CELEX: 51997PC0240
Language: en
Date: 1997-06-12
Title: Amended proposal for a Council Directive amending Directive 90/219/EEC on the contained use of genetically modified micro-organisms

COMMISSION OF THE EUROPEAN COMMUNITIES
                                       Brussels, 12.06.1997
                                       COM(97) 240 final
                                       95/0340 (SYN)
                  Amended proposal for a
                  COUNCIL DIRECTIVE
               amending Directive 90/219/EEC
on the contained use of genetically modified micro-organisms
(presented by the Commission pursuant to Article 189 a (2)
                      of the EC-Treaty)
 ---pagebreak---  ---pagebreak---                               EXPLANATORY MEMORANDUM
Pursuant to Article 189 (a) paragraph 2 of the EC treaty, the Commission submits an amended
proposal for a Council Directive amending Directive 90/219/EEC on the contained use of
genetically modified micro-organisms. The amended proposal takes account of a number of
amendments from the European Parliament adopted at its March 1997 Plenary Session.
 In general the Commission cannot accept amendments that seek to limit the information given
 to the public or the Commission, introduce specific requirements for liability insurance, change
the legal basis of the Directive or complicate its operation. However the Commission can
accept in full amendments 2, 3, 9, 10, 16, 17, 19, 31, 41, 42,49 and 56 which clarify or further
the principles of the Commission Proposal.
In addition the Commission can partially accept amendments 4, 11, 27, 30 (merged with 29),
37, 38, 39,43,47,48, 54 and 55. Commentary on these amendments follows:-
Amendment 4 (Article 2 (a)) seeks to delete the words "including viruses, viroids, animal and
plant cells in culture, but excluding naked nucleic acid molecules.". The Commission accepts
the deletion of "but excluding naked nucleic acid molecules", but wishes to retain the other
words to assist clarity and maintain the intended scope of the Directive.
Amendment 11 makes a textual change in Article 6 (a) (1) deleting the word risk and adding
the plural form of activity. The Commission accepts this but has substituted contained use(s)
in place of activities to be consistent with other amendments.
Amendment 27 requires in Article 14 (b) information on safety measures to be included,
regional administrative authorities to be informed and a system of co-operation be established
to guarantee public informed in detail. The Commission accepts, with rewording, the
requirement for information on safety measures which must be relevant to the emergency
plans. However the Commission cannot accept that the Directive would require the
implementation of a regional system for co-operation within a Member State to guarantee the
public are informed in detail. This is under the responsibility of the Member State.
Amendment 30 the restriction of serious damage to public health or the environment in Article
15.1 is not acceptable to the Commission. An accident is defined in Article 2(f) and the
proposed wording implies that damage must have occurred, whereas the current definition
covers the potential hazard from the accident. The proposed addition of the words "and
unintentionally released" added at end of the second indent of Article 15.1 has not been
accepted because it restricts the article to not covering accidents by self inoculation
(injection).     The deletion of the word emergency in the fourth indent of Article Î5.1 is
already in the Proposal. The replacement of the word avoid with prevent in Article 15.2 is
accepted by the Commission.
Amendment 37 (Article 20) seeks to limit the annexes that can be modified by the committee
procedure to Annex III par.l -5 and annexes IV & V. The Commission accepts that annexes I
& IIB (should be only amendable by the full procedure. The Commission is unable to accept
restriction on the procedure to amend annexes II and III. The restriction on amending annex
                                               2
 ---pagebreak--- ÏI would prevent the operation of the list of types of GMMs shown to be safe for human
health and the environment. It would also prevent the rapid modification of annex IIA which
lists techniques of genetic modification not leading to a GMM should an, as yet unknown,
safety issue indicate the need to further restrict this annex. The exclusion of some parts of
annex III would complicate amendments to the annex as a whole.
Amendment 38 requires in Article 20 (a) (new) that within 6 months of implementation of the
Directive, following a Commission proposal, the criteria defining GMMs suitable for
inclusion into Annex II B shall be made in accordance with Article 100a of the EC Treaty.
The Commission has accepted this, but not the suggested Treaty base of 100a since the
Directive is made under Article 130S1.
Amendment 39 concerns Article 21. The Commission has accepted a 2a comitology procedure
which gives flexibility to the Council to adopt different measures to those proposed by the
Commission instead of the 3b procedure contained in the Commission Proposal for the
modification of Directive 90/2 î 9/EEC. Concerning the report of experience with the Directive
the Commission considers that this requirement is present in Article 18.3 and the report will be
made available to Parliament. However the proposal in the amendment that the decisions and
minutes of the committee are made available to the public is not acceptable to the Commission,
 since it conflicts with the agreement between the Commission and the European Parliament
 (applicable from 1.12.1996) on transparency and publicity of committee meetings.
 Amendment 43 proposes in Annex III new wording for par.2 a and a specific reference to
 Directive 90/679/EEC on the protection of workers from biological agents in par. 3. These
 changes are acceptable to the Commission. The addition of a specific risk assessment
 procedure for human health is not acceptable to the Commission since the Directive covers
 human health and the environment. The Commission feels specific guidance of this nature
 would best be produced in guidance to the Annex. The Commission has accepted text from par.
 5a and par. 5b which assist the clarity of the Commission Proposal.
 Amendments 47 and 48 (Annex IV Table la) amend the requirements for surfaces in
 laboratories. The Commission accepts that the surfaces should be resistant to water,
 decontamination agents and easy to clean. The Commission has not accepted the change in
 specification for floors walls and ceilings which are in excess of the requirements of Directive
 90/679/EEC on the protection of workers from biological agents, which also covers GMMs,
 since this measure is primarily related to worker protection.
 Amendments 54 and 55 (Annex IV Table II) amend the requirements for surfaces in facilities
 for other activities. The Commission accepts that benches, if fitted, should be included at all
 levels and that the surfaces should be resistant to water and decontamination agents. The
 Commission has not accepted the change in specification for floors walls and ceilings. The
 requirement that floors must be resistant at level 2 should remain to be applied on a case by case
 basis depending on the risk assessment which considers the size of the operation. The
 alterations at levels 3 and 4 are not required due to the absence of very large scale production of
 those agents,
 The Commission can accept in principle amendments 7, 8, 14,15, 21, 22, 23, 24,25, 35 and
  68. Commentary on these amendments follows:-
                                                       2>
 ---pagebreak---  Amendment 7 concerning Article 2 (c) is acceptable with a minor rewording to refer to annex II
 C.
 Amendment 8 links the risk assessment to the containment and control measures in Article 6a,
 the Commission accepts the principle but has altered the wording to assist clarity.
 Amendments 14 and 15 seek to introduce the principle of good microbiological practice and the
 requirement to review its application in the workplace in Article 6a (2). The Commission
 accepts the inclusion of the principle in the Directive, but feels that such technical measures are
 best located in the preface to Annex IV which details the containment and control measures to
 be applied.
 Amendments 21, 22, 23, 24, 25, and 35 introduce the separation of classes 3 and 4 for different
 notification requirements in Articles 10, 11, 12 and 18, requiring an explicit consent for
 subsequent activities for class 4 and implicit consent for class 3. The Commission accepts the
 principle of these amendments to strengthen the administrative controls for high risk work but
 intends to retain the equal treatment of classes 3 & 4, accordingly making both subject to
 explicit consent for all uses in Article 10a (3).
Amendment 68 seeks to amend the definition of contained use in Article 2 (c) to avoid possible
confusion over the use of the word limit. The Commission accepts the principle of this
amendment but proposes to replace "avoid their contact with" by expressing the principle aim
of the Directive using the words "provide a high level of safety for".
The Commission has not accepted amendments 1, 6, 12, 13, 18, 20, 26, 28, 32, 33, 34, 36, 40,
44, 45, 46, 50, 51, 52, 53, 57 and 58. Commentary on these amendments follows:-
Amendment 1 proposing to change the legal basis of the Proposal from 130S.1 to 100A is not
acceptable to the Commission. Legally, since the scope of Directive 90/219/EEC is not being
significantly altered, and it does not impact directly on the functioning of the harmonised
market, there is no legal argument to change the legal basis of the Directive from 130S1 to
100A. In addition the change of legal base would prevent Member States from providing in
their national legislation containment and control measures which are more stringent than those
provided for in the Directive.
Amendments 18 & 20 seek to separate class 3 and 4 activities for different notification
requirements are not acceptable because the Commission believes that such a separation would
complicate the operation of the Directive and could lead to confusion.
Amendments 44, 45 and 46 which seek to reintroduce the distinction of purpose into the
revision of the Directive, are not acceptable to the Commission. The Commission seeks to
regulate the activity, for example laboratory work, irrespective of the final purpose for which
the work is being undertaken.
Amendments 26, 36, 57 and 58 have not been accepted by the Commission. These amendments
seek to limit the information available to the public or aspects of activities that can be subject to
public consultation to solely health and environmental protection and emergency plans. The
                                               VJ
 ---pagebreak--- Commission feels that these restrictions will not improve public confidence in the regulation of
this technology.
Amendments 32 and 33 seek to restrict information required to be given to Competent
Authorities and the Commission in the event of an accident, to that which presents possible
serious damage. Under these amendments the choice of what is covered by health and
environmental protection and emergency plans is left with the notifier. These amendments are
not acceptable to the Commission.
Amendments 13 and 28 deal with the issue of liability insurance and the provision of financial
security and are not acceptable to the Commission. The subject of liability is under
consideration by the Commission, which intends to produce a white paper on environmental
liability. The Commission wishes to deal with this matter in a horizontal manner to avoid
different liability requirements in different Directives.
Amendments 6, 12 and 34 have not been accepted by the Commission because they duplicate
provisions present in Article 2(h), 12.2 and duties present in Articles 8, 9 and 10 respectively.
Amendment 40 has not been accepted by the Commission because it produces a duplication of
existing text within the same annex, which does not assist the clarity of the text.
Amendments 50 and 51 have not been accepted by the Commission. These amendments
increase the burden of control measures, by making them requirements, without the option to
decide if they are necessary in all cases. These measures will not always be required and thus
not always increase safety levels.
Amendment 52 has not been accepted by the Commission. This precautionary measure should
not be specifically required for class 2 activities. The amendment is in excess of the
requirements of Directive 90/679/EEC on the protection of workers from biological agents,
which covers GMMs, and this measure is primarily related to worker protection.
Amendment 53 is technically invalid since the genetically modified micro-organisms are not
required to be in a closed system and as such has not been accepted by the Commission.
                                               S
 ---pagebreak--- Amended Proposal for a
                                     COUNCIL DIRECTIVE
                                 amending Directive 90/219/EEC
                 on the contained use of genetically modified micro-organisms
     (presented by the Commission pursuant to Article 189a paragraph 2 of the EC Treaty)
       COMMISSION PROPOSAL                              AMENDED PROPOSAL
                                          Recital 3a (new)
                                                Whereas the. principle of good
                                               microbiological practice and the principles
                                               of safety and health at work laid down in
                                               the relevant Community laws should apply
                                               to all activities in which genetically
                                               modified micro-organisms are used;
                                          Recital 4a (new)
                                               Whereas specific measures should be
                                               adopted and used for the control of the
                                               disposal of material from the activities of
                                               the contained use of genetically modified
                                               micro-organisms:
                                            Article 2(a)
(a) The following words are added at the (a) The following words are added at the
end of paragraph (a): "including viruses, end of paragraph (a): "including viruses,
viroids and animal and plant cells in viroids and animal and plant cells in
culture but excluding naked nucleic acid culture (words deleted).":
molecules-";
                                            Article 2(c)
  (c) "contained use" shall mean: any (c) "contained use" shall mean: any
operation in which micro-organisms are operation in which micro-organisms are
genetically modified or in which such genetically modified or in which such
genetically modified micro-organisms are genetically modified micro-organisms are
cultured, stored, used, transported or cultured, stored, used, transported or
destroyed [deleted words], and for which destroyed [deleted words], and for which
physical barriers, or a combination of physical barriers, or a combination of
physical barriers together with chemical physical barriers together with chemical
and/or biological barriers, are used to limit and/or biological barriers, are used to
their contact with the general population provide a high level of safety for the
and the environment; or any activity in general population and the environment;
which genetically modified micro- or any activity in which genetically
organisms are disposed o[\ for which modified micro-organisms are disposed of,
physical or chemical or biological barriers, for which physical or chemical or
or any combination of these types, are biological barriers, or any combination of
used to limit their contact with the general these types, are used to provide a high
population and the environment;"                level of safety for the general population
                                                and the environment;"
                                             G
 ---pagebreak---                                             Article 3
This Directive shall not apply where This Directive shall not apply where
genetic modification is obtained through genetic modification is obtained through
the use of the techniques or methods listed the use of the techniques or methods listed
in Annex II, or for contained-use activities in Annex II, or for contained-use activities
involving other types of genetically involving other types of genetically
modified micro-organisms known to be modified micro-organisms known to be
safe for human health and the safe for human health and the
environment. Such types of genetically environment. Such types of genetically
modified micro-organisms and their modified micro-organisms and their
characteristics are listed in Annex II, Part characteristics are listed in Annex II, Part
B                                              Band Part C:
                                           Article 6 (3)
3. The assessment should result in the 3. The assessment shall result in the final
categorization of the contained-use categorization of the contained-use
activities in the following four classes of activities in the following four classes of
risk:                                          risk and serve to determine the level of
                                               containment and control measures in
                                               accordance with Article 6a:
                                       Article 6 (3 a) (new)
                                               3 a Where there is doubt as to which of
                                               two classes of risk is appropriate for the
                                               proposed contained-use activityfiesl the
                                               higher classification should be assigned
                                               until sufficient evidence justifies the use of
                                               the lower classification.
                                       Article 6 (4a) (new)
                                               4a. When assessing the risk entailed in an
                                               activity involving genetically modified
                                               micro-organisms, the question of disposal
                                               shall be taken especially into account.
                                               Where appropriate, the necessary safety
                                               measures shall be implemented in order to
                                               protect human health and the environment.
                                           Article 6a (1)
 1. The user shall apply the containment 1. The user shall apply the containment
and control measures from the appropriate and control measures from the appropriate
Table(s) in Annex IV corresponding to the Table(s) in Annex IV corresponding to the
risk class of the activity, so as to class of the contained use(s). so as to
 keep workplace       and     environmental keep workplace           and      environmental
exposure to any genetically modified exposure to any genetically modified
 micro-organisms to the lowest reasonably micro-organisms to the lowest reasonably
 practicable level, and so that a high level practicable level, and so that a high level
 of safety is ensured."                        of safety is ensured."
                                                    "3
 ---pagebreak---                                             Article 10(1)
 1. For the first and subsequent Class 2 1. For the first and subsequent Class 2
 activities to be carried out in premises contained usefs^ to be carried out in
 notified in accordance with Article 8, a premises notified in accordance with
notification containing the information Article 8, a notification containing the
 listed in Annex V, Part B shall be information listed in Annex V, Part B shall
 submitted.                                     be submitted.
                                        Article 10 (2a) (new)
                                                 2a. The applicant can, however, himself
                                                 request a decision on a formal
                                                authorization       from     the competent
                                                authority. This decision must be made
                                                 within a maximum of 45 days from the
                                                 notification.
                                           Article 10a (2)
2.      If no previous notification has been 2.           If no previous notification has been
submitted for Class 3 or a higher class of submitted for Class 3 or a higher class of
activities, the contained use may not contained use, the contained use may not
proceed without the consent of the proceed without the consent of the
competent authority. The competent competent authority. The competent
authority shall communicate its decision in authority shall communicate its decision in
writing at the latest 90 days after writing at the latest 90 days after
submission of the notification.                 submission of the notification.
                                           Article 10a (3)
3.        If a previous notification has been 3.          If a previous notification has been
submitted for Class 3 or a higher class of submitted for Class 3 or a higher class of
activities and the associated consent activities and the associated consent
requirements have been satisfied, the requirements have been satisfied for the
contained use may in absence of any same or higher class, the contained use
indication to the contrary from the may not proceed without the consent of
competent authority proceed 45 days after the competent authority. The competent
submission of the new notification, or authority shall communicate its decision in
earlier with the agreement of the writing at the latest 45 days after
competent authority."                           submission of the notification.
                                           Article 14(b)
 (b)          Information on emergency (b)               Information on emergency plans
plans is supplied in an appropriate manner, and relevant safety measures is supplied in
and without their having to request it, to an appropriate manner, and without their
bodies and authorities liable to be affected having to request it, to bodies and
by the accident. The information shall be authorities liable to be affected by the
updated at appropriate intervals. It shall accident. The information shall be updated
also be made publicly available.               at appropriate intervals. It shall also be
                                               made publicly available.
                                           Article 15(2)
                                               (a)       in the second indent, the word
                                                "avoid" is replaced by the word "prevent"
                                                           £
 ---pagebreak---                                     Article 16(1) (a) (new)
                                             In point (a) of paragraph 1 of Article 16.
                                             the word "liable" is replaced bv the word
                                               liKciy .
                               !
                                           Article 20
In Article 20, the words "Annexes II to V" In Article 20, the words "Annexes II to V"
are replaced 1 iy the words "Annexes I to are replaced by the word,s "Annexes II part
V".                                          A. II part C and annexes III to V".
                                       Article 20a (new)
                                             Within six months of the implementation
                                             date of this Directive specified in Article 2.
                                             the criteria for the inclusion of certain
                                             types of genetically modified micro-
                                             organisms in Annex II. Part B. shall be
                                             laid down in accordance with Article
                                              130Slofthe EC Treaty.
                                           Article 21
                                              3.      The Commission shall adopt
                                             measures which shall apply immediately.
                                              Howeverr if these measures are not in
                                             accordance with the opinion of the
                                              committee, they shall be communicated by
                                             the Commission to the Council forthwith.
                                              In that event the Commission mav defer
                                              application of the measures which it has
                                              decided for a period of not more than one
                                              month     from     the    date    of    such
                                              communication-
                                              The Council, acting by a qualified
                                              majority, may take a different decision
                                              within the time-limit referred to in the
                                             previous subparagraph.
                                        Annex II part B
B.      Types of genetically modified        B. Criteria establishing the safety of
micro-organisms wliich have j)een shown       genetically modified micro-organisms to
to be safe for luman health and the           human health and the environment,
environment ; nd which are, therefore,
 excluded front the Directive:"
                                     Annex II part C (new)
                                              CL Types of genetically modified micro-
                                              organisms which meet tie criteria listed
                                              in part B
                                        Annex III par. 2
                                                 3
 ---pagebreak--- 2.     a.     The assessment referred to in 2.        The assessment referred to in Article
Article 6 should be based on the 6 should be based on the following:
following:
                                                a. The identification of any potentially
(i) the recipient micro-organism;               harmful effects of the operation in
                                                particular any potentially harmful effects
(ii) the inserted (donated) genetic caused by:
material;
                                                (i) the recipient micro-organism;
(iii) the vector;
                                                (ii) the inserted (donated) genetic
(iv) the donor micro-organism (if the material;
donor micro-organism is used during the
operation);                                     (iii) the vector;
(v)       the resulting genetically modified    (iv) the donor micro-organism (if the
micro-organisms.                                donor micro-organism is used during the
                                                operation);
b.     The severity      of   the   potentially (v)      the resulting genetically modified
harmful effects.
                                                micro-organisms.
c.        The likelihood of the potentially
harmful effects being realized.                 b.     The severity      of  the   potentially
                                                harmful effects.
                                                c.       The likelihood of the potentially
                                                harmful effects being realized.
                                            Annex III par. 3
Procedure                                       Procedure
   3. In order to arrive at the categorization    3. In order to arrive at the categorization
of a particular activity, as referred to in     of a particular activity, as referred to in
Article 6, the user may take into               Article 6, the user may take into
consideration the risk class of the             consideration the risk class of the
recipient, the vector and, if applicable,       recipient, the vector and, if applicable,
donor micro-organism as given in other          donor micro-organism as given in other
Community legislation, international or         Community legislation, in particular
national schemes (e.g. WHO, NIH etc.).          Directives 90/679/EEC~ on the protection
          These classification schemes          of workers from risks related to exposure
                                                to biological agents at work as amended
concern natural micro-organisms and are
                                                by Directive 93/88/EEC" and adapted to
usually based on the ability of micro-          technical progress by Directive 95/30/EC".
organisms to cause disease to humans or         Internationa! or national schemes (e.g.
animals, and on the severity and                 Wl 10, NIH etc.) and their revisions due to
transmissibiiity of the disease likely to be    new scientilic knowledge and technical
                                                progress may also be considered.
caused. The user may also take into
consideration classification schemes                     These classification schemes
referring to plant pathogens (which are         concern natural micro-organisms and are
usually established on a national basis).        usually based on the ability of micro-
                                                organisms to cause disease to humans or
    OJ No L 374 31.12.1990 p.l
    OJ No L 268 29.10.1993 p. 0071
    OJ No L 155 06.07.1995 p. 0041
 ---pagebreak--- The above mentioned classification             animals, and on the severity and
schemes give only a provisional indication     transmissibility of the disease likely to be
of the risk class of the activity and the      caused. Directive 90/679/EEC classifies
corresponding set of containment and           micro-organisms, as biological agents, into
control measures required.                      four classes of risk on the basis of potential
                                                effects on a healthy human adult. These
                                                classes of risk can be used as guidance to
                                                the categorization of the contained use
                                                activities in the four Classes of risk
                                                referred to in Article 6(3). The user may
                                                also take into consideration classification
                                                schemes referring to plant pathogens
                                                (which are usually established on a
                                                national basis). The above mentioned
                                                classification schemes give only a
                                                provisional indication of the risk class of
                                                the activity and the corresponding set of
                                                containment and control measures
                                                required.
                                        Annex 111 par.5b (new)
                                                 5b. Risk assessments for human health
                                                 and the environment may give rise to
                                                 different classifications of the contained
                                                 use. Where this occurs, the final
                                                 classification will be the higher of the two
                                                 classifications with its accompanying
                                                 containment and control measures.
                                  Annex IV Preface (new paragraphs)
                                                 As a minimum, in addition to specific
                                                 safety measures, the following principles
                                                 of good microbiological practice at work
                                                 shall invariably apply to genetically
                                                 modified micro-organisms:
                                                 (a)      when necessary, tests shall be
                                                 carried out to ascertain the presence of
                                                 viable used organisms outside the physical
                                                 boundaries within which they are
                                                 primarily contained:
                                                 (b)      provision shall be made for basic
                                                 and regular further training of personnel;
                                                 (c)      biological safety committees or
                                                 subcommittees shall be set up according to
                                                 requirements:
                                                 (d)      internal practical rules of conduct
                                                 -i/|
 ---pagebreak---                                               shall be drawn up and enforced to ensure
                                              the safety of personnel.
                                              The application of 'Good microbiological
                                              practice' shall be reviewed by the user
                                              periodically. The persons employed in
                                              this area shall take part in the review,
                                              without prejudice to Article 11 of
                                              Directive 89/391/HEC on the introduction
                                              of measures to encourage improvements in
                                              the safety and health of workers at work-.
                                         Table I a (line 3)
   Surfaces resistant to acids, alkalis,      3     Surfaces resistant to water, acids,
   solvents, disinfectants                         alkalis, solvents, disinfectants,
   Containment levels                              decontamination agents and which
   1 yes (bench)                                   are easy to clean
   2 yes (bench)                                   Containment levels
   3 yes (bench, floor)                             1 yes(bench)
   4 yes (bench, floor, ceiling, walls)            2 yes(bench)
                                                   3 yes (bench, floor)
                                                   4 yes (bench, floor, ceiling, walls)
                                        Table I a (line 12)
12 Washing and decontamination                 12 Handwashing and decontamination
   provisions for personnel                        provisions for personnel
   Containment levels                              Containment levels
   1 yes                                            1 yes
   2 yes                                           2 yes
   3 yes                                            3 yes
   4 yes                                           4 yes
                                         Table II (line 9)
      Surfaces resistant to acids, alkalis,            Surfaces resistant to water, acids,
   solvents, disinfectants                         alkalis, solvents, disinfectants,
      Containment levels                           decontamination agents and which are
       1      optional                             easy clean
      2       optional                                 Containment levels
      3        yes (bench if any, floor)                1       yes (bench if any)
      4       yes (bench, floor, ceiling,              2       yes (bench if any)
      walls)                                           3        yes (bench if any, floor)
                                                       4       yes (bench if any, floor,
  OJ N o .  L183,     29.6.1989,         p.l.
                                            1£
 ---pagebreak---                                                 ceiling, walls)
                                  Table II (line 16)
16    Washing and decontamination       16      Handwashing and decontamination
   provisions for personnel                  provisions for personnel
      Containment levels                         Containment levels
      1        yes                               1       yes
      2       yes                                2       yes
      3       yes                                3       yes
      4       yes                                4       yes
                                      * %
 ---pagebreak---  ---pagebreak---                                                                   ISSN 0254-1475
                                                            COM(97) 240 final
                                              DOCUMENTS
EN                                                                  05 14 15
                                    Catalogue number : CB-CO-97-232-EN-C
                                                             ISBN 92-78-19877-3
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