Search Legislation

Advanced Search

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

Help about what version

What Version

Help about UK-EU Regulation

Legislation originating from the EU

When the UK left the EU, legislation.gov.uk published EU legislation that had been published by the EU up to IP completion day (31 December 2020 11.00 p.m.). On legislation.gov.uk, these items of legislation are kept up-to-date with any amendments made by the UK since then.

Close

This item of legislation originated from the EU

Legislation.gov.uk publishes the UK version. EUR-Lex publishes the EU version. The EU Exit Web Archive holds a snapshot of EUR-Lex’s version from IP completion day (31 December 2020 11.00 p.m.).

Status:

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. 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 27. Adaptation of annexes to technical progress

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

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

    7. Article 30.Committee procedure

    8. Article 31.Exchange of information and reporting

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

    10. Article 33.Penalties

    11. Article 34.Transposition

    12. Article 35.Pending notifications

    13. Article 36.Repeal

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

    15. 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. Characteristics of GMOs and releases

        2. C.2. Steps in the e.r.a.

          1. 1. Identification of characteristics which may cause adverse effects:

          2. 2. Evaluation of the potential consequences of each adverse effect, if...

          3. 3. Evaluation of the likelihood of the occurrence of each identified...

          4. 4. Estimation of the risk posed by each identified characteristic of...

          5. 5. Application of management strategies for risks from the deliberate release...

          6. 6. Determination of the overall risk of the GMO(s)

      8. D. Conclusions on the potential environmental impact from the release or...

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

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

      9. GUIDANCE NOTES ON THE OBJECTIVE, ELEMENTS, GENERAL PRINCIPLES AND METHODOLOGY...

        1. 1. INTRODUCTION

        2. 2. OBJECTIVE

        3. 3. GENERAL PRINCIPLES

        4. 4. METHODOLOGY

          1. 4.1. Characteristics of GMOs and releases

          2. 4.2. Steps in the analysis of ERA

            1. 4.2.1. Step 1: Identification of characteristics which may cause adverse effects...

            2. 4.2.2. Step 2: Evaluation of the potential consequences of each adverse...

            3. 4.2.3. Step 3: Evaluation of the likelihood of the occurrence of...

            4. 4.2.4. Step 4: Estimation of the risk posed by each identified...

            5. 4.2.5. Step 5: Application of management strategies for risks from the...

            6. 4.2.6. Step 6: Determination of the overall risk of the GMO(s)...

        5. 5. CONCLUSIONS ON THE POTENTIAL ENVIRONMENTAL IMPACT FROM THE RELEASE OR...

        6. 6. REVIEW AND ADAPTATION

          1. 6.1. Review and adaptation of an ERA

          2. 6.2. Review and adaptation of the ERA guidance

    4. ANNEX III

      INFORMATION REQUIRED IN THE NOTIFICATION

      1. A notification referred to in part B or part C...

      2. Not all the points included will apply to every case....

      3. The level of detail required in response to each subset...

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

      5. The description of the methods used or the reference to...

      6. Annex III A applies to releases of all types of...

      7. The term ‘higher plants’ means plants which belong to the...

    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. A. GENERAL INFORMATION

      2. B. INFORMATION RELATING TO (A) THE RECIPIENT OR (B) (WHERE APPROPRIATE)...

      3. C. INFORMATION RELATING TO THE GENETIC MODIFICATION

      4. D. INFORMATION RELATING TO THE GENETICALLY MODIFIED PLANT

      5. E. INFORMATION RELATING TO THE SITE OF RELEASE (ONLY FOR NOTIFICATIONS...

      6. F. INFORMATION RELATING TO THE RELEASE (ONLY FOR NOTIFICATIONS SUBMITTED PURSUANT...

      7. G. INFORMATION ON CONTROL, MONITORING, POSTRELEASE AND WASTE TREATMENT PLANS (ONLY...

    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

Back to top

Options/Help

Print Options

You have chosen to open the Whole Directive

The Whole Directive you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.

Would you like to continue?

Close

Legislation is available in different versions:

Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.

Original (As adopted by EU): The original version of the legislation as it stood when it was first adopted in the EU. No changes have been applied to the text.

Point in Time: This becomes available after navigating to view revised legislation as it stood at a certain point in time via Advanced Features > Show Timeline of Changes or via a point in time advanced search.

Close

Opening Options

Different options to open legislation in order to view more content on screen at once

Close

More Resources

Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:

  • the original print PDF of the as adopted version that was used for the EU Official Journal
  • lists of changes made by and/or affecting this legislation item
  • all formats of all associated documents
  • correction slips
  • links to related legislation and further information resources
Close

Timeline of Changes

This timeline shows the different versions taken from EUR-Lex before exit day and during the implementation period as well as any subsequent versions created after the implementation period as a result of changes made by UK legislation.

The dates for the EU versions are taken from the document dates on EUR-Lex and may not always coincide with when the changes came into force for the document.

For any versions created after the implementation period as a result of changes made by UK legislation the date will coincide with the earliest date on which the change (e.g an insertion, a repeal or a substitution) that was applied came into force. For further information see our guide to revised legislation on Understanding Legislation.

Close

More Resources

Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:

  • the original print PDF of the as adopted version that was used for the print copy
  • correction slips

Click 'View More' or select 'More Resources' tab for additional information including:

  • lists of changes made by and/or affecting this legislation item
  • confers power and blanket amendment details
  • all formats of all associated documents
  • links to related legislation and further information resources