EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL

Ref. Ares(2014)4213898-15/12/2014 EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Directorate F - Food and Veterinary Office DG(SANCO) 2014-7153 - MR FINAL FINAL REPORT OF AN AUDIT CARRIED OUT IN CROATIA FROM 10 TO 20 JUNE 2014 IN ORDER TO EVALUATE THE FOOD SAFETY CONTROL SYSTEMS IN PLACE GOVERNING THE PRODUCTION AND PLACING ON THE MARKET OF POULTRY MEAT AND PRODUCTS DERIVED THEREFROM

Executive Summary This report describes the outcome of a Food and Veterinary Office audit in Croatia, which took place from 10 to 20 June 2014, in order to evaluate the official food safety control system in place governing the production and placing on the market of poultry meat and products derived therefrom. The report concludes that there is a system of official controls on poultry meat and products derived therefrom, which includes regular and risk based controls. There are provisions in place for delegating competence for performing official controls in food establishments to control bodies including provisions intending to avoid cases of conflict of interest. However these provisions are not always effective. Some shortcomings in the implementation of the official control system were noted with respect to post-mortem inspection, to approval procedures of establishments and in relation to the verification of FBO's implementation of provisions of Regulation (EC) No 2073/2005 on microbiological criteria. The report includes a number of recommendations addressed to the central competent authority, aimed at rectifying the identified shortcomings and deficiencies and enhancing the implementation of the official control system in place. I

Table of Contents 1 INTRODUCTION...1 2 OBJECTIVES...1 3 LEGAL BASIS...1 4 BACKGROUND...2 4.1 PREVIOUS FVO AUDIT...2 4.2 PRODUCTION AND TRADE INFORMATION...2 5 FINDINGS AND CONCLUSIONS...2 5.1 LEGISLATION AND IMPLEMENTING MEASURES...2 5.2 COMPETENT AUTHORITY...3 5.3 OFFICIAL CONTROLS OF PRODUCTION AND PLACING ON THE MARKET...6 5.3.1 CONTROLS AT FARM LEVEL...6 5.3.2 APPROVAL PROCEDURES...7 5.3.3 ANTE-MORTEM AND POST-MORTEM INSPECTION...7 5.3.4 ANIMAL WELFARE AT SLAUGHTER...8 5.3.5 CONTROLS AT ESTABLISHMENTS LEVEL...9 5.3.6 CONTROLS ON FBOS COMPLIANCE WITH MICROBIOLOGICAL CRITERIA FOR FOODSTUFFS OFFICIAL SAMPLING...10 5.3.7 CONTROLS ON TRACEABILITY LABELLING IDENTIFICATION MARKING...11 5.3.8 CONTROL ON THE USE OF FOOD ADDITIVES...12 5.4 RAPID ALERT SYSTEM FOR FOOD AND FEED (RASFF)...12 5.5 LABORATORIES...13 6 OVERALL CONCLUSIONS...13 7 CLOSING MEETING...14 8 RECOMMENDATIONS...14 ANNEX 1 - LEGAL REFERENCES...16 II

ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT Abbreviation AV CA/CCA EU FBO FVO HACCP MA MSM NRL OG RASFF VFSD VI Explanation Authorised Veterinarian Competent Authority/Central Competent Authority European Union Food Business Operator Food and Veterinary Office Hazard Analysis - Critical Control Points Ministry of Agriculture Mechanically separated meat National Reference Laboratory Official Gazette Narodne novine Raspid Alert System for Food and Feed Veterinary and Food Safety Directorate Veterinary Inspector III

1 INTRODUCTION This audit took place in Croatia from 10 to 20 June 2014 and was undertaken as part of the Food and Veterinary Office's (FVO) planned audit programme. The audit team comprised two FVO auditors. Representatives from the competent authority (CA) accompanied the audit team during the whole audit. 2 OBJECTIVES The objective of the audit was to verify that official controls for poultry meat and products derived therefrom are carried out in compliance with EU legislation. In pursuit of this objective, the audit proceeded as follows: An opening meeting was held on 10 June 2014 with the Central CA (CCA). At this meeting the audit team confirmed the objectives of, and itinerary for the audit, and requested additional information required for its satisfactory completion; The following sites were visited: Competent authority visits CCA 1 Opening and closing meeting Regional CAs 2 Laboratory visits Official 2 Primary production Farms 1 Food processing facilities Slaughterhouses 9 Cutting plants 8 Attached to slaughterhouses Meat preparation establishments 3 Attached to slaughterhouses Mechanically separated meat (MSM) establishments 3 Attached to slaughterhouses Meat product establishments 2 Attached to slaughterhouses 3 LEGAL BASIS The audit was carried out under the general provisions of EU legislation and, in particular Article 45 of Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls in Member States performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules. A full list of the EU legal instruments referred to in this report is provided in the Annex and refers, where applicable, to the last amended version. 1

4 BACKGROUND 4.1 PREVIOUS FVO AUDIT This audit was the first audit concerning poultry meat and products derived therefrom since accession of Croatia to the EU. Prior to accession the FVO carried out audits in the framework of the accession preparation of Croatia, in order to assist and monitor progress with the adoption of the relevant EU requirements. The Accession Treaty foresees a transitional period until 31 December 2015 for certain establishments for meat, milk, fish and animal by-products, regarding some structural requirements. Products originating from those establishments can only be placed on the national market of Croatia and bear a different health or identification mark. In Croatia there are six poultry meat establishments from the total number of 36 approved which currently do not meet all the relevant EU requirements and produce for the national market only. 4.2 PRODUCTION AND TRADE INFORMATION The audit team was informed by the CA that 36 872 061 chicken, 834 760 turkey and 35 847 other species was slaughtered in Croatia in 2013. 5 FINDINGS AND CONCLUSIONS 5.1 LEGISLATION AND IMPLEMENTING MEASURES Article 4.2 (e) and Article 8 of Regulation (EC) No 882/2004. Articles 1 (3) (d), Article 1 (4) and Article 10 of Regulation (EC) No 853/2004. Directive 98/34/EC. A comprehensive review of the Croatian legislation was not carried out as a part of this audit. The CA informed the audit team that EU legislation had been transposed into the following national Acts: Food Act (Official Journal (OG) 81-2/13), implementing Regulation (EC) No 178/2002 and defines the area of competences for different national ministries. Veterinary Act (OG 82-3/13) as amended (OG 148-17/13) implementing Regulations (EC) Nos 853/2004 and 854/2004 and Regulation (EC) No 2074/2005. Act on Food Hygiene Criteria and Microbiological criteria for Food (OG 81-3/13) implementing Regulations (EC) Nos 852/2004 and 2073/2005. Act on Official Controls (OG 81-4/13) specifies the authorities and their tasks related to the organisation, coordination and implementation of official controls. Act on Water for Human Consumption (OG 56-7/13) implements Directive 98/83/EC). Act on Food Additives, Flavourings and Food Enzymes (OG 39-8/13) implements Regulation (EC) No 1333/2008. 2

The following secondary legislation develops further the above legal Acts: Ordinance on Keeping the Register of Registered and Approved Establishments and on Procedures for the Registration and Approval of Food Business Operators (FBOs) (OG 125-21/08); as amended (OG 55-10/09). Ordinance on the Health and Identification Marks of Food of Animal Origin (OG 92-34/ 12). Ordinance on sampling frequency of carcasses, fresh poultry meat, minced meat, meat preparations and MSM and conditions and method for reducing the number of samples in the small capacity establishments(og 30-30/10) as amended (OG 38-18/12). Ordinance on compliance parameters and method of analysis for water for human consumption (OG 125-19/13) as amended (OG 141-19/13). Ordinance OG 30-30/10 provides for the sampling frequency for Salmonella in minced meat, meat preparations and MSM. However this Ordinance does not provide for the testing for process hygiene criteria ( for Escherichia coli and aerobic colony count) as required by Regulation (EC) No 2073/2005. This has resulted in the absence of tests for both these parameters in the establishments (see also Chapter 5.3.6). There is no national legislation in place regarding the direct supply, by the producer, of small quantities of meat from poultry and lagomorphs slaughtered on the farm to the final consumer or to local retail establishments directly supplying such meat to the final consumer as fresh meat as laid down in Article 1(3)(d) of Regulation (EC) No 853/2004. There is also no national legislation in place concerning the operation of low throughput establishments in the context of Article 10(4) (b) of Regulation (EC) No 853/2004. Conclusions While an in depth review of Croatian legislation was not carried out during this audit, the provisions of the legal texts reviewed by the audit team appear to be in compliance with EU requirements. However, a discrepancy regarding the testing parameters for process hygiene criteria in poultry meat preparations, minced meat and MSM was noted. There are no national laws concerning slaughtering on the farm or on low throughput establishments. 5.2 COMPETENT AUTHORITY Article 3, 4, 5, 6, 8, 9, 54 and 55 of Regulation (EC) No 882/2004. Section III of Annex I to Regulation (EC) No 854/2004, in particular Chapter III and IV. Veterinary and Food Safety Directorate (VFSD) under the Ministry of Agriculture (MA) is the designated CA responsible for official controls of poultry meat and products derived therefrom. There is a direct line of command from central to regional level. Within the VFSD there are two sectors responsible for the tasks in the area of the audit: The Veterinary Public Health and Food Safety Sector is responsible for legislation on food of animal origin; preparing guidelines, instructions, checklists, etc. to be used by the official and delegated staff; for keeping and updating of register of establishments dealing with food 3

of animal origin; The Veterinary Inspection Sector is responsible for the organisation of official controls and enforcement of the legislation. Official controls are carried out by Veterinary Inspectors (VIs) from 14 veterinary regional offices with branch offices and by Authorised Veterinarians (AVs) from authorised veterinary organisations (control bodies). There are 55 control bodies delegated by the MA for performing official controls in food establishments. According to the procedures MA drafts contract, which is sent to the control body and, if accepted, signed and sent back to the MA. In each contract of five years duration, are listed the tasks the control body is mandated to carry out. Payment to the control bodies is regulated in the Ordinance of fees and charges (OG 79-60/09). On the basis of this Ordinance FBOs pay fees for official controls directly to the state budget. Remuneration for carrying out controls is paid to AVs from the state budget reducing the risk of a potential conflict of interest. Control bodies are accredited by the Hrvatska akreditacijska agencija (Croatian Accreditation Agency) to ISO 17020 standards. This agency can additionally apply classification procedures and classify the control bodies into three classes: A, B and C. If a body belongs to class A it means that there is no potential conflict of interest whereas a body with potential conflict of interest are classed as C. Authorised veterinary organisations in Croatia belong to class C. There are procedures in place for the official supervision of the control bodies. Until 2013 only senior state VIs were authorised to supervise control bodies. Currently in every region there are designated VIs to carry out this task. The frequency of these controls is twice per year. A harmonised checklist created in 2011 by the CCA is used for these supervisions which cover among others the accreditation, contract and quality system. In two regions visited the audit team saw evidence that these control bodies are under regular supervision by regional veterinary services where among others the potential conflict of interest and training provided to AVs are covered. In one region visited the audit team noted that that the contracted control body was inspected twice in 2013. One of these inspections was done by the regional veterinary service together with CCA. In another region in 2013 during an inspection of the control body a non- compliance was detected which could have led to a conflict of interest. The follow-up inspection confirmed that this irregularity had been rectified. In one visited establishment the control body authorised for its official control also had a contract with the establishment for pest control. The audit team was informed that according to the procedures there are different AVs doing these activities (official controls and private activity). The audit team was also informed that each AV was designated to carry out specific duties which are set out in the official contract. This designation does not allow for AVs to perform other tasks than the ones specified in the contract in relation to the establishment. In another region with a control body which also had contracts with establishments, AVs were designated for specific tasks on a weekly basis. In practical terms, AV performing official controls in an establishment one week would carry out pest control tasks for the same establishment the following week. In a farm visited the same AV can carry out Salmonella sampling as a member of control body and at the same time be designated for the treatment in the farm as member of veterinary organisation The last two cases described could lead to the potential conflict of interest. 4

Training VFSD is responsible for organising training for VIs and AVs designated for official controls. The audit team was provided with a summary of events organised including topics covered and number of VIs and AVs participating in the training. In 2012 in a workshop for hazard analysis and critical control points (HACCP) system 20 VIs participated; In 2013/2014 VFSD organised a series of events for every region covering EU requirements for establishments and in 2013 practical training on HACCP assessment; In 2012 and 2013 there were a series of training sessions on animal welfare organised by VFSD and TAIEX. These courses covered among others the requirements on protection of animals at the time of slaughter. In 2014 on-line training is foreseen on animal welfare during slaughter as well as a workshop (1 day theory and 1 day practice) for ante- and post-mortem inspection which also covers animal welfare; VIs have also participated in Better Training for Safer Food events which covered among others audits in food area, animal welfare, microbiological criteria in foodstuff, official controls on meat and meat products and HACCP systems; In May 2014 there was a training organised by TAIEX on the prevention of conflicts of interest related to the performance of Vis; In regional offices and establishments visited VIs and AVs provided evidence of participation in the above training activities. Verification There are procedures in place to verify the effectiveness of official controls at establishment level. The evaluation process of VIs until 2014 was carried out by the CCA. Since 2014 VIs are assessed while performing official controls in the relevant establishment in by the heads of the regional/ local veterinary offices. The results of this assessment are recorded in an Official Note which forms part of the inspection report and introduced into the VETI system which is the electronic database for recording the official controls. The assessment of the particular VI is based on the quality of this inspection. The performance of AVs is regularly evaluated by VIs from regional veterinary service during official controls in establishments. This evaluation covers the ante- and post-mortem inspections and other official controls carried out by AVs. The results of this assessment are included in the respective part of inspection report. In the regions visited the audit team noted that every AV is regularly evaluated by the regional level. The audit team was provided with the evidence that the checklist used includes a specific part related to the assessment of the work of AVs. AVs performance is also verified once per month in the regional offices by checking the records in the VETI system. This computer system records all data related to official controls e.g. the date and length of inspection, the results of inspection, number of birds for ante-and post-mortem inspection etc. Internal audits Internal audits are carried out by the Internal Audit Department of the CCA. The audit team was informed that six out of 55 contracted control organisations have already been audited by this department. It is planned over time to audit all control bodies. Particular attention will be paid to the procedures aimed to exclude conflict of interest and to the smaller organisations where the low 5

number of employees could lead to a potential conflict of interest. Conclusions The CAs responsible for official controls in the scope of the audit is clearly designated in compliance with EU requirements. There are provisions in place for delegating competence for performing official controls in food establishments to control bodies including some provisions intended to avoid cases of conflict of interest. However these provisions are not always effective. Staff performing official controls receive regular training in line with Article 6 of Regulation (EC) No 882/2004. Tools are available to the CA to verify the effectiveness and appropriateness of official controls at establishment level. Internal audits in the context of Article 4(6) of Regulation (EC) No 882/2004 have been carried out. 5.3 OFFICIAL CONTROLS OF PRODUCTION AND PLACING ON THE MARKET 5.3.1 Controls at farm level Article 3 of Regulation (EC) No 882/2004 Annex I to Regulation (EC) No 852/2004 Article 4 (2) of Regulation (EC) No 854/2004 The frequency of official controls in poultry farms is determined by the CCA and is, at a minimum, once per year. In addition Veterinary offices at regional level can increase the frequency taking into account the risks related to the individual farms. Poultry farms have to be registered in a national registration system and the official controls on the farms are always carried out by VIs. The audit team visited one poultry farm that supplies broilers and turkeys to slaughterhouses. This poultry farm was registered in the national registration system. The FBO s records were properly kept and they were available to the audit team. The flock records included, among other data, information on daily mortality, feed and water consumption, use of veterinary medicine and vaccination. Pest control programmes were in place. The municipal water was sampled twice annually and analysed for physico-chemical and microbiological parameters Heat treated feed is produced in the farm and both feed and ingredients are tested twice annually for Salmonella. In 2013 there was one positive Salmonella test result. Measures such as improvement in HACCP system in the feed mill and training of the staff were undertaken to avoid a repeat of this incidence. The farm visited was maintained in adequate conditions and applied appropriate biosecurity measures and was subject to regular official controls with a frequency once per year. Inspection reports were available to the audit team. The harmonised checklist used covered welfare on the farm and treatment. There is no specific part related to biosecurity conditions on the farm however the audit team was informed that non-compliances detected are recorded in the inspection report. Conclusions Official controls are implemented on the poultry farms in order to verify FBO compliance with the 6

provisions of Regulation (EC) No 852/2004. Flock records contain all necessary information as required by Regulation (EC) No 852/2004. 5.3.2 Approval procedures Article 6 of Regulation (EC) No 852/2004. Article 4 of Regulation (EC) No 853/2004. Article 31 (2) of Regulation (EC) No 882/2004. The procedures for the approval of establishments are included in Article 6 of Ordinance OG 125-21/08 as amended. According to this Ordinance the food establishments are approved at regional level following an inspection visit. If the establishment passes the inspection the conditional approval is granted and the establishment is entered into the Register of Food Establishments with the unique approval number. Before the expiry of conditional approval which should not be longer than 6 months the inspection visit from regional level should take place. If result satisfactory the decision for permanent approval is issued by regional level. The establishments visited were approved for the specific activities however the audit team noted that: In one establishment visited the approval document covered the production of minced meat although no minced meat has been produced on this site and there are no facilities for this production; Another establishment visited was approved as a cutting plant although this activity had never been carried out. This particular discrepancy had already been noted by the CA and corrective action was taken. Conclusions Establishment approval procedures are in place and in compliance with EU legislation. However they are not always implemented correctly as some establishments have been approved for activities that are not carried out and this is not in compliance with Article 31(2) (c) of Regulation (EC) No 882/2004. 5.3.3 Ante-mortem and post-mortem inspection Article 4 and 5 of Regulation (EC) No 854/2004. Ante- mortem inspection. The audit team was informed that ante-mortem inspection is carried out by VIs or AVs exclusively in the slaughterhouses. The harmonized health certificate has to accompany the birds send to the slaughterhouses. In the nine slaughterhouses visited the audit team noted that:- Veterinarians in slaughterhouses are informed 24 hours in advance about the number and 7

origin of birds to be sent to the slaughterhouse via the VETI system (the responsibility of the FBO concerned); The health certificate contains all the food chain information required under EU food law including Salmonella test result, treatment applied and withdrawal period. This certificate is signed both by the FBO and private veterinarian responsible for the farm. Post- mortem inspection Post-mortem inspection is carried out by AVs. In three slaughterhouses visited the audit team noted that designated post-mortem inspection points did not provide adequate conditions for AVs to carry out this task fully in compliance with the requirements of Regulation (EC) No 854/2004 (viscera were removed before the post-mortem inspection point). In one turkey slaughterhouse abnormalities of carcasses had already been removed by slaughterhouse staff before the post-mortem inspection point. The AV had no access to the designated post-mortem inspection point and the external surfaces of carcasses could not be viewed as required under Regulation (EC) No 854/2004). These deficiencies had not been detected/recorded by the CA during supervisory visits. In the slaughterhouses visited the results of ante and post-mortem inspection were available to the audit team. The records were duly completed and included in the ''VETI'' system. Conclusions Ante-mortem inspection at slaughterhouse is carried out generally in line with EU requirements. EU legal requirements for post-mortem inspection are not fully complied with (i.e. deficiencies in designation/access to post-mortem inspection points, some birds subject to only partial post-mortem inspection). 5.3.4 Animal welfare at slaughter Articles 3, 4, 5 and 17 of Regulation (EC) No 1099/2009 on the protection of animals at the time of killing. The CCA has created a guidance document to be used in daily checks on animal welfare in the slaughterhouses. The guide includes a checklist where among others stunning parameters and symptoms of correct stunning are included. This checklist was used in the slaughterhouses visited. According to Ordinance OG 135/06, establishments slaughtering less than 150,000 birds per year are exempt from the obligation to employ an animal welfare officer. However in all slaughterhouses visited, regardless of the slaughter capacity, animal welfare officers had been appointed by the FBOs and evidence of their training was available. FBOs sent the requests for issuing the certificates of competence for animal welfare officers as required under this ordinance. In the slaughterhouses visited the audit team noted that, after stunning, the birds did not present any signs of consciousness or sensibility. However in three slaughterhouses it was not possible to verify if the required stunning parameters in electrical water bath had been met as no equipment was available to read stunning current or frequency. Only in one slaughterhouse had this deficiency been recorded and a recommendation was issued by the CA. Additionally in one slaughterhouse the birds were exposed to electrical shock before submerging in the water bath. Back-up equipment was available in all slaughterhouses visited. 8

Conclusions Animal welfare requirements in slaughterhouses visited were found to be generally respected however some shortcomings related to the equipment of electrical waterbath stunners were found by the audit team. 5.3.5 Controls at establishments level Article 4 of Regulation (EC) No 854/2004. General findings The official controls at establishment level are carried out by VIs, AVs and in some cases together with officials from the CCA. Since the start of 2014, the minimum frequency and the scope of official controls by VIs and AVs have been determined centrally. The various checklist templates to be used by VIs and AVs are available on the VFSD website. Templates for VIs cover among others animal welfare issues, HACCP based procedures, hygiene and maintenance, performance of AVs. AV s templates cover hygiene conditions, establishment maintenance, Critical Control Points and animal welfare issues. AVs have no power to enforce the legislation however in the case of non-compliances found they can request the corrective action from the FBOs or inform the VIs about the problems identified. In establishments visited the audit team noted that regular inspections had been carried out and set frequency targets met. In some cases there were additional inspections carried out by the CCA. The harmonised checklists were used and reports were available to the audit team. When deficiencies were identified, follow-up was carried out to verify the correction of the recorded non-compliances during either the next inspection or after the deadline set for their correction. Nine establishments visited by the audit team were broadly in line with EU requirements, although with some minor deficiencies were detected (Note: not all deficiencies were presented in all establishments) as follows:- In some areas premises were not protected against the formation of condensation in contravention of paragraph 2(b), Chapter I of Annex II to Regulation (EC) No 852/2004. Condensation was observed in some instances above exposed products. In one establishment there was direct access from the outside to internal production areas where food was being handled which is not in line with Point 2(a), chapter I, Annex II to Regulation (EC) No 852/2004. In one establishment protective and private clothes are stored together without separation; Potential contamination of packaging material and frozen products with wooden pallets was noted; No separation between packed and unpacked MSM during defrosting; Dirty ceiling and rusty overhead structures with possible shedding of particles onto product; Potential contamination of frozen raw material by broken and dirty packaging; Inadequate storage conditions for packaging materials in a dirty area, with direct contact of 9

packaging and wrapping materials with dirty surfaces); Insufficient equipment to avoid contamination of carcasses (no possibility for hand washing during manual evisceration); Cleaned plastic crates used for fresh meat placed directly on the floor; In one establishment producing MSM in accordance with conditions laid down under point 4, Chapter 3, Section V of Annex III to Regulation (EC) No 853/2004 the shelf life on the label was one year which is not in compliance with the point 4(f) of the mentioned EU legislation which requires this type of frozen MSM to be stored for no longer than three months. The audit team noted that only some of these deficiencies had been recorded in the inspection reports made available. related to HACCP based procedures In all establishments visited HACCP plans were in place and were subject to regular official control. These plans had been implemented in accordance with EU requirements. However in one establishment visited, a discrepancy between the monitoring procedures established in the HACCP plan and the records of one particular critical control point were found. Conclusions There is a regular and documented system of official controls of poultry meat establishments. However, some shortcomings in the performance of the official controls were found as some noncompliances concerning the maintenance and good hygiene practices at the establishments visited had not been detected and/or recorded during official controls. HACCP plans were present in the establishments visited and generally well implemented. 5.3.6 Controls on FBOs compliance with microbiological criteria for foodstuffs official sampling Article 4 of Regulation (EC) No 854/2004. Article 11 of Regulation (EC) No 882/2004. Regulation (EC) No 2073/2005, in particular Article 1. FBO sampling activities In all establishments visited own-check samples had been taken and analysed for microbiological parameters. For neck skin sampling the frequency for Salmonella sampling is determined in the national legislation (Ordinance OG 30-30/10). Under this ordinance, slaughterhouses are classified according to the annual slaughter capacity as B1, B2 and B3 and the frequency depends on the category e.g. for the slaughter capacity less than 100,000 per year (B2) the frequency is once every three months. In all establishments visited the frequency of sampling was in compliance with the national legislation. The composition of the samples was, in all cases reviewed, five samples obtained from 15 carcases. The EU reference method ISO 6579 was used for testing. Only in one establishment Salmonella trend analyses had not been done however this deficiency was detected by the CA and a recommendation was issued. 10

In most of the establishments visited the sampling programme provided also for testing of poultry carcases, poultry liver and cuts. In all establishments visited a sampling programme for water for microbiological and physicochemical criteria was being implemented. The frequency was set at between four and five times per year. The shelf-life for poultry meat, meat preparations and poultry meat products was determined on the basis of organoleptic checks and microbiological analyses (for the presence of Salmonella, Enterobacteriacea, total bacteria count, Staphylococcus and Listeria monocytogenes. However some shortcomings in own-check sampling were noted by the audit team as follows:- In one establishment producing meat preparations the audit team noted that FBO sampling programme foresaw serotyping when Salmonella spp was detected even though it is not required by Regulation (EC) No 2073/2005. The HACCP programme included this procedure but it did not specify what measures should be taken after serotyping and provision was not made to ensure that product which tested positive for non-relevant Salmonella would not be placed on the market. In another establishment sampling frequency and parameters tested were in line with national legislation however the number of units taken was one instead of the required five. The national legislation provides the frequency of sampling and parameters to be tested. However analyses are related only to food safety criteria (Salmonella) and not to process hygiene criteria. In the establishments visited the frequency of sampling was respected however samples were tested only for Salmonella (see also Chapter 5.1). Official sampling The CA informed the audit team that official sampling in poultry meat establishments is scheduled to commence in 2014. The CA explained that during official controls in establishments they verify the implementation of FBOs own-check sampling programmes and stated that the own-check samples testing method is the EU reference one and that on many occasions samples are tested in official laboratories. This statement was confirmed by the auidt team during visits in the establishments. However the deficiencies detected by the audit team in own-check sampling as regards inadequate number of units had not been recorded in official control reports. Conclusions FBO's own-check sampling programmes on poultry meat and products derived therefrom are implemented however not fully in compliance with EU legislation, in particular concerning sampling for process hygiene criteria as this is not required under national legislation and number of sampling units. Documentary verification of own-check sampling is done regularly during official controls however not all deficiences identified by the FVO team had been recorded by the CA during these controls. 5.3.7 Controls on traceability Labelling Identification marking Traceability: Article 4.6 of Regulation (EC) No 854/2004. Labelling: Chapter IV, Section V, Annex III of Regulation (EC) No 853/2004. 11

Identification marking: Article 4.6 of Regulation (EC) No 854/2004; Section I, Annex II of Regulation (EC) No 853/2004. Evidence was provided to the audit team that CA carries out regular audits on traceability, identification marking and labels. Traceability systems were in place in all the establishments visited and were found to be satisfactory. Labels and identification marks were correctly applied in all the establishments visited. Conclusions Checks on traceability, identification mark and labelling are part of official controls and they provide guarantees that it is done in accordance with EU requirements. 5.3.8 Control on the use of food additives Regulation (EC) No 1333/2008. VIs are obliged to perform official controls on the use of food additives at production level and sanitary inspections at the retail level as required by the Act on official controls, OG 81-4/13. There is no specific part in checklists for control on additives. The audit team was informed in one establishment visited that during official controls certificates for food additives and weighing the components of additives are checked. However in one out of five establishments visited using food additives, the audit team noted that phosphates were used for meat preparations, which is not in compliance with Annex II of Regulation (EC) No 1333/2008) and this had not been recorded during official control. Conclusions FBO use of food additives in a manner not authorised by Regulation (EC) No 1333/2008 was not always detected/recorded by official controls. 5.4 RAPID ALERT SYSTEM FOR FOOD AND FEED (RASFF) Article 50 of Regulation (EC) No 178/2002. Since 2010 there have been no RASFF notifications concerning poultry meat and products derived therefrom originating from Croatia. 12

5.5 LABORATORIES Articles 11, 12 and 33 of Regulation (EC) No 882/2004. The FVO team visited two official laboratories. The Croatian Veterinary Institute is the National Reference Laboratory (NRL) for Salmonella and for Listeria monocytogenes. The central unit located in Zagreb has five branches which are also designated official laboratories for testing of official samples. The FVO team noted that:- The NRL has been accredited to ISO 17025 by the Croatian Accreditation Agency since 2008. The most recent accreditation was granted in 2013 for a period of five years; The methods used for testing of poultry meat and products derived therefrom are the EU reference methods and are within its scope of accreditation; The laboratory has qualified staff. Documentary evidence was available showing that the staff participate regularly in workshops organised by, among others, the EU Reference Laboratory, e.g. in 2014 representative of the staff participated in a workshop for Listeria monocytogenes; The NRL participated regularly in comparative tests organised by EU reference laboratories and by laboratories located in other MS with satisfactory results; Since 2013 serotyping of bacteria isolates of Salmonella species is within its scope of accreditation. The second laboratory visited is the official laboratory under the Ministry of Health which carries out the analyses of own-check samples for poultry meat and products derived therefrom. This laboratory is also accredited to ISO 17025 and had participated in comparative tests for Salmonella and Listeria monocytogenes with chicken meat as matrix. Conclusions. The official laboratories visited meet the requirements of Article 12 of Regulation (EC) No 882/2004. 6 OVERALL CONCLUSIONS There is a system of official controls on poultry meat and products derived therefrom, which includes regular and risk based controls. There are provisions in place for delegating competence for performing official controls in food establishments to control bodies including provisions intending to avoid cases of conflict of interest. However these provisions are not always effective. Some shortcomings in the implementation of the official control system were noted mainly with respect to post-mortem inspection, to approval procedures of establishments and in relation to the verification of FBO's implementation of provisions of Regulation (EC) No 2073/2005 on microbiological criteria. 13

7 CLOSING MEETING During the closing meeting held in Zagreb on 20/06/2014, the audit team presented the main findings and preliminary conclusions of the audit to the CAs. During this meeting, the CAs provided evidence that, for most of the deficiencies noted by the audit team, corrective actions were in train. The audit team was informed that a summary of the noncompliances noted would be sent to all regions and that a meeting of heads of units from all regional offices to discuss the results of the FVO office was scheduled. A representative from the internal audit department stressed that the current internal audit on control bodies is aimed to harmonise, across the whole country, Croatia s approach to official controls in the sector. 8 RECOMMENDATIONS The CCA should provide Commission services with guarantees and an action plan, including a timetable for its completion, within twenty five working days of receipt of the report, in order to address all the deficiencies identified and in particular the following recommendations: N. Recommendation 1. The CCA should ensure that the testing parameters provided for in the national legislation for minced meat, mechanically separated meat and meat preparation are in line with the EU requirements established in Regulation (EC) No 2073/2005. 2. Where specific tasks related to official controls are delegated to control bodies, the CA should ensure that these control bodies meet all the relevant EU requirements, in particular that they are impartial and free from any conflict of interest (paragraph 2(b) (iii) of Article 5 of Regulation (EC) No 882/2004. 3. The CA should ensure that establishments are only approved for those activities for which they continue to demonstrate compliance with the relevant requirements of food legislation, as required by Article 31(2)(c) of Regulation (EC) No 882/2004. 4. The CA should ensure that EU requirements on post-mortem inspection are respected in particular those described in Part B, Chapter V, section IV, Annex I to Regulation (EC) No 854/2004. 5. The CA should ensure that electrical waterbath stunners are equipped with devices that enable monitoring of the stunning parameters specified in Annex I of Regulation (EC) No 1099/2009. 6. The CA shall ensure that FBOs establishments comply with the requirements laid down in Regulations (EC) Nos 852/2004 and 853/2004 as required by Article 4 of Regulation (EC) No 854/2004, in particular should ensure that the deficiencies found by the audit team are corrected in the establishments visited and are not present in 14

N. Recommendation other approved ones 7. The CCA should ensure that FBOs own-check sampling programmes comply with the requirements of Regulation (EC) No 2073/2005, in particular concerning the sampling plans and microbiological parameters to be tested 8. The CA should ensure that the use of food additives in the production of products derived from poultry meat is carried out in accordance with Regulation (EC) No 1333/2008, in particular concerning their use for the specific category of food established in Part E of Annex II to this Regulation. 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=2014-7153 15

ANNEX 1 - LEGAL REFERENCES Legal Reference Official Journal Title Dir. 98/83/EC OJ L 330, 5.12.1998, p. 32-54 Reg. 178/2002 OJ L 31, 1.2.2002, p. 1-24 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. 853/2004 OJ L 139, 30.4.2004, p. 55, Corrected and re-published in OJ L 226, 25.6.2004, p. 22 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. 882/2004 OJ L 165, 30.4.2004, p. 1, Corrected and re-published in OJ L 191, 28.5.2004, p. 1 Reg. 2073/2005 OJ L 338, 22.12.2005, p. 1-26 Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption 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 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 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 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 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 Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs 16

Legal Reference Official Journal Title Reg. 2074/2005 OJ L 338, 22.12.2005, p. 27-59 Reg. 1333/2008 OJ L 354, 31.12.2008, p. 16-33 Reg. 1099/2009 OJ L 303, 18.11.2009, p. 1-30 Dir. 98/34/EC OJ L 204, 21.7.1998, p. 37-48 Commission Regulation (EC) No 2074/2005 of 5 December 2005 laying down implementing measures for certain products under Regulation (EC) No 853/2004 of the European Parliament and of the Council and for the organisation of official controls under Regulation (EC) No 854/2004 of the European Parliament and of the Council and Regulation (EC) No 882/2004 of the European Parliament and of the Council, derogating from Regulation (EC) No 852/2004 of the European Parliament and of the Council and amending Regulations (EC) No 853/2004 and (EC) No 854/2004 Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives Council Regulation (EC) No 1099/2009 of 24 September 2009 on the protection of animals at the time of killing Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations 17