Part I Interpretation and General

3 Application
1 These Regulations shall have effect with a view to—
(a) protecting persons against risks to their health, whether immediate or delayed, arising from activities involving genetic modification of organisms; and
(b) protecting the environment against harm from activities involving genetic modification of micro-organisms.
2 These Regulations (except regulation 17) shall not apply to the genetic modification of organisms solely by any of the techniques referred to in Part III of Schedule 2 nor to any organisms so modified.
3 These Regulations shall 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—
(i) a product marketed in pursuance of either—
(aa) a consent granted by the Department of the Environment under Article 8(1) of the Genetically Modified Organisms (Northern Ireland) Order 1991, or
S.I.1991/1714 (N.I. 19)
(bb) a written consent given by the competent authority of an EEA State in accordance with Article 13(4) of Council Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms,
O.J. No. L117, 8.5.90, p. 15, as amended by Commission Directive 94/15/EC (O.J. No. L103, 22.4.94, p. 20) and Commission Directive 97/35/EC (O.J. No. L169, 27.6.97, p. 72)
and, in either case, that activity is conducted in accordance with any conditions or limitations attached to that consent,
(ii) a medicinal product for human or veterinary use marketed in accordance with Council Regulation (EEC) No. 2309/93, or
O.J. No. L124, 24.8.93, p. 1, as amended by Commission Regulation (EC) 649/98 (OJNo. L88, 24.3.98, p. 7)
(iii) a novel food or novel food ingredient marketed in accordance with the provisions of Regulation (EC) No. 258/97 of the European Parliament and of the Council; or
O.J. No. L43, 14.2.97, p. 1 (to be read with Corrigenda published in O.J. No. L173, 1.7.97, p. 12 and O.J. No. L187, 20.7.99, p. 74)
(b) genetically modified organisms are released or marketed in cases or circumstances in which the consent of the Department of the Environment is required under Article 8(1) of the Genetically Modified Organisms (Northern Ireland) Order 1991.
4 Regulations 8 to 15, 17(2) and (3), 18 and 19 shall not apply to the transport of genetically modified organisms by road, rail, inland waterway, sea or air.
5 Regulation 6 shall apply to the transport of genetically modified organisms by road, rail, inland waterway, sea or air, except that, in making the assessment required by regulation 6(1), the person undertaking that assessment shall not be required to include the steps set out in paragraph 3(h) to (j) of Part II of Schedule 3.
6 In this regulation, “product” means a product consisting of or containing a genetically modified organism or a combination of genetically modified organisms.