CELEX: 51989PC0409
Language: en
Date: 1989-08-01
Title: MODIFIED PROPOSAL FOR A COUNCIL DIRECTIVE ON THE CONTAINED USE OF GENETICALLY MODIFIED MICRO-ORGANISMS Presented by the Commission pursuant to Article 149(3) of the EEC Treaty

ARCHIVES HISTORIQUES
DE LA COMMISSION
COLLECTION RELIEE DES
DOCUMENTS "COM"
COM (89) 409
Vol. 1989/0136
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 ---pagebreak--- COMMISSION OF THE EUROPEAN COMMUNITIES
                                        COM(89) 409 final - SYN 131
                                        Brussels /  1 August .1989
      MODIFIED PROPOSAL FOR A COUNCIL DIRECTIVE ON THE
    CONTAINED USE OF GENETICALLY MODIFIED MICRO-ORGANISMS
   Presented by the Commission pursuant to Article 149(3 )
                      of the EEC Treaty
 ---pagebreak---                                       2
                        EXPLANATORY MEMORANDUM
1 . In May 1988 , the Commission submitted a proposal for a
    Council Directive on the Contained use of Genetically
    modified micro-organisms ( COM(88 ) 160 final - SYN 131 ).
2 . After a   first reading      the European      Parliament adopted    an
    opinion on the above proposal for a Directive on 24 May
    1989 , approving a number of amendments to the text proposed
    by the Commission .         In its legislative resolution the
    European Parliament called on the Commission to amend its
    proposal accordingly , pursuant to Article 149(3 ) of the EEC
    Treaty .
3 . The Commission , having considered the amendments approved by
    the European Parliament , agreed to incorporate a number
    of them in a modified proposal in as far as they are within
    the spirit of the Commission 's original proposal and serve
    to clarify it .
4 . In the   explanatory memorandum         of its original proposal for
    this   directive     ( COM ( 88 )   160    final )   the    Commission
    recognised that        installations carrying          out work with
    genetically modified microorganisms should do this in a
    manner which prevents or minimises any potential risk to man
    and the     environment , and         the use of OGM should be
    undertaken     with     the    degree      of    security    ( control )
    commensurate with        the potential         risk    involved .   The
    Commission 's proposal differentiated to a certain extent
    between degrees of risk involved in various operations by
    taking into account both the type of operation and the type
    of OGM used .
5 . Within the framework of this approach ( endorsed by the
    European    Parliament        in     its      opinion ) the     limited
    modifications now being made to the original proposal
    provide further differentiation in the procedure foreseen in
    relation to the degree of potential risk of the contained
    uses involved , as well as as further clarification of the
    provisions foreseen in case of accident . Confidentiality
    provisions are introduced to safegard commercially sensitive
    information , accompanied by wider information provisions for
    none confidential information as well as an option for wider
    consultation .
 ---pagebreak---                                  3
MODIFIED PROPOSAL FOR A COUNCIL DIRECTIVE ON THE CONTAINED USE
             OF GENETICALLY MODIFIED MICROORGANISMS
The Commission , on the basis of the Opinion delivered by the
European Parliament on 24.5.89 , modified its original Proposal
for   a   Council   Directive   on  the    Contained   Use  of  OGM
( O.J. C 198 , 28.7.88 )  pursuant to   Article 149(3 ) of  the EEC
Treaty , as follows : -
RECITALS
Third recital to be amended as follows : -
Whereas under the Treaty , action by the Community relating to
the environment shall be based on the principle that preventive
action shall be taken and shall have the objective to preserve ,
protect and improve the quality of the environment and to
contribute towards protecting human health .
Eighth recital to be amended as follows : -
Whereas it is therefore necessary to approximate legislation in
the Member States establishing a common legislative framework
for the evaluation and the reduction of the potential risks
arising in the course of the contained use of genetically
modified micro-organisms in research , development , manufacture ,
storage , transport , waste treatment and disposal in order to
enable the safe development of biotechnology throughout the
Community .
Ninth recital to be amended as follows :   -
Whereas the precise nature and scale of risks associated with
genetically modified micro-organisms are not fully known and
the hazards involved must be assessed case by case ;
Whereas particular attention must be given to operations using
certain genetically modified micro-organisms .
Tenth recital to be amended as follows :   -
Whereas genetically modified micro-organisms must be classified
in relation to their hazard ; whereas in the absence , at present
of specifications necessary for allocation in these classes it
seems appropriate to develop criteria for classification ;
whereas to evaluate hazard for human health and the environment
it is necessary to lay down essential requirements         for risk
assessment and appropriate conditions of use .
 ---pagebreak---                                   4
Twelfth recital to be replaced by : -
Whereas a permanent inventory of information related to the
contained use of GMOs within each Member State is necessary in
order to   monitor the   contained use  of GMOs    and to trace the
origin of any negative effects or accidents that might arise .
Thirteenth recital to be replaced by : -
Whereas any person , before undertaking for the first time the
contained use of genetically modified micro-organisms , in a
particular installation must forward to the competent authority
a notification with information allowing the authority to
ensure that the proposed installation is appropriate to carry
out an activity in a manner that does not present a danger to
man and the environment .
The Sixteenth recital to be amended as follows : -
Whereas , if an accident occurs , the user must immediately
inform the competent authority and communicate the information
necessary for assessing the impact of that accident ; whereas in
the case of an accident that could pose a threat to human
health and the environment , the competent authority must
immediately inform the public .
Article 4
A new Article 4.5 . to be added :
The results    of the  risk-assessment cannot   be   considered  as
confidential .    A summary of the risk-assessment , excluding
strictly confidential information , shall be made available to
the public .
Article 6 . to be replaced bv the following text : -
When a particular installation is to be used for the first time
for operations involving the contained use of genetically
modified micro-organisms , the user shall be required to submit
to the competent authorities , before commencing such use a
notification containing at least the information listed in
Annex IVA . A separate notification shall be made for first use
of GMMs in Group I and Group II respectively .
Article 7 . to be replaced bv the following text : -
1 . Users of genetically modified micro-organisms classified in
    Group I non-industrial scale operations shall be required to
    keep records of the work carried out which shall be
    available to the competent authority on request .
 ---pagebreak---                                   5
2 . Users of  genetically modified micro-organisms classified in
    Group I industrial scale operations shall , before commencing
    the contained use , be reguired to submit to the competent
    authorities a notification containing the information listed
    in Annex IVB .   The information shall be sufficient to enable
    the competent    authority to   assess the   correctness of  the
    classification .
Article 8 . to be replaced bv t he following text : -
1 . Users of genetically modified micro-organisms classified in
    Group II non-industrial scale operations shall , before
    commencing the contained use , be required to submit to the
    competent authorities      a    notification    containing   the
    information listed in Annex IVC .
2 . Users of genetically modified micro-organisms classified in
    Group II in industrial scale operations shall , before
    commencing the contained use , be required to submit to the
    competent authorities a notification containing :
    - information on the genetically modified micro-organism ( s ) ;
    - information on personnel and training ;
    - information on the installation ;
    - information on waste management ;
    - information on accident prevention and emergency response
      plans ;
    - the safety assessment referred to in Article 4 ,
    the details of which are listed in Annex IVD .
Article 9 . to be replaced by the following text : -
1 . Member States shall designate the authority or authorities
    competent to implement the measures which they adopt in
    application of this Directive and to receive and acknowledge
    the notifications referred to in Article 6 , Article 7
    paragraph 2 and Article 8 .
2 . The Competent Authorities shall examine the conformity of
    the notifications with the requirements of this Directive ,
    the accuracy and completeness of the information given , the
    correctness of the classification and , where appropriate ,
    the adequacy of the waste management , safety , and emergency
    response measures , and provide for adequate information and
    consultation of the public , where necessary .
3 . If necessary , the competent authority may :
a ) ask the user to provide further information or to modify the
    conditions of the proposed contained use . In this case , the
    proposed contained use cannot proceed until the competent
    authority has given its approval on the basis of the further
    information obtained    or of   the modified   conditions of the
    contained use .
 ---pagebreak---                                     6
    b ) limit the   time for   which the    contained use   should  be
        permitted or subject it to certain specific conditions .
4 . In the case of first-time use in an installation as referred
    to in article 6 s
    - where such use involves GMMs in Group I , the contained use
       may , in the absence of any indication to the contrary from
       the competent authority , proceed 90 days after submission
       of the notification , or earlier with the agreement of the
       competent authority ;
    - where such    use involves    GMMs in   Group II , the contained
       use may not proceed without the consent of the competent
       authority .    The competent authority shall communicate its
       decision in writing at the latest 90 days after submission
       of the notification .
5 . a ) Operations notified    under   Article   7  paragraph   2  and
        Article 8 paragraph 1 , may , in the absence of any
        indication to the contrary from the competent authority ,
        proceed 60 days after submission of the notification , or
        earlier with the agreement of the competent authority .
    b ) Operations notified under Article 8 paragraph 2 may not
        proceed without the consent of the competent authority .
        The competent authority shall communicate its decision
        in writing at the latest 90 days after submission of the
        notification .
6 . For the calculation of the periods referred to in paragraphs
    4 and 5 above , the periods during which the competent
    authority :
    - is awaiting any further information which it may have
       requested from the notifier in accordance with paragraph
       3a ) of this Article
    or
    - is carrying    out   a  public   enquiry   or  consultation   in
       accordance with Article 11.2 .
    shall not be taken into account .
Article 10 , to be replaced by the following text :
1 . The user has an obligation to inform as soon as possible the
    competent authority of       any relevant new information or
    modification of     the contained   use , or of any change in the
    category of genetically modified micro-organisms used and to
    modify accordingly the notification submitted under Articles
    6 , 7 and 8 .
2 . If    information    becomes   available    subsequently   to  the
    competent authority by whatever means indicating that there
 ---pagebreak---                                     7
    may be consequences for the risks posed by the contained use
    or for   the conditions    under which the contained use should
    be carried out , the competent authority must re-examine
    the notification and       may require the user to provide
    additional information , modify the conditions of , suspend or
    terminate the contained use .
Article 1 1 r text to be replaced by ; -
1 . The competent      authorities shall        ensure    that ,   where
    necessary , before an operation commences :
a ) an emerqency    plan is   drawn    up  to   deal   with  biological
    hazards outside the installation in the event of an accident
    and the emergency services are aware of the hazards and
    informed thereof in writing and that the emergency services
    are adequately trained and equipped for dealing with such
    accidents .
b ) information on safety measures and on the correct behaviour
    to adopt in the case of an accident is supplied in an
    appropriate manner , and without their having to request it ,
    to persons liable to be affected by the accident .               The
    information shall be repeated and updated at appropriate
    intervals .    It shall also be made publicly available ,
    together with the summary of the proposed project .
    The Member    States concerned     shall at   the same   time   make
    available to other Member States concerned , as a basis for
    all necessary consultation within the framework of their
    bilateral relations , the same information as that which is
    disseminated to their own nationals .
2 . Where the competent authority considers it appropriate , it
    may consult groups or the public on any aspect of the
    proposed contained use .
Article 12 . text to be replaced by :
1 . Member States shall take the necessary measures            to ensure
    that , in the event of an accident , the user              shall be
    required immediately to inform the competent              authority
    specified in      Article 9       and   provide     the    following
    information :
    - the circumstances of the accident ,
    - the identity and quantities of the genetically modified
      micro-organism ( s ) released ,
    - any information necessary to assess the effects of the
      accident on the health of the general population and the
      environment ,
    - the emergency measures taken ,
    - subséquent steps taken to avoid future accidents .
 ---pagebreak---                                      8
2 . The Member States shall be required to : -
- ensure that any emergency , medium and long-term measures
   necessary are taken , and immediately alert any Member States
   which could be affected by the accident ,
- collect , where possible , the information necessary for a full
   analysis of     the accident   and ensure that measures are taken
   to avoid     similar accidents    in the    future and   to limit the
   effects thereof .
Article 13.1 .. point ( c ). to be modified as follows : -
( c ) inform the Commission as soon as possible of any accident
      within the scope of this Directive , giving details of the
      circumstances of the accident , the identity and quantities
      of the genetically modified micro-organisms released , the
      emergency     response     measures      employed     and       their
      effectiveness , and an analysis of the accident including
      requirements to       limit its effects and avoid similar
      accidents in the future .
A new Article 14a to be inserted :       -
1 . The Commission and the competent authorities shall not
     divulge to      third Parties any confidential information
     notified or otherwise provided under this Directive .
2 . The   notifier     may   indicate      the   information     in     the
     notifications submitted under this Directive , the disclosure
     of which might harm his competitive position , that should be
     treated as confidential .       Verifiable justification must be
     given in such cases .
3 . The   competent     authority      shall    decide ,   after      prior
     consultation with     the notifier ,    which information     will be
     kept confidential     and shall    inform   the   notifier    of   its
     decision .
4 . In no       case may     the  following      information    be     kept
     confidential .
     - description of the GMMs , name and address of the notifier ,
       purpose of the contained use , and location of use ;
     - methods and plans for monitoring of           the GMMs    and    for
       emergency response ;
     - the evaluation of foreseeable effects , in particular any
       pathogenic and/or ecologically disruptive effects .