REGULATION (EC) No 1946/2003 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCILDangos y teitl llawn

CHAPTER IV U.K. COMMON PROVISIONS

Article 15 U.K. Participation in the international information procedure

1. The [F1 GB focal point] shall, without prejudice to the protection of confidential information in accordance with the provisions of the Protocol, inform the BCH F2 ... of:

(a) national legislation and guidelines relevant to the implementation of the Protocol, in accordance with Article 11(5) and Article 20(3)(a) of the Protocol;

(b) national contact points for notification of unintentional transboundary movements, in accordance with Article 17 of the Protocol;

(c) any bilateral, regional and multilateral agreement and arrangements entered into by the [F3 United Kingdom] regarding intentional transboundary movements of GMOs, in accordance with Article 20(3)(b) of the Protocol;

(d) any information concerning cases of unintentional or illegal transboundary movements pertaining to them, in accordance with Articles 17 and 25 of the Protocol;

[F4 (e) any final decision taken by a relevant GMO authority on the use of GMOs, including decisions in accordance with Article 11 and Article 20(3)(d) of the Protocol, within 15 days of the adoption of that decision, where that decision is—

(i) on contained use classified in risk class 3 or 4 of GMOs which are likely to be subject to transboundary movements;

(ii) on the marketing or import of GMOs;

(iii) to grant a consent for the deliberate release of a GMO—

• — in England, pursuant to regulation 21 of the Genetically Modified Organisms (Deliberate Release) Regulations 2002;

• — in Wales, pursuant to regulation 22 of the Genetically Modified Organisms (Deliberate Release) (Wales) Regulations 2002;

• — in Scotland, pursuant to regulation 21 of the Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002;]

(f) any summary of risk assessments or environmental reviews of GMOs generated by [F5 Great Britain’s] regulatory process and carried out in accordance with Article 15 of the Protocol, including, where appropriate, relevant information regarding products thereof, namely, processed materials that are of GMO origin, containing detectable novel combinations of replicable genetic material obtained through the use of modern biotechnology, in accordance with Article 20(3)(c) of the Protocol;

(g) any review of national decisions regarding an intentional transboundary movement, in accordance with Article 12 of the Protocol;

[F6 (h) any decision to take emergency measures under Article 34 of Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed, or any decision to serve a prohibition notice—

(i) in relation to England, pursuant to regulation 32 of the Genetically Modified Organisms (Deliberate Release) Regulations 2002;

(ii) in relation to Wales, pursuant to regulation 33 of the Genetically Modified Organisms (Deliberate Release) (Wales) Regulations 2002;

(iii) in relation to Scotland, pursuant to regulation 32 of the Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002;

(i) any application of procedures, agreements or regulations instead of the procedures of the Protocol for intentional movements within or imports into Great Britain of GMOs, in accordance with Article 14(3) and (4) of the Protocol;

(j) reports submitted pursuant to Article 19 of this Regulation, including those on implementation of the advanced informed agreement procedure, in accordance with Article 20(3)(e) of the Protocol.]

F7 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F1 Words in Art. 15(1) substituted (31.12.2020) by The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/90), regs. 1(2)(b), 5(10)(a)(i)(aa) (as amended by S.I. 2020/1421, Sch. para. 3(8)(a)); 2020 c. 1, Sch. 5 para. 1(1)

F2 Words in Art. 15(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(10)(a)(i)(bb); 2020 c. 1, Sch. 5 para. 1(1)

F3 Words in Art. 15(1)(c) substituted (31.12.2020) by The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/90), regs. 1(2)(b), 5(10)(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F4 Art. 15(1)(e) substituted (31.12.2020) by The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/90), regs. 1(2)(b), 5(10)(a)(iii) (as amended by S.I. 2020/1421, Sch. para. 3(8)(b)); 2020 c. 1, Sch. 5 para. 1(1)

F5 Words in Art. 15(1)(f) substituted (31.12.2020) by The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/90), regs. 1(2)(b), 5(10)(a)(iv) (as amended by S.I. 2020/1421, Sch. para. 3(8)(c)); 2020 c. 1, Sch. 5 para. 1(1)

F6 Art. 15(1)(h)-(j) substituted (31.12.2020) by The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/90), regs. 1(2)(b), 5(10)(a)(v) (as amended by S.I. 2020/1421, Sch. para. 3(8)(d)); 2020 c. 1, Sch. 5 para. 1(1)

F7 Art. 15(2) 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(10)(b); 2020 c. 1, Sch. 5 para. 1(1)

Article 16 U.K. Confidentiality

1. The [F8 relevant GB competent authorities] shall not divulge to third parties any confidential information received or exchanged under this Regulation.

2. The exporter may indicate the information in the notification submitted under Article 4 which should be treated as confidential. Justification shall be given in such cases upon request.

3. In no case may the following information when submitted according to Articles 4, 9 or 12 be kept confidential:

(a) name and address of the exporter and importer,

(b) general description of the GMO or GMOs,

(c) a summary of the risk assessment of the effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and

(d) any methods and plans for emergency response.

4. If, for whatever reasons, the exporter withdraws the notification, the [F9 relevant GB competent authorities] must respect the confidentiality of commercial and industrial information, including research and development information, as well as information on which the Party or non-Party of import and the exporter disagree as to its confidentiality.

Textual Amendments

F8 Words in Art. 16(1) substituted (31.12.2020) by The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/90), regs. 1(2)(b), 5(11)(a) (as amended by S.I. 2020/1421, Sch. para. 3(9)(a)); 2020 c. 1, Sch. 5 para. 1(1)

F9 Words in Art. 16(4) substituted (31.12.2020) by The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/90), regs. 1(2)(b), 5(11)(b) (as amended by S.I. 2020/1421, Sch. para. 3(9)(b)); 2020 c. 1, Sch. 5 para. 1(1)

Article 17 U.K. Competent authorities and focal [F10 point]

F11 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F12 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F13 3. The GB focal point must forthwith inform the Secretariat of any change in the designation of the focal point, and of any changes in the names, addresses or responsibilities of the relevant GB competent authorities.]

Textual Amendments

F10 Word in Art. 17 heading substituted (31.12.2020) by The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/90), regs. 1(2)(b), 5(12)(a); 2020 c. 1, Sch. 5 para. 1(1)

F11 Art. 17(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(12)(b); 2020 c. 1, Sch. 5 para. 1(1)

F12 Art. 17(2) 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(12)(b); 2020 c. 1, Sch. 5 para. 1(1)

F13 Art. 17(3) substituted (31.12.2020) by The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/90), regs. 1(2)(b), 5(12)(c) (as amended by S.I. 2020/1421, Sch. para. 3(10)); 2020 c. 1, Sch. 5 para. 1(1)

F14 Article 18 U.K. Penalties

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Textual Amendments

F14 Art. 18 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(13); 2020 c. 1, Sch. 5 para. 1(1)

Article 19 U.K. Monitoring and reporting

F15 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2. The [F16 GB focal point] shall, at intervals to be determined by the Conference of the Parties to the Convention serving as the meeting of the Parties to the Protocol, compile a report on the [F17 implementation of the Protocol in Great Britain] and present it to the Conference of the Parties to the Convention serving as the meeting of the Parties to the Protocol.

Textual Amendments

F15 Art. 19(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(14)(a); 2020 c. 1, Sch. 5 para. 1(1)

F16 Words in Art. 19(2) substituted (31.12.2020) by The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/90), regs. 1(2)(b), 5(14)(b)(i) (as amended by S.I. 2020/1421, Sch. para. 3(11)(a)); 2020 c. 1, Sch. 5 para. 1(1)

F17 Words in Art. 19(2) substituted (31.12.2020) by The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/90), regs. 1(2)(b), 5(14)(b)(ii) (as amended by S.I. 2020/1421, Sch. para. 3(11)(b)); 2020 c. 1, Sch. 5 para. 1(1)

Article 20 U.K. Entry into force

1. This Regulation shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.

2. This Regulation shall apply from the date of entry into force of the Protocol, in accordance with Article 37(1) of the Protocol, or from the date of entry into force of this Regulation, whichever shall be the later.