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)
Grade B
mapped from publisher markup. A grade says how a document's structure was obtained, not how reliable the law is.
Address https://gelex.eu/eli/EU/decision/2016/321@2016-03-03/en
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,
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.
(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.
(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.
(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 the territories listed in the Annex to this Decision.
Article 2
The information set out in this Decision shall be entered in the Community Register of genetically modified food and feed referred to in Article 28 of Regulation (EC) No 1829/2003.
Article 3
This Decision is addressed to Monsanto Europe SA, Avenue de Tervuren, 270-272, 1150 Brussels, Belgium.
Done at Brussels, 3 March 2016. For the Commission Vytenis Andriukaitis Member of the Commission
ANNEX
ANNEX TERRITORIES WHERE THE CULTIVATION OF MON 810 MAIZE IS PROHIBITED
(1) Wallonia (Belgium);
(2) Bulgaria;
(3) Denmark;
(4) Germany (except for research purposes);
(5) Greece;
(6) France;
(7) Croatia;
(8) Italy;
(9) Cyprus;
(10) Latvia;
(11) Lithuania;
(12) Luxembourg;
(13) Hungary;
(14) Malta;
(15) Netherlands;
(16) Austria;
(17) Poland;
(18) Slovenia;
(19) Northern Ireland (United Kingdom);
(20) Scotland (United Kingdom);
(21) Wales (United Kingdom).
Versions
Cited by
- Judgment of the Court (First Chamber) 5 February 2026 Judgment · Grade B
These requests for a preliminary ruling concern the validity of Articles 26b and 26c of 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 Council Directive 90/220/EEC (OJ 2001 L 106, p. 1), as amended by Directive (EU) 2015/412 of the European Parliament and of the Council of 11 March 2015 (OJ 2015 L 68, p. 1) (Directive 2001/18), and the validity and interpretation of Commission Implementing Decision (EU) 2016/321 of 3 March 2016 adjusting the geographical scope of
- Judgment of the Court (First Chamber) 5 February 2026 Judgment · Grade B
By Implementing Decision 2016/321, which is based on Directive 2001/18 and, in particular, Article 26c(3) thereof, the Commission took note, in accordance with that article, of the demands by which 19 Member States, including the Italian Republic, demanded, pursuant to that provision, that the cultivation of MON 810 GMO maize be prohibited in all or part of their territory. The authorisation holder, to whom those demands had been presented, did not request confirmation of the initial geographical scope of its authorisation and thus consented to the adjustment of the geographical scope.
- Judgment of the Court (First Chamber) 5 February 2026 Judgment · Grade B
Implementing Decision 2016/321
- Judgment of the Court (First Chamber) 5 February 2026 Judgment · Grade B
By order of 14 October 2021, the Ministero delle Politiche Agricole, Alimentari e Forestali (Ministry of Agriculture, Food and Forestry Policies, Italy) pointed out to Mr Fidenato that, under Implementing Decision 2016/321, the cultivation of MON 810 GMO maize was prohibited on the territory of the Member States having made a demand to that effect, which includes the Italian Republic, and ordered him, on the basis of Article 35 bis of Legislative Decree No 224/2003, to destroy within five days, by way of milling and burrowing, the crops of that maize variety that he had illegally planted, and
- Judgment of the Court (First Chamber) 5 February 2026 Judgment · Grade B
The referring court is uncertain whether the possibility available to Member States on the basis of Articles 26b and 26c of Directive 2001/18 to seek the prohibition of the cultivation of GMOs within their territory, without those Member States having to provide any justification to that effect or proof of an actual threat that the GMO product in question, having obtained an authorisation to place on the market, could represent for health or the environment, is in conformity with primary EU law, in particular the fundamental freedoms of the internal market, as interpreted by the Court in its j
- Judgment of the Court (First Chamber) 5 February 2026 Judgment · Grade B
In connection with the action before it, the Tribunale di Udine (District Court, Udine), which is the referring court, is uncertain as to the validity of Articles 26b and 26c of Directive 2001/18 in the light of, inter alia, the rules of primary EU law on the free movement of goods, freedom to conduct a business and non-discrimination, as well as the WTO Agreements. That court notes, in particular, that Article 22 of Directive 2001/18 stipulates that Member States may not prohibit, restrict or impede the placing on the market of GMOs, as or in products, which comply with the requirements of th
- Judgment of the Court (First Chamber) 5 February 2026 Judgment · Grade B
Should Articles 26b and 26c of Directive 2001/18 be invalid, the referring court has doubts as to how the prohibition introduced by Implementing Decision 2016/321, which to that court seems rather unclear and which, according to that court, does not mention the grounds on which the adjustment of the geographical scope of the authorisation concerning MON 810 GMO maize is based, is to be interpreted. Moreover, the referring court is uncertain as to the validity of that decision and wonders whether the decisions taken pursuant to Article 26c of Directive 2001/18 must be based on the same grounds
- Judgment of the Court (First Chamber) 5 February 2026 Judgment · Grade B
Are the provisions of Directive [2015/412], which insert Articles 26b and 26c into [Directive 2001/18], to include the possibility for Member States to … demand that the geographical scope of the written consent or authorisation be adjusted to the effect that all or part of the territory of that Member State is to be excluded from cultivation …, and the ensuing [Implementing Decision 2016/321] consistent with the principle of non-discrimination between national and non-national products, with the principle of proportionality and with Articles 34, 36 and [Article] 216(2) TFEU?
- Judgment of the Court (First Chamber) 5 February 2026 Judgment · Grade B
Are the provisions of Directive [2015/412], which insert Articles 26b and 26c into Directive [2001/18], to include the possibility for Member States to … demand that the geographical scope of the written consent or authorisation be adjusted to the effect that all or part of the territory of that Member State is to be excluded from cultivation …, and the ensuing [Implementing Decision 2016/321] consistent with Articles 16 and 52 of the [Charter]?
- Judgment of the Court (First Chamber) 5 February 2026 Judgment · Grade B
Are the provisions of Directive [2015/412], which insert Articles 26b and 26c into Directive [2001/18], to include the possibility for Member States to … demand that the geographical scope of the written consent or authorisation be adjusted to the effect that all or part of the territory of that Member State is to be excluded from cultivation …, and the ensuing [Implementing Decision 2016/321], consistent with Article 18 TFEU and Article 21 of the [Charter], given that the principle of non-discrimination is a pillar of the European Union? If so: …
- Judgment of the Court (First Chamber) 5 February 2026 Judgment · Grade B
Must [Implementing Decision 2016/321] be interpreted as meaning that applications for restrictions of the right to cultivate MON810 GMO maize seeds are permitted by, and are in accordance with, the TEU and the TFEU only on the grounds set out in Article 26b(3)(a) to (g) of Directive [2001/18], or have they been permitted under the transitional rules laid down in Article 26c of Directive [2001/18], as well as on other grounds, including economic grounds, which may differ from State to State? …
- Judgment of the Court (First Chamber) 5 February 2026 Judgment · Grade B
Is [Implementing Decision 2016/321] therefore valid, in the light of the whole body of rules governing GMOs in the single European market, and does it not preclude national rules sanctioning the prohibition contained therein?
- Judgment of the Court (First Chamber) 5 February 2026 Judgment · Grade B
By the first to third questions and the first part of the fifth question in Case C‑393/24, the referring court expresses its doubts as to the validity of Implementing Decision 2016/321 in so far as it was adopted on the basis of provisions of secondary law which themselves are invalid.
- Judgment of the Court (First Chamber) 5 February 2026 Judgment · Grade B
In view of the answer given to those questions in paragraph 89 of the present judgment with respect to the validity of Article 26c(1) and (3) of Directive 2001/18, on the basis of which Implementing Decision 2016/321 was adopted, the consideration of those questions has disclosed no factor of such a kind as to affect the validity of that decision.
- Judgment of the Court (First Chamber) 5 February 2026 Judgment · Grade B
The first to third questions and the first part of the fifth question in Case C‑393/24, in so far as they concern the validity of Implementing Decision 2016/321
- Judgment of the Court (First Chamber) 5 February 2026 Judgment · Grade B
By the fourth question in Case C‑393/24, the referring court asks whether Implementing Decision 2016/321 must be interpreted as meaning that the prohibition on the cultivation of MON 810 GMO maize seeds laid down in that decision may only be based on one of the grounds referred to in points (a) to (g) of the first subparagraph of Article 26b(3) of Directive 2001/18 or whether, within the framework of the transitional provisions of Article 26c of that directive, that prohibition may be based on other grounds.
- Judgment of the Court (First Chamber) 5 February 2026 Judgment · Grade B
Last, by the second part of the fifth question, the referring court in Case C‑393/24 asks the Court whether Implementing Decision 2016/321 must be interpreted as precluding national legislation which imposes a penalty for non-compliance with the prohibition provided for in that decision.
- Judgment of the Court (First Chamber) 5 February 2026 Judgment · Grade B
In the present case, even though Implementing Decision 2016/321 was adopted by the Commission, that decision draws the consequences, under Article 26c(3) of Directive 2001/18, from the demands for adjustment of the geographical scope of the authorisation for MON 810 GMO maize submitted by several Member States with a view to securing the prohibition of the cultivation of that variety of maize in all or part of their territory, in the absence of any opposition by the holder of that authorisation. Since the national measures in question were adopted in accordance with the provisions of that dire
- Judgment of the Court (First Chamber) 5 February 2026 Judgment · Grade B
It follows from the foregoing that the answer to the second part of the fifth question in Case C‑393/24 is that Implementing Decision 2016/321 must be interpreted as not precluding national legislation which imposes a penalty for the non-compliance with the prohibition provided for therein.
- Judgment of the Court (First Chamber) 5 February 2026 Judgment · Grade B
Consideration of the questions referred for a preliminary ruling has disclosed no factor of such a kind as to affect the validity of Article 26c(1) and (3) of 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 Council Directive 90/220/EEC, as amended by Directive (EU) 2015/412 of 11 March 2015, nor that of Commission Implementing Decision (EU) 2016/321 of 3 March 2016 adjusting the geographical scope of the authorisation for cultivation of genetically modified maize (