EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Directorate F - Food and Veterinary Office Ares(2012)761159 DG(SANCO) 2012-6575 - MR FINAL FINAL REPORT OF AN AUDIT CARRIED OUT IN TURKEY FROM 28 FEBRUARY TO 09 MARCH 2012 IN ORDER TO EVALUATE THE OPERATION OF CONTROLS OVER THE PRODUCTION OF HEAT TREATED MILK AND DAIRY PRODUCTS FOR HUMAN CONSUMPTION DESTINED FOR EXPORT TO THE EUROPEAN UNION, AS WELL AS CERTIFICATION PROCEDURES 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.
Executive Summary The report describes the outcome of an audit carried out by the Food and Veterinary Office (FVO) in Turkey from 28 February to 9 March 2012. The objectives of the audit were to evaluate the operation of controls over the production of heat treated milk and dairy products for human consumption destined for export to the European Union (EU), as well as certification procedures. Turkey is listed in Column C of Annex I to Commission Regulation (EU) No 605/2010, as a country eligible for export of heat treated dairy products to the EU. There are currently no establishments listed for export of heat treated milk and dairy products for human consumption to the EU. In relation to the action plan provided by the Central Competent Authorities (CCA), in response to the previous mission DG(SANCO)2008-7878), most of the nine recommendations have been fully addressed. Progress was noted in addressing the proper implementation of instructions and rules, finalising the adjustment of legislation and administrative procedures, animal identification and official controls prior to approval and procedures to issue certificates. A system for regular official controls at holding level is in place and progress has been achieved in relation to animal identification and controls of animal health status. Discrepancies were detected during this audit in the cross check between animals present on holdings and their registration in the holding registers. Subsequently it could not be demonstrated that all eligible animals were tested for tuberculosis and brucellosis. The establishments visited mainly met the general and specific hygiene requirements. Procedures for separation of EU and non-eu eligible production were in place. The food business operators (FBOs) could demonstrate that potential EU eligible dairy products underwent one of the heat treatments described in the model certificate Milk-HTC laid down in Regulation (EU) No 605/2010. A number of recommendations have been made to the Competent Authority (CA) with a view to addressing the deficiencies identified during this audit. I
Table of Contents 1 INTRODUCTION...1 2 OBJECTIVES...1 3 LEGAL BASIS...1 4 BACKGROUND...2 5 FINDINGS AND CONCLUSIONS...2 5.1 LEGISLATION AND COMPETENT AUTHORITIES...2 5.1.1 LEGAL BASIS...2 5.1.2 FINDINGS...2 5.1.3 CONCLUSIONS...6 5.2 HOLDING REGISTRATION, ANIMAL IDENTIFICATION...6 5.2.1 LEGAL REQUIREMENTS...6 5.2.2 FINDINGS...6 5.2.3 CONCLUSIONS...7 5.3 LABORATORY SERVICES...8 5.3.1 LEGAL REQUIREMENTS...8 5.3.2 FINDINGS...8 5.3.3 CONCLUSIONS...9 5.4 CONTROL OF MILK PRODUCTION HOLDINGS...9 5.4.1 LEGAL REQUIREMENTS...9 5.4.2 FINDINGS...9 5.4.3 CONCLUSIONS...10 5.5 CONTROL OF RAW MILK UPON COLLECTION...10 5.5.1 LEGAL REQUIREMENTS...10 5.5.2 FINDINGS...10 5.5.3 CONCLUSIONS...11 5.6 LISTING OF ESTABLISHMENTS...11 5.6.1 LEGAL REQUIREMENTS...11 5.6.2 FINDINGS...11 5.6.3 CONCLUSIONS...12 5.7 OFFICIAL CONTROLS AT ESTABLISHMENT LEVEL...12 5.7.1 LEGAL REQUIREMENTS...12 5.7.2 FINDINGS...13 5.7.3 CONCLUSIONS...14 5.8 OFFICIAL CERTIFICATION...15 5.8.1 LEGAL REQUIREMENTS...15 5.8.2 FINDINGS...15 6 OVERALL CONCLUSION...15 7 CLOSING MEETING...15 8 RECOMMENDATIONS...16 ANNEX 1 - LEGAL REFERENCES...17 II
ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT Abbreviation Explanation CA(s) Competent Authority(ies) CCA(s) Central Competent Authority(ies) DD District Directorate DG(SANCO) Health & Consumers Directorate General EC European Community(ies) EU European Union FBO(s) Food Business Operator(s) FMD Foot and Mouth Disease FVO Food and Veterinary Office GDFC General Directorate of Food and Control HACCP Hazard Analysis of Critical Control Points Hygiene Package Regulations (EC) No 852/2004, No 853/2004 and No 854/2004 MoFAL Ministry of Food, Agriculture and Livestock PD Provincial Directorate OV Official Veterinarian SCC Somatic Cell Count TBC Total Bacterial Count (Plate count at 30 C) UHT Ultra high temperature III
1 INTRODUCTION The audit took place in Turkey from 28 February to 9 March 2012 as part of the planned audit programme of the FVO. The audit team comprised 3 inspectors from the FVO. The FVO audit team was accompanied by representatives from the CCA, the Ministry of Food, Agriculture and Livestock (MoFAL) (Gida Tarim ve Hayvancilik Bakanliği). The opening meeting was held on 28 February 2012 with the CCA in Ankara. 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 objective of the audit was to evaluate the official controls related to the production of heat treated milk and dairy products for human consumption destined for export to the EU 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, and the correct implementation of the chain of certification. In particular, controls over raw milk and dairy products in the framework of Regulations (EC) No 852/2004, No 853/2004, No 854/2004 and No 882/2004 as well as Regulation (EU) No 605/2010 were subject to this evaluation. In pursuit of these objectives, the audit itinerary included the following: COMPETENT AUTHORITIES Competent Authorities Central 1 Regional Local 5 Comments Opening and closing meetings Eskisehir, Bursa, Balikesir, Kirklareli and Denizli provinces and districts met during on site visits. One provincial office was visited. FOOD PRODUCTION / PROCESSING / DISTRIBUTION ACTIVITIES Milk processing plants 4 Dairy holdings 4 3 LEGAL BASIS The audit was carried out under the general provisions of EU legislation and, in particular Article 46 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 1
animal welfare rules. 4 BACKGROUND The previous mission concerning the safety of food of animal origin in Turkey was carried out from 30 October to 7 November 2008, the results of which are described in report DG(SANCO)/2008-7878 MR Final (hereafter referred to as previous report). This report is accessible at: http://europa.eu.int/comm/food/fvo/ir_search_en.cfm The action plan received from the Turkish authorities provided satisfactory guarantees in response to all of the report's recommendations. 5 FINDINGS AND CONCLUSIONS 5.1 LEGISLATION AND COMPETENT AUTHORITIES 5.1.1 Legal basis Article 46.1 of Regulation (EC) No 882/2004 stipulates that official controls by Commission experts in third countries shall verify compliance or equivalence of third country legislation and systems with EU feed and food law, and EU animal health legislation. These controls shall have particular regard to points (a) to (e) and (g) of the aforementioned Article. 5.1.2 Findings 5.1.2.1 Legislation In recommendation 2 of the previous FVO report the CCA was requested to finalise the adjustment of legislation and administrative procedures to take full account of specific EU requirements relating to animal health control and production of milk and milk based products intending to export to the EU. To address this recommendation a new framework legislation was adopted by the CCA on 11 June 2010 - Law on Veterinary Services, Plant Health, Food and Feed No 5996 and lays down hygiene requirements in line with EU legislation to be met at dairy holdings and milk processing establishments producing EU eligible milk and dairy products. On the basis of this new legislation several implementing regulations were elaborated and published. List of the new implementing regulations relevant to the scope of this audit: Regulation of Special Hygiene rules for Food of Animal origin in force since 27 12 2011 Regulation on Food hygiene in force since 17.12.2011 Regulation Determining the Special Rules about the Official Controls on Food of Animal Origin in force since 17 12 2011 Regulation related to the Registry and Approval of the Food Businesses in force since 17 12 2011 Regulation regarding Official Controls of Food and Feed - in force since 17 12 2011 Regulation on Turkish Food Codex Microbiological Criteria in force since 29.12.2011. 2
In recommendation 3 of the previous FVO report the CCA was requested to implement animal health controls in line with Council Directive 64/432/EEC on bovine holdings intended for the supply of EU compliant milk. To address this recommendation implementing regulations on bovine tuberculosis and bovine brucellosis were prepared in alignment with Council Directive 64/432/EEC and came into force in 2009: Regulation on Bovine Tuberculosis (in force since 02/04/2009) and the Regulation on Combat of Brucellosis (in force since 03/04/2009). On the basis of the framework law, specific instructions relevant to the scope of this audit were provided: Providing the EU Market with Dairy Products of Turkey (26/4/2011), Businesses Free From Disease and Approved Farms (26/4/2011). Observations: Progress had been made in relation to the national legislation being in line with EU legislation. The CA has transposed the food hygiene package and the relevant legislation for the scope of this audit is in place. FBOs have a transitional period for the application of the new provisions. However, the CA confirmed that establishments applying for export of milk and dairy products to the EU are not subject to this transitional period and the new national rules are applicable immediately. 5.1.2.2 Competent Authorities 5.1.2.2.1 Organisation of Competent Authorities A decree concerning the re-organisation and restructuring of the Turkish Ministries entered into force on 8 June 2011. The name of the Ministry of Agriculture and Rural Affairs was changed to the Ministry of Food Agriculture and Livestock (MoFAL) which is responsible for official controls in the dairy sector. The structure of the Turkish CA remains with three levels, central, provincial and district levels with roles and responsibilities well defined. The CCA is the General Directorate of Food and Control (GDFC) of the MoFAL. Within the GDFC at central level there are 11 departments. There are 81 Provincial Directorates (PD) and 846 District Directorates (DD) and there is a clear line of command from central to provincial and district levels. Within the GDFC there are three departments that are involved in the official controls regarding milk processing establishment: The Department of Food Establishments and Codex is responsible for Legislation on food hygiene, co-ordination of approval/registration of FBOs, the Turkish Food Codex and related guidance documents. The Department of Food Control and Laboratories is responsible for Co-ordination of all official controls in the milk sector in Turkey, food laboratories and the multi-annual control plan for sampling. The Department of Animal Health and Quarantine is responsible for Animal health and legislation in this field, animal identification and controls on dairy farms. The CCA considers that they have sufficient staff to carry out official controls over the production of milk and dairy products destined for export to the EU. Observations: 3
Co-ordination between the GDFC and the PD was in place and effective distribution of instructions and circulars was observed. The Animal Health Directorate of the PD informs both the Control Unit in the same PD and the FBO of the milk processing establishment about the change of animal health status (in particular foot and mouth disease (FMD) outbreaks) at EU eligible dairy holdings. 5.1.2.2.2 Competent Authorities' powers, independence and authority for enforcement The national legislation gives the necessary inspection and enforcement powers to the CA and the officials have powers of access to food business premises and their documentation. Administrative fines and sanctions can be introduced on the basis of Article 36 (Animal Health, Animal Welfare and Zootechnics), Article 40 (Food and Feed) and Article 41 (Hygiene and Official Controls) of the Law on Veterinary Services, Plant Health, Food and Feed No 5996. 5.1.2.2.3 Supervision There is a system in place to carry out official controls over milk processing establishments for EU production by the PD and the CCA jointly during the pre-approval period. According to this system the CCA obtain information on the control activities of the CAs and their effectiveness. 5.1.2.2.4 Training of staff in performance of official controls The CCA provided information on training and made a detailed training programme available for their staff in 2011 and 2012. In 2011 the CCA provided training on Hazard Analysis Critical Control Points (HACCP) with 149 participants. A series of food inspector training programmes has taken place in 25 provinces all together with 1 266 participants. In the Turkish milk processing sector training was organised on hygiene requirements and the control of milk processing establishments with 125 participants. Specific training within the project of Supporting the Exportation of Turkish Dairy Sector into the EU Market took place on requirements for and official controls of EU eligible holdings and milk processing establishments intended to export to the EU on 31 March and 1 April 2011. Not only OVs, but FBOs from milk processing establishments and farm personnel, participated (in total 175 trainees). Observations: It was found that OVs were aware of specific heat-treatment requirements as set out in Regulation (EU) No 605/2010 and the production processes were evaluated accordingly during the inspections. Most of the local officials could demonstrate good knowledge about animal health and public health requirements for export of milk and dairy products to the EU as is laid down in Regulation (EU) No 605/2010, but two cases were seen where OVs needed specific training on animal health and milking hygiene requirements. 4
5.1.2.2.5 Resources The CA stated to the FVO audit team that they have appropriate facilities and equipment to perform official controls. 5.1.2.2.6 Organisation of control systems Responsibilities and duties of staff carrying out official controls are defined (Section 7 of Law on Veterinary Services, Plant Health, Food and Feed No 5996). Observations: Official controls are based on risk with a minimum frequency of once per year for milk processing establishments and twice per year at EU eligible dairy holdings 1. Official controls regarding compliance with animal health and public health requirements for export of milk and dairy products were carried out in general according to the frequency set. The official veterinarians (OVs) from the PD have to visit the EU eligible holdings twice and the milk processing establishments once per year. Following the instruction for approval of milk processing establishments for EU export, PD and GDFC officials carried out joint inspections. Evidence was seen that teams were set up for pre-approval official controls involving experienced officials from another province. 5.1.2.2.7 Documented control procedures The CA carries out official controls in accordance with documented procedures. The procedures in place ensure that follow-up inspections are carried out and corrective actions are taken when needed. The CCA issues instructions and checklists regarding official controls for dairy holdings producing EU eligible milk as well as for milk processing establishments intending to export to the EU (see point 5.1.1). Nevertheless, the following shortcomings were found by the FVO audit team: There is no official control over the raw milk found to be positive for inhibitors and sent back to the holding. All the animals have to be tested and sampled at the holding according to the test regimes specified in the Regulation on Bovine Tuberculosis and Regulation on Combat of Brucellosis. Nevertheless the CA has no documented control procedures in place for sampling for brucellosis and for testing of tuberculosis (see details under point 5.4.2). Imported animals should be tested for tuberculosis and brucellosis. However, there is no written instructions for testing of imported animals and their release into the herd, as well as for animals introduced into disease free herds coming from a holding with the same or a lower health status. 1 In their response to the draft report the CCA stated that according to Point (c) Section 8 Annex 2 to the Circular No. 2012/07 (27 February 2012) the frequency of inspections for establishment that have applied for exportation to the EU must be at least twice per year following the approval. 5
Although it was checked during the official controls, the checklist for approved holdings producing EU eligible milk has no reference for rolling geometrical average of Total Bacterial Count (TBC) and Somatic Cells Count (SCC) and the checklist for milk processing establishments has no point for microbiological tests of final product. In addition the CA did not write their final evaluation and conclusion on the checklists. All these issues had been noted by the CA shortly before the FVO audit and the revised version of these checklists entered into force on 27 February 2012. 5.1.3 Conclusions The relevant legislation for the scope of this audit is in place. Specific instructions and checklists largely in line with EU legislation were provided regarding dairy holdings producing EU eligible milk and for milk processing establishments intending to export to the EU. Documented control procedures are in place but due to missing instructions or guidance, officials were not always able to satisfactorily ensure compliance with the EU requirements. With some exceptions, the majority of local officials could demonstrate good knowledge of EU animal health and public health requirements. 5.2 HOLDING REGISTRATION, ANIMAL IDENTIFICATION 5.2.1 Legal Requirements The veterinary certification requirements for the introduction into the EU of raw milk and dairy products are laid down in Regulation (EU) No 605/2010. Point II.2 of the model certificates, in Part 2 of Annex II to the Regulation, requires that raw milk comes from holdings registered in accordance with Regulation (EC) No 852/2004 and checked in accordance with Annex IV to Regulation (EC) No 854/2004. 5.2.2 Findings Since the previous mission the system of holding registration has not been changed. All bovine holdings have to be registered and should be in the national database (TURKVET). The CCA guaranteed in their response to recommendation 4 of the previous report that: the list of disease free holdings and list of EU eligible dairy holdings will be updated regularly. Holdings intending to supply EU eligible milk should be approved according to Circular No 2008/26. Approval can only be granted if the holdings are certified disease free for brucellosis and tuberculosis and if the results of the CA controls regarding animal health and food hygiene requirements are favourable. Circular No 2008/26 is no longer in force. The owner of the bovine holding has to follow the instruction of Business Free From Disease and Approved Farms in order to obtain the Disease Free Health Certificate. All the disease free holdings have to be in compliance with the requirements of the Regulation on Bovine Tuberculosis and the Regulation on Combat of Brucellosis. Bovine holdings certified as disease free holdings can apply for Approved Dairy Farm Certificate. These holdings are supervised and controlled by the PD using the Approved Dairy Farm audit checklist. The Approved Dairy Farm Certificate is granted by the Directorate of Animal Health of the competent PD. The Control Directorate in the same PD is informed and a copy of this certificate is sent to the milk processing establishment to where the milk is delivered. 6
The CCA guaranteed in their response to recommendation 5 of the previous report that: inspections on animal identification will be carried out, in particular on disease free holdings and EU eligible dairy holdings. The Disease Free Health Certificate and the Approved Dairy Farm Certificate can be granted where animals are identified in accordance with the national provisions. The CCA explained that only authorised suppliers (published on the MoFAL website) can provide ear tags. This is in order to avoid poor quality supply and problems of the high number of lost ear tags detected during the previous FVO audits. In order to maintain the approval, the OV from the PD has to carry out at least two official controls in a year on the EU eligible holding using the specific checklist. The Approved Dairy Farm certificate is valid until the Disease Free Health Certificate is cancelled, suspended or non-compliance is detected during the supervisions of the PD regarding milking hygiene, raw milk criteria and collection or other elements specified in the Approved Dairy Farm checklist. The CCA had approved 14 dairy holdings by the time of the FVO audit. Observations: Although the CCA has the list of disease free holdings and the list of EU eligible dairy holdings, they are not publicly available to the FBOs. At one holding visited, discrepancies were identified between the cattle registered in the central database and the register kept on the holding. 1586 animals are registered in the central database as being present on the holding, however the holding register recorded 1448 animals, thus 8.7 % difference. This was not noted or investigated by the CA during the official controls. At three holdings visited a few animals were seen that had lost one or both of the required double set of ear tags but action had been taken to replace them. In the fourth dairy holding visited a high number of animals were not properly identified: one or both ear tags had been lost or contrary to the national requirements, handwritten ear tags were used. In addition the FBO could not demonstrate that replacement tags for all animals with one or both lost ear tags had been ordered. Moreover, the FBO systematically ordered double sets of replacement tags and consequently ordered pairs for those animals that had lost only one. The CA has no system in place to control the disposal of unused tags. However, the animals kept on the four holdings visited were still identifiable through the farm management tag or where it was applied through the electronic identification. Links to the official identification number were always demonstrated. 5.2.3 Conclusions The CA confirmed that all holdings where cattle are kept are registered in the central database. The CCA has lists available with disease free and EU eligible dairy holdings. Progress was seen regarding animal identification and FBOs were always able to demonstrate the official identification number of animals. National rules were not satisfactorily implemented regarding the procedures for the replacement of lost ear tags. 7
5.3 LABORATORY SERVICES 5.3.1 Legal Requirements The animal and public health and veterinary certification conditions for the introduction into the EU of raw milk and dairy products intended for human consumption are laid down in Regulation (EU) No 605/2010. Point II.2 of the model certificates, in Part 2 of Annex II to the Regulation, sets out the public health requirements to be met, including the requirement to meet the criteria for raw milk laid down in Chapter I of Section XI of Annex III to Regulation (EC) No 853/2004, and to meet the relevant microbiological criteria laid down in Regulation (EC) No 2073/2005. 5.3.2 Findings 5.3.2.1 Laboratories testing microbiological criteria for foodstuffs At the time of the FVO audit out of the 41 provincial control laboratories 26 have been accredited for certain products and analysis. Laboratories are authorised and have to be approved by the MoFAL to carry out testing. They also have to have approval for the analysis, and they are inspected by the Ministry concerning their fields of activities. The Ministry assigned national laboratories to carry out SCC, TBC and inhibitor testing. Observations: Microbiological testing of final products has to be carried out regularly by the FBO on the basis of the Regulation on Turkish Food Codex Microbiological Criteria containing more strict requirements than Regulation (EC) No 2073/2005, e.g. E. coli for fermented dairy products and melted cheese, Salmonella and L. monocytogenes for pasteurised cream and ice cream. The in-house laboratories are not accredited but in one milk processing establishment visited staff participated in proficiency tests (for TBC and Coliforms) organised once a year by a French provider of proficiency tests. 5.3.2.2 Laboratories for the control of raw milk There are 24 provincial laboratories authorised for SCC analysis, 36 for TBC and 9 for inhibitor testing. Regarding TBC only one laboratory is accredited and ISO 4832 standard is applied as a reference method. 15 out of the 36 laboratories are accredited for the total mesophilic aerobic bacteria test using FDA BAM 2001 analytical method. In the remaining 20 laboratories methods used for TBC are varied. None of the laboratories performing tests for SCC has yet been accredited for this analysis. According to the CCA, methods used to determine TBC and SCC are with one exception not validated against the reference method provided for in Regulation (EC) No 2074/2005. 8
5.3.3 Conclusions Legislation for microbiological testing of final products is in place. Twenty-nine laboratories have been accredited for certain products and analysis. At the time of the FVO audit only one laboratory was accredited for TBC. There are different methods used for both TBC and SCC and the test method used was not validated against the reference method. 5.4 CONTROL OF MILK PRODUCTION HOLDINGS 5.4.1 Legal requirements Point II.1 of the model certificates in Part 2 of Annex II to Regulation (EU) No 605/2010, requires official controls of milk production holdings. 5.4.2 Findings The CCA has established procedures for controls at EU eligible dairy holdings with a minimum frequency of twice per year. These controls cover animal health and welfare, hygiene on holdings, milking hygiene, criteria for raw milk and water quality. A checklist has been developed for this purpose and training was organised. The animals are subject to regular veterinary inspections to ensure that they satisfy the animal health conditions of the relevant EU legislation. The CCA confirmed that none of the 14 EU eligible dairy holdings is located in a FMD restricted area. The implementing regulations for tuberculosis and brucellosis came into force in 2009. Young breeding animals are vaccinated by official staff against brucellosis with live virus strain S19. Official staff carry out tuberculosis testing and take samples for brucellosis. Observations: The four holdings visited had adequate milking and refrigeration equipment. The premises for the storage of milk were in general protected against pests and have adequate separation from the premises where animals are housed. At one EU eligible dairy holding visited, the personal hygiene of the milking staff was inadequate. Staff did not clean their hands and arms during the milking process and did not wear clean clothes. In addition the milking equipment was not sufficiently cleaned, in particular the liners. This was not identified during official controls. Controls of tuberculosis and brucellosis are carried out regularly, based on national legislation which is in line with the relevant EU requirements. At one holding visited the CA did not test all cattle over 12 months old for brucellosis. Instead only cattle over 18 months old were tested, which is a requirement of the former national legislation. 9
At the same holding the OV could not demonstrate the proper reading of the cutimeter. Instead the official estimated the reading and recorded the estimated decimals. Moreover the OV had no knowledge of the current requirements for the interpretation of the reaction for intradermal tuberculine testing. Discrepancies were detected during this audit in the cross check between animals present on holdings and their registration in the holding registers. Subsequently it could not be demonstrated that all eligible animals were tested for tuberculosis and brucellosis. At one EU eligible dairy holding the CA did not respect the frequency of controls. In 2010 the holding was visited once instead of the required bi-annual control. Shortcomings were noted by the FVO audit team in one holding visited regarding animal identification which were not detected during the official controls (see details under point 5.2). 5.4.3 Conclusions In general the four EU eligible dairy holdings visited met the requirements for premises and equipment, hygiene during milking, collection and transport and staff hygiene. A system for regular official controls at holding level is in place and progress has been achieved in relation to controls of animal health status. However, the cross check between animals present on holdings and their registration in the holding registers is insufficient and discrepancies were detected during the audit. Subsequently it could not be demonstrated that all eligible animals were tested for tuberculosis and brucellosis. Testing for tuberculosis was not in line with all provisions (age of animals tested, methods used) on one out of four holdings visited. 5.5 CONTROL OF RAW MILK UPON COLLECTION 5.5.1 Legal requirements Point II.2 of the model certificates, in Part 2 of Annex II to Regulation (EU) No 605/2010, requires that raw milk is produced in accordance with the provisions of the Hygiene Package. 5.5.2 Findings According to the action plan provided by the CCA to recommendation 2 of the previous report, control procedures had been established for raw milk quality upon collection. Until December 2011 the CA could take both the samples on the holding for raw milk quality control or evaluate the result of the own checks obtained from the milk processing establishment to where the milk was delivered to. Since December 2011 officials take samples twice per month for TBC and SCC and the geometrical average is calculated on the basis of this official test results for all the EU eligible dairy holdings. Observations: At the holdings visited records were kept with results of the tests on antibiotic residues as well as the results of the raw milk testing for TBC and SCC. 10
At the holdings procedures are in place to discard milk of animals treated with veterinary medicines and to respect the withdrawal period in the case of treatment. Testing for antibiotics was carried out on raw milk both at holding and at establishment levels using rapid tests. The officials responsible for official controls on the EU eligible dairy holdings did not understand all the questions on the checklist. Although one question is applicable for milk from other species (total plate count < 1 500 000) this was completed on holdings having only cows. The checklist does not refer to rolling geometrical average for TBC and SCC and evidence was seen that approval was granted to holdings on the basis of one good result for TBC and SCC. Moreover, the total mesophilic aerobic bacteria test was accepted as TBC. Nevertheless the own check result of the establishment supplied by the holding met the criteria laid down in Regulation (EC) No 853/2004. In two provinces the FVO audit team noted significant differences between the in-house laboratory and official laboratory test results. In all cases the own check result was lower. This discrepancy was not followed by the CA. The geometrical average, when calculated, met the criteria laid down in Regulation (EC) No 853/2004. 5.5.3 Conclusions Although some deficiencies have been identified in the official control of raw milk up to collection, in general, the CA could guarantee through their controls that raw milk from EU eligible dairy holdings meet the criteria for raw milk for TBC and SCC. The FBOs have adequate procedures in place to ensure that raw milk is not placed on the marked if antibiotic residues exceed the maximum limits. The CA has not investigated the significant differences between the official and the in-house laboratory test results and the CA could not clarify the differences. 5.6 LISTING OF ESTABLISHMENTS 5.6.1 Legal requirements Article 12 of Regulation (EC) No 854/2004 requires that products of animal origin may be imported into the EU only if they have been dispatched from, and obtained or prepared in, establishments that appear on lists drawn up, kept up-to-date and communicated to the Commission. 5.6.2 Findings The project of Supporting the Exportation of Turkish Dairy Sector into the EU Market subsidised by the Association of Packaged Dairy Products was launched in April 2010 and provides support to the establishments to fulfil the requirements for EU production. The CCA elaborated a checklist for milk processing establishments applying for EU export. If the FBO sends an application to the PD, it carries out an official control, fills in the checklist and sends a report to the Ministry if the result is favourable. After that the CCA and the PD carry out a joint inspection and the same checklist is filled in again. The milk processing establishment has to implement procedures based on HACCP 11
principles and officials from the PD carry out controls and fill in the control forms for the evaluation of the HACCP system. In addition particular attention has been made that the establishment should set up procedures for separation (physical and/or time) of EU and non-eu production. The establishment should specify the heat treatment process applied in accordance with Regulation (EU) No 605/2010. The CCA set up a list of establishments that have filled in an application and were assessed by the CA for exporting dairy products to the EU. The list provided to the FVO audit team contains nine establishments. According to the CA's assessment three out of the nine establishments on the list will soon be ready and six have been evaluated as compliant. A milk processing establishment cannot be authorised for export to the EU only in the case where it has at least one supplier from the list of EU eligible dairy holdings. Observations: In all establishments visited a complete file of pre-listing official controls and documentation was presented. During these controls checklists were filled in and in the case of non-compliances being detected, PD officials carried out a follow-up inspection. All the establishments visited have at least one raw milk supplier on the list of EU eligible dairy holdings. The copy of Approved Dairy Farm certificate of the holding supplying EU eligible raw milk to the establishment was presented. The FVO audit team noted the following: The CA carried out pre-approval official controls and filled in the checklist for milk processing establishments that applied for export to the EU. However the CA did not provide a conclusion on the checklist about the compliance of the establishments and eligibility for EU export. The PDs carried out controls and filled in the control forms for the evaluation of the HACCP system and the checklist was attached to the approval file. The evaluation of the HACCP plan and HACCP based procedures for pre-approval were carried out. In one case though the production of yoghurt was evaluated and accepted in the pre-approval of an establishment applying for export of milk treated at ultra high temperature (UHT) to the EU. 5.6.3 Conclusions A system is in place for the approval of milk processing establishments and only minor shortcomings, a missing conclusion regarding the compliance of establishments and not specially targeted official control of HACCP, were detected. 5.7 OFFICIAL CONTROLS AT ESTABLISHMENT LEVEL 5.7.1 Legal requirements Article 12 of Regulation (EC) No 854/2004 lays down that the CA of a third country of origin has to guarantee that establishments placed on the list of establishments from which imports of specified products of animal origin to the EU are permitted, together with any establishments handling raw material of animal origin used in the manufacture of the products of animal origin concerned, complies with relevant EU requirements, in particular those of Regulation (EC) No 853/2004, or with requirements that were determined to be equivalent. It also lays down that an official 12
inspection service supervises the establishments and has real powers to stop the establishments from exporting to the EU in the event that the establishments fail to meet the relevant requirements. The animal and public health and veterinary certification requirements for the introduction into the EU of products of animal origin intended for human consumption are laid down in the product specific Commission Regulations covered by the scope of the audit, i.e. (Regulation (EU) No 605/2010) 5.7.2 Findings 5.7.2.1 General and specific hygiene In response to recommendation 1 to the previous report the CCA was requested To ensure that new instructions and rules are properly implemented at regional level and the official controls in milk processing establishments proposed for EU approval take specific EU and national requirements into account to be able to guarantee that the requirements under point 9 and 11 of the model certificate Milk-HTC as provided for by Commission Decision 2004/438/EC are met. To address this recommendation the CCA committed themselves to carrying out the necessary audits and controls over animal health and public health requirements in the milk processing establishments intended to export to the EU. Dairy establishments have to implement the requirements of the national framework law on Veterinary Services, Plant Health, Food and Feed, as well as the Regulation of Special Hygiene rules for Animal food. Documented procedures are in place for the official controls of the dairy processing establishments, including the follow-up in case of non-compliances. Controls must be carried out at a frequency of at least once per year. A checklist has been developed for this purpose and official staff have received training on the general and specific requirements related to the dairy processing. The FVO audit team visited three milk processing establishments that intend to export UHT milk to the EU and one establishment that intends to produce pasteurised milk for export to the EU. The Turkish CA considers that all four milk processing establishments are EU compliant. Observations: The potential EU eligible dairy products were only sourced from raw milk from cows. The establishments visited met the general and specific hygiene requirements and they have in principle satisfactory layout, structures and equipment. The maintenance, operational and general hygiene standards were mainly acceptable but in a few areas, rusty, mould and leaking pipes were noted. Two establishments visited were not properly pest proof (gaps under the doors, direct openings to outside). In two provinces the results of the SCC and TBC differed considerably between the samples taken by the CA and the samples taken by the FBO. Nevertheless none exceeded the geometric average for the periods defined in the hygiene package. The establishments visited could demonstrate that potential EU eligible dairy products underwent one of the heat treatments described in the model certificate Milk-HTC laid down in Regulation (EU) No 605/2010. The alkaline phosphatase test was commonly used to verify the efficiency of 13
pasteurisation as required by the aforementioned Regulation. Moreover, in the establishments producing UHT dairy products, the milk underwent a pasteurisation process before sterilisation, which was controlled by an alkaline phosphatase test, applied immediately after the heat treatment. 5.7.2.2 HACCP-based systems HACCP based procedures were in place in all establishments visited. The HACCP plans were well developed, updated and reflected the current activities. In an individual case critical limits set up for a critical control point were not properly defined and recorded accordingly. In recommendation 6 of the previous FVO report the CCA was requested To ensure that establishments proposed for approval to the EU include procedures to guarantee full separation between EU and non-eu production in their HACCP plan. The milk processing establishments visited have written procedures in place about separation (in time or place) of the EU and national production. A simulation of EU production was carried out and FBOs were able to demonstrate and provided guarantees for separation of EU and non-eu at all stages of production. 5.7.2.3 Microbiological testing In one establishment visited, producing pasteurised milk, the product was tested for enterobacteriaceae once per week. Although six samples were taken, not all of them were taken at the end of the manufacturing process. This is not in line with the requirements of Regulation (EC) 2073/2005. Even though they used the ISO 21528-1 method for testing on enterobacteriaceae it was not reflected in their procedures. The FVO audit team checked in two out of the three establishments intend to export UHT milk to the EU, that appropriate heat treatment and microbiological stability was demonstrated by a method which complies with specifications mentioned in Regulation (EC) No 853/2004. 5.7.2.4 Traceability and identification marking Recommendation 7 of the previous report concerning internal traceability in establishments that also process non-eu eligible milk was addressed. All establishments visited had traceability systems in place for separate production and storage of EU and non-eu compliant milk and their products. 5.7.2.5 Documentation of official controls Documented control procedures are in place for the official controls of the milk processing establishments, including follow-up in the case of non-compliances. Nevertheless, the CA did not note the deficiencies found by the FVO audit team (rust and not pest proof) during the official controls. 5.7.3 Conclusions The establishments visited generally met the hygiene requirements and procedures for separation of EU and non-eu eligible production were in place. The FBOs could demonstrate that potential EU 14
eligible dairy products underwent one of the heat treatments described in the model certificate Milk-HTC laid down in Regulation (EU) No 605/2010. 5.8 OFFICIAL CERTIFICATION 5.8.1 Legal requirements Council Directive 96/93/EC lays down the general rules to be observed by third countries in issuing certificates required for exports to the EU, according to the specific EU veterinary legislation. The specific animal health, public health and veterinary certification requirements for the introduction into the EU of products of animal origin intended for human consumption, are laid down in the product specific Commission Regulations (see point 5.7.1) and these requirements were officially controlled. 5.8.2 Findings Since the previous mission the CCA has established procedures for official certification of dairy products intended for export to the EU. However, as currently no actual export to the EU takes place, it was not possible to evaluate the implementation and the topic was removed from the scope of the audit. 6 OVERALL CONCLUSION In relation to the action plan provided by the CCA, in response to the previous mission, most of the nine recommendations have been fully addressed. Progress was noted in addressing the proper implementation of instructions and rules, finalising the adjustment of legislation and administrative procedures, animal identification and official controls prior to approval. A system for regular official controls at holding level is in place and progress has been achieved in relation to animal identification and controls of animal health status. Discrepancies were detected during this audit in the cross check between animals present on holdings and their registration in the holding registers. Subsequently it could not be demonstrated that all eligible animals were tested for tuberculosis and brucellosis. The establishments visited mainly met the general and specific hygiene requirements. Procedures for separation of EU and non-eu eligible production were in place. The FBOs demonstrated that potential EU eligible dairy products underwent one of the heat treatments described in the model certificate Milk-HTC laid down in Regulation (EU) No 605/2010. 7 CLOSING MEETING A closing meeting was held on 9 March 2012 with the CCA, the General Directorate of Food and Control. At this meeting the FVO audit team presented the findings and preliminary conclusions of the audit and advised the CCA of the relevant time limits for production of the report and their response. The representatives of the CCA acknowledged the findings and conclusions presented by the FVO audit team. In addition, information on action already taken and planned, in order to address 15
particular findings during the audit, and information about laboratories and training was provided. 8 RECOMMENDATIONS An action plan, describing the action(s) taken or planned in response to the recommendations of this report and setting out a timetable to correct the deficiencies found, should be presented to the Commission within 25 working days of receipt of the report. N. Recommendation 1. To ensure that officials involved in official controls of European Union eligible dairy holdings have adequate knowledge of national and EU animal health and public health requirements for export to the EU in order to evaluate if the conditions of the certificate MILK-HTC as laid down in Annex II, part 2 of Commission Regulation (EU) No 605/2010 are met. 2. To review documented procedures for official controls of European Union eligible dairy holdings and milk processing establishments, whether these procedures contain all the information and instructions for staff performing official controls in order to provide satisfactory assurances that the requirements of Commission Regulation (EU) No 605/2010 are met. 3. To ensure that official controls at European Union eligible dairy holdings include a cross check between animals present on the holding and their registration in the holding registers in order to guarantee that all eligible bovine animals on the holding were tested for tuberculosis an brucellosis as laid down in Council Directive 64/432/EEC. 4. To ensure that laboratory testing methods for Total Bacteria Count and Somatic Cell Count are validated against the reference method laid down in Chapter I, Annex VIa to Regulation (EC) No 2074/2005 in the case of the laboratory analyses of raw milk intended to be used for European Union production. The competent authority's response to the recommendations can be found at: http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_inspection_ref=2012-6575 16
ANNEX 1 - LEGAL REFERENCES Legal Reference Official Journal Title Dir. 96/22/EC OJ L 125, 23.5.1996, p. 3-9 Dir. 96/23/EC OJ L 125, 23.5.1996, p. 10-32 Dir. 96/93/EC OJ L 13, 16.1.1997, p. 28-30 Dir. 97/78/EC OJ L 24, 30.1.1998, p. 9-30 Dir. 2002/99/EC OJ L 18, 23.1.2003, p. 11-20 Dir. 2004/41/EC OJ L 157, 30.04.2004, p.33 corrected and republished in OJ L 195, 02.06.2004, p. 12 Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of ß-agonists, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EEC Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC Council Directive 96/93/EC of 17 December 1996 on the certification of animals and animal products Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption Directive 2004/41/EC of the European Parliament and of the Council of 21 April 2004 repealing certain Directives concerning food hygiene and health conditions for the production and placing on the market of certain products of animal origin intended for human consumption and amending Council Directives 89/662/EEC and 92/118/EEC and Council Decision 95/408/EC 17
Legal Reference Official Journal Title Reg. 882/2004 OJ L 165, 30.4.2004, p. 1, Corrected and re-published in OJ L 191, 28.5.2004, p. 1 Reg. 854/2004 OJ L 139, 30.4.2004, p. 206, Corrected and re-published in OJ L 226, 25.6.2004, p. 83 Reg. 853/2004 OJ L 139, 30.4.2004, p. 55, Corrected and re-published in OJ L 226, 25.6.2004, p. 22 Reg. 852/2004 OJ L 139, 30.4.2004, p. 1, Corrected and re-published in OJ L 226, 25.6.2004, p. 3 Reg. 178/2002 OJ L 31, 1.2.2002, p. 1-24 Reg. 2073/2005 OJ L 338, 22.12.2005, p. 1-26 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 Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs 18