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) 2019-6668

FINAL REPORT OF AN AUDIT

CARRIED OUT IN

FRANCE

FROM 02 DECEMBER 2019 TO 13 DECEMBER 2019

IN ORDER TO

ASSESS THE OFFICIAL CONTROLS ON THE PRODUCTION OF MILK AND MILK PRODUCTS, AND TO FOLLOW UP ON THE AUDIT DG(SANCO)/2012-6434 ON THE

PRODUCTION OF MECHANICALLY SEPARATED MEAT

Ref. Ares(2020)3724375 - 14/07/2020

I

Executive Summary

The report describes the outcome of an audit carried out by Directorate-General for Health and Food Safety in France from 2 to 13 December 2019. The objective of this audit was to assess the system in place for official controls related to the safety of milk and dairy products, and to assess the actions taken by the competent authorities in response to the recommendations made in the previous audit report on mechanically separated meat (ref. DG(SANTE)/2012-6434).

The competent authorities responsible for food safety have clear competencies and are distributed efficiently across the national territory, with communication flows established within and between the competent authorities involved. The network of experts ("personnes ressources") effectively supports the competent authorities and the food business operators with professional advice and training.

The national legislative framework and implementing instructions are suitable for the provision of appropriate legal bases for the performance of official controls, although certain elements of the national provisions on the production and designation of mechanically separated meat differ from the requirements laid down in the EU regulations.

A clear procedure for the approval and registration of food business operators is available for all official staff involved; however, it is not always followed. Five out of nine establishments visited were not approved in accordance with the EU provisions.

Official controls are planned on the basis of the risk categorisation, which does not reflect the real situation of the establishments and the food business operators' performance. As a consequence, the frequency of controls and follow-up of previously detected non-conformities may be not appropriate.

All establishments visited that produce mechanically separated meat presented significant deficiencies, which had not been identified or appropriately followed-up by official controls. The officials met during these visits were reluctant to impose immediate corrective actions on the food business operators.

In the dairy sector, official controls on holdings are performed on a small percentage of farms, whilst desk evaluation of results for raw milk criteria remains the main method to verify their compliance with hygiene requirements. A robust and reliable system of controls over raw milk criteria has been delegated to the National Interbranch Agreement, with responsibility for enforcement in cases of non-compliances.

Official controls are generally, with some exceptions, able to identify the non-conformities present in the dairy establishments (including cases of presence of pathogens which may render the products unsafe for human consumption) and to follow-up properly and within the agreed deadlines.

Procedures are in place in order to ensure that RASFF notifications are investigated and followed-up; in addition, numerous "national" notifications of presence of pathogens in dairy products are notified to the competent authorities. Both are generally followed-up

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and documented.

Stricter procedures and actions have been implemented at the time of the outbreak of Salmonellosis in infant formulae, allowing the production in the premises to resume only after full implementation of the corrective measures agreed and supervised by the competent authorities at all levels. Some inaccuracies in the recall of affected products from the market point to weaknesses in the recall and withdrawal procedures, and are currently subject to administrative actions initiated by the competent authorities.

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

III

Table of Contents

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

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

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

4 Background .........................................................................................................................2

5 Findings and Conclusions ...................................................................................................3

5.1 Legislation and implementing measures ......................................................................3

5.2 Competent authorities ..................................................................................................5

5.3 Registration and approval of food business operators .................................................8

5.4 Official controls over production and placing on the market.....................................10

5.4.1 Organisation of official controls.........................................................................10

5.4.2 Control procedures and verification...................................................................13

5.4.3 Documentation of official controls .....................................................................13

5.5 Official controls over mechanically separated meat ..................................................14

5.6 Official controls over milk and colostrum production holdings ................................17

5.6.1 Health requirements for raw milk and colostrum...............................................17

5.6.2 Hygiene on milk and colostrum production holdings .........................................17

5.6.3 Controls over raw milk upon collection..............................................................19

5.6.4 Official controls at establishment level...............................................................20

5.7 Sampling and analysis................................................................................................21

5.7.1 Sampling .............................................................................................................22

5.7.2 Laboratories........................................................................................................22

5.7.3 Methods of analysis.............................................................................................22

5.8 Rapid alert system for food and feed .........................................................................23

5.9 Follow up ...................................................................................................................25

6 Overall Conclusions ..........................................................................................................26

7 Closing Meeting................................................................................................................27

8 Recommendations .............................................................................................................27

ANNEX 1 – LEGAL REFERENCES

IV

ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT

Abbreviation Explanation

AFNOR French Agency for Normalisation (Association française de normalisation)

CA Competent authority

CC Consumer Code (Code de la Consommation)

CCA Central competent authority

CNIEL National Interbranch Centre for Dairy Economy (Centre National Interprofessionnel de l’Economie Laitière)

CRPM Rural and Sea Fishery Code (Code Rural et de la Pêche Maritime)

DD(CS)PP Departmental Directorates for Social Cohesion and Protection of Population (Directions Départementales (de la Cohésion Sociale) et de la Protection des Populations)

DGAL Directorate-General for Food (Direction Générale de l'Alimentation)

DGCCRF Directorate-General for Competition, Consumers and Fraud Repression (Direction Générale de la Concurrence, Consommation et Répression des Fraudes)

DG Health and Food Safety

Directorate-General for Health and Food Safety

EC European Community

EU European Union

FBO Food business operator

FSMP Food Safety Management Plan

HACCP Hazard Analysis and Critical Control Points based systems

MSM Mechanically separated meat

OV Official Veterinarian

Personnes ressources

Network of experts

RASFF Rapid alert system for food and feed

RFSD Regional Food Safety Directorates

SCC Somatic cell count

SNE National Investigation Service (Service National des Enquêtes)

SpF Santé publique France

SPN Specific National Surveillance (Surveillance Ponctuelle Nationale)

SRN Regular National Surveillance (Surveillance Régulière Nationale)

V

Abbreviation Explanation

TN National tasks (Tâches Nationales)

TPC Total plate count

VMPs Veterinary medicinal products

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1 INTRODUCTION

This audit took place in France from 2 to 13 December 2019. The audit was undertaken as part of the Directorate-General for Health and Food Safety (DG Health and Food Safety) planned audit programme.

The audit team comprised two auditors from DG Health and Food Safety, which were accompanied throughout the audit by representatives of the two central competent authorities (CCAs) involved in the controls covered by this audit, the Directorate-General for Food (Direction Générale de l'Alimentation - DGAL) of the Ministry of Agriculture and Food, and the Directorate-General for Competition, Consumers and Fraud Repression (Direction Générale de la Concurrence, Consommation et Répression des Fraudes - DGCCRF) of the Ministry of Economy and Finances.

An opening meeting was held on 2 December 2019 with the two CCAs in Paris. At this meeting, the audit team confirmed the objectives of, and itinerary for, the audit, and additional information required for the satisfactory completion of the audit was requested.

2 OBJECTIVES AND SCOPE

The main objective of the audit is to assess the system in place for official controls related to the safety of milk and dairy products.

In addition, the audit team followed-up the actions taken by the competent authorities (CAs) following an outbreak of salmonellosis in infants in 2017-2018. More details on this subject are given in Chapter 5.8 of this report.

Moreover, the audit assessed the response of the CCAs to the recommendations of the DG Health and Food Safety audit report ref. DG(SANTE)/2012-6434 on mechanically separated meat (MSM).

In terms of scope, the audit focused on the organisation and performance of the CAs and on the official control system in place covering the production, processing and distribution chains applicable to milk and dairy products.

In relation to MSM, the audit focused on the organisation and performance of the CAs and on the official control system in place covering the production and distribution of MSM and the labelling of products manufactured with, or containing, MSM.

In pursuit of these objectives, the audit itinerary included the following meetings and visits:

COMPETENT AUTHORITIES

Central 2 Opening and closing meeting with the representatives of CCAs

Departmental 4

2

FOOD PRODUCTION/PROCESSING ACTIVITIESDairy holdings 1 One sheep holding.Milk processing establishments 4MSM producing establishments 2MSM using establishments 1

3 LEGAL BASIS

The audit was carried out under the general provisions of European Union (EU) legislation and, in particular, Article 45 of Regulation (EC) No 882/2004 of the European Parliament and of the Council on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules.

A full list of the EU legal instruments relevant to the scope of this audit is provided in Annex I to this report. Legal acts quoted refer, where applicable, to the last amended version.

4 BACKGROUND

Two audits were carried out previously in France in order to evaluate the official controls related to the safety of milk and dairy products (ref. DG(SANCO)/2014-7210) and the production and use of MSM (ref. DG(SANCO)/2012-6434).

These audit reports can be found at:

http://ec.europa.eu/food/audits-analysis/audit_reports/details.cfm?rep_id=3306

http://ec.europa.eu/food/audits-analysis/audit_reports/details.cfm?rep_id=3091

In order to address the recommendations of the above audit reports, the CAs transmitted two action plans to the Commission services: the list of the remaining open recommendations, that were followed-up on during this audit, can be found under Section 5.9 of this report.

The dairy sector in France (source: CNIEL – Edition 2018) accounts for a total of 743 processing sites and the raw cow milk production 23.8 million tonnes:

2000 2010 2016

MILK PRODUCTION (in tonnes)

Dairy cattle holdings 120,406 75,737 58,462

Dairy cows 4,324,000 3,712,000 3,629,000

Cow milk production 23,100,000 23,300,000 24,400,000

Dairy goats 844,000 962,000 839,000

Goat milk production 476,000 648,000 603,000

Dairy sheep 1,366,000 1,324,000 1,234,000

Sheep milk production 246,000 265,000 293,000

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5 FINDINGS AND CONCLUSIONS

5.1 LEGISLATION AND IMPLEMENTING MEASURES

Legal requirements

Article 291 of the Treaty on the Functioning of the EU.

Point 2 of Chapter I, Section X, Annex III to Regulation (EC) No 853/2004.

Findings

1. In addition to the applicable EU legislation, several national provisions and instructions have been issued by the Ministry of Agriculture and Food and the DGAL in respect of the production of dairy products and MSM.

2. There are three national provisions for MSM:

Note de Service DGAL/SDSSA/2014-1027 of 18 December 2014, repealing the letter DGCCRF/DGAL of 25 February 2008 concerning the denomination of "viandes gros grains" used for designating the MSM, in order to avoid misleading the user/consumer regarding such meat;

Instruction Technique DGAL/SDSSA/2016-352 of 2 May 2016 on the production requirements of MSM: some of the elements of this instruction do not seem to be fully in line with the EU requirements (see paragraph 69). The CCA informed the audit team that they have submitted a request for legal opinion to the Commission services and is awaiting an answer;

Instruction Technique DGAL/SDSSA/2016-353 of 10 May 2016 on the production of meat preparations, contains interpretative elements for identification of meat preparations and MSM from poultry and lagomorphs.

3. The national provisions for milk and dairy products are:

Instruction Technique DGAL/SDSSA/2019-452 focusing on the production of infant formulae;

Arrêtés of 9 November 2012 (payment of milk based on quality criteria) and of 29 March 2019 (analytical laboratories), as well as Instruction Technique DGAL/SDSSA/2019-584 of 31 July 2019 (screening methods for detection of residues of antibiotics);

4. The national provisions for food safety alerts:

A guide on management of foodborne alerts between food business operators (FBOs) and CAs was revised in July 2009; and

The protocol ensuring coordination between the three CAs was drafted in 2006 and renewed and updated in 2014.

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5. The national provision for the approval of food establishments is the Arreté of 8 June 2006, integrated by Instruction Technique DGAL/SDSSA/2019-38 on the approval procedures and composition of the approval file.

6. The Code de la Consommation (CC) and the Code Rural et de la Pêche Maritime (CRPM) contain enforcement provisions and related sanctions to be applied in cases of food safety issues.

7. The Law No. 2018-938 du 30 octobre 2018 pour l’équilibre des relations commerciales dans le secteur agricole et alimentaire et une alimentation saine, durable et accessible à tous (known as Law "EGAlim") has been published, among other reasons, to correct weaknesses in FBO notifications to the CAs and in the recall/withdrawals of products, both identified during the outbreak of Salmonellosis in infant formulae in 2017-2018. Article 50 of this law, which modifies Article L. 201-7 of CRPM, makes it mandatory for an FBO to inform the CA when they believe that food is not safe and when they are aware that conditions within the working environment can potentially cause a food safety issue (in the latter case, only the corrective measures planned or implemented need to be notified). Article L. 237-2 of the CRPM had also been modified to make it mandatory for any laboratory to make available to the CA, following an official request, all analyses performed in the framework of FBOs’ own-checks. Article 51 defines specific conditions (amendments to Articles L. 423-3, L. 452-5, L. 237-2, L. 237-4 and L. 205-7-1 of the CRPM) for the withdrawal and recall of products by FBOs, including traceability and mass balance of batches and notification to the CAs.

8. Following the publication of Law "EGAlim", the DGAL has issued Instruction Technique DGAL/SDSSA/2019-555 to clarify the application of Article 50. In the preamble, it states that as the FBO holds the primary responsibility for the safety of its products, that they must assess which part of their own-checks would be most likely to detect a food safety risk; only these results must be transmitted/notified to the CA. In case of unfavourable results:

found in products:- if corrective measures are foreseen in the Food Safety Management Plan

(FSMP), are regularly updated and have been proven to be effective (e.g. heat-treatment in case of detection of pathogens, or disposal), then notification to the CA is not mandatory;

- if corrective measures are not foreseen in the FSMP or are not suitable to correct the situation, the CA must be notified of the results and of the corrective actions implemented, including the update of the FSMP;

found in the production environment, the FBO must notify the CA indicating the corrective measures planned or already implemented: on the basis of its FSMP, the FBO can identify which results need to be notified to the CA.

9. The CCA stated that, whilst the above points regarding product do not change the obligations of the FBOs towards the CA, the point on production environment introduces a new obligation. Based on its own risk assessment, if the FBO judges that part of its

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own-checks on the working environment would be most likely to detect a food safety risk, they now have the obligation to inform the CA and provide details of the analytical results, the risk analysis and of the corrective measures planned and implemented. In two of the seven establishments visited there was no evidence that such information, although present, had been forwarded to the CAs.

10. Flexibility measures applicable to FBOs' procedures based on the HACCP principles are laid down in Instruction Technique DGAL/SDSSA/2018-924 (complemented by technical guidelines for specific sectors, including dairy products) and Arrêté of 7 November 2012 laying down requirements for dairy products with traditional characteristics.

11. DGCCRF has issued instructions for its staff, mainly concerning the procedures for the planning and implementation of controls on products that are to be placed on the market for the first time.

Conclusions on legislation and implementing measures

12. The French legislative framework and implementing instructions are suitable, with some exceptions, to provide appropriate legal bases for the performance of official controls.

13. The national provisions on the production and designation of MSM differ in some points from the requirements laid down in the EU regulations.

14. Law No. 2018-938 introduces the obligation for FBOs to notify the CAs in cases where their own checks detect health risks in the products and/or in the working environment. However, the implementing rules that have since been published leave to the FBO's assessment to identify which non-conformities should be notified; thus, such notifications did not occur in two establishments visited.

5.2 COMPETENT AUTHORITIES

Legal requirements

Articles 4 and 6 of Regulation (EC) No 882/2004.

Findings

15. Detailed information on the structure and organisation of the CAs including its centralised administration, 27 regions and 101 departments, can be found in the country profile for France (ref. DG(SANCO)/2011-6092 – hereafter referred to as the country profile for France), which is accessible at: http://ec.europa.eu/food/fvo/country_profiles_en.cfm.

16. Within the scope of the audit three Ministries are involved in the controls over the production of milk, dairy products and MSM:

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The DGAL, of the Ministry of Agriculture, Agri-food and Forestry, divided into regional and departmental services, is responsible for controls over the primary production of animal and non-animal origin, and for the entire chain of food of animal origin. It includes the National Brigade for Veterinary and Phytosanitary Investigations (Brigade Nationale d'Enquêtes Vétérinaires et Phytosanitaires – BNEVP), which is involved when health risks exceed the scope of the departmental and/or regional services. Moreover, the Health Emergencies Unit (Mission Urgences Sanitaires – MUS) acts as the coordinating unit in case of alerts involving foodstuffs;

The DGCCRF of the Ministry of Economy and Finances, divided into regional and departmental services, is responsible for the chain of food of non-animal origin (excluding its primary production), baby food, consumers information, quality and composition of foodstuffs at all stages of the food chain. Its Alert Unit (Unité Alertes – UA) acts as the coordinating unit in case of alerts involving the consumer and supervises withdrawals and recalls. Some controls performed complement those that are performed by DGAL staff, especially on emerging risks such as additives, and endeavour to avoid gaps and overlapping; and

The Directorate General for Health (Direction Générale de la Santé - DGS) of the Ministry of Social Affairs and Health, divided into regional and departmental services, intervenes in health and sanitary crises.

17. At local (departmental) level, DGAL and DGCCRF services are represented in the Departmental Directorates for Social Cohesion and Protection of Population (Directions Départementales (de la Cohésion Sociale) et de la Protection des Populations – DD(CS)PP), which are responsible for the implementation of the control programmes drafted at central level.

18. A protocol ensuring coordination between the three CAs was drafted in 2006 and was renewed and updated in 2014. A further update of this protocol has been envisaged, but not yet initiated. It states the competencies of each CA and thus defines the CCA that is “chef de file” in cases of sanitary alerts. Depending of the organisation of the services at departmental level, an alert unit between local services of DGAL and DGCCRF which is activated on demand, or regular meetings between the services, ensure coordination at local level.

19. Santé publique France (SpF) is the agency created in 2016 grouping four previous public institutions (Institut de Veille Sanitaire - InVS, Institut National de Prévention et d’Education pour la Santé - INPES, Etablissement de Préparation et de Réponse aux Urgences Sanitaires - EPRUS and Adalis - Addiction, Drogue, Alcool Info Service) as a reference centre for public health. One of the tasks of SpF is to ensure the implementation of a system of surveillance to detect health risks nationally (by collecting and analysing statistical data originating from the health organisations (hospitals, research institutes, etc.) and to help decision makers in the national administrations.

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20. The National Agency for Food, Environment and Work Safety (Agence Nationale Sécurité Sanitaire de l’Alimentation, Environnement et Travail – ANSES) provides technical advice to the CAs.

21. The CCA informed the audit team that no major changes have taken place since the last general review in order to update the country profile for France.

22. The national Court of Auditors (Cour des Comptes) carries out audits on control systems: in 2014 and 2018 it carried out audits on the performance of official controls related to food safety and management of food crises. In its audit report in 2018, the Court noted that, although improvements had been noted in the planning/targeting/follow-up of inspections, weaknesses persist at all stages of the control chain on food safety, from the implementation of own-checks by operators to the publication of results of inspections.

23. All but one of the representatives of the local services of DGAL met by the audit team had expressed concern about the availability of sufficient staff to carry out all of the official controls. This situation obliges the services to prioritise the tasks, firstly ensuring the staffing of establishments with the permanent presence of official veterinarians (OVs), then to ensure the performance of national tasks, including certification for export (mainly desk-based). Remaining resources, when available, can be dedicated to other tasks (mandatory or not, according to the national instructions issued annually by DGAL) (see paragraph 45).

24. The audit team was informed that a further re-organisation of the public services will be carried out during the first semester of 2020, which will involve a further concentration of the services at departmental level with the aim of making better use of the limited human resources available.

25. Specific technical knowledge is provided by national reference experts for the dairy, meat and fish sectors (the expert dealing with the dairy sector had also elaborated the specific control vade-mecum) and by a network of experts based at regional or local level (“personnes ressources”). The experts assist the DGAL and the CAs at departmental level and carry out inspections in the establishments at the request of the CAs; they provide help, technical advice and specific training to the DD(CS)PP, which had been documented during this audit. There are eight “personnes resources” with specific skills and knowledge in the dairy sector and they are led by the national reference expert. The National referent for the meat sector was met during the visits to MSM establishments. One “personne resource” for the dairy sector and the two national reference experts met during the audit were found to be skilled and motivated.

26. Any information on raw milk exceeding the criteria for somatic cells count (SCC) and/or for total plate count (TPC), should, according to the CCA procedures, be notified by the food quality and safety (SSA) to the animal health (SA) services of the DD(CS)PP. However, this flow of information is not always well defined and documented (sometimes this is done through e-mails, sometimes by phone calls or in person, etc.).

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The CAs at local level stated that this information may be used to prioritise inspections at holding level.

27. There is no clearly established supervisory system of the activities of the inspectors in the field by their hierarchy at DD(CS)PP level. However, the content of an inspection report is discussed between the inspector and the head of service before it is dispatched to the FBO: this discussion generally focuses on the evaluation of non-conformities and on the appropriateness of their risk categorisation (relevant for the risk classification of the FBO and for the frequency of inspections to be carried out the following year).

28. In two DD(CS)PP visited, the CA stated that a period of mentoring is planned to allow newly recruited staff to become familiar with the internal procedures and to acquire the specific inspection skills.

29. Internal audits are carried out by the relevant service of the CCA on the activities of the DD(CS)PP; all sector should be audited within a cycle of five years. A review of two internal audit reports (neither of which focused on the meat or milk sectors) demonstrated that only minor deficiencies were reported, none of which impacted the activities for ensuring food safety. At the closing meeting the internal audit service provided a report, specific to the dairy sector, of a DD(CS)PP: the conclusions of the audit were classified into strong and weak points, and non-conformities, giving a clear picture of the organisation of the services and of their performance. In this specific dairy sector report provided, the lack of risk analysis to justify the presence or absence of supervision related to the performance of staff (including possible training needs) was raised as a non-conformity, which had already been identified in 2017 and had not yet been addressed.

Conclusions on competent authorities

30. The CAs responsible for food safety have clear competencies and are distributed across the national territory. The network of “personnes resources” significantly supports the CAs and the FBOs with professional advice and training.

31. Communication flows are established within and between the CAs involved.

32. A defined supervisory system of the activities of official staff and DD(CS)PPs is not established; however, some activities such as external and internal audits cover this topic.

5.3 REGISTRATION AND APPROVAL OF FOOD BUSINESS OPERATORS

Legal requirements

Article 6 of Regulation (EC) No 852/2004, Article 4 of Regulation (EC) No 853/2004, Article 3 of Regulation (EC) No 854/2004 and Article 31 of Regulation (EC) No 882/2004.

9

Findings

33. Clear national provisions for the approval of FBOs are available (Arrêté of 8 June 2006 and Instruction Technique DGAL/SDSSA/2019-38), including provisions for granting conditional approvals.

34. Visits and inspection aimed at granting approval/registration to FBOs are not considered part of the working planning (“hors programmation”) but as additional tasks, and they further increase the workload of official staff at local level.

35. The list publicly available on the DGAL website with regard to MSM operators (listing 39 operators) was not up to date: the CCA stated that most of the operators listed are not carrying out MSM production, following controls carried out in preparation of this audit. DGAL had updated its list on 28 November 2019, which now contains 19 approved FBOs.

36. With regard to small cheesemakers processing their own milk or small quantities of milk purchased from other dairies or collection centres (“producteurs fermiers”) it should be noted that three categories of approvals are possible: 1) approved FBOs; 2) registered FBOs; and 3) FBOs “derogataires”, which are not approved but only registered under a specific procedure, as they supply their products only directly to the final consumers. This latter category has limitations with regard to the extent of their market (usually only within an 80 km radius of their premises) and regarding the quantities of products being exceptionally delivered to other retailers (normally not more than 30%).

37. As a result of official controls carried out on a cheesemaker who had notified the CA of the presence of Listeria monocitogenes in their products, the CA noted that the FBO had bought the raw cow milk from a dairy which was not approved as a collection centre. The CA responsible for such a case had been reluctant to take appropriate measures on-the-spot, claiming that there was no risk for safety of final products.

38. The CCA informed the audit team that in case of urgency or relevant sanitary alert, it is more appropriate to suspend the activity of the establishment instead of commencing an administrative procedure aimed at the suspension or withdrawal of its approval. This can be done by Arrêté signed by the representative of the Government at departmental level (“Prefet”), following presentation of a dossier by the local CA. The conditions for re-starting production, should it be the case, follow the same procedure. This has been demonstrated to the audit team during a visit to an establishment that had been involved in a food alert notified through the Rapid alert system for food and feed (RASFF) network.

39. The approval procedure, as noted in previous DG Health and Food Safety audit reports, is nationally linked to the SIRET number (referring to a specific business activity in a physical location), which is obtained by the FBO prior to its application for approval and indication of a specific address for the business. The DD(CS)PP staff did not check, when receiving the FBO application for approval, if the SIRET number indicated in the approval file is linked to a single address of the FBO and to its declared activities; nor is

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such verification carried out during the following “routine” inspection visits. The result of which is that in several cases the approval did not match with the current location of the establishment(s) and/or with its activities. In some cases, this appeared to be as a result of historical updates of the approvals. In particular, the audit team noted that:

two meat establishments (one slaughterhouse for turkeys with annexed cutting plant, and one meat produce plant) located on the same site, but divided by a physical fence and by a private road had received the same approval number;

two dairy establishments located on the same site, but divided by a physical fence and by a private road had received two different approval numbers;

a dairy plant regularly dispatches additional raw sheep milk that exceeds its needs (e.g. the day of the visit 94 000 litres out of a total of 250 000 litres) was not approved as a collection centre;

Three maturation caves for Roquefort cheese, with a distance of 200-300 metres apart and with separate responsible staff (up until 2014 having different approval numbers) were jointly given one approval number;

An establishment melting cheeses was covered by the approval given to the packaging establishment (belonging to the same company), which were located 1°km apart. In particular, the CA could not provide evidence that this melting cheese plant has been approved;

At the approved cheesemaker visited, the FBO had applied in August 2019 for an extension of approval for the activity of maturation/ageing of cheeses. The approval file had been examined by the DD(CS)PP and its update had been requested; the FBO has completed the file which is currently being assessed by the CA (deadline January 2020). During the visit it was noted that the activity of maturation of cheeses in the new room had already started in July 2019 without being covered by a specific approval.

Conclusions on registration/approval of FBOs

40. A clear procedure for approval and registration of FBOs is available for all official staff involved; however, it is not followed. Five out of nine establishments visited were not approved in accordance with the EU requirements.

41. The list of FBOs approved for the production of MSM and dairy products (for this latter concerning some activities) was not up to date and the CAs had no clear overview of the sectors. A modified/updated version of the list of approved MSM operators was only published on 28 November 2019.

5.4 OFFICIAL CONTROLS OVER PRODUCTION AND PLACING ON THE MARKET

Legal requirements

Articles 3, 8, 9, 54 and 55 of Regulation (EC) No 882/2004, Articles 4 and 8 of Regulation (EC) No 854/2004 and Article 1 of Regulation (EC) No 2073/2005.

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5.4.1 Organisation of official controls

42. Specific control plans are issued annually by DGAL, which amend, where necessary, the instructions that were issued the previous year. Instructions Techniques DGAL/SDSSA/2018-656 and DGAL/SDSSA/2019-707 lay down, respectively, the requirements for official controls for 2018 and 2019 and are based on two main plans:

Regular National Surveillance (Surveillance Régulière Nationale – SRN), on approved FBOs, based on an annual risk evaluation and classifying the operators into four risk classes with inspection frequency ranging from biannual (class IV) to once every two years (class I).

Specific National Surveillance (Surveillance Ponctuelle Nationale – SPN), which mainly targets the retail and restaurant sectors, but also includes the small cheesemakers (at a frequency of a minimum of 10% of the total number of operators per year) and direct sale of raw milk at dairy holding level.

43. Risk classification is determined by DGAL by the application of a formula which comprises the outcome of the last inspection and the volume, type and target of production; the reliability of the FBOs, in performing their own-checks and informing the CAs of any real or potential risk, is not weighted appropriately in this formula. It is noted that the highest risk class IV does not necessarily include insufficiently performing FBOs; FBOs with high volumes of production, or targeting highly sensible consumers, may also be included in this class. On the other hand, a very negative notation of one of the elements of the formula does not necessarily lead to an increase in the risk classification of the FBO. Consequently, the risk classification of establishments might not exactly reflect the situation seen by the DG Health and Food Safety audit team during visits to premises (see paragraph 63). Local CAs stated that they may update the risk classification given at central level (only up or down by one class), but this is rarely done.

44. The SRN includes the tasks of permanent presence of official staff (OVs and auxiliaries) at slaughterhouses level, and the “inspections itinérantes” which include all inspections in premises not requiring the permanent presence of inspection staff (e.g. in cutting plants). Priority is given to routine activities as presence in slaughterhouses.

45. The number of “inspections itinérantes” of the SNR and of the SPN can be adapted at local level in relation to local staffing conditions; in the case of the reduction of the number of inspections, the updated programme needs to be validated at the regional level of DGAL. All DD(CS)PPs visited, but one, stated that, due to staffing shortage, some activities within the SNR and the SPN had not been carried out, and that less than 10% of cheesemakers had been inspected (see paragraph 23).

46. Moreover, DGAL has annual targeted control programmes.

47. A few DD(CS)PP, depending on staffing conditions, may have additional local control plans for certain commodities relevant for local producers.

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48. The results of official controls carried out by the DGAL staff are uploaded into the computerised system called RESYTAL; basic information about the products manufactured, the targeted consumers and the size of production are also detailed, allowing the system to automatically calculate the risk of each establishment at the end of each year. During the visits to four DD(CS)PPs, the functioning, the risk classification of FBOs and information on data uploaded in RESYTAL were all demonstrated to the audit team.

49. In 2018 DGAL implemented a surveillance plan, sampling cheeses made with raw milk sampled at producing establishments: 694 cheeses made from cows' milk, 146 from goats' milk and 160 from ewes' milk had been sampled during that year for detection of Listeria m., Salmonella spp. and E.coli STEC. Positive results ranged from 2.2% to 1.8% (Listeria m. in cows' and ewes' milk respectively), from 1.3% to 1.8% (Salmonella in cows' and ewes' milk respectively) and from 0.7% to 1.8% (E.coli STEC in cows' and ewes' milk respectively).

50. The audit team observed that in a number of departments visited, the CAs (DGAL) did not follow-up on the FBOs' shortcomings, identified during official controls, when the deadline had recently expired, but only did so within the yearly timeframe of the inspection cycle. The main justification for this was presented as staff shortages and the heavy workload of existing staff (see paragraph 23). In one case the longest deadline for implementing corrective action given to, or agreed with, the FBO had expired in April 2019, but no follow-up inspection had yet been planned at the time of this audit. The audit team visited the establishment in question and noted that not all corrective actions had as yet been implemented, even though the FBO had informed the CA in May that the action plan had been completed; during this visit, the FBO stated that some corrective actions had never been planned e.g. the identification of a dedicated room in which to store salt (which was still stored outside in the yard at the time of this visit). The local CA claimed that in cases of major non-compliances not being adequately corrected by the FBO within the prescribed deadlines, their detection at the following inspection can then lead to the suspension or withdrawal of the approval: its representatives also claimed that this latter measure might be considered as disproportionate in relation to the presence of the non-compliances.

51. Some follow-up activities are only carried out at the time of the next planned inspection, independently of the deadline given for corrective action, or are based on desk evaluation of the documentation submitted by the FBO (sometimes complemented by photographs documenting the implementation of corrective actions). In some cases, it appeared that generic answers were accepted as satisfactory.

52. The different interpretation between Instruction technique DGAL/SDSSA/2019-555 and of the provisions of Article 50 of the Law “EGAlim” (see paragraph 8) does not lead to a harmonised approach by the relevant services of the DD(CS)PP, as noted by the audit team during the audit.

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53. The DGCCRF organises its controls in two ways:

a specific control plan defined in sub-programmes (“Tâches Nationales” - TNs) targeting particular sectors each year, identified from those sectors that presented a particular relevance for the country. In 2016 one TN focused on meat supplied to canteens (including proper labelling of MSM), in 2018 baby food was one of the topics, whilst in 2019 the relevant TNs included identification of contaminants in infant formulae (laits infantiles) and microbiological quality of food (focussing on Listeria and Salmonella) with follow-up ensured at local level. The results of the analyses performed on the 153 samples of infant formulae showed a 0.65% of non-conformities, resulting in two penal prosecutions;

the national control plan of first marketing (“Contrôle première mise sur le marché” – CPMM), which focusses on the retail sector and verifies compliance with labelling, composition and commercial loyalty requirements.

54. Results of the official controls are uploaded into the DGCCRF managed computerised database. DGCCRF stated that 80% of controls are carried out under the national plans, whereas 20% are carried out as a result of planning at local level. A comprehensive evaluation grid allows the services to classify FBOs into three risk categories, and to include the history of compliance of the establishment among the criteria to be taken into account for the risk assessment. Low risk FBOs are inspected at a frequency of every 5 years, medium risk every 3 years and high risk FBOs are inspected annually.

55. The National Investigation Service (Service National des Enquêtes - SNE) of the DGCCRF, may participate in the implementation of TNs, but may also be responsible for specific investigative tasks, delegated by the State Prosecutors, in cases of sanitary alerts.

5.4.2 Control procedures and verification

56. Since March 2010 the quality management system of the DGAL had been accredited based on the standard ISO 17020, which includes the programme to establish the risk-based frequency of control, the methods of inspection, the reporting of inspection and the qualification of inspectors. However, the DGAL is currently not anymore accredited according to that standard, and is currently following the standard ISO 9001, which has a more extended scope.

57. To facilitate the official controls in the dairy and MSM sectors, the DGAL has developed, in co-operation with the inspectors, two inspection vade-mecums (one general and one specific for the dairy sector) and two check-lists (“grilles d’inspection”) which are published on the internet. In addition, three guidance documents have been published regarding good hygiene practice: one for primary production, one for milk collecting and processing and one for production at farm level. These guides have been validated by the CCA.

58. The audit team noted that the officials were using the check-lists mentioned above.

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59. During the visits, the audit team noted a general inaction of the both OVs and the FBO with regard to the non-compliances noted (e.g. condensation dripping directly onto exposed raw materials/final products/clean equipment ready to be used in production, etc. (see paragraphs 73, 74 and 99 for more details).

5.4.3 Documentation of official controls

60. After each inspection a report with the findings is created and signed by the official. The FBO receives the report with an accompanying letter containing the final decision, signed at Department level. The findings are recorded in the RESYTAL database and are scored, according to their seriousness, within the formula used for the risk classification of FBOs for the following year (see paragraph 43).

61. The follow-up of FBOs’ corrective action plans, submitted to the official services (DGAL and DGCCRF at local level) in response to the CA's findings during official controls, may be carried out through physical inspection or desk evaluation of the dossier.

62. The planning/implementation of corrective actions addressing the recommendations of DG Health and Food Safety's 2010 general audit on official controls (ref. DG(SANCO)/2010-8627) is still being discussed with the CCA (for details see the country profile for France - paragraph 15 above).

63. In several cases seen by the audit team, the reports did not reflect the current situation that was noted by the audit team during the visits to the establishments, in particular in those FBOs that are producing or using MSM: for instance, relevant deficiencies concerning hygiene practices were not mentioned, and incorrect labelling of MSM was not identified (see paragraph 73). In the dairy sector some activities being carried out were not listed (e.g. collection centres of raw milk).

64. The review of the approvals was not carried out or documented in the inspection reports, and this is reflected in the number of establishments that presented conditions not in compliance with the requirements of Article 3 of Regulation 854/2004 and Article 4 of Regulation 853/2004. Flexibility conditions granted to FBOs were also not mentioned in the approvals or in the inspection reports.

Conclusions on organisation of official controls

65. Official controls are planned on the basis of the risk categorisation of FBOs, which does not give the necessary weight to the key elements supporting the categorisation. As a consequence, the frequency of controls and follow-up of previously detected non-conformities may be not appropriate.

66. Specific annual targeted control programmes allow a better use of the limited human resources and an optimal overview over certain sectors.

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5.5 OFFICIAL CONTROLS OVER MECHANICALLY SEPARATED MEAT

Legal requirements

Section V of Annex III to Regulation (EC) No 853/2004.

Findings

67. Following the previous DG Health and Food Safety audit on MSM in 2012 (ref. DG(SANCO)/2012-6434), the CCA undertook to operate changes in the instructions, with the aim of aligning them to the requirements of Regulation (EC) No 853/2004. The instruction that is currently applicable, dated 2016, is:

MSM must be designed and labelled as such at all steps of production, distribution and use. Misleading designations as “viandes gros grain”, “viandes 3 mm” or “viandes egreenes” shall not be used.

68. Recommendation No 1 of the 2012 report ("the CA should ensure that the EU requirements established in Regulation (EC) No 853/2004 on the production of MSM are applied and therefore any instruction related to them is in alignment") was considered, based on desk evaluation of the CCA response, as being satisfactorily addressed.

69. However, the audit team noted the following, which seems to not yet be in line with the EU requirements(1):

Point 3.3.3 of Instruction Technique DGAL/SDSSA/2016-352 allows frozen MSM, as defined at point 4 of Section V to Annex II of Regulation (EC) No 853/2004 (“MSM high pressure”), to be labelled with use by date of three months from their production and freezing. However, both local CAs and FBOs met during the audit considered this deadline to be only mandatory for the first producer; as a consequence, such products were often seen labelled with a durability date of nine months;

Point 1.2.4 of Instruction Technique DGAL/SDSSA/2016-352 allows the definition of meat preparation for MSM obtained in equipment complying with the conditions laid down in point 3 of Section V to Annex II of Regulation (EC) No 853/2004 (“MSM obtained by a method that does not alter the structure of the bone and the calcium content of which is not significantly higher than that of minced meat”). The same national provision states that such products must originate from previously manually cut anatomical parts of the carcases of poultry and lagomorphs, including bones, having been passed through a sieve or holes without mincing, and must present a calcium content not exceeding 300 ppm. The legal reason for such classification by the CA was that the products obtained could not be legally identified as minced meat, nor as meat; however, when it is used as

(1) In their comment to the draft report the French CCA stated that several contacts have been made with the Commission services on the definition of the raw materials/processing able to produce either MSM or meat preparations. In the meantime, the French authorities have drafted national rules allowing products obtained by mechanical separation but maintaining the aspect of muscular fibres to be defined as meat preparations.

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ingredient, it is indicated as “meat of…”, instead of MSM. Moreover, no validated analytical methods are currently available to identify if muscular fibres have been significantly altered.

70. FBOs producing and/or using MSM were inspected at the frequency stated in Instructions Techniques DGAL/SDSSA/2018-656 and DGAL/SDSSA/2019-707. In 2016 a case of incorrect labelling of MSM was brought to the Court; the CCA informed the audit team that first-instance judgement in this case is still pending.

71. In 2016 the SNE of DGCCRF performed a series of controls on meat destined for communities (e.g. canteens, schools, etc.) and found products containing MSM that were incorrectly labelled, for instance as “viandes égrenées”.

72. The CCA stated that some operators are producing, or intend to produce, meat that has been mechanically separated from fleshy bones that then undergo a brining or a cooking treatment, thus not being considered as raw material for MSM production. The CCA has asked for the Commission services' opinion about the correct legal definition of such products.

73. The audit team visited two FBOs producing MSM, and one establishment using MSM for the manufacture of heat-treated meat products. All establishments presented several deficiencies regarding structure as well as hygiene practices, most of which had not been reflected in the inspection reports seen(2). Both FBOs and OVs did not pay the necessary attention to these deficiencies, but relied on the final heat-treatment of the products to ensure their safety. Among the deficiencies noted, the most relevant were:

storage of animal by-products (ABPs) in non-hermetically sealed containers, together with raw materials in the same chiller;

thawing of frozen raw materials in stacked crates, thus allowing thawing blood and water to drip down onto the lower crates;

extensive condensation dripping directly onto exposed raw materials, and the use of hoses to wash the equipment and the rooms where exposed raw materials were stored (large amounts of such water were seen in the crates);

appearance of cracks and damages on covings and other structures.

74. When brought to the attention of the OVs and of the FBOs, such findings did not lead to an immediate corrective action, such as the removal of crates of raw material from the areas where condensation was present and dripping was occurring.

75. Recommendation No 5 of the 2012 report ("the CAs should ensure that MSM sold to other establishments is accompanied by the necessary information which allows FBOs to use it in meat preparations and meat products in accordance with the requirements of points 3(e) and 4(g), Section V of Annex III to Regulation (EC) No 853/2004") was

(2) In their comment to the draft report the French CCA stated that the non-compliances noted in the establishments visited have been mostly corrected, or provisional corrective measures have been put in place when structural works were envisaged. Moreover, the risk classification of two premises has been increased to reflect the current assessment of the establishments.

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considered, based on desk evaluation of the CCA response, as being satisfactorily addressed. In one case seen by the audit team, the transfer of MSM between two adjacent, but distinct, establishments belonging to the same company was not accompanied by the complete information that is required. The final products manufactured in the second establishment were, however, correctly labelled for supplying the required information to the final consumer.

Conclusions on controls over mechanically separated meat

76. National provisions adopted since the previous DG Health and Food Safety audit in 2012 are not yet fully aligned to the requirements of the EU legislation.

77. All visited establishments presented relevant deficiencies that had not been identified by official controls. The officials met during these visits were reluctant to impose immediate corrective actions on the FBOs, resulting in a risk of cross-contamination up to the final products.

5.6 OFFICIAL CONTROLS OVER MILK AND COLOSTRUM PRODUCTION HOLDINGS

5.6.1 Health requirements for raw milk and colostrum

78. Commission Decision 2003/467/EC, establishing the official tuberculosis, brucellosis and enzootic-bovine-leucosis free status of certain Member States and regions of Member States as regards bovine herds, declares France as officially tuberculosis and brucellosis-free. CA surveillance for such diseases is carried out in accordance with the requirements of Council Directive ECC/64/432. Fifty-two departments are free of bovine brucellosis and tuberculosis, and therefore do not perform routine testing of herds, whilst 44 other departments undergo a reinforced surveillance which include regular routine testing in bovine holdings. For both cases the surveillance is complemented by post-mortem inspection procedures at slaughterhouses, with sampling of lesions for culture tests. In case of abortions, material is also sampled at holding level for culture tests. The CCA stated that raw milk of healthy animals from infected herds must undergo mandatory heat treatment before it can be processed.

79. All results concerning animal health controls are uploaded in the animal health database of DGAL, which is available to all official staff having the appropriate access rights.

80. In some of the DD(CS)PPs visited, the exchange of information regarding the health status of the holdings (notification of post-mortem findings or of doubtful/positive results from diagnostic test), did not take place through auditable practices such as by e-mails or letters. However, exchange of knowledge about these findings was positively assessed during the meetings with staff of both services (i.e. public health and animal health).

5.6.2 Hygiene on milk and colostrum production holdings

81. The CAs at local level (and the CCA on an annual basis) receive the results of raw milk analyses performed by the laboratories with regard to TPC and SCC. In cases of non-

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conformities the CAs stated that the holdings may be targeted for inspection by the animal health services of the DD(CS)PPs. However, this had never been the case in the services visited; any enforcement is carried out within the provisions of specific ministerial decrees, the requirements of which are linked to the National Interbranch Agreement (see paragraphs 90, 91 and 93). There are rare cases of raw milk found positive for inhibitory substances which are notified annually.

82. A programme of inspections on dairy holdings is drafted by the DGAL in order to ensure that the provisions of cross-compliance are adhered to: the number of holdings to be visited is defined at CCA level for each year and broken down at regional level among the DD(CS)PPs under their responsibility. A set of checklists is used to cover topics, such as hygiene of milking, animal welfare and the correct use of veterinary medicinal products (VMPs).

83. At the DD(CS)PPs visited, the number of holdings checked under this programme amounted to a few dozen. Some additional inspections may be required for holdings presenting recurrent findings of reactors for tuberculosis and/or brucellosis. In general, the percentage of holdings visited did not exceed 1-2% of the total number.

84. The audit team visited one sheep holding: the hygiene conditions of the milking parlour and the records of medical treatments were satisfactory, with the VMPs seen accompanied by the veterinary prescription. The farmer also used the antimicrobial streptomycin, the detection of which was not covered by the rapid test used by the milk collector (see paragraph 95 for more details).

85. The audit team also visited an approved cheesemaker who was processing his own raw cows' milk, originating from the adjoining holding. His procedures within the FSMP require that in cases of results for SCC exceeding the regulatory limits, the concerned cows must been treated or dried, while separated from the herd; however, none of these actions have been documented in the records for several cows that were examined. Cows showing high SCC (sometimes above 3 million cells, and in one case above 10 million), indicating the occurrence of a severe mastitis, with decrease of milk production of ca. 40%, were not treated or segregated and, at the following check ten days later, showed very low counts (250 000 ca.). No explanation was given by the farmer or by the official inspector for this occurence.

86. In the same holding the farmer stated that, corresponding to the recurrent invasion of voles (Arvicola terrestris) in the region, that excavate the soil, the hay displays a high content of soil. In recent years, the presence of Listeria monocytogenes in raw milk is a regular occurrence and is found both in the raw milk and in the cheeses manufactured therefrom. Disposal of such cheeses has been ordered several times by the CA and has been recorded by the FBO.

87. A FBO manufacturing cheeses from raw milk has, for several years, been testing the bulk milk in the collection trucks for pathogens (Listeria monocytogenes, Salmonella spp. and E.coli STEC); in cases of positive results, the milk is pasteurised and diverted

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for the manufacture of other products. Since the start of the current season, this FBO’s testing programme has been altered to now test each individual farmer's milk.

Conclusions on official controls over milk and colostrum production holdings

88. Official controls on dairy holdings in the field are performed on a small percentage of farms, mainly targeting holdings with recurrent health problems.

89. Desk evaluation of results for raw milk criteria remains the main method used to verify the compliance of dairy production holdings, with enforcement of EU and national provisions in cases of non-compliance left to the application of the ministerial decrees linked to the National Interbranch Agreement.

5.6.3 Controls over raw milk upon collection

90. The price of raw cows' milk is determined by the National Interbranch Agreement (Accord Interprofessionnel National), defining the quality parameters of the milk and is in force for three years. No similar national agreement exists for raw milk of other species, the trade of which is regulated by commercial contracts between farmers and dairies (see paragraph 92). The Agreement that is currently in force was approved under Arreté 13 October 2016 of the Ministry of Agriculture and Food.

91. The National Interbranch Agreement includes provisions for the management of non-compliances with regard to TPC, SCC and the presence of inhibitory substances. Whilst the presence of inhibitory substance renders milk immediately unsuitable for human consumption, the results for TPC and/or SCC that result in the geometric average exceeding the legal limits (so-called “lait hors-normes”) lead to a mandatory, heat-treatment of the milk or to enhanced microbiological verifications on the final products in cases of dairy products made with raw milk (this last option is not in line with the provisions of Annex VI.(a) to Regulation (EC) No. 854/2004). Moreover, if limits are exceeded for more than three months, some periods of interruption of the collection of raw milk might further penalise the farmer, but this is seldom applied.

92. Two separate agreements between farmers and milk processing dairy sector also cover the quality parameters for ewes' milk in the Roquefort cheese production area (covering six departments) and in the south-west area.

93. Fifteen laboratories of the National Interbranch Centre for Dairy Economy (Centre National Interprofessionnel de l’Economie Laitière – CNIEL) analyse the composition and quality of raw cows' milk in order for producers to be paid according the quality of their deliveries. Sheep and goat raw milk is also tested there. The laboratories are also in charge of controls over sampling procedures and sampling devices, at prescribed frequencies. In 2018 the laboratories have carried out 7.5 million analyses, of which 1,461,828 for determination of TPC, 3,043,820 for SCC and 2,865,100 for detection of inhibitory substances.

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94. Flexibility measures foreseen by national legislation/CCA instructions/AOP cahiers des charges allow FBOs producing traditional products to test for bacteria using a method that has better hygiene or safety indicators than those listed in Regulation (EC) No. 2073/2005. One FBO visited had criteria for raw cows' milk that included coliforms (limit 100/ml) instead of TPC.

95. In one dairy, the testing for inhibitory substances was split: the service responsible for collection was testing the raw milk with a test detecting only beta-lactams and tetracycline, whilst the dairy was testing the raw milk with a method of also detecting streptomycin (antimicrobial used in the local farming practice). However, this latter test was carried out on the milk stored in the reception silo, containing the bulk milk originating from several collection routes, with an evident dilutive effect.

96. Reports of analyses of raw milk (both from cows and sheep and goats) seen by the audit team in the DD(CS)PPs offices and at dairies, show excellent results for the vast majority.

Conclusions on controls on raw milk upon collection

97. Controls over raw milk quality are mainly delegated to the National Interbranch Agreement and, in general, document compliant results.

98. Delegated controls also cover sampling procedures at prescribed frequencies.

5.6.4 Official controls at establishment level

5.6.4.1 General and specific hygiene requirements

99. In general, these requirements were complied with in the dairy establishments visited. However, some evident non-compliances, such as like condensation (dripping onto exposed products or onto clean equipment ready to be used in production), or storage of products and raw materials in areas exposed to risks of cross-contamination, were not properly identified and thus not followed-up.

100. Evidence of proper follow-up of corrective actions in response of findings identified by the CA in previous inspections was requested and obtained by the audit team.

5.6.4.2 Hazard Analysis and Critical Control Points based systems

101. All establishments visited had FSMPs in place and implemented. Most of these included extensive testing of final products (e.g. in cases of cheeses made with raw milk) for pathogenic microorganisms (Listeria m, Staphylococcus aureus and Staphylococcal enterotoxin, E.coli STEC and Salmonella spp) and corrective measures to be implemented in cases of positive results. A review of some of these cases showed that the planned measures had been correctly implemented; these ranged from heat-treatment (production of melted cheese) to disposal of an affected product.

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102. In the majority of the cases seen, the inspection reports mentioned the need to update these FSMPs. However, this has not systematically been followed-up on during the next inspection, nor had an update been provided by the FBO to the satisfaction of the inspection staff. In one case, the FSMP covered the activities of two distinct establishments with the same approval number.

5.6.4.3 Microbiological criteria for foodstuffs

103. At the dairy establishments visited, final products were regularly tested for the presence of pathogenic bacteria (Salmonella spp., E.coli STEC and Listeria monocytogenes); any presence detected of such bacteria rendered the products unsuitable for human consumption. In the case of presence of E.coli STEC and Salmonella spp the product is sent for disposal. Products in which Listeria m. is detected may be sent for a sanitising heat-treatment in an approved establishment. The CA procedures include the channelling of product to the plant carrying out the heat treatment, through the issue of a “laissez-passer sanitaire”. However, in most of the cases checked by the audit team, the issuing of a “laissez-passer sanitaire” by the CA was not required and/or requested.

104. In one department, cheeses are generally sent by the cheesemaker to a few warehouses (“affineurs”) for the purpose of ageing and maturation; part of the totality of the cheeses may be sold to the “affineurs”, or the manufacturer may keep some. The transport to the “affineur” is considered by the local DD(CS)PP as being put on the market (“mise sur le marché”), with all the legal consequences (e.g. obligation to immediately inform the CA about the presence of pathogens in the products).

5.6.4.4 Traceability, labelling and identification marking

105. Verification of labelling, identification marking and performance of traceability exercises on final products are the tasks included in the control checklists. Records of official controls showed satisfactory results for such verifications.

106. Some checks on traceability (including quantitative reconciliation) were carried out by the audit team in the establishments visited, with the aim of verifying the accuracy of the official controls, with satisfactory results.

Conclusions on official controls at dairy establishment level

107. Official controls are generally, with some exceptions, able to identify the non-conformities present in the establishments and to follow them properly and within the agreed deadlines.

108. Follow-up of corrective actions in cases of presence of pathogens that may render the products unsafe for human consumption, is generally satisfactory.

109. Traceability and identification marking are subject to official controls with satisfactory results.

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5.7 SAMPLING AND ANALYSIS

Legal requirements

Articles 11 and 12 of Regulation (EC) No 882/2004, Part III of Chapter I, of Section IX of Annex III to Regulation (EC) No 853/2004.

Findings

5.7.1 Sampling

110. As part of the procedures for the performance of official controls, CA staff is required to take official samples of final products manufactured by the FBOs in order to verify compliance with the regulatory requirements. The sampling may include environmental swabs. The choice of the number of samples, the type of products and the areas being sampled are all left to the professional discretion of the personnel.

111. Annual targeted control plans of DGAL (at production establishments) and/or DGCCRF (mainly at retail level) include sampling of the commodities included in the plan.

112. As part of the reinforced official controls in the establishment that had the outbreak of Salmonellosis, the official services of the DD(CS)PP designed and implemented an extensive plan of official sampling in all areas of the renewed premises, on the raw materials, intermediate and final products. Particular attention was paid to the buffer areas between high, medium and low risk areas, to staff and to the equipment used for the movement of materials. Most of the areas sampled were also subject to sampling by FBO staff, so that the CA could also evaluate the reliability of sampling and analyses carried out by the FBO.

113. In other establishments not subject to "reinforced controls", official sampling is not routinely used to verify the reliability of FBOs' sampling procedures, nor for the verification of laboratories' performance, e.g. by "parallel sampling". However, in cases of positive results, follow-up and corrective actions by the FBO are required and documented.

5.7.2 Laboratories

114. Official samples are tested in official laboratories under the networks of the DGAL and DGCCRF; none of these were visited during this audit.

115. For certain analyses, both CAs may contract private laboratories that are accredited according to the ISO 17025 standard.

5.7.3 Methods of analysis

116. All analytical reports seen by the audit team were included in the accreditation scope of the laboratory. Some methods were not the reference ones, but alternative methods validated by the French Agency for Normalisation (AFNOR) against the reference

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methods in accordance with internationally validated protocols. Such methods were included in the official list of validated methods available on the AFNOR website.

Conclusions on official sampling and analysis

117. Official sampling is part of the routine control activities, with adequate follow-up by officials when unfavourable results are documented.

118. In special cases, when reinforced official controls are required, analytical results on official samples also give an indication regarding the reliability of FBO procedures.

5.8 RAPID ALERT SYSTEM FOR FOOD AND FEED

Legal requirements

Article 50 of Regulation (EC) No 178/2002 and Regulation (EU) No 16/2011.

Findings

119. A guide for management of foodborne alerts between FBOs and CAs was been revised in July 2009; a further revision and update is ongoing, but no deadlines have been set for their completion.

120. Moreover, as mentioned at paragraph18, a protocol ensuring coordination between the three CAs is applicable; it identifies the CCA as "chef de file" based on the commodity involved in the alert. Whilst outbreaks involving foodstuffs of animal origin generally fall under the primary competency of DGAL, investigation on outbreaks having identified baby foods and infant formulae as vectors are the of responsibility of DGCCRF.

121. A total of 150 RASFF alerts on dairy products have been notified for France since 2014. Details are given in the table below (*until 11 November 2019):

Salmonella spp. Listeria m. E.coli

STEC

Foreign bodies/hygiene

bacteriaTotal

2014 5 9 10 0 24

2015 6 17 7 31

2016 3 9 7 1 20

2017 6 8 5 1 20

2018 4 10 9 4 27

2019* 4 13 9 2 28

122. In addition, a few hundred alerts are notified to DGAL every year, involving the presence of pathogens in dairy products sold locally by small producers. The audit team

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received documented evidence of the CAs action in a few cases that were randomly selected during the visits to the DD(CS)PPs offices.

123. The audit team followed-up the RASFF notification on the presence of Salmonella in cheese made from raw milk. The actions undertaken by the FBO, in coordination with the local CA, involved the recall and the re-direction of the product to heat-treatment (production of melted cheese). Furthermore, the FBO had implemented a sampling scheme to verify the absence of pathogens in the raw milk and diverted the affected milk to heat-treatment and for the production of alternative products.

124. Moreover, the audit team specifically followed-up the notification related to the presence of Salmonella Agona in infant formulae in 2017 (Salmonella outbreak), which involved more than 3,300 batches, more than 11,000 tonnes and a total of 12 million units of product distributed in 86 countries, and affected 40 infants with clinical signs of salmonellosis. The actions undertaken by the CAs (including the DGAL and DGCCRF at central level) included suspension of activity, enforcement of renovation of structures and of new layout of the premises, intensive sampling and analyses of raw materials, products and the environment (under the responsibility of both the FBO and the CAs), all while under a limited scale of production, until full scale production was re-authorised.

125. With regard to the same outbreak, the CAs undertook to supervise a massive recall of products nationally from retail outlets, hospitals, clinics, pharmacies, etc.; a Ministerial Decree was issued to identify a list of batches larger than what was initially communicated by the FBO. At the closure of the recall the CCAs were informed that more than 2 000 of units of product had been not recalled and were still on the shelves, accessible by consumers. Investigations were carried out which resulted in the detection of incorrect practices (e.g. products not identified as having been recalled, staff not informed, etc.) at the FBO's premises: about 50 administrative procedures have been launched by the CAs as a result of these incorrect practices.

126. The recall of implicated batches from third countries required more time; the audit team was informed that the last container was returned to France shortly before the start of this audit.

127. The activity of the affected production premises was suspended at the initiative of the Government’s representative at department level - Prefet (see paragraph 38) and strict production conditions were set up prior to resumption of its operation. The layout of the premises has been completely changed, an extensive sampling plan (more than 4 000 samples/month) has been drafted and implemented, in parallel with a reinforced official sampling plan, and a mandatory monthly communication to the CA of all analytical results also takes place.

Conclusions on Rapid Alert System for Food and Feed

128. Procedures are in place in order to ensure that RASFF notifications are investigated and followed-up; in addition, numerous "national" notifications of presence of pathogens in dairy products are notified to CAs. Both are generally well followed-up

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and documented.

129. Stricter procedures and actions were implemented at the time of the outbreak of Salmonellosis in infant formulae, allowing FBO to resume production only after full implementation of the corrective measures were agreed and supervised by the CAs at all levels.

130. Some inaccuracies in the recall of affected products from retailers have identified weaknesses in FBOs' recall and withdrawal procedures, subject to administrative actions initiated by the CAs.

5.9 FOLLOW UP

131. The table below summarises the follow-up to the relevant recommendations made in report DG(SANCO)/2012-6434 MR Final. (Close-Out-Note: Adequate responses were provided by the CA for recommendations Nos. 1, 2 and 5. However, the responses provided for recommendations Nos. 3, 4 and 6 cannot be considered as satisfactory. Follow-up of all recommendations is still required).

No Previous recommendation Assessment

3 The CA should ensure that EU requirements for the production and use of each type of MSM are respected (Chapter III (3) and (4) of Section V of Annex III to Regulation (EC) No 853/2004).

Not addressed.

See finding, paragraphs 69, 73 and 74.

See recommendation No 3 of this audit report.

4 The CAs should ensure that, when non-compliances are identified during official controls, these are followed-up and that effective enforcement actions are taken. (Article 54 and 55 of Regulation (EC) No 882/2004).

New applicable legislation: Article 138 of Regulation (EU) 2017/625.

Not addressed.

See findings, paragraphs 73 and 74.

See recommendation No 2 of this audit report.

6 The CAs should ensure that the products destined to the final consumers are labelled in accordance with the requirements of Directive 2000/13/EC and of paragraph 2, section VI of Annex III to Regulation (EC) No 853/2004.

Addressed.

See finding, paragraph 75.

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6 OVERALL CONCLUSIONS

The CAs responsible for food safety have clear competencies and are distributed efficiently across the national territory, with communication flows established within and between the CAs involved. The network of "personnes resources" effectively supports the CAs and the FBOs with professional advice and training.

The national legislative framework and implementing instructions are suitable for the provision of appropriate legal bases for the performance of official controls, although certain elements of the national provisions on the production and designation of MSM differ from the requirements laid down in the EU regulations.

A clear procedure for the approval and registration of FBOs is available for all official staff involved; however, it is not followed. Five out of nine establishments visited were not approved in accordance with the EU provisions.

Official controls are planned on the basis of the risk categorisation, which does not always reflect the real situation of the establishments and the FBOs' performance. As a consequence, the frequency of controls and follow-up of previously detected non-conformities may be not appropriate.

All establishments visited that produce MSM presented significant deficiencies, which had not identified by official controls or adequately followed-up. The officials met during these visits were reluctant to impose immediate corrective actions on the FBOs.

In the dairy sector, official controls on holdings are performed on a small percentage of farms, whilst desk evaluation of results for raw milk criteria remains the main method to verify their compliance with hygiene requirements. A robust and reliable system of controls over raw milk criteria has been delegated to the National Interbranch Agreement, with responsibility for enforcement in cases of non-compliances.

Official controls are generally, with some exceptions, able to identify the non-conformities present in the dairy establishments (including cases of presence of pathogens which may render the products unsafe for human consumption) and to follow-up properly and within the agreed deadlines.

Procedures are in place in order to ensure that RASFF notifications are investigated and followed-up; in addition, numerous "national" notifications of presence of pathogens in dairy products are notified to the CAs. Both are generally well followed-up and documented.

Stricter procedures and actions have been implemented at the time of the outbreak of Salmonellosis in infant formulae, allowing the production to resume only after full implementation of the corrective measures agreed and supervised by the CAs at all levels. Some inaccuracies in the recall of affected products from the market point to weaknesses in

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the recall and withdrawal procedures and are currently subject to administrative actions initiated by the competent authorities.

7 CLOSING MEETING

A closing meeting was held on 13 December 2019 with the CCAs in Paris. At this meeting the audit team presented the findings and preliminary conclusions of the audit. During this meeting, the CCAs acknowledged the findings and conclusions presented and provided some additional information.

8 RECOMMENDATIONS

No. Recommendation

1. The competent authority should ensure that the criteria for the risk assessment of food producing establishments, as required by Article 3 of Regulation (EC) No 882/2004 (since 14/12/2019 Article 9 of Regulation (EU) 2017/625), based upon which the frequency of the inspection of an establishment is established, are reliable and correctly reflect the real conditions of the inspected food producing establishments, by:

envisaging the introduction in the formula of a “corrective factor” to take into account particular non-conformities identified during previous inspections;

ensuring that the official veterinarians correctly evaluate any non-conformities and categorise them by relevance and gravity.

Recommendation based on conclusion No 65.

Associated findings Nos 43 and 60.

2. The competent authority should ensure official controls identify relevant non-compliances and that the action plans presented by food business operators to correct any non-compliances are evaluated and verified within the specified deadlines, as required by Article 54 of Regulation (EC) No 882/2004 ( since 14/12/2019 Article 138 of Regulation (EU) 2017/625).

Recommendation based on conclusions Nos 65 and 77.

Associated findings Nos 5, 50, 51, 59, 63, 64, 73,74, 99 and 102.

3. The competent authority should ensure that the definition and the production of mechanically separated meat is brought in line with that of Regulation (EC) No 853/2004, in its Section V to Annex III.

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No. Recommendation

Recommendation based on conclusions Nos 76 and 77.

Associated findings Nos 69, 72, 73, 74 and 75.

4. The competent authority should ensure that approvals of food producing establishments are kept up to date and are reflected in the lists made publicly available by the central CA, as required by Article 31.2 of Regulation (EC) No 882/2004 (since 14/12/2019 Articles 10(2), 138(2)(j) and 148 of Regulation (EU) 2017/625 and Article 45 of Commission Implementing Regulation (EU) 2019/1715).

Recommendation based on conclusions Nos 40 and 41.

Associated findings Nos 35, 37 and 39.

5. The competent authority should ensure that a system of supervision is established of the performance of official staff that are carrying out official controls, as required by Article 12.2 of Regulation (EU) 2017/625.

Recommendation based on conclusion No 32.

Associated findings Nos 27 and 29.

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=2019-6668

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. 852/2004 OJ L 139, 30.4.2004, p. 1, Corrected and re-published in OJ L 226, 25.6.2004, p. 3

Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs

Reg. 853/2004 OJ L 139, 30.4.2004, p. 55, Corrected and re-published in OJ L 226, 25.6.2004, p. 22

Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin

Reg. 2073/2005 OJ L 338, 22.12.2005, p. 1-26

Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs

Reg. 1169/2011 OJ L 304, 22.11.2011, p. 18-63

Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004

Dir. 98/83/EC OJ L 330, 5.12.1998, p. 32-54

Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption

Reg. 2074/2005 OJ L 338, 22.12.2005, p. 27-59

Commission Regulation (EC) No 2074/2005 of 5 December 2005 laying down implementing measures for certain products under Regulation (EC) No 853/2004 of the European Parliament and of the Council and for the organisation of official controls under Regulation (EC) No 854/2004 of the European Parliament and of the Council and Regulation (EC) No 882/2004 of the European Parliament and of the Council, derogating from Regulation (EC) No 852/2004 of the European Parliament and of the Council and amending Regulations (EC) No 853/2004 and (EC) No 854/2004

Dir. 64/432/EEC OJ 121, 29.7.1964, p. 1977-2012

Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine

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

Reg. 16/2011 OJ L 6, 11.1.2011, p. 7-10

Commission Regulation (EU) No 16/2011 of 10 January 2011 laying down implementing measures for the Rapid alert system for food and feed

Reg. 2019/627 OJ L 131, 17.5.2019, p. 51–100

Commission Implementing Regulation (EU) 2019/627 of 15 March 2019 laying down uniform practical arrangements for the performance of official controls on products of animal origin intended for human consumption in accordance with Regulation (EU) 2017/625 of the European Parliament and of the Council and amending Commission Regulation (EC) No 2074/2005 as regards official controls