22 February 2024 – Case C‑745/22
Micreos Food Safety BV v Eniaios Foreas Elenchou Trofimon (EFET)
Request for a preliminary ruling from the Symvoulio tis Epikrateias (Council of State, Greece)
(Reference for a preliminary ruling – Food safety – Specific hygiene rules for food of animal origin – Regulation (EC) No 853/2004 – Article 3(2) – Substance intended to remove surface contamination from products of animal origin – Definition – Contamination by the pathogenic bacterium Listeria monocytogenes – Substance intended to prevent surface contamination from products of animal origin and applied outside of slaughterhouses during the final stages of the production process – Placing on the market – Prior approval by the European Commission)
Parties
| Party | Representative |
|---|---|
| Micreos Food Safety BV | S. Pappas, lawyer |
| Eniaios Foreas Elenchou Trofimon (EFET) | A. Strataki, dikigoros |
| Greek Government | E. Leftheriotou and A.-E. Vasilopoulou, Agents |
| European Commission | M. Konstantinidis, B. Rechena and M. Zerwes, Agents |
Judgment
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This request concerns the interpretation of Article 3(2) of Regulation (EC) No 853/2004 of 29 April 2004 on specific hygiene rules for food of animal origin, as amended by Regulation (EU) 2019/1243 of 20 June 2019, and of Article 3(2)(a) and (b) of Regulation (EC) No 1333/2008 on food additives.
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The dispute arises from the Greek refusal to authorise Listex™ P100, a spray product designed to prevent the presence of Listeria monocytogenes in ready‑to‑eat food of animal origin.
Legal context
Regulation (EC) No 178/2002 – General principles of food law (OJ 2002 L 31, p. 1).
Regulation (EC) No 852/2004 – Hygiene of foodstuffs (OJ 2004 L 139, p. 1).
Regulation No 853/2004 – Specific hygiene rules for food of animal origin.
Regulation No 1333/2008 – Food additives.
Relevant provisions
- Article 1(1) of Regulation 853/2004 – Scope of the regulation.
- Article 2(1) of Regulation 853/2004 – Definitions (reference to Regulations 178/2002 and 852/2004).
- Article 3(2) of Regulation 853/2004 – *"Food business operators shall not use any substance other than potable water … to remove surface contamination from products of animal origin, unless the substance has been approved by the Commission."
- Annex I point 8.1 of Regulation 853/2004 – Definition of “products of animal origin”.
- Article 2(1)(f) of Regulation 852/2004 – Definition of “contamination”.
- Article 3 point 14 of Regulation 178/2002 – Definition of “hazard”.
Facts
- Micreos applied to the Commission (2015) for approval of Listex™ P100 as a decontaminant under Article 3(2) of Regulation 853/2004.
- The Commission, after an EFSA opinion (7 July 2016), prepared a draft regulation but did not pursue the approval (informally Oct 2017, formally 19 Feb 2018).
- Micreos later argued that Listex™ P100 is a processing aid under Regulation 1333/2008, not a decontaminant.
- The Commission reiterated its position that the product falls within the scope of Regulation 853/2004 and requires approval.
- The Greek authority (EFET) dismissed Micreos’ application (24 June 2020) citing lack of legal basis and EFSA concerns.
- The referring court (Council of State) raised two questions for a preliminary ruling:
- (1) Whether Article 3(2) of Regulation 853/2004 requires Commission approval for a product intended to prevent contamination when used outside slaughterhouses.
- (2) Whether Regulation 1333/2008 classifies the product as a food additive or a processing aid (subsidiary question).
Court’s reasoning (selected excerpts)
- The concept of “food business operator” is broad and includes any unit of a food business, not only slaughterhouses.
- Recital 18 of Regulation 853/2004 extends the structural and hygiene requirements to all establishments, including those outside slaughterhouses.
- The definition of “products of animal origin” (Annex I point 8.1) includes food produced outside slaughterhouses.
- “Contamination” is defined as the presence or introduction of a hazard; the regulation therefore covers measures aimed at preventing such hazards.
- The Court concludes that the EU legislature intends a broad scope for Article 3(2), covering both removal and prevention of surface contamination.
Ruling
Article 3(2) of Regulation (EC) No 853/2004 must be interpreted as requiring the European 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.
The second question is therefore moot.
Costs – The decision on costs is left to the referring court.
Judgment of the Court (Seventh Chamber), 22 February 2024