JUDGMENT OF THE GENERAL COURT (Ninth Chamber)

29 September 2021 (*)

(Agriculture – Regulation (EU) 2016/2031 – Protective measures against pests of plants – List of Union regulated non-quarantine pests – Threshold above which the presence of a Union regulated non-quarantine pest on plants for planting has an unacceptable economic impact – Implementing Regulation (EU) 2019/2072 – Professional associations – Action for annulment – Locus standi – Admissibility – Proportionality – Obligation to state reasons)

In Case T‑116/20,

Società agricola Vivai Maiorana Ss, established in Curinga (Italy),

Confederazione Italiana Agricoltori – CIA, established in Rome (Italy),

MIVA – Moltiplicatori Italiani Viticoli Associati, established in Faenza (Italy),

represented by E. Scoccini and G. Scoccini, lawyers,

applicants,

v

European Commission, represented by B. Eggers and F. Moro, acting as Agents,

defendant,

supported by

Council of the European Union, represented by S. Emmerechts A. Vitro and S. Barbagallo, acting as Agents,

and by

European Parliament, represented by L. Knudsen and G. Mendola, acting as Agents,

interveners,

ACTION for annulment of Parts A, B, C, F, I and J of Annex IV to Commission Implementing Regulation (EU) 2019/2072 of 28 November 2019 establishing uniform conditions for the implementation of Regulation (EU) 2016/2031 of the European Parliament and the Council, as regards protective measures against pests of plants, and repealing Commission Regulation (EC) No 690/2008 and amending Commission Implementing Regulation (EU) 2018/2019 (OJ 2019 L 319, p. 1),

THE GENERAL COURT (Ninth Chamber),

composed of M.J. Costeira, President, D. Gratsias (Rapporteur) and M. Kancheva, Judges,

Registrar: J. Palacio González, Principal Administrator,

having regard to the written part of the procedure and further to the hearing on 9 June 2021,

gives the following

Judgment

 Background to the dispute

1        The purpose of Regulation (EU) 2016/2031 of the European Parliament and of the Council of 26 October 2016 on protective measures against pests of plants, amending Regulations (EU) No 228/2013, (EU) No 652/2014 and (EU) No 1143/2014 of the European Parliament and of the Council and repealing Council Directives 69/464/EEC, 74/647/EEC, 93/85/EEC, 98/57/EC, 2000/29/EC, 2006/91/EC and 2007/33/EC (OJ 2016 L 317, p. 4) is to establish measures to determine the phytosanitary risks posed by pests that threaten plant health and to reduce those risks to an acceptable level.

2        Under Article 36 of Regulation 2016/2031:

‘A pest is a “Union regulated non-quarantine pest” if it fulfils all of the following conditions and it is included in the list referred to in Article 37:

(a)      its identity is established in accordance with point (1) of Section 4 of Annex I;

(b)      it is present in the Union territory;

(c)      it is not a Union quarantine pest or a pest subject to measures adopted pursuant to Article 30(1);

(d)      it is transmitted mainly through specific plants for planting, in accordance with point (2) of Section 4 of Annex I;

(e)      its presence on those plants for planting has an unacceptable economic impact, as regards the intended use of those plants for planting, in accordance with point (3) of Section 4 of Annex I;

(f)      feasible and effective measures are available to prevent its presence on the plants for planting concerned.’

3        Article 37(2) of Regulation 2016/2031 provides, essentially, that the European Commission is to establish, by means of an implementing act, a list setting out the Union regulated non-quarantine pests (‘RNQPs’) and the specific plants for planting. Under the first subparagraph of Article 37(1) of Regulation 2016/2031, ‘professional operators shall not introduce [an RNQP] into, or move that pest within, the Union territory on the plants for planting through which it is transmitted, as specified in the list referred to in paragraph 2’.

4        Article 37(8) of Regulation 2016/2031 provides that, where point (e) of Article 36 of that regulation is only fulfilled if the pest concerned is present at an incidence above a certain threshold higher than zero, the list referred to in Article 37(2) must set out that threshold stating that the prohibition of introduction and movement only applies above that threshold. However, in order for the Commission to establish such a threshold, in accordance with that provision, it must be possible for professional operators to ensure that the incidence of the RNQPs on those plants for planting does not exceed that threshold, and it must be possible to verify whether that threshold is not exceeded in lots of the plants in question.

5        The concept of a ‘professional operator’ is defined in Article 2(9) of Regulation 2016/2031 as including any person, governed by public or private law, involved professionally in, and legally responsible for, one or more of the following activities concerning plants, plant products and other objects:

–        planting;

–        breeding;

–        production, including growing, multiplying and maintaining;

–        introduction into, and movement within and out of, the Union territory;

–        making available on the market;

–        storage, collection, dispatching and processing.

6        On the basis, inter alia, of Article 37(2) of Regulation 2016/2031 (see paragraph 3 above), the Commission adopted Implementing Regulation (EU) 2019/2072 of 28 November 2019 establishing uniform conditions for the implementation of Regulation 2016/2031 of the European Parliament and the Council, as regards protective measures against pests of plants, and repealing Commission Regulation (EC) No 690/2008 and amending Commission Implementing Regulation (EU) 2018/2019 (OJ 2019 L 319, p. 1) (‘the contested implementing regulation’).

7        Article 5 of the contested implementing regulation provides:

‘The list of [RNQPs] and specific plants for planting with categories and thresholds, as referred to in Article 37(2) of Regulation (EU) 2016/2031, are set out in Annex IV to this Regulation. Those plants for planting shall not be introduced into, or moved within, the Union if the presence of the RNQPs, or symptoms caused by RNQPs, on those plants for planting is above those thresholds.

The prohibition of introduction and movement provide for in the first paragraph shall apply only to the categories of plants for planting as provided for in Annex IV.’

8        Annex IV to the contested implementing regulation establishes the list of RNQPs concerning 12 specific plants. Thus, the annex in question is divided into 12 parts, from A to L, including:

–        Part A, which mentions two combinations of RNQPs and fodder plant seed;

–        Part B, which mentions two combinations of RNQPs and cereal seed;

–        Part C, which mentions nine combinations of RNQPs and vine propagating material;

–        Part F, which mentions 13 combinations of RNQPs and vegetable seed;

–        Part I, which mentions 15 combinations of RNQPs and vegetable propagating and planting material, other than seeds;

–        Part J, which mentions 155 combinations of RNQPs and fruit propagating material and fruit plants intended for fruit production.

9        Pursuant to those parts of Annex IV to the contested implementing regulation, the Commission established, with just four exceptions, a 0% threshold for the presence of RNQPs.

 Procedure and forms of order sought

10      By application lodged at the Court Registry on 20 February 2020, the applicants, Società agricola Vivai Maiorana Ss, Confederazione Italiana Agricoltori – CIA (‘CIA’) and MIVA – Moltiplicatori Italiani Viticoli Associati (‘MIVA’), brought the present action.

11      By documents lodged at the Court Registry, on 11 and 27 May 2020 respectively, the European Parliament and the Council of the European Union sought leave to intervene in these proceedings in support of the form of order sought by the Commission. By respective decisions of 8 and 22 July 2020, the President of the Ninth Chamber of the General Court allowed those interventions. The interveners lodged their statements and the main parties lodged their observations on those statements within the periods prescribed.

12      The applicants claim that the Court should:

–        annul Parts A, B, C, F, I and J of Annex IV to the contested implementing regulation in so far as, under those parts, thresholds are established for the presence of RNQPs on the plants concerned;

–        declare Article 36 and Article 37(2) of Regulation 2016/2031, and point 3 of Section 4 of Annex I thereto, invalid;

–        order the Commission to pay the costs.

13      The Commission, the Parliament and the Council contend that the Court should:

–        dismiss the action as inadmissible in part and unfounded in part;

–        order the applicants to pay the costs.

14      In the context of the measures of organisation of procedure provided for in Article 89 of the Rules of Procedure of the General Court, the Court put written questions to the applicants on 8 February and 30 April 2021. The applicants complied with those measures by letters of 24 February and 14 May 2021 respectively. By letter of 17 May 2021, the Commission lodged its observations on the evidence submitted by the applicants on 24 February 2021.

15      Acting on a proposal from the Judge-Rapporteur, the General Court (Ninth Chamber) decided to open the oral part of the procedure.

16      As the Judge-Rapporteur initially designated was prevented from sitting, the present case was assigned to a new Judge-Rapporteur sitting in the Ninth Chamber by decision of the President of the General Court of 8 June 2021. In addition, by decision of 8 June 2021, the President of the Ninth Chamber designated another Judge to complete the Chamber.

 Law

17      In support of their action, the applicants raise four pleas in law, alleging respectively:

–        infringement of Article 36(e) and (f) of Regulation 2016/2031, failure to comply with the principle of proportionality and a failure to state adequate reasons;

–        infringement of the International Treaty on Plant Genetic Resources for Food and Agriculture (‘the ITPGRFA’), the conclusion of which was approved, on behalf of the European Community, by Council Decision 2004/869/EC of 24 February 2004 (OJ 2004 L 378, p. 1);

–        infringement of Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007 (OJ 2018 L 150, p. 1);

–        incompatibility of the contested parts of Annex IV to the contested implementing regulation with the common agricultural policy.

18      Before challenging the merits of the action, the Commission expresses doubts as to admissibility of the action in the light of the applicants’ interest in bringing proceedings and their standing to do so as well as the clarity of the pleas in law raised. For their part, the Parliament and the Council are of the view that the plea of illegality raised against Regulation 2016/2031 does not set out with the necessary clarity the grounds upon which it is based, and that it should therefore be dismissed as inadmissible.

 Admissibility

 Standing to bring proceedings

19      In the first place, the Commission states that the contested implementing regulation is a regulatory act that does not entail implementing measures within the meaning of the fourth paragraph of Article 263 TFEU. In its view, it follows that, for the action at issue to be admissible, that regulation must be of direct concern to the applicants within the meaning of the latter provision.

20      The Commission argues that that is not, however, the case with Società agricola Vivai Maiorana, a vineyard nursery and the first applicant, since that applicant does not claim to be a professional operator concerned by Parts A, B, F, I and J of Annex IV to the contested implementing regulation. As a vineyard nursery, only Part C of that annex is therefore of direct concern to the first applicant.

21      As for the two applicant associations, that is to say, CIA and MIVA, the Commission claims that they have standing to bring an action for annulment of the contested implementing regulation in three situations only: first, where the law expressly affords them such a right; second, where some of the members that they represent have standing to bring proceedings individually; or, third, where they can claim their own interest.

22      First, those applicants do not claim that the first of those situations is applicable in the present case.

23      Second, the applicant associations do not specify which of their members are professional operators active in the production and marketing of the plants concerned by those parts of Annex IV to the contested implementing regulation, the annulment of which is sought by them. That information is not clear from the articles of association of CIA or MIVA or provided in the documents produced in the annex to the reply. Furthermore, since the first applicant brought the action in its own name, MIVA cannot base its standing to bring proceedings on the fact that the applicant in question is one of its members. As regards the operators named in the applicants’ reply of 24 February 2021, the applicants have not established that those operators were entered in the official register of professional operators which the Member States were required to keep and update pursuant to Article 65 of Regulation 2016/2031. In addition, the Commission challenges the relevance of the invoices produced by the applicants. In that connection, the Commission argues, depending on the professional operator in question, either that those invoices do not relate to the plants covered by the contested parts of Annex IV to the contested implementing regulation, or that they concern only some of those plants, or that they are dated after the date on which the action was brought. The Commission adds that the doubts that persist as regards the applicants’ standing to bring proceedings make the scope of the action uncertain and may infringe its rights of defence.

24      Third, in so far as CIA claims its own interest with a view to establishing its standing to bring proceedings, the Commission observes that the parts of Annex IV to the contested implementing regulation, the annulment of which is sought, do not alter CIA’s rights or obligations as an association, such that the parts at issue are not of direct concern to it.

25      For their part, the applicants also take the view that the contested implementing regulation is a regulatory act which does not entail implementing measures, but consider that the provisions of that regulation are of direct concern to them. In that connection, the applicants state, first, that CIA’s members are farmers covering the entire spectrum of agricultural activities, whereas MIVA’s members are exclusively producers of vine propagating material. It follows that all members of the applicant associations have standing to bring an action for annulment of the contested parts of Annex IV to the contested implementing regulation as producers or purchasers of seed covered by those parts. In that regard, in response to a measure of organisation of procedure, the applicant associations produced evidence showing, in their view, that they represented at least one professional operator whose activity fell within the scope of Parts A, B, C, F, I or J of Annex IV to the contested implementing regulation.

26      Given its number of members, CIA is, moreover, a particularly representative association. In the present case, CIA seeks to protect a collective interest in accordance with its statutory object of developing and enhancing the rural environment, developing agriculture and promoting biodiversity.

27      It must be recalled from the outset that the contested implementing regulation was adopted on the basis, inter alia, of Article 37(2) of Regulation 2016/2031. Since it is intended to give effect to the latter provision, it is the purpose of the contested implementing regulation, in accordance with recitals 2, 14 and 15 thereof, to list the RNQPs and the specific categories of plants for planting, whilst establishing thresholds for the maximum presence of RNQPs, if the conditions for so doing are met (see paragraphs 3, 4 and 6 above).

28      In that connection, Annex IV to the contested implementing regulation contains the list of RNQPs and specific plants for planting together with categories and thresholds. Under Article 5 of the contested implementing regulation, those plants for planting are not to be introduced into, or moved within, the Union if the presence of RNQPs, or of symptoms caused by RNQPs, on those plants for planting is above those thresholds (see paragraphs 7 to 9 above).

29      In that regard, as the applicants and the Commission argue (see paragraphs 19 and 25 above), as a non-legislative act of general application, the contested implementing regulation is a regulatory act within the meaning of Article 263 TFEU (see, to that effect, order of 6 September 2011, Inuit Tapiriit Kanatami and Others v Parliament and Council, T‑18/10, EU:T:2011:419, paragraph 56).

30      In addition, it must be observed, again as the applicants and the Commission submit, that, in so far as they establish thresholds for the presence of RNQPs on the plants for planting concerned, the contested parts of Annex IV to the contested implementing regulation do not entail implementing measures within the meaning of the fourth paragraph of Article 263 TFEU. Moreover, Article 5 of the latter regulation lays down a prohibition of introduction into, and movement within, the Union if the presence of RNQPs, or of symptoms caused by RNQPs, on those plants for planting is above those thresholds; that prohibition likewise does not entail implementing measures.

31      Accordingly, for the applicants to have standing to bring proceedings, it is enough to establish that the provisions the annulment of which they are seeking are of direct concern to them, within the meaning of the fourth paragraph of Article 263 TFEU.

32      The condition that a natural or legal person must be directly concerned by the decision against which an action is brought, as laid down in the fourth paragraph of Article 263 TFEU, requires two cumulative criteria to be met. First, the contested measure must directly affect the legal situation of the individual. Second, it must leave no discretion to its addresses who are entrusted with the task of implementing it, such implementation being purely automatic and resulting from the EU rules alone without the application of other intermediate rules (see judgment of 6 November 2018, Scuola Elementare Maria Montessori v Commission, Commission v Scuola Elementare Maria Montessori and Commission v Ferracci, C‑622/16 P to C‑624/16 P, EU:C:2018:873, paragraph 42 and the case-law cited).

33      Without raising a plea of inadmissibility by separate document, the Commission disputes that the first condition, which relates to the effect on the applicants’ legal situation, is satisfied in the present case with respect to all the applicants and in relation to all the contested parts of Annex IV to the contested implementing regulation (see paragraphs 19 to 24 above).

34      It must be observed that the prohibition under Article 5 of the contested implementing regulation of introducing and moving plants for planting, if the presence of RNQPs, or of symptoms caused by RNQPs, is above the thresholds established by the contested parts of Annex IV to that regulation, is of direct concern to ‘professional operators’ within the meaning of Article 2(9) of Regulation 2016/2031 (see paragraph 5 above). In accordance with Article 37(1) of Regulation 2016/2031, they are the operators covered by the prohibition at issue (see paragraph 3 above). That prohibition does not leave any discretion to the Member States, which are entrusted with the task of implementing it. Therefore, a professional operator within the meaning of Article 2(9) of Regulation 2016/2031, who carries out its activities in relation to the category of plants concerned by one or more of the contested parts of Annex IV to the contested implementing regulation, has its legal situation directly affected by the prohibition laid down in the latter regulation.

35      In the latter regard, it must be stated, first, that Regulation 2016/2031 distinguishes between ‘professional operators’, as defined in Article 2(9) thereof, on the one hand, and ‘registered operators’, who, under Article 2(10) of the same regulation, on the other hand, are professional operators registered in accordance with Article 65 of that regulation. The latter provision states, in essence, that the competent national authority is to keep and update a register containing the professional operators who fulfil certain criteria. However, it is clear from Article 65(3) of Regulation 2016/2031 that the professional operators who fulfil certain criteria linked to the pest risk presented by the plants grown by them do not have to be entered in the register in question.

36      Accordingly, the prohibition of introducing and moving plants for planting, if the presence of RNQPs, or of symptoms caused by RNQPs, is above the thresholds established by the contested parts of Annex IV to the contested implementing regulation, covers professional operators within the meaning of Article 2(9) of Regulation 2016/2031 and not just registered operators within the meaning of Article 2(10) of the same regulation. The Commission’s argument based on the fact that it is not established that the operators who are members of the second and third applicants are registered operators must therefore be dismissed.

37      Second, according to Article 2(9) of Regulation 2016/2031, the concept of ‘professional operator’ includes any person, governed by public or private law, involved professionally in one or more of the activities mentioned in paragraph 5 above, which concern inter alia plants.

38      In addition, the term ‘plants’ is defined in Article 2(1) of Regulation 2016/2031 as including living plants and living parts of plants, such as, inter alia, seeds, fruits, vegetables, tubers, budwood, cuttings and grafts.

39      Moreover, it is clear from Article 37(1) and (2) of Regulation 2016/2031 that the list of RNQPs and specific plants for planting which the Commission is to establish by means of an implementing regulation, such as the contested implementing regulation, does not necessarily include all plants for planting, but only those plants for planting ‘through which [the RNQP] is transmitted’. In particular, as set out in paragraph 8 above, Annex IV to the contested implementing regulation is divided into 12 parts, from A to L, each of which mentions a number of combinations of plants and RNQPs.

40      For instance, Council Directive 66/401/EEC of 14 June 1966 on the marketing of fodder plant seed (OJ, English Special Edition, 1965-1966, p. 132) lists, in Article 2(1)(A) thereof, 87 genera or species of fodder plants. However, Part A of Annex IV to the contested implementing regulation, which is entitled ‘RNQPs concerning fodder plant seed’, lists only the species of lucerne (Medicago sativa L.), via which the two RNQPs mentioned therein (Clavibacter michiganensis and Ditylenchus dipsaci) are transmitted.

41      It follows that the concept of ‘professional operator’ includes all operators involved in one or more of the activities listed in Article 2(9) of Regulation 2016/2031 and concerning ‘plants’, as the latter are defined in Article 2(1) of Regulation 2016/2031 and listed in each of the directives concerning their marketing.

42      Thus, it is true that the prohibition under Article 5 of the contested implementing regulation, read together with Article 37(1) of Regulation 2016/2031, of introducing RNQPs into, and moving them within, the Union territory covers, ratione materiae, the plants for planting listed in Annex IV to the contested implementing regulation. However, that prohibition covers, ratione personae, all professional operators within the meaning of Article 2(9) of Regulation 2016/2031.

43      In that way, the legislature intended to limit the risk of transmission of RNQPs from not only ‘registered operators’ or operators who have carried out activities related specifically to the plants included in Annex IV to the contested implementing regulation, but from any professional operator active in the field of plants, who, by virtue of that fact, may carry out activities related to plants through which RNQPs listed in that Annex IV are transmitted.

44      It follows that the Commission’s approach, under which only the legal situation of those professional operators who have carried out their activity in relation solely to the plants listed in the contested annexes to the implementing regulation is affected, cannot be accepted. Aside from the fact that the approach in question is contrary to the applicable provisions (see paragraphs 35 to 41 above), it is based on the premiss that the prohibition under Article 5 of the contested implementing regulation does not apply to all professional operators within the meaning of Article 2(9) of Regulation 2016/2031, but only to those who have in the past carried out their activity in relation to plants through which RNQPs are transmitted. However, accepting that view would have the effect of seriously undermining the practical effect of the policy seeking to prevent the transmission of RNQPs in the European Union.

45      In that connection, it must be held that, as a vineyard nursery undertaking active in the vine propagating material sector, the first applicant is a professional operator within the meaning of Article 2(9) of Regulation 2016/2031. However, in that capacity, as the Commission argues, the legal situation of the first applicant is affected only by Part C of Annex IV to the contested implementing regulation, which relates to RNQPs concerning vine propagating material. The first applicant therefore has standing to bring proceedings only in so far as it seeks the annulment of that part of the contested implementing regulation.

46      With regard to the two applicant associations, CIA and MIVA, it must be recalled that an association responsible for defending the collective interests of its members is permitted to bring an action for annulment because of the impact on its own interests as an association or where the people who it represents, or some of those people, have standing to bring proceedings individually (judgment of 30 April 2019, UPF v Commission, T‑747/17, EU:T:2019:271, paragraph 20).

47      With regard to the first of those conditions invoked by CIA (see paragraph 26 above), it must be held, as the Commission observes, that the contested parts of Annex IV to the contested implementing regulation does not alter the rights or obligations of that association as such, meaning that they do not affect CIA’s legal position. It follows that CIA cannot legitimately claim that it has standing to bring proceedings because of the impact on its own interests.

48      As for the standing to bring proceedings of the people represented by CIA, it must be observed from the outset that, in accordance with the eighteenth indent of Article 3 of its articles of association, one of the objects of that organisation is to promote its members’ interests. The applicants enclosed with the reply a list containing the names and addresses of the association’s 584 842 members. In response to the measures of organisation of procedure (see paragraph 14 above), the applicants produced evidence to establish that eight of CIA’s members are professional operators active in the fodder plant seed, cereal seed, vine propagating material, vegetable seed, vegetable plant and fruit plant sectors. Those sectors are concerned by Parts A, B, C, F, I and J of Annex IV to the contested implementing regulation.

49      As for MIVA, it is clear from Article 8 of that association’s articles of association that it has members who are professional operators within the meaning of Article 2(9) of Regulation 2016/2031 as far as concerns vine propagating material. That is certainly the case with the first applicant. However, that fact is incapable of entailing the admissibility of the action as it is brought by MIVA, since the first applicant brought the action in its own name (see, to that effect, judgment of 30 April 2019, UPF v Commission, T‑747/17, EU:T:2019:271, paragraphs 25 to 27).

50      In response to the measure of organisation of procedure adopted on 8 February 2021, the applicants produced evidence to establish that three of MIVA’s members, other than the first applicant, are professional operators active in the vine propagating material, vegetable plant and fruit plant sectors. Those sectors are concerned by Parts C, I and J of Annex IV to Implementing Regulation (EU) 2019/2072. It must be added, in that regard, that, in accordance with Article 3 of MIVA’s articles of association, one of the objects of that association is to promote the interests related to its members’ activities, but does not exclude from those activities agricultural activities concerning plants other than vine propagating material.

51      As for the Commission’s argument that certain invoices produced by the applicants are dated after the date on which the action was brought, that argument cannot be upheld. The status of ‘professional operator’ within the meaning of Article 2(9) of Regulation 2016/2031 is, by definition, to be established by means of a body of consistent evidence. If the Commission’s logic were followed, that would mean that only evidence bearing the same date as that on which the action was brought would be capable of establishing the status of professional operator, since, for example, it would be impossible to rule out on the basis of invoices issued prior to that date that the operator in question has not in the meantime ceased the activity relating to the plants concerned.

52      In the present case, the applicants have produced several invoices, for substantial amounts, from which it is clear that the persons who issued them, members of the applicant associations, are professional operators within the meaning of Article 2(9) of Regulation 2016/2031. In addition, as the applicants claimed at the hearing, in order for plants for planting to be marketed, a series of preliminary steps have to be undertaken which, depending on the plant in question, take varying periods of time. It follows that the production of invoices dated after the date on which the action was brought, with a view to establishing that the members of the second and third applicants have the status of professional operators within the meaning set out above, is not, in itself, capable of excluding the relevance of that evidence.

53      Finally, since the Commission was duly afforded the opportunity to submit, in writing and orally, its observations on all the evidence produced by the applicants in relation to their standing to bring proceedings, there cannot be found to have been a breach of its rights of defence.

54      It follows that the applicants have demonstrated their standing to bring proceedings, subject to the following clarifications:

–        the first applicant has standing to bring an action for annulment of Part C of Annex IV to the contested implementing regulation;

–        CIA has standing to bring an action for annulment of Parts A, B, C, F, I and J of Annex IV to the contested implementing regulation;

–        MIVA has standing to bring an action for annulment of Parts C, I and J of Annex IV to the contested implementing regulation.

 Interest in bringing proceedings

55      The Commission claims that any annulment of Parts A, B, C, F, I and J of Annex IV to the contested implementing regulation would invalidate the thresholds for the presence of the RNQPs set out pursuant to the parts in question, and therefore the plants concerned would no longer be subject to the prohibition of introduction into, and movement within, the Union territory. However, such annulment would not affect the obligations of sanitation incumbent on professional operators, as laid down in various directives governing the marketing of those same plants. Those directives are independent acts which merely take into account the thresholds for the presence of RNQPs established in the contested parts of Annex IV to the contested implementing regulation. They cannot therefore be regarded as implementing measures of the contested implementing regulation, the validity of which would be affected following any annulment of that implementing regulation. It follows that, even if the applicants were to obtain the annulment sought in the present case, the professional operators concerned would still be required to comply with the plant health requirements laid down in the abovementioned directives as regards both the relatively inexpensive sanitation at the production stage and the sanitation required to market the plants concerned. Finally, in the Commission’s view, the applicants’ interest in protecting biodiversity is based purely on assumptions.

56      It is settled case-law that an action for annulment brought by a natural or legal person is admissible only in so far as that person has an in interest in having the contested act annulled. Such an interest requires that the annulment of the act must be capable, in itself, of having legal consequences and that the action may therefore, through its outcome, procure an advantage to the party which brought it (see judgment of 17 September 2015, Mory and Others v Commission, C‑33/14 P, EU:C:2015:609, paragraph 55 and the case-law cited).

57      In that connection, the Commission argues that the applicants derive no advantage from the potential annulment of the contested parts of Annex IV to the contested implementing regulation because such annulment would leave intact the sanitation obligations applicable to the plants for planting concerned, as laid down in the respective directives governing the marketing of those plants.

58      In order to assess the merits of that argument raised by the Commission, it is necessary to set out the fundamentals of the Union plant health system vis-à-vis RNQPs, as provided for in Regulation 2016/2031, the contested implementing regulation and the directives governing the marketing of the plants concerned by the present action.

59      In particular, first, as is clear from Article 36 of Regulation 2016/2031, RNQPs are pests that are present in the Union territory, which are transmitted primarily via certain plants for planting and the presence of which on those plants has an unacceptable economic impact as regards the intended use of the plants in question.

60      According to recital 23 of Regulation 2016/2031, in order to limit the presence of RNQPs, their introduction into, or movement within, the Union territory on the plants for planting concerned should be prohibited where those pests are present at an incidence above a certain threshold.

61      As set out in paragraphs 3 and 4 above, the Commission is to establish a list of RNQPs and specific plants for plants together, where appropriate, with thresholds greater than zero from which the presence of an RNQP on the plants for planting has an unacceptable economic impact. That list appears in Annex IV to the contested implementing regulation (see paragraph 8 above).

62      Second, the rules governing the marketing of each plant for planting concerned by a part of Annex IV to the contested implementing regulation are laid down under directives. The correspondence between the RNQPs listed in each contested part of Annex IV to the contested implementing regulation and the related marketing directives is shown in the following table:

Part of Annex IV to the contested implementing regulation	Directive on marketing
Part A RNQPs concerning fodder plant seed	Directive 66/401
Part B RNQPs concerning cereal seed	Council Directive 66/402/EEC of 14 June 1966 on the marketing of cereal seed (OJ, English Special Edition, 1965-1966, p. 143)
Part C RNQPs concerning vine propagating material	Council Directive 68/193/EEC of 9 April 1968 on the marketing of material for the vegetative propagation of the vine (OJ, English Special Edition, 1968(I), p. 93)
Part F RNQPs concerning vegetable seed	Council Directive 2002/55/EC of 13 June 2002 on the marketing of vegetable seed (OJ 2002 L 193, p. 33)
Part I RNQPs concerning vegetable propagating and planting material, other than seeds	Council Directive 2008/72/EC of 15 July 2008 on the marketing of vegetable propagating and planting material, other than seed (OJ 2008 L 205, p. 28) Commission Directive 93/61/EEC of 2 July 1993 setting out the schedules indicating the conditions to be met by vegetable propagating and planting material, other than seed, pursuant to Council Directive 92/33/EEC (OJ 1993 L 250 p. 19)
Part J RNQPs concerning fruit propagating material and fruit plants intended for fruit production	Council Directive 2008/90/EC of 29 September 2008 on the marketing of fruit plant propagating material and fruit plants intended for fruit production (OJ 2008 L 267, p. 8) Commission Implementing Directive 2014/98/EU of 15 October 2014 implementing Directive 2008/90 as regards specific requirements for the genus and species of fruit plants referred to in Annex I thereto, specific requirements to be met by suppliers and detailed rules concerning official inspections (OJ 2014 L 298, p. 22)

63      The directives governing marketing lay down the plant health measures that must be adopted in order to manage the risk of the presence of RNQPs and to ensure that the plants introduced into, and moving within, the Union are consistent with the requirements of the relevant part of Annex IV to the contested implementing regulation as regards the presence of RNQPs.

64      Thus, following the adoption of the contested implementing regulation, the directives governing the marketing of plants were amended by Commission Implementing Directive (EU) 2020/177 of 11 February 2020 amending Council Directives 66/401, 66/402, 68/193, 2002/55, 2002/56/EC and 2002/57/EC, Commission Directives 93/49/EEC and 93/61 and Implementing Directives 2014/21/EU and 2014/98 as regards pests of plants on seeds and other plant reproductive material (OJ 2020 L 41, p. 1).

65      In particular, it is clear from recitals 5, 6, 8, 10 to 12, 14 and 19 to 23 of Implementing Directive 2020/177 that the directives governing the marketing of the plants concerned by the contested parts of the contested implementing regulation had to be amended to provide for measures so that plant reproductive material falling within their scope satisfy the requirements relating, inter alia, to the RNQPs established in the contested parts of Annex IV to the contested implementing regulation. Directive 66/401 on the marketing of fodder plant seed constitutes a partial exception, in that it was amended to provide that the seed in question also had to satisfy the requirements regarding RNQPs established pursuant to Part A of Annex IV to the contested implementing regulation, without however laying down requirements in addition to those in force prior to the adopting of Implementing Directive 2020/177.

66      That systematic relationship between the contested implementing regulation, on the one hand, and the directives governing the marketing of the plants for planting covered by the contested parts of Annex IV to that regulation, on the other hand, is explicitly affirmed by the Commission in paragraphs 24 to 27 of the defence and 68 and 70 of the rejoinder.

67      It is clear from those findings that, even though, as the Commission states, the directives in question are not implementing measures of the contested implementing regulation, they do lay down obligations on operators, who are to take account of the rules on the presence of RNQPs established by the latter regulation and which seek to ensure that the operators in question comply with those rules. That conclusion is likewise valid in respect of Directive 66/401, which now provides that fodder plant crop and seed must also fulfil the requirements as regards the presence of RNQPs established pursuant to Part A of Annex IV to the contested implementing regulation, even though it did not establish additional measures in that regard.

68      The Commission cannot therefore reasonably claim that any annulment of the contested parts of Annex IV to the contested implementing regulation cannot, in any case, procure an advantage for the first applicant or for the members of CIA and MIVA. Given the internal consistency of the EU plant health system, which is characterised by the systematic relationship between the contested implementing regulation and the related directives governing the marketing of plants for planting, if that implementing regulation were to be annulled in part, the legislature could be prompted, depending on the grounds of the annulment and on the measures to be adopted pursuant to Article 266 TFEU, to review the directives at issue, which would have lost their regulatory basis as it currently stands.

69      Accordingly, the provisions of the directives on the marketing of plants for planting do not invalidate the applicants’ interest in seeking the annulment of the contested parts of Annex IV to the contested implementing regulation, which directly affect their legal situation in accordance with the clarifications set out in paragraphs 34 to 54 above. Moreover, it follows that, for the purposes of the admissibility of the action from the perspective of the interest in bringing proceedings, there is no need for the applicants to establish their own specific interest in the protection of biodiversity, so that the Commission’s argument based on the allegedly hypothetical nature of such an interest must be dismissed as irrelevant.

 The clarity of the action

70      The Commission, supported by the Parliament and the Council, first, claims that it is not clear from the pleas in law which rules of law are allegedly infringed by Article 36, Article 37(2) and point 3 of Section 4 of Annex I to Regulation 2016/2031 and the infringement of which renders those provisions invalid in accordance with form of order sought by the applicants. Second, the Commission states that the applicants submit specific arguments explaining the alleged illegality only in respect of Part C of Annex IV to the contested implementing regulation. By contrast, the application for annulment of the other contested parts of Annex IV to that regulation is based solely on general points lacking the precision required by Article 21 of the Statute of the Court of Justice of the European Union, even taking into account the explanations given in the reply. In any case, Regulation 2016/2031 is not, in its view, vitiated by any of the illegalities that may be regarded as being raised against it.

71      It is true that the application does not contain arguments capable of constituting a detailed statement of reasons for the alleged illegality of Regulation 2016/2031 and that it does not include a specific analysis of the contested parts of Annex IV to the contested implementing regulation other than of Part C of the annex in question. In addition, it is likewise true that a number of the applicants’ arguments are presented as claims that are often not clearly linked to the contested parts of Annex IV to the contested implementing regulation.

72      However, first, in the reply the applicants did include arguments concerning certain contested parts of Annex IV to the contested implementing regulation other than Part C. Those arguments, which are made in the context of the pleas in law raised in the application, constitute an admissible extension of those pleas. Second, even though the link between certain arguments set out in support of the pleas in law raised is not always clear, the scope of the complaints put forward by the applicants can be determined from the detailed study of the legal context in its entirety. Third, the references to the alleged breach, by Regulation 2016/2031, of the principle of proportionality allow the Court, taking into account the line of argument put forward by the applicants in its entirety, to conduct its review vis-à-vis that principle.

73      The plea of inadmissibility relating to the clarity of the action must therefore be dismissed.

 Substance

 The first plea in law, alleging infringement of Article 36(e) and (f) of Regulation 2016/2031, failure to comply with the principle of proportionality and a failure to state reasons

74      The applicants point out that, pursuant to Article 36 of Regulation 2016/2031, a pest can be included in the list of RNQPs only if it fulfils the conditions laid down in that provision. Those conditions include conditions relating to the unacceptable economic impact entailed by the presence of the pest, within the meaning of point 3 of Section 4 of Annex I to that regulation, and to the availability of feasible and effective measures to prevent its presence on those plants (Article 36(e) and (f) of Regulation 2016/2031). However, the reasons given for the thresholds established pursuant to the contested parts of Annex IV to the contested implementing regulation do not refer to a detailed analysis of the economic impact that the presence of RNQPs on the plants concerned would have, and nor are they based on the availability of feasible and effective measures to prevent their presence. In addition, establishing 0% thresholds for the presence of RNQPs entails plant health sanitation obligations, by way of genetic selection, for the varieties concerned, which, in turn, ultimately destroys the diversity of the ‘standard’ category varieties, which are not currently subject to sanitation, and removes the differentiation between the varieties falling into the ‘standard’ category, on the one hand, and the ‘certified’ category, on the other hand.

75      For instance, the thresholds established pursuant to Part C of Annex IV to the contested implementing regulation entail, in the absence of clones capable of ensuring compliance with the zero threshold for the presence of RNQPs, the prohibition of the marketing of 57.7% of the grape varieties registered in the Italian register of vines for the production of wine. That prohibition makes it impossible, for at least a decade, to renew or replant native varieties covered by designations of origin or geographical indications and has the effect of simplifying dramatically certain biotypes of varieties. The marked reduction in intra-varietal biodiversity is the primary result of the sanitation measures necessary to combat the viruses, viroids and virus-related diseases. Such harmful effects are not, however, associated with any benefit and do not guarantee that the sanitised plants will not be infected, via insect vectors, after being planted. The Commission should have taken account of those effects in its assessment regarding the unacceptable economic impact of the RNQPs on the plants for planting. It is clear, however, from the current situation that the presence of the RNQPs forming the subject of the contested parts of Annex IV to the contested implementing regulation has not affected the profitability of the agricultural holdings concerned, and that, therefore, an unacceptable economic impact cannot be regarded as resulting from such presence within the meaning of Article 36(e) of Regulation 2016/2031.

76      In those circumstances, it must be held that the study by the European and Mediterranean Plant Protection Organization (‘the EPPO’), which the Commission took as a basis for the adoption of the contested parts of Annex IV to the contested implementing regulation, is vitiated by errors and deficiencies, in so far as it found that 0% thresholds vis-à-vis RNQPs present in Europe had been established for a very long time, without those thresholds being associated with a negative economic impact.

77      The applicants add that the sanitation required entails a cost of EUR 120 000 for each variety and 10 years’ work in specialised structures, with no prospect of recovering that expenditure. That constitutes an intolerable financial burden if the area farmed is less than approximately 1 000 hectares per variety, which is the case for native varieties with limited coverage. In the rare cases in which the sanitation in question is of economic interest, it restricts the genetic pool of the original variety. The Commission failed to take account of those effects before establishing the thresholds for the presence of RNQPs under the contested parts of Annex IV to the contested implementing regulation, and therefore the condition laid down in Article 36(f) of Regulation 2016/2031 is not fulfilled.

78      In that context, it must be held that the fact that Articles 36 and 37 of Regulation 2016/2031 did not provide for the establishment of incidence thresholds proportionate, first, to the risk represented by the RNQPs for specific terroirs and, second, to the costs of sanitation constitutes a breach of the principle of proportionality and of the obligation to protect the identity of those terroirs.

79      Finally, the applicants claim that the consequences of establishing a 0% threshold for the presence of RNQPs for biodiversity and for the costs of sanitation by way of genetic selection now required should have been the subject of an impact assessment in accordance with the ‘Better Law-Making’ interinstitutional agreement between the Parliament, the Council and the Commission (OJ 2016 L 123, p. 1). The absence of any such analysis means that the contested parts of Annex IV to the contested implementing regulation are vitiated by a failure to state reasons and a breach of the principle of proportionality.

80      The Commission, for its part, contests those assessments.

81      With regard to the first plea in law, the applicants claim, in essence, that the Commission infringed Article 36(e) and (f) of Regulation 2016/2031. In support of that claim, the applicants essentially put forward three complaints.

82      The first complaint is based on the alleged harmful consequences that establishing 0% thresholds for the presence of RNQPs has for biodiversity. In the context of that complaint, the applicants argue that establishing that 0% incidence threshold has the effect of imposing obligations of sanitation by way of genetic selection, which dramatically reduces the diversity of ‘standard’ category plants for planting, of which there are a very high number at present. In the applicants’ view, establishing that threshold also removes the distinction between the ‘standard’ and ‘certified’ categories of material (see paragraph 92 below) and has adverse consequences for the wine sector. According to the applicants, the Commission should have taken account of those factors in order to assess whether the slightest presence of RNQPs on the plants for planting had an unacceptable economic impact in accordance with Article 36(e) of Regulation 2016/2031, and also to determine whether feasible and effective measures were available to prevent such presence pursuant to Article 36(f) of the same regulation. In that context, the applicants add that RNQPs can be transmitted via insect vectors and that the analysis of the economic impact of RNQPs conducted by the EPPO is deficient (see paragraphs 74 to 76 above).

83      The second complaint alleges that the Commission failed to take account of the cost of the sanitation measures required following the establishment of the 0% threshold for the presence of the RNQPs listed, which constitutes an infringement of Article 36(f) of Regulation 2016/2031 (see paragraph 77 above). Furthermore, the applicants claim that, by allowing such an approach, Articles 36 and 37 of Regulation 2016/2031 are vitiated by a breach of the principle of proportionality and of the obligation to ‘protect the identity of the terroir’ (see paragraph 78 above).

84      The third complaint alleges that the Commission failed to conduct an environmental, social and economic impact assessment before adopting the contested implementing regulation. In that context, the applicants also claim that a statement of reasons was not provided and that the principle of proportionality was breached (see paragraph 79 above).

85      All those complaints are based on a single premiss, namely the claim that establishing the 0% threshold for the presence of the RNQPs listed in the contested parts of Annex IV to the contested implementing regulation entails an obligation of sanitation by way of genetic selection of the plants for planting concerned by the parts in question. The applicants claim that that obligation has adverse consequences for biodiversity, on the one hand, and entails exorbitant sanitation costs for professional operators, on the other hand. In their view, the Commission’s failure to take account of those factors when establishing the thresholds for the presence of RNQPs on the plants for planting constitutes, primarily, an infringement of Article 36(e) and (f) of Regulation 2016/2031. If it were held that Article 36(e) and (f) of Regulation 2016/2031 did not require that account be taken of those factors, the applicants allege that that provision constitutes a breach of the principle of proportionality and of the obligation to ‘protect the identity of the terroir’.

86      First, it must be held, as is set out in recital 12 of the contested implementing regulation, that the EPPO made a reassessment of the pests listed previously in Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (OJ 2000 L 169, p. 1) and the marketing directives for plants for planting.

87      According to recital 13 of the contested implementing regulation, that reassessment was necessary to update the phytosanitary status of those pests in accordance with the most recent technical and scientific developments, and also to assess their compliance with the respective criteria of Article 36 of Regulation 2016/2031, in respect of the Union territory, and Section 4 of Annex I thereto (see paragraph 2 above).

88      On completion of the reassessment, certain pests were found to fulfil the conditions provided for in Article 36 of Regulation 2016/2031 in respect of the Union territory and were therefore to be included in the list of RNQPs (recital 14 of the contested implementing regulation). Account was also taken of the conditions laid down in Article 37(8) of the same regulation as regards the possible establishment of thresholds for the presence of RNQPs higher than 0% (recital 15 of the contested implementing regulation).

89      That process culminated in the adoption of Annex IV to the contested implementing regulation, which establishes standards for the presence of RNQPs on plants for planting, so that those plants can be introduced into, and move within, the Union.

90      Second, that plea in law is based entirely on a misperception of the obligations entailed, for the relevant professional operators, by the establishment of the 0% threshold for the presence of the RNQPs listed in the contested parts of Annex IV to the contested implementing regulation.

91      In particular, as set out in paragraph 63 above, the directives governing the marketing of plants for planting provide for measures that must be adopted in order to manage risk, and to ensure that the plants introduced into, and moving within, the Union are comply with the requirements of the relevant part of Annex IV to the contested implementing regulation as regards the presence of RNQPs.

92      In that connection, some of those directives divide plants for planting into categories. For instance, Directive 68/193 on the marketing of material for the vegetative propagation of the vine, on which the applicants’ analysis is focused, divides, in parts D, E, F and G of Article 2(1) thereof, the propagation material falling within its scope into ‘initial’ material, ‘basic’ material, ‘certified’ material and ‘standard’ material respectively.

93      In that connection, the eighth recital of Directive 68/193 read as follows:

‘whereas it would be desirable to restrict marketing to certified vine propagation material obtained by clonal selection; whereas, however, it is at present impossible to attain this objective since Community requirements could not be entirely covered by such material; whereas, therefore, the marketing of checked standard material which must also possess identity and varietal purity but which does not always afford the same assurances as propagation material obtained by clonal selection should be allowed provisionally; whereas, however, this category should gradually be eliminated[.]’

94      However, it is clear from Part G of Article 2(1) of Directive 68/193 and from point 6(c) of Section 8 of Annex I thereto, as amended by Implementing Directive 2020/177, that the ‘standard’ category of vine propagating material is still being marketed (see paragraph 101 below). In particular, the table contained in Part C of Annex IV to the contested implementing regulation establishes a threshold for the presence of RNQPs for ‘initial’, ‘basic’ and ‘certified’ propagating material, on the one hand, and for ‘standard’ material, on the other hand.

95      For their part, the applicants take the view that the effects entailed by establishing 0% thresholds for the presence of RNQPs relate primarily to the ‘standard’ categories of the plants for planting. According to the applicants, those categories include native material, which is subject to marketing that is limited to specific territories.

96      With regard to the effects of the thresholds for the presence of RNQPs, it is true that the marketing directives, as amended by Implementing Directive 2020/177 (see paragraphs 64 and 65 above), do provide for certain sanitation measures for propagating material with that in mind. However, as the Commission sets out, none of those directives requires the professional operators concerned to carry out sanitation by way of genetic selection that could impact on biodiversity in the ways described by the applicants.

97      More specifically:

–        Directive 66/401 on the marketing of fodder plant seed was amended with a view to providing that fodder plant crop and seed was also to comply with the requirements concerning the presence of RNQPs laid down pursuant to Part A of Annex IV to the contested implementing regulation, even though an additional requirement is not laid down therein for specific RNQPs (see recital 8 and Article 1 of Implementing Directive 2020/177 and Annex I thereto);

–        Directive 66/402 on the marketing of cereal seed was amended with a view to providing that the presence of RNQPs on crops and seed complied with the requirements laid down pursuant to Part B of Annex IV to the contested implementing regulation. In addition, the amended version of that directive specifies the maximum number of symptomatic plants seen during inspections of a representative sample for the crop to be regarded as being ‘practically free’ from the fungus Gibberella fujikuroi Sawada [GIBBFU], as required in Part B of Annex IV to the contested implementing regulation (see recital 10 and Article 2 of Implementing Directive 2020/177 and Annex II thereto);

–        Directive 68/193 on the marketing of material for the vegetative propagation of the vine was amended in order to provide, in essence, that the stock nurseries and the cutting nurseries were to be inspected visually and, where appropriate, sampled and tested to ensure that they were free from the RNQPs listed in Part C of Annex IV to the contested implementing regulation. If RNQPs or related symptoms are found to be present, Annex I to Directive 68/193, as amended, provides, depending on the RNQP and the category of propagating material, for the adoption of measures such as the roguing out and the destruction of the vines concerned, the exclusion of those vines from propagation, hot water treatment, bactericide treatment, maintenance in insect-proof facilities, appropriate grafting or fumigation (see recital 11 and Article 3 of Implementing Directive 2020/177 and Annex III thereto);

–        Directive 2002/55 on the marketing of vegetable seed was amended to provide that the presence of RNQPs on vegetable seed was not to exceed, at least upon visual inspection, the respective thresholds set out in Part F of Annex IV to the contested implementing regulation (see recital 14 and Article 6 of Implementing Directive 2020/177 and Annex VI thereto);

–        Directive 93/61 on the marketing of vegetable propagating and planting material other than seed was amended to provide that the presence of RNQPs on those plants is not to exceed, at least upon visual inspection, the thresholds established in Part I of Annex IV to the contested regulation (see recital 12 and Article 5 of Implementing Directive 2020/177 and Annex V thereto);

–        Implementing Directive 2014/98, which lays down specific requirements for, inter alia, the marketing of fruit plant propagating material and fruit plants intended for fruit production, was amended to provide that pre-basic mother plants, pre-basic material, basic mother plants, basic material, certified mother plants and certified material had, by means of a visual inspection, and, in the case of doubts, sampling and testing, to be found to be free from the RNQPs listed in Part J of Annex IV to the contested implementing regulation. If RNQPs or related symptoms are found to be present, Annex IV to Implementing Directive 2014/98, as amended, provides, depending on the RNQP and the category of propagating material, for the adoption of measures such as the roguing out and the destruction of the propagating material and plants concerned, and the testing of a representative sample of the asymptomatic propagating material and plants (see recitals 19 to 23 and Article 10 of Implementing Directive 2020/177 and Annex X thereto).

98      It is clear from the foregoing that, as the Commission observes, the thresholds for the presence of RNQPs established pursuant to the contested parts of Annex IV to the contested implementing regulation do, indeed, entail the obligation to take certain steps, namely the plants are to be to subject to visual observation and, should symptoms attributable to RNQPs appear, to hygiene measures or to appropriate treatments. However, no obligation whatsoever on the part of professional operators to carry out sanitation by way of genetic selection is apparent from the contested provisions of the contested implementing regulation or from the directives on the marketing of the plants concerned.

99      Furthermore, nor do the applicants rely on any provision imposing such an obligation.

100    In that connection, the applicants focus (see paragraph 75 above) on the alleged effects entailed by Part C of Annex IV to the contested implementing regulation on the diversity of vine propagating material infected with viruses, viroids or virus-related diseases. The applicants claim that, if hygiene measures are not taken or antiviral products applied, the varieties affected by those diseases can be sanitised only by methods such as thermotherapy, apical meristem culture or somatic embryogenesis, which, in their view, spell a marked reduction in intra-varietal biodiversity.

101    However, it is sufficient to observe that, according to points 2 and 3 of Section 2, and point 6(c) of Section 8, of Annex I to Directive 68/193, as amended by Implementing Directive 2020/177, further to a visual inspection, symptoms of such RNQPs can be tolerated on no more than 10% of vines in the stock nurseries intended for the production of ‘standard’ material, and that the vines concerned are to be eliminated from propagation. By contrast, it is clear from point 5(c) of Section 8 of the same annex to that directive that ‘initial’, ‘basic’ and ‘certified’ propagating material (see paragraph 93 above) are subject to much more stringent standards in relation to the symptoms in question, without however provision being made therein for genetic selection in that situation either.

102    Furthermore, the applicants do not claim that all ‘standard’ material is, by definition, affected by RNQPs, and that therefore the application of a 0% incidence threshold automatically entails an obligation to exclude it in its entirety from propagation. The very provision of a 10% upper limit in point 6(c) of Section 8 of Annex I to Directive 68/193, as amended by Implementing Directive 2020/177 (see paragraph 101 above) in fact points to the contrary.

103    Accordingly, as the Commission observes, Part C of Annex IV to the contested implementing regulation has neither the object nor the effect of requiring professional operators to implement methods of sanitation by way of genetic selection, such as those mentioned in paragraph 100 above, or of prohibiting the marketing of vine propagating material falling into the ‘standard’ category.

104    In the same context, it must be added, as the Commission points out, that several directives governing the marketing of plants for planting contain derogations that are specifically intended to promote genetic diversity.

105    Those include, in particular:

–        Article 3(3)(c) of Directive 68/193 on the marketing of material for the vegetative propagation of the vine;

–        Article 8(2)(c) of Directive 2008/72 on the marketing of vegetable propagating and planting material, other than seed; and

–        Article 3(4)(c) of Directive 2008/90 on the marketing of fruit plant propagating material and fruit plants intended for fruit production.

106    The purpose of those provisions is to allow the marketing of certain quantities of plants for planting, despite the fact that they do not fulfil the related plant health conditions, where such marketing is intended to contribute to preserving genetic diversity.

107    In that connection, reference must likewise be made to Article 44(2)(a) of Directive 2002/55 on the marketing of vegetable seed, which was the basis for the adoption of Commission Directive 2009/145/EC of 26 November 2009 providing for certain derogations, for acceptance of vegetable landraces and varieties which have been traditionally grown in particular localities and regions and are threatened by genetic erosion and of vegetable varieties with no intrinsic value for commercial crop production but developed for growing under particular conditions and for marketing of seed of those landraces and varieties (OJ 2009 L 312, p. 44).

108    The applicants’ argument based on the alleged ineffectiveness of establishing 0% thresholds for the presence of RNQPs as those pests can be transmitted via insect vectors must also be dismissed. As the Commission explains, providing that any plant material for planting must be free from RNQPs in accordance with the provisions of the contested parts of Annex IV to the contested implementing regulation prevents the transmission of the pests at issue via insect vectors.

109    As for the argument based on the allegedly inadequate assessment of the economic impact of RNQPs carried out by the EPPO (see paragraph 76 above), it must be stated that the marketing of ‘standard’ vine propagating material over many years cannot cast doubt upon the existence of an unacceptable economic impact on the planned use of plants for planting on account of the presence of RNQPs within the meaning of Article 36(e) of Regulation 2016/2031. As is clear from the study summarising the work carried out within the EPPO, the fact that an RNQP is already present in Union territory means that it has been possible to observe that impact on the basis of first-hand, detailed information that is already available.

110    In that regard, is also clear from that study that, since RNQPs are already the subject of certification schemes which limit the economic impact of their presence, the related analysis must take account of the impact that would occur if the restrictions in place were lifted. Thus, the economic impact assessment was based on information provided by the national plant protection authorities and by the interested parties who contributed to the assessment process.

111    In so far as the EPPO’s analysis is called into question on account of the alleged failure to take account of the imminent disappearance of propagating material under the ‘standard’ category on account of the exorbitant sanitation costs, that argument must be rejected for the reasons set out in paragraphs 90 to 108 above.

112    There is therefore no need to allow the applicants’ request for the adoption of the measure of inquiry to appoint an expert.

113    It is clear from those assessments that the applicants’ first complaint, alleging infringement of Article 36(e) and (f) of Regulation 2016/2031, on account of the alleged adverse consequences for biodiversity of establishing the 0% threshold for the presence of RNQPs, is based on the erroneous premiss that the threshold in question requires that methods of sanitation by way of genetic selection are implemented in relation to the plants for planting. That complaint must therefore be dismissed.

114    On the same grounds, the second complaint, alleging that the Commission failed to take into account the cost of the sanitation measures required following the establishment of the 0% threshold for the presence of the RNQPs listed and that that constitutes an infringement of Article 36(f) of Regulation 2016/2031 (see paragraph 83 above), must also be dismissed.

115    First, the applicants’ arguments regarding the allegedly exorbitant costs of the sanitation measures entailed by establishing the 0% threshold for the presence of RNQPs are also based on the premiss that the sanitation in question is to be carried out by way of genetic selection. However, as set out in paragraphs 90 to 113 above, that premiss is incorrect.

116    Second, as the Commission argues, it is apparent from reading Article 36(e) and (f) together with Article 37(8) of Regulation 2016/2031 that the availability of feasible and effective measures to prevent the presence of a pest on plants for planting is a condition for the inclusion of that pest in the list of RNQPs and is unrelated to the possibility of establishing a threshold for the presence of that pest that is higher than 0%. In addition, the applicants are not seeking the annulment of the contested parts of Annex IV to the contested implementing regulation in so far as, pursuant to those provisions, the Commission established the list of RNQPs, but rather only in so far as the parts in question set the thresholds for the presence of those pests at 0%.

117    It is likewise clear from the erroneous premiss upon which the first complaint of that plea in law is based that the plea of illegality raised against Articles 36 and 37 of Regulation 2016/2031 must be dismissed. In support of that plea, the applicants argue, in essence, that those provisions are vitiated by a breach of the principle of proportionality because they did not prevent the Commission from imposing, when establishing the 0% threshold for the presence of RNQPs, disproportionate obligations relating to sanitation by way of genetic selection. However, since the contested implementing regulation has neither the object nor the effect of imposing such obligations, the complaint alleging that the related provisions of Regulation 2016/2031 are vitiated by a breach of the principle of proportionality or by the failure to comply with some form of obligation to ‘protect the terroir’ must, in any case, be dismissed as ineffective (see paragraph 78 above).

118    The third complaint, based on the lack of an impact assessment (see paragraph 79 above), must also fail, since it is based on the alleged adverse consequences for biodiversity and on the allegedly exorbitant costs of the measures of sanitation by way of genetic selection entailed by establishing the 0% threshold for the presence of RNQPs, allegations which are however unfounded (see paragraphs 90 to 113 above).

119    As for the argument based on a failure to comply with the obligation to state reasons, it must be recalled that the statement of reasons required by Article 296 TFEU must be appropriate to the nature of the act at issue and must disclose in a clear and unequivocal fashion the reasoning followed by the institution which adopted the measure in question in such a way as to enable the persons concerned to ascertain the reasons for the measure and to enable the Union Court to exercise its power of review. It is not necessary for the reasoning to go into all the relevant facts and points of law, since the question whether the statement of reasons for a measure meets the requirements of Article 296 TFEU must be assessed with regard not only to its wording but also to its context and to all the legal rules governing the matter in question. In the latter regard, in the case of a measure intended to have general application, as here, the statement of reasons may be limited to indicating, first, the general situation which led to its adoption and, second, the general objectives which it is intended to achieve (judgment of 7 September 2006, Spain v Council, C‑310/04, EU:C:2006:521, paragraphs 57 and 58).

120    It must be stated that recitals 12 to 15 of the contested implementing regulation (see paragraphs 86 to 88 above) clearly set out the context in which that regulation was adopted and the objectives which it is intended to achieve. Moreover, the content of Implementing Directive 2020/177 attests to the fact that the health requirements recommended by the EPPO for the marketing of the plants for planting further to the establishment of the 0% threshold for the presence of RNQPs did not provide for sanitation by way of genetic selection. Therefore, Commission was not required to state reasons for the adoption of the contested parts of Annex IV to the contested implementing regulation by reference to the cost of such sanitation methods or to the alleged consequences of those methods for biodiversity.

121    It follows that the first plea in law must be dismissed.

 The second plea in law, alleging infringement of the ITPGRFA

122    The applicants claim that establishing a 0% threshold for the presence of RNQPs on native varieties of plants infringes Article 9(3) of the ITPGRFA. That provision guarantees farmers the rights to save, use, exchange and sell farm-saved seed or propagating material. However, according to the applicants, the genetic selection required by the contested parts of Annex IV to the contested implementing regulation for the purposes of the necessary sanitation jeopardises the conservation of the genetic pool of plant resources to the extent that it renders the rights that farmers are to enjoy under the abovementioned provision meaningless.

123    The second plea in law, just like the first, is based on the incorrect premiss that establishing the 0% threshold for the presence of RNQPs in the contested parts of Annex IV to the contested implementing regulation entails an obligation of sanitation by way of genetic selection vis-à-vis the plants for planting concerned by the parts in question. This plea must therefore be dismissed on that ground.

124    In any case, in order for the validity of an act of EU law to be examined in the light of an international treaty, it is necessary, inter alia, for the provision relied upon to contain a clear and precise obligation which is not subject, in its implementation or effects, to the adoption of any subsequent measure (judgment of 21 December 2011, Air Transport Association of America and Others, C‑366/10, EU:C:2011:864, paragraph 55).

125    In that regard, Article 9 of the ITPGRFA provides that the Contracting Parties should, ‘as appropriate, and subject to [their] national legislation’, take measures to protect and promote farmers’ rights.

126    Paragraph 2 of that article provides, in particular, that, in accordance with its needs and priorities, each Contracting Party should, ‘as appropriate, and subject to its national legislation’, take measures to protect and promote farmers’ rights, including:

–        protection of traditional knowledge relevant to plant genetic resources for food and agriculture;

–        the right to participate equitably in sharing benefits arising from the utilisation of plant genetic resources for food and agriculture; and

–        the right to participate in making decisions, at the national level, on matters related to the conservation and sustainable use of plant genetic resources for food and agriculture.

127    In that context, Article 9(3) of the ITPGRFA, upon which the applicants rely, provides that nothing in Article 9 is to be interpreted as limiting any rights that farmers have to save, use, exchange and sell farm-saved seed or propagating material, ‘subject to national law and as appropriate’.

128    It is true that the purpose of Article 9(3) of the ITPGRFA is to prevent that article from being interpreted so as to limit any rights that farmers have to save, use, exchange and sell farm-saved seed or propagating material. However, those rights are not guaranteed by Article 9(3) of the ITPGRFA. As Article 9(3) thereof expressly provides, those rights, in so far as they are conferred by national law, are to be exercised subject to the provisions of national law.

129    Therefore, Article 9(3) of the ITPGRFA does not entail any obligation for the European Union, so that the legality of Regulation 2016/2031 or of the contested parts of Annex IV to the contested implementing regulation cannot, in any event, be assessed in the light of that provision (see, to that effect, judgment of 12 July 2012, Association Kokopelli, C‑59/11, EU:C:2012:447, paragraphs 90 to 92).

130    Therefore, second plea in law must be dismissed.

 The third plea in law, alleging infringement of Regulation 2018/848

131    The applicants state that establishing a 0% threshold for the presence of RNQPs on native varieties of plants infringes Article 13 of Regulation 2018/848. With a view to protecting plant genetic variability, that provision permits the marketing of plant reproductive material of organic heterogeneous material without complying with the requirements for registration and without complying with the certification categories of ‘pre-basic’, ‘basic’ and ‘certified’ material or with the requirements for other categories, which are set out in the directives governing the marketing of plants for planting.

132    It must be observed from the outset that, since Regulation 2018/848 has the same ranking as Regulation 2016/2031, the latter cannot be relied upon to challenge the validity of the former. That plea in law can therefore be understood as relating exclusively to the contested implementing regulation.

133    Next, it is true that recital 18 of Regulation 2018/848 refers to the need to focus on agronomic performance, genetic diversity, disease resistance, longevity, and adaptation to diverse local soil and climate conditions, and to respect the natural crossing barriers.

134    Thus, according to recital 36 of Regulation 2018/848, research in the Union on plant reproductive material that does not fulfil the variety definition as regards uniformity shows that there could be benefits of using such diverse material, in particular with regard to organic production, for example to reduce the spread of diseases, to improve resilience and to increase biodiversity.

135    In that context, recital 37 of Regulation 2018/848 states that plant reproductive material that does not belong to a variety, but rather belongs to a plant grouping within a single botanical taxon with a high level of genetic and phenotypic diversity between individual reproductive units, should be available for use in organic production. It is for that reason that, according to that same recital, the legislature allowed operators to market plant reproductive material of organic heterogeneous material without having to comply with the requirements for registration and without having to comply with the certification categories of ‘pre-basic’, ‘basic’ and ‘certified’ material or with the requirements for other categories set out in the directives governing marketing.

136    In that connection, Article 13 of Regulation 2018/848 reads as follows:

‘1. Plant reproductive material of organic heterogeneous material may be marketed without complying with the requirements for registration and without complying with the certification categories of pre-basic, basic and certified material or with the requirements for other categories, which are set out in Directives [66/401], [66/402], [68/193], 98/56/EC, 2002/53/EC, 2002/54/EC, [2002/55], 2002/56/EC, 2002/57/EC, [2008/72] and [2008/90] or acts adopted pursuant to those Directives.

2. Plant reproductive material of organic heterogeneous material as referred to in paragraph 1 may be marketed following a notification of the organic heterogeneous material by the supplier to the responsible official bodies referred to in Directives [66/401], [66/402], [68/193], 98/56/EC, 2002/53/EC, 2002/54/EC, [2002/55], 2002/56/EC, 2002/57/EC, [2008/72] and [2008/90] …’

137    Article 13(2) of Regulation 2018/848 also sets out the main contents of the notification mentioned in that same provision as well as the related procedural rules, whilst paragraph 3 of the same article empowers the Commission to set out rules governing the production and the marketing of plant reproductive material of organic heterogeneous material of particular genera or species.

138    Thus, rather than casting doubt on the legality of the establishment of thresholds for the presence of RNQPs pursuant to the contested parts of Annex IV to the contested implementing regulation, Article 13 of Regulation 2018/848 permits, by way of exception and with a strictly defined framework, the marketing of plant reproductive material of organic heterogeneous material without complying with the requirements set out in the directives governing marketing. It follows that that provision cannot be relied upon to challenge the legality of the contested parts of Annex IV to the contested implementing regulation in so far as, pursuant to those parts, 0% thresholds were established for the presence of RNQPs on plants for planting.

139    The third plea in law must therefore be dismissed.

 The fourth plea in law, alleging that the contested parts of Annex IV to the contested implementing regulation are incompatible with the common agricultural policy

140    The applicants claim that the establishment of 0% thresholds for the presence of RNQPs pursuant to the contested parts of Annex IV to the contested implementing regulation:

–        makes it impossible, on account of the process of genetic selection of a small number of species imposed by it, to comply with the obligation to prevent the introduction of non-native species, as laid down under specific provisions of Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora (OJ 1992 L 206, p. 7);

–        runs counter to the policy of preserving non-sanitised, native plant resources, as implemented pursuant to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (OJ 2012 L 343, p. 1);

–        undermines the principle of sustainable agricultural development and the enhancement of plant biodiversity, which are funded under instruments covered by Regulation (EU) No 1305/2013 of the European Parliament and of the Council of 17 December 2013 on support for rural development by the European Agricultural Fund for Rural Development (EAFRD) and repealing Council Regulation (EC) No 1698/2005 (OJ 2013 L 347, p. 487);

–        is inconsistent with, first, the rules of international law and of EU law intended to preserve agricultural biodiversity, second, with the rules of EU law intended to preserve semi-natural habitats and rural development and, third, the directives governing the marketing of seed and of fruit plant reproductive material.

141    It must be observed from the outset that, since they are of the same ranking as Regulation 2016/2031, the regulations mentioned in the first to third indents of paragraph 140 above cannot be relied upon to challenge the validity of that regulation. That plea can therefore be understood as relating exclusively to the contested implementing regulation.

142    It is clear from all the arguments put forward in support of that plea that it too is based on the assumption that the establishment of the 0% threshold for the presence of the RNQPs listed in the contested parts of Annex IV to the contested implementing regulation entails an obligation of sanitation by way of genetic selection of the plants for planting concerned by the parts in question, which would have adverse consequences for biodiversity. Nevertheless, as is clear from the analysis of the first plea in law (see paragraphs 90 to 113 above), that premiss is incorrect.

143    In the light of the foregoing considerations, the fourth plea in law must be dismissed as must, therefore, the action in its entirety.

 Costs

144    Under Article 134(1) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. Since the applicants have been unsuccessful, they must be ordered to pay the Commission’s costs, in accordance with the form of order sought by that institution.

145    Under Article 138(1) of the Rules of Procedure, the institutions which have intervened in the proceedings are to bear their own costs. It is therefore appropriate to order the Parliament and the Council each to bear their own costs.

On those grounds,

THE GENERAL COURT (Ninth Chamber)

hereby:

1.      Dismisses the action;

2.      Orders Società agricola Vivai Maiorana Ss, Confederazione Italiana Agricoltori – CIA and MIVA – Moltiplicatori Italiani Viticoli Associati to bear their own costs and to pay those incurred by the European Commission;

3.      Orders the European Parliament and the Council of the European Union each to bear their own costs.

Costeira Gratsias Kancheva

Delivered in open court in Luxembourg on 29 September 2021.

[Signatures]

*      Language of the case: Italian.