Contents
Judgment of the Court (Seventh Chamber)19 October 2023note(Reference for a preliminary ruling — Hygiene of foodstuffs — Reduction of salmonella in breeding flocks of Gallus gallus — Regulation (EU) No 200/2010 — Annex — Point 2.2.2.2(c) — Routine sampling — Positive result — Confirmatory sampling — Exceptional cases — Doubt as to the results — Scope)In Case C‑591/22,REQUEST for a preliminary ruling under Article 267 TFEU from the College van Beroep voor het bedrijfsleven (Supreme Administrative Court for Trade and Industry, Netherlands), made by decision of 6 September 2022, received at the Court on 12 September 2022, in the proceedingsL. VOFvMinister van Landbouw, Natuur en Voedselkwaliteit,THE COURT (Seventh Chamber),composed of F. Biltgen, President of the Chamber, J. Passer and M.L. Arastey Sahún (Rapporteur), Judges,Advocate General: L. Medina,Registrar: A. Calot Escobar,having regard to the written procedure,after considering the observations submitted on behalf of:– the Netherlands Government, by M.K. Bulterman and J.M. Hoogveld, acting as Agents,– the Danish Government, by J. Kronborg, C. Maertens and Y. Thyregod Kollberg, acting as Agents,– the Finnish Government, by A. Laine and M. Pere, acting as Agents,– the European Commission, by B. Eggers, M. ter Haar and M. Zerwes, acting as Agents,having decided, after hearing the Advocate General, to proceed to judgment without an Opinion,gives the following
Judgment
1This request for a preliminary ruling concerns the interpretation of point 2.2.2.2(c) of the annex to Commission Regulation (EU) No 200/2010 of 10 March 2010 implementing Regulation (EC) No 2160/2003 of the European Parliament and of the Council as regards a Union target for the reduction of the prevalence of Salmonella serotypes in adult breeding flocks of Gallus gallus (OJ 2010 L 61, p. 1), as amended by Commission Regulation (EU) 2019/268 of 15 February 2019 (OJ 2019 L 46, p. 11) (‘Regulation No 200/2010’).
2The request has been made in proceedings between L. VOF (‘L.’) and the Minister van Landbouw, Natuur en Voedselkwaliteit (Minister for Agriculture, Nature and Food Quality, Netherlands) (‘the Minister’) concerning the measures to control salmonella adopted by the Minister in respect of the breeding flock of Gallus gallus operated by L.
Legal context
European Union law
Regulation No 2160/2003
3Recital 28 of Regulation (EC) No 2160/2003 of the European Parliament and of the Council of 17 November 2003 on the control of salmonella and other specified food-borne zoonotic agents (OJ 2003 L 325, p. 1), as amended by Commission Regulation (EC) No 213/2009 of 18 March 2009 (OJ 2009 L 73, p. 5) (‘Regulation No 2160/2003’), states:‘As regards control of salmonella, available information tends to show that poultry products are a major source of human salmonellosis. Control measures should, therefore, be applied to production of those products … As regards the production of table eggs, it is important to establish specific measures concerning the placing on the market of products originating from flocks that have not been tested free of relevant salmonella. As regards poultry meat, the aim is to place on the market poultry meat with reasonable assurance that it is free from relevant salmonella. …’
4According to Article 1(1) of that regulation:‘The purpose of this Regulation is to ensure that proper and effective measures are taken to detect and to control salmonella and other zoonotic agents at all relevant stages of production, processing and distribution, particularly at the level of primary production, including in feed, in order to reduce their prevalence and the risk they pose to public health.’
5Article 4(1) of that regulation states:‘Community targets shall be established for the reduction of the prevalence of zoonoses and zoonotic agents listed in Annex I, column 1, in the animal populations listed in Annex I, column 2 …’
6Article 5 of that regulation, entitled ‘National control programmes’, provides, in paragraph 1:‘To achieve the Community targets provided for in Article 4, Member States shall establish national control programmes for each zoonosis and zoonotic agent listed in Annex I. National control programmes shall have regard to the geographical distribution of zoonoses within each Member State and to the financial implications for primary producers and feed and food business operators of establishing effective controls.’
7Annex II to Regulation No 2160/2003 defines the regime for the control of zoonoses and zoonotic agents listed in Annex I to that regulation.
8Under the heading ‘Specific requirements concerning breeding flocks of Gallus gallus and breeding turkeys’, Part C of Annex II contains, inter alia, the following provisions:‘1. The measures laid down in points 3 to 5 must be taken whenever the analysis of samples taken in accordance with part B, or in accordance with the testing schemes set out in the Annexes to [Commission Regulation (EC) No 1003/2005 of 30 June 2005 implementing Regulation (EC) No 2160/2003 as regards a Community target for the reduction of the prevalence of certain salmonella serotypes in breeding flocks of Gallus gallus and amending Regulation (EC) No 2160/2003 (OJ 2005 L 170, p. 12), and to Commission Regulation (EC) No 584/2008 of 20 June 2008 implementing Regulation (EC) No 2160/2003 of the European Parliament and of the Council as regards a Community target for the reduction of the prevalence of Salmonella enteritidis and Salmonella typhimurium in turkeys (OJ 2008 L 162, p. 3)] indicates the presence of Salmonella enteritidis or Salmonella typhimurium in a breeding flock of Gallus gallus or breeding turkeys in in the circumstances set out in point 2.…3. Non-incubated eggs from the flock must be destroyed.…4. All birds, including day-old chicks, in the flock must be slaughtered or destroyed so as to reduce as much as possible the risk of spreading salmonella. …5. Where eggs for hatching from flocks in which Salmonella enteritidis or Salmonella typhimurium is present are still present in a hatchery, they must be destroyed or treated in accordance with Regulation (EC) No 1774/2002 [of the European Parliament and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption (OJ 2002 L 273, p. 1)].…’
Regulation No 200/2010
9Recitals 1 and 3 of Regulation No 200/2010 state:(1) The purpose of [Regulation No 2160/2003] is to ensure that measures are taken to detect and control salmonella and other zoonotic agents at all relevant stages of production, processing and distribution, particularly at the level of primary production, in order to reduce their prevalence and the risk they pose to public health.…(3) Annex I to [Regulation No 2160/2003] refers to all salmonella serotypes with public health significance in breeding flocks of Gallus gallus. Those breeding flocks may spread salmonella infection to their progeny, in particular to flocks of laying hens and broilers. Therefore, a reduction in the prevalence of salmonella in breeding flocks contributes to the control of that zoonotic agent in eggs and meat derived from the progeny, which is an important public health risk.’
10Article 1 of that regulation, entitled ‘Union target’, is worded as follows:1. From 1 January 2010, the [European] Union target, as referred to in Article 4(1) of [Regulation No 2160/2003], for the reduction of Salmonella spp. in breeding flocks of Gallus gallus (“the Union target”) shall be a reduction to 1% or less of the maximum percentage of adult breeding flocks of Gallus gallus remaining positive for Salmonella enteritidis … (the relevant salmonella serotypes).…2. The testing scheme which is necessary to ascertain progress in the achievement of the Union target is set out in the Annex.’
11Point 2.1 of the annex to Regulation No 200/2010 provides:‘Breeding flocks shall be sampled at the initiative of the food business operator and as part of official controls.’
12Point 2.2.2.1 of that annex sets out the sampling protocol applicable to routine sampling in the holding carried out at the initiative of the food business operator.
13Point 2.2.2.2 of that annex, which lays down the sampling protocol applicable to sampling as part of official controls, provides:(a) Routine sampling shall be performed as described in point 2.2.2.1.(b) Confirmatory sampling following the detection of the relevant Salmonella serotypes from sampling at the hatchery shall be performed as described in point 2.2.2.1.…(c) Suspicion of false resultsIn exceptional cases where the competent authority has reason to question the results of the testing (such as false positive or false negative results), it may decide to repeat the testing in accordance with point (b).’
14Point 4 of that annex, entitled ‘Results and reporting’, is worded as follows:‘A breeding flock shall be considered positive for the purpose of ascertaining the achievement of the Union target:– when the presence of the relevant Salmonella serotypes (other than vaccine strains) has been detected in one or more samples taken in the flock, even if the relevant Salmonella serotypes is only detected in the dust sample, or– when the confirmatory sampling as part of official controls in accordance with point 2.2.2.2(b) does not confirm the detection of relevant Salmonella serotypes but antimicrobials or bacterial growth inhibitors have been detected in the flock.This rule shall not apply in exceptional cases described in point 2.2.2.2(c) where the initial Salmonella positive result from sampling at the initiative of the food business operator has not been confirmed by the sampling as part of official controls.…’
Netherlands law
15The Minister implemented the obligation laid down in Article 5(1) of Regulation No 2160/2003 by drawing up the ‘Nationale Salmonella Controle en Bestrijdingsplan’ (National plan for the control and combating of salmonella). The implementation of that plan was developed in the ‘Draaiboek afhandelen verdenking en besmetting Zoönotische Salmonella pluimvee’ (Roadmap to deal with cases of suspicion or infection as regards zoonotic salmonella in poultry) (‘the roadmap’) which, following the position adopted by the European Commission on the standard application test provided for in that roadmap, was revised in January 2020.
16The revised version of the roadmap includes, inter alia, the following provisions:‘… A diagnosis for farmed breeding flocks shall be made where the accredited laboratory isolates, in a control sample, one of the specified salmonella serotypes or where examination of five hens reveals the presence of antibiotic residues.For farmed breeding flocks, confirmatory tests are not therefore carried out systematically; the flock concerned shall be declared infected on the basis of the control samples taken by the breeder or veterinary surgeon.Confirmatory tests can be carried out only where the positive control sample result is considered to be unreliable. The flock and its hatching eggs in the holding itself and in the hatchery are then, during the time required for the tests, blocked for the purpose of removal …’
The dispute in the main proceedings and the questions referred for a preliminary ruling
17L. is the operator of a poultry breeding farm for the Gallus gallus species in the Netherlands, with a flock of approximately 27000 hens. On 10 February 2020, L., in the course of routine sampling, took samples from the five houses where that flock was located. On 17 February 2020, an accredited laboratory detected the presence of salmonella in the samples of the left boot swabs of three of those houses.
18Following the positive test results, by a decision of 18 February 2020 (‘the initial decision’), the Minister declared those three houses to be infected with salmonella from that date and imposed control measures on the holding. In particular, under those measures, from that date, it was prohibited to remove poultry, eggs and poultry droppings from the infected houses and to take poultry and eggs into those houses. In addition, the poultry and eggs present in those houses had to be removed or even destroyed in a manner stipulated by the Nederlandse Voedsel- en Warenautoriteit (Food and Consumer Product Safety Authority, Netherlands). Those measures were implemented on 28 February 2020.
19In accordance with the revised version of the roadmap, the initial decision was adopted without a confirmatory test being carried out beforehand, since the Minister considered that there was no reasonable doubt as to the accuracy of the positive result of the routine sampling carried out on 10 February 2020.
20In that regard, the Minister stated before the College van Beroep voor het bedrijfsleven (Supreme Administrative Court for Trade and Industry, Netherlands), which is the referring court, that, until January 2020, in the event of a positive result, the authority responsible for monitoring food and consumer product safety always carried out a confirmatory test on the basis of which the flock was or was not declared infected. However, by letter of 13 January 2020, the Commission stated that that standard confirmatory test was contrary to EU law and that it would therefore be obliged to cease the European co-financing of the Netherlands plan to combat salmonella. By letter of 24 January 2020, the Kingdom of the Netherlands informed the Commission that it accepted the latter’s position and that it had therefore adapted its control policy. Thus, in accordance with point 2.2.2.2(c) of the annex to Regulation No 200/2010, the revised version of the roadmap does not provide for any standard confirmatory test, and the latter can be carried out only where the positive result of the control sample is considered to be unreliable.
21Following the Minister’s rejection of the objection lodged by L. against the initial decision, L. brought an action before the referring court against the decision on that objection.
22In that action, L. claims that, in the present case, there were reasons which enabled the competent authority to call into question the positive results of the routine sampling carried out on 10 February 2020 and, therefore, to carry out a confirmatory test before adopting the initial decision. In support of that argument, L. relies, in particular, on the following circumstances. First, the laboratory responsible for analysing the samples taken during that routine sampling found a positive result for only one of the two samples, namely that of the left boot swab of the three relevant houses. Second, the result of several subsequent tests carried out by L. on samples taken on 18 February 2020 was negative. Third, the flock concerned was young and completely vaccinated against salmonella, and L.’s holding had, moreover, particularly satisfactory biosecurity. Fourth, infection with salmonella in only three of the five houses was highly unlikely. Fifth, samples were taken every two weeks in the holding concerned and no other positive result was obtained either before or after that routine sampling.
23The Minister considers that point 2.2.2.2(c) of the annex to Regulation No 200/2010 must be interpreted strictly. Once a positive result for salmonella has been established, a confirmatory test should be carried out only in exceptional cases, which the present case is not.
24The referring court considers that the restrictive interpretation of point 2.2.2.2(c) of the annex to Regulation No 200/2010 advocated by the Minister seems to deprive that provision of any purpose where routine sampling leads to a positive result. Such an interpretation does not appear to allow any possibility of carrying out a confirmatory test in such a case, since, according to the Minister, such a test cannot undermine that positive result. The possibility of carrying out a confirmatory test thus appears to be reduced to the situation in which the Minister suspects that a routine sampling result is a false negative. Furthermore, the referring court states that it does not clearly understand how that interpretation relates to the second paragraph of point 4 of the annex to Regulation No 200/2010.
25In those circumstances, the College van Beroep voor het bedrijfsleven (Supreme Administrative Court for Trade and Industry) decided to stay the proceedings and to refer the following questions to the Court of Justice for a preliminary ruling:(1) What constitutes an exceptional case within the meaning of point 2.2.2.2(c) of the Annex to [Regulation No 200/2010], where the competent authority has reason to question the correctness of a positive test result for salmonella obtained from a routine sampling [carried out] at the initiative of the food business operator, so that the competent authority may decide to repeat the testing?(2) Are the following factors relevant in determining whether an exceptional case exists within the meaning of point 2.2.2.2(c) of the Annex to Regulation [No 200/2010]:(a) (multiple) negative test results for the relevant Salmonella type obtained from subsequent samples taken at the initiative of the food business operator;(b) the fact that only one of the two samples per house yielded a positive result for salmonella;(c) the vaccination status of the (sampled) flock for the relevant Salmonella type in relation to the age of the flock;(d) the number of houses with a positive result for salmonella in relation to the sampling frequency applicable to the relevant Salmonella type;(e) the history of the holding in terms of the prevalence of the Salmonella (zoonotic) type detected?(3) If the answer to question 2(a) is in the affirmative, how much time may be granted to a food business operator to carry out subsequent samplings (or to have them carried out) and submit the results of the investigation, before the competent authority proceeds to implement irreversible follow-up measures following the declaration of contamination?’
Consideration of the questions referred
The first two questions
26By its first two questions, which it is appropriate to examine together, the referring court asks the Court of Justice to interpret point 2.2.2.2(c) of the annex to Regulation No 200/2010. In particular, the referring court seeks, in essence, to ascertain in what circumstances the situation of a holding of breeding flocks of Gallus gallus which has been tested using routine sampling, the results of which have revealed the presence of salmonella, may be regarded as falling within the concept of ‘exceptional cases where the competent authority has reason to question the results of the testing’, within the meaning of that provision, and whether, in that regard, the existence of several negative results for the type of salmonella detected, obtained from samples taken subsequently at the initiative of the operator concerned, the fact that only some of the houses presented positive results and that only one of the two samples taken per house was positive, the vaccination status of the flock and the history of the holding as regards prevalence of the type of salmonella detected constitute relevant circumstances.
27As a preliminary point, it should be noted that, in order to protect public health against diseases and infections caused by salmonella, the EU legislature considered it essential to take proper and effective measures to detect and control salmonella at all relevant stages of the production, processing and distribution of products of animal origin, particularly at the level of primary production, in order to reduce their prevalence in the relevant animal populations and the risk they pose to human health. It is in that context that Regulation No 2160/2003, which is aimed, as is apparent from Article 1 thereof, at ensuring that such measures are taken, was adopted.
28In that regard, as is reflected in recital 28 of Regulation No 2160/2003 and recital 3 of Regulation No 200/2010, the finding that poultry products are a major source of human salmonellosis led the EU legislature to promote the reduction of the prevalence of salmonella in breeding flocks of Gallus gallus, which may spread salmonella infection to their progeny, in particular to flocks of laying hens and broilers, such a reduction being particularly significant in order to ensure that eggs and meat derived from that progeny are placed on the market with a reasonable assurance that they are free from salmonella.
29In order to reduce such prevalence, Article 1(1) of Regulation No 200/2010 defined as an EU target, within the meaning of Article 4(1) of Regulation No 2160/2003, a maximum percentage of breeding flocks of Gallus gallus remaining positive for the salmonella serotypes referred to in Article 1(1) (‘the salmonella serotypes referred to’), which must be reduced to 1% or less. In addition, the annex to Regulation No 200/2010 established the testing programme necessary to ensure the attainment of that target.
30In that regard, point 2.1 of that annex provides for the monitoring of such flocks by means of regular sampling with a view to carrying out research tests for the salmonella serotypes referred to, carried out at the initiative of the food business operator and as part of official controls.
31As regards, in particular, samples taken as part of official controls, point 2.2.2.2(c) of the annex to Regulation No 200/2010, the interpretation of which is requested by the referring court, provides, in certain circumstances and under certain conditions, for confirmatory sampling to be carried out where false results are suspected.
32In particular, according to that provision, ‘in exceptional cases where the competent authority has reason to question the results of the testing (such as false positive or false negative results), it may decide to repeat the testing in accordance with point (b)’.
33Thus, the confirmatory sampling carried out on the basis of point 2.2.2.2(c) of the annex to Regulation No 200/2010, following the competent authority’s decision to repeat the tests, must, in accordance with point 2.2.2.2(b) of that annex, be carried out in the manner set out in point 2.2.2.1 of that annex, which refers to the sampling protocol applicable to routine sampling carried out in the holding at the initiative of the food business operator.
34Those preliminary observations having been made, it is necessary, in order to answer the questions raised by the referring court, first, to define the concept of ‘exceptional cases where the competent authority has reason to question the results of the testing’, within the meaning of point 2.2.2.2(c) of the annex to Regulation No 200/2010, and, second, to ascertain whether the circumstances stated by the referring court in its second question, as set out in paragraph 26 of the present judgment, are relevant in order to determine whether the situation of a holding of a breeding flock of Gallus gallus which has been tested using routine sampling, the results of which have revealed the presence of salmonella, may be regarded as falling within that concept.
The concept of exceptional cases where the competent authority has reason to question the results of the testing, within the meaning of point 2.2.2.2(c) of the annex to Regulation No 200/2010
35It is clear from the wording of point 2.2.2.2(c) of the annex to Regulation No 200/2010 and, in particular, the use of the verb ‘may’ and the adjective ‘exceptional’, that, while leaving to the competent authority a margin of discretion as regards the need to repeat the tests, that regulation limited that discretion by establishing the existence of certain cases identified as ‘exceptional’, with the result that that provision must be interpreted strictly (see, by analogy, judgment of 16 February 2023, Lufthansa Technik AERO Alzey, C‑393/21, EU:C:2023:104, paragraph 34 and the case-law cited).
36It is also apparent from the wording of that provision that Regulation No 200/2010 limited the exceptional cases in which the competent authority may decide to repeat the tests solely to situations in which that authority has reason to cast doubt on the results of the tests, that is to say, to suspect that those results do not reflect the reality and, therefore, are inaccurate. The heading of that provision, namely ‘Suspicion of false results’, supports that assessment.
37It follows that, first, it is for the competent authority to assess whether, in a given case, there are factors capable of casting doubt on the results of the tests. Such an assessment must therefore be made on a case-by-case basis, having regard to the particular circumstances of each case.
38Second, since the accuracy of the test results depends on the processes of sampling and analysis of the samples being carried out correctly, the wording of point 2.2.2.2(c) of the annex to Regulation No 200/2010 makes it possible to limit the concept of ‘exceptional cases where the competent authority has reason to question the results of the testing’, set out in that provision, solely to situations relating to the occurrence, when the samples are taken, packaged, transported to the laboratory, received, stored, prepared, processed and analysed by that laboratory or when the results are reported, of events or incidents which compromised the performance of the sampling and analysis processes in accordance with the protocols governing those processes and, in particular, in accordance with the rules aimed at ensuring, at each of the stages of those processes, the integrity, safety and identity of the samples.
39Thus, the concept of ‘exceptional cases where the competent authority has reason to question the results of the testing’, within the meaning of point 2.2.2.2(c) of the annex to Regulation No 200/2010, must be understood as covering situations in which that authority finds that events or incidents have occurred which compromise the proper performance of the processes of sampling and analysis of the samples or considers, in the light of the particular circumstances of the case, that there is a serious risk that such events or incidents may have occurred.
40In that regard, in view of the strict interpretation that must be given to point 2.2.2.2(c) of the annex to Regulation No 200/2010, it must be held that the circumstances which may lead the competent authority to suspect that the positive test results are inaccurate and, consequently, that, during the processes of sampling and analysis of the samples, events or incidents occurred which compromised the proper performance of those processes are linked to a level of excellence in all the conditions of the holding concerned, which, having regard in particular to the epidemiological characteristics of salmonella, shows that that holding’s situation is incompatible or very difficult to reconcile with those results, so that the occurrence of those events or incidents is highly likely.
41Those conditions include, inter alia, the history of the holding as regards compliance with the salmonella monitoring programme and the results of the checks carried out in that context, compliance with national requirements relating to the keeping and breeding of poultry in the context of combating salmonella and biosecurity measures, in connection with both the operation and physical protection of the holding and the persons involved within it, implemented in the holding in order to prevent the occurrence, development and risk of spread of salmonella, such as, in particular, measures concerning the entrance to and perimeter of the holding, cleaning and disinfection of the houses, monitoring the quality of water and poultry feed, monitoring access to the holding, training staff in the management of the biosafety plan and good hygiene practices, disinfection and change of clothes and material from one breeding to another, containment of animals, restriction on the movement of poultry between different houses and protection against vermin, such as rodents, and wild animals.
42Accordingly, the situation of a holding of breeding flocks of Gallus gallus which has been tested using routine sampling, the results of which have revealed the presence of salmonella, may be regarded as falling within the concept of ‘exceptional cases where the competent authority has reason to question the results of the testing’, within the meaning of point 2.2.2.2(c) of the annex to Regulation No 200/2010, where the competent authority finds that events or incidents have occurred which compromised the proper performance of the processes of sampling and analysis of the samples or where such an authority considers that, in the light of the level of excellence achieved by all the conditions of the holding and in view of the epidemiological characteristics of salmonella, there is a serious risk that such events or incidents may have occurred.
43That restrictive interpretation is consistent with the objective pursued by both Regulation No 200/2010 and Regulation No 2160/2003, namely the protection of public health, since it enables the rapid adoption of the control measures necessary to prevent the spread of salmonella and its transmission to humans, in accordance, in particular, with Part C of Annex II to Regulation No 2160/2003, and thus to protect public health effectively, without having to wait, save in exceptional cases, for those results to be confirmed by the carrying out of new tests.
44It should be added that there is no difficulty in relating that interpretation to the second paragraph of point 4 of the annex to Regulation No 200/2010. That provision must be interpreted as meaning that where, first, the results of the analysis of the samples taken in the context of routine sampling carried out at the initiative of the operator of a breeding flock of Gallus gallus have revealed the presence of salmonella in one or more of the samples taken and where, second, the competent authority, taking the view, in the light of the level of excellence achieved by all the conditions of the holding concerned and in view of the epidemiological characteristics of salmonella, that there is a serious risk that events or incidents compromising the proper performance of the processes of sampling and analysis of the samples may have occurred during those processes, or establishing that such events or incidents have occurred, decides to repeat the tests, the flock concerned can be considered to be positive for the purposes of verifying that the EU target has been achieved only where the result of the analysis of the confirmatory sampling carried out on the basis of point 2.2.2.2(c) of the annex to Regulation No 200/2010 following that decision is also positive for salmonella.
The relevance of the circumstances stated by the referring court for the purposes of the assessment of the existence of an exceptional case within the meaning of point 2.2.2.2(c) of the annex to Regulation No 200/2010
45In order to ascertain whether the circumstances set out in paragraph 26 of the present judgment are relevant in order to determine whether the situation of a holding of a breeding flock of Gallus gallus which has been tested using routine sampling, the results of which have revealed the presence of salmonella, may be regarded as falling within the concept of ‘exceptional cases where the competent authority has reason to question the results of the testing’, within the meaning of point 2.2.2.2(c) of the annex to Regulation No 200/2010, it is necessary to take account of the interpretation criteria set out in paragraphs 39 to 41 of the present judgment.
46In the first place, as regards the existence of several negative results, for the type of salmonella detected during routine sampling, obtained from subsequent samples taken at the initiative of the operator concerned after the routine sampling which led to a positive result, it should be noted that, as follows from paragraphs 35 and 36 of the present judgment, point 2.2.2.2(c) of the annex to Regulation No 200/2010 specifically limited, for the purposes of the protection of public health, the possibility for the competent authority to conduct a new test to confirm or invalidate the results of a test carried out in the context of the monitoring programme established by that annex to exceptional cases. Thus, in the context of such a programme, the carrying out of a single test is regarded as the principle and a repetition of the test as the exception.
47In those circumstances, an interpretation of point 2.2.2.2(c) of the annex to Regulation No 200/2010 to the effect that the results obtained from the carrying out of a new test after the competent authority has adopted a decision are relevant factors in order to derogate from such a principle would run counter to the logic underlying that provision.
48That is demonstrated by the circumstances of the case at issue in the main proceedings, in which, as follows from paragraphs 17, 18 and 22 of the present judgment, the Minister’s decision to impose measures on the holding, following the positive results of the analysis of the samples taken as part of the routine sampling carried out on 10 February 2020, was adopted on 18 February 2020, that is, only one day after those results were obtained. The samples taken by the operator concerned in order to carry out another test took place on the same day, that is, 18 February 2020. In view of the chronology of the facts, as set out in the request for a preliminary ruling, it is likely that the results of the analysis of the latter samples were not obtained before 25 February 2020.
49Thus, an interpretation of point 2.2.2.2(c) of the annex to Regulation No 200/2010 to the effect that the existence of several negative results in the subsequent sampling operations carried out after the routine sampling which led to a positive result, with those negative results being sent to the competent authority after the latter has adopted a decision, constitutes a relevant circumstance in order to classify the situation of a food business operator concerned as an ‘exceptional case’, within the meaning of that provision, not only would encourage the systematic carrying out of a new test in order to confirm that result, but would also delay the competent authority’s adoption of measures to control the infection and the spread of that infection at least until the results of the new test are obtained, with the risk that would entail for public health.
50By contrast, negative results in the subsequent sampling operations carried out after the routine sampling which led to a positive result, those negative results being sent to the competent authority before the latter has adopted a decision, may constitute a relevant circumstance in order to classify the situation of a food business operator concerned as an ‘exceptional case’ within the meaning of that provision.
51In the second place, in view of the fact that the first paragraph of point 4 of the annex to Regulation No 200/2010 expressly provided that a breeding flock is considered positive for salmonella when the presence of the serotypes referred to is detected in one or more samples, it must be held that the fact that only one of the two samples taken in the context of routine sampling has been found to be positive for salmonella does not support the conclusion that there is a serious risk that events or incidents compromising the proper performance of the processes of sampling and analysis of the samples occurred during those processes, for the purposes of the application of point 2.2.2.2(c) of the annex to Regulation No 200/2010.
52For the same reasons, the fact that certain houses present a positive result and others a negative result is not a relevant factor for the purposes of such a consideration, especially since it is possible that external sources of infection, such as rats or certain wild birds, are present only in certain houses, depending on the latter’s conditions.
53As regards, in the third place, the vaccination status of the flock concerned and the history of the holding as regards the prevalence of salmonella, it must be held that those elements are relevant in order to assess whether the holding’s situation falls within the concept of ‘exceptional cases’ within the meaning of point 2.2.2.2(c) of the annex to Regulation No 200/2010, in that, in the light of the interpretation criteria set out in paragraphs 39 to 41 of the present judgment, the fact that the flocks concerned are vaccinated against salmonella and that the period of the vaccines’ effectiveness has not expired, and the fact that the holding has an excellent history as regards the prevalence of salmonella, are minimum conditions for such a holding to be capable of falling within that concept.
54That said, since neither of those elements ensures the absence of infection with salmonella, those elements, even taken together, do not, alone, make it possible to characterise the situation of the holding concerned as being incompatible or very difficult to reconcile with positive results, as referred to in paragraph 40 of the present judgment.
55In the light of the foregoing considerations, the answer to the first two questions is that point 2.2.2.2(c) of the annex to Regulation No 200/2010 must be interpreted as meaning that the situation of a holding of breeding flocks of Gallus gallus which has been tested by way of routine sampling, the results of which have revealed the presence of salmonella, may be regarded as falling within the concept of ‘exceptional cases where the competent authority has reason to question the results of the testing’, within the meaning of that provision, where the competent authority finds that events or incidents compromising the proper performance of the processes of sampling and analysis of the samples have occurred, or considers, in view of the level of excellence achieved by all of the conditions of the holding and in view of the epidemiological characteristics of salmonella, that there is a serious risk that such events or incidents have occurred.
56The existence of several negative results for the type of salmonella detected, obtained from samples taken subsequently at the initiative of the operator concerned and reported to the competent authority after the latter has adopted a decision, and the fact that only some of the houses have produced positive results and that only one of the two samples taken per house has proved to be positive, do not constitute relevant circumstances in order to classify such a situation as falling within that concept. The vaccination status of the flock and the history of the holding as regards prevalence of the type of salmonella detected, where they are excellent, constitute circumstances to be taken into consideration for that purpose, but do not alone enable that situation to be classified as falling within that concept.
The third question
57In view of the answer given to the first two questions, there is no need to answer the third question.
Costs
58Since 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.
Operative part
On those grounds, the Court (Seventh Chamber) hereby rules: Point 2.2.2.2(c) of the annex to Commission Regulation (EU) No 200/2010 of 10 March 2010 implementing Regulation (EC) No 2160/2003 of the European Parliament and of the Council as regards a Union target for the reduction of the prevalence of Salmonella serotypes in adult breeding flocks of Gallus gallus, as amended by Commission Regulation (EU) 2019/268 of 15 February 2019,must be interpreted as meaning that the situation of a holding of breeding flocks of Gallus gallus which has been tested by way of routine sampling, the results of which have revealed the presence of salmonella, may be regarded as falling within the concept of ‘exceptional cases where the competent authority has reason to question the results of the testing’, within the meaning of that provision, where the competent authority finds that events or incidents compromising the proper performance of the processes of sampling and analysis of the samples have occurred, or considers, in view of the level of excellence achieved by all of the conditions of the holding and in view of the epidemiological characteristics of salmonella, that there is a serious risk that such events or incidents have occurred.The existence of several negative results for the type of salmonella detected, obtained from samples taken subsequently at the initiative of the operator concerned and reported to the competent authority after the latter has adopted a decision, and the fact that only some of the houses have produced positive results and that only one of the two samples taken per house has proved to be positive, do not constitute relevant circumstances in order to classify such a situation as falling within that concept. The vaccination status of the flock and the history of the holding as regards prevalence of the type of salmonella detected, where they are excellent, constitute circumstances to be taken into consideration for that purpose, but do not alone enable that situation to be classified as falling within that concept.
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