CELEX: 62021CJ0051
Reference for a preliminary ruling
Food law
Regulation (EC) No 2073/2005
Microbiological criteria for foodstuffs
Article 3(1)
Obligations of food business operators
Annex I
Point 1.2 of Chapter 1
Limit values for the presence of Listeria monocytogenes in fish products before and after being placed on the market
Regulation (EC) No 178/2002
Article 14(8)
Official controls of the product at the stage at which it is placed on the market
Scope

This request for a preliminary ruling concerns the interpretation of Article 3(1) and point 1.2 of Chapter 1 of Annex I to Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs (
OJ 2005 L 338, p. 1
, and corrigendum
OJ 2010 L 174, p. 54
), as amended by Commission Regulation (EU) 2019/229 of 7 February 2019 (
OJ 2019 L 37, p. 106
) (‘Regulation No 2073/2005’).
The request has been made in proceedings between Aktsiaselts M.V.WOOL (‘MVWOOL’), a manufacturer of fish foodstuffs, and the Põllumajandus- ja Toiduamet (Office for Agriculture and Food, Estonia) (‘the Estonian authority’) concerning the lawfulness of two decisions addressed by that authority to MVWOOL, as a result of the detection of the bacterium
Listeria monocytogenes
in foodstuffs placed on the market by that company.
Legal context
Regulation (EC) No 178/2002
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
) entitled ‘Other definitions’ provides in paragraph 8 thereof:
‘For the purposes of this Regulation:
…
(8)
“placing on the market” means the holding of food or feed for the purpose of sale, including offering for sale or any other form of transfer, whether free of charge or not, and the sale, distribution, and other forms of transfer themselves;
…’
Article 14 of that regulation, entitled ‘Food safety requirements’, provides in paragraph 8 thereof:
‘Conformity of a food with specific provisions applicable to that food shall not bar the competent authorities from taking appropriate measures to impose restrictions on it being placed on the market or to require its withdrawal from the market where there are reasons to suspect that, despite such conformity, the food is unsafe.’
Regulation No 2073/2005
Recitals 1 to 3 of Regulation No 2073/2005 state:
‘(1)
A high level of protection of public health is one of the fundamental objectives of food law, as laid down in Regulation [No 178/2002]. …
(2)
Foodstuffs should not contain micro-organisms or their toxins or metabolites in quantities that present an unacceptable risk for human health.
(3)
… Food business operators have an obligation to withdraw unsafe food from the market. In order to contribute to the protection of public health and to prevent differing interpretations, it is appropriate to establish harmonised safety criteria on the acceptability of food, in particular as regards the presence of certain pathogenic micro-organisms.’
Article 1 of Regulation No 2073/2005, entitled ‘Subject matter and scope’, provides:
‘This Regulation lays down the microbiological criteria for certain micro-organisms and the implementing rules to be complied with by food business operators when implementing the general and specific hygiene measures … The competent authority shall verify compliance with the rules and criteria laid down in this Regulation … without prejudice to its right to undertake further sampling and analyses for the purpose of detecting and measuring other micro-organisms, their toxins or metabolites, either as a verification of processes, for food suspected of being unsafe, or in the context of a risk analysis.
…’
Article 2 of that regulation contains the following definitions:
‘…
(b)
“microbiological criterion” means a criterion defining the acceptability of a product, a batch of foodstuffs or a process, based on the absence, presence or number of micro-organisms, and/or on the quantity of their toxins/metabolites, per unit(s) of mass, volume, area or batch;
…
(f)
“shelf-life” means either the period corresponding to the period preceding the “use by” or the minimum durability date, as defined respectively in Articles 9 and 10 of Directive 2000/13/EC [of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (
OJ 2000 L 109, p. 29
)];
…
(l)
“compliance with microbiological criteria” means obtaining satisfactory or acceptable results set in Annex I when testing against the values set for the criteria through the taking of samples, the conduct of analyses and the implementation of corrective action, in accordance with food law and the instructions given by the competent authority;
…’
Article 3 of that regulation, entitled ‘General requirements’, provides, in paragraph 1:
‘Food business operators shall ensure that foodstuffs comply with the relevant microbiological criteria set out in Annex I. To this end the food business operators at each stage of food production, processing and distribution, including retail, shall take measures, as part of their procedures based on HACCP [(hazard analysis and critical control point)] principles together with the implementation of good hygiene practice, to ensure the following:
…
(b)
that the food safety criteria applicable throughout the shelf-life of the products can be met under reasonably foreseeable conditions of distribution, storage and use.’
Annex I to that regulation, in Chapter 1, entitled ‘Food safety criteria’, provides in point 1.2:
‘Food category
Micro-organisms/their toxins, metabolites
Sampling-plan …
Limits …
Analytical reference method
Stage where the criterion applies
n.
C
m
M


1.2 Ready-to-eat foods able to support the growth of [
Listeria
]
monocytogenes
, other than those intended for infants and for special medical purposes
Listeria monocytogenes
100 [colony-forming units (cfu)/grams (g)] (
)
EN ISO 11290-2 …
Products placed on the market during their shelf-life
Not detected in 25 g (
)
EN ISO 11290-1
Before the food has left the immediate control of the food business operator, who has produced it
…
(
) This criterion applies if the manufacturer is able to demonstrate, to the satisfaction of the competent authority, that the product will not exceed the limit 100 cfu/g throughout the shelf-life. The operator may fix intermediate limits during the process that should be low enough to guarantee that the limit of 100 cfu/g is not exceeded at the end of the shelf-life.
…
(
) This criterion applies to products before they have left the immediate control of the producing food business operator, when he is not able to demonstrate, to the satisfaction of the competent authority, that the product will not exceed the limit of 100 cfu/g throughout the shelf-life.’
The dispute in the main proceedings and the questions referred for a preliminary ruling
On 2 August 2019, the Estonian authority took samples from a retail store of some salmon and trout products manufactured by MVWOOL. The analysis of those samples having detected the presence of
Listeria monocytogenes
, the Estonian authority, by decision of 7 August 2019, ordered the manufacturer to suspend the manufacturing of those products, to recall the entire batch and to inform consumers of the recall.
In October 2019, after having detected the presence of
Listeria monocytogenes
in some of its products, MVWOOL carried out a disinfection operation of two operating sites. Notwithstanding that measure, the presence of
Listeria monocytogenes
continued to be detected in some products from those sites. Consequently, by decision of 25 November 2019, the Estonian authority ordered MVWOOL to suspend its activity at those sites until it adduced proof of the elimination of that contamination.
MVWOOL brought an action before the Tallinna Halduskohus (Administrative Court, Tallinn, Estonia) for annulment of those decisions, claiming that the Estonian authority was not entitled to apply, in respect of samples taken from a retail store, the limit requiring the absence of detection of
Listeria monocytogenes
in 25 g of the food product concerned, laid down in point 1.2 of Chapter 1 of Annex I to Regulation No 2073/2005 (‘the zero tolerance limit’). In its view, that limit does not apply to products already placed on the market. For the latter products, the limit applicable is that of 100 cfu/g during the shelf-life of the product, laid down in the same provision. MVWOOL asserts that the presence of
Listeria monocytogenes
in excess of that limit has never been found to be present in its products.
The Estonian authority takes the view that, since MVWOOL has not demonstrated that its products would not exceed the limit of 100 cfu/g of
Listeria monocytogenes
throughout their shelf-life, it is the zero tolerance limit that is applicable, regardless of whether those products are under the immediate control of the manufacturer or have already been placed on the market. That interpretation is confirmed by the practice of other Member States and by the Codex Alimentarius of the United Nations Food and Agriculture Organisation and the World Health Organisation.
The national court notes that the interpretation of the provisions in point 1.2 of Chapter 1 of Annex I to Regulation No 2073/2005, on which the parties to the main proceedings disagree, has a direct impact on the lawfulness of the Estonian authority’s decisions of 7 August and 25 November 2019.
According to that court, the interpretation advocated by MVWOOL is supported by the general scheme of Regulation No 2073/2005, from which it is apparent that the cases in which the zero tolerance limit is applicable are exhaustively laid down by that regulation. If that interpretation were to be accepted, it would result in the unlawfulness of the decisions contested by MVWOOL.
By contrast, the interpretation supported by the Estonian authority is, according to the national court, in compliance with the objective of Regulation No 2073/2005, which is to guarantee food safety throughout its shelf-life and a high level of protection of public health. According to that interpretation, MVWOOL, by having placed on the market foodstuffs which did not comply with the zero tolerance limit while they were under its immediate control, infringed its obligation under Article 3(1) of Regulation No 2073/2005.
In those circumstances, the Tallinna Halduskohus (Administrative Court, Tallinn) decided to stay the proceedings and to refer the following questions to the Court of Justice for a preliminary ruling:
‘(1)
Must the … microbiological criterion [requiring a zero tolerance limit] set out in Article 3(1) of Regulation No 2073/2005 and point 1.2 … in Chapter 1 of Annex I thereto be interpreted, having regard to that regulation, the protection of public health and the objectives pursued by [that regulation and by] Regulation No 178/2002 …, as meaning that in the case where the food business operator has been unable to demonstrate to the satisfaction of the competent authority that ready-to-eat foods able to support the growth of
Listeria monocytogenes
, other than those intended for infants and for special medical purposes, will not exceed the limit of 100 cfu/g during their shelf-life, the microbiological criterion … then also applies in any event to products placed on the market during their shelf-life?
(2)
If the answer to the first question is in the negative, must the second microbiological criterion [requiring a zero tolerance limit] be interpreted, in the light of the objective of protecting public health and the objectives pursued by Regulation No 2073/2005, and by [Regulation] No 178/2002 …, as meaning that, irrespective of whether the food business operator is able to demonstrate, to the satisfaction of the competent authority that the food will not exceed the limit of 100 cfu/g during the shelf-life, two alternative microbiological criteria then apply to that food, namely: first, the criterion ‘zero tolerance limit’ while the food is under the control of the food business operator, and second, the criterion “100 cfu/g” after the food has left the control of the food business operator?’
Consideration of the questions referred
By its questions, which it is appropriate to examine together, the national court asks, in essence, whether the combined provisions of Article 3(1) and point 1.2 of Chapter 1 of Annex I to Regulation No 2073/2005 must be interpreted as meaning that, where the manufacturer is unable to demonstrate, to the satisfaction of the competent authority, that, throughout their shelf-life, foodstuffs will not exceed the limit of 100 cfu/g, the zero tolerance limit as regards the presence of
Listeria monocytogenes
applies to foodstuffs which have been placed on the market throughout their shelf-life.
It is apparent from Article 3(1) of Regulation No 2073/2005 that food business operators must ensure that the foodstuffs they manufacture comply with the relevant microbiological criteria, within the meaning of Article 2(b) and (l) of that regulation, set out in Annex I thereto, at each stage of food production, processing and distribution of those foodstuffs, including retail, throughout the shelf-life of the products, within the meaning of Article 2(f) of that regulation.
Point 1.2 of Chapter 1 of Annex I to Regulation No 2073/2005 lays down, for the category of ready-to-eat foods able to support the growth of
Listeria monocytogenes
, other than those intended for infants and for special medical purposes, two limits as regards the presence of that bacterium.
The first limit, fixed at 100 cfu/g, applies to products placed on the market during their shelf-life, where the manufacturer is able to demonstrate to the satisfaction of the competent authority that those products will not exceed that limit throughout their shelf-life, as stated in footnote 5 to that provision.
The second limit, establishing zero tolerance, is applicable, according to that provision, ‘before the food has left the immediate control of the food business operator, who has produced it’ and, as stated in footnote 7 of that provision, where that operator is unable to demonstrate to the satisfaction of the competent authority that that product will not exceed the limit of 100 cfu/g throughout the shelf-life.
It must be stated that a situation, such as that at issue in the main proceedings, where a food product, in respect of which the manufacturer is unable to demonstrate to the satisfaction of the competent authority that it will not exceed the limit of 100 cfu/g during its shelf-life, has already been placed on the market, is not covered by those provisions.
Although point 1.2 of Chapter 1 of Annex I to Regulation No 2073/2005, read in the light of footnote 7, refers to the situation where the manufacturer is unable to demonstrate, ‘to the satisfaction of the competent authority’, that his products will not exceed the limit of 100 cfu/g during their shelf-life, it nevertheless requires that the zero tolerance limit as regards the presence of
Listeria monocytogenes
be applied to such a situation for these products which have not yet left the ‘immediate control’ of the manufacturer and consequently have not been placed on the market.
It follows that the combined provisions of Article 3(1) of Regulation No 2073/2005 and point 1.2 of Chapter 1 of Annex I thereto must be interpreted as meaning that, where the manufacturer is unable to demonstrate to the satisfaction of the competent authority that, throughout their shelf-life, foodstuffs will not exceed the limit of 100 cfu/g, the zero tolerance limit as regards the presence of
Listeria monocytogenes
does not apply to food products which have been placed on the market during their shelf-life. In such a case, that manufacturer must refrain from placing those products on the market.
In that regard, it should be noted that the objective of Regulation No 2073/2005 is to guarantee the safety of foodstuffs throughout their shelf-life but also a high level of protection of public health, as evidenced by recitals 1 to 3. To that end, Article 1 of that regulation grants the competent authority a broad discretion to be able to carry out further controls on foodstuffs in order to verify compliance with the rules and criteria laid down in that regulation (see, by analogy, judgment of 12 September 2019, A and Others,
C‑347/17
,
EU:C:2019:720
, paragraph
) However, although Regulation No 2073/2005 lays down the microbiological criteria with which foodstuffs must comply at each stage of the food chain, it does not contain any provisions on the action which the competent authority may undertake following the placing on the market of foodstuffs in breach of those criteria.
In that respect, it is appropriate to refer to Regulation No 178/2002. In particular, Article 14(8) of that regulation states that competent national authorities can take ‘appropriate measures’ to impose restrictions on food being placed on the market or to require its withdrawal from the market, despite its conformity to specific provisions of EU law which are applicable to it, where those authorities have objective reasons to suspect that that food is unsafe. That provision, having regard to its importance for the attainment of a high level of protection of human health and consumer interests, must be interpreted broadly (see, to that effect, judgment of 28 April 2022, Romega,
C‑89/21
,
EU:C:2022:313
, paragraph
).
The application of the zero tolerance limit to food products which have been placed on the market, without the manufacturer having demonstrated to the satisfaction of the competent authority that, during their shelf-life, those products would not exceed the limit of 100 cfu/g, may thus constitute an ‘appropriate measure’ within the meaning of Article 14(8) of Regulation No 178/2002.
In the light of the foregoing, the answer to the questions referred by the national court is that the combined provisions of Article 3(1) and point 1.2 of Chapter 1 of Annex I to Regulation No 2073/2005 must be interpreted as meaning that where the manufacturer is unable to demonstrate, to the satisfaction of the competent authority, that, throughout their shelf life, foodstuffs will not exceed the limit of 100 cfu/g as regards the presence of
Listeria monocytogenes
, the zero tolerance limit will not apply to foodstuffs which have been placed on the market throughout their shelf-life.
Costs
Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the national 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.

On those grounds, the Court (Eighth Chamber) hereby rules:

The combined provisions of Article 3(1) and point 1.2 of Chapter 1 of Annex I to Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs, as amended by Commission Regulation (EU) 2019/229 of 7 February 2019, must be interpreted as meaning that, where the manufacturer is unable to demonstrate, to the satisfaction of the competent authority, that, throughout their shelf-life, foodstuffs will not exceed the limit of 100 colony-forming units/grams (g), as regards the presence of
Listeria monocytogenes
, the limit requiring the absence of detection of
Listeria monocytogenes
in 25 g of the food product concerned laid down in that point 1.2 of that Annex I, does not apply to foodstuffs which have been placed on the market throughout their shelf-life.

[Signatures]
(
*1
)	Language of the case: Estonian.