1

The applicant, Biofa AG, is a company which produces and markets plant protection products and the holder of a marketing authorisation for a fungicide with a potassium hydrogen carbonate basis, VitiSan.

2

Potassium hydrogen carbonate is an ‘active substance’ listed in the annex to Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ 2011 L 153, p. 1).

3

Following an application from the Danish Environmental Protection Agency, the European Commission adopted, on 17 November 2015, Implementing Regulation (EU) 2015/2069 approving the basic substance sodium hydrogen carbonate in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the annex to Commission Implementing Regulation (EU) No 540/2011 (OJ 2015 L 301, p. 42; ‘the contested regulation’).

4

After receiving the technical report of the European Food Safety Authority (EFSA) on the substance in question, the Commission approved, by the contested regulation, sodium hydrogen carbonate as a ‘basic substance’ within the meaning of Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ 2009 L 309, p. 1).

5

Sodium hydrogen carbonate is present on the market as a food additive within the meaning of Commission Regulation (EU) No 1130/2011 of 11 November 2011 amending Annex III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives by establishing a Union list of food additives approved for use in food additives, food enzymes, food flavourings and nutrients (OJ 2011 L 295, p. 178). Approval of that substance as a ‘basic substance’ thus permits that product, which is commonly used for a wide range of purposes, to be used also for plant protection purposes.

6

By application lodged at the Court Registry on 22 December 2015, the applicant brought the present action.

7

By separate document lodged at the Court Registry on the same date, the applicant made an application for interim measures. That application was dismissed by order of the President of the General Court of 18 January 2016 and the costs were reserved.

8

By separate document lodged at the Court Registry on 5 February 2016, the Commission raised a plea of inadmissibility under Article 130 of the Rules of Procedure of the General Court. The applicant submitted its observations on that plea on 31 March 2016.

9

By document lodged at the Court Registry on 7 April 2016, the Kingdom of Denmark applied to intervene in the present proceedings in support of the form of order sought by the Commission.

10

The applicant claims that the Court should:

11

The Commission contends that the Court should:

12

In its observations on the plea of inadmissibility, the applicant contends that the Court should:

13

Under Article 130(1) of its Rules of Procedure, the General Court may rule on inadmissibility without going to the substance of the case, if the defendant so requests. In the present case, the General Court considers that it has sufficient information from the documents in the file and has decided to rule without taking further steps in the proceedings and without it being necessary to reserve a decision on the plea of inadmissibility for final judgment.

14

The Commission raises two pleas of inadmissibility, the first alleging that the applicant is not directly concerned, and the second alleging that it lacks a legal interest in bringing proceedings.

15

It is appropriate to examine, first of all, the first plea of inadmissibility put forward by the Commission.

16

Under the fourth paragraph of Article 263 TFEU, any natural or legal person may, under the conditions laid down in the first and second paragraphs of that article, institute proceedings against an act addressed to that person or which is of direct and individual concern to them, and against a regulatory act which is of direct concern to them and does not entail implementing measures.

17

In the present case, it is common ground that the contested regulation was not addressed to the applicant, which is therefore not the addressee of that measure. Therefore, the applicant may bring an action for annulment of that regulation only if, first, it is directly concerned by it and, second, it is individually concerned within the meaning of the second limb of the fourth paragraph of Article 263 TFEU or the contested act constitutes a regulatory act not entailing implementing measures for the purposes of the third limb of that provision.

18

The applicant argues that it is directly concerned by the contested regulation, on the basis of two arguments, the first relating to Article 59(1) of Regulation No 1107/2009, and the second relating to the economic repercussions of the contested regulation on its market position.

19

By the first argument, the applicant submits that, in the technical report EFSA provided to the Commission in the context of the approval of sodium hydrogen carbonate as a basic substance, that authority used, without its consent, the results of the studies it had submitted for the approval of potassium hydrogen carbonate as an active substance. More specifically, in the technical report in question, EFSA ruled out the possibility that sodium hydrogen carbonate might have adverse effects on honey bees on account of the fact that those effects had been ruled out for potassium hydrogen carbonate in the context of the authorisation concerning VitiSan and another product.

20

In that regard, the applicant argues that Article 59(1) of Regulation No 1107/2009 provides inter alia that test and study reports concerning an active substance registered in accordance with that regulation are to benefit from data protection under certain conditions, which are met in the present case. More particularly, it notes that that provision states that, where a report is protected, it may not be used by the Member State which received it for the benefit of other applicants for authorisation of plant protection products, except in certain situations set out by the regulation in question, which are not relevant in this case.

21

First, in the applicant’s view, that provision gives it an individual right which was impaired by the Commission, since, in the context of the approval of sodium hydrogen carbonate as a basic substance, the Commission used data of the applicant pertaining to the approval of potassium hydrogen carbonate as an active substance, without its consent and before the expiry of the period of data protection of ten years enjoyed by that data.

22

Second, according to the applicant, the fact that the wording of Article 59(1) of Regulation No 1107/2009 does not provide for data protection in the context of the simplified procedure for the approval of a basic substance does not preclude those conclusions, since, like an authorisation decision in respect of an active substance, a decision approving a substance as a basic substance permits a third party to market a plant protection product competing with that of the applicant. This is all the more evident given that approval of a basic substance has larger implications for competition, since it enables an unlimited number of persons to market that basic substance within the territory of the European Union as a plant protection product, and for an unlimited time.

23

Third, the applicant’s conclusion is confirmed by the fact that Article 23(1) of Regulation No 1107/2009, which provides for derogations from certain articles of that regulation, does not mention Article 59(1) thereof.

24

Fourth, the applicant invokes breach of the principle of subsidiarity. Under Article 23 of Regulation No 1107/2009, the special scheme for basic substances may be applied only where the need to use the substances in question is not covered by existing plant protection products, in order to prevent other market operators from giving themselves a competitive advantage over authorisation holders by placing on the market plant protection products that do not require authorisation.

25

In that regard, sodium hydrogen carbonate is regarded by the Commission as an active substance of plant protection products and there is no commercial interest in obtaining authorisation for that active substance, given that it is already permitted to be used for plant protection purposes in certain Member States in accordance with national provisions.

26

In addition, approval of sodium hydrogen carbonate as a basic substance is not useful for plant protection purposes given the existence of a chemically comparable or identical active substance, in particular as regards the rules for classification and labelling, their manufacturing processes, their use and their fungicidal mode of action, as is confirmed by EFSA’s technical report and by international documents and publications.

27

Fifth, according to the applicant, under the ‘principle of priority’, approval of an active substance blocks every pending application for approval of the same substance as a basic substance. Thus, since the applicant applied for approval of sodium hydrogen carbonate as an active substance, its approval as a basic substance should be revoked.

28

By the second argument, the applicant submits that the adoption of the contested regulation has direct economic repercussions on its market position, since sodium hydrogen carbonate, approved by the Commission as a basic substance, is a substitute for plant protection products with a potassium hydrogen carbonate basis and is thus in competition with its product VitiSan.

29

As a preliminary point, it should be borne in mind that, according to settled case-law, direct concern of an individual is based on two cumulative conditions. First, the contested EU measure must directly affect the legal situation of that individual and, second, there must be no discretion left to the addressees of that measure who are responsible for its implementation, that implementation being purely automatic and resulting from the EU rules alone without application of other intermediate rules (order of 6 September 2011, Inuit Tapiriit Kanatami and Others v Parliament and Council, T‑18/10, EU:T:2011:419, paragraph 71, and judgment of 25 October 2011, Microban International and Microban (Europe) v Commission, T‑262/10, EU:T:2011:623, paragraph 27).

30

In the present case, it must be stated that the first argument put forward by the applicant, based on Article 59(1) of Regulation No 1107/2009, is not such as to establish that the applicant is directly concerned by the contested regulation.

31

In the technical report it provided to the Commission in the context of the approval of sodium hydrogen carbonate as a basic substance, EFSA mentioned, in a very general fashion, the results of the studies submitted by the applicant for the approval of potassium hydrogen carbonate as an active substance. In that technical report, EFSA ruled out the possibility that sodium hydrogen carbonate might have adverse effects on honey bees on account of the fact that those effects had been ruled out for potassium hydrogen carbonate in the context of the authorisation concerning VitiSan and another product.

32

However, Article 59(1) of Regulation No 1107/2009 provides that the data protection enjoyed by an applicant for authorisation for placing on the market or use of a plant protection product containing an active substance who submitted a test or study report concerning that substance prohibits the Member State which received that report from using it for the benefit of other applicants for authorisation, except in the cases provided for in that regulation.

33

That provision is aimed, as follows from recital 39 of Regulation No 1107/2009, at protecting the major investment that may have been made by the applicant for authorisation who submitted the report at issue against use by another competing applicant.

34

It therefore cannot be interpreted as protecting that applicant for authorisation from references to the report in question made by EFSA in the context of the approval, by the Commission, of a basic substance. As is stated in recital 18 of Regulation No 1107/2009, ‘substances which are not predominantly used as plant protection products may be of value for plant protection, [even though] the economic interest of applying for approval may be limited’. Thus, a substance is approved as a basic substance not for the benefit of individual applicants, but for the benefit of all users, and such approval therefore does not fall within the scope of the protection afforded by Article 59(1) of Regulation No 1107/2009. Moreover, it should also be noted, as is apparent from Article 28(2)(a) of that regulation, that the approval of a substance as a basic substance permits only the ‘use’ of that substance for plant protection purposes, and not the placing of that substance on the market as a plant protection product, a fact which confirms an individual applicant’s lack of economic interest in such an approval.

35

In any event, the applicant does not prove how the contested regulation, even though its sole purpose is to allow the use — and not the placing on the market — of sodium hydrogen carbonate for plant protection purposes, could directly affect its situation by undermining any right to commercial protection of the data contained in the test or study reports submitted by it that it would derive from the provisions of Article 59(1) of Regulation No 1107/2009.

36

So far as concerns the second argument put forward by the applicant, based on the economic repercussions of the contested regulation on its market position, it must be pointed out that, in its observations, the applicant merely raises the possibility, in a very general manner, of loss due to the use of sodium hydrogen carbonate instead of its product, VitiSan, without providing evidence capable of showing that its legal situation would be directly affected by the contested regulation.

37

While it cannot be ruled out that the contested regulation might have repercussions on the marketing possibilities of the applicant’s product, as the Commission itself acknowledges in its pleadings, such economic consequences arising out of that regulation do not affect the applicant’s legal situation, but only its factual situation (see, to that effect, judgment of 28 April 2015, T & L Sugars and Sidul Açúcares v Commission, C‑456/13 P, EU:C:2015:284, paragraph 37, and order of 6 September 2011, Inuit Tapiriit Kanatami and Others v Parliament and Council, T‑18/10, EU:T:2011:419, paragraph 75).

38

In that regard, the mere fact that a measure may exercise an influence on an applicant’s substantive position cannot suffice to allow it to be regarded as directly concerned by the measure (orders of 18 February 1998, Comité d’entreprise de la Société française de production and Others v Commission, T‑189/97, EU:T:1998:38, paragraph 48, and of 21 September 2011, Etimine and Etiproducts v ECHA, T‑343/10, EU:T:2011:509, paragraph 41; see, to that effect, judgment of 10 December 1969, Eridania and Others v Commission, 10/68 and 18/68, EU:C:1969:66, paragraph 7).

39

In view of the foregoing, it must be held that the contested regulation does not directly affect the applicant’s legal situation, since that regulation merely allows the use, for plant protection purposes, of a product different from that which is marketed by the applicant. Since the first condition for direct concern has not been satisfied, it is necessary to conclude that the applicant is not directly concerned by the contested regulation and therefore has no legal standing to institute proceedings against it, without it being necessary to rule on whether the applicant is individually concerned within the meaning of the second limb of the fourth paragraph of Article 263 TFEU and without it being necessary to rule on whether the contested regulation constitutes a regulatory act which does not entail implementing measures within the meaning of the third limb of that provision.

40

Accordingly, the first plea of inadmissibility raised by the Commission must be upheld and the action must be dismissed as inadmissible, without it being necessary to rule on the second plea of inadmissibility.

41

Pursuant to Article 144(3) of the Rules of Procedure, where the defendant lodges a plea of inadmissibility or of lack of competence, as provided in Article 130(1) of those rules, a decision on the application to intervene is not to be given until after the plea has been rejected or the decision on the plea reserved.

42

In the present case, since the action is being dismissed in its entirety, there is no need to adjudicate on the application to intervene.

43

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 applicant has been unsuccessful, it must be ordered to pay the costs, including those relating to the proceedings for interim measures, in accordance with the form of order sought by the Commission.

44

Furthermore, pursuant to Article 144(10) of the Rules of Procedure, the Kingdom of Denmark must bear its own costs relating to the application to intervene.

On those grounds,

THE GENERAL COURT (Second Chamber)

hereby orders:

Luxembourg, 9 November 2016.