Provisional text

delivered on 26 June 2025 (1)

Joined Cases C‑364/24 and C‑393/24

Giorgio Fidenato, on his own account and as owner of the agricultural holding ‘In Trois’

Ministero dell’Agricoltura, della Sovranità Alimentare e delle Foreste,

other party:

WX, on his own account and as owner of the agricultural holding Li Pocis de WX (C-364/24)

(Request for a preliminary ruling from Consiglio di Stato (Council of State, Italy))

and

Giorgio Fidenato, on his own account and as owner of the agricultural holding ‘In Trois’

Ministero dell’Agricoltura, della Sovranità Alimentare e delle Foreste (C‑393/24)

(Request for a preliminary ruling from the Tribunale di Udine (District Court, Udine, Italy))

( Reference for a preliminary ruling – Deliberate release into the environment of genetically modified organisms – Directive 2001/18/EC – Article 26c(3) – Implementing Decision (EU) 2016/321 – Prohibition on the cultivation of genetically modified MON 810 maize in Italy – Validity )

I.Introduction

It seems that the cultivation of genetically modified organisms (GMOs) enjoys little support within the European Union. Thus, 35 years after the first harmonisation of the provisions on the deliberate release into the environment of GMOs, (2) only one variety of GMO is still authorised today for cultivation in the European Union: the genetically modified MON 810 maize from the undertaking Monsanto (‘MON 810 maize’). (3) That authorisation also received a mixed reception from the Member States. Indeed, some of them adopted measures to restrict or prohibit such cultivation, having recourse to various provisions of primary and secondary EU law. (4)

In that situation, in 2015, the EU legislature decided, in essence, to give carte blanche to the Member States, which may thus restrict or prohibit the cultivation of GMOs on their territories, subject only to the condition that they obtain the consent of the economic operator concerned. This has led to the creation of a system of ‘cultivation à la carte’ of GMOs within the European Union, (5) under which many Member States (6) have restricted or prohibited the cultivation of MON 810 maize on all or part of their territory.

Ten years later, the Court is called upon to assess, in the present cases, the validity of the provisions establishing that ‘cultivation à la carte’ of GMOs and the legality of the prohibition on the cultivation of MON 810 maize introduced in Italy on the basis of those provisions.

II.Legal framework

A.European Union law

1.Directive 2001/18/EC

Recital 4 of Directive 2001/18/EC (7) states:

‘Living organisms, whether released into the environment in large or small amounts for experimental purposes or as commercial products, may reproduce in the environment and cross national frontiers thereby affecting other Member States. The effects of such releases on the environment may be irreversible.’

Article 1 of that directive 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:

…

–placing on the market genetically modified organisms as or in products within the Community.’

Article 22 of the directive provides:

‘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.’

Article 33 of the same directive, entitled ‘Penalties’, provides:

‘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 2001/18 has been amended, inter alia, by Directive (EU) 2015/412. (8)

Recitals 5 to 8 of Directive 2015/412 state:

‘(5) Once a GMO is authorised for cultivation purposes in accordance with the Union legal framework on GMOs and complies, as regards the variety that is to be placed on the market, with the requirements of Union law on the marketing of seed and plant propagating material, Member States are not authorised to prohibit, restrict, or impede its free circulation within their territory, except under the conditions defined by Union law.

(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 …, should not be adversely affected by such flexibility.

(7) In the past, in order to restrict or prohibit the cultivation of GMOs, some Member State had recourse to the safeguard clauses and emergency measures pursuant to Article 23 of [Directive 2001/18] and Article 34 of Regulation (EC) No 1829/2003 [(9)] 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.’

Article 1(2) of that directive inserted Articles 26b and 26c into Directive 2001/18 (‘the contested provisions’).

Directive 2001/18, as amended by Directive 2015/412 (‘Directive 2001/18’), provides, in paragraphs 1 to 3 and 8 of Article 26b, entitled ‘Cultivation’:

‘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 … The Commission shall present the demand of the Member State to the notifier/applicant and to the other Member States without delay. …

In the absence of confirmation, the adjustment of the geographical scope of the notification/application shall be implemented …

…

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 and 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.

…

8.Measures adopted under this Article shall not affect the free circulation of authorised GMOs as, or in, products.’

Article 26c of that directive, entitled ‘Transitional measures’, provides:

‘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.

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.

2.Implementing Decision (EU) 2016/321

Implementing Decision (EU) 2016/321, (10) adopted on the basis of Article 26c(3) of Directive 2001/18, provides, in Article 1 thereof, that ‘the cultivation of [MON 810 maize] shall be prohibited in the territories listed in the Annex to this Decision’.

The territories listed in the annex to that implementing decision include, in point 8, the Italian territory.

3.Regulation No 1829/2003

Regulation No 1829/2003 supplements the legal framework applicable to GMOs for cultivation throughout the European Union as seeds or other plant propagating materials. Under Article 1(a) of that regulation, the objective of the Regulation is to ‘provide the basis for ensuring a high level of protection of human life and health, animal health and welfare, environment and consumer interests in relation to genetically modified food and feed, whilst ensuring the effective functioning of the internal market’.

Article 34 of that regulation provides for the adoption of emergency measures ‘where it is evident that products authorised by or in accordance with [that] 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 (EFSA)] …, the need to suspend or modify urgently an authorisation arises’.

B.Italian law

Article 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, (11) in the version applicable to the dispute in the main proceedings (‘Legislative Decree No 224/2003’), entitled ‘Penalties relating to Title III-bis’, provides, in paragraphs 1 to 3 thereof:

‘1. Unless the acts constitute a criminal offence, an administrative fine of between EUR 25 000 and EUR 75 000 shall be imposed on any person who infringes:

(a)prohibitions on cultivation introduced by the adjustment of the geographical scope established, in the cases provided for, by one of the following measures:

(1)an authorisation granted by the European Commission in accordance with Articles 7 and 19 of [Regulation No 1829/2003];

(2)an authorisation issued by the competent national authority of a Member State in accordance with Articles 15, 17 and 18 of [Directive 2001/18];

(3)an authorisation issued by the competent national authority referred to in Article 2(1) in accordance with Article 18(1) and, if the conditions are met, the decision taken by that authority in accordance with Article 18(3);

(b)prohibitions on cultivation adopted pursuant to Article 26-quarter, paragraph 6;

(c)temporary prohibitions on the planting of the GMO(s) concerned provided for in Article 26-quarter, paragraph 5, point (b), and Article 26-sexies, paragraph 3.

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 inspections in the course of an adversarial process with the persons concerned. The authority referred to in paragraph 4 shall order the operations necessary for that purpose and shall lay down the period within which they are to take place, after which it shall enforce the order against the obligated parties and shall recover the sums advanced.’

III.The disputes in the main proceedings, the questions referred for a preliminary ruling and the procedure before the Court

A.Case C‑364/24

The applicant in the main proceedings, Mr Fidenato, is the owner of the agricultural holding ‘In Trois’, which is located in Arba (Province of Pordenone, Italy). In 2021, ignoring the prohibition in force in Italy, the applicant began cultivating MON 810 maize on some of his land.

On 8 September 2021, an inspection was carried out on the land in question and samples were taken. By order No 511800 of 14 October 2021, the Ministero delle Politiche Agricole, Alimentari e Forestali (Ministry of Agriculture, Food and Forestry Policies) stated that analysis of those samples had shown the presence of GMOs and ordered the applicant in the main proceedings, on the basis of Article 35-bis of Legislative Decree No 224/2003, to destroy, by grinding and landfill, the GMO crops unlawfully planted on the land at issue and to restore the areas affected to their original condition at his own expense, all within a five-day period. On 19 October 2021, staff of the Forestale (State Forestry Body, Italy), having found that the applicant in the main proceedings had failed to comply, destroyed the MON 810 maize crops.

The applicant in the main proceedings brought an action against that decision before the Tribunale amministrativo regionale per il Friuli Venezia Giulia (Regional Administrative Court, Friuli-Venezia Giulia, Italy), claiming that it had been adopted on the basis of rules incompatible with primary EU law and the EU legal order. That court dismissed the action.

The applicant in the main proceedings lodged an appeal before the Consiglio di Stato (Council of State, Italy), the referring court, in the context of which he claims, in essence, that Directive 2001/18 is invalid because it allows a Member State to introduce a prohibition on the cultivation of an authorised GMO (here: MON 810 maize) on the basis of a simple, unreasoned request addressed to the authorisation holder. He also claims that that prohibition constitutes a disproportionate restriction on the freedom to conduct a business.

In that regard, the referring court asks whether the possibility provided for in the contested provisions of Member States prohibiting the cultivation of GMOs on their territory, without that prohibition being based on health or environmental considerations, is compatible with EU primary law, in particular the fundamental freedoms of the internal market, the freedom to conduct a business and, more generally, the principle of proportionality. It notes that the potential invalidity of the contested provisions could affect the validity of Implementing Decision 2016/321.

It is in those circumstances that 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)‘(1) Are [the contested provisions] 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 of Fundamental Rights of the European Union (‘the Charter’)]?

(2)If the above question is answered in the negative, may [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 [EU and FEU Treaties]?’

B.Case C‑393/24

In separate proceedings, an Italian administrative authority (12) imposed on the applicant in the main proceedings, Mr Fidenato, by an injunction of 19 June 2023, pursuant to point (a) of paragraph 1 of Article 35-bis of Legislative Decree No 224/2003, an administrative fine of EUR 50 000 for infringement of the prohibition on cultivating MON 810 maize in Italy.

By an action brought on 18 July 2023, the applicant in the main proceedings challenged that injunction before the Tribunale di Udine (District Court, Udine, Italy), the referring court, which has jurisdiction to rule on the action that relates to a sum of EUR 25 000 corresponding to the penalty imposed for the sowing of GMOs in the province of Udine.

That court has doubts, inter alia, about the validity of Directive 2001/18 and of Implementing Decision 2016/321 in the light of the fundamental principles of the EU and FEU Treaties. It asks, in that regard, whether the prohibition on the use of previously authorised seeds is compatible with the internal market, whether it is a measure having an equivalent effect to a quantitative restriction and whether that measure is compatible with Article 36 TFEU. It also asks about the validity of the contested provisions in the light of Articles 16, 18, 21 and 52 of the Charter and of international agreements concluded by the European Union.

It is in those circumstances that 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)‘(1) Are the [contested provisions] and [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 216(2) TFEU?

(2)Are the [contested provisions] and [Implementing Decision 2016/321] consistent with Articles 16 and 52 of the [Charter]?

(3)Are the [contested provisions] and [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 [MON 810 maize] seeds are permitted by, and in accordance with, the [EU and FEU Treaties] 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 [that directive], 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?’

Cases C‑364/24 and C‑393/24 were joined for the purposes of the written and oral parts of the procedure and of the judgment. Written observations were submitted by the applicant in the main proceedings, the Italian, Greek, French, Luxembourg, Hungarian and Polish Governments, and the European Parliament, the Council of the European Union and the European Commission. No hearing was held.

IV.Analysis

The referring courts are asking the Court, in essence, first, about the validity of the contested provisions and of Implementing Decision 2016/321 (13) and, second, about the interpretation of that implementing decision. (14)

I intend to structure my analysis in three parts. After a few preliminary remarks about the prohibition on the cultivation of GMOs under the contested provisions and Implementing Decision 2016/321, I will turn to the question of the admissibility of the questions referred for a preliminary ruling before analysing all the common questions put by the referring courts relating to validity of the contested provisions and Implementing Decision 2016/321, as well as the two questions, referred in Case C-393/24, concerning the interpretation of that decision.

A.Preliminary remarks on the prohibition on the cultivation of GMOs under the contested provisions

Before considering the admissibility of the questions referred for a preliminary ruling and examining their substance, I should make a few observations on the possibility of the Member States to introduce the prohibition (15) on the cultivation of GMOs on the basis of the contested provisions.

Directive 2015/412 added the contested provisions to Directive 2001/18 with effect from 2 April 2015. They each provide for a mechanism that allows the cultivation of a particular GMO to be prohibited on all or part of the territory of a Member State. As for the differences between those two mechanisms, the main difference lies in the fact that the applicability of the mechanism provided for in Article 26b of Directive 2001/18 is not subject to a time limit, whereas the mechanism laid down in Article 26c of that directive was a transitional measure, applicable only for the six months following the entry into force of Directive 2015/412. In addition, the mechanism laid down in that second provision was applicable to all authorisations granted before 2 April 2015, whereas that laid down in the first provision applies only during the authorisation procedure for a particular GMO or the renewal of an authorisation.

Notwithstanding those differences, the two mechanisms laid down in the contested provisions are similar and each provides, in essence, for the possibility of a Member State prohibiting the cultivation of a GMO following an adjustment of the geographical scope of a notification/application submitted or of an authorisation granted. That prohibition can be introduced in one or two stages, depending on the position taken by the economic operator concerned (the notifier/applicant or the holder of the previously granted authorisation) vis-à-vis the adjustment of the geographical scope of a notification/application submitted or of an authorisation granted, as requested by a Member State. If that operator does not oppose the adjustment requested (by not confirming the geographical scope of its notification/initial application/authorisation), a national measure does not have to be adopted for the prohibition to enter into force (first stage), However, if the economic operator concerned does oppose that adjustment and, therefore, the introduction of the prohibition on cultivation requested (by confirming the geographical scope of its notification/initial application/authorisation), the Member State concerned must, in order to introduce that prohibition, adopt national measures satisfying the conditions laid down in Article 26b(3) of Directive 2001/18 (second stage).

I note that the prohibition on the cultivation of MON 810 maize in Italy at issue here was introduced pursuant to a Commission implementing regulation adopted on the basis of Article 26c(3) of Directive 2001/18, that is, at the end of the first stage of the application of the transitional mechanism.

B.Admissibility

1.Observance of the requirements concerning the content of requests for a preliminary ruling

The Greek Government points out that the referring courts do not set out the information referred to in Article 94 of the Rules of Procedure of the Court of Justice for each provision of primary law mentioned in their questions. Similarly, the Italian Government argues that the first question in Case C‑393/24 is inadmissible, since the referring court has not specifically set out the reasons which prompted it to inquire about the validity of the contested provisions.

I recall that the order for reference must set out the precise reasons which led the national court to question the validity of certain provisions of EU law and set out the grounds of invalidity which, consequently, appear to it to be capable of being upheld. This is also a requirement under Article 94(c) of the Rules of Procedure. (16) It follows from the foregoing, first, that in a reference for a preliminary ruling, the Court will examine the validity of an EU act or certain provisions thereof in the light of the grounds of invalidity set out in the order for reference. Second, if there is no mention of the precise reasons which led the referring court to question the validity of that act or of those provisions, the questions relating to the invalidity thereof will be inadmissible. (17)

In the present case, although the statements of reasons are rather brief for certain questions, I am of the view that the Court has, in principle, the information necessary to answer the questions put to it. However, this is not the case, in my view, as regards the first question in Case C‑364/24 in so far as it concerns the validity of the contested provisions in the light of Articles 2 and 3 TFEU. Even taking into account the pleas in law raised in the context of the dispute in the main proceedings in that case, which are reproduced in the order for reference, and with a view to determining the scope of the review to be carried out by the Court, none of the arguments put forward concerns the validity of the contested provisions in the light of those articles of the Treaty. I therefore take the view that that part of the first question in Case C‑364/24 is inadmissible.

2.Real or artificial nature of the disputes in the main proceedings

The Parliament argues that the requests for a preliminary ruling do not satisfy the conditions for admissibility established in the judgment in Foglia. (18) The Parliament considers that the applicant in the main proceedings sought artificially to create the conditions exposing him to the effects of the prohibition on cultivating the genetically modified seeds at issue on the Italian territory and leading to him, inter alia, being ordered to destroy those seeds and having the fine provided for in Italian law imposed on him.

I do not share the Parliament’s view.

I recall that it is solely for the national court before which the 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. Consequently, where the questions submitted concern the interpretation or the validity of a rule of EU law, the Court is, in principle, bound to give a ruling. Accordingly, questions concerning EU law enjoy a presumption of relevance. (19)

It is indeed true that a request for a preliminary ruling made pursuant to Article 267 TFEU must be rejected where it appears obvious, as in the case which gave rise to the judgment in Foglia, (20) upon which the Parliament relies, that the purpose of the procedure provided for in that article has been distorted and is in reality designed to induce the Court to give a ruling by means of a fictitious dispute. (21)

However, for a dispute to be deemed to be ‘fictitious’, the parties to the main proceedings must have colluded to obtain a ruling from the Court on a question. (22) That cannot be held to be the case here from reading the requests for a preliminary ruling. First, there is nothing to indicate that the applicant in the main proceedings acted together with the administrative authorities and, second, those authorities imposed various penalties on him, a fact which is beyond doubt. In any case, for a dispute to be deemed to be ‘fictitious’, it is not enough, in my view, to establish that an individual who has infringed provisions in force and bears the actual and negative consequences of his infringement acted so as to prompt the Court to assess the validity of those provisions.

In those circumstances, the disputes in the main proceedings should not be regarded as ‘fictitious’, within the meaning of the judgment in Foglia, (23) and therefore the requests for a preliminary ruling must be deemed admissible.

3.The questions relating to the validity of Article 26b and Article 26c(4) of Directive 2001/18

The French Government disputes the admissibility of the first question in Case C‑364/24 and of the first three questions in Case C‑393/24 in so far as they concern the validity of Article 26b and Article 26c(4) of Directive 2001/18. According to that government, the questions referred for a preliminary ruling relating to those provisions are unconnected with the subject matter of the disputes in the main proceedings and concern a hypothetical issue. It asserts that the prohibition on cultivating MON 810 maize on Italian territory, which is at the heart of the two disputes in the main proceedings, is the result of Implementing Decision 2016/321, which was adopted on the basis of Article 26c(3) of Directive 2001/18.

I agree wholeheartedly with that view.

It is apparent from the actual wording of Article 267 TFEU that questions referred for a preliminary ruling must be ‘necessary’ to enable the referring court to ‘give judgment’ in the case before it. (24)

Here, the subject matter of the disputes in the main proceedings concerns, in essence, the legality of the penalties imposed on the applicant in the main proceedings on account of infringement of the prohibition on the cultivation of MON 810 maize on Italian territory, a prohibition introduced pursuant to Implementing Decision 2016/231. That decision was adopted on the basis of Article 26c(3) of Directive 2001/18. Neither Article 26b nor Article 26c(4) of that directive constitutes the basis for that implementing decision and the prohibition on the cultivation of MON 810 maize in Italy was not introduced in accordance with the rules established in those provisions.

In those circumstances, answering the questions concerning the validity of Article 26b and Article 26c(4) of Directive 2001/18 would clearly amount to providing an advisory opinion on a hypothetical question, in disregard of the task assigned to the Court in the context of the judicial cooperation established by Article 267 TFEU. (25)

)

In the light of those observations, I am therefore of the view, like the French Government, that the first question in Case C‑364/24 and the first three questions in Case C‑393/24 are inadmissible in so far as they concern the validity of Article 26b and Article 26c(4) of Directive 2001/18.

4.Conclusion on admissibility

In the light of the foregoing considerations, it is my view that the questions put by the referring courts are inadmissible in so far as they concern:

–the assessment of the validity of Article 26b and Article 26c(4) of Directive 2001/18;

–the assessment of the validity of the other paragraphs of the contested provisions as regards their validity in the light of Articles 2 and 3 TFEU.

C.Substance

1.The questions in Case C‑364/24 and the first three questions and the first part of the fifth question in Case C‑393/24

The questions referred for a preliminary ruling relating to validity concern, on the one hand, the contested provisions and, on the other hand, Implementing Decision 2016/321. (26) I note that, since that decision is based on Article 26c(3) of Directive 2001/18, its validity is dependent upon the validity of the provision forming its legal basis. While it cannot be ruled out that the implementing decision is invalid for other reasons, I would however observe that neither the referring courts nor the applicant in the main proceedings has raised any arguments to that effect. (27) It follows from the foregoing that the answer to be given to the question concerning the validity of Implementing Decision 2016/321 will turn on the answer to be given to the question concerning the validity of Article 26c(3) of Directive 2001/18.

In those circumstances, I will begin by examining the validity of Article 26c of Directive 2001/18 in so far as the questions relating to its validity are admissible. In view of the line of argument put forward in the context of the disputes in the main proceedings and in these cases, the examination of validity must relate, in my view, to paragraph 3 of that article (‘the provision at issue’), which forms the legal basis of Implementing Decision 2016/321 and which establishes the main rule for the first stage of the transitional mechanism in question in the present cases. (28) I will then consider how the outcome of that examination affects the answer to be given to the questions concerning the validity of Implementing Decision 2016/321.

(a)The validity of the provision at issue

The referring courts ask about the validity of the provision at issue in the light of various provisions of primary EU law, principles of EU law and a provision of secondary law.

I will examine the validity of that provision in turn in the light of (1) all the provisions relied upon relating to the internal market and of the principle of proportionality; (2) the principle of non-discrimination; (3) the principle of the freedom to conduct a business; (4) international agreements; and, finally, (5) Article 34 of Regulation No 1839/2003.

(1)The validity in the light of Article 3 TEU, Articles 26, 34 to 36 and 114 TFEU and the principle of proportionality

Although, in Case C‑364/24, the referring court asks the Court to assess the validity of the provision at issue in the light of Article 3 TEU, it is however apparent from the order for reference and from the line of argument put forward by the applicant in the main proceedings that that article is relied upon in so far as it provides, in paragraph 3 thereof, for the establishment of the internal market. In that context, I consider it appropriate to assess the validity of the provision at issue in the light of all the provisions and principles relied upon relating to the establishment of the internal market and of the principle of proportionality.

(i)Arguments raised

The referring courts has doubts, essentially, as to whether the prohibition, in certain Member States, on the cultivation of a genetically modified product already placed on the market, which is not based on considerations dictated by issues of health and environmental safety, contributes to the functioning of the internal market for the purposes of Article 114 TFEU. In that regard, they ask whether the EU legislature disregarded the rules on the free movement of goods and the principle of proportionality.

(ii)Assessment

It is true, as the referring courts point out, that the provision at issue, read in conjunction with Implementing Decision 2016/321 adopted on its basis, led to certain barriers being established within the internal market on account of the prohibition on the cultivation of MON 810 maize in certain Member States only. Accordingly, a product placed on the market such as, here, MON 810 maize seeds authorised for cultivation purposes cannot be used in certain Member States in accordance with its intended purpose, which affects the free movement of the product.

The free movement of goods between Member States is a fundamental principle of the FEU Treaty which is expressed in the prohibition, set out in Article 34 TFEU, of quantitative restrictions on imports between Member States and all measures having equivalent effect. (29) That 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. (30)

However, the provision at issue is a measure not of a Member State but of EU law. While that does not preclude the assessment of its validity in the light of the provisions of primary law, (31) it should however be borne in mind, in that context, that the provision at issue is based on Article 114 TFEU. That article 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.

I note, in that regard, that Article 114 TFEU is the correct legal basis for the adoption of the provision at issue. First, the contested provisions were inserted into Directive 2001/18, which was adopted on the basis of Article 95 EC (now Article 114 TFEU). There can therefore be no doubt that Directive 2015/412, which supplemented Directive 2001/18 with two articles relating exclusively to the cultivation of GMOs, has the same legal basis. Second, the provision at issue established a mechanism for introduction of the prohibition on the cultivation of GMOs common to all Member States and is, therefore, a ‘measure for approximation’ within the meaning of Article 114 TFEU.

As the Court has repeatedly held, 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. (32) Accordingly, where the application of such measures does entail certain restrictions on the free movement of goods, it is necessary to determine whether those measures nevertheless contribute to the establishment and the functioning of the internal market, within the meaning of Article 114 TFEU.

The provision at issue provides for a mechanism for introduction of the prohibition on the cultivation of GMOs by Member States. However, since that provision supplements Directive 2001/18, the measure provided for therein cannot, in my view, be analysed in isolation and, above all, without taking into consideration all the legal rules of which it forms part. In view of the fact that the provision at issue applies to GMO marketing authorisations granted on the basis of that directive and of Regulation No 1829/2003, those two acts should be taken into account in the analysis of the measure in question.

The contested provisions amend the legal framework established by those acts as regards the cultivation of GMOs. Before their entry into force, neither Directive 2001/18 nor Regulation No 1829/2003 contained specific provisions on cultivation. The general rules therefore applied to it, inter alia Article 22 of that directive. In accordance with that provision, Member States may prohibit, restrict or impede the placing on the market of GMOs, as or in products which complied with the requirements of the directive. If the Member States intended to prohibit the cultivation of GMOs placed on the market, they had to have recourse to the safeguard clauses or emergency measures pursuant to Article 23 of the same directive and Article 34 of Regulation No 1829/2003, or indeed the notification procedure set out in Article 114(5) and (6) TFEU. (33)

The addition of the contested provisions tends to indicate that the EU legislature considered, in relation to GMO seeds, that even though the risks associated with the environment and with health had already been assessed when they were placed on the market, the question of their use for cultivation purposes required the adoption of a special approach, which goes beyond the framework of the mere assessment of health or environmental risks in the strict sense. This is apparent from recital 6 of Directive 2015/412, which states that the cultivation of GMOs ‘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 that regard, I consider that the introduction, by the EU legislature, of a specific regime concerning the cultivation of GMOs cannot be considered unjustified. It is necessary to recognise the special nature of cultivation as compared with other ways of using goods. Whereas the consumption or the use of certain goods placed on the market affects, in principle, only the purchasers or users, the situation is different as regards the cultivation of plants. Such cultivation affects not only the purchasers of seeds but may have irreversible effects on the environment. In turn, the cultivation of GMOs is inter alia liable to have an irreversible impact on traditional and organic cultivation. This environmental aspect is emphasised in recital 4 of Directive 2001/18 and in recital 6 of Directive 2015/412.

I recall, in that context, that it is apparent from the case-law of the Court that, depending on the circumstances, the measures adopted on the basis of Article 114 TFEU may consist in requiring all the Member States to authorise the marketing of the product or products concerned, subjecting such an obligation of authorisation to certain conditions, or even provisionally or definitively prohibiting the marketing of a product or products. (34) This also applies, in my view, to the prohibition on cultivation.

While the strong national, regional and local dimensions of the cultivation of GMOs justifies the introduction of a special scheme, it is logical that the decision concerning the prohibition of such cultivation was entrusted to the Member States, who are best placed to be able to assess whether considerations at the national, regional and local level justify such a prohibition. This is consistent with the principle of subsidiarity enshrined in Article 2(2) TFEU.

Nevertheless, the question arises whether the measure that consists in allowing Member States to prohibit the cultivation of GMOs without them being obliged to state the reasons for their decision is appropriate having regard to the objectives pursued by the EU legislature.

In that regard, it must be stated that the issue of the release of GMOs into the environment is very complex and, as is stated in recital 7 of Directive 2015/412, gives rise to many concerns which do not only relate to issues associated with the safety of GMOs for health or the environment.

In addition, as is apparent from the case-law of the Court, when the EU legislature 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, it must be allowed a broad discretion. Only the manifestly inappropriate nature of a measure adopted in such an area in relation to the objective which the competent institutions are seeking to pursue can affect the lawfulness of such a measure. (35)

In the present cases, since the measure at issue cannot be analysed in isolation, (36) account should be taken, with regard to the objective pursued by the EU legislature, of all the rules of which that measure forms part, that is, the body of rules established by Directive 2001/18 and Regulation No 1829/2003. As is apparent from Article 1 of that directive and Article 1 of that regulation, the objective of the directive is to protect human health and the environment against the risks arising from the deliberate release of GMOs, and the objective of the regulation is to protect human life and health, animal health and welfare and environment and consumer interests, whilst ensuring the effective functioning of the internal market.

In my view, the measure introduced by the provision at issue is not manifestly inappropriate in relation to those objectives for the following reasons.

In the first place, that measure contributes to the effective functioning of the internal market for the purposes of Article 114 TFEU. Recital 7 of Directive 2015/412 states that the decision-making process in relation to the cultivation of GMOs is particularly difficult in the light of the national concerns expressed. In my view, the provision at issue can remedy that situation by simplifying the mechanism for introduction of the prohibition on the cultivation of GMOs on a territory and, in so doing, contributing to legal certainty. It is apparent from recital 8 of that directive that the grant to the Member States of the possibility of deciding whether or not they wish to cultivate GMOs on their territory is likely to improve the process for authorisation of GMOs.

In the second place, following the adoption of the provision at issue, the situation in the European Union as regards the cultivation of GMOs has become clearer, both for economic operators and for consumers. In the past, the former could not rule out, despite the cultivation of GMOs being authorised, the Member State concerned – because it did not have other means of prohibiting such cultivation – deciding nevertheless to do so by having recourse, inter alia, to the safeguard clauses or emergency measures, whether or not such recourse was actually justified. In view of the special nature of agricultural production, the risk of such a change to the legal framework was detrimental, inter alia, to the interests of farmers. As for consumers, they now have clearer information at their disposal about the presence of GMOs in the environment.

In the third place, I recall that the provision at issue concerns not the free movement of GMOs placed on the market in general terms, but simply the cultivation of GMOs. Accordingly, the prohibition of such cultivation does not affect the right of consumers or economic operators to import goods containing GMOs.

In the fourth place, the provision at issue does not lay down a general prohibition on the cultivation of GMOs in all Member States. Furthermore, Member States have the possibility to prohibit such cultivation on part of their territory or simply to restrict it, depending on the considerations prevailing at the national, regional and local level.

In the fifth place, as paradoxical as this may seem, I am of the view that the measure introduced by the provision at issue does not undermine the rights which economic operators could derive from the free movement of goods. This stems from the fact that the application of the mechanism introduced by the provision at issue is subject to the condition that the holder of the marketing authorisation does not oppose the introduction of the prohibition on the cultivation of GMOs.

First, the (tacit) consent of the holder of the marketing authorisation for a GMO to the introduction of the prohibition on the cultivation of GMOs means that the rights that that holder derives from the free movement of the goods concerned are not affected by any barrier to that free movement which results from the application of the provision at issue. Volenti non fit iniuria.

Second, other than that authorisation holder, the prohibition on the cultivation of GMOs introduced on the basis of the provision at issue affects only farmers. In the case of a product such as GMO seeds, I would observe, however, that the fact that the introduction of the prohibition on the cultivation of GMOs on a territory is subject to the consent of the holder of the marketing authorisation has the effect that those farmers cannot enforce the rights derived from the free movement of goods against the prohibition on the cultivation of GMOs.

The marketing of GMOs is strictly regulated within the European Union, in particular by Directive 2001/18 and Regulation No 1829/2003. In principle, an authorisation granted following a procedure to assess the risks associated with the deliberate release into the environment of GMOs and with their use in food and animal feed is required to market GMOs. Furthermore, the use of GMOs placed on the market is subject to compliance with the conditions contained in the marketing authorisation. In particular, under Article 19(1) of that directive, only if such consent has been given for a GMO as or in a product may that product be used without further notification throughout the European Union, in so far as the specific conditions of use and the environments and/or geographical areas stipulated in those conditions are strictly adhered to. Similarly, Articles 9 and 21 of Regulation No 1829/2003 stress the obligation on the authorisation holder and on the parties concerned to comply with any conditions or restrictions imposed in the authorisation in question.

It follows that the free movement of goods such as GMO seeds is, first and foremost, conditional on obtaining an authorisation and restricted to the strict framework of that authorisation. In that context, the provision at issue amends the existing legal framework, in that it introduces special rules for determining the geographical scope of the GMO marketing authorisation as regards cultivation. The prohibition on the cultivation of GMOs is introduced further to the limitation of the geographical scope of that authorisation, to which the authorisation holder consented. The latter’s consent for the purpose of the prohibition on the cultivation of GMOs restricts that geographical scope vis-à-vis third parties, in particular farmers. Farmers cannot therefore engage in such cultivation on a territory not covered by the marketing authorisation.

In the sixth place, turning to the referring court’s doubts regarding the lack of obligation on the Member States to state the reasons for their decision to prohibit the cultivation of GMOs on their territory, it is my view that the lack of that obligation is justified by the authorisation holder’s consent to the prohibition. As I noted in the preceding point, the prohibition of the cultivation of GMOs is just one of the factors determining the geographical scope of the marketing authorisation. That authorisation defines the authorisation holder’s rights. It is for the authorisation holder not only to apply for authorisation to market his product but also to oppose, or not, any territorial restriction of that authorisation. The authorisation holder’s position in relation to that restriction is, in that case, decisive: if he does not oppose it, there is no need for the specific reasons for introducing the prohibition on the cultivation of GMOs to be stated in each Member State.

Lastly, in the seventh and final place, with regard to the objective pursued by Directive 2001/18 and Regulation No 1829/2003 to ensure the protection of human health and of the environment against the risks arising from the deliberate release of GMOs and from their use in food and animal feed, I should point out that the addition of the provision at issue changes nothing in relation to the part of the rules established by those two acts concerning the procedures for assessment of those risks.

In the light of all the foregoing considerations, since the measure introduced by the provision at issue is not manifestly inappropriate in relation to the objectives pursued by the EU legislature, I am of the view that there is nothing in the provision at issue to suggest that the EU legislature went beyond the limits imposed by Article 114 TFEU. In particular, it does not appear that the mechanism introduced by the provision at issue constitutes an unjustified barrier to the free movement of goods.

(2)The validity in the light of Article 18 TFEU, Article 21 of the Charter and the principle of non-discrimination

(i)Arguments raised

The referring court in Case C‑393/24 asks whether there is a form of discrimination between the citizens/farmers of the different Member States as a result of the different choices made by the Member States when adjusting the geographical scope, in breach of Article 18 TFEU and Article 21 of the Charter.

The applicant in the main proceedings claims that the contested provisions introduce discrimination, both between Member States and within a Member State in so far as agricultural producers wishing to use organic or traditional production methods are favoured to the detriment of producers wishing to cultivate genetically modified plants.

(ii)Assessment

There are two components to the question as to whether discrimination exists: first, discrimination between agricultural producers carrying on their activities in Member States which authorise the cultivation of a particular GMO and agricultural producers carrying on their activities in Member States which prohibit it and, second, discrimination within a Member State that prohibits the cultivation of GMOs between agricultural producers wishing to cultivate genetically modified plants and those who do not wish to do so.

The first form of alleged discrimination concerning the difference in treatment between agricultural producers from different Member States would be on grounds of nationality.

With regard, more specifically, to the principle of non-discrimination on grounds of nationality, while Article 21(2) of the Charter sets out that principle, Article 52(2) thereof provides that rights recognised by the Charter for which provision is made in the Treaties are to be exercised under the conditions and within the limits defined by those Treaties. In that vein, Article 21(2) corresponds to the first paragraph of Article 18 TFEU, as confirmed by the Explanations relating to the Charter of Fundamental Rights (37) relating to that provision, and must be applied in accordance with that article. (38)

In that regard, Article 18 TFEU, which lays down a general principle prohibiting all discrimination on grounds of nationality, prohibits not only direct discrimination on grounds of nationality but also all indirect forms of discrimination which, by the application of other criteria of differentiation, lead in fact to the same result. (39)

It is established that Article 18 TFEU applies independently only to situations governed by EU law for which the FEU Treaty lays down no specific rules of non-discrimination. (40) Since, in the area of the free movement of goods, the principle of non-discrimination is laid down, inter alia, by Articles 34 and 35 TFEU, (41) it is necessary to assess the validity of the provision at issue in the light not of Article 18 TFEU but of Articles 34 and 35 TFEU.

In that regard, I note, in relation to GMO seeds for cultivation purposes, that they are a specific product of a particular economic operator, the provenance of which was not specified in the request for a preliminary ruling. Furthermore, as the provision at issue is not an autonomous measure of a Member State but an EU measure, the issue of the discrimination of foreign goods as compared with national goods does not arise.

As regards the discrimination between agricultural producers, I should point out that the principle of non-discrimination set out in Article 18 TFEU and Article 21 of the Charter requires that comparable situations must not be treated differently and that different situations must not be treated in the same way unless such treatment is objectively justified. (42)

However, first, the situation of farmers cultivating traditional and organic varieties and that of farmers wishing to engage in the cultivation of GMOs are not comparable. The cultivation of GMOs is characterised by its specific nature, which is, moreover, at the root of the establishment of the special legal framework applicable to it.

Second, the situations of farmers from different Member States are likewise not comparable, since agricultural production is intrinsically linked to the place of production and to the specific nature of that place. This aspect is stressed in recital 6 of Directive 2015/412 and forms the underlying premiss of the legislature’s decision to adopt the contested provisions, which I have already analysed. (43)

In those circumstances, I take the view that an examination of the questions referred for a preliminary ruling has revealed nothing capable of affecting the validity of the provision at issue in the light of Article 18 TFEU and Article 21 of the Charter.

(3)The validity in the light of Articles 16 and 52 of the Charter

(i)Arguments raised

In its first question, the referring court in Case C‑364/24 invokes Articles 16 and 52 of the Charter, without however putting forward any argument relating to the validity of the provision at issue in the light of those articles. Furthermore, the referring court in Case C‑393/24 simply finds that the general principles of EU law relating to the freedom to conduct a business, set out in Articles 16 and 52 of the Charter, can be used as criteria for assessment of the validity of the provision at issue.

As for the applicant in the main proceedings, he claims that the prohibition on the cultivation of GMOs constitutes an infringement of Articles 16 and 52 of the Charter in so far as it affects the freedom to conduct a business of farmers who wish to cultivate genetically modified plants. Such farmers cannot offer to consumers goods offered by organic producers active on territories where the cultivation of GMOs is not prohibited.

(ii)Assessment

Under Article 16 of the Charter, the freedom to conduct a business in accordance with EU law and national laws and practices is recognised. As is apparent from the explanations relating to the Charter of Fundamental Rights, (44) the right guaranteed in that provision ‘is[, of course,] to be exercised with respect for Union law and national legislation. It may be subject to the limitations provided for in Article 52(1) of the Charter’.

In addition, as the Court has observed, the freedom to conduct a business is not absolute, but must be viewed in relation to its social function. (45) It may be subject to a broad range of interventions on the part of the public authorities which may limit the exercise of economic activity in the public interest. (46)

That circumstance is reflected, inter alia, in the way in which Article 52(1) of the Charter requires the principle of proportionality to be implemented. (47)

In accordance with that provision, any limitation on the exercise of the rights and freedoms recognised by the Charter must be provided for by law, respect the essence of those rights and freedoms and, subject to the principle of proportionality, be necessary and genuinely meet objectives of general interest recognised by the European Union or the need to protect the rights and freedoms of others.

The limitation on the freedom to conduct a business arising from the prohibition on the cultivation of GMOs at issue in the present case is ‘provided for by law’, namely by the provision at issue and by Implementing Decision 2016/321. As is observed, inter alia, by the Greek Government, the prohibition on the cultivation of one GMO variety by no means prevents, in principle, the pursuit of activities by the economic operators concerned, that is, professional farmers, since that obligation is extremely limited and, therefore, respects the essence of the freedom to conduct a business. As for the proportionality of that prohibition, my analysis of the prohibition set out above (48) applies equally to the analysis of the lawfulness of the limitation on the freedom of establishment.

In those circumstances, I consider that an examination of the questions referred for a preliminary ruling has revealed nothing capable of affecting the validity of the provision at issue in the light of Articles 16 and 52 of the Charter.

(4)The validity in the light of Article 216(2) TFEU

(i)Arguments raised

The referring court in Case C‑393/24 asks whether the conclusion, by the European Union, of agreements such as the Agreement establishing the World Trade Organization (WTO) (49) and the General Agreement on Tariffs and Trade1994 (GATT), annexed to the Agreement establishing the WTO, (50) does not run counter to the restrictions imposed on the use of a product which is present only in certain Member States, which would adversely affect the internal market in authorised goods.

(ii)Assessment

As a preliminary point, and as the French and Hungarian Governments and the Council note, it is settled case-law of the Court 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 an exception based on the illegality of such an act 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 therefore 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. (51) This likewise applies to the assessment of validity in the context of a preliminary ruling procedure.

In addition, with regard to the WTO agreements, the Court has already 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. Second, it follows from settled case-law that, taking account of their nature and structure, the Agreement establishing the WTO and the agreements listed in Annexes 1 to 4 to that agreement are not in principle among the rules in the light of which the Court may review the legality of measures adopted by the EU institutions. (52)

It is 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, that the Court has accepted that it is for the Courts of the European Union, if necessary, to review the legality of an EU measure and of the measures adopted for its application in the light of those agreements or a decision of the WTO Dispute Settlement Body establishing non-compliance with those 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 act of the European Union at issue expressly refers to specific provisions of those agreements. (53)

In the present case, in adding the contested provisions, the EU legislature did not intend to give effect to a specific obligation assumed under the WTO agreements and neither Directive 2001/18 nor Directive 2015/412 expressly refers to specific provisions of those agreements.

It follows that the provision at issue cannot be found to be invalid on the basis of the WTO agreements and Article 216(2) TFEU.

(5)The validity in the light of Article 34 of Regulation No 1829/2003

(i)Arguments raised

The referring court in Case C‑364/24 asks whether the contested provisions are compatible with Article 34 of Regulation No 1829/2003. In its view, the solution adopted by the contested provisions gives rise to doubts since, in essence, the Member States are given the possibility of obtaining an adjustment of the geographical scope of an authorisation relating to a genetically modified product, without having to provide the slightest justification or evidence that a serious risk exists.

(ii)Assessment

As the Commission rightly argues, the validity of provisions of secondary law cannot be examined in the light of rules of the same rank. (54)

Furthermore, as the French Government notes, the procedure established by the contested provisions and that established by Article 34 of Regulation No 1829/2003 are not mutually exclusive and are reconcilable by virtue of their separate subject matter and rules.

The provision at issue gave the Member States the possibility to prohibit the cultivation of GMOs on their territory, provided that the relevant authorisation holder does not oppose such prohibition. For its part, Article 34 of Regulation No 1829/2003 provides for the possibility of adopting emergency measures where it is evident that products authorised by or in accordance with that 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 EFSA, the need to suspend or modify urgently an authorisation arises. That provision can apply to the prohibition on the cultivation of GMOs in Member States which have not prohibited it on the basis of the provision at issue. The authorisation of such cultivation in a territory does not preclude the possibility of adopting emergency measures subsequently where the conditions laid down in that article are met.

It follows that the provision at issue cannot be found to be invalid on the basis of Article 34 of Regulation No 1829/2003.

(6)Conclusion on the validity of the provision examined

In the light of the foregoing, I would observe that an examination of the questions referred for a preliminary ruling has revealed nothing capable of affecting the validity of the provision at issue.

(b)The validity of Implementing Decision 2016/321

As I have observed, (55) first, Implementing Decision 2016/321 was adopted on the basis of Article 26c(3) of Directive 2001/18 and, second, the referring courts, the applicant in the main proceedings and the institutions and governments which have submitted written observations have not raised any argument to the effect that the invalidity of Implementing Decision 2016/321 could relate to reasons other than the invalidity of the article forming its basis.

In that situation, given my assessment concerning the validity of the provision at issue, I propose that the Court take the view that an examination of the questions referred for a preliminary ruling has revealed nothing capable of affecting the validity of Implementing Decision 2016/321.

Furthermore, since the second question in Case C‑364/24 is submitted in the event that the contested decisions are found to be invalid, there is no need to answer it.

(c)Interim conclusion on validity

In the light of the foregoing, it is my view that an examination of the questions referred for a preliminary ruling has revealed nothing capable of affecting the validity of Article 26c(3) of Directive 2001/18 or of Implementing Decision 2016/321.

2.The fourth question referred in Case C‑393/24

The fourth question in Case C‑393/24 concerns, in essence, the question whether Implementing Decision 2016/321 must be interpreted as meaning that the introduction of the prohibition on the cultivation of MON 810 maize provided for therein is based on compelling grounds set out in Article 26b(3)(a) to (g) of Directive 2001/18.

As is apparent from my analysis of the validity of the provision at issue, (56) the introduction of the prohibition on the cultivation of GMOs pursuant to that provision is not subject to the presentation of specific grounds, such as those set out in Article 26b(3)(a) to (g) of Directive 2001/18. Indeed, Article 26b(3) of that directive does not apply to the prohibition on cultivation introduced on the basis of Article 26c(3) of the directive.

In those circumstances, I propose that the fourth question in Case C‑393/24 is answered to the effect that Implementing Decision 2016/321 must be interpreted as meaning that the grounds for the prohibition on the cultivation of MON 810 maize introduced by that implementing decision are not defined in Article 26b(3)(a) to (g) of Directive 2001/18.

3.The second part of the firth question in Case C‑393/24

The second part of the fifth question in Case C‑393/24 concerns the question whether Implementing Decision 2016/321 precludes national rules sanctioning non-compliance with the prohibition provided for in that implementing decision.

In that connection, Article 33 of Directive 2001/18 lays down the obligation on Member States to determine the penalties applicable to breaches of the national provisions adopted pursuant to that directive. Those penalties are to be effective, proportionate and dissuasive.

Although Article 33 of Directive 2001/18 concerns the infringement of national provisions whereas, formally speaking, the prohibition on the cultivation of GMOs in Italy stems from an act of EU law, I take the view that that provision also applies, a fortiori, to the prohibition provided for in Implementing Decision 2016/321. This is particularly so since that implementing decision, whilst it is an act of EU law, is based on the decisions adopted by Member States to prohibit the cultivation of GMOs on their territories.

I therefore propose that the Court answer the second part of the fifth question in Case C‑393/24 to the effect that Implementing Decision 2016/321 does not preclude national rules sanctioning non-compliance with the prohibition provided for in that implementing decision.

In the light of all the foregoing considerations, I propose that the Court of Justice answer the questions referred for a preliminary ruling by the Consiglio di Stato (Council of State, Italy) and the Tribunale di Udine (District Court, Udine, Italy) as follows:

(1)An examination of the questions referred for a preliminary ruling has revealed nothing capable of affecting the validity of Article 26c(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)Implementing Decision 2016/321

must be interpreted as meaning that the grounds for the prohibition on the cultivation of genetically modified maize (Zea mays L.) MON 810 (MON-ØØ81Ø-6) introduced therein are not defined in Article 26c(3)(a) to (g) of Directive 2001/18, as amended by Directive (EU) 2015/412.

(3)Implementing Decision 2016/321

must be interpreted as not precluding national rules sanctioning non-compliance with the prohibition provided for in that implementing decision.

—

1Original language: French.

2Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (OJ 1990 L 117, p. 15).

3Commission Decision 98/294/EC of 22 April 1998 concerning the placing on the market of genetically modified maize (Zea mays L. line MON 810), pursuant to Council Directive 90/220 (OJ 1998 L 131, p. 32).

4Several national measures have been challenged before the Court in the context of requests for a preliminary ruling. See, inter alia, judgments of 8 September 2011, Monsanto and Others (C‑58/10 to C‑68/10, EU:C:2011:553); of 6 September 2012, Pioneer Hi Bred Italia (C‑36/11, EU:C:2012:534); of 13 September 2017, Fidenato and Others (C‑111/16, EU:C:2017:676); and of 7 July 2022, PH (Regional ban on the cultivation of GMOs) (C‑24/21, EU:C:2022:526).

5See Dubouis, L., and Blumann, C., Droit matériel de l’Union européenne, LGDJ, 7th ed., Paris, 2015, paragraph 322.

6There are 18 such Member States at present: the Kingdom of Belgium (but only in Wallonia), the Republic of Bulgaria, the Kingdom of Denmark, the Federal Republic of Germany (except for research purposes), the Hellenic Republic, the French Republic, the Republic of Croatia, the Italian Republic, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Grand Duchy of Luxembourg, Hungary, the Republic of Malta, the Kingdom of the Netherlands, the Republic of Austria, the Republic of Poland and the Republic of Slovenia.

7Directive 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 (OJ 2001 L 106, p. 1).

8Directive of the European Parliament and of the Council 11 March 2015 amending Directive 2001/18 (OJ 2015 L 68, p. 1).

9Regulation of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (OJ 2003 L 268, p. 1).

10Commission Implementing Decision 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).

11GURI No 194 of 22 August 2003, p. 14.

12The 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).

13Referred to in all the questions in Case C‑364/24 and in the first three questions and the first part of the fifth question in Case C‑393/24.

14Referred to in the fourth question and the second part of the fifth question in Case C‑393/24.

15As is apparent from the legal framework set out in this Opinion, the contested provisions allow not only for the possibility of prohibiting the cultivation of GMOs but also for restricting such cultivation. In view of Implementing Decision 2016/321, which provides for the prohibition on the cultivation of MON 810 maize in Italy, I will refer, in this Opinion, only to the prohibition on the cultivation of GMOs, unless reference to restriction is particularly necessary. My considerations concerning the prohibition on the cultivation of GMOs introduced on the basis of the contested provisions, or on one of them, do however also apply, mutatis mutandis, to the restriction of such cultivation introduced on the basis of those provisions.

16Judgment of 22 June 2023, Vitol (C‑268/22, EU:C:2023:508, paragraph 53 and the case-law cited).

17Judgment of 22 June 2023, Vitol (C‑268/22, EU:C:2023:508, paragraph 55 and the case-law cited).

18Judgment of 11 March 1980 (104/79, EU:C:1980:73).

19Judgment of 16 June 2015, Gauweiler and Others (C‑62/14, EU:C:2015:400, paragraphs 24 and 25 and the case-law cited).

20Judgment of 11 March 1980 (104/79, EU:C:1980:73).

21Order of 17 December 2019, Di Girolamo (C‑618/18, EU:C:2019:1090, paragraph 27 and the case-law cited).

22See, to that effect, judgment of 13 July 2000, Idéal tourisme (C‑36/99, EU:C:2000:405, paragraph 22).

23Judgment of 11 March 1980 (104/79, EU:C:1980:73).

24Judgment of 26 March 2020, Miasto Łowicz and Prokurator Generalny (C‑558/18 and C‑563/18, EU:C:2020:234, paragraph 45 and the case-law cited).

25See, to that effect, judgment of 22 February 2022, Stichting Rookpreventie Jeugd and Others (C‑160/20, EU:C:2022:101, paragraph 84 and the case-law cited).

26In Case C‑364/24, the second question concerns the possibility of disapplying Implementing Decision 2016/321 and declaring it ‘ineffective’ if the contested provisions are invalid. I interpret that question as concerning, in reality, the validity of Implementing Decision 2016/321.

27In Case C‑393/24, the fifth question concerns the validity of Implementing Decision 2016/321 in the light of the whole body of rules governing GMOs in the ‘single European market’. However, the referring court does not put forward any argument which would justify assessing the validity of that decision in the light of provisions other than Article 26c(3) of Directive 2001/18, which forms the legal basis for that implementing decision.

28See points 33 and 34 of this Opinion. I note that although paragraphs 1, 5 and 6 of Article 26c of Directive 2001/18 supplement the legal framework that defines the first stage of the transitional mechanism, they nevertheless also apply to the second stage of it. Accordingly, the possible invalidity of the provision at issue cannot result in the invalidity of those paragraphs, which would continue to apply to the second stage of that mechanism. Moreover, while paragraph 2 is concerned solely with the first stage of that mechanism, it applies not to an authorisation that has already been granted but to pending notifications/applications. It is therefore not relevant to the present cases.

29Judgment of 21 December 2023, CDIL (C‑96/22, EU:C:2023:1025, paragraph 31 and the case-law cited).

30Judgment of 21 December 2023, CDIL (C‑96/22, EU:C:2023:1025, paragraph 33 and the case-law cited).

31See, to that effect, judgments of 9 August 1994, Meyhui (C‑51/93, EU:C:1994:312, paragraph 11), and of 12 July 2012, Association Kokopelli (C‑59/11, EU:C:2012:447, paragraph 80 and the case-law cited).

32Judgment of 22 June 2017, E.ON Biofor Sverige (C‑549/15, EU:C:2017:490, paragraph 49 and the case-law cited).

33See recital 7 of Directive 2015/412.

34Judgment of 3 December 2019, Czech Republic v Parliament and Council (C‑482/17, EU:C:2019:1035, paragraph 61 and the case-law cited).

35Judgment of 22 June 2017, E.ON Biofor Sverige (C‑549/15, EU:C:2017:490, paragraph 50 and the case-law cited).

36See point 62 of this Opinion.

37OJ 2007 C 303, p. 17.

38Judgment 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).

39Judgment 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 312 and the case-law cited).

40Judgment of 20 June 2024, Faurécia (C‑420/23, EU:C:2024:534, paragraph 18 and the case-law cited).

41Judgment of 7 March 2024, Fallimento Esperia and GSE (C‑558/22, EU:C:2024:209, paragraph 39).

42Judgment 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 308 and the case-law cited).

43See points 64 and 65 of this Opinion.

44OJ 2007 C 303, p. 17 (Explanation on Article 16 - Freedom to conduct a business).

45Judgment of 12 January 2023, TP (Audiovisual editor for public television) (C‑356/21, EU:C:2023:9, paragraph 75 and the case-law cited).

46Judgment of 22 January 2013, Sky Österreich (C‑283/11, EU:C:2013:28, paragraph 46).

47Judgment of 22 January 2013, Sky Österreich (C‑283/11, EU:C:2013:28, paragraph 47).

48See points 68 to 84 of this Opinion.

49Agreement establishing the World Trade Organization (WTO), signed in Marrakesh on 15 April 1994 and approved by 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).

50OJ 1994 L 336, p. 3.

51Judgment of 28 September 2023, Changmao Biochemical Engineering v Commission (C‑123/21 P, EU:C:2023:708, paragraph 69 and the case-law cited).

52Judgment 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).

53Judgment 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).

54Judgment of 15 April 2021, Netherlands v Council and Parliament (C‑733/19, EU:C:2021:272, paragraph 44).

55See point 51 of this Opinion.

56See point 82 of this Opinion.