Proposal for a Council Directive on the control of high activity sealed radioactive sources
Date: 2002-03-18
Institutions: European Commission
Subjects: nuclear accident, nuclear safety, radiation protection, radioactive materials, radioactivity

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Proposal for a Council Directive on the control of high activity sealed radioactive sources

(2002/C 151 E/25)

(Text with EEA relevance)

COM(2002) 130 final

(Submitted by the Commission on 18 March 2002)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Atomic
Energy Community, and in particular Articles 31(2) and 32
thereof,

and for the environment and therefore need to be subject
from the moment they are manu-
to a strict control
conferred to a
factured to the moment
recognised installation for
long-term storage or
disposal.

they are
their

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, from among scientific
experts in the Member States, in accordance with Article 31 of
Energy
the Treaty
the
Community and, having regard to the opinion of
the
Economic and Social Committee,

European Atomic

establishing

Having regard to the opinion of the European Parliament,

Whereas:

(1) Article 30 of the Euratom Treaty requires basic standards
to be laid down within the Community for the protection
of the health of workers and the general public against
the dangers arising from ionising radiation.

(2) 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 ionising radiation (1), continues the
line of directives laying down basic safety standards since
1959.

(3) Council Directive 96/29/Euratom in Article 4(1)(e)
requires prior authorisation for, amongst other practices,
the use of radioactive sources for industrial radiography
or processing of products or research or the exposure of
persons for medical treatment. It is appropriate to extend
this requirement to all practices involving high activity
radioactive sources.

(4) Shipments of sealed sources between Member States are
subject to the procedure established by Council Regu-
lation (Euratom) No 1493/93 of 8 June 1993 on
radioactive substances between Member
shipments of
States (2).

(6) Prevention of radiological accidents and injuries requires
that
location of each high activity source is known,
recorded and verified from the moment the source is
manufactured or imported into the Community to the
moment it is transferred to a recognised installation for
its long-term storage or its disposal or it is exported from
the Community. Physical or financial obstacles should not
hinder an appropriate reuse, recycling or disposal of such
sources when disused under any reasonably foreseeable
circumstances.

(7) Movements within the Community of high activity
sources make it necessary to harmonise the control of
such sources through the application of minimum criteria.

(8) The experience shows that, despite the existence of an
appropriate regulatory framework, high activity sources
may nevertheless get out of control. Furthermore,
the
existence of orphan sources resulting from past activities
(the historical legacy) requires that specific initiatives be
undertaken.

(9) Accordingly,

it is necessary to provide for the identifi-
cation, marking and record-keeping of each high activity
source as well as for specific training and information of
those involved in activities related to the use of
all
sources.
is advisable to provide also appropriate
training and information to those who may deal acci-
dentally with orphan sources.

It

(10) It

is also necessary to provide for suitable means of
inter-
for
dealing with orphan high activity sources,
information in
national cooperation and exchange of
this
for making
financial provision for the circumstances in which the
original holder either cannot be identified or, even if
identified, is found to be insolvent.

inspection and,

finally,

area,

for

(5) Although the legal requirements deriving from existing
legislation ensure basic protection, high activity sources
still imply considerable potential risks for human health

(11) The IAEA issues regulations for the safe transport of
radioactive material (3) that include activity limits for the
requirements of the regulations.

(1) OJ L 159, 29.6.1996, p. 1.
(2) OJ L 148, 19.6.1993, p. 1.

(3) IAEA Safety Standards Series No TS-R-1 (ST-1, Revised), Vienna,

2000.

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(12) The Member States should lay down rules on penalties
applicable to infringements of
this
Directive and ensure that they are implemented; those
penalties must be effective, proportionate and dissuasive,

the provisions of

(g) Orphan source means a source which is not under regu-
latory control, either because it has never been under
regulatory control, or because it has been abandoned,
lost, misplaced, stolen or transferred without proper auth-
orisation;

HAS ADOPTED THIS DIRECTIVE:

Article 1

Purpose and scope

(h) Recognised installation means a facility located in the
territory of a Member State authorised by the competent
that Member State in accordance with
authorities of
national
law for the long-term storage or disposal of
high activity sources;

The purpose of this Directive is to prevent exposure to
1.
ionising radiation arising from inadequate control of high
activity sealed radioactive sources and to harmonise controls
in place in the Member States by setting out
specific
requirements ensuring that each such source is kept under
control.

(i) Reused source means a source which is used by another user

for the same or another practice;

(j)

Sealed source has the meaning given to it by Directive
96/29/Euratom;

The Directive applies to high activity sources as defined

2.
in Article 2.

This

Directive

3.
Directive
supplements
96/29/Euratom laying down basic safety standards for the
protection of the health of workers and the general public
against the dangers arising from ionising radiation.

Council

(k) Supplier means any natural or legal person who supplies or

makes available a high activity source;

(l) User means any natural or legal person who uses a high

activity source;

(m) Transfer of a high activity source means a transfer of a high

activity source from one holder to another one.

Article 2

Definitions

Article 3

Authorisation

For the purpose of this Directive, the following definitions shall
apply:

1. Member States shall require prior authorisation for any
practice involving a high activity source.

(a) High activity

source or

source means a sealed source
containing a radionuclide whose activity at the time of
fabrication or of the first placing on the market is equal
to or exceeds
specified in
Annex I.

the relevant activity level

2. Member States shall ensure that, before issuing an auth-
orisation:

(a) arrangements have been made for the safe management of
high activity sources, including when they become disused
sources;

(b) Authorisation means a permission granted in a document
by competent authorities, on application, to carry out a
practice involving a high activity source;

(b) financial provision has been made for the safe management
of high activity sources when they become disused sources.

(c) Competent authority means any authority designated by a
Member State to carry out tasks under this directive;

3. Member States shall ensure that the authorisation covers:

(d) Disused source means a source which is no longer intended
to be used for the practice for which an authorisation was
granted;

(e) Holder means any natural or legal person who is in

possession of a source;

(a) responsibilities;

(b) minimum staff competencies;

(c) minimum equipment performance criteria;

(d) requirements for emergency procedures and communi-

cation links:

(f) Manufacturer means any natural or legal person who manu-

factures a source;

(e) work procedures to be followed;

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(f) maintenance of equipment and high activity sources;

(a) to ensure that leak tests are undertaken regularly to check

the integrity of each high activity source;

(g) adequate management of disused high activity sources,
including agreements regarding the possible transfer of
disused sources to a supplier or a recognised installation.

(b) to regularly verify that each high activity source is present

at its place of use or of storage;

Article 4

Transfers

(c)

to ensure that each fixed and mobile high activity source is
subject
to adequate measures to prevent unauthorised
access to or loss, theft, fire and unlawful use of the source;

Member States shall set up a system for the adequate control of
individual transfers of high activity sources.

(d) to promptly notify to the competent authority loss, theft,
unlawful use of a high activity source and any event,
including fire, that may have damaged the source;

Article 5

Records

1. Member States shall require the competent authority to
maintain appropriate records of holders of authorisations, with
a clear indication of the type(s) of such sources that they are
authorised to hold. They shall also require the competent
authority to maintain appropriate records of the transfer and
disposal of high activity sources on termination of author-
isation.

2. Member States shall require that the holder keeps records
of all high activity sources in his possession, their location and
their transfer. The records shall be drawn up in compliance
with the standard record sheet set out in Annex II as regards
both the information contained and the format.

3. Member States shall require the holder to notify forthwith
the competent authority a copy of the records referred to in
paragraph 2

— at the time of opening of such records;

— at intervals of 12 months thereafter,

— at the closing of such records, when he no longer holds any

sources and

— whenever so requested by the competent authority.

The holder's records shall be available for inspection by the
competent authority.

The Commission shall update the standard record sheet

4.
for the records set out in Annex II.

(e)

to return or transfer each disused high activity source to a
supplier or to a recognised installation unless otherwise
agreed by the competent authority, without undue delay
after termination of the use.

Article 7

Identification and marking

1. Member States shall require:

(a) The manufacturer to identify each high activity source by a
unique number. Where practicable, the number shall be
marked on the source.

(b) The manufacturer to mark and label both high activity
sources, where practicable, and their container with an
appropriate sign to warn people of the radiation hazard.
Where this is not practicable, as a minimum the container
must be so marked and labelled.

2. Member States shall ensure that each high activity source
the source is
is accompanied by written information that
identified and marked in compliance with paragraphs 1 and
2. The information shall include photographs of source, source
container, transport packaging, device and equipment as appro-
priate.

Article 8

Training and information

1. When arranging training in the
radiation
protection in compliance with Article 22 of Directive
96/29/Euratom,
this training
includes specific requirements on the safe management of
high activity sources.

the holder shall ensure that

field of

Article 6

Requirements for holders

The training shall give particular emphasis to the necessary
safety culture and it shall contain specific information on
possible consequences of
loss of adequate control on high
activity sources.

Member States shall
sources:

require each holder of high activity

The training shall be repeated at regular intervals.

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2. Member States shall encourage that the management and
the workers of installations where orphan high activity sources
are most likely to be found or processed like large metal scrap
scrap recycling plants, and the
yards and major metal
transit
management and the workers of significant nodal
points like custom posts, are

(a)

informed of the possibility that they may be confronted
with a high activity source;

(b) advised on the visual detection of high activity sources and

of their containers;

(c)

informed on basic facts about radioactivity and its effects;

(d) informed on the actions to be taken in the event of the
detection or suspected detection of a high activity source.

Article 9

Orphan high activity sources

1. Member States shall ensure that the competent authorities
are prepared, or have
including
assignment of responsibilities, to recover orphan high activity
sources and to deal with radiological emergencies and have
established appropriate response plans and measures.

established provisions,

2. Member States shall ensure that specialised technical
advice and assistance is promptly available to the persons,
subject
not normally involved in operations
to radiation
protection requirements,
the presence of an
suspect
orphan high activity source. The primary aim of advice and
assistance shall be the radiation protection of workers and
members of the public and the safety of the source.

that

3. Member States shall ensure the establishment of controls
aimed at detecting orphan high activity sources. Such controls
should be performed in places where orphan sources may be
like large metal scrap yards and major metal
encountered,
transit
scrap recycling installations or at significant nodal
points, like customs posts.

4. Member States shall ensure the organisation of campaigns
for recovering orphan high activity sources, which are part of
the historical legacy.

Article 10

International cooperation and information exchange

Each Member State shall exchange information and cooperate
with other Member States or non-Member States and with
relevant international organisations as regards losses, removal,
theft and discovery of high activity sources and as regards
related investigations.

Article 11

Guarantee

Member States shall ensure the establishment of a system of
guarantee for damage to human health caused by high activity
sources as well as for the costs of interventions relating to
them, in particular those intervention costs which may result
from implementation of the requirements set out in Article 9,
so as to apprehend such situations as may arise from the
impossibility of identifying a holder or where the holder is
found to be insolvent.

Article 12

Inspections

Member States shall establish a system of inspection to enforce
the provisions introduced in compliance with this Directive.

Article 13

Competent authority

1. Member States shall designate the competent authority to
carry out tasks under this Directive.

2. Member States shall forward to the Commission by . . . at
the latest (within two years from the entry into force of this
Directive) the name and the address of the competent authority
and all necessary information for rapidly communicating with
such authorities.

In the event that within a Member State several auth-
3.
orities are competent, Member States shall designate one
point of contact to act as an interface with correspondents
in other Member States.

4. Member States shall
changes to data referred to in paragrahs 2 and 3.

forward to the Commission any

The campaigns may include financial participation of Member
States in the costs of recovering, managing and disposing of
the sources and surveys of historical records of authorities, like
customs, and of holders, such as research institutes, material
testing institutes or hospitals.

5.
The Commission shall communicate the information
referred to in paragraphs 2, 3 and 4 to all competent auth-
orities in the Community and shall publish it in the Official
Journal of the European Communities.

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Article 14

Report on experience

(within two years from the
Directive by . . . at
adoption of this Directive). They shall forthwith inform the
Commission thereof.

the latest

Five years after the date referred to in Article 17(1),
Member States
experience gained in the implementation of this Directive.

the
to the Commission on the

report

shall

On that basis, the Commission shall present a report to the
European Parliament, the Council and the Economic and Social
Committee.

Article 15

Penalties

Member States shall lay down the rules on penalties applicable
to infringements of the national provisions adopted pursuant
to this Directive and shall take all measures necessary to ensure
that they are implemented. The penalties provided for must be
effective, proportionate and dissuasive. Member States shall
to the Commission by the date
notify those provisions
specified in Article 16(1) at
the latest and shall notify it
without delay of any subsequent amendment affecting them.

Article 16

Implementation

When Member States adopt those provisions, they shall contain
a reference to this Directive or be accompanied by such a
reference on the occasion of
their official publication.
Member States shall determine how such reference is to be
made.

2. Member States shall communicate to the Commission the
text of the main laws, regulations or administrative provisions,
which they adopt in the field covered by this Directive.

Article 17

Entry into force

1.
This Directive shall enter into force on the twentieth day
following that of its publication in the Official Journal of the
European Communities.

Articles 3, 4, 5 and 6 shall apply as from 24 months
2.
from the date referred in Article 16(1) for high activity sources
put on the market before that date.

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this

Article 18

This Directive is addressed to the Member States.

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ANNEX I

ACTIVITY LEVELS

For radionuclides not listed in the table below, the relevant activity level is one hundredth of the corresponding A1
value given in the IAEA Regulations for the safe transport of radioactive materials, no TS-R-1 (ST-1, Revised) —
International Atomic Energy Agency, Vienna 2000.

Element (Atomic number)

Radionuclide

Activity level (Bq)

Iron (26)

Cobalt (27)

Selenium (34)

Krypton (36)

Strontium (38)

Palladium (40)

Iodine (53)

Caesium (55)

Promethium (61)

Gadolinium (64)

Thulium (69)

Iridium (77)

Thallium (81)

Radium (88)

Plutonium (94)

Americium (95)

Californium (98)

Fe-55

Co-60

Se-75

Kr-85

Sr-90 (a)

Pd-103 (a)

I-125

Cs-137 (a)

Pm-147

Gd-153

Tm-170

Ir-192

Tl-204

Ra-226 (b)

Pu-238 (a)

Am-241 (b)

Cf-252

4 × 1011

4 × 109

3 × 1010

1 × 1011

3 × 109

4 × 1011

2 × 1011

2 × 1010

4 × 1011

1 × 1011

3 × 1010

1 × 1010

1 × 1011

2 × 109

1 × 1011

1 × 1011

5 × 108

(a) The activity level includes contributions from daughter nuclides with half-lives less than 10 days.
(b) Includes neutron sources with beryllium.

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