CELEX: 51989PC0409
Language: en
Date: 1989-08-01
Title: MODIFIED PROPOSAL FOR A COUNCIL DIRECTIVE ON THE CONTAINED USE OF GENETICALLY MODIFIED MICRO-ORGANISMS

No C 246/6                            Official Journal of the European Communities                                  27. 9. 89
        (b) notify the competent authority of the new                 2. Techniques involving the direct introduction into
            information available and/or of the modifi-                   an organism of heritable material prepared
            cations of the release in advance of such                     outside the organism including micro-injection,
            modifications being undertaken.'                              macro-injection and micro-encapsulation.
Article 5.4. is replaced by the following:                            3. Cell fusion or hybridization techniques where live
                                                                          cells with new combinations of heritable genetic
    '4.    The notifier may proceed with the release only                 material are formed through the fusion of two or
    when he has received the written consent of the                       more cells by means of methods that do not occur
    competent authority, in conformity with any                           naturally.
    conditions required in this consent.'
                                                                                                PART 2
Article 17.4 is replaced by the following:
                                                                      Techniques referred to in Article 2 (2) (ii) which are
    '4.    The Commission and the competent authorities               not considered to result in genetic modification, on
    shall not divulge to third parties any confidential               condition that they do not involve the use of r-DNA
    information notified or exchanged under this                      molecules or GMOs.
    Directive.'
                                                                      1. In vitro fertilization
Annex I is replaced by the following:
                                                                      2. Conjugation, transduction, transformation or any
                             'ANNEX I                                     other natural process.
                              PARTI                                   3. Polyploidy induction.
    Techniques of genetic modification referred to in
    Article 2, (2) (i) are inter alia
                                                                 Annex II.3.(b), 3rd indent is replaced by:
     1. Recombinant DNA techniques using vector
        systems as previously covered by Council recom-               '— geographical, geological, hydrological and pedo-
        mendation 82/472/EEC.                                              logical characteristics.'
              Modified proposal for a Council Directive on the contained use of genetically modified micro-
                                                        organisms (')
                                              COM(89) 409 final — SYN 131
               (Submitted by the Commission pursuant to Article 149 (3) of the EEC Treaty on 23 August 1989)
                                                       (89/C 246/07)
              The Commission, on the basis of the opinion delivered by the European Parliament on 24 May
              1989, modified its original proposal for a Council Directive on the contained use of O G M
              pursuant to Article 149 (3) of the EEC Treaty, as follows:
Third recital is amended as follows:                             Eighth recital is 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               'Whereas it is therefore necessary to approximate
    shall have the objective to preserve, protect and                 legislation in the Member States establishing a
    improve the quality of the environment and to                     common legislative framework for the evaluation and
    contribute towards protecting human health.'                      the reduction of the potential risks arising in the
                                                                      course of the contained use of genetically modified
(») OJ No C 198, 28. 7. 1988, p. 9.                                   micro-organisms in research, development, manu-
 ---pagebreak--- 27. 9. 89                               Official Journal of the European Communities                              No C 246/7
    facture, storage, transport, waste treatment and              A new Article 4.5. is added:
    disposal in order to enable the safe development of
    biotechnology throughout the Community.'                          '5.     The results of the risk-assessment cannot be
                                                                      considered as confidential. A summary of the risk-
                                                                      assessment, excluding strictly confidential infor-
Ninth recital is amended as follows:                                  mation, shall be made available to the public'
                                                                  Article 6 is replaced by the following:
    'Whereas the precise nature and scale of risks asso-
    ciated with genetically modified micro-organisms are               'Article 6
    not fully known and the hazards involved must be
    assessed case by case; whereas particular attention               When a particular installation is to be used for the
    must be given to operations using certain genetically             first time for operations involving the contained use
    modified micro-organisms.'                                        of genetically modified micro-organisms, the user
                                                                      shall be required to submit to the competent auth-
                                                                      orities, before commencing such use a notification
Tenth recital is amended as follows:                                  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.'
    'Whereas genetically modified micro-organisms must
    be classified in relation to their hazard; whereas in         Article 7 is replaced by the following:
    the absence, at present of specifications necessary for
    allocation in these classes it seems appropriate to                'Article 7
    develop criteria for classification; whereas to evaluate
    hazard for human health and the environment it is                 1.     Users of genetically modified    mirco-organisms
    necessary to lay down essential requirements for risk             classified in Group I non-industrial    scale operations
    assessment and appropriate conditions of use.'                    shall be required to keep records of   the work carried
                                                                      out which shall be available to          the competent
                                                                      authority on request.
Twelfth recital is replaced by:
                                                                      2.     Users of genetically modified micro-organisms
                                                                      classified in Group I industrial scale operations shall,
    'Whereas a permanent inventory of information                     before commencing the contained use, be required to
    related to the contained use of GMOs within each                  submit to the competent authorities a notification
    Member State is necessary in order to monitor the                 containing the information listed in Annex IV B. The
    contained use of GMOs and to trace the origin of                  information shall be sufficient to enable the
    any negative effects or'accidents that might arise.'              competent authority to assess the correctness of the
                                                                      classification.'
Thirteenth recital is replaced by:                                Article 8 is replaced by the following:
                                                                       'Article 8
    'Whereas any person, before undertaking for the first
    time the contained use of genetically modified micro-             1.     Users of genetically modified micro-organisms
    organisms, in a particular installation must forward              classified in Group II non-industrial scale operations
    to the competent authority a notification with infor-             shall, before commencing the contained use, be
    mation allowing the authority to ensure that the                  required to submit to the competent authorities a
    proposed installation is appropriate to carry out an              notification containing the information listed in
    activity in a manner that does not present a danger to            Annex IV C.
    man and the environment.'
                                                                      2.     Users of genetically modified micro-organisms
                                                                      classified in Group II in industrial scale operations
The Sixteenth recital is amended as follows:                          shall, before commencing the contained use, be
                                                                      required to submit to the competent authorities a
                                                                      notification containing:
    'Whereas, if an accident occurs, the user must
    immediately inform the competent authority and                    — information on the genetically modified micro-
    communicate the information necessary for assessing                    organism^),
    the impact of that accident; whereas in the case of an
    accident that could pose a threat to human health                 — information on personnel and training,
    and the environment, the competent authority must
    immediately inform the public'                                    — information on the installation,
 ---pagebreak--- No C 246/8                               Official Journal of the European Communities                                  27. 9. 89
    — information on waste management,                                 5. (a) Operations notified under Article 7 (2) and
                                                                                Article 8 (1), may, in the absence of any indi-
    — information        on     accident    prevention     and                  cation to the contrary from the competent
         emergency response plans,                                              authority, proceed 60 days after submission of
                                                                                the notification, or earlier with the agreement
                                                                                of the competent authority;
    — the safety assessment referred to in Article 4,
                                                                           (b) Operations notified under Article 8 (2) may
    the details of which are listed in Annex IV D.'                             not proceed without the consent of the
                                                                                competent authority.
Article 9 is replaced by the following:                                    The competent authority shall communicate its
                                                                           decision in writing at the latest 90 days after
                                                                           submission of the notification.
     'Article 9
                                                                       6.     For the calculation of the periods referred to in
    1.     Member States shall designate the authority or              paragraphs 4 and 5 above, the periods during which
    authorities competent to implement the measures                    the competent authority:
    which they adopt in application of this Directive and
    to receive and acknowledge the notifications referred              — is awaiting any further information which it may
    to in Article 6, Article 7 (2) and Article 8.                           have requested from the notifier in accordance
                                                                            with paragraph 3a of this Article
    2.     The Competent Authorities shall examine the                      or
    conformity of the notifications with the requirements              — is carrying out a public enquiry or consultation in
    of this Directive, the accuracy and completeness of                     accordance with Article 11.2.
    the information given, the correctness of the classifi-
    cation and, where appropriate, the adequacy of the
    waste management, safety, and emergency response               shall not be taken into account.'
    measures, and provide for adequate information and
    consultation of the public, where necessary.                   Article 10 is replaced by the following:
                                                                        Article 10
    3.     If necessary, the competent authority may:
                                                                       1.     The user has an obligation to inform as soon as
                                                                       possible the competent authority of any relevant new
    (a) ask the user to provide further information or to              information or modification of the contained use, or
         modify the conditions of the proposed contained               of any change in the' category of genetically modified
         use. In this case, the proposed contained use                 micro-organisms used and to modify accordingly the
         cannot proceed until the competent authority has              notification submitted under Articles 6, 7 and 8.
         given its approval on the basis of the further
         information obtained or of the modified
                                                                       2.     If information becomes available subsequently
         conditions of the contained use;
                                                                       to the competent authority by whatever means indi-
                                                                       cating that there may be consequences for the risks
    (b) limit the time for which the contained use should              posed by the contained use or for the conditions
         be permitted or subject it to certain specific                under which the contained use should be carried out,
         conditions.                                                   the competent authority must re-examine the notifi-
                                                                       cation and may require the user to provide additional
                                                                       information, modify the conditions of, suspend or
    4.     In the case of first-time use in an installation as         terminate the contained use.'
    referred to in Article 6:
    — where such use involves GMMs in Group I, the                 Article 11 is replaced by:
         contained use may, in the absence of any indi-
                                                                        Article 11
         cation to the contrary from the competent
         authority, proceed 90 days after submission of the
                                                                       1.     The competent authorities shall ensure that,
         notification, or earlier with the agreement of the
                                                                       where necessary, before an operation commences:
         competent authority,
                                                                       (a) an emergency plan is drawn up to deal with bio-
    — where such use involves GMMs in Group II, the                         logical hazards outside the installation in the
         contained use may not proceed without the                          event of an accident and the emergency services
         consent of the competent authority. The                            are aware of the hazards and informed thereof in
         competent authority shall communicate its                          writing and that the emergency services are
         decision in writing at the latest 90 days after                    adequately trained and equipped for dealing with
         submission of the notification.                                    such accidents;
 ---pagebreak--- 27. 9. 89                              Official Journal of the European Communities                              No C 246/9
    (b) information on safety measures and on the                    — collect, where possible, the information necessary
         correct behaviour to adopt in the case of an                    for a full analysis of the accident and ensure that
         accident is supplied in an appropriate manner,                  measures are taken to avoid similar accidents in
         and without their having to request it, to persons              the future and to limit the effects thereof.'
         liable to be affected by the accident. The infor-
         mation shall be repeated and updated at appro-          Article 13.1. point (c) is modified as follows:
         priate intervals. It shall also be made publicly
         available, together with the summary of the                 '(c) inform the Commission as soon as possible of
         proposed project.                                                 any accident within the scope of this Directive,
                                                                          giving details of the circumstances of the
         The Member States concerned shall at the same                     accident, the identity and quantities of the gen-
         time make available to other Member States                       etically modified micro-organisms released, the
         concerned, as a basis for all necessary consul-                  emergency response measures employed and
         tation within the framework of their bilateral                   their effectiveness, and an analysis of the
         relations, the same information as that which is                  accident including requirements to limit its
         disseminated to their own nationals.                              effects and avoid similar accidents in the future.'
    2. Where the competent auhtority considers it                A new Article 14a is inserted:
    appropriate, it may consult groups or the public on
    any aspect of the proposed contained use.                         'Article 14a
                                                                      1. The Commission and the competent authorities
Article 12 is replaced by:                                           shall not divulge to third parties any confidential
                                                                     information notified or otherwise provided under this
     'Article 12
                                                                     Directive.
    1. Member States shall take the necessary
    measures to ensure that, in the event of an accident,            2. The notifier may indicate the information in the
    the user shall be required immediately to inform the             notifications submitted under this Directive, the
    competent authority specified in Article 9 and                   disclosure of which might harm his competitive
    provide the following information:                               position, that should be treated as confidential. Veri-
                                                                     fiable justification must be given in such cases.
    — the circumstances of the accident,
                                                                     3. The competent auhtority shall decide, after
    — the identity and quantities of the genetically                 prior consultation with the notifier, which infor-
        modified micro-organism(s) released,                         mation will be kept confidential and shall inform the
                                                                     notifier of its decision.
    — any information necessary to assess the effects of
        the accident on the health of the general popu-              4. In no case may the following information be
        lation and the environment,                                  kept confidential.
    — the emergency measures taken,                                  — description of the GMMs, name and address of
                                                                         the notifier, purpose of the contained use, and
    — subsequent steps taken to avoid future accidents.
                                                                         location of use;
    2.     The Member States shall be required to:                   — methods and plans for monitoring of the GMMs
                                                                         and for emergency response;
    — ensure that any emergency, medium and
        long-term measures necessary are taken, and                  — the evaluation of foreseeable effects, in particular
         immediately alert any Member States which could                 any pathogenic and/or ecologically disruptive
        be affected by the accident,                                     effects.'