11.—(1) An application for a consent to release genetically modified organisms must contain—
(a)[F1subject to paragraph (1A),] the information prescribed in—
(i)Schedule 1, where the application is for consent to release any genetically modified higher plant, or
(ii)Schedule 2 in any other case,
F2...
(b)information on data or results from any previous release of the organisms, or of the same combination of organisms, which has been carried out by the applicant, and information from any previous application for the release of the organisms, or of the same combination of organisms, which the applicant has made to the Secretary of State pursuant to the Act or to another competent authority in accordance with Article 6 of the Deliberate Release Directive,
(c)an environmental risk assessment prepared in accordance with regulation 6,
(d)a summaryF3... of the information contained in the application [F4, in the relevant format set out in the Annex to Council Decision 2002/813/EC].
[F5(e)summaries and results of studies referred to in the application, including an explanation of their relevance to the environmental risk assessment, as appropriate.]
[F6(1A) The information specified in paragraph (1)(a) is only required to be provided if it is necessary for the completion of an environmental risk assessment in the context of a specific application, and the level of detail to be provided may vary according to the nature and the scale of the proposed deliberate release.]
(2) The application may contain—
(a)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, and
(b)any other information that the applicant considers relevant.
Textual Amendments
F1Words in reg. 11(1)(a) inserted (29.9.2019) by The Genetically Modified Organisms (Deliberate Release) (Amendment) (England) Regulations 2019 (S.I. 2019/1252), regs. 1(1), 4(a)(i)
F2Words in reg. 11(1)(a) omitted (29.9.2019) by virtue of The Genetically Modified Organisms (Deliberate Release) (Amendment) (England) Regulations 2019 (S.I. 2019/1252), regs. 1(1), 4(a)(ii)
F3Words in reg. 11(1)(d) omitted (31.12.2020) by virtue of The Genetically Modified Organisms (Amendment) (England) (EU Exit) Regulations 2019 (S.I. 2019/88), regs. 1(2)(b), 3(4)(a); 2020 c. 1, Sch. 5 para. 1(1)
F4Words in reg. 11(1)(d) inserted (31.12.2020) by The Genetically Modified Organisms (Amendment) (England) (EU Exit) Regulations 2019 (S.I. 2019/88), regs. 1(2)(b), 3(4)(b); 2020 c. 1, Sch. 5 para. 1(1)