
industrial applications influences largely the volume of TRAM. 

6 

7 

8 

NPRB,  GRS,  ANPA,  NRG,  IRSN,  CEPN,  Statistics  on  the  Transport  of  Radioactive  Materials  and 
Statistical Analyses. March 2003 
Riskaudit  IRSN/GRS  International,  Study  on  the  Codification  of  the  European  Union  Regulatory 
Framework regarding the Transport of Radioactive Material, July 2007 
European  Parliament,  Commission  on  Regional  Policy,  Transport  and  Tourism,  Hearing  on  Nuclear 
Transport, 21/06/2000 

EN 

7 

   EN 

 
                                                 
Given  the  nature  of  RAM,  its  handling,  use  and  its  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  safety  of  TRAM  is 
ensured by a large set of binding and non-binding rules. This regulative framework 
for  the  transport  of  radioactive  materials  comprises  international,  European  and 
national  legislation,  which  creates  a  rather  complex  regulatory  framework.  Figures 
indicate that the transport of radioactive materials is the safest category of transport.  

As a general principle, if you want to transport RAM you may need  

•  an approval of the package containing the material, 

•  a licence or registration for the carrier allowing him to transport RAM, 

•  depending on the quality of the material, an approval for the shipment from or a 

notification to the relevant Competent Authority. 

A major fraction of RAM transports are trans-boundary shipments9 in which case all 
or  a  sub-set  of  these  four  administrative  steps  need  to  be  taken  in  every  Member 
State.  The  problem  is  compounded  by  the  fact  that  Member  States  differently 
interpret  international  arrangements  and  EU  Directives  and/or  have  additional 
requirements. 

Some  of  these  deviations  of,  for  example,  licensing  or  approval  requirements  at 
Member State level interfere with fundamental goals of the EU, such as the internal 
market.  

All in all, TRAM is more expensive and more regulated than other – partially equally 
hazardous - classes of dangerous goods. 

9 

This is particularly true for many radioisotopes used in medicine where only a few production centres 
exist worldwide. 

EN 

8 

   EN 

 
 
                                                 
The  objective  is,  therefore,  to  examine  whether  and  how  Community  legislation 
should be revised in order to assure high safety standards, prevent undue burden on 
all  parties,  including  the  Competent  Authorities,  and  mitigate  the  barriers  to  the 
smooth functioning of TRAM in Europe. 

On basis of multiple reports and the interviews already held with experts in the field 
of  TRAM,  drivers  and  effects  of  these  barriers  have  been  summarised  in  the 
following figure and are analysed in the two chapters following the overview of the 
legal framework.  

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 licences and training sessions 

Barriers to entry 

Administrative burden 

Risks for supply to medical patients 

Limitations to controls and inspections 

Additional costs 

2.2. 

Overview of the regulatory framework 

TRAM Legislation has developed in the past decades leading to a body of existing 
regulatory instruments and regulations consisting of: 

•  International rules  

–  International  regulations,  like  the  UN  Model  Regulations  including  the  IAEA 

Transport Regulations, 

–  Modal  Regulations  of  the  regional  and  international  transport  organisations 

(International Modal Regulations),  

–  A variety of international conventions, codes and agreements. 

•  Community law 

•  National law 

This  framework  assigns  specific  responsibilities  of  compliance  with  certain  duties, 
requirements  and  practices  to  the  parties  involved  in  TRAM  (e.g.  Competent 
Authorities,  transport  operators).  To  reach  the  primary  objective  of  ensuring  safety 
and  security,  TRAM  is  subject  to  a  more  stringent  regulatory  regime  than  other 
dangerous goods as it is being covered by, on the one hand, the rules governing the 

EN 

9 

   EN 

 
 
transport  of  dangerous  goods  and,  on  the  other  hand,  radiation  protection 
requirements. 

2.2.1. 

International rules 

2.2.1.1.  International regulations 

Radioactive materials are classified as Class 7 out of nine classes of dangerous goods 
whose  transport  is  governed  by  the  United  Nations  “Recommendations  on  the 
Transport of Dangerous Goods”. 

The  International  Atomic  Energy  Agency  (IAEA)  is  tasked  to  formulate  specific 
recommendations for the transport of Class 7 materials. The standards are defined in 
the  IAEA  Safety  Requirements  No.  TS-R-1  “Regulations  for  the  Safe  Transport  of 
Radioactive  Materials”  (latest  edition  of  2009)  and  are  included  in  the  UN 
Recommendations. 

The IAEA Regulations establish the standards of safety which provide an acceptable 
level of control of the radiation, criticality and thermal hazards to persons, property 
and the environment that are associated with the transport of RAM. 

These IAEA Transport Regulations are of a recommendatory nature and not legally 
binding but for the IAEA's own activities. Member States and transport organisations 
concerned  are  encouraged,  however,  to  take  the  Regulations  as  a  basis  for 
corresponding  national  laws  and  regulatory  activities.  Currently,  almost  all 
international  organisations  concerned  and  more  than  60  IAEA  Member  States  are 
known to have adopted the recommended Regulations directly or indirectly for their 
own regions. 

2.2.1.2.  Modal Regulations 

The IAEA Regulations have been incorporated into the mode-specific regulations by 
specialised  regional  and  international  organisations,  as  presented  in  the  following 
table: 

Mode of 
transport 

Organisation  Modal Regulation 

Road 

UN/ECE 

European Agreement concerning the International Carriage of 
Dangerous Goods by Road (ADR) 

Inland 
waterways 

Inland 
waterways 

Rail 

Air 

Air 

Sea 

Post 

UN/ECE 

European Agreement concerning the International Carriage of 
Dangerous Goods by Inland Waterways (ADN) 

CCNR 

OTIF 

ICAO 

Provisions concerning the Carriage of Dangerous Goods on the 
Rhine (ADNR) 

Regulations Concerning the International Carriage of Dangerous 
Goods by Rail (RID) 

Technical Instructions for the Safe Transport of Dangerous Goods 
by Air (TI) 

IATA 

Dangerous Goods Regulations (DGR) 

IMO 

UPU 

International Maritime Dangerous Goods Code (IMDG Code) 

Universal Postal Convention and its detailed regulations 

EN 

10 

   EN 

 
These  Modal  Regulations  are  binding  to  those  countries  that  are  parties  to  the 
agreements. Most EU Member States are party to the Modal Regulations10. 

2.2.1.3.  International conventions, codes and agreements 

Next  to  these specific transport rules, there are additional international conventions 
and  agreements  on  civil  nuclear  liability,  physical  protection,  early  notification, 
mutual emergency assistance and safeguards control of nuclear material which also 
affect TRAM. 

These rules have found wide acceptance and are only binding to contracting parties. 
Their number being limited (about 10) this legislation does not greatly increase the 
complexity of TRAM.  

2.2.2.  Community regulatory framework 

Safety in the transport of radioactive material is a primary concern of the European 
Union and its Member States. 

The legal basis for the actions at European level lies in the Treaty on the Functioning 
of  the  European  Union  (TFEU),  which  makes  transport  a  shared  competence,  in 
particular  in  Title  VI,  and  in  chapter  3  of  title  II  of  the  Euratom  Treaty,  which 
provides the legal frame for setting the basic standards on radiation protection. 

Council Directive 94/55/EC with regard to the transport of dangerous goods by road 
has made the provisions of the Modal Regulation for road transport (ADR) uniformly 
applicable  to  road  transport  by  adopting  in  particular  the  technical  annexes  to  the 
ADR  agreement.  These  annexes  set  standards  for  the  classification,  packaging  and 
labelling of dangerous goods and the construction of vehicles used to transport them. 
A  similar  Directive  was  introduced  for  the  transport  of  dangerous  goods  by  rail 
(Council Directive 96/49/EC on the approximation of the laws of the Member States 
with regard to the transport of dangerous goods by rail). Directive 2008/68/EC of the 
European  Parliament  and  of  the  Council  of  24  September  2008  on  the  inland 
transport  of  dangerous  goods  combined  all  inland  transport  modes  of  dangerous 
goods, which significantly simplified Community rules. 

In addition to the legislation based on the EC Treaty, specific TRAM rules are based 
on  the  EURATOM  Treaty,  whereby  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  ionizing  radiation  is 
particularly  relevant.  Article  2  of  this  Directive  defines  transport  as  one  of  the 
"practices which involve a risk form ionizing radiation emanating from an artificial 
source or from a natural radiation source in cases where natural radionuclides are or 
have been processed in view of their radioactive, fissile or fertile properties". Hence, 
Articles  3  and  4  apply,  under  which  "reporting"  (requirement  of  submitting  a 
document to the competent authority to notify the intention to carry out a practice) is 
required  by  carriers  and  Member  States  can  impose  prior  "authorization"  (a 
permission  granted  in  a  document  by  the  competent  authority,  on  application,  or 
granted  by  national  legislation,  to  carry  out  a  practice  on  carriers).  This  allows 

10 

Except Malta, Cyprus and Estonia for RID 

EN 

11 

   EN 

 
                                                 
competent authorities to better check if the standards contained in that Directive are 
being respected. 

In addition, two shipment control procedures are in force to supervise the movements 
of radioactive materials between Member States (Council Regulation (Euratom) No 
1493/93  of  8  June  1993  on  shipments  of  radioactive  substances  between  Member 
States) and the supervision and control of shipments of radioactive waste and spent 
fuels (Council Directive 2006/117/Euratom of 20 November 2006 on the supervision 
and  control  of  shipments  of  radioactive  waste  and  spent  fuel).  Finally,  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  and  Council  Directive  2003/122/Euratom  of  22  December 
2003  on  the  control  of  high-activity  sealed  radioactive  sources  and  orphan  sources 
also touch upon transport. 

The  Directives  are  complemented  by  a  number  of  legal  instruments  and  associated 
EU legislation.  

These  instruments  state  many  duties,  obligations  and  technical  and  administrative 
requirements  to  both  Member  States  and  transport  operators  as  indicated  in  the 
following table. 

In  a  simplified  way,  the  acquis  ranging  from  general  to  very  specific  rules  can  be 
regrouped in the following way: 

EN 

12 

   EN 

 
 
TFEU Law
TFEU Law

Euratom Law
Euratom Law

Transport of goods
Transport of goods

Transport of dangerous 
Transport of dangerous 
goods (e.g. uniform road 
goods (e.g. uniform road 
checks 2008/54/EC)
checks 2008/54/EC)

Protection of the 
Protection of the 
health of workers
health of workers
and the general 
and the general 
public
public

Supervision of 
Supervision of 
material 
material 
(safeguards, 
(safeguards, 
shipments, sealed 
shipments, sealed 
sources, waste, 
sources, waste, 
spent fuel
spent fuel

Inland Transport Directive 
Inland Transport Directive 
2008/68/EC
2008/68/EC

Basic Safety 
Basic Safety 
Standards 
Standards 
Directive 
Directive 
(96/29/Euratom)
(96/29/Euratom)

Information in case 
Information in case 
of accidents
of accidents

2.2.3.  National law 

National laws of EU Member States related to the transport of dangerous goods, use 
of  nuclear  energy,  radiation  protection,  security,  waste  management,  occupational 
and  industrial  safety  etc.  do  result  in  additional  requirements  for  the  transport  of 
radioactive  materials.  By  transporting  radioactive  materials  across  several  Member 
States,  the  different  sets  of  national  legislation  result  in  a  web  of  differing 
regulations.  Among  others  this  is  the  result  of  EU  Directives  defining  minimum 
levels. This is for example the case of Council Directive 96/29/Euratom on the basic 
safety standards, where Member States have, if at all, implemented the reporting and 
authorization requirements of Art. 3 and 4 in different ways. 

Some examples of such differences can be found in the following table: 

EN 

13 

   EN 

 
2.3. 

Causes for problems related to the transport of radioactive materials 

Stakeholders  have  repeatedly  referred  to  the  following  causes  for  problems  on 
TRAM: 

2.3.1.  Complex regulatory framework 

The  transport  of  radioactive  substances  has  been  subject  to  a  comprehensive  and 
stringent regulatory regime for many years which has helped to assure safety of the 
public,  the  environment  and  the  workers  involved.  As  a  matter  of  fact,  there  has 
never  been  a  transport  incident  that  has  caused  significant  radiological  damage  to 
persons  or  the  environment  over  the  past  decades.  This  is  in  large  parts  due  to  the 
implementation in Europe of the IAEA Transport Regulations which, as mentioned 
above,  provide  for  an  acceptable  level  of  control  of  the  radiation,  criticality  and 
thermal hazards to persons, property and the environment that are associated with the 
transport of RAM. 

Many  rules  are,  as  the  codification  study  concluded,  indispensable  given  the 
technical  complexity  in  providing  an  acceptable  level  of  safety  and  prevention 
against the hazards arising from radioactivity and proliferation potential. 

Nevertheless,  TRAM  activities  are  nowadays  more  heavily  regulated  than  other 
dangerous  goods.  The  complete  set  of  rules  has  many  layers,  making  it  overly 
complex. Thus the main objective has been achieved – at the cost of having a very 
complex system.  

EN 

14 

   EN 

 
 
2.3.2.  Requirements differ between Member States 

As  seen  above,  there  are  major  differences  between  Member  States  in  terms  of 
procedures, assessments, administrative requirements and application formats, which 
are  not  relate  to  safety.  There  is  ample  room  to  decrease  the  burden,  in  particular 
with regards to extra requirements that rather interfere with fundamental goals of the 
EU, such as the internal market. 

2.3.3.  Need for multiple licences and training sessions for trans-boundary transports 

Unlike  for  other  classes  of  dangerous  goods,  carriers  of  RAM  may  need  particular 
licences in a majority of Member States. The costs for obtaining these licences and 
the costs for training, especially of the drivers, are high in comparison to the amount 
of class 7 goods to be carried. Most licences cost between a few hundred Euros and 
three thousands Euros.  

However, it is the fact that you need several of these ‘national’ licences, which by the 
way have to be renewed at differing, but often short intervals, that substantially drive 
up  the  costs.  A  carrier  regularly  transporting  radioisotopes  from  Belgium  to  Italy 
would need the corresponding licences from several Member States involved. 

2.3.4.  Administrative burden 

The  administrative  burden  for  transport  of  medical  RAM  is  comparatively  heavy, 
among others due to shipment notification requirements.  

2.3.5.  Limitations to controls and inspections 

The  stakeholder  consultation  emphasized  that  there  is  a  shortage  of  resources  with 
the Competent Authorities to check TRAM activities appropriately - notwithstanding 
the fact that enforcement is considered as very important.  

2.4. 

Effects 

These causes lead among others to the following effects: 

2.4.1.  Non-compliance 

The  current  complexity  of  the  current  legislation  has  led  to  a  situation  where 
inspections  reveal  a  relatively  high  number  of  non-compliant  transports.  According 
to data for Belgium, 58% of TRAM vehicles inspected were considered  to be  non-
compliant, compared to 40% of non-compliance for transport of dangerous goods in 
general.  According  to  information  of  the  French  authorities  they  experience  most 
problems with relatively small carriers and less frequently with the larger specialised 
carriers. 

EN 

15 

   EN 

 
According to a recent evaluation, frequent reasons for non-compliance in dangerous 
goods in general appear to be found in incorrect transport documents, missing orange 
panels and fire extinguishers as well as inappropriate vehicles or packaging.11  

This certainly calls for more stringent enforcement by the relevant bodies, which in 
turn requires them to have a better oversight of who the market participants are. 

2.4.2.  Delays and denials of shipments 

National  official  bodies  cannot  deny  the  transport  of  radioactive  material  if 
shipments  fulfil  the  compulsory  requirements.  Nonetheless,  carriers,  ports  and 
handling facilities do deny shipments – for two main causes: Negative perceptions of 
radioactive materials as well as the complexity of regulation and related costs. 

Some ferry services and harbours, for example, have refused to transport and handle 
radioactive  material  although  the  risk  created  by  the  material  is  very  low;  even 
"excepted  packages",  which  per  se  do  not  pose  any  danger  to  persons  involved  in 
their transport, have been refused.  

Delays and denials of shipments are of growing concern. According to information 
by  the  IAEA,  which  has  set  up  a  Steering  Committee  on  Denial  of  Shipments  in 
2006,  there  are  more  and  more  denials  in  international  shipments.  Indeed,  data 
reported to the IAEA over a six-month period between September 2007 and March 
2008  indicate  69  reports  of  delays  and  denials  of  shipments.  Most  of  these  were 
delays  (42).  The  majority  of  the  reports  concerned  air  transport  (46  reports),  while 
the remaining 23 cases concerned sea, rail and road transport. Most of these reports 
concerned 
iodine-131, 
fluorodeoxyglucose and cobalt-60) with short half-life times. It can be fairly assumed 
that the majority of denials goes unreported. 

radioisotopes  used 

for  medical 

purposes 

(e.g. 

2.4.3.  Barriers to entry 

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 rules, effective barriers to market 
entry  exist  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.  

However,  the  lack  of  competition  and  the  dependence  on  a  limited  number  of 
specialised  carriers  do  represent  inherent  risks  to  the  transport  of  RAM.  This  is 
further  aggravated  in  the  field  of  medical  isotopes  where only very few production 
centres exist. Therefore, the lack of competition contributes to making the system of 
transporting RAM vulnerable.  

In  addition,  certain  Member  States  are  reported  to  have  national  rules  which  either 
keep  foreign  carriers  off  their  markets  or  put  them  at  a  disadvantage  to  their  own 
carriers.12 

11 

European  Commission  (2005)  Evaluation  of  EU  Policy  on  the  Transport  of  Dangerous  Goods  since 
1994 (TREN/E3/43-2003) – Final Report 

EN 

16 

   EN 

 
                                                 
2.4.4.  Risks for supply to medical patients 

Radioactive materials are widely used in hospitals, most commonly for the purposes 
of  diagnosis  and  treatment.  Some  of  the  radioactive  materials  are  transported  to 
hospitals  and  then  dispensed  and  used  on  a  regular  basis,  sometimes  weekly,  to 
ensure a constant supply. 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,  which  by  definition  have  a 
limited preparation time. 

The  Council  has  reviewed  the  security  of  supply  of  radioisotopes  and  invited  the 
Commission and Member States "to propose measures to ensure efficient transport of 
radioactive material within the European Union"13. 

2.4.5.  Additional costs borne eventually by the society at large 

All  these  four  effects  contribute  to  pushing  costs  up.  In  general  terms,  certain 
experience shows that TRAM can be 15 to 20 % more expensive than the transport 
of other classes of dangerous goods.  

These  costs  must  ultimately  be  paid  for  –  first  by  the  users.  In  the  case  of  medical 
uses they  are ultimately borne  by the social security  systems  of  Member  States,  an 
aspect that has not been considered in detail yet. 

2.5. 

Scope of an EU level initiative 

Facing  these  problems,  DG  Energy  (and  Transport,  before  the  recent  split)  has 
embarked on a review of the issues involved and the possible solutions. Whereas the 
initial  idea  was  to  recast  the  complete  legislation  governing  the  transport  of 
radioactive  materials,  it  soon  emerged  that  the  main  issue  with  TRAM,  when 
compared  to  other  classes  of  dangerous  goods,  are  the  existence  of  differing 
the  Basic  Safety  Standards 
administrative  requirements  when 
Directive 96/29. 

implementing 

Acknowledging  the  work  undertaken  by  the  Standing  Working  Group  and  the 
Association of Competent Authorities of a sub-set of Member States, in particular on 
package  design  approval,  and  replying  to  the  request  by  the  SWG  "to  review  the 
justification of these variations and assess the cost-benefit of harmonisation of these 
requirements  within  the  EU"14,  the  Commission  focussed  on  these  administrative 
procedures for the access to the carrier market. 

As seen above, Directive 96/29 defines transport as a so-called "practice" for which 
Member  States  have  to  define  reporting  requirements  and  may  define  authorisation 
requirements. 

12  

13  

14 

There  is  anecdotal  evidence  that  certain  transports  have  even  been  cancelled  because  the  Competent 
Authority was very difficult to reach 
Council  Conclusions  on 
AGRICULTURE and FISHERIES Council meeting, Brussels, 15 December 2009 
6th  Report  of  the  Standing  Working  Group  on  the  Safe  Transport  of  Radioactive  material  in  the 
European Union (March 2009), p. 9 

the  security  of  supply  of  radioisotopes  for  medical  use,  2986th 

EN 

17 

   EN 

 
                                                                                                                                                         
Out  of  the  22  Member  States  that  replied  to  a  questionnaire  sent  out  by  the 
Commission  in  July  2009,  six  Member  States  (Austria,  Czech  Republic,  Finland, 
Sweden, United Kingdom) require neither a licence, nor a registration for carriers. In 
Denmark  and  Spain  only  a  registration  is  required  while  six  countries  (France, 
Germany,  Lithuania,  Netherlands,  Poland,  Slovenia)  have  introduced  a  "graded" 
licence or graded authorisation (with stricter rules for more dangerous materials) and 
eight  others  (Belgium,  Bulgaria,  Greece,  Ireland,  Italy,  Luxembourg,  Romania, 
Slovakia) use a general licence (all packages, all modes). 

As  the  Standing  Working  Group  notes,  and  as  companies  involved  confirmed,  this 
"could jeopardise the proper functioning of the internal market in this sector" – apart 
from  being  one  of  the  causes  of  denials.  "EP  and  Council  are  invited  to  support 
measures aimed at reducing unjustified administrative and regulatory burdens for the 
safe transport of RAM"15 . 

It must be noted at this stage that the scope of any new initiative will not and cannot 
interfere  with  rules  on  safety,  security,  safeguards,  control  of  sources  where  these 
rules continue to apply. 

Taking into account  

•  the  need  to  provide  for  high  safety  standards  for  the  transport  of  radioactive 

materials in all 27 Member States , 

•  the  need  to  tackle  the  problems  encountered  in  trans-boundary  transports,  in 
particular,  the  variety  in  the  implementation  of  Articles  3  and  4  of  the  Basic 
Standards Directive, 

it is more than evident that EU action can help to harmonise and simplify rules in the 
Community and increase transparency while continuing to guarantee a high level of 
safety. 

3. 

OBJECTIVES 

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. 

Both these general objectives are enshrined or at least referred to in the EURATOM 
Treaty,  but  can  similarly  be  found  in  the  TFEU.  They  underscore  that  actions  on 
TRAM can very well contribute to the Europe 2020 strategy and the simplification of 
legislation. 

15 

6th  Report  of  the  Standing  Working  Group  on  the  Safe  Transport  of  Radioactive  material  in  the 
European Union (March 2009), p. 10 

EN 

18 

   EN 

 
                                                 
Considering the specificities and relatively low number of transports involving fissile 
materials, the main problems concern radioisotopes and radiation sources. 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 easily 

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, the following policy options were 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  entry  into  the  transport 
market. 

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 

EN 

19 

   EN 

 
in 

the  different  Member  States. 

necessary 
In  addition,  a  Commission 
Recommendation would interpret the applicable rules of Directive 96/29 with a view 
to  harmonising  implementation  and,  in  particular,  to  urging  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  the  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. 

4.5. 

Excluded option 

Currently, the Competent Authorities of certain Member States are cooperating more 
and  more  closely  together  on  some  of  the  procedures  involved.  Such  a  voluntary 
formation can be seen as an important first step to addressing some of the detected 
problems. However, the pace of change that will be initiated by this Association with 
regards  to  the  different  sets  of  existing  national  legislation  risks  to  be  slow  and  to 
remain limited to a subset of Member States. Independent experts having judged this 
option  to  be  inferior  to  the  alternatives  mentioned  above,  this  option  was  not 
considered any further.16 

Nevertheless,  the  Commission  is  committed  to  building  upon  the  results  of  this 
initiative and to foster closer cooperation of the authorities involved. 

5. 

ANALYSIS OF IMPACT 

The  policy  options  presented  above  have  varying  degrees  of  economic,  social  and 
environmental impact. Even though the impact in general appears to be modest from 
a  global  viewpoint,  the  impact  would  be  important  enough  for  such  a  small  sector. 

16 

ECORYS Nederland BV, Impact Assessment of the Proposal for a Council Regulation on the Revision 
of the Regulatory Framework for TRAM Activities, August 2008 

EN 

20 

   EN 

 
                                                 
The impacts outside the European Union have been left out of the considerations as 
they are minuscule.17 

5.1. 

Types of impact and underlying assumptions 

The impacts are categorised in five groups, namely: Public sector expenses and fees, 
Regulatory  effects,  Transport  operations,  Safety  and  environment,  and  Social 
impacts. The following table gives examples of impacts under the different headings: 

Regulatory frame 

Transport 
operations 

Safety and 
environment 

Public sector 
expenses, fees 

Fewer costs for 
coordination 
between 
Member States 

Costs for 
establishing 
institutional 
means 

Fewer 
derogations from 
the regulative 
framework 

Better and 
harmonised rules 
on TRAM at 
European level 

Decrease in 
delays of trans-
boundary 
shipments 

Decrease of 
denials and non-
compliance of 
shipments 

Social impacts 

Timely arrival of 
medicines due to 
less disruptions 
during shipment 

Decrease of need 
for human 
resources as 
consequence of 
efficiency impacts 

Level of safety in 
TRAM 

Less fuel 
consumption and 
less pollution due 
to efficient 
shipments 

Less exposure of 
the general public 
due to fewer 
disruptions during 
shipment 

Change of costs 
for licences 

Reduced 
complexity of 
regulations 

Tear down entry 
barriers for small 
and medium-
sized enterprises 

Decrease of costs 
due to less 
administrative 
burden 
Costs of additional 
requirements in 
national law 

Less time needed 
to approve TRAM 

For  the  first  three  groups,  the  experts  of  ECORYS  have  calculated  the  economic 
impact.  The  assessments  in  their  support  study  were  based  on  desk  research, 
interviews and results of the stakeholder consultation. The nominal figures they came 
up with should be seen as a rough approximation because data available on the sector 
is scarce. In addition, only a few Competent Authorities and companies had provided 
the requested information. 

In order to come up with figures, the researchers first estimated the costs under the 
three  headings  by  focussing  on  administrative  burden  for  competent  authorities, 
carriers, producers and users, as well as costs for inspection, licence fees and denials 
of  shipments.  In  doing  so,  the  experts  made  use  of,  among  others,  costs 
communicated  by  competent  authorities,  the  administrative  burden  calculations  for 
dangerous  goods  of  the  UK  Department  of  Transport,  interviews  with  isotope 
producers and expert judgement. 

17 

Outside enterprises would benefit of possible administrative savings, but they play a minor role, which 
is not expected to rise considerably. 

EN 

21 

   EN 

 
 
  
 
 
  
  
 
 
  
  
  
  
  
                                                 
To  evaluate  the  impacts  of  the  individual  options,  ECORYS  experts  defined 
coefficients indicating how far an initiative may reduce the different kinds of costs. 

As to the transport operations, for example, the researchers proposed evaluating the 
costs  of  denials  of  shipments  by  splitting  them  in  three  parts:  costs  of  waste, 
administrative costs and operational costs. Per denial these were assumed to set aside 
5000, 750 and 1500 €, respectively. Multiplying thes e unit prices with the number of 
shipments  resulted  in  the  total  potential  costs  to  which  the  researchers  applied 
different coefficients depending on the option evaluated. A Recommendation in their 
eyes  would  avoid  10%  of  denials,  which  results  in  savings  of  180.000  €  for 
operational costs alone. Adding up all these savings and additional costs under one 
headline  leads  to  the  amounts  given  in  the  table  below.  In  the  example,  a 
Recommendation  would  lead  to  savings  in  transport  operations  of  900.000  €  per 
year. 

For  the  public  sector  expenses,  the  researchers  estimated  institutional  costs  per 
option,  e.g.  €  5  million  for  an  EU  agency  or  the  costs  for  additional  inspections. 
Commission services estimated the costs for licences based on the rough information 
available. 

The  savings  related  to  the  regulatory  framework  were  calculated  by  using  the 
administrative  burden  calculations  for  dangerous  goods  of  the  UK  Department  of 
Transport, which allows to calculate burdens along the transport chain. 

More  details  on  the  assumptions  underlying  the  calculations  as  well  as  the 
assessment of the impacts of the options can be found in Annex 3. 

The  impacts  on  safety  and  environment  as  well  as  the  social  impacts  are  not 
quantitatively  defined,  but  are  presented  in  a  qualitative  manner  since  there  is  not 
enough detailed information available to present figures. 

The  following  assessments  include,  by  the  way,  the  expectations  that  stakeholders 
voiced during the stakeholder consultation. 

5.2. 

Baseline scenario 

The  absence  of  any  serious  accidents  shows  that  the  current  legal  framework  does 
ensure safe transport operations. 

Under  the  baseline  scenario,  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. 

5.3. 

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

A Recommendation on how to interpret existing legislation is largely welcomed by 
producers  and  users.  The  Competent  Authorities  see  the  advantages  on  specific 
topics,  whilst  carriers  on  average  do  not  see  the  point  of  a  Recommendation.  This 
legal tool is expected to reduce  delays and denials and to remove barriers to entry. 

EN 

22 

   EN 

 
Competent  Authorities  and  producers,  on 
that  a 
Recommendation  may  contribute  to  reducing  derogations  in  Member  States  and 
increasing harmonisation. Users and carriers, on the other hand, doubt this effect. 

the  one  hand,  assume 

As  a  Recommendation  is,  however,  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. The administrative costs would be reduced by € 1.2 million. 

Public sector expenses, fees

0,6 Regulatory frame

Costs

Savings

Transport operations
Total impact

Safety and environment

+

Social impacts

1,6
0,9
1,9

x

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

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

5.4. 

Option  2:  Regulation  with  harmonised  rules  a  and  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 above. The administrative costs of enterprises would be reduced by € 
7.35 million. 

The  Commission  would  have  to  cover  the  electronic  registration  system  whose 
development  is  estimated  to  cost  €  400.000  while  hosting  and  maintenance  is 
estimated  to  cost  €  50.000  annually;  these  figur es  are  included  in  the  public  sector 
expenses. 

The  effects  on  transport  operations  considerably  higher  than  under  option  1,  the 
security  of  supply  of  radioisotopes  can  be  enhanced  and  the  social  impacts  of  this 
option are therefore positive. 

Public sector expenses, fees

1,4 Regulatory frame

Costs

Savings

Transport operations
Total impact

Safety and environment

+

Social impacts

9,8
5,2
13,6

+

EN 

23 

   EN 

 
 
 
On average, stakeholders are in favour of such adjusted legislation. They support, in 
particular, uniform licences and expect considerable impacts of such an approach.  

However  the  adjustments  in  legislation  could  result  in  some  regulators  losing 
revenues.  All  respondents  emphasised  that  such  new  legislation  may  not  lead  to  a 
higher  administrative  burden  for  any  of  the  parties  active  in  the  transport  of 
radioactive materials in Europe. 

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. 

5.5. 

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. 
ECORYS  estimated  that  savings  could  reach 
administrative savings would reach € 9.75 million. 

€  13  million  annually.  The 

Although most stakeholders are against an EU agency, they believe such an agency 
could  generate  many  positive  impacts.  An  EU  agency  in  conjunction  with  a 
Regulation  will  ultimately  reduce  the  derogations  of  the  regulatory  framework  to 
zero  and  greatly  reduce  the  complexity  of  the  framework  by  harmonising  it. 
Furthermore, according to the stakeholders, the number of denials and delays would 
decrease. 

The expectations that establishing an EU agency could generate positive impacts are 
endorsed by the calculations in the table underneath. The biggest possible reduction 
is  related  to  the  regulatory  framework.  On  the  other  hand,  running  an  EU  agency 
costs  additional  money,  estimated  here  at  €  5  million,  driving  up  the  costs  for  this 
policy options. 

The effects on transport operations are considerably higher than under option 1, the 
security  of  supply  of  radioisotopes  can  be  enhanced  and  the  social  impacts  of  this 
option are therefore positive. 

Public sector expenses, fees

5,2 Regulatory frame

Costs

Savings

Transport operations
Total impact

Safety and environment

+

Social impacts

13,0
5,2
13,0

+

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. 

5.6. 

Effects on small and medium-sized enterprises 

The  exact  effects  on  small  and  medium-sized  enterprises  are  hardly  computable 
given the data available. Taking into account that in particular small ones are often 

EN 

24 

   EN 

 
 
effectively  blocked  out  of  the  market  today,  they  tend  to  reap  a  major  share  of  the 
expected savings. 

In  general  terms,  small  and  medium-sized  enterprises  are  expected  to  benefit  in 
proportion  to  the  total  savings  achieved  under  the  above  options:  the  higher  the 
savings in total, the higher the savings for these enterprises. Options 2 and 3 would 
be, therefore, most beneficial for them. 

6. 

COMPARING THE OPTIONS 

6.1. 

Summary of impacts 

In general, all options other than the baseline scenario lead to additional costs on the 
public administration side, either by additional structures that need to be set up or a 
loss  of  income.  These  costs  are  always  outweighed  by  the  savings  due  to  a  better 
regulatory  framework  and  easier  transport  operations.  Safety  is  estimated  to  go 
slightly up once the general rules are harmonised as unclarities about differing rules 
disappear. 

The  social  impact,  that  is,  mainly  the  secure  supply  of  radioisotopes  as  far  as  it  is 
impaired by transport operations, would be more positive under options 2 and 3. 

Whereas  transparency  for  carriers  can  be  increased  under  all  non-baseline  options, 
there are certain doubts with regard to option 3 in the context of subsidiarity. 

The following comparative tables summarises the estimated impact for the options.  

COMPARATIVE TABLE OF EFFECTS 
Policy options 

Baseline  Recommendation 

Regulation 

EU Agency 

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

Safety and environment 

Social impacts 

Transparency, access to 
information improved 

Subsidiarity 

+ 

6.2. 

Preferred option 

1,9 

13,6 

+ 

+ 

+ 

+ 

+ 

+ 

+ 

13 

+ 

+ 

+ 

- 

With  regards  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, the following aspects have to be factored in:  

•  The  success  of  such  an  initiative  is  highly  unlikely:  Member  States,  and  the 

Commission itself, are very critical of setting up additional EU agencies; 

EN 

25 

   EN 

 
 
 
 
 
 
 
•  The  whole  process  of  setting  up  such  an  agency  and  making  it  work  is  time 
consuming,  concrete  results  can  only  be  expected  years  after  the  decisions  enter 
into force; 

•  The  solution  is  problematic  in  relation  to  the  subsidiarity  principle  and 
proportionality as a similar value added could be reached by measures that leave 
responsibilities with the Member States.  

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.  

6.3. 

Political feasibility and social acceptance 

As  radioactivity,  and  in  particular  nuclear  energy,  raises  tensions,  the  social 
acceptance and the political feasibility of any measure to be taken in these areas need 
to be carefully evaluated. 

With regards to this initiative it is important to recall again that the safety concept for 
the  transport  of  radioactive  materials  very  much  depends  on  the  safety  of  the 
transport container and that the international rules as implemented in the EU and its 
Member  States  provide  already  for  an  acceptable  level  of  control  of  the  radiation, 
criticality and thermal hazards to persons, property and the environment.  

A Regulation on the implementation of the reporting and authorization requirements 
will  not  change  anything  about  that.  The  same  goes  for  other  rules  concerning,  for 
example, security, safety, third party liability or safeguards. 

On the contrary, this proposal will contribute to assuring the supply of radioisotopes 
in the medical sector. 

6.4. 

Proportionality 

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. 

EN 

26 

   EN 

 
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. 

EN 

27 

   EN 

 
Annex 1: Stakeholder consultation during the supporting study 

A  questionnaire  was  distributed  among  a  series  of  stakeholders:  competent  authorities, 
carriers,  producers  and  users.  Out  of  556  stakeholders  approached,  just  64  respondents 
answered the questionnaire.  

Organisation 
type 

Competent 
authorities 

Approached: 
27 

Respondents: 

22 

SUMMARY TABLE OF THE FOCUSED CONSULTATION 

Questions  

Answers (number) 

Fully 
agree 

Agree 

Not 
agree 

Fully 
not 
agree 

Are actual TRAM problems? 

TRAM legislation is relevant in your country? 

Legislation is easy to understand? 

Legislation is not interpretable? 

Legislation is effective? 

Are important independent external audits?  

Clarity of the system can be improved for 
consignors 

The system is not clear for carriers 

The system is not clear for consignees 

You provided carriers standard sufficient 
information 

Import/export need notification in your country  

Licence required in your country 

Licence is not free of charges 

Transporters of radioisotopes only need 1 licence 

Licence should be valid in multiple countries 

Administrative burden is high in your country 

CA are responsible to control carriers  

CA are enough resources to control carriers 

CA  are  aware  of  other  countries  requirements  for 
application procedures 

Are you in favour to harmonise the procedures 

Have  you  additional  requirements  to  international 
ones 

Harmonisation should be done by the EC 

Besides safety, security requirements are needed 

Security provision in ADR are adequate  

CA collect data of TRAM 

Should vehicles be equipped with tracking devices 

You have a safety plan in case of accident 

2 

13 

4 

2 

10 

7 

1 

0 

0 

5 

7 

10 

6 

6 

1 

12 

5 

7 

10 

5 

6 

7 

2 

4 

2 

11 

14 

8 

13 

9 

11 

9 

10 

5 

3 

9 

10 

4 

15 

3 

6 

4 

5 

4 

11 

10 

7 

10 

12 

11 

12 

9 

10 

3 

0 

4 

10 

0 

5 

8 

11 

10 

4 

1 

3 

4 

7 

5 

9 

1 

7 

4 

1 

5 

1 

2 

8 

3 

9 

0 

2 

1 

0 

1 

0 

1 

2 

5 

5 

3 

1 

4 

1 

2 

6 

3 

3 

0 

1 

5 

3 

1 

0 

0 

1 

0 

EN 

28 

   EN 

 
 
 
 
 
Are actual TRAM problems? 

Carriers 

TRAM legislation is relevant in your country? 

Approached: 
351 

Respondents: 

13 

Legislation is easy to understand? 

Legislation is not interpretable? 

Legislation is effective? 

Competent Authorities in your country give you 
the necessary information 

Competent Authorities in other countries give you 
the necessary information 

Licence required in your country 

High cost of licence 

Transporters of radioisotopes only need 1 licence 

Administrative burden is high in your country 

Not  harmonised  regulation  on  EU  level  causes 
unfair competition 

The  use  of  an  uniform  transport  document  would 
minimise denial and delays 

You send on regular basis TRAM data to your CA 

Should vehicles be equipped with tracking devices 

6 

6 

1 

2 

7 

7 

3 

9 

1 

7 

5 

5 

7 

4 

You have a safety plan in case of accident 

10 

Denials are a main problem 

Denials are most of the time related to the content 
of packages 

Denials  are  most  of 
documentation of packages 

the 

time 

related 

to 

Denials are in many cases relative to the negative 
perception of RAM 

Denials  are  in  many  cases  related  to  a  lack  of 
harmonisation of TRAM legislation 

Denials  are 
compliance with international requirements 

in  many  cases  related 

to  non 

Denials are the most common for type B packages 

Denials occur only for transboundary shipments 

Training is the most expansive indirect cost 

Are actual TRAM problems? 

Users 

TRAM legislation is relevant in your country? 

Approached: 

Legislation is easy to understand? 

132 

Legislation is not interpretable? 

Respondents: 

Legislation is effective? 

22 

Competent Authorities in your country give you 
the necessary information 

Administrative burden is high in your country 

1 

0 

0 

3 

0 

0 

0 

0 

2 

2 

6 

3 

2 

6 

5 

8 

6 

4 

3 

2 

4 

6 

7 

1 

10 

2 

3 

2 

5 

1 

3 

3 

4 

3 

4 

4 

7 

5 

4 

1 

6 

13 

13 

7 

10 

8 

12 

5 

1 

2 

5 

5 

2 

0 

0 

0 

1 

3 

2 

4 

0 

3 

5 

0 

7 

7 

8 

3 

3 

4 

6 

8 

2 

6 

2 

6 

6 

8 

3 

7 

0 

1 

4 

4 

0 

0 

2 

3 

5 

0 

1 

2 

2 

1 

0 

1 

3 

1 

1 

3 

4 

3 

4 

3 

0 

0 

6 

3 

0 

2 

0 

EN 

29 

   EN 

 
 
 
 
 
Are you in favour to harmonise the procedures 

13 

Are actual TRAM problems? 

Producers 

TRAM legislation is relevant in your country? 

Approached: 

Legislation is easy to understand? 

46 

Legislation is not interpretable? 

Respondents:7 

Legislation is effective? 

Competent  Authorities  in  your  country  give  you 
the necessary information 

Competent Authorities in other countries give you 
the necessary information 

Administrative burden is high in your country 

The  use  of  an  uniform  transport  document  would 
minimise denial and delays 

Denials are a main problem 

Denials are most of the time related to the content 
of packages 

Denials  are  most  of 
documentation of packages 

the 

time 

related 

to 

Denials  are  in  many  cases  related  to  a  lack  of 
harmonisation of TRAM legislation 

Denials  are 
compliance with international requirements 

in  many  cases  related 

to  non 

Denials are the most common for type B packages 

Denials occur only for transboundary shipments 

Transport cost is a reasonable part of the total cost  

There enough supply of carriers 

4 

3 

1 

0 

1 

3 

0 

1 

0 

2 

1 

0 

0 

0 

0 

1 

0 

0 

7 

3 

4 

4 

5 

5 

3 

2 

2 

3 

2 

1 

1 

0 

0 

1 

2 

2 

0 

1 

0 

0 

2 

2 

1 

0 

2 

3 

2 

1 

1 

2 

1 

1 

1 

0 

2 

4 

1 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

1 

1 

3 

3 

1 

0 

1 

1 

Due  to  the  specificity  and  complexity  of  the  subject,  the  following  statements  should  be 
advanced in the assessment of the results: 

The number of inputs (answers) received in the different consultation processes is considered 
as  relatively  low  to  draw  significant  statistically  conclusions  in  some  of  the  categories  of 
actors. 

Some  groups  of  consulted  stakeholders  have  contradictory  views  due  to  their  different 
involvement  and  role  in  TRAM  activities  (carriers  vs.  users  or  regulators).  Therefore,  the 
number of answer coming from each stakeholder's group could strongly bias the results based 
strictly on statistics. 

EN 

30 

   EN 

 
 
Annex 2: Public consultation 

The  questionnaire  in  the  public  consultation  process  by  Internet  included  36  technical 
questions,  related  to  Safety  (10  questions),  Administrative  Burden  (7  questions),  Market  (6 
questions),  Public  Opinion  (4  questions)  and  Policy  Options  (9  questions).  54  replies  were 
received,  of  which  11  came  from  citizens  and  43  from  organisations/stakeholders.  The 
questions and an overview of the distribution of replies are shown in the following table. 

SUMMARY TABLE OF PUBLIC CONSULTATION 

Theme 

General question 1:  

Answers (%) 

What problems do you perceive in the field of TRAM?  Yes 

No 

No opinion 

The certification of containers 

Safety 

Package approval 

Regulatory labelling / making of containers 

Training of staff 

Conveyance / transport equipment 

Radiation protection programme 

Physical protection 

Quality assurance management 

Track and trace system  

Other 

Complexity for obtaining national permissions 

Administrative 

Complexity of notification procedures 

burden 

Cost for preparing / obtaining documentation 

Revalidation of package certificates 

Staffing resources 

Transport documentation  

Other 

Import / export requirements 

Market 

Delay of shipments 

Denial of shipments 

Additional fees affecting competitiveness 

Insurance 

Others 

Emergency, preparedness and response 

Public opinion 

Citizens concerns 

Incident notification 

Other 

General question 2:  

33 

30 

17 

30 

24 

20 

30 

20 

24 

9 

41 

32 

33 

44 

41 

20 

9 

17 

33 

32 

22 

28 

9 

30 

48 

24 

7 

50 

56 

70 

63 

70 

72 

63 

74 

59 

48 

50 

59 

56 

44 

48 

69 

48 

59 

50 

48 

52 

46 

52 

61 

41 

69 

57 

17 

14 

13 

7 

6 

8 

7 

6 

17 

43 

9 

9 

11 

12 

11 

11 

43 

24 

17 

20 

26 

26 

40 

9 

11 

7 

35 

Theme 

What proposals you believe could contribute to solve 
the above mentioned problems? 

Yes 

No 

No opinion 

EN 

31 

   EN 

 
 
 
 
 
 
 
 
 
Business as 
usual 

No need of action 

Other 

Implement harmonised / common information systems  

Soft law 
measures 

Common guides for transport preparation 

More efficiency emergency reports 

Others 

Amendment of Council Regulation 1493/93/Euratom 

New directive superseding current regulatory measures 

Other 

Regulatory 
measures 

26 

24 

63 

74 

33 

12 

26 

28 

17 

44 

35 

24 

18 

62 

44 

31 

33 

22 

30 

41 

13 

7 

15 

44 

43 

39 

61 

EN 

32 

   EN 

 
 
 
Annex 3: Impact calculations18 

This  annex  describes,  in  more  detail,  how  the  impacts  presented  in  chapter  5  of  this  report 
were  calculated.  To  that  effect,  the  annex  presents  first  the  assumptions  used  for  the 
calculations followed by the assessment of the options themselves. 

The  assessments  take  account  of  expert  judgements  of  researchers  of  ECORYS  and  the 
Nuclear Research Group (NRG), as well as interviews with competent authorities, producers 
and carriers. 

It  must  be  noted,  however,  that  all  calculations  are  based  on  a  limited  number  of  figures. 
Given  the  time  and  the  budget  for  this  project,  the  researchers  had  to  work  with  the  best 
available  sources  in  order  to  approach  reality  for  defining  assumptions  and  calculating 
impacts.  In  the  questionnaire  and  with  help  of  separate  mailing  and  telephone  calls,  the 
researchers have tried to gather as much reliable information as possible. In fact, only a few 
companies and competent authorities took the time to help with additional information for the 
calculations of the impacts. 

The researchers proposed to look into the impact of the options on 

–  administrative burden for competent authorities,  

–  administrative burden for carriers,  

–  administrative burden for producers, 

–  administrative burden for users,  

–  inspection costs, 

–  fees for licences, 

–  costs of denials and delays. 

Generally  speaking,  the  researchers  first  estimated  unit  prices  for  the  different  impact 
categories. These unit prices were then multiplied with the applicable variables. To evaluate 
the effects of the different options, the researchers proposed to apply coefficients, specific for 
every option and based on their expert judgement, to these estimated amounts, resulting in the 
calculated impact per option.  

To make this process clearer, let's take a look at how the effects on the administrative burden 
of  competent  authorities  were  estimated:  from  consulting  authorities  in  five  Member  States 
(Belgium,  France,  Italy,  Netherlands,  Spain)  the  costs  of  procedures  and  administration 
(including personnel) were estimated at € 240.000 per country - multiplied by 27 the total cost 
within the EU amounts to € 6,48 million. Assuming that a Recommendation may reduce this 

18 

This  annex  reflects  the  corresponding  annex  of  the  support  study  (ECORYS  Nederland  BV,  Impact 
Assessment of the Proposal for a Council Regulation on the Revision of the Regulatory Framework for 
TRAM Activities, August 2008) and was adapted to take account of mainly editorial changes and the 
focus on the administrative options. 

EN 

33 

   EN 

 
                                                 
burden by 5% and a Regulation by 30% the effective savings would amount to € 324.000 or € 
1,94 million, respectively. 

This approach is repeated for each of the different cost types. 

Adding up the single effects results in the amounts presented in chapter 5. 

The next chapter gives additional information on the underlying assumptions and data sources 
whereas  the  final  chapter  gives  some  background  on  how  the  researchers  came  up  with  the 
coefficients for the options evaluated. 

Assumptions for the impact assessment  

•  Administrative burden for competent authorities 

A decrease or increase of the administrative burden of the competent authorities is calculated 
with help of the fixed costs per competent authority. On basis of information of the competent 
authorities  of  France,  Italy,  Spain,  Belgium  and  the  Netherlands  the  average  fixed  cost  per 
European competent authority was estimated to be € 240.000. Th is includes, amongst others, 
cost of personnel, cost for training, and costs for participating in international meetings. For 
the whole EU, this amounts to € 6,48 million. 

•  Administrative burden for carriers, producers and users 

By  using  the  administrative  burden  calculator  of  the  UK  Department  of  Transport,  that 
estimates  the  burden  of  regulations  in  the  UK  government  and  in  particular  for  dangerous 
goods,  the  researchers  have  allocated  costs  to  the  different  parties  of  the  transport  chain. 
Furthermore, the researchers assumed that the UK administrative burden is a ninth of the total 
burden  within  the  EU  (which  is  roughly  in  line  with  the  UK  share  in  the  EU  population). 
Finally  a  conversion  in  real  terms  provided  the  prices  which  then  served  for  evaluating  the 
options. 

•  Inspection 

The costs of inspections are calculated on basis of information gathered from interviews. It is 
assumed  that  resources  freed  up  in  the  competent  authorities  because  of  reducing  the 
administrative  burden  would  be  used  for  additional  inspections.  The  cost  of  inspections  is 
estimated  with  help  of  the  costs  per  inspector,  as  being  the  largest  cost  driver.  Under  the 
hypothesis that every country has 3 inspectors, this results in inspection costs of € 8.1 million. 

•  Licence 

The costs  of  licences were not easy to estimate because there are large differences  between 
countries in Europe. Commission services have assumed that 1500 carriers are active on the 
European market with licences for five countries costing 400 € each. 

•  Denials/delays 

An  effective  initiative  will  contribute  to  reducing  the  number  of  denials  and  delays  of 
shipments, e.g. by reducing the needs for (short-notice) notifications of individual shipments. 
The costs of these are composed of three different parts: the expenses for dealing with waste 

EN 

34 

   EN 

 
as  result  of  denials  of  shipment,  the  administrative  costs  of  denials  of  shipment  and  the 
operational costs of denials of shipment. In case of a denial the radioactive materials that the 
shipment consists of have to be returned to the producer and recycled. The recycling costs are 
estimated  at  €  5.000  per  shipment.  The  administ rative  handling  costs  are  the  procedures 
related to a denial and the resending of the package and are guessed to be € 750. In addition, 
the  carrier  may  face  additional  operational  costs  in  case  the  truck  cannot  continue,  and  the 
driver  works  additional  hours,  which  is  estimated  to  cost  €  1.500.  For  the  purposes  of  this 
impact assessment 1.200 cases of denials and delays are assumed to happen per year. 

The table on the following page gives an overview of these assumptions:

EN 

35 

   EN 

 
Assumptions for calculations of impacts 

Subject 

Part of 

Administrative 
burden CA 

Regulatory 
frame 

Item (costs per 
year in €) 
Cost of 
procedures, 
administration 

Unit 

Unit price 

Price 

Cost per 
CA 

240.000,00 €

6.480.000,00 €

Administrative 
burden carrier 

Regulatory 
frame 

Cost of 
procedures, 
administration 

Cost for 
carriers 

Administrative 
bruden 
producer 

Regulatory 
frame 

Cost of 
procedures, 
administration 

Cost for 
producers

Administrative 
burden user 

Regulatory 
frame 

Inspection 

Licence 

Public 
sector 
Public 
sector 

Cost of 
procedures, 
administration 

Cost of 
inspections 

Cost of licence 

Denials 

Transport  Cost of waste 

Cost for 
users 

Cost per 
inspector 
Cost per 
licence 

Cost per 
denial 

1.045.898,00 €

4.706.541,00 €

4.740.352,00 €

21.331.582,00 €

22.083,00 €

99.375,00 €

400,00 €

3.000.000,00 €

5.000,00 €

6.000.000,00 €

Denials 

Transport 

Administrative 
costs 

Cost per 
denial 

750,00 €

900.000,00 €

Denials 

Transport 

Operational 
costs 

Cost per 
denial 

1.500,00 €

1.800.000,00 €

Source 
Consultation CA 
FR, BE, NL, ES, 
IT 
UK administrative 
burden 
calculations for 
dangerous goods  
UK administrative 
burden 
calculations for 
dangerous goods  
UK administrative 
burden 
calculations for 
dangerous goods  

Variables   

Number 
of CA 

27

UK=1/9 of 
EU 

0,5 

UK=1/9 of 
EU 

0,5 

UK=1/9 of 
EU 

0,5 

9

9

9

Commission 
estimation 

Expert judgement 
ECORYS/NRG 

Expert judgement 
ECORYS/NRG 

Expert judgement 
ECORYS/NRG 

3 

5 

1500

27 Coutries 
Number 
of carriers 
Number 
of 
shipments
Number 
of 
shipments
Number 
of 
shipments

1200000

1200000

1200000

Convert 
into real 
terms 

Convert 
into real 
terms 

Convert 
into real 
terms 
Inspectors 
per 
country 
Licences 
per carrier 

100.000,00 €

8.100.000,00 €

I nterview Isotopes 

EN 

36 

EN 

 
  
  
  
  
  
  
  
  
  
  
  
Assessing the options 

In  order  to  assess  now  the  impact  of  a  certain  initiative  on  the  costs  derived  above,  the 
researchers  have  estimated  coefficients  for  each  of  the  categories  mentioned  above  under 
every option. In addition, they estimated fixed institutional costs per measure – for example 
the running costs of an EU agency under option 3. 

These  coefficients  and  costs  are  presented  in  the  following  table.  Please  note  that  positive 
values mean savings induced by the measure, negative values additional burden. 

Recommendation

Regulation 

EU Agency 

Regulatory frame 
Harmonisation 
Complexity 
Administrative burden 

Public sector 
expenses, fees 
Inspection 
Licences 
Institutional 
Transport 

Delays and denials 

Costs CA 
Costs Carrier 
Costs Producer 
Costs User 

Costs Inspections 
Costs Licences 
Costs Institution 

Costs denials and 
delays 

5% 
5% 
5% 
5% 

30% 
30% 
30% 
30% 

40% 
40% 
40% 
40% 

-5% 
10% 
-500.000 € 

-15% 
60% 

-2.000.000 € 

-40% 
60% 
-5.000.000 € 

10% 

60% 

60% 

In defining these values use was made of expert judgements by ECORYS and NRG. In doing 
so,  they  assessed  many  studies  on  the  effects  of  harmonisation  and  reduced  complexity  in 
regulations in other sectors. The tendency of these reports is in general a positive effect. In the 
last couple of years, ECORYS has done several impact assessments in other transport sectors 
where the issue of harmonisation has played an important role. The outcome is that there are 
in  general  positive  effects  as  results  of  harmonisation  and  less  complexity.  Therefore,  this 
tendency is continued in this assessment by considering the impacts of the measures for the 
transport of radioactive materials. 

As  result  of  the  closer  cooperation  of  the  competent  authorities  of  member  states,  the 
expectation is that the developments on a multilateral approval of licences will further expand 
and will result in savings in the future. Also in case of organisational and legislative measures 
it is therefore expected that the costs of licences will considerably decrease. This expectation 
is  equal  for  the  delays  and  denials  in  TRAM.  Harmonisation,  less  complexity,  and  faster 
approval of licences will have positive effects on the number of denials and delays. 

The  institutional  costs  are  estimations  about  the  costs  needed  for  the  establishment  of  a 
organisation  like  an  EU  agency.  These  costs  are  roughly  assessed  and  are  strongly 
hypothetical. 

EN 

37 

   EN