EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL

Transcription

1 Ref. Ares(2014) /04/2014 EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Directorate F - Food and Veterinary Office DG(SANCO) MR FINAL FINAL REPORT OF AN AUDIT CARRIED OUT IN GREECE FROM 17 TO 27 SEPTEMBER 2013 IN ORDER TO EVALUATE THE OFFICIAL CONTROLS AND THE FOLLOW-UP ACTION TAKEN BY THE COMPETENT AUTHORITIES WITH REGARD TO THE SAFETY OF FOOD OF ANIMAL ORIGIN, SPECIFICALLY MILK AND DAIRY PRODUCTS 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.

2 Executive Summary The report describes the outcome of an audit carried out by the Food and Veterinary Office (FVO) in Greece from 17 to 27 September The main objective of the audit was to evaluate the official controls related to production and storage of food of animal origin and the follow-up action taken by the competent authorities (CAs) with regard to official controls related to the safety of food of animal origin, in particular milk and their products. The evaluation of the follow-up action taken by the CAs in relation to the recommendations of the previous FVO audit report (reference number (DG(SANCO)/ ) was included in the objective. The general framework system for official controls in dairy establishments in Greece is well established and in line with most aspects of Regulation (EC) No 882/2004. The controls are in general implemented with the determined frequency and they cover most relevant aspects of the European Union (EU) legislation. Good practices for co-operation between the different CAs were noted, although full effectiveness and consistency are not ensured yet. Some weaknesses of the system had been noted in following-up of identified non-compliances, keeping up-to date operational licences and approvals of establishments, ensuring effectiveness of controls in relation to certain aspects of the general hygiene requirements and the food business operators' (FBOs) risk management systems and verifying the effectiveness of controls. The organisation of official controls on the spot in the dairy sector prior to arrival of milk at establishment level is not fully in line with the requirements of the Hygiene Package. The collection points and small collection centres are neither registered nor approved and not subject to official controls on the spot while the activity of the milk purchasers is not clearly defined. The controls at holding level are limited, not always documented and a set frequency for performance of controls was not established. The framework system of raw milk quality control is well established and functions formally well. Currently over 96% of the ovine and caprine milk delivered to milk processing establishments complies with the requirements of Regulation (EC) No 853/2004, while for raw bovine milk the level of compliance is of approximately 70% for somatic cells count (SCC)s and of 80% for total plate count (TPC). The Hellenic Agricultural Organisation Demeter (ELGO Dimitra) carries out its duties in a mainly satisfactory manner. The designated National Reference Laboratories (NRLs) for milk and dairy products do not carry out their duties required by Article 33(2) of Regulation (EC) No 882/2004. The recommendations of the previous report in relation to compliance with the raw milk criteria have not yet been fully addressed, although progress was noted in this regard. A number of recommendations have been made to the CA with a view to addressing the deficiencies identified during this audit. I

3 Table of Contents 1 INTRODUCTION OBJECTIVES LEGAL BASIS BACKGROUND FINDINGS AND CONCLUSIONS COMPETENT AUTHORITIES LEGISLATION DESIGNATION OF COMPETENT AUTHORITIES CO-OPERATION AND CO-ORDINATION BETWEEN AND WITHIN COMPETENT AUTHORITIES REGISTRATION/APPROVAL OF FOOD BUSINESS ESTABLISHMENTS PRIORITISATION OF OFFICIAL CONTROLS OFFICIAL SAMPLING AND LABORATORY ANALYSIS PROCEDURES FOR PERFORMANCE OF CONTROL ACTIVITIES AND DOCUMENTATION OF OFFICIAL CONTROLS TRAINING ENFORCEMENT MEASURES VERIFICATION AND REVIEW OF OFFICIAL CONTROLS AND PROCEDURES OFFICIAL CONTROLS OVER FOOD BUSINESS OPERATORS' COMPLIANCE WITH HYGIENE RULES AT ESTABLISHMENT LEVEL GENERAL AND SPECIFIC HYGIENE REQUIREMENTS HACCP-BASED SYSTEMS MICROBIOLOGICAL CRITERIA FOR FOODSTUFFS TRACEABILITY, LABELLING AND IDENTIFICATION MARKING CONTROL OF MILK PRODUCTION HOLDINGS AND OF RAW MILK UPON COLLECTION OVERALL CONCLUSIONS CLOSING MEETING RECOMMENDATIONS...21 ANNEX 1 - LEGAL REFERENCES...23 II

4 ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT Abbreviation ABP(s) CA(s) CCA(s) CCP(s) DGVS DG(SANCO) EC EFET ( ΕΦΕΤ) ELGO Dimitra Explanation Animal By-Product(s) Competent Authority(ies) Central Competent Authority(ies) Critical Control Point(s) Directorate General of Veterinary Services Health & Consumers Directorate General European Commission Hellenic Food Authority (Ενιαίος Φορέας Ελέγχου Τροφίμων) Hellenic Agricultural Organisation Demeter EU FBO(s) FVO HACCP European Union Food Business Operator(s) Food and Veterinary Office Hazard Analysis of Critical Control Points Hygiene Package Regulations (EC) No 852/2004, No 853/2004 and No 854/2004 Listeria monocytogenes IMANCP MRDF (ΥπΑΑΤ ) NRL OV(s) PDO QAS REVM RGDREVM RVU SCC TBC L. monocytogenes Integrated Multi-Annual National Control Plan Ministry of Rural Development and Food (Υπουργείο Αγροτικής Ανάπτυξης κα Τροφίμων) National Reference Laboratory Official Veterinarian(s) Protected designation of origin Quality Assurance System Rural Economy and Veterinary Medicine Regional General Directorate for Rural Economy and Veterinary Medicine Regional Veterinary Unit (Local level) Somatic Cell Count Total Plate Counts III

5 1 INTRODUCTION The audit took place in Greece from 17 to 27 September 2013 as part of the planned audit programme of the FVO. The FVO audit team comprised two auditors from the FVO. The FVO audit team was accompanied throughout the audit by representatives from the Central Competent Authority (CCA), the Ministry of Rural Development and Food (MRDF) and of Hellenic Food Authority (EFET). The opening meeting was held on 17 September 2013 with the CCA in Athens. At this meeting the FVO audit team confirmed the objectives of, and itinerary for the audit, and additional information required for the satisfactory completion of the audit was requested. 2 OBJECTIVES The main objective of the audit was to evaluate the official controls related to the production and storage of raw milk and dairy products and the follow-up action taken by the competent authorities (CAs) in response to the recommendations made in report DG(SANCO)/ MR Final with regard to: CA organisation and operation; official controls over FBOs' compliance with general and specific rules on the hygiene of food of animal origin. In particular, controls over raw milk and dairy products in the framework of Regulations (EC) No 178/2002, (EC) No 852/2004, (EC) No 853/2004, (EC) No 854/2004 and (EC) No 882/2004 were subject to this evaluation. In pursuit of these objectives, the audit itinerary included the following meetings and visits: Table 1 Competent authorities Comments Central 2 Opening and closing meeting with the representatives of MRDF and EFET The Regional Veterinary Directorates and Regional 3 Regional EFET representatives in Central Competent Macedonia, Crete and Peloponnese authorities The representatives of Regional Veterinary Units Local 7 responsible for official controls in the milk processing establishments, the collection centre and the dairy holdings visited Food production / processing / distribution Activities Milk processing Three in Central Macedonia, one in Crete and one 5 establishments in Peloponnese Laboratories 4 One governmental raw milk laboratory in Pella, and three FBO own laboratories Milk Collection Centre 1 In Peloponnese Dairy holdings 3 Two ovine and caprine dairy holdings (one in Central Macedonia and one in Crete) and a bovine dairy holding in Peloponnese 1

6 3 LEGAL BASIS The audit was carried out under the general provisions of European Union (EU) legislation and, in particular Article 45 of Regulation (EC) No 882/2004 of the European Parliament and of the Council on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules. Full EU legal references are provided in Annex 1. Legal acts quoted in this report refer, where applicable, to the latest amended version. 4 BACKGROUND The previous FVO audit concerning the official controls related to safety of milk and dairy products in Greece was carried out from 22 June to 3 July 2009, the results of which are described in the report DG(SANCO)/ MR Final (hereafter referred to as report ) which is accessible at: The recommendations of the report relevant for the dairy sector and a summary of the CA response can be found under the relevant headings of this report. The actions taken to address these recommendations were considered in progress at the time of this audit. Greece is not officially free of bovine tuberculosis and brucellosis. The World Organisation for Animal Health (OIE) animal health status in relation to bovine tuberculosis, Brucella abortus and Brucella melitensis in Greece is clinical disease. The programme currently in place for the control (in mainland Greece) and eradication (in the islands) of ovine and caprine brucellosis is available at The sale of raw milk in Greece is prohibited by the national legislation (see chapter 5.1.1). The FVO carried out an audit to evaluate the operation of the bovine tuberculosis and brucellosis and the ovine and caprine brucellosis eradication programmes, the results of which are described in the report DG(SANCO)/ MR Final accessible at According to Eurostat, cows milk production in 2011 in Greece was of tones which amounts for 0.5% of the cows' milk production in the then EU-27. Ewes milk production in 2011 (including milk processed or consumed on the farm) was at about the same level as for cows milk (40%), while goats milk accounted for the remaining 20% of the milk collected in 2011 in Greece. The main dairy product produced in Greece is cheese. Only one alert related to milk and dairy products of Greek origin was notified in the Rapid Alert System for Food and Feed between 2009 and September It referred to non-compliant test results for Listeria monocytogenes (L. monocytogenes) in a batch of cheese. 2

7 5 FINDINGS AND CONCLUSIONS 5.1 COMPETENT AUTHORITIES Legislation Article of the Treaty on the functioning of the EU requires that the Member States adopt all measures of national law necessary to implement binding Union acts. 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. According to Article 10 of Regulation (EC) No 853/2004 Member States may, without compromising the achievement of the objectives of Regulation (EC) No 853/2004 adopt national measures adapting the requirements laid down in Annex III. The national measures refer to continued use of traditional methods and regions subject to geographical constraints and are subject to notification to the Commission and other Member States. National rules may be maintained or established for prohibiting or restricting the placing on the market of raw milk or raw cream for direct human consumption or to permit the use of raw milk not meeting the criteria for plate count and somatic cell count. Article 7 of Regulation (EC) No 2074/2005 allows Member States to grant establishments manufacturing foods with traditional characteristics derogations from certain requirements set out in Regulation (EC) No 852/2004. The national legislation in relation to controls of milk and dairy products comprises the following main acts: Joint Ministerial Decision 15523/2006 and Presidential Decree 79/2007 which enacted the supplementary measures needed for implementing Regulations (EC) No 178/2002, 852/2004, 853/2004, 854/2004 and 882/2004. They comprise provisions in relation to the CAs competences at each level of control and delegation of responsibilities, FBOs approval procedure, organisation of official controls, enforcement powers and procedures, fines, auditing, inspections and official sampling. Articles 79 to 86 of the Food and Drink Code, concerning the composition, production techniques and labelling of milk and dairy products. Article 80 of the Food and Drink Code includes the prohibition of the sale of raw milk and Article 81 the prohibition of the sale of raw cream. Presidential Decree 113/1999 (Greek Government Gazette, No 115/ ) laying down the specifications for pasteurised milk and high - temperature pasteurised milk. It allows for a time temperature combination of 71.7 C for 15 seconds or any other time-temperature combination that would result in an alkaline phosphatase negative test. Presidential Decree No 9/1988 which in its Article 22 prohibits the placing on the market of non-pasteurised cream, the production of butter from non-pasteurised cream and the manufacturing of cheeses from non-pasteurised milk. The CCA stated that a new piece of legislation providing for new enforcement measures and 3

8 sanctions for all CAs (and amongst other things for giving powers to the Regional General Directorates of Rural Economy and Veterinary Medicine (RGDREVM) to withdraw FBOs' approval and operational licence without involvement of the Local Governor) was drafted and it is in the final stage of dicussion and adoption in the Parliament. National derogations National measures for small dairy establishments, direct sale of dairy products and on farm production of dairy products were recently established and included in a draft Joint Ministerial Decision which was notified to the European Commission in August The EFET Circular No of provides for derogations from certain requirements of Regulation (EC) No 852/2004 (in accordance with Article 7 of Regulation (EC) No 2074/2005) which may be granted to the establishments that produce the 20 types of cheese that have protected designation of origin (PDO) in Greece and other traditional dairy products. This circular was notified to the European Commission by EFET letter No 119 of Industry guides The CCA (EFET) issued a guide for the dairy industry: "General Guide for the application of a system based on HACCP principles in small dairy establishments" Designation of Competent Authorities Article 4 of Regulation (EC) No 882/2004 requires Member States to designate the CAs responsible for the purposes and official controls set out in the Regulation. It also lays down operational criteria for the CAs. Audit findings The Country Profile for Greece provides an overview of the organisation of the official control system in place in relation to the safety of foodstuffs in Greece, based on the information provided by the CA. The Country Profile is available at The Directorate General of Veterinary Supervision (DGVS) within the MRDF is responsible for the design and monitoring of the control system and for the evaluation of the system relating to primary production and first processing of products of animal origin, while EFET has the same responsibilities at processing and distribution level. According to the CCA, for the dairy sector DGVS has responsibilities until and including the pasteurisation process while EFET after the pasteurisation process. The 58 Regional Veterinary Units (RVUs) and the 8 EFET Regional Directorates are responsible for implementation of the controls on the spot. The 13 Regional RGDREVM of the MRDF perform visits on the spot only in relation to approval/withdrawal of approval of establishments and enforcement. 1 In the five regions where the EFET is not yet fully operational, this responsibility is with the RVUs, acting under a co-ordinated programme issued centrally by the EFET. 1 In their comments to the draft report and additional clarification provided, the CCA noted that Each of the 13 Regions of the country has (a) the Regional General Directorate of Rural Economy and Veterinary Medicine (which includes a Regional Veterinary Directorate) and (b) the Directorates for Rural Economy and Veterinary Medicine of the Regional Units (which include veterinary departments). The Regional General Directorate of Rural Economy and Veterinary Medicine and the Directorates for Rural Economy and Veterinary Medicine of the Regional Units (which include veterinary departments) belong administratively to the Minister of the Interior, but the powers with respect to official inspection have been assigned to them by the DGVS and EFET. 4

9 Since the last update of the country profile, the following changes took place: EFET is supervised by the MRDF, not by the Ministry of Health and Social Solidarity. The change was introduced by Presidential Decree No 84/2012. The Greek Meat and Milk Organisation (ELOGAK) merged together with three other previously existing organisations (the National Institute for Agriculture and Research, the Agency for Certification of Agricultural Products - Agrocert, the Agency for Agricultural Education, Training and Employment) into a single governmental body, the Hellenic Agricultural Organisation Demeter (ELGO Dimitra) 2. The merger was introduced by Joint Ministerial Decision No /2011. The legislation governing the activity of this new body is currently under development. The eight laboratories of ELOGAK (Rethymno, Patras, Ioannina, Larissa, Pella, Drama, Alexandroupolis and Mytilini) have been taken over by ELGO Dimitra and they continue to carry out their activities in relation to raw milk testing, compiling all raw milk testing results (see chapters 5.1.3, and 5.3). An additional National Reference Laboratory (NRL) has been designated for milk and dairy products, the Veterinary Laboratory of Patras. This was notified to the European Commission by the EFET in Co-operation and co-ordination between and within Competent Authorities Article 4(3) of Regulation (EC) No 882/2004 provides for efficient and effective co-ordination and co-operation between CAs. Article 4(5) of the Regulation requires that, when, within a CA, more than one unit is competent to carry out official controls, efficient and effective co-ordination and cooperation shall be ensured between the different units. Audit findings The co-ordination mechanisms in place between and within the different CAs are described in the Country Profile for Greece. In the dairy sector numerous circulars and guidance documents for ensuring coordination both for technical matters as well as for procedural matters have been issued by the CCAs and to a greater extent and more detail by the EFET (see chapter 5.1.7). Examples of close co-operation between them the RGDREVM and the RVUs were seen in the regions visited. The national legislation defines the responsibilities of the DGVS in the dairy sector up to the point of pasteurisation and of the EFET for dairy production after pasteurisation. In practice, at establishment level, the EFET performs controls also on raw milk and the veterinary services also on the production process after pasteurisation. 3 Co-ordination between the regional CAs is within the remit of their responsibility and may differ between the regions. Observations In the regions visited by the FVO audit team, the distribution of work between RGDREVM and the EFET (in order to ensure that all establishments are controlled using the available resources) is 2 In their comments to the draft report the CCA noted that according to Article 1(1) of Joint Ministerial Decision /2011, ELGO Dimitra belongs to the broader public sector, is administratively and financially independent and is supervised by the Minister for Rural Development and Food. 3 In their comments to the draft report the CCA noted that the veterinary services are responsible for carrying out inspections throughout the food of animal origin production and distribution chain. This power has been conferred both by the DGVS for primary production and by EFET for after processing. EFET has no power in primary production and thus in the area of milk reception. However it checks compliance with raw milk criteria as an integral part of the own-checks systems of the milk industry. 5

10 discussed and agreed annually between the two CAs. The written agreements seen in Crete and Peloponnese assigned only one CA for performing controls in each dairy establishment. This was also the case in the establishments visited by the FVO audit team in these regions. The practice in place in the cases assessed by the FVO audit team was to exchange (by means of e- mail) the results of inspection at establishment level between the two CAs. In the region of Central Macedonia the agreements between the RGDREVM and the EFET are only informal. In one of the establishments visited in this region, both CAs perform parallel official controls (both the EFET and Veterinary Services control the same aspects each once per year). The need for using working agreements between the different CAs and the overlapping of responsibilities had been identified also by the recent audit in the milk sector carried out by the Veterinary Audit Unit. 4 ELGO Dimitra compiles all results of raw milk testing in Greece (see chapter 5.3) and informs the veterinary services when non-compliances related to total plate count (TPC), somatic cell count (SCC) and antibiotic residues are identified. ELGO Dimitra issues written recommendations when it identifies shortcomings during the visits on the spot (see chapter 5.1.6). Nevertheless, it does not inform the CA responsible for control at establishment level (neither the veterinary services, nor the EFET). A notification system of raw milk non-compliances and animal health issues between FBOs, farmers and the veterinary services was in place in the cases assessed. No such system was seen for notifying the EFET. In certain establishments only the EFET carries out controls. The reports in the establishment visited which was under dual supervision indicated that the EFET rather than the Veterinary Services checked compliance with the raw milk criteria Registration/approval of Food Business establishments Article 31 of Regulation (EC) No 882/2004 requires Member States to establish procedures for the registration/approval of food and feed business establishments, for reviewing compliance with conditions of approval and for the withdrawal of approvals. Audit findings The procedures for registration, granting operational licence and approval to food business establishments (including for the dairy sector) are provided by the Presidential Decree 79/2007 and the Joint Ministerial Decision No 15523/2006. The report following the audit DG(SANCO)/ available at: describes these procedures. The dairy establishments are granted an approval number by the EFET while the milk collection centres are granted the approval number by the MRDF. According to the national procedures in place, the operational licence which is granted by the RGDREVM has to mention all the types of final products produced by the establishment and the capacity of the establishment for each of these products. The operational licences are a pre-requisite 4 In their comments to the draft report the CCA noted that a protocol of cooperation has been concluded between the Regional Directorate of EFET of Central Macedonia and all services of the Region of Central Macedonia (including DREVMs). This protocol was signed on 18 December 2013 (EFET Protocol No 10006/ and Region Protocol No 4978/ ) and includes an apportionment of all inspections of food businesses. 6

11 for granting the approval. The approval letter states the specific approval number and that approval is granted for processing activity. Cases of withdrawal of approval were seen by the FVO audit team during the visit to the CA office in Crete. Observations During the visits on the spot it was found that the approval procedure was followed in the cases assessed by the FVO audit team. All establishments visited by the FVO audit team, including a large collection centre, had been approved and had had operational licences issued prior to the approval (and where applicable also prior to the re-approval). In one dairy establishment in Central Macedonia the operational licence issued in 2009 was not updated to include the production of extended shelf-life milk although this type of production was running for a few years according to the FBO. In another establishment visited by the FVO audit team in Central Macedonia, the operational licence did not mention the type of dairy products for which the approval was granted and the capacity of the establishment. In this establishment, raw cream (not pasteurised) was sold (according to the FBO, to bakeries and restaurants) although forbidden by the national legislation (see chapter ). During the FVO audit team visit to an ELGO Dimitra Laboratory it was found that the laboratories of this network perform testing also for milk purchasers (milk dealers, farm cooperatives). The CAs interviewed on the spot were not aware that milk purchasers were involved in the milk trade and consequently such operators were not subject to official controls. During the final meeting the CCA clarified that milk purchasers would be included in the list for registered means of transportation. No more information was available on whether these operators have also collection facilities. The collection points (milk tanks shared by neighbouring farms) are neither registered nor approved and not subject to official controls on the spot. In the final meeting the CCA stated that these collection points are covered by the approval of establishments. This could not be verified by the FVO audit team during the visits on the spot. According to the CCA, only large collection centres supplying milk to establishments other than local ones are subject to approval. There are no written procedures or rules to differentiate between the collection points and the collection centres and to describe which collection centres require approval and which do not Prioritisation of official controls 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 product placed on the EU market. 7

12 Audit findings The system for risk categorisation of establishments described in the report following the audit DG(SANCO)/ applies also for establishing the frequency of inspection in dairy establishments and collection centres. In accordance with Presidential Decree 79 and the EFET Guide for the performance of official controls, the minimum frequency of inspection in dairy establishments and milk collection centres is of once per year. 5 EFET Circular No 17784/2009 available to both EFET and Veterinary services describes the risk categorisation process, the criteria to be taken into consideration and the weighing system. It largely takes into consideration the provisions of points (a) to (d) of paragraph 1, Article 3 of Regulation (EC) No 882/2004. Observations According to the CA, the frequency can be increased to twice a year or decreased to maximum once every 18 months (depending on the results of the risk categorisation). In practice all the risk categorisations carried out by the CAs visited by the FVO audit team resulted in the same frequency of once per year (in line with the provisions of Presidential Decree 79 and the EFET Guide for the performance of official controls). In the establishments visited by the FVO audit team this yearly frequency was complied with either by the Veterinary Services or by the EFET or by both (EFET and Veterinary Services). Additional visits on the spot were carried out in relation to complaints and recall procedures. During the visit to the CA office in Heraklion it was found that this minimum frequency of inspection was not implemented for all establishments subject to official controls in the region, according to the CA due to staff shortages. Currently for the entire island of Crete there are four EFET staff, and 1.5 full time equivalents in the RGDREVM responsible for performing official controls in the dairy establishments of the island and also for other food safety controls. The eight official veterinarians in the Regional Unit of Heraklion perform the official controls on the holdings and in the meat sector. As regards controls at holding level for compliance with the relevant dairy requirements of the Hygiene Package it could not be demonstrated that these controls are carried out with a determined risk based frequency in any of the regions visited. This had been identified as a weakness also in the recent dairy audit of the Veterinary Services Audit Unit at central level. The CCA stated that a new circular is currently being drafted to determine a percentage of controls to be carried out at holding level. No on the spot controls are carried out in milk collection centres which are not approved, in milk collection points and at milk purchaser level (milk dealers and farm co-operatives) except related to the transportation means Official sampling and laboratory analysis Article 4 of Regulation (EC) No 882/2004 requires CAs to have, or to have access to, adequate 5 In their comments to the drat report the CCA noted: Circular No / of the Directorate for Veterinary Public Health, which was replaced by Circular No 219/7548/ on Guidelines for traceability and planning in hazard-based official inspections, provides for hazard-based inspections for the official inspections which must be carried out in the food establishments laid down in Article 3(2a) of Presidential Decree 79/2007. In particular, milk collection centres are classified as medium-risk establishments and are subject to the minimum of official inspections, i.e. one full regular inspection or one audit per year. 8

13 laboratory capacity. Article 11 of the Regulation establishes requirements for sampling and analysis and Article 12 requires the CA to designate laboratories that may carry out analysis of samples taken during official controls. It also lays down accreditation criteria for the laboratories so designated. Audit findings Official sampling of foodstuffs (including dairy products) for monitoring and verification purposes is carried out by Regional EFET staff according to instructions and sampling plans issued by the CCA. Circulars related to sampling programmes for monitoring the levels of mycotoxins, polycyclic aromatic hydrocarbons, heavy metals and inorganic tin, polychlorinated dibenzodioxins, dibenzofurans and polychlorinated biphenyls (whether or not similar to dioxins), testing for the presence of allergenic substances, plant protection products, Salmonella spp. and L. monocytogenes in foodstuffs, control of the quality of dairy products were in place at the time of the FVO audit. The FVO audit team evaluated the sampling activity of dairy products for microbiological criteria. In general only testing for food safety criteria in final products is performed. The number of samples to be taken by each region and the place of sampling (retail/production) is established by the CCA (EFET). 6 The particular FBO to be sampled and the laboratory to be used are decided by the sampling officer within the Regional EFET Units. An overview of the official samples of dairy products tested in 2011 and 2012 is presented below. Year Official samples of dairy products tested Samples tested for microbiological parameters Non-compliant The RVU does not implement sampling plans (except for residues). It has however the option of taking samples upon suspicion of non-compliance or following complaint. The CCA provided the FVO audit team with the list of accredited laboratories designated and used for official testing for the different criteria. The sampling officers are required to check the accreditation status of the methods on the Hellenic Accreditation Body website ( before sending the samples to the laboratory. 7 The ELGO Dimitra laboratories are official laboratories performing raw milk testing and carrying out controls of the private laboratories performing such testing. They are accredited to ISO by the Hellenic Accreditation Body. They carry out regular parallel and unannounced sampling and testing with the private laboratories and FBOs' own laboratories testing raw milk (at least twice/year/laboratory for cows' milk) and on the spot inspections in these laboratories (at least once annually). During the inspections of the private laboratories the ELGO Dimitra staff checks the test methods and the equipment used, the sampling and testing frequency, if the milk from all supplying holdings is tested, the follow-up of non-compliant results, whether the private laboratories notify the veterinary services when required by the legislation. Observations 6 In their comments to the draft report the CCA noted that EFET (CCA) also determines the laboratories that will receive the samples. 7 In the comments to the draft report, the CCA noted that the accreditation status of the authorised laboratories participating in the official inspection is verified in advance by the CCA (as regards EFET) and not by the sampling officers. 9

14 Official sampling of dairy products was carried out according to the plan in the region of Central Macedonia. Although in Crete and Peloponnese no sampling for microbiological criteria was included in the EFET sampling plan for 2012, the official control staff took samples which were tested for microbiological criteria on suspicion of non-compliance and following complaints. The ELGO Dimitra raw milk laboratory visited by the FVO audit team had adequate facilities, equipment, quality control and documentation. The laboratory used accredited reference and routine methods. It had participated successfully in annual proficiency tests organised by a commercial provider. The laboratory issued the notifications when the geometrical averages for TPC or SCC had exceeded the criteria of the Regulation (EC) No 853/2004 or antibiotic residues had been detected in the raw milk. The laboratory visited collected and tested monthly two samples from each farmer. The reports of audits carried out in private laboratories comprised findings, results of parallel testing and recommendations. According to the summary statistics received, in 2012, of the 53 inspections in private laboratories, 20 resulted in issuing recommendations, while of the 218 parallel testing carried out 37 resulted in recommendations being issued. The recommendations were not routinely accompanied by deadlines. No information from the milk and dairy products NRLs is received in the ELGO Dimitra laboratories. The NRLs had not organised any proficiency test rounds and had not co-ordinated the participation of the raw milk laboratories in any such schemes. The ELGO Dimitra laboratories do not send any information of their participation in proficiency tests to the NRLs Procedures for performance of control activities and documentation of official controls Article 8 of Regulation (EC) No 882/2004 requires that CAs carry out their official controls in accordance with documented procedures, containing information and instructions for staff performing official controls. Article 9 of Regulation (EC) No 882/2004 requires CAs to draw up reports on the official controls carried out, including a description of the purpose of official controls, the methods applied, the results obtained and any action to be taken by the business operator concerned Audit findings Numerous circulars and guidelines have been issued by the EFET for the organisation of official controls of which the main relevant ones for the dairy sector are summarised below: Guidelines for the performance of official controls of establishments producing food of animal origin, guidelines for determining the frequency of inspections on the basis of a risk analysis, guidelines on the control of water at food-producing establishments, guidelines on HACCP inspection. EFET circulars on issues concerning official controls on milk and dairy products, on measures in the field of food of animal origin, on granting derogations for establishments producing traditional dairy products. Some of these guidelines and circulars have been issued in order to address recommendations of the report They are available to both EFET and veterinary services. The content of some of them (eg for establishing the frequency of inspection at establishment level) is reflected in MRDF instructions as well. Report templates and comprehensive check-lists for official controls of FBOs compliance with the 10

15 general and specific hygiene requirements in approved dairy establishments and holdings have been issued by the CCAs and used by the official control staff in the cases assessed by the FVO audit team. Observations The reports following official controls on the spot were available in most cases assessed by the FVO audit team. A copy was given to the FBO and the reports contained the scope, the methods, the results and the action required of the FBO. According to the CA, compliance with the relevant requirements of the Hygiene Package at holding level is checked by the CA on the occasion of the controls on animal health and animal identification. Nevertheless the results are not always recorded. According to the CA, 4 of the 78 documented official controls at holding level in Heraklion in 2012, covered also compliance with the dairy requirements of the Hygiene Package at holding level. There are over holdings in Heraklion. The figures provided by the CCA for the whole country indicate that 896 controls in dairy holdings were carried out in 2011 and in In Peloponnese the CA met were not able to provide on the day of the FVO audit any documented evidence of checks carried out on dairy holdings as the official veterinarians (OVs) carrying out these checks were on strike. The OV available stated that they had reports for checks carried out for various purposes on bovine holdings, but no reports for checks carried on dairy sheep holdings. An undated control report for the bovine dairy holding visited by the FVO audit team was made available at a later stage and according to the CCA it was the report of the visit in In the other two holdings, the only reports available were of visits in 2013 and according to the CA and the farmers met these were the only CA reports of control of milking hygiene since the holdings started their activity (2008 and 2009 respectively) Training 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. Audit findings The CCA (EFET) organises yearly training sessions for its staff performing official controls. In recent years numerous topics relevant for the general organisation and performance of controls at establishment level have been covered and are mentioned in the report following the audit DG(SANCO)/ available at Specific training for official controls in dairy establishments has also been organised. These training sessions are open also for staff of the Veterinary Services. Observations The official control staff met during the visits on the spot were in general knowledgeable and most of them participated to a number of training sessions, organised either by central EFET, the European Commission (BTSF) or internal training. Few of the Veterinary Services staff met performing controls in the dairy sector had not yet participated in specific training. The recent internal audit of the veterinary services identified the lack of an adequately coordinated system to ensure that all official control staff performing controls in the dairy sector is trained for it. 11

16 5.1.9 Enforcement measures Article 54 of Regulation (EC) No 882/2004 requires a CA which identifies a non-compliance to take appropriate action to ensure that the operator remedies the situation. Article 55 of the Regulation states that Member States shall lay down the 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 all measures necessary to ensure that they are implemented. The sanctions provided for must be effective, proportionate and dissuasive. Audit findings The national legislation lays down the necessary provisions for the implementation of the provisions of Articles 54 and 55 of Regulation (EC) No 882/2004 and related procedures are available as well for the official control staff. Observations. In most of the cases assessed by the FVO audit team the official control reports issued by the CAs had identified several non-compliances. The enforcement action taken was in general limited to giving recommendations to the FBO and mentioning the date of the next CA visit on the spot. In general, no deadlines were given to the FBO for addressing the non-compliances. A structured system for following up on non-compliances and in particular of re-occurring ones was not in place in any of the regions visited. The CAs stated that the follow-up of the action taken by FBOs in relation to the deficiencies is carried out during each yearly visit. Nevertheless this was not adequately documented in most cases. The non-compliances were either repeated in the reports of the following visits on the spot or not mentioned (in the latter case according to the CA this meant that the CA recommendation has been addressed by the FBO). In practice, despite subsequent CA visits on the spot, certain long-standing deficiencies were either not addressed by the FBO (see chapters and 5.2.2) or only addressed prior to the FVO audit team's visit on the spot. For example in a dairy establishment in Peloponnese the same shortcomings were repeated in two official control reports in 2012 and not identified in the report for the visit in August The FBO started to take corrective action only in September 2013 prior to the visit of the FVO audit team. Financial penalties were imposed only in a few cases in each of the regions visited, only at establishment level and were in general related to food-safety non-compliant test results. Only written notices were given following controls at holding level. The lack of fines following controls at holding level had also been identified during the recent internal dairy audit of the MRDF Verification and review of official controls and procedures Article 4 of Regulation (EC) No 882/2004 requires the CAs to ensure the impartiality, consistency and quality of official controls at all levels and to guarantee the effectiveness and appropriateness of official controls. Article 8 states that they must have procedures in place to verify the effectiveness of official controls, to ensure effectiveness of corrective action and to update documentation where needed. Under Article 4 of the Regulation CAs are required to carry out internal audits, or have external audits carried out. These must be subject to independent scrutiny and carried out in a 12

17 transparent manner. Audit findings The General Directorate for Internal Audit within the MRDF is in charge of auditing the veterinary services at central, regional and local levels. In 2013, the milk sector was one of the targets of these internal audits. It was the first audit on this topic carried out after the previous FVO audit in the dairy sector. The report of the audit of the central veterinary services has been finalised, while the one regarding the activity of the regional services was at a draft stage at the time of the FVO audit. Numerous findings of the current FVO audit were also reflected in the internal audit report of the central veterinary services (references to them are made in the different chapters of this report). Observations The operational audit unit set-up by the EFET, described in the report following the audit DG(SANCO) / available at has not yet started its audit activity. According to the regional veterinary CAs met, verification of effectiveness of controls carried out by the RVUs is performed during the joint visits for approval or in the context of enforcement in Central Macedonia and Peloponnese. In Crete the RGDREVM carries out the duties of the RVUs in dairy establishments. In Peloponnese joint visits at establishment level had been carried out in previous years. In all regions visited, the shortcomings identified by the FVO audit team indicate that official controls have not been effective for certain aspects of the legislation (see chapters 5.2.1, 5.2.2, 5.2.3, 5.3, 5.1.9). Conclusions on Competent Authorities The framework official control system for the dairy sector in Greece is generally satisfactory in terms of CAs' designation, powers for carrying out controls and for taking enforcement action. Good practices for co-operation between the different CAs were noted. Nevertheless, raw milk criteria non-compliances were not communicated to the relevant CAs performing the controls in all cases. In the regions visited numerous non-compliances were identified by CA controls at establishment level which were performed in general with the determined frequency and following the comprehensive procedures available. In general, a lack of implementation of a structured system for following-up on non-compliances was noted by the FVO audit team and the enforcement of EU requirements was not effective for some long-standing deficiencies. The operational licences and approvals of establishments were not always kept up-to-date. The collection points and the small collection centres are neither registered nor approved and therefore not under the control of the CAs. Only large collection centres are approved and subject to official controls and the milk purchasers activity is not clearly defined. The official controls for verification of FBOs' compliance with the obligations of Regulations (EC) No 852/2004 and 853/2004 at dairy holding level are in general not carried out in accordance with the provisions of Annex IV of Regulation (EC) No 854/2004. The verification of the effectiveness of controls at all levels does not fully address the requirements of Regulation (EC) No 882/2004. The designated NRLs for milk and dairy products have not carried out their co-ordination duties as required by Article 33.2 of the Regulation (EC) No 882/2004 for the past few years. The ELGO Dimitra carries out their duties largely satisfactory. 13

18 5.2 OFFICIAL CONTROLS OVER FOOD BUSINESS OPERATORS' COMPLIANCE WITH HYGIENE RULES AT ESTABLISHMENT LEVEL General and specific hygiene requirements Article 4(2) of Regulation (EC) No 852/2004 establish that the FBO carrying out any stage of production, processing and distribution of food after the stage of primary production/associated operations shall comply with general hygiene requirements as set out in Annex II to Regulation (EC) No 852/2004. These provisions relate to cleaning and maintenance, layout, design, construction, siting and size of food premises. Article 3 of Regulation (EC) No 853/2004 sets out that the FBO shall comply with the specific requirements of Annexes II and III to this Regulation. Article 4(3) of Regulation (EC) No 852/2004 states that FBOs shall adopt specific hygiene measures regarding compliance with microbiological criteria for foodstuffs, compliance with temperature control requirements and sampling and analyses. 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 the FBO's compliance with these requirements. Audit findings Official controls over FBOs' compliance with general and specific hygiene requirements are part of the controls scheduled to be carried out by the CAs (EFET and/or the Veterinary Services at local or regional level) in all dairy establishments with the minimum frequency of once per year. The specific comprehensive checklists issued by the CCA were used for such controls in the establishments visited by the FVO audit team. The establishments visited had been inspected with the planned frequencies and reports of the official controls were available. Shortcomings had been identified in the CA reports. Observations During the visit to one of the CA offices it was noted that not all establishments in the region were visited with the established frequency (see chapter 5.1.5). In all establishments visited, the FVO audit team noted shortcomings which had either not been noted before by the CA or had not been enforced (for example cracked tiles, flaking paint, some rusty equipment, few external doors not pest proof and keeping some exposed final products in the chiller or maturation room together with wrapped final products). In two of the establishments visited these shortcomings were more serious and additional ones were present as well. For example in one of these two establishments the ceiling above exposed product in the production room was rusty, unprotected exposed cheese was kept in the packed products cold store in a spot with condensation water dripping from the ceiling. These aspects had not been identified by the CA. In the same establishment, a CA report of 2011 noted there was no drain in the yoghurt production room and that packing was inadequate. This had not changed prior to the FVO visit. In the other establishment numerous deficiencies in relation to cleaning, maintenance and pest control were present. For example, in the soft cheese production area, animal droppings were found on the floor, a loose rodent bait was found in one of the cheese maturation rooms, the cold store for intermediate storage of whey-cheese had rusty cooling equipment which was also leaking above exposed products. Dirty wooden pallets, a bad smell coming from the drain that had no grid, open ducting of the sink were present in a production room where open vats were used. An old table in a very poor hygienic condition was used for waxing of cheese. Direct food contact shelves were not 14