Micreos Food Safety v Commission (Action for annulment - Public health - Phage-based product used to reduce the presence of the bacterial pathogen Listeria monocytogenes in animal-derived ready-to-eat food - Order) [2020] EUECJ T-568/19

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	Court of Justice of the European Communities (including Court of First Instance Decisions)
You are here: BAILII >> Databases >> Court of Justice of the European Communities (including Court of First Instance Decisions) >> Micreos Food Safety v Commission (Action for annulment - Public health - Phage-based product used to reduce the presence of the bacterial pathogen Listeria monocytogenes in animal-derived ready-to-eat food - Order) [2020] EUECJ T-568/19_CO (18 December 2020) URL: http://www.bailii.org/eu/cases/EUECJ/2020/T56819_CO.html Cite as: [2020] EUECJ T-568/19_CO, ECLI:EU:T:2020:647, EU:T:2020:647

(Action for annulment – Public health – Regulation (EC) No 853/2004 – Phage-based product used to reduce the presence of the bacterial pathogen Listeria monocytogenes in animal-derived ready-to-eat food – Rejection of the request to approve Listex™ P100 as a decontaminant in animal-derived ready-to-eat food – Act not open to challenge – Act not intended to produce binding legal effects – Purely confirmatory act – Informative act – Inadmissibility)

Micreos Food Safety BV, established in Wageningen (Netherlands), represented by S. Pappas, lawyer,

European Commission, represented by B. Eggers, W. Farrell and I. Galindo Martín, acting as Agents,

ACTION pursuant to Article 263 TFEU seeking the annulment of the alleged decisions of the Commission of 17 June 2019 by which the Commission: (i) rejected the original application by the applicant for the approval of Listex^™ P100 as a decontaminant in animal-derived ready-to-eat food, or re-examined that application; (ii) rejected the alternative application to regard Listex^™ P100 as a non-decontaminating processing aid; and, (iii) prohibited the placing on the market of the European Union of that product as a processing aid in such food,

composed of J. Svenningsen, President, T. Pynnä (Rapporteur) and J. Laitenberger, Judges,

1 The product Listex^™ P100 is intended to reduce the pathogenic bacterium Listeria monocytogenes in ready-to-eat food, in particular those of animal origin, such as sausages and cheeses.

2 The applicant, Micreos Food Safety BV, manufactures phage-based products for pharmaceutical and food safety purposes, one of which is Listex^™ P100.

3 In 2007, the applicant contacted the European Commission in order, according to its statements, to obtain confirmation that Listex^™ P100 could be used as a non-decontaminating processing aid in animal-derived ready-to-eat food.

4 On 17 June 2008, in response to a parliamentary question, the Commission stated that, subject to a definitive interpretation, it considered that bacteriophages used on food of animal origin could be considered as either food additives, which are subject to approval under Directive 95/2/EC of the European Parliament and the Council of 20 February 1995 on food additives other than colours and sweeteners (OJ 1995 L 61, p. 1) (since repealed by Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (OJ 2008 L 354, p.16)), or as substances used for reducing surface contamination (decontaminants), which are subject to approval pursuant to Article 3(2) of Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (OJ 2004 L 139, p. 55), as amended by Regulation (EC) No 219/2009 of the European Parliament and the Council of 11 March 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny (OJ 2009 L 87, p. 109).

5 The latter provision, in the relevant version applicable in this case, provides as follows:

‘Food business operators shall not use any substance other than potable water … to remove surface contamination from products of animal origin, unless use of the substance has been approved by the Commission. Those measures, designed to amend non-essential elements of this Regulation, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 12(3) …’

6 According to the applicant, the Commission stated that Listex^™ P100 used on animal-derived ready-to-eat food must be treated as a decontaminant, which requires its approval in accordance with Article 3(2) of Regulation No 853/2004.

7 In a letter of 14 July 2009 sent to the applicant, the Netherlands authorities stated that they regarded Listex^™ P100 used on animal-derived ready-to-eat food as a processing aid, and not as an additive.

8 On 19 June 2015, the applicant lodged an application for approval of the use of Listex^™ P100 as a decontaminant to reduce the presence of Listeria monocytogenes in animal-derived ready-to-eat food.

9 In view of the decontaminating effect of Listex^™ P100, the Commission processed that application on the basis of Article 3(2) of Regulation No 853/2004.

10 On 7 July 2016, the European Food Safety Authority (EFSA) adopted a scientific opinion on Listex^™ P100.

11 On 12 July 2016, the Commission adopted a draft regulation authorising the use of Listex^™ P100 for the reduction of Listeria monocytogenes in animal-derived ready-to-eat food, under Article 3(2) of Regulation No 853/2004.

12 That draft regulation was submitted to the Standing Committee on Plants, Animals, Food and Feed (‘SCoPAFF’) on 17 May 2017, and was the subject of public consultation from 12 July to 9 August 2017.

13 According to the Commission, in October 2017 the Commission informed the applicant of its intention not to approve the product.

14 By letter of 19 February 2018 (‘the letter of 19 February 2018’), the Member of the Commission with responsibility for health and food safety (‘the competent Commissioner’) informed the applicant that, owing in particular to the lack of foreseeable political support, the Commission did not intend to pursue the evaluation of its application.

15 By letter of 26 February 2018 sent to the competent Commissioner (‘the letter of 26 February 2018’), the applicant submitted that Listex^™ P100 should be regarded not as a decontaminant but as a processing aid which does not fall within the scope of application of Regulation No 853/2004, and requested that the issue be discussed at the next meeting of SCoPAFF, in May 2018.

16 By letter of 9 April 2018, the competent Commissioner informed the applicant that he did not intend to organise a new discussion in SCoPAFF.

17 At the SCoPAFF meeting of 3 July 2018 (‘the meeting of 3 July 2018’) Listex^™ P100, which was not included on the agenda, was discussed. The minutes of that meeting published by the Commission state as follows:

‘Belgium and the Netherlands asked the Commission to clarify the state-of-play on the application (a bacteriophage that could be used as a decontaminant on ready-to-eat food). Several Member States took the floor to indicate that they were contacted by the applicant company. The Commission indicated that it is attentive to all aspects when considering the authorisation of decontaminants, as they are perceived as a disincentive to invest in hygiene at all steps of the food production. It reminded Member States of the discussions both at working group and at Committee level and, in light of the numerous comments received and the difficulty to find support, stopped the discussion on this application. The company has been informed by the Commission accordingly.’

18 By letters of 17 August and 15 October 2018 sent to the competent Commissioner (‘the letter of 17 August 2018’ and ‘the letter of 15 October 2018’, respectively), Public Advice International Foundation (‘PA International’), which represents the applicant, and the applicant itself submitted that Listex^™ P100 used on animal-derived ready-to-eat food must be regarded not as a decontaminant but, rather, as a processing aid.

19 PA International and the applicant also submitted that, at the meeting of 3 July 2018, the Commission and the Member States failed to reach agreement on the question of whether Listex^™ P100 used on animal-derived ready-to-eat food must be classified as a decontaminant, an additive, or a processing aid. They submitted that, contrary to what is stated in the minutes of the meeting of 3 July 2018 published by the Commission, it is clear from the minutes taken by the Member States, first, that the Commission and the Member States agreed that the classification of decontaminant was not appropriate and, second, that it was for the applicant to decide whether to try to obtain the classification of Listex^™ P100 as an additive, or to try to obtain a classification for it as a processing aid.

20 On 27 November 2018, the applicant lodged a complaint with the European Ombudsman, which was rejected on 4 March 2019.

21 On 13 March 2019, the Estonian authorities sent an email to several companies ordering the cessation of use of Listex^™ P100 on ready-to-eat food.

22 By a letter of 25 April 2019 (‘the letter of 25 April 2019’) sent to the Directorate-General (DG) of the Commission for Health and Food Safety, PA International submitted that, pending a specific regulation on phages, Listex^™ P100 used on animal-derived ready-to-eat food should be regarded as a processing aid and indicated that it hoped that that position would be adopted by the Commission at the meeting of its food hygiene working group of 29 April 2019 (‘the meeting of 29 April 2019’).

23 At the meeting of 29 April 2019, Listex^™ P100 was discussed. The minutes of that meeting drawn up by the Commission state as follows:

‘Belgium raised the point that there could be a distortion of the internal market, if Member States classify the product Listex^™ P100 differently. The Netherlands asked for clarification if it is a processing aid (national authorisation needed), a food additive or a decontaminant according to hygiene rules. Some Member States indicated that they could accept it as a food additive (Germany, France). Germany and Austria highlighted that the safety of this product remains unclear. Following discussions, the chair indicated to be willing to ask for legal advice, if an authorisation in accordance with Article 3(2) of Regulation (EC) No 853/2004 is applicable, although repeating, that in his understanding this is the case.’

24 By a letter of 9 May 2019, addressed to DG Health and Food Safety (‘the letter of 9 May 2019’), the applicant welcomed the Commission’s decision taken at the meeting of 29 April 2019 to seek legal advice regarding Listex^™ P100, called for a specific regulation on phages and stated that it trusted that, pending such a regulation, Listex^™ P100 used on animal-derived ready-to-eat food would be regarded as a processing aid, which did not fall within the scope of application of Regulation No 853/2004.

25 On 5 June 2019, the applicant received an email from the Belgian authorities ordering the cessation of use of bacteriophages on ready-to-eat food.

26 By two letters of 17 June 2019, addressed to the applicant and PA International respectively (‘the contested acts’), the Commission:

– recalled, regarding the applicant’s request to approve Listex^™ P100 on the basis of Article 3(2) of Regulation No 853/2004, that, by its letter of 19 February 2018, it had informed the applicant that it did not intend to pursue the evaluation of the application file;

– stated, regarding the new request by the applicant for Listex^™ P100 to be regarded as a processing aid outside the scope of Regulation No 853/2004, that, even if Listex^™ P100 were to be classified as a processing aid, it would fall within the scope of Regulation No 853/2004, to the extent that it is used for decontaminating purposes;

– clarified, in that regard, that that was the interpretation of its services, but that the Court of Justice of the European Union had exclusive competence to interpret EU law;

– clarified that, at the meeting of 29 April 2019, it had merely recalled that no authorisation had been granted at EU level for the placing on the market of Listex^™ P100 in accordance with Article 3(2) of Regulation No 853/2004;

27 By application lodged at the Court Registry on 16 August 2019, the applicant brought the present action.

28 By application lodged at the Court Registry on the same day, the applicant made an application, pursuant to Articles 278 and 279 TFEU, for the suspension of the contested decision of the Commission of 17 June 2019, by which it allegedly prohibited the placing on the market of Listex^™ P100 in the European Union as a processing aid for animal-derived ready-to-eat food.

29 In its observations on that application for interim measures, the Commission submitted that the application was inadmissible because the alleged decision prohibiting the placing on the market of Listex^™ P100, contested in the main application, did not exist.

30 By order of 26 September 2019, Micreos Food Safety v Commission (T‑568/19 R, not published, EU:T:2019:694), the President of the General Court dismissed the application for interim measures as inadmissible and reserved the decision as to costs. The President of the General Court held that it was not possible to conclude, prima facie, that by the contested acts the Commission had adopted a decision prohibiting the placing on the market of Listex^™ P100 for the following reasons:

– in the first place, the applicant did not set out in a clear and coherent manner the content of the alleged decision at issue, and did not specify whether the decision was addressed to the Member States or to itself;

– in the second place, the applicant merely asserted that, by the contested acts, the Commission had prohibited the placing on the EU market of the product Listex^™ P100 as a non-decontaminating processing aid for use on animal-derived ready-to-eat food, without advancing arguments supporting its assertion as to the existence of such a decision;

– in the third place, the applicant did not advance any argument as to why the contested acts should be understood as a decision having the alleged content rather than a mere interpretation of the applicable regulatory framework, despite the fact that the Commission expressly referred to the statements made as an ‘interpretation’ of the applicable regulatory framework by its ‘services’.

– in the fourth place, the applicant did not provide any explanation regarding the regulatory framework as to why the contested acts should be understood as entailing a decision prohibiting the placing on the market of Listex^™ P100 rather than constituting a mere interpretation of the applicable legal framework, despite the fact that the alleged prohibition of the marketing of Listex^™ P100 as a decontaminant stems, prima facie, directly from Regulation No 853/2004, as interpreted by the Commission and was not the result of the alleged decision;

– lastly, the applicant’s allegation that the Belgian and Estonian authorities had applied the prohibition on marketing was not capable of substantiating the applicant’s position, since the documents emanating from the Belgian and Estonian authorities, produced by the applicant, preceded the alleged decision in question.

31 By separate document lodged at the Court Registry on 8 November 2019, the Commission raised a plea of inadmissibility under Article 130 of the Rules of Procedure of the General Court. The applicant lodged its observations on that plea on 9 January 2020.

32 On 23 November 2020, the applicant produced further evidence pursuant to Article 85(3) of the Rules of Procedure. The Commission lodged its observations on this evidence on 10 December 2020.

34 In its plea of inadmissibility, the Commission contends that the Court should:

– order the applicant to pay the costs, including those of the interim proceedings which were reserved.

35 Under Article 130(1) and (7) of the Rules of Procedure, the Court may, if the defendant so requests, rule on inadmissibility without considering the merits of the case. In the present case, as the Commission has applied for a decision on inadmissibility, the Court, finding that it has sufficient information from the documents in the case file, has decided to rule on that application without taking further steps in the proceedings.

36 According to the applicant, by the contested acts, the Commission, first, rejected its original application for approval of Listex^™ P100 as a decontaminant in animal-derived ready-to-eat food, or re-examined that application (‘the first alleged decision’). Secondly, the Commission rejected its alternative application for that product to be recognised as a non-decontaminating processing aid (‘the second alleged decision’). Thirdly, the Commission prohibited the placing on the market of that product in the European Union as a processing aid for that food (‘the third alleged decision’).

37 The Commission contends that the action is inadmissible. In essence, it submits that the contested acts are not decisions or acts that are open to challenge and annulment: they are merely informative. The application is therefore manifestly inadmissible, for lack of an act that is open to challenge.

38 According to settled case-law, only measures the legal effects of which are binding on, and capable of affecting the interests of, the applicant by bringing about a distinct change in its legal position may be the subject of an action for annulment (judgments of 11 November 1981, IBM v Commission, 60/81, EU:C:1981:264, paragraph 9, and of 26 January 2010, Internationaler Hilfsfonds v Commission, C‑362/08 P, EU:C:2010:40, paragraph 51).

39 By contrast, any act not producing such effects, such as preparatory acts, confirmatory measures and implementing measures, mere recommendations and opinions and, in principle, internal instructions, falls outside the scope of the judicial review provided for in Article 263 TFEU (see order of 27 October 2015, Belgium v Commission, T‑721/14, EU:T:2015:829, paragraph 17 and the case-law cited).

40 Having regard to the case-law, in order to determine whether an act is capable of having legal effects and, therefore, whether an action for annulment under Article 263 TFEU can be brought against it, it is necessary to examine its wording and context, its substance, and the intention and the powers of the institution which enacted it (see, to that effect, order of 27 October 2015, Belgium v Commission, T‑721/14, EU:T:2015:829, paragraphs 18 and 66 and the case-law cited).

41 In the present case, it is therefore appropriate to examine, taking into account the content of the contested acts and the context in which they were adopted, whether those acts are capable of producing any binding legal effects on the applicant’s situation, in accordance with the case-law referred to in paragraph 38 above.

42 As regards the first alleged decision (see paragraph 36 above), the Commission disputes that the contested acts contain a new decision rejecting the authorisation of Listex^™ P100 under Regulation No 853/2004. The Commission submits that the contested acts merely refer to the earlier Commission decision of 19 February 2018 not to pursue the authorisation procedure for Listex^™ P100 as a decontaminant under Regulation No 853/2004 (‘the decision of 19 February 2018’), by confirming it. Since they are purely confirmatory, the contested acts cannot constitute acts against which an action may be brought under Article 263 TFEU.

43 That analysis is corroborated by the context of the contested acts. Those acts respond to the letters of 25 April and 9 May 2019. In those letters, the applicant does not raise any new matters that would have led the Commission to re-examine its decision of 19 February 2018, but rather it made a new application seeking the recognition of Listex^™ P100 as a non-decontaminating processing aid.

44 As regards the meeting of 3 July 2018, the Commission states that that meeting did not lead it either to review the decision of 19 February 2018, or, contrary to the applicant’s submission on the basis of unofficial minutes of that meeting, to decide to invite the applicant to clarify the appropriate classification for Listex^™ P100.

45 As regards the meeting of 29 April 2019, the Commission submits that it did not, in that meeting, ‘re-examine’ any new legal or factual arguments in relation to the closed procedure for authorisation of Listex^™ P100 as a decontaminant under Regulation No 853/2004. The discussion mainly covered Member States’ diverging practices as to the possible classification of Listex^™ P100 as a processing aid.

46 In that regard, the legal opinion that the Commission undertook at the meeting of 29 April 2019 to obtain concerned only the separate question regarding the possibility of Member States authorising that product as a processing aid, and the legal framework relating to phages.

48 According to the applicant, first, the letter of 19 February 2018, informing the applicant of the Commission’s intention not to pursue the procedure relating to the use of Listex^™ P100 in animal-derived ready-to-eat food as a decontaminant, in accordance with Regulation No 853/2004, does not constitute a decision. The Commissioner who wrote the letter of 19 February 2018 is not competent to take such a decision. The letter of 19 February 2018 is therefore merely informative.

49 Second, even if the letter of 19 February 2018 was a decision, the position adopted in that letter was later re-examined. By the letter of 26 February 2018, the applicant repeated the request and provided new evidence, which gave rise to a new assessment at the meeting of 3 July 2018.

50 The applicant submits that even if, during the discussion on Listex^™ P100 on 3 July 2018 or on 29 April 2019, no new information was brought forward or this information was not such as to prompt the Commission to reconsider its position, the fact that those meetings were held to discuss the same issues as those dealt with in the letter of 19 February 2018 means that that letter did not definitively close the administrative procedure.

51 According to the applicant, it was therefore with the adoption of the contested acts, following a re-examination, and not by the letter of 19 February 2018, that the Commission definitively rejected the authorisation of the use of Listex^™ P100 as a decontaminant on animal-derived ready-to-eat food.

52 It should be recalled that, according to settled case-law, an action for annulment brought against a decision which is purely confirmatory of an earlier decision that has not been challenged within the time limit is inadmissible. A decision is purely confirmatory where it contains no new factors as compared with the earlier decision and is not preceded by a re-examination of the situation of the addressee of the earlier decision (see order of 9 July 2002, Ripa di Meana v Parliament, T‑127/01, EU:T:2002:179, paragraph 25 and the case-law cited).

54 The decisions alleged to have been adopted by the Commission do not emerge clearly from the contested acts. The applicant does not specify which parts of the contested acts contain the first alleged decision.

55 As regards the first alleged decision, the relevant passages of the letter of 17 June 2019 sent to the applicant are as follows:

‘As indicated in your letter, Micreos submitted in 2015 its request for approval of Listex^™ P100, a phage-based product that could be used against the contamination by Listeria of ready-to-eat food, on the basis of Article 3(2) of Regulation (EC) No 853/2004.

Regulation (EC) No 853/2004 forbids the use of any substance other than potable water for the decontamination of food, unless expressly allowed. Authorising substances for decontamination is thus done by derogation from a hygiene rule established by the Parliament and the Council. It reflects the farm to fork approach applied in the EU for food safety, which is based on attention to hygiene at all stages of production. A decontamination step is considered by stakeholders, the public, the European Parliament and Member States as a disincentive from investing in hygiene. The Commission is thus attentive to ensuring clear support for granting such derogations.

The application was processed by the Commission, and further to an EFSA assessment of safety and efficacy of the product in 2016, a draft measure was discussed with Member States as well as submitted to stakeholders for feedback in 2017.

From the discussions with Member States, it became clear that there was too much opposition against Listex^™ P100 to allow the application for its approval any possibility of obtaining political support. In that regard, by letter dated 19th February 2018, the Commission informed Micreos Food Safety of its decision that it did not intend to pursue the evaluation of the application file.’

56 The content of the letter sent to PA International on the same day is almost identical to the extract set out in paragraph 55 above.

57 It is clear from a reading of the contested acts that the Commission recalled therein its decision not to proceed with the evaluation of the applicant’s request for authorisation of the use of Listex^™ P100 as a decontaminant in animal-derived ready-to-eat food on the basis of Regulation No 853/2004, as stated in the letter of 19 February 2018, and the grounds of that decision.

58 As a matter of fact, a comparison with the letter of 19 February 2018 confirms that the contested acts repeat the content of that letter, which stated:

‘The Commission received an application from Micreos in June 2015 for the approval of Listex^™ P100, a solution intended to reduce Listeria monocytogenes in a broad range of ready-to-eat products. In light of its decontamination effect, this application was processed in accordance with Article 3.2 of Regulation (EC) No 853/2004, which states that: “Food business operators shall not use any substance other than potable water to remove surface contamination from products of animal origin, unless use of the substance has been approved by the Commission.”

At the request of the Commission, the European Food Safety Authority published in August 2016 its scientific opinion on the use of Listex^™ P100 for reduction of Listeria monocytogenes in different ready-to-eat products including meat and poultry, fish and seafood, and dairy products.

The application file was subsequently discussed with Member States over 2017. …

The farm to fork approach applied in Europe for the production of food relies deeply on the commitment at all stages of production to produce in the most hygienic manner for the sake of marketing highly safe products. The principle of decontamination of food is seen as a disincentive to invest in hygiene. This is why the authorisation of potential decontaminants must be backed by both strong scientific evidence and regulators.

The discussions held on the use of Listex^™ P100 to reduce Listeria monocytogenes in ready-to-eat products indicate that there is too much uncertainty around the product to allow the current application any possibility of obtaining political support.

Having considered all those elements, the Commission does thus not intend to pursue the evaluation of this application file.’

59 In particular, the reasons that led the Commission not to pursue the evaluation of the applicant’s request to authorise the use of Listex^™ P100 on the basis of Regulation No 853/2004 remain unchanged. As regards the first alleged decision, the contested acts merely confirm the letter of 19 February 2018.

60 That finding is not called into question by the applicant’s arguments. The applicant submits that the letter of 19 February 2018 does not constitute a decision because the Commissioner who wrote that letter was not competent to take such a decision.

61 In the first place, it should be noted that the applicant does not demonstrate that the Commissioner who wrote that letter was not competent to take such a decision. The judgment of 29 September 2009, Thomson Sales Europe v Commission (T‑225/07 and T‑364/07, not published, EU:T:2009:363, paragraph 184), on which the applicant relies is clearly irrelevant for this case because its subject matter was a situation in which the national authorities, not the Commission, were competent.

62 In that regard, it cannot be seriously disputed that the letter of 19 February 2018, emanating from the competent Commissioner, engages the Commission, while it is not disputed moreover that investigation in the course of the present case has shown that the Commission had intended to take ownership of the content.

63 Thus, as the applicant itself remarks, at the meeting of 3 July 2018, according to the Commission’s minutes and those of the Netherlands’ authorities, the Commission reminded the Member States it had closed the examination of the applicant’s request to authorise the use of Listex^™ P100 as a decontaminant in animal-derived ready-to-eat food (see paragraph 17 above). Furthermore, the Commission expressly referred, in the contested acts, to the letter of 19 February 2018, by repeating the content of that letter (see paragraph 55 above).

64 In the second place, the fact that that letter emanates from the competent Commissioner rather than the Commission’s services does not, having regard to the principles set out in the case-law cited in paragraphs 38 to 40 above, have any effect on its nature as a decision, since the letter in question contains a clear and definitive assessment of the request received by the Commission.

65 First, the letter of 19 February 2018 was written after a series of steps were taken by the Commission, including obtaining a scientific opinion of the EFSA and the adoption of a draft regulation, in July 2016, which led to a meeting of SCoPAFF, in May 2017, and a public consultation, in July and August 2017. The letter of 19 February 2018 recalls those steps, without referring to the additional steps that would still be needed.

66 Secondly, in the letter of 19 February 2018, the Commission, in the light of the results of those various steps, communicated its decision not to pursue the evaluation of the applicant’s request for authorisation of the use of Listex^™ P100 as a decontaminant in animal-derived ready-to-eat food. In so doing, the Commission expressly adopted a position on the applicant’s request and rejected it, thus terminating the procedure that had been instituted.

67 Thirdly, in its later exchanges with the applicant and with the Member States, the Commission referred to the decision announced in the letter of 19 February 2018 or to its intention not to reconsider that decision, thus confirming that it was definitive.

68 First, by letter of 9 April 2018, the competent Commissioner informed the applicant that he did not intend to organise a new discussion in SCoPAFF (see paragraph 16 above). Next, at the meeting on 3 July 2018 and then in the contested acts, the Commission recalled, to the Member States and the applicant respectively, that it had informed the latter of its decision not to pursue the evaluation of its request to authorise the use of Listex^™ P100 as a decontaminant in animal-derived ready-to-eat food (see paragraph 63 above).

69 In that regard, a distinction should be drawn between this case and a case in which the Commission is inactive or passive, which may give rise to a cause of action for failure to act, laid down in Article 265 TFEU, rather than an action for annulment, laid down in Article 263 TFEU.

70 In any event, the lack of competence of the author of a decision is a ground for annulment (see, to that effect, judgment of 9 October 1990, France v Commission, C‑366/88, EU:C:1990:348, paragraph 25). Consequently, as the Commission rightly submits, even if the applicant had doubts regarding the competence of the Commissioner who wrote the letter of 19 February 2018 to communicate to it the decision it contains, the applicant could have brought an action against that decision.

71 If that were not the case, the commencement of an action against a Commission act, such as the letter of 19 February 2018, would depend on an assessment of the Commission’s competences made by the litigant itself, which would not be satisfactory from the perspective of the protection of the latter’s interests.

72 It follows from the foregoing, as regards the first alleged decision, that the contested acts appear, having regard to their content, to be purely confirmatory of the letter of 19 February 2018. However, whether a measure is confirmatory or not cannot be determined solely by reference to its content as compared with that of the previous decision which it is said to confirm. It is also necessary to assess the nature of the contested act in relation to the nature of the request to which that act responds (see order of 24 May 2011, United Kingdom v Commission, T‑115/10, not published, EU:T:2011:242, paragraph 29 and the case-law cited).

73 It is therefore necessary to determine, having regard to the context of the contested acts, whether they were adopted, as the applicant submits, following a re-examination of the decision of the Commission set out in the letter of 19 February 2018.

74 It is clear from settled case-law that, where an applicant lets the time limit for bringing an action against a decision unequivocally laying down a measure with legal effects affecting its interests and binding on it expire, it cannot start time running again by asking the author of the measure in question to reconsider its decision and bringing an action against the refusal confirming the decision previously taken (see judgment of 24 March 2017, Estonia v Commission, T‑117/15, EU:T:2017:217, paragraph 58 and the case-law cited).

75 A letter, which merely recalls an earlier decision, written well after the time limit for bringing proceedings against that earlier decision has expired, and in the absence of elements that could have altered the assessment by the institution concerned at the time of the decision or re-examination regarding the applicant’s situation, cannot be regarded as having been adopted following a re-examination of the applicant’s situation, with the result that it did not substantially alter the applicant’s legal position compared with that resulting from the act adversely affecting its interests (order of 8 March 2012, Octapharma Pharmazeutika v EMA, T‑573/10, not published, EU:T:2012:114, paragraph 57).

76 If it were otherwise, applicants could re-open time limits that had expired for instituting proceedings by provoking the European Union institution or body to recall an earlier decision, which has become definitive, to which that institution may, in the spirit of sound and transparent administration, provide a reply (order of 8 March 2012, Octapharma Pharmazeutika v EMA, T‑573/10, not published, EU:T:2012:114, paragraph 59).

77 However, the existence of substantial new facts may justify the submission of a request for the re-examination of a previous decision which has become definitive. If an act constitutes the reply to a request in which substantial new facts are relied on, and whereby the administration is requested to reconsider its previous decision, that measure cannot be regarded as purely confirmatory in nature, since it constitutes a decision taken on the basis of the supposed substantial new facts and thus contains a new factor as compared with the previous decision. Thus, following a re-examination, based on substantial new facts, of a decision which has become definitive, the institution concerned must take a new decision, the legality of which may, where necessary, be challenged before the EU judicature. However, in the absence of substantial new facts, the institution is not required to reconsider its earlier decision (see judgment of 24 March 2017, Estonia v Commission, T‑117/15, EU:T:2017:217, paragraph 59 and the case-law cited).

78 It follows from that case-law that a measure is regarded as adopted after a re-examination of the circumstances, which prevents it from being confirmatory in nature, where that measure was adopted either at the request of the person concerned, or at the initiative of its author, on the basis of substantial factors which were not taken into account at the time of adoption of the preceding measure. It is precisely because those factors had not been taken into account at the time of adoption of the earlier measure that they are new. However, if the matters of fact or law on which the new measure is based are not different from those which justified the adoption of the preceding measure, that new measure is purely confirmatory of the preceding measure (judgment of 24 March 2017, Estonia v Commission, T‑117/15, EU:T:2017:217, paragraph 60 and the case-law cited).

79 In the present case, the applicant’s submissions according to which the contested acts were adopted after a re-examination must be rejected.

80 In the first place, the applicant submits that, in the annex to its letter of 26 February 2018, it produced ‘new scientific evidence’, namely a statement by a professor dated 21 January 2018. It also submits that, in the letters of 17 August 2018, 15 October 2018 and 25 April 2019, it provided ‘further clarifications’. The applicant does not however give precise details of the ‘new legal and factual arguments’ that it alleges were the subject of a re-examination by the Commission, nor in what respects they were new. The existence of substantial new elements is therefore not established.

81 In the second place, the applicant relies on the judgment of 15 October 1997, IPK v Commission (T‑331/94, EU:T:1997:154, paragraph 26), in support of the submission that even if the contested acts limit themselves to the Commission’s earlier decision and even if new information such as to prompt the Commission to adopt a different position has not been shown, the fact that the same matter dealt with in the letter of 19 February 2018 was discussed at the meetings of 3 July 2018 and 29 April 2019 and that, following the latter meeting, the Commission undertook to seek legal advice on the matter must mean that the letter of 19 February 2018 does not constitute the definitive position of the Commission.

82 In that regard, it should be recalled that it is clear from the case-law cited in paragraph 77 above that an act is not regarded as purely confirmatory if it constitutes the reply to a request for re-examination of a previous decision based on substantial new facts (order of 24 May 2011, United Kingdom v Commission, T‑115/10, not published, EU:T:2011:242, paragraph 41).

83 In the present case, in addition to the fact that the applicant has not shown that it had adduced substantial new elements capable of leading the Commission to adopt a different position, it is appropriate to set out the following matters.

84 First, the Commission, far from re-examining the decision set out in the letter of 19 February 2018, referred to that decision or to its intention not to reconsider that decision in its later exchanges with the applicant and with the Member States, first in the letter of 9 April 2018, then at the meeting of 3 July 2018 and, lastly, in the contested acts (see paragraphs 63, 67 and 68 above).

85 It is therefore clear both from the content of the contested acts, as stated in paragraph 55 above, and from the contextual elements referred to above, that the Commission had no intention of re-examining the decision set out in its letter of 19 February 2018.

86 Secondly, it should be recalled that the meetings of 3 July 2018 and 29 April 2019 were meetings of SCoPAFF and of the food hygiene working group respectively, in which the Commission and Member States participated, and which were intended for the discussion of various matters. They were not meetings that the Commission had organised in order to discuss the applicant’s requests. Contrary to the latter’s submissions, the question of Listex^™ P100 was not included in the agenda for the meeting of 3 July 2018, but was raised at the request of the Kingdom of Belgium and of the Kingdom of the Netherlands, after the applicant had contacted several Member States (see paragraph 17 above).

87 Thirdly, as is clear from the case file, the applicant never asked the Commission to reconsider its decision not to approve the use of Listex^™ P100 as a decontaminant in animal-derived ready-to-eat food under Regulation No 853/2004, set out in the letter of 19 February 2018.

88 In its exchanges with the Commission after that date, the applicant did not try to obtain a decision of the Commission approving the use of Listex^™ P100 as a decontaminant, but submitted that Listex^™ P100 must be regarded, not as a decontaminant, but as a processing aid that did not fall within the scope of application of Regulation No 853/2004. In other words, the applicant never made an application for a re-examination of the decision set out in the letter of 19 February 2018.

89 The applicant submits that, at the meeting of 3 July 2018, according to the minutes of the Netherlands authorities, the Commission stated that the applicant could lodge an application for authorisation of the use of Listex^™ P100 as a processing aid for ready-to-eat food.

90 In addition, it is clear from the minutes of the meeting of 29 April 2019 drawn up by the Commission that, at that meeting, while recalling its position that Listex^™ P100 was required to be authorised in accordance with Regulation No 853/2004, the Commission stated that it was prepared to seek legal advice on the matter (see paragraph 23 above). The applicant submits that that necessarily means that the Commission had not decided definitively whether Listex^™ P100, when used on animal-derived ready-to-eat food, must be classified as a decontaminant.

91 However, neither of the two statements calls into question the Commission decision, set out in the letter of 19 February 2018, not to pursue the evaluation of the applicant’s request to approve Listex^™ P100 as a decontaminant in animal-derived ready-to-eat food.

92 It follows from the foregoing considerations that the contested acts contain no new element compared with the letter of 19 February 2018, and cannot be regarded as the result of a re-examination of the decision set out in that letter. The contested acts therefore constitute acts that are purely confirmatory of that decision.

93 As that decision was not challenged within the time limit for bringing legal proceedings, the action, to the extent that it is directed against the first alleged decision, is inadmissible.

94 It should additionally be noted that, in the case giving rise to the order of 14 December 2005, Arizona Chemical and Others v Commission (T‑369/03, EU:T:2005:458), confirmed by the Court of Justice on appeal in the order of 13 March 2007, Arizona Chemical and Others v Commission (C‑150/06 P, not published, EU:C:2007:164, paragraphs 21 to 25) the Commission had, by the act at issue in that case, rejected the applicants’ request that sought the withdrawal of a chemical from the list of dangerous substances set out in Annex I to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (OJ, English Special Edition (I) 1967, p. 234).

95 In that case, the General Court observed that the procedure leading to the classification or declassification of a substance in Annex I to Directive 67/548 was a complex one which results in the adoption of measures of general application, comparable to a ‘comitology’ procedure. It also held that, by the act at issue, the Commission had refused to submit, to a regulatory committee composed of representatives of the Member States, a proposal for a draft amendment of Directive 67/548, which proposal would have been a provisional and preparatory act, preceding the adoption of the amendment of the directive (order of 14 December 2005, Arizona Chemical and Others v Commission, T‑369/03, EU:T:2005:458, paragraphs 51 and 53).

96 The General Court then recalled that the Commission’s refusal to take steps for the withdrawal or amendment of an act can constitute in itself an act the lawfulness of which is open to challenge under the fourth paragraph of Article 263 TFEU only if the act that the Commission has refused to withdraw or amend could itself have been open to challenge under that provision (see, to that effect, order of 14 December 2005, Arizona Chemical and Others v Commission, T‑369/03, EU:T:2005:458, paragraph 64 and the case-law cited).

97 The General Court concluded that, notwithstanding the fact that the act at issue was a definitive response of the Commission to the applicants’ request, it was merely a position adopted in relation to a purely preliminary and preparatory measure which therefore was not open to an action for annulment (order of 14 December 2005, Arizona Chemical and Others v Commission, T‑369/03, EU:T:2005:458, paragraph 66).

98 The General Court also held that Directive 67/548 did not contain a provision conferring on interested economic operators in the applicants’ situation, the power to initiate the adaptation procedure in question, or any procedural guarantees capable of rendering the action admissible (order of 14 December 2005, Arizona Chemical and Others v Commission, T‑369/03, EU:T:2005:458, paragraphs 76 and 80).

99 Similarly, in the case giving rise to the order of 22 January 2010, Makhteshim-Agan Holding and Others v Commission (C‑69/09 P, not published, EU:C:2010:37), in the act at issue, after an unfavourable position had been adopted by the Council of the European Union, the Commission had stated its intention not to pursue the evaluation procedure for a given substance with a view to its inclusion in Annex I to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ 1991 L 230, p. 1).

100 In that case, the Court concluded that such an intention could not be interpreted as being a decision refusing to include the substance in question in the said annex, since the Commission did not have any power to authorise such an inclusion, and could not therefore render the act at issue in that case open to an action for annulment. In any event, since the measures refused to the applicants were preparatory, they could not be the subject of an action for annulment (order of 22 January 2010, Makhteshim-Agan Holding and Others v Commission, C‑69/09 P, not published, EU:C:2010:37, paragraphs 40, 41 and 46).

101 In the present case, the Commission treated the applicant’s request, which sought the authorisation of Listex^™ P100 as a decontaminant in animal-derived ready-to-eat food, on the basis of Article 3(2) of Regulation No 853/2004. That provision provides that a substance other than water cannot be used to remove surface contamination from products of animal origin, unless such a use of the substance has been approved by the Commission in accordance with the regulatory procedure with scrutiny referred to in Article 12(3) of the same regulation (see paragraphs 5 and 9 above).

102 The latter provision refers inter alia to Article 5a(1) to (4) of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (OJ 1999 L 184, p. 23), as amended by Council Decision 2006/512/EC of 17 July 2006 (OJ 2006 L 200, p. 11) which laid down the procedures for the regulatory procedure with scrutiny.

103 Article 5a(2) of Decision 1999/468 provides that the Commission is to submit to the regulatory committee with scrutiny, composed of representatives of the Member States, a draft of the measures to be taken and that the committee is to deliver its opinion on the draft by qualified majority.

104 Article 5a(3) of Decision 1999/468 provides that, if the measures envisaged by the Commission are in accordance with the opinion of the committee, the Commission is to submit the draft measures for scrutiny by the European Parliament and by the Council. If neither the Parliament nor the Council has opposed the draft measures, they are to be adopted by the Commission.

105 Article 5a(4) of Decision 1999/468 provides that, if the measures envisaged by the Commission are not in accordance with the opinion of the committee, or if no opinion is delivered, the Commission is to submit a proposal relating to the measures to be taken to the Council and to the Parliament. If neither the Council nor the Parliament has opposed the proposed measures, they are to be adopted by the Council or by the Commission.

106 Notwithstanding that the applicant does not make submissions in this regard, the case-law considerations set out in the orders of 14 December 2005, Arizona Chemical and Others v Commission, (T‑369/03, EU:T:2005:458), of 13 March 2007, Arizona Chemical and Others v Commission (C‑150/06 P, not published, EU:C:2007:164), and of 22 January 2010, Makhteshim-Agan Holding and Others v Commission (C‑69/09 P, not published, EU:C:2010:37), may be applied in the present case by analogy.

107 First, it is clear from paragraphs 101 to 105 above that the procedure leading to the approval of use of a substance as a decontaminant on the basis of Article 3(2) of Regulation No 853/2004 is a complex procedure comparable to a ‘comitology’ procedure. The regulatory procedure with scrutiny, applicable in this case, also provides for additional scrutiny by the Parliament and the Council, permitting the latter institutions to block the adoption of a measure proposed by the Commission.

108 Secondly, Regulation No 853/2004 does not provide that the Commission was obliged to commence the procedure leading to the approval of use of a substance as a decontaminant if it received a request to that effect by an operator in the industry.

109 Having regard to the foregoing, it is possible to hold that, irrespective of whether the letter of 19 February 2018 was a definitive response by the Commission to the applicant’s request, that letter merely adopted a position on a preliminary and preparatory measure and consequently, and applying the case-law recalled in paragraphs 39 and 96 above, it was not open to an action for annulment.

110 In those circumstances, that letter and consequently – and even more forcefully – the contested acts, which merely reiterate the position adopted in that letter, cannot be regarded as constituting acts open to challenge for the purposes of Article 263 TFEU, with the result that the conclusion, namely that the action, to the extent that it is directed against the first alleged decision, is, in any event, inadmissible, is not called into question.

111 As regards the second alleged decision (see paragraph 36 above), the Commission submits that the contested acts contain merely interpretive guidance on the issue of processing aids, which fall within the responsibility of Member States and not that of the Commission. The Commission merely expressed its opinion, which is not binding on the national authorities and does not change the legal situation of the parties before the court. The contested acts, which set out the Commission’s interpretation of the obligations that are binding on Member States, are not therefore acts within the meaning of Article 263 TFEU.

112 Moreover, the documents emanating from the Estonian and Belgian authorities produced by the applicant precede the second alleged decision and make no reference to it.

113 The Commission submits that it would be for the applicant, if necessary, to challenge the decisions taken by the Member States, for example by Estonia or by Belgium, not to authorise Listex^™ P100 as a processing aid. If those Member States were to rely, in their defence, on the Commission’s interpretation that Listex^™ P100 cannot be authorised as a processing aid because it is a decontaminant, the national court ought to refer that question to the Court of Justice.

115 The applicant submits that, while the decision to authorise processing aids lies with the Member States, the Commission is competent to determine whether a product is a processing aid, an additive or a decontaminant. By declaring, in the contested acts, that Listex^™ P100 is covered by Article 3(2) of Regulation No 853/2004, an assessment that it is competent to carry out, the Commission deprived the applicant of the possibility of requesting an authorisation for Listex^™ P100 as a non-decontaminating processing aid in the Member States.

116 According to the applicant, even though they are formulated in the form of an interpretation, the contested acts produce binding legal effects. Consequently, it would not be appropriate to regard the Commission’s refusal to examine the applicant’s request for Listex^™ P100 to be recognised for its use as a non-decontaminating processing aid in animal-derived ready-to-eat food as a mere interpretation.

117 In that regard, according to the case-law, a document in which the Commission merely gives its interpretation of a legislative provision is not capable of being the subject of an action for annulment. A written expression of opinion emanating from a European Union institution cannot constitute a decision in respect of which an action for annulment may be brought, since it is not capable of producing any legal effects nor is it intended to produce such effects. In such circumstances, it is not the interpretation of a legislative provision suggested by the Commission that is capable of producing legal effects, but its application to a given situation (see judgment of 16 July 1998, Regione Toscana v Commission, T‑81/97, EU:T:1998:180, paragraphs 22 and 23 and the case-law cited; see also, to that effect, order of 15 September 2016, Bagni Delfino di Paperini Stefano & C. v Commission, T‑667/15, EU:T:2016:511, paragraph 16).

118 It is also clear from the case-law that the statement of a simple legal opinion is incapable of producing legal effects (see, to that effect, judgment of 25 October 2017, Romania v Commission, C‑599/15 P,EU:C:2017:801, paragraph 62).

120 The decisions alleged to have been adopted by the Commission do not emerge clearly from the contested acts. The applicant does not specify which parts of the contested acts contain the second alleged decision.

121 The applicant refers, however, to the Commission’s statements in the contested acts, according to which:

‘Processing aids are defined in Regulation (EC) No 1333/2008 on food additives. However, Listex^™ P100 aims at reducing the Listeria contamination in ready-to-eat food. It therefore falls under the scope of Article 3(2) of Regulation (EC) No 853/2004’ and ‘a possible qualification as a processing aid for the purpose of decontamination would not remove the prevailing authorisation obligation under Regulation (EC) No 853/2004, as it was in the case of lactic acid authorised by Commission Regulation (EU) No 101/2013’.

122 As regards the second alleged decision, the relevant passages of the letter of 17 June 2019 sent to the applicant are as follows:

‘You now claim that the product should be considered as a processing aid, falling outside Regulation (EC) No 853/2004 laying down specific hygiene rules for food of animal origin. Processing aids are defined in Regulation (EC) No 1333/2008 on food additives.

However, Listex^™ P100 aims at reducing the Listeria contamination in ready-to-eat food. It therefore falls under the scope of Article 3(2) of Regulation (EC) No 853/2004, which stipulates that: “Food business operators shall not use any substance other than potable water … to remove surface contamination from products of animal origin, unless use of the substance has been approved by the Commission”. Therefore, a possible qualification as a processing aid for the purpose of decontamination would not remove the prevailing authorisation obligation under Regulation (EC) No 853/2004, as it was in the case of lactic acid authorised by Commission Regulation (EU) No 101/2013.

This interpretation remains that of Commission services. The Court of Justice constitutes the judicial authority of the Union and it remains its exclusive competence to interpret EU law.’

123 The content of the letter sent to PA International on the same day is almost identical to the extract set out in paragraph 122 above.

124 It is clear from a reading of the contested acts that the Commission provided therein a legal position regarding the interpretation of Article 3(2) of Regulation (EC) No 853/2004. In particular, the Commission adopted a position on the question of whether Listex^™ P100 falls within the scope of application of that provision and whether the obligation to obtain an authorisation from the European Union under that provision continued to apply for a processing aid used for the purposes of decontaminating ready-to-eat food.

125 The Commission appears therefore to provide clarification in response to the letters from the applicant and PA International dated 26 February, 17 August and 15 October 2018, and 25 April and 9 May 2019, in which they had submitted that Listex^™ P100 used on animal-derived ready-to-eat food must be regarded, not as a decontaminant, but as a processing aid falling outside the scope of Regulation No 853/2004.

126 In so doing, the Commission merely clarified the state of the existing law as it understood it. It is clear from the case-law cited in paragraph 117 above that a document in which the Commission merely gives its interpretation of a legislative text, in the same way as a written expression of opinion emanating from a European Union institution, cannot constitute a decision in respect of which an action for annulment may be brought, since it is not capable of producing any legal effects nor is it intended to produce such effects.

127 In that regard, it must be observed that the wording used by the Commission unequivocally translates its wish to communicate to the applicant a simple informative opinion as to its interpretation of Article 3(2) of Regulation No 853/2004, subject to a future judgment by the EU judicature. In addition, the explanations are formulated in purely hypothetical terms.

128 As regards the second alleged decision, it is clear from the foregoing that the contested acts, having regard to their content and in the light of the case-law recalled in paragraph 117 above, despite containing legal assessments, are not intended to produce binding legal effects.

129 That is all the more obvious having regard to the fact that the Commission was not, in any event, in a position to adopt a decision producing binding legal effects in respect of the applicant or the Member States on the subject of processing aids.

130 A written expression of opinion from a European Union institution cannot constitute a decision open to challenge through an action for annulment if it is expressed in a field in which that institution has no decision-making power, but only the possibility of expressing its opinion, which does not bind the competent authorities, and there is nothing in the wording or content of that expression to indicate that it is intended to produce any legal effects whatsoever (judgment of 24 March 2017, Estonia v Commission, T‑117/15, EU:T:2017:217, paragraph 45; see also, to that effect, order of 12 February 2010, Commission v CdT, T‑456/07, EU:T:2010:39, paragraph 55).

131 In the present case, it is not disputed between the parties that processing aids, except when used as food additives, are not governed at EU level, with the result that the Member States may legislate on the subject at national level. The decision to authorise processing aids therefore lies with the Member States.

132 It follows that the Commission, taking into account the competences available to it, only had the possibility – as is always open to it – of expressing its opinion, which cannot constitute a decision capable of being the subject of an action for annulment. Such an opinion does not in any case bind the national authorities, to the extent that they remain free to decide how to respond to the request made by the applicant (see, to that effect, judgment of 29 September 2009, Thomson Sales Europe v Commission, T‑225/07 and T‑364/07, not published, EU:T:2009:363, paragraph 186).

133 That conclusion must apply a fortiori in the present case, since, by the contested acts, the Commission set out its opinion to the applicant, at the request of the applicant, and not to a national authority.

134 In any event, the non-binding nature of a position adopted by the Commission cannot be called into question by the fact that the competent national authority may possibly comply with it (see, to that effect, judgment of 29 September 2009, Thomson Sales Europe v Commission, T‑225/07 and T‑364/07, not published, EU:T:2009:363, paragraph 187).

135 In that regard, the applicant is incorrect to submit that the Commission by stating, in the contested acts, that Listex^™ P100 fell within the scope of Article 3(2) of Regulation No 853/2004 deprived the applicant of the possibility of requesting authorisation of that product as a non-decontaminating processing aid in the Member States. The applicant is free to request a Member State to authorise Listex^™ P100 as a processing aid, since such a decision, as the applicant itself submits, falls within the competence of the Member States.

136 Therefore, it must be held that the contested acts, as regards the second alleged decision, are not capable of producing binding legal effects such as to affect the applicant’s interests by bringing about a distinct change in its legal position, in accordance with the case-law referred to in paragraph 38 above.

137 It follows that the action, in so far as it is directed against the second alleged decision, is inadmissible.

138 As regards the third alleged decision (see paragraph 36 above), the Commission submits that no decision prohibiting the placing on the market was taken at EU level. In that regard, the Commission remarks that the applicant does not indicate, in the text of the contested acts, any explicit prohibition on placing on the market.

139 According to the Commission, the contested acts merely recall the law as it interprets it: if Listex^™ P100 is a decontaminant, as the Commission considers it to be, the prohibition on marketing it flows directly from Regulation No 853/2004, since that product has not been authorised. The contested acts set out only the interpretation of the obligations binding on Member States under EU law where they consider, in their internal legal order, that Listex^™ P100 is a processing aid, namely that Listex^™ P100 should never have been placed on the market for the treatment of animal-derived food, even in the absence of a decision prohibiting the placing on the market having been taken at EU level.

140 In that regard, the Commission submits that responsibility for withdrawing from the market a product which does not comply with EU rules lies with the Member States, and not with the Commission.

142 The applicant alleges that ‘by formally declaring to all Member States that “no authorisation had been given at EU level for the placing on the market of [Listex^™ P100] in accordance with Article 3(2) of Regulation (EC) No 853/2004”, the Director-General, in fact, prohibited the marketing of the product within the EU and obliged the applicant to refrain from its production’. According to the applicant, no authorisation would be required if it had been accepted that Listex^™ P100 was not used as a decontaminant.

143 The decisions alleged to have been adopted by the Commission do not emerge clearly from the contested acts. As regards the third alleged decision, it is particularly difficult to understand which parts of the contested acts, according to the applicant, contain that decision.

144 On the one hand, the applicant alleges that ‘by formally declaring to all Member States that “no authorisation had been given at EU level for the placing on the market of [Listex^™ P100] in accordance with Article 3(2) of Regulation (EC) No 853/2004”, the Director-General, in fact, prohibited the marketing of the product within the EU’.

145 On the other hand, the applicant submits that the third alleged decision results from the combined effect of the first and second alleged decisions, to the extent that the Commission de facto prohibited the marketing of Listex^™ P100 owing to its refusal to recognise the use of Listex^™ P100 as a decontaminant in animal-derived ready-to-eat food under Regulation No 853/2004 (first alleged decision), and its refusal to examine, in the alternative, the use of Listex^™ P100 as a non-decontaminating processing aid (second alleged decision).

146 The applicant further submits that the third alleged decision results, ‘to the understanding of the applicant’, from the combined effect of the declaration referred to in paragraph 144 above, the second alleged decision and from the context.

147 As regards the third alleged decision, other than the parts corresponding to the first and second alleged decisions, in respect of which it has earlier been found that they were not capable of constituting acts open to challenge, the relevant parts of the letter sent to the applicant on 17 June 2019 are the following:

‘Furthermore I would like to clarify that the discussion held in the Working Group of hygiene experts of Member States on 29 April 2019 was at the request of a Member State who drew the attention of the Commission to the fact that Micreos was advertising its product to companies on that Member State’s territory despite not being allowed on the market and that its recognition as a processing aid in another Member State created difficulties for the competent authorities. The Commission merely recalled at this occasion that no authorisation had been given at EU level for the placing on the market of the Micreos product in accordance with Article 3(2) of Regulation (EC) No 853/2004.’

148 The content of the letter sent to PA International on the same day is almost identical to the extract set out in paragraph 147 above.

149 It should be noted that, given that the contested acts are not addressed ‘to all Member States’ (see paragraph 144 above), but to the applicant and its representative, it is difficult to understand whether the applicant considers that the third alleged decision is the result of the position adopted by the Commission at the meeting of 29 April 2019 or of the contested acts.

150 The applicant does not therefore describe in a clear and coherent manner the content of the third alleged decision.

151 The existence of such a decision is not clear from the contested acts. In those acts, the Commission merely informed the applicant, which had referred to the meeting of 29 April 2019 in its letter of 9 May 2019, of the nature of the discussions that had taken place with the Member States at that meeting, and indicated that it recalled, at that meeting, that no authorisation had been granted at EU level for the placing on the market of Listex^™ P100 under Article 3(2) of Regulation No 853/2004.

152 It must be recalled that an act of a purely informative character can neither affect the interests of the addressee nor change its legal position compared with the situation prior to receipt of that act (see order of 12 June 2019, Durand and Others v Parliament, T‑702/18, not published, EU:T:2019:408, paragraph 34 and the case-law cited).

153 In the present case, it must be held that, as regards the third alleged decision, the contested acts are purely informative and do not, in themselves, change the legal situation of the applicant.

154 The analysis of the context of the contested acts also does not permit the existence of the third alleged decision to be established.

155 First, it is clear from the application that Listex^™ P100 has been marketed in the European Union since 2006, in the absence of an authorisation, in the context of use in ready-to-eat food. The applicant acknowledges that Listex^™ P100 has been marketed since 2006 ‘without specific authorisation’, submitting that it would have requested authorisation from the Commission in 2015 with the sole aim of ‘expanding its market and [obtaining] official recognition and further visibility for its product’.

156 Only the Netherlands authorities, in 2009, indicated that they regarded Listex^™ P100 used in animal-derived ready-to-eat food as a processing aid, which, according to the applicant, amounted to authorisation on their part.

157 It follows that Listex^™ P100 is marketed in the European Union without having been authorised either by the Commission, as a decontaminant, or by the vast majority of the Member States as a processing aid. The Commission thus states, in the contested acts, that, at the meeting of 29 April 2019, ‘a Member State … drew the attention of the Commission to the fact that [the applicant] was advertising its product to companies on the Member State’s territory despite not being allowed on the market’.

158 In other words, by recalling that no authorisation had been granted at EU level for the placing on the market of Listex^™ P100 under Article 3(2) of Regulation No 853/2004, the Commission was simply making an observation. The applicant is therefore in the same legal position both before and after the adoption of the contested acts. Those acts do not constitute a re-examination of the obligations of the applicant or the Member States, but a reiteration of them. The Commission did not seek to impose obligations on the applicant’s legal situation that were new compared with its legal situation before the adoption of the contested acts. Therefore, those acts are not capable of producing binding legal effects as regards the applicant.

159 Secondly, the applicant’s claims that the third alleged decision had legal effects in the form of decisions taken by national authorities must be rejected.

160 The applicant submits, first, that the Estonian and Belgian authorities prohibited the marketing of Listex^™ P100 on their markets for use on animal-derived ready-to-eat food in March and June 2019 respectively.

161 In that regard, it must be observed that, as the applicant itself notes, those decisions arose before the adoption of the contested acts, with the result that it is difficult to comprehend how they could constitute the legal effects of those acts.

162 The applicant submits, second, that the Netherlands authorities indicated to it, in an email of 13 November 2019, that Listex^™ P100 could not be used as a non-decontaminating processing aid on animal-derived ready-to-eat food, and that the Belgian authorities indicated, in an email of 3 January 2020, that the use of bacteriophages on food was prohibited in the European Union.

163 In that regard, it must be observed that the applicant itself submits that the Netherlands and Belgian authorities adopted that position on the basis of the following circular, addressed by the Commission to the Member States on 8 November 2019: ‘As already recalled at the meeting on 29 April 2019, there is no authorisation for the placing on the market of Listex^™ P100 in accordance with Article 3(2) of Regulation (EC) No 853/2004 for its use in food of animal origin and there is, in the view of the Commission, no scope for Member States to authorise Listex as processing aid for food of animal origin’.

164 Therefore, it is difficult to understand how those decisions of national authorities are the legal effects of the contested acts, which were, in any event, addressed to the applicant and not to the Member States.

165 On 23 November 2020, the applicant produced, among others, further documents from the Belgian, Estonian, Irish and Spanish authorities, dated February, March, May and June 2020, respectively, recalling, in essence, the Commission position according to which the use of Listex™ P100 in animal-derived food is not authorised in the European Union.

166 In that regard, it should be recalled that, according to Article 85(1) to (3) of the Rules of Procedure, evidence is to be submitted in the first exchange of pleadings, the main parties exceptionally having the opportunity to produce further evidence before the decision of the General Court to rule without an oral part of the procedure, provided that the delay in the submission of such evidence is justified. In the present case, it must be observed that all the documents concerned post-date the lodging of the applicant’s observations on the plea of admissibility, on 9 January 2020, and that the applicant therefore could not produce them in the first exchange of pleadings between the parties. In those circumstances, the evidence concerned must be held to be admissible.

167 However, for the same reasons as those set out in paragraphs 163 and 164 above, these documents cannot be considered to be legal effects of the contested acts.

168 Thirdly, as has been stated earlier in the context of the assessment of the second alleged decision, since the decision to authorise processing aids falls within the competence of the Member States, the contested acts cannot be binding on the Member States.

169 It is clear from the foregoing that, in the present case, no binding legal consequence capable of affecting the applicant’s interests flows from the contested acts.

170 It follows that the action, in so far as it is directed against the third alleged decision, is inadmissible.

171 It follows from all the foregoing considerations that the contested acts do not contain any of the three alleged decisions that the applicant sees in them and that they cannot therefore be regarded as acts that are open to challenge for the purpose of Article 263 TFEU.

172 It is therefore necessary to uphold the plea of inadmissibility and to dismiss the action as being inadmissible.

173 Contrary to the applicant’s submission, the latter is not however denied judicial protection.

174 In that regard, it must be recalled that judicial review of compliance with the European Union legal order is ensured, as can be seen from Article 19(1) TEU, by the Court of Justice of the European Union and the courts and tribunals of the Member States (see judgment of 3 October 2013, Inuit Tapiriit Kanatami and Others v Parliament and Council, C‑583/11 P, EU:C:2013:625, paragraph 90 and the case-law cited).

175 To that end, the FEU Treaty has established, by Articles 263 and 277, on the one hand, and Article 267, on the other, a complete system of legal remedies and procedures designed to ensure judicial review of the legality of European Union acts, and has entrusted such review to the Courts of the European Union (see judgment of 3 October 2013, Inuit Tapiriit Kanatami and Others v Parliament and Council, C‑583/11 P, EU:C:2013:625, paragraph 92 and the case-law cited).

176 As regards the role of the national courts and tribunals, it must be recalled that the national courts and tribunals, in collaboration with the Court of Justice, fulfil a duty entrusted to them both of ensuring that in the interpretation and application of the Treaties the law is observed (see judgment of 3 October 2013, Inuit Tapiriit Kanatami and Others v Parliament and Council, C‑583/11 P, EU:C:2013:625, paragraph 99 and the case-law cited).

177 Consequently, and as the Commission correctly submits, if the applicant disputes the legal position expressed by the Commission in the contested acts, it is free to commence proceedings against acts adopted by the national authorities, such as those adopted by the Estonian and Belgian authorities to which the applicant refers, before the national courts, allowing those courts to make an order for reference to the Court of Justice pursuant to Article 267 TFEU.

178 Article 134(1) of the Rules of Procedure provides that the unsuccessful party is to be ordered to pay the costs if they have been asked for in the successful party’s pleading. Since the applicant has been unsuccessful, it must be ordered to pay the costs, including those of the application for interim measures, in accordance with the form of order sought by the Commission.

2. Micreos Food Safety BV shall pay the costs, including those of the interim proceedings.

Court of Justice of the European Communities (including Court of First Instance Decisions)