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

Section 1 U.K. GMOs intended for deliberate release into the environment

Article 4 U.K. Notification to Parties and non-Parties of import

The exporter shall ensure notification, in writing, to the competent authority of the Party or non-Party of import prior to the first intentional transboundary movement of a GMO intended for deliberate release into the environment and destined for the use specified in accordance with Annex I, point (i). The notification shall contain, as a minimum, the information specified in Annex I. The exporter shall ensure the accuracy of the information contained in the notification.

Article 5 U.K. Cases of non-decision

1. A failure by the Party of import to acknowledge receipt of a notification or to communicate its decision shall not imply its consent to an intentional transboundary movement. No first intentional transboundary movement may be made without prior written express consent of the Party or, where appropriate, non-Party of import.

2. In cases where the Party of import does not communicate its decisions in response to a notification within 270 days from the date of receiving the notification, the exporter shall send a written reminder, with a deadline for response of 60 days from receipt of this reminder, to the competent authority of that Party of import, with a copy to the Secretariat [F1 and to the relevant GB competent authority for each constituent nation in which the exporter is based]. In calculating the time within which a Party of import is to respond, the number of days it has to wait for additional relevant information shall not be taken into account.

3. Without prejudice to paragraph 1, the exporter shall not proceed with the first intentional transboundary movement of a GMO intended for deliberate release unless the procedures determined by the Party of import in accordance with Articles 9 and 10 of the Protocol or, where appropriate, equivalent procedures required by a non-Party of import have been followed.

4. Paragraphs 1, 2 and 3 shall not apply to cases of transboundary movements covered by simplified procedures or bilateral, regional and multilateral agreements or arrangements entered into in accordance with Article 13 and 14 of the Protocol.

5. The [F2 GB focal point] shall, in consultation with the Secretariat, take appropriate action in accordance with any appropriate procedures and mechanisms to facilitate decision-making or to promote compliance with the provisions of the Protocol by the Parties of import as decided by the Conference of the Parties to the Convention serving as the meeting of the Parties to the Protocol.

Textual Amendments

F1 Words in Art. 5(2) substituted (31.12.2020) by The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/90), regs. 1(2)(b), 5(4)(a) (as amended by S.I. 2020/1421, Sch. para. 3(3)(a)); 2020 c. 1, Sch. 5 para. 1(1)

F2 Words in Art. 5(5) substituted (31.12.2020) by The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/90), regs. 1(2)(b), 5(4)(b) (as amended by S.I. 2020/1421, Sch. para. 3(3)(b)); 2020 c. 1, Sch. 5 para. 1(1)

Article 6 U.K. Informing the [F3 relevant GB competent authority]

The exporter shall for a period of a minimum of five years keep a record of the notification referred to in Article 4 and the acknowledgement of receipt and the decision of the Party or, where appropriate, non-Party of import and send a copy of these documents to the competent authority [F4 for each constituent nation in which the exporter is based].

Without prejudice to Article 16, the [F5 relevant GB competent authority for each constituent nation in which the exporter is based] shall make these documents available to the public in accordance with [F6 [F7 assimilated] law] on access to environmental information.

Textual Amendments

F3 Words in Art. 6 heading substituted (31.12.2020) by The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/90), regs. 1(2)(b), 5(5)(a) (as amended by S.I. 2020/1421, Sch. para. 3(4)(a)); 2020 c. 1, Sch. 5 para. 1(1)

F4 Words in Art. 6 substituted (31.12.2020) by The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/90), regs. 1(2)(b), 5(5)(b) (as amended by S.I. 2020/1421, Sch. para. 3(4)(b)); 2020 c. 1, Sch. 5 para. 1(1)

F5 Words in Art. 6 substituted (31.12.2020) by The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/90), regs. 1(2)(b), 5(5)(c)(i) (as amended by S.I. 2020/1421, Sch. para. 3(4)(c)); 2020 c. 1, Sch. 5 para. 1(1)

F6 Words in Art. 6 substituted (31.12.2020) by The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/90), regs. 1(2)(b), 5(5)(c)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F7 Word in Art. 6 substituted (27.2.2025) by The Retained EU Law (Revocation and Reform) Act 2023 (Consequential Amendments) Regulations 2025 (S.I. 2025/82), reg. 1(2), Sch. 15 para. 65(2)(a)

Article 7 U.K. Review of decisions

1. If the exporter considers that a change in circumstances has occurred that may influence the outcome of the risk assessment upon which the decision was based or that additional relevant scientific or technical information has become available, he may ask the Party or, where appropriate, non-Party of import to review a decision it has made concerning notification pursuant to Article 10 of the Protocol.

2. Where a Party or non-Party of import does not respond to such a request within 90 days, the exporter shall send a written reminder to the competent authority of that Party or, where appropriate, non-Party of import, with a copy to the Secretariat, requesting a response within a set period following receipt of the reminder.

Article 8 U.K. Exceptions to Section 1 of this Chapter

1. GMOs intended for deliberate release into the environment identified in a decision of the Conference of the Parties to the Convention serving as the Meeting of the Parties to the Protocol as being not likely to have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, shall be excluded from the scope of section 1 of this Chapter.

2. Section 1 of this Chapter shall not apply to GMOs intended for direct use as food or feed, or for processing.

3. The obligations referred to in section 1 of this Chapter shall not apply if the Party of import has specified in advance to the BCH, in accordance with Article 13(1)(b) and Article 14(3) of the Protocol, that such imports of GMOs are to be exempted from the Advance Informed Agreement Procedure, as set out in Articles 7 to 10, 12 and 14 of the Protocol, provided that adequate measures are applied to ensure their safe intentional transboundary movement in accordance with the objective of the Protocol.