Chwilio Deddfwriaeth

Chwiliad Uwch

Council Directive of 23 April 1990 on the contained use of genetically modified micro-organisms (90/219/EEC) (repealed)

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EU Directives are published on this site to aid cross referencing from UK legislation. Since IP completion day (31 December 2020 11.00 p.m.) no amendments have been applied to this version.

  1. Introductory Text

  2. Article 1.This Directive lays down common measures for the contained use...

  3. Article 2.For the purposes of this Directive: (a) ‘micro-organism’ shall mean...

  4. Article 3.Without prejudice to Article 5(1) this Directive shall not apply:...

  5. Article 4.Article 5(3) and 5(6) and Articles 6 to 12 shall not...

  6. Article 5.(1) Member States shall ensure that all appropriate measures are...

  7. Article 6.(1) The user shall apply, except to the extent that...

  8. Article 7.When premises are to be used for the first time...

  9. Article 8.Following the notification referred to in Article 7, subsequent class...

  10. Article 9.(1) For first and subsequent class 2 contained uses to...

  11. Article 10.(1) For first and subsequent class 3 or class 4...

  12. Article 11.(1) Member States shall designate the authority or authorities competent...

  13. Article 12.If the user becomes aware of relevant new information or...

  14. Article 13.Where a Member State considers it appropriate, it may provide...

  15. Article 14.The competent authorities shall ensure that before a contained use...

  16. Article 15.(1) Member States shall take the necessary measures to ensure...

  17. Article 16.(1) Member States shall be required to:

  18. Article 17.Member States shall ensure that the competent authority organizes inspections...

  19. Article 18.(1) Member States shall send to the Commission, at the...

  20. Article 19.(1) Where its disclosure affects one or more of the...

  21. Article 20.Amendments necessary to adapt Annex II, Part A, and Annexes...

  22. Article 20a.Before 5 December 2000 Annex II, Part B, listing the...

  23. Article 21.(1) The Commission shall be assisted by a committee.

  24. Article 22.Member States shall bring into force the laws, regulations and...

  25. Article 23.This Directive is addressed to the Member States.

    1. ANNEX I

      1. PART A

      2. PART B

    2. ANNEX II

      1. PART A

      2. PART B

        1. Criteria establishing the safety of GMMs for human health and...

          1. 1. INTRODUCTION

          2. 2. GENERAL CRITERIA

            1. 2.1. Strain verification/authentication

            2. 2.2. Documented and established evidence of safety

            3. 2.3. Genetic stability

          3. 3. SPECIFIC CRITERIA

            1. 3.1. Non-pathogenic

              1. 3.1.1. Non-toxigenic

              2. 3.1.2. Non-allergenic

            2. 3.2. No harmful adventitious agents

            3. 3.3. Transfer of genetic material

            4. 3.4. Safety for the environment in the event of a significant...

        2. Guidance notes supplementing part B of Annex II to Directive...

          1. INTRODUCTION

          2. 1. GENERAL CRITERIA

            1. 1.1. Strain verification/authentication

            2. 1.2. Documented and established safety

            3. 1.3. Genetic stability

          3. 2. SPECIFIC CRITERIA

            1. 2.1. Non-pathogenic

              1. 2.1.1. Non-toxigenic

              2. 2.1.2. Non-allergenic

            2. 2.2. No harmful adventitious agents

            3. 2.3. Transfer of genetic material

            4. 2.4. Safety for the environment in the event of an escape...

              1. 2.4.1. Organism survival

              2. 2.4.2. Dispersal

              3. 2.4.3. Organism establishment in the environment

              4. 2.4.4. Transfer of genetic material

        3. APPENDIX 1

          1. Definitions of terms used in this document

      3. PART C

    3. ANNEX III

      PRINCIPLES TO BE FOLLOWED FOR THE ASSESSMENT REFERRED TO IN ARTICLE 5(2)

      1. This Annex describes in general terms the elements to be...

      2. These guidance notes shall be completed no later than 5...

      3. A. ELEMENTS OF ASSESSMENT

        1. 1. The following should be considered as potentially harmful effects:

        2. 2. The assessment referred to in Article 5(2) should be based...

      4. B. PROCEDURE

        1. 3. The first stage in the assessment process should be to...

        2. 4. In general, only GMMs which show the following characteristics would...

        3. 5. In order to obtain the necessary information to implement this...

        4. 6. The hazard identification process carried out in accordance with paragraphs...

        5. 7. Selection of the containment and other protective measures should then...

        6. 8. The analysis carried out as described above will finally lead...

        7. 9. The final classification of the contained use should be confirmed...

    4. ANNEX IV

      CONTAINMENT AND OTHER PROTECTIVE MEASURES

      1. General principles

        1. 1. These tables present the normal minimum requirements and measures necessary...

        2. 2. The titles of the tables are indicative:

        3. 3. Member states may, in implementing this Annex, incorporate in addition...

      2. Table I A Containment and other protective measures for laboratory activities

      3. Table I B Containment and other protective measures for glasshouses and growth-rooms

      4. Table I C Containment and other protective measures for activities in animal units...

      5. Table II Containment and other protective measures for other activities

    5. ANNEX V

      1. PART A

      2. PART B

      3. PART C

Yn ôl i’r brig

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