Contents
Judgment of the Court (First Chamber)5 February 2026note(References for a preliminary ruling — Environment — Deliberate release of genetically modified organisms (GMOs) — Measures to avoid the unintended presence of GMOs in the environment — Directive 2001/18/EC — Article 26c(1) and (3) — Regulation (EC) No 1829/2003 — Implementing Decision (EU) 2016/321 — Prohibition of the cultivation of MON 810 GMO maize in Italy — Validity — Free movement of goods — Articles 34 and 114 TFEU — Principles of proportionality and non-discrimination — Freedom to conduct a business — Articles 16 and 21 of the Charter of Fundamental Rights of the European Union)In Joined Cases C‑364/24 and C‑393/24,REQUESTS for a preliminary ruling under Article 267 TFEU from the Consiglio di Stato (Council of State, Italy), made by decision of 14 May 2024, received at the Court on 17 May 2024, and from the Tribunale di Udine (District Court, Udine, Italy), made by decision of 7 May 2024, received at the Court on 5 June 2024, in the proceedingsGiorgio Fidenato, on his own account and as owner of the agricultural holding In Trois,vMinistero dell’Agricoltura, della Sovranità alimentare e delle Foreste,other parties to the proceedings:WX, on his own account and as owner of the agricultural holding Li Pocis of WX,andGiorgio Fidenato, on his own account and as owner of the agricultural holding In Trois,vMinistero dell’Agricoltura, della Sovranità alimentare e delle Foreste,THE COURT (First Chamber),composed of F. Biltgen, President of the Chamber, I. Ziemele, A. Kumin, S. Gervasoni (Judge-Rapporteur) and M. Bošnjak, Judges,Advocate General: M. Szpunar,Registrar: A. Calot Escobar,having regard to the written procedure,after considering the observations submitted on behalf of:– Giorgio Fidenato, on his own account and as owner of the agricultural holding In Trois, by G. Martorana, avvocato,– the Italian Government, by S. Fiorentino, acting as Agent, and by M. Di Benedetto, avvocato dello Stato, and G. Lillo, procuratore dello Stato,– the Greek Government, by E. Leftheriotou and A. Vasilopoulou, acting as Agents,– the French Government, by P. Chansou, B. Fodda and B. Travard, acting as Agents,– the Luxembourg Government, by A. Germeaux and T. Schell, acting as Agents,– the Hungarian Government, by M.Z. Fehér and K. Szíjjártó, acting as Agents,– the Polish Government, by B. Majczyna, acting as Agent,– the European Parliament, by W. Kuzmienko and M. Menegatti, acting as Agents,– the Council of the European Union, by M. Moore, P. Pecheux and S. Scarpa Ferraglio, acting as Agents,– the European Commission, by C. Biz, F. Castilla Contreras and I. Galindo Martín, acting as Agents,after hearing the Opinion of the Advocate General at the sitting on 26 June 2025,gives the following
Judgment
1These 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 the authorisation for cultivation of genetically modified maize (Zea mays L.) MON 810 (MON-ØØ81Ø-6) (OJ 2016 L 60, p. 90), in the light of Article 3 TEU, Articles 2, 3, 18, 26, 34 to 36 TFEU, Article 216(2) TFEU, Articles 16, 21 and 52 of the Charter of Fundamental Rights of the European Union (‘the Charter’), the principles of non-discrimination and proportionality, and Article 34 of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (OJ 2003 L 268, p. 1).
2The requests have been made in proceedings between Mr Giorgio Fidenato, a farmer, and the Italian authorities concerning the implementation of measures to destroy and burrow genetically modified maize plants (Zea mays L.) MON 810 (MON-ØØ81Ø-6) (‘MON 810 GMO maize’) and the imposition on Mr Fidenato of an administrative fine of EUR 50000 for having cultivated such plants.
Legal context
International law
3By Council Decision 94/800/EC (of 22 December 1994) concerning the conclusion on behalf of the European Community, as regards matters within its competence, of the agreements reached in the Uruguay Round multilateral negotiations (1986-1994) (OJ 1994 L 336, p. 1), the Council of the European Union approved the Agreement establishing the World Trade Organization (WTO), signed in Marrakesh on 15 April 1994, and the agreements in the annexes to that agreement (‘the WTO Agreements’).
European Union law
Directive 2001/18
4Article 1 of Directive 2001/18, entitled ‘Objective’, provides:‘In accordance with the precautionary principle, the objective of this Directive is to approximate the laws, regulations and administrative provisions of the Member States and to protect human health and the environment when:– carrying out the deliberate release into the environment of genetically modified organisms [(“the GMOs”)] for any other purposes than placing on the market within the Community,– placing on the market [GMOs] as or in products within the Community.’
5Under Article 4 of that directive, entitled ‘General obligations’:1. Member States shall, in accordance with the precautionary principle, ensure that all appropriate measures are taken to avoid adverse effects on human health and the environment which might arise from the deliberate release or the placing on the market of GMOs. GMOs may only be deliberately released or placed on the market in conformity with part B or part C respectively.…’
6Article 22 of that directive, entitled ‘Free circulation’, stipulates:‘Without prejudice to Article 23, 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 this Directive.’
7Article 23 of that directive, entitled ‘Safeguard clause’, provides:1. Where a Member State, as a result of new or additional information made available since the date of the consent and affecting the environmental risk assessment or reassessment of existing information on the basis of new or additional scientific knowledge, has detailed grounds for considering that a GMO as or in a product which has been properly notified and has received written consent under this Directive constitutes a risk to human health or the environment, that Member State may provisionally restrict or prohibit the use and/or sale of that GMO as or in a product on its territory.The Member State shall ensure that in the event of a severe risk, emergency measures, such as suspension or termination of the placing on the market, shall be applied, including information to the public.The Member State shall immediately inform the [European] Commission and the other Member States of actions taken under this Article and give reasons for its decision, supplying its review of the environmental risk assessment, indicating whether and how the conditions of the consent should be amended or the consent should be terminated, and, where appropriate, the new or additional information on which its decision is based.2. Within 60 days of the date of receipt of the information transmitted by the Member State, a decision shall be taken on the measure taken by that Member State in accordance with the regulatory procedure referred to in Article 30(2). For the purpose of calculating the 60-day period, any period of time during which the Commission is awaiting further information which it may have requested from the notifier or is seeking the opinion of the Scientific Committee or Committees which has or have been consulted shall not be taken into account. The period of time during which the Commission is awaiting the opinion of the Scientific Committee or Committees consulted shall not exceed 60 days.Likewise, the period of time the Council takes to act in accordance with the regulatory procedure referred to in Article 30(2) shall not be taken into account.’
8Article 26b of Directive 2001/18, entitled ‘Cultivation’, stipulates:1. During the authorisation procedure of a given GMO or during the renewal of consent/authorisation, a Member State may 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. That demand shall be communicated to the Commission at the latest 45 days from the date of circulation of the assessment report under Article 14(2) of this Directive, or from receiving the opinion of the European Food Safety Authority under Article 6(6) and Article 18(6) of Regulation [No 1829/2003]. The Commission shall present the demand of the Member State to the notifier/applicant and to the other Member States without delay. The Commission shall make the demand publicly available by electronic means.2. Within 30 days from the presentation by the Commission of that demand, the notifier/applicant may adjust or confirm the geographical scope of its initial notification/application.In the absence of confirmation, the adjustment of the geographical scope of the notification/application shall be implemented in the written consent issued under this Directive and, where applicable, the decision issued in accordance with Article 19 of this Directive as well as the decision of authorisation adopted under Articles 7 and 19 of Regulation [No 1829/2003].The written consent issued under this Directive and, where applicable, the decision issued in accordance with Article 19 of this Directive, as well as the decision of authorisation adopted under Articles 7 and 19 of Regulation [No 1829/2003], shall then be issued on the basis of the adjusted geographical scope of the notification/application.Where a demand in accordance with paragraph 1 of this Article is communicated to the Commission after the date of circulation of the assessment report under Article 14(2) of this Directive, or after receipt of the opinion of the European Food Safety Authority under Article 6(6) and Article 18(6) of Regulation [No 1829/2003], the timelines set out in Article 15 of this Directive to issue the written consent or, as the case may be, in Articles 7 and 19 of Regulation [No 1829/2003] to submit to the Committee a draft of the decision to be taken, shall be extended by a single period of 15 days regardless of the number of Member States presenting such demands.3.Where no demand was made pursuant to paragraph 1 of this Article, or where the notifier/applicant has confirmed the geographical scope of its initial notification/application, a Member State may adopt measures restricting or prohibiting the cultivation in all or part of its territory of a GMO, or of a group of GMOs defined by crop or trait, once authorised in accordance with Part C of this Directive or with Regulation [No 1829/2003], provided that such measures are in conformity with Union law, reasoned, proportional and non-discriminatory and, in addition, are based on compelling grounds such as those related to:(a) environmental policy objectives;(b) town and country planning;(c) land use;(d) socioeconomic impacts;(e) avoidance of GMO presence in other products without prejudice to Article 26a;(f) agricultural policy objectives;(g) public policy.Those grounds may be invoked individually or in combination, with the exception of the ground set out in point (g) which cannot be used individually, depending on the particular circumstances of the Member State, region or area in which those measures will apply, but shall, in no case, conflict with the environmental risk assessment carried out pursuant to this Directive or to Regulation [No 1829/2003].4.A Member State which intends to adopt measures pursuant to paragraph 3 of this Article shall first communicate a draft of those measures and the corresponding grounds invoked to the Commission. This communication may take place before the GMO authorisation procedure under Part C of this Directive or under Regulation [No 1829/2003] has been completed. During a period of 75 days starting from the date of such communication:(a) the Member State concerned shall refrain from adopting and implementing those measures;(b) the Member State concerned shall ensure that operators refrain from planting the GMO or GMOs concerned; and(c) the Commission may make any comments it considers appropriate.On expiry of the 75-day period referred to in the first subparagraph, the Member State concerned may, for the whole duration of the consent/authorisation and as from the date of entry into force of the Union authorisation, adopt the measures either in the form originally proposed, or as amended to take account of any non-binding comments received from the Commission. Those measures shall be communicated to the Commission, the other Member States and the authorisation holder without delay.Member States shall make publicly available any such measure to all operators concerned, including growers.5. Where a Member State wishes all or part of its territory to be reintegrated into the geographical scope of the consent/authorisation from which it was previously excluded pursuant to paragraph 2, it may make a request to that effect to the competent authority which issued the written consent under this Directive or to the Commission if the GMO has been authorised under Regulation [No 1829/2003]. The competent authority which has issued the written consent or the Commission, as the case may be, shall amend the geographical scope of the consent or of the decision of authorisation accordingly.6.For the purposes of an adjustment of the geographical scope of the consent/authorisation of a GMO under paragraph 5:(a) for a GMO which has been authorised under this Directive, the competent authority which has issued the written consent shall amend the geographical scope of the consent accordingly and inform the Commission, the Member States and the authorisation holder once this is complete;(b) for a GMO which has been authorised under Regulation [No 1829/2003], the Commission shall amend the decision of authorisation accordingly, without applying the procedure set out in Article 35(2) of that Regulation. The Commission shall inform the Member States and the authorisation holder accordingly.7. Where a Member State has revoked measures taken pursuant to paragraphs 3 and 4, it shall notify the Commission and the other Member States without delay.8. Measures adopted under this Article shall not affect the free circulation of authorised GMOs as, or in, products.’
9Under Article 26c of Directive 2001/18, entitled ‘Transitional measures’:1. From 2 April 2015 until 3 October 2015, a Member State may demand that the geographical scope of a notification/application submitted, or of an authorisation granted, under this Directive or Regulation [No 1829/2003] before 2 April 2015 be adjusted. The Commission shall present the demand of the Member State to the notifier/applicant and to the other Member States without delay.2. Where the notification/application is pending and the notifier/applicant has not confirmed the geographical scope of its initial notification/application within 30 days from the communication of the demand referred to in paragraph 1 of this Article, the geographical scope of the notification/application shall be adjusted accordingly. The written consent issued under this Directive and, where applicable, the decision issued in accordance with Article 19 of this Directive as well as the decision of authorisation adopted under Articles 7 and 19 of Regulation [No 1829/2003], shall then be issued on the basis of the adjusted geographical scope of the notification/application.3. Where the authorisation has already been granted and the authorisation holder has not confirmed the geographical scope of the authorisation within 30 days from the communication of the demand referred to in paragraph 1 of this Article, the authorisation shall be modified accordingly. For a written consent under this Directive, the competent authority shall amend the geographical scope of the consent accordingly and shall inform the Commission, the Member States, and the authorisation holder once this is complete. For an authorisation under Regulation [No 1829/2003], the Commission shall amend the decision of authorisation accordingly, without applying the procedure set out in Article 35(2) of that Regulation. The Commission shall inform the Member States and the authorisation holder accordingly.4. Where no demand was made pursuant to paragraph 1 of this Article, or where a notifier/applicant or, as the case may be, an authorisation holder has confirmed the geographical scope of its initial application or, as the case may be, authorisation, paragraphs 3 to 8 of Article 26b shall apply mutatis mutandis.5. This Article is without prejudice to the cultivation of any authorised GMO seeds and plant propagating materials which were planted lawfully before the cultivation of the GMO is restricted or prohibited in the Member State.6. Measures adopted under this Article shall not affect the free circulation of authorised GMOs as, or in, products.’
10Article 33 of Directive 2001/18, entitled ‘Penalties’, is worded as follows:‘Member States shall determine the penalties applicable to breaches of the national provisions adopted pursuant to this Directive. Those penalties shall be effective, proportionate and dissuasive.’
Directive 2015/412
11Recitals 6 to 8, 16 and 27 of Directive 2015/412 state:(6) Experience has shown that cultivation of GMOs is an issue which is more thoroughly addressed at Member State level. Issues related to the placing on the market and the import of GMOs should remain regulated at Union level to preserve the internal market. Cultivation may however require more flexibility in certain instances as it is an issue with strong national, regional and local dimensions, given its link to land use, to local agricultural structures and to the protection or maintenance of habitats, ecosystems and landscapes. In accordance with Article 2(2) [TFEU], Member States are entitled to have the possibility to adopt legally binding acts restricting or prohibiting the cultivation of GMOs in their territory after such GMOs have been authorised to be placed on the Union market. However, the common authorisation procedure, in particular the evaluation process conducted primarily by the European Food Safety Authority …, should not be adversely affected by such flexibility.(7) In the past, in order to restrict or prohibit the cultivation of GMOs, some Member States had recourse to the safeguard clauses and emergency measures pursuant to Article 23 of Directive [2001/18] and Article 34 of Regulation [No 1829/2003] as a result of, depending on the cases, new or additional information made available since the date of the consent and affecting the environmental risk assessment, or of the reassessment of existing information. Other Member States have made use of the notification procedure set out in Article 114(5) and (6) TFEU which requires putting forward new scientific evidence relating to the protection of the environment or the working environment. In addition, the decision-making process has proved to be particularly difficult as regards the cultivation of GMOs in the light of the expression of national concerns which do not only relate to issues associated with the safety of GMOs for health or the environment.(8) In that context, it appears appropriate to grant Member States, in accordance with the principle of subsidiarity, more flexibility to decide whether or not they wish to cultivate GMOs on their territory without affecting the risk assessment provided in the system of Union authorisations of GMOs, either in the course of the authorisation procedure or thereafter, and independently of the measures that Member States cultivating GMOs are entitled or required to take by application of Directive [2001/18] to avoid the unintended presence of GMOs in other products. The grant of that possibility to Member States is likely to improve the process for authorisations of GMOs and, at the same time, is also likely to ensure freedom of choice of consumers, farmers and operators whilst providing greater clarity to affected stakeholders concerning the cultivation of GMOs in the Union. This Directive should therefore facilitate the smooth functioning of the internal market.…(16) The restrictions or prohibitions adopted pursuant to this Directive should refer to the cultivation, and not to the free circulation and import, of genetically modified seeds and plant propagating material as, or in, products and of the products of their harvest, and should, furthermore, be in conformity with the Treaties, in particular as regards the principle of non-discrimination between national and non-national products, the principle of proportionality and [Articles 34 and 36] and Article 216(2) TFEU.…(27) The provisions laid down in Articles 26b and 26c of Directive [2001/18] apply without prejudice to Article 23 of that Directive as well as Article 34 of Regulation [No 1829/2003].’
Implementing Decision 2016/321
12By 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.
Regulation No 1829/2003
13Under Article 34 of Regulation No 1829/2003, entitled ‘Emergency measures’:‘Where it is evident that products authorised by or in accordance with this Regulation are likely to constitute a serious risk to human health, animal health or the environment, or where, in the light of an opinion of the [European Food Safety Authority] issued under Article 10 or Article 22, the need to suspend or modify urgently an authorisation arises, measures shall be taken under the procedures provided for in Articles 53 and 54 of Regulation (EC) No 178/2002 [of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ 2002 L 31, p. 1)].’
Italian law
14Article 35 bis of decreto legislativo n. 224 – Attuazione della direttiva 2001/18/CE concernente l’emissione deliberata nell’ambiente di organismi geneticamente modificati (Legislative Decree No 224 – Implementation of Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms) of 8 July 2003 (GURI No 194 of 22 August 2003), as amended by decreto legislativo n. 227 (Legislative Decree No 227) of 14 November 2016 (GURI No 288 of 10 December 2016) (‘Legislative Decree No 224/2003’), entitled ‘Penalties relating to Title III-bis’, provides:1.Unless the act constitutes a criminal offence, an administrative fine of between EUR 25000 and EUR 75000 shall be imposed on any person who fails to have regard to:(a) prohibitions on cultivation introduced by an adjustment of the geographical scope laid down, in the cases provided for, by one of the following measures:(1) an authorisation granted by the [Commission] pursuant to Articles 7 and 19 of Regulation [No 1829/2003];(2) consent of the competent national authority of a Member State pursuant to Articles 15, 17 and 18 of Directive [2001/18];(3) an authorisation issued by the competent national authority referred to in Article 2(1) pursuant to Article 18(1) and, if the conditions are met, the decision taken by that authority pursuant to Article 18(3);(b) prohibitions on cultivation adopted pursuant to Article 26c(6);(c) temporary prohibitions on the planting of the GMO(s) concerned provided for in Article 26c(5)(b), and Article 26e(3).2. Offenders shall be subject, by way of order, to an ancillary administrative penalty consisting of the suspension, for up to six months, of the authorisation to cultivate GMOs conferred under the marketing decisions.3. Anyone who infringes the prohibitions laid down in paragraph 1 shall be required to destroy the GMO crops that have been unlawfully planted and to restore the areas affected to their original condition at their own expense, jointly and severally with the owner and the holders of real or personal rights of enjoyment over the area, to whom that infringement is attributable either by reason of intent or through their fault, on the basis of findings made by the persons responsible for inspection after hearing the persons concerned. The authority referred to in paragraph 4 shall order the measures necessary for that purpose and shall lay down the period within which they are to be implemented, after which it shall implement the order against those involved and shall recover the sums advanced.…’
The disputes in the main proceedings and the questions referred for a preliminary ruling
Case C‑364/24
15Mr Giorgio Fidenato, owner of the agricultural holding In Trois whose seat is in Arba, in the province of Pordenone (Italy), cultivated, in the year of sowing 2021, MON 810 GMO maize plants.
16On 8 September 2021, an inspection was carried out in order to test for the presence of GMO on Mr Fidenato’s land. In that context, Mr Fidenato stated that he had sowed GMO maize for exclusively research purposes and that he would continue that practice ‘until the question of the lawfulness of Directive [2015/412] would be brought to the attention of the Court of Justice of the European Union for a ruling’.
17By 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 to restore the areas to their original state.
18As Mr Fidenato had not implemented that order, agents of the Corpo forestale dello Stato (State Forestry Corps, Italy) destroyed the crops in question themselves on 19 October 2021.
19Mr Fidenato brought an action against the order of 14 October 2021 before the Tribunale Amministrativo Regionale per il Friuli Venezia Giulia (Regional Administrative Court, Friuli-Venezia Giulia, Italy), claiming, inter alia, that the order to destroy the crops and to restore the areas to their original state, which had been issued against him, was unlawful on the ground that it had been adopted on the basis of rules that were themselves incompatible with primary EU law. In addition, according to Mr Fidenato, the existence of an authorisation to place on the market, issued on the basis of Regulation No 1829/2003, implied that the GMO product in question does not pose any actual threat to health or the environment. It is therefore impossible to understand why the EU legislature would permit that, on the mere demand of a Member State, the geographical scope of that authorisation could be adjusted without that State having to provide any justification in that regard.
20When that action was dismissed, Mr Fidenato brought an appeal against the judgment of the Tribunale Amministrativo Regionale per il Friuli Venezia Giulia (Regional Administrative Court, Friuli-Venezia Giulia) before the Consiglio di Stato (Council of State, Italy), which is the referring court.
21The 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 judgment of 13 September 2017, Fidenato and Others (C‑111/16, EU:C:2017:676), and in its order of 23 November 2017, Fidenato and Others (C‑107/16, EU:C:2017:900), and, more generally, with the principle of proportionality. That court takes the view that Articles 26b and 26c of the directive contradict other provisions in that directive, more specifically Articles 22 and 23, and that any invalidity of Articles 26b and 26c could have consequences for the validity of Implementing Decision 2016/321.
22In those circumstances, the Consiglio di Stato (Council of State) decided to stay the proceedings and to refer the following questions to the Court of Justice for a preliminary ruling:(1) Are Articles 26b and 26c of [Directive 2001/18] compatible with Article 34 of Regulation [No 1829/2003], Article 3 TEU, Articles 2, 3, 26, 34, 35 and 36 TFEU and Articles 16 and 52 of the [Charter]?(2) If the above question is answered in the negative, may Commission Implementing Decision [2016/321], adopted on the basis of Article 26c of [Directive 2001/18], be disregarded by the referring court or declared invalid on the ground that that Article 26c has been found not to comply with the higher-ranking rules of the TEU and the TFEU?’
Case C‑393/24
23By order of 19 June 2023 of the Director of the Direzione Generale per il riconoscimento degli organismi di controllo e certificazione e tutela del consumatore (Directorate-General for the Recognition of Inspection, Certification and Consumer Protection Bodies, Italy) of the Dipartimento dell’Ispettorato Centrale della Tutela della Qualità e Repressione Frodi dei Prodotti Agroalimentari (Department of the Central Inspectorate for the Protection of Quality and Fraud Prevention for Agri-Food Products, Italy), adopted on the basis of Article 35 bis of Legislative Decree No 224/2003, an administrative fine totalling EUR 50000 was imposed on Mr Fidenato for having infringed the prohibition of the cultivation of MON 810 GMO maize in Italy. Half of those fines concerned seedlings of that variety of maize cultivated in the Province of Udine (Italy) and the other half concerned seedlings of that variety of maize cultivated in the Province of Pordenone (Italy).
24Mr Fidenato lodged an action against that order before the Tribunale di Udine (District Court, Udine, Italy) in so far as it concerns the amount of EUR 25000 corresponding to the fine imposed on him for the seedlings of MON 810 GMO maize cultivated in that province. A similar action was brought by Mr Fidenato before the Tribunale di Pordenone (District Court, Pordenone, Italy) concerning the amount of EUR 25000 corresponding to the fine imposed on him for the seedlings of MON 810 GMO maize cultivated in that other province.
25In 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 that directive. That court also is uncertain whether Implementing Decision 2016/321 could be adopted on the basis of Article 114 TFEU which concerns measures which are aimed at improving functioning of the internal market.
26Should 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 as those stated in Article 26b(3) of that directive.
27In those circumstances, the Tribunale di Udine (District Court, Udine) decided to stay the proceedings and to refer the following questions to the Court of Justice for a preliminary ruling:‘…(1) 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?(2) 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]?(3) 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: …(4) 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?…(5) 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?’
Consideration of the questions referred
Admissibility
28As regards the admissibility of the questions raised, it should be recalled that it is solely for the national court before which a dispute has been brought, and which must assume responsibility for the subsequent judicial decision, to determine, in the light of the particular circumstances of the case, both the need for a preliminary ruling in order to enable it to deliver judgment and the relevance of the questions which it submits to the Court. Thus, where the questions referred concern the validity or the interpretation of a rule of EU law, the Court is, in principle, bound to give a ruling (see judgments of 21 April 1988, Pardini, 338/85, EU:C:1988:194, paragraph 8, and of 22 October 2024, Kolin Inşaat Turizm Sanayi ve Ticaret, C‑652/22, EU:C:2024:910, paragraph 36).
29The situation is different only where it is quite obvious that the ruling sought by a national court on the interpretation or validity of a rule of EU law bears no relation to the actual facts of the main action or its purpose, where the problem is hypothetical, or where the Court does not have before it the factual or legal material necessary to give a useful answer to the questions submitted to it (see judgments of 13 July 2000, Idéal tourisme, C‑36/99, EU:C:2000:405, paragraph 20, and of 30 April 2024, M.N. (EncroChat), C‑670/22, EU:C:2024:372, paragraph 65 and the case-law cited).
30In that context, a request for a preliminary ruling must be rejected where it is quite obvious that the procedure provided for in Article 267 TFEU has been misused and been resorted to, in fact, in order to elicit a ruling from the Court by means of a fictious dispute (see, to that effect, judgments of 8 November 1990, Gmurzynska-Bscher, C‑231/89, EU:C:1990:386, paragraph 23, and of 26 April 2012, DR and TV2 Danmark, C‑510/10, EU:C:2012:244, paragraph 22).
31As concerns, in the first place, the actual facts of the disputes in the main proceedings, it is apparent from the request for a preliminary ruling in Case C‑364/24 that Mr Fidenato stated that he intended to pursue the sowing of MON 810 GMO maize for the purposes of research until the Court has given a ruling on the lawfulness of Directive 2015/412. The European Parliament infers from that that the disputes in the main proceedings have been fabricated in their entirety by Mr Fidenato and that the requests for a preliminary ruling must be found inadmissible on that ground.
32However, it is not obvious from the material before the Court that the parties to the main proceedings colluded to obtain a ruling from the Court by means of a fictitious dispute, unlike in the case that gave rise to the judgment of 16 December 1981 in Foglia (244/80, EU:C:1981:302) (see, by analogy, judgments of 13 July 2000, Idéal tourisme, C‑36/99, EU:C:2000:405, paragraph 22, and of 26 April 2012, DR and TV2 Danmark, C‑510/10, EU:C:2012:244, paragraph 22). As the Advocate General observed in point 42 of his Opinion, Mr Fidenato does not appear to have acted together with the national authorities, which have imposed on him administrative fines, a fact which is beyond doubt.
33As concerns, in the second place, the doubts expressed by the French Government regarding the relevance of the questions raised, in so far as they concern the validity of Article 26b and Article 26c(4) of Directive 2001/18, in view of the subject matter of the disputes in the main proceedings, it is apparent from the material submitted to the Court that the measure prohibiting the cultivation of MON 810 GMO maize at issue in the main proceedings, which concerned an authorisation already granted, was decided on the basis of the transitional provisions in Article 26c(1) and (3) of that directive. Those questions are therefore inadmissible in so far as they concern Article 26b and Article 26c(2) and (4) of that directive, which, having regard to the material available to the Court, do not appear to be applicable to the disputes in the main proceedings.
34Last, as concerns, in the third place, the content of the requests for a preliminary ruling, it must be pointed out that, in accordance with settled case-law, which is reflected in Article 94(a) and (b) of the Rules of Procedure of the Court, the need to provide an interpretation of EU law which will be of use to the national court makes it necessary for the national court to define the factual and regulatory context of the questions it is asking or, at the very least, to explain the factual hypotheses on which those questions are based. Furthermore, it is essential, as stated in Article 94(c) of the Rules of Procedure, that the request for a preliminary ruling itself contain a statement of the reasons which prompted the referring court or tribunal to enquire about the interpretation or validity of certain provisions of EU law, and the connection between those provisions and the national legislation applicable to the dispute in the main proceedings (see, to that effect, judgments of 26 January 1993, Telemarsicabruzzo and Others, C‑320/90 to C‑322/90, EU:C:1993:26, paragraph 6, and of 1 August 2025, Tiberis Holding, C‑514/23, EU:C:2025:597, paragraph 30 and the case-law cited).
35In the present case, the Italian and Greek Governments submit that the requests for a preliminary ruling do not contain all the information required by Article 94 of the Rules of Procedure. In particular, in Case C‑393/24, the Italian Government submits that the referring court does not specifically state the reasons which prompted it to enquire about the validity of Articles 26b and 26c of Directive 2001/18.
36It must, however, be found that, despite a sometimes succinct presentation of the reasoning concerning certain aspects, the requests for a preliminary ruling contain, overall, sufficient information to enable the Court to provide a useful response to the questions raised. The situation is different only regarding the compatibility with Articles 2 and 3 TFEU of the provisions the validity of which is called into question, as the referring court in Case C‑364/24 does not state, in the grounds of the order for reference, how the mechanism established by Directive 2015/412 may be incompatible with those articles.
37It follows from the foregoing that the questions raised are inadmissible in so far as they concern Article 26b and 26c(2) and (4) of Directive 2001/18, and in so far as they concern the validity of Article 26c(1) and (3) of that directive in the light of Articles 2 and 3 TFEU.
Substance
38As a preliminary point, it should be borne in mind that Directive 2015/412 established, in Articles 26b and 26c of Directive 2001/18, a mechanism which, in two different ways, allows Member States to restrict or prohibit, in all or part of their territory, the cultivation of GMOs.
39First, under Article 26b(1) and (2) of that directive, any Member State may, during the authorisation procedure or during the renewal of consent/authorisation of a given GMO, demand that the cultivation of that GMO be excluded in all or part of its territory. That demand is to be communicated by the Commission to the notifier/applicant of the authorisation and to the other Member States, and it is to be made publicly available. In the absence of confirmation within 30 days by the notifier/applicant of the geographical scope as initially applied for by the notifier/applicant, the adjustment of the geographical scope is to be implemented by the Commission in accordance with the demand of the Member State concerned.
40Second, where no demand was submitted by a Member State during the authorisation procedure or during the renewal of consent/authorisation of the GMO, or where the notifier/applicant has confirmed the geographical scope of its initial application, any Member State may, under Article 26b(3) and (4) of Directive 2001/18, adopt measures prohibiting or restricting the cultivation in all or part of its territory of a GMO, or a group of GMOs. The measures in question must be in conformity with EU law, reasoned, proportional, non-discriminatory and must address one or several of the compelling grounds listed in points (a) to (g) of the first subparagraph of Article 26b(3) of that directive. Those measures may be adopted only at the end of a preliminary procedure allowing the Commission to present its observations and must be communicated to the Commission, the other Member States and to the authorisation holder.
41The mechanism set out in Article 26b of Directive 2001/18 is, in essence, echoed in Article 26c of that directive, which concerns transitional measures and which allowed Member States, in the period from 2 April 2015 until 3 October 2015, to demand, as the case may be, that the geographical scope of an application for authorisation submitted prior to 2 April 2015 or of an authorisation granted before that date be adjusted.
The first question in Case C‑364/24 and 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 Article 26c(1) and (3) of Directive 2001/18
42By the first question in Case C‑364/24, the first to third questions and the first part of the fifth question in Case C‑393/24, which it is appropriate to examine together, the referring courts ask the Court, in essence, whether Article 26c(1) and (3) of Directive 2001/18 is in conformity with primary EU law, and more specifically with Article 3 TEU, Articles 18, 26, 34 to 36 and 114 TFEU, Article 216(2) TFEU, Articles 16, 21 and 52 of the Charter as well as with the principles of proportionality and non-discrimination.
The validity of Article 26c(1) and (3) of Directive 2001/18 in the light of Article 3 TEU, Articles 26, 34 to 36 and Article 114 TFEU and the principle of proportionality
43The referring courts have expressed doubts, in the first place, about the validity of Article 26c(1) and (3) of Directive 2001/18 in the light of the rules of primary law governing the functioning of the internal market and, more specifically, the free movement of goods.
44As Article 3 TEU and Article 26 TFEU are mentioned by the referring court in Case C‑364/24 only in so far as those provisions underline that the European Union is based on the establishment of the internal market, they do not call for a separate analysis from the one concerning Articles 34 to 36 and 114 TFEU, and the principle of proportionality.
45As a preliminary point, it must be recalled that the free movement of goods is a fundamental principle of EU law which is expressed in the prohibition, set out in Article 34 TFEU, of quantitative restrictions on imports and all measures having equivalent effect (judgment of 21 December 2023, CDIL, C‑96/22, EU:C:2023:1025, paragraph 31 and the case-law cited).
46That prohibition covers any measure of the Member States that is capable of hindering, directly or indirectly, actually or potentially, access to the market of a Member State of products originating in other Member States, even if it has neither the object nor the effect of treating goods coming from other Member States less favourably (judgment of 21 December 2023, CDIL, C‑96/22, EU:C:2023:1025, paragraph 33 and the case-law cited). The prohibition applies also to measures adopted by the EU institutions (see, to that effect, judgment of 22 June 2017, E.ON Biofor Sverige, C‑549/15, EU:C:2017:490, paragraph 45).
47Furthermore, when there are obstacles to trade, or it is likely that such obstacles will emerge in the future, because the Member States have taken, or are about to take, divergent measures with respect to a product or a class of products such as to bring about different levels of protection, Article 114 TFEU authorises the EU legislature to intervene by adopting appropriate measures, in compliance with Article 114(3) TFEU and with the legal principles referred to in the FEU Treaty or identified in the case-law, in particular the principle of proportionality (judgment of 22 June 2017, E.ON Biofor Sverige, C‑549/15, EU:C:2017:490, paragraph 49 and the case-law cited).
48The Court has previously held that, given the discretion enjoyed by the EU legislature as regards the method of approximation most appropriate for achieving the desired result, the measures adopted on the basis of Article 114 TFEU may, inter alia, consist in, depending on the circumstances, requiring all the Member States to authorise the marketing of the product or products concerned, subjecting such an authorisation to certain conditions, or even provisionally or definitively prohibiting the marketing of a product or products (see, to that effect, judgment of 3 December 2019, Czech Republic v Parliament and Council, C‑482/17, EU:C:2019:1035, paragraphs 60 and 61).
49In the present case, Directive 2015/412, which introduced Articles 26b and 26c into Directive 2001/18, was adopted on the basis of Article 114 TFEU, like Directive 2001/18, which in turn was adopted on the basis of Article 95 EC, now Article 114 TFEU. Article 114 TFEU allows the EU legislature to adopt measures for the approximation of the provisions laid down by law, regulation or administrative action in Member States which have as their object the establishment and functioning of the internal market.
50Article 1 of Directive 2001/18 thus provides that, in accordance with the precautionary principle, the objective of that directive is to approximate the laws, regulations and administrative provisions of the Member States and to protect human health and the environment when ‘carrying out the deliberate release into the environment of [GMOs] for any other purposes than placing on the market within the [European Union]’ and when ‘placing on the market [GMOs] as or in products within the [European Union]’.
51As concerns more specifically Articles 26b and 26c of that directive, in the context of which the mechanism set out in Article 26c(1) and (3) of that directive must be viewed, it should be observed that those provisions establish common rules setting out the conditions under which a Member State may prohibit the cultivation of a GMO or a group of GMOs in all or part of its territory and, therefore, those provisions are covered by the concept of ‘measure for the approximation of the provisions laid down by law, regulation or administrative action in Member States’ within the meaning of Article 114 TFEU.
52As regards the respect, by measures decided on the basis of Article 114 TFEU, for the free movement of goods and the principle of proportionality, it must be borne in mind that the EU legislature must be allowed a broad discretion when it is called upon to legislate in an area which entails political, economic and social choices on its part, and in which it is called upon to undertake complex assessments, as is the case with the placing on the market and the cultivation of GMOs. The lawfulness of a measure adopted in that sphere can be affected only if the measure is manifestly inappropriate in relation to the objective which the competent institutions are seeking to pursue (see, to that effect, judgment of 22 June 2017, E.ON Biofor Sverige, C‑549/15, EU:C:2017:490, paragraph 50).
53As concerns the objective pursued by the EU legislation on GMOs, Article 1 of Directive 2001/18 and Article 1 of Regulation No 1829/2003 provide that that legislation aims to ensure protection of health and the environment, and the interests of consumers, while also ensuring the proper functioning of the internal market.
54It follows from recitals 6 and 8 of Directive 2015/412 that, by adopting Articles 26b and 26c of Directive 2001/18, the EU legislature, while continuing to regulate issues related to the placing on the market and the import of GMOs at EU level to preserve the internal market, intended more specifically and in accordance with the principle of subsidiarity, within the framework laid down in Article 2(2) TFEU, to afford Member States more flexibility as regards the cultivation of GMOs, as that is an issue ‘with strong national, regional and local dimensions, given its link to land use, to local agricultural structures and to the protection or maintenance of habitats, ecosystems and landscapes’. However, those recitals also state that that flexibility should not adversely affect the common authorisation procedure for the placing on the market of GMOs, which is based on the evaluation of the risks to human health and the environment.
55By so allowing that the cultivation of a GMO or a group of GMOs, by means of a clear and predictable mechanism, may be excluded in all or part of the territory of a Member State, the EU legislature also intended, as it is apparent, in essence, from recital 7 of Directive 2015/412, to facilitate the decision-making process as regards the cultivation of GMOs. In the past, in order to restrict or prohibit the cultivation of GMOs, some Member States had recourse to the safeguard clauses and emergency measures pursuant to Article 23 of Directive 2001/18 and Article 34 of Regulation No 1829/2003. Other Member States made use of the notification procedure under Article 114(5) and (6) TFEU.
56In the light of those objectives, the mechanism established in Article 26c(1) and (3) of Directive 2001/18 does not appear to be manifestly inappropriate.
57First, it should be observed that it is apparent from Article 26c(6) of Directive 2001/18 that the measures decided pursuant to Article 26c – including the prohibition measures adopted on the basis of Article 26c(1) and (3) of that directive – are limited to the cultivation of GMOs as they may not ‘affect the free circulation of authorised GMOs as, or in, products’. Therefore, as the Advocate General found in point 75 of his Opinion, the prohibition of such cultivation does not affect the right of economic operators to import products containing GMOs. Moreover, that prohibition does not affect the freedom of choice of consumers, who may continue to consume, if they so wish, irrespective of the Member State where they reside, the products derived from cultivation of the GMO in question.
58Second, the adoption of measures prohibiting the cultivation of GMOs on the basis of Article 26c(1) and (3) of Directive 2001/18 is subject to the tacit consent by the holder of the authorisation for the GMO in question, in the form of a lack of opposition of that holder to the demand submitted by a Member State seeking the adjustment of the geographical scope of the authorisation with respect to the seeds concerned, within 30 days from the communication of that demand. As the Advocate General observed, in essence, in point 78 of his Opinion, since that holder consented to it, the rights that that holder derives from the free movement of the goods concerned may not be regarded as being affected by any barrier to that free movement which results from the application of those provisions.
59In addition, as the Advocate General stated in point 81 of his Opinion, the free movement of GMO seeds is conditional on obtaining an authorisation for the placing on the market of, or in, such products and that free movement is restricted to the strict framework of that authorisation. It follows that, where the geographical scope of such an authorisation has been restricted, with the tacit consent of its holder, so that the cultivation of a GMO seed is prohibited in all or part of the territory of a Member State, farmers cannot rely on the rights deriving from the free movement of goods in order to circumvent that prohibition.
60Third, by giving Member States the possibility to seek the prohibition of the cultivation of a GMO in all or part of their territory, Article 26c(1) and (3) of Directive 2001/18 affords them, in the absence of consensus on the issue, more flexibility to make the choices that they deem appropriate with respect to the cultivation of GMOs, while safeguarding the uniform process for assessing the risks to health and the environment of GMOs undertaken at EU level. From that point of view, as stated in recital 6 of Directive 2015/412, the issues related to the placing on the market and the import of GMOs, including the assessment of the risks that GMOs could pose to health and the environment, are to remain regulated at EU level to preserve the internal market.
61Fourth, the mechanism established in those provisions facilitates the GMO authorisation procedure and contributes to the legal certainty for operators, in accordance with the objectives referred to in paragraph 53 of the present judgment.
62It follows from the foregoing considerations that Article 26c(1) and (3) of Directive 2001/18 (i) does not undermine any rights that economic operators may derive from the free movement of goods; (ii) does not affect the freedom of choice of consumers; and (iii) contributes to the proper functioning of the internal market within the meaning of Article 114 TFEU.
63The fact that Article 26c(3) of Directive 2001/18 does not make the prohibition of the cultivation of a GMO on the basis of that provision conditional on any particular justification on the part of the Member States is not capable of calling into question the finding made in paragraph 56 of the present judgment since, as has been stated, such a measure may only be adopted with the tacit consent of the holder of the authorisation for the GMOs in question. Where, by contrast, the authorisation holder objects to the adjustment of the geographical scope of the authorisation, Article 26c(4) of Directive 2001/18 requires Member States wishing to prohibit the cultivation of a given GMO in all or part of their territory to provide compelling grounds in support of their demand, such as those set out in points (a) to (g) of the first subparagraph of Article 26b(3) of that directive.
64It should also be noted that, even on the assumption that the mechanism established by Article 26c(1) and (3) of Directive 2001/18 could result in certain restrictions on the free of movement of goods, within the meaning of Article 34 TFEU, such restrictions would be justified by the objectives of general interest referred to in paragraphs 53 to 55 of the present judgment and would not infringe the principle of proportionality.
65It follows from all of the foregoing that the EU legislature did not exceed the limits of its discretion conferred on the basis of Article 114 TFEU nor has it introduced any restrictions to the free movement of goods by adopting Article 26c(1) and (3) of Directive 2001/18.
The validity of Article 26c(1) and (3) of Directive 2001/18 in the light of Article 18 TFEU, Article 21 of the Charter and the principle of non-discrimination
66In the second place, the referring court in Case C‑393/24 has doubts as to whether, by allowing the prohibition of the cultivation of a GMO or a group of GMOs in all or part of the territory of the Member States, Article 26c(1) and (3) of Directive 2001/18 introduces discrimination contrary to Article 18 TFEU and Article 21 of the Charter, both between farmers of different Member States, depending on whether those Member States authorise or prohibit the cultivation of GMOs, and between farmers of a Member State prohibiting the cultivation of GMOs, to the prejudice of the farmers wishing to cultivate seeds thus modified.
67On the first point, it should be recalled that the provisions of Article 21(2) of the Charter, which prohibit discrimination on grounds of nationality, correspond to the provisions of the first paragraph of Article 18 TFEU and must be applied in accordance with that article (see, to that effect, judgment of 4 October 2024, Lithuania and Others v Parliament and Council (Mobility package), C‑541/20 to C‑555/20, EU:C:2024:818, paragraph 311 and the case-law cited). It should also be borne in mind that Article 18 TFEU applies independently only in situations governed by EU law for which the FEU Treaty lays down no specific rules of non-discrimination (judgment of 20 June 2024, Faurécia, C‑420/23, EU:C:2024:534, paragraph 18 and the case-law cited). As the principle of non-discrimination is implemented, in the field of free movement of goods, inter alia by Articles 34 and 35 TFEU, it is in the light of those provisions that an answer is to be given to the referring court.
68In that regard, it must be held that, as is also stated in recital 16 of Directive 2015/412, the adoption of measures prohibiting the cultivation of GMOs on the basis of Article 26c(1) and (3) of Directive 2001/18, does not introduce any distinction between national and non-national products. It follows that any prohibition with respect to cultivation by those provisions applies indistinctly, irrespective of the place of origin of the seeds in question.
69Moreover, the prohibition on discrimination does not cover any disparities in treatment which may result from divergences existing between the rules applicable in the various Member States, so long as those rules affect all the persons subject to them equally.
70In addition, given the broad discretion which the EU legislature enjoys when it intervenes in an area which entails political, economic and social choices and when it is called upon to undertake complex assessments and evaluations, that legislature, without exceeding the limits of its discretion and as the Advocate General observed in point 95 of his Opinion, could assume that the situations of farmers from different Member States are not comparable given the specific nature of GMO cultivation, which, inter alia, is linked to the place of production and to the specific nature of that place.
71In those circumstances, no discrimination can be found between farmers from different Member States on the ground that some of those States prohibit the cultivation of a given GMO in all or part of their territory and others do not.
72On the second point, it should be noted that the cultivation of GMOs has particularities due to, inter alia, the effects that it may have on other crops, so that the situation of farmers wishing to cultivate a given GMO is not comparable to the situation of farmers who have not expressed such a wish. Consequently, no discrimination can be found between the former and the latter on the ground that the cultivation of that GMO was prohibited in all or part of the territory of a Member State.
73It follows from the foregoing that consideration of the questions raised has disclosed no factor of such a kind as to affect the validity of Article 26c(1) and (3) of Directive 2001/18 in the light of the principle of non-discrimination, implemented in Articles 34 and 35 TFEU and enshrined in Article 21 of the Charter.
The validity of Article 26c(1) and (3) of Directive 2001/18 in the light of Articles 16 and 52 of the Charter
74As concerns, in the third place, the questions of the referring courts concerning the validity of Article 26c(1) and (3) of Directive 2001/18 in the light of Articles 16 and 52 of the Charter, it should be recalled that, under Article 16, the freedom to conduct a business in accordance with EU law and national laws and practices is recognised. It is apparent from the case-law of the Court that the protection afforded by Article 16 covers the freedom to exercise an economic or commercial activity, the freedom of contract and free competition and covers, in particular, the freedom to choose with whom to do business (judgment of 12 January 2023, TP (Audiovisual editor for public television), C‑356/21, EU:C:2023:9, paragraph 74 and the case-law cited).
75In the present case, it is apparent from the orders for reference that the disputes in the main proceedings concern the lawfulness of the measures prohibiting the cultivation of GMOs in a Member State that were adopted on the basis of Article 26c(1) and (3) of Directive 2001/18.
76Given that, contrary to the measures prohibiting the cultivation of GMOs adopted under the procedure set out in Article 26c(2) and (4) of Directive 2001/18, the measures decided on the basis of Article 26c(1) and (3) of that directive may only be adopted with the tacit consent of the holder of the authorisation for the GMO in question, Article 26c(1) and (3) of Directive 2001/18 cannot be regarded as constituting an interference with the authorisation holder’s freedom to conduct a business.
77The same applies, a fortiori, to any users of GMO seeds affected by the restriction of the geographical scope of the authorisation as initially requested, since the freedom to conduct a business does not confer on third parties the right to pursue an economic activity by making use of products whose placing on the market or use has been prohibited.
78In those circumstances, it is not necessary to rule on the validity of Article 26c(1) and (3) of Directive 2001/18 in the light of Article 52 of the Charter as such an analysis would imply that the measures prohibiting the cultivation of a GMO set out in Article 26c(1) and (3) could be regarded as restrictions to the freedom to conduct a business.
79In the light of the foregoing, Article 26c(1) and (3) of Directive 2001/18 does not appear to be contrary to Article 16 of the Charter.
The validity of Article 26c(1) and (3) of Directive 2001/18 in the light of Article 216(2) TFEU and the WTO Agreements
80In the fourth place, the referring court in Case C‑393/24 asks the Court, in essence, whether Article 26c(1) and (3) of Directive 2001/18, in that it allows certain Member States to prohibit the cultivation of GMOs in all or part of their territory, is contrary to Article 216(2) TFEU to which recital 16 of Directive 2015/412 refers and which provides that the agreements concluded by the European Union are binding upon the EU institutions and on its Member States.
81It is apparent from the request for a preliminary ruling that that question refers, more specifically, to the WTO Agreements.
82In that regard, it should be pointed out that the provisions of an international agreement to which the European Union is a party can be relied on in support of an action for annulment of an act of secondary EU legislation or a plea that such an act is unlawful only where, first, the nature and the broad logic of that agreement do not preclude it and, second, those provisions appear, as regards their content, to be unconditional and sufficiently precise. It is only when both those conditions are met that such provisions may be relied upon before the EU Courts as a criterion in order to assess the legality of an EU act (see, to that effect, judgment of 28 September 2023, Changmao Biochemical Engineering v Commission, C‑123/21 P, EU:C:2023:708, paragraph 69 and the case-law cited). That analysis likewise applies to the assessment of the validity of an act of secondary EU legislation in the context of a preliminary ruling procedure.
83As concerns the WTO Agreements, the Court has previously stated, first, that those agreements are not such as to create rights for individuals which they may rely on directly before the courts by virtue of EU law and, second, taking account of their nature and structure, those agreements are not, in principle, among the rules in the light of which the Court is to review the legality of measures adopted by the EU institutions (judgment of 28 September 2023, Changmao Biochemical Engineering v Commission, C‑123/21 P, EU:C:2023:708, paragraphs 70 and 71 and the case-law cited).
84It is otherwise only in two exceptional situations, which are the result of the EU legislature’s own intention to limit its discretion in the application of the WTO rules, where the Court has accepted that it was for the EU Courts, if necessary, to review the legality of an EU measure and of the measures adopted for its application in the light of the WTO Agreements. That concerns, first, the situation in which the European Union intended to give effect to a specific obligation assumed under the WTO Agreements and, second, the situation in which the EU act at issue expressly refers to specific provisions of those agreements (see, to that effect, judgment of 28 September 2023, Changmao Biochemical Engineering v Commission, C‑123/21 P, EU:C:2023:708, paragraphs 74 and 75 and the case-law cited).
85In the present case, it is not apparent that, by adopting the provisions of Article 26c(1) and (3) of Directive 2001/18, the EU legislature had intended to give effect to a specific obligation assumed under the WTO Agreements. Furthermore, neither that directive nor Directive 2015/412 expressly refers to specific provisions of those agreements.
86It follows that Article 26c(1) and (3) of Directive 2001/18 cannot be regarded as being invalid in the light of Article 216(2) TFEU and the WTO Agreements.
The validity of Article 26c(1) and (3) of Directive 2001/18 in the light of Article 34 of Regulation No 1829/2003
87In the fifth place, the referring court in Case C‑364/24 asks the Court whether Article 26c(1) and (3) of Directive 2001/18 is in conformity with Article 34 of Regulation No 1829/2003.
88In that regard it should be recalled, as emphasised by the Commission, that the validity of provisions of secondary law cannot be examined in the light of rules of the same rank (judgment of 15 April 2021, Netherlands v Council and Parliament, C‑733/19, EU:C:2021:272, paragraph 44).
89It follows from all the foregoing considerations that consideration of the first question in Case C‑364/24 as well as the first to third questions and the first part of the fifth question in Case C‑393/24 has disclosed no factor of such a kind as to affect the validity of Article 26c(1) and (3) of Directive 2001/18 in the light of Article 3 TEU, Articles 18, 26, 34 to 36, 114 TFEU, Article 216(2) TFEU, Articles 16 and 21 of the Charter and the principles of non-discrimination and proportionality.
The second question in Case C‑364/24
90In view of the answer given to the first question in Case C‑364/24, it is not necessary to answer the second question referred in that case.
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
91By 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.
92In 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.
The fourth question in Case C-393/24
93By 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.
94The question referred should be reformulated as asking, in essence, whether Article 26c(1) and (3) of Directive 2001/18 must be interpreted as meaning that the decisions adopted by the Commission on the basis of those provisions must be covered by one of the grounds referred to in points (a) to (g) of the first subparagraph of Article 26b(3) of that directive.
95As has been stated in paragraphs 38 to 41 of the present judgment, Article 26c(1) and (3) of Directive 2001/18 allowed Member States, in the transitional period from 2 April until 3 October 2015, to demand the prohibition of the cultivation of GMOs in all or part of their territory, without being required to provide any specific justification, as such a demand could not prosper without the tacit consent of the holder of the authorisation for the GMO in question.
96It is only in the absence of a demand for the prohibition of cultivation by a Member State or in the case of opposition to that demand by the holder of the authorisation for the GMOs in question, in the form of confirmation, by that person, of the geographical scope of the authorisation as initially requested, that Article 26c(4) of Directive 2001/18 refers to the application, mutatis mutandis, of Article 26b(3) of that directive. In the absence of consent by the holder of the authorisation for the GMOs in question, Article 26b(3) of Directive 2001/18 makes the adoption by a Member State of measures restricting or prohibiting the cultivation of a GMO or a group of GMOs in all or part of its territory conditional on the measures being in conformity with EU law, reasoned, proportional and non-discriminatory and based on compelling grounds such as those referred to in points (a) to (g) in the first subparagraph of Article 26b(3) of that directive.
97Consequently, the answer to the fourth question in Case C‑393/24 is that Article 26c(1) and (3) of Directive 2001/18 must be interpreted as meaning that the decisions adopted on the basis of those provisions, which are not conditional on any specific justification, must not necessarily be covered by one of the grounds set out in points (a) to (g) in the first subparagraph of Article 26c(3) of that directive.
The second part of the fifth question in Case C‑393/24
98Last, 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.
99Under Article 33 of Directive 2001/18, Member States are to determine the penalties applicable to breaches of the national provisions adopted pursuant to that directive. Those penalties must be effective, proportionate and dissuasive.
100In 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 directive, it is for the Member States to provide for effective, proportionate and dissuasive penalties, in accordance with Article 33 of Directive 2001/18, in the event that those provisions are infringed.
101It 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.
Costs
102Since these proceedings are, for the parties to the main proceedings, a step in the actions pending before the referring courts, the decision on costs is a matter for those courts. Costs incurred in submitting observations to the Court, other than the costs of those parties, are not recoverable.
Operative part
On those grounds, the Court (First Chamber) hereby rules:
1.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 (Zea mays L.) MON 810 (MON-ØØ81Ø-6).
2.Article 26c(1) and (3) of Directive 2001/18, as modified by Directive 2015/412,must be interpreted as meaning that the decisions adopted on the basis of those provisions, which are not conditional on any specific justification, must not necessarily be covered by one of the grounds set out in points (a) to (g) of the first subparagraph of Article 26b(3) of Directive 2001/18, as amended by Directive 2015/412.
3.Implementing Decision 2016/321must be interpreted as not precluding national legislation which imposes a penalty for the non-compliance with the prohibition provided for therein.
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