EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

Transcription

1 Ref. Ares(2015) /03/2015 EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Directorate F - Food and Veterinary Office DG(SANTE) MR FINAL FINAL REPORT OF AN AUDIT CARRIED OUT IN THE RUSSIAN FEDERATION FROM 15 TO 26 SEPTEMBER 2014 IN ORDER TO EVALUATE THE OPERATION OF CONTROLS OVER THE PRODUCTION OF MILK, HEAT-TREATED MILK AND DAIRY PRODUCTS, AS WELL AS CASINGS, DESTINED FOR EXPORT TO THE EUROPEAN UNION

2 Executive Summary The report describes the outcome of an audit carried out by the Food and Veterinary Office (FVO) in the Russian Federation (RF) from 15 to 26 September The objective of the audit was to evaluate the operation of controls that support the guarantees given by the authorities of the RF for export of dairy products and casings to the European Union (EU), taking into account the relevant requirements of EU legislation. Within this context the FVO audit team assessed the measures taken by the Russian authorities to address the recommendations of the FVO audit report DG(SANCO)/ The FVO audit team, in particular, assessed the official controls in place over the production of dairy products and natural casings intended for export to the EU, as well as certification procedures. Significant deficiencies were identified during this audit; the official veterinarians have insufficient knowledge of EU requirements and the production processes in place. The system of supervision is ineffective as it does not guarantee that certification requirements for dairy products and casings intended for export to the EU are met. The Russian authorities cannot guarantee that the approval procedure of establishments to be listed for export of products of animal origin to the EU is in line with the requirements set out in Article 12 of Regulation (EC) No 854/2004. The Russian authorities' responses to recommendations of the audit report DG(SANCO) are not satisfactorily implemented. The report makes a number of recommendations to the Competent Authorities (CAs) aimed at rectifying the shortcomings identified and enhancing the control system in place. I

3 Table of Contents 1 INTRODUCTION OBJECTIVES LEGAL BASIS BACKGROUND FINDINGS AND CONCLUSIONS COMPETENT AUTHORITIES TRAINING OF STAFF IN THE PERFORMANCE OF OFFICIAL CONTROLS ORGANISATION OF OFFICIAL CONTROLS AND DOCUMENTED CONTROL PROCEDURES APPROVAL OF ESTABLISHMENTS OFFICIAL CONTROLS AT DAIRY HOLDINGS OFFICIAL CONTROLS AT ESTABLISHMENT LEVEL HACCP-BASED SYSTEMS WATER TESTING MICROBIOLOGICAL TESTING TRACEABILITY, LABELLING AND IDENTIFICATION MARKING DOCUMENTATION OF OFFICIAL CONTROLS CERTIFICATION OVERALL CONCLUSIONS CLOSING MEETING RECOMMENDATIONS...11 ANNEX 1 - LEGAL REFERENCES...13 II

4 ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT Abbreviation CA(s) CCA(s) CAS DG(SANCO) EC EU FBO FVO HACCP Milk-HTC Previous FVO 2008 audit Previous FVO 2010 audit RF Rospotrebnadzor Rosselkhoznadzor SVS Explanation Competent Authority(ies) Central Competent Authority(ies) Model certificate for natural casings, laid down in Annex IA to Commission Decision 2003/779/EC Health and Consumers Directorate-General European Commission European Union Food Business Operator Food and Veterinary Office Hazard Analysis of Critical Control Points Model certificate for dairy products for human consumption, laid down in Part 2 of Annex II to Regulation (EU) No 605/2010 DG(SANCO) DG(SANCO) the Russian Federation The Federal Service for the Control of Consumer Protection and Human Well-being The Federal Service for Veterinary and Phytosanitary Surveillance State Veterinary Service III

5 1 INTRODUCTION This audit took place in the Russian Federation (RF) from 15 to 26 September The audit was undertaken as part of the Food and Veterinary Office's (FVO) planned audit programme. The audit team comprised two FVO auditors. The audit team was accompanied throughout the audit by representatives of the Federal Service for Veterinary and Phytosanitary Surveillance, the Rosselkhoznadzor which is one of the Central Competent Authorities (CCA) responsible for controls within the scope of this audit. Representaives from the other CCA The Federal Service for the Control of Consumer Protection and Human Well-being (Rospotrebnadzor) did not accompany the audit team. The opening meeting was held on 15 September 2014 with the CCA in Moscow. At this meeting the FVO audit team confirmed the objectives of the audit, and additional information required for the satisfactory completion of the audit was requested. The audit itinerary was discussed but a definitive itinerary was not agreed. 2 OBJECTIVES The objective of the audit was to assess the guarantees given by the authorities of the RF for export of dairy products and casings to the European Union (EU), taking into account the relevant requirements of EU legislation. Within this content the FVO audit team assessed the measures taken by the Russian authorities to address the recommendations of the FVO audit report DG(SANCO)/ (hereafter referred to as the previous FVO 2010 audit). The FVO audit team in particular: assessed the official controls in place over the production of milk and dairy products intended for export to the EU assessed the official controls in place over the production of natural casings intended for export to the EU; and reviewed the system for certification of dairy products and casings in relation to the requirements of Council Directive 96/93/EC as well for consignments of products of animal origin intended for transit through the EU from Russia to Russia (Kalingrad). In pursuit of these objectives, the audit itinerary included the following: Meetings/visits No Comments CCA and regional CAs Opening and closing meeting. Meeting with the CCA regarding procedures on the approval of establishments. Local CAs Meetings with the local CA at the sites visited and one meeting at a local office. Food production/processing/distribution activities Milk production holding 1 Bovine dairy holding. Dairy processing establishments 3 Establishments actively exporting to the EU. Casing processing establishments 2 Establishments actively exporting to the EU. Warehouse for temporary storage 1 Assessment of official controls on export and transit. 1

6 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. A full list of references to EU Legislation referred to in this report is provided in the Annex. Legal acts quoted in this report refer, where applicable, to the latest amended version. 4 BACKGROUND The previous FVO 2010 audit report contains seven recommendations addressed to the CCA. On the basis of a desk evaluation, three recommendations were considered as having been satisfactorily addressed; these related to training, analytical methods for somatic cell count and total bacterial count and to deficiencies at establishment level. The four objectives which were not satisfactorily addressed were related to raw milk quality criteria, the testing procedure for potable water, certification of dairy products and on-farm records of treatment with veterinary medical products. A number of similar recommendations had previously been made following an FVO audit carried out in 2008 in the RF related to the export of dairy product to the EU (reference DG(SANCO)/ ; hereafter referred to as the FVO 2008 audit). The 2008 audit concluded that the actions taken in response to these recommendations had been unsatisfactory. At present 3 out of 15 listed dairy processing establishments export to the EU, exporting ice cream and cheeses. This was the first FVO audit to evaluate the official controls related to export of natural casings to the EU. Both listed casings processing establishments export to the EU. The FVO 2008 and 2010 audit reports are available on the Health and Consumer Directorate General (DG(SANCO)) website at: 5 FINDINGS AND CONCLUSIONS 5.1 COMPETENT AUTHORITIES 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 heath legislation. These controls shall have particular regard to points (a) to (e) and (g) of the aforementioned Article. Findings The CCA Rosselkhoznadzor stated that no major changes took place in the structure of the competent authorities (CA) since the previous FVO 2010 audit. For clarification purposes the following CAs are considered for the scope of this audit: In relation to Sanitary and Phytosanitary measures, the Ministry of Agriculture is responsible for, legislation and for planning, co-ordination and supervision of activities in the veterinary and phytosanitary fields. 2

7 The Rosselkhoznadzor, which is a federal executive Agency under the Ministry of Agriculture with 59 territorial departments, carries out controls and supervision on animal health, food safety and plant health, the use of pesticides and agricultural chemicals, including imports. The Rosselkhoznadzor represents Russian interests in international organisations and collaboration with other countries in the field of animal health protection, safety of raw materials and processed products of animal origin and feed. Within the scope of this audit the responsibility of the Rosselkhoznadzor includes the issuance of certificates for dairy products and casings at the export facilities for transit within the RF and for export to the EU; the issuance of certificates for imported products replacing the original certificate of the exporting country; the issuance of certificates for transit of products of animal origin over EU territory at the external border. The State Veterinary Services (SVS) under the responsibility of the Ministry of Agriculture are responsible for the operational management of official controls within each of the 91 regions. Each SVS has district veterinary offices, responsible for carrying out control activities in the processing establishments and livestock holdings and for issuing domestic veterinary certificates during transport of products and live animals. The Federal Service for the Control of Consumer Protection and Human Well-being (Rospotrebnadzor), under the responsibility of the Ministry of Health with 84 territorial departments, is the federal Agency responsible for control on compliance of products with the Federal standards of quality, including packaging, labelling and relevant information. The CCA informed the FVO audit team that the Rospotrebnadzor is the CA which is, amongst other issues, responsible for the registration of and controls on the use of colourants, additives and flavourings in foodstuffs Training of staff in the performance of official controls Recommendation no. 1 of the FVO 2010 audit report was: to provide appropriate training on the relevant EU requirements as laid out in Regulations (EC) No 852/2004, No 853/2004, No 854/2004 and Council Directive 96/93/EC for the CA involved in official controls of dairy establishments from which imports of the Community are permitted to ensure that they are aware of the legal provisions, as required in points 9.2 and 11.2 of the model health certificate Milk-HTC of Annex II, part 2 of Commission Decision 2004/438/EC 1 In response, the CCA stated: that they planned to instruct the Russian experts on the relevant EU requirements during the fourth quarter of 2010 and 2011; that training has been provided for Food Business Operators (FBO) producing food of animal origin and officials on Hazard Analysis of Critical Control Points (HACCP) principles in the fourth quarter of 2010; and that, for 2011, training for officials was planned in respect of the application of relevant EU legislation, including the certification Directive 96/93/EC. The FVO audit team made the following observations: The FVO 2008 audit report contained a similar recommendation on training. The CCA Rosselkhoznadzor re-confirmed at the opening meeting that the above-mentioned training was provided to the Rosselkhoznadzor officials and was repeated quarterly; and that all participants have sufficient knowledge of the relevant EU requirements. The SVS 1 Commission Decision 2004/438/EC of 29 April 2004 laying down animal and public health and veterinary certifications for introduction in the community of heat-treated milk, milk-based products and raw milk intended for human consumption is repealed by Regulation (EU) No 605/

8 confirmed to the FVO audit team that they had received training on EU requirements in 2013 and The FVO audit team observed that the officials at different CA levels had an insufficient knowledge of relevant EU requirements on official controls related to the production of dairy products and natural casings intended for export to the EU and certification thereof. More details are provided in the sections below. In one establishment visited, using raw materials imported from the EU, the territorial Rosselkhoznadzor, the SVS and the FBO were not aware of the Russian import ban of the products used for the production of ice-cream Organisation of official controls and documented control procedures The CCA Rosselkhoznadzor informed the FVO audit team that in line with the Russian Federal Law 294 inspection visits to establishments and dairy holdings may only take place at a maximum once in three years. The inspection visits must be announced and the FBO has the right to object. The FBO may request the CA to carry out additional inspections based on mutual agreement. The FVO audit team made the following observations: There is no documented procedure for official controls to be carried out in the establishments proposed for, or listed for export of their products, to the EU. Within the scope of the audit a report model for control in dairy establishments producing EU eligible products was recently published on the Rosselkhoznadzor website, but, so far, the CCA has not given instructions for its implementation. No such report model exists for casings processing establishments. Further issues related to availability and/or the implementation of documented procedures as well as assurances regarding compliance with, or equivalence to EU requirements, are described in the relevant sections of the report. Conclusions The training provided to CA control staff has not been effective as their knowledge of EU requirements remains insufficient to ensure that these are met. The CCA has not adequately addressed the previous recommendations from the FVO 2008 and 2010 reports. The official controls and procedures are insufficient to ensure respect of EU requirements. 5.2 APPROVAL OF ESTABLISHMENTS Legal requirements Article 12 of Regulation (EC) No 854/2004. Findings The CCA Rosselkhodznadzor informed the FVO audit team that six dairy establishments, for which the CCA did not provide trade statistics prior to and during this audit, are in the process of being delisted. However, no request to amend the current list of establishments exporting to the EU has been forwarded by the CCA to the FVO. The FVO audit team made the following observations: The CCA Rosselkhodznadzor informed the FVO audit team that there is no procedure 4

9 established for listing of establishments for export of products of animal origin to the EU. The FVO audit team saw applications by the FBOs being sent to different CA levels, including to the Ministry of Agriculture. For some commodities, a variety of reports was seen, which did not always contain sufficient information to conclude compliance of both, facilities and production with the relevant EU requirements. Officials of the territorial Rosselkhodznadzor explained that a variety of approaches are taken in relation to the FBO application process, the organisation of and performance of preapproval inspection visits, the method for granting an approval number and on how requests should be made for amendment of the list of establishments approved for export to the EU. These various approaches were supported by documents provided to the FVO audit team. Examples were seen of establishments, for which the CCA Rosselkhoznadzor had provided guarantees that they met the the relevant EU requirements, where: Conclusion a) the establishments were not yet in operation at the time of the initial approval inspection and where no follow up inspection had been carried out; and b) the initial inspection reports referred to an incorrect scope and the subsequent inspection reports did not identify that the processing was not in line with the certification requirements and/or continued to refer to the incorrect scope; and c) the initial and subsequent inspection reports did not demonstrate that processing procedures and test protocols were in line with relevant EU legislation. The CCA procedures for approval of establishments for export to the EU are not reliable and, as a consequence, the CCA is not in a position to guarantee that all 15 dairy and the 2 casings processing establishments listed for export of products of animal origin to the EU meet relevant EU requirements. 5.3 OFFICIAL CONTROLS AT DAIRY HOLDINGS Legal requirements Points II.1 and II.2 of the model certificate Milk-HTC in part 2 of Annex II to Regulation (EU) No 605/2010 sets out the animal and public health requirements to be met, including those related to the production of raw milk. Findings Recommendation no 6 of the previous FVO 2010 audit report was: to ensure that a register on veterinary treatments on food producing animals, from which milk and milk products are obtained for export to the EU, is kept on the holding, as required by Article 10 of Council Directive 96/23/EC and by Annex I, part A(III), point 8(b) to Regulation (EC) No 852/2004, and that this register includes the withdrawal period. A similar recommendation had been made in the FVO 2008 report. In summary, the CCA responded that all cattle farms keep anti-epizootic treatment logs and that the log includes registration of the withdrawal period. Both the FVO 2008 and 2010 reports made recommendations (nos. 4 and 2 respectively) on ensuring that the raw milk, used for the production of product to be exported to the EU, was in line with the requirement specified in Section IX, Chapter I.III.3 (a) of Annex III to Regulation (EC) No 853/

10 The CCA response to the recommendation of the previous FVO 2010 audit may be summarised as an undertaking to issue instructions to operators and the official services to ensure compliance with the EU raw milk criteria. The FVO audit team made the following observations: At the dairy holding visited, records on veterinary treatments were present, but incomplete regarding the withdrawal period of veterinary medicine products. Where a group of animals had been treated with antibiotics, the identification of the treated animals within the group was not recorded. At this holding, 4 and 48 tuberculosis reactor animals had been detected in 2013 and 2014 respectively. The SVS could not demonstrate that the milk of these animals was excluded from EU production. The 4 reactor animals in 2013 and 11 out of 48 in 2014 had been sent for diagnostic slaughter and tuberculosis was not confirmed. 37 reactor animals remained on the farm. None of the cattle reacted positive to brucellosis testing in the last two years. The SVS confirmed that cattle are vaccinated against foot and mouth disease, strains A, O, C and Asian 1 as well as strain Krasnodar 13 in response to an outbreak which occurred in the District Mostovskoy in Krasnodarskiy Kray on 16 June 2013 (approximately 220 km distance of the dairy holding visited). At the dairy holding visited, only three test results for somatic cell count and total bacterial count were present, even though samples of raw milk are taken three times per month. The three test results seen at the dairy holding did not correspond with the test results provided by the SVS. The laboratory test results for 2012, 2013 and 2014 showed little of the expected seasonal variation for total bacterial count and somatic cell count. The official control report from the on-farm inspection was carried out in 2013 before the production started in the dairy processing establishment. The report describes the situation and availability of documentation rather than reporting on the results of the inspection. The limited time taken to perform the inspection was insuffient for an in-depth verification of all the subjects covered in the report, including the animal identification and registration of more than cattle. The report does not conclude that the raw milk meets the criteria laid down in Regulation (EU) No 605/2010. The report makes reference to compliance reports which were three years old (issued in 2010) at the time of the inspection, one issued by a district laboratory and one by the SVS. Conclusions The CCA has not fully implemented the guarantees given to address the recommendation of the previous FVO 2010 audit report regarding keeping registers of veterinary treatments of food producing animals. The CCA did not demonstrate that the quality criteria for raw milk, used for the production of EU eligible dairy products, meet the relevant EU requirements and, as a consequence have not fulfilled the commitments made in relation to previous FVO recommendations. 5.4 OFFICIAL CONTROLS AT ESTABLISHMENT LEVEL Legal requirements Points II.1 and II.2 of the model certificate Milk-HTC in part 2 of Annex II to Regulation (EU) 6

11 No 605/2010 sets out the animal and public health requirements to be met for heat treated dairy products intended for export to the EU. Point 9 of the model certificate CAS in Annex IA to Commission Decision 2003/779/EC sets out the animal health requirements to be met for natural casings intended for export to the EU. Findings HACCP-based systems The HACCP-based systems were not evaluated in depth during this audit Water testing Recommendation no 4 of the previous FVO 2010 audit report was to adapt the testing procedure for potable water in all EU export establishments to ensure all parameters as required in Annex I to Council Directive 98/83/EC are examined. In summary, the CCA responded that the FBOs shall conduct water analysis for the parameters specified in Annex I and ordered that the CA shall confirm that drinking water used by the FBOs for products intended to be exported to the EU is in line with the requirements of the said Directive. The FVO 2008 audit report contained a similar recommendation on the testing procedure for potable water. The FVO audit team made the following observations: The CA had insufficient knowledge of the EU requirements to evaluate the frequency and the parameters to be tested to ensure the use of potable water and rely on test results provided by the FBO only. In addition, in two establishments where the FVO audit team evaluated the test results, the frequency of testing and the microbiological and physicochemical parameters tested were not in line with relevant EU requirements Microbiological testing The FVO audit team made the following observations: The SVS, in two dairy establishments visited, could not demonstrate that the microbiological criteria for finished dairy products intended for export to the EU, as established in the FBOs control programmes are in line with the relevant EU requirements set out in Regulation (EC) No 2073/2005. The CA rely on test results provided by the FBO only. 7

12 5.4.4 Traceability, labelling and identification marking The FVO audit team made the following observations: None of the establishments visited was producing EU eligible products, none had such products in storage and simulation of EU production did not take place during this audit. Regarding traceability, the SVS and the territorial Rosselkhodznadzor rely mainly on the information provided by the FBO, without in-depth verification and, in a few cases seen, without sufficient knowledge of the process. Traceability of ingredients other than products of animal origin, in particular additives, herbs, start cultures and stabilisers, are not verified during the official controls, or at the moment of certification, by the SVS and the territorial Rosselkhoznadzor. Certificates were issued for dairy products exported to the EU stating that a high temperature-short time pasteurisation was applied twice to the milk with a ph equal to or greater than 7.0 achieving, where applicable, a negative reaction to an alkaline phosphatase test, applied immediately after the heat treatment. FBO records did not contain information on double pasteurisation, on the ph control and also not on test results to alkaline phosphatase. The FBO confirmed that a treatment process, different to that specified in the certificate, is applied. The process was described as a high temperature-short time pasteurisation followed by another physical treatment. However, the records seen did not contain sufficient details to guarantee that the entire process was under control Documentation of official controls The SVS stated that yearly inspection visits have been carried out in the establishments visited. For the reports checked by the FVO audit team, the inspections were carried out in relation to RF standards and EU legislation was taken into account. No non-compliances were identified in any of the establishments visited during official controls in the last three annual visits and also during the above-mentioned yearly inspection. This is at variance with the observations made by the FVO audit team: potential contamination of raw material in production areas (floors with pooled water, old dirt on ceiling, corroded overhead structures with flaking paint and dirty ventilation); potential contamination in production areas (use of dirty crates directly in contact with the products, corroded overhead structure, use of a worn-out conveyor belt and rusty equipment (both in direct contact with the cheeses), dirty ventilation, storage of dirty packaging material); insufficient pest control (flies were present in the production and packing area, accumulation of dirt in a bait station); insufficient personal hygiene with potential contamination of products (FBO staff member with an open wound). No corrective measures were taken regarding the potentially contaminated cheese when the FVO audit team drew attention to this. the production information on the label attached to a barrel used for the storage of herbs did not correspond with the label on the incoming packaging of the herbs. Examples of reports on official controls carried out by the territorial Rosselkhodznadzor and the SVS in listed establishments were seen by the FVO audit team, which: 8

13 were descriptive and refer to the availability of documentation rather than reporting results of inspections carried out. referred to EU legislation which is not applicable to the type of products processed or which is no longer applicable e.g. Commission Decision 2007/777/EC for natural casings, Directive 92/46/EEC 2 for dairy products. did not or insufficiently contain information to conclude that establishments and their production were in line with relevant EU requirements e.g. for natural casings the 30 days salting process was described, but not all casings (fat ends and bladders) were scraped; for dairy products one report did not contain information that all relevant microbiological criteria for the production of dairy products intended for EU export were verified and in line with relevant EU requirements. did not evaluate the establishment in production (one establishment was not in operation when the pre-approval inspection took place. The next visit is planned for November this year. Consequently no official controls were carried out to verify if diary products produced for export to the EU are EU eligible). The territorial Rosselkhoznadzor and the SVS staff confirmed they did not receive reports of official controls carried out by the Rospotrebnadzor. Officials of the Rospotrebnadzor were not represented during the FVO audit. Conclusions The official control system in place is not fully effective and does take sufficiently into account the relevant EU requirements on general and specific hygiene requirements, microbiological criteria and traceability of all ingredients. The CCA Rosselkhodznadzor did not implement the guarantees provided in their response to the recommendations of the previous FVO 2008 and 2010 audit reports regarding the testing procedure for potable water. 5.5 CERTIFICATION Legal requirements Article 5 of Regulation (EU) No 605/2010 requires that consignments of dairy products are accompanied by a health certificate drawn up in accordance with the appropriate model drawn up in Part 2 of Annex II to that Regulation and that the certificate is completed in accordance with the explanatory notes set out in Part I of that Annex. Letter (h) of those explanatory notes requires that the CAs of the exporting third country shall ensure that principles of certification equivalent to those laid down in Directive 96/93/EC are complied with. Article 1 of Decision 2003/779/EC requires that consignments of animal casings are accompanied by a health certificate drawn up in accordance with the appropriate model laid down in Annex IA to 2 Council Directive 92/46/EEC of 16 June 1992 laying down the health rules for the production and placing on the market of raw milk, heat-treated milk and milk-based products is repealed as of by Directive of the European Parliament and of the Council 2004/41/EC. 9

14 that Decision. Derogations from relevant Articles for transit by road or by rail through the EU of consignments coming from and destined to Russia directly or via another third country are laid down in relevant EU legislation; for meat products in Article 6 of Decision 2007/777/EC, for dairy products Article 7 of Regulation (EU) No 605/2010, for table eggs and egg products in Article 18 of Commission Regulation (EC) No 798/2008. Findings Recommendation no 5 of the previous FVO 2010 audit report was: to take urgent action to ensure that certification of dairy products destined for EU exports is carried out according the requirement of Council Directive 96/93/EC and Commission Decision 2004/438/EC. In summary, the CCA responded that the requirements of Regulation (EU) No 605/2010 must be followed and the model certificate Milk-HTC must be signed by a State Veterinary Inspector. In addition a procedure for certification of products intended for export was being drafted. The FVO 2008 audit report contained a similar recommendation on certification. The FVO audit team made the following observations: The above-mentioned procedure for certification of products of animal origin intended for export to the EU is not in place. The requirements laid down in the certificates model Milk-HTC for heat treated dairy products and the model CAS are not guaranteed by the signing officials when certificates are issued. Certificates were issued for products intended for export to the EU even though the production process is not in line with the EU requirements. For example salted casings (fat ends) and bladders are not scraped. The guarantees provided on processing could not be justified by the signing officials for the products exported. For example: in one casings establishment, at the location where casings (fat ends) and bladders were salted, condensation dripped from the ceiling and the overhead structures were corroded and had flaking paint; in a dairy processing establishment, the certification on the heat treatment of milk referred to a different process to that actually used. The signing official was unaware of the actual treatment employed (see section 5.4.4); in the dairy holding supplying the raw milk, there were no records providing evidence that milk of tuberculosis reactor animals was excluded from EU production. The internal veterinary certificates Russian model form 2 issued by the SVS do not contain sufficient information to support all the attestations laid down in the certificates model Milk-HTC and model CAS which are subsequently issued for export. The certificate Russian model form 2 is in principle designed to certify freedom of certain animal diseases in the district where the holding or processing establishment is located. Related to the certification of products of animal origin intended for transit through the EU, at the warehouse visited, the territorial Rosselkhodznadzor had not identified a number of 10

15 Conclusions non-compliances in incoming certificates (Russian model form 2 ) upon which transit certificates were to be issued. The FVO audit team identified non-compliances with the statements made in 10 incoming veterinary certificates: the means of transport had not been sufficiently cleaned (mould around the ventilation equipment and dirt on walls); the actual temperature of one part of the consignment did not correspond with the temperature mentioned in the certificate (Russian model form 2 ). The procedure for certification of products of animal origin intended for export to the EU is not reliable. The CCA Rosselhodznadzor has not implemented the guarantees provided in response to the recommendation of the previous FVO 2010 and the certification of products of animal origin is still not line with the certification procedures set out in Directive 96/93/EC. The requirements laid down in the certificates model Milk-HTC for heat-treated dairy products and the model CAS for casings are not guaranteed by the signing officials when certificates are issued. 6 OVERALL CONCLUSIONS Significant deficiencies were identified during this audit; the official veterinarians have insufficient knowledge of EU requirements and the production processes in place. Their system of supervision is insufficient to guarantee that certification requirements for dairy products and casings intended for export to the EU are met. The CCA cannot guarantee that the approval procedure of establishments to be listed for export of products of animal origin to the EU is in line with the requirements set out in Article 12 of Regulation (EC) No 854/2004. The CCA's responses to the recommendations of the previous FVO 2010 audit report have not been satisfactorily implemented. 7 CLOSING MEETING A closing meeting was held on 26 September 2014 with representatives of the Rosselkhodznadzor. At this meeting the FVO audit team presented the main findings and preliminary conclusions of the mission and advised the CCA of the relevant time limits for the production of the report and their response. The representative of the CCA acknowledged the main findings and preliminary conclusions presented by the FVO audit team. 8 RECOMMENDATIONS An action plan describing the action taken or planned in response to the recommendations of this report and setting out a time table 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 staff in the performance of official controls in the milk production holdings, the dairy processing establishments and the casings processing establishments and staff responsible for certification procedures have sufficient knowledge of the requirements set out in Points II.1 and II.2 of the model certificate 11

16 N. Recommendation Milk-HTC laid down in Part 2 of Annex II to Regulation (EU) 605/2010 and of the requirements set out in Point 9 of the model certificate CAS laid down in Annex IA to Commission Decision 2003/779/EC. 2. To review all listed casings and dairy processing establishments and to ensure that only casings and dairy processing establishments, together with milk production holdings where they source the raw milk, which meet the relevant EU requirements as set out in Article 12 of Regulation (EC) No 854/2004 are listed for EU export. 3. To ensure that the testing procedure for potable water in all EU export establishments includes the parameters required in Annex I to Council Directive 98/83/EC so that such water is in compliance with these requirements. 4. To take measures in order to ensure that the principles of certification equivalent to those laid down in Council Directive 96/93/EC are applied and to review the internal certification system as a basis for issuing the final export certificates. 5. To establish and implement documented control procedures for official controls at casings processing establishments in order to ensure verification of the requirements set out in the certificate model CAS laid down in Annex IA to Commission Decision 2003/779/EC, in particular the requirements for the animal health attestations. It is expected that the control procedures should include official controls during processing of EU eligible products and that these controls should include verification of traceability. 6. To establish and implement documented control procedures for official controls at dairy processing establishments and milk production holdings in order to ensure verification of the requirements set out in the certificate model Milk-HTC laid down in Part 2 of Annex II to Regulation (EU) 605/2010, in particular the requirements for the animal health and public health attestations. It is expected that the control procedures should include official controls during processing of EU eligible products, and that these controls should include verification of traceability. 7. To ensure that a register on veterinary treatments on food producing animals, from which milk and dairy products are obtained for export to the EU, is kept on the holding, as required by Article 10 of Council Directive 96/23/EC and by Annex I, part A(III), point 8(b) to Regulation (EC) No 852/2004, and that this register includes the withdrawal period. The competent authority's response to the recommendations can be found at: 12

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18 ANNEX 1 - LEGAL REFERENCES Legal Reference Official Journal Title Reg. 852/2004 OJ L 139, , p. 1, Corrected and re-published in OJ L 226, , p. 3 Reg. 853/2004 OJ L 139, , p. 55, Corrected and re-published in OJ L 226, , p. 22 Reg. 854/2004 OJ L 139, , p. 206, Corrected and re-published in OJ L 226, , p. 83 Reg. 882/2004 OJ L 165, , p. 1, Corrected and re-published in OJ L 191, , p. 1 Reg. 2073/2005 OJ L 338, , p Reg. 798/2008 OJ L 226, , p Reg. 605/2010 OJ L 175, , p 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 Commission Regulation (EC) No 798/2008 of 8 August 2008 laying down a list of third countries, territories, zones or compartments from which poultry and poultry products may be imported into and transit through the Community and the veterinary certification requirements Commission Regulation (EU) No 605/2010 of 2 July 2010 laying down animal and public health and veterinary certification conditions for the introduction into the European Union of raw milk and dairy products intended for human consumption 14

19 Legal Reference Official Journal Title Dir. 96/23/EC OJ L 125, , p Dir. 96/93/EC OJ L 13, , p Dir. 98/83/EC OJ L 330, , p Dir. 2004/41/EC OJ L 157, , p.33 corrected and republished in OJ L 195, , p. 12 Dec. 2003/779/EC OJ L 285, , p Dec. 2004/438/EC OJ L 154, , p , corrected and re-published in OJ L 92, , p. 47 Dec. 2007/777/EC OJ L 312, , p 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 98/83/EC of 3 November 1998 on the quality of water intended 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 2003/779/EC: Commission Decision of 31 October 2003 laying down animal health requirements and the veterinary certification for the import of animal casings from third countries Commission Decision 2004/438/EC of 29 April 2004 laying down animal and public health and veterinary certifications conditions for introduction in the Community of heat-treated milk, milk-based products and raw milk intended for human consumption 2007/777/EC: Commission Decision of 29 November 2007 laying down the animal and public health conditions and model certificates for imports of certain meat products and treated stomachs, bladders and intestines for human consumption from third countries and repealing Decision 2005/432/EC 15