REGULATION (EC) No 1946/2003 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCILShow full title

CHAPTER I U.K. OBJECTIVES, SCOPE AND DEFINITIONS

Article 1 U.K. Objectives

In accordance with the precautionary principle, F1 ... the objectives of this Regulation are to establish a F2 ... system of notification and information for transboundary movements of genetically modified organisms (GMOs) and to ensure coherent implementation of the provisions of the Protocol F3 ... in order to contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of GMOs that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health.

Textual Amendments

F1 Words in Art. 1 omitted (31.12.2020) by virtue of The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/90), regs. 1(2)(b), 5(2)(a); 2020 c. 1, Sch. 5 para. 1(1)

F2 Word in Art. 1 omitted (31.12.2020) by virtue of The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/90), regs. 1(2)(b), 5(2)(b); 2020 c. 1, Sch. 5 para. 1(1)

F3 Words in Art. 1 omitted (31.12.2020) by virtue of The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/90), regs. 1(2)(b), 5(2)(c); 2020 c. 1, Sch. 5 para. 1(1)

Article 2 U.K. Scope

1. This Regulation shall apply to the transboundary movements of all GMOs that may have adverse effects on the conservation and sustainable use of biological diversity, also taking into account risks to human health.

2. Pharmaceuticals for humans that are addressed by other relevant international agreements or organisations are excluded from the scope of this Regulation.

[F4 3. In relation to England, precision bred plants are excluded from the scope of this Regulation.]

Textual Amendments

F4 Art. 2(3) inserted (13.11.2025) by The Genetic Technology (Precision Breeding) Regulations 2025 (S.I. 2025/581), reg. 1(1), Sch. 5 para. 3(2)

Article 3 U.K. Definitions

For the purpose of this Regulation, the following definitions shall apply:

(1)

‘organism’ means organism as defined in Article 2(1) of Directive 2001/18/EC;

(2)

‘genetically modified organism’, or ‘GMO’, means genetically modified organism as defined in Article 2(2) of Directive 2001/18/EC, excluding organisms obtained through the techniques of genetic modification listed in Annex IB to Directive 2001/18/EC;

(3)

‘deliberate release’ means deliberate release as defined in Article 2(3) of Directive 2001/18/EC;

(4)

‘placing on the market’ means placing on the market as defined in Article 2(4) of Directive 2001/18/EC;

(5)

‘contained use’ means:

(a)

activities defined in Article 2(c) of Directive 90/219/EEC (1);

(b)

activities in which organisms other than micro-organisms are genetically modified or in which such GMOs are cultured, stored, transported, destroyed, disposed of or used in any other way, and for which specific containment measures, based on the same principles of containment as in Directive 90/219/EEC, are used appropriately to limit their contact with the general population and the environment;

(6)

‘food’ means food as defined in Article 2 of Regulation (EC) No 178/2002 (2);

(7)

‘feed’ means feed as defined in Article 3(4) of Regulation (EC) No 178/2002;

(8)

‘notification’ means the submission of the information required from the exporter under this Regulation to the competent authority of a Party to the Protocol or to the competent authority of a non-Party;

(9)

‘the Biosafety Clearing-House’ or ‘the BCH’ means the Biosafety Clearing-House established under Article 20 of the Protocol;

(10)

‘export’ means:

(a)

[F5 the permanent or temporary leaving of Great Britain of GMOs which originated—

(i)

in Great Britain, or

(ii)

in a third country but have entered, and are in free circulation in, Great Britain;]

(b)

the re-export of GMOs not meeting the conditions referred to in (a) which are placed under a customs procedure other than transit procedure;

(11)

‘import’ means the placing under a customs procedure, other than transit procedure, of GMOs introduced into the customs territory of a Party or non-Party [F6 outside Great Britain by an exporter];

(12)

‘exporter’ means any natural or legal person by whom or on whose behalf a notification is made, that is to say the person who, at the time when the notification is sent, holds the contract with the consignee in the third country and has the power to determine that the GMO is to be sent out of [F7 Great Britain]. If no export contract has been concluded or if the holder of the contract does not act on its own behalf, the power to determine that the GMO is to be sent out of [F7 Great Britain] shall be decisive;

(13)

‘importer’ means any natural or legal person, under the jurisdiction of the Party or non-Party of Import, who arranges for a GMO to be imported;

(14)

‘transboundary movement’ means the intentional or unintentional movement of a GMO between one Party or non-Party and another Party or non-Party F8 ... ;

(15)

[F9 “Party” means—

(a)

Great Britain,

(b)

Northern Ireland, or

(c)

any other country or regional economic integration organisation being a Party to the Protocol;]

(16)

‘non-Party’ means any country or regional economic integration organisation not being a Party to the Protocol;

(17)

‘the Protocol’ means the Cartagena Protocol on Biosafety to the Convention on Biological Diversity (the Convention);

(18)

‘biological diversity’ means the variability among living organisms from all sources including, inter alia, terrestrial, marine and other aquatic ecosystems and the ecological complexes of which they are part; this includes diversity within species, between species and of ecosystems;

(19)

‘competent authority’ [F10 , other than in the expression “relevant GB competent authority”,] means a competent authority designated by a Party to the Protocol, or the relevant equivalent body of a non-Party, which is responsible for performing the administrative functions required by the Protocol, or equivalent functions in the case of a non-Party, and is authorised to act on its behalf with respect to those functions;

(19A)

[F11 “relevant GB competent authority”—

(a)

in relation to performing the administrative functions required by the Protocol in England, means the Secretary of State;

(b)

in relation to performing the administrative functions required by the Protocol in Wales, means the Welsh Ministers;

(c)

in relation to performing the administrative functions required by the Protocol in Scotland, means the Scottish Ministers.]

(20)

‘focal point’ means the entity designated by a Party [F12 (other than Great Britain)] to be responsible on its behalf for liaising with the Secretariat;

(20A)

[F13 “GB focal point” means the Secretary of State, who has been designated as Great Britain’s entity to be responsible on its behalf for liaising with the Secretariat;]

(21)

‘Secretariat’ means the Secretariat to the Protocol.

(22)

[F14 “constituent nation” means England, Wales or Scotland, as the case may be;

(23)

“relevant GMO authority” means a relevant GB competent authority, together with the Food Standards Agency, the Health and Safety Executive, the Medicines and Healthcare products Regulatory Agency or other agencies as the case may be and as appropriate in the circumstances.

(24)

“third country” means a country other than Great Britain.]

(25)

[F15 ‘precision bred plant’ has the same meaning as in section 1, as read with section 2(1), of the Genetic Technology (Precision Breeding) Act 2023.]

Textual Amendments

F5 Art. 3(10)(a) substituted (31.12.2020) by The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/90), regs. 1(2)(b), 5(3)(a) (as substituted by S.I. 2019/759, regs. 1(a), 12(2) (as amended by S.I. 2020/1421, Sch. para. 3(2)(a))); 2020 c. 1, Sch. 5 para. 1(1)

F6 Words in Art. 3(11) substituted (31.12.2020) by The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/90), regs. 1(2)(b), 5(3)(b) (as amended by S.I. 2020/1421, Sch. para. 3(2)(b)); 2020 c. 1, Sch. 5 para. 1(1)

F7 Words in Art. 3(12) substituted (31.12.2020) by The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/90), regs. 1(2)(b), 5(3)(c) (as amended by S.I. 2020/1421, Sch. para. 3(2)(c)); 2020 c. 1, Sch. 5 para. 1(1)

F8 Words in Art. 3(14) omitted (31.12.2020) by virtue of The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/90), regs. 1(2)(b), 5(3)(d); 2020 c. 1, Sch. 5 para. 1(1)

F9 Art. 3(15) substituted (31.12.2020) by The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/90), regs. 1(2)(b), 5(3)(da) (as inserted by S.I. 2020/1421, reg. 1(4), Sch. para. 3(2)(d)); 2020 c. 1, Sch. 5 para. 1(1)

F10 Art. 3(19) substituted (31.12.2020) by The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/90), regs. 1(2)(b), 5(3)(e) (as amended by S.I. 2020/1421, Sch. para. 3(2)(e)) ; 2020 c. 1, Sch. 5 para. 1(1)

F11 Art. 3(19A) inserted by The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/90), regs. 1(2)(b), 5(3)(ea) (as inserted by S.I. 2020/1421, reg. 1(4), Sch. para. 3(2)(f)); 2020 c. 1, Sch. 5 para. 1(1)

F12 Art. 3(20) substituted (31.12.2020) by The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/90), regs. 1(2)(b), 5(3)(f) (as amended by S.I. 2020/1421, Sch. para. 3(2)(g)); 2020 c. 1, Sch. 5 para. 1(1)

F13 Art. 3(20A) inserted by The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/90), regs. 1(2)(b), 5(3)(fa) (as substituted by S.I. 2020/1421, reg. 1(4), Sch. para. 3(2)(g)); 2020 c. 1, Sch. 5 para. 1(1)

F14 Art. 3(22)-(24) inserted (31.12.2020) by The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/90), regs. 1(2)(b), 5(3)(g) (as amended by S.I. 2020/1421, Sch. para. 3(2)(h)); 2020 c. 1, Sch. 5 para. 1(1)

F15 Art. 3(25) inserted (13.11.2025) by The Genetic Technology (Precision Breeding) Regulations 2025 (S.I. 2025/581), reg. 1(1), Sch. 5 para. 3(3)

(1)

Council Directive 90/219/EEC of 23 April 1990 on the contained use of genetically modified micro-organisms (OJ L 117, 8.5.1990, p. 1). Directive as last amended by Decision 2001/204/EC (OJ L 73, 15.3.2001, p. 32).

(2)

Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).