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Commission Regulation (EC) No 65/2004Dangos y teitl llawn
Commission Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms
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Changes over time for: Commission Regulation (EC) No 65/2004 (without Annexes)
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CHAPTER IU.K.SCOPE
[F1Article 1U.K.
1.This Regulation applies to genetically modified organisms, hereinafter ‘GMOs’, authorised for placing on the market in accordance with Regulation 1829/2003 of the European Parliament and of the Council or—
(a)in England, the Genetically Modified Organisms (Deliberate Release) Regulations 2002,
(b)in Wales, the Genetically Modified Organisms (Deliberate Release) (Wales) Regulations 2002,
(c)in Scotland, the Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002,
and applications for placing on the market under such legislation.
2. This Regulation does not apply to medicinal products for human and veterinary use authorised under—
(a)Regulation (EC) No 726/2004 of the European Parliament and of the Council,
(b)the Human Medicines Regulations 2012, or
(c)the Veterinary Medicines Regulations 2013,
or applications for authorisation under such legislation.]
Textual Amendments
F1Art. 1 substituted (31.12.2020) by The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/90), regs. 1(2)(b), 6(2) (as amended by S.I. 2019/759, regs. 1(a), 12(3) and S.I. 2020/1421, reg. 1(4), Sch. paras. 4(2), 5(2)); 2020 c. 1, Sch. 5 para. 1(1)
CHAPTER IIU.K.APPLICATIONS FOR THE PLACING ON THE MARKET OF GMOs
Article 2U.K.
1.Applications for the placing on the market of GMOs shall include a unique identifier for each GMO concerned.
2.Applicants shall, in accordance with the formats set out in the Annex, develop the unique identifier for each GMO concerned, following consultation of the OECD BioTrack product database, and the Biosafety clearing house [F2established by the Cartagena Protocol on Biosafety to the Convention on Biological Diversity (the “Biosafety clearing house”)], to determine whether or not a unique identifier has already been developed for that GMO in accordance with these formats.
Textual Amendments
F2Words in Art. 2(2) inserted (31.12.2020) by The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/90), regs. 1(2)(b), 6(3); 2020 c. 1, Sch. 5 para. 1(1)
Article 3U.K.
Where consent or authorisation is granted for the placing on the market of a GMO:
(a)the consent or authorisation shall specify the unique identifier for that GMO;
(b)the [F3Secretary of State] shall ensure that the unique identifier for that GMO is communicated as soon as possible, in writing, to the Biosafety clearing house;
[F4(c)for GMOs authorised under Regulation (EC) No 1829/2003, the unique identifier must be recorded in the register maintained in accordance with Article 28 of that Regulation.]
Textual Amendments
F3Words in Art. 3(b) substituted (31.12.2020) by The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/90), regs. 1(2)(b), 6(4)(a); 2020 c. 1, Sch. 5 para. 1(1)
F4Art. 3(c) substituted (31.12.2020) by The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/90), regs. 1(2)(b), 6(4)(b); 2020 c. 1, Sch. 5 para. 1(1)
CHAPTER IIIU.K.GMOs FOR WHICH CONSENT FOR THEIR PLACING ON THE MARKET HAS BEEN GRANTED PRIOR TO THE ENTRY INTO FORCE OF THIS REGULATION
F5Article 4U.K.
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Textual Amendments
F5Arts. 4-6 omitted (31.12.2020) by virtue of The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/90), regs. 1(2)(b), 6(5); 2020 c. 1, Sch. 5 para. 1(1)
F5Article 5U.K.
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Textual Amendments
F5Arts. 4-6 omitted (31.12.2020) by virtue of The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/90), regs. 1(2)(b), 6(5); 2020 c. 1, Sch. 5 para. 1(1)
F5Article 6U.K.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F5Arts. 4-6 omitted (31.12.2020) by virtue of The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/90), regs. 1(2)(b), 6(5); 2020 c. 1, Sch. 5 para. 1(1)
CHAPTER IVU.K.FINAL PROVISION
Article 7U.K.
This Regulation shall enter into force on the date of its publication in the Official Journal of the European Union.
F6...
Done at Brussels, 14 January 2004.
For the Commission
Margot Wallström
Member of the Commission
Textual Amendments
F6Words in Signature omitted (31.12.2020) by virtue of The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/90), reg. 6(6); 2020 c. 1, Sch. 5 para. 1(1)
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