CELEX: 51991PC2282(01)S
Language: en
Date: 1991-11-29
Title: Proposal for a Council Regulation (ECSC, EEC, EURATOM) correcting with effect from 1 July 1990 the remuneration and pensions of officials and other servants of the European Communities

Sén£    COMMISSION OF THE EUROPEAN COMMUNITIES
         aftf^                                          C0M(91) 282 final
                                                        Brussels, 23 July 1991
                                         Proposal for a
                                        COUNCIL     DFCIStf^
                     CONCERNING IB£ NUMMARY NOTIFICATION INFORMATION FORMAT
                        REFERRED IÛ iM A R T i g e £ P£ DIRECTIVE 90/220/EEC
                                 (presented by the Commission)
  lilt
 lbs '.&&
mm.
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                            EEPtANATORY MEMQRANPUM
In accordance with the procedure laid down in Article 9 of Council Directive
90/220/EEC* 1 >, the competent authorities must send to the Commission,
within 30 days of its receipt, a summary of each notification received. The
format of this summary must be established by the Commission in accordance
with the procedure laid down in Article 21.
The Commission    submitted for its opinion the proposed Decision to     the
Committee for    the Release of Genetically Modified Organisms to        the
Env i ronment.
Because the delegations were divided on the issue, the vote of the Committee
did not reach the required qualified majority and it therefore did not give
a favourable opinion on the proposal on 5 July 1991.
Pursuant to Article 21 of Directive 90/220/EEC, the Commission must submit
without delay the proposal to the Council.
The Council must act by qualified majority within three months of receiving
the proposal.
(1)    OJ N* L117, 8.5.1990
 ---pagebreak---                                    -4Pt
Proposal for a Council Decision of                      1991 concerning the
Summary Notification Information Format     referred  to In Article 9 of
Directive 90/220/EEC.
THE COUNCIL OF THE EUROPEAN COMMUN IITI ES,
Having regard to the Treaty establishing the European Economic Community,
Having regard to Directive 90/220/EEC of 23 April 1990 on the deliberate
release into the environment of genetically modified organ isms* 1 ), and in
particular articles 9 and 21 thereof,
Having regard to the proposal from the Commission
Whereas the Competent Authorities appointed by the Member States have to
send to the Commission a summary of each notification received under part B
of Directive 90/220/EEC,
Whereas the Comisslon is required to establish, before 23 October 1991 the
format of this summary,
Whereas the Committee for the Release of Genetically Modified Organisms to
the Environment did not give a favourable opinion on the draft of the
measure which was submitted to it by the Commission,
HAS ADOPTED THE FOLLOWING DECISION:
                                  Article 1
The Competent Authorities appointed by Member States under Directive
90/220/EEC must use the annexed Summary Notification Information Format when
sending to the Commission the summary of a notification received, as
specified under part B of Directive 90/220/EEC.
                                  Article 2
This Decision is addressed to the Member States
Done in Brussels,
CD    OJ N* L117, 8.5.1990
 ---pagebreak---                   -1s-
                                        ANNEX
SUMMARY NOTIFICATION INFORMATION FQRMAT
     FOR QMO RELEASES FOR RESEARCH
        AND DEVELOPMENT PURPOSES
in accordance with Directive 90/220/EEC
               (Article 9)
 ---pagebreak---                                   - 2 &*'o —
                              INTRODUCTION
The Summary Notification Information Format has been established for
the purposes and according to the procedures envisaged by Directive
90/220/EEC, article 9.
It is recognised that the Summary Notification Information Format is
not designed to contain all the information required for carrying out
an environmental risk assessment in the detail necessary for such an
assessment. The information entered should, however, adequately reflect
(in a condensed form) the Information submitted to the Competent
Authority according to Articles 5 and 6 of Directive 90/220/EEC under
the conditions specified in the preface to Annex II. The space provided
after each question is not indicative of the depth of the information
required for the purposes of the Summary Notification Information
Format.
 ---pagebreak---         - 3 -
GENERAL  I N F O R M A T I O N
 ---pagebreak---                                    - 4 -
 1
   -  Petal!s of Notificatif
      Member State of notification
      Not i f|cat ion number
      Date of acknowledgment of
      not ification
      Title of the project
     Proposed period of release
2. Notifier
     Name of institution or company
3. QMO characterisation
     a) Indicate whether the GMO is a:
     viroid
     RNA virus
     DNA virus
     bacterium
     fungus
     plant
     animal
     other, please specify   ! !
     b)   Identity of the GMO:
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4.  Is the same GMO release planned elsewhere     in the Community (in
   conformity with article 5.1.) ?
        YES   |  |    NO     !  |     NOT KNOWN
   If Yes. Insert the country cade(s) I.
5. Has the same GMO been notified       for  release e I sewhere in the
   CommunIty by the same notifier?
       YES    O       NO       O
   If Yfi&:
   - Member State of notification::
   - Notification number
 ---pagebreak---               - 6 -
INFORMATION RELATING TO ANNEX I I
     (DIRECTIVE 90/220/EEC)
 ---pagebreak---                                     - 7 -
A.  INFORMATION RELATING TO THE RECIPIENT OR PARENTAL ORGANISMS FROM
   WHICH THE GMO IS DERIVED
1.  Indicate whether the recipient or parental organism is a:
   viroid
   RNA virus
   DNA virus
   bacterium
   fungus
   plant
   animal
   other, please specify     ! I
2. a)   Complete name:
        i)     order and/or higher taxon (for animals)
        ii)    family name (for plants)
        ill) genus
        iv)    species
        v)     subspecies
        vl)    stra i n
        vli) cultlvar
        vlii) pathovar (biotype, ecotype, race, etc.)
        ix)    common name
3. Geographical distribution of the organism:
   a) indigenous to the country where the notification is made
      Yes    iZZl       No I   I        Nat known   I {
   b) indigenous to other EC countries:
       I ) Yes     d\
            If ves. indicate the type of ecosystem in which it is found:
           Atlantic             Mediterranean  !  j   Continental
       ii) No    !~!        Not known    i !
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     c)   is it regularly grown In the country where the notification is
          made?
         Yes    !__!     No   |_|
     d)   is it regularly used in the country where the notification is
         made?
         Yes    !__!     No  !__!
     e)   is It regularly kept in the country where the notification is
         made?
         Yes    }_!      No !___!
4.  Natural habitat of the organism:
M   a) if the organism is a microorganism
        water                j !
        soil, free-living    I {
        soil in association with plant-root systems
        in association with plant leaf/stem systems
        in association with animals
        other (specify)
P.A     b) if the organism Is an animal or a plant:
        natural habitat or usual agroecosystem:
5.  a) Detection techniques:
    b) Identification techniques
 ---pagebreak---                                   - 9-
 6.  Is the recipient organism classified under existing Community rules
    relating to the protection of human health and/or the environment?
         YES        |~|                  NO    J~|
          If yes, spec Ify :
7.  is the recipient organism pathogenic or harmful In any other way
    (including Its extracellular products), either living or dead?
         YES       CZ\                   NO     \~\
    if Yes.
    a) to which of the following organisms?
        humans
        an i ma I s
        plants
    b) Give the relevant information specified under Annex II, I l'A I1d/
8.  Information concerning reproduction:
    a) Generation time in natural ecosystems
    b) Generation time in the ecosystem where the release will take
         place:
    c) Way of reproduction:
         Sexual      î J     ,                   Vegetative    Î I
£   d) In the case of plants:
         I) Mode of reproduction:
             autogamous
             a Ilogamous
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        ii) In case of allogamy
            wInd po111natIon
            insect polI(nation
            other
   e)  Factors affecting reproduction
9. Survivability
   a)  Ability to form structures enhancing survival or dormancy
        I)    seeds
        iI)   tubers
        Mi)   bulbs
       iv)    rhizomes
       v)     endospores
       vi)    cysts
       vii)   sclerotia
       viii) asexual spores(fungi)
       ix)    sexual spores (fungi)
       x)     eggs
       x i)   pupae
       xii)   larvae
       x)     other, please specify
   b)  Relevant factors affecting survivability:
 ---pagebreak---                                  - 111 -
10. a) Ways of dissemination:
    b) Factors affecting dissemination:
11. Previous genetic modifications of the recipient or parental
    organism already notified for release in the country where the
    notification is made (give notification numbers):
 ---pagebreak---                                   - 12 -
B.  INFORMATION RELATING TO THE GENETIC MODIFICATION
1. Type of the genetic modification:
    i)    Insertion of genetic material
   II) Deletion of genetic material
   ill) Base substitution
   iv) Cell fusion
   v)  Other, please specify
2. Intended result of the genetic modification:
3. a) Has a vector been used in the process of modification?
            Yes    CZ\       No     \ZZ\
        If No_, go straight to question 5.
   b)   If Yes, is the vector     wholly   or partially present  in the
       modified organism?
           Yes     CZ\       No     iZZl
        If No, go straight to question 5.
4. If the answer to 3b is Yes, supply the following Information::
   a)  Type of vector:
       pi asm id                | I
       bacteriophage            I !
       virus                    I I
       cosmid                   i |
       phasmid                  I I
       transposable element     I I
       other, please specify    î J
 ---pagebreak---                               - 13 -
b)   Identity of the vector:
c) Host range of the vector:
d)  Presence in the vector of sequences giving a selectable or
     identifiable phenotype:
                                           Yes          No
         Antibiotic resistance
         Heavy metal resistance
         Other, specify
e)  Constituent fragments of the vector:
f)  Method for introducing the vector into the recipient organism:
    i)    transformation
    ii)   electroporation
   .ill) macro inject ion
    iv)   microinjection
    v)    infection
    vi)   other, please specify
 ---pagebreak---                                      14 -
5.  If the answer to question B.3.a) and b) is Ua, what was the method
    used to introduce the Insert into the recipient/parental cell?
         I)   transformation
         ii) microinjection
         iii) microencapsulation
         iv) macroinjection
        v)    other, please specify
6.  Information on the insert:
   a)   Composition of the insert:
   b)   Source of each constituent part of the insert
   c)   Intended function of each constituent part of the insert in the
        GMO:
   d)   Location of the insert in the host organism:
        - on a free pi asm id
        - integrated in the chromosome
        - other, please specify
   e)   Does the Insert contain parts whose product or function are not
        known?
       Yes           !~!             No      CZ\
        I f Yes, pI ease spec i fy :
 ---pagebreak---                                          - 15 -
C.  INFORMATION ON THE ORGANISM(S) FROM W H I C H THE         INSERT IS DERIVED
    (DONOR)
    Indicate w h e t h e r It is a:
   vlrold                C~
   RNA virus           |"
   DNA virus            I.
   bacterium
   fungus                I |
   plant
   animal
   other, please specify
2. a) Complete name:
        i)     order and/or higher taxon (for animals)
        ii)    family name (for plants)
        i i i) genus
        iv)     species
        v)     subspecies
        vi)     st ra i n
        vii)   cultivar
        vi11)  pathovar
        ix)    common name
3. Is the organism pathogenic or harmful in any other way (including
   its extracellular p r o d u c t s ) , either living or dead?
   YES      CZ\            NO       i~!       NOT KNOWN      !~!
   if yes, specify the following:
   a) to which of the following organisms?
        humans
        animals
       plants
 ---pagebreak---                                  - 16 -
   b) are the donated sequences Involved in any way to the pathogenic
        or harmful properties of the organism?
   YES     SZZS       NO     CZ\      NOT KNOWN       CZ\
    if yes, give the relevant information under Annex II. I l'A, ltd:
4.  is the donor organism classified under existing Community rules
   relating to the protection of human health and the environment?
   YES     |ZJ                NO      ilj
   If yes, please specify:
5. Do the donor and recipient organism exchange genetic material
   naturally?
   YES     I I       NO     ! !        Not known        |"Zj
 ---pagebreak---                                   - 17 -
D.  INFORMATION RELATING TO THE GENETICALLY MODIFIED ORGANISM
1» Genetic traits and phenotyplc characteristics of the recipient or
   parental organism which have been changed as a result of the
   genetic modification:
   a)   Is the GMO different from the recipient as far as survivabi I ity
        Is concerned?
            YES       |  I         NO
        if Yes, please specify:
   b)   is the GMO in any way different from the recipient as far as
        mode and/or rate of reoroduct ion is concerned?
            YES       |~!          NO       !  !     Not known   | |
        if Yes, please specify:
   c)   is the GMO in any way different from the recipient as far as
        disséminât ion is concerned?
            YES       CZ\          NO       i  i     Not known   | !
        if Yes, please specify:
2. Genetic stability of the genetically modified organism:
3. Is the GMO pathogenic or harmful in any other way (including its
   extracellular products), either living or dead?
        YES       !~!         NO      ! !      Not known   ! i
        if YfiS.,
 ---pagebreak---                                  - 18 -
   a)   to which of the following organisms?
       humans
       animals
       plants
   b)  Give the relevant Information specified under Annex II, IIA 11d
       and IIC 2(i)
4. Description of Identification and detection methods:
   a) techniques used to detect the GMO in the environment
   b) techniques used to identify the GMO:
 ---pagebreak---                                  - 19 -
E.  INFORMATION RELATING TO THE RELEASE
1. Purpose of the release:
2.  Is the site of the release different from the natural habitat or
   from the ecosystem In which the recipient organism is regularly
   used, grown, kept or found?
   YES        !  i              NO     ! I
   if Yes, please specify:
3. Information concerning the release and the surrounding area:
   a)  Geographical    location    (administrative region   and   where
       appropriate grid reference):
   b)  Size of the site (m 2 ):
        i) actual release site (m 2 ):
        il) wider release area (m 2 ):
   c)  Proximity to internationally recognised biotopes or protected
       areas (including drinking water reservoirs), whIch cou Id be
        iffected:
   d)  Flora and fauna including crops, livestock and         migratory
       species which may potentially interact with the GMO:
 ---pagebreak---                                 - 20 -
4. Method and amount of Release:
   a) Quantities of GMOs to be released:
   b) Duration of the operation:
   c) Methods and procedures to avoid and/or minimize the spread of
       the GMOs beyond the site of the release:
 ---pagebreak---                                  - 21 -
F.  INTERACTIONS OF THE GMO WITH THE ENVIRONMENT AND POTENTIAL IMPACT
   ON THE ENVIRONMENT
   Complete name of target organisms:
        I)    order and/or higher taxon (for animals)
        II)   family name (for plants)
        III)  genus
        iv)   species
        v)    subspecies
        vi)   strain
        viI)  cultivar
        viII) pathovar
        ix)   common name
   Anticipated mechanism and result of        interaction   between the
   released GMOs and the target organism:
3. Other potentially significant interactions with other organisms in
   the environment:
4. Is post-release selection for the GMO likely to occur?
   YES          O           NO    lZJ                     ~
   if Yes, give detaiIs:
5. Types of ecosystems to which the GMO could be disseminated from the
   site of release and in which it could become established:
 ---pagebreak---                                   - 22 -
6. Complete name     of  non-target  organisms which  may  be  effected
   unwittingly:
        i)    order and/or higher taxon (for animals)
        ii)   family name (for plants)
        ill) genus
        iv)   species
       v)     subspecies
       v i)   strain
       v11) cu111var
       vi i i) pathovar
        ix)   common name
7. Likelihood of genetic exchange in vivo
   a)  from the GMO to other organisms in the release ecosystem:
   b)  from other organisms to the GMO:
8. Give references to relevant results from studies of the behaviour
   and characteristic of the GMO and its ecological Impact carried out
   in simulated natural environments (e.g. microcosms, etc.):
 ---pagebreak---                                 - 23 -
G.  INFORMATION RELATING TO MONITORING
1. Methods for monitoring the GMOs :
2. Methods for monitoring ecosystem effects:
3. Methods for detecting transfer of the donated genetic material from
   the GMO to other organisms:
4. Spatial extent of the monitoring area (m 2 )
5. Duration of the monitoring:
6. Frequency of the monitoring:
 ---pagebreak---                                   - 24 -
H-   INFORMATION ON POST-RELEASE AND WASTE TREATMENT
1. Post-release treatment of the site:
2.  Post-release treatment of the GMOs:
3a) Type and amount of waste generated:
3b) Treatment of waste:
 ---pagebreak---                                   - 25 -
 I.  INFORMATION ON EMERGENCY RESPONSE PLANS
1. Methods and procedures for controlling GMOs in case of unexpected
    spread:
2.  Methods for decontamination of the areas affected:
3.  Methods for disposal or sanitation of plants, animals, soils etc.
    that were exposed during or after the spread:
4.  Plans for protecting human health and the environment  in case of
    the occurence of an undesirable effect:
                                  ****
 ---pagebreak---                                                                       ISSN 0254-1475
                                                               COM(91) 282 final
                                                      DOCUMENTS
EN                                                                               01
                                 Catalogue number : CB-CO-91-326-EN-C
                                                             ISBN 92-77-74667-X
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