Judgment;Summary — ECLI:EU:C:2022:515
Date: 2022-06-30
Language of the case: Estonian
Court formation: Eighth Chamber
Subject matter: Agriculture and Fisheries;Foodstuffs;Consumer protection;Approximation of laws;Public health
Procedure: Reference for a preliminary ruling
Origin: Estonia

Summary of the request for a preliminary ruling pursuant to Article 98(1) of 
the Rules of Procedure of the Court of Justice 
Date lodged: 
28 January 2021 
Referring court: 
Tallinna Halduskohus (Administrative Court, Tallinn, Estonia) 
Date of the decision to refer: 
28 January 2021 
Applicant: 
Aktsiaselts M.V.WOOL 
Defendant: 
Põllumajandus- ja Toiduamet (Agriculture and Food Board, 
formerly Veterinaar- ja Toiduamet, Veterinary and Food Board) 
  
Subject matter of the main proceedings 
Action brought by AS M.V.Wool seeking the annulment of the order in a control 
report of the Agriculture and Food Board dated 7 August 2019 (Order No 1) and 
seeking to have the order of 25 November 2019 (Order No 2) declared null and 
void on procedural grounds, or, in the alternative, annulled on substantive grounds 
and partially suspended for the duration of the present administrative proceedings 
Subject matter and legal basis of the request 
The request for a preliminary ruling seeks an interpretation of Article 3(1) of 
Commission Regulation (EC) No 2073/2005 of 15 November 2005 on 
microbiological criteria for foodstuffs (OJ 2005 L 338, p. 1) and point 1.2 of the 
table in Chapter 1 of Annex I thereto, read in conjunction with 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 
EN 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-51/21 
 
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safety (OJ 2002 L 31, p. 1) and Regulation (EC) No 882/2004 of the European 
Parliament and of the Council of 29 April 2004 on official controls performed to 
ensure the verification of compliance with feed and food law, animal health and 
animal welfare rules (OJ 2004 L 165, p. 1). 
Questions referred for a preliminary ruling 
1. Must the second microbiological criterion ‘Absence in 25 g’ set out in 
Article 3(1) of Regulation No 2073/2005 and point 1.2 of the table in Chapter 1 of 
Annex I thereto be interpreted, having regard to that regulation, the protection of 
public health and the objectives pursued by Regulations No 178/2002 and 
No 882/2004, 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 L. 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 ‘Absence in 
25 g’ then also applies in any event to products placed on the market during their 
shelf-life? 
2. If Question 1 is answered in the negative: Must the second microbiological 
criterion ‘Absence in 25 g’ set out in Article 3(1) of Regulation No 2073/2005 and 
point 1.2 of the table in Chapter 1 of Annex I thereto be interpreted, having regard 
to that regulation, the protection of public health and the objectives pursued by 
Regulations No 178/2002 and No 882/2004, 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 
(1) the criterion ‘Absence in 25 g’ while the food is under the control of the food 
business operator, and (2) the criterion ‘100 cfu/g’ after the food has left the 
control of the food business operator? 
Relevant provisions of EU law 
Commission Regulation (EC) No 2073/2005 of 15 November 2005 on 
microbiological criteria for foodstuffs (OJ L 338, p. 1), recitals 1 to 3 and 5, 
Article 2(b), (c), (f), (g), (l), Article 3(1)(a) and (b) of the explanatory table in 
Chapter 1 of Annex I of Notes 5 and 7 to Annex I. 
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), recitals 2, 8, 10 and 12, Article 5(1), 
Article 7(1), Article 14(1) and (2), Article 14(3)(a) and (b), Article 14(5) 
Regulation (EC) No 882/2004 of the European Parliament and of the Council of 
29 April 2004 on official controls performed to ensure the verification of 
AKTSIASELTS M.V.WOOL 
 
3 
compliance with feed and food law, animal health and animal welfare rules (OJ 
2004 L 165, p. 1, and corrigendum OJ 2004 L 191, p. 1), recitals 1, 4 and 6, 
Article 3(3) 
Decision No 1082/2013/EU of the European Parliament and of the Council of 
22 October 2013 on serious cross-border threats to health and repealing Decision 
No 2119/98/EC (OJ 2013 L 293, p. 1), Article 9(a) and (b) 
Provisions of national law relied on 
General Law on economic activities (‘the MSÜS’), Paragraph 43(1)(1) 
Law on foodstuffs (‘the ToiduS’), Paragraph 49(4) and (5). 
Succinct presentation of the facts and procedure in the main proceedings 
1 On 7 August 2019, the Veterinary and Food Board (‘the VLA’ or ‘the defendant’) 
issued an order in a control report (‘Order No 1’) requiring AS M.V.Wool 
(‘M.V.Wool’ or ‘the applicant’) to suspend the further handling of its products 
(sliced cold smoked salmon, [use by 19 August 2019] and sliced cured trout [use 
by 10 August 2019]), to recall the entire batch from the market and to inform 
consumers of the recall of the non-compliant food from the market. The reasons 
given for Order No 1 were as follows. 
2 VLA employees took food samples, in a Maxima store, from four products made 
in M.V.Wool’s fish plant in Harku. The analysis of the samples revealed that 
Listeria monocytogenes (‘L.m.’) was present in 3 samples of cold smoked trout 
(use by 6 August 2019), 5 samples of sliced cold smoked salmon (use by 
19 August 2019) and 1 sample of sliced cured trout (use by 10 August 2019). 
3 The control report of 18 March 2018 had already imposed on M.V.Wool the 
obligation to establish the absence of L.m. for each product batch (absence in 25 g, 
in 5 samples) before the food had left the immediate control of the food business 
operator. In the event of a positive result, the batches were not allowed to depart 
the company (the ‘zero tolerance’ requirement). The applicant has not challenged 
the orders on which the abovementioned form of order sought by it was based. 
4 Since the applicant did not duly demonstrate to the VLA that the quantity of L.m. 
present at the end of the shelf-life would not exceed 100 cfu/g, only criterion II, 
provided for in point 1.2 of the table in Chapter 1 of Annex I to Regulation 
No 2073/2005, namely that L.m. must be absent in 25 g in five product samples, 
can apply. The applicant breached its obligation of self-regulation by placing on 
the market products that did not meet food safety criteria. 
5 On 25 November 2019 the VLA issued an order (‘Order No 2’) to M.V.Wool 
requiring it to suspend completely its activities (including manufacturing, 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-51/21 
 
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brokering, storage, import of raw materials, export of raw materials and of goods) 
at two operating sites: the Harku fish plant and the Vihterpalu fish plant. The 
operative part of Order No 2 also states that if the action plan to improve the 
operations of M.V.Wool includes the production of a sample batch, the VLA must 
be informed of this and a corresponding action plan must be submitted to the VLA 
for coordination purposes. In addition, M.V.Wool was required to inform the 
VLA of the following on 25 November 2019: a) the stock level determined at the 
relevant establishments, and b) where and in what way the Category-2 animal by-
products to be disposed of at the establishment are handled. Part of that order was 
mandatory from the time of service. The suspension of activities was to apply 
until M.V.Wool had demonstrated to the VLA that the L.m. strain ST1247 of the 
outbreak had been eliminated from M.V.Wool’s operating sites, the VLA had 
been informed of this and the VLA had confirmed it on the basis of the results of 
rinse samples taken as part of a government control measure. The reasons given 
for Order No 2 were as follows. 
6 After analysing samples taken from the Harku fish plant and Vihterpalu fish plant 
and the products made there, the VLA found L.m. in six samples taken from the 
production areas in the Harku fish plant, in one sample taken from the warehouse 
and in six samples taken from a reseller’s store. At the Vihterpalu fish plant, L.m. 
was detected in four samples taken from the production areas. 
7 The previously imposed restrictions had failed. In 2019, M.V.Wool had been 
issued with eight separate orders obliging it to withdraw from the market the 
product contaminated with L.m., which had been produced at the Harku fish plant. 
The VLA also found further non-conformities in the products of the Vihterpalu 
fish plant and asked M.V.Wool to clarify that it itself had withdrawn the products 
from the market or had not placed them on the market. In the course of the control 
measures, attention was also repeatedly drawn to cross-contamination at the 
Vihterpalu fish plant. 
8 According to the sequencing results, the L.m. strain ST1247 was isolated in the 
products of M.V.Wool and in the rinse samples. 
9 On 15 October 2019, M.V.Wool informed the VLA that it planned to completely 
sterilise the Harku fish plant from 17 October 2019 to 18 October 2019 in order to 
eliminate the L.m. strain ST1247. It was also considering a significant reduction of 
the shelf-life of products that did not contain L.m.-inhibiting preservatives. 
Nevertheless, after the large-scale cleaning and disinfection operation carried out 
by M.V.Wool at the fish plant, L.m. was found both in rinse samples and in the 
products, in both Vihterpalu and Harku. The ST1247 strain poses a risk to the 
public. 
10 M.V.Wool has failed to comply with food law and there has been non-compliance 
on its part within the meaning of point 10 of Article 2 of Regulation No 882/2004, 
with the result that there are grounds, pursuant to Article 54(1) of that regulation, 
for applying the measure provided for in Article 54(2)(e) of that regulation, 
AKTSIASELTS M.V.WOOL 
 
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namely the suspension of the entire operation of the Harku and Vihterpalu fish 
plants. At the same time, pursuant to point 1 of Paragraph 43(1) of the MSÜS, 
there are grounds for suspending the company’s operating licence, as it has 
breached essential requirements of an economic activity, entailing a significant 
risk to public health. The measures applicable to M.V.Wool are lawful, 
appropriate, necessary and proportionate to achieve the objective pursued, that is 
to say, they are necessary for the protection of human health and life. The shelf-
life established by the company is not sufficient to ensure the safety of the 
products until the end of the shelf-life. 
11 On 5 September 2019, M.V.Wool brought an action before the Tallinna 
Halduskohus (Administrative Court, Tallinn, Estonia) seeking to have Order No 1 
of the VLA declared null and void and, on 26 November 2019, it brought an 
action before that court seeking to have Order No 2 of the VLA declared null and 
void on procedural grounds, or, in the alternative, annulled on substantive grounds 
and partially suspended for the duration of the present administrative proceedings. 
The actions were joined for the purposes of the judgment. 
Essential arguments of the parties in the main proceedings 
12 The applicant seeks to have Order No 1 declared null and void on the ground that 
the defendant was not entitled either to prohibit the sale of foodstuffs which had 
not been shown to be dangerous in accordance with point 1.2 of the table in 
Chapter 1 of Annex I to Regulation No 2073/2005 or to require the applicant to 
withdraw those foodstuffs from the market. The applicant takes the view that 
Order No 1 is unlawful and must be declared null and void on the grounds that (1) 
the defendant was not entitled to analyse the samples taken from the store on the 
basis of the zero tolerance criterion (absence of L.m. in 25 g); (2) the content of 
L.m. in the fish products is not clear from the defendant’s control report; (3) the 
defendant prohibited the sale of fish products which had not been found to be 
dangerous and it therefore misinterpreted the food safety criteria provided for in 
Regulation No 2073/2005; (4) the deficiencies in the order do not allow the 
defendant to prohibit the sale of foodstuffs which comply with the food safety 
criteria set out in Regulation No 2073/2005. 
13 With regard to Order No 1, the defendant states that, since the applicant did not 
duly demonstrate to the VLA that the amount of L.m. present in the applicant’s 
products would not exceed 100 cfu/g at the end of the shelf-life, only criterion II, 
provided for in point 1.2 of the table in Chapter 1 of Annex I to Regulation 
No 2073/2005, namely that L.m. must be absent in 25 g in five product samples, 
could apply. According to the defendant, the applicant was not able to carry out 
appropriate endurance tests (challenge tests) to show that the amount of L.m. in 
the products did not exceed 100 cfu/g at the end of the implementation period. 
The applicant breached the obligation of self-regulation incumbent on food 
business operators by placing on the market products that do not meet food safety 
criteria. 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-51/21 
 
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14 According to the applicant, Order No 2 is unlawful because a total suspension of 
the company’s operations is disproportionate, given that there were no cases of 
illness related to strain ST1247 in Estonia when that order was issued. The 
absence of such cases of illness was confirmed by representatives of the VLA and 
by the Health Board. 
15 The applicant takes the view that it is clear from Order No 2 that the purpose of 
that administrative act was to ensure that production hygiene requirements were 
met at the applicant’s company. Regulation No 2073/2005 makes a very clear 
distinction between food safety criteria (that is to say, whether food is compliant, 
or safe) and production hygiene criteria (that is to say, whether production areas 
are clean). In the event of non-compliance with production hygiene requirements 
(which can be proven by means of surface samples and rinse samples), the 
inspection body can take measures to improve hygiene or improve the selection of 
raw materials. In the event of non-compliance with production hygiene 
requirements, it is not possible to take measures intended for the identification of 
non-compliant food. 
16 The applicant takes the view that the criterion set out in point 1.2 of the table in 
Chapter 1 of Annex I to Regulation No 2073/2005, namely that a food is safe if 
the content of L.m. in the food is less than 100 cfu/g at the end of the shelf-life, is 
applicable. It is not apparent from the contested administrative act that the 
applicant placed on the market foodstuffs that exceeded the food safety criterion 
of 100 cfu/g during the shelf-life as provided for in Regulation No 2073/2005. The 
samples taken from the applicant’s products were never found to contain L.m. in 
excess of the limit. 
17 The applicant submits that it complied with the defendant’s order of 18 March 
2019 in relation to the Harku fish plant and the order of 5 November 2019 in 
relation to the Vihterpalu fish plant, according to which: ‘The operator must carry 
out a test for L. monocytogenes for each product batch (presence in 25 g, in 5 sub-
samples) before the food has left the immediate control of the food business 
operator, who has produced it (the ‘zero tolerance’ criterion). In the event of a 
positive result, the batches are not allowed to depart the company.’ According to 
the applicant, it is not clear from the contested administrative act why that 
measure is not sufficient to ensure product safety. It takes the view that the 
ST1247 strain was not found in any of the product samples taken at the Vihterpalu 
plant in 2019. 
18 The applicant submits that the defendant relies solely on positive samples 
analysed by the Veterinary and Food Laboratory (VTL), despite the fact that two 
other state-accredited laboratories had produced negative results for the same 
batches and surfaces. The defendant refused the applicant’s request for the 
appointment of a third, independent laboratory in such a situation. The applicant 
claims that such conduct infringes Article 11(5) of Regulation No 882/2004. This 
therefore constitutes a procedural irregularity which, according to the applicant, 
renders the order unlawful. 
AKTSIASELTS M.V.WOOL 
 
7 
19 The applicant challenges Order No 2 in so far as it relates to the ineffectiveness of 
the large-scale cleaning operation carried out at its fish plant in Harku. On 
23 October 2019, the VLA took samples showing the presence of L.m. from 
production areas at the factory while production activities were being carried out, 
and found that it had ‘reasonable grounds to believe that the L.m. found both in 
rinse samples taken after the cleaning operation and in product samples is still 
strain ST1247’. M.V.Wool submits, in essence, that the presence of strain ST1247 
cannot be assumed, because its presence must be properly established by means of 
analysis, and that, after the large-scale cleaning operation, it provided the 
defendant with rinse and product samples in which no L.m. was detected, that is to 
say, evidence that the cleaning had been effective. The applicant further asserts 
that the defendant did not take the post-cleaning samples until the third day after 
the start of production, and not before the start of production, which would have 
been the correct approach. Furthermore, at the time when the samples were taken, 
raw fish had been processed on the production line on which L.m. had been found, 
which is why L.m. had also been found on that line. 
20 According to the applicant, the so-called zero tolerance requirement (absence of 
L.m. in 25 g before the food leaves the food business operator’s control) does not 
extend to food at retail level. The applicant had analyses of all product batches 
carried out in approved laboratories in order to determine the presence of L.m. in 
25 g. The goods were dispatched from the plant for sale only if the result of the 
analysis was 0 in 25 g in all 5 sub-samples, submits the applicant. According to 
Annex I to Regulation No 2073/2005 (Interpretation of the test results), a result of 
0 is satisfactory. According to point 1.1 of the table in Chapter 1 of Annex I to 
Regulation No 2073/2005, a zero-tolerance limit is provided for ready-to-eat 
foods intended for infants and ready-to-eat foods for special medical purposes, 
that is to say, ‘absence in 25 g in 5 samples’. The stage where the criterion applies 
is specified as being ‘Products placed on the market during their shelf-life’. 
According to point 1.2 of the table in Chapter 1 of Annex I to Regulation 
No 2073/2005, zero tolerance for L.m. applies to other ready-to-eat foods, that is 
to say, ‘Absence in 25 g’ in 5 samples, for the stage ‘Before the food has left the 
immediate control of the food business operator, who has produced it’. It is clear 
from the comparison that, when it comes to the application of zero tolerance for 
L.m., provision is made for different stages where that criterion applies. 
21 The applicant considers that the VLA is incorrect in its assessment that, if strain 
ST1247 is detected, the food is dangerous even if the L.m. does not exceed 100 
cfu/g. Regulation No 2073/2005 does not distinguish between different strains, 
since all highly pathogenic and virulent strains are taken into account when 
establishing the criterion in the interest of public health. 
22 According to the applicant, Article 14(8) of Regulation No 178/2002 does not 
permit food which complies with Community microbiological requirements to be 
regarded as dangerous. In the guidance document on the interpretation of 
Regulation No 882/2004, which forms the legal basis for the order, the following 
explanation can be found under the heading ‘Absence of Community criteria’: ‘In 
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the absence of Community microbiological criteria the evaluation of the food can 
be done in accordance with Article 14 of Regulation (EC) No 178/2002, which 
provides that unsafe food products must not be placed on the market.’ According 
to the guidance document for Regulation No 178/2002, Article 14(8) is aimed at 
cases where a food contains a piece of glass or a hazardous chemical not 
specifically identified by legislation on contaminants in food. Even if it were 
accepted that Article 14(8) of Regulation No 178/2002 allows a food which 
complies with the microbiological requirements to be regarded as dangerous, the 
only conceivable measure would be the imposition of restrictions on the placing of 
the food on the market and its withdrawal from the market, but not the suspension 
of the company’s operations. 
23 The applicant considers that the operative part of the order is contradictory, 
according to which the food does not comply with the microbiological 
requirements within the meaning of Regulation No 2073/2005, but is also 
dangerous even if it does comply with the microbiological requirements 
(Article 14(8) of Regulation No 178/2002). 
24 According to M.V.Wool, there was no cross-border threat to health, because the 
criteria set out in Article 9(a) and (b) of Decision No 1082/2013/EU of the 
European Parliament and of the Council have not been met, and, therefore, the 
measures taken to contain the threat by Order No 2 were unlawful. 
25 The disproportionate nature of Order No 2 is also confirmed by the fact that, with 
regard to the various activities (import of raw materials, storage, production, 
dispatch of goods and brokering), no consideration was given to the possibility of 
taking alternative measures (for example, temporary suspension of sales of 
unheated goods because L.m. is eliminated when heated; product recall; 
shortening of the shelf-life of the products by way of an order, or similar). The 
applicant claims that, since Regulation No 2073/2005 establishes microbiological 
requirements only for ready-to-eat food, it is unlawful to prohibit the import and 
storage of the raw materials. The danger posed by the imported or stored raw 
materials has not been proven. 
26 M.V.Wool considers that it is incorrect to conclude that the food was dangerous 
on the basis of the L.m. found in the production areas, as no limits for L.m. have 
been set for the production environment. 
27 The applicant contests the VLA’s view that, in the event of the presence of the 
ST1247 strain, which is allegedly more dangerous than others, it is not necessary 
to comply with the food safety criteria provided for in Regulation No 2073/2005. 
All L.m. strains have been declared pathogenic by the Scientific Panel operating 
under the auspices of the European Union. According to the applicant, the 
application of a special measure is based on the fact that a food does not comply 
with the food safety criteria under EU and national law, which, in the present case, 
is to be assessed on the basis of the L.m. content and not on the basis of the strain. 
AKTSIASELTS M.V.WOOL 
 
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The VLA fails to recognise that L.m. can be harmful to human health only in 
quantities that exceed the food safety criteria. 
28 The defendant takes the view that Order No 2 is not invalid. Unlike Article 54 of 
Regulation No 882/2004, Paragraph 49(4) and (5) of the ToiduS does not require 
that a food business operator has failed to comply with the requirements, but, 
rather, it requires only that there is reason to believe that a specific food may pose 
a risk. 
29 According to the VLA, that order is lawful because the applicant has failed to 
comply with food law. According to point 10 of Article 2 of Regulation 
No 882/2004, ‘non-compliance’ means non-compliance with feed or food law, 
and with the rules for the protection of animal health and welfare. According to 
Article 54(1) of Regulation No 882/2004, when the competent authority identifies 
non-compliance, it is to take action to ensure that the operator remedies the 
situation. When deciding which action to take, the competent authority is to take 
account of the nature of the non-compliance and that food business operator’s past 
record with regard to non-compliance. Therefore, the application of the measure 
depends on whether the food business operator has failed to comply with food law 
and not only, as the applicant claims, the food safety criteria applicable to the 
food. According to the VLA, food law also includes the requirements provided for 
in other food law provisions. 
30 The VLA states that point 1.2 of the table in Chapter 1 of Annex I to Regulation 
No 2073/2005 lays down two criteria for the presence of L.m. with regard to 
products manufactured by the food business operator and able to support the 
growth of L.m. With regard to the first criterion – the limit – the table explains that 
‘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 applicant did not demonstrate to the VLA by 
challenge/endurance tests that the products would not exceed the value of 100 
cfu/g throughout the shelf-life. In addition, submits the VLA, the report concerned 
states that the applicant carried out a total of 589 shelf-life tests for the period 
from January 2016 to April 2019, of which 55, or 9%, exceeded 100 cfu/g. 
31 According to Order No 3 of 27 March 2019, the applicant was required to check 
for the presence of L.m. in each product batch at the Harku fish plant, that is to 
say, to carry out batch-by-batch checks (‘zero tolerance’ requirement), and to do 
the same at the Vihterpalu fish plant from 23 October 2019. Notwithstanding the 
zero tolerance measure, the VLA had to recall from the market the applicant’s 
products in which L.m. had been found, and it was later found that the products 
contained strain ST1247. 
32 According to the VLA, it took new samples after the cleaning operation had been 
carried out in October 2019 at the Harku and Vihterpalu fish plants. L.m. was 
found in those samples, and L.m. strain ST1247 was found at the Vihterpalu fish 
plant at the beginning of October. The VLA submits that, during that sampling, 
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L.m. was detected in the products that had left the production areas at both the 
Harku and Vihterpalu fish plants. In that regard, the order of 25 November 2019 
states that, with respect to the L.m. found in the products of the Vihterpalu fish 
plant (herring fillets), the applicant breached either its obligation to take 
subsamples from each batch in accordance with the order of 5 November 2019 or 
its obligation to recall the entire non-compliant batch. According to Paragraph 22 
of the ToiduS, the food business operator is responsible for ensuring that food is 
handled and processed properly; it must use all means to ensure this and must not 
receive, use in processing or deliver food that does not comply with the 
requirements. 
33 The VLA states that, to date, the applicant has not identified the source of the 
infection, and that even after the cleaning operation carried out in the fish plants in 
October, L.m. – once again strain ST1247 – was found in rinse samples, as was 
demonstrated at the beginning of December. The VLA correctly assumed that it 
would not be possible for the L.m. strain ST1247 to be eliminated by a couple of 
days of cleaning carried out by the applicant. Strain ST1247 poses a significant 
risk to public health that cannot be definitively eliminated until the L.m. strain 
ST1247 has been eliminated. 
34 However, Article 14(8) of Regulation No 178/2002 provides that conformity of a 
food with specific provisions applicable to that food is not to bar the competent 
authorities from taking appropriate measures to impose restrictions on that food 
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. The 
VLA is therefore entitled to impose restrictions on the applicant’s products, as the 
L.m. strain ST1247 has repeatedly been found in the applicant’s fish plants in 
Vihterpalu and Harku, that is to say, in the products, and L.m. had also previously 
been found in the products of the Vihterpalu fish plant. 
35 The defendant takes the view that the analyses carried out by the VTL comply 
with the applicable requirements. Only one laboratory can analyse one and the 
same sample, with the result that it cannot be claimed that the results of the 
analyses differ. 
36 According to the defendant, the order is proportionate and the defendant also 
explained in the order why it is not possible to suspend the activity separately at 
specific stages. 
37 The defendant takes the view that the applicant failed to fulfil its obligation as a 
food business operator to ensure that the consumer receives safe food. L.m. had 
already been found in the applicant’s products in 2013, and it later emerged that 
the strain was ST1247, but the facts show that the applicant has not addressed the 
L.m. problem in a timely manner and has not paid sufficient attention to 
production hygiene in order to ensure that the consumer receives safe food. It is 
therefore reasonable to conclude that, as a result, the strain of bacteria in the 
applicant’s production environment became more contagious and resistant, 
AKTSIASELTS M.V.WOOL 
 
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subsequently causing an international outbreak of listeriosis. Between 2014 and 
2019, several cases of illness and death in Estonia and Europe were linked to 
strain ST1247, and samples taken at retail level showed that the applicant’s 
products proved to be a common denominator in the spread of the outbreak. 
38 The VLA disagrees with the applicant’s view that all L.m. strains are equally 
contagious. According to the VLA, L.m. is a dangerous bacterium and can cause 
listeriosis, which can be fatal for humans, so there is no such thing as a ‘safe’ 
strain. However, the VLA considers strain ST1247 to be more pathogenic, has 
provided relevant evidence and expert opinions, and draws attention to related 
cases of illness and death in Estonia and elsewhere in Europe. 
39 The VLA submits that point 1.2 of the table in Chapter 1 of Annex I to Regulation 
No 2073/2005 has established two criteria for the presence of L.m.: (i) 0/25 g and 
(ii) 100 cfu/g, the latter applying under the regulation where the food business 
operator is not able to demonstrate that its products will not exceed the limit of 
100 cfu/g throughout the shelf-life. The applicant has not provided evidence of 
this. If the 0/25 g criterion applies to the food business operator’s products (as it 
does to the applicant’s products in the present case), it applies irrespective of 
whether the product is located in the applicant’s plant or its retailer. This is also 
confirmed by the practice of other countries and, for example, by the Codex 
Alimentarius guidelines. Otherwise, the purpose of that criterion would be 
incomprehensible if the detection of L.m. before departure from the applicant’s 
warehouse were to constitute a reason for requiring the withdrawal of the goods 
from the market, whereas if L.m. has been detected in samples taken immediately 
after departure from the warehouse, the applicant would still be entitled to market 
the product. L.m. cannot come into being by itself in the applicant’s products after 
they have left the applicant’s warehouse, with the result that if L.m. were found in 
a sample taken at retail level, it must have been there before the product left the 
warehouse. 
Succinct presentation of the reasoning in the request for a preliminary ruling 
40 The key issue in the dispute between the parties is whether or not it is permissible 
to take samples in a store in order to determine the absence of L.m. in 25 g. The 
answer to this question also depends on the merits of the applicant’s complaint 
that the defendant prohibited the sale of fish products which had not been proven 
to be dangerous to the consumer. This is a question that has a direct impact on the 
lawfulness of the two contested orders. The parties are ultimately in dispute as to 
how the criterion of the stage of application in explanatory note 5 of the table in 
Chapter 1 of Annex I to Regulation No 2073/2005 is to be understood. 
41 According to the applicant, a clear distinction must be made between two different 
stages: (1) products placed on the market during their shelf-life, and (2), ‘Before 
the food has left the immediate control of the food business operator, who has 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-51/21 
 
12  
produced it’. The limit of ‘100 cfu/g’ applies to the first case, while ‘absence in 25 
g’ applies to the second case. 
42 The applicant’s position is supported by a systematic interpretation of the 
regulation. It is clear throughout that regulation that in cases where it is intended 
to set the limit of ‘Absence in 25 g’, this is expressly done. This also applies to 
ready-to-eat foods intended for infants or for special medical purposes, which are 
listed in the first column of the table in Chapter 1 of Annex I to Regulation 
No 2073/2005. It is clear from the judgment of the Court of Justice in Case 
C-443/13 that the linking of the criterion ‘Absence in 25 g’ to products placed on 
the market during their shelf-life was intentional. 
43 If the applicant’s interpretation is correct, the defendant applied an incorrect 
method (the VLA did not quantify the presence of L.m. in the samples taken in the 
store) and an incorrect limit (that is to say, absence of L.m. in 25 g, in 5 samples) 
in relation to the applicant, on the basis of which it concluded in the two contested 
administrative acts that the applicant had marketed a product dangerous to the 
health of consumers. In this respect, the applicant rightly takes the view that a 
food cannot be deemed to be unsafe without quantifying L.m. 
44 The defendant, on the other hand, takes the view that the criteria are not to be 
applied simultaneously, but that the conditions provided for in Regulation 
No 2073/2005 must be met in order for a specific criterion to apply. According to 
Note 5 to the table in Chapter 1 of Annex I to Regulation No 2073/2005, the 
application of the first criterion is subject to the following condition: ‘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 control report of 27 March 2019 also explains that 
a ‘zero tolerance’ limit applies to the applicant’s products (L.m. must be absent in 
25 g, in five subsamples, before the food has left the immediate control of the 
food business operator) until the applicant has been able to carry out proper 
endurance/challenge tests to show that the amount of L.m. in the products did not 
exceed 100 cfu/g at the end of the implementation period. The applicant has not 
demonstrated to the VLA that the products do not exceed the limit of 100 cfu/g 
throughout the shelf-life. 
45 The VLA’s position is supported by a teleological interpretation of the regulation. 
Article 3 of Regulation No 2073/2005 lays down the general requirements under 
which food business operators are to 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, are to 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: (1) that the supply, handling and 
processing of raw materials and foodstuffs under their control are carried out in 
such a way that the process hygiene criteria are met; (2) that the food safety 
criteria applicable throughout the shelf-life of the products can be met under 
AKTSIASELTS M.V.WOOL 
 
13 
reasonably foreseeable conditions of distribution, storage and use. As necessary, 
the food business operators responsible for the manufacture of the product are to 
conduct studies in accordance with Annex II in order to investigate compliance 
with the criteria throughout the shelf-life. In particular, this applies to ready-to-eat 
foods that are able to support the growth of Listeria monocytogenes and that may 
pose a Listeria monocytogenes risk for public health. 
46 It follows from the foregoing that the purpose of the regulation is to ensure food 
safety at all stages throughout its shelf-life, paying particular attention to the risk 
posed by L.m. The defendant’s interpretation is also supported by the fact that, 
with regard to the first criterion – the limit – the table explains that that 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 defendant’s interpretation is also consistent with the 
objective set out in the recitals in the preamble to Regulation No 178/2002, of 
ensuring a high level of protection of human life and health and ensuring that feed 
and food should be safe and wholesome. Taking into account Articles 5(1), 
Article 7(1) and Article 14(1) to (3) and (5) of Regulation No 178/2002, a high 
level of health protection can be ensured, in particular, by a risk management 
measure ensuring the high level of health protection provided for in the 
Community. This is better ensured by the defendant’s interpretation, which is 
supported, inter alia, by the provisions of recitals 1, 4 and 6 and Article 3(3) of 
Regulation No 882/2004, which refer specifically to the stage of placing on the 
market. 
47 As regards the view of the law taken by the defendant, the applicant failed to 
comply with the obligation incumbent on it to ensure the safety of its products 
because a food containing L.m. had entered the market. In other words, the 
requirement that L.m. must be absent in 25 g in 5 subsamples is not met. 
48 It follows from the foregoing that the provisions of the regulation at issue are open 
to different interpretations, which means that they cannot be regarded as clear 
(acte claire), and that there is no relevant case-law providing appropriate 
interpretative guidance (acte éclairé). Since this is a directly binding regulation of 
the European Union, the referring court is obliged in such a situation to seek a 
preliminary ruling from the Court of Justice. In so doing, the referring court takes 
note of the defendant’s submissions that the relevant provisions of Regulation 
No 2073/2005 should be amended at European Union level and that the new 
wording would make it clearer that the interpretation proposed by the defendant is 
correct. This strengthens the referring court’s conviction that a request for a 
preliminary ruling is necessary.