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

Exempt activities S

15.— [F1 (1)] The cases and circumstances prescribed for the purposes of sections 108(7) and 111(7) of the Act in which persons are exempt from the requirements of section 108(1)(a) of the Act (to carry out a risk assessment) and of section 111(1)(a) of the Act (to obtain consent), respectively, insofar as they relate to marketing genetically modified organisms, are all cases and circumstances in which–

(a) an approved product is marketed for a use for which it has approval [F2 and in accordance with the limitations and conditions to which the use of that product is subject];

(b) genetically modified micro-organisms are made available for activities regulated under the Contained Use Directive (including culture collections);

(c) genetically modified organisms other than micro-organisms referred to in paragraph (b) are made available to be used exclusively for activities where appropriate stringent containment measures based on the same principles of containment as laid down in the Contained Use Directive are used to limit their contact with and to provide a high level of safety for the general population and the environment;

(d) genetically modified organisms are made available to be used exclusively for deliberate releases complying with the requirements laid down in Part II;

(e) a genetically modified organism authorised under Regulation 2309/93 [F3 or [F4 Regulation (EC) No 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency]] is marketed; [F5 and]

F6 (f) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F7 (g) genetically modified food or feed authorised under the Food and Feed Regulation is marketed.]

[F8 (2) In paragraph (1)(e), “Regulation 2309/93” means Council Regulation (EEC) No 2309/93 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products, as it had effect before it was repealed by Regulation (EC) No 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency].

Textual Amendments

F1 Reg. 15 renumbered as reg. 15(1) (15.3.2019) by The Genetically Modified Organisms (Deliberate Release etc.) (Miscellaneous Amendments) (Scotland) Regulations 2019 (S.S.I. 2019/86), regs. 1(1), 7(a)

F2 Words in reg. 15(a) added (15.11.2004) by The Genetically Modified Organisms (Deliberate Release) (Scotland) Amendment Regulations 2004 (S.S.I. 2004/439), regs. 1, 4(a)

F3 Words in reg. 15 inserted (20.11.2005) by The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005 (S.I. 2005/2759), reg. 1(b), Sch. para. 9

F4 Words in reg. 15(1)(e) substituted (15.3.2019) by The Genetically Modified Organisms (Deliberate Release etc.) (Miscellaneous Amendments) (Scotland) Regulations 2019 (S.S.I. 2019/86), regs. 1(1), 7(b)

F5 Word in reg. 15(1)(e) inserted (15.3.2019) by The Genetically Modified Organisms (Deliberate Release etc.) (Miscellaneous Amendments) (Scotland) Regulations 2019 (S.S.I. 2019/86), regs. 1(1), 7(c)

F6 Reg. 15(1)(f) and word omitted (15.3.2019) by virtue of The Genetically Modified Organisms (Deliberate Release etc.) (Miscellaneous Amendments) (Scotland) Regulations 2019 (S.S.I. 2019/86), regs. 1(1), 7(d)

F7 Reg. 15(g) added (15.11.2004) by The Genetically Modified Organisms (Deliberate Release) (Scotland) Amendment Regulations 2004 (S.S.I. 2004/439), regs. 1, 4(c)

F8 Reg. 15(2) inserted (15.3.2019) by The Genetically Modified Organisms (Deliberate Release etc.) (Miscellaneous Amendments) (Scotland) Regulations 2019 (S.S.I. 2019/86), regs. 1(1), 7(e)