3.—(1) These Regulations (except regulation 18) do not apply to the genetic modification of organisms solely by any of the techniques referred to in Part 3 of Schedule 2 nor to any organisms so modified.
(2) These Regulations do not apply to any activity in which—
(a)genetically modified organisms are cultured, stored, transported, destroyed, disposed of or used, where such organisms are, or are contained in, a product marketed in accordance with—
(i)the consent of any of the following granted under section 111(1) of the Environmental Protection Act 1990 M1—
(aa)the Secretary of State;
(bb)the Scottish Ministers, as regards Scotland;
(cc)the Welsh Ministers, as regards Wales;
(ii)a consent granted by the Northern Ireland Department of the Environment under article 8(1) of the Genetically Modified Organisms (Northern Ireland) Order 1991 M2;
(iii)a written consent given by the competent authority of an EEA state in accordance with Article 15(3), 17(6), or 18(2) of Directive (EC) No 2001/18 of the European Parliament and the Council on the deliberate release into the environment of genetically modified organisms M3,
and, in each case, that activity is conducted in accordance with any conditions or limitations attached to that consent;
(b)genetically modified organisms are cultured, stored, transported, destroyed, disposed of or used, where such organisms are, or are contained in—
(i)a medicinal product for human or veterinary use marketed in accordance with Regulation (EC) No 726/2004 of the European Parliament and 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 M4;
(ii)food or feed authorised in accordance with the provisions of Regulation (EC) No 1829/2003 of the European Parliament and the Council on genetically modified food and feed M5; or
(iii)food products notified to the Commission in accordance with the provisions of Article 8.1, or feed products notified to the Commission in accordance with the provisions of Article 20.1, of Regulation (EC) No 1829/2003 of the European Parliament and the Council;
(c)genetically modified organisms are released or marketed in cases or circumstances in which—
(i)the consent of any of the following is required under section 111(1) of the Environmental Protection Act 1990—
(aa)the Secretary of State;
(bb)the Scottish Ministers, as regards Scotland;
(cc)the Welsh Ministers, as regards Wales; or
(ii)the consent of the Northern Ireland Department of the Environment is required under article 8(1) of the Genetically Modified Organisms (Northern Ireland) Order 1991.
(3) Regulations 7, 9 to 17, 18(2) and (4), 19, 20, and 23 to 25 do not apply to the transport of genetically modified organisms by road, rail, inland waterway, sea or air.
(4) Regulation 5 applies to the transport of genetically modified organisms by road, rail, inland waterway, sea or air, except that, in making the assessment required by regulation 5(1), the person undertaking that assessment is not required to include the steps set out in paragraph 3(i) to (k) of Part 2 of Schedule 3.
(5) These Regulations do not extend to Northern Ireland.
(6) In this regulation, “product” means a product consisting of, or containing, a genetically modified organism or a combination of genetically modified organisms.
Marginal Citations
M11990 c. 43. The functions of the Secretary of State under section 111(1) are exercisable in relation to Scotland by the Scottish Ministers, by virtue of section 53 of the Scotland Act 1998 (c. 46). The functions of the Secretary of State under section 111(1) are exercisable in relation to Wales by the Welsh Ministers. Those functions were originally conferred on the National Assembly for Wales under S.I. 1999/672, which was an Order in Council made under section 22 of the Government of Wales Act 1998 (c. 38). Functions which had been conferred on the Assembly under an Order in Council under section 22 were transferred to the Welsh Ministers by virtue of paragraph 30 of Schedule 11 to the Government of Wales Act 2006 (c. 32).
M3OJ No L 106, 17.04.2001, p1. Under Article 4.4 member States must designate a competent authority responsible for complying with the requirements of the Directive.
M4OJ No L 136, 30.4.2004, p1 as amended by Regulation (EC) No 1901/2006 (OJ No L 378, 27.12.2006, p1), Regulation (EC) No 1394/2007 (OJ No L 324, 10.12.2007, p121), Regulation (EC) No 219/2009 (OJ No L 87, 31.3.2009, p109), Regulation (EC) No 470/2009 (OJ No L 152, 16.6.2009, p11), Regulation (EU) No 1235/2010 (OJ No L 348, 31.12.2010, p1) (which was corrected by Corrigendum, OJ No L 201, 27.7.2012, p138) and Regulation (EU) No 1027/2012 (OJ No L 316, 14.11.2012, p38).
M5OJ No L 268 18.10.2003, p1 as amended by Regulation (EC) No 1981/2006 (OJ No L 368, 23.12.2006, p[99) and Regulation (EC) No 298/2008 (OJ No L 97 9.4.2008, p64).