# EUR-Lex - 52012PC0561 - EN

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# 52012PC0561

**Proposal for a COUNCIL REGULATION establishing a Community system for registration of carriers of radioactive materials /* COM/2012/0561 final - 2011/0225 (NLE) */**

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EXPLANATORY MEMORANDUM

1.           JUSTIFICATION AND OBJECTIVE

At European level, carriers of radioactive
materials are covered by transport legislation under the Treaty on the
Functioning of the European Union (TFEU) and legislation on radiation-specific
aspects including the health protection of workers and the general public under
the Treaty establishing the European Atomic Energy Community (Euratom).

TFEU legislation has been simplified by
Directive 2008/68/EC of the European Parliament and of the Council of 24
September 2008 on the inland transport of dangerous goods by combining all
inland transport modes.

Council Directive 96/29/Euratom of 13 May
1996 lays down basic safety standards for the protection of the health of
workers and the general public against the dangers arising from ionising
radiation. According to Article 30 of the Treaty, these basic standards mean:

· maximum permissible doses compatible with adequate safety;

· maximum permissible levels of exposure and contamination;

· the fundamental principles governing the health surveillance of
workers.

In accordance with Article 33, Member
States must lay down appropriate provisions to ensure compliance with the basic
standards.

For the sake of protecting the health of
workers and the general public and to better focus their work, Member States’
authorities need to know which persons, organisations or undertakings to check
on. To that end, Articles 3 and 4 of the Directive require Member States to
submit certain practices involving a hazard from ionising radiation to a system
of reporting (notification) and prior authorisation or to prohibit certain
practices.

Directive 96/29/Euratom applies to all
practices which involve a risk from ionising radiation emanating from an
artificial source or from a natural radiation source, including transport.

Given the frequent cross-border nature of
transport operations, a carrier may have to comply with reporting and
authorisation procedures in several Member States. In addition, Member States
have implemented these procedures in different ways, thereby adding to the
complexity of transport operations.

Replacing these national reporting and
authorisation procedures with a single registration system for conducting
transport will therefore contribute to simplifying the procedure, reduce the
administrative burden and do away with barriers to entry, while the high
radiation protection levels reached will be maintained.

This Regulation replaces the reporting and
authorisation systems in the Member States for the purpose of implementing
Council Directive 96/29/Euratom with a single registration. The Regulation
establishes a European System for Carrier Registration. Carriers should apply
through a central web interface. These applications will be screened by the
respective national competent authority, which will issue the registration if
the applicant fulfils the basic safety standards. At the same time, the system
affords the competent authorities a better overview of the carriers that are
active in their country.

The Regulation adopts a graded approach by
exempting carriers who transport exclusively ‘excepted packages’ from the need
to register. On the other hand, the Regulation leaves it up to the Member
States to add additional registration requirements for carriers of fissile and
highly radioactive materials.

Other Community law and international rules
regarding physical protection, safeguards, and third-party liability continue
to apply. This is true, in particular, for Directive 2008/68/EC.

2.           LEGAL BASIS

The provisions of this Regulation relate to
the basic safety standards for the protection of the health of workers and the
general public. Consequently, the legal basis is Chapter 3 of the Treaty
establishing the European Atomic Energy Community, and, in particular, Articles
31 and 32 thereof.

3.           SUBSIDIARITY
AND PROPORTIONALITY

As recognised by the Court of Justice of
the European Union in its case-law, the provisions of Chapter 3 of the Euratom
Treaty on health and safety form a coherent whole conferring upon the
Commission powers of some considerable scope in order to protect the population
and the environment against risks of nuclear contamination[1].

Based on the Court’s ruling in Case
C-29/99, the existing basic safety standards, which are mainly at protecting
the health of workers and the general public against the dangers arising from
ionising radiations can be ‘supplemented’. The proposed
Regulation would supplement the basic safety standards provided for in Article
30 of the Euratom Treaty, which have been revised several times since the
Treaty entered into force and more recently on 13 May 1996 (Directive
96/29 Euratom)[2].

In its ruling of 10 December 2002 in Case
C-29/99, the Court favours a wide interpretation of the scope of Directive
96/29/Euratom, stating that ‘it is not appropriate, in order to define the
Community’s competencies, to draw an artificial distinction between the
protection of the health of the general public and the safety of sources of
ionising radiation’. The Court recognises that under Articles 30 to 32 of the
Euratom Treaty the Community possesses wide ‘legislative competence to
establish, for the purpose of health protection, a related authorisation system
which must be applied by the Member States. Such a legislative act constitutes
a measure supplementing the basic standards referred to in that article’. As
the proposed Regulation falls under the scope of Directive 96/29/Euratom, the
subsidiarity principle does not apply because of the exclusive nature of the
Community’s legislative powers under Chapter 3 of the
Euratom Treaty.

4.           BUDGETARY
IMPLICATIONS

Developing the registration system, whose
website will also include links to the competent authorities in Member States,
will cost roughly €1 million in operational appropriations followed by annual
running costs of €0.18 million. To oversee the development process existing
human resources costing €0.7 million would be required followed by assistance
costing €0.1 million annually.

For the purposes of the Advisory Committee
established under this Regulation, no additional budgetary implications would
be incurred if the Member States agreed to make use of the existing Standing
Working Group on the safe transport of radioactive materials. The financing for
covering meetings of the Committee (less than € 30.000 per year) will be
provided through redeployment of existing resources. No additional costs above
the allocation foreseen on the budget line will be incurred.

While the impact assessment report
accompanying this proposal refers to an optional website with additional
information on the competent authorities in the Member States, only a page with
basic information is to become part of the registration system so that no
additional costs will be incurred.

2011/0225 (NLE)

Proposal for a

COUNCIL REGULATION

establishing a Community system for
registration of carriers of radioactive materials

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing
the European Atomic Energy Community, and in particular the second paragraph of
Article 31 and Article 32 thereof,

Having regard to the proposal from the
Commission, drawn up after obtaining the opinion of a group of persons
appointed by the Scientific and Technical Committee,

Having regard to the opinion of the
European Economic and Social Committee[3],

Having regard to the opinion of the
European Parliament[4],

Whereas:

(1)       Article 33 of the Treaty
requires Member States to lay down the appropriate provisions to ensure
compliance with the basic safety standards for the protection of the health of
workers and the general public against the dangers arising from ionising
radiation.

(2)       The basic safety standards
for the protection of the health of workers and the general public against the
dangers arising from ionising radiation are established by Council Directive
96/29/Euratom of 13 May 1996[5].
That Directive applies to all practices which involve a risk of ionising
radiation emanating from an artificial or a natural radiation source, including
transport.

(3)       In order to ensure
compliance with the basic safety standards persons, organisations or
undertakings are subject to regulatory control by the authorities of the Member
States. For that purpose Directive 96/29/Euratom requires Member States to
submit certain practices involving a hazard from ionising radiation to a system
of reporting and prior authorisation or to prohibit certain practices.

(4)       Transport being the only
practice of a frequent cross-border nature, carriers of radioactive materials
may be required to comply with requirements related to reporting and
authorisation systems in several Member States. This Regulation replaces those
reporting and authorisation systems in the Member States with a single
registration system valid across the European Atomic Energy Community
(hereinafter the ‘Community’).

(5)       For carriers by air and
sea, such registration and certification systems already exist. Council
Regulation (EEC) No 3922/91 of 16 December 1991 on the harmonization of
technical requirements and administrative procedures in the field of civil aviation[6] lays down that air carriers
need a specific air operator certificate for the transportation of dangerous
goods. For transports by sea, Directive 2002/59/EC of the European Parliament
and of the Council of 27 June 2002 establishes a Community vessel traffic
monitoring and information system[7].
The certificates issued by the civil aviation authorities and the reporting
system for maritime vessels are deemed to satisfactorily implement the
reporting and authorisation requirements of Directive 96/29/Euratom.
Registration of air and sea carriers under this Regulation is therefore not
necessary to enable Member States to ensure compliance with the basic safety
standards in these transport modes.

(6)       Carriers of radioactive
material are subject to a number of requirements of Union and Euratom
legislation as well as international legal instruments. The International
Atomic Energy Agency (IAEA) Regulations for the Safe Transport of Radioactive
Material (TS-R-1) and the Modal Regulations for the Transport of Dangerous
Goods continue to apply directly or are implemented by Member States under
Directive 2008/68/EC of the European Parliament and of the Council of 24
September 2008 on the inland transport of dangerous goods[8] for road, rail and inland
waterway transport. The provisions of this Directive are, however, without
prejudice to the application of other provisions in the fields of occupational
safety and health and environmental protection.

(7)       In order to ensure uniform
conditions for implementation of this Regulation, implementing powers should be
conferred on the Commission. Those powers should be exercised in accordance
with Regulation (EU) No 182/2011 of the European Parliament and of the Council
of 16 February 2011 laying down the rules and general principles concerning
mechanisms for the control by the Member States of the Commission’s exercise of
implementing powers.

HAS ADOPTED THIS REGULATION

Article 1
Subject matter and scope

(1)
This Regulation establishes a Community system
for the registration of carriers of radioactive materials which facilitates the
Member States’ task of ensuring that the basic safety standards for the
protection of the health of workers and the general public against the dangers
arising from ionising radiations laid down in Directive 96/29/Euratom are
complied with.

(2)
This Regulation shall apply to any carrier
transporting radioactive materials within the Community, from third countries
into the Community and from the Community into third countries. It shall not
apply to carriers transporting radioactive materials by air and sea.

Article 2
Definitions

For the purposes of this Regulation

(a)
‘carrier’ means any person, organisation or
public undertaking conducting the carriage of radioactive material by any means
of transport in the Community. This includes carriers for hire or reward and
carriers on own account;

(b)
‘competent authority’ means any authority
designated by the Member State to carry out tasks provided for in this
Regulation;

(c)
‘transport’ means all transport operations from
the place of origin to the place of destination, including loading, storage in
transit and unloading of radioactive material;

(d)
‘radioactive material’ means any material
containing radionuclides where both the activity concentration and the total
activity in the consignment exceed the values specified in paragraphs 402–407
of the IAEA Regulations for the Safe Transport of Radioactive Material, Safety
Requirements No. TS-R-1, Vienna, 2009;

(e)
‘high consequence
dangerous goods - radioactive material’ means radioactive material which have
the potential for misuse in a terrorist incident and which may, as a result,
produce serious consequences such as mass casualties or mass destruction as defined in Appendix A.9. of the IAEA Nuclear Security Series No.9
‘Security in the Transport of Radioactive Material’, Vienna, 2008;

(f)
‘excepted package’ means any package in which
the allowed radioactive content does not exceed the activity levels laid down
in Table V of Section IV of the IAEA Regulations for the Safe Transport of
Radioactive Material, Safety Requirements No. TS-R-1, Vienna, 2009, or one
tenth of these limits for transport by post and which is labelled as UN No.
2908, 2909, 2910 or 2911;

(g)
‘fissile material’ means uranium-233,
uranium-235, plutonium-239 and plutonium-241 or any combination of these
radionuclides.

Article 3
General provisions

1.           Carriers of radioactive
materials shall have a valid registration obtained in
accordance with Article 5. The registration shall allow
the carrier to conduct transport throughout the whole Union.

2.           Individual transport
operations shall be accompanied by a copy of the carrier’s registration
certificate or by the licence or registration obtained in accordance with the
applicable national procedure in the case of transport referred to in paragraph
3.

3.           A holder of valid licences
or registrations issued in accordance with Directive 96/29/Euratom for the
handling of radioactive material or for the use of equipment containing
radioactive material or sources may transport these materials or sources
without registration under this Regulation if transportation is included in the
licences or registrations for all Member States where the transport takes
place.

4.           National reporting and
authorisation requirements that are additional to the requirements laid down by
this Regulation may only apply to the carriers of the following materials:

(a)
fissile material, except for natural uranium or
depleted uranium which has been irradiated in a thermal reactor only;

(b)
high consequence dangerous goods - radioactive
material.

5.           A registration shall not
be required for carriers transporting exclusively excepted packages.

Article 4
Electronic System for Carrier Registration (ESCReg)

1.           Electronic System for
Carrier Registration (ESCReg) shall be established and maintained by the
Commission for the supervision and control of the transport of radioactive
material. The Commission shall define the information to be included in the
system, technical specifications and requirements for the ESCReg.

2.           The ESCReg shall grant
restricted and secure access to the competent authorities of the Member States,
to registered carriers and to applicants, subject to the relevant provisions on
personal data protection, as laid down by Directive 95/46/EC of the European
Parliament and of the Council[9].
The competent authorities shall have access to all data available.

3.           The Commission shall not
be responsible for the content and the accuracy of information submitted
through the ESCReg.

Article 5
Registration procedure

1.           A carrier shall apply for
registration through the ESCReg.

The applicant carrier shall submit the
completed electronic application form set out in Annex I.

2.           Upon completion and
submission of the application form, the applicant shall receive an automatic
acknowledgement of receipt, together with an application number.

3.           If the applicant is
established in one or more Member States, the competent authority of the Member
State where the head office of the applicant is established shall process the
application.

If the applicant is established in a third
country, the competent authority of the Member State where the carrier intends
to first enter the territory of the Union shall process the application.

The competent authority of the Member State
which issues the first certificate of carrier registration shall issue also the
new certificate in the event of modification of data in accordance with Article
6.

4.           Within eight weeks of
issuing the acknowledgement of receipt the competent authority shall issue a
certificate of carrier registration if it considers the submitted information
to be complete and in compliance with this Regulation, Directive 96/29/Euratom
and Directive 2008/68/EC.

5.           The certificate of carrier
registration shall contain the information set out in Annex II and shall be
issued in the form of the standardized registration certificate through the
ESCReg.

A copy of the certificate of carrier
registration shall be provided automatically through the ESCReg to all the
competent authorities of the Member States where the carrier intends to
operate.

6.           If the competent authority
refuses to issue a certificate of carrier registration on the grounds that the
application is not complete or not in compliance with the applicable
requirements, it shall respond in writing to the applicant within eight weeks
after issuing the acknowledgement of receipt. Prior to such refusal, the
competent authority shall require that the applicant corrects or suplements the
application within three weeks from the receipt of this request. The competent authority
shall provide a statement of the reasons for refusal.

A copy of the refusal and statement of the
reasons shall be provided automatically through the ESCReg to all the competent
authorities of the Member States where the carrier intends to operate.

7.           If the request for a
certificate of carrier registration is refused, the applicant may lodge an
appeal in accordance with the applicable national legal requirements.

8.           A valid certificate of
registration shall be recognized by all Member States.

9.           The certificate of carrier
registration shall be valid for a period of five years and may be renewed upon
application by the carrier.

Article 6
Modification of data

1.           The carrier shall be
responsible for ensuring the continued accuracy of the data provided in the
application form for Community carrier registration submitted to the ESCReg.

2.           The carrier shall apply
for a new certificate in the event of modification of the data contained in
part A of the application form for Community carrier registration.

Article 7
Compliance assurance

1.           If a carrier does not
comply with the requirements of this Regulation the competent authority of the
Member State where the non-compliance was discovered shall apply enforcement
measures within the legal framework of that Member State, such as written
notices, training and education measures, suspension, revocation or
modification of the registration or prosecution, depending on the safety
significance of the non-compliance and the record of compliance of the carrier.

2.           The competent authority of
the Member State where the non-compliance was discovered shall communicate to
the carrier and to the competent authorities of the Member States where the
carrier was planning to transport radioactive materials, information on enforcement
action applied and a statement of reasons for application of that action. If
the carrier does not comply with the enforcement action applied pursuant to
paragraph 1, the competent authority of the Member State of establishment of
the head office of the carrier or, if the carrier is established in a third
country, the competent authority of the Member State, where the carrier
intended to first enter the territory of the Community shall revoke the
registration.

3.           The competent authority
shall communicate to the carrier and to the other competent authorities
concerned the revocation together with a statement of reasons.

Article 8
Competent authorities and national contact point

1.           Member States shall
designate a competent authority and a national contact point for the transport
of radioactive materials.

Member States shall forward to the Commission
not later than one month after the entry into force of this Regulation the
name(s), address(es) and all necessary information for rapid communication with
the competent authorities and with the national contact point for the transport
of radioactive materials, as well as any subsequent change to such data.

The Commission shall communicate this
information and any changes thereto to all competent authorities in the
Community through the ESCReg.

2.           The information on the
national rules on radiaton protection applicable to the transport of
radioactive materials shall be easily accessible to carriers through the
contact points.

3.           Upon carriers’ request the
contact point and the competent authority of the respective Member State shall
provide complete information on the requirements for the transport of
radioactive materials on the territory of that Member State.

The information shall be easily accessible at a
distance and by electronic means and kept up to date.

The contact points and the competent
authorities shall respond as quickly as possible to any request for information
and in cases where the request is faulty or unfounded, inform the applicant
accordingly without delay.

Article 9
Cooperation between competent authorities

Competent authorities of Member States
shall cooperate with a view to harmonising their requirements for issuing a
registration and to ensuring the harmonised application and enforcement of this
Regulation.

Where there are several competent
authorities within a Member State, they shall liaise and cooperate closely on
the basis of legal or formal agreements between them covering the
responsibilities of each authority. They shall communicate with and provide
information to each other, to the national contact point, and to other
governmental and non-governmental organisations that have related
responsibilities.

Article 10
Implementation

The Commission shall adopt
implementing acts establishing the Electronic System for Carrier Registration
(ESCReg) described in Article 4.

These implementing acts shall be
adopted in accordance with the advisory procedure referred to in Article 11.

Article 11
Advisory Committee

The Commission shall be
assisted by a committee. That committee shall be a committee within the meaning
of Regulation (EU) No 182/2011 of the European parliament and of the Council of
16 February 2011 laying down the rules and the general principles concerning
mechanisms for control by Member States of the Commission’s exercise of
implementing powers[10].

Where reference is made to this paragraph,
Article 4 of Regulation (EU) No 182/2011 shall apply.

The committee shall advise and assist the
Commission in the performance of its tasks provided for in this Regulation.

The committee shall be composed of experts
nominated by the Member States and of experts nominated by the Commission and
shall be chaired by a representative of the Commission.

Article 12
Entry into force

This
Regulation shall enter into force on the twentieth day following that of its
publication in the Official Journal of the European Union.

This Regulation shall be binding in its
entirety and directly applicable in all Member States.

Done at Brussels,

For
the Council

The
President

ANNEX

ANNEX I
APPLICATION FORM FOR COMMUNITY CARRIER REGISTRATION

PLEASE SEND THIS APPLICATION ONLY USING
THE EUROPEAN COMMISSION’S SECURE ELECTRONIC SYSTEM FOR CARRIER REGISTRATION
(ESCReg)

IF THERE IS ANY CHANGE IN THE
INFORMATION IN PART A, A NEW REGISTRATION MUST BE REQUESTED. The carrier is responsible for ensuring that the data provided in
the application form for Community carrier registration submitted through this
system remain accurate.

The information provided in the present
application form will be processed by the European Commission in compliance
with Directive 95/46/EC of the European Parliament and
of the Council.

⁭         NEW CERTIFICATE OF REGISTRATION

⁭         MODIFICATION OF AN EXISTING
REGISTRATION

⁭         RENEWAL OF AN EXISTING
REGISTRATION

Registration Certificate number/s:

Please give details of why a change to an
existing registration is being sought

1. IDENTIFICATION OF THE APPLICANT:

PART A || PART B

COMPANY NAME: FULL ADDRESS: NATIONAL REGISTRATION NUMBER: || 1. Name, position, full address, telephone number and e-mail-address of the responsible representative of the carrier’s organisation (person empowered to commit the carrier’s organisation): 2. Name, position, full address, telephone number and e-mail-address of the contact person for the authorities on technical/administrative issues (who has the responsibility for compliance with the regulations for the activities deployed by the carrier company): 3. Name, position and full address of the safety adviser (only for inland transport modes and if different from 1 or 2): 4. Name, position and full address of the person responsible for the implementation of the Radiation Protection Programme if different from 1 or 2 or 3:

2. NATURE OF TRANSPORT:

PART A || PART B

⁭         ROAD ⁭         RAIL ⁭         INLAND WATERWAYS ⁭ || 1 Staff involved and trained for transport (information) ⁭         1 to 5   ⁭         5 to 10 ⁭         10 to 20           ⁭         >20 2 Transport activity sector: general description of the nature of the transport activities to be undertaken (information) ⁭ medical use   ⁭ industrial use, non-destructive testing use, research           ⁭ nuclear fuel cycle use            ⁭ waste ⁪ high consequence dangerous goods - radioactive material

3. GEOGRAPHICAL COVERAGE

Please tick in the list below those Member
States in which radioactive material is planned to be transported and select
the nature of the activity

If activities are also deployed in Member States other than the Member State where the application for registration is made, please provide more specific details for every country, i.e. transit only, or major loading/unloading places within the particular country, frequency:

PART A || PART B

⁭Austria ⁭Belgium ⁭Bulgaria ⁭Cyprus ⁭Czech Republic ⁭Denmark ⁭Estonia ⁭Finland ⁭France ⁭Germany ⁭Greece ⁭Hungary ⁭Ireland ⁭Italy ⁭Latvia ⁭Lithuania ⁭Luxembourg ⁭Malta ⁭Netherlands ⁭Poland ⁭Portugal ⁭Romania ⁭Slovakia ⁭Slovenia ⁭Spain ⁭Sweden ⁭United Kingdom || ⁭ transit ⁭ unloading ⁭ loading major loading places: major unloading places: frequency: ⁭ daily ⁭ weekly ⁭ monthly ⁭ less frequent

4. TYPE OF CONSIGNMENTS

Registration is requested for:

PART A PACKAGE TYPE - Classification following TS-R-1 || PART B: Estimated number of packages /year

UN 2908 RADIOACTIVE MATERIAL, EXCEPTED PACKAGE — EMPTY PACKAGING UN 2909 RADIOACTIVE MATERIAL, EXCEPTED PACKAGE — ARTICLES MANUFACTURED FROM NATURAL URANIUM or DEPLETED URANIUM or NATURAL THORIUM UN 2910 RADIOACTIVE MATERIAL, EXCEPTED PACKAGE — LIMITED QUANTITY OF MATERIAL UN 2911 RADIOACTIVE MATERIAL, EXCEPTED PACKAGE — INSTRUMENTS or ARTICLES UN 2912 RADIOACTIVE MATERIAL, LOW SPECIFIC ACTIVITY (LSA-I), non-fissile or fissile excepted UN 2913 RADIOACTIVE MATERIAL, SURFACE CONTAMINATED OBJECTS (SCO-I or SCO-II), non-fissile or fissile excepted UN 2915 RADIOACTIVE MATERIAL, TYPE A PACKAGE, non-special form, non-fissile or fissile excepted UN 2916 RADIOACTIVE MATERIAL, TYPE B(U) PACKAGE, non-fissile or fissile excepted UN 2917 RADIOACTIVE MATERIAL, TYPE B(M) PACKAGE, non-fissile or fissile excepted UN 2919 RADIOACTIVE MATERIAL, TRANSPORTED UNDER SPECIAL ARRANGEMENT, non-fissile or fissile excepted UN 2977 RADIOACTIVE MATERIAL, URANIUM HEXAFLUORIDE, FISSILE UN 2978 RADIOACTIVE MATERIAL, URANIUM HEXAFLUORIDE, non-fissile or fissile excepted UN 3321 RADIOACTIVE MATERIAL, LOW SPECIFIC ACTIVITY (LSA-II), non-fissile or fissile excepted UN 3322 RADIOACTIVE MATERIAL, LOW SPECIFIC ACTIVITY (LSA-III), non-fissile or fissile excepted UN 3323 RADIOACTIVE MATERIAL, TYPE C PACKAGE, non-fissile or fissile excepted UN 3324 RADIOACTIVE MATERIAL, LOW SPECIFIC ACTIVITY (LSA-II), FISSILE UN 3325 RADIOACTIVE MATERIAL, LOW SPECIFIC ACTIVITY (LSA-III), FISSILE UN 3326 RADIOACTIVE MATERIAL, SURFACE CONTAMINATED OBJECTS (SCO-I or SCO-II), FISSILE UN 3327 RADIOACTIVE MATERIAL, TYPE A PACKAGE, FISSILE, non-special form UN 3328 RADIOACTIVE MATERIAL, TYPE B(U) PACKAGE, FISSILE UN 3329 RADIOACTIVE MATERIAL, TYPE B(M) PACKAGE, FISSILE UN 3330 RADIOACTIVE MATERIAL, TYPE C PACKAGE, FISSILE UN 3331 RADIOACTIVE MATERIAL, TRANSPORTED UNDER SPECIAL ARRANGEMENT, FISSILE UN 3332 RADIOACTIVE MATERIAL, TYPE A PACKAGE, SPECIAL FORM, non-fissile or fissile excepted UN 3333 RADIOACTIVE MATERIAL, TYPE A PACKAGE, SPECIAL FORM, FISSILE ||

5. RADIATION PROTECTION PROGRAMME (RPP)

PART A: ⁭By ticking this box: I declare that we have an RPP that is fully implemented and strictly applied || PART B: reference and date of the document describing the RPP Upload of the RPP

6. QUALITY ASSURANCE PROGRAMME (QAP)

This QAP must be available for inspection
by the competent authority (in accordance Article 1(7)(3) of the ADR)

PART A: ⁭By ticking this box: I declare that we have a QAP that is fully implemented and strictly applied || PART B: Reference and date of the document

7. Declaration

⁭ I, the carrier, hereby certify that I
comply with all the relevant international, Community and national regulations
relating to the transport of radioactive materials.

⁭ I, the carrier, hereby certify that the
information contained in this form is correct.

Date ...........  Name ...................  Signature .........

ANNEX II
ELECTRONIC CERTIFICATE OF CARRIER
REGISTRATION FOR THE TRANSPORT OF RADIOACTIVE MATERIAL

NOTE:

A COPY OF THIS CERTIFICATE OF REGISTRATION
SHALL ACCOMPANY EACH TRANSPORT FALLING UNDER THE SCOPE OF THIS REGULATION.

This certificate of registration is issued
in compliance with Council Regulation (Euratom) xxxxx

This certificate does not relieve the
carrier from compliance with the other applicable transport regulations.

1) REGISTRATION REFERENCE NUMBER: BE/ xxxx
/ dd-mm-yyyy

2) NAME OF THE AUTHORITY / COUNTRY:

3) COMPANY NAME & ADDRESS

4) MODE OF TRANSPORT:

⁭         ROAD
⁭         RAIL
⁭         INLAND WATERWAYS

7) MEMBER STATES where the certificate is
applicable

8) PACKAGE TYPE – UN NUMBER (see annex
1- same format )

9) DATE

ELECTRONIC SIGNATURE

VALIDITY PERIOD : DATE + 5 years

LEGISLATIVE FINANCIAL STATEMENT

1.           FRAMEWORK OF THE PROPOSAL/INITIATIVE

1.1.    Title of the proposal/initiative

1.2.    Policy
area(s) concerned in the ABM/ABB structure

1.3.    Nature
of the proposal/initiative

1.4.    Objective(s)

1.5.    Grounds
for the proposal/initiative

1.6.    Duration
and financial impact

1.7.    Management
method(s) envisaged

2.           MANAGEMENT MEASURES

2.1.    Monitoring
and reporting rules

2.2.    Management
and control system

2.3.    Measures
to prevent fraud and irregularities

3.           ESTIMATED FINANCIAL IMPACT OF THE
PROPOSAL/INITIATIVE

3.1.    Heading(s)
of the multiannual financial framework and expenditure budget line(s) affected

3.2.    Estimated
impact on expenditure

3.2.1. Summary of
estimated impact on expenditure

3.2.2. Estimated impact
on operational appropriations

3.2.3. Estimated impact
on appropriations of an administrative nature

3.2.4. Compatibility
with the current multiannual financial framework

3.2.5. Third-party
participation in financing

3.3.    Estimated impact on revenue

LEGISLATIVE FINANCIAL STATEMENT

1.           FRAMEWORK OF THE PROPOSAL/INITIATIVE

1.1.        Title of the
proposal/initiative

COUNCIL REGULATION establishing a Community system for registration
of carriers of radioactive materials

1.2.        Policy area(s) concerned
in the ABM/ABB structure[11]

Energy

Nuclear safety

1.3.        Nature of the
proposal/initiative

X The proposal/initiative relates to a
new action

 ̈ The proposal/initiative relates to a new action
following a pilot project/preparatory action[12]

 ̈ The
proposal/initiative relates to the extension of an existing action

 ̈ The proposal/initiative relates to an action redirected
towards a new action

1.4.        Objectives

1.4.1.     The Commission's
multiannual strategic objective(s) targeted by the proposal/initiative

1. Sustainable Growth

1a. Competitiveness for growth and employment

The general objectives of the proposal are
directly linked to the fundamental objectives of EU policy, as applied in this
specific field, that is,

•        to ensure and maintain adequate safety
standards to protect the public and the environment during transports of
radioactive materials and

•        to aim at an European single market for
transport services of radioactive materials

1.4.2.     Specific objective(s) and
ABM/ABB activity(ies) concerned

The specific objectives of the proposed Community action should be

•        to guarantee safety and health protection of citizens
during the transport of radioactive materials in the territory of the EU,

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

•        to increase transparency in TRAM legislation allowing
carriers and users to easily find the information needed and authorities
involved,

•        to create the appropriate legislative and organisational
conditions to ensure delivery in time and in good conditions of lifesaving
radioisotopes essential for trials and therapy treatments concerning 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
licenses in other Member States,

•        to establish national Contact Points guiding carriers to
the information and authorities needed,

•        to drop notification requirements for individual transports
for radioactive materials – apart from fissile and high-consequence radioactive
materials.

With regards to expenditure the objective is to develop and maintain
a the European System of Carrier Registration.

ABM/ABB activity(ies) concerned

32 05 Nuclear Energy

1.4.3.     Expected result(s) and
impact

Specify
the effects which the proposal/initiative should have on the
beneficiaries/groups targeted.

Results

•        to ensure and maintain adequate safety standards to protect
the public and the environment during transports of radioactive materials and

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

Impact:

By providing for, among others, the mutual
recognition of licences for carriers, the Regulation is expected to lead to annual
savings of € 13.6 million per year across the economy. The proposed approach
would reduce the bureaucratic burden on carriers, users and producers while
freeing resources in authorities, which then could be partially, at least, used
for compliance checks.

The savings coming from an improved regulatory
frame total (Fewer derogations from the regulative framework; better and
harmonised rules at European level; Reduced complexity of regulations; Decrease
of costs due to less administrative burden; Costs of additional requirements in
national law; Less time needed for approvals) would total € 9.8 million while
costs for transport operations would be reduced by € 5.2 million (Decrease in
delays of trans-boundary shipments; Decrease of denials and non-compliance of
shipments; Tear down entry barriers for small and medium-sized enterprises).

These savings of € 15 million would be countered
by public sector costs of € 1.4 million per year including the set-up and
running costs of the registration system.

The Regulation will effectively simplify the current
approval systems, introduce transparency and eliminate barriers to a
functioning internal market while maintaining a high level of safety.

1.4.4.     Indicators of results and
impact

Specify
the indicators for monitoring implementation of the proposal/initiative.

The European Commission will closely follow the impacts of the
Regulation through intensive consultation of the stakeholdes involved: Member
States, carriers and those demanding such transport services.

The lack of reliable statistics in the area makes it difficult to
quantify exact targets. The close contacts Commission services have with all
stakeholders should allow, however, whether the specific objectives of this
initiative are met:

•        to guarantee safety and health
protection of citizens during the transport of radioactive materials in the
territory of the EU,

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

•        to increase transparency in legislation
allowing carriers and users to easily find the information needed and
authorities involved,

•        to create the appropriate legislative
and organisational conditions to ensure delivery in time and in good conditions
of lifesaving radioisotopes essential for trials and therapy treatments
concerning a large number of diseases

With regards to the registration system, the
following indicators will be used:

•        To have the system operational in time
and on budget;

•        The features provided fully comply with
the Regulation;

•        The system is user friendly

1.5.        Grounds for the proposal/initiative

1.5.1.     Requirement(s) to be met in
the short or long term

The registration system must be fully and reliably available.

1.5.2.     Added value of EU
involvement

Taking into account

•        the need to provide for high safety standards for the transport
of radioactive materials in all 27 Member States ,

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

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

1.5.3.     Lessons learned from
similar experiences in the past

Opening the full potential of the internal market has provided
benefits to both consumers and producers or service providers.

1.5.4.     Coherence and possible
synergy with other relevant instruments

The Regulation is fully in line with the general objectives of the
EU/Euratom (single market, protection of workers and the public).

1.6.        Duration and financial
impact

 ̈ Proposal/initiative of limited duration

–  ̈  Proposal/initiative in effect from [DD/MM]YYYY to
[DD/MM]YYYY

–  ̈  Financial impact from YYYY to YYYY

X Proposal/initiative of unlimited
duration

– Implementation with a start-up period from Year
N[13] to Year N+3,

– followed by full-scale operation.

1.7.        Management mode(s)
envisaged[14]

X Centralised direct
management by the Commission

 ̈ Centralised indirect management with the delegation of implementation tasks to:

–  ̈  executive agencies

–  ̈  bodies set up by the Communities[15]

–  ̈  national public-sector bodies/bodies with public-service
mission

–  ̈  persons entrusted with the implementation of specific
actions pursuant to Title V of the Treaty on European Union and identified in
the relevant basic act within the meaning of Article 49 of the Financial
Regulation

 ̈ Shared
management with the Member
States

 ̈ Decentralised
management with third countries

 ̈ Joint
management with international
organisations (to be specified)

If more
than one management mode is indicated, please provide details in the
"Comments" section.

Comments

2.           MANAGEMENT MEASURES

2.1.        Monitoring and reporting
rules

Specify
frequency and conditions.

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

2.2.        Management and control
system

2.2.1.     Risk(s) identified

MS unwilling to make the necessary investments (in terms of effort)
in the project

Legal base delay. The proposal is being adopted
by the EC but with an unknown time horizons on the Council outcomes

Legal base blockage for whatever reason (eg. The
proposal will not reach the requested majority in the Council)

The final text of the Regulation will differ
significantly with respect to the actual version

National authorization procedures are difficult
to be integrated in a unified EU27 framework

The subcontractor may not deliver the project at
the required quality level and, as a result, the reliability of the total
system may not meet performance specifications.

Requirements mismatch

Architecture faults; difficulty in integrating commercial
off-the-shelf software

2.2.2.     Control method(s) envisaged

The development of the registration systems follows the guidelines
set by DIGIT and will make use of the DIGIT Framework Contracts in place and
therefore follow the standard procedure in agreement with the Financial
Regulation including all the controls foreseen there. In addition, hosting will
be done through administrative agreement with DIGIT.

2.3.        Measures to prevent fraud
and irregularities

Specify
existing or envisaged prevention and protection measures.

DG ENER will apply all regulatory control mechanisms.

3.           ESTIMATED FINANCIAL IMPACT OF THE
PROPOSAL/INITIATIVE

3.1.        Heading(s) of the
multiannual financial framework and expenditure budget line(s) affected

· Existing expenditure budget lines

In order of multiannual financial framework headings and
budget lines.

Heading of multiannual financial framework || Budget line || Type of expenditure || Contribution

Number [Description........................................] || Diff./non-diff. ([16]) || from EFTA[17] countries || from candidate countries[18] || from third countries || within the meaning of Article 18(1)(aa) of the Financial Regulation

N°1 || 32.0502 "Sureté Nucléaire et Radioprotection" || Diff || NO || NO || NO || NO

· New budget lines requested

In
order
of multiannual financial framework headings and budget lines.

Heading of multiannual financial framework || Budget line || Type of expenditure || Contribution

Number [Heading............................................] || Diff./non-diff. || from EFTA countries || from candidate countries || from third countries || within the meaning of Article 18(1)(aa) of the Financial Regulation

|| [XX.YY.YY.YY] || || YES/NO || YES/NO || YES/NO || YES/NO

3.2.        Estimated impact on
expenditure

3.2.1.     Summary of estimated impact
on expenditure

EUR million (to 3 decimal places)

Heading of multiannual financial framework: || 1a || Competitiveness for growth and employment

DG: ENER || || || N || N+1 || N+2 || N+3 || N+4 and next || TOTAL

 Operational appropriations [19] || || || || || || || ||

32.0502 || Commitments || (1) || 0.142 || 0.471 || 0.412 || 0.193 || 0.177 || 0.177 || 0.177 ||

Payments || (2) || 0.100 || 0.450 || 0.400 || 0.200 || 0.200 || 0.200 || 0.199 ||

|| || || || || || || || || ||

|| || || || || || || || ||

Appropriations of an administrative nature financed  from the envelope for specific programmes[20] || || || || || || || ||

Number of budget line || || (3) || || || || || || || ||

TOTAL appropriations for DG ENER || Commitments || =1+1a +3 || 0.142 || 0.471 || 0.412 || 0.193 || 0.177 || 0.177 || 0.177 ||

Payments || =2+2a +3 || 0.100 || 0.450 || 0.400 || 0.200 || 0.200 || 0.200 || 0.197 ||

 TOTAL operational appropriations || Commitments || (4) || 0.142 || 0.471 || 0.412 || 0.193 || 0.177 || 0.177 || 0.177 ||

Payments || (5) || 0.100 || 0.450 || 0.400 || 0.200 || 0.200 || 0.200 || 0.197 ||

 TOTAL appropriations of an administrative nature financed from the envelope for specific programmes || (6) || || || || || || || ||

TOTAL appropriations under HEADING N°1 of the multiannual financial framework || Commitments || =4+ 6 || 0.142 || 0.471 || 0.412 || 0.193 || 0.177 || 0.177 || 0.177 ||

Payments || =5+ 6 || 0.100 || 0.450 || 0.400 || 0.200 || 0.200 || 0.200 || 0.197 ||

If more than one heading is affected by
the proposal / initiative:

 TOTAL operational appropriations || Commitments || (4) || || || || || || || ||

Payments || (5) || || || || || || || ||

 TOTAL appropriations of an administrative nature financed from the envelope for specific programmes || (6) || || || || || || || ||

TOTAL appropriations under HEADINGS 1 to 4 of the multiannual financial framework (Reference amount) || Commitments || =4+ 6 || || || || || || || ||

Payments || =5+ 6 || || || || || || || ||

Heading of multiannual financial framework: || 5 || " Administrative expenditure "

EUR million (to 3 decimal places)

|| || || Year N || Year N+1 || Year N+2 || Year N+3 || N+4 and next || TOTAL

DG: ENER ||

 Human resources || 0,191 || 0,318 || 0,191 || 0,095 || 0,095 || 0,095 || 0,095 ||

 Other administrative expenditure || 0,05 || 0,05 || 0,05 || 0,05 || 0,03 || 0,03 || 0,03 ||

TOTAL DG ENER || Appropriations || 0,241 || 0,368 || 0,241 || 0,145 || 0,125 || 0,125 || 0,125 ||

TOTAL appropriations under HEADING 5 of the multiannual financial framework || (Total commitments = Total payments) || 0,241 || 0,368 || 0,241 || 0,145 || 0,125 || 0,125 || 0,125 ||

EUR million (to 3 decimal places)

|| || || Year N || Year N+1 || Year N+2 || Year N+3 || N+4 and next || TOTAL

TOTAL appropriations under HEADINGS 1 to 5 of the multiannual financial framework || Commitments || 0,383 || 0,838 || 0,653 || 0,338 || 0,302 || 0,302 || 0,302 ||

Payments || 0,341 || 0,818 || 0,641 || 0,345 || 0,325 || 0,325 || 0,320 ||

3.2.2.     Estimated impact on
operational appropriations

–  ̈  The proposal/initiative does not require the use of
operational appropriations

– x   The proposal/initiative requires the use of
operational appropriations, as explained below:

Commitment appropriations in EUR million
(to 3 decimal places)

Indicate objectives and outputs ò || || || N || N+1 || N+2 || N+3 || N+4 and next || TOTAL

OUTPUTS

Type of output[21] || Average cost of the output || Number of outputs || Cost || Number of outputs || Cost || Number of outputs || Cost || Number of outputs || Cost || Number of outputs || Cost || Number of outputs || Cost || Number of outputs || Cost || Total number of outputs || Total cost

SPECIFIC OBJECTIVE No 1[22]... || || || || || || || || || || || || || || || ||

European System for Carrier Registration || || || || 0.142 || || 0.471 || || 0.412 || || 0.193 || || 0,177 || || 0.177 || || 0.177 || ||

3.2.3.     Estimated impact on
appropriations of an administrative nature

3.2.3.1.  Summary

–  ̈  The proposal/initiative does not require the use of
administrative appropriations

– x   The proposal/initiative requires the use of
administrative appropriations, as explained below:

EUR
million (to 3 decimal places)

|| N || N+1 || N+2 || N+3 || N+4 and next || TOTAL

HEADING 5 of the multiannual financial framework || || || || || || || ||

Human resources || 0,191 || 0,318 || 0,191 || 0,095 || 0,095 || 0,095 || 0,095 ||

Other administrative expenditure || 0,05 || 0,05 || 0,05 || 0,05 || 0,03 || 0,03 || 0,03 ||

Subtotal HEADING 5 of the multiannual financial framework || 0,241 || 0,368 || 0,241 || 0,145 || 0,125 || 0,125 || 0,125 ||

Outside HEADING 5[23] of the multiannual financial framework || || || || || || || ||

Human resources || || || || || || || ||

Other expenditure of an administrative nature || || || || || || || ||

Subtotal outside HEADING 5 of the multiannual financial framework || || || || || || || ||

TOTAL || 0,241 || 0,368 || 0,241 || 0,145 || 0,125 || 0,125 || 0,125 || 1,37

3.2.3.2.  Estimated requirements of
human resources

–  ̈  The proposal/initiative does not require the use of human
resources

– X  The proposal/initiative requires the use of
human resources, as explained below:

Estimate to be expressed in
full amounts (or at most to one decimal place)

|| N || N+1 || N+2 || N+3 || N+4 and next

 Establishment plan posts (officials and temporary agents)

XX 01 01 01 (Headquarters and Commission’s Representation Offices) || 1,5 || 2,5 || 1,5 || 0,75 || 0,75 || 0,75 || 0,75

XX 01 01 02 (Delegations) || || || || || || ||

XX 01 05 01 (Indirect research) || || || || || || ||

10 01 05 01 (Direct research) || || || || || || ||

 External personnel (in Full Time Equivalent unit: FTE)[24]

XX 01 02 01 (CA, INT, SNE from the "global envelope") || || || || || || ||

XX 01 02 02 (CA, INT, JED, LA and SNE in the delegations) || || || || || || ||

XX 01 04 yy [25] || - at Headquarters[26] || || || || || || ||

- in delegations || || || || || || ||

XX 01 05 02 (CA, INT, SNE - Indirect research) || || || || || || ||

10 01 05 02 (CA, INT, SNE - Direct research) || || || || || || ||

Other budget lines (specify) || || || || || || ||

TOTAL || 1,5 || 2,5 || 1,5 || 0,75 || 0,75 || 0,75 || 0,75

Nuclear safety is the policy area or budget title concerned.

The human
resources required will be met by staff from the DG who are already assigned to
management of the action and/or have been redeployed within the DG, together if
necessary with any additional allocation which may be granted to the managing
DG under the annual allocation procedure and in the light of budgetary
constraints.

Description
of tasks to be carried out:

Officials and temporary agents || Development of the European System of carrier Registration

External personnel ||

3.2.4.     Compatibility with the
current multiannual financial framework

– X  Proposal/initiative is compatible with both
2007-2013 and 2014-2010 multiannual financial frameworks.

–  ̈  Proposal/initiative will entail reprogramming of the
relevant heading in the multiannual financial framework.

Explain what reprogramming is
required, specifying the budget lines concerned and the corresponding amounts.

–  ̈  Proposal/initiative requires application of the
flexibility instrument or revision of the multiannual financial framework[27].

Explain what is required,
specifying the headings and budget lines concerned and the corresponding
amounts.

3.2.5.     Third-party contributions

– The proposal/initiative does not provide for
co-financing by third parties

3.3.        Estimated impact on
revenue

– X  Proposal/initiative has no financial impact
on revenue.

–  ̈  Proposal/initiative has the following financial impact:

–
 ̈         on own resources

–
 ̈         on miscellaneous revenue

EUR million (to 3 decimal places)

Budget revenue line: || Appropriations available for the ongoing budget year || Impact of the proposal/initiative[28]

Year N || Year N+1 || Year N+2 || Year N+3 || ... insert as many columns as necessary in order to reflect the duration of the impact (see point 1.6)

Article ............. || || || || || || || ||

For
miscellaneous assigned revenue, specify the budget expenditure line(s)
affected.

Specify
the method for calculating the impact on revenue.

[1]               C-187/87 (1988 ECR p.5013) and
C-29/99 (2002 ECR p. I-11221)

[2]               OJ L 159, 29.6.1996, p. 1.

[3]               OJ C 143, 22.5.2012, p. 110.

[4]               OJ , , , p. .

[5]               OJ L 159, 29.6.1996, p. 1.

[6]               OJ L 373, 31.12.1991, p. 4.

[7]               OJ L 208, 5.8.2002, p. 10.

[8]               OJ L 260, 30.9.2008, p. 13.

[9]               OJ L 281, 23.11.1995, p. 31.

[10]             OJ L 55, 28.2.2011, p. 13.

[11]             ABM: Activity-Based Management – ABB: Activity-Based
Budgeting.

[12]             As referred to in Article 49(6)(a) or (b) of the
Financial Regulation.

[13]             Year N is the first year after
the Adoption of a Council Regulation establishing a Community system for
registration of carriers of radioactive materials.

[14]             Details of management modes and references to the
Financial Regulation may be found on the BudgWeb site: http://www.cc.cec/budg/man/budgmanag/budgmanag_en.html

[15]             As referred to in Article 185 of the Financial
Regulation.

[16]             Diff. = Differentiated appropriations / Non-diff. =
Non-Differentiated Appropriations

[17]             EFTA: European Free Trade Association.

[18]             Candidate countries and, where applicable, potential
candidate countries from the Western Balkans.

[19]             The commitments are split as follows; the payments are
slightly deferred taking into account how the contractors are expected to be
reimbursed. The running costs covering maintenance, support and infrastructure
will be phased in and be stable at € 177000 from 2016 .

|| N || N+1 || N+2 || N+3 || N+4

Development || 114 || 352 || 116 || ||

Test || 9 || 44 || 122 || ||

Maintenance || || || 29 || 58 || 52

Support || || || 50 || 50 || 50

Training || || || 20 || 10 ||

Infrastructure || 19 || 75 || 75 || 75 || 75

|| 142 || 471 || 412 || 193 || 177

[20]             Technical and/or administrative assistance and
expenditure in support of the implementation of EU programmes and/or actions
(former "BA" lines), indirect research, direct research.

[21]             Outputs are products and services to be supplied (e.g.:
number of student exchanges financed, number of km of roads built, etc.).

[22]             As described in Section 1.4.2. "Specific
objective(s)..."

[23]             Technical and/or administrative assistance and
expenditure in support of the implementation of EU programmes and/or actions
(former "BA" lines), indirect research, direct research.

[24]             CA= Contract Agent; INT= agency staff ("Intérimaire");
JED= "Jeune Expert en Délégation" (Young Experts in
Delegations); LA= Local Agent; SNE= Seconded National Expert;

[25]             Under
the ceiling for external personnel from operational
appropriations (former "BA" lines).

[26]             Essentially for Structural Funds, European Agricultural
Fund for Rural Development (EAFRD) and European Fisheries Fund (EFF).

[27]             See points 19 and 24 of the Interinstitutional
Agreement.

[28]             As regards traditional own resources (customs duties,
sugar levies), the amounts indicated must be net amounts, i.e. gross amounts
after deduction of 25% for collection costs.