Opinion of the Advocate General — ECLI:EU:C:2025:489
Date: 2025-06-26
Language of the case: Italian

Summary C-364/24 – 1 
Case C-364/24 [Dalfardo] i 
Summary of the request for a preliminary ruling pursuant to Article 98(1) of 
the Rules of Procedure of the Court of Justice 
Date lodged: 
17 May 2024 
Referring court: 
Consiglio di Stato (Italy) 
Date of the decision to refer: 
14 May 2024 
Applicant at first instance and appellant: 
PH, on his own account and as owner of the agricultural holding ‘In 
Trois’ 
Defendant at first instance and respondent: 
Ministero dell’Agricoltura, della Sovranità Alimentare e delle 
Foreste 
  
Subject matter of the main proceedings 
Action brought against an act of the Ministero delle Politiche Agricole, Alimentari 
e Forestali (Ministry of Agricultural, Food and Forestry Policies) ordering the 
destruction of certain MON 810 genetically modified maize crops, and against the 
penalty resulting from the applicant’s failure to comply with that measure, 
claiming that the decision at issue is unlawful. 
Subject matter and legal basis of the request 
The reference for a preliminary ruling, made by the Consiglio di Stato (Council of 
State) pursuant to Article 267 TFEU, concerns the compatibility of Articles 26b 
and 26c of Directive 2001/18/EC with certain provisions of Regulation 
No 1829/2003, of the TEU, of the TFEU and of the Charter of Fundamental 
 
i The name of the present case is fictitious. It does not correspond to the real name of any of the parties to the proceedings. 
EN 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-364/24 
 
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Rights of the European Union, and the determination of whether those articles are 
unlawful. In addition, if those articles are found to be unlawful, the question arises 
as to whether that would result in Commission Implementing Decision (EU) 
2016/321, adopted on the basis of Article 26c of Directive 2001/18/EC, being 
invalid. 
Questions referred for a preliminary ruling 
(1) Are Articles 26b and 26c of Directive 2001/18/EC, as amended by Directive 
(EU) 2015/412, 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? 
(2) If the above question is answered in the negative, may Commission 
Implementing Decision (EU) 2016/321 of 3 March 2016, adopted on the basis of 
Article 26c of Directive 2001/18/EC, 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? 
Provisions of European Union law and case-law relied on 
Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 
22 September 2003 on genetically modified food and feed; Article 34 
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, Articles 22 and 23 and 
26b and 26c introduced by Directive (EU) 2015/412 
Directive (EU) 2015/412 of the European Parliament and of the Council of 
11 March 2015 amending Directive 2001/18/EC as regards the possibility for the 
Member States to restrict or prohibit the cultivation of genetically modified 
organisms (GMOs) in their territory;  
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); recitals 6 to 8 
Treaty on European Union (TEU); Articles 3, 6(1) and 19(1) 
Treaty on the Functioning of the European Union (TFEU); Articles 2, 3, 26, 34, 
35 and 36  
Charter of Fundamental Rights of the European Union; Articles 16 and 52  
DALFARDO 
 
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Judgments of the Court of Justice of 6 September 2012, Pioneer Hi Bred Italia, 
C-36/11, and of 13 September 2017, C-111/16, and order of 23 November 2017 in 
Case C-107/16 
Provisions of national law relied on 
Article 35 bis of decreto legislativo 8 luglio 2003, n. 224, “Attuazione della 
direttiva 2001/18/CE concernente l'emissione deliberata nell'ambiente di 
organismi geneticamente modificati” (Legislative Decree No 224 of 8 July 2003, 
‘Implementation of Directive 2001/18/EC on the deliberate release into the 
environment of genetically modified organisms’), as introduced by decreto 
legislativo 14 novembre 2016, n. 227, “Attuazione della direttiva (UE) 2015/412, 
che modifica la direttiva 2001/18/CE per quanto concerne la possibilità per gli 
Stati membri di limitare o vietare la coltivazione di organismi geneticamente 
modificati (OGM) sul loro territorio” (Legislative Decree No 227 of 14 November 
2016, ‘Implementation of Directive (EU) 2015/412 amending Directive 
2001/18/EC as regards the possibility for the Member States to restrict or prohibit 
the cultivation of genetically modified organisms (GMOs) in their territory’: 
‘Penalties relating to Title III-bis: 
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 fails to have 
regard to: 
(a) prohibitions banning cultivation introduced by an adjustment to the 
geographical scope laid down, in the cases provided for, by one of the following 
measures: 
(1) authorisation granted by the European Commission pursuant to Articles 7 and 
19 of Regulation (EC) No 1829/2003; 
(2) consent issued by the competent national authority of a Member State pursuant 
to Articles 15, 17 and 18 of Directive 2001/18/EC; 
(3) 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 banning cultivation adopted pursuant to paragraph 6 of Article 26-
quater; 
(c) temporary prohibitions on the planting of the GMO(s) concerned provided for 
in paragraph 5(b) of Article 26-quater and paragraph 3 of Article 26-sexies. 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-364/24 
 
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2. Offenders shall be subject, pursuant to an injunction, to an ancillary 
administrative penalty consisting of the suspension, for up to six months, of the 
authorisation to cultivate GMOs conferred under the marketing measures. 
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 the inspection in the course of a procedure involving the persons 
concerned in which they are given the opportunity to be heard. 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 
implement the order against those involved and shall recover the sums advanced. 
(…)’. 
Succinct presentation of the facts and procedure in the main proceedings 
1 The applicant in the main proceedings (‘the applicant’) is the owner of an 
agricultural holding. On some of his land, he cultivated 16 rows of MON 810 
GMO maize, type DKC 6729 YG and DKC 5741 YG, planted in the 2021 sowing 
year. 
2 On 8 September 2021, an inspection was carried out on that land and samples 
were taken, which were then tested for the presence of GMOs. 
3 By order No 511800 of 14 October 2021, appealed at first instance, the Ministry 
of Agriculture, Food and Forestry Policies (‘the Ministry’) stated that the samples 
taken from the applicant’s land and analysed in the laboratory showed the 
presence of the CaMV 355 transgenic promoter, and thus the presence of GMOs 
in the maize crops on the land used. 
4 Since the cultivation of MON 810 genetically modified maize is prohibited in 
Italy under Commission Implementing Decision (EU) 2016/321 of 3 March 2016, 
the Ministry imposed on the applicant the penalty provided for in Article 35-bis of 
Legislative Decree No 224 of 8 July 2003. 
5 Pursuant to that penalty, the applicant should have destroyed the GMO crops 
unlawfully planted on his land and restored the areas affected to their original 
condition at his own expense, at the latest five days from notification of the 
measure at issue. The applicant was also advised that, if he did not comply with 
the request within the above-mentioned period, the administration would itself 
proceed with the destruction and would then recover from the applicant the sums 
advanced for that purpose. 
DALFARDO 
 
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6 On 19 October 2021, since the applicant had not complied with the order to 
destroy the GMO maize cultivated, the administration proceeded to remove it. 
7 The applicant brought an action before the Tribunale Amministrativo Regionale 
per il Friuli Venezia Giulia (Regional Administrative Court, Friuli-Venezia 
Giulia) against the decision at issue, claiming that it was unlawful both on the 
ground of defects inherent in the act itself and on the ground of derived 
unlawfulness, in so far as it was adopted on the basis of provisions of national and 
EU law that were incompatible with EU law. 
8 After the Regional Administrative Court, Friuli-Venezia Giulia had dismissed his 
action, the applicant brought an appeal before the referring court. 
The essential arguments of the parties in the main proceedings 
9 The applicant stated that he had sown maize crops with GMOs solely for research 
purposes and in order for the issue of the lawfulness of Directive 412/2015/EU to 
be raised before the Court of Justice. In particular, he submits that Articles 26b 
and 26c of Directive 2001/18/EEC, introduced by Directive 2015/415, are 
unlawful, and that therefore Commission Implementing Decision 2016/321, 
adopted on the basis of Article 26c of that directive, is also unlawful. 
10 The applicant claims that MON 810 maize was authorised for cultivation by 
Commission Decision 294/1998 on the basis of Article 19 of Directive 
2001/18/EC and on the basis of paragraph 74 of the judgment of the Court of 
Justice in Case C-36/11; according to the applicant, therefore, once a GMO maize 
has obtained authorisation for cultivation and benefits from full and complete 
freedom of movement, it is for the Member State, not an individual, to justify the 
derogation from the free movement of those goods. 
11 The applicant argues that Directive 2001/18/EC is contrary to Article 36 TFEU in 
two respects: on the one hand, it allows the introduction of a prohibition on 
cultivation – known as the ‘adjustment of the geographical scope’ – of a GMO 
authorised on the basis of a simple and unreasoned demand by the Member State 
to the holder of the authorisation and, on the other hand, it provides that a Member 
State may introduce a prohibition on cultivation on the basis of the new and 
different grounds referred to in Article 26b(3) and Article 26c(4) of that directive. 
However, Article 36 TFEU states, with regard to the free movement of goods, that 
prohibitions and restrictions are not to constitute a means of arbitrary 
discrimination or a disguised restriction on trade between Member States. 
12 In the applicant’s view, the authorisation already granted for the cultivation of 
MON 810 GMO maize shows that there is no specific risk of harm to health and 
the environment, and therefore the issue of its legitimate economic interest should 
be regarded as secondary. 
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13 The applicant adds that the total or partial prohibition of GMO cultivation is a 
disproportionate and unreasonable instrument for the appropriate and effective 
pursuit of the objective of enabling the exercise of the right to engage in business. 
He maintains that the protection of health and the environment is ensured because 
there are agronomic techniques capable of preventing the unintended presence of 
GMOs in other products grown nearby. 
14 According to the applicant, the measures provided for in Directive 2001/18/EC do 
not meet objectives of general interest recognised by the Union and are manifestly 
and irreparably contrary to the essence of the freedoms enshrined in the EU 
Treaties. 
Succinct presentation of the reasoning in the request for a preliminary ruling 
15 The referring court recalls that the cultivation of MON 810 maize was prohibited 
in Italy as a result of Commission Implementing Decision EU 2016/321. 
Authorisation for the product had initially been granted to Monsanto Europe SA, 
which had applied for renewal of the authorisation in May 2007. In view of the 
Court of Justice’s ruling in Case C-36/11, MON 810 maize had to be regarded as 
authorised in Italy on the basis of Regulation No 1829/2003, the assessment of the 
risks to health and the environment having thus been bypassed. 
16 Subsequently, Directive (EU) 2015/412 introduced the possibility for a Member 
State to request the adjustment of the geographical scope of a cultivation 
authorisation already granted, so as to exclude all or part of its territory from 
cultivation. The Italian State submitted such a request for adjustment in respect of 
MON 810 maize and, by Implementing Decision 2016/321, adopted pursuant to 
Article 26c of Directive 2001/18, the cultivation of genetically modified maize 
(Zea mays L.) MON 810 was prohibited. 
17 In those circumstances, the Italian authorities charged the applicant with the 
offence provided for in Article 35-bis of Legislative Decree No 224/2003, which 
penalises [infringements of] the cultivation bans introduced through the 
adjustment of the geographical scope. 
18 The referring court examines the applicant’s argument that the system established 
by Articles 26b and 26c of Directive 2001/18/EC has the effect of prohibiting the 
cultivation of certain GMO products in only some of the Member States, thus 
introducing conditions that could create imbalances in the internal market. 
Furthermore, as regards the geographical adjustment of authorisations, it is argued 
that this creates genuine internal barriers to the single market which impede the 
movement of products and lead to quantitative restrictions. 
19 The referring court concludes that the solution adopted in Articles 26b and 26c of 
Directive 2001/18/EC raises doubts, in so far as the latter directive grants Member 
States, in essence, a change to the geographical scope of an authorisation relating 
DALFARDO 
 
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to a GMO product, without having to provide any justification or proof of the 
existence of any serious harm. 
20 According to the referring court, the requirement that there must be a serious risk 
to human health, animal health or to the environment in order for an urgent 
suspension or modification of an authorisation to be ordered is also apparent from 
Article 34 of Regulation No 1829/2003, as interpreted by the Court of Justice in 
the order in Case C-107/16 and the judgment in Case C-111/16. Furthermore, 
citing recitals 6 to 8 in the preamble to Directive (EU) 2015/412 (which amended 
Directive 2001/18/EC), the referring court concludes that that directive did not 
seek to call into question the confidence placed in the risk assessment carried out 
when an authorisation for a GMO product was granted, and that the above-
mentioned recitals state that the opposition of certain Member States to GMOs 
stems from considerations not associated with safety for health and the 
environment. 
21 According to the referring court, it is clear, on the contrary, that Directive (EU) 
2015/412 sought to grant the Member States an area of decision-making 
autonomy, but on the basis of reasoning which appears to be forced: the 
limitations relied on by a Member State may, in its view, increase the lack of 
confidence of the citizens of that State in relation to GMO products, making it 
more difficult for them to circulate within EU territory, despite the fact that their 
production and placing on the market are covered by an authorisation issued 
pursuant to the provisions of EU law.  
22 In addition, the referring court states that Articles 26b and 26c of Directive 
2001/18/EC conflict with Article 22 of Directive 2001/18/EC, which requires 
Member States not to prohibit, restrict or impede the placing on the market of 
GMOs, and with Article 23 of that directive, which lays down a safeguard clause 
under which Member States may provisionally restrict or prohibit the use of GMO 
products if they have detailed grounds for considering that the products constitute 
a risk to health or the environment on the basis of new or additional scientific 
knowledge. In the referring court’s view, on the one hand it is reaffirmed that 
restrictions on the movement of GMO products that have already been authorised 
are permissible only if they are supported by new studies showing their danger, 
while, on the other hand, Member States are permitted to avoid the obligation to 
allow the free movement of products covered by a specific authorisation, issued 
after a risk assessment has been carried out. 
23 According to the referring court, the legal basis of Articles 26b and 26c of 
Directive 2001/18/EC does not therefore appear capable of justifying the injury to 
the rights of economic operators, which is directly linked to the ‘geographical 
adjustments’ of authorisations to produce GMO products and place them on the 
market. 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-364/24 
 
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24 In its view, such an adverse effect is not justified and cannot therefore be regarded 
as consistent with the principle of proportionality; furthermore, the rules at issue 
are liable to affect the internal market. 
25 Therefore, if Articles 26b and 26c of Directive 2001/18/EC, as amended by 
Directive (EU) 2015/412, were found to be unlawful, the question would arise as 
to whether Commission Implementing Decision 2016/321, which allowed the 
Italian State to prohibit the cultivation of MON 810 maize in Italian territory, is 
still valid. 
26 A judgment by the Court of Justice is necessary because, if it were to find that 
Articles 26b and 26c of Directive 2001/18/EC were unlawful, that would lead to 
the annulment of the penalty at issue in the main proceedings.