dg(sante) 2021-7320 final report of an audit carried …

In response to information provided by the competent authority, any factual error noted in the draft report has been corrected; any clarification appears in the form of a footnote.

EUROPEAN COMMISSIONDIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

Health and food audits and analysis

DG(SANTE) 2021-7320

FINAL REPORT OF AN AUDIT

CARRIED OUT IN

THE NETHERLANDS

FROM 15 MARCH 2021 TO 25 MARCH 2021

IN ORDER TO

EVALUATE THE SALMONELLA NATIONAL CONTROL PROGRAMMES IN PARTICULAR POULTRY POPULATIONS

Ref. Ares(2021)5106008 - 13/08/2021

I

Executive Summary

This report describes the outcome of an audit of the Netherlands from 15 to 25 March 2021 as part of the published Directorate-General for Health and Food Safety work programme. This audit was carried out by remote means and did not involve on-site assessments.

The objective of the audit was to evaluate the actions taken by the Dutch competent authority in order to control Salmonella, in particular the implementation of the Salmonella national control programmes in the four relevant poultry populations (breeding flocks of Gallus gallus, laying hens, turkeys and broiler flocks).

Subsequent to the latest audit (DG(SANCO) 2013-6696) the Dutch competent authorities have made changes to the Salmonella national control programmes, and to the related instructions and official checks. These have effectively addressed the shortcomings identified at the time, even if with significant delay for two recommendations concerning systematic confirmatory sampling.

The Salmonella national control programmes are currently in line with EU requirements, are generally well implemented by the operators, the delegated control bodies and under adequate official supervision. The implementation of the programmes is supported by a network of accredited official laboratories. The competent authorities correctly monitor and continuously review the progress of the programmes.

The implementation of the Salmonella national control programmes has achieved a low Salmonella prevalence, in compliance with Union targets, for all relevant poultry populations.

Measures imposed after positive cases to targeted Salmonella serovars at the affected holdings were in line with EU requirements. All necessary documented evidence was available to confirm the restrictions imposed and the channelling of affected animals and poultry products. Nevertheless, measures taken on eggs after positive results are adopted with unnecessary delays and did not fully cover the required production period.

The report contains recommendations to the competent authorities to address the shortcomings identified.

II

Table of Contents

1 Introduction ....................................................................................................................................1

2 Objectives and scope......................................................................................................................1

3 Legal Basis .....................................................................................................................................2

4 Background ....................................................................................................................................3

5 Findings and Conclusions ..............................................................................................................4

5.1 Preventive measures ................................................................................................................4

5.2 Monitoring and sampling scheme ...........................................................................................7

5.2.1 General points in relation to SNCPs................................................................................7

5.2.2 Laboratories .....................................................................................................................8

5.2.3 SNCP for breeding flocks of Gallus gallus ....................................................................11

5.2.4 SNCP for laying hens .....................................................................................................11

5.2.5 SNCP for broilers...........................................................................................................12

5.2.6 SNCP for turkeys............................................................................................................13

5.3 Measures taken at time of suspicion and confirmation of Salmonella ..................................14

5.4 Official controls, verification and audits ...............................................................................17

5.5 Assessment of the progress and reviewing of the SNCPs.....................................................20

5.6 Investigation of food-borne outbreaks (salmonellosis) and coordination .............................21

6 Overall Conclusions .....................................................................................................................24

7 Closing Meeting ...........................................................................................................................25

8 Recommendations ........................................................................................................................26

III

ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT

Abbreviation Explanation

COKZ The Netherlands Controlling Authority for Dairy and Eggs (Controle Orgaan Kwaliteits Zaken)

DG Health and Food SafetyDirectorate-General for Health and Food Safety of the EuropeanCommission

EU European Union

MSRV Modified Semi-Solid Rappaport-Vassiliadis

NVWA Dutch Food and Consumer Product Safety Authority (Nederlandse Voedsel en Waren Autoriteit

NRL National Reference Laboratory

PCR Polymerase chain reaction

SNCP Salmonella National Control Programme

1

1 INTRODUCTION

This audit took place from 15 to 25 March 2021 and was undertaken as part of the Directorate-General (DG) for Health and Food Safety’s planned work programme.

It was carried out by remote means via correspondence exchanges with the competent authority, prior to and during the audit dates, and supplemented, throughout the audit period, with remote meetings/video-conferencing with the competent authority and other relevant parties. It did not involve on-site assessments and therefore the results of the audit are limited by the fact that certain aspects (such as observation of performance of official controls, sample collection and handling, farm biosecurity) could not be seen in practice.

All the authorities, and other parties involved in the audit, provided excellent collaboration prior to and during the audit. This mitigated many of the difficulties and handicaps of a fully remote audit, helped ensure the validity of the audit findings and was a major contribution to the possible added value from the audit.

The audit team comprised two auditors from DG Health and Food Safety and an observer from the EFTA Surveillance Authority. Representatives from the competent authority the Dutch Food and Consumer Product Safety Authority (NVWA, Nederlandse Voedsel en Waren Autoriteit) participated in all meetings throughout the audit.

On 15 March 2021, the audit team held an opening meeting with the competent authorities. At this meeting the audit team confirmed the objective and schedule for the audit.

2 OBJECTIVES AND SCOPE

The objective of the audit was to evaluate the effectiveness of:

1. the actions taken by the Dutch competent authorities in order to control Salmonella in poultry, in particular the implementation of the Salmonella National Control Programmes (SNCPs) in some poultry populations (breeding flocks of Gallus gallus, laying hens, turkeys and broiler flocks);

2. the actions taken in response to recommendations in the previous audit report (DG SANCO 2013-6696);

3. the system in place to prevent contamination of the production chain of table eggs and poultry meat/meat products by Salmonella.

The scope of the audit covered:

SNCPs, approved by the Commission services, in specific poultry populations (breeding flocks, laying hens of Gallus gallus, turkeys and broiler flocks for the years 2017 to 2020);

Preventive and control measures (sampling scheme applied, food business operators' control programmes, confirmatory sampling policy, investigation of food-borne

2

outbreaks, timely implementation of trade restrictions in case of Salmonella detection in laying hens, monitoring of Salmonella);

Competent authority processes (verification and analyses of results, audits); Any management tools and laboratories (e.g. information systems for management

and monitoring, in particular for collecting data needed to evaluate the means used and results obtained, traceability tools for poultry/poultry products, laboratories participating in the SNCPs).

In order to achieve this objective the audit team evaluated the organisation of the NVWA and its capacity for implementing the relevant EU requirements.

The table below lists the different relevant parties met in video meetings held in order to achieve the above objective.

Meetings

Competent authoritiesNVWA (several different departments/services), the Netherlands Enterprise Agency.

Delegated control bodies COKZ and C-Mark

LaboratoriesThe national reference laboratory for salmonella, and two private laboratories involved in SNCP testing.

Breeding holdings Two, both positive for Salmonella in the last two years.

Laying hen holdings One, with rearing flocks, and positive for Salmonella in the last two years.

Turkey fattener holdings One, positive for Salmonella in the last two years.

Broiler holdings One, positive for Salmonella in the last two years.

Other relevant parties The Dutch Council for Accreditation, AVINED, Wageningen Bioveterinary Research.

3 LEGAL BASIS

The audit was carried out under the general provisions of EU legislation and, in particular:

Articles 116, 117, and 119 of Regulation (EU) 2017/625 of the European Parliament and of the Council;

Article 17 of Regulation (EC) No 2160/2003 of the European Parliament and of the Council.

Full references to EU legal instruments quoted in this report are provided in Annex 1 and refer, where applicable, to the last amended version.

3

4 BACKGROUND

The Commission last audited the actions taken by the Dutch competent authorities in order to control Salmonella in 2013. The report (DG(SANCO) 2013-6696) of that audit is available at: https://ec.europa.eu/food/audits-analysis/audit_reports/details.cfm?rep_id=3245

The report made recommendations to address relevant points noted, the Dutch competent authorities informed the Commission of the actions taken and that they had addressed all recommendations. However, that was not the case for two of the recommendations and in 2020, the Commission services took action to recover part of the payments made for the SNCPs. The competent authorities committed again to correct their procedures and correctly adhere to the EU legal requirements for confirmatory sampling in breeders and in laying hens. The other recommendations concerned the delegation of official control tasks to control bodies (relevant bodies should be accredited, free from conflict of interest, and subject to audits or inspections), and that it should be possible to distinguish official sampling results from operator sampling.

The table below shows the number of holdings and adult flocks in 2020 per poultry population included in the scope of this audit, according to data provided by the NVWA.

Poultry population Number of holdings Number of adult flocksBreeders of Gallus gallus 337 1307

Laying hens 746 1860Broilers 830 16363

Fattening turkeys 41 475

For products that include the Netherlands as origin, and during the period between 1 January 2017 and 1 July 2020, in the Rapid Alert System for Food and Feed, there was a total of:

Nine notifications linked to Salmonella in table eggs and egg products (approximately 66% of which were due to Salmonella enteritidis).

39 notifications linked to Salmonella in poultry meat or poultry meat products (approximately 25% of which were due to Salmonella enteritidis).

29 notifications related to Salmonella detection in feed materials (including feed premixes and compound feeds) that can be used for poultry. The most frequent serotypes found in feedstuffs/feed material were Salmonella Senftenberg and Salmonella mbandaka.

Table eggs and egg products (Salmonella

enteritidis)

Poultry meat or poultry meat products (Salmonella enteritidis)

Feed materials used for poultry

2017 2 (1) 5 (1) 10

2018 5 (4)43

13 (3)4

https://ec.europa.eu/food/audits-analysis/audit_reports/details.cfm?rep_id=3245

4

2019 1 (1) 18 (5) 13Jan-Jun

20201 3 2

Total 9 (6) 39 (9) 29

According to the European Food Safety Authority and European Centre for Disease Control "The European Union One Health 2018 Zoonoses Report"1 the Netherlands had a low notification rate of human cases of Salmonella amongst the EU Member States in 2018, with 9.6 per 100,000 population versus an EU average of 20.1 per 100,000 population.

5 FINDINGS AND CONCLUSIONS

5.1 PREVENTIVE MEASURES

Legal requirements

Articles 3, 5 and 7 of Regulation (EC) No 2160/2003.

The approved Salmonella national control programmes.

Article 3 of Commission Regulation (EC) No 1177/2006.

Findings

1. The NVWA is the designated competent authority for the implementation of the SNCPs.

2. The Netherlands created an Animal Health Fund to help monitor and combat animal diseases and to prevent and reduce welfare problems. The responsibility and tasks under the Animal Health Fund are split between:

the Ministry of Agriculture, Nature and Food Quality, responsible for policy; the NVWA, responsible for veterinary supervision of monitoring and control; and the Netherlands Enterprise Agency (Rijksdienst voor Ondernemend Nederland),

responsible for some administrative support tasks, such as managing contracts for delegated controls, checking payment requests and issuing payments under the fund, including for the SNCPs.

3. Poultry producers, of both egg and meat sectors, can enrol in a private quality scheme called IKB. The NVWA informed that around 90-95% of the poultry holdings (including breeding flocks) are enrolled in this scheme, and that this will namely require those holdings to undergo a yearly IKB inspection. That IKB inspection includes hygiene requirements such as annual water testing, and swabs for verification of effectiveness of cleaning and disinfection.

1 https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2019.5926

https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2019.5926

5

4. Additional details on organisation of SNCP official controls are included in section 5.2.1 of this report, and on the overall organisation of the control systems in the Netherlands are described in the country profile, which is available at: https://ec.europa.eu/food/audits-analysis/country_profiles/details.cfm?co_id=NL

5. National legislation obliges feed manufacturers and suppliers to monitor feed materials and compound feed for the presence of Salmonella at a given frequency.

6. In case of positive test results of samples taken by a feed producer or supplier, serotyping must be carried out by an accredited laboratory. If Salmonella enteritidis, Salmonella typhimurium, Salmonella hadar, Salmonella infantis, Salmonella virchow or Salmonella java is present, the feed producer or supplier has to notify the NVWA and the farmer(s) concerned. The feed manufacturer or supplier shall inform the competent authority of the measures taken and collaborate with the competent authority on action taken in order to avoid risks posed by a feed which they supply or have supplied. Laboratory analysis results are reported in a private database and are made available to the authorities for trend analysis.

7. From 2017 to 2019 the NVWA did not perform official sampling of feed materials nor compound feed. The number of samples, and results, from feed producers and suppliers during that same time period was:

Year Samples Positive Salmonella spp Positive for a notifiable Salmonella2017 11 642 6 1 (S. typhimurium)2018 3 543 5 02019 7 879 34 1 (S. typhimurium)

8. The NVWA carries out controls over feed producers and suppliers via a combination of inspections and audits. To select which operators to control it gives priority to those it has not visited for over 3 years, or are newly registered.

9. From 2017 to 2019, the NVWA performed 564 inspections and 309 audits to feed producers/suppliers. These reported very few non-compliances in relation to salmonella, including one case in 2018 of non-verification of salmonella in feed, another of lack of an hazard analysis and critical control points plan; and in 2018 and 2019 of lack of a risk analysis of incoming feed materials.

10. The SNCPs do not require Salmonella vaccination. Nevertheless, farmers may use authorised Salmonella vaccines on a voluntary basis and vaccination of breeding and laying hens is subsided by the government. This vaccination goes beyond requirements for laying hens, Article 3(3) of Regulation 1177/2006, which requires vaccination only when prevalence of Salmonella in the country is above 10 %.

https://ec.europa.eu/food/audits-analysis/country_profiles/details.cfm?co_id=NL

6

11. Ten different vaccines with S. enteritidis and S. typhimurium strains (five of them with live attenuated strains) are authorised in the Netherlands. They are intended for oral vaccination and provide protection against one or both Salmonella serovars.

12. The NVWA provided the following data on the number of vaccinated flocks, for which a subsidy was requested.

Poultry type

Age YearNo of flocks

No of flocks vaccinated

(% )

No of birds vaccinated

No of dosesadministered

Breeders Adult 2017 1082 43 (3.9) 690 088 2 070 264

2018 1302 61 (4.7) 1 164 423 3 493 269

2019 1699 47 (2.8) 1 049 781 3 149 343

Layers Adult 2017 2686 1 184 (44.1) 25 732 021 77 196 0632018 2812 1 078 (38.3) 24 184 452 72 553 3562019 2547 1 028 (40.4) 23 979 286 71 937 858

13. Vaccination uptake is not recorded in a database available to the NVWA or the laboratories. Information on if a flock is vaccinated is sent to the laboratories in the sampling form, completed by the samplers after checking the farmer's records.

14. Flocks vaccinated with one particular live attenuated vaccine will sometimes give “false” Salmonella enteritidis positive results. This happens because the test also detects the vaccination strain not only a wild-type strain that could cause disease. If Salmonella enteritidis is detected in a flock vaccinated with this vaccine, the isolate is tested in a designated laboratory with a differentiating method (vaccine vs. wild-type strain, as required by Article 3(1) of Regulation 1177/2006) validated in Germany but not yet for the Netherlands. The designated laboratory performing this test is in the latest stages to obtain the certification for the Netherlands.

15. When S. enteritidis or S. typhimurium is detected in a flock vaccinated with any of the other four authorised live attenuated vaccines (either at own or official sampling), the results are considered positive and no further differentiating test is officially considered. Although the manufacturers of these vaccines provide a differentiating method, as required, the NVWA does not use them within the SNCP.

16. The vaccination schedules, described for two laying hen holdings, were solely during the rearing period, in line with Article 3 of Regulation 1177/2006. The audit team confirmed compliance with vaccination rules on records reviewed, and that when rearing flocks are moved to another holding they are duly accompanied by production documents, listing all vaccinations done and Salmonella test results.

7

Conclusions on preventive measures

17. The preventive measures in place are in line with the approved SNCPs and are suitable for reducing the risk of introducing Salmonella in poultry populations.

5.2 MONITORING AND SAMPLING SCHEME

5.2.1 General points in relation to SNCPs

Legal requirements

Articles 3 and 5 of Regulation (EC) No 2160/2003.

The approved Salmonella national control programmes.

Articles 5(4), 8(2), 12(4), 13(4), 16(6), 28(1), 29 and 32 of Regulation (EU) 2017/625.

Findings

18. National legislation is in place for all SNCPs. Article 81c of the Dutch legislation ‘Gezondheids- en welzijnswet voor dieren’ is the basis for implementation of Regulation 2160/2003 and the underlying poultry population specific Regulations.

Articles 15, 17, 19 to 22, 24 and 32, of that national legislation provide the basis for the prevention of transmission of contagious animal diseases and eradication measures. Articles 83 to 92 cover compensation payments.

Monitoring and eradication regulations are adopted in the Dutch legislation ‘Regeling preventie, bestrijding en monitoring besmettelijke dierziekten en zoonosen en TSE’s’, in particular articles 95 to 98p.

19. National legislation (entitled ‘Besluit zoönosen’) designates as relevant six Salmonella serovars: Salmonella enteritidis, typhimurium, infantis, hadar, virchow and java. The designation of Salmonella java as a relevant serovar goes beyond EU requirements, and applies only in broilers, and in breeding flocks for the meat line.

20. For the egg production chain, the NVWA delegated some SNCP tasks to The Netherlands Controlling Authority for Dairy and Eggs (COKZ, Controle Orgaan Kwaliteits Zaken) to perform the supervision.

21. The NVWA also delegated all the routine official sampling of the four relevant poultry populations (breeding flocks of Gallus gallus, laying hens, turkeys and broiler flocks) to C-Mark.

22. AVINED (a poultry industry body) manages the central database, called KIPnet, where all Salmonella sampling results, from both official and operator sampling, must be registered.

8

23. The NVWA provided data showing that since 2018 the sampling frequencies implemented for all four relevant poultry populations respected EU requirements, for both routine official and operator sampling.

24. The NVWA delegations of certain official control tasks to both COKZ and C-Mark are generally in line with the relevant requirements of Regulation 2017/625, which effectively address the recommendation in report DG(SANCO) 2013-6696 about the accreditation and impartiality of delegated control bodies. The noted exception is for COKZ in relation to the requirement in its’ Article 29(a) for a ‘precise description’ of controls (see also paragraphs 79 and 80).

25. Laboratories analysing operator and/or official monitoring samples within the SNCPs must enter the results into the KIPnet database. Operator samples are identified as ‘regular’ and samples taken by C-Mark and COKZ are identified as ‘official’. This effectively addressed the recommendation in report DG(SANCO) 2013-6696 to ensure this distinction.

26. National legislation (Article 100(2) of ‘Gezondheids – en Welzijnswet voor dieren’) requires any laboratory that examines samples and detects a designated animal disease, such as the six designated serovars of Salmonella, to report it to the NVWA as soon as possible.

27. Registration of a positive Salmonella test result (from official or operator sampling) in KIPnet generates an automatic alert that is sent to the NVWA Incident and crisis Centre. If, for some reason, positive results cannot be entered in the database they must be reported by telephone or e-mail.

28. Slaughterhouses are obliged to assess food chain information prior to accepting animals for slaughter. The NVWA supervises this by also assessing the food chain information and takes action if necessary.

5.2.2 Laboratories

Legal requirements

Articles 37, 38, 39 and 100 of Regulation (EU) 2017/625.


Findings

29. The National Institute for Public Health and the Environment (Rijksinstituut voor Volksgezondheid en Milieu) is the designated national reference laboratory (NRL) in the Netherlands. It is also the EU reference laboratory for Salmonella, although both are kept operationally separated.

9

30. Official and operator samples within the SNCP for detection and serotyping of Salmonella are all analysed in designated laboratories as required by Art. 12(1) of Reg. 2160/2003.

31. The NVWA designated 15 laboratories in the Netherlands, and a further seven laboratories in other Member States, to carry out testing for detection of Salmonella. For serotyping Salmonella it designated 12 laboratories in the Netherlands and a further two laboratories in other Member States. The NVWA updates the list of designated laboratories regularly.

32. The laboratory designations include the information prescribed by EU requirements. In some cases, the audit team noticed that the designation letter still refers to the previous ISO reference instead of the most recent update. Nevertheless, the designations clearly state that the laboratory should use the most current methods. In addition, the NVWA communicated with all laboratories confirming that all but one designated laboratory for this method is operating under the latest update, ISO 6579-1.

33. The NVWA has well established procedures for the designation of laboratories within the SNCP. NVWA takes into account, for each laboratory, the NRL assessments of standard operating procedures and at least two satisfactory proficiency tests for each method. NVWA also requires that all laboratories are accredited to ISO 17025 and have the relevant ISO certifications for each method included in the designation, in line with the required by Article 12 of Regulation 2160/2003.

34. The Dutch Council for Accreditation accredits the laboratories established in the Netherlands. If the laboratory is established in another Member State the accreditation must be granted by an European Accreditation recognised organisation.

35. However, the NVWA does not have records that designated laboratories for the Dutch SNCPs, located outside the Netherlands, are also designated as an official laboratory by the competent authorities of that Member State. This is not in line with Art. 37(2) of Reg. 2017/625. The NVWA informed that it is planning to send a letter, and to organise a meeting, with all the designated laboratories to improve communication and to address this (as well as the reported in paragraph 43 below).

36. All laboratories need to participate quarterly in proficiency tests for the methods covered by their designation (detection and/or serotyping) in order to maintain the designation. This proficiency testing is organised by a designated body. The laboratories send the results for each round of tests to the NRL for assessment. The NVWA considers the proficiency unsatisfactory when there are two or more incorrect results out of five for each round. In case of unsatisfactory results in one proficiency test round, the NRL contacts the relevant laboratory requesting explanations for the results and if necessary gives advice for improvement.

37. The NRL summarises the results quarterly and sends a report, including the trend analysis over 1-2 years, to the laboratories and to the NVWA. In case of unsatisfactory

10

trend results in successive proficiency test rounds, the NRL contacts immediately not only the laboratory but also the NVWA. The NVWA can suspend the lab designation based on this but has not yet found it necessary, in any of the few times it happened.

38. The NRL provides training and advice to official laboratories when needed. It performs serotyping of Salmonella isolates only upon request or in special cases with very rare Salmonella serovars.

39. The designated laboratories use one or more of the following methods, all according to, or validated in line with EU requirements:

Modified Semi-Solid Rappaport-Vassiliadis (MSRV) is the standard detection method for Salmonella;

IQ check II real-time polymerase chain reaction (PCR) as the alternative method for detection of Salmonella; and

Kauffmann-White-LeMinor as the serotyping method.

40. The laboratories designated for both MSRV and the alternative PCR method, analysed the samples combining the two detection methods. If the PCR gives a positive result, the laboratory continues the analysis using MSRV followed by serotyping. If the PCR gives a negative signal this is considered conclusive and is reported. Laboratories that are not designated for PCR, use only MSRV and will report based on it. Laboratories not designated for serotyping, must send the isolates to a laboratory that is.

41. The NVWA initiated in 2020 a project to carry out some official controls over the information flow from sampling to reporting of laboratory results. The analysis of times from sampling to reception, to processing, to results, compares different databases available (financial department, laboratories' databases and KIPnet). The NVWA used this analysis for prioritising on-the-spot audits to designated laboratories in 2020 and 2021. The NVWA will review this project at the end of 2021 and decide whether to stop or to increase/decrease the number of audits and/or modify the audits’ criteria.

42. In 2020, the NVWA performed one on-the-spot laboratory audit. The NVWA detected some deficiencies on the information flow and requested the laboratory an action plan to address them. For 2021, it plans to carry out one audit follow-up visit and five audits.

43. The NVWA currently is not auditing laboratories located outside the Netherlands. It also does not have records of if/when the competent authority of that Member State audited these laboratories. In addition, the audit team found a lack of NVWA checks on if the accreditations are maintained up-to-date in these laboratories. This is not in line with Article 40(1) of Regulation 2017/625.

44. The two designated laboratories met by the audit team had procedures for verification of samples at reception. There had been no need to reject any of the official samples. In one laboratory 5% of the operator samples had issues (mostly time delays) noted at reception while in the other this had also been a problem previously but currently almost never happened. Any samples that could not met the required deadline to start the

11

examination, were either rejected (and a new sample requested) or, at the operator’s request and responsibility, the laboratory performed the examination but indicated in the report form that the results provided were not covered by the laboratory certification.

5.2.3 SNCP for breeding flocks of Gallus gallus

Legal requirements

Article 5 of Regulation (EC) No 2160/2003.

Article 1 of Commission Regulation (EU) No 200/2010.

Findings

45. In line with EU requirements, an official sample must be taken at least twice during the production cycle.

46. The prescribed operator sampling times and intervals in breeding flocks are in line with EU requirements for both rearing and adult flocks.

47. Until 24 January 2020 Salmonella positive results in breeding flocks always resulted in a confirmatory sampling procedure, contrary to the required by point 2.2.2.2(c) of the Annex to Regulation 200/2010. This was the object of a recommendation in the audit report DG(SANCO) 2013-6696.

48. The NVWA amended official instructions related to these procedures and they now correctly reflect the legal requirements for confirmatory sampling to be done only exceptionally. After January 2020, positive results for Salmonella are now by default considered positive and confirmatory sampling can no longer be systematically performed in this poultry population.

49. The NVWA informed that after 24 January 2020 there were a total 27 flocks positive for targeted Salmonella serovars. Only one of these was subjected to confirmatory sampling. This NVWA confirmatory sampling had a negative result and was performed because the original test was not conclusive.

5.2.4 SNCP for laying hens

Legal requirements



Findings

50. In line with EU requirements, an official sample must be taken every year at holdings with at least 1,000 adult laying hens. To facilitate timely sampling, every three weeks the Netherlands Enterprise Agency provides C-Mark with an update on the flocks in laying hen holdings.

12

51. The prescribed operator sampling times and intervals in laying hens are in line with EU requirements for both rearing and adult flocks.

52. According to national requirements in laying hen flocks samples must also be taken within three weeks before slaughter, and it must be by a veterinarian or veterinary assistant.

53. Until 1 January 2021, Salmonella positive results in laying hen flocks always resulted in a confirmatory sampling procedure, contrary to the required in Reg. 2160/2003, Annex II part D. point 4. This was the object of a recommendation in the audit report DG(SANCO) 2013-6696.

54. The NVWA updated an instruction to state that from January 2021 positive results for Salmonella must, by default, be considered positive. Confirmatory sampling in laying hen flocks can only be done to exclude false-positive initial results.

55. The NVWA informed that after 1 January 2021 six flocks where initially positive for targeted Salmonella serovars under the routine monitoring. Two flocks were immediately declared positive. In the other four the positive results might be caused by presence of a vaccine strain of Salmonella enteritidis. The differentiation test confirmed that these four positives concerned the vaccine strain, and no restrictions or additional measures were imposed. Additional flocks in three other houses located nearby were sampled and two of them were also positive for targeted Salmonella serovars.

5.2.5 SNCP for broilers

Legal requirements



Findings

56. In line with EU requirements, the Netherlands performs official sampling at 10% of the broiler holdings with more than 5,000 broilers.

57. NVWA delegated the official sampling to C-Mark first in mid-2107 and in that year the 10% of holdings sampled was a combination of C-Mark samples and NVWA samples. NVWA selects annually the holdings to sample and informs C-Mark. In 2018, the selection of the 10% of holdings to sample was partly based on notifications from slaughterhouses and partly random. Since that date, the NVWA selects randomly, from holdings that were not officially sampled in the previous five years.

58. Broiler holdings covered by the SNCP have two operator sampling moments:

Day-old chicks at arrival, when 40 faecal samples are taken from the basket liners with the incoming chicks. This is a national requirement that goes beyond EU requirements; and

Three weeks before slaughter, in line with EU requirements.

13

59. For broilers flocks it is a national requirement that it must be a veterinarian, or veterinary assistant, that takes the samples within three weeks before slaughter.

60. The results of the Salmonella testing prior to slaughter are included in the food chain information form sent to the slaughterhouse 24 hours before slaughter. The date of sampling, which could be used to check the respect of the ‘within three weeks before slaughter’ requirement, is not indicated but the laboratory test result form includes that date and it must accompany the poultry to slaughter. Additionally the NVWA instruction for checks at the slaughterhouse correctly indicates that those checks should confirm this SNCP requirement.

5.2.6 SNCP for turkeys

Legal requirements



Findings

61. There are no holdings with breeding turkeys in the Netherlands and rearing of fattening turkeys is very limited. Holdings with fattening turkeys are under contract with, and send their turkeys for slaughter in Germany.

62. In line with EU requirements, the Netherlands performs official sampling at 10% of the turkey holdings with more than 500 fattening turkeys. The NVWA selects the holdings and informs C-Mark.

63. In turkey holdings, the operator must always sample all flocks within three weeks before slaughter, in line with EU requirements.

64. As turkeys are sent for slaughter in Germany, in addition to the food chain information (prepared and sent in the same way as for broilers, see paragraph 60) an Intra-Union trade health certificate must accompany them, as required by Article 9 of Regulation 2160/2003.

65. In 2019, a turkey holding that had a positive test result in one house had tested twice more all houses, prior to sending them to slaughter, with those subsequent tests giving negative results. The operator informed that:

All the Salmonella test results were sent to the slaughterhouse; and that the turkeys from the house with the initial positive result had been correctly

registered as Salmonella positive in the food chain information form, even with two subsequent negative results.

66. However, the NVWA had issued an health certificate declaring that this flock was Salmonella negative.

14

67. The NVWA department that issues the health certificates (a different department from the one in charge of the SNCPs) fills in the flocks’ Salmonella status based on the laboratory test result provided by the operator. If the operator tests more than once this department is unaware of it because it does not have access to KIPnet. The NVWA confirmed that this was a, until now undetected, gap in the system. Additionally, access to the information currently in KIPNet could raise suspicions on the Salmonella status but would not by itself ensure sufficient traceability for certification requirements.

68. The audit team requested the NVWA to investigate if it had issued any other Intra-Union health certificates incorrectly stating ‘Salmonella negative’ in 2019 and 2020, for either turkeys (all slaughtered in Germany) or broilers sent for slaughter in another Member State. The NVWA investigated and informed that this had not happened with any broiler flock, and that it had happened one more time with turkeys in 2019.

Conclusions on monitoring and sampling scheme

69. The operator and the, delegated, official monitoring and sampling schemes are implemented in line with the approved SNCPs. The NVWA has tools to monitor and continuously review the progress of both, and this has helped in ensuring good compliance with the required sampling frequencies in all relevant poultry populations.

70. The minor shortcomings noted in relation to laboratories are mainly on documentation, the NVWA has plans to address them promptly, and do not raise doubts on the quality of the testing. All designated laboratories involved in the SNCP are accredited for the relevant Salmonella testing method, and participate in regular proficiency tests with satisfactory results. The network of designated laboratories has the capacity to provide reliable analysis results to support the correct delivery of the SNCP.

71. The NVWA has effectively addressed the relevant recommendations in the DG(SANCO) 2013-6696 audit report. In the case of confirmatory sampling this was achieved after a significant delay.

72. The gap in the NVWA certification system concerning the Salmonella status of a flock had little to no impact in the possible spread of Salmonella. This due to the very low number of incorrect certificates and the correct reporting in the food chain information.

5.3 MEASURES TAKEN AT TIME OF SUSPICION AND CONFIRMATION OF SALMONELLA

Legal requirements


15

Part C and D of Annex II to Regulation (EC) No 2160/2003.

Findings

73. The SNCPs include relevant control measures to implement when infection with targeted Salmonella serovars is detected.

74. The NVWA issued a “Procedure for dealing with (suspected) zoonotic Salmonella infection in poultry”. It applies to all poultry populations and was latest updated in February 2021. Any positive result for a targeted Salmonella serovars must be reported to the NVWA. The NVWA Incident and Crisis centre then determines any further action needed.

Breeding hens

75. Detection of a targeted Salmonella serovar in breeders, be it pullets or adults, triggers official restrictive measures from the NVWA. The audit team saw data showing that until 24 January 2020, the NVWA systematically performed confirmatory sampling to decide if it would maintain of lift the restrictive measures. After that date, the flocks are by default considered positive without the confirmatory sampling (see also paragraphs 47 to 49).

76. The NVWA imposes restrictive measures from the date that the serotyping confirms a targeted Salmonella serovar. The measures taken with regards to the eggs and the flock are in line with EU requirements and include:

tracing and recall of all eggs placed on the national market (if sent to other Member States or exported the relevant authorities in those countries are officially informed) since the date of the last previous negative Salmonella monitoring result;

sending the eggs for destruction or heat treatment; arrangements for correct slaughter or destruction of the flock.

Laying hens

77. Notification of a targeted Salmonella serovar in laying hen holdings (pullets or adults) triggers action from the NVWA. NVWA data shows that until 1 January 2021 the NVWA systematically performed confirmatory sampling to decide if it would maintain of lift restrictive measures, and that after that date the flocks are by default considered positive without the confirmatory sampling (see also paragraphs 53 to 55).

78. NVWA action in these cases include:

formal notification to the holding owner of the applicable restriction measures; a visit to the holding and completion of a specific form with relevant details such as

number of houses, number and age of birds, number of eggs; a notification to COKZ, who is responsible for ensuring restriction, recall and

correct channelling (heat treatment or destruction) of the eggs.

79. The audit team saw documented evidence of both NVWA and COKZ activities demonstrating that those are in line with EU requirements with two exceptions:

16

The national legislation and SNCP related instructions only require the NVWA to impose restrictive measures (in particular a ban on marketing of eggs) after confirmation of targeted Salmonella serovars. Therefore, a ban on the marketing of eggs is not imposed during the period when the positive Salmonella spp. results are already available and the flock should be considered suspect of being infected. This is not in line with Part D 2. of Annex II to Regulation 2160/2003. The timeframe between date of sampling and the date of reception of positive result for a targeted Salmonella serovar can range from 4-5 to 14 days which, depending on the size of the infected flock(s), can correspond to a few thousand eggs or as much as several hundred thousand; which is compounded by the fact that

COKZ imposes restrictive measures on the eggs at holdings from the date of the test result of the targeted Salmonella serovar instead of from the date of the sampling. This meant that any eggs laid after the date of sampling and until the date of the test result were not blocked, nor recalled, from the market and could be sold as Class A eggs. This is not in line with Part D 2. of Annex II to Regulation 2160/2003.

80. The NVWA confirmed that restrictive measures on the eggs, and recall, should be applied from the date of sampling instead of the date of the test results. Additionally, it informed that it had been under the impression that COKZ had been doing so, but that apparently this procedure was not clear enough in the delegation to COKZ. This is not in line with Art. 29(a) of Regulation 2017/625.

81. In the data analysed, the audit team saw that in laying hen holdings with a positive flock for targeted Salmonella serovars, official samples were taken from all other flocks in the holding, as well as in the next placed flock in the same building (at the age of 24 +/- two weeks). This is in line with the required in 2.1 of the Annex to Regulation 517/2011.

Broilers

82. The NVWA Incident and Crisis centre forwards notifications for broiler flocks to the meat inspection department of the NVWA. That department follows up on the obligations of the operator when it sends the broilers for slaughter. Flocks must be slaughtered in the right sequence, starting with Salmonella free flocks, followed by any flocks infected with non-targeted Salmonella serovars, and only at the end any flocks infected with targeted Salmonella serovars.

83. The audit team reviewed documentation on one broiler holding where samples had tested positive for a targeted Salmonella serovar: This holding had four houses, with two houses having positive results when all were

sampled on arrival of day-old chicks, in line with the national requirement. In the sampling done five weeks later, prior to sending the broilers for slaughter, one of these two houses was still positive, the other was now negative and one of the two houses negative on arrival of the day-old chicks was now positive. The operator explained that this was likely because of a mix-up with the identification of the samples taken on arrival;

The two flocks that tested positive were slaughtered at the end of the slaughter day. The food chain information accompanying the flocks to slaughter indicated

17

Salmonella positive. The test results of neck skin samples taken at the slaughterhouse after slaughtering the flocks were negative for one house and positive for the other. Based on these results, and in line with EU requirements, the meat from the negative flock was placed on the market as fresh poultry meat while the meat from the positive flock had to be heat treated.

Another recent Salmonella spp. positive recent result in this same holding after serotyping was shown to not be a targeted Salmonella serovar. The food chain information for this flock correctly identified it as Salmonella positive but not a targeted Salmonella serovar.

Cleaning and disinfection

84. Currently there are no legal requirements imposing disinfection and cleaning of poultry houses after depopulation of flocks infected with Salmonella.

85. Holdings that participate in the IKB quality scheme (approx. 90%) after the depopulation must: Clean and disinfect the empty poultry house; Send surface swab samples for laboratory testing to confirm the effectiveness of

cleaning; and only after that can they repopulate the house

Epidemiological investigation

86. Epidemiological investigations are performed exclusively when there is a food-borne outbreak, not upon detection of targeted Salmonella serovars.

87. Data of Salmonella isolates covered by the SNCPs are usually not compared with isolates from the national surveillance programme for Salmonella infections in humans.

Conclusions on measures taken at time of suspicion and confirmation of Salmonella

88. After positive cases of targeted Salmonella serovars, the authorities impose correct measures at the affected holdings. There was documented evidence to confirm the restrictions imposed and the channelling of affected animals and poultry products for all poultry populations. The risk of spreading Salmonella from poultry meat is correctly mitigated

89. The system in place provides guarantees that correct measures are taken when a laying hen flock is positive for a targeted Salmonella serovar. Measures taken on eggs after positive results are in general acceptable, but adopted with unnecessary delay (after serotyping). Additionally, the lack of clarity in one aspect of the delegation of control tasks to COKZ meant that there are no restrictions to placing on the market possibly contaminated eggs produced between the date of sampling and the date of reception of positive results, nor is recalling imposed. Therefore, the risk of Salmonella being spread from eggs to consumers is not fully mitigated.

18

5.4 OFFICIAL CONTROLS, VERIFICATION AND AUDITS

Legal requirements

Article 3(2) of Regulation (EC) No 2160/2003.

Articles 4, 5, 6, 9, 10, 11, 12, 13 and 33 of Regulation (EU) 2017/625.

Findings

90. The NVWA carries out official controls at poultry holdings, following relevant instructions that correctly address the SNCP requirements. Each year it inspects a risk based selection of poultry holdings, with almost all inspections being administrative/documental. On-site inspections related to the SNCP are done usually only in case of a notification of a Salmonella positive, or when combined with an animal welfare check as was done in 2018.

91. NVWA administrative inspections on the SNCPs use the central database called ‘KIPnet’ to check whether the operator adheres to the sampling frequency. They check how often and how many samples are taken and by whom, whether the samples were delivered to the laboratory on time, which laboratory examined the samples, whether the examination was carried out on time and whether the Salmonella type is registered in case of a positive result.

92. Non-compliances are followed up (and incur a charge for performing it) until corrected. Additionally they result in a written warning. If another sampling non-compliance is detected within three years, it will originate an investigative report that is sent to the public prosecutor.

93. NVWA delegated all the routine official sampling of the four relevant poultry populations to C-Mark. In addition to the measures in place to check if C-Mark respects the required sampling frequencies (see also paragraphs 107 and 108), the NVWA plans to start annual audits of C-Mark, and scheduled the first such audit for September 2021.

Total number of inspectionsYear

planned performed (on-site)Number of deviations in

sampling frequency

2017 225 12 (2) Not available2018 100 93 (46) 02019 100 77 (4) 12020 150 166 (4) 5

19

94. C-Mark staff that takes samples in poultry farms attended specific training on the subject. They also undergo an annual formal peer review, which has reported one minor point for improvement on cleaning of safety glasses in between taking samples.

95. The Dutch Accreditation Council accredited the sampling process of C-Mark in 2017. Since then it carries out annual audits covering a selection of procedures. The latest on-site audit, that included sample taking at poultry holdings, was in 2019 and reported no deviations.

96. For the eggs sector the NVWA has delegated some SNCP tasks to COKZ. NVWA and COKZ agree annually on the work plan that COKZ has to deliver, and which is adapted depending on the findings from previous years.

97. The COKZ work related to the SNCP concerns controls of hygiene on laying holdings, and on egg channelling when restriction measures are imposed on laying hen holdings.

98. The hygiene controls cover the poultry house as well as the egg bands, storage, sorting and packaging. COKZ also controls the trade and traceability of eggs, and cross contamination and the hygiene of egg transport to packing stations and the following routing of the eggs.

99. Hygiene controls on laying holdings in the recent years were affected in particular by outbreaks of avian influenza that limited access to holdings. The multi-annual national control plan data indicates that in 2017 and 2018, respectively, COKZ performed 300 of the 395 planned inspections and 313 of the planned 364. For both years only 1% of the inspections reported hygiene shortcomings. The 2019 COKZ activity report indicates that the planned inspections frequency was also not respected (237 performed vs. 290 planned) again due to restrictions on access to holdings, together with farm closures and extra work related to the investigation of a foodborne outbreak.

100. Starting at the end of 2019, and subsequent to a risk analysis of the egg chain (see also paragraph 109) the NVWA required COKZ to collect official samples in laying hen holdings, additional to minimum mandatory official sampling that is performed by C-Mark. The NVWA decided to require these samples as an additional check, in line with point 2.1.(e) of the Annex to Regulation 517/2011. COKZ sampling is done at random moments to fall at any time in-between the regular 15 weeks sampling interval. In each holding it targets older laying flocks, since those are considered higher risk due to being “exposed” for longer to Salmonella contamination, and a likely lowering immunity from vaccination.

101. From 2017 to 2019, the NVWA performed annual audits on COZK controls over laying hen holdings, and establishments further along in the egg production and marketing chain. The audits included accompanying a few COKZ inspections on the spot at each of those establishments. None of the audits detected deficiencies with COKZ performance in relation to the tasks delegated by the NVWA.

20

102. The NVWA audits did not look into how COKZ performed the egg channelling after the imposition of restriction measures in laying hen holdings. NVWA did not detect that COKZ was imposing restrictions on the eggs, and/or recalling those eggs, only from the date of the positive test result instead of from the date of the sampling for that test.

Conclusions on official controls, verification and audits

103. The NVWA controls are effectively detecting non-compliances in holdings and ensuring their correction as required. This contributes to better implementation of the requirements.

104. The NVWA audits and inspects COKZ, inspects the work of C-Mark and will carry out an audit of C-Mark in September 2021. This effectively addresses the DG(SANCO) 2013-6696 report recommendation on the performance of audits or inspections of delegated bodies and contributes to ensure the objectivity and effectiveness of the controls these bodies perform.

105. The NVWA controls on delegated bodies have effectively ensured compliance from C-Mark. It did not detect that COKZ has been imposing restrictions on egg marketing later than required which indicates weaknesses in the effectiveness of NVWA controls over this body.

5.5 ASSESSMENT OF THE PROGRESS AND REVIEWING OF THE SNCPS

Legal requirements

Article 3(2) of Regulation (EC) No 2160/2003.

Findings

106. According to data submitted by the Dutch authorities to EFSA, the Netherlands was well below the EU Salmonella prevalence target for its four relevant poultry populations (broilers, turkey fatteners, breeding hens and laying hens) from 2015 to 2018. The NVWA informed the audit team that it continued to be within targets in 2019.

107. C-Mark sends a quarterly report on the progress of official sampling to the NVWA. The NVWA and C-Mark also have periodic consultations (every 6-7 months) to discuss the progress of sampling and if any changes are needed. NVWA requested from C-Mark changes such as performing the sampling within a shorter time frame, and improving the hygiene protocol during sampling.

108. Additionally the NVWA uses the information in KIPnet as another, daily updated, means of confirming that C-Mark respects the SNCP sampling frequencies.

109. In early 2018, the Office for Risk Assessment & Research, an independent part of the NVWA, carried out an 'Integral risk analysis of the poultry meat chain' and published

21

the 'Comprehensive risk assessment of the egg supply chain'. These analyses identify the risks that may be present in those supply chains, and are based on scientific risk assessment, fraud assessment and information from regulatory and supervisory practices. They include an assessment of microbiological risks, such as zoonotic Salmonella.

110. At farm level, the main Salmonella risk indicated, and directly related to the SNCPs, was the legal maximum of 15 weeks time interval for Salmonella sampling in laying hen farms. A flock infected during the 15 weeks in between sampling could allow for possibly contaminated eggs to be placed on the market for some time before detecting the infection. The risk analysis advised for stricter monitoring of the private sector component of the SNCP. As part of that stricter monitoring, the NVWA has requested COKZ to also collect additional official samples at laying hen farms from 2019 to at least 2021. After 2021, the results from this sampling will be reviewed to establish if it is useful and to be continued.

111. The NVWA carries out an annual evaluation at operational level of the implementation of the SNCPs by the operators/farms. Summaries of these evaluations are converted in factsheets and published on the website of the NVWA. The factsheet for 2019 indicated as main points evaluated the; timely and correctness of sampling at the farms, the timely and correct recording of the respective laboratory test results, and the validity of test result. It noted that the most frequently detected non-compliance with requirements (over four times more frequent than the second non-compliance) was performing the sampling later than allowed and/or sending it to the laboratory too late to respect the examination deadline.

112. The NVWA has annual meeting with representatives of the Ministry of Agriculture Nature and Food Quality, the Netherlands Enterprise Agency and AVINED in which the SNCPs are also evaluated.

Conclusions on assessment of the progress and reviewing of the SNCPs

113. SNCP data from the delegated body, and from the test results database, provides the NVWA with the necessary information to assess their progress throughout the year. This helps ensuring that delays and/or non-respect of sampling frequencies are noted and addressed promptly, decreasing the risk of Salmonella contamination going undetected.

114. The NVWA implements a system of reviewing the data and results obtained within the SNCPs. It used it to make adjustments to the actions and measures taken, and improve the efficacy of the control programmes.

5.6 INVESTIGATION OF FOOD-BORNE OUTBREAKS (SALMONELLOSIS) AND COORDINATION

Legal requirements

Article 8 of Directive 2003/99/EC of the European Parliament and of the Council.

22


Article 18 of Regulation (EC) No 178/2002 of the European Parliament and of the Council.

Findings

115. The NVWA informed that in the Netherlands in 2017 and 2018 there were no reported Salmonella outbreaks that could be attributed to eggs or poultry meat products. In 2019:

Two outbreaks of S. enteritidis infection could be linked to eggs. One outbreak could be linked to eggs from a laying hen holding in another Member State, while the other could be linked to a Dutch laying hen holding;

One more strong evidence outbreak was a cluster of S. virchow human infections linked to broiler meat and products thereof.

Number of Salmonella outbreaks (strong evidence) in 2017, 2018 and 2019 attributed to eggs or poultry meat/meat products

Food vehicleYear Outbreaks Causative agent

Eggs Poultry meat/ products Other

1Salmonella enteritidis - - unknown

2017

1Salmonella spp.,

unspecified- - unknown

2018 1Salmonella goldcoast - - Pig meat

1Salmonella enteritidis Yes - -

1Salmonella enteritidis Yes - -

2019

1 Salmonella virchow - Yes -

116. All three 2019 outbreaks were investigated and required different levels of coordination and cooperation with other authorities at national level and, in two outbreaks, at EU level.

One S. enteritidis outbreak due to eggs from another Member State. Investigation of a local cluster of S. enteritidis infections, laboratory analysis on sampled eggs and additional whole genome sequencing analysis on food and human isolates, confirmed eggs as the vehicle of infection. The NVWA in collaboration with COKZ carried out an investigation that led to a Dutch packing station distributing eggs from a holding in another Member State, to the catering industry and small/local supermarkets in the Netherlands. All eggs with the relevant identifying code were traced and withdrawn from the market. Additionally consumers were informed by means of shelf cards in the mostly smaller/local supermarkets. Further analysis of

23

human isolates found that this local cluster was part of a national cluster with 20 additional cases throughout the country. The NVWA informed the Member State of origin of the eggs about the holding identification, the outbreak cluster and egg-isolates.

One S. enteritidis outbreak linked to Dutch eggs. Another Member State notified the NVWA at the end of 2019, about four people who presumably became ill at the beginning of November after consuming eggs with a Dutch stamp code. Food analysis revealed contamination of the egg shells with S. enteritidis. The eggs were bought in a supermarket chain with shops in the Netherlands and in that Member State. Following the notification, consultation of the KIPnet database showed:

o The last official Salmonella control at the holding in cause was one month prior to the RASFF notification, and had negative results;

o The holding complied with the operator sampling frequencies and all houses tested within that monitoring were negative as well;

o Considering the above the NVWA decided no further investigation was needed. Nevertheless, the farmer, informed of the cases in the other Member State, decided voluntarily to, from that date, sell eggs from all houses only to the egg product industry. Thus ensuring they would undergo an heat treatment process, sufficient to destroy any Salmonella that might be present.

There was concurrently an ongoing investigation on an outbreak of S. enteritidis in the Netherlands and the Dutch public health department decided to contact their other Member State counterpart. This investigation was to check if a firm link could be found between those four cases and the Dutch cluster of cases, which other data indicated was a possibility. Whole genome sequencing confirmed the S. enteritidis strain was identical for both clusters. Based on this further trace back of the consumption of eggs in the Dutch outbreak was initiated, to investigate possible links with the same Dutch egg holding. The outcome of the trace back did indicated a strong link. Concluding that the Dutch outbreak could be linked to those four other cases and the same holding based on epidemiological research and trace-back, the holder was informed of the following:

o An official control by the NVWA was mandatory prior to selling eggs from the same flock as class A eggs again.

o Before a new flock could be placed in one or more of these houses, all houses in the holding should be thoroughly cleaned.

The results of this investigation were also shared with the Member State that issued the notification.

S. virchow outbreak linked to poultry meat products. A cluster of 6 human cases of S. virchow infection, reported by the National Institute for Public Health and the Environment, could be linked to poultry meat and products thereof based on whole genome sequencing analysis. The human isolates of the outbreak cluster (Nov 2019-Feb 2020) revealed an identical genetic pattern to six food isolates originating from poultry meat sampled in 2018 and 2019. That meat originated from a batch of

24

imported chicken meat, from consumer packaging chicken meat sampled in a supermarket and chicken meat sampled at a wholesaler. The NVWA food chain investigation showed that the food isolates came from different flows of goods with no mutual relationship found between the companies involved. The investigation traced back to the slaughterhouse and importer. Investigation of the food samples in question led to measures being taken for those samples where the legal standard had been exceeded. At the time, products were withdrawn from the market for this non-compliance. Although it is plausible that there is a common origin, no link was found between the companies from which the food isolates originated.

117. The NVWA notifications to laying hen farmers of the imposition of restrictive measures, whenever they have a test result positive for Salmonella enteritidis or Salmonella typhimurium, must be sent with a copy to the public health services at municipality level as well for information.

Conclusions on investigation of food-borne outbreaks (salmonellosis) and coordination

118. The communication, traceability and coordination systems in place ensure a correct flow of information, in both directions, between public health level authorities and the veterinary/production side. That should help limit the impact of possible Salmonella contaminations.

6 OVERALL CONCLUSIONS

Subsequent to the latest audit (2013) the competent authorities have made changes to the SNCPs, and to the related instructions and official checks. These have effectively addressed the shortcomings identified at the time, even if with significant delay for two recommendations concerning systematic confirmatory sampling.

The SNCPs are currently in line with EU requirements, are generally well implemented by the operators, the delegated control bodies and under adequate official supervision. A network of accredited official laboratories supports the implementation of the programmes. The competent authorities correctly monitor and continuously review the progress of the programmes.

The implementation of the SNCPs has achieved a low Salmonella prevalence, in compliance with EU targets, for all relevant poultry populations.

Measures imposed after positive cases to targeted Salmonella serovars at the affected holdings were in line with EU requirements. All necessary documented evidence was available to confirm the restrictions imposed and the channelling of affected animals and poultry products. Nevertheless, measures taken on eggs after positive results are adopted with unnecessary delays and did not fully cover the required production period.

25

7 CLOSING MEETING

A closing meeting was held on 25 March 2021 with representatives of the competent authorities. The audit team presented the main findings and preliminary conclusions of the audit which the competent authorities accepted.

26

8 RECOMMENDATIONS

The competent authorities are invited to provide, within 25 working days of receipt of the report, an action plan containing details of the actions taken and planned, including deadlines for their completion, aimed at addressing the recommendations set out below:

No. Recommendation

1. The CA should ensure that when issuing health certificates for Intra-Community trade, to accompany live poultry for slaughter in another Member State, it uses the information available to the official controls to accurately reflect the Salmonella monitoring test results, in line with the required by Article 88, 3(c) of Regulation (EU) 2017/625 and Article 9 of Regulation (EC) No 2160/2003.

Recommendation based on conclusion: 72.

Associated findings: 65 to 68.

2. The CA should ensure that in laying hen flocks restrictive measures are taken on eggs originating from flocks already when suspected of being infected with relevant Salmonella serotypes in order to comply with Part D (2), Annex II to Regulation (EC) No 2160/2003.


Associated findings: 79 first bullet point.

3. The CA should ensure that in order for delegated bodies to perform their tasks correctly the delegation contains a precise description of those official control tasks, as required by Article 29(a) of Regulation (EU) 2017/625.


Associated findings: 79 second bullet point, and 80.

4. The CA should ensure that the audits or inspections, required by Article 33(a) of Regulation (EU) 2017/625, that it performs on delegated bodies verify the correct understanding and performance of all delegated control tasks.


Associated findings: 101 and 102.

27

The competent authority's response to the recommendations can be found at:

http://ec.europa.eu/food/audits-analysis/rep_details_en.cfm?rep_inspection_ref=2021-7320

http://ec.europa.eu/food/audits-analysis/rep_details_en.cfm?rep_inspection_ref=2021-7320

ANNEX 1 – LEGAL REFERENCES

Legal Reference Official Journal TitleReg. 2017/625 OJ L 95, 7.4.2017, p.

1–142Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation)Text with EEA relevance.

Reg. 2160/2003 OJ L 325, 12.12.2003, p. 1-15

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

Dir. 2003/99/EC OJ L 325, 12.12.2003, p. 31-40

Directive 2003/99/EC of the European Parliament and of the Council of 17 November 2003 on the monitoring of zoonoses and zoonotic agents, amending Council Decision 90/424/EEC and repealing Council Directive 92/117/EEC

Reg. 200/2010 OJ L 61, 11.3.2010, p. 1-9

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

Reg. 517/2011 OJ L 138, 26.5.2011, p. 45-51

Commission Regulation (EU) No 517/2011 of 25 May 2011 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 certain Salmonella serotypes in laying hens of Gallus gallus and amending Regulation (EC) No 2160/2003 and Commission Regulation (EU) No 200/2010

Reg. 200/2012 OJ L 71, 9.3.2012, p. 31-36

Commission Regulation (EU) No 200/2012 of 8 March 2012 concerning a Union target for the reduction of Salmonella enteritidis and Salmonella typhimurium in flocks of broilers, as provided for in Regulation (EC) No 2160/2003 of the European Parliament and of the Council

Reg. 1177/2006 OJ L 212, 2.8.2006, p. 3-5

Commission Regulation (EC) No 1177/2006 of 1 August 2006 implementing Regulation (EC) No 2160/2003 of the European Parliament and of the Council as regards requirements for the use of specific control methods in the framework of the national programmes for the control of salmonella in poultry

Reg. 1190/2012 OJ L 340, 13.12.2012, p.29-34

Commission Regulation (EU) No 1190/2012 of 12 December 2012 concerning a Union target for the reduction of Salmonella Enteritidis and Salmonella Typhimurium in flocks of turkeys, as provided for in Regulation (EC) No 2160/2003 of the European Parliament and of the Council (Text with EEA relevance)

Reg. 178/2002 OJ L 31, 1.2.2002, p. 1-24

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

dg(sante) 2021-7320 final report of an audit carried …

Documents