Opinion of the Economic and Social Committee on the "Proposal for a Council Directive on the control of high activity sealed radioactive sources" (COM(2002) 130 final)
Date: 2002-07-17
Institutions: European Economic and Social Committee
Subjects: ionising radiation, nuclear accident, nuclear safety, radioactive materials, radioactivity

C 241/46

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Official Journal of the European Communities

7.10.2002

Opinion of the Economic and Social Committee on the ‘Proposal for a Council Directive on the
control of high activity sealed radioactive sources’

(COM(2002) 130 final)

(2002/C 241/08)

On 18 March 2002 the Commission decided to consult the Economic and Social Committee, under the
second paragraph of Article 31 of the Treaty establishing the European Atomic Energy Community, on
the above-mentioned proposal.

The Section for Transport, Energy, Infrastructure and the Information Society, which was responsible for
the Committee’s work on the subject, adopted its opinion on 19 June 2002. The rapporteur was Mr Wolf.

At its 392nd Plenary Session (meeting of 17 July 2002), the Economic and Social Committee adopted the
following opinion with 123 votes in favour and two abstentions.

1.

Introduction

1.1.
Radioactive sources are used on a worldwide basis for
a large variety of purposes, particularly in the fields of industry,
medicine and research. The associated risks depend on a
number of factors, including the degree of radioactivity, the
different radionuclides being employed and the specific mode
of employment.

1.2.
As human beings do not, however, have a sensory
organ which can alert them to the danger to health posed by
radiation or the intake of radioactive materials, specially-
developed measuring equipment has to be used for this
purpose. The lack of such a sensory organ gives rise to the
danger of lax use of such material and the underestimation of
the possible risks; it may also, on the other hand, prompt
inappropriate anxiety and rejection of possible applications
for such materials.

1.3.
The potential dangers inherent in the intentional use
of radioactive sources are generally well-known and the use of
this material is already subject to strict radiological protection
rules. A particular problem is caused by radiation sources
which, for various reasons, escape control (‘orphan sources’).

1.4.
In the case of sealed radioactive sources, the radiation-
emitting material must be so effectively and safely encapsulated
as to rule out any escape of radioactive material
into the
environment under normal conditions of use.

1.6.
In view of the consequences for both public health and
to the economy which may ensue as a result of accidents
involving radioactive sources which are not subject to adequate
control, the Commission considered itself obliged to present
the proposal for a Directive under review. The proposed
Directive is designed to supplement Directive 96/29/Eura-
tom (1) which is currently in force.

1.7.
The Commission’s aim in presenting this proposal for
a Directive is therefore to prevent undue exposure to ionising
radiation as a result of the inadequate control of high activity
sealed radioactive sources. The control measures already
introduced by the Member States are also to be harmonised
through the establishment of specific minimum requirements
for ensuring that every single radioactive source meeting the
requisite criteria is subject to ongoing control.

1.8. With this aim in view, and in accordance with the
principle of subsidiarity, the Commission wishes to ensure that
EU-wide minimum standards are observed in this sector.

2. Particular features of the proposal for Directive

2.1.
The Member States are to stipulate that all activities
involving the use of high activity radioactive sources require
prior authorisation.

2.2.
The Member States are to introduce a system for
ensuring that transfers of individual high activity radioactive
sources are subject to adequate control.

1.5.
The Commission’s proposal for a Directive concerns
the control of ‘high activity sealed radioactive sources’. In the
light of the accidents involving serious damage to health which
have occurred in the past, the Commission defines ‘high
activity radioactive sources’ as ‘sources giving a dose rate at
one metre distance of more than 1 mSv/h’.

(1) Council Directive laying down basic safety standards for the
protection of the health of workers and the general public against
the dangers arising from ionising radiation — OJ L 159 of
29.6.1996.

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2.3.
The Member States are to require the competent
authority to maintain appropriate records of holders of
the transfer and disposal of high
authorisations and of
activity radioactive sources on termination of the respective
authorisations.

The proposal

2.4.
governing:

for a Directive also sets out rules

4.1.1.
It is pointed out in point 6.2 of the Explanatory
Memorandum that the Directive is to apply to sealed radioac-
tive sources ‘giving a dose rate at one metre distance of more
than 1 mSv/h’. The following definition is, however, provided
in Article 2 of the proposal for a Directive: ‘High activity
source or source means a sealed source containing a radio-
nuclide 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 the Annex I’.

— identification and marking

— training and information

— orphan radioactive sources

— guarantees, inspections and reports on experience gained.

3. General comments

3.1.
The ESC basically welcomes the Commission’s inten-
tions and regards several points in the proposal for a Directive
as constituting a clear improvement over the current rules.
The proposed Directive would also provide the opportunity
for enhancing the level of safety in the use of radioactive
sources. The ESC does, however, note a lack of clarity with
regard to some points, which need to be amended.

3.2.
The ESC not only highlights the need for further
clarification but also proposes that, in the light of the stricter
rules already applicable in a number of Member States, the
Commission should consider whether the field of application
of the proposal for a Directive could be extended to cover
sources involving lower levels of radioactivity. Under no
circumstances should the field of application proposed by the
Commission be rendered less strict by confining the appli-
cation of the Directive to higher activity radioactive sources.

the document

3.3.
The ESC also recommends that in the descriptive part
the Commission should explain more
of
precisely which individual provisions of the proposed Directive
are new provisions vis-à-vis the rules currently applicable in
the EU. It would, in the ESC’s view, also be advisable to make
a comparison in the Explanatory Memorandum between the
measures proposed in the present document and the provisions
already existing in the Member States.

The Committee has not examined whether the pro-
3.4.
posed measures will be sufficient to prevent the deliberate
misuse of such sources and urges that this issue be considered
too.

Annex I does, however, comprise a table of selected
4.1.2.
radionuclides, their specified activity level and the following
additional observation: ‘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 Agency, Vienna 2000)’.

4.2.
Regardless of the lack of clarity in this point, the
observations made below by the ESC refer to what is surely
the requirement which the proposal for a Directive intends to
stipulate, namely that authorisation shall be required in respect
of all activities involving the use of sealed radioactive materials
having an activity level of more than one hundredth of the
A1 value set out in IAEA Regulation No. TS-R-1.

4.2.1.
The ESC wishes to reiterate in this context the
recommendation which it made in point 3.2 above, namely
that this value should under no circumstance be exceeded.
Consideration should, however, even be given to setting lower
limit values, in this case by specifying the exemption value.
The ESC sets out conclusions in this respect under point 4.10.2
below.

4.2.2.
The values proposed by the Commission are much
higher than the exemption values set out under the EU basic
standards laid down in Directive 96/29 Euratom; in the case
of Co-60 the figures differ by a factor of 40 000! The above-
mentioned exemption values have also been incorporated, for
example, into the German radiological protection regulation
with regard to the control of sealed radioactive sources.

4.2.3.
The authorisation requirement set out in the proposal
for a Directive thus falls short of the existing requirement under
EU law and, for example, under German law. Article 4.1(e) of
Directive 96/29/Euratom stipulates a general authorisation
requirement, for radioactive sources exceeding the exemption
value,
in respect of all such sources used for ‘industrial
radiography or processing of products or research or the
exposure of persons for medical treatment ...’.

4. Special comments

The first unclear point which the ESC would highlight
4.1.
occurs in the definition of ‘high activity source’ set out in the
proposal for a Directive.

4.2.4.
The requirement set out in Article 3 of the proposal
for a Directive may therefore give rise to inappropriate action
as the (mistaken) impression is given that the use of radioactive
sources with an activity level below 1/100 A 1 is still not
subject to authorisation.

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4.2.5.
It should therefore be clearly indicated in the pro-
posal for a Directive that, under EU law, the use of radioactive
sources having an activity level above the exemption value is
already subject to authorisation in the case of sources used
for industrial radiography and other special applications, as
stipulated in Article 4.1(e) of Directive 96/29/Euratom, which
sets out EU basic safety standards. It should also be pointed
out that, under Article 3 of Directive 96/29/Euratom, the use
of all other radioactive sources having an activity level above
the exemption value is, at
to a reporting
requirement.

least, subject

4.3.
Article 3 establishes the important principle that prior
authorisation is required for any practice involving a high
activity source.

4.3.1.
Article 2(a) defines the precautions which should be
regarded as the standard for radiological protection under the
banner of ‘good practice’. The Committee therefore welcomes
the directive’s requirement that these precautions be planned
and laid down in advance in the framework of the authoris-
ation procedure.

4.3.2.
requirement
further specified.

The Committee also welcomes Article 3(2)(b). The
for ‘financial provision’ should, however, be

The system of records proposed in Article 5 goes

4.5.
further than current practice.

4.5.1.
Thus for example, the current practice in Germany is
that a holder is allowed to handle, store and appropriately
dispose of a radioactive source only in the area to which the
authorisation applies. As a result, locating radioactive sources
has so far posed no problem. This requirement does, however,
place a high degree of reliance on the holder.

4.5.2.
The system of official records proposed in Article 5
appears an appropriate safeguard against unreliable holders.
The requirement that the holder report to the authorities at
least once a year will prevent the disappearance of radioactive
sources going unnoticed for years. The Committee considers
this provision too appropriate.

4.6.

Article 6 deals with the requirements for holders.

First, the Committee points out once again that there
4.6.1.
are no minimum requirements for the reliability of
the
operator, and the Committee recommends that this omission
be rectified. (See also point 4.3.3)

4.3.2.1.
One possibility would be to require firms purchas-
ing or hiring a radioactive source to pay a deposit, refundable
on return of the source.

4.6.2.
The other provisions of Article 6, such as regular
leak tests, physical checks, measures to guard against fire and
theft, and the requirement to report any loss promptly are to
be welcomed.

4.3.2.2.
Similarly, firms required to dispose of or reprocess
used radioactive sources could be required to establish a
reprocessing reserve.

The requirement to return used sources to the
4.6.3.
supplier (in return for refund of the deposit) is a new element
which is also wholeheartedly welcomed.

set

out

The

requirements

authorisation

in
4.3.3.
Article 3(3)(a)-(f) cover responsibilities, competencies, techni-
cal equipment, emergency procedures, work procedures and
maintenance. These requirements are a clarification of existing
EU rules. Article 3(3)(g) on the management and return of
disused high activity sources is a new addition to the authoris-
ation requirements, which the Committee welcomes. The
requirements concerning theft prevention which have been
dropped from Article 3 now appear instead in Article 6, and
those concerning guarantees in Article 11. However, the
Committee recommends that new requirements be added
regarding the reliability of the user.

4.7.
The rules set out in Article 7 regarding the identifi-
cation and marking of sources are state-of-the-art. The phrase
‘written information’ requires further clarification, however. It
also needs to be made clear whether this information is
required to be carried during every transport. At all events the
container should also carry information on the radionuclide
and the initial activity.

4.8.
Article 8 covers training and information. The Com-
mittee considers that the article should be more clearly worded.

4.4.
The system for the control of transfers of high activity
sources provided for in Article 4 is a further development of
the EU basic safety standards set out in Article 5 of Directive
96/29. The Committee recommends that this rule be extended
to require the holder of a radioactive source to check, before a
transfer is made,
that the recipient holds an appropriate
authorisation.

4.8.1.
For example, Article 8(1) does not define the persons
to be trained and informed. In the case of mobile sources the
relevant persons are the responsible team leader, the staff using
the source and those responsible for transport. These persons
must receive information on handling, loss and emergency
procedures and reporting requirements.

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4.8.2.
The safety culture required in dealing with radioactive
sources should be mentioned in the preamble and then, as a
development of this, the persons required to be trained and
informed defined in Article 8. The persons concerned are
those:

— either working permanently or temporarily with a radio-
active source or using it for their work. These persons
should be informed of the nature and physical properties
of the source and its radiation, and also of possible risks
and safety requirements to be complied with in handling
the source;

— or for various reasons may be in the direct vicinity of the
radioactive source, e.g. for cleaning, transport etc. These
persons should receive introductory and follow-up infor-
mation on conduct and regulations, and they should also
be drawn from among a firm’s most reliable employees.

4.8.3. With regard to the timetable for training, the Com-
mittee recommends:

— that initial and regular refresher training and information
be provided for staff using radioactive sources or working
in the immediate vicinity of sources,

— that training be repeated under specific circumstances,
and specifically geared to those circumstances (e.g. special
applications, transport etc).

consideration to the cost of any measures — especially for
SMEs — before opting for a particular procedure.

4.9.2.
The provisions should specify the frequency of
checks and the procedures to be followed. The sensitivity of
the tests and the measuring procedures should also be defined
in detail.

4.9.3.
Finding orphan sources where there is efficient
shielding or where no high-energy gamma radiation is present
is, however, likely to be difficult. The popular belief in the
reliability of detection methods could even under certain
circumstances lead to those affected developing a false sense
of security.

In this context,

4.9.4.
is also unclear what exactly
is meant by the phrase ‘campaigns for recovering orphan
sources’.

it

4.10. With reference to the content of point 4.1, the
Committee points out that the table in Annex 1, which defines
the scope of the directive, is difficult understand and needs to
be clarified.

4.10.1.
Thus, maximum activity levels are related to A1
values rather than dose rate values. The statement that these
values are equivalent to 1 mSv/h at a distance of 1 m. is not
generally speaking correct; the intake risk also plays a part in
relation to A1 values.

4.10.2.
In general, it also needs to be asked whether it
makes sense to limit the directive to sources with activity
exceeding 1/100 A1. Many, although not necessarily all, of the
directive’s provisions could, the Committee feels, be extended
to all sources with activity above the exemption values.

4.9.
Article 9 covers the action to be taken in the event of
radioactive sources being lost: orphan sources. This provision
is important and necessary.

5. Conclusion

4.9.1.
Checks to detect the presence of radioactivity at
scrap yards and smelting works have already been carried out
in the Member States in the past in order to prevent the
occurrence and spread of radioactive contamination. Before
the EU draws up formal requirements for the Member States,
the Committee recommends that the Commission give detailed

5.1.
In principle, the Committee welcomes the intention,
and to a great extent also the content, of the proposal for a
directive, many aspects of which are a clear improvement on
the rules currently in force

5.2.
In relation to a number of points, however, the
Committee feels that the proposal needs to be revised, clarified,
and its content amended.

Brussels, 17 July 2002.

The President

of the Economic and Social Committee

Göke FRERICHS