The Genetically Modified Organisms (Deliberate Release) Regulations 1992

Information to be contained in application for consent to release

6.—(1) Subject to regulation 7 (Exemptions from regulation 6), the following is the information which an application for a consent to release genetically modified organisms must contain:—

(a) the information prescribed in Schedule 1 to these Regulations, to the extent that such information is appropriate to the proposed release,

(b) information on data or results from any previous release of the organisms, or of organisms of the same description, which has been carried out by the applicant, and information from any previous application for the release of the organisms, or of organisms of the same description, which the applicant has made to the Secretary of State in accordance with the Act and these Regulations or to another competent authority of a member State in accordance with Article 5 of the Deliberate Release Directive,

(c) a statement evaluating the impacts and risks posed to human health and the environment by the release of the organisms,

(d) a statement whether the detailed description of the organisms and the details of the purpose for which the organisms will be released have been published, and the bibliographic reference for any information so published,

(e) a summary, in the format established by the Commission under Article 9(1) of the Deliberate Release Directive, of the information contained in the application.

(2) The information prescribed in Schedule 1 shall be included in the application at the level of detail which is appropriate to the nature and scale of the proposed release.

(3) Where the applicant considers, on the basis that it is not technically possible or it does not appear to the applicant to be necessary, that it is not appropriate for the application to contain the information prescribed in one or more of the paragraphs of Schedule 1, the application shall contain a statement of the reasons why the inclusion of the information is not appropriate.

(4) The application must contain the description of the methods used to obtain the information contained in the application in accordance with paragraph (1) and a bibliographic reference, or, where standardised or internationally recognised methods are used, a reference to which method was used to obtain the information and its bibliographic references, together with the name of the body or bodies responsible for carrying out the studies.

(5) The application may in addition contain data or results from an application for consent to release genetically modified organisms previously made by some other person, provided that a copy of that person’s agreement in writing is contained in the application.