EUROPEAN COMMISSIONHEALTH AND CONSUMERS DIRECTORATE-GENERAL

Directorate F - Food and Veterinary Office

FINAL REPORT OF AN AUDIT

CARRIED OUT IN

FRANCE

FROM 23 JANUARY TO 03 FEBRUARY 2012

IN ORDER TO EVALUATE THE OFFICIAL CONTROLS ON FOOD SAFETY AND PROCESS HYGIENE CRITERIA (COMMISSION REGULATION (EC) NO 2073/2005)

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.

DG(SANCO) 2012-6330 - MR FINAL

Ares(2012)1036496

Executive SummaryThe report describes the outcome of a Food and Veterinary Office (FVO) audit in France which took place from 23 January to 3 February 2012. The objective of the audit was to evaluate the official controls of food safety and process hygiene criteria (Commission Regulation (EC) No 2073/2005). The French competent authorities (CAs) are well organised with clearly defined responsibilities. The audit team identified some shortcomings in relation to enforcement measures taken and the implementation of the annual official control plans. The system of official controls is risk-based and was applied in the departments visited largely according to the instructions. The national control plan comprises minimum inspection frequencies that were established based on a risk assessment and considered appropriate and to be in line with Article 3 of Regulation (EC) No 882/2004. However, the inspection frequencies applied in relation to certain food processing sectors were significantly lower than those determined at national level and therefore not appropriate. In addition the audit team noted deficiencies in relation to the availability of OVs for ante- and post-mortem controls in slaughterhouses (SHs) and the implementation of the annual control plans in two of the departments visited. The authorities of the Directorate General of Food (DGAL) and the authorities of the Directorate General of Competition, Consumer Affairs and Fraud Repression (DGCCRF), had prepared instructions and guidance documents on the requirements of Regulation (EC) No 2073/2005. The two networks of laboratories involved in controls of foodstuffs were well organised. However, the national reference laboratory (NRL) for Listeria monocytogenes (L. monocytogenes) was only starting to carry out its duties as a NRL. The methods used for sampling and analysis in the context of official controls and food business operators' (FBOs) own controls were adequate. Comprehensive microbiological surveillance and monitoring programmes were implemented for different types of foodstuffs of animal and non-animal origin. The French CA do not consider official sampling as a primary tool to validate or verify the FBOs' Hazard Analysis Critical Control Points (HACCP)-based programmes. Accordingly, no official sampling had been carried out for this purpose in the departments visited. The official sampling was also limited in relation to alerts and files on food poisoning investigations studied by the audit team. The controls over HACCP-based procedures by the DGAL staff of the local competent authority (LCA) covered the relevant parts of the procedures and had been carried out with the planned frequency in most of the establishments visited by the audit team. Shortcomings were noted in the implementation of controls by the DGCCRF staff in the plant visited producing sprouted seeds. Two of the FBOs and two of the CAs met did not have a proper awareness of all HACCP requirements and the specific requirements concerning HACCP in Article 4 of Regulation (EC) No 2073/2005. Some shortcomings were noted in relation to the CA's evaluation of the HACCP-based principles. The controls over FBOs' compliance with food safety criteria were carried out in most aspects in compliance with the requirements of Regulation (EC) No 2073/2005 in eight of the nine establishments visited (excluding the plant producing sprouted seeds). The controls over FBOs' requirements over process hygiene criteria were carried out adequately in eight out of nine establishments visited. The controls over carcass sampling rules had not been carried out adequately in the red meat SH visited. Although most of the FBOs visited had included testing of processing areas and equipment for L. monocytogenes, two FBOs manufacturing ready to eat (RTE) foodstuffs supporting the growth of this pathogen had not complied with this requirement of Article 5(2) of Regulation (EC) No 2073/2005. Two of the FBOs visited had not complied with the requirements for shelf-life studies and analysis of trends, as stipulated in Articles 3(2) and 9 of Regulation (EC) No 2073/2005. The report includes a number of recommendations addressed to the French CAs aimed at rectifying the shortcomings identified and improving the control systems in place.

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 NATIONAL LEGISLATION/CONTROL AND VERIFICATION PROCEDURES/CRITERIA AND GUIDELINES ....................3 5.2 COMPETENT AUTHORITIES ................................................................................................................7

5.2.1 DESIGNATION OF THE COMPETENT AUTHORITIES ..........................................................................7 5.2.2 CO-ORDINATION BETWEEN COMPETENT AUTHORITIES ....................................................................8 5.2.3 CO-ORDINATION AND CO-OPERATION WITHIN COMPETENT AUTHORITIES .............................................8 5.2.4 LEGAL POWERS FOR PERFORMANCE OF CONTROLS ..........................................................................9 5.2.5 STAFFING PROVISIONS, FACILITIES, QUALIFICATIONS AND TRAINING .....................................................9 5.2.6 ENFORCEMENT REQUIREMENTS ................................................................................................10

5.3 LABORATORY NETWORK ................................................................................................................11 5.3.1 LABORATORY ACCREDITATION AND QUALITY CONTROLS ...................................................................12 5.3.2 NATIONAL REFERENCE LABORATORIES ........................................................................................12

5.4 METHODS OF SAMPLING AND ANALYSIS ............................................................................................14 5.4.1 METHODS USED FOR OFFICIAL SAMPLING AND TESTING .................................................................14 5.4.2 METHODS USED IN THE FRAMEWORK OF FBOS' OWN CONTROLS ....................................................14

5.5 OFFICIAL CONTROLS .....................................................................................................................14 5.5.1 ORGANISATION OF OFFICIAL CONTROLS ......................................................................................16 5.5.2 OFFICIAL SAMPLING AND TESTING ............................................................................................18 5.5.3 CONTROLS OVER HACCP-BASED PROCEDURES .........................................................................22 5.5.4 CONTROLS OVER FBOS' COMPLIANCE WITH FOOD SAFETY CRITERIA ................................................23 5.5.5 CONTROLS OVER FBOS' COMPLIANCE WITH PROCESS HYGIENE CRITERIA ..........................................24 5.5.6 CONTROLS OVER SAMPLING AND TESTING OF PROCESSING AREAS AND EQUIPMENT (ESPECIALLY FOR L. MONOCYTOGENES WHEN MANUFACTURING READY-TO-EAT FOODS) ..............................................................25 5.5.7 CONTROLS OVER ALTERNATIVE SAMPLING AND TESTING PROCEDURES ................................................26 5.5.8 CONTROLS OVER SHELF-LIFE STUDIES AND OVER ANALYSES OF TRENDS .............................................26 5.5.9 SUPERVISION OF IN-HOUSE AND OTHER PRIVATE LABORATORIES USED BY THE FBOS FOR MICROBIOLOGICAL ANALYSES OF FOODSTUFFS ................................................................................................................28

5.6 LABELLING REQUIREMENTS FOR MINCED MEAT, MEAT PREPARATIONS AND MEAT PRODUCTS INTENDED TO BE EATEN COOKED ...................................................................................................................................28

6 CLOSING MEETING ................................................................................................................29 7 OVERALL CONCLUSION ..........................................................................................................29 8 RECOMMENDATIONS ...............................................................................................................29ANNEX 1 - LEGAL REFERENCES .................................................................................................31

ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT

Abbreviation ExplanationAFNOR French Standardisation Body (Association Française de

Normalisation)

ANSES French National Food, Environment and Work Safety Agency (l’Agence Nationale de Sécurité Sanitaire, de l'Environnement et du Travail)

CA(s) Competent Authority(ies)CCA(s) Central Competent Authority(ies)CCP Critical control point

cfu Colony-forming units

COFRAC French Accreditation Body (Comité Français d'Accréditation)

DDPP/ DD(CS)PP Departmental Direction in charge of the Protection of the Population / Departmental Direction in charge of Social Cohesion and Protection of the Population (Direction Départementale en charge de la Protection des Populations/Direction Départementale en charge de la Cohésion Sociale et de la Protection de Populations)

DGCCRF Directorate General of Competition, Consumer Affairs and Fraud Repression (Direction Générale de la Concurrence, de la Consommation et de la Répression des Fraudes)

DGAL Directorate-General for Food (Direction Générale d’Alimentation)

DGS Directorate-General for Health (Direction Générale de la Sante)

DG(SANCO) Health and Consumers Directorate-GeneralEN European NormEURL European Union Reference laboratory E.coli Escherichia coliEC European CommunityEU European UnionFBO(s) Food Business Operator(s)FVO Food and Veterinary OfficeHACCP Hazard Analysis critical control pointsHP Set of the following Regulations: Regulations (EC) No 852/2004,

No 853/2004, No 854/2004, No 882/2004ISO International Organisation for StandardisationLCA Local competent authority(DDPP/DDCSPP)

L. monocytogenes Listeria monocytogenesMAAPRAT Ministry of Agriculture, Food, Fisheries, Rural Areas and

Territories (Ministère de l’Agriculture, de L’alimentation, de la Pèche, de la Ruralité et de L'aménagement du Territoire)

MINEFI Ministry of Economy and Finances (Ministère de l'Économie et des Finances)

MS Ministry of Health (Ministère chargé de la Santé)NRL National Reference laboratoryOV Official veterinarianRASFF Rapid Alert System for Food and FeedRTE Ready-to-eatS. aureus Staphylococcus aureusSCL Central Laboratory of the DGCCRF (Service Commun des

Laboratoires)SH SlaughterhouseSp Subspecies

1 INTRODUCTION

The audit to evaluate the official controls on food safety and process hygiene criteria (Commission Regulation (EC) No 2073/2005) in France formed part of the FVO's planned audit programme. It took place from 23 January to 3 February 2012. It is part of a series of audits to eight Member States in 2011 and 2012. The audit team comprised three inspectors from the FVO and two observers from the Canadian Food Inspection Agency. The audit team was accompanied during the whole audit by a representative of the central competent authority (CCA), the DGAL of the Ministry of Agriculture, Food, Fisheries, Rural Areas and Territories (Ministère de l’Agriculture, de l’alimentation, de la Pèche, de la Ruralité et de l'aménagement du Territoire, MAAPRAT) and partly by a representative of the DGCCRF of the Ministry of Economy and Finances (Ministère de l'Économie et des Finances, MINEFI). An opening meeting was held on 23 January with the CCA. At this meeting, the objectives of, and itinerary for the audit were confirmed by the audit team and the control systems were described by the authorities.

2 OBJECTIVES AND SCOPE

The objective of the audit was to evaluate the implementation of official controls on food safety and process hygiene criteria, mainly in products of animal origin, including in addition RTE foods, pre-cut RTE fruits and vegetables, and unpasteurised fruit and vegetable juices, in the framework of Regulations (EC) No 178/2002, No 852/2004, No 853/2004, No 854/2004, No 882/2004 and No 2073/2005.

The scope of the audit covered the chain involved in the production of the above foodstuffs (from the establishment receiving the primary products to retail). Special emphasis was given to the implementation of the official controls in relation to RTE foods and to the use of shelf-life (durability) studies or other scientific based demonstration of the implementation of the Listeria criteria in RTE foods and the application of the criteria in the absence of such studies.

The table below lists the activities of the establishments visited and meetings held in order to achieve the objectives of the audit:

Meetings/Visits No CommentsCompetent authorities

Central 2 With representatives of MAAPRAT and MINEFI Opening and closing meeting

Local (Department level)

3 Departmental Direction of the Population/Departmental Directorate for Social Cohesion and Protection of the Population (Direction Départementale de la Protection des Populations/Direction Départementale de la Cohésion Sociale et de la Protection de Populations)

Laboratories Reference/central

2 National and Community reference laboratory for Listeria monocytogenes (L. monocytogenes) and Staphylococcus aureus (S. aureus) and its enterotoxins

1 central laboratory of the DGCCRF (Service Commun des Laboratoires, SCL)

Local 2 2 Departmental laboratories of the DGAL laboratory

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networkFBOs 1 pig SH and cutting plant also producing meat products and

preparations 1 pork meat products and preparations establishment 1 establishment producing poultry meat preparations and products 1 dairy establishment 2 fish processing establishments (1 sushi and 1 fishery products plant)1 establishment producing egg products1 establishments producing RTE sprouted seeds and salads1 establishment producing RTE salads and composite products

FBOs' own control laboratories 1

3 LEGAL BASIS

The audit was carried out under the general provisions of the legislation of the European Union (EU) and, in particular Article 45 of Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules.

References to relevant EU legislation are given in Annex I and refer, where applicable, to the last amended version.

In addition to the standards established by the EU legislation against which the evaluation was carried out, account was taken of the relevant international standards, in particular the standards, guidelines and recommendations developed by Codex Alimentarius and the International Organisation for Standardisation (ISO).

4 BACKGROUND

The Hygiene Package (HP) and Regulation (EC) No 2073/2005 provide specific rules on FBO's obligations in relation to food safety and process hygiene criteria and official controls over these criteria. FVO audits to eight Member States on official controls in relation to food safety and process hygiene criteria have been scheduled in 2011-2012. This is the first audit round in the Member States targeted at official controls solely on this area of activity.

Several FVO audits to France covering different sectors of food and feed production were carried out in 2010. The reports of the individual audits can be found at:

http://ec.europa.eu/food/fvo/ir_search_en.cfm

The number of rapid alert notifications made in 2010 related to foodstuffs produced in France are given in the table below.

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Commodity Number of alerts

Notified by France

Notified by another country

Comments

Bivalve molluscs and products thereof

6 1 5 Mostly norovirus

Cereals and bakery products

1 1 0 Staphylococcus sp.

Fish and fish products 4 3 1 All L. monocytogenes Fruits and vegetables 2 0 2 1 Norovirus and 1

SalmonellaMeat and meat products (other than poultry)

10 9 1 5 L. monocytogenes, 2 Salmonella, 3 unidentified

Milk and milk products

5 4 1 3 L. monocytogenes, 2 Salmonella (all from cheeses)

In total 28 18 10

The number of foodborne outbreaks in 2010 caused by bacteria or viruses was 611. Most outbreaks were caused by Staphylococcal enterotoxins (220), followed by Salmonella (139), norovirus (110), Bacillus cereus (61), Clostridium perfringens (45), Campylobacter (20) and enteropathogenic Escherichia coli (E. coli, 7). No food-borne outbreaks caused by L. monocytogenes were reported in 2010. The causative agent of a large number of the outbreaks could not be identified (344).

5 FINDINGS AND CONCLUSIONS

5.1 NATIONAL LEGISLATION/CONTROL AND VERIFICATION PROCEDURES/CRITERIA AND GUIDELINES

Legal requirements

Article 291.1 of the Treaty on the functioning of the EU requires that the Member States adopt all measures of national law necessary to implement legally binding Union acts.

Article 8(1) of Regulation (EC) No 882/2004 requires that CAs carry out official controls in accordance with documented procedures. These procedures shall contain information and instructions for staff performing official controls.

Article 7 of Regulation (EC) No 852/2004 stipulates that Member States shall encourage the development of national guides to good practice for hygiene and for the application of HACCP in accordance with Article 8 of the Regulation and that Community Guides should be developed in accordance with Article 9 of the Regulation. Article 8.1 of the same Regulation stipulates that national guides to good practice shall be developed and disseminated by food business sectors in consultation with the stakeholders. The guides should have regard to relevant codes of practice of the Codex Alimentarius. The Member States shall forward the national guides to the Commission. According to Article 3.2 of Regulation (EC) No 2073/2005 guidelines for conducting shelf-life

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studies may be included in the guides to good practice referred to in Article 7 of Regulation (EC) No 852/2004.

Findings

National legislation

The audit team received the following national legislation covering controls of food safety and process hygiene criteria of food of non-animal origin:

• Decree on hygiene rules on certain foods and food preparations for human consumption of 28 May 1997;

This Decrees comprises hygiene rules for both raw and heat-treated vegetables;

• Decree No 2009-1121 of 16 September 2009 concerning the application of Article L. 214-1 of the Consumer Code on hygiene of products of non-animal origin and foodstuffs containing such products; and

• Decree of 9 May 1995 on hygiene rules for direct sales.

The following national legislation in relation to controls on food safety on foodstuffs of animal origin was provided to the audit team:

• Ministerial Decree of 8 June 2006 on approval of establishments placing on the market foodstuffs of animal origin and products containing foodstuffs of animal origin; and

• Ministerial Decree of 28 December 2011 on sanitary rules applicable to products of animal origin and foodstuffs containing such products.

The CCA had prepared a national guideline on alerts and stated this would be forwarded to the Commission Services.

Guidance documents and instructions of the DGAL

The DGAL procedures for carrying out inspections in different types of establishments manufacturing food of animal origin are compiled in a single structured source of information (vademecum, hereafter referred to as the handbooks). Each handbook includes the legal framework for the inspections comprising both the EU Regulations (HP, Regulation (EC) No 2073/2005, Regulation (EC) No 178/2002) as well as the relevant national legislation and possible flexibility rules and comprehensive instructions and guidance on how to carry out the inspections. The handbooks are specific to the various kinds of foodstuffs of animal origin. The items to be checked are all listed in a numerical way and the numbers correspond to the same points covered in the harmonised check-lists. The requirements of the Regulation (EC) No 2073/2005 are covered in point E09 and HACCP in point G12. The guidance document also refers to specific Service Notes and other guidance documents if they are relevant for the aspects that form part of the inspection activity.

The DGAL has issued several Service Notes which detail and clarify regulatory requirements and contain additional guidance. The most relevant Service Notes are listed below:

• Service Note DGAL/SDSSA/N2011-8285 of 26 December 2011 on modification of an earlier note on microbiological criteria applicable on carcasses (red meat and poultry) and guidelines for own controls of surfaces in slaughterhouses and cutting plants (red meat and poultry);

This note details the requirements of Regulation (EC) No 1086/2011, which modifies

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Regulation (EC) No 2073/2005 (Introduction of Salmonella typhimurium and Salmonella enteritidis as food safety criteria for fresh poultry meat);

• Service Note DGAL/SDSSA/N2007-8275 of 11 November 2007 on microbiological criteria applicable for carcasses;

• Service Note 2008-8009 of 14 January 2008 (modified by Service Note N2009-8247 and N2010-8245) on procedures for the implementation of microbiological analyses of food and operating results;

• Service Note DGAL/SDSSA/N2010-8245 of 23 August 2010 modifying the above Service Note;

This note specifies and explains the requirements of the HP, and especially the requirements on microbiological criteria. Requirements such as validation and verification of the HACCP-based principles, the use and limits of microbiological criteria, sampling programmes, analysis methods and selection of laboratories are explained.

• Service Note DGAL/SDSSA/N2008-8056 of 17 March 2008 on controlling health risk in poultry abattoirs (link with HACCP procedure);

• Service Note DGAL/SDSSA/N2008-8290 of 20 November 2008 establishing the list of hazards and priority inspection points in slaughterhouses, including check-lists and reporting forms;

• Service Note DGAL/SDSSA/N2010-8062 of 9 March 2010 on shelf-life of foodstuffs;

• Service Note DGAL/SDSSA/N2008-8041 of 27 February 2008 on microbiological analysis in the framework of official controls;

Service Note DGAL/SDSSA/N2008-8044 of 4 March 2008 on manufacturing minced meat and meat preparations in approved establishments and establishments with derogations;

This Service Note includes guidance on sampling and microbiological testing of minced meat and meat preparations; and

• Service Note DGAL/SDSSA/N2006–8138 of 7 June 2006 on inspection of HACCP based principles in the framework of official controls (except primary production).

In addition to the above guidelines, several guidelines on food hygiene criteria have been developed by national industry organisations. These are available on the corresponding web pages. The audit team received industry guidelines destined for the distribution level, for FBOs dealing with poultry meat, rabbit meat and game meat, for butchers shops, for restaurants, and for artisanal butchers shops.

Guidance documents and instructions of the DGCCRF

The instructions of the DGCCRF have been provided to the inspectors in the form of Service and Information Notes (as listed below). The central laboratory of the DGCCRF (Service Commun des Laboratoires, SCL) has also prepared some instructions.

• Service Note No 2006-10 on the consequences of the HP for the controls on foodstuffs destined for human consumption1;

1 In their response to the draft report, the CAs noted that Annex III of this Note has been replaced by Service Note No 2007-22.

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This note explains the consequences of the entry into force of the HP, including Regulation (EC) No 2073/2005.

• Service Note 2007-22 on microbiological sampling. The note comprises microbiological criteria and additional sampling requirements for different product groups. The Note is under revision.

• Information Note No 2009-105 on managing alerts; and.

• SCL Instruction IN-CS-01 of 18 April 2011 on sampling, interpretation and conclusions of microbiological analysis.

This instruction covers microbiological criteria for several types of foodstuffs and also includes in addition to the criteria of Regulation (EC) No 2073/2005 national criteria for foodstuffs at retail level (for example, criteria for L. monocytogenes in spices and aromatic herbs at distribution level). It also includes in its Annex II an interpretation of the results if the limits for different microbiological criteria are exceeded.

The French Standardisation Body (Association Française de Normalisation, AFNOR) has established detailed guidelines for the FBOs for carrying out challenge tests and shelf-life tests. The National Food, Environment and Work Safety Agency (l’Agence Nationale de Sécurité Sanitaire, de l'Environnement et du Travail, ANSES) has prepared several opinions and scientific advice in relation to the sampling plans of foodstuffs for pathogens and process hygiene criteria. These documents were provided to the audit team. In addition, the audit team received a draft industry guideline on good hygiene practices and the application of HACCP practices for raw RTE vegetables. The guideline also covers germinated sprouts and RTE fruits and vegetable/fruit juices.

Observations:

• The national Decree on hygiene rules on certain foods and food preparations for human consumption of 28 May 19972 includes testing of RTE raw vegetables for E. coli as required in point 2.5. of Chapter 2 of Annex I to Regulation (EC) No 2073/2005 but does not include the testing of vegetables and fruits for the food safety pathogens L. monocytogenes and Salmonella.

• The draft industry guidelines for raw RTE vegetables are of a general nature and do not specify, for example, the microbiological dangers on a microbial species level3.

• Annex 2 to the SCL Instruction IN-CS-01 of 18 April 2011 on sampling, interpretation and conclusions of microbiological analysis gives the same limits for L. monocytogenes in RTE foods regardless of whether the samples are taken from RTE that can support the growth of L. monocytogenes or not and regardless whether the sample is taken from retail level or production level. No action is required if the level is less than 10 cfu/g, This is not in line with the requirements given in Chapter 1 of Annex I to Regulation (EC) No 2073/20054.

• The instructions prepared by the DGCCRF for controls on microbiological criteria do not cover all aspects of Regulation (EC) No 2073/2005 (for example, testing of the environment and equipment for microbiological contamination and trend analysis are not included).

2 In their response to the draft report the CAs noted that this Decree is to be repealed and that its provisions are covered by Regulation (EC) No 852/2004.

3 In their response to the draft report the CAs noted a draft guide to good hygiene practice has been prepared and is currently evaluated by ANSES.

4 In their response to the draft report the CAs noted that the instruction is due to be revised in October 2012 by the SCL's microbiology network. The revision will specifically include the case of a sample taken at the FBO's establishment supporting the growth of L. monocytogenes (no specific count is possible but the sole criteria is absence in 25 g).

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ConclusionsBoth the DGAL and the DGCCRF authorities have prepared instructions and guidance documents on the requirements of Regulation (EC) No 2073/2005. However, the guidance documents of the DGCCRF do not cover all aspects of Regulation (EC) No 2073/2005 and the SCL interpretation in relation to the results of L. monocytogenes is not in all aspects in line with the requirements of Chapter I of Annex I to Regulation (EC) No 2073/2005.

5.2 COMPETENT AUTHORITIES

5.2.1 Designation of the Competent Authorities

Legal requirements

Article 4 of Regulation (EC) No 882/2004 requires that the Member States shall designate CAs responsible for the purposes and official controls set out in the Regulation.

Findings

Four Ministries are involved in the controls over the HP, namely the MAAPRAT, the MINEFI, the Ministry of Health (Ministère chargé de la Santé, MS) and the Ministry of Defence (Ministère de la Déférence, for establishments under its control).

A description of the CAs can be found in the country profile of France which is accessible at: http://ec.europa.eu/food/fvo/ir_search_en.cfm

Within the MAAPRAT the DGAL, in the MINEFI the Directorate General of Competition, Consumer Affairs and Fraud Repression (Direction Générale de la Concurrence, de la Consommation et de la Répression des Fraudes, DGCCRF) and in the MS the Directorate General for Health (Direction Générale de la Santé, DGS) are the three main CAs responsible for official controls on foodstuffs and food hygiene. For some sectors the responsibilities are separate and for some others the DGAL and the DGCCRF share the responsibility.

The DGAL has the responsibility for controls over primary agricultural production of foods of animal and non-animal origin, production and processing of food of animal origin, fishery products and shellfish. The DGCCRF is responsible for, among other things, controls over foodstuffs of non-animal origin at stages after the primary production, foods of animal origin at the distribution stage, labelling, contact materials, irradiation and additives. The DGAL and the DGCCRF share for example the responsibility for controls over distribution and direct sale, storage, transport. The DGS is responsible for general food hygiene, food borne infections, water quality, and canteens in health and social facilities.

The above-mentioned Ministries are represented at regional level. The MAAPRAT is represented by the Regional Department of Foodstuffs, Agriculture and Forestry (Directions Régionales de Alimentation, Agriculture et de la Foret), the MINEFI by the Regional Directorate of Enterprises, Competition, Consumption, Labour and Employment (Directions Régionales des Entreprises, de la Concurrence, de la Consommation, du Travail et de l’Emploi) and the MS through the Regional Health Services (Agence Régionale de Santé). The regional level has mainly co-ordination tasks and functions as an interlocutor. In addition it has a net of national experts who help the departmental inspection authorities.

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As a result of the reform of the French public service in 2010, the two main ministries involved in the controls in the framework of the HP, the MAAPRAT and the MINEFI, have merged their inspection services at the departmental level. This local CA (LCA), the DD(CS)PP incorporates both the staff of the DGAL and the DGCCRF origin. The LCAs are responsible for the implementation of official controls of products of animal and non-animal origin, including the implementation of Regulation (EC) No 2073/2005.

The DGAL has been accredited (ISO 17020) by the French Accreditation Body (Comité Français d'Accréditation, COFRAC) as an inspection body.

Rapid Alert system for food and feed (RASFF)

The DGCCRF (Alerts Unit) and the DGAL (Missions for health emergencies, Mission des Urgences Sanitaires), are central control points for the RASSF of the Commission. A protocol on inter-ministerial co-ordination was signed in 2007.

The audit team received statistics on the rapid alerts (both national and EU alerts) for 2010 and 2011.

5.2.2 Co-ordination between Competent Authorities

Legal Requirements

Article 4(3) of Regulation (EC) No 882/2004 provides for efficient and effective co-ordination between CAs.

Findings

The different Ministries responsible for the controls in relation to the HP have adopted a protocol on co-operation related to safety of foodstuffs and implementation of food hygiene (Service Note 2007-07).The protocol covers the central, regional and departmental levels of the authorities. The protocol has been updated to take into account the reform of the French public services.

Evidence of effective co-operation between the CAs of the different Ministries in relation to dealing with food poisoning suspicions and alerts was available in the departments visited.

5.2.3 Co-ordination and co-operation within Competent Authorities

Legal Requirements

Article 4(5) of Regulation (EC) No 882/2004 requires that, when, within a CA, more than one unit is competent to carry out official controls, efficient and effective co-ordination and co-operation shall be ensured between the different units.

Findings

Evidence was available on the effective and efficient co-ordination between the different CA levels. Information on the controls of food establishments controlled by the DGAL are collated in the national database SIGAL whereas data on establishments controlled by the DGCCRF staff are collated in the database SORA. Reporting of official controls takes place at the departmental level. Evidence of top-down and down-top information flow was available. The audit team observed the use of the SIGAL database at one of the LCAs visited.

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5.2.4 Legal powers for performance of controls

Legal Requirements

Article 4(2) of Regulation (EC) No 882/2004 requires that the necessary legal powers to carry out controls are in place and that there is an obligation on FBOs to undergo inspection by the CAs. Article 8 (2) of the above Regulation requires that CAs have the necessary powers of access to food business premises and documentation.

Findings

The legal basis for official controls in the framework of Regulation (EC) No 882/2004 are given in the Rural Codes, Consumer Codes and Public Health Codes as specified in the MANCP, section 6.2. and available on the webpage: www.legifrance.gouv.fr .

Information Note No 2008-23 on the implementation of controls on HP gives the inspectors of the DGCCRF powers to carry out controls (including sampling) in the framework of the HP.

5.2.5 Staffing provisions, facilities, qualifications and training

Legal Requirements

Article 4 (2) of Regulation (EC) No 882/2004 requires the CA to ensure that they have access to sufficient number of suitably qualified and experienced staff; that appropriate and properly maintained facilities and equipment are available; and that staff performing controls are free of any conflict of interest.

Article 6 of Regulation (EC) No 882/2004 requires CAs to ensure that staff receives appropriate training, and are kept up-to-date in their competencies.

Findings

The staffing provisions are described in the Country profile. The facilities and equipment seen by the audit team were appropriate. The independence of staff preforming official controls is anchored in the Statute of official employees.

Provisions were in place to ensure that the DGAL and the DGCCRF staff receive appropriate training. The training comprised initial training and continuous training. The CAs establish annual training plans for their staff. Several training events have been organised on microbiological criteria. A one day session comprising going through practical cases was organised in 2010 and 2011 with 145 and 143 participants, respectively. In 2011 the training events covered. the following topics:

• Food microbiology, laboratories, risk analysis and sampling (3 days , 15 participants);

• Risk analysis tools for inspections (4 days, 25 participants);

• Practical approach to food microbiology (4 days); and

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• Legislative requirements and microbiology (2 days).

In addition, three staff members also participated in the Better Training for Safer Food course on microbiological criteria and outbreak investigations.

The same training sessions are organised also in 2012. In addition the 2012 training plan covers two training sessions on alerts and two on food poisonings. The Ministry of Defence's training plan includes a one-day seminar on the determination of shelf-life studies for the CAs working in the Army Health Services.5

The staff met at the different CAs' offices and FBOs' premises and official laboratories visited were, in general, suitably qualified and experienced.

Observations:

• The audit team noted that three of the local inspectors responsible for the official controls in the food processing establishments visited during the audit had not received any special training on microbiological criteria and two of them were not familiar with all the relevant requirements of Regulation (EC) No 2073/2005.

5.2.6 Enforcement requirements

Legal requirements

Article 54 of Regulation (EC) No 882/2004 requires a CA that identifies a non-compliance to take appropriate action to ensure that the operator remedies the situation. Article 55 of Regulation (EC) No 882/2004 states that a Member State shall lay down rules on sanction applicable to infringements on feed and food law and other EU provisions relating to the protection of animal health and welfare and shall take measures necessary to ensure that they are implemented. The sanctions provided must be effective, proportionate and dissuasive.

Findings

The measures to be taken in case of non-compliance are laid down in the Rural Code and in the Consumer Code and are also included in some of the Service Notes of the DGAL.

Legislative provisions for sanctions and penalties are in place. Decree No 2011-1866 of 12 December 2011 completes the list of offences and violations provided for in Book II of the Rural Code and marine fisheries to European regulations on food safety and feed.

The French CCA stated that another Decree relating to administrative penalties will be published in spring 2012.6

5 In their response to the draft report, the CAs noted that the slaughtering industry had organised several training events for their staff in connection with risk analysis and verification of health control plans (in 2008-2010 three days for 1 600 staff, since 2009 training on health inspection in poultry SHs; 4 days with 1 or 2 annual sessions for 20 or 40 staff, since 2005 4 days training on health inspection for staff in SHs for domestic ungulates 4 days for 20-25 staff). The training focused on microbiological criteria.

6 In their response to the draft report the CAs noted that the Decree No 2012-390 of 21 March 2012 on product, food and feed hygiene referred to in Article L. 214-1 of the Consumer Code was published in the Official Journal of the French Republic on 23 March 2012.

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Evidence of enforcement measures taken in relation to non-compliances was seen in the departments visited. The enforcement measures taken ranged from imposition of sanitation procedures, increased own control sampling, recalls/withdrawals to destruction of the foodstuffs. For example, in the one establishment producing RTE foodstuffs the DD(CS)PP inspector had noted during a routine inspection that the manufacturer had extended the shelf-life of a cheese used as an ingredient in the RTE product against the national rules. The FBO had agreed to voluntarily withdraw the lot from the market and had subsequently destroyed the product.

Observations:

• In relation to some of the establishments visited, deadlines were not given for the FBOs to remedy the shortcomings and some of the shortcomings existed for a long time without the CA taking further action.

• Some of the reports seen did not include evidence that the CA had checked the implementation of corrective actions included in the FBOs action plan during the next audit. (for example, in relation to potable water).

• In relation to some alert files reviewed, the audit team noted that enforcement measures imposed had not always been carried out:

◦ In relation to an alert seen foodstuffs had been ordered to be destructed but no documentary evidence was kept about the destruction.

◦ In relation to another alert, the official, planned follow-up sampling in an establishment had not been carried out.

Conclusions

The French authorities are well organised with clearly defined responsibilities. The training system is well defined and covers microbiological criteria. However, not all of the inspectors responsible for the controls of the establishments visited had participated in training on microbiological criteria. The CA have the necessary legal powers to carry out official controls. The audit team identified some shortcomings in relation to enforcement measures taken in the departments visited.

5.3 LABORATORY NETWORK

Legal requirements

Article 12 of Regulation (EC) No 882/2004 requires that the CA designates laboratories that may carry out the analyses of samples taken during official controls. Point 2 (c) of Article 4 of Regulation (EC) No 882/2004 stipulates that the CAs must ensure that they have or have access to an adequate laboratory capacity for testing.

Findings

In France (including the overseas departments), a total of 92 microbiological laboratories are involved in the analysis of official food samples (approved laboratories). Out of these 92 laboratories, 81 are approved by the DGAL and 6 are SCL laboratories under the authority of the DGCCRF.

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Laboratories approved by the DGAL have either a permanent, temporary or provisional approval, which is valid only for specific analysis methods or groups thereof.

The laboratories visited had adequate quality control measures and documentation in place. The two laboratories of the DGAL visited analysed mostly private samples (90 and 95 %, respectively).

5.3.1 Laboratory accreditation and quality controls

Legal requirements

Point 2 of Article 12 of Regulation (EC) No 882/2004 requires that the designated laboratories have to be accredited in accordance with the following European standards:

(a) EN/ISO/IEC 17025 on "General requirements for the competence of testing and calibrating laboratories".

(b) EN/ISO/IEC 17011 on "General requirements for accreditation bodies accrediting conformity assessment bodies", taking into account criteria for different testing methods laid down in the feed and food law of the EU.

The accreditation and assessment of testing laboratories referred to above may relate to individual tests or groups of tests.

Findings

The accreditation certificates (ISO/EN 17025) were available for the laboratories visited. The laboratories were accredited as such and for the methods/pathogen they test for. The accreditation has to be done either by the French Accreditation Body (COFRAC) or an equivalent European accreditation body.

Evidence was available of the successful participation of the laboratories visited in the relevant proficiency testing schemes for food pathogens.

5.3.2 National reference laboratories

Legal requirements

Article 33 of Regulation (EC) No 882/2004 stipulates that the Member States shall arrange for the designation of one or more NRLs for each EU reference laboratory (EURL) referred to in Article 32. Article 33(5) of the same Regulation requires that Member States that have more than one NRL for a EURL must ensure that these laboratories work closely together, so as to ensure effective co-ordination. The tasks of the NRLs are laid down in Article 33(2).

Findings

The MAAPRAT and MINEFI have appointed 29 laboratories to be NRLs for a total of 87 areas of competence. Of the NRLs, 24 laboratories, are under the responsibility of the DGAL and 5 laboratories, under the responsibility of DGCCRF. The SCL laboratories under the DGCCRF are the NRLS for eight areas of competence. However, these competences do not cover food microbiology. The DGAL has designated eight NRLs in the area of food microbiology covering 15

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areas of microbiological contaminants in foodstuffs.

EURL/NRL for L monocytogenes

The laboratory visited was appointed as an EURL in 2006 and as a NRL in 2009. The EURL had carried out its tasks as an EURL as required in Article 32 of Regulation (EC) No 882/2004. For example, a proficiency test round was organised in 2010 with the participation of 31 laboratories and a 4 day practical training session was organised in October 2010 for participants from 5 NRLs.

The NRL laboratory had sent out a questionnaire to the laboratories in the network in 2011 in order to gather information on the type of samples they analyse, the methods they use, quality controls in place, training needs etc. and was currently analysing the results. Evidence was available that the NRL had provided scientific and technical support to the DGAL. The NRL also supports the DGAL in the areas of training and legislation (for example, it has been involved in the preparation of Service Notes). In addition, it is involved in the surveillance and the intervention of alerts and carrying out of and support with shelf-life studies. The laboratory had participated in proficiency tests rounds organised by a commercial proficiency test provider with satisfactory results. The NRL had scheduled a laboratory meeting to which also the six SCL laboratories are invited.

Observations:

• The NRL laboratory has not yet taken up all the tasks as required in Article 33(2) of Regulation (EC) No 882/2004. For example, no meetings and proficiency test rounds have yet been organised for the laboratory network and no information/guidance documents have been distributed to the network.

• The audit team noted that if a national alert on L. monocytogenes had been initiated as a result of FBO's own programme control sample, there was no procedure in place to send the isolate to the NRL for characterisation.7 However, the two central laboratories involved in the characterisation of the Listeria strains plan to include this step in the future.

EURL/NRL for S. aureus

The laboratory was appointed as a NRL in 2009 but had already been pre-nominated in 2005. The laboratory had taken up its duties as an EURL/NRL. It had carried out proficiency tests rounds, organised training on S. aureus (seven sessions since 2007) and disseminated information to the laboratory network. The NRL organises yearly proficiency tests for the laboratory network and had also taken part in the national ring tests as well as an international one with good results.

Conclusions

The laboratories networks are well organised. The NRL for S. aureus and its enterotoxins has taken up its function as an EURL/NRL. The EURL for L. monocytogenes had carried out its duties as an EURL. However, it had not yet taken up all its duties as a NRL since its 2009 nomination and has

7 In their response to the draft report, the CAs noted that there is an agreement in place between the NRL and the national reference centre, that specifies the procedure to be followed for isolated L. monocytogenes strains. The procedure depends on the context (health alert, official control sample or FBOs own control sample). The NRL carries out molecular typing of L. monocytogenes strains detected in the course of the DGAL's or DGCCRF's surveillance or control plans.

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only starting to function as such.

5.4 METHODS OF SAMPLING AND ANALYSIS

Legal requirements

Article 11 of Regulation (EC) No 882/2004 requires that sampling and analysis methods used in the context of official controls shall comply with relevant rules of the EU or, if such rules do not exist, with internationally recognised rules and protocols or those agreed in national legislation. In the absence of above, other methods fit for the intended purpose or developed with a scientific protocol may be used. Whenever possible, the methods of analysis should be characterised by the criteria set out in Annex III to Regulation (EC) No 882/2004.

Article 5 of Regulation (EC) No 2073/2005 stipulates that the analytical methods and sampling plans and methods laid down in Annex I to this Regulation have to be applied as reference methods.

Findings

5.4.1 Methods used for official sampling and testing

The official sampling and analysis methods were either the reference methods as given in Annex I to Regulation (EC) No 2073/2005 or alternative methods that had been validated according to the protocol of ISO 1640. The reference methods are published on the following web page: http://agriculture.gouv.fr/IMG/pdf/Microbiologie_alimentaire_-_Liste_des_methodes_officielles.pdf .

The list of reference methods on the above web page does not include the reference method for Chronobacter spp (Enterobacter Sakazakii), as given in point 1.24 of Chapter 1 of Annex I to Regulation (EC) No 2073/2005.

5.4.2 Methods used in the framework of FBOs' own controls

On their web page the CCA instruct FBOs to be aware of the limitations of the alternative methods as given in the validation certificates (for example, the alternative validated method for Salmonella does not detect the immobile forms) before choosing which methods to use.

The methods used by the FBOs in the framework of their own controls were either alternative, validated methods or official methods, except for a single case where the alternative method was used for enterobactericeae in egg products. This method had not been validated as such but was, according to the AFNOR, more sensitive but less specific than the reference method. The CCA stated that the reference method would, however, be used for confirmation in the case of positive results.

Conclusions

The methods used for sampling and analysis in the context of official controls and FBOs' own controls were adequate and in line with the provisions of Regulation (EC) No 2073/2005.

5.5 OFFICIAL CONTROLS

Legal requirements

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Article 3 of Regulation (EC) No 882/2004 requires that official controls are carried out regularly, on a risk basis and with appropriate frequency. Controls shall be carried out at any of the stages of the production and processing chain and, in general, are to be carried out without prior warning. Controls shall be applied with the same care to exports from the EU, imports into the EU and to products placed on the EU market.

Article 10(1) of Regulation (EC) No 882/2004 stipulates that tasks related to official controls shall, in general, be carried out using appropriate control methods and techniques such as monitoring, surveillance, verification, audit, inspection, sampling and analysis.

Point (2) (d) of Article 10 of Regulation (EC) No 882/2004 requires that official controls on food shall include, inter alia, the assessment of procedures on good manufacturing practices, good hygiene practices and HACCP, taking into account the use of guides drawn up in accordance with EU legislation.

Article 4(2) of Regulation (EC) No 854/2004 specifies that the CA shall carry out official controls in respect of products of animal origin to verify FBO compliance with these requirements.

Point 5 (a) of Article 4 of Regulation (EC) No 854/2004 stipulates that the CA's audits of HACCP-based procedures shall determine whether the procedures guarantee, to the extent that it is possible, that products of animal origin comply with microbiological criteria laid down in the legislation of the EU. Point 8 (c) of the same Article requires the CA to take special care to take samples for laboratory analysis when necessary. The second paragraph of Point 5 of Article 4 of the same Regulation stipulates that if the FBO uses procedures set out in guides to the application of HACCP principles rather than establishing its own specific procedures, the audit should cover the correct use of these guides.

Preamble (15) of Regulation (EC) No 852/2004 states that HACCP requirements should provide sufficient flexibility to be applicable in all situations, including in small businesses. Point 4(a) of Article 5 of the said Regulation stipulates that the FBO has to provide the CA with evidence of their compliance with the implementation of procedures based on HACCP principles in a manner that the CA requires, taking account of the nature and size of the food business.

Point 1(f) of Article 5 of Regulation (EC) No 854/2004 requires that the inspection tasks of the OV in a SH, game handling establishment and cutting plant placing fresh meat on the market, should include inspections on laboratory testing.

Point F 1 (a) of Chapter II, Section I of Annex I to Regulation (EC) No 854/2004 requires that the OV has to ensure that sampling takes place and that samples are appropriately identified and handled and sent to the appropriate laboratory within the framework of the monitoring and control of zoonosis and zoonotic agents.

Article 1 of Regulation (EC) No 2073/2005 requires that the CAs verify compliance with the rules and criteria laid down in Regulation (EC) No 2073/2005 in accordance with Regulation (EC) No 882/2004.

Findings

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5.5.1 Organisation of official controls

France has established a risk-based system for official controls covering the whole chain of food production (from primary production to the retail level) in line with the requirements of Article 3 of Regulation (EC) No 882/2004. The risk assessment of the DGAL takes into account the establishment type, the processing volume, and sensitivity of the population and the results of the previous inspection, including the reliability of the own checks already carried out. Based on these factors the establishments receive a numeric risk note, which determines the basic minimum inspection frequency.

The risk-based approach of the DGCCRF classifies different types of food processing establishments into low, medium or high risk category (theoretical risk) based on different risk factors (microbiological, physico-chemical risks, use of additives, etc.) This is combined with the result of the local risk assessment carried out before the first placing of products on the market.

The minimum control frequencies are established in a national control plan. The current national control plan has been established for a five-year period. The inspection plans are adjusted annually. The minimum inspection frequency ranges from two annual inspections to one inspection every three years.

The SHs and cutting plants are classified according to their degree of conformity and this has been used since 2008 to determine their inspection frequency. The minimum inspection frequency has been determined on a national level for this type of establishments (to be inspected at least twice or once annually, respectively) and for other establishments belonging to the high risk category.8 For establishments in other categories the departments can modify the inspection frequencies according to their own priorities and staff resources. In line with this flexibility provision, for certain establishments with good performance, the frequency was as low as one inspection every five years in the departments visited by the audit team.

In the national control plan of the DGAL food processing establishments are divided into three groups based on priorities, namely prevention, improvement and keeping under control (suppression). In the 2011-2012 plan, the prevention group covers high risk establishments (e.g. slaughterhouses and establishments with a risk note higher than 480, certain cutting plants and producers of raw milk for human consumption). The improvement group covers e.g. fishery vessels, fish farms, raw milk distributors, on-farm producers, and certain establishments producing minced meat. The suppression group covers lower risk establishments such as fish halls, egg packaging centres and restaurants. Depending on the group the establishment is placed in, the controls are focussed on certain aspects; e.g. for the improvement group special emphasis should be given in 2012 to potable water, primary materials and ingredients.

The CCA stated that France is running a pilot project in line with Article 17.4 of Regulation (EC) No 854/2004 in some poultry and rabbit slaughterhouses in relation to new approaches to hygiene controls in meat (less controls carried out by the OVs). This was notified to the Commission Services in 2009 (notification 2009/0525/F). Additional information was provided to the Commission Services in January 2012 and the provisions of the pilot project are currently assessed by the Commission Services.

The FVO report DG(SANCO)2008-7827 of an audit carried out in France in November 2008 in order to evaluate the control systems in place governing the production and placing on the market of poultry meat included the following recommendation which is linked with microbiological criteria:

8 In their response to the draft report the CAs noted that the SHs have improved substantially during the operation of the current system (the last 4 years). The authorities noted in addition that the system will be modified in summer 2012 to place more emphasis on following up measures taken after the inspection.

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• The CCA should ensure that the inspectors verify the results of laboratory analysis on own controls available in the establishments and, as required in paragraph 8 of Article 4 to Regulation (EC) No 854/2004, that these are followed up immediately if the results indicate an immediate risk to the consumer.

The audit team checked the implementation of this recommendation in the establishments visited.

The nine establishments visited covered a broad range of food production including RTE foods (red meat, poultry meat, dairy, egg, and fishery products, sprouted seeds, and salads). The establishments belonged to different risk categories. The establishment producing sprouted seeds had been earlier classified as a low risk establishment and the CCA stated that they planned to move it to a higher risk category. In summer 2011, it had been inspected five times by the DD(CS)PP linked to the food-borne outbreaks caused by E. coli in Germany and France, but not against the requirements of Regulation (EC) No 2073/2005.

Observations:

• The audit team noted in two departments visited that the inspection frequencies in the departmental level plans could be significantly lower than the frequencies given in the national framework plan for certain types of food processing establishments. For example, in one department visited the minimum inspection frequency was one inspection in five years for low risk category fishery and dairy plants with a good inspection and own control system history.

• In one department visited the two annual inspections planned for in the national control plan for high risk category establishments had not been reached and the planned inspection frequencies for poultry slaughterhouses had also not been reached (of 30 planned inspections of poultry SHs only 10 had been carried out in 2011). The inspection targets in some other sectors had also not been adhered to.

• The audit team noted that in two departments visited the ante- and post-mortem controls in poultry slaughterhouses were carried out routinely by auxiliaries and the official veterinarians (OVs) visited these premises only periodically (see also point 5.5.1).

• Evidence was also available that ante- and post-mortem controls in small capacity red meat slaughterhouses were routinely carried out by auxiliaries without the supervision of an OV (the OV was not present on the spot), although points 2 and 3 of Chapter I, Section III, Annex I to Regulation (EC) No 854/2004 require that in relation to ante-mortem inspections, the auxiliaries may only carry out an initial check and help with purely practical tasks, and in relation to post-mortem inspections checks, OVs must regularly check the work of the auxiliaries, respectively9.

• The inspection tasks of the OVs in SHs in two of the departments visited had not been carried out as required in Chapter II of Section I of Annex I to Regulation (EC) No 854/2004. This shortcoming has been noted in earlier FVO reports,(for example report DG(SANCO)2008-7827 on an audit in relation to control systems on poultry meat included

9 In their response to the draft report, the CAs noted that they had informed the Commission services about the ante-mortem arrangements in SHs for domestic ungulates by providing the Commission services with the Service Note of 23 June 2010. Furthermore, the conclusions of a seminar on modernisation of sanitary inspection in SHs held in Lyon in 2008 during the French Presidency invited the Commission to look into the possibility of extending the responsibilities of the auxiliaries in view of their training. The authorities noted in addition, that the method for calculating full-time equivalent staffing needs based on tonnages slaughtered has proved inadequate and adjustment factors are being introduced.

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a recommendation to address this shortcoming).

• In the establishment visited producing sprouted seeds the DGCCRF staff had not yet carried out the local risk assessment before first placing of products on the market10; and

• Regarding the implementation of the recommendation of the FVO report 2008-7827 in relation to verification of the results of laboratory analysis on own controls available in the establishments and the follow-up actions taken if the results indicate an immediate risk to the consumer, evidence of controls in relation to HACCP-based own control programmes was available in the meat establishments visited. However, in the red meat establishment visited the controls had not been thorough enough, as the audit team noted several deficiencies in this establishment in relation to carcass sampling (see. 5.5.5).

ConclusionsThe system of official controls is risk-based and was applied in the departments visited largely according to the instructions. The national control plan comprises minimum inspection frequencies that were established based on a risk assessment and considered appropriate and to be in line with Article 3 of Regulation (EC) No 882/2004. However, the inspection frequencies applied in relation to certain food processing sectors were significantly lower than those determined at national level and therefore not appropriate. In addition the audit team noted deficiencies in relation to the availability of OVs for ante- and post-mortem controls in SHs and the implementation of the annual control plans in two of the departments visited.

5.5.2 Official sampling and testing

Guidance on official sampling and testing is given in the Service Note DGAL/SDSSA/N2008-8041 of 27 February 2008 on microbiological analysis in the framework of official controls.

The above guideline includes in addition advice on how microbiological criteria should be applied during official controls (use of laboratories, methods, and interpretation of results).

The CCA stated that plans are under way to establish a database (“Food Observatory”) comprising results of both official and of FBOs' own control sampling programmes for microbiological criteria. The funds for this project have been granted by the DGAL in the first instance; the DGCCRF, DGS and the ANSES are involved in the data selection.

According to the French approach official sampling is not a primary tool for validation and verification of the FBOs HACCP-based programme. Instead the CA rely primarily on inspections, audits and checking of the FBOs' HACCP-based own control plan. Official sampling is carried out in the framework of official surveillance and monitoring plans, in connection with food alerts and food-borne disease outbreaks and monitoring results of previous years, as part of the official controls carried out in an establishment before the first placing on the market of their products, as part of the controls of imported and of food destined for export and in specific cases (for example, testing of detained carcasses).

The national surveillance and monitoring plans are annually established and co-ordinated by the CCAs. The implementation is under the responsibility of the departmental joint structures of the DGAL and the DGCCRF (DD(CS)PP).

The details of the DGAL sampling plans in 2010 are published on the Ministry of Agriculture

10 In their response to the draft report the CAs noted that before the Hemolytic-Uremic Syndrome epidemic in Europe in 2011 linked to eating sprouted seeds, this establishment had been classified as a low risk. It has been placed in a higher risk category since.

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website at http://agriculture.gouv.fr/IMG/pdf/recueil_tt_public_PSPC_2010_v4.pdf

Evidence of the implementation of such plans was available in the departments visited. The summary results of the 2010 plans are given in the table below:

Sample type CA Pathogen Number of samples

Number of unsatisfactory samples

% of unsatisfactory samples

Fresh poultry and pork meat distribution level

DGAL Salmonella 980 36 3.7%

Bivalve molluscs at production level

DGAL E. coli 483 43 8.9%

Fishery products DGAL Histamine 628 18 2.9%Poultry carcasses in high capacity SHs

DGAL Contamination (Salmonella, E. coli,Enterobacteriaceae)

51 SH with 15 carcasses/SH

9 SHs with Salmonella-positive carcasses

17.7 % of the SHs

Mechanically separated meat (MSM) derived from poultry at production level

DGAL Salmonella 198 22 11.1%

MSM derived from poultry at production level

DGAL E. coli 198 184 92.9%

MSM derived from poultry at production level

DGAL Total aerobic colony count

198 28 14.10%

Minced meat at distribution level

DGAL Shiga-toxin producing E coli

2476 5 0.2%

Foodstuffs at distribution level (meat products, seafood, cheese)

DGCCRF L. monocytogenes

3534 58 (in 2 samples 100 cfu/ml was exceeded)

1.60%

Foodstuffs at distribution level

DGCCRF Microbiological quality

10866 884 8.1%

Pork meat products at distribution level

DGCCRF Salmonella 469 0 0.00%

Fishery products DGCCRF Vibrio sp. 87 14 16.10%

The summary results of the 2010 official microbiological sampling of food in the context of import

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controls are given below:

Sample CA Analysis No of samples

No of unsatisfactory samples

% unsatisfactory samples

Products derived from red meat

DGAL Microbiology 8 0 0.00%

Poultry products

DGAL Microbiology 4 0 0.00%

Milk and dairy products

DGAL Microbiology 2 0 0.00%

Fishery products

DGAL Microbiology 141 10 8.00%

Meat products

DGAL Microbiology 2 0 0.00%

Fishery products

DGAL L. monocytogenes 46 10 21.70%

The 2011 surveillance plans of the DGAL comprised the following plans:

• Surveillance plan on shigatoxin producing E. coli and Salmonella in minced meat at production level (2 000 samples);

• Surveillance plan on beta-glucuronidase-positive E. coli and L. monocytogenes in cheeses at production level (500 samples);

• Surveillance plan on Salmonella in meat products of poultry and pig origin at production level (200 samples);

• Surveillance plan on histamine in fishery products (620 samples); and

• Surveillance plan on E. coli in live bivalve molluscs (500 samples).

The 2011 sampling plans of DGCCRF comprised the following sampling:

• Control plan regarding the microbiological quality of foodstuffs (11 070 samples);

• Control plan regarding the microbiological quality of raw sprouted seeds to be consumed fresh and of seed for germination (all 22 regions and the three overseas departments had to take two samples every fortnight;

• Surveillance plan on L. monocytogenes in foodstuffs at distribution level (4 000 samples);

• Surveillance plan on L. monocytogenes in RTE foodstuffs (1 600 samples);

• Surveillance plan on Salmonella in fruits, vegetables and fresh spices which are consumed raw (1 500 samples); and

• Surveillance plan on shigatoxin-producing E. coli in vegetables to be eaten raw (2 samples/region to be taken monthly in 4 regions).

The results of the analysis carried out in the framework of the 2011 surveillance and control plans were not yet available.

For 2012, the following sampling for microbiological criteria is planned:

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DGAL: • Surveillance plan on L. monocytogenes and beta-glucuronidase-positive E. coli in cheeses at

production level (500 samples);

• Surveillance plan on shigatoxin producing E. coli contamination of minced meat (derived from beef);

• Surveillance plan regarding Campylobacter sp in bovine and porcine meat and Salmonella in fresh bovine meat at distribution level (1 000 samples; 500 bovine and 500 porcine meat);

• Control plan on E. coli contamination in live bivalve molluscs (300 samples);

• Surveillance plan on histamine in fishery products (620 samples); and

• Surveillance plan on microbiological contamination in food of plant origin.

DGCCRF:

• Surveillance plan on L. monocytogenes in foodstuffs at distribution level (3 500 samples);

• Control plan regarding the microbiological quality of foodstuffs of plant origin (6000 samples in total including 550 samples of sprouted seeds and 50 of non-germinated seeds); and

• Control plan regarding the microbiological quality of foodstuffs of animal origin (6 000 samples). This sampling plan is reduced by 50 % when compared with the 2011 plan.

Evidence of implementation of the above surveillance and control plans was available in the departments visited.

The audit team checked the management and follow-up of several national alerts in the departments visited. The actions taken were in general adequate. The audit team noted that most follow-up sampling in relation to alerts had been imposed on the FBOs involved in the alerts. However, official sampling had also been carried out to some extent.

The official sampling as part of the controls carried out by the DGCCRF arm of the LCA in an establishment before the first placing on the market of their products can be carried out if the inspector carrying out the control deems it necessary.

Observations:

• No evidence of official sampling to verify the FBOs' HACCP-based programmes was available for the nine establishments visited in three departments.

• In the sprout producing establishment which had been part of the follow-up of a national alert in 2011 for an E. coli outbreak, no official sampling was carried out in the framework of the alert. However, extensive sampling linked to this investigation was carried out as part of the FBOs' own control sampling.

• In one of the alert files assessed, the official sampling carried out as part of an alert investigation did not comply with the requirements issued by the CCA, as the follow-up sampling should have covered the previous and following batches. Instead, the sampling was carried out only from the batch under investigation and on a different date than was required.

• No evidence of sampling carried out by the DGCCRF in establishments before the first placing on the market of the products was seen in the DGCCRF-controlled establishments.

ConclusionsComprehensive microbiological surveillance and monitoring programmes have been implemented

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for different types of foodstuffs of animal and non-animal origin.

According to the French approach official sampling is not a primary tool to validate or verify the FBOs' HACCP-based programmes. Accordingly, no official sampling had been carried out for this purpose in the departments visited and the official sampling was also very limited in relation to alerts and files on food poisoning investigations studied by the audit team. No evidence of sampling carried out by the DGCCRF in establishments before the first placing on the market of the products was seen in the the DGCCRF-controlled establishments.

The CA did not always follow their own procedures in relation of official sampling of foodstuffs in case of alerts.

5.5.3 Controls over HACCP-based procedures

Detailed guidance for inspection staff to carry out controls over HACCP based procedures are given in the DGAL's handbook. The item E8 covers surveillance of critical control points (CCPs) and the application of corrective action whereas Chapter G covers the documentary check over HACCP.

In relation to establishments controlled by the DGCCRF staff, control of HACCP based procedures formed a part of the inspection check-list but detailed instructions for these controls were not included.

Evidence of the CA's audits over the FBOs' own control systems and HACCP was available in the establishments under the DGAL official supervision (in eight of the nine plants visited).

The FBOs' procedures based on HACCP principles were in general well implemented, except for the establishments producing sprouted seeds.

Observations:

• The DGCCRF has not established detailed instructions for their inspection staff on checking of the HACCP-based principles. Although control of the FBO's test results as part of the own control plan is included in the check-list, no detailed instructions are available on what items need to be checked for under this heading.

• Two of the FBOs and two of the CAs met did not have a proper awareness of all HACCP requirements and the specific requirements concerning HACCP in Article 4 of Regulation (EC) No 2073/2005.

• Not all of the CAs met had carried out a proper evaluation of the HACCP-based principles:

◦ The DGCCRF arm of the LCA had not yet checked the HACCP-based principles of the establishment producing sprouted seeds;

◦ In the egg product establishment the decision on whether a control point should be a CCP was taken based on the availability of the monitoring equipment;

◦ In the same plant, the CA had accepted proof of the efficacy of pasteurisation as a challenge study;

◦ The CA responsible for the controls in the fishery product establishment had considered a CCP monitoring system appropriate although a critical limit for a CCP was missing;

◦ In another establishment, the corrective action in the case of non-compliance with the food safety criteria did not include a root cause analysis; and

◦ In the red meat SH visited no evidence was available that the OV had carried out a

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proper evaluation of the validity of the carcass sampling method.

• The FBO of the establishment producing sprouted seeds had not yet finalised the HACCP-based procedures and the FVO audit team identified several non-compliances in relation to the procedures based on the draft HACCP principles available. For example, no procedure had been established for environmental sampling and no evidence of any routine environmental sampling was presented to the audit team.

ConclusionsThe controls over HACCP-based procedures by the DGAL staff of the LCA covered the relevant parts of the procedures and had been carried out with the planned frequency in most of the establishments visited by the audit team.

The DGCCRF has not prepared detailed instructions on how to carry out these controls and shortcomings were noted in the implementation of these controls in the establishment plant visited were sprouted seeds were manufactured.

Two of the FBOs and two of the CAs met did not have a proper awareness of all HACCP requirements and the specific requirements concerning HACCP in Article 4 of Regulation (EC) No 2073/2005.

Some shortcomings were noted in relation to the CA's evaluation of the HACCP-based principles.

5.5.4 Controls over FBOs' compliance with food safety criteria

The instructions for controls over the FBOs' compliance with food safety criteria are detailed in the DGAL's handbook.

Point 3 of the Service Note No 2007-22 of the DGCCRF includes instructions on enumeration of L. monocytogenes in sensitive products and interpretation of the results. If the enumeration of L. monocytogenes exceeds 100 cfu/g in raw RTE products or cooked RTE products, the food is unfit for human consumption. If the product is a raw product that has to be cooked before consumption by the consumer, the foodstuff carries a potential risk and has to be heat-treated and the process needs to be monitored by the FBO.

The SCL instruction IN-CS-01 of 18 April 2011 on sampling, interpretation and conclusions of microbiological analysis also includes national criteria to be applied for foodstuffs at retail level (for example, criteria for L. monocytogenes in spices and aromatic herbs at distribution level).

Evidence of the controls carried out on these requirements were available in the inspection reports of the establishments visited by the audit team.

Most establishments visited tested their final products for food safety criteria and most results seen were in compliance with the criteria given in Annex I to Regulation (EC) No 2073/2005.

Most FBOs visited had carried out shelf-life studies based on being able to demonstrate that L. monocytogenes growth would not exceed 100 cfu/g at the end of the shelf-life.

Some of the establishments visited required that the raw materials received had been tested with satisfactory results by the supplier and some tested the raw materials for food safety criteria. For example, the FBO preparing RTE sushi and the establishment producing RTE fishery products tested the raw materials received for L. monocytogenes. The establishment producing fishery products tested all lots of frozen fish and every fifth lot of fresh fish received for L. monocytogenes (surface swabs). Frozen raw fish was subject to a positive release policy. In relation to fresh fish, if the pathogen was found in five consecutive lots of the raw material from the same provider, the

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provider was removed from the list of suppliers. This policy had led to a better quality of the raw fresh fish being received.

The establishment producing RTE sprouted seeds had started to require testing by the suppliers of seeds since the 2011 E. coli outbreaks linked to sprouted seeds.

Observations:

• In the sushi establishment, the limit for Listeria in the raw material mentioned an absence but did not specify in what quantity.

• The audit team noted that the FBO manufacturing RTE egg products had used frozen samples for analysis of Listeria in follow-up sampling related to an alert.

• In the sprouted seeds establishment, the LCA (DGCCRF) had not checked the FBOs compliance with food safety criteria and the CA on-the-spot was not aware that testing of the end product for L. monocytogenes is required. Testing for L. monocytogenes had been carried out only during the E. coli outbreak in 2011, while currently it was not part of the sampling plan (although indicated in the FBO's HACCP programme)11.

Conclusions The controls over FBOs' compliance with food safety criteria were carried out in most aspects in compliance with the requirements of Regulation (EC) No 2073/2005 in eight of the nine establishments visited (excluding the plant producing sprouted seeds). Shortcomings were noted in relation to the testing programme of the establishment producing sprouted seeds and contrary to the requirements of Article 1 of Regulation (EC) No 2073/2005 compliance with the rules of this Regulation had not yet been verified.

5.5.5 Controls over FBOs' compliance with process hygiene criteria

The instructions for controls over the FBOs' compliance with process hygiene criteria are detailed in the DGAL's handbook.

The Decree on hygiene rules on certain foods and food preparations for human consumption of 28 May 1997 comprises hygiene rules for both raw and heat-treated vegetables. The rules include testing of raw RTE vegetables for E. coli as required in point 2.5. of Chapter 2 of Annex I to Regulation (EC) No 2073/2005. In addition, the Decree includes testing criteria for heat-treated vegetables. These have to be subjected to incubation tests (21 days at 32° C and 7 days at 55° C, if pH of the final, sterilised product is higher than 4.5). If the pH is lower than 4.5 the heat treatment must result in a microbiologically stable product and the required incubation test is 21 days at 32°C.

Evidence of the controls carried out on these requirements were available in the inspection reports of the establishments controlled by the DGAL.

Observations:

• In a SH visited, the pig carcasses were processed on two lines. The carcasses processed on the slaughter-line which involved skinning were not tested for any of the microbiological criteria for carcases given in Annex I to Regulation (EC) No 2073/2005. This deficiency had not been not mentioned in any of the inspection reports.

• In the same establishment, the audit team observed the sampling procedure of carcasses for the other pig slaughter line. This was carried out in a chiller, after the carcasses have passed

11 In their response to the draft report, the CAs noted that this was because the establishment had been classified as a low risk.

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through a shock refrigeration unit for 60 minutes at -18 °C. In addition, during the on-the-spot sampling observed, the FBO staff sampled from different sites than were indicated in their own procedure and sprayed the gloves with alcohol before taking the sponge for Salmonella sampling. These shortcomings had not been picked up during previous inspections. The OV currently responsible for the official controls in the establishment stated that she had been employed in November 2011 and that she had not yet checked the sampling procedure. In the same establishment both the frequency of testing and the size of the sample units were reduced based on the good evaluation of the HACCP based procedures. The accompanying CCA reminded both the FBO staff carrying out the sampling and the OV responsible for the supervision of the plant of the method for carrying out checks on surfaces.

• Although the establishment manufacturing RTE sprouted seeds, under the control of the DDCCRF arm of the LCA, had been visited by the LCA five times since the summer 2011 E.coli outbreaks in Germany and France caused by sprouted seed, the plant had not yet been controlled for compliance with the requirements of Regulation (EC) No 2073/2005; and

• In the egg product establishment, the method used for Enterobacteriaceae testing was a nationally recognised method, not a validated method (see point 5.5.7).

ConclusionsThe controls over FBOs' requirements over process hygiene criteria were carried out in line with the requirements of article 4 and Chapter 2 of Annex I to Regulation (EC) No 2073/2005 in eight out of the nine establishments visited.

The controls over sampling rules (Chapter 2 and point 3.2. of Chapter 3 of Annex I to Regulation (EC) No 2073/2005) had not been carried out adequately in the red meat SH visited. The sampling observed by the audit team was not in line with these requirements.

5.5.6 Controls over sampling and testing of processing areas and equipment (especially for L. monocytogenes when manufacturing ready-to-eat foods)

The sections on meat and fishery products of the DGAL's handbook includes instructions for sampling and testing of processing areas and equipment for microbiological contamination but other sections of the handbook covering other food of animal origin do not include similar instructions. However, some of the inspection reports of the DGAL's inspectors seen for these commodities had included this point in their inspection report.

Seven of the nine establishments visited that manufactured RTE foodstuffs had carried out regular verification of their cleaning and disinfection and environmental sampling for L. monocytogenes as required by Article 5.2. of Regulation (EC) No 2073/2005.

Observations:

• The sections of the DGAL's handbook for dairy products, meat preparations, minced meat and MSM) and the DGCCRF instructions do not include specific instructions for sampling and testing of processing areas and equipment for microbiological contamination;

• Two establishments manufacturing RTE foods which may pose a L. monocytogenes risk for public health did not sample processing areas and equipment for this pathogen; and

• In one establishment visited the documentation in relation to corrective actions taken after detection of L. monocytogenes in the working environment was poorly documented.

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Conclusions

Although most of the FBOs visited had included testing of processing areas and equipment for L. monocytogenes, two FBOs manufacturing RTE foodstuffs supporting the growth of this pathogen had not complied with this requirement of Article 5(2) of Regulation (EC) No 2073/2005. The CA had not included this point in their instructions for all types of RTE foodstuffs which might support the growth of L. monocytogenes.

5.5.7 Controls over alternative sampling and testing procedures

The controls over alternative sampling and testing procedures are given in the DGAL's handbook.

The website of MAAPRAT has a link to the list of AFNOR-validated alternative methods (http://www.afnor-validation.org/pdf/liste-methodes-validees-titulaires.pdf) and one of the CA audited demonstrated the list was used during the inspection.

The approach taken by the DGAL in the handbook is that for monitoring purposes, after a period of satisfactory results, the operator can reduce the number of sampling units to one, whereas the number of sampling units should be five at the validation stage, in case of changes in the procedure, suspicions and alerts.

Service Note DGAL/SDSSA/N2008-8041 of 27 February 2008, in line with Chapter 3.2 of Annex I to Regulation (EC) No 2073/2005, includes the possibility to reduce the microbiological sampling frequency in establishments producing less than 100 kg minced meat/week and less than 250 kg meat preparations/week from weekly sampling to monthly sampling and reducing the sampling size to one unit. However, the required sampling size (5 units) cannot be reduced for Salmonella.

The FBO of the combined red meat establishment visited used the above option, and the option given in Annex I, Chapter 3.2. to reduce the sampling frequencies for carcasses, minced meat and meat preparations. Minced meat and meat preparations and also the sampling of carcasses for enterobactericeae and aerobic colony count was reduced to one sampling session in 15 days.

Observations:

• As stated previously in point 5.5.5, the carcass sampling was carried out incorrectly. Thus the results used for justification of reduced frequency for carcass sampling had not been valid.

• In the egg product establishment, the method used for enterobacteriaceae testing is a nationally recognised method, which although not validated as such, according to the AFNOR (national validation body) has more sensitivity, but less specificity. For the positive cases, the reference method is used for confirmation.

Conclusions

The alternative sampling and testing procedures seen were largely in line with the procedures given in the DGAL's handbook. However, the audit team noted shortcomings related to the alternative sampling and testing procedures in one red meat establishment visited.

5.5.8 Controls over shelf-life studies and over analyses of trends

Service Note DGAL/SDSSA/N2010-8062 of 9 March 2010 on the shelf-life of foodstuffs is

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addressed to the FBOs and advises on shelf-life studies. The guidance document comprises definitions for use by and best before date, challenge studies, ageing tests, mathematical modelling. In addition, it includes links to French Norms on the topic (Norms NF V01-003 and NFV01-009) and to EU guidelines on shelf-life studies.

In the DGAL's handbooks specific requirements for official controls over FBO shelf-life studies are included indirectly in Chapter E09 of the meat products section and of the fishery products section. In the above-mentioned two sections it is required that the FBO demonstrates to the satisfaction of the CA that L. monocytogenes does not exceed 100 cfu/g throughout the product shelf-life for RTE foods able to support the growth of this pathogen.

In the Section dedicated to dairy product, this point is missing as the approach is different and the absence of L. monocytogenes in 25 g is required by default for RTE dairy products able to support the growth of Listeria. In the Section dedicated to egg products the microbiological testing in accordance with Regulation (EC) No 2073/2005 is mentioned under chapter G13 which specifies that the own control plan should include analysis of pathogens according to Regulation (EC) No 2073/2005.

Annex II to the DGCCRF instruction IN CS 01 of 18.04.2011 mentions that testing for L. monocytogenes resulting in a contamination level between 10 and 100 cfu/g should be followed up. According to the interpretation of the CA met, this means that the inspector has to check that the FBO has carried out shelf-life studies demonstrating that the limit of 100 cfu/g is not exceeded throughout the shelf-life.

Trend analysis is included in part G of the DGAL's handbook, where it is mentioned that all microbiological results of testing in the framework of own controls should be analysed and interpreted. The importance and necessity for the use of trend analysis is emphasised.

The DGCCRF has not established specific guidance on trend analysis.

The CA control reports did not always specify if the controls had included these aspects but in relation to some establishments, detailed findings were available.

During the on-the-spot visits to the FBO producing RTE foodstuffs, shelf-life studies had in general been carried out. Seven of the nine FBOs visited were using trend analysis.

The seven FBOs visited producing RTE foodstuffs of animal origin had carried out shelf-life studies. The FBOs stated that they would, in addition, rely on historical data and test results received when testing the products after the end of the planned shelf-life.

Four of the nine FBOs visited had carried out challenge tests. Of the FBOs visited, one had in addition used mathematical modelling.

Observations:

• No shelf-life studies had been carried out in two of the nine establishments visited.

• No trend analysis had been carried out in the two establishments manufacturing RTE sprouted seeds and salads.

ConclusionsMost of the FBOs visited had carried out shelf-life studies and trend analysis and some of the control reports seen demonstrated that these aspects had also been controlled. However, two of the FBOs visited had not complied with the requirements for shelf-life studies and analysis of trends, as stipulated in Articles 3(2) and 9 of Regulation (EC) No 2073/2005.

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5.5.9 Supervision of in-house and other private laboratories used by the FBOs for microbiological analyses of foodstuffs

The meat products section of the DGAL handbook includes a definition for recognised laboratories (either accredited laboratories or laboratories within a network of laboratories participating in inter-laboratory testing). In addition, it includes a definition for recognised methods: ISO, EN, and AFNOR methods or alternative, validated methods are all accepted as recognised methods. The others sections of the handbook covering other foodstuffs of animal origin do not include these definitions.

The representatives of the DGAL arm of the LCA met during the audit, responsible for the controls of the establishments, stated that they would check if the methods used had been validated and if the laboratories had some quality control measures in place (for example, regular participation in proficiency test rounds with satisfactory results).

In the sprouted seeds establishment which had not yet been inspected for the requirements of Regulation (EC) No 2073/2005, no proof that the own control testing scheme and methods used had been checked by the DGCCRF arm of the LCA was available. Nevertheless, the laboratory used by the FBO was accredited and the methods had been validated.

The methods used by the FBOs visited by the audit team had all been validated by the AFNOR except a method seen in one establishment applied for the testing of enterobactericeae (see 5.5.7). Evidence of quality control measures in place was available in the establishments visited.

Conclusions

Evidence of quality control measures was available for the laboratories used for own controls.

5.6 LABELLING REQUIREMENTS FOR MINCED MEAT, MEAT PREPARATIONS AND MEAT PRODUCTS INTENDED TO BE EATEN COOKED

Legal requirements

Article 6 of Regulation (EC) No 2073/2005 sets out labelling requirements for batches of minced meat, meat preparations and meat products of all species, intended to be eaten cooked, which fulfil the requirements for Salmonella as set down in Annex I. Such batches must be clearly labelled by the manufacturer in order to inform the consumer of the need for thorough cooking prior to consumption.

Findings

The above-mentioned labelling requirement is emphasised in Service Note No 2006-10 of the DGCCRF about consequences of the HP for the controls on foodstuffs destined for human consumption and it is also included in Section 3, point D05L21 of the DGAL handbook but no specific procedure has been established for this requirement.

The DGCCRF representatives within the local DD(CS)PP have the responsibility for checking the compliance in relation to labelling requirements, including the requirement for labelling the batches of minced meat and meat preparations intended to be eaten cooked in order to inform the consumer of the need for thorough cooking prior to consumption.

The labels seen in the two establishments visited where compliance with the above-mentioned requirement was assessed by the FVO audit team, were correctly applied and in line with the above

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requirements.

Conclusions

The labelling requirements for minced meat, meat preparations and meat products intended to be eaten cooked were followed and in line with the requirements of Article 6 of Regulation (EC) No 2073/2005 in the two establishments visited where this requirement was checked.

6 CLOSING MEETING

A closing meeting was held on 3 February 2012 with representatives of the CCA. At this meeting, the audit team presented the main findings and preliminary conclusions of the audit. The authorities did not express disagreement with the main findings and preliminary conclusions and provided clarification to some of the issues raised during the presentation.

7 OVERALL CONCLUSION

The authorities of the DGAL have established an adequate framework for official controls over food safety and process hygiene criteria as required by Regulation (EC) No 2073/2005 whereas the approach of the DGCCRF is less harmonised. No official sampling was carried out to validate and verify the FBOs HACCP-based programmes and the use of official sampling was also limited in relation to alerts and food poisoning investigations. Although the control system based on risk assessment is as such correctly applied, the resulting frequencies are for some sectors very low (once every three to five years) and the audit team noted that in two departments visited the annual inspection frequency target had not been reached.

The French CAs rely largely on the FBOs' own control systems. With the described long inspection intervals for establishments in the lower risk categories it is difficult for the CAs to validate and verify the correct implementation of the Regulation (EC) No 2073/2005 by the FBOs in these establishments.

The audit team noted some deficiencies in relation to the implementation of Regulation (EC) No 2073/2005 in some of the establishments visited.

8 RECOMMENDATIONS

The competent authorities are invited to provide details of the actions taken and planned, including deadlines for their completion ('action plan'), aimed at addressing the recommendations set out below, within twenty five working days of receipt of this specific audit report.

N°. Recommendation

1. To ensure that official controls are carried out with appropriate frequency and based on the requirements of Article 3 of Regulation (EC) No 882/2004.

2. To ensure that OVs carry out the inspection tasks in slaughterhouses as required in

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N°. Recommendation

Chapter II , Section I, Annex I to Regulation (EC) No 854/2004.

3. To ensure that the DGCCRF develops documented control procedures in line with the requirements of Article 8 (1) of Regulation (EC) No 882/2004, that include information and instructions to staff performing official controls over food safety and processing criteria.

4. To ensure that national instructions on microbiological criteria in relation to L. monocytogenes and the interpretation of the results are in line with Annex I to Regulation (EC) No 2073/2005.

5. To ensure that official samples are taken when necessary, as laid down in point 8 (c) of Article 4 of Regulation (EC) No 854/2004 and foreseen in the internal procedures of the CAs.

6. To ensure that RTE sprouted seeds are controlled by the FBO and CAs in line with Articles 1 and 4 of Regulation (EC) No 2073/2005.

7. To ensure that the NRL for L. monocytogenes takes up all its duties as required in Article 33 of Regulation (EC) No 882/2004.

8. To ensure that FBOs operators follow the requirements of carcass sampling, as stipulated in Chapter 2 and Chapter 3.2 of Annex I to Regulation (EC) No 2073/2005.

9. To ensure that FBOs manufacturing RTE foods, which may pose a L. monocytogenes risk for public health, sample processing areas and equipment for L. monocytogenes as part of their sampling scheme, as stipulated in Article 5.2. of Regulation (EC) No 2073/2005.

10. To ensure that all FBOs carry out shelf-life studies as necessary, in particular FBOs manufacturing RTE foods that are able to support L. monocytogenes and analysis of trends, respectively, as required in Articles 3(2) and 9 of Regulation (EC) No 2073/2005.

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

http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_inspection_ref=2012-6330

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ANNEX 1 - LEGAL REFERENCES

Legal Reference Official Journal Title

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. 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. 854/2004 OJ L 139, 30.4.2004, p. 206, Corrected and re-published in OJ L 226, 25.6.2004, p. 83

Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption

Reg. 882/2004 OJ L 165, 30.4.2004, p. 1, Corrected and re-published in OJ L 191, 28.5.2004, p. 1

Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules

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

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