Commission Implementing Decision (EU) 2016/321
of 3 March 2016
adjusting the geographical scope of the authorisation for cultivation of genetically modified maize (Zea mays L.) MON 810 (MON-ØØ81Ø-6)
(notified under document C(2016) 1231)
(Text with EEA relevance)

THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Directive 90/220/EEC, and in particular Article 26c, paragraph 3, thereof,
OJ L 106, 17.4.2001, p. 1.
Whereas:
(1) The cultivation of genetically modified maize MON 810 was initially authorised pursuant to Council Directive 90/220/EEC by Commission Decision 98/294/EC. On 3 August 1998, France granted consent to Monsanto Europe SA (hereinafter ‘Monsanto’) for the placing on the market of MON 810 maize products.
Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (OJ L 117, 8.5.1990, p. 15).
Commission Decision 98/294/EC of 22 April 1998 concerning the placing on the market of genetically modified maize (Zea mays L. line MON 810), pursuant to Council Directive 90/220/EEC (OJ L 131, 5.5.1998, p. 32).
(2) In July 2004, Monsanto notified MON 810 maize seeds for cultivation as ‘existing products’ pursuant to the transitional provisions set out in Article 20(1)(a) of Regulation (EC) No 1829/2003 of the European Parliament and of the Council. As a consequence, they could continue to be placed on the market pursuant to the regime of ‘existing products’ under Regulation (EC) No 1829/2003.
Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (OJ L 268, 18.10.2003, p. 1).
(3) In April 2007, Monsanto applied for the renewal under Article 23 of Regulation (EC) No 1829/2003 of the authorisation for cultivation of MON 810 maize. In accordance with Article 23(4) of that Regulation, the period of authorisation is automatically extended until a decision is taken on its renewal.
(4) Directive (EU) 2015/412 of the European Parliament and of the Council introduced the possibility, for a Member State, to demand that the geographical scope of an authorisation for cultivation already granted be adjusted to the effect that all or part of the territory of that Member State be excluded from cultivation. Such demands had to be presented from 2 April until 3 October 2015.
Directive (EU) 2015/412 of the European Parliament and of the Council of 11 March 2015 amending Directive 2001/18/EC as regards the possibility for the Member states to restrict or prohibit the cultivation of genetically modified organisms (GMOs) in their territory (OJ L 68, 13.3.2015, p. 1).
(5) Nineteen Member States demanded, pursuant to Article 26c of Directive 2001/18/EC, the prohibition of the cultivation of MON 810 in all or part of their territory. These demands were received by the Commission before 3 October 2015: on 3 July 2015 from Latvia; on 27 July 2015 from Greece; on 15 September 2015 from France; on 17 September 2015 from Croatia; on 18 September 2015 from Austria; on 21 September 2015 from Hungary; on 23 September 2015 from the Netherlands and Belgium; on 24 September 2015 from Poland; on 25 September 2015 from Lithuania and the United Kingdom; on 30 September 2015 from Bulgaria, Germany and Cyprus; on 1 October 2015 from Denmark and Italy; and on 2 October 2015 from Luxembourg, Malta and Slovenia.
(6) All of the demands received by the Commission cover the whole territory of the Member States concerned, except for Belgium, which communicated a demand covering only the territory of Wallonia, and for the United Kingdom, which communicated a demand covering only the territories of Northern Ireland, Scotland and Wales. The demand of Germany does not cover cultivation for research purposes.
(7) The Commission presented each of the demands of the Member States concerned to Monsanto. Monsanto did not object to any of these demands within the 30-day period allowed by Article 26c(3) of Directive 2001/18/EC and thereby did not confirm the geographical scope of the authorisation for cultivation of MON 810 maize. In accordance with Article 26c(3) of that Directive, the geographical scope of the authorisation granted to MON 810 maize seeds for cultivation should therefore be adjusted in accordance with the demands of Member States concerned, without applying the procedure referred to in Article 35(2) of Regulation (EC) No 1829/2003.
(8) This Decision is without prejudice to the decision to be taken on the renewal of the authorisation in accordance with Article 23 of Regulation (EC) No 1829/2003.
(9) All relevant information on the authorisation of MON 810 maize should be entered in the Community register of genetically modified food and feed, as provided for in Regulation (EC) No 1829/2003 and the Member States will be informed of this Decision,
HAS ADOPTED THIS DECISION:

Article 1 The cultivation of genetically modified maize (Zea mays L.) MON 810 shall be prohibited in Wales, Scotland and Northern Ireland.
Words in Art. 1 substituted (31.12.2020) by The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/90), regs. 1(2)(b), 12(2); 2020 c. 1, Sch. 5 para. 1(1)
Article 2 The information set out in this Decision must be entered—
(a) in Wales, in the register maintained under the Genetically Modified Organisms (Deliberate Release) (Wales) Regulations 2002;
(b) in Scotland, in the register maintained under the Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002;
(c) in Northern Ireland, in the register maintained under the Genetically Modified Organisms (Deliberate Release) Regulations (Northern Ireland) 2003.
Art. 2 substituted (31.12.2020) by The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/90), regs. 1(2)(b), 12(3); 2020 c. 1, Sch. 5 para. 1(1)
Article 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 3 omitted (31.12.2020) by virtue of The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/90), regs. 1(2)(b), 12(4); 2020 c. 1, Sch. 5 para. 1(1)
Done at Brussels, 3 March 2016.
For the Commission
Vytenis Andriukaitis
Member of the Commission

ANNEX TERRITORIES WHERE THE CULTIVATION OF MON 810 MAIZE IS PROHIBITED
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Annex omitted (31.12.2020) by virtue of The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/90), regs. 1(2)(b), 12(5); 2020 c. 1, Sch. 5 para. 1(1)