16. 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 [F1and in accordance with the limitations and conditions to which the use of that product is subject];
[F2(b)genetically modified organisms are made available for activities regulated under the Genetically Modified Organisms (Contained Use) Regulations 2014;]
F3(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(d)genetically modified organisms are made available to be used exclusively for deliberate releases complying with the requirements laid down in Part II [F4; or]
[F5(e)a genetically modified organism, which is contained in a medicinal product authorised under the Human Medicines Regulations 2012 or the Veterinary Medicines Regulations 2013, is marketed.]
F6(f). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F7(g). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F1Words in reg. 16(a) inserted (15.7.2005) by The Genetically Modified Organisms (Deliberate Release) (Wales) (Amendment) Regulations 2005 (S.I. 2005/1913), regs. 1, 2(3)(a)
F2Reg. 16(b) substituted (31.12.2020) by The Genetically Modified Organisms (Deliberate Release and Transboundary Movement) (Miscellaneous Amendments) (Wales) (EU Exit) (No. 2) Regulations 2019 (S.I. 2019/1492), regs. 1(3), 2(5)(a); 2020 c. 1, Sch. 5 para. 1(1)
F3Reg. 16(c) omitted (31.12.2020) by virtue of The Genetically Modified Organisms (Deliberate Release and Transboundary Movement) (Miscellaneous Amendments) (Wales) (EU Exit) (No. 2) Regulations 2019 (S.I. 2019/1492), regs. 1(3), 2(5)(b); 2020 c. 1, Sch. 5 para. 1(1)
F4Word in reg. 16(d) substituted (31.12.2020) by The Genetically Modified Organisms (Deliberate Release and Transboundary Movement) (Miscellaneous Amendments) (Wales) (EU Exit) (No. 2) Regulations 2019 (S.I. 2019/1492), regs. 1(3), 2(5)(c); 2020 c. 1, Sch. 5 para. 1(1)
F5Reg. 16(e) substituted (31.12.2020) by The Genetically Modified Organisms (Deliberate Release and Transboundary Movement) (Miscellaneous Amendments) (Wales) (EU Exit) (No. 2) Regulations 2019 (S.I. 2019/1492), regs. 1(3), 2(5)(d); 2020 c. 1, Sch. 5 para. 1(1)