Search Legislation

Advanced Search

Genetically Modified Organisms (Deliberate Release) Regulations 2002

Changes to legislation:

There are outstanding changes not yet made by the legislation.gov.uk editorial team to Genetically Modified Organisms (Deliberate Release) Regulations 2002. Those changes will be listed when you open the content using the Table of Contents below. Any changes that have already been made by the team appear in the content and are referenced with annotations. Help about Changes to Legislation

Close

Changes to Legislation

Revised legislation carried on this site may not be fully up to date. Changes and effects are recorded by our editorial team in lists which can be found in the ‘Changes to Legislation’ area. Where those effects have yet to be applied to the text of the legislation by the editorial team they are also listed alongside the affected provisions when you open the content using the Table of Contents below.

View outstanding changes

Changes and effects yet to be applied to :

  • Sch. 3 para. 7 words omitted by S.I. 2019/88 reg. 3(18)(c) (This amendment not applied to legislation.gov.uk. Reg. 3(18)(c) omitted (29.9.2019) by virtue of S.I. 2019/1252, regs. 1(1), 9)
  • reg. 23(1)(b) substituted by S.I. 2019/88 reg. 3(9)(a)(i) (This amendment not applied to legislation.gov.uk. Reg. 3(9)(a) omitted immediately before IP completion day by virtue of S.I. 2019/759, regs. 1(a), 11)
  • reg. 23(1)(e) substituted by S.I. 2019/88 reg. 3(9)(a)(ii) (This amendment not applied to legislation.gov.uk. Reg. 3(9)(a) omitted immediately before IP completion day by virtue of S.I. 2019/759, regs. 1(a), 11)
  • reg. 23(4) omitted by S.I. 2019/88 reg. 3(9)(d) (This amendment not applied to legislation.gov.uk. Reg. 3(9)(d) omitted immediately before IP completion day by virtue of S.I. 2019/759, regs. 1(a), 11)
  • reg. 24(1)-(4) substituted by S.I. 2019/88 reg. 3(10)(a) (This amendment not applied to legislation.gov.uk. Reg. 3(10)(a) omitted immediately before IP completion day by virtue of S.I. 2019/759, regs. 1(a), 11)

Changes and effects yet to be applied to the whole Instrument associated Parts and Chapters:

  1. Introductory Text

  2. PART I GENERAL

    1. 1. Citation, commencement, extent and application

    2. 2. Interpretation

    3. 3. Purpose of Part VI of the Act and meaning of “genetically modified organisms” etc

    4. 4. Meaning of “damage to the environment” etc

    5. 5. Techniques of genetic modification

    6. 6. Environmental risk assessment

    7. 7. Communication with applicant for consent

  3. PART II RELEASING ORGANISMS FOR ANY OTHER PURPOSE THAN MARKETING

    1. 8. Requirement for consent to release

    2. 9.Exemption for approved products

    3. 9A.Exemption for release of qualifying higher plants

    4. 9B.Notification requirement for release of qualifying higher plants

    5. 10. Applications for consent to release—general provisions

    6. 11. Information to be contained in applications for consent to release

    7. 12. Advertisement of applications for consent to release

    8. 13. Transitional provisions for release

  4. PART III MARKETING ORGANISMS

    1. 14. Requirement for consent to market

    2. 15. Exempt activities

    3. 16. Applications for consent to market

    4. 17. Transitional provisions for marketing

    5. 17A.Transitional measures for adventitious or technically unavoidable presence of genetically modified material which has benefited from a favourable risk evaluation.

    6. 18. Applications for renewal of consent to market

  5. PART IV DUTIES AFTER THE MAKING OF APPLICATIONS

    1. 19. Duty of the applicant after applying for consent to release or to market

    2. 20. Duties of the Secretary of State in relation to applications for consent to release

    3. 21. Decisions by the Secretary of State on applications for consent to release

    4. 22. Variation or revocation of consents to release

    5. 23. Duties of the Secretary of State in relation to applications for consent to market

    6. 24. Decisions by the Secretary of State on applications for consent to market

    7. 25. Duties of the Secretary of State on receiving applications for renewal of consent to market

    8. 26. Decisions by the Secretary of State on applications for renewal of consent to market

    9. 27. Genetically modified organisms containing antibiotic resistance markers

  6. PART V GENERAL PROVISIONS FOR CONSENTS

    1. 28. General provisions of consents to market

    2. 29. General conditions in consents to release or market

    3. 30. Proof of compliance with consent conditions

    4. 31. Variation or revocation of a consent to market

  7. PART VI SAFEGUARD

    1. 32. Safeguard

  8. PART VII CONFIDENTIALITY

    1. 33. Confidentiality

  9. PART VIII REGISTER OF INFORMATION

    1. 34. Information to be included in the register

    2. 35. Keeping the register

    3. 36. Publication of representations

  10. PART IX MISCELLANEOUS

    1. 37. Revocations

    2. 38. Application of Part VI of the Act to territorial sea and continental shelf

    3. 39. Application of Part VI of the Act: England and Wales

  11. Signature

    1. SCHEDULE 1

      Information to be included in applications for consent to release genetically modified higher plants for non-marketing purposes

      1. PART I General Information

        1. 1.The name and address of the applicant, and the name,...

        2. 2.The title of the project.

      2. PART II Information relating to the parental or recipient plant

        1. 3.The full name of the plant— (a) family name,

        2. 4.Information concerning— (a) the reproduction of the plant:

        3. 5.Information concerning the survivability of the plant:

        4. 6.Information concerning the dissemination of the plant:

        5. 7.The geographical distribution of the plant in Europe.

        6. 8.Where the application relates to a plant species which is...

        7. 9.Any other potential interactions, relevant to the genetically modified organism,...

      3. PART III Information relating to the genetic modification

        1. 10.A description of the methods used for the genetic modification....

        2. 11.The nature and source of the vector used.

        3. 12.The size, intended function and name of the donor organism...

      4. PART IV Information relating to the genetically modified plant

        1. 13.A description of the trait or traits and characteristics of...

        2. 14.The following information on the sequences actually inserted or deleted:...

        3. 15.Information on parts of the plant where the insert is...

        4. 15A.The genetic stability of the insert and phenotypic stability of...

        5. 15B.Conclusions on the molecular characterisation of the genetically modified plant....

        6. 16.Information on how the genetically modified plant differs from the...

        7. 17.The genetic stability of the insert and phenotypic stability of...

      5. PART 4A Information on specific areas of risk

        1. 18.Information on— (a) any change to the persistence or invasiveness...

        2. 19.Information on any toxic, allergenic or other harmful effects on...

        3. 20.Information on the safety of the genetically modified plant to...

        4. 21.The mechanism of interaction between the genetically modified plant and...

        5. 22.The potential changes in the interactions of the genetically modified...

        6. 23.The potential interactions with the abiotic environment.

        7. 24.A description of detection and identification techniques for the genetically...

        8. 25.Information about previous releases of the genetically modified plant, if...

      6. PART V Information relating to the site of release

        1. ...

          1. 26.The location and size of the release site or sites....

          2. 27.A description of the release site ecosystem, including climate, flora...

          3. 28.Details of any sexually compatible wild relatives or cultivated plant...

          4. 29.The proximity of the release sites to officially recognised biotopes...

      7. PART VI Information relating to the release

        1. ...

          1. 30.The purpose of the release of the genetically modified plant,...

          2. 31.The foreseen date or dates and duration of the release....

          3. 32.The method by which the genetically modified plants will be...

          4. 33.The method for preparing and managing the release site, prior...

          5. 34.The approximate number of genetically modified plants (or plants per...

      8. PART VII Information on control, monitoring, post-release and waste treatment plans

        1. ...

          1. 35.(1) A description of any precautions to maintain spatial and,...

          2. 36.A description of the methods for post-release treatment of the...

          3. 37.A description of the post-release treatment methods for the genetically...

          4. 38.A description of monitoring plans and techniques.

          5. 39.A description of any emergency plans.

          6. 40.Methods and procedures to protect the site.

      9. PART VIII Information on methodology

        1. 41.A description of the methods used or a reference to...

    2. SCHEDULE 1A

      Information to be included in applications for consent to market genetically modified higher plants

      1. PART 1 General information

        1. 1.The name and address of the applicant, and the name,...

        2. 2.The designation and specification of the genetically modified plant, and...

      2. PART 2 Information relating to the parental or recipient plant

        1. 3.The full name of the plant— (a) family name,

        2. 4.Information concerning— (a) the reproduction of the plant—

        3. 5.Information concerning the survivability of the plant—

        4. 6.Information concerning the dissemination of the plant—

        5. 7.The geographical distribution of the plant in Europe.

        6. 8.Where the application relates to a plant species which is...

        7. 9.Any other potential interactions, relevant to the genetically modified organism,...

      3. PART 3 Information Relating to the Genetic Modification

        1. 10.A description of the methods used for the genetic modification....

        2. 11.The nature and source of the vector used.

        3. 12.The size, intended function and name of the donor organism...

      4. PART 4 Information relating to the genetically modified plant

        1. 13.A description of the trait or traits and characteristics of...

        2. 14.(1) The following information on the sequences inserted or deleted—...

        3. 15.The following information on the expression of the insert—

        4. 16.The genetic stability of the insert and phenotypic stability of...

        5. 17.Conclusions on the molecular characterisation of the genetically modified plant....

        6. 18.The following information on the comparative analysis of agronomic and...

      5. PART 5 Information on specific areas of risk

        1. 19.For each of the areas of risk listed in section...

        2. 20.The applicant must provide— (a) the information described in paragraphs...

        3. 21.Information relating to the persistence and invasiveness including plant to...

        4. 22.Information relating to plant to micro-organism gene transfer including—

        5. 23.Information relating to the interactions of the genetically modified plant,...

        6. 24.(1) Information on the interactions of the genetically modified plant...

        7. 25.Information on the impacts of the specific cultivation, management and...

        8. 26.Information on biogeochemical processes including— (a) an assessment of the...

        9. 27.Information on the effects on human and animal health including—...

        10. 28.(1) The overall risk evaluation and conclusions must include a...

      6. PART 6 Information about the detection, identification and previous releases of the genetically modified plant

        1. 30.A description of detection and identification techniques for the genetically...

        2. 31.Information about previous releases of the genetically modified plant, if...

    3. SCHEDULE 2

      Information to be included in applications for consent to release or market organisms other than genetically modified higher plants

      1. PART I General information

        1. 1.The name and address of the applicant, and the name,...

        2. 2.The title of the project.

      2. PART II Information relating to the organisms

        1. Characteristics of donor, parental and recipient organisms

          1. 3.Scientific name and taxonomy.

          2. 4.Usual strain, cultivar or other name.

          3. 5.Phenotypic and genetic markers.

          4. 6.The degree of relatedness between donor and recipient or between...

          5. 7.The description of identification and detection techniques.

          6. 8.The sensitivity, reliability (in quantitative terms) and specificity of detection...

          7. 9.The description of the geographic distribution and of the natural...

          8. 10.The organisms with which transfer of genetic material is known...

          9. 11.Verification of the genetic stability of the organisms and factors...

          10. 12.The following pathological, ecological and physiological traits—

          11. 13.The sequence, frequency of mobilisation and specificity of indigenous vectors,...

          12. 14.The history of previous genetic modifications.

        2. Characteristics of the vector

          1. 15.The nature and source of the vector.

          2. 16.The sequence of transposons, vectors and other non-coding genetic segments...

          3. 17.The frequency of mobilisation, genetic transfer capabilities and/or methods of...

          4. 18.The degree to which the vector is limited to the...

        3. Characteristics of the modified organisms

          1. 19.The methods used for the modification.

          2. 20.The methods used— (a) to construct the insert or inserts...

          3. 21.The description of any insert and/or vector construction.

          4. 22.The purity of the insert from any unknown sequence and...

          5. 23.The methods and criteria used for selection;

          6. 24.The sequence, functional identity and location of the altered, inserted...

        4. Characteristics of the genetically modified organisms in their final form

          1. 25.The description of genetic trait or traits or phenotypic characteristics...

          2. 26.The structure and amount of any vector or donor nucleic...

          3. 27.The stability of the organisms in terms of genetic traits....

          4. 28.The rate and level of expression of the new genetic...

          5. 29.The activity of the gene product.

          6. 30.The description of identification and detection techniques, including techniques for...

          7. 31.The sensitivity, reliability (in quantitative terms), and specificity of detection...

          8. 32.The history of previous releases or uses of the organisms....

          9. 33.In relation to human health, animal health and plant health—...

      3. PART III Information relating to the conditions of release

        1. The release

          1. 34.The description of the proposed deliberate release, including the initial...

          2. 35.The intended dates of the release and time planning of...

          3. 36.The preparation of the site before the release.

          4. 37.The size of the site.

          5. 38.The method or methods to be used for the release....

          6. 39.The quantity of organisms to be released.

          7. 40.The disturbance on the site, including the type and method...

          8. 41.The worker protection measures taken during the release.

          9. 42.The post-release treatment of the site.

          10. 43.The techniques foreseen for elimination or inactivation of the organisms...

          11. 44.Information on, and the results of, previous releases of the...

        2. The environment (both on the site and in the wider environment)

          1. 45.The geographical location and national grid reference of the site...

          2. 46.The physical or biological proximity of the site of the...

          3. 47.The proximity to significant biotopes, protected areas or drinking water...

          4. 48.The climatic characteristics of the region or regions likely to...

          5. 49.The geographical, geological and pedological characteristics.

          6. 50.The flora and fauna, including crops, livestock and migratory species....

          7. 51.The description of the target and non-target ecosystems likely to...

          8. 52.The comparison of the natural habitat of the recipient organisms...

          9. 53.Any known planned developments or changes in land use in...

      4. PART IV Information relating to the interactions between the organisms and the environment

        1. Characteristics affecting survival, multiplication and dissemination

          1. 54.The biological features which affect survival, multiplication and dispersal.

          2. 55.The known or predicted environmental conditions which may affect survival,...

          3. 56.The sensitivity to specific agents.

        2. Interactions with the environment

          1. 57.The predicted habitat of the organisms.

          2. 58.The studies on the behaviour and characteristics of the organisms...

          3. 59.The capability of post-release transfer of genetic material—

          4. 60.The likelihood of post-release selection leading to the expression of...

          5. 61.The measures employed to ensure and to verify genetic stability,...

          6. 62.The routes of biological dispersal, known or potential modes of...

          7. 63.The description of ecosystems to which the organisms could be...

          8. 64.The potential for excessive population increase of the organisms in...

          9. 65.The competitive advantage of the organisms in relation to the...

          10. 66.The identification and description of the target organisms if applicable....

          11. 67.The anticipated mechanism and result of interaction between the released...

          12. 68.The identification and description of non-target organisms which may be...

          13. 69.The likelihood of post release shifts in biological interactions or...

          14. 70.The known or predicted interactions with non-target organisms in the...

          15. 71.The known or predicted involvement of the organisms in biogeochemical...

          16. 72.Any other potential interactions of the organisms with the environment....

      5. PART V Information on monitoring, control, waste treatment and emergency response plans

        1. Monitoring techniques

          1. 73.Methods for tracing the organisms and for monitoring their effects....

          2. 74.Specificity (to identify the organisms, and to distinguish them from...

          3. 75.Techniques for detecting transfer of the donated genetic material to...

          4. 76.Duration and frequency of the monitoring.

        2. Control of the release

          1. 77.Methods and procedures to avoid and/or minimise the spread of...

          2. 78.Methods and procedures to protect the site from intrusion by...

          3. 79.Methods and procedures to prevent other organisms from entering the...

        3. Waste treatment

          1. 80.Type of waste generated.

          2. 81.Expected amount of waste.

          3. 82.Description of treatment envisaged.

        4. Emergency response plans

          1. 83.Methods and procedures for controlling the organisms in case of...

          2. 84.Methods, such as eradication of the organisms, for decontamination of...

          3. 85.Methods for disposal or sanitation of plants, animals, soils, and...

          4. 86.Methods for the isolation of the areas affected by the...

          5. 87.Plans for protecting human health and the environment in case...

      6. PART VI Information on methodology

        1. A description of the methods used or a reference to...

    4. SCHEDULE 3

      Information to be included in applications for consent to market genetically modified organisms

      1. PART I General information

        1. 1.The proposed commercial name of the product and names of...

        2. 2.The name and address in the Community of the person...

        3. 3.The name and address of the supplier or suppliers of...

        4. 4.A description of how the product and the genetically modified...

        5. 5.A description of the geographical area or areas and types...

        6. 6.A description of the intended categories of users of the...

        7. 7.(1) Information on— (a) methods for the detection, identification and,...

        8. 8.The proposed labelling, which must include, in a label or...

      2. PART II Additional relevant information

        1. 9.The measures to be taken in the event of the...

        2. 10.Specific instructions or recommendations for storage and handling of the...

        3. 11.Specific instructions for carrying out monitoring and reporting to the...

        4. 12.The proposed restrictions in the approved use of the genetically...

        5. 13.The proposed packaging.

        6. 14.The estimated production in and/or imports to England.

        7. 15.Any proposed additional labelling, which may include, at least in...

    5. SCHEDULE 3A

      Information to be provided to the Secretary of State alongside a notice of intention to release a qualifying higher plant

      1. 1.The title of the project under which the qualifying higher...

      2. 2.The aim of the project (including any matters being investigated...

      3. 3.The name, address, telephone number and email address of the...

      4. 4.The name, qualifications and experience of every person responsible for...

      5. 5.The name, qualifications and experience of every person responsible for...

      6. 6.The full name of the qualifying higher plant to be...

      7. 7.The expected date on which the project will start.

      8. 8.The expected duration of the project.

    6. SCHEDULE 4

      Information to be included in an assessment report

      1. 1.An identification of the characteristics of the recipient organism which...

      2. 2.A description of the way in which the characteristics of...

      3. 3.An identification of any known risks of damage to the...

      4. 4.An assessment of whether the genetic modification has been characterised...

      5. 5.An identification of any new risks of damage to the...

      6. 6.A conclusion which addresses the proposed use of the product,...

    7. SCHEDULE 5

      REVOCATIONS

  13. Explanatory Note

Back to top

Options/Help

Print Options

You have chosen to open The Whole Instrument

The Whole Instrument 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?

You have chosen to open The Whole Instrument as a PDF

The Whole Instrument you have selected contains over 200 provisions and might take some time to download.

Would you like to continue?

You have chosen to open the Whole Instrument

The Whole Instrument 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 Enacted or Made): The original version of the legislation as it stood when it was enacted or made. No changes have been applied to the text.

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 enacted version that was used for the print copy
  • lists of changes made by and/or affecting this legislation item
  • confers power and blanket amendment details
  • 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 points in time where a change occurred. The dates 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. The first date in the timeline will usually be the earliest date when the provision came into force. In some cases the first date is 01/02/1991 (or for Northern Ireland legislation 01/01/2006). This date is our basedate. No versions before this date are available. For further information see the Editorial Practice Guide and Glossary under Help.

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 made 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

The data on this page is available in the alternative data formats listed: