CELEX: 51989PC0408
Language: en
Date: 1989-08-01
Title: MODIFIED PROPOSAL FOR A COUNCIL DIRECTIVE ON THE DELIBERATE RELEASE TO THE ENVIRONMENT OF GENETICALLY MODIFIED ORGANISMS

27. 9. 89                              Official Journal of the European Communities                                 No C 246/5
                                                               II
                                                        (Preparatory Acts)
                                                 COMMISSION
              Modified proposal for a Council Directive on the deliberate release to the environment of
                                               genetically modified organisms (')
                                                COM(89) 408 final — SYN 131
               (Submitted by the Commission pursuant to Article 149 (3) of the EEC Treaty on 23 August 1989)
                                                          (89/C 246/06)
              The Commission, on the basis of the opinion delivered by the European Parliament in its first
              reading on 25 May 1989, modifies its original proposal for a Council Directive on the
              deliberate release of GMOs pursuant to Article 149 (3) of the EEC Treaty, as follows:
A new recital 9a is inserted:                                               (ii) the techniques listed in Annex I Part 2, are
                                                                                 not considered to result in genetic modifi-
                                                                                 cation.'
    'Whereas no product containing or consisting of
    GMOs, and intended for deliberate release shall be
    considered for placing on the market without it first
    having been subjected to satisfactory field testing at          A new Article 3.3. is added:
    the research and development stage in all the
    ecosystems which could be affected by its use;'
                                                                        '3.     Member States shall ensure that the competent
                                                                        authority organizes inspections and other control
A new recital 12a is inserted:                                          measures as appropriate, to ensure compliance with
                                                                        this Directive, and shall ensure that effective penalties
    'Whereas, after notification, no deliberate release of              are imposed for infringement of this Directive.'
    GMOs shall be carried out unless the consent of the
    competent authorities has been obtained'
                                                                    A new Article 3.4. is added:
A new recital 12b is inserted:
                                                                        4.     Member States shall ensure that adequate infor-
    'Whereas a competent authority shall only give its                  mation is provided in advance of a planned release to
    consent after it has been satisfied that the release will           the inhabitants of the areas concerned.'
    have no negative impact on the environment and
    humans'
                                                                    Article 4.6. is replaced by the following:
Article 2.2. is replaced by the following:
                                                                        '6. In the event of any modification of the deliberate
    '2. Genetically modified organism (GMO) means an                        release of GMOs which could have consequences
        organism in which the genetic material has been                     with regard to the risks for man or the envi-
        altered in a way that does not occur naturally by                   ronment or if new information has become
        mating and/or natural recombination.                                 available on such risks, either while the notifi-
                                                                            cation is being examined by the competent auth-
                                                                            orities or after consent for the release has been
        Within the terms of this definition:
                                                                            obtained, the notifier shall immediately:
         (i) genetic modification occurs at least through
             the use of the techniques listed in Annex I
             Part 1;                                                         (a) revise the measures specified in the notifi-
                                                                                 cation and adopt all measures necessary to
(') OJ No C 198, 28. 7. 1988, p. 19.                                             protect human health and the environment;
 ---pagebreak--- 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-