I EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL

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1 Ref. Ares(2014) /06/2014 I EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Directorate F - Food and Veterinary Office DG(SANCO) FINAL MICROBIOLOGICAL CRITERIA FOR FOOD OVERVIEW OF FVO REPORTS

2 Executive Summary The Food and Veterinary Office (FVO) carried out twelve audits from March 2011 to June 2013 in order to evaluate the official controls on food safety and process hygiene criteria (Commission Regulation (EC) No 2073/2005, hereafter referred to as the Regulation). The audits were carried out in Denmark, Ireland, Germany, France, Finland, Hungary, Czech Republic, Spain, Belgium, Cyprus, Poland and Italy. This report covers the main findings of all the audits carried out. The competent authorities (CAs) of all Member States (MS(s)) visited have implemented controls offood safety and process hygiene criteria as required by Regulation (EC) No 2073/2005. All MSs had issued guidelines for the interpretation ofprovisions of Regulation (EC) No 2073/2005for the officials carrying out the controls.. In most MSs the official control plans were well implemented in relation to most aspects of the Regulation. However, shortcomings were noted in the following areas: Implementation of controls over HACCP-based procedures, Implementation of controls over food safety and process hygiene criteria, Insufficient documentation of the controls in some MSs, 9 Insufficient controls of Food Business Operators (FBOs) producing sprouted seeds in several MSs (especially before the 2011 Escherichia coli (E. coli) human outbreaks in Germany and France), Enforcement actions in some MSs were weakened due to the application of national rules for official sampling or late detection of the non-compliance. In most MSs, the procedures/check-lists were not specific enough to support a comprehensive control on the implementation of the Regulation. The FBOs visited used the tools stipulated in the Regulation to establish the shelf-life of the products to a varying degree. The FBOs' procedures based on HACCP principles were in most cases well implemented. However, adequate validation and verification of the programmes were not always carried out. In general, a gradual improvement was noted in the outcome of the audits during the audit series. Several of the MSs visited during the later course of the audit series stated that they had used the results and recommendations of the previous audit reports published as part of their audit preparation. The FVO audit team identified issues in relation to difficulty in the interpretation of Regulation (EC) No 2073/2005, which caused in some cases inadequate FBO controls and official controls in particular in relation to determination of sampling frequencies, the use of rapid methods for testing of food stuffs with a short shelf-life; placing of Salmonella-positive fresh poultry meat on the market (поп-s. typhimurium and non-s.enteritidis); sampling of meat preparations (MP) and meat products (MPR) - not applying the definitions in Regulation (EC) No 853/2004 correctly; placing on the market of non-compliant mechanically separated meat (MSM) without strict public health requirements; the frequency of environmental sampling in general and of Listeria monocytogenes (L. monocytogenes) in particular; and the use of alternative methods for carcass sampling and related criteria. I

3 Table of Contents 1 INTRODUCTION 1 2 OBJECTIVES AND SCOPE 1 3 LEGAL BASIS 1 4 BACKGROUND. 1 5 FINDINGS AND CONCLUSIONS NATIONAL LEGISLATION/CRITERIA AND GUIDELINES COMPETENT AUTHORITIES DESIGNATION OF THE COMPETENT AUTHORITIES CO-ORDINATION BETWEEN COMPETENT AUTHORITIES AND CO-ORDINATION AND CO-OPERATION WITHIN COMPETENT A UTHORITIES STAFF PROVISIONS AND FACILITIES ENFORCEMENT REQUIREMENTS LABORATORY NETWORK NATIONAL REFERENCE LABORATORIES LABORATORY ACCREDITATION AND QUALITY CONTROLS METHODS OF SAMPLING AND ANALYSIS METHODS USED FOR OFFICIAL SAMPLING AND TESTING METHODS USED IN THE FRAMEWORK OF FOOD BUSINESS OPERATORS' OWN CONTROLS OFFICIAL CONTROLS ORGANISATION OF OFFICIAL CONTROLS OFFICIAL SAMPLING AND TESTING CONTROLS OVER HACCP BASED PROCEDURES CONTROLS OVER FOOD BUSINESS OPERATORS' COMPLIANCE WITH FOOD SAFETY CRITERIA CONTROLS OVER FOOD BUSINESS OPERATORS' COMPLIANCE WITH PROCESS HYGIENE CRITERIA CONTROLS OVER SAMPLING AND TESTING OF PROCESSING AREAS AND EQUIPMENT (ESPECIALLY FOR LISTERIA MONOCYTOGENES WHEN MANUFACTURING READY-TO-EAT FOODS) CONTROLS OVER ALTERNATIVE SAMPLING AND TESTING PROCEDURES CONTROLS OVER SHELF-LIFE STUDIES AND OVER ANALYSES OF TRENDS SUPERVISION OF IN-HOUSE AND OTHER PRIVATE LABORATORIES USED BY THE FOOD BUSINESS OPERATORS FOR MICROBIOLOGICAL ANALYSES OF FOODSTUFFS LABELLING REQUIREMENTS FOR MINCED MEAT, MEAT PREPARATIONS AND MEAT PRODUCTS INTENDED TO BE EATEN COOKED 15 6 RECOMMENDATIONS 15 7 ACTION TAKEN BY COMMISSION SERVICES FOLLOW UP OF AUDIT RECOMMENDATIONS 17 ANNEX I - LEGAL REFERENCES 18 ANNEX II DETAILS OF AUDITS CARRIED OUT. 19 II

4 ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT Abbreviation CA(s) CCA(s) DG(SANCO) Explanation Competent Authority(ies) E. coli Escherichia coli EC EU EURL FBO(s) FVO Hygiene Package HACCP ISO Central Competent Authority(ies) Health and Consumers Directorate-General European Community European Union European Union Reference Laboratory Food Business Operator(s) Food and Veterinary Office Set of the following Regulations : Regulations (EC) No 852/2004, No 853/2004, No 854/2004, No 882/2004. Hazard Analysis Critical Control Points International Standardisation Organisation L. monocytogenes Listeria monocytogenes MP MPR MS MSM NRL RASFF RTE Meat Preparations Meat Products Member State Mechanically Separated Meat National Reference Laboratory Rapid Alert System for Food and Feed Ready to eat III

5 1 INTRODUCTION The Food and Veterinary Office (FVO) carried out twelve audits to evaluate the official controls on food safety and process hygiene criteria (Commission Regulation (EC) No 2073/2005) from March 2011 to June 2013). The audits were carried out in Denmark, Ireland, Germany, France, Finland, Hungary, Czech Republic, Spain, Belgium, Cyprus, Poland and Italy. Reports of individual audits are available on DG SANCO's website: en.htm Details on specific reports (MSs, audit references, and dates) are available in Annex II. This report reflects the status observed at the time of the audits, although some systems may have improved in the meantime. 2 OBJECTIVES AND SCOPE The objective of the audits was to evaluate the implementation of official controls on food safety and process hygiene criteria, mainly in products of animal origin, including in addition ready to eat (RTE) foods, pre- cut RTE finits and vegetables, and unpasteurised fruit and vegetable juices, in the framework of Regulations (EC) No 178/2002, No 852/2004, 853/2004, 854/2004, 882/2004 and 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. 3 LEGAL BASIS The audits were 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 (EN/ISO). 4 BACKGROUND The Hygiene Package 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 MSs on official controls in relation to food safety and process hygiene criteria were scheduled in

6 This is the first audit round in the MSs targeted at official controls solely on this area of activity. 5 FINDINGS AND CONCLUSIONS 5.1 NATIONAL LEGISLATION/CRITERIA AND GUIDELINES Legal Requirements Article of the Treaty on the functioning of the EU requires that the MSs adopt all measures of national law necessary to implement legally binding Union acts. Article 7 of Regulation (EC) No 852/2004 stipulates that MSs 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 MSs shall forward the national guides to the Commission. According to Article 3.2 of Regulation (EC) No 2073/2005 guidelines for conducting shelf-life studies may be included in the guides to good practice referred to in Article 7 of Regulation (EC) No 852/2004. All MSs had issued guidelines for the interpretation of provisions of Regulation (EC) No 2073/2005 for the officials carrying out the controls. However, the guidelines did not cover all aspects of the Regulation. Moreover, in most MSs, the procedures and check-lists were not specific enough to support a comprehensive control of the implementation of the Regulation. The guidelines for sampling in point 3.1. of Chapter 3, Annex 1 to the Regulation allow the CA to give exemptions in relation to sampling frequencies for small slaughterhouses and establishments producing minced meat, MP and fresh poultry meat in small quantities. The exemptions have to be justified on the basis of a risk analysis and authorised by the CA. In the majority of the MS, exemptions for the sampling frequencies for small slaughterhouses and establishments producing MM, MPs and fresh poultry meat had been authorised by the CA based on a risk analysis. However, in two MSs visited these exemptions had not been regulated and in some MSs visited, the CA had not carried out a risk-analysis on a case by case basis on small-capacity slaughterhouses, when accepting a derogation for sampling frequency. Twenty six MSs have sent national guidelines on good hygiene practice and for the application of HACCP to the Commission services. They are included in a register for national guides to good practice, accessible by the following link: practice en.htr. Some guidelines also cover shelf-life studies. Conclusions on national legislation/criteria and guidelines All MSs had initiated procedures to ensure effective and consistent implementation of the provisions of Regulation (EC) No 2073/2005. However, in most MSs, the procedures and check- 2

7 lists issued were not sufficiently specific to achieve this objective. The system in place for granting exemptions for the sampling frequencies for small slaughterhouses and establishments producing MM, MPs and fresh poultry meat in small quantities did comply with the requirements of point 3.1. of Chapter 3, Annex 1 to Regulation (EC) No 2073/2005 in most of the MSs, except for some where the risk assessment was not individually based and in two MSs this issue had not been regulated. 5.2 COMPETENT AUTHORITIES Designation of the Competent A uthorities Legal requirements Article 4 of Regulation (EC) No 882/2004 requires that the MSs shall designate CAs responsible for the purposes and official controls set out in the Regulation. All the MSs had designated CAs responsible for the purposes of official controls of the Regulation (EC) No 2073/2005 as required by Article 4 of Regulation (EC) No 882/2004. In some MSs different CAs were designated depending on the food sector to be controlled Co-ordination between Competent Authorities and co-ordination and co-operation within Competent Authorities Legal Requirements Article 4(3) of Regulation (EC) No 882/2004 provides for efficient and effective co-ordination between CAs. 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. The CAs responsible for the controls over microbiological criteria were well organised and evidence of adequate co-operation and co-ordination was in general available. However, in relation to co-ordination the situation varied from a satisfactory picture in a MS with a centralised organisation, to a MS with several CAs and/or a regionalised-/federal structure, where problems were more predominant. The reporting of official sampling programmes to the CA regarding the context in which the samples were taken was inadequate in some cases. In one case the data were only kept at district/local level. This limited the usefulness of the data for control planning and risk assessments. 3

8 5.2.3 Staffprovisions andfacilities Legal requirements Article 4 (2) of Regulation (EC) No 882/2004 requires the CA to ensure that they have access to a 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 C As to ensure that staff receive appropriate training, and are kept up-to-date in their competencies. In several MSs, evidence indicated that the training provided in relation to official controls of Regulation (EC) No 2073/2005 had been inadequate or had been organised only recently 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 MS shall lay down rules on sanctions applicable to infringements of 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. In general, proportionate enforcement actions were taken in case of non-compliances detected. Nevertheless, the FVO audit teams noted that action taken by the CAs had sometimes been delayed. This was caused by either the application of national rules for official sampling in a couple of cases or late detection of the non-compliances in other cases. In all MSs visited, the FVO auditors reviewed some Rapid Alert notifications in the framework of the Rapid Alert System for Food and Feed. In most MSs visited and in cases stated, the system had functioned adequately. However, in some cases delays in relation to corrective actions taken were noted. Conclusions on Competent Authorities All the MSs had designated CAs responsible for the purpose of official controls of Regulation (EC) No 2073/2005 as required by Article 4 of Regulation (EC) No 882/2004. In most MSs visited, the training provided in relation to the official controls of Regulation (EC) No 2073/2005 was inadequate or had not been timely, contrary to the requirements of Article 6 of Regulation (EC) No 882/2004. The CAs responsible for the controls over microbiological criteria were well organised and evidence of adequate co-operation and co-ordination was in general available in the MSs visited. 4

9 However, in a few MSs the reporting of the results of official sampling to the CA was inadequate jeopardising a proper risk assessment and control planning as required by Article 3 of Regulation (EC) No 882/2004. The systems in place and action taken in relation to enforcement and follow-up on rapid alert notifications were in general adequate in the MSs visited and in line with the requirements of Article 54 of Regulation (EC) No 882/ 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. Article 33 of Regulation (EC) No 882/2004 stipulates that the MSs shall arrange for the designation of one or more National Reference Laboratories (NRLs) for each EU reference laboratory (EURL) referred to in Article 32. Article 33(5) of the same Regulation requires that MSs 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) National Reference Laboratories In general NRLs had been designated for all EURLs referred to in Article 32 of Regulation (EC) No 882/2004. The NRLs in most MSs visited had adequately carried out the tasks as stipulated in Article 33 of Regulation (EC) No 882/2004. An adequate official laboratory network was in place in all MSs. The FVO auditors noted some shortcomings in relation to the organisation of proficiency tests and the task of the NRL to pass on information from the EURLs to the official laboratory network contrary to the requirements of Article 33 (2) of Regulation (EC) No 882/ Laboratory accreditation and quality controls Legal requirements Article 12 (2) of Regulation (EC) No 882/2004 requires that the designated laboratories have to be accredited in accordance with the following European standards: EN/ISO/IEC on "General requirements for the competence of testing and calibrating laboratories". EN/ISO/IEC 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. 5

10 The accreditation and assessment of testing laboratories referred to above may relate to individual tests or groups of tests. The official laboratories visited in the MSs were all accredited and had in general adequate quality controls in place in line with the requirements of Article 12 (2) of Regulation (EC) No 882/2004. Conclusions on laboratory network The official laboratory network in the MSs was adequate and in general organised in line with the requirements of Articles 12 (2) and 33 of Regulation (EC) No 882/2004. However, in some cases inadequate coordination of proficiency tests and flows of EURL information from the NRLs to the official laboratory network was noted. This is contrary to the requirements of Article 33 (2) of Regulation (EC) No 882/ 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 such rules, 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 Methods used for official sampling and testing The methods used for testing of official samples were either reference methods or valid alternative methods. In a few MSs lists were published of alternative validated methods that could be used for analysing for process hygiene and food safety criteria Methods used in the framework of Food Business Operators' own controls The external private laboratories used by the FBOs for own controls were in most cases accredited and the methods were usually ISO methods or validated alternative methods. Internal private laboratories were only accredited in a few cases. The methods used were either the reference ISO methods, vaudated alternative methods. However, some cases alternative methods that had not been validated against the reference method using ISO This is contrary to Article 5 (5) of Regulation (EC) No 2073/2005. Conclusions on methods of sampling and analysis The methods used by the CA in the framework of official control on microbiological criteria were 6

11 either accredited or had been validated against reference methods according to ISO Nevertheless, in most cases the reference methods as given in Annex I to Regulation (EC) No 2073/2005 were used routinely. In the majority of MSs the external private laboratories use of testing methods were in line with the provisions of Article 5 of Regulation (EC) No 2073/2005. However, in some MSs the methods used in internal private laboratories had not been validated against the reference method contrary to the requirements of Article 5 (5) of Regulation (EC) No 2073/ OFFICIAL CONTROLS Legal requirements 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 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. Preamble (15) of Regulation (EC) No 852/2204 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. 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/ Organisation of official controls In all MSs official controls on FBO's compliance with the requirements of Regulation (EC) No 2073/2005 were carried out according to annual plans and were in the majority of cases risk based in accordance with Article 3 of Regulation (EC) No 882/2004. The controls on Regulation (EC) No 2073/2005 requirements were usually carried out as a part of the control over the FBOs' own-check programme. The official controls and the documentation of the controls over HACCP, food safety criteria, 7

12 process hygiene criteria, environmental sampling, alternative sampling and testing procedures, shelf-life studies and challenges tests, in-house laboratories and other private laboratories, were in most MSs only partly adequate. Shortcomings were noted in particular as regards controls on validation of HACCP, the basis for the established sampling frequencies, correct laboratory method applied, validity of test results from private laboratories, trend analysis, shelf life studies and environmental controls. Many of these shortcomings were related to inadequately designed procedures and check-lists on those aspects and lack of specific training. In two MSs with low Salmonella incidence, although the sampling plans in general were organised on a risk basis, testing of foodstuffs for Salmonella in relation to intra-union trade at the first point of entry, while comprehensive, was not risk based and non-discriminatory. Conclusions on organisation of official controls In most MSs the official controls largely took into account Article 3 (1) of Regulation (EC) No 882/2004. In most MSs the documented procedures and check-lists were inadequate with regard to official controls over Regulation (EC) No 2073/2005. In two MSs the checks on compliance with food law was not non-discriminatory, as required by Article 3 (6) of Regulation (EC) No 882/2004. In most MSs the audit systems of HACCP based procedures in order to determine to the best extent possible that the procedures guarantee compliance with microbiological criteria in EU legislation as required by point 5 (a) of Article 4 of Regulation (EC) No 854/2004 were not adequate Official sampling and testing In all MSs sampling plans were carried out according to annual plans but the sampling schemes varied considerably between the MSs. In most MSs visited the control and sampling plans were risk- based and taking into account most of the criteria of Article 3 of Regulation (EC) No 882/2004. However, in some MSs not all risk factors were taken into account. In one MS visited the results of official sampling were not used as a tool for assessing the effectiveness and appropriateness of HACCP-based programmes. In this MS official sampling was carried out only in the framework of special monitoring or surveillance projects. In another MS visited, the official annual sampling programme targets had not been reached. The FVO auditors noted shortcomings in relation to the reporting and collation of official sampling results in some MSs. In general, the situation varied from a satisfactory picture in MSs with a centralised organisation, whereas in a MS with several CAs and/or a regionalised/federal structure there were more problems with the reporting system. Conclusions on official sampling and testing In general the official sampling programmes were adequately designed taking into account the criteria of Article 3 of Regulation (EC) No 882/2004 with only shortcomings in a few MSs with regarding the application of all criteria. In those MSs, particularly those where several CAs were involved and/or those with a 8

13 regionalised-/federal structure, where laboratory data on compliance with microbiological criteria are not all reported to/collated at central level, accurate risk assessment was jeopardised and, as a consequence, the design and use of the official sampling programmes was not in accordance with Article 3 of Regulation (EC) No 882/ Controls over HACCP based procedures The controls over the Regulation (EC) No 2073/2005 were usually carried out as a part of the control of the FBOs' own-check programme. Article 4(2) of the Regulation stipulates that the FBOs should decide the appropriate sampling frequencies in the context of their HACCP programmes, in cases where a fixed frequency has not been stipulated. This leaves a lot of leeway for the FBOs. The FVO audit team noted that in most MSs visited, in several cases the sampling frequency had not been established within the context of the FBOs' HACCP programmes. Furthermore, there are no clear provisions in the Regulation or in the Hygiene Package on how to address situations when FBOs producing large volumes of high risk products have inadequately designed and/or implemented HACCP programmes. Moreover, a very low sampling frequency was noted in several cases, even in establishments with high production volumes and/or in situations where non-compliant products had been distributed to the market. In these situations it was evident that the sampling frequency established by the FBO had been too low. Article 4 of the Regulation requires the FBOs to perform testing as appropriate against the microbiological criteria set out in Annex I, when they are validating and verifying the correct functioning of their procedures based on HACCP principles and good hygiene practice. The FBOs' procedures based on HACCP principles were in most cases well implemented except for validation and verification of the programmes, which was only implemented infrequently. Some small-scale FBOs visited were operating with inadequate HACCP-based programmes. Some FBOs visited had not taken the product characterisation (water activity and ph) into account, when the risk of L. monocytogenes growth was assessed. Conclusions on controls over HACCP based procedures Although controls over the FBOs' compliance with Regulation (EC) No 2073/2005 were carried out as part of the control of the FBOs 1 own-check programme the following points were not addressed adequately by the CA: the sampling frequency had not been established within the context of the FBOs' HACCP programmes contrary to the requirements of Article 4 (2) of Regulation (EC) No 2073/2005 by many FBOs in most MSs visited. In addition, a very low sampling frequency was noted in several cases, even in establishments with high production volumes and/or in situations where non-compliant products had been distributed to the market. In these cases it was evident that the frequency was too low to address the public health risk associated with the products; in most cases a verification or validation of the programmes within the context of Regulation (EC) No 2073/2005 had not taken place, contrary to Article 4 of the Regulation; 9

14 Contrary to the requirements of Article 5 of Regulation (EC) No 852/2004, in some cases the product characterisation (water activity and ph) was not taken into account when the risk of L. monocytogenes growth was assessed Controls over Food Business Operators ' compliance with food safety criteria Article 7 (2) of Regulation (EC) No 2073/2005 stipulates that in the case where testing against food safety criteria provides unsatisfactory results, the product or batch of foodstuffs shall be withdrawn or recalled. However, if minced meat or another foodstuff with a short shelf-life is tested Salmonella positive using the reference method EN/ISO 6579, the time frame required for test results with the reference method is often too long for this type of product. When the test results are ready no product recall is possible, as the product has already been sold or the shelf-life has expired. The Regulation does not specify that in such cases a faster alternative validated method should be used. The FVO audit teams noted several such cases. Commission Regulation (EC) No 1086/2011, amending Regulation (EC) No 2073/2005, introduced Salmonella typhimurium and -enteritidis as food safety criteria for fresh poultry meat in Annex I of Regulation (EC) No 2073/2005. The food safety criterion for minced meat, MPs intended to be eaten raw or cooked, for mechanically separated meat (MSM) and for MPR intended to be eaten raw (excluding products where the manufacturing process or the composition of the product will eliminate the Salmonella risk) is generic Salmonella (without requiring serotyping). Based on these two different approaches, it can be interpreted that it is safe to place on the market fresh poultry meat tested Salmonella-positive as long as the serovar is not Salmonella typhimurium or enteritidis but MM, MP, MSM and MPR, derived from such poultry meat is not considered safe. The definition of a MP in Regulation (EC) No 853/2004 leaves room for some interpretation which has economic consequences for the FBOs. Some FBOs visited had classified their product that still had characteristics of fresh meat as a MPR instead of a MP, to avoid a more extensive testing scheme and higher testing costs (MP have to be tested for Salmonella and E.coli whereas for MPR this testing is not necessary). According to Chapter 1 of Annex lof Regulation (EC) No 2073/2005 sprouted RTE seeds have to be tested for L. monocytogenes and Salmonella (food safety criteria). Pre-cut fruit and vegetables (RTE) have to be tested also for E. coli as a process hygiene criteria. The FVO auditors noted several shortcomings in relation to the controls in place over FBOs producing sprouted seeds in six MSs. However, the controls and official sampling had been increased after the 2011 sprouted seedsrelated E. coli outbreaks in Germany and France. The majority of the FBOs visited had tested their final products for food safety criteria according to the requirements of Regulation (EC) No 2073/2005. However, some shortcomings were noted with regard to sampling size when testing RTE foodstuffs for food safety criteria. Point 1.2 of Chapter 1, Annex 1 to Regulation (EC) No 2073/2005 allows the FBOs to choose between two different criteria in relation to L. monocytogenes in RTE foods able to support the growth of L. monocytogenes, depending on whether he can prove that the limit of 100 cfu /g is not exceeded during the shelf life. In the majority of cases a precautionary principle was followed as regards L. monocytogenes in RTE products able to support the growth. Most FBOs visited, producing RTE food, used the "absence in 25g" criteria for L. monocytogenes for their own control 10

15 testing of the final products even when they had data to demonstrate that the level of L. monocytogenes would stay below the criteria of 100 cfu/g in the product during shelf-life. Some of the small FBOs visited stated that they considered the required testing to prove that the foodstuffs do not support the growth of L. monocytogenes to be too costly and time consuming. Conclusions on controls over Food Business Operators' compliance with food safety criteria The controls over FBOs' compliance with food safety criteria were carried out in a largely adequate manner in most MSs in line with Regulation (EC) No 2073/2005. However, some shortcomings were noted with regard to sampling size when testing RTE foodstuffs for food safety criteria. Difficulties experienced by CAs and FBOs, in interpretation of some rules concerning food safety criteria within Regulations (EC) No 2075/2005 and No 853/2004, led to inconsistent application of these rules, in some cases resulting in a reduction in the level of protection of public health. The FBOs testing for L. monocytogenes, as a food safety criteria, was in most MS in line with the requirements of Regulation (EC) No 2073/2005. In addition, in the majority of cases a precautionary principle was followed as regards L. monocytogenes in RTE products able to support the growth using the "absence in 25g" criteria for L. monocytogenes for their own control testing of the final products even when they had data to demonstrate that the level of L. monocytogenes would stay below the criteria of 100 cfu/g in the product during shelf-life. The official controls over FBOs producing sprouted seeds was in most MS, where these controls were relevant, inadequate with many shortcomings related to sampling and testing for food safety contrary to the requirements of Regulation (EC) No 2073/2005. However, the controls and official sampling had increased after the 2011 sprouted seeds-related E. coli outbreaks in Germany and France Controls over Food Business Operators' compliance with process hygiene criteria The majority of the FBOs visited had tested their products for process hygiene criteria according to the requirements of the Regulation (EC) No 2073/2005. However, some shortcomings were noted: According to point 3(e), of Chapter II, Section V, Annex III to Regulation (EC) No 853/2004, MSM (produced using techniques that do not alter the structure of the bones used in its production and the calcium content of which is not significantly higher than that of minced meat) not complying with the microbiological criteria for MM can only be used for manufacturing heat-treated MPs. However, the parameters for the heat treatment (e.g. temperature and duration) are not specified although especially poultry MSM can have a high level of bacterial contaminants and a short time/low temperature heat-treatment might not guarantee the inactivation of all pathogens. For example, at one FBO visited, poultry MSM was not complying with limits 10 times higher than the ones established by Regulation (EC) No 2073/2005. Chapter 2.1 of Annex 1 to Regulation (EC) No 2073/2005 requires that samples are taken from cattle, sheep, goats, horses and pigs carcasses after dressing but before chilling. However, some FBOs visited carried out sampling of carcasses after cooling without a proper validation of this change to the sampling procedure 11

16 Conclusions on controls over Food Business Operators' compliance with process hygiene criteria The FBOs testing for process hygiene criteria were in the majority of MSs in line with the requirements of the Regulation (EC) No 2073/2005. In the absence of specified parameters for the heat treatment of microbiologically non-compliant MSM being incorporated in a MPR, the treatment applied might not be sufficient to inactivate all micro-organisms in heavily contaminated MSM (e.g. poultry MSM). However, Regulation (EC) No 2073/2005 does not lay down an upper bacterial limit for contaminated MSM which would make it unfit for human consumption. The provisions of Article 5 (5) of Regulation (EC) No 2073/2005 were not always complied with since some FBOs carried out sampling of carcasses after cooling without demonstrating to the CA that this method was equivalent to the standard method. While CA controls were generally satisfactory, the issues described above created some difficulties in the consistent application of some requirements Controls over sampling and testing of processing areas and equipment (especially for Listeria monocytogenes when manufacturing ready-to-eat foods) According to Article 5 (2) of Regulation (EC) No 2073/2005 samples shall be taken from processing areas and equipment used for food production, when such sampling is necessary for ensuring that the criteria are met. The wording "as necessary" is ambiguous and allows for interpretation in relation to whether such studies have to be carried out. The FVO audit team noted a big variation in testing frequencies and practices. It is further required, that FBOs manufacturing RTE foods, which may pose a L. monocytogenes risk for public health, shall sample the processing areas and equipment for L. monocytogenes as part of their sampling scheme. Not all FBOs visited could demonstrate that they carry out regular verification of their cleaning and disinfection. Furthermore, not all FBOs manufacturing RTE foods that could pose a L. monocytogenes risk for public health carried out the required environmental sampling for L. monocytogenes. Conclusion on controls over sampling and testing of processing areas and equipment (especially for L. monocytogenes when manufacturing ready-to-eat foods) Regular microbiological verification of cleaning and disinfection and for the presence of L. monocytogenes in the environment, where RTE products posing a L. monocytogenes risk for public health were produced, was not carried out by FBOs, or enforced by the CAs, in all MSs. This may be the result of difficulties in interpretation of the requirements specified in Article 5 (2) of Regulation (EC) No 2073/

17 5.5.7 Controls over alternative sampling and testing procedures Article 5.3 of Regulation (EC) No 2073/2005 stipulates that the number of sampling units of the sampling plans set out in Annex I to the Regulation can be reduced if the FBO can demonstrate by historical documentation that effective HACCP-based procedures are in place. The wording "historical documentation" is not very precise compared with the detailed requirements given in Chapter 3.2 of the said Regulation for carcass sampling. The FVO audit teams noted a big variety in relation to the required historical documentation and consequently in the number of sampling units between sampling plans of the FBOs. Article 5 (5) of the Regulation (EC) No 2073/2005 allows the FBOs to use sampling and testing procedures other than the reference methods given in Annex I of the said Regulation, if they can demonstrate to the satisfaction of the CA that these procedures provide at least equivalent guarantees. The use of alternative analytical methods is acceptable when the methods are validated against the reference method in Annex I of the Regulation. In MSs visited the FBOs had pooled samples together (which reduces the costs of testing). Instead of testing five units individually the FBOs pooled five sample units to one sample. Although a validation of this procedure had been carried out in most cases, concerns can be raised about this approach. A larger test sample requires more attention to ensure homogenisation of the sample and the growth media in order to guarantee an even distribution of temperature and nutrients allowing for the proper growth of the possible pathogenic micro-organism in the sample. In relation to carcass sampling, the FBOs can also apply the alternative, non-destructive method (swab technique), but the Regulation (EC) No 2073/2005 does not contain any limits for the above bacteria for this method whereas Chapter 2 of Annex I to the Regulation only provides limits for aerobic colony counts and Enterobactericeae in carcasses for the destructive method. In several MSs visited the non-destructive method was used by the FBOs without a validation study against the destructive sampling technique in order to ensure equivalent guarantees as required by Article 5 (5) of Regulation (EC) No 2073/2005. Conclusions on controls over alternative sampling and testing procedure A big variation in the number of sampling units between sampling plans was noted in the MSs. This is considered to be related to the imprecise phrasing of the requirements for sampling frequency and practice for these issues in Article 5 (3) of Regulation (EC) No 2073/2005. Although pooling of samples took place relatively frequently and validation of this process was carried out in most MSs by the FBOs as required by Article 5 (5) of the Regulation (EC) No 2073/2005 doubts are raised about the measures to ensure the sensitivity of the testing procedures in such cases. In several MSs visited the non-destructive method for carcass sampling was used by the FBOs without a validation study against the destructive sampling technique, which is the only carcass sampling method criteria that has been defined in the Regulation in order to ensure equivalence. This is contrary to the requirements of Regulation (EC) No 2073/2005. In general, CA controls had not identified the issues described above and there is significant variation in the standards applied. 13

18 5.5.8 Controls over shelf-life studies and over analyses of trends According to Article 3 (2) of the Regulation (EC) No 2073/2005, the FBOs have to conduct studies in order to investigate compliance with the criteria throughout the shelf-life of their products "as necessary". This wording is ambiguous and allows for interpretation in relation to whether such studies have to be carried out. In the MSs visited, numerous FBOs visited had not carried out such studies in cases where they could be considered appropriate. Article 3 (1) of the Regulation lays down that the FBOs shall take measures at each stage of food production, processing and distribution, including retail, as part of their procedures based on HACCP principles together with the implementation of good hygiene practice, to ensure that the process and food safety criteria are met. Moreover, according to point I (b) of Article 3 of the Regulation, the FBO shall take measures to ensure that the food safety criteria applicable throughout the shelf-life can be met under reasonable foreseeable conditions of distribution, storage and use. However, the shelf-life studies carried out by the FBOs as required by Article 3.2 of the Regulation frequently failed to take into account how products were likely to be stored by the final consumer. Annex II of the Regulation (EC) No 2073/2005 stipulates that when necessary, the FBO shall conduct additional studies on the basis of the shelf-life studies, such as predictive mathematical modelling, challenge studies and studies to evaluate the growth or survival of the micro-organisms present in the products during the shelf-life. However, predictive mathematical modelling and challenge studies were very rarely used as tools and only by FBOs with large-scale production. Conclusions on controls over shelf-life studies and over analyses of trends The shelf-life studies carried out by the FBOs as required by Article 3.2 of the Regulation (EC) 2073/2005 frequently failed to take into account how products were likely to be stored by the final consumer. Predictive mathematical modelling and challenge studies as stipulated in Annex II to Regulation (EC) No 2073/2005 were very rarely used as tools and only by FBOs with a large-scale production. In general, CA controls had not identified the issues described above Supervision of in-house and other private laboratories used by the Food Business Operators for microbiological analyses of foodstuffs The Regulation and the Hygiene Package do not set out rules in relation to controls in place over the FBOs' own control laboratories situated within the establishment and consequently the laboratories were not included in the official controls carried out by the CAs. In the majority of MSs the majority of external private laboratories were accredited according to ISO and had adequate facilities. In general the in-house own check laboratories visited had adequate facilities. However, the FVO audit team detected shortcomings in relation to the quality assurance schemes in place in some of them. 14

19 Conclusion on the supervision of in-house and other private laboratories used by the Food Business Operators for microbiological analyses of foodstuffs There are no provisions in Regulation (EC) No 2073/2005 or other relevant EU legislation for ensuring adequate official supervision of private in-house laboratories and thereby for the verification of the reliability of the microbiological laboratory test results of the FBO. 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 (except poultry), 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. The FBOs visited by the FVO audit teams had labelled the above mentioned products correctly in the majority of cases reviewed. Conclusions on the labelling requirements for minced meat, meat preparations and meat products intended to be eaten cooked In the majority of cases the FBOs complied with the labelling requirements set out in Article 6 of Regulation (EC) No 2073/ RECOMMENDATIONS The following is a summary of the main recommendations made in individual audit reports. It should be noted that not every recommendation applies to each MS. To update national guidance documents covering the requirements given in Regulation (EC) No 2073/2005. To further develop appropriate documented procedures for official controls of Regulation (EC) No 2073/2005 as required by Article 8 (1) of Regulation (EC) No 882/2004. To improve the information flow to central level from the different Competent Authorities on the implementation of official controls and follow-up of non-compliances, in order to ensure a proper risk assessment as required by Article 3.1 of Regulation (EC) No 882/2004 with regard to Regulation (EC) No 2073/2005. To ensure that official control staff is trained in relation to all relevant requirements of Regulation (EC) No 2073/2005 as required by Article 6 of Regulation (EC) No 882/2004. To ensure when pooling samples take place that adequate documentation is in place to 15

20 provide for a proper evaluation of the food safety criteria in Regulation (EC) No 2073/2005. To ensure that appropriate action is taken by the food business operators when Competent Authorities identify a non-compliance in relation to the requirements of Regulation (EC) No 2073/2005, as required by Article 54 of Regulation (EC) No 882/2004. To ensure appropriate co-ordination by the National Reference Laboratories of the participation of official laboratories in relevant proficiency tests and to improve the flow of the European Union Reference Laboratory information to the official laboratories as required by Article 33 of Regulation (EC) No 882/2005. To ensure that when alternative sampling methods are used by the food business operator when testing for compliance with process hygiene criteria that these procedures provide at least equivalent guarantees as required by Article 5 (5) of Regulation (EC) No 2073/2005 and that all laboratory methods are validated against the reference method. To ensure that the checks on the compliance with food law of foodstuffs originating from other Member States are carried out by means of non-discriminatory checks, as required in Article 3.6 of Regulation (EC) No 882/2004. To ensure that the system of official controls for both services is organised in a way that ensure that the applied frequency is appropriate in all cases taking into account the relevant risks as required by Article 3 (1) of Regulation (EC) No 882/2004. To ensure that official controls over food business operators' Hazard Analysis Critical Control Points based procedures cover all relevant aspects, including the requirements of Articles 3, 4, 5 and 7 of Regulation (EC) No 2073/2005 in particular in relation to the actions in case of non-compliant test results, trend analysis, shelf-life studies, sampling and testing procedures for both food safety and process hygiene criteria. To ensure that ready-to-eat sprouted seeds are controlled by the food business operator and Competent Authorities in line with Articles 1 and 4 of Regulation (EC) No 2073/2005. To ensure that food business 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. To ensure that testing of red meat and poultry carcasses against the microbiological criteria set out in Annexes I and II to Regulation (EC) No 2073/2005 is carried out at the frequencies prescribed in the same Annex and that the method stipulated in Chapter 3.2. of Annex I is adhered to. To correctly classify meat preparations according to the definition in Annex I of Regulation (EC) No 853/2004 and to ensure they are tested for the microbiological parameters prescribed by Regulation (EC) No 2073/2005. To ensure that the systems of audits of Hazard Analysis Critical Control Point procedures are fully implemented in order to verify compliance with microbiological criteria as required by Article 4.5 (a) of Regulation (EC) No 2073/2005 and are carried out in all cases. 16

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