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Directive 2001/18/EC of the European Parliament and of the CouncilShow full title

Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC

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  1. Introductory Text

  2. PART A GENERAL PROVISIONS

    1. Article 1.Objective

    2. Article 2.Definitions

    3. Article 3.Exemptions

    4. Article 4.General obligations

  3. PART B DELIBERATE RELASE OF GMOs FOR ANY OTHER PURPOSE THAN FOR PLACING ON THE MARKET

    1. Article 5.(1.) Articles 6 to 11 shall not apply to medicinal...

    2. Article 6.Standard authorisation procedure

    3. Article 7.Differentiated procedures

    4. Article 8.Handling of modifications and new information

    5. Article 9.Consultation of and information to the public

    6. Article 10.Reporting by notifiers on releases

    7. Article 11.Exchange of information between competent authorities and the Commission

  4. PART C PLACING ON THE MARKET OF GMOs AS OR IN PRODUCTS

    1. Article 12.Sectoral legislation

    2. Article 12a. Transitional measures for adventitious or technically unavoidable presence of genetically modified organisms having benefited from a favourable risk evaluation

    3. Article 13.Notification procedure

    4. Article 14.Assessment report

    5. Article 15.Standard procedure

    6. Article 16.Criteria and information for specified GMOs

    7. Article 17.Renewal of consent

    8. Article 18.Community procedure in case of objections

    9. Article 19.Consent

    10. Article 20.Monitoring and handling of new information

    11. Article 21.Labelling

    12. Article 22.Free circulation

    13. Article 23.Safeguard clause

    14. Article 24.Information to the public

  5. PART D FINAL PROVISIONS

    1. Article 25.Confidentiality

    2. Article 26.Labelling of GMOs referred to in Article 2(4), second subparagraph

    3. Article 26a. Measures to avoid the unintended presence of GMOs

    4. Article 26b. Cultivation

    5. Article 26c. Transitional measures

    6. Article 27. Adaptation of annexes to technical progress

    7. Article 28.Consultation of Scientific Committee(s)

    8. Article 29.Consultation of Committee(s) on Ethics

    9. Article 30.Committee procedure

    10. Article 31.Exchange of information and reporting

    11. Article 32.Implementation of the Cartagena Protocol on biosafety

    12. Article 33.Penalties

    13. Article 34.Transposition

    14. Article 35.Pending notifications

    15. Article 36.Repeal

    16. Article 37.This Directive shall enter into force on the day of...

    17. Article 38.This Directive is addressed to the Member States.

    1. ANNEX I A

      TECHNIQUES REFERRED TO IN ARTICLE 2(2)

      1. PART 1

      2. PART 2

    2. ANNEX I B

      TECHNIQUES REFERRED TO IN ARTICLE 3

      1. Techniques/methods of genetic modification yielding organisms to be excluded from...

      2. mutagenesis, cell fusion (including protoplast fusion) of plant cells of...

    3. ANNEX II

      PRINCIPLES FOR THE ENVIRONMENTAL RISK ASSESSMENT

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

      2. With a view to contributing to a common understanding of...

      3. ‘direct effects’ refers to primary effects on human health or...

      4. A general principle for environmental risk assessment is also that...

      5. A. Objective

      6. B. General Principles

      7. C. Methodology

        1. C.1. General and specific considerations for the e.r.a.

          1. 1. Intended and unintended changes

          2. 2. Long-term adverse effects and cumulative long-term adverse effects in the...

          3. 3. Quality of the data

          4. 4. Stacked transformation events in Part C notifications

        2. C.2. Characteristics of the GMO and of the releases

        3. C.3. Steps in the e.r.a.

          1. 1. Problem formulation including hazard identification

          2. 2. Hazard characterisation

          3. 3. Exposure characterisation

          4. 4. Risk characterisation

          5. 5. Risk management strategies

          6. 6. Overall risk evaluation and conclusions

      8. D. Conclusions on the specific areas of risk of the e.r.a....

        1. D.1. In the case of GMOs other than higher plants

        2. D.2. In the case of genetically modified higher plants (GMHP)

    4. ANNEX III

      INFORMATION REQUIRED IN THE NOTIFICATION

      1. Notifications referred to in Parts B and C of this...

      2. The provision of a given subset of information listed in...

      3. The appropriate level of detail for each subset of information...

      4. For each required subset of information, the following shall be...

      5. the summaries and results of the studies referred to in...

      6. Future developments in genetic modification may necessitate adapting this Annex...

    5. ANNEX III A

      INFORMATION REQUIRED IN NOTIFICATIONS CONCERNING RELEASES OF GENETICALLY MODIFIED ORGANISMS OTHER THAN HIGHER PLANTS

      1. I. GENERAL INFORMATION

      2. II. INFORMATION RELATING TO THE GMO

        1. A. Characteristics of (a) the donor, (b) the recipient or (c)...

        2. B. Characteristics of the vector

        3. C. Characteristics of the modified organism

      3. III. INFORMATION RELATING TO THE CONDITIONS OF RELEASE AND THE RECEIVING...

        1. A. Information on the release

        2. B. Information on the environment (both on the site and in...

      4. IV. INFORMATION RELATING TO THE INTERACTIONS BETWEEN THE GMOs AND THE...

        1. A. Characteristics affecting survival, multiplication and dissemination

        2. B. Interactions with the environment

      5. V. INFORMATION ON MONITORING, CONTROL, WASTE TREATMENT AND EMERGENCY RESPONSE PLANS...

        1. A. Monitoring techniques

        2. B. Control of the release

        3. C. Waste treatment

        4. D. Emergency response plans

    6. ANNEX III B

      INFORMATION REQUIRED IN NOTIFICATIONS CONCERNING RELEASES OF GENETICALLY MODIFIED HIGHER PLANTS (GMHPs) (GYMNOSPERMAE AND ANGIOSPERMAE)

      1. I. INFORMATION REQUIRED IN NOTIFICATIONS SUBMITTED PURSUANT TO ARTICLES 6 AND...

        1. A. General information

          1. 1. Name and address of the notifier (company or institute)

          2. 2. Name, qualifications and experience of the responsible scientist(s)

          3. 3. Title of the project

          4. 4. Information relating to the release

          5. 5. Information relating to the site of release

        2. B. Scientific information

          1. 1. Information relating to the recipient plant or, where appropriate, to...

          2. 2. Molecular characterisation

          3. 3. Information on specific areas of risk

          4. 4. Information on control, monitoring, post-release and waste treatment plans

          5. 5. Description of detection and identification techniques for the GMHP.

          6. 6. Information about previous releases of the GMHP, if applicable.

      2. II. INFORMATION REQUIRED IN NOTIFICATIONS SUBMITTED PURSUANT TO ARTICLE 13

        1. A. General information

          1. 1. Name and address of the notifier (company or institute).

          2. 2. Name, qualifications and experience of the responsible scientist(s).

          3. 3. Designation and specification of the GMHP.

          4. 4. Scope of the notification.

        2. B. Scientific information

          1. 1. Information relating to the recipient plant or, where appropriate, to...

          2. 2. Molecular characterisation

          3. 3. Comparative analysis of agronomic and phenotypic characteristics and of composition...

          4. 4. Specific information for each area of risk

          5. 5. Description of detection and identification techniques for the GMHP.

          6. 6. Information about previous releases of the GMHP, if applicable.

    7. ANNEX IV

      ADDITIONAL INFORMATION

      1. This Annex describes in general terms the additional information to...

      2. The following information shall be provided in the notification for...

    8. ANNEX V

      CRITERIA FOR THE APPLICATION OF DIFFERENTIATED PROCEDURES (ARTICLE 7)

      1. The criteria referred to in Article 7(1) are set out...

      2. The taxonomic status and the biology (for example mode of...

    9. ANNEX VI

      GUIDELINES FOR THE ASSESSMENT REPORTS

      1. The assessment report provided for by Articles 13, 17, 19...

      2. Identification of the characteristics of the recipient organism which are...

    10. ANNEX VII

      MONITORING PLAN

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

      2. A. Objective

      3. B. General principles

      4. C. Design of the monitoring plan

    11. ANNEX VIII

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