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}  
 
EN 2   EN TABLE OF CONTENTS 
1. Procedural issues and consulta tion of interested parties.............................................. 4 
1.1. Agenda Planning .......................................................................................................... 4  
1.2. Organisation and timing............................................................................................... 4 1.3. 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. Problem definition........................................................................................................ 7 2.1. Background ................................................................................................................ .. 7 
2.2. 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 tr ansport 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 ......................................................................................................... 1 5 
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 3   EN 2.5. Scope of an EU level initiative................................................................................... 17 
3. Objectives.................................................................................................................. . 18 
4. Policy options............................................................................................................. 1 9 
4.1. Baseline scenario: No policy changes/business as usual ........................................... 19 
4.2. Option 1: Commission Recommendation to  harmonise implementation of existing 
law; Website with access to legislation...................................................................... 19 
4.3. Option 2: Regulation with harmonised rules and more efficient role of the Competent 
Authorities.................................................................................................................. 20  
4.4. Option 3: Regulation with a new EU Agency as central Competent Authority ........ 20 4.5. Excluded option ......................................................................................................... 20  
5. Analysis of impact...................................................................................................... 20 5.1. Types of impact and underlying assumptions............................................................ 21 
5.2. Baseline scenario........................................................................................................ 2 2 
5.3. Option 1: Commission Recommendation to  harmonise implementation of existing 
law; Website with access to legislation...................................................................... 22 
5.4. Option 2: Regulation with harmonised rules and more efficient role of the Competent 
Authorities.................................................................................................................. 23  
5.5. Option 3: Regulation with a new EU Agency as central Competent Authority ........ 24 
5.6. Effects on small and medium-sized enterprises......................................................... 24 6. Comparing the options ............................................................................................... 25 6.1. Summary of impacts .................................................................................................. 25 6.2. Preferred option.......................................................................................................... 25 
6.3. Political feasibility and social acceptance.................................................................. 26 6.4. Proportionality........................................................................................................... . 26 
7. Monitoring and Evaluation ........................................................................................ 26 
Annex 1: Stakeholder consulta tion during the supporting study ............................................. 28 
Annex 2: Public consultation ................................................................................................... 31 
Annex 3: Impact calculations................................................................................................... 33 
 
EN 4   EN 1. PROCEDURAL ISSUES AND CONSULTATION OF INTERESTED PARTIES  
1.1. Agenda Planning 
The recast of the Community regulator y 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 asse ss the Community re gulatory framework 
regarding the transport of radio active material was commissioned.
1  
With a view to preparing this impact assessment report, ECORYS Nederland BV, a 
team of independent consultants, carri ed out a supporting study between October 
2007 and June 20082.  
The Impact Assessment Steering Group (IA SG) including representatives of DG 
Environment, the Secretariat General and f our different directorates of the lead DG 
took up its work in Octobe r 2007 and met in January a nd June 2008 to discuss the 
work progress. Taking onboard the results of the codification study as well as the 
appropriate remarks received in these di scussions 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 Ju ly 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 radioac tive 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 thos e specialised in radioactive materials; 
                                                 
1 Riskaudit IRSN/GRS International, Study on the Codification of the European Union Regulatory 
Framework regarding the Transport of  Radioactive Material, July 2007 
2 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 5   EN • main producers of radioactive materials in Europe, for example GE Healthcare, 
Amersham, CISBIO, Advanced Acce lerator Applications, Covedien; 
• users such as hospitals, clinics and the Eu ropean Association of  Nuclear Medicine 
(EANM)3. 
The Competent Authorities are by nature au thorities 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 interv iewed (face-to face or by telephone) to get 
targeted information as well as spec ific input for impact evaluations. 
From the users of transport, mainly hosp itals and medical institutes in different 
countries have responded. Also the larg e producers in Europe like Advanced 
Accelerator Applications and GE Health care have replied. Moreover, the main 
producer of technetium, Covedien, has been  interviewed. Airlines, logistic service 
providers and, of course, road transpor t 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-gr oup of the SWG advised the Commission on 
the administrative procedures of the propos ed initiative after th e Group of experts 
referred to in Art. 31 of the Treaty es tablishing the European Atomic Energy 
Community (Euratom) had given its green ligh t to the principles of the proposal in 
their meeting of November 2009. 
                                                 
3 EANM has further distributed the questionnaire among ca. 100 members) 
4 The Standing Working Group (SWG), established in 1982 following a request of the European 
Parliament, consists of national experts with speci fic competence in the field of safe transport of 
radioactive materials. 
 
EN 6   EN 1.3.2.  Public consultation 
As foreseen in the minimum standards for consultation5, the public was consulted via 
internet ("Your Voice in Europe") fr om 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 playin g field across the Eu ropean 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 trai ning due to the multitude of Member 
States; 
• Barriers to entry for carriers, in particul ar small and medium-s ized enterprises. 
Regarding available policy options, the stakeholders support a codification of 
existing rules. They are gene rally in favour of adjusted legislation if it reduces the 
legislative burden while diverg ing 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 ce rtainly 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 wi th 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 defin ition 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 revi sed along the lines 
indicated. In particular, the scope of the initiative and the legal framework affected have been described in more detail in ch apter 2.5 and the objectives adapted to this 
more concrete approach. Secondly, the underl ying assumptions have been integrated 
into the main body of the text and the re sults of the cost-ben efit analysis better 
                                                
 
5 General principles and minimum standards for consultation of interested parties by the Commission, 
COM(2002)704 
 
EN 7   EN explained in chapter 5 and Annex 3. Thir dly, chapter 6 on the comparison of the 
identified options has been ed ited to better clarify the criteri a used and to identify the 
coherence with other EU le gislation. Due to the social and political concerns, 
political feasibility and social accepta nce have been addressed as well. 
2. PROBLEM DEFINITION  
2.1. Background 
Radioactive materials are used in many applic ations that help us in our daily lives, 
ranging from healthcare, research, industr ial manufacturing a nd agriculture to 
electric power generation. Radioactive ma terial (RAM) is shipped in packages 
varying from small boxes with tiny amounts of radiopharmaceutical s for healthcare 
use to heavy steel containers with spent nuclear fuel and vitr ified waste from the 
nuclear fuel cycle, both of whic h are highly radioactive materials. 
According to a study on the transport of radioactive material  (TRAM) in Europe6 
over 1 million packages of RAM were trans ported 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 danger ous goods packages. Most (nearly 90%) of 
these packages contain relati vely 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). Th e packages used in the nuclear fuel 
cycle are mostly large and heavy. These ar e 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 fu lly developed nuclear programme, about 750 
Type B packages containing fuel cycle mate rials 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 carri ers active in the European Union. 
TRAM traffic, both domestic and intern ationally, varies significantly between 
countries (see figure below). Whether a c ountry has a national nuclear programme, a 
major producer or commercial supplier of ra dioisotopes for medical, scientific and 
industrial applications  influences largely the volume of TRAM. 
                                                 
6 NPRB, GRS, ANPA, NRG, IRSN, CEPN, Statistics on the Transport of Radioactive Materials and 
Statistical Analyses. March 2003 
7 Riskaudit IRSN/GRS International, Study on the Codification of the European Union Regulatory 
Framework regarding the Transport of  Radioactive Material, July 2007 
8 European Parliament, Commission on Regional Policy, Transport and Tourism, Hearing on Nuclear 
Transport, 21/06/2000 
 
EN 8   EN 
 
Given the nature of RAM, its handling, us e 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-bi nding rules. This regulative framework 
for the transport of radioactive material s comprises international, European and 
national legislation, which creates a rath er complex regulatory framework. Figures 
indicate that the transport of radioactive ma terials 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 transpor ts are trans-boundary shipments
9 in which case all 
or a sub-set of these four administrative steps need to be ta ken in every Member 
State. The problem is compounded by the f act that Member States differently 
interpret international arrangements and EU Directives and/ or have additional 
requirements. 
Some of these deviations of, for exampl e, licensing or approval requirements at 
Member State level interfere with fundamental goals of th e EU, such as the internal 
market.  
All in all, TRAM is more expensive and mo re regulated than other – partially equally 
hazardous - classes of dangerous goods. 
                                                 
9 This is particularly true for many radioisotopes used in medicine where on ly a few production centres 
exist worldwide. 
 
EN 9   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 Author ities, and mitigate the barriers to the 
smooth functioning of TRAM in Europe. 
On basis of multiple reports and the intervie ws 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.  
 
2.2. Overview of the regulatory framework 
TRAM Legislation has developed in the pa st decades leading to a body of existing 
regulatory instruments and regulations c onsisting 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 conve ntions, codes and agreements. 
• Community law 
• National law 
This framework assigns specific responsibil ities of compliance with certain duties, 
requirements and practices to the part ies 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 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 
 
EN 10   EN transport of dangerous goods and, on th e other hand, radiation protection 
requirements. 
2.2.1.  International rules 
2.2.1.1.  International regulations 
Radioactive materials are classified as Cla ss 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 (IA EA) 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” (l atest edition of 2009) and are included in the UN 
Recommendations. 
The IAEA Regulations establish the standard s of safety which provide an acceptable 
level of control of the radi ation, criticality and thermal hazards to persons, property 
and the environment that are associ ated with the transport of RAM. 
These IAEA Transport Regulations are of a recommendatory natu re and not legally 
binding but for the IAEA's ow n activities. Member States and transport organisations 
concerned are encouraged, however, to take the Regulations as a basis for 
corresponding national laws and regulator y activities. Currently, almost all 
international organisations concerned and m o r e  t h a n  6 0  I A E A  M e m b e r  S t a t e s  a r e  
known to have adopted the recommended Regula tions directly or i ndirectly for their 
own regions. 
2.2.1.2.  Modal Regulations 
The IAEA Regulations have been incorporat ed 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 UN/ECE European Agreement concerning the International Carriage of 
Dangerous Goods by Inland Waterways (ADN) 
Inland 
waterways CCNR Provisions concerning the Carri age of Dangerous Goods on the 
Rhine (ADNR) 
Rail OTIF Regulations Concerning the International Carriage of Dangerous 
Goods by Rail (RID) 
Air ICAO Technical Instructions for the Safe Transport of Dangerous Goods 
by Air (TI) 
Air IATA Dangerous Goods Regulations (DGR) 
Sea IMO International Maritime Dangerous Goods Code (IMDG Code) 
Post UPU Universal Postal Conv ention and its detailed regulations 
 
EN 11   EN These Modal Regulations are binding to th ose 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 trans port rules, there are additiona l international conventions 
and agreements on civil nuclear liabilit y, 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 c ontracting parties. 
Their number being limited (about 10) this le gislation does not greatly increase the 
complexity of TRAM.  
2.2.2.  Community regulatory framework 
Safety in the transport of radioactive mate rial is a primary conc ern of the European 
Union and its Member States. 
The legal basis for the actions at European  level lies in the Tr eaty on the Functioning 
of the European Union (TFEU), which ma kes 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 Regul ation for road trans port (ADR) uniformly 
applicable to road transport by adopting in particular the technical annexes to the ADR agreement. These annexes set standa rds for the classification, packaging and 
labelling of dangerous goods and the construction of vehicl es used to transport them. 
A similar Directive was introduced for th e 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 C ouncil 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 th e 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 ioni zing radiation emanating from an artificial 
source or from a natural radiat ion source in cases where na tural radionuclides are or 
have been processed in view of their radioactive, fissile or fertile properties". Hence, 
Articles 3 and 4 apply, under which "re porting" (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 ou t a practice on carriers). This allows 
                                                
 
10 Except Malta, Cyprus and Estonia for RID 
 
EN 12   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 Regul ation (Euratom) No 
1493/93 of 8 June 1993 on shipments of ra dioactive substances between Member 
States) and the supervision and control of shipments of radioac tive waste and spent 
fuels (Council Directive 2006/117/Euratom of 20 November 2006 on the supervision and control of shipments of  radioactive waste and spen t fuel). Finally, Council 
Directive 89/618/Euratom of 27 Novemb er 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 Dire ctive 2003/122/Euratom of 22 December 
2003 on the control of high-activ ity 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, oblig ations and technical and administrative 
requirements to both Member States and tr ansport operators as indicated in the 
following table. 
 
In a simplified way, the acquis ranging from general to very spec ific rules can be 
regrouped in the following way: 
 
EN 13   EN TFEU Law
Transport of goodsTransport of dangerous 
goods (e.g. uniform road 
checks 2008/54/EC)
Inland Transport Directive 
2008/68/ECTFEU Law
Transport of goodsTransport of dangerous 
goods (e.g. uniform road 
checks 2008/54/EC)
Inland Transport Directive 
2008/68/ECEuratom Law
Protection of the 
health of workers
and the general 
publicSupervision of 
material 
(safeguards, 
shipments, sealed 
sources, waste, 
spent fuel
Basic Safety 
Standards 
Directive 
(96/29/Euratom)Information in case 
of accidentsEuratom Law
Protection of the 
health of workers
and the general 
publicSupervision of 
material 
(safeguards, 
shipments, sealed 
sources, waste, 
spent fuel
Basic Safety 
Standards 
Directive 
(96/29/Euratom)Information in case 
of accidents
2.2.3.  National law 
National laws of EU Member States relate d to the transport of dangerous goods, use 
of nuclear energy, radiation protection, s ecurity, waste management, occupational 
and industrial safety etc. do result in a dditional requirements for the transport of 
radioactive materials. By transporting ra dioactive materials across several Member 
States, the different sets of national legislation re sult in a web of differing 
regulations. Among others this is the resu lt 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 Ar t. 3 and 4 in different ways. 
Some examples of such differences can be found in the following table: 
 
EN 14   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 i nvolved. As a matter of  fact, there has 
never been a transport incide nt that has caused significa nt radiological damage to 
persons or the environment over the past deca des. This is in large parts due to the 
implementation in Europe of the IAEA Tr ansport Regulations which, as mentioned 
above, provide for an acceptable level of co ntrol of the radia tion, criticality and 
thermal hazards to persons, property and the environment that are associated with the transport of RAM. 
Many rules are, as the codification st udy concluded, indispensable given the 
technical complexity in providing an accep table level of safety and prevention 
against the hazards arising from radi oactivity and proliferation potential. 
Nevertheless, TRAM activities are nowaday s more heavily regulated than other 
dangerous goods. The complete set of ru les has many layers, making it overly 
complex. Thus the main objective has been ac hieved – at the cost  of having a very 
complex system.  
 
EN 15   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 re quirements and application formats, which 
are not relate to safety. There is ample r oom to decrease the bur den, in particular 
with regards to extra requirements that rath er 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 ma y need particular 
licences in a majority of Member States. The costs for obtaining these licences and the costs for training, especially of the dr ivers, are high in comparison to the amount 
of class 7 goods to be carried. Most lic ences cost between a few hundred Euros and 
three thousands Euros.  
However, it is the fact that you need severa l of these ‘national’ licences, which by the 
way have to be renewed at differing, but ofte n short intervals, that  substantially drive 
up the costs. A carrier regularly transpor ting radioisotopes from Belgium to Italy 
would need the corresponding licences fr om 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 vehicl es inspected were c onsidered to be non-
compliant, compared to 40% of non-complia nce 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 16   EN According to a recent evaluation, frequent reasons for non-compliance in dangerous 
goods in general appear to be found in inco rrect 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 over sight of who the market  participants are. 
2.4.2.  Delays and denials of shipments 
National official bodies cannot deny the tr ansport of radioactive material if 
shipments fulfil the compulsory requireme nts. Nonetheless, carriers, ports and 
handling facilities do deny shipments – for tw o main causes: Negative perceptions of 
radioactive materials as well as the comp lexity of regulation and related costs. 
Some ferry services and harbours, for exam ple, have refused to transport and handle 
radioactive material although the risk crea ted by the material is very low; even 
"excepted packages", which per se do not pose any dang er 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 dela ys and denials of shipment s. Most of these were 
delays (42). The majority of the reports concerned air transpor t (46 reports), while 
the remaining 23 cases concerned sea, rail and road transport. Most of these reports concerned radioisotopes used for medical purposes (e.g. iodine-131, 
fluorodeoxyglucose and cobalt-60) with short ha lf-life times. It can be fairly assumed 
that the majority of denials goes unreported. 
2.4.3.  Barriers to entry 
Increasingly, the transport of radioactive ma terials is becoming a case for specialised 
large carriers. As a result of the complexi ty 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 carri ers, 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 represen t inherent risks to the transport of RAM. This is 
further aggravated in the field of medi cal 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 repo rted 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 17   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 th e transport of radio active materials might 
have an impact on the treatment of patients, especially in the case of last-minute shipments of short-lived medical radioact ive 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 meas ures to ensure efficient transport of 
radioactive material with in the European Union"
13. 
2.4.5.  Additional costs borne eventual ly 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 c onsidered in detail yet. 
2.5. Scope of an EU level initiative 
Facing these problems, DG Energy (and Tran sport, before the recent split) has 
embarked on a review of the issues invol ved and the possible solutions. Whereas the 
initial idea was to recast the complete legislation governing the transport of radioactive materials, it soon emerged th at the main issue with TRAM, when 
compared to other classes of dangerous  goods, are the existence of differing 
administrative requirements when implementing the Basic Safety Standards Directive 96/29. 
Acknowledging the work undertaken by th e Standing Working Group and the 
Association of Competent Aut horities of a sub-set of Memb er 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 de fine authorisation 
requirements. 
                                                                                                                                                         
12  There is anecdotal evidence that  certain transports have even be en cancelled because the Competent 
Authority was very difficult to reach 
13  Council Conclusions on the security of supply of radioisotopes for medical use, 2986th 
AGRICULTURE and FISHERIES Council m eeting, Brussels, 15 December 2009 
14 6th Report of the Standing Working Group on the Safe Transport of Radioactive material in the 
European Union (March 2009), p. 9 
 
EN 18   EN Out of the 22 Member States that repl ied to a questionnaire sent out by the 
Commission in July 2009, six Member Stat es (Austria, Czech Republic, Finland, 
Sweden, United Kingdom) require neither a lice nce, 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 func tioning 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 admi nistrative 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, sa feguards, control of sources where these 
rules continue to apply.  
Taking into account  
• the need to provide for high safety sta ndards for the transport of radioactive 
materials in all 27 Member States , 
• the need to tackle the problems encount ered in trans-bounda ry 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 guaran tee 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 st andards in order to pr otect the public and 
the environment during transports  of radioactive materials and 
• to aim at a European single market for se rvices 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 19   EN Considering the specificities and relatively lo w number of transpor ts involving fissile 
materials, the main problems concern radioi sotopes and radiation sources. Hence, the 
specific objectives  of the proposed Comm unity action should be: 
• to guarantee the safety and health prot ection 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 legisl ation allowing carriers and users to easily 
find the information needed and iden tify the authoritie s involved easily, 
• to create the appropriate legislative and organisational conditions to ensure 
delivery in time and in good conditions of  the life-saving radi oisotopes that are 
essential for trials and therapy treatm ents for a large number of diseases. 
Finally, operational objectives  are related to the speci fic outputs of Community 
action: 
• to apply internationally accepted regulati ons so as to make repetitive Member 
States rules obsolete, 
• to allow carriers to trans port materials in the Commun ity without the need for 
additional administrative procedures for re gistration or licences in other Member 
States, 
• to establish national contact points guidi ng carriers to the relevant information and 
authorities, 
• to abandon notification re quirements for individual tr ansports for radioactive 
materials – apart from fissile and hi gh-consequence radio active 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 transpor t 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. Me mber 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 Commi ssion would make available a central website giving 
access to the different Competent Authorit ies, the legal framework and the forms 
 
EN 20   EN necessary in the different Member  States. In addition, a Commission 
Recommendation would interpret the applicab le rules of Directive 96/29 with a view 
to harmonising implementation and, in part icular, 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 furthe r – by proposing directly applicable 
harmonised rules such as a common regist ration system for carriers which does away 
with the different systems used in th e 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 Co mmission 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 Competen t Authority would oversee all transport of 
radioactive materials in the European Un ion and issue the lic ences 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 certa in Member States are cooperating more 
and more closely together on some of the procedures invol ved. Such a voluntary 
formation can be seen as an important firs t step to addressing some of the detected 
problems. However, the pace of change that will be initiated by th is Association with 
regards to the different sets of existing na tional legislation risks to be slow and to 
remain limited to a subset of Member Stat es. Independent expert s having judged this 
option to be inferior to the alternativ es mentioned above, this option was not 
considered any further.
16 
Nevertheless, the Commission is committe d to building upon the results of this 
initiative and to foster closer c ooperation of the au thorities involved. 
5. ANALYSIS OF IMPACT  
The policy options presented above have va rying 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 21   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: 
Public sector 
expenses, fees Regulatory frame Transport 
operations Safety and 
environment Social impacts 
Fewer costs for 
coordination 
between 
Member States Fewer 
derogations from 
the regulative 
framework Decrease in 
delays of trans-
boundary 
shipments Level of safety in 
TRAM Timely arrival of 
medicines due to 
less disruptions 
during shipment 
Costs for 
establishing 
institutional 
means Better and 
harmonised rules 
on TRAM at 
European level Decrease of 
denials and non-
compliance of 
shipments Less fuel 
consumption and 
less pollution due 
to efficient shipments Decrease of need 
for human 
resources as 
consequence of efficiency impacts 
Change of costs 
for licences Reduced 
complexity of 
regulations Tear down entry 
barriers for small 
and medium-
sized enterprises Less exposure of 
the general public 
due to fewer 
disruptions during shipment  
  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 th e stakeholder consultation. The nominal figures they came 
up with should be seen as a rough approximation because da ta available on the sector 
is scarce. In addition, only a few Competen t Authorities and companies had provided 
the requested information. 
In order to come up with figures, the rese archers first estimated  the costs under the 
three headings by focussing on administra tive burden for competent authorities, 
carriers, producers and users, as well as co sts for inspection, licence fees and denials 
of shipments. In doing so, the expe rts 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 22   EN To evaluate the impacts of the indi vidual options, ECORYS experts defined 
coefficients indicating how far an initiativ e may reduce the different kinds of costs. 
As to the transport operations, for exampl e, the researchers proposed evaluating the 
costs of denials of shipme nts by splitting them in three parts: costs of waste, 
administrative costs and operational costs. Pe r 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 op tion evaluated. A Recommendation in their 
eyes would avoid 10% of denials, wh ich results in savings of 180.000 € for 
operational costs alone. Adding up all thes e 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 rese archers 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 fr amework were calculated by using the 
administrative burden calculations for da ngerous goods of the UK Department of 
Transport, which allows to calculate burdens along the transport chain. 
More details on the assumptions underlyi ng 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 ava ilable 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 existin g legislation is largely welcomed by 
producers and users. The Competent Author ities see the advantages on specific 
topics, whilst carriers on average do not see the point of a Recommendation. This 
legal tool is expected to re duce delays and denials and to remove barriers to entry. 
 
EN 23   EN Competent Authorities and producers,  on the one hand, assume that a 
Recommendation may contribute to reducin g derogations in Member States and 
increasing harmonisation. Users and carrier s, on the other hand, doubt this effect. 
As a Recommendation is, however, not bi nding 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 th e 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 1,6
Transport operations 0,9
Total impact 1,9
Safety and environment + Social impacts xCosts Savings
 
Increasing transparency by making all inform ation available at one central point, in 
addition to the Recommendation, could incr ease 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 effi cient 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 au thorities, 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 admi nistrative costs of enterpri ses would be reduced by € 
7.35 million. 
The Commission would have to cover th e 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 9,8
Transport operations 5,2
Total impact 13,6
Safety and environment + Social impacts +Costs Savings
 
 
EN 24   EN On average, stakeholders are in favour of such adjusted legislat ion. They support, in 
particular, uniform licences and expect cons iderable impacts of such an approach.  
However the adjustments in legislation could result in some regulators losing 
revenues. All respondents emphasised that su ch 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, in troduce 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 c ould reach € 13 million annually. The 
administrative savings would reach € 9.75 million. 
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 der ogations of the regulatory framework to 
zero and greatly reduce the complexity  of the framewor k 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 tabl e 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 c onsiderably higher th an 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 13,0
Transport operations 5,2
Total impact 13,0
Safety and environment + Social impacts +Costs Savings
 
Given the nature of the measures incl uded in this option, the objectives are 
achievable, although a certain doubt may pers ist as to whether this option complies 
fully with the subsidiarity principle a nd with the current restrained approach 
concerning new agencies. 
5.6. Effects on small and medium-sized enterprises 
The exact effects on small and medium-si zed enterprises are hardly computable 
given the data available. Ta king into account that in part icular small ones are often 
 
EN 25   EN effectively blocked out of the market toda y, 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 fo r 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 baseli ne scenario lead to additional costs on the 
public administration side, either by additiona l structures that need  to be set up or a 
loss of income. These costs are always out weighed 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 contex t 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.)  1,9 13,6 13 
Safety and environment  + + + 
Social impacts   + + 
Transparency, access to 
information improved  + + + 
Subsidiarity + + + - 
6.2. Preferred option 
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 asp ects 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 26   EN • The whole process of setting up such an agency and making it work is time 
consuming, concrete results can only be e xpected 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 implem entation 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 in formation on the different Competent 
Authorities, the respective national lega l framework and the necessary forms.  
6.3. Political feasibility and social acceptance 
As radioactivity, and in particular nucl ear 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 agai n that the safety concept for 
the transport of radioactive materials ve ry 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 accepta ble 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 suppl y of radioisotopes 
in the medical sector. 
6.4. Proportionality 
The preferred option strikes a careful ba lance between effective protection of 
workers and the public during TRAM opera tions, the legitimate interests of the 
stakeholders involved and the interests of Member States. Above all, the preferred 
option is the minimum necessary to effectiv ely 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 obj ectives defined above. 
 
EN 27   EN DG Energy proposes to follow the expert advice  received and to evaluate the effects 
of this Regulation two years after it has ente red into force. This interim evaluation 
could reveal any difficulties and bottleneck s to be resolved. After this initial 
evaluation it might be useful to revisit the i ssue at five-year intervals to monitor what 
barriers to the smooth operation of the tran sport of radioactive materials in the 
European Union may still exist. 
Use could be made in this context of th e expert group which might be needed in 
order to advise the Commission on th e administrative re quirements under the 
proposed instrument. 
 
EN 28   EN Annex 1: Stakeholder consultati on during the supporting study  
A questionnaire was distributed among a series  of stakeholders: competent authorities, 
carriers, producers and users. Out of 556 st akeholders approached, just 64 respondents 
answered the questionnaire.  
SUMMARY TABLE OF THE FO CUSED CONSULTATION 
Answers (number) 
Organisation 
type Questions  Fully 
agree Agree Not 
agree Fully 
not 
agree 
Are actual TRAM problems? 2 14 3 2 
TRAM legislation is relevant in your country? 13 8 0 1 
Legislation is easy to understand? 4 13 4 0 
Legislation is not interpretable? 2 9 10 1 
Legislation is effective? 10 11 0 0 
Are important independent external audits?  7 9 5 1 
Clarity of the system can be improved for 
consignors 1 10 8 2 
The system is not clear for carriers 0 5 11 5 
The system is not clear for consignees 0 3 10 5 
You provided carriers standard sufficient 
information 5 9 4 3 
Import/export need notification in your country  7 10 1 1 
Licence required in your country 10 4 3 4 
Licence is not free of charges  15 4  
Transporters of radioisotopes only need 1 licence 6 3 7 1 
Licence should be valid in multiple countries 6 6 5 2 
Administrative burden is high in your country 1 4 9 6 
CA are responsible to control carriers  12 5 1 3 
CA are enough resources to control carriers 5 4 7 3 
CA are aware of other countries requirements for 
application procedures 7 11 4 0 
Are you in favour to harmonise the procedures 10 10 1 1 
Have you additional requirements to international 
ones 5 7 5 5 
Harmonisation should be done by the EC 6 10 1 3 
Besides safety, security requirements are needed 7 12 2 1 
Security provision in ADR are adequate  2 11 8 0 
CA collect data of TRAM 4 12 3 0 
Should vehicles be equipped with tracking devices 2 9 9 1  
Competent 
authorities 
 
Approached: 
27 
Respondents: 
22 
You have a safety plan in case of accident 11 10 0 0 
 
EN 29   EN Are actual TRAM problems? 6 6 1 0 
TRAM legislation is relevant in your country? 6 4 2 1 
Legislation is easy to understand? 1 3 5 4 
Legislation is not interpretable? 2 2 5 4 
Legislation is effective? 7 4 2 0 
Competent Authorities in your country  give you 
the necessary information 7 6 0 0 
Competent Authorities in other countries  give you 
the necessary information 3 7 0 2 
Licence required in your country 9 1 0 3 
High cost of licence  10 1  
Transporters of radioisotopes only need 1 licence 1 2 3 5 
Administrative burden is high in your country 7 3 2 0 
Not harmonised regulation on EU level causes 
unfair competition 5 2 4 1 
The use of an uniform transport document would 
minimise denial and delays 5 5 0 2 
You send on regular basis TRAM data to your CA 7 1 3 2 
Should vehicles be equipped with tracking devices 4 3 5 1 
You have a safety plan in case of accident 10 3 0 0 
Denials are a main problem 1 4 7 1 
Denials are most of the time related to the content 
of packages 0 3 7 3 
Denials are most of the time related to 
documentation of packages 0 4 8 1 
Denials are in many cases relative to the negative 
perception of RAM 3 4 3 1 
Denials are in many cases related to a lack of 
harmonisation of TRAM legislation 0 7 3 3 
Denials are in many cases related to non 
compliance with international requirements 0 5 4 4 
Denials are the most common for type B packages 0 4 6 3 
Denials occur only  for transboundary shipments 0 1 8 4  
Carriers 
Approached: 
351 
Respondents: 
13 
Training is the most e xpansive indirect cost 2 6 2 3 
Are actual TRAM problems? 2 13 6 0 
TRAM legislation is relevant in your country? 6 13 2 0 
Legislation is easy to understand? 3 7 6 6 
Legislation is not interpretable? 2 10 6 3 
Legislation is effective? 6 8 8 0 
Competent Authorities in your country  give you 
the necessary information 5 12 3 2  
Users 
Approached: 
132 
Respondents: 
22 
Administrative burden is high in your country 8 5 7 0 
 
EN 30   EN Are you in favour to harmonise the procedures 13 7 1 1 
Are actual TRAM problems? 4 3 0 0 
TRAM legislation is relevant in your country? 3 4 0 0 
Legislation is easy to understand? 1 4 2 0 
Legislation is not interpretable? 0 5 2 0 
Legislation is effective? 1 5 1 0 
Competent Authorities in your country  give you 
the necessary information 3 3 0 0 
Competent Authorities in other countries  give you 
the necessary information 0 2 2 0 
Administrative burden is high in your country 1 2 3 0 
The use of an uniform transport document would 
minimise denial and delays 0 3 2 0 
Denials are a main problem 2 2 1 0 
Denials are most of the time related to the content 
of packages 1 1 1 1 
Denials are most of the time related to documentation of packages 0 1 
2 1 
Denials are in many cases related to a lack of 
harmonisation of TRAM legislation 0 0 1 3 
Denials are in many cases related to non 
compliance with international requirements 0 0 1 3 
Denials are the most common for type B packages 0 1 1 1 
Denials occur only  for transboundary shipments 1 2 0 0 
Transport cost is a reasonable  part of the total cost  0 2 2 1  
Producers 
Approached: 
46 
Respondents:7  
There enough supply of carriers 0 0 4 1 
Due to the specificity and complexity of th e subject, the following statements should be 
advanced in the asse ssment of the results:  
The number of inputs (answers) r eceived in the different consu ltation 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 du e to their different 
involvement and role in TRAM activities (carri ers 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 31   EN Annex 2: Public consultation  
The questionnaire in the public consultation process by Internet included 36 technical 
questions, related to Safety (10 questions), Ad ministrative 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 an d 43 from organisations/stakeholders. The 
questions and an overview of th e distribution of replies are shown in the following table. 
SUMMARY TABLE OF PU BLIC CONSULTATION 
Answers (%) Theme General question 1:  
What problems do you perceive in the field of TRAM? Yes No No opinion 
The certification of containers 33 50 17 
Package approval 30 56 14 
Regulatory labelling / making of containers 17 70 13 Training of staff 30 63 7 
Conveyance / transport equipment 24 70 6 
Radiation protection programme 20 72 8 Physical protection 30 63 7 
Quality assurance management 20 74 6 
Track and trace system  24 59 17  
Safety  
Other 9 48 43 
Complexity for obtaining national permissions 41 50 9 
Complexity of notification procedures 32 59 9 
Cost for preparing / obtaining documentation 33 56 11 
Revalidation of package certificates 44 44 12 Staffing resources 41 48 11 
Transport documentation  20 69 11  
Administrative 
burden 
Other 9 48 43 
Import / export requirements 17 59 24 
Delay of shipments 33 50 17 
Denial of shipments 32 48 20 Additional fees affecting competitiveness 22 52 26 
Insurance 28 46 26  
Market 
Others 9 52 40 
Emergency, preparedness and response 30 61 9 
Citizens concerns 48 41 11 
Incident notification 24 69 7  
Public opinion 
Other 7 57 35 
 
Theme General question 2:  
What proposals you believe could contribute to solve 
the above mentioned problems?  
Yes  
No  
No opinion 
 
EN 32   EN No need of action 26 44 30 Business as 
usual Other 24 35 41 
Implement harmonised / common information systems  63 24 13 Common guides for transport preparation 74 18 7 
More efficiency emergency reports 33 62 15  
Soft law 
measures 
Others 12 44 44 
Amendment of Council Regulation 1493/93/Euratom 26 31 43 
New directive superseding current regulatory measures 28 33 39  
Regulatory 
measures Other 17 22 61 
 
EN 33   EN Annex 3: Impact calculations18 
This annex describes, in more detail, how the impacts presente d in chapter 5 of this report 
were calculated. To that effect, the annex presents first the assumptions used for the calculations followed by the assessm ent of the options themselves. 
The assessments take account of expert judg ements of researchers of ECORYS and the 
Nuclear Research Group (NRG), as well as inte rviews with competent authorities, producers 
and carriers. 
It must be noted, however, that all calculatio ns 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 real ity 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 reliabl e 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 esti mated 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 research ers proposed to apply coefficients, specific for 
every option and based on their expert judgement, to these estimated amou nts, 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 ed itorial changes and the 
focus on the administrative options. 
 
EN 34   EN burden by 5% and a Regulation by 30% the eff ective 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 bac kground on how the researchers came up with the 
coefficients for the options evaluated. 
Assumptions for the im pact assessment  
• Administrative burden for competent authorities 
A decrease or increase of the administrative burd en of the competent authorities is calculated 
with help of the fixed costs pe r competent authority. On basis of information of the competent 
authorities of France, Italy, Spain, Belgium an d 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 trai ning, and costs for participating in international meetings. For 
the whole EU, this amounts to € 6,48 million. 
• Administrative burden for car riers, 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 th e 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 comp etent authorities because of reducing the 
administrative burden would be used for additi onal 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, th is results in inspection costs of € 8.1 million. 
• Licence 
The costs of licences were not easy to estimat e because there are large differences between 
countries in Europe. Commission services have assumed that  1500 carriers are active on the 
European market with licences fo r 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-no tice) notifications of individual shipments. 
The costs of these are composed of three differe nt parts: the expenses for dealing with waste 
 
EN 35   EN as result of denials of shipment, the administ rative costs of denial s of shipment and the 
operational costs of denials of sh ipment. 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 re sending of the package and are guessed to be € 750. In addition, 
the carrier may face additional operational cost s in case the truck cannot continue, and the 
driver works additional hours, which is estima ted to cost € 1.500. For the purposes of this 
impact assessment 1.200 cases of denials a nd delays are assumed to happen per year. 
The table on the following page gives an overview of these assumptions:
 
EN 36   EN Assumptions for calculations of impacts 
Subject Part of Item (costs per 
year in €) Unit Unit price Price Source Variables       
Administrative 
burden CA Regulatory 
frame Cost of 
procedures, 
administration Cost per 
CA 240.000,00 € 6.480.000,00 €Consultation CA 
FR, BE, NL, ES, 
IT 27Number 
of CA     
Administrative burden carrier Regulatory 
frame Cost of 
procedures, administration Cost for 
carriers 1.045.898,00 € 4.706.541,00 €UK administrative 
burden calculations for 
dangerous goods  9UK=1/9 of 
EU 0,5 Convert 
into real terms 
Administrative bruden producer Regulatory 
frame Cost of 
procedures, administration Cost for 
producers 4.740.352,00 € 21.331.582,00 €UK administrative 
burden calculations for 
dangerous goods  9UK=1/9 of 
EU 0,5 Convert 
into real terms 
Administrative burden user Regulatory 
frame Cost of 
procedures, administration Cost for 
users 22.083,00 € 99.375,00 €UK administrative 
burden calculations for 
dangerous goods  9UK=1/9 of 
EU 0,5 Convert 
into real terms 
Inspection Public 
sector Cost of 
inspections Cost per 
inspector 100.000,00 € 8.100.000,00 € I nterview Isotopes 27 Coutries 3 Inspectors 
per 
country 
Licence Public 
sector Cost of licence Cost per 
licence 400,00 € 3.000.000,00 €Commission 
estimation 1500Number 
of carriers 5 Licences 
per carrier 
Denials Transport Cost of waste Cost per 
denial 5.000,00 € 6.000.000,00 €Expert judgement 
ECORYS/NRG 1200000Number 
of 
shipments     
Denials Transport Administrative 
costs Cost per 
denial 750,00 € 900.000,00 €Expert judgement 
ECORYS/NRG 1200000Number 
of 
shipments     
Denials Transport Operational 
costs Cost per 
denial 1.500,00 € 1.800.000,00 €Expert judgement 
ECORYS/NRG 1200000Number 
of shipments     
 
EN 37   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 fo r each of the categorie s 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 meas ure, negative values additional burden. 
  Recommendation Regulation EU Agency 
Regulatory frame     
Harmonisation Costs CA 5% 30% 40% 
Complexity Costs Carrier 5% 30% 40% 
Administrative burden Costs Producer 5% 30% 40% 
 Costs User 5% 30% 40% 
Public sector 
expenses, fees     
Inspection Costs Inspections -5% -15% -40% 
Licences Costs Licences 10% 60% 60% 
Institutional Costs Institution - 500.000 € -2.000.000 € -5.000.000 € 
Transport     
Delays and denials Costs denials and 
delays 10% 60% 60% 
In defining these values use was made of e xpert 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 th ese 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 im pacts 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 multila teral 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 licen ces will considerably decrease. This expectation 
is equal for the delays and denials in TR AM. 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 cost s are roughly assesse d and are strongly 
hypothetical.