# 62021CJ0024

JUDGMENT OF THE COURT (Second Chamber)

7 July 2022 (
  *1
  )

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(Reference for a preliminary ruling – Agriculture – Genetically modified food and feed – Regulation (EC) No 1829/2003 – Deliberate release into the environment of genetically modified organisms – Directive 2001/18/EC – Article 26a – Possibility for Member States to take appropriate measures to avoid the unintended presence of genetically modified organisms in other products – Conditions of application – Principle of proportionality – Guidelines for the development of national coexistence measures to avoid the unintended presence of genetically modified organisms in conventional and organic crops – Measure adopted by an infra-State body prohibiting on its territory the cultivation of genetically modified maize)

In Case C‐24/21,

REQUEST for a preliminary ruling under Article 267 TFEU from the Tribunale ordinario di Pordenone (District Court, Pordenone, Italy), made by decision of 4 January 2021, received at the Court on 14 January 2021, in the proceedings

PH

PH

v

Regione Autonoma Friuli Venezia Giulia,

Regione Autonoma Friuli Venezia Giulia,

Direzione centrale risorse agroalimentari, forestali e ittiche – Servizio foreste e corpo forestale della Regione Autonoma Friuli Venezia Giulia,

Direzione centrale risorse agroalimentari, forestali e ittiche – Servizio foreste e corpo forestale della Regione Autonoma Friuli Venezia Giulia,

THE COURT (Second Chamber),

composed of A. Prechal (Rapporteur), President of the Chamber, J. Passer, F. Biltgen, N. Wahl and M.L. Arastey Sahún, Judges,

Advocate General: M. Szpunar,

Registrar: A. Calot Escobar,

having regard to the written procedure,

after considering the observations submitted on behalf of:

| – | PH, by G. Martorana, avvocato, |
| --- | --- |

–

PH, by G. Martorana, avvocato,

| – | the Regione Autonoma Friuli Venezia Giulia, by B. Croppo, D. Iuri and E. Massari, avvocati, |
| --- | --- |

–

the Regione Autonoma Friuli Venezia Giulia, by B. Croppo, D. Iuri and E. Massari, avvocati,

| – | the Italian Government, by G. Palmieri, acting as Agent, and P. Gentili, avvocato dello Stato, |
| --- | --- |

–

the Italian Government, by G. Palmieri, acting as Agent, and P. Gentili, avvocato dello Stato,

| – | the European Commission, by F. Castilla Contreras, I. Galindo Martín and F. Moro, acting as Agents, |
| --- | --- |

–

the European Commission, by F. Castilla Contreras, I. Galindo Martín and F. Moro, acting as Agents,

having decided, after hearing the Advocate General, to proceed to judgment without an Opinion,

gives the following

Judgment

Judgment

| 1 | This request for a preliminary ruling concerns the interpretation of Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ 2001 L 106, p. 1), as amended by Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 (OJ 2003 L 268, p. 1) (‘Directive 2001/18’), read in the light of Regulation No 1829/2003 and the Commission Recommendation of 13 July 2010 on guidelines for the development of national coexistence measures to avoid the unintended presence of GMOs in conventional and organic crops (OJ 2010 C 200, p. 1; ‘the recommendation of 13 July 2010’) and Articles 34, 35 and 36 TFEU. |
| --- | --- |

1

This request for a preliminary ruling concerns the interpretation of Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ 2001 L 106, p. 1), as amended by Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 (OJ 2003 L 268, p. 1) (‘Directive 2001/18’), read in the light of Regulation No 1829/2003 and the Commission Recommendation of 13 July 2010 on guidelines for the development of national coexistence measures to avoid the unintended presence of GMOs in conventional and organic crops (OJ 2010 C 200, p. 1; ‘the recommendation of 13 July 2010’) and Articles 34, 35 and 36 TFEU.

| 2 | The request has been made in the course of proceedings between, on the one hand, PH and, on the other hand, the Regione Autonoma Friuli Venezia Giulia (Autonomous Region of Friuli Venezia Giulia, Italy) (‘the FVG region’) and the Direzione centrale risorse agroalimentari, forestali e ittiche – Servizio foreste e corpo forestale della Regione Autonoma Friuli Venezia Giulia (Central Directorate for Agricultural, Food, Forestry and Fisheries Resources – Forestry Service and Forestry Corps of the Autonomous Region of Friuli Venezia Giulia, Italy) regarding an order imposing a fine on PH for breach of the ban on the cultivation of genetically modified maize. |
| --- | --- |

2

The request has been made in the course of proceedings between, on the one hand, PH and, on the other hand, the Regione Autonoma Friuli Venezia Giulia (Autonomous Region of Friuli Venezia Giulia, Italy) (‘the FVG region’) and the Direzione centrale risorse agroalimentari, forestali e ittiche – Servizio foreste e corpo forestale della Regione Autonoma Friuli Venezia Giulia (Central Directorate for Agricultural, Food, Forestry and Fisheries Resources – Forestry Service and Forestry Corps of the Autonomous Region of Friuli Venezia Giulia, Italy) regarding an order imposing a fine on PH for breach of the ban on the cultivation of genetically modified maize.

Legal framework

Legal framework

European Union law

European Union law

Directive 2001/18

Directive 2001/18

| 3 | Article 1 of Directive 2001/18, entitled ‘Objective’, provides:
  ‘In accordance with the precautionary principle, the objective of this Directive is to approximate the laws, regulations and administrative provisions of the Member States and to protect human health and the environment when:





  – | carrying out the deliberate release into the environment of genetically modified organisms [(GMOs)] for any other purposes than placing on the market within the [European Union], |
| --- | --- | --- |

3

Article 1 of Directive 2001/18, entitled ‘Objective’, provides:

‘In accordance with the precautionary principle, the objective of this Directive is to approximate the laws, regulations and administrative provisions of the Member States and to protect human health and the environment when:

–

carrying out the deliberate release into the environment of genetically modified organisms [(GMOs)] for any other purposes than placing on the market within the [European Union],

| – | placing on the market [GMOs] as or in products within the [European Union].’ |
| --- | --- |

–

placing on the market [GMOs] as or in products within the [European Union].’

| 4 | Article 4 of that directive, entitled ‘General obligations’, provides:
  ‘1.   Member States shall, in accordance with the precautionary principle, ensure that all appropriate measures are taken to avoid adverse effects on human health and the environment which might arise from the deliberate release or the placing on the market of GMOs. GMOs may only be deliberately released or placed on the market in conformity with part B or part C respectively [which make that release and placing on the market subject to prior authorisation].
  ...’ |
| --- | --- |

4

Article 4 of that directive, entitled ‘General obligations’, provides:

‘1.   Member States shall, in accordance with the precautionary principle, ensure that all appropriate measures are taken to avoid adverse effects on human health and the environment which might arise from the deliberate release or the placing on the market of GMOs. GMOs may only be deliberately released or placed on the market in conformity with part B or part C respectively [which make that release and placing on the market subject to prior authorisation].

...’

| 5 | Article 22 of that directive, entitled ‘Free circulation’, states:
  ‘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.’ |
| --- | --- |

5

Article 22 of that directive, entitled ‘Free circulation’, states:

‘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.’

| 6 | Article 23 of the same directive, entitled ‘Safeguard clause’, provides, in the first and second subparagraphs of paragraph 1:
  ‘Where a Member State, as a result of new or additional information made available since the date of the consent and affecting the environmental risk assessment or reassessment of existing information on the basis of new or additional scientific knowledge, has detailed grounds for considering that a GMO as or in a product which has been properly notified and has received written consent under this Directive constitutes a risk to human health or the environment, that Member State may provisionally restrict or prohibit the use and/or sale of that GMO as or in a product on its territory.
  The Member State shall ensure that in the event of a severe risk, emergency measures, such as suspension or termination of the placing on the market, shall be applied, including information to the public.’ |
| --- | --- |

6

Article 23 of the same directive, entitled ‘Safeguard clause’, provides, in the first and second subparagraphs of paragraph 1:

‘Where a Member State, as a result of new or additional information made available since the date of the consent and affecting the environmental risk assessment or reassessment of existing information on the basis of new or additional scientific knowledge, has detailed grounds for considering that a GMO as or in a product which has been properly notified and has received written consent under this Directive constitutes a risk to human health or the environment, that Member State may provisionally restrict or prohibit the use and/or sale of that GMO as or in a product on its territory.

The Member State shall ensure that in the event of a severe risk, emergency measures, such as suspension or termination of the placing on the market, shall be applied, including information to the public.’

| 7 | Article 26a of Directive 2001/18, entitled ‘Measures to avoid the unintended presence of GMOs’, provides:
  ‘1.   Member States may take appropriate measures to avoid the unintended presence of GMOs in other products.
  2.   The Commission shall gather and coordinate information based on studies at [EU] and national level, observe the developments regarding coexistence in the Member States and, on the basis of the information and observations, develop guidelines on the coexistence of genetically modified, conventional and organic crops.’ |
| --- | --- |

7

Article 26a of Directive 2001/18, entitled ‘Measures to avoid the unintended presence of GMOs’, provides:

‘1.   Member States may take appropriate measures to avoid the unintended presence of GMOs in other products.

2.   The Commission shall gather and coordinate information based on studies at [EU] and national level, observe the developments regarding coexistence in the Member States and, on the basis of the information and observations, develop guidelines on the coexistence of genetically modified, conventional and organic crops.’

Regulation No 1829/2003

Regulation No 1829/2003

| 8 | Recital 9 of Regulation No 1829/2003 reads as follows:
  ‘The new authorisation procedures for genetically modified food and feed should include the new principles introduced in Directive 2001/18/EC. They should also make use of the new framework for risk assessment in matters of food safety set up by Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety [(OJ 2002 L 31, p. 1)]. Thus, genetically modified food and feed should only be authorised for placing on the [EU] market after a scientific evaluation of the highest possible standard, to be undertaken under the responsibility of the European Food Safety Authority (Authority), of any risks which they present for human and animal health and, as the case may be, for the environment. This scientific evaluation should be followed by a risk management decision by the [European Union], under a regulatory procedure ensuring close cooperation between the Commission and the Member States.’ |
| --- | --- |

8

Recital 9 of Regulation No 1829/2003 reads as follows:

‘The new authorisation procedures for genetically modified food and feed should include the new principles introduced in Directive 2001/18/EC. They should also make use of the new framework for risk assessment in matters of food safety set up by Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety [(OJ 2002 L 31, p. 1)]. Thus, genetically modified food and feed should only be authorised for placing on the [EU] market after a scientific evaluation of the highest possible standard, to be undertaken under the responsibility of the European Food Safety Authority (Authority), of any risks which they present for human and animal health and, as the case may be, for the environment. This scientific evaluation should be followed by a risk management decision by the [European Union], under a regulatory procedure ensuring close cooperation between the Commission and the Member States.’

| 9 | Article 1 of Regulation No 1829/2003, entitled ‘Objective’, provides:
  ‘The objective of this Regulation, in accordance with the general principles laid down in Regulation (EC) No 178/2002, is to:





  (a) | 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; |
| --- | --- | --- |

9

Article 1 of Regulation No 1829/2003, entitled ‘Objective’, provides:

‘The objective of this Regulation, in accordance with the general principles laid down in Regulation (EC) No 178/2002, is to:

(a)

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;

| (b) | lay down [EU] procedures for the authorisation and supervision of genetically modified food and feed; |
| --- | --- |

(b)

lay down [EU] procedures for the authorisation and supervision of genetically modified food and feed;

| (c) | lay down provisions for the labelling of genetically modified food and feed.’ |
| --- | --- |

(c)

lay down provisions for the labelling of genetically modified food and feed.’

| 10 | Article 3(1) of Regulation No 1829/2003, entitled ‘Scope’, provides:
  ‘This Section shall apply to:





  (a) | GMOs for food use; |
| --- | --- | --- |

10

Article 3(1) of Regulation No 1829/2003, entitled ‘Scope’, provides:

‘This Section shall apply to:

(a)

GMOs for food use;

| (b) | food containing or consisting of GMOs; |
| --- | --- |

(b)

food containing or consisting of GMOs;

| (c) | food produced from or containing ingredients produced from GMOs.’ |
| --- | --- |

(c)

food produced from or containing ingredients produced from GMOs.’

| 11 | Article 4 of that regulation, entitled ‘Requirements’, states:
  ‘1.   Food referred to in Article 3(1) must not:





  (a) | have adverse effects on human health, animal health or the environment; |
| --- | --- | --- |

11

Article 4 of that regulation, entitled ‘Requirements’, states:

‘1.   Food referred to in Article 3(1) must not:

(a)

have adverse effects on human health, animal health or the environment;

...

2.   No person shall place on the market a GMO for food use or food referred to in Article 3(1) unless it is covered by an authorisation granted in accordance with this Section and the relevant conditions of the authorisation are satisfied.

...

5.   An authorisation as referred to in paragraph 2 shall not be granted, refused, renewed, modified, suspended or revoked except on the grounds and under the procedures set out in this Regulation.

...’

| 12 | Article 16 of that regulation provides:
  ‘...
  2.   No person shall place on the market, use or process [GMOs for feed use, feed containing or consisting of GMOs or feed produced from GMOs] unless [they are] covered by an authorisation granted in accordance with this Section and the relevant conditions of the authorisation are satisfied.
  ...
  5.   An authorisation as referred to in paragraph 2 shall not be granted, refused, renewed, modified, suspended or revoked except on the grounds and under the procedures set out in this Regulation.
  ...’ |
| --- | --- |

12

Article 16 of that regulation provides:

‘...

2.   No person shall place on the market, use or process [GMOs for feed use, feed containing or consisting of GMOs or feed produced from GMOs] unless [they are] covered by an authorisation granted in accordance with this Section and the relevant conditions of the authorisation are satisfied.

...

5.   An authorisation as referred to in paragraph 2 shall not be granted, refused, renewed, modified, suspended or revoked except on the grounds and under the procedures set out in this Regulation.

...’

| 13 | Article 19(5) of the same regulation provides:
  ‘The authorisation granted in accordance with the procedure referred to in this Regulation shall be valid throughout the [European Union] for 10 years and shall be renewable in accordance with Article 23. ...’ |
| --- | --- |

13

Article 19(5) of the same regulation provides:

‘The authorisation granted in accordance with the procedure referred to in this Regulation shall be valid throughout the [European Union] for 10 years and shall be renewable in accordance with Article 23. ...’

| 14 | Article 20(1) of Regulation No 1829/2003 states:
  ‘By way of derogation from Article 16(2), products falling within the scope of this Section which have been lawfully placed on the market in the [European Union] before the date of application of this Regulation may continue to be placed on the market, used and processed provided that the following conditions are met:





  (a) | in the case of products which have been authorised under [Council] Directives 90/220/EEC [of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (OJ 1990 L 117, p. 15)] or [2001/18], including use as feed, under [Council] Directive 82/471/EEC [of 30 June 1982 concerning certain products used in animal nutrition (OJ 1982 L 213, p. 8)], which are produced from GMOs, or under [Council] Directive 70/524/EEC [of 23 November 1970 concerning additives in feeding-stuffs (OJ, English Special Edition 1970(III), p. 840)], which contain, consist of or are produced from GMOs, operators responsible for placing on the market the products concerned shall, within six months after the date of application of this Regulation, notify the Commission of the date on which they were first placed on the market in the [European Union]; |
| --- | --- | --- |

14

Article 20(1) of Regulation No 1829/2003 states:

‘By way of derogation from Article 16(2), products falling within the scope of this Section which have been lawfully placed on the market in the [European Union] before the date of application of this Regulation may continue to be placed on the market, used and processed provided that the following conditions are met:

(a)

in the case of products which have been authorised under [Council] Directives 90/220/EEC [of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (OJ 1990 L 117, p. 15)] or [2001/18], including use as feed, under [Council] Directive 82/471/EEC [of 30 June 1982 concerning certain products used in animal nutrition (OJ 1982 L 213, p. 8)], which are produced from GMOs, or under [Council] Directive 70/524/EEC [of 23 November 1970 concerning additives in feeding-stuffs (OJ, English Special Edition 1970(III), p. 840)], which contain, consist of or are produced from GMOs, operators responsible for placing on the market the products concerned shall, within six months after the date of application of this Regulation, notify the Commission of the date on which they were first placed on the market in the [European Union];

...’

| 15 | Article 23(1) of that regulation provides:
  ‘Authorisations under this Regulation shall be renewable for 10-year periods, on application to the Commission by the authorisation holder at the latest one year before the expiry date of the authorisation.’ |
| --- | --- |

15

Article 23(1) of that regulation provides:

‘Authorisations under this Regulation shall be renewable for 10-year periods, on application to the Commission by the authorisation holder at the latest one year before the expiry date of the authorisation.’

| 16 | Article 43 of Regulation No 1829/2003 amended Directive 2001/18 with effect from the date of entry into force of that regulation by inserting Article 26a. |
| --- | --- |

16

Article 43 of Regulation No 1829/2003 amended Directive 2001/18 with effect from the date of entry into force of that regulation by inserting Article 26a.

The recommendation of 13 July 2010

The recommendation of 13 July 2010

| 17 | Recitals 1 and 3 of the recommendation of 13 July 2010 are worded as follows:





  ‘(1) | Article 26a of Directive [2001/18] provides that Member States may take appropriate measures to avoid the unintended presence of [GMOs] in other products. This applies in particular to avoiding the presence of GMOs in other crops, such as conventional or organic. |
| --- | --- | --- |

17

Recitals 1 and 3 of the recommendation of 13 July 2010 are worded as follows:

‘(1)

Article 26a of Directive [2001/18] provides that Member States may take appropriate measures to avoid the unintended presence of [GMOs] in other products. This applies in particular to avoiding the presence of GMOs in other crops, such as conventional or organic.

...

| (3) | It may be necessary for Member States’ public authorities to define, in the areas where GMOs are cultivated, appropriate measures to allow consumers and producers a choice between conventional, organic and GM production (hereinafter referred to as “coexistence measures”).’ |
| --- | --- |

(3)

It may be necessary for Member States’ public authorities to define, in the areas where GMOs are cultivated, appropriate measures to allow consumers and producers a choice between conventional, organic and GM production (hereinafter referred to as “coexistence measures”).’

| 18 | Point 1 of that recommendation provides:
  ‘In developing national measures to avoid the unintended presence of GMOs in conventional and organic crops Member States should follow the guidelines provided in the Annex to this Recommendation.’ |
| --- | --- |

18

Point 1 of that recommendation provides:

‘In developing national measures to avoid the unintended presence of GMOs in conventional and organic crops Member States should follow the guidelines provided in the Annex to this Recommendation.’

| 19 | The guidelines annexed to that recommendation state, in the final paragraph of point 1.2:
  ‘Since only authorised GMOs can be cultivated in the [European Union] and the environmental and health aspects are already covered by the environmental risk assessment of the EU authorisation process, the pending issues still to be addressed in the context of co-existence concern the economic aspects associated with the admixture of GM and non-GM crops.’ |
| --- | --- |

19

The guidelines annexed to that recommendation state, in the final paragraph of point 1.2:

‘Since only authorised GMOs can be cultivated in the [European Union] and the environmental and health aspects are already covered by the environmental risk assessment of the EU authorisation process, the pending issues still to be addressed in the context of co-existence concern the economic aspects associated with the admixture of GM and non-GM crops.’

| 20 | Point 1.4 of those guidelines, entitled ‘Purpose and scope of the guidelines’, states:
  ‘The present guidelines take the form of non-binding recommendations addressed to the Member States. They are intended to provide general principles for the development of national measures to avoid the unintended presence of GMOs in conventional and organic crops. It is recognised that many of the factors that are important in this context are specific to national, regional and local conditions.’ |
| --- | --- |

20

Point 1.4 of those guidelines, entitled ‘Purpose and scope of the guidelines’, states:

‘The present guidelines take the form of non-binding recommendations addressed to the Member States. They are intended to provide general principles for the development of national measures to avoid the unintended presence of GMOs in conventional and organic crops. It is recognised that many of the factors that are important in this context are specific to national, regional and local conditions.’

| 21 | Point 2 of those guidelines, entitled ‘General principles for the development of national co-existence measures to avoid the unintended presence of GMOs in conventional and organic crops’, contains the following passage:
  ‘2.2. Proportionality

  Measures to avoid unintended presence of GMOs in other crops should be proportionate to the objective which is pursued (protection of the particular needs of conventional or organic farmers). Co-existence measures should avoid any unnecessary burden for farmers, seed producers, cooperatives and other operators associated with any production type. The choice of measures should take into account the regional and local constraints and characteristics, such as the shape and size of the fields in a region, the fragmentation and geographical dispersion of fields belonging to individual farms and regional farm management practices.
  2.3. Levels of admixture to be attained through national co-existence measures to avoid the unintended presence of GMOs in conventional and organic crops

  National measures to avoid the unintended presence of GMOs in conventional and organic crops should take into account available knowledge on the probability and sources of admixture between GM and non-GM crops. These measures should be proportionate to the level of admixture to be pursued, which will depend on regional and national specificities and the particular local needs of conventional, organic and other types of crops and production.





  2.3.1. | In some cases, the presence of GMO traces in food and feed has an economic effect only when they exceed the 0.9% labelling threshold. In these cases, Member States should consider that measures to ensure compliance with the 0.9% labelling threshold would be sufficient. |
| --- | --- | --- |

21

Point 2 of those guidelines, entitled ‘General principles for the development of national co-existence measures to avoid the unintended presence of GMOs in conventional and organic crops’, contains the following passage:

‘2.2. Proportionality

Proportionality

Measures to avoid unintended presence of GMOs in other crops should be proportionate to the objective which is pursued (protection of the particular needs of conventional or organic farmers). Co-existence measures should avoid any unnecessary burden for farmers, seed producers, cooperatives and other operators associated with any production type. The choice of measures should take into account the regional and local constraints and characteristics, such as the shape and size of the fields in a region, the fragmentation and geographical dispersion of fields belonging to individual farms and regional farm management practices.

2.3. Levels of admixture to be attained through national co-existence measures to avoid the unintended presence of GMOs in conventional and organic crops

Levels of admixture to be attained through national co-existence measures to avoid the unintended presence of GMOs in conventional and organic crops

National measures to avoid the unintended presence of GMOs in conventional and organic crops should take into account available knowledge on the probability and sources of admixture between GM and non-GM crops. These measures should be proportionate to the level of admixture to be pursued, which will depend on regional and national specificities and the particular local needs of conventional, organic and other types of crops and production.

2.3.1.

In some cases, the presence of GMO traces in food and feed has an economic effect only when they exceed the 0.9% labelling threshold. In these cases, Member States should consider that measures to ensure compliance with the 0.9% labelling threshold would be sufficient.

| 2.3.2. | Member States should consider that there may be no need to pursue specific levels of admixture where labelling a crop as GM has no economic implications. |
| --- | --- |

2.3.2.

Member States should consider that there may be no need to pursue specific levels of admixture where labelling a crop as GM has no economic implications.

| 2.3.3. | In several other cases, the potential loss of income for organic and some conventional producers (e.g. certain food producers) may be due to the presence of GMO traces at levels lower than 0.9%. In those cases, and in the interest of protecting particular types of production, concerned Member States may define measures that aim at reaching levels of presence of GMOs in other crops lower than 0.9%.
  Regardless of the level of admixture to be pursued through co-existence measures, the thresholds established in the EU legislation ... will continue to apply for the labelling of GMO presence in food, feed and products intended for direct processing. |
| --- | --- |

2.3.3.

In several other cases, the potential loss of income for organic and some conventional producers (e.g. certain food producers) may be due to the presence of GMO traces at levels lower than 0.9%. In those cases, and in the interest of protecting particular types of production, concerned Member States may define measures that aim at reaching levels of presence of GMOs in other crops lower than 0.9%.

Regardless of the level of admixture to be pursued through co-existence measures, the thresholds established in the EU legislation ... will continue to apply for the labelling of GMO presence in food, feed and products intended for direct processing.

| 2.4. | Measures to exclude GMO cultivation from large areas (“GM-free areas”)

  Differences in regional aspects, such as climatic conditions (that influence the activity of pollinators and the transport of airborne pollen), topography, cropping patterns and crop rotation systems or farm structures (including surrounding structures, such as hedges, forests, uncultivated areas and the spatial arrangement of fields) may influence the degree of admixture between GM and conventional and organic crops and the measures necessary to avoid unintended presence of GMOs in other crops.
  Under certain economic and natural conditions, Member States should consider the possibility to exclude GMO cultivation from large areas of their territory to avoid the unintended presence of GMOs in conventional and organic crops. Such exclusion should rest on the demonstration by Member States that, for those areas, other measures are not enough to achieve sufficient levels of purity. Moreover, the restriction measures should be proportionate to the objective pursued (i.e. protection of particular needs of conventional and/or organic farming).’ |
| --- | --- |

2.4.

Measures to exclude GMO cultivation from large areas (“GM-free areas”)

Measures to exclude GMO cultivation from large areas (“GM-free areas”)

Differences in regional aspects, such as climatic conditions (that influence the activity of pollinators and the transport of airborne pollen), topography, cropping patterns and crop rotation systems or farm structures (including surrounding structures, such as hedges, forests, uncultivated areas and the spatial arrangement of fields) may influence the degree of admixture between GM and conventional and organic crops and the measures necessary to avoid unintended presence of GMOs in other crops.

Under certain economic and natural conditions, Member States should consider the possibility to exclude GMO cultivation from large areas of their territory to avoid the unintended presence of GMOs in conventional and organic crops. Such exclusion should rest on the demonstration by Member States that, for those areas, other measures are not enough to achieve sufficient levels of purity. Moreover, the restriction measures should be proportionate to the objective pursued (i.e. protection of particular needs of conventional and/or organic farming).’

Italian law

Italian law

| 22 | Article 2.1 of legge regionale Friuli Venezia Giulia n. 5/2011 recante disposizioni relative all’impiego di organismi geneticamente modificati (OGM) in agricoltura (Regional Law FVG No 5/2011 on provisions relating to the use of genetically modified organisms (GMOs) in agriculture) of 8 April 2011, in the version applicable to the facts in the main proceedings (‘Regional Law No 5/2011’), provides:
  ‘In order to avoid the unintended presence of GMOs in conventional and organic maize crops in the territory of Friuli Venezia Giulia, characterised by production models and farm structures that influence the degree of admixture between transgenic and non-transgenic crops, the cultivation of genetically modified maize shall be excluded in accordance with the recommendation [of 13 July 2010]. The cultivation of genetically modified maize shall give rise to the application of a financial administrative penalty of EUR 5000 to EUR 50000 issued by the competent regional Forestry Corps.’ |
| --- | --- |

22

Article 2.1 of legge regionale Friuli Venezia Giulia n. 5/2011 recante disposizioni relative all’impiego di organismi geneticamente modificati (OGM) in agricoltura (Regional Law FVG No 5/2011 on provisions relating to the use of genetically modified organisms (GMOs) in agriculture) of 8 April 2011, in the version applicable to the facts in the main proceedings (‘Regional Law No 5/2011’), provides:

‘In order to avoid the unintended presence of GMOs in conventional and organic maize crops in the territory of Friuli Venezia Giulia, characterised by production models and farm structures that influence the degree of admixture between transgenic and non-transgenic crops, the cultivation of genetically modified maize shall be excluded in accordance with the recommendation [of 13 July 2010]. The cultivation of genetically modified maize shall give rise to the application of a financial administrative penalty of EUR 5000 to EUR 50000 issued by the competent regional Forestry Corps.’

The case in the main proceedings and the questions referred for a preliminary ruling

The case in the main proceedings and the questions referred for a preliminary ruling

| 23 | On 9 May 2015, PH, the owner of a farm in the FVG region, cultivated a variety of genetically modified maize known as MON 810. |
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23

On 9 May 2015, PH, the owner of a farm in the FVG region, cultivated a variety of genetically modified maize known as MON 810.

| 24 | On 11 August 2015, the competent environmental services in the FVG region imposed a fine of EUR 10000 on PH for having cultivated that maize in breach of Article 2.1 of Regional Law No 5/2011. |
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24

On 11 August 2015, the competent environmental services in the FVG region imposed a fine of EUR 10000 on PH for having cultivated that maize in breach of Article 2.1 of Regional Law No 5/2011.

| 25 | Following PH’s challenge to that penalty, by order of 8 October 2019, the Deputy Director of the Forestry Service and Forestry Corps of the FVG region confirmed that infringement, but reduced the amount of the fine to EUR 5000. |
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25

Following PH’s challenge to that penalty, by order of 8 October 2019, the Deputy Director of the Forestry Service and Forestry Corps of the FVG region confirmed that infringement, but reduced the amount of the fine to EUR 5000.

| 26 | PH lodged an opposition to that order before the Tribunale ordinario di Pordenone (District Court, Pordenone, Italy), the referring court. |
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26

PH lodged an opposition to that order before the Tribunale ordinario di Pordenone (District Court, Pordenone, Italy), the referring court.

| 27 | After recalling the content of Article 2.1 of Regional Law No 5/2011, point 2.4 of the guidelines annexed to the recommendation of 13 July 2010, Article 26a of Directive 2001/18 and Articles 16 and 17 of Council Directive 2002/53/EC of 13 June 2002 on the common catalogue of varieties of agricultural plant species (OJ 2002 L 193, p. 1), that court notes that the dispute in the main proceedings concerns not the fact that MON 810 maize may be freely marketed within the European Union, but that, under Regional Law No 5/2011, it may not be cultivated in the entire territory of the FVG region. It recalls in this regard, first, that, in the order of 8 May 2013, Fidenato (C‐542/12, not published, EU:C:2013:298), the Court of Justice held that Article 26a of Directive 2001/18 must be interpreted as precluding a Member State from opposing the cultivation on its territory of a GMO, such as the MON 810 maize varieties, on the ground that obtaining a national authorisation would constitute a coexistence measure designed to avoid the unintended presence of GMOs in other crops and, secondly, that, by 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-ØØØ81Ø‐6) (OJ 2016 L 60, p. 90), the cultivation of genetically modified maize MON 810 was prohibited throughout the territory of Italy. |
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27

After recalling the content of Article 2.1 of Regional Law No 5/2011, point 2.4 of the guidelines annexed to the recommendation of 13 July 2010, Article 26a of Directive 2001/18 and Articles 16 and 17 of Council Directive 2002/53/EC of 13 June 2002 on the common catalogue of varieties of agricultural plant species (OJ 2002 L 193, p. 1), that court notes that the dispute in the main proceedings concerns not the fact that MON 810 maize may be freely marketed within the European Union, but that, under Regional Law No 5/2011, it may not be cultivated in the entire territory of the FVG region. It recalls in this regard, first, that, in the order of 8 May 2013, Fidenato (C‐542/12, not published, EU:C:2013:298), the Court of Justice held that Article 26a of Directive 2001/18 must be interpreted as precluding a Member State from opposing the cultivation on its territory of a GMO, such as the MON 810 maize varieties, on the ground that obtaining a national authorisation would constitute a coexistence measure designed to avoid the unintended presence of GMOs in other crops and, secondly, that, by 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-ØØØ81Ø‐6) (OJ 2016 L 60, p. 90), the cultivation of genetically modified maize MON 810 was prohibited throughout the territory of Italy.

Zea mays L

| 28 | In the light of those factors and the claims and pleas in law raised by the parties, the referring court asks whether, first, the ban, in accordance with Article 2.1 of Regional Law No 5/2011, on the cultivation of genetically modified maize in the territory of the FVG region is consistent with Directive 2001/18, read in the light of Regulation No 1829/2003 and the recommendation of 13 July 2010, and whether, secondly, that ban may constitute a measure having equivalent effect which is contrary to Articles 34 to 36 TFEU. |
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28

In the light of those factors and the claims and pleas in law raised by the parties, the referring court asks whether, first, the ban, in accordance with Article 2.1 of Regional Law No 5/2011, on the cultivation of genetically modified maize in the territory of the FVG region is consistent with Directive 2001/18, read in the light of Regulation No 1829/2003 and the recommendation of 13 July 2010, and whether, secondly, that ban may constitute a measure having equivalent effect which is contrary to Articles 34 to 36 TFEU.

| 29 | It was in that context that the Tribunale ordinario di Pordenone (District Court, Pordenone) decided to stay the proceedings and to refer the following questions to the Court for a preliminary ruling:





  ‘(1) | Is the ban imposed by Article 2.1 of Legge regionale Friuli Venezia Giulia n. 5/2011, which introduces coexistence measures that amount to a ban on cultivating maize variety MON 810 in the territory of the [FVG region], consistent with or contrary to the overall scheme of Directive 2001/18, particularly in the light of Regulation [No 1829/2003] and [the recommendation of 13 July 2010]? |
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29

It was in that context that the Tribunale ordinario di Pordenone (District Court, Pordenone) decided to stay the proceedings and to refer the following questions to the Court for a preliminary ruling:

‘(1)

Is the ban imposed by Article 2.1 of Legge regionale Friuli Venezia Giulia n. 5/2011, which introduces coexistence measures that amount to a ban on cultivating maize variety MON 810 in the territory of the [FVG region], consistent with or contrary to the overall scheme of Directive 2001/18, particularly in the light of Regulation [No 1829/2003] and [the recommendation of 13 July 2010]?

| (2) | Does that ban also constitute a measure having equivalent effect and is it thus contrary to Articles 34, 35 and 36 TFEU?’ |
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(2)

Does that ban also constitute a measure having equivalent effect and is it thus contrary to Articles 34, 35 and 36 TFEU?’

The questions referred for a preliminary ruling

The questions referred for a preliminary ruling

The first question

The first question

Jurisdiction of the Court and admissibility

Jurisdiction of the Court and admissibility

| 30 | The Italian Government disputes the admissibility of the first question on the grounds that, first, the referring court does not set out the reasons why the national legislation at issue in the main proceedings might be contrary to Directive 2001/18, Regulation No 1829/2003 and the recommendation of 13 July 2010 and, secondly, that question does not specify either the parts of the recommendation of 13 July 2010 or the provisions of Directive 2001/18 and of Regulation No 1829/2003 which are applicable in the present case. The Italian Government further submits that the first question is inadmissible in so far as it relates to the recommendation of 13 July 2010, since the jurisdiction of the Court in relation to questions referred for a preliminary ruling is limited to the interpretation of acts of the institutions producing binding legal effects. |
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30

The Italian Government disputes the admissibility of the first question on the grounds that, first, the referring court does not set out the reasons why the national legislation at issue in the main proceedings might be contrary to Directive 2001/18, Regulation No 1829/2003 and the recommendation of 13 July 2010 and, secondly, that question does not specify either the parts of the recommendation of 13 July 2010 or the provisions of Directive 2001/18 and of Regulation No 1829/2003 which are applicable in the present case. The Italian Government further submits that the first question is inadmissible in so far as it relates to the recommendation of 13 July 2010, since the jurisdiction of the Court in relation to questions referred for a preliminary ruling is limited to the interpretation of acts of the institutions producing binding legal effects.

| 31 | In the first place, in so far as, by that latter argument, the Italian Government is in fact seeking to call into question the Court’s jurisdiction to rule on the first question in so far as it concerns the interpretation of the recommendation of 13 July 2010, it is important to recall that Article 267 TFEU confers on the Court jurisdiction to give a preliminary ruling on the validity and interpretation of all acts of the EU institutions without exception (judgments of 13 December 1989, Grimaldi, C‐322/88, EU:C:1989:646, paragraph 8, and of 13 June 2017, Florescu and Others, C‐258/14, EU:C:2017:448, paragraph 30). |
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31

In the first place, in so far as, by that latter argument, the Italian Government is in fact seeking to call into question the Court’s jurisdiction to rule on the first question in so far as it concerns the interpretation of the recommendation of 13 July 2010, it is important to recall that Article 267 TFEU confers on the Court jurisdiction to give a preliminary ruling on the validity and interpretation of all acts of the EU institutions without exception (judgments of 13 December 1989, Grimaldi, C‐322/88, EU:C:1989:646, paragraph 8, and of 13 June 2017, Florescu and Others, C‐258/14, EU:C:2017:448, paragraph 30).

| 32 | It follows that the Court has jurisdiction to rule on the interpretation of the recommendation of 13 July 2010 and, therefore, to rule on the first question in its entirety. |
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32

It follows that the Court has jurisdiction to rule on the interpretation of the recommendation of 13 July 2010 and, therefore, to rule on the first question in its entirety.

| 33 | As regards, in the second place, the Italian Government’s challenge to the admissibility of the first question on the ground that the referring court does not set out sufficiently the reasons why it raises that question, it is important to recall that, according to the Court’s settled case-law, the requirements concerning the content of a request for a preliminary ruling are expressly set out in Article 94 of the Court’s Rules of Procedure, of which the referring court should, in the context of the cooperation instituted by Article 267 TFEU, be aware and which it is bound to observe scrupulously (judgment of 9 March 2017, Milkova, C‐406/15, EU:C:2017:198, paragraph 72 and the case-law cited). |
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33

As regards, in the second place, the Italian Government’s challenge to the admissibility of the first question on the ground that the referring court does not set out sufficiently the reasons why it raises that question, it is important to recall that, according to the Court’s settled case-law, the requirements concerning the content of a request for a preliminary ruling are expressly set out in Article 94 of the Court’s Rules of Procedure, of which the referring court should, in the context of the cooperation instituted by Article 267 TFEU, be aware and which it is bound to observe scrupulously (judgment of 9 March 2017, Milkova, C‐406/15, EU:C:2017:198, paragraph 72 and the case-law cited).

| 34 | Thus, the referring court must set out the precise reasons that led it to raise the question of the interpretation of certain provisions of EU law and to consider it necessary to refer questions to the Court for a preliminary ruling (judgment of 9 March 2017, Milkova, C‐406/15, EU:C:2017:198, paragraph 73 and the case-law cited). |
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34

Thus, the referring court must set out the precise reasons that led it to raise the question of the interpretation of certain provisions of EU law and to consider it necessary to refer questions to the Court for a preliminary ruling (judgment of 9 March 2017, Milkova, C‐406/15, EU:C:2017:198, paragraph 73 and the case-law cited).

| 35 | In the present case, it is sufficiently clear from the request for a preliminary ruling that (i) the referring court is seised of a dispute concerning the legality of a penalty imposed pursuant to a legislative provision laid down by a region prohibiting the cultivation of genetically modified maize MON 810 throughout its territory for reasons seeking to avoid the unintended presence of GMOs in conventional and organic crops; (ii) on the date on which that penalty was imposed, that variety was authorised to be cultivated and marketed freely within the European Union under Article 20 of Regulation No 1829/2003; (iii) the provision at issue in the main proceedings was adopted on the basis of Article 26a of Directive 2001/18 and that that court is asking, in the first question, about the validity of that provision having regard to that directive, read in the light of Regulation No 1829/2003 and the recommendation of 13 July 2010. |
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35

In the present case, it is sufficiently clear from the request for a preliminary ruling that (i) the referring court is seised of a dispute concerning the legality of a penalty imposed pursuant to a legislative provision laid down by a region prohibiting the cultivation of genetically modified maize MON 810 throughout its territory for reasons seeking to avoid the unintended presence of GMOs in conventional and organic crops; (ii) on the date on which that penalty was imposed, that variety was authorised to be cultivated and marketed freely within the European Union under Article 20 of Regulation No 1829/2003; (iii) the provision at issue in the main proceedings was adopted on the basis of Article 26a of Directive 2001/18 and that that court is asking, in the first question, about the validity of that provision having regard to that directive, read in the light of Regulation No 1829/2003 and the recommendation of 13 July 2010.

| 36 | Moreover, the fact that, in that question, the referring court did not refer to any specific provision of Directive 2001/18 and Regulation No 1829/2003, or to any specific part of the recommendation of 13 July 2010, has no bearing on the admissibility of that question. |
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36

Moreover, the fact that, in that question, the referring court did not refer to any specific provision of Directive 2001/18 and Regulation No 1829/2003, or to any specific part of the recommendation of 13 July 2010, has no bearing on the admissibility of that question.

| 37 | It is clear from the settled case-law of the Court that the latter has a duty to interpret all provisions of EU law which national courts need in order to decide the actions pending before them, even if those provisions are not expressly indicated in the questions referred to the Court by those courts (judgment of 28 June 2018, Crespo Rey, C‐2/17, EU:C:2018:511, paragraph 40 and the case-law cited). |
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37

It is clear from the settled case-law of the Court that the latter has a duty to interpret all provisions of EU law which national courts need in order to decide the actions pending before them, even if those provisions are not expressly indicated in the questions referred to the Court by those courts (judgment of 28 June 2018, Crespo Rey, C‐2/17, EU:C:2018:511, paragraph 40 and the case-law cited).

| 38 | It follows that the first question is admissible. |
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38

It follows that the first question is admissible.

Substance

Substance

| 39 | By its first question, the referring court asks, in essence, as is clear from paragraph 35 of the present judgment, whether Article 26a of Directive 2001/18, read in the light of Regulation No 1829/2003 and the recommendation of 13 July 2010, must be interpreted as precluding a national measure which, for the purpose of avoiding the unintended presence of GMOs in other products, prohibits the cultivation in the territory of a region of the Member State concerned of GMOs authorised under Regulation No 1829/2003. |
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39

By its first question, the referring court asks, in essence, as is clear from paragraph 35 of the present judgment, whether Article 26a of Directive 2001/18, read in the light of Regulation No 1829/2003 and the recommendation of 13 July 2010, must be interpreted as precluding a national measure which, for the purpose of avoiding the unintended presence of GMOs in other products, prohibits the cultivation in the territory of a region of the Member State concerned of GMOs authorised under Regulation No 1829/2003.

| 40 | As a preliminary point, it should be recalled that the objective of Directive 2001/18, as is clear from Article 1 thereof, is to approximate the laws, regulations and administrative provisions of the Member States and to protect human health and the environment when carrying out the deliberate release of GMOs into the environment, whether by placing GMOs on the market within the European Union as products or for any purposes other than such placing on the market. In order to achieve those objectives, it makes those methods of deliberate release of GMOs into the environment subject to authorisation procedures involving the assessment and monitoring of risks to human health and the environment in accordance with harmonised procedures and principles. |
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40

As a preliminary point, it should be recalled that the objective of Directive 2001/18, as is clear from Article 1 thereof, is to approximate the laws, regulations and administrative provisions of the Member States and to protect human health and the environment when carrying out the deliberate release of GMOs into the environment, whether by placing GMOs on the market within the European Union as products or for any purposes other than such placing on the market. In order to achieve those objectives, it makes those methods of deliberate release of GMOs into the environment subject to authorisation procedures involving the assessment and monitoring of risks to human health and the environment in accordance with harmonised procedures and principles.

| 41 | Moreover, as is clear from Article 1 of Regulation No 1829/2003, that regulation provides 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. To that end, it establishes uniform procedures for the authorisation and supervision of such food and feed which, as is clear from recital 9 thereof, include the principles introduced in Directive 2001/18. Under Article 19(5) of that regulation, the authorisation granted in accordance with the procedures provided for by that regulation is valid throughout the European Union. |
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41

Moreover, as is clear from Article 1 of Regulation No 1829/2003, that regulation provides 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. To that end, it establishes uniform procedures for the authorisation and supervision of such food and feed which, as is clear from recital 9 thereof, include the principles introduced in Directive 2001/18. Under Article 19(5) of that regulation, the authorisation granted in accordance with the procedures provided for by that regulation is valid throughout the European Union.

| 42 | As regards the specific case of genetically modified maize, the placing on the market of MON 810 maize was authorised by Commission Decision 98/293/EC of 22 April 1998 concerning the placing on the market of genetically modified maize (Zea mays L. T25), pursuant to Council Directive 90/220/EEC (OJ 1998 L 131, p. 30). While it is true that Directive 90/220 was repealed by Directive 2001/18, the authorisation for placing MON 810 maize on the market remained valid pursuant to Articles 20 and 23 of Regulation No 1829/2003 and was still valid at the time when the penalty at issue in the main proceedings was imposed on PH. |
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42

As regards the specific case of genetically modified maize, the placing on the market of MON 810 maize was authorised by Commission Decision 98/293/EC of 22 April 1998 concerning the placing on the market of genetically modified maize (Zea mays L. T25), pursuant to Council Directive 90/220/EEC (OJ 1998 L 131, p. 30). While it is true that Directive 90/220 was repealed by Directive 2001/18, the authorisation for placing MON 810 maize on the market remained valid pursuant to Articles 20 and 23 of Regulation No 1829/2003 and was still valid at the time when the penalty at issue in the main proceedings was imposed on PH.

Zea mays L. T25

| 43 | However, the fact remains that Article 26a(1) of Directive 2001/18 provides that Member States may take appropriate measures to avoid the unintended presence of GMOs in other products. |
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43

However, the fact remains that Article 26a(1) of Directive 2001/18 provides that Member States may take appropriate measures to avoid the unintended presence of GMOs in other products.

| 44 | It was on the basis of that provision that the FVG region adopted Regional Law No 5/2011, Article 2.1 of which prohibits the cultivation of genetically modified maize throughout its territory and the validity of which is challenged by PH in the dispute in the main proceedings. |
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44

It was on the basis of that provision that the FVG region adopted Regional Law No 5/2011, Article 2.1 of which prohibits the cultivation of genetically modified maize throughout its territory and the validity of which is challenged by PH in the dispute in the main proceedings.

| 45 | In order to answer the first question as reformulated in paragraph 39 of the present judgment, it is therefore necessary to examine the conditions for the application of Article 26a(1) of Directive 2001/18. |
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45

In order to answer the first question as reformulated in paragraph 39 of the present judgment, it is therefore necessary to examine the conditions for the application of Article 26a(1) of Directive 2001/18.

| 46 | In that regard, first of all, that provision is intended to apply not only to GMO varieties which have been authorised in accordance with the provisions of that directive, but also to those whose authorisations have been notified or renewed in accordance with Articles 20 and 23 of Regulation No 1829/2003, such as the genetically modified maize varieties at issue in the main proceedings (see, to that effect, judgment of 6 September 2012, Pioneer Hi Bred Italia, C‐36/11, EU:C:2012:534, paragraphs 60, 67 and 68, and order of 8 May 2013, Fidenato, C‐542/12, not published, EU:C:2013:298, paragraph 23). |
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46

In that regard, first of all, that provision is intended to apply not only to GMO varieties which have been authorised in accordance with the provisions of that directive, but also to those whose authorisations have been notified or renewed in accordance with Articles 20 and 23 of Regulation No 1829/2003, such as the genetically modified maize varieties at issue in the main proceedings (see, to that effect, judgment of 6 September 2012, Pioneer Hi Bred Italia, C‐36/11, EU:C:2012:534, paragraphs 60, 67 and 68, and order of 8 May 2013, Fidenato, C‐542/12, not published, EU:C:2013:298, paragraph 23).

| 47 | Next, the preventive measures taken by the Member States in accordance with Article 26a(1) of Directive 2001/18 must be aimed at avoiding the unintended presence of GMOs in other products, in order to enable producers and consumers to have the choice between organic production, conventional production and production using GMOs. Those measures cannot have the objective of protecting human health or the environment. The protection of the latter objectives is ensured by the harmonised authorisation procedures for the deliberate release of GMOs established by Directive 2001/18 and by Regulation No 1829/2003, which make the grant of such authorisations subject to an assessment of the risks of that release for human health and the environment. By contrast, those measures are intended to preserve the plurality of crops and, in particular, in so far as possible, the coexistence between GMOs, on the one hand, and organic and conventional crops, on the other. Therefore, they involve taking account of the economic challenges for organic and conventional producers of the admixture of GMOs in their crops. |
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47

Next, the preventive measures taken by the Member States in accordance with Article 26a(1) of Directive 2001/18 must be aimed at avoiding the unintended presence of GMOs in other products, in order to enable producers and consumers to have the choice between organic production, conventional production and production using GMOs. Those measures cannot have the objective of protecting human health or the environment. The protection of the latter objectives is ensured by the harmonised authorisation procedures for the deliberate release of GMOs established by Directive 2001/18 and by Regulation No 1829/2003, which make the grant of such authorisations subject to an assessment of the risks of that release for human health and the environment. By contrast, those measures are intended to preserve the plurality of crops and, in particular, in so far as possible, the coexistence between GMOs, on the one hand, and organic and conventional crops, on the other. Therefore, they involve taking account of the economic challenges for organic and conventional producers of the admixture of GMOs in their crops.

| 48 | Consequently, a Member State is not entitled to make the cultivation of GMOs authorised under Regulation No 1829/2003 conditional on national authorisation based on considerations of protection of health or the environment. In addition, Article 26a of Directive 2001/18 can give rise to restrictions, or, a fortiori, to geographically restricted prohibitions, only through the effect of coexistence measures actually adopted in compliance with the objective of that directive (see, to that effect, judgment of 6 September 2012, Pioneer Hi Bred Italia, C‐36/11, EU:C:2012:534, paragraphs 69 and 75). Finally, that article precludes a national authorisation procedure for the cultivation of GMOs from constituting a measure of coexistence (see, to that effect, order of 8 May 2013, Fidenato, C‐542/12, not published, EU:C:2013:298, paragraph 33). |
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48

Consequently, a Member State is not entitled to make the cultivation of GMOs authorised under Regulation No 1829/2003 conditional on national authorisation based on considerations of protection of health or the environment. In addition, Article 26a of Directive 2001/18 can give rise to restrictions, or, a fortiori, to geographically restricted prohibitions, only through the effect of coexistence measures actually adopted in compliance with the objective of that directive (see, to that effect, judgment of 6 September 2012, Pioneer Hi Bred Italia, C‐36/11, EU:C:2012:534, paragraphs 69 and 75). Finally, that article precludes a national authorisation procedure for the cultivation of GMOs from constituting a measure of coexistence (see, to that effect, order of 8 May 2013, Fidenato, C‐542/12, not published, EU:C:2013:298, paragraph 33).

| 49 | Moreover, as is clear from the wording of Article 26a(1) of Directive 2001/18, the measures taken to avoid the unintended presence of GMOs in other products must be necessary. That requirement of necessity, read in the light of the principle of proportionality, requires Member States to have recourse to measures which, whilst enabling them effectively to attain the objective of avoiding the unintended presence of GMOs in other products in order to preserve the choice of consumers and producers, do not go beyond what is necessary and are the least detrimental to the objectives and principles laid down by that directive. In accordance with the Court’s case-law on this principle, when there is a choice between several appropriate measures, recourse must be had to the least onerous, and the disadvantages caused must not be disproportionate to the aims pursued (see, to that effect, judgment of 29 June 2017, Commission v Portugal, C‐126/15, EU:C:2017:504, paragraph 64 and the case-law cited). |
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49

Moreover, as is clear from the wording of Article 26a(1) of Directive 2001/18, the measures taken to avoid the unintended presence of GMOs in other products must be necessary. That requirement of necessity, read in the light of the principle of proportionality, requires Member States to have recourse to measures which, whilst enabling them effectively to attain the objective of avoiding the unintended presence of GMOs in other products in order to preserve the choice of consumers and producers, do not go beyond what is necessary and are the least detrimental to the objectives and principles laid down by that directive. In accordance with the Court’s case-law on this principle, when there is a choice between several appropriate measures, recourse must be had to the least onerous, and the disadvantages caused must not be disproportionate to the aims pursued (see, to that effect, judgment of 29 June 2017, Commission v Portugal, C‐126/15, EU:C:2017:504, paragraph 64 and the case-law cited).

| 50 | Finally, in order to assess whether a coexistence measure satisfies those conditions for the application of Article 26a(1) of Directive 2001/18, the referring court must take into account the guidelines annexed to the recommendation of 13 July 2010, which were adopted by the Commission on the basis of Article 26a(2) of that directive. |
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50

Finally, in order to assess whether a coexistence measure satisfies those conditions for the application of Article 26a(1) of Directive 2001/18, the referring court must take into account the guidelines annexed to the recommendation of 13 July 2010, which were adopted by the Commission on the basis of Article 26a(2) of that directive.

| 51 | While it is true that guidelines of the kind annexed to the recommendation of 13 July 2010 do not produce binding effects as such, the fact remains that the national courts are required to take them into consideration in order to decide disputes submitted to them, in particular where they cast light on the interpretation of EU measures implemented by national provisions or where they are designed to supplement binding EU provisions (see, to that effect, judgment of 3 September 2014, Baltlanta, C‐410/13, EU:C:2014:2134, paragraph 64 and the case-law cited). |
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51

While it is true that guidelines of the kind annexed to the recommendation of 13 July 2010 do not produce binding effects as such, the fact remains that the national courts are required to take them into consideration in order to decide disputes submitted to them, in particular where they cast light on the interpretation of EU measures implemented by national provisions or where they are designed to supplement binding EU provisions (see, to that effect, judgment of 3 September 2014, Baltlanta, C‐410/13, EU:C:2014:2134, paragraph 64 and the case-law cited).

| 52 | The guidelines annexed to the recommendation of 13 July 2010 set out, in point 2, the general principles for the development of coexistence measures by the Member States and thus clarify Article 26a(1) of Directive 2001/18. |
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52

The guidelines annexed to the recommendation of 13 July 2010 set out, in point 2, the general principles for the development of coexistence measures by the Member States and thus clarify Article 26a(1) of Directive 2001/18.

| 53 | In the present case, it will be for the referring court to assess whether the prohibition laid down in Article 2.1 of Regional Law No 5/2011 on the cultivation of genetically modified maize throughout the territory of the FVG region actually pursues the objective of guaranteeing consumers and producers the choice between a production of genetically modified maize and productions of organic or conventional maize. |
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53

In the present case, it will be for the referring court to assess whether the prohibition laid down in Article 2.1 of Regional Law No 5/2011 on the cultivation of genetically modified maize throughout the territory of the FVG region actually pursues the objective of guaranteeing consumers and producers the choice between a production of genetically modified maize and productions of organic or conventional maize.

| 54 | That court will also have to assess, in the light of the arguments put forward by the parties to the main proceedings, whether that prohibition is necessary and proportionate in order to attain that objective. In that connection, it will also have to take into consideration the general principles set out in points 2.2, 2.3 and 2.4 of the guidelines annexed to the recommendation of 13 July 2010, which specify relevant factors for defining the scope of the measure required, in order to preserve the choice of producers and consumers between GMO and non-GMO crops. |
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54

That court will also have to assess, in the light of the arguments put forward by the parties to the main proceedings, whether that prohibition is necessary and proportionate in order to attain that objective. In that connection, it will also have to take into consideration the general principles set out in points 2.2, 2.3 and 2.4 of the guidelines annexed to the recommendation of 13 July 2010, which specify relevant factors for defining the scope of the measure required, in order to preserve the choice of producers and consumers between GMO and non-GMO crops.

| 55 | Those factors include the level of admixture to be attained through national coexistence measures, referred to in point 2.3 of those guidelines, which depends on regional and national specificities and the particular local needs of conventional, organic and other types of crops and production, but also on the available knowledge on the probability and sources of admixture between GMO and non-GMO crops. In that regard, the degree of admixture between those crops is, in accordance with point 2.4 of those guidelines, likely to vary according to various parameters such as climatic conditions, topography, cropping patterns and crop rotation systems or farm structures, including surrounding structures. |
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55

Those factors include the level of admixture to be attained through national coexistence measures, referred to in point 2.3 of those guidelines, which depends on regional and national specificities and the particular local needs of conventional, organic and other types of crops and production, but also on the available knowledge on the probability and sources of admixture between GMO and non-GMO crops. In that regard, the degree of admixture between those crops is, in accordance with point 2.4 of those guidelines, likely to vary according to various parameters such as climatic conditions, topography, cropping patterns and crop rotation systems or farm structures, including surrounding structures.

| 56 | Thus, the examination of the proportionality of the ban on cultivating genetically modified maize, at issue in the main proceedings, throughout the territory of the FVG region for the purposes of the objective of guaranteeing choice for producers and consumers must take into account the degree of admixture of genetically modified maize to be achieved and the probability of admixture between that genetically modified maize and organically or conventionally grown maize. |
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56

Thus, the examination of the proportionality of the ban on cultivating genetically modified maize, at issue in the main proceedings, throughout the territory of the FVG region for the purposes of the objective of guaranteeing choice for producers and consumers must take into account the degree of admixture of genetically modified maize to be achieved and the probability of admixture between that genetically modified maize and organically or conventionally grown maize.

| 57 | This will involve, inter alia, defining the level of purity to be achieved in view of the economic impact of the adventitious presence of genetically modified maize in conventional or organic crops. In that regard, it will be important, in particular, to assess the economic effect of exceeding the labelling threshold in accordance with points 2.3.1 to 2.3.3 of the guidelines annexed to the recommendation of 13 July 2010. |
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57

This will involve, inter alia, defining the level of purity to be achieved in view of the economic impact of the adventitious presence of genetically modified maize in conventional or organic crops. In that regard, it will be important, in particular, to assess the economic effect of exceeding the labelling threshold in accordance with points 2.3.1 to 2.3.3 of the guidelines annexed to the recommendation of 13 July 2010.

| 58 | In addition, account will have to be taken of the sources of the risk of mixing and the effectiveness of the methods of crop separation, which must be assessed in the light of, inter alia, the geographical and climatic constraints and characteristics of the FVG region and the methods of cultivation used there. As is stated in point 2.2 of those guidelines, those characteristics are, inter alia, the shape and size of the fields in that region, the fragmentation and geographical dispersion of fields belonging to individual farms and the regional farm management practices. Moreover, as provided for in point 2.4 of those guidelines, such exclusion must rest on the demonstration by the authorities which adopted it that, for the FVG region, other measures would not be enough to achieve a sufficient level of purity. |
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58

In addition, account will have to be taken of the sources of the risk of mixing and the effectiveness of the methods of crop separation, which must be assessed in the light of, inter alia, the geographical and climatic constraints and characteristics of the FVG region and the methods of cultivation used there. As is stated in point 2.2 of those guidelines, those characteristics are, inter alia, the shape and size of the fields in that region, the fragmentation and geographical dispersion of fields belonging to individual farms and the regional farm management practices. Moreover, as provided for in point 2.4 of those guidelines, such exclusion must rest on the demonstration by the authorities which adopted it that, for the FVG region, other measures would not be enough to achieve a sufficient level of purity.

| 59 | In the light of the foregoing considerations, the answer to the first question must be that Article 26a of Directive 2001/18, read in the light of Regulation No 1829/2003 and the recommendation of 13 July 2010, must be interpreted as not precluding a national measure which, for the purpose of avoiding the unintended presence of GMOs in other products, prohibits the cultivation in the territory of a region of the Member State concerned of GMOs authorised under Regulation No 1829/2003, provided that that measure enables the attainment of the objective of ensuring that producers and consumers have the choice between products from genetically modified crops and products from organic or conventional crops and that, having regard to the particular characteristics of those crops in that territory, that measure is necessary in order to attain that objective and is proportionate thereto. |
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59

In the light of the foregoing considerations, the answer to the first question must be that Article 26a of Directive 2001/18, read in the light of Regulation No 1829/2003 and the recommendation of 13 July 2010, must be interpreted as not precluding a national measure which, for the purpose of avoiding the unintended presence of GMOs in other products, prohibits the cultivation in the territory of a region of the Member State concerned of GMOs authorised under Regulation No 1829/2003, provided that that measure enables the attainment of the objective of ensuring that producers and consumers have the choice between products from genetically modified crops and products from organic or conventional crops and that, having regard to the particular characteristics of those crops in that territory, that measure is necessary in order to attain that objective and is proportionate thereto.

The second question

The second question

| 60 | In the light of the content of the first question, the second question must be understood as seeking to ascertain whether, in the case where a national measure prohibits the cultivation in the territory of a region of the Member State concerned of GMOs authorised under Regulation No 1829/2003, in accordance with Article 26a of Directive 2001/18, read in the light of Regulation No 1829/2003 and the recommendation of 13 July 2010, it is necessary also to verify, separately, whether that measure complies with Articles 34 to 36 TFEU. |
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60

In the light of the content of the first question, the second question must be understood as seeking to ascertain whether, in the case where a national measure prohibits the cultivation in the territory of a region of the Member State concerned of GMOs authorised under Regulation No 1829/2003, in accordance with Article 26a of Directive 2001/18, read in the light of Regulation No 1829/2003 and the recommendation of 13 July 2010, it is necessary also to verify, separately, whether that measure complies with Articles 34 to 36 TFEU.

| 61 | It is settled case-law that, where a matter has been the subject of exhaustive harmonisation at EU level, any national measure relating thereto must be assessed in the light of the provisions of that harmonising measure and not in the light of primary law (judgment of 1 July 2014, Ålands Vindkraft, C‐573/12, EU:C:2014:2037, paragraph 57 and the case-law cited). |
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61

It is settled case-law that, where a matter has been the subject of exhaustive harmonisation at EU level, any national measure relating thereto must be assessed in the light of the provisions of that harmonising measure and not in the light of primary law (judgment of 1 July 2014, Ålands Vindkraft, C‐573/12, EU:C:2014:2037, paragraph 57 and the case-law cited).

| 62 | In that regard, it should be noted that Directive 2001/18 and Regulation No 1829/2003 make the placing on the market of GMOs in a product, food or feed subject to a system of prior authorisation established at EU level. |
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62

In that regard, it should be noted that Directive 2001/18 and Regulation No 1829/2003 make the placing on the market of GMOs in a product, food or feed subject to a system of prior authorisation established at EU level.

| 63 | Thus, Article 4(2) and (5) and Article 16(2) and (5) of Regulation No 1829/2003 provide, respectively, that GMOs for food use or food, on the one hand, and GMOs for feed use or feed containing or consisting of GMOs, or feeds produced from GMOs, on the other, may not be placed on the market where no authorisation has been granted, refused, renewed, modified, suspended or revoked except on the grounds and under the procedures set out in that regulation. |
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63

Thus, Article 4(2) and (5) and Article 16(2) and (5) of Regulation No 1829/2003 provide, respectively, that GMOs for food use or food, on the one hand, and GMOs for feed use or feed containing or consisting of GMOs, or feeds produced from GMOs, on the other, may not be placed on the market where no authorisation has been granted, refused, renewed, modified, suspended or revoked except on the grounds and under the procedures set out in that regulation.

| 64 | Moreover, Article 4 of Directive 2001/18 provides that GMOs may be deliberately released or placed on the market only in conformity with the authorisation procedures referred to in that directive. Article 22 of that directive expressly states that Member States may not prohibit, restrict or impede the placing on the market of GMOs, as or in products, which comply with the requirements of that directive. |
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64

Moreover, Article 4 of Directive 2001/18 provides that GMOs may be deliberately released or placed on the market only in conformity with the authorisation procedures referred to in that directive. Article 22 of that directive expressly states that Member States may not prohibit, restrict or impede the placing on the market of GMOs, as or in products, which comply with the requirements of that directive.

| 65 | Finally, the exceptions to that prohibition constituted by the safeguard clause in Article 23 of Directive 2001/18 and the possibility of adopting coexistence measures provided for in Article 26a of that directive are precisely circumscribed and therefore cannot call into question the fact that the conditions for the placing on the market of GMOs are essentially governed in a uniform manner at EU level. |
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65

Finally, the exceptions to that prohibition constituted by the safeguard clause in Article 23 of Directive 2001/18 and the possibility of adopting coexistence measures provided for in Article 26a of that directive are precisely circumscribed and therefore cannot call into question the fact that the conditions for the placing on the market of GMOs are essentially governed in a uniform manner at EU level.

| 66 | It must therefore be held that Directive 2001/18 and Regulation No 1829/2003 harmonised the conditions for the placing on the market of GMOs in products, food or feed. Any national measure prohibiting the cultivation and placing on the market of GMOs must therefore be assessed in the light of the provisions of that regulatory framework and not in the light of Articles 34 to 36 TFEU. |
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66

It must therefore be held that Directive 2001/18 and Regulation No 1829/2003 harmonised the conditions for the placing on the market of GMOs in products, food or feed. Any national measure prohibiting the cultivation and placing on the market of GMOs must therefore be assessed in the light of the provisions of that regulatory framework and not in the light of Articles 34 to 36 TFEU.

| 67 | In the light of the foregoing considerations, the answer to the second question must be that, where a national measure prohibits the cultivation in the territory of a region of the Member State concerned of GMOs authorised under Regulation No 1829/2003, in accordance with Article 26a of Directive 2001/18, read in the light of Regulation No 1829/2003 and the recommendation of 13 July 2010, it is not necessary also to verify, separately, whether that measure complies with Articles 34 to 36 TFEU. |
| --- | --- |

67

In the light of the foregoing considerations, the answer to the second question must be that, where a national measure prohibits the cultivation in the territory of a region of the Member State concerned of GMOs authorised under Regulation No 1829/2003, in accordance with Article 26a of Directive 2001/18, read in the light of Regulation No 1829/2003 and the recommendation of 13 July 2010, it is not necessary also to verify, separately, whether that measure complies with Articles 34 to 36 TFEU.

Costs

Costs

| 68 | Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the referring court, the decision on costs is a matter for that court. Costs incurred in submitting observations to the Court, other than the costs of those parties, are not recoverable. |
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68

Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the referring court, the decision on costs is a matter for that court. Costs incurred in submitting observations to the Court, other than the costs of those parties, are not recoverable.

| | On those grounds, the Court (Second Chamber) hereby rules: |
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On those grounds, the Court (Second Chamber) hereby rules:

| | 1. | Article 26a 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 Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed, read in the light of that regulation and the Commission Recommendation of 13 July 2010 on guidelines for the development of national coexistence measures to avoid the unintended presence of GMOs in conventional and organic crops, must be interpreted as not precluding a national measure which, for the purpose of avoiding the unintended presence of genetically modified organisms in other products, prohibits the cultivation in the territory of a region of the Member State concerned of genetically modified organisms authorised under Regulation No 1829/2003, provided that that measure enables the attainment of the objective of ensuring that producers and consumers have the choice between products from genetically modified crops and products from organic or conventional crops and that, having regard to the particular characteristics of those crops in that territory, that measure is necessary in order to attain that objective and is proportionate thereto. |
| --- | --- | --- |

1.

1.

Article 26a 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 Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed, read in the light of that regulation and the Commission Recommendation of 13 July 2010 on guidelines for the development of national coexistence measures to avoid the unintended presence of GMOs in conventional and organic crops, must be interpreted as not precluding a national measure which, for the purpose of avoiding the unintended presence of genetically modified organisms in other products, prohibits the cultivation in the territory of a region of the Member State concerned of genetically modified organisms authorised under Regulation No 1829/2003, provided that that measure enables the attainment of the objective of ensuring that producers and consumers have the choice between products from genetically modified crops and products from organic or conventional crops and that, having regard to the particular characteristics of those crops in that territory, that measure is necessary in order to attain that objective and is proportionate thereto.

Article 26a 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 Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed, read in the light of that regulation and the Commission Recommendation of 13 July 2010 on guidelines for the development of national coexistence measures to avoid the unintended presence of GMOs in conventional and organic crops, must be interpreted as not precluding a national measure which, for the purpose of avoiding the unintended presence of genetically modified organisms in other products, prohibits the cultivation in the territory of a region of the Member State concerned of genetically modified organisms authorised under Regulation No 1829/2003, provided that that measure enables the attainment of the objective of ensuring that producers and consumers have the choice between products from genetically modified crops and products from organic or conventional crops and that, having regard to the particular characteristics of those crops in that territory, that measure is necessary in order to attain that objective and is proportionate thereto.

| | 2. | Where a national measure prohibits the cultivation, in the territory of a region of the Member State concerned, of genetically modified organisms authorised under Regulation No 1829/2003, in accordance with Article 26a of Directive 2001/18, as amended by Regulation No 1829/2003, read in the light of that regulation and the Commission Recommendation of 13 July 2010 on guidelines for the development of national coexistence measures to avoid the unintended presence of GMOs in conventional and organic crops, it is not necessary also to verify, separately, whether that measure complies with Articles 34 to 36 TFEU. |
| --- | --- | --- |

2.

2.

Where a national measure prohibits the cultivation, in the territory of a region of the Member State concerned, of genetically modified organisms authorised under Regulation No 1829/2003, in accordance with Article 26a of Directive 2001/18, as amended by Regulation No 1829/2003, read in the light of that regulation and the Commission Recommendation of 13 July 2010 on guidelines for the development of national coexistence measures to avoid the unintended presence of GMOs in conventional and organic crops, it is not necessary also to verify, separately, whether that measure complies with Articles 34 to 36 TFEU.

Where a national measure prohibits the cultivation, in the territory of a region of the Member State concerned, of genetically modified organisms authorised under Regulation No 1829/2003, in accordance with Article 26a of Directive 2001/18, as amended by Regulation No 1829/2003, read in the light of that regulation and the Commission Recommendation of 13 July 2010 on guidelines for the development of national coexistence measures to avoid the unintended presence of GMOs in conventional and organic crops, it is not necessary also to verify, separately, whether that measure complies with Articles 34 to 36 TFEU.

| | [Signatures] |
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[Signatures]

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  *1
  )	Language of the case: Italian.

*1