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The Genetically Modified Organisms (Deliberate Release) (Wales) Regulations 2002

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  1. Introductory TextNext Match

  2. Part I GeneralPrevious MatchNext Match

    1. 1. Citation, commencement and applicationPrevious MatchNext Match

    2. 2. InterpretationPrevious MatchNext Match

    3. 3. Designation of competent authorityPrevious MatchNext Match

    4. 4. Purpose of Part VI of the Act and meaning of “genetically modified organisms” etc.Previous MatchNext Match

    5. 5. Meaning of “damage to the environment” etc.Previous MatchNext Match

    6. 6. Techniques of genetic modificationPrevious MatchNext Match

    7. 7. Environmental risk assessmentPrevious MatchNext Match

    8. 8. Communication with applicant for consentPrevious MatchNext Match

  3. Part II DELIBERATE RELEASE OF ORGANISMS FOR ANY OTHER PURPOSE THAN FOR PLACING ON THE MARKETPrevious MatchNext Match

    1. 9. Requirement for consent to releasePrevious MatchNext Match

    2. 10. Exempt activitiesPrevious MatchNext Match

    3. 11. Applications for consent to release — general provisionsPrevious MatchNext Match

    4. 12. Information to be contained in application for consent to releasePrevious MatchNext Match

    5. 13. Advertisement of application for consent to releasePrevious MatchNext Match

    6. 14. Transitional provisions for releasePrevious MatchNext Match

  4. Part III PLACING ON THE MARKET OF ORGANISMS AS OR IN PRODUCTSPrevious MatchNext Match

    1. 15. Requirement for consent to marketPrevious MatchNext Match

    2. 16. Exempt activitiesPrevious MatchNext Match

    3. 17. Application for consent to marketPrevious MatchNext Match

    4. 18. Transitional provision for marketingPrevious MatchNext Match

    5. 18A.Transitional measures for adventitious or technically unavoidable presence of genetically modified material which has benefited from a favourable risk evaluationPrevious MatchNext Match

    6. 19. Applications for renewal of consent to marketPrevious MatchNext Match

  5. Part IV DUTIES AFTER THE MAKING OF APPLICATIONSPrevious MatchNext Match

    1. 20. Duty of the applicant after applying for consent to release or to marketPrevious MatchNext Match

    2. 21. Duties of the National Assembly for Wales on receiving applications for consent to releasePrevious MatchNext Match

    3. 22. Decisions by the National Assembly for Wales on applications for consent to releasePrevious MatchNext Match

    4. 23. Variation or revocation of a consent to release genetically modified organismsPrevious MatchNext Match

    5. 24.Duties of the Welsh Ministers in relation to applications for consent to market genetically modified organismsPrevious MatchNext Match

    6. 25.Decisions by the Welsh Ministers on applications for consent to market genetically modified organismsPrevious MatchNext Match

    7. 26. Duties on the National Assembly for Wales on receiving applications for renewal of consent to market genetically modified organismsPrevious MatchNext Match

    8. 27. Decisions by the National Assembly for Wales on applications for renewals of consents to market genetically modified organismsPrevious MatchNext Match

    9. 28. Genetically modified organisms containing antibiotic resistance markersPrevious MatchNext Match

  6. Part V GENERAL PROVISIONS FOR CONSENTSPrevious MatchNext Match

    1. 29. General provisions of consents to market genetically modified organismsPrevious MatchNext Match

    2. 30. General conditions in consents to release or market genetically modified organismsPrevious MatchNext Match

    3. 31. Proof of compliance with consent conditionsPrevious MatchNext Match

    4. 32.Variation or revocation of a consent to marketPrevious MatchNext Match

  7. Part VI SAFEGUARDPrevious MatchNext Match

    1. 33. SafeguardPrevious MatchNext Match

  8. Part VII CONFIDENTIALITYPrevious MatchNext Match

    1. 34. ConfidentialityPrevious MatchNext Match

  9. Part VIII REGISTER OF INFORMATIONPrevious MatchNext Match

    1. 35. Information to be included on the registerPrevious MatchNext Match

    2. 36. Keeping the registerPrevious MatchNext Match

    3. 37. Publication of representationsPrevious MatchNext Match

  10. Part IX MISCELLANEOUSPrevious MatchNext Match

    1. 38. Precautionary principlePrevious MatchNext Match

    2. 39. RevocationsPrevious MatchNext Match

    3. 40. Application of Part VI of the Act to the territorial seaPrevious MatchNext Match

    4. 41. Application of Part VI of the Act to WalesPrevious MatchNext Match

  11. SignaturePrevious MatchNext Match

    1. SCHEDULE 1Previous MatchNext Match

      INFORMATION TO BE INCLUDED IN APPLICATIONS FOR CONSENT TO RELEASE GENETICALLY MODIFIED HIGHER PLANTS FOR NON-MARKETING PURPOSESPrevious MatchNext Match

      1. Part I GENERAL INFORMATIONPrevious MatchNext Match

        1. 1.The name and address of the applicant, and the name,...Previous MatchNext Match

        2. 2.The title of the project. Previous MatchNext Match

      2. Part II INFORMATION RELATING TO THE PARENTAL OR RECIPIENT PLANTPrevious MatchNext Match

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

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

        3. 5.Information concerning the survivability of the plant: Previous MatchNext Match

        4. 6.Information concerning the dissemination of the plant: Previous MatchNext Match

        5. 7.The geographical distribution of the plant in Europe. Previous MatchNext Match

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

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

      3. Part III INFORMATION RELATING TO THE GENETIC MODIFICATIONPrevious MatchNext Match

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

        2. 11.The nature and source of the vector used. Previous MatchNext Match

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

      4. Part IV INFORMATION RELATING TO THE GENETICALLY MODIFIED PLANTPrevious MatchNext Match

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

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

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

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

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

        6. 16.. . . . . . . . . ....Previous MatchNext Match

        7. 17.. . . . . . . . . ....Previous MatchNext Match

        8. 19.. . . . . . . . . ....Previous MatchNext Match

        9. 20.. . . . . . . . . ....Previous MatchNext Match

        10. 21.. . . . . . . . . ....Previous MatchNext Match

        11. 22.. . . . . . . . . ....Previous MatchNext Match

        12. 23.. . . . . . . . . ....Previous MatchNext Match

        13. 24.A description of detection and identification techniques for the genetically...Previous MatchNext Match

        14. 25.Information about previous releases of the genetically modified plant, if...Previous MatchNext Match

      5. PART 4A Information on specific areas of riskPrevious MatchNext Match

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

      6. Part V INFORMATION RELATING TO THE SITE OF RELEASEPrevious MatchNext Match

        1. ...Previous MatchNext Match

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

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

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

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

      7. Part VI INFORMATION RELATING TO THE RELEASEPrevious MatchNext Match

        1. ...Previous MatchNext Match

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

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

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

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

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

      8. Part VII INFORMATION ON CONTROL, MONITORING, POST-RELEASE AND WASTE TREATMENT PLANSPrevious MatchNext Match

        1. ...Previous MatchNext Match

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

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

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

          4. 38.A description of monitoring plans and techniques. Previous MatchNext Match

          5. 39.A description of any emergency plans. Previous MatchNext Match

          6. 40.Methods and procedures to protect the site. Previous MatchNext Match

      9. Part VIII INFORMATION ON METHODOLOGYPrevious MatchNext Match

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

    2. SCHEDULE 1APrevious MatchNext Match

      Information to be included in applications for consent to market genetically modified higher plantsPrevious MatchNext Match

      1. PART 1 General informationPrevious MatchNext Match

        1. 1.The name and address of the applicant, and the name,...Previous MatchNext Match

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

      2. PART 2 Information relating to the parental or recipient plantPrevious MatchNext Match

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

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

        3. 5.Information concerning the survivability of the plant— Previous MatchNext Match

        4. 6.Information concerning the dissemination of the plant— Previous MatchNext Match

        5. 7.The geographical distribution of the plant in Europe. Previous MatchNext Match

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

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

      3. PART 3 Information Relating to the Genetic ModificationPrevious MatchNext Match

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

        2. 11.The nature and source of the vector used. Previous MatchNext Match

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

      4. PART 4 Information relating to the genetically modified plantPrevious MatchNext Match

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

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

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

        4. 16.The genetic stability of the insert and phenotypic stability of...Previous MatchNext Match

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

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

      5. PART 5 Information on specific areas of riskPrevious MatchNext Match

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

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

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

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

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

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

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

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

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

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

      6. PART 6 Information about the detection, identification and previous releases of the genetically modified plantPrevious MatchNext Match

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

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

    3. SCHEDULE 2Previous MatchNext Match

      INFORMATION TO BE INCLUDED IN APPLICATIONS FOR CONSENT TO RELEASE OR MARKET GENETICALLY MODIFIED ORGANISMS OTHER THAN GENETICALLY MODIFIED HIGHER PLANTSPrevious MatchNext Match

      1. Part I GENERAL INFORMATIONPrevious MatchNext Match

        1. 1.The name and address of the applicant, and the name,...Previous MatchNext Match

        2. 2.The title of the project. Previous MatchNext Match

      2. Part II INFORMATION RELATING TO THE GENETICALLY MODIFIED ORGANISMSPrevious MatchNext Match

        1. Characteristics of donor, parental and recipient organismsPrevious MatchNext Match

          1. 3.Scientific name and taxonomy. Previous MatchNext Match

          2. 4.Usual strain, cultivar or other name. Previous MatchNext Match

          3. 5.Phenotypic and genetic markers. Previous MatchNext Match

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

          5. 7.The description of identification and detection techniques. Previous MatchNext Match

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

          7. 9.The description of the geographic distribution and of the natural...Previous MatchNext Match

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

          9. 11.Verification of the genetic stability of the organisms and factors...Previous MatchNext Match

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

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

          12. 14.The history of previous genetic modifications. Previous MatchNext Match

        2. Characteristics of the vectorPrevious MatchNext Match

          1. 15.The nature and source of the vector. Previous MatchNext Match

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

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

          4. 18.The degree to which the vector is limited to the...Previous MatchNext Match

        3. Characteristics of the genetically modified organismsPrevious MatchNext Match

          1. 19.The methods used for the modification. Previous MatchNext Match

          2. 20.The methods used— (a) to construct inserts and to introduce...Previous MatchNext Match

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

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

          5. 23.The methods and criteria used for selection. Previous MatchNext Match

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

        4. Characteristics of the genetically modified organismsPrevious MatchNext Match

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

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

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

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

          5. 29.The activity of the gene product. Previous MatchNext Match

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

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

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

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

      3. Part III INFORMATION RELATING TO THE CONDITIONS OF RELEASEPrevious MatchNext Match

        1. The releasePrevious MatchNext Match

          1. 34.The description of the proposed deliberate release, including the purpose...Previous MatchNext Match

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

          3. 36.The preparation of the site before the release. Previous MatchNext Match

          4. 37.The size of the site. Previous MatchNext Match

          5. 38.The methods to be used for the release. Previous MatchNext Match

          6. 39.The quantity of organisms to be released. Previous MatchNext Match

          7. 40.The disturbance of the site, including the type and method...Previous MatchNext Match

          8. 41.The worker protection measures taken during the release. Previous MatchNext Match

          9. 42.The post-release treatment of the site. Previous MatchNext Match

          10. 43.The techniques foreseen for elimination or inactivation of the genetically...Previous MatchNext Match

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

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

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

          2. 46.The physical or biological proximity of the site of the...Previous MatchNext Match

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

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

          5. 49.The geographical, geological and pedological characteristics. Previous MatchNext Match

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

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

          8. 52.The comparison of the natural habitat of the recipient organisms...Previous MatchNext Match

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

      4. Part IV INFORMATION RELATING TO THE INTERACTIONS BETWEEN THE GENETICALLY MODIFIED ORGANISMS AND THE ENVIRONMENTPrevious MatchNext Match

        1. Characteristics affecting survival, multiplication and disseminationPrevious MatchNext Match

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

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

          3. 56.The sensitivity to specific agents. Previous MatchNext Match

        2. Interactions with the environmentPrevious MatchNext Match

          1. 57.The predicted habitat of the genetically modified organisms. Previous MatchNext Match

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

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

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

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

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

          7. 63.The description of ecosystems to which the genetically modified organisms...Previous MatchNext Match

          8. 64.The potential for excessive population increase of the genetically modified...Previous MatchNext Match

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

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

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

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

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

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

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

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

      5. Part V INFORMATION ON MONITORING, CONTROL, WASTE TREATMENT AND EMERGENCY RESPONSE PLANSPrevious MatchNext Match

        1. Monitoring techniquesPrevious MatchNext Match

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

          2. 74.Specificity (to identify the genetically modified organisms, and to distinguish...Previous MatchNext Match

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

          4. 76.Duration and frequency of the monitoring. Previous MatchNext Match

        2. Control of the releasePrevious MatchNext Match

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

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

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

        3. Waste treatmentPrevious MatchNext Match

          1. 80.Type of waste generated. Previous MatchNext Match

          2. 81.Expected amount of waste. Previous MatchNext Match

          3. 82.Description of treatment envisaged. Previous MatchNext Match

        4. Emergency response plansPrevious MatchNext Match

          1. 83.Methods and procedures for controlling the genetically modified organisms in...Previous MatchNext Match

          2. 84.Methods, such as eradication of the genetically modified organisms, for...Previous MatchNext Match

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

          4. 86.Methods for the isolation of the areas affected by the...Previous MatchNext Match

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

      6. Part VI INFORMATION ON METHODOLOGYPrevious MatchNext Match

        1. 88.A description of the methods used or a reference to...Previous MatchNext Match

    4. SCHEDULE 3Previous MatchNext Match

      INFORMATION TO BE INCLUDED IN AN APPLICATION FOR CONSENT TO MARKET GENETICALLY MODIFIED ORGANISMSPrevious MatchNext Match

      1. Part I GENERAL INFORMATIONPrevious MatchNext Match

        1. 1.The proposed commercial name of the product and names of...Previous MatchNext Match

        2. 2.The name and address in the Community of the person...Previous MatchNext Match

        3. 3.The name and address of the supplier or suppliers of...Previous MatchNext Match

        4. 4.A description of how the product and the genetically modified...Previous MatchNext Match

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

        6. 6.A description of the intended categories of users of the...Previous MatchNext Match

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

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

      2. Part II ADDITIONAL RELEVANT INFORMATIONPrevious MatchNext Match

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

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

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

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

        5. 13.The proposed packaging. Previous MatchNext Match

        6. 14.The estimated product in and/or imports to Wales. Previous MatchNext Match

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

    5. SCHEDULE 4Previous MatchNext Match

      INFORMATION TO BE INCLUDED IN AN ASSESSMENT REPORTPrevious MatchNext Match

      1. 1.An identification of the characteristics of the recipient organism which...Previous MatchNext Match

      2. 2.A description of the way in which the characteristics of...Previous MatchNext Match

      3. 3.An identification of any known risks of change to the...Previous MatchNext Match

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

      5. 5.An identification of any new risks to human health and...Previous MatchNext Match

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

    6. SCHEDULE 5Previous MatchNext Match

      REVOCATIONSPrevious MatchNext Match

  13. Explanatory NotePrevious Match

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