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

Information to be contained in application for consent to release S

11.—(1) An application for a consent to release genetically modified organisms must contain–

[F1 (a) the information prescribed in Part 1 of schedule 2, where the application is for consent to release any genetically modified higher plant, or schedule 3 in any other case, to the extent that such information is—

(i) appropriate to the nature and scale of the release or application, and

(ii) in the case of schedule 2, relevant and necessary for the purposes of the environmental risk assessment referred to in sub-paragraph (c), in view particularly of the characteristics of the genetically modified organism and of the scale and conditions of the release or of its intended conditions of use;

(aa) where the application is for consent to release a genetically modified higher plant, summaries and results of studies referred to in the application for consent to release, including an explanation of their relevance to the environmental risk assessment under sub-paragraph (c), where applicable,]

(b) information on data or results from any previous release of the organisms, or 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 [F2 under section 111(1) of the Act (in relation to any part of the United Kingdom) or] to any competent authority of [F3 a member] State F4 ... in accordance with Article 6 of the Deliberate Release Directive or Article 5 of the 1990 Directive;

(c) an environmental risk assessment prepared in accordance with regulation 6; and

(d) a summary F5 ... of the information contained in the application [F6 , in the relevant format set out in the Annex to Decision 2002/813/EC].

(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 where the data or results are confidential a copy of that person’s agreement in writing is contained in the application; and

(b) any other information which the applicant considers is relevant.

Textual Amendments

F1 Reg. 11(1)(a)(aa) substituted for reg. 11(1)(a) (15.3.2019) by The Genetically Modified Organisms (Deliberate Release etc.) (Miscellaneous Amendments) (Scotland) Regulations 2019 (S.S.I. 2019/86), regs. 1(1), 4

F2 Words in reg. 11(1)(b) inserted (31.12.2020) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(b), 3(5)(a)(i); 2020 c. 1, Sch. 5 para. 1(1)

F3 Words in reg. 11(1)(b) substituted (28.3.2019) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(a), 2(4)

F4 Words in reg. 11(1)(b) omitted (31.12.2020) by virtue of The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(b), 3(5)(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F5 Words in reg. 11(1)(d) omitted (31.12.2020) by virtue of The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(b), 3(5)(b)(i); 2020 c. 1, Sch. 5 para. 1(1)

F6 Words in reg. 11(1)(d) inserted (31.12.2020) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(b), 3(5)(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)