Proposal for a Council Directive on the control of high activity sealed radioactive sources
Date: 2003-01-24
Institutions: European Commission
Subjects: environmental risk prevention, ionising radiation, nuclear accident, nuclear safety, radioactive materials, radioactive pollution, radioactive waste, waste management

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 24.01.2003
COM(2003) 18 final

2003/0005 (CNS)

Proposal for a

COUNCIL DIRECTIVE

on the control of high activity sealed radioactive sources

(presented by the Commission)

EXPLANATORY MEMORANDUM

1.

FOREWORD

Radioactive sources are used throughout the world for a wide variety of purposes
notably in industry, medicine and research. The risks posed by such sources vary
widely, depending on their activity, contained radionuclides, construction, etc.

Risks associated with the planned use of the sources are normally well known. In the
European Union, the use of radioactive sources is subject to the requirements set out
by the radiation protection legislation adopted pursuant to Chapter III Health and
Safety of the Euratom Treaty.

Recently, however, a number of events have drawn the Commission’s attention to
the problem of sources that for various reasons are not under control. Such “orphan”
sources are likely to be recovered by persons, whether workers or members of the
public, unaware of the possible risks. This has led to serious radiation injuries and in
some cases, although not in the European Union, to death.

Sealed sources may imply particular risks because of their small size, often the size
of a pen or smaller, their use in mobile devices, etc. The metallic capsule containing
the radioactive substances makes likely their collection by members of the public or
by metal scrap handlers. Findings of sources in scrap-yards and in metal production
facilities are recurrent events worldwide. Details concerning the nature of radioactive
sources of concern, the main risks associated with their use or misuse, a summary of
their applications, and a list of the most significant accidents which occurred during
the last years are given in the attached Technical Annex.

2.

BACKGROUND

The radiation protection authorities worldwide are confronted by the issue of the
correct management of radiation sources, especially high activity sealed radioactive
sources. Maybe due to their mobility, they have been involved in many of the known
radiation incidents and accidents.

Since the first medical applications of radium sources at the beginning of the 20th
century, there has been a significant
increase in the number and utilisation of
radiation sources, especially following the relatively wide availability of artificial
radionuclides since the fifties and the sixties.

Within the framework of the Community Plan of Action in the field of radioactive
waste1, the European Commission recently published a study on management and
disposal of disused sealed radioactive sources in the European Union2 .The authors
of the study, using their own technique and assumptions, arrived at a rough
estimation that approximately 500 000 sealed sources have been supplied during the
past 50 years to operators in the EU’s current fifteen Member States. Of these,
approximately 110 000 sources are currently in use. Most of the remainder have been

1 Council Resolution of 15 June 1992 on the renewal of the Community Plan of Action in the field of radioactive

waste. OJ C158, 25.06.1992

2 Angus et al. Management and disposal of disused sealed radioactive sources in the European Union – EUR

1886 (2000)

2

sent to central interim stores, returned to manufacturers or have been disposed of.
The sources at greatest risk of being lost from regulatory control are disused sources
held in local storage at the users’ premises. The study estimates that there are about
30 000 such sources throughout the EU. Further information from the study is
summarized in the attached Technical Annex.

Occasionally, the national competent authorities have to deal with cases in which
radiation sources are inadequately managed, or radiation sources are found outside of
any regulatory control. Both those categories of events could result in serious health
consequences for the workers or members of the public involved. The likelihood of
such events is increased when the sources are no longer actively used and they are
put in storage or simply left unattended for long periods. In fact, there are indications
that controls, can become weak between the time when the sources are removed from
active use and the time they are returned to producers for possible reuse, or declared
as waste and placed under systems of radioactive waste management.

The health and economic consequences of possible accidents involving inadequately
controlled radiation sources may be particularly severe. An overview of recent
significant events is given in the attached Technical Annex.

3.

EXISTING COMMUNITY LEGISLATION

Member States of the European Union, via the Euratom Treaty, conferred on the
European Atomic Energy Community the task of establishing uniform safety
standards to protect the health of workers and of the general public against dangers
arising from ionising radiation. A Directive, first adopted in 1959 and last revised in
19963, lays down the basic safety standards for the protection of the health of
workers and the general public against the dangers arising from ionising radiation.
The Directive applies to all practices, which involve a risk from ionising radiation,
and it
imposes the basic principles for radiation protection and other generic
requirements, without however giving detailed rules for the wide variety of existing
practices.

Although the Basic Safety Standards Directive is of general application, in the past it
has already been necessary to complement its requirements with measures aimed at
specific purposes. The adoption of such measures was sometimes the response to
particular events. For example, the European Parliament Resolution of 6 July 1988
on the findings of the Committee of Inquiry into the Handling and Transport of
Nuclear Materials4 resulted in the adoption of Directive 92/3/Euratom on shipments
of radioactive wastes5.

Another example is the adoption of Regulation 1493/93/Euratom on shipments of
radioactive substances between Member States6 that resulted from the abolition of
controls at the intra-Community borders on 31.12.1992.

3 Council Directive laying down basic safety standards for the health protection of the general public and

workers against the dangers of ionising radiation. OJ L159, 29.06.1996

4 European Parliament Resolution of 6 July 1988 on the findings of the Committee of Inquiry into the handling

and transport of nuclear materials. OJ C235, 12.09.1988

5 Council Directive on the supervision and control of shipments of radioactive waste between Member States and

into and out of the Community. OJ L35, 12.02.1992

6 Council Regulation on shipments of radioactive substances between Member States. OJ L148, 19.06.1993

3

In addition to the regulatory activities, the Commission carried out other actions
specific to the management of radioactive sources and to the presence of radioactive
materials in scrap metals. Such actions are summarized in the Technical Annex.

4.

INTERNATIONAL ACTIONS

At the international level, the European Commission co-sponsored together with the
International Atomic Energy Agency (IAEA),
the International Criminal Police
Organisation (INTERPOL) and the World Custom Organisation (WCO) a
symposium on the safety of radiation sources and security of radioactive material
that was held in Dijon in 1998 hosted by the French Government7. It resulted from
the conference that the issue of a strengthened control on radiation sources is
particularly topical, due to the intensification of international exchanges, and to the
fact that the sources produced in the fifties and the sixties are approaching the end of
their life, a phase in which the loss of control is particularly relevant. The IAEA, as a
follow-up to the Dijon Symposium established an action plan on Safety of Radiation
Sources and Security of Radioactive Materials that was endorsed by the IAEA
General Conference in October 19998. Among the initiatives of the action plan
particular emphasis is given to the assistance to States in maintaining or establishing
their regulatory infrastructures.

Two important achievements in this context are the Code of Conduct on the safety
and security of radioactive sources, endorsed by the IAEA General Conference in
September 20009, and the technical document on Categorisation of radiation
sources10.

The issue of radioactive contamination of scrap metal and of metal products is
presently being addressed by a team of specialists convened by the United Nations
Economic Commission for Europe (UNECE) in which experts from the European
Commission and from the IAEA participate together with experts from industrial
is expected that a report
associations and from Member States of UNECE. It
prepared by the team of specialists will be available shortly.

5.

THE WAY FORWARD

to adopt

the European Commission is of the opinion that

it would be
In conclusion,
appropriate
legislation, based on the Euratom Treaty,
supplementing the Basic Safety Standards Directive with a view to strengthen the
control by the competent national authorities on those sealed radioactive sources
posing the greatest risk and to emphasise the responsibilities of holders of such
sources.

specific

A specific regulatory text on the management of sealed sources would improve the
protection of man and of the environment by, on one hand strengthening and
harmonising the regulatory practices applied in the Member States on the basis of the
general requirements of the Basic Safety Standards Directive and, on the other hand,

7 Safety of Radiation Sources and Security of Radioactive Materials. Proceeding Series – IAEA, Vienna, 1999
8 IAEA GC (43)/RES/10
9 Code of Conduct on the Safety and Security of Radioactive Sources. IAEA/CODEOC/2001 – Vienna 2001
10 Categorisation of Radiation Sources - IAEA – TECDOC 1191, Vienna 2000

4

by strengthening the European Union legal acquis,
enlargement of the Union.

in the eve of a further

6.

PROVISIONS OF THE PROPOSAL

6.1.

Preamble

Article 2b of the Euratom Treaty sets out that the Community shall “establish
uniform safety standards to protect the health of workers and of the general public
and ensure that they are applied”. Article 31 of the Euratom Treaty lays down the
procedure for establishing the standards or for supplementing them as provided for
by Article 32.

Therefore, Articles 31 and 32 of the Euratom Treaty provide the legal basis for the
proposal.

6.2.

Purpose and scope (Article 1)

Council Directive 96/29/Euratom sets out a number of provisions that, properly
applied, would prevent the risks connected with the manufacture, use and disposal of
high activity sealed sources. However, with respect to potentially highly dangerous
sources, additional Community provisions should be in place to further reduce the
likelihood of accidents involving such sources.

Many of the provisions required by the proposal are already in place in several
Member States pursuant their implementation of the basic safety standards Directive.
The proposal extends to the whole European Union the most effective practices
applied by some Member States. The form of a Directive, in contrast to a Regulation,
allows Member States to modify their regulatory system only for those requirements
that are not already in place.

Basically, the Directive would apply to sealed sources giving a dose rate in the order
of more than 1 mSv/h at one meter distance. The resulting activity of the source
depends on the radionuclides and on the quality of the radiation emitted. Such
activity for the radionuclides most utilised in sealed sources is given in Annex 1. The
values tabulated are one hundredth of the activity limits applicable for the regulations
on the safe transport of radioactive material issued by the International Atomic
Energy Agency11 and above which transport must take place in packages designed
and tested to ensure containment of the radioactive substances in accident conditions.

6.3.

Definitions (Article 2)

The key definition is that of High Activity Sources. Such definition would include all
the radioactive sources that in the last years caused accidents with serious health
effects reported in published surveys, all the sources that caused major contamination
at plants handling metal scrap, all sources in the IAEA category 1 and a large
fraction of those in category 212. The definition has been carefully chosen to strike an
optimum balance between the additional technical and administrative burden and the

11 Regulation for the Safe Transport of Radioactive Materials, Safety Standard Series No. TS-R-1 (ST-1,

Revised), IAEA, Vienna 2000

12 See footnote 10

5

reduction of the health risks posed by the sources. The Definition of High Activity
Sources is not linked to the exemption values in Directive 96/29/Euratom, as these
values were defined on the basis of a negligible level of risk, and the requirements of
the present Proposal should not put an administrative burden on the holders of small
sources that is not commensurate to the possible health detriment.

The definition of Orphan Source is an adaptation of the definition given in the IAEA
Code of Conduct on the safety and security of radioactive sources13.

6.4.

Authorisation (Article 3)

The use of radioactive sources for industrial radiography or processing of products or
to prior
treatment
research or the exposure of persons for medical
authorisation under Directive 96/29/Euratom (Article 4 (1) (e)).

is subject

The proposal requires prior authorisation for any practice involving a high activity
source. Before issuing an authorisation, the competent authorities shall ensure that
arrangements have been made not only for the safe use of the source, but also for the
proper management of the source when it becomes disused. It is in fact proven that
the sources most at risk of creating accidents are those that are no longer in active
use and whose safe management tends to be neglected. It is therefore necessary to
ensure that
the control continues until the source has been transferred for its
recycling, reuse or disposal under controlled conditions. The authorities must also
ensure that financial provisions have been made for the management of the disused
sources.

One element that prevents, in some cases, sources from being transferred for disposal
is the cost of the disposal that would be normally requested to the last holder of the
source. It is therefore necessary that, before the source is used in the practice from
which the holder expects to obtain a benefit, financial provisions are made for the
end of life of the source. Some examples of financial provisions are provided in
paragraph 2(b).

6.5.

Transfers (Article 4)

The term transfer used in the proposal refers to the conveyance of responsibility and
property from one person to another. It is not to be confounded with the term
shipment used in Regulation 1493/93/Euratom where it is defined as follows:

“Shipment means transport operations from the place of origin to the place of
destination, including loading and unloading of radioactive substances”

Provisions on shipments of sealed sources are set out by Council Directive
92/3/Euratom14 and by Council Regulation 1493/93/Euratom15. The Commission
undertook to review such provisions, in particular to address shipments of sources
into and out of the European Union, an issue not covered by the existing provisions.
Article 4 of the proposal requires Member States to set up a system of control on

13 See footnote 9
14 See footnote 5
15 See footnote 6

6

transfers of high activity sealed sources without exceptions, including those within
one Member State, and those involving non-Member States.

6.6.

Records (Article 5)

The expert advice collected by the Commission recognises that, with a view to
ensure safety, it is more efficient to focus the control by the authorities on holders of
sources, instead than on the sources themselves. It is therefore proposed the use of a
standard record sheet to be kept by holders of sources with information on the holder
of the source, checks and tests performed on the source, and its transfers.

The use of the standard record sheet will facilitate exchange of information and the
establishment of registers held by the authorities at national or local level, if they so
wish.

The annual return to the competent authorities (paragraph 3) ensures that the holder
is still in existence and discharges its obligations as regards the source. Failure to
report by a holder should be considered an indication that sources are at risk, and
should prompt closer verifications by the authorities.

6.7.

Common requirements for holders (Article 6)

Leak tests are essential to ensure that sealed sources maintain their integrity. The
integrity of the source ensures that in normal operating conditions and in many
accidental conditions, the radioactive materials are firmly contained in the source,
and they do not cause contamination of individuals, the working premises or the
environment. Risks of contamination can however never be completely ruled out
because no source can be designed to resist tampering or processing, for example in a
scrap facility.

Paragraph (e) requires holders to return or transfer sources to a supplier or to a
recognised installation for the recycling, long-term storage or disposal without undue
delay after termination of the use.

Competent authorities have several possibilities to ensure that sources are properly
transferred after termination of the use. They include:

• annual fee for holding the source

• time limitation of the authorisation

• deposit of a caution, given back when the source is transferred.

Direct transfer of a source from a user to another user is allowed. However, it must
be agreed by the competent authorities, in compliance with paragraph (e), and the
transferor must have checked whether the recipient user holds an appropriate
authorisation, as specified in paragraph (f).

6.8.

Identification and marking (Article 7)

Provisions on identification and marking of sources are needed especially in the
event that the control on a source is lost. The information will facilitate the retrieval
of the source and ensure that adequate safety measures are taken if it is found. In

7

addition to these safety needs, identification and marking may be used to trace the
holder, or last authorised holder, of the source for prosecution or cost attribution.

6.9.

Training and Information (Article 8)

The basic safety standards Directive requires training of persons deliberately dealing
with sources. Specific training shall be addressed to the relevant workers using or
handling high activity sources or being in the proximity of these sources.

In view of the possibility that sealed sources are found out of control, it is necessary
to give appropriate information and training to the persons who normally do not deal
with radioactive sources but who work in installations where orphan sources are
most likely to appear.

6.10.

Orphan sources (Article 9)

The proposal deals mainly with requirements aimed at preventing sources from
becoming orphan. However, Article 9 sets out requirements aimed at regaining
control on actual orphan sources.

The measures proposed require

• assignment of

responsibilities for adequate preparedness in the event of
interventions following the detection of an orphan source. Following the Spanish
accident of 1998 (see paragraph 4 of the technical annex), the Spanish authorities
promoted the establishment of a Protocol for cooperation on the radiological
surveillance of metallic materials. The Protocol assigns clear responsibilities for
the various actions following the detection of an orphan source, and it has been
signed by all the Authorities and Industrial Associations involved. The assignment
of responsibilities will depend on the structure of the national administrations
involved.

• identification of competent national bodies or points of contact where persons
suspecting of being in presence of an orphan source can rapidly obtain advice and
assistance.

• establishment of controls where orphan sources are most likely to appear, like
large metal scrap yards, major metal recycling installations or significant nodal
transit points. Equipment for the detection of radioactivity has been already
installed by large industrial operators, aware of the risks posed by orphan sources
to the health of their workers and to the quality of their products. Timely detection
of orphan sources before processing in the installation will also prevent
the
sometimes very high costs resulting from the contamination of the installation and
of the environment.

• organisation of campaigns for recovering orphan sources, or sources in danger of

becoming orphan.

6.11.

International cooperation and information exchange (Article 10)

Sources are used throughout the world, and trade in recycled metals is essentially
to exchange
international. The proposal

therefore requires Member States

8

information and to cooperate with other States with a view to re-establish control on
orphan sources.

6.12.

Guarantee (Article 11)

In the case of orphan sources, it is not easy to identify who is liable for the costs and
damage caused by the source, and often liability has been put on the person who
detected an orphan source. Member States have several possibilities for addressing
the issue, for instance, the establishment of a fund, to cover the costs and damage
resulting from the detection of orphan sources. The fund may be financed by
guarantees deposited by persons making benefits from the use of sources

6.13.

Inspections (Article 12)

Standard text.

6.14.

Competent authorities (Article 13)

It is necessary that the competent authorities empowered the carry out tasks under the
Directive have all the information necessary for communicating, pursuant to Article
10, with authorities in other Member States.

The Commission shall publish the necessary information in the Official Journal of
the European Communities.

6.15.

Report on experience (Article 14)

Three years of practical experience with the implementation of the Directive will
allow the Commission, together with the Member States, to make a first assessment
of the efficacy of the Directive, and the identification of possible simplifications,
additional requirements or clarifications.

6.16.

Penalties (Article 15)

Standard text.

6.17.

Implementation (Article 16)

Two years are considered a reasonable time for the implementation of the Directive,
considering that all Member States have already regulations covering the subject that
may need to be completed or modified.

6.18.

Entry into force (Article 17)

It is expected that the national provisions implementing the Directive will be applied
initially to sources put on the market following the date of implementation. A period
of two further years is foreseen for implementing the Directive with respect to the
pre-existing sources.

9

Technical annex

1.

DEFINITION OF RADIOACTIVE SEALED SOURCES

A sealed radioactive source is a “source whose structure is such as to prevent, under normal
conditions of use, any dispersion of the radioactive substances into the environment”16.

Sealed radioactive sources are widely used in industry, medicine and research. Until the
1950s, only radionuclides of natural origin, particularly Radium-226, were used to produce
sealed sources. Since then, radionuclides produced artificially in nuclear facilities and
electrical generators have become widely available. According to the type of radiation, there
are four main categories of sealed sources, i.e.

• Gamma sources – mainly used in industry, external beam radiotherapy, brachytherapy and

sterilisation;

• Beta sources – mainly used in industry, e.g. in thickness gauges, clinical therapy, education

and training;

• Alpha sources – mainly used in smoke detectors, heat sources, in analytical practices,

education and training;

• Neutron sources – mainly used in analytical practices, industry, calibration techniques,

education and training.

Appendix A gives a summary of the sealed sources used in a variety of applications, with
their respective range of radioactivity. The sources, the activity of which may result in a dose-
rate at one metre distance exceeding 1 mSv/h, are posing important radiological risks. Very
few radionuclides are concerned (mainly Cobalt-60, Caesium-137, Iridium-192, Americium-
241, Strontium-90, and Radium-226).

In addition to sources in use or disused17, there is a third category of sources that should be
taken into consideration: the so-called “orphan sources” referred to in the IAEA Code of
Conduct on the safety and security of radioactive sources. According to the Code18, orphan
sources are those sources:

• that were never subject to regulatory control;

• that were subject to regulatory control but have been abandoned;

• that were subject to regulatory control but have been lost or misplaced;

• that were subject to regulatory control but have been stolen or removed without proper

authorisation.

16 Council Directive laying down basic safety standards for the health protection of the general public and

workers against the dangers of ionising radiation. OJ L159, 29.06.1996 - Article 1

17.C. Crumpton. Management of spent radiation sources in the European Union: quantities, storage, recycling

and disposal. Ref. EUR 16960 en (1996)

18 Code of Conduct on the Safety and Security of Radioactive Sources. IAEA/CODEOC/2001 – Vienna 2001

10

2.

INVENTORY OF RADIOACTIVE SEALED SOURCES IN THE EUROPEAN UNION

According to a recent EC-funded study19 about 500 000 sources were supplied to users in the
current Member States (MS) of the European Union (EU) over the past 50 years. Of these
500 000 sources about 110 000 would be still in use. The remaining 390 000 sources that are
temporarily or permanently useless for their holders are referred to as being “disused”. These
latter are stored or disposed of either in central facilities (about 360 000 sources) or at users’
premises (about 30 000 sources). However, the fact that sources are disused does not indicate
that their radioactivity is negligible nor that the sources have become harmless to man and the
environment.

3.

EXPOSURE SCENARIOS

In the European Union, disused sources, which are stored at users’ premises, are giving the
most radiological concern. This is due to the fact that these sources have a significant
probability of becoming lost from regulatory control and thereby of becoming “orphan
sources”. The reasons for this include (by order of importance):

• intentional discarding of sources in order to reduce the liability of the owner with respect

to its obligations towards long-term storage and disposal;

• unintentional loss of the source due to the lack of awareness of users.

• poor record keeping by the user (nobody knows the whereabouts of the disused sources);

• disappearance (e.g. bankruptcy) of the user, which would reduce or even suspend any

control on the sources;

• theft of the source or the equipment that contains the source (to sell it as scrap).

Orphan sources may cause serious injury including death to workers and members of the
public, who are not aware of their existence. This can be the case in steel factories where
scrap metal is recycled.

Finally, sealed sources may leak. This might dramatically increase the radiological
consequences resulting from their handling both in normal operation and in accidental
conditions.

4.

RECENT ACCIDENTS

The health and economic consequences of possible accidents involving inadequately
controlled radiation sources may be particularly severe. The 1993 report of the United Nations
Scientific Committee on the Effects of Atomic Radiation (UNSCEAR) and more recent
literature20 report on several significant accidents, amongst which:

19 M. Angus et al. Management and disposal of disused sealed radioactive sources in the European Union. EUR

18186 (2000)

20 IAEA Bulletin Vol 41 No 3.1999

11

• In Goiania, Brazil, in 1987, a ceasium-137 teletherapy source was removed from its
housing and broken up. Fifty-four people were hospitalised following radiation exposure
and four died. Contamination of the environment was extensive.

• In China, in 1992, a cobalt-60 source was lost and picked up by a man. Three persons in

the family died of overexposure.

• In 1997 in Georgia, after several border frontier guards became ill and showed signs of
radiation induced diseases, a group of radioactive sources were found abandoned in a
barracks that used to be under the control of the Soviet Union Army. A programme was set
up to verify the radiological situation and more than 70 sources were found in many
locations throughout the country. Three of the most irradiated guards were treated in
France and four others in Germany to benefit from high-specialised treatment techniques.

• In Istanbul, Turkey, in 1998 two cobalt-60 sources in their shipping containers were sold as
scrap metal. Ten persons were treated for acute radiation syndrome. Several months
following the discovery of the event one of the two sources was still missing.

• In 1999 in Peru, an iridium-192 source intended for non-destructive material testing was
left uncontrolled. An unaware worker put the source in its pocket and suffered severe
radiation injuries. He was temporarily transferred in France to benefit from highly
specialised treatment techniques.

Fortunately, no similar accidents causing deaths occurred in the European Union. However,
their possibility cannot be completely ruled out. In May 1998, a caesium-137 source was
accidentally melted in a steel factory in Spain. A substantial part of the activity was released
to the atmosphere, the rest of the activity was retained in the dust collection systems and as a
consequence 270 tons of steel became contaminated. About 400 people were monitored for
internal contamination and six of them were found to have detectable levels of caesium
contamination. Fortunately,
the resulting doses were of no radiological concern. The
economic consequences of the accident, including suspension of operation of the practices,
decontamination operations and management of the resulting radioactive waste was estimated
to the order of 26 million Euro. The origin of the source, whether it came from within the
European Union or whether it was imported together with a consignment of metal scrap could
not be assessed.

A study21 reviewing the different management practices for sources in the EU estimated to a
maximum of 70 those sources that are lost from regulatory control per year throughout the
EU.

5.

MAIN REASONS FOR WHICH SOURCES BECOME LOST FROM REGULATORY CONTROL

The reasons for which sources are lost from regulatory control in Member States may be
grouped into the hereafter categories. The respective importance of each of these categories is
very variable; however the lack of awareness of users, the absence of stringent regulations in
the past, and the disappearance of the user are likely to be the three main reasons which could
explain why sources are sometimes lost:

21 See footnote 4

12

(1)

(2)

(3)

(4)

(5)

The lack of awareness of users of sources about the risks that could occur if some
unauthorised persons, workers or members of the public have access to the source.
The consequences of this are: diminished control of sealed sources at users’
premises, inadequate security during storage and/or disposal of sources.

The traceability of sources and disused sealed sources is not assured in every step of
their management from their manufacture or importation into a user’s country up to
their recycling, long-term storage and/or disposal.

The long-term storage and/or disposal route for disused sources is variable from
one Member State to another. In Member States where centralised storage facilities
are available, storage and disposal services are generally charged to the users of
sources. It is important to note that storage and disposal cost may reveal in some
countries unexpectedly high, much higher than the purchase price of the radiation
source itself. Therefore, users may be tempted to keep them in their own premises for
undefined periods, increasing thereby the risks that sources are lost from regulatory
control. Member States, which do not have available facilities for storage and
disposal of disused sources on their territory, require the users to return disused
sources to the supplier based abroad. In this case, the cost of storage and disposal
may be included into the purchase price of the source.

The user is no longer able to meet his responsibilities concerning the management
of sealed sources (lack of management control following change of circumstances,
bankruptcy, theft…etc). In this case, if there is no structure (e.g. network of users of
sealed sources, state organisation, etc) capable of taking over the responsibility for
managing sealed sources and disused sealed sources, accidental exposure is likely to
occur.

There was no satisfactory regulatory system in force when the sources were being
supplied. This is mainly the case for historical sources (Radium-226) that were used
in Member States up to the nineteen fifties.

REGULATORY FRAMEWORKS IN FORCE IN MEMBER STATES OF THE EUROPEAN

6.
UNION

All Member States of the European Union operate regulatory systems, which in particular
require users of sealed sources to hold a licence.

In some cases, most regulatory attention is paid to assessing the competence of the
prospective user before issuing a licence and thereafter, the amount of attention is limited.
This means that the user should have suitably qualified staff and management systems. The
management system should be able to ensure that the user knows the location of all sources at
any time. In this context, regulatory efforts are placed on inspection of the users to make sure
that this is the case.

In other cases, regulatory control is applied throughout the source life cycle, with particular
attention being paid to approval of individual source transfers. The regulatory structures also
vary considerably. In countries with small sealed sources markets, a single regulator is
responsible for all aspects of the use and disposal of sealed sources. In larger states there may
be multiple regulators sharing responsibilities on a regional or functional basis.

13

7.

COMMUNITY ACTIONS

The European Commission is well aware of the possibility of accidents occurring with the
mismanagement of high activity sealed radioactive sources.

Already in 1996 it organised a meeting with experts from the Member States to analyse the
issue with particular attention to the possible presence of radioactivity in scrap metals. At that
time, the prevailing attitude was to further industrial agreements on the quality and control of
the incoming consignments of scrap metal, and to promote exchanges of information on the
origin and movements of possibly contaminated consignments.

Both the national authorities and the operators intensified their controls and, as a
consequence, the number of detection of radioactive sources in scrap metals continued to
increase. A follow-up meeting on the subject was organised in 1999. In June 1999, the
Council22 concluded that there was a need for the European Union to develop common views
to address the problems related to radioactive scrap metals and proper management of spent
radioactive sealed sources.

For several years, the Commission services have been actively working in the field of the
management of spent or disused sealed radioactive sources with the view to improving the
safety of current management schemes in Member States23 24, in the Candidate countries as
well as in the Russian Federation25. A technical workshop reviewing and analysing the
management practices for spent sealed radioactive sources in Member States was held in June
1999 in Brussels. Recommendations drawn from this workshop have been taken into account.

This subject has been addressed also in the framework of the Community Plan of Action26 in
the field of radioactive waste.

22 2190th Council meeting – Luxembourg 14-15 June 1999
23 See footnote 2
24 See footnote 4
25 J.M. Alardin et al. Management of sealed radioactive sources produced and sold in the Russian Federation.

EUR report 18191 (1999)

26 Council Resolution of 15 June 1992 on the renewal of the Community Plan of Action in the field of

radioactive waste. OJ C158, 25.06.1992

14

APPENDIX A: USE OF RADIATION SOURCES (Table reproduced from “Methods to Identify and
Locate Sealed Disused Sources”, IAEA TECDOC 804, July 1995

Application

Radionuclide Half Life

Source Activity in
GBq

Comments

Use of Radiation Sources in Industry

Industrial Radiography

60Co

192Ir

Moisture Detector

241 Am/Be

Well Logging

Conveyor Gauge

Density Gauge

Level Gauge

Thickness Gauge

Static Eliminators

Lightning preventers

137Cs

241Am/Be

137Cs

137 Cs

137 Cs

241Am

137Cs

60Co

85Kr

90Sr

241Am

210Po

241Am

5.3 y

74 d

433 y

30 y

433 y

30 y

30 y

30 y

433 y

30 y

5.3 y

10.8 y

28.6 y

433 y

138 d

433 y

100-5000

100-5000

0.1-2

0.4

1-800

1-100

0.1-40

1-20

1-10

0.1 – 20

0.1 – 10

0.1-50

0.1-4

1-4

1-4

Often portable units.

Portable units to measure moisture content /density. Normally contains
both a neutron and gamma emitter.

Portable units.

Fixed installations to measure density of coal, silt or ores.

Fixed installations to measure density of materials in a constant volume.

Fixed installations to measure level of materials in tanks, silos or
packages.

Fixed installations to measure thickness of papers, plastic or similar
materials.

Fixed installations and portable units.

0.05-0.5

Fixed installations.

15

Electron capture
detectors

X-ray fluorescence
analyser

63Ni

3H

55Fe

109Cd

100 y

12.3 y

2.7 y

463 d

0.2-0.5

1-7.4

0.1-5

1-8

Fixed or portable equipment.

Often portable units to analyse alloys by simulating fluorescence X-rays.

Application

Radionuclides Half life

Source Activity in GBq

Comments

Uses of Radiation sources in Industry (continued)

Sterilisation and food preservation

60Co

Calibration facilities

Smoke detectors

Dredgers

Blast furnace control

137Cs

60Co

137Cs

241Am

60Co

137Cs

60Co

105–4x108

105–4x108

103 – 105

5.3 y

30 y

5.3 y

30 y

Fixed installations (individual sources up to 6x105 GBq).

Fixed installations

433 y

2x10-5 – 3x10-3

Fixed (easily removed)

5.3 y

1 – 100

Fixed installations for silt density measurements

30 y

1 – 100

5.3 y

2

Fixed.

16

Application

Radionuclides Half life

Source Activity in GBq

Comments

Use of Radiation Sources in Medicine

Bone densitometry

Manual brachytherapy

Remote afterloading brachytherapy

Teletherapy

Blood irradiation

241Am

153Gd

125I

137Cs

226Ra

60Co

90Sr

103Pd

125I

192Ir

131I

198Au

252Cf

60Co

137Cs

192Ir

60 Co

137Cs

137Cs

433 y

242 d

60 d

30 y

1 – 10

1 – 40

1 – 10

Mobile Units.

0.05 - 0.5

Small portable sources.

1600 y

0.03 - 0.3

5.3 y

0.05 - 0.5

28.6 y

0.05 - 1.5

17 d

60 d

74 d

8 d

2.7 d

2.6 d

5.3 y

30 y

74 d

5.3 y

30 y

30 y

0.05 - 1.5

0.05 - 1.5

0.02 - 1.5

0.05 - 1.5

0.05 - 1.5

0.05 - 1.5

10
3x10-5 - 10-2

400

5x104 – 106
5x105

2x103 – 105

17

Mobile units.

Fixed installations

Fixed installations.

Application

Radionuclide

Half life

Source Activity in GBq

Comments

Use of Radiation Sources in Research

Calibration sources

Many

Electron capture detector

Irradiators

Calibration facilities

Tritium targets

3H

63Ni

60Co

137Cs

60Co

252Cf

3H

< 0.1

1 – 50

0.2 – 0.5

103 – 106

<105
<105
<105

12.3 y

100 y

5.3 y

30 y

5.3 y

2.6 y

Small portable sources.

Can be used in portable units and gas chromatograph
detectors.

Fixed installations.

Fixed installations.

12.3 y

103 – 104

Fixed installations for neutron production by D.T reaction.

18

2003/0005 (CNS)

Proposal for a

COUNCIL DIRECTIVE

on the control of high activity sealed radioactive 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 Commission27, 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
establishing the European Atomic Energy Community,

Having regard to the opinion of the European Economic and Social Committee28,

Having regard to the opinion of the European Parliament29,

Whereas:

(1)

(2)

(3)

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.

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 radiation30, continues the line of directives laying down
basic safety standards since 1959.

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, in order to further reduce the likelihood of accidents involving
such sources.

27 OJ C , , p.
28 OJ C , , p.
29 OJ C , , p.
30 OJ L 159, 29.6.1996,p.1.

19

(4)

(5)

(6)

(7)

(8)

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 Directive31.

In Directive 96/29/Euratom exemption values have been laid down for the reporting
of a practice to the authorities. These values have been 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 to
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 Regulation (Euratom) N° 1493/93 of 8 June 1993 on shipments
of radioactive substances between Member States32.

level ensure basic protection, high activity sources still

Although the legal requirements deriving from existing legislation at Community
and at national
imply
considerable potential risks for human health and for the environment and therefore
need to be subject to a strict control from the moment they are manufactured to the
moment they are conferred to a recognised installation for their long-term storage or
disposal.

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.

(9)

Movements within the Community of high activity sources make it necessary to

harmonise the control of such sources through the application of minimum criteria.

(10)

(11)

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 requires that specific
initiatives be undertaken.

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

(12)

It is also necessary to provide for suitable means of dealing with orphan high
activity sources, for international cooperation and exchange of information in this
area, for inspection and, finally, for making financial provision for the circumstances

31 IAEA Safety Standards Series No TS R 1 (ST, Revised), Vienna, 2000
32 OJ L 148, 19.6.1993, p. 1

20

in which the original holder either cannot be identified or, even if identified, is found
to be insolvent.

(13)

The Member States should lay down rules on penalties applicable to infringements
they are implemented; those

of the provisions of this Directive and ensure that
penalties must be effective, proportionate and dissuasive

HAS ADOPTED THIS DIRECTIVE:

Article 1
Purpose and scope

1.

2.

3.

The purpose of this Directive is to prevent exposure to 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.

The Directive applies to high activity sources as defined in Article 2.

The obligations resulting from this Directive supplement those set out in Directive
96/29/Euratom.

Article 2
Definitions

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

(a)

(b)

(c)

(d)

(e)

(f)

(g)

(h)

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 the relevant activity level specified in Annex I;

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

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

Disused source means a source which is no longer used, nor intended to be used, for
the practice for which an authorisation was granted;

Holder means any natural or legal person who is in possession of a source;

Manufacturer means any natural or legal person who manufactures a source;

Orphan source means a source 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 authorisation;

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

21

(i)

(j)

(k)

(l)

(m)

1.

2.

Reused source means a source which is used by another user for the same or another
practice;

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

Supplier means any natural or legal person who supplies or makes available a high
activity source;

User means any natural or legal person who uses a high activity source;

Transfer of a high activity source means a transfer of a high activity source from one
holder to another one.

Article 3
Authorisation

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

Member States shall ensure that, before issuing an authorisation:

(a)

(b)

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

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

The financial provision referred to in point (b) of paragraph 2 may consist inter
alia in:

(i)

(ii)

an institutionalised bank deposit under the control of the Member
State;

an auditable provision made within an organisation’s
account;

fiscal

(iii)

an insurance provision used only when normal commercial
processes fail.

3.

Member States shall ensure that the authorisation covers:

(a)

responsibilities;

(b) minimum staff competencies;

(c) minimum equipment performance criteria;

(d)

requirements for emergency procedures and communication links;

(e) work procedures to be followed;

(f) maintenance of equipment and high activity sources;

22

(g)

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

Article 4
Transfers

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

Article 5
Records

1.

2.

3.

The competent authority shall maintain appropriate records of holders of
authorisations, with a clear indication of the type(s) of such sources that they are
authorised to hold. The competent authority shall also maintain appropriate records
of the transfer and disposal of high activity sources on termination of authorisation.

The holder shall keep 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.

The holder shall notify forthwith the competent authority a copy of the records
referred to in paragraph 2

(a)

at the time of opening of such records;

(b)

at intervals of 12 months thereafter;

(c)

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

(d) whenever so requested by the competent authority.

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

4.

The Commission may update the standard record sheet for the records set out in
Annex II.

Article 6
Requirements for holders

Each holder of high activity sources shall:

(a)

(b)

ensure that leak tests are undertaken regularly to check the integrity of each
high activity source;

regularly verify that each high activity source is present at its place of use or of
storage;

23

(c)

(d)

(e)

(f)

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;

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;

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.

ascertain before any transfer of a high radioactive source that the recipient
holds an appropriate authorisation.

Article 7
Identification and marking

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

The manufacturer shall mark and label the container, and where practicable, also the
high activity sources, with an appropriate sign to warn people of the radiation hazard.

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

Article 8
Training and information

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

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

The training shall be addressed to the relevant workers using or handling high
activity sources or being in the proximity of these sources.

The training shall be repeated at regular intervals.

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 yards and major metal scrap recycling plants, and the management
and the workers of significant nodal transit points like custom posts, are

1.

2.

1.

2.

24

(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.

2.

3.

4.

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

Member States shall ensure that specialised technical advice and assistance is
promptly available to the persons, not normally involved in operations subject to
radiation protection requirements,
the presence of an orphan high
that suspect
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.

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

Member States shall ensure the organisation of campaigns for recovering orphan
high activity sources, which are left behind from past activities.

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.

Article 10
International co-operation and information exchange

Each Member State shall exchange information and co-operate with other Member States or
third countries 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

25

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.

2.

3.

4.

5.

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

Member States shall forward to the Commission by [……………….] at the latest,
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 authorities are competent, Member
States shall designate one point of contact to act as an interface with correspondents
in other Member States.

Member States shall forward to the Commission any changes to data referred to in
paragraphs 2 and 3.

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

Article 14
Report on experience

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

On that basis, the Commission shall present a report to the European Parliament, the Council
and the European 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 notify those provisions to the Commission by the date
specified in Article 16 (1) at the latest and shall notify it without delay of any subsequent
amendment affecting them.

26

Article 16
Transposition

1.

2.

Member States shall bring into force the laws, regulations and administrative
provisions necessary to comply with this Directive by [………………..] at the latest.
They shall forthwith inform the Commission thereof.

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.

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
Transitory provision

As regards high activity sources put on the market before the date set out in Article 16,
Articles 3, 4, 5 and 6 shall apply at the latest 24 months from that date.

Article 18
Entry into force

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

Article 19

This Directive is addressed to the Member States.

Done at Brussels,

For the Council
The President

27

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 x 1011

4 x 109

3 x 1010

1 x 1011

3 x 109

4 x 1011

2 x 1011

2 x 1010

4 x 1011

1 x 1011

3 x 1010

1 x 1010

1 x 1011

2 x 109

1 x 1011

1 x 1011

5 x 108

the activity level includes contributions from daughter nuclides with half-lives less

(a)
than 10 days;

(b)

Includes neutron sources with beryllium

28

ANNEX II

STANDARD RECORD SHEET FOR HIGH ACTIVITY SOURCES (HAS) (optional in italics)

(1) HAS IDENTIFICATION NUMBER:

(4) REGISTRATION
Date of start of registration:
Date of transfer of
Registration to historic file:

(7) HAS CHARACTERISTIC

Radionuclide:
Activity at the date
of manufacturing:
Date of manufacturing:
Manufacturer / Supplier33:

Name:
Address:
Country:

Physical and chemical
characteristics:
Source type identification:
Capsule identification:
ISO classification:
ANSI classification:
Special form certificate:

(2) IDENTIFICATION OF AUTHORISED HOLDER
Name:
Address:
Country:
Manufacturer:
(5) AUTHORIZATION
Number:
Date of issue:
Date of expiry:

Supplier:

User:

(cid:1)

(cid:1)

(cid:1)

(8) RECEIPT OF HAS

Date of receipt:

Receipt from

Name:
Address:
Country:
Manufacturer:

(cid:1)

Supplier:

(cid:1)

Another user:

(cid:1)

(9) TRANSFER OF HAS

Date of transfer

Transfer to:
Name:
Address:
Country:
Manufacturer:
Recognized installation:

(cid:1)

Supplier:
(cid:1)

(cid:1)

Another user:

(cid:1)

(3) LOCATION OF HAS (USE OR STORAGE)
Name:
Address:

(cid:1)

(cid:1)

Storage (mobile):

Fixed use:
(6) OPERATIONAL CONTROL OF HAS
Date:
Date:
Date:
Date:
Date:
Date:
Date:
Date:
Date:
Date:
Date:
Date:
Date:
Date:
Date:
Date:
Date:
Date:
Date:
Date:
Date:
Date:

Leak test:
Leak test:
Leak test:
Leak test:
Leak test:
Leak test:
Leak test:
Leak test:
Leak test:
Leak test:
Leak test:
Leak test:
Leak test:
Leak test:
Leak test:
Leak test:
Leak test:
Leak test:
Leak test:
Leak test:
Leak test:
Leak test:

(cid:1)
(cid:1)
(cid:1)
(cid:1)
(cid:1)
(cid:1)
(cid:1)
(cid:1)
(cid:1)
(cid:1)
(cid:1)
(cid:1)
(cid:1)
(cid:1)
(cid:1)
(cid:1)
(cid:1)
(cid:1)
(cid:1)
(cid:1)
(cid:1)
(cid:1)

(cid:1)
(cid:1)
(cid:1)
(cid:1)
(cid:1)
(cid:1)
(cid:1)
(cid:1)
(cid:1)
(cid:1)
(cid:1)
(cid:1)
(cid:1)
(cid:1)
(cid:1)
(cid:1)
(cid:1)
(cid:1)
(cid:1)
(cid:1)
(cid:1)
(cid:1)

Location:
Location:
Location:
Location:
Location:
Location:
Location:
Location:
Location:
Location:
Location:
Location:
Location:
Location:
Location:
Location:
Location:
Location:
Location:
Location:
Location:
Location:

33 In case the manufacturer of the sources is established outside the Community, the name and address of the importer-supplier may be provided instead.

29