Orders nº T-568/19 of Tribunal General de la Unión Europea, December 18, 2020

• Resolution Date: December 18, 2020
• Issuing Organization: Tribunal General de la Unión Europea
• Decision Number: T-568/19

(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)

In Case T-568/19,

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

applicant,

v

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

defendant,

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,

THE GENERAL COURT (Eighth Chamber),

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

Registrar: E. Coulon,

makes the following

Order

Background to the dispute

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’)...