1 This request for a preliminary ruling concerns the interpretation of 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, and corrigendum OJ 2004 L 226, p. 22), as amended by Regulation (EU) 2019/1243 of the European Parliament and of the Council of 20 June 2019 (OJ 2019 L 198, p. 241) (‘Regulation No 853/2004’), and of Article 3(2)(a) and (b) of 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).
2 The request has been made in proceedings between Micreos Food Safety BV, a company established in the Netherlands, and Eniaios Foreas Elenchou Trofimon (EFET) (Hellenic Food Authority, Greece) concerning the latter’s refusal to authorise ListexTM P100 to be placed on the Greek market, a spray product designed to prevent the presence of the pathogenic bacterium Listeria monocytogenes in ready-to-eat food of animal origin, such as fish, dairy and meat products.
3 Article 3 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ 2002 L 31, p. 1) states, in points 3 and 14 thereof: ‘For the purposes of this Regulation: … 3. “food business operator” means the natural or legal persons responsible for ensuring that the requirements of food law are met within the food business under their control; … 14. “hazard” means a biological, chemical or physical agent in, or condition of, food or feed with the potential to cause an adverse health effect’.
4 Article 2(1) of Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (OJ 2004 L 139, p. 1, and corrigendum OJ 2004 L 226, p. 3) provides in subparagraphs (c) and (f): ‘For the purposes of this Regulation: … (c) “establishment” means any unit of a food business; … (f) “contamination” means the presence or introduction of a hazard’.
5 Recitals 6, 9, 10 and 18 of Regulation No 853/2004 are worded as follows: ‘(6) It is desirable to achieve further simplification by applying the same rules wherever appropriate to all products of animal origin. … (9) The principal objectives of the recasting are to secure a high level of consumer protection with regard to food safety, in particular by making food business operators throughout the [European] Community subject to the same rules, and to ensure the proper functioning of the internal market in products of animal origin, thus contributing to the achievement of the objectives of the common agricultural policy. (10) It is necessary to maintain and, where required to ensure consumer protection, to tighten detailed hygiene rules for products of animal origin. … (18) It is appropriate for the structural and hygiene requirements laid down in this Regulation to apply to all types of establishments, including small businesses and mobile slaughterhouses.’
6 Article 1(1) of that regulation, entitled ‘Scope’, provides: ‘This Regulation lays down specific rules on the hygiene of food of animal origin for food business operators. These rules supplement those laid down by Regulation (EC) No 852/2004. They shall apply to unprocessed and processed products of animal origin.’
7 Article 2 of Regulation No 853/2004, entitled ‘Definitions’, states: ‘The following definitions shall apply for the purposes of this Regulation: 1. the definitions laid down in Regulation (EC) No 178/2002; 2. the definitions laid down in Regulation (EC) No 852/2004; …’
8 Article 3(2) of Regulation No 853/2004, entitled ‘General obligations’, provides: ‘Food business operators shall not use any substance other than potable water or, when Regulation (EC) No 852/2004 or this Regulation permits its use, clean water, to remove surface contamination from products of animal origin, unless use of the substance has been approved by the [European] Commission. For that purpose the Commission is empowered to adopt delegated acts in accordance with Article 11a supplementing this Regulation. …’
9 Point 8.1 of Annex I to Regulation No 853/2004 states: ‘“Products of animal origin” means: - food of animal origin, including honey and blood; - live bivalve molluscs, live echinoderms, live tunicates and live marine gastropods intended for human consumption; and - other animals destined to be prepared with a view to being supplied live to the final consumer.’
10 The first paragraph of Article 1 of Regulation No 1333/2008 provides: ‘This Regulation lays down rules on food additives used in foods with a view to ensuring the effective functioning of the internal market whilst ensuring a high level of protection of human health and a high level of consumer protection, including the protection of consumer interests and fair practices in food trade, taking into account, where appropriate, the protection of the environment.’
11 Article 2 of that regulation is worded as follows: ‘1. This Regulation shall apply to food additives. 2. This Regulation shall not apply to the following substances unless they are used as food additives: (a) processing aids; …’
12 In accordance with Article 3(2) of that regulation: ‘For the purposes of this Regulation the following definitions shall also apply: (a) “food additive” shall mean any substance not normally consumed as a food in itself and not normally used as a characteristic ingredient of food, whether or not it has nutritive value, the intentional addition of which to food for a technological purpose in the manufacture, processing, preparation, treatment, packaging, transport or storage of such food results, or may be reasonably expected to result, in it or its by-products becoming directly or indirectly a component of such foods; … (b) “processing aid” shall mean any substance which: (i) is not consumed as a food by itself; (ii) is intentionally used in the processing of raw materials, foods or their ingredients, to fulfil a certain technological purpose during treatment or processing; and (iii) may result in the unintentional but technically unavoidable presence in the final product of residues of the substance or its derivatives provided they do not present any health risk and do not have any technological effect on the final product; …’
13 Micreos Food Safety manufactures phage-based products, one of which is Listex™ P100.
14 In 2015, following several informal contacts starting in 2007, Micreos Food Safety applied to the Commission to have Listex™ P100 approved as a decontaminant for ready-to-eat food of animal origin, in accordance with Article 3(2) of Regulation No 853/2004.
15 On the basis of a scientific opinion given on 7 July 2016 by the European Food Safety Authority (EFSA), the Commission prepared a draft regulation authorising the use of Listex™ P100 and submitted it to the Standing Committee on Plants, Animals, Food and Feed. However, as that draft regulation did not receive the necessary support from the committee, the Commission informed Micreos Food Safety, informally in October 2017 and formally by letter dated 19 February 2018, that it did not intend to pursue the approval process, as it was lacking the necessary political support.
16 By letter of 26 February 2018, Micreos Food Safety submitted to the Commission that Listex™ P100 was not a ‘decontaminant’ for the purposes of Regulation No 853/2004, but was a ‘processing aid’, within the meaning of Article 3(2)(b) of Regulation No 1333/2008, and that, therefore, it does not come within the scope of Regulation No 853/2004.
17 By letter of 9 April 2018, the Commission reiterated its decision not to pursue the approval process for Listex™ P100.
18 On 15 October 2018, Micreos Food Safety requested the Commission to pursue the approval process and submitted, following the decision of the Commission not to pursue the approval procedure, a complaint to the European Ombudsman, which was rejected by a decision of 4 March 2019.
19 By letters of 25 April and 9 May 2019, Micreos Food Safety again requested the Commission to assess the classification of Listex™ P100 as a ‘non-decontaminating processing aid’.
20 By two letters of 17 June 2019, (‘the two letters of 17 June 2019’), addressed respectively to Micreos Food Safety and to the Public Advice International Foundation, which represented that company, the Commission stated, first, its intention not to pursue the approval process of Listex™ P100 on the basis of Regulation No 853/2004. Secondly, that institution asserted that, even if Listex™ P100 were classified as a ‘processing aid’, within the meaning of Article 3(2)(b) of Regulation No 1333/2008, the product would still be covered by Regulation No 853/2004 inasmuch as it is used for decontamination purposes. Moreover, Listex™ P100 had not been approved pursuant to Article 3(2) of Regulation No 853/2004.
21 On 16 August 2019, Micreos Food Safety brought before the General Court of the European Union an action for annulment of the decisions allegedly contained within the two letters of 17 June 2019 and lodged an application for interim measures seeking the suspension of the operation of those decisions, namely, (i) the rejection of the application for approval of Listex™ P100 as a decontaminant, in accordance with Regulation No 853/2004, (ii) the rejection of the alternative application for classification of the product as a ‘processing aid’ within the meaning of Article 3(2)(b) of Regulation No 1333/2008, and (iii) the prohibition on placing Listex™ P100 on the market in the European Union as a ‘processing aid’.
22 By the order of 26 September 2019, Micreos Food Safety v Commission (T‑568/19 R, EU:T:2019:694), the President of the General Court dismissed the application for interim measures submitted by Micreos Food Safety, on the ground that, first, the two letters of 17 June 2019 were not a decision which prohibited the placing on the market of Listex™ P100. Secondly, the company was not left without judicial protection, in so far as it could, as a first step, challenge the corresponding acts at national level before the national courts, thereby allowing those courts, as a second step, to make an order for reference to the Court of Justice for a preliminary ruling.
23 On 8 November 2019, the Commission sent a document to the heads of the veterinary services of the Member States, asserting that Listex™ P100 comes within the scope of Article 3(2) of Regulation No 853/2004, as it is intended to reduce contamination from the pathogenic bacterium Listeria monocytogenes in ready-to-eat food of animal origin. Therefore, even if it were classified as a ‘processing aid’ within the meaning of Article 3(2)(b) of Regulation No 1333/2008, that product would still be subject to approval under Regulation No 853/2004. In addition, the Commission recalled that Listex™ P100 had not been approved in accordance with Article 3(2) of Regulation No 853/2004 and that EU law does not give the Member States discretion to approve the product as a ‘processing aid’.
24 On 27 April 2020, Micreos Food Safety applied to the Deputy Minister for Health (Greece) for approval to place its product Listex™ P100 on the Greek market as a ‘processing aid’ for ready-to-eat food of animal origin. That application was then sent to the Ministry of Rural Development and Food (Greece), then to the EFET, the competent authority at national level.
25 By decision of 24 June 2020, the president of the management board of the EFET dismissed the application, due to, first, the absence of a clear legal framework in Greek law regarding processing aids, and secondly, reservations expressed in the EFSA scientific opinion of 7 July 2016 regarding the classification and safe use of Listex™ P100.
26 On 28 September 2020, Micreos Food Safety brought an action for annulment of the decision of 24 June 2020 before the Symvoulio tis Epikrateias (Council of State, Greece), the referring court.
27 In support of its action, Micreos Food Safety submits that, first, Article 3(2) of Regulation No 853/2004 relates exclusively to the decontamination of food of animal origin in slaughterhouses. Secondly, Listex™ P100 is intended also for use outside slaughterhouses in the very final stages of the production process, namely after the thermal processing of the food, once it has already been decontaminated and is ready for cutting and packaging. Thirdly, Listex™ P100 is not intended to remove contamination, but to prevent contamination in the event that the presence of the pathogenic bacterium Listeria monocytogenes exceeds the permitted thresholds.
28 By order of 18 December 2020, Micreos Food Safety v Commission (T‑568/19, EU:T:2020:647), the General Court dismissed as inadmissible Micreos Food Safety’s action seeking annulment of the two letters of 17 June 2019, on the ground that those letters, first, are not ‘acts that are open to challenge’ for the purpose of Article 263 TFEU and, secondly, are not intended to produce binding legal effects, despite containing legal assessments. Furthermore, the General Court reiterated that Micreos Food Safety was not left without judicial protection, as it is free to challenge the acts adopted by the national authorities before the national courts, thereby allowing the latter to make an order for reference to the Court of Justice pursuant to Article 267 TFEU.
29 By letter of 7 February 2022, the president of the management board of the EFET informed the referring court that, (i) Listex™ P100 should be regarded as requiring approval as a ‘decontaminant’, in accordance with Article 3(2) of Regulation No 853/2004, in so far as that product is intended to reduce contamination by the pathogenic bacterium Listeria monocytogenes of ready-to-eat food of animal origin, (ii) in the absence of approval at EU level, the product could not be placed on the market as a ‘decontaminant’ in accordance with Article 3(2) of Regulation No 853/2004 and, (iii) that product would continue to fall within the scope of Regulation No 853/2004, even if it were classified as a ‘processing aid’ under Regulation No 1333/2008. The document of 7 February 2022 also explained why it was not possible to classify Listex™ P100 as a ‘processing aid’ intended for purposes other than decontamination, the reason being, inter alia, the failure to produce the necessary evidence and the doubts as to the effectiveness and safety of that product.
30 The referring court takes the view that Micreos Food Safety’s action must be dismissed on the ground that, first, the objectives pursued by the EU legislature are, as stated in recital 9 of Regulation No 853/2004, to secure a high level of consumer protection with regard to food safety and, secondly, that Article 3(2) of that regulation encompasses the decontamination of products of animal origin in all types of establishments, as follows from recital 18 of that regulation, therefore also including outside of slaughterhouses, irrespective of the stage in the production process. Furthermore, Micreos Food Safety’s submission that Listex™ P100 is intended to prevent contamination is irrelevant, as it is still used to ‘remove surface contamination from products of animal origin’ within the meaning of Article 3(2) of Regulation No 853/2004.
31 Nevertheless, the Symvoulio tis Epikrateias (Council of State) decided to stay the proceedings and to refer the following questions to the Court of Justice for a preliminary ruling: ‘(1) Must [Regulation No 853/2004] be interpreted as meaning that a product such as Listex™ Ρ100 manufactured by [Micreos Food Safety], which has the characteristics described in the [scientific] opinion of 7 July 2016 of [EFSA] and, moreover, according to [Micreos Food Safety]’s submissions, is applied outside of slaughterhouses during the final stages of the production process and is intended to prevent rather than to remove surface contamination on products of animal origin, comes within the scope of Article 3(2) of the regulation (and its distribution on the European market is therefore subject to prior approval by the Commission in accordance with Article 11a of [Regulation No 853/2004])? If the answer to Question 1 is in the negative: (2) Must [Regulation No 1333/2008] be interpreted as meaning that [Micreos Food Safety]’s product referred to above is a ‘food additive’ or a ‘processing aid’ ([within the meaning of] Article 3(2)(a) and (b) of [that regulation, respectively])?’
32 By its first question, the referring court asks, in essence, whether Article 3(2) of Regulation No 853/2004 must be interpreted as requiring the Commission to approve the use of a product, such as Listex™ P100, intended to prevent the presence of the pathogenic bacterium Listeria monocytogenes in ready-to-eat food of animal origin.
33 In that regard, it must be recalled that Article 3(2) of Regulation No 853/2004 provides that food business operators are not to use any substance other than potable water, or, when Regulation No 852/2004 or No 853/2004 permits its use, clean water, to remove surface contamination from products of animal origin, unless use of the substance has been approved by the Commission.
34 With regard, first, to the activities and persons referred to in Article 3(2) of Regulation No 853/2004, which forms part of Chapter II thereof, entitled ‘Food business operators’ obligations’, it should be noted that that article refers generally to ‘food business operators’.
35 In accordance with Article 2 of Regulation No 853/2004, the definitions given in Regulations No 178/2002 and No 852/2004 apply for the purposes of Regulation No 853/2004. Point 3 of Article 3 of Regulation No 178/2002 defines ‘food business operator’ as ‘the natural or legal persons responsible for ensuring that the requirements of food law are met within the food business under their control’.
36 Furthermore, it follows from recital 18 of Regulation No 853/2004 that the structural and hygiene requirements laid down in that regulation apply to all types of establishments, including small businesses and mobile slaughterhouses. Article 2(1)(c) of Regulation No 852/2004 specifies that the term ‘establishment’ means ‘any unit of a food business’.
37 It follows that Article 3(2) of Regulation No 853/2004 cannot be interpreted as applying only to slaughterhouses, since the EU legislature has adopted a broad definition of the concept of ‘food business operator’.
38 Secondly, such an interpretation is supported by the wording of the definition of ‘products of animal origin’ in point 8.1 of Annex I to Regulation No 853/2004, which refers, inter alia, to products present outside slaughterhouses, namely ‘food of animal origin, including honey and blood’. A limitation of the scope of Article 3(2) of that regulation to carcasses as products of slaughterhouses cannot therefore be inferred from the wording of that provision either. Such a restriction would also run counter to the objective set out in recital 6 of that regulation, which is to achieve further simplification by applying the same hygiene rules wherever appropriate to all products of animal origin.
39 Thirdly, regarding the definition of the concept of ‘contamination’, within the meaning of Article 3(2) of Regulation No 853/2004, it must be noted that that provision requires prior approval from the Commission for the use of any substance other than water to remove surface contamination from products of animal origin.
40 The referring court has doubts as to the validity of Micreos Food Safety’s submission according to which Listex™ P100 aims not to remove contamination by the pathogenic bacterium Listeria monocytogenes, but to prevent such contamination and to avoid foodstuffs exceeding the microbiological contamination thresholds authorised by Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs (OJ 2005 L 338, p. 1) throughout their storage and until consumption.
41 In that regard, Article 2(1)(f) of Regulation No 852/2004 defines the term ‘contamination’ as ‘the presence or introduction of a hazard’. As for the concept of a ‘hazard’, it is defined in Article 3, point 14 of Regulation No 178/2002 as ‘a biological, chemical or physical agent in, or condition of, food or feed, with the potential to cause an adverse health effect’.
42 It follows that the EU legislature clearly wished to encourage attainment of a high standard of food safety by retaining a broad definition also of the concept of ‘contamination’ within the meaning of Article 3(2) of Regulation No 853/2004 (see, to that effect, judgment of 12 September 2019, A and Others, C‑347/17, EU:C:2019:720, paragraph 40).
43 It is apparent from the file before the Court that, first, the pathogenic bacterium Listeria monocytogenes is ever-present in nature and that, secondly, Listex™ P100 requires the presence of that bacterium in order to be able to deploy its decontaminating effect. It thus appears that the attainable objective relied on by Micreos Food Safety, consisting in preventing that bacterium from exceeding the thresholds authorised by Regulation No 2073/2005, constitutes, in the present case, the removal of contamination. It cannot be inferred from the broad definition of the concept of ‘contamination’, as set out in the preceding paragraph, that the potentially harmful effect of the presence of that bacterium depends on whether or not the thresholds authorised by Regulation No 2073/2005 are exceeded.
44 In addition, as the Commission points out in its written observations, the concept of ‘contamination’, within the meaning of Article 3(2) of Regulation No 853/2004, covers the risk of introducing a hazard linked to the pathogenic bacterium Listeria monocytogenes at any stage of the production, processing and packaging of food of animal origin, since Article 3(2) of that regulation does not define or fix the moment at which such contamination is to be removed.
45 Such an interpretation is supported by the objective pursued by Regulation No 853/2004 which, as set out in recital 9 thereof, is to secure a high level of consumer protection with regard to food safety. In addition, recital 10 of that regulation clearly demonstrates that the EU legislature makes consumer health its primary concern, in so far as it states that ‘it is necessary to maintain and, where required to ensure consumer protection, to tighten detailed hygiene rules for products of animal origin’ (see, to that effect, judgment of 12 September 2019, A and Others, C‑347/17, EU:C:2019:720, paragraph 43).
46 Therefore, both the general scheme of Regulation No 853/2004 and its objective require all sources of contamination to be covered (judgment of 12 September 2019, A and Others, C‑347/17, EU:C:2019:720, paragraph 44), with such an interpretation highlighting the choice of the EU legislature to prioritise the implementation of specific hygiene rules intended to prevent surface contamination over the subsequent use of decontaminants.
47 Having regard to all the foregoing considerations, the answer to the first question is that Article 3(2) of Regulation No 853/2004 must be interpreted as requiring the Commission to approve the use of a product, such as Listex™ P100, intended to prevent the presence of the pathogenic bacterium Listeria monocytogenes in ready-to-eat food of animal origin.
48 In the light of the answer given to the first question, it is not necessary to answer the second question, which was raised in the event that the Court should answer the first question in the negative.
49 Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the referring court, the decision on costs is a matter for that court. Costs incurred in submitting observations to the Court, other than the costs of those parties, are not recoverable.