This document is an excerpt from the EUR-Lex website
Document 52011SC1005
COMMISSION STAFF WORKING PAPER SUMMARY OF THE IMPACT ASSESSMENT
COMMISSION STAFF WORKING PAPER SUMMARY OF THE IMPACT ASSESSMENT
COMMISSION STAFF WORKING PAPER SUMMARY OF THE IMPACT ASSESSMENT
/* SEC/2011/1005 final - NLE 2011/0225 */
COMMISSION STAFF WORKING PAPER SUMMARY OF THE IMPACT ASSESSMENT /* SEC/2011/1005 final - NLE 2011/0225 */
TABLE OF CONTENTS 1........... Problem definition:.......................................................................................................... 2 2........... Analysis of Subsidiarity................................................................................................... 2 3........... Objectives of EU initiative............................................................................................... 2 4........... Policy options................................................................................................................. 2 4.1........ Baseline scenario: No policy changes/business as usual.................................................... 2 4.2........ Option 1: Commission Recommendation to harmonise implementation of
existing law; Website with access to legislation........................................................................................................................ 2 4.3........ Option 2: Regulation with harmonised rules and more efficient role
of the Competent Authorities 2 4.4........ Option 3: Regulation with a new EU Agency as central Competent
Authority................... 2 5........... Assessment of impacts.................................................................................................... 2 5.1........ Baseline scenario: No policy changes/business as usual.................................................... 2 5.2........ Option 1: Commission Recommendation to harmonise implementation of
existing law; Website with access to legislation........................................................................................................................ 2 5.3........ Option 2: Regulation with harmonised rules and more efficient role
of the Competent Authorities 2 5.4........ Option 3: Regulation with a new EU Agency as central Competent
Authority................... 2 6........... Comparison of options.................................................................................................... 2 7........... Monitoring and evaluation............................................................................................... 2
1.
Problem definition:
Radioactive materials are used in many
applications that help us in our daily lives, ranging from healthcare,
research, industrial manufacturing and agriculture to electric power
generation. Radioactive material (RAM) is shipped in packages varying from
small boxes with tiny amounts of radiopharmaceuticals for healthcare use to
heavy steel containers with spent nuclear fuel and vitrified waste from the
nuclear fuel cycle, both of which are highly radioactive materials. It is estimated that 2.5 million RAM
packages are shipped annually across the EU, which represents about 2% of all
dangerous goods packages. Most (nearly 90%) of these packages contain relatively
small quantities of RAM. Stakeholders involved in the transport of
radioactive materials (TRAM) have repeatedly voiced their concern about barriers
to the smooth functioning of TRAM activities in Europe. They complain about
a complex regulatory framework, differing requirements between Member States,
the multitude of licences, approvals and training courses needed for transports
involving more than one Member State, the high administrative burden and the
lack of controls and inspections. These elements lead to non-compliance, denials
and delays of shipments, barriers to entry (in particular for small and
medium-sized companies), risks for the supply to medical patients and
ultimately higher than necessary costs. These drivers and effects have been
summarised in picture above: Given the nature of RAM, its handling, use
and transport in the public domain, adequate attention is required in order to
protect the public and workers exposed to RAM and to prevent any releases to
the environment. The existing legislation, which ranges from non-binding
international regulations, binding modal rules and Community law to national
law, results in a level of control and supervision that is more intensive than
for other classes of dangerous goods. The complete set of rules is
multi-layered, which makes it very complex, although the main objective of
safety is attained (over the past decades there has never been a transport
incident that has caused significant radiological damage to persons or the
environment). In addition, there are major differences
between Member States in terms of procedures, assessments, administrative
requirements and application formats, which are not related to safety. Increasingly, the transport of radioactive
materials is becoming a case for specialised large carriers. As a result of the
complexity of the regulatory framework and the high costs that are associated
with compliance with the regulations, this does indeed create barriers to
market entry for new (and especially small and medium-sized) carriers. Due to
their specialisation, the remaining established carriers, in addition to
benefitting from the reduced competition, appear to be able to run TRAM without
major difficulties. Radioactive materials are widely used in
hospitals, most commonly for the purposes of diagnosis and treatment. Problems
with the transport of radioactive materials might have an impact on the
treatment of patients, especially in the case of last-minute shipments of short-lived
medical radioactive materials. The main issue with TRAM, when compared to
other classes of dangerous goods, is the existence of differing administrative
requirements when implementing the Basic Safety Standards Directive
96/29/Euratom. By defining transport as one of the "practices which
involve a risk from ionizing radiation", the Directive requires Member
States to establish a "reporting" system (requirement to submit a
document to the competent authority to notify their intention to carry out a
practice), while still allowing them to impose prior "authorization"
(a permission granted in a document by the competent authority to carry out a
practice, on application, or granted by national legislation). This enables the
competent authorities to check more closely whether the standards contained in
that Directive are being respected.
2.
Analysis of Subsidiarity
EU action is justified under Title II Chapter
3 of the Euratom Treaty, which provides the Community with the powers to set basic
standards of radiation protection and their implementation. At the same time,
this EU action in a growing market for transport services would harmonise and
effectively tackle the particular problems relating to trans-boundary shipments
which require a multitude of licences and approvals, and thereby create real
added value. Indeed, EU action can successfully help to
harmonise and simplify rules in the Community and to increase transparency,
while continuing to guarantee a high level of safety.
3.
Objectives of the EU initiative
The general objectives of TRAM
policy are directly linked to the fundamental objectives of EU policy, as
applied in this particular field, i.e. · to ensure and maintain adequate safety standards in order to protect
the public and the environment during transports of radioactive materials and · to aim at a European single market for services for the transport of
radioactive materials. Considering the specificities and
relatively low number of transports involving fissile materials, the main
problems concern radiopharmaceutical isotopes. Hence, the specific
objectives of the proposed Community action should be: · to guarantee the safety and health protection of citizens during the
transport of radioactive materials in the territory of the EU, · to help remove obstacles to the internal market in this sector, · to increase transparency in TRAM legislation, allowing carriers and
users to find the information needed and identify the authorities involved easily, · to create the appropriate legislative and organisational conditions
to ensure delivery in time and in good conditions of the life-saving
radioisotopes that are essential for trials and therapy treatments for a large
number of diseases. Finally, operational objectives are
related to the specific outputs of Community action: · to apply internationally accepted regulations so as to make
repetitive Member States rules obsolete, · to allow carriers to transport materials in the Community without
the need for additional administrative procedures for registration or licences
in other Member States, · to establish national Contact Points guiding carriers to the
relevant information and authorities, · to abandon notification requirements for individual transports for
radioactive materials – apart from fissile and high-consequence radioactive
materials.
4.
Policy options
In order to maintain the safety of TRAM
activities, simplify legislation, increase transparency and eliminate barriers
to a functioning internal market, and after comparing different experiences in
transport sectors as well as the available legal instruments, four options have
been evaluated.
4.1.
Baseline scenario: No policy changes/business as
usual
Under this option, the scope and content of
the existing EU legislation on TRAM would be kept in its present format. Member
States would be in a position to continue setting their own administrative
requirements for registering carriers of radioactive materials.
4.2.
Option 1: Commission Recommendation to harmonise
implementation of existing law; website with access to legislation
Under this option, the Commission would
make available a central website giving access to the different Competent
Authorities, the legal framework and the forms necessary in the different
Member States. In addition, a Commission Recommendation would interpret the
applicable rules of Directive 96/29 with a view to harmonising implementation and, in particular, to
urging the Member States to recognise, where necessary, the licences and
registrations issued by other Member States.
4.3.
Option 2: Regulation with harmonised rules and the
Competent Authorities playing a more efficient role
A Regulation would go one step further – by
proposing directly applicable harmonised rules such as a common registration
system for carriers which does away with the different systems used in the
Member States for reporting and authorization and giving carriers access to the
EU27 transport market in one "slimmed-down" procedure, while adopting
a graded approach. To allow for the necessary exchange of data, the Commission
would set up a secure online registration system.
4.4.
Option 3: Regulation with a new EU agency as
central Competent Authority
Going beyond option 2, while ensuring safe
standards and completing the internal market, an EU agency as central Competent
Authority would oversee all transport of radioactive materials in the European
Union and issue the licences and approvals needed, thereby replacing existing
procedures in the Member States, in a manner similar to the European Aviation
Safety Agency based in Cologne.
5.
Assessment of impacts
Although the options analysed by ECORYS -
the independent experts who carried out a supporting study for the Commission -
seem to have a rather modest impact from a global viewpoint, this impact does
matter to such a small sector. The impacts are categorised in five groups,
namely: Public sector expenses and fees, Regulatory effects, Transport, Safety
and environment, and Social impacts. Small and medium-sized companies are
expected to benefit in proportion to the total savings achieved under these
options: the higher the savings in total, the higher the savings for these
enterprises that nowadays are often effectively blocked out of the market.
5.1.
Baseline scenario: No policy changes/business as
usual
The absence of any serious accidents in the
past shows that the current legal framework does ensure safe transport
operations. The current inconsistencies in legislation and the high
administrative costs are likely to remain – potentially leading to reduced
competition, barriers to entry and risks to the supply of radioisotopes in the
medical field. The varying legal regimes in the Member States would continue to
exist and transporters would continue to suffer the burden described above.
5.2.
Option 1: Commission Recommendation to harmonise
implementation of existing law; Website with access to legislation
As a Recommendation on how to interpret
rules laid down in Directives is not binding in nature, differences between
Member States are likely to persist. Users, carriers and producers can expect
variations between those countries that have implemented the Recommendation and
those that have not. ECORYS estimated the savings at € 1.9 million per year
over the baseline scenario. Increasing transparency by making all
information available at one central point, in addition to the Recommendation,
could increase the impact while creating only a negligible strain on Commission
resources. This option does not guarantee the
reduction of the burden on the part of users, carriers and producers to the
extent possible. At the same time, the internal market is unlikely to be
completed.
5.3.
Option 2: Regulation with harmonised rules and a
more efficient role for the Competent Authorities
By providing, among others, for the mutual
recognition of licences for carriers, a Regulation would lead to savings of €
13.6 million per year over the baseline scenario. Such an approach would reduce
the bureaucratic burden on carriers, users and producers, while freeing up
resources in authorities, which could then be used , at least partially, for
compliance checks, the lack of which has been identified as one of the problems
mentioned above. Because a Regulation is binding, this
option will be effective in helping to attain the objectives - i.e. to simplify
the system, introduce transparency and eliminate barriers to a functioning
internal market, while maintaining a high level of safety.
5.4.
Option 3: Regulation with a new EU Agency as
central Competent Authority
This option combines the advantages of a
Regulation with a central and harmonised implementation of rules through a
central Competent Authority as EU agency. Savings could reach € 13 million
annually. An EU Agency in conjunction with a
Regulation will ultimately reduce the complexity of the framework by
harmonising it. Furthermore, according to the stakeholders, the number of
denials and delays would decrease. The biggest possible reduction is related to
the administrative burden because of the simplified regulatory framework. On
the other hand, running an EU Agency costs additional money, which is clearly
seen in the high costs for this policy option. Given the nature of the measures included
in this option, the objectives are achievable, although a certain doubt may
persist as to whether this option complies fully with the subsidiarity
principle and with the current restrained approach concerning new agencies.
6.
Comparison of options
The following comparative table summarises
the impact of the options: 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 || + || + || + || - With regard to the stated objectives, a
central European Competent Authority (option 3) appears to be a very effective
solution. However, the high costs involved with setting up such an agency
completely negate these advantages compared to option 2. In addition, such an
initiative is unlikely to succeed, due to opposition of the Member States, the
lengthy process needed to establish such an agency and concerns about
subsidiarity. Against this background, a Regulation making
use of the national Competent Authorities (option 2), which in addition leads
to the highest estimated savings of all of the options, is clearly the
preferred option. By simplifying parts of the existing legislation,
harmonising its implementation and providing for recognition of licences, this
option is effective, feasible and acceptable. Under certain circumstances, this option
could be complemented by setting up the website contained in option 1 with
information on the different Competent Authorities, the respective national
legal framework and the necessary forms. The preferred option strikes a careful
balance between effective protection of workers and the public during TRAM
operations, the legitimate interests of the stakeholders involved and the
interests of Member States. Above all, the preferred option is the minimum
necessary to effectively achieve the objectives, while keeping the costs within
reasonable limits.
7.
Monitoring and evaluation
Following the preferred option by making
use of a Regulation reduces the need for monitoring implementation in the
Member States, as a Regulation would apply immediately throughout the EU.
Nevertheless, the proposed change should also be evaluated against the
objectives defined above. DG Energy proposes to follow the expert
advice received and to evaluate the effects of this Regulation two years after
it has entered into force. This interim evaluation could reveal any
difficulties and bottlenecks to be resolved. After this initial evaluation, it
might be useful to revisit the issue at five-year intervals to monitor what
barriers to the smooth operation of the transport of radioactive materials in
the European Union may still exist. Use could be made in this context of the
expert group, which might be needed in order to advise the Commission on the
administrative requirements under the proposed instrument.