12.—[F1(1)] The Secretary of State may only grant an authorisation in respect of seed of a genetically modified variety under paragraphs 8 to 11 if the marketing and release of the genetically modified material by the applicant have F2...—
(a)[F3before the day on which IP completion day falls, been authorised under] Directive 2001/18/EC of the European Parliament and of the Council (on the deliberate release into the environment of genetically modified organisms(1)), F4...
(b)[F5been authorised under] Regulation (EC) No 1829/2003 (on genetically modified food and feed) [F5, or]
[F6(c)been authorised under the GMO Regulations.
(2) For the purpose of paragraph (1), “the GMO Regulations” means—
(a)in relation to England, the Genetically Modified Organisms (Deliberate Release) Regulations 2002;
(b)in relation to Wales, the Genetically Modified Organisms (Deliberate Release) (Wales) Regulations 2002;
(c)in relation to Scotland, the Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002;
(d)in relation to Northern Ireland, the Genetically Modified Organisms (Deliberate Release) Regulations (Northern Ireland) 2003.]
Textual Amendments
F1 Sch. 4 para. 12 renumbered as Sch. 4 para. 12(1) (31.12.2020) by virtue of The Marketing of Seeds and Plant Propagating Material (Amendment) (England and Wales) (EU Exit) Regulations 2019 (S.I. 2019/131), regs. 1(b), 7(15)(h)(i); 2020 c. 1, Sch. 5 para. 1(1)
F2Words in Sch. 4 para. 12(1) omitted (31.12.2020) by virtue of The Marketing of Seeds and Plant Propagating Material (Amendment) (England and Wales) (EU Exit) Regulations 2019 (S.I. 2019/131), regs. 1(b), 7(15)(h)(ii)(aa); 2020 c. 1, Sch. 5 para. 1(1)
F3Words in Sch. 4 para. 12(1)(a) inserted (31.12.2020) by The Marketing of Seeds and Plant Propagating Material (Amendment) (England and Wales) (EU Exit) Regulations 2019 (S.I. 2019/131), regs. 1(b), 7(15)(h)(ii)(bb) (as amended by S.I. 2020/1388, regs. 1(2)(a), 29(5)(k)(vi)); 2020 c. 1, Sch. 5 para. 1(1)
F4Word in Sch. 4 para. 12(1)(a) omitted (31.12.2020) by virtue of The Marketing of Seeds and Plant Propagating Material (Amendment) (England and Wales) (EU Exit) Regulations 2019 (S.I. 2019/131), regs. 1(b), 7(15)(h)(ii)(bb); 2020 c. 1, Sch. 5 para. 1(1)
F5Words in Sch. 4 para. 12(1)(b) inserted (31.12.2020) by The Marketing of Seeds and Plant Propagating Material (Amendment) (England and Wales) (EU Exit) Regulations 2019 (S.I. 2019/131), regs. 1(b), 7(15)(h)(ii)(cc); 2020 c. 1, Sch. 5 para. 1(1)
F6Sch. 4 para. 12(1)(c), (2) inserted (31.12.2020) by The Marketing of Seeds and Plant Propagating Material (Amendment) (England and Wales) (EU Exit) Regulations 2019 (S.I. 2019/131), regs. 1(b), 7(15)(h)(ii)(dd); 2020 c. 1, Sch. 5 para. 1(1)
OJ No L 106, 17.4.2001, p. 1, as last amended by Directive 2008/27/EC (OJ No L 81, 20.3.2008, p. 45).