Regulation 3 Application

Changes not yet applied. Later legislation changes this provision in ways not yet written into the text below:

reg. 3(3)(a)(i)(aa) words added by Genetically Modified Organisms (Contained Use) 2005 reg. 2(3)(a)
reg. 3(3)(a)(i)(bb) inserted by Genetically Modified Organisms (Contained Use) 2005 reg. 2(3)(b)
reg. 3(3)(a)(i)(cc) reg. 3(3)(a)(i)(bb) renumbered as reg. 3(3)(a)(i)(cc) by Genetically Modified Organisms (Contained Use) 2005 reg. 2(3)(c)
reg. 3(3)(a)(i)(cc) words inserted by Genetically Modified Organisms (Contained Use) 2005 reg. 2(3)(c)
reg. 3(3)(a)(ii) words inserted by Medicines (Marketing Authorisations Etc.) 2005 Sch. para. 7
reg. 3(3)(a)(iii) substituted by Genetically Modified Organisms (Contained Use) 2005 reg. 2(3)(d)
reg. 3(3)(a)(iv) inserted by Genetically Modified Organisms (Contained Use) 2005 reg. 2(3)(e)
reg. 3(3)(b) words added by Genetically Modified Organisms (Contained Use) 2005 reg. 2(3)(f)(i)
reg. 3(3)(b) words added by Genetically Modified Organisms (Contained Use) 2005 reg. 2(3)(f)(ii)

(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 Secretary of State, or, as regards Scotland, by the Scottish Ministers, under section 111(1) of the Environmental Protection Act 1990^f1, or

(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^f2 on the deliberate release into the environment of genetically modified organisms,

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^f3, or

(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^f4; or

(b)

genetically modified organisms are released or marketed in cases or circumstances in which the consent of the Secretary of State, or, as regards Scotland, the Scottish Ministers, is required under section 111(1) of the Environmental Protection Act 1990.

(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)

These Regulations shall not extend to Northern Ireland.

(7)

In this regulation, “product” means a product consisting of or containing a genetically modified organism or a combination of genetically modified organisms.

Annotations

Footnotes

f1: 1990 c. 43.
f2: OJ No. L117, 8.5.90, p. 15, as amended by Commission Directive 94/15/EC (OJ No. L103, 22.4.94, p. 20) and Commission Directive 97/35/EC (OJ No. L 169, 27.6.97, p. 72).
f3: OJ No. L 124, 24.8.93, p. 1, as amended by Commission Regulation (EC) 649/98 (OJ No. L 88, 24.3.98, p. 7).
f4: OJ No. L 43, 14.2.97, p. 1 (to be read with Corrigenda published in OJ L 173, 1.7.97, p. 12 and OJ L 187, 20.7.99, p. 74.