Council Directive 2003/122/Euratom of 22 December 2003 on the control of high-activity sealed radioactive sources and orphan sources
Date: 2003-12-22
Institutions: Council of the European Union
Subjects: environmental risk prevention, nuclear accident, nuclear safety, radiation protection, radioactive materials, radioactivity

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COUNCIL DIRECTIVE 2003/122/EURATOM

of 22 December 2003

on the control of high-activity sealed radioactive sources and orphan sources

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,

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
the Treaty,

consulting

After
Committee,

the

European

Economic

and

Social

Having regard to the opinion of the European Parliament (1),

Whereas:

(1)

(2)

(3)

(4)

(5)

Article 30 of the 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.

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

Article 4(1)(e) of Directive 96/29/Euratom requires prior
authorisation for, amongst other practices, the use of
radioactive sources for industrial radiography or proces-
sing 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 radio-
active sources in order further to reduce the likelihood
of accidents involving such sources.

Prior to authorisation, adequate arrangements and provi-
sion for the safe management of sources should exist.

The International Atomic Energy Agency (IAEA) issues
regulations for the safe transport of radioactive material
that include activity limits for the requirements of the
regulations, which should provide an appropriate basis
for defining high-activity sealed radioactive sources
within the scope of this Directive (3).

(1) Opinion of 18 November 2003 (not yet published in the Official

Journal).

(2) OJ L 159, 29.6.1996, p. 1.
(3) IAEA Safety Standards Series No TS-R-1 (ST, Revised), Vienna,

2000.

(6)

(7)

(8)

(9)

In Directive 96/29/Euratom exemption values were laid
down for the reporting of a practice to the authorities.
These values were defined in that Directive on the basis
of a negligible level of risk. As the requirements of this
Directive should not put an administrative burden on
the holders of small sources that is not commensurate
with the possible health detriment, the definition of high
activity radioactive sources should not be extended to
the exemption levels of Directive 96/29/Euratom.

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 ship-
ments of
substances between Member
States (4).

radioactive

Although the legal requirements deriving from existing
legislation at Community and at national
level ensure
basic protection, high-activity sources still imply consid-
erable potential risks for human health and for the envir-
onment and therefore need to be subject to a strict
control from the time they are manufactured to the time
they are placed in a recognised installation for their
long-term storage or disposal.

Prevention of radiological accidents and injuries requires
the location of each high-activity source to be known,
recorded and verified from the time the source is manu-
factured or imported into the Community to the time it
is placed in a recognised installation for its long-term
storage or disposal or it is exported from the Com-
munity. Changes in the situation of a high-activity
source, e.g. its location or use, should also be recorded
and notified. Physical or financial obstacles should not
hinder any appropriate reuse, recycling or disposal of
such sources when disused under any reasonably fore-
seeable circumstances.

(10)

Cases of unintentional exposure should be notified to
the competent authority.

(11) Movements within the Community of high-activity
sources make it necessary to harmonise the control of
and information on such sources through the applica-
tion of minimum criteria.

(12)

Experience shows that, despite the existence of an appro-
priate regulatory framework, control of high-activity
sources may nevertheless be lost. Furthermore, the exis-
tence of orphan sources resulting from past activities
requires that specific initiatives be undertaken.

(4) OJ L 148, 19.6.1993, p. 1.

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(13) Accordingly, it is necessary to provide for the identifica-
tion, marking and recording of each high-activity source
as well as for the specific training and informing of all
those involved in activities relating to the use of sources.
However, the marking of existing high-activity sources
by engraving or stamping by persons other than the
manufacturer could be problematic and should be
avoided.
is also advisable to provide appropriate
training and information for those who may deal acci-
dentally with orphan sources.

It

(14)

(15)

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

The Member States should lay down rules on penalties
applicable to infringements of
this
Directive and ensure that they are implemented; those
penalties should be effective, proportionate and dissua-
sive,

the provisions of

HAS ADOPTED THIS DIRECTIVE:

Article 1

Purpose and scope

1.
The purpose of this Directive is to prevent exposure of
workers and the public to ionising radiation arising from inade-
quate control of high-activity sealed radioactive sources and
orphan sources and to harmonise controls in place in the
Member States by defining specific requirements ensuring that
each such source is kept under control.

2.
This Directive applies to high-activity sources as defined
in Article 2. Member States may exclude sources from the
scope of this Directive once their activity has fallen below the
exemption levels specified in Directive 96/29/Euratom.

The minimum obligations resulting from this Directive

3.
supplement those set out in Directive 96/29/Euratom.

Article 2

Definitions

Euratom, and which is not under regulatory control, either
because it has never been under regulatory control or
because it has been abandoned, lost, misplaced, stolen or
transferred, without proper notification of the competent
authority, to a new holder or without informing the reci-
pient;

(b) ‘high-activity source’, hereinafter referred to as ‘source’,
means a sealed source containing a radionuclide whose
activity at the time of manufacture or, if this is not known,
of the first placing on the market is equal to or exceeds
the relevant activity level specified in Annex I;

(c) ‘practice’ has the meaning given to it by Directive 96/29/

Euratom;

(d) ‘authorisation’ means permission granted in a document
by competent authorities, on request, to carry out a prac-
tice involving a source;

(e) ‘competent authority’ means any authority designated by a
Member State to carry out tasks in accordance with this
Directive;

(f) ‘disused source’ means a source which is no longer used or
intended to be used for the practice for which authorisa-
tion was granted;

(g) ‘holder’ means any natural or legal person who is respon-
sible under national law for a source, including manufac-
turers, suppliers and users of sources but excluding ‘recog-
nised installations’;

(h) ‘manufacturer’ means any natural or legal person who

manufactures a source;

(i) ‘recognised installation’ means a facility located in the terri-
tory of a Member State authorised by the competent
authorities of that State in accordance with national law
for the long-term storage or disposal of sources or an
installation duly authorised under national
law for the
interim storage of sources;

(j) ‘exposed worker’ has the meaning given to it by Directive

96/29/Euratom;

(k) ‘sealed source’ has the meaning given to it by Directive 96/
29/Euratom and includes the capsule, where applicable,
enclosing the radioactive material as an integral part of the
source;

(l) ‘supplier’ means any natural or legal person who supplies

or makes available a source;

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

(m) ‘transfer’ of a source means a transfer of a source from one

holder to another one;

(a) ‘orphan source’ means a sealed source, the activity level of
which, at the time of its discovery, is above the exemption
level referred to in Article 3(2)(a) of Directive 96/29/

(n) ‘source container’ means the containment of a sealed
source not being an integral part of the source, but meant
for transport, handling, etc.

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Article 3

Authorisation

The holder shall provide the competent authority with an
2.
electronic or written copy of all or part of the records referred
to in paragraph 1, as required by the Member State concerned,

1. Member States shall require the holder to obtain prior
authorisation for any practice involving a source,
including
taking possession of a source.

— without undue delay, at the time of the establishment of
such records, which should be as soon as possible after the
source is acquired,

2. Member States shall ensure that, before issuing authorisa-
tion:

— at intervals, to be determined by Member States/competent

authorities, of not more than 12 months thereafter,

(a) adequate arrangements,

including those arising from this
Directive, have been made for the safe management of
sources,
including when they become disused sources.
These latter arrangements may provide for the transfer of
these sources to the supplier or their placement in a recog-
nised installation or an obligation for the manufacturer or
the supplier to receive these sources;

(b) adequate provision, by way of a financial security or any
other equivalent means appropriate to the source in ques-
tion, have been made for the safe management of sources
when they become disused sources,
including the case
where the holder becomes insolvent or goes out of busi-
ness.

3. Member States shall ensure that the authorisation covers:

(a) responsibilities;

(b) minimum staff competencies,

including information and

training;

(c) minimum source, source container and additional equip-

ment performance criteria;

(d) requirements for emergency procedures and communica-

tion links;

(e) work procedures to be followed;

(f) maintenance of equipment, sources and containers;

(g) adequate management of disused sources, including agree-
ments regarding the transfer,
if appropriate, of disused
sources to a supplier, another authorised holder or a recog-
nised installation.

Article 4

Transfers

Member States shall set up a system to enable them to be
adequately informed of individual transfers of sources.

— if

the situation indicated on the information sheet has

changed,

— without undue delay on the closure of the records for a
specific source when the holder no longer holds this source;
in this case the name of the holder or recognised installa-
tion to which the source is transferred shall be included,

— without undue delay on the closure of such records when

the holder 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

shall

authorities

competent

3.
keep records of
authorised holders and of the sources they hold. These records
shall include the radionuclide involved, the activity at the time
of manufacture, or if this activity is not known, the activity at
the time of the first placing on the market or at the time the
holder acquired the source, and the type of source.

The competent authorities shall keep the records up to

4.
date, taking transfers into account, among other factors.

The Commission shall make available in electronic format

5.
the standard record sheet for the records set out in Annex II.

6.
The Commission may, in accordance with the procedure
referred to in Article 17, update the required information set
out in Annex II and the standard record sheet for the records
set out in Annex II.

Article 5

Records

Article 6

Requirements for holders

1.
The holder shall keep records of all sources under his
responsibility, their location and their transfer. The records
shall include the information set out in Annex II. This informa-
tion may be recorded on a standard record sheet pursuant to
paragraph 5.

Each holder of sources shall:

(a) ensure that suitable tests, such as leak tests based on inter-
national standards, are undertaken regularly in order to
check and maintain the integrity of each source;

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(b) regularly verify, at specific intervals which may be deter-
mined by Member States, that each source and, where rele-
vant, the equipment containing the source, is still present
and in apparently good condition at its place of use or of
storage;

(c) ensure that each fixed and mobile source is subject to
adequate documented measures, such as written protocols
and procedures, aimed at preventing unauthorised access to
or loss or theft of the source or its damage by fire;

(d) promptly notify the competent authority of any loss, theft
or unauthorised use of a source, arrange for a check on the
integrity of each source after any event, including fire, that
may have damaged the source and, if appropriate, inform
the competent authority thereof and of the measures taken;

(e) return each disused source to the supplier or place it in a
recognised installation or transfer it to another authorised
holder unless otherwise agreed by the competent authority,
without undue delay after termination of the use;

Article 8

Training and information

1. When arranging information and training in the field of
radiation protection in compliance with Article 22 of Directive
96/29/Euratom,
the holder shall ensure that such training
includes specific requirements for the safe management of
sources.

The information and training shall place particular emphasis on
the necessary safety requirements and shall contain specific
information on possible consequences of the loss of adequate
control of sources.

The information and training shall be repeated at regular inter-
vals and documented, with a view to preparing the relevant
workers adequately for such events.

(f) ascertain that, before a transfer is made, the recipient holds

appropriate authorisation;

The relevant information and training shall be addressed to
exposed workers.

(g) promptly notify the competent authority of any incident or
accident resulting in unintentional exposure of a worker or
a member of the public.

Article 7

Identification and marking

The manufacturer shall identify or, in the case of sources
1.
imported from outside the Community,
the supplier shall
ensure that each source is identified by a unique number. This
number shall be engraved or stamped on the source, where
practicable.

This number shall also be engraved or stamped on the source
container. If this is not feasible or in the case of reusable trans-
port containers, the source container shall at least have infor-
mation on the nature of the source.

The manufacturer or the supplier shall ensure that the source
container and, where practicable, the source are marked and
labelled with an appropriate sign to warn people of the radia-
tion hazard.

The manufacturer shall provide a photograph of each manufac-
tured source design type and of the typical source container.

the management and workers

2. Member States shall provide encouragement to ensure
that
in installations where
orphan sources are most likely to be found or processed (e.g.
large metal scrap yards and major metal scrap recycling plants),
and the management and workers in significant nodal transit
points (e.g. customs posts), are

(a) informed of the possibility that they may be confronted

with a source;

(b) advised and trained in the visual detection of sources and

of their containers;

(c) informed of basic facts about ionising radiation and its

effects;

(d) informed of and trained in the action to be taken on site in
the detection or suspected detection of a

the event of
source.

Article 9

Orphan sources

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

The holder shall ensure that each source is accompanied
2.
by written information indicating that the source is identified
and marked in compliance with paragraph 1 and that the
markings and labels referred to in paragraph 1 remain legible.
The information shall
the source,
source container, transport packaging, device and equipment as
appropriate.

include photographs of

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

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shall encourage the establishment of
3. Member States
systems aimed at detecting orphan sources in places such as
large metal scrap yards and major metal scrap recycling instal-
lations where orphan sources may generally be encountered, or
at significant nodal transit points, wherever appropriate, such
as customs posts.

4. Member States shall ensure that campaigns are organised,
as appropriate, to recover orphan sources left behind from past
activities.

The campaigns may include the financial participation of
Member States in the costs of recovering, managing and
disposing of the sources and may also include surveys of histor-
ical records of authorities, such as customs, and of holders,
such as research institutes, material testing institutes or hospi-
tals.

Article 10

Financial security for orphan sources

Member States shall ensure that, on the basis of arrangements
to be decided by Member States, a system of financial security
is established or any other equivalent means to cover interven-
tion costs relating to the recovery of orphan sources and which
may result from implementation of the requirements set out in
Article 9.

Article 11

International cooperation and information exchange

Each Member State shall promptly exchange information and
cooperate with other relevant Member States or third countries
and with relevant international organisations as regards loss,
removal, theft or discovery of sources and as regards related
follow-up or investigations, without prejudice to relevant confi-
dentiality requirements and relevant national regulations.

Article 12

Inspections

Member States shall establish or maintain a system of inspec-
tion 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 in accordance with this Directive.

2. Member States shall forward to the Commission the name
and the address of the competent authority and all necessary
information for rapidly communicating with such authorities.

3. Where Member States have more than one competent
authority, they shall designate one point of contact to act as an
interface with correspondents in other Member States.

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

forward to the Commission any

5.
The Commission shall communicate the information
referred to in paragraphs 2, 3 and 4 to all competent authori-
ties in the Community and shall publish it periodically in the
Official Journal of the European Union, at intervals of no more
than two years.

Article 14

Report on experience

By 31 December 2010, Member States shall report to the
Commission on the experience gained in the implementation
of this Directive, including consideration of any effect which
Article 1(2) may have had.

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

Article 15

Penalties

Member States shall determine the penalties applicable to
breaches of the national provisions adopted pursuant to this
Directive. The penalties shall be effective, proportionate and
dissuasive.

Article 16

Transposition

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive before 31 December 2005.

Member States may provide, as regards sources placed on the
market before the date referred to in the first subparagraph,
that:

(a) Articles 3 to 6 shall not apply until 31 December 2007;

(b) Article 7 shall not apply, with the exception of

the
following requirements which shall apply by 31 December
2007 at the latest:

— the holder shall ensure that,

if practicable, each such
source and the source container are accompanied by
written information to identify the source and its
nature,

— the holder shall ensure that,

if practicable, each such
source,
if practicable, and the source container are
labelled with an appropriate sign to warn people of the
radiation hazard.

Where these measures are adopted by the Member States, they
shall contain a reference to this Directive or shall be accompa-
nied by such reference on the occasion of their official publica-
tion. The methods of making such reference shall be laid down
by Member States.

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2. Member States shall communicate to the Commission the
text of the main provisions of national law which they adopt in
the field covered by this Directive,
together with a table
showing how the provisions of this Directive correspond to the
national provisions adopted.

Article 17

Committee

The Commission shall be assisted in performing the tasks laid
down in Article 5(6) by an Advisory Committee composed of
the representatives of the Member States and chaired by the
representative of the Commission.

the Commission shall submit

to the
The representative of
Committee a draft of the measures to be taken. The Committee
shall deliver its opinion on the draft within a time limit which
the Chairman may lay down according to the urgency of the
matter, if necessary by taking a vote.

The opinion of the Committee shall be recorded in the minutes;
in addition, each Member State shall have the right to ask to
have its position recorded in the minutes.

The Commission shall take the utmost account of the opinion
delivered by the Committee. It shall inform the Committee of
the manner in which its opinion has been take into account.

Article 18

Entry into force

This Directive shall enter into force on the day of its publica-
tion in the Official Journal of the European Union.

Article 19

This Directive is addressed to the Member States.

Done at Brussels, 22 December 2003.

For the Council

The President

A. MATTEOLI

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ANNEX I

Activity levels

For radionuclides not listed in the table below, but referred to in Annex I, Table A, of Directive 96/29/Euratom, the rele-
vant activity level is one hundredth of the corresponding A1 value given in the IAEA Regulations for the safe transport
of radioactive materials (1).

Element (Atomic number)

Radionuclide

Activity level (Bq)

Iron (26)

Cobalt (27)

Selenium (34)

Krypton (36)

Strontium (38)

Palladium (46)

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.

(1) No TS-R-1 (ST-1, revised) — International Atomic Energy Agency, Vienna 2000.

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I
I

X
E
N
N
A