{
  "url": "https://openlegislation.uk/genetically-modified-organisms-deliberate-release-regulations-northern-ireland-2003/note",
  "json_url": "https://openlegislation.uk/genetically-modified-organisms-deliberate-release-regulations-northern-ireland-2003/note.json",
  "legislation": "nisr/2003/167",
  "legislation_title": "The Genetically Modified Organisms (Deliberate Release) Regulations (Northern Ireland) 2003",
  "legislation_url": "https://openlegislation.uk/genetically-modified-organisms-deliberate-release-regulations-northern-ireland-2003",
  "path": "note",
  "kind": "note",
  "number": null,
  "heading": "Explanatory note",
  "text": "(This note is not part of the Regulations)\nThese Regulations implement, in respect of Northern Ireland, Council Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms (“the Directive”) which replaced Council Directive 1990/220/EEC (as amended) of the same title.\nThe subject matter of the Directive and its predecessor is the control of the deliberate release into the environment and the placing on the market of genetically modified organisms by means of the imposition of a requirement to obtain consent for those activities and to comply with the conditions imposed on the consent. The changes introduced by the Directive strengthen the existing control regime, particularly in respect of post marketing monitoring.\nDirective 1990/220/EEC was implemented partly by the provisions of the Genetically Modified Organisms (NI) Order 1991 (“the Order”) and partly by the Genetically Modified Organisms (Deliberate Release) Regulations (Northern Ireland) 1994 (subsequently amended).\nThese Regulations include amendments to the Order required to implement the Directive and revoke the 1994 Regulations. The Order is also amended to take account of the Advisory Committee on Releases to the Environment.\nThe statutory basis for the requirement to obtain consent for the release or marketing of genetically modified organisms is Article 8 (1) of the Order. The cases and circumstances in which consent is required are prescribed in these Regulations. A general requirement to obtain consent for the release or marketing of genetically modified organisms is imposed by regulation 8 (for release) and regulation 14 (for marketing). This general requirement is subject to the exemptions provided for in regulations 9 (for release) and 15 (for marketing).\nThe definitions used in the provisions relating to the control regime are contained in Articles 2, 3, and 4 of the Order. Regulations 3 and 4 amend a number of these definitions to reflect the Directive. Regulation 3 also amends the power in Article 3 for the Department to prescribe techniques which result in organisms becoming “genetically modified”. However, on coming into operation of these Regulations, references in the Order to “genetically modified organisms” will be interpreted by reference to the modification techniques described in regulation 5.\nParts II and III of the Regulations impose requirements for applications for consent to release and place on the market, respectively, genetically modified organisms (including transitional provisions).\nPart IV lays down the procedure for dealing with applications from their receipt to their determination (and, in the case of consents to release, their subsequent variation or revocation). For release consents this includes provisions for public consultation and for marketing consents (and renewals of such consents) their agreement at European Community level.\nPart V includes general requirements for marketing consents and amends Article 9 of the Order (which imposes conditions on consents). It also provides for what should happen when new information becomes available which affects the risk assessment for the marketing of a genetically modified organism.\nPart VI supplements Article 7 of the Order insofar as it allows action to be taken to prohibit the marketing of a genetically modified organism which has consent so as to bring it into line with the taking of “safeguard action” under the Directive. Part VII prescribes additional categories of information to be made public notwithstanding that they may be commercially confidential, for the purposes of Article 20(7) of the Order.\nCopies of the Directive may be obtained at http://europa.eu.int/eur-lex/en/index.html and from the Stationery Office Ltd., 16 Arthur Street, Belfast, BT1 4GD",
  "extent": "N.I.",
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/nisr/2003/167/note",
    "retrieved_at": "2026-10-29T02:03:35.311152+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}