(This note is not part of the Regulations)
These Regulations implement, in respect of Scotland, Directive 2001/18/EC of the European Parliament and of the Council 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.
The subject matter of the Directive and its predecessor is the control of the deliberate release into the environment and the marketing 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.
Directive 1990/220/EEC was implemented partly by the (pre-existing) provisions of Part VI of the Environmental Protection Act 1990 (“the Act”) and partly by the Genetically Modified Organisms (Deliberate Release) Regulations 1992 (as subsequently amended).
These Regulations include amendments to the Act, applicable only to Scotland, required to implement the Directive and revoke, subject to exceptions, the 1992 Regulations.
The statutory basis for the requirement to obtain consent for the release or marketing of genetically modified organisms is section 111(1) of the Act. 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).
The definitions used in the provisions relating to the control regime are contained in sections 106, 107 and 127(1) of the Act. Regulations 3 and 4 amend a number of these definitions to reflect provisions of the Directive. Regulation 3 also amends the power in section 106 for the Scottish Ministers to prescribe techniques which result in organisms becoming “genetically modified”. However under regulation 5, until the coming into force of the first regulations made by the Scottish Ministers prescribing such techniques, references in the Act to “genetically modified organisms” will be interpreted by reference to the modification techniques described in that regulation.
Parts II and III of the Regulations impose requirements for applications for consent to release and market, respectively, genetically modified organisms (including transitional provisions).
Part 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.
Part V includes general requirements for marketing consents and amends section 112 of the Act (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.
Part VI supplements section 110 of the Act 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 section 123(7) of the Act.
Part VIII includes the requirement for different categories of information to be included in the public register to be kept by the Scottish Ministers under section 122 of the Act.
Part IX and Schedule 6 principally update the Scotland Act 1998 (Agency Arrangements) (Specification) (No. 2) Order 2002 in consequence of the implementation of the Directive, which permits the Scottish Ministers to enter into agency arrangements with the Secretary of State to allow her to carry out specified functions on behalf of the Scottish Ministers. It also corrects an omission from that Order. Such agency arrangements will not affect the Scottish Ministers’ powers or responsibilities in relation to these functions.
Schedule 7 provides for certain revocations of the Genetically Modified Organisms (Deliberate Release) Regulations 1992 and amending instruments.