EUROPEAN COMMISSION HEALTH & CONSUMERS DIRECTORATE-GENERAL Directorate F - Food and Veterinary Office DG(SANCO)/ 2009-8218 - MR - FINAL FINAL REPORT OF A MISSION CARRIED OUT IN BELARUS FROM 20 JANUARY TO 30 JANUARY 2009 IN ORDER TO EVALUATE THE OPERATION OF CONTROLS OVER THE PRODUCTION OF MILK, HEAT TREATED MILK AND MILK BASED PRODUCTS FOR HUMAN CONSUMPTION DESTINED FOR EXPORT TO THE EUROPEAN UNION 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 an endnote.
Executive Summary The objective of the mission was to evaluate the operation of controls over the production of milk, heat treated milk and milk based products for human consumption destined for export to the European Union (EU). The food safety requirements of Belarus are close to those of the EU, in particular in relation to Food Business Operators' (FBOs) responsibility for food safety, requirement for regular official controls and a Hazard Analysis Critical Control Point (HACCP) based system. Three Competent Authorities (CAs) are involved in the control over the production of milk and milk-based products from farm to the final product. The Veterinary Service has the coordinating role at central level. In the field, all three CAs have clearly defined fields of responsibility and perform their tasks on the basis of their own separate legislation. There was little co-operation seen between the services at district and regional levels. No gaps were noted in the official controls of the production chain. The establishments visited were approved by the CA for export of dairy products to the EU., but no imports took place. To date, imports of milk and milk-based products for human consumption from Belarus to the EU are not allowed. The general animal health situation is satisfactory. Belarus is recognised by the World Organisation for Animal Health (OIE) as free from Foot and Mouth Disease (FMD) without vaccination and free from Rinderpest. The CA stated that the country is free from Bovine brucellosis since 1977 and there are only sporadic cases of Bovine tuberculosis. However, testing for Tuberculosis and Brucellosis differs from the requirements of Council Directive 64/432/EEC. All three farms visited have adequate structure and equipment with a few minor shortcomings. Raw milk is regularly tested by the FBO and official samples are taken by the CAs. The supply of milk of EU eligible quality is not controlled by the CA. The percentage of EU eligible milk varied in the establishments visited from 5% to 12%. The establishments were technically prepared for the separate reception and processing of such milk, but no official instructions or complete FBO procedures yet exist for this purpose. Two of the establishments visited were found to be compliant, with only minor deficiencies. In the third one, more substantial deficiencies were found, mostly in relation to structure and maintenance. The FBO has an action plan to be completed in 2009. All three establishments have their own laboratories and comprehensively implemented HACCP plans which have been audited and certified. In case of export each consignment is tested for all relevant national parameters. Some microbiological parameters required by Regulation (EC) No 2073/2005 are different in national standards and therefore not tested for. All CAs performed frequent documented controls, and took official samples. In addition, an Official Veterinarian (OV) is present permanently during production hours. The official controls were in general efficient and effective; however, official controls were carried out on the basis of national legislation and no evidence of checks of the compliance of procedures and products with EU requirements, as required by Article 12 i
2 (a) of Regulation (EC) No 854/2004, could be provided. Each CA has its own network of laboratories. The laboratories visited were well equipped and staffed, keeping good records, using accredited methods and participating in ring tests. The certification system for the exported products is not in conformity with the requirements of Council Directive 96/93/EC, as the certifying officers certify data of which they have no personal knowledge or which cannot be ascertained by them. The CA indicated that the same system would be used for export of milk-based products to the EU. The current system of official controls over the production of milk and milk based products in Belarus intended to be exported to the EU is largely adequate and close to fulfilling the requirements of the relevant EU legislation with regards to public health aspects. The existing deficiencies noted by the mission team may be relatively easily addressed. However, to date, the Central Co-ordinating Authority (CCoA) cannot guarantee all the conditions required in the certificate laid down in Decision 2004/438/EC. In light of the findings and conclusions recommendations have been made to the CA to address the deficiencies identified. ii
TABLE OF CONTENTS 1 INTRODUCTION... 1 2 OBJECTIVES OF THE MISSION... 1 3 LEGAL BASIS FOR THE MISSION... 2 4 BACKGROUND... 2 4.1 Livestock and Production Information... 2 5 MAIN FINDINGS... 2 5.1 Legislation... 2 5.2 Competent Authorities Performance... 4 5.2.1 Organisation of competent authorities... 4 5.2.2 Legal/enforcement powers... 5 5.2.3 Supervision of the competent authorities and control systems... 5 5.2.4 Training of staff... 5 5.2.5 Approval of dairy plants... 6 5.3 Animal Health Controls... 6 5.3.1 Holding registration and animal identification... 7 5.4 Application of Hygiene Rules on Dairy Holdings...7 5.4.1 Dairy holdings... 7 5.4.2 Criteria for raw milk and controls upon collection... 8 5.5 Application of Hygiene Rules on Dairy Establishments... 9 5.5.1 Dairy Plants... 9 5.5.2 Separation of EU eligible raw material and products... 9 5.5.3 Heat Treatment... 10 5.5.4 Water supply... 10 5.5.5 In-house laboratory facilities...11 5.5.6 FBOs' own check procedures... 11 5.6 Official Controls of Dairy Farms and Establishments...12 5.6.1 Official Controls of Dairy Farms... 12 5.6.2 Official Controls of Dairy Establishments... 12 5.7 Official Laboratories... 13 5.7.1 Public health controls... 13 5.8 Official Certification... 14 6 CONCLUSIONS... 15 6.1 Legislation... 15 6.2 Competent Authorities Performance... 15 iii
6.3 Animal Health Controls... 15 6.4 Application of Hygiene Rules on Dairy holdings... 15 6.5 Application of Hygiene Rules on Dairy Establishments... 16 6.6 Official controls...16 6.7 Official Laboratories... 16 6.8 Official Certification... 16 6.9 Overall conclusion... 17 7 CLOSING MEETING... 17 8 RECOMMENDATIONS... 17 iv
ABBREVIATIONS & SPECIAL TERMS USED IN THE REPORT Abbreviation CA CCoA DVO EU FBO FMD FVO Gosstandart GOST HACCP ISO OIE OV PHS PPD SCC TB TPC VS Explanation Competent Authority Central Co-ordinating Authority District Veterinary Office European Union Food Business Operator Foot-and-Mouth Disease Food and Veterinary Officer State Committee of Standardisation, Metrology and Certification Official technical standards used in the Commonwealth of Independent States Hazard Analysis Critical Control Point International Standardisation Organisation World Organisation for Animal Health Official Veterinarian Public health service - State Sanitary Epidemiological Inspectorate Purified Protein Derivates Somatic Cell Count Tuberculosis Total Plate Count Veterinary Service (General Department of Veterinary with State Veterinary and State Food Inspectorates and its regional and district branches) v
1 INTRODUCTION The mission took place in Belarus from 20 to 30 January 2009. The mission team comprised two inspectors from the Food and Veterinary Office (FVO). The mission was undertaken as part of the FVO s planned mission programme, evaluating control systems and operational standards in the dairy sector. The team was accompanied throughout the mission by representatives of the CA. An opening meeting was held on 20 January 2009 with the CCoA, the Veterinary Service. At this meeting, the objectives of, and the itinerary for, the mission were confirmed by the inspection team and the action undertaken to develop exports from dairy sector in Belarus, including the control systems, were described by the CCoA. 2 OBJECTIVES OF THE MISSION The objective of the mission was to evaluate the implementation of official animal and public health controls over the production and processing of dairy products destined for export to the EU, in the framework of Regulation (EC) No 852/2004, No 853/2004, No 854/2004, No 882/2004 and Commission Decision 2004/438/EC. Competent authorities Comments Competent authorities (veterinary, public health and Gosstandart) Central 3 Minsk Regional 2 Brest region Districts 4 In district offices, laboratories, farms and establishments visited Laboratories Public Health laboratories 4 2 Regional Public Health Laboratories In house laboratories 3 In the establishments visited Food producing establishments Dairy holdings 3 Milk processing plants 3 1
3 LEGAL BASIS FOR THE MISSION The mission was carried out under the general provisions of Community legislation and, in particular Article 46 of Regulation (EC) No 882/2004. A full list of the legal instruments referred to in this report is provided in Annex 1. Legal acts quoted in this report refer, where applicable, to the last amended version. 4 BACKGROUND The current mission was the second food safety mission to Belarus, carried out by the FVO. The previous one took place in 2003 for the assessment of the conditions of production of fishery products. The report of that mission can be found on the DG SANCO web-site: http://ec.europa.eu/food/fvo/index_en.htm. Currently, imports of milk and milk based products for human consumption from Belarus to the EU are not allowed. Commission Decision 2004/438/EC establishes animal and public health conditions and certificate model to be used for import of mild and milkbased products from Belarus to the EU, but there is no list of establishments in Belarus, drawn up in accordance with Article 12 of Regulation (EC) No 854/2004, from which imports of milk and milk-based products are permitted. 4.1 LIVESTOCK AND PRODUCTION INFORMATION According to data provided by the CCoA, the bovine population in Belarus by the end of 2008 was 3 843 900, including 1 225 000 cows on large state or co-operative farms and 226 000 cows kept by individual farmers on small farms. In large farms, Belarus produced 5.1 million tonnes of milk in 2008 and the average yield per cow was 4 456 kg, of which 4 395 500 tonnes was placed on the market. The share of milk of EU-eligible quality (see section 5.4.2) was 88 000 tonnes or 2 %. Belarus is a large exporter of milk and milk-based products, mostly to the Russian Federation and the Commonwealth of Independent States. By October 2008, forty eight Byelorussian dairy establishments were approved for export to the Russian Federation. 5 MAIN FINDINGS 5.1 LEGISLATION The following main pieces of legislation are relevant for the scope of the current mission: Law of the Republic of Belarus of 2 December 1994 No 3423-XII on Veterinary 2
activity as amended by Law of 07071998 No 177-3 (hereinafter referred to as the Veterinary Law), Law of the Republic of Belarus of 23 November 1993, No 2583-XII on the Epidemiological Safety of the Population (hereinafter referred to as the Public Health Law), Law of the Republic of Belarus of 29 June 2003, no 217-# on Quality and safety of raw materials and food products for human life and health (hereinafter referred to as the Food Safety Law), Law of the Republic of Belarus of 5 January 2004 no 262-3 on the Technical norms and standardisation (hereinafter referred to as the Standardisation Law), Law of the Republic of Belarus of 5 January 1998 No 122-3 on the Radiological Safety of the Population, as amended by Law of 21.12.2005 No. 72-3, Veterinary public health rules for dairy farms supplying milk for production of 17.03.2005 No 16, Veterinary rules for the State veterinary supervision of the respect of the veterinary public health rules and standards at production, transformation, storage transport and placing on the market of products of animal origin in the Republic of Belarus of 12 October 2005 no 59 (hereinafter referred to as Veterinary Supervision Rules), Production of milk and milk-based products (Public health rules and standards SanPiN 2.3.4.13-19-2002), Hygiene requirements for the quality and safety of food raw materials and food products (Public health rules and standards SanPiN 11 63 RB 98), Decision of the Ministry of Agriculture and Food of the Republic of Belarus of 4 February 2004, No 7 about rules for the issuing of veterinary documents for commodities under state veterinary control as last amended by 07.02.2008, No 6, Decision of 28 December 2008 of the Minister of Agriculture and Food in agreement with the Minister of Health Protection and the President of the State Committee of Standardisation about the CCoA. The national legislation contains, in particular, the principle that the FBO is responsible for food quality and safety. It requests that the FBO should have an own control programme based on the HACCP principles, audited and certified by the CA. It also lays down the powers of the CA, the request of coordination between the CA, the principle of risk-based inspections, the procedure of carrying out inspections, including sampling frequency. It lays down technical parameters and standards for structures, raw materials and products. In addition, there is a number of instructions and technical standards which are relevant for the scope of the mission. The mission team noted that there were no administrative notices or legislation in place requiring compliance, in establishments approved for export of products, procedures and establishments with the standards of the importing country. 3
5.2 COMPETENT AUTHORITIES PERFORMANCE 5.2.1 Organisation of competent authorities Three CAs are involved in controls over the production of milk, heat treated milk and milk based products: 1. The Veterinary Department with State Veterinary and State Food Inspectorates (hereinafter referred to as the Veterinary Service - VS) of the Ministry of Agriculture and Food, 2. The State Sanitary Epidemiological Inspectorate (hereinafter referred to as the Public Health Service - PHS) of the Ministry of Health Protection, 3. The State Committee of Standardisation, Metrology and Certification (hereinafter referred to as the Gosstandart), under the Council of Ministers of the Republic of Belarus. Observations: According to the agreement of 28 December 2008 signed by the Minister of Agriculture and Food, the Ministry of Health Protection and the President of the Gosstandart, the VS is in charge of general coordination of control in the field of official controls food of animal origin, including their export, as CCoA. The VS is in charge of animal health of dairy livestock, approval of the establishments for export, hygiene supervision of the production in the establishments, certification of the food stuff intended for export, and the implementation of the National Residue Plan. The PHS is in charge of approval and supervision of food establishments, supervision of dairy farms (including official control of the quality of raw milk, hygiene of primary production), final product and potable water. The Gosstandart is in charge of metrology (calibration of equipment), official control of quality management control systems (HACCP, International Standardisation Organisation (ISO), in-house laboratories) but also controls of the final products. All three CAs have central and territorial services: Regional and District divisions for VS and PHS, and fifteen regional centres for the Gosstandart. All three CAs work independently on the basis of their own legislation and control plans. Little co-ordination was in the districts visited. In principle, one joint inspection per year with the participation of the VS and PHS took place in the establishments visited. In addition, all three CAs participated in the joint inspections for the approval of two of the establishments for export to the Russian Federation. 4
The Gosstandart and PHS are also involved in the process of official certification and registration of foodstuffs, equipment and materials coming into contact with the food. For each consignment arriving at an establishment, a certificate of origin is provided by the FBO, with a link to the official certification and registration documents. 5.2.2 Legal/enforcement powers According to the Public Health Law, the PHS have the right to enter the food business at any time and without warning, to take samples, to stop the production, out-loading, transport and placing on the market of a product which may present a potential risk for consumers, to impose administrative sanctions and to bring a case to Court. Similar powers exist for the VS (Article 10 of the Veterinary Law) and the Gosstandart (Articles 13 and 21 of the Standardisation Law). 5.2.3 Supervision of the competent authorities and control systems No system of audit of CAs exist. A flow of information from the District Veterinary Offices (DVOs) to the Regional Veterinary Offices, based on monthly reports of different activities was demonstrated. However, records of official controls seen by the mission team did not indicate that such information would be used for supervisory activities. 5.2.4 Training of staff All three CAs have their own systems for postgraduate education with their own training centres and yearly training programmes. Documentation provided to the mission team indicated, that every year, an extensive number of courses is organised. As an example, the PHS organised some forty one - two week courses in 2008, and a similar number is planned for 2009. Some of them are relevant for the scope of official food control as safety management systems in food, HACCP in particular, auditing techniques, general food production quality in the EU. Among numerous training courses organised by the VS, there are three two-week courses in HACCP/ISO for OVs in the meat sector, but no course is foreseen for the milk sector. Moreover, no specific training directly related to the specific scope of the current mission, on the EU requirements for the export of milk and milk based products to the EU at different levels of the production chain, was provided to officials of the CAs concerned. For the staff of food businesses, including farms supplying raw milk to them, there is a compulsory training system provided by the PHS, on essential hygienic rules in a food business. This training is provided to each member of staff on commencement of employment, and repeated every one to three years, depending on how closely the staff concerned is working with food. 5
5.2.5 Approval of dairy plants All food businesses in Belarus are approved by the PHS on the basis of national legislation. The VS has the power to approve and withdraw approval for export. The dairy establishments visited by the mission team have been approved for export to the EU in 2004 on the basis of national legislation. According to information received from the CCoA and the FBOs, no export of dairy products for human consumption from Belarus to the EU took place since the approval date. According to the CCoA, the establishments approved for export have to comply with the requirements of the exporting country, but no legal basis nor written procedure could be provided. In the establishments visited, the mission team saw evidence of inspections carried out to confirm compliance with the requirements of the Russian Federation, but no similar procedures existed for the EU requirements. 5.3 ANIMAL HEALTH CONTROLS According to the OIE Belarus is recognised as free from FMD without practising vaccination and from Rinderpest. The CCoA stated that the epidemiological situation in cattle concerning other diseases relevant for certification of milk and milk-based products intended for export to EU is satisfactory: outbreaks of Brucella melitensis and Brucella abortus were never detected, and the last positive Bovine brucellosis case was notified in 1977. According to the Veterinary Law, all abortions and stillborns must be notified and samples taken in order to rule out suspicions of brucellosis, listeriosis and leptospirosis. Free status of holdings is certified monthly by the OV, and a copy of such a certificate must be sent to the milk processing establishment. Observations: In relation to TB, all animals over 1 year must be tested twice a year; however, an amendment was made to the national legislation on 13 January 2009, requesting testing of all bovines over six weeks old. Some differences with the testing method as described in Annex # of Directive 64/432/EEC were noted: skin measurements was made only at the time of test reading (comparing skin thickness at the injection site with that in another site of the neck), bovine tuberculin (PPD - Purified Protein Derivates) injected by jet injection, not a TB syringe and definition of the cut-off value as more than 3 mm of thickness difference. At the dairy holdings visited, PPD with a strength of 50 000 ± 10 000 IU, was used, leading to a single dose (0.2 ml ) strength of 10 000 ± 2 000 IU A bovine animal reacting to the tuberculin skin test is considered to be infected only if positive skin reaction is confirmed at the post-mortem examination carried out at the slaughterhouse by a team of inspectors and/or by microbiological examination and biological test on guinea pigs. Slaughter of reactors (prior to their isolation at holding level) is compulsory, and animals must be accompanied by the movement 6
document mentioning their status. Compensation is paid only in case of stamping out of the whole herd. TB reactors were detected in two out of three holdings visited (0.4% on average), but none was confirmed by post-mortem examination or laboratory tests. Free status of the farm was not suspended or withdrawn pending the results of all tests following sanitary slaughter. No simultaneous comparative test (bovine and avian tuberculin PPD) is foreseen, except in the case where more than ten reactors are detected in the same herd. In relation to bovine brucellosis, milking cows and pregnant heifers are tested serologically once every three years; an amendment was made to the national legislation on 13 January 2009 requesting testing of all female animals of age over 24 months. Documented evidence was collected by the mission team on notification and sampling in case of abortions and stillborn; however, not all cases were sampled as material from the foetus or placenta was not always available. In this case, only blood from the mother was sampled. 5.3.1 Holding registration and animal identification A national register is kept, for reproduction livestock only, by the State Animal Reproduction Authority; information on animals must be sent by keepers to the DVO and the local branches of the State Animal Reproduction Authority. Commercial farms are registered at DVO level. Small holdings (backyard farms) are registered at local executive committees. Bovine animals must be identified by double official yellow ear tags within 24 hours of birth. When moved, animals must be accompanied by a movement document signed by the OV. Observations: Animals on the farms visited were identified with the official ear tags, but almost 50% had only one tag; however, they also had a neck collar with microchip so that a link could be established with the official tag. 5.4 APPLICATION OF HYGIENE RULES ON DAIRY HOLDINGS 5.4.1 Dairy holdings Three dairy holdings supplying milk of EU quality to the dairy establishments proposed by CCoA for listing as foreseen by Art. 12 of Regulation (EC) 854/2004 have been visited by the mission team. Observations: All holdings visited have adequate structure and equipment, with some maintenance 7
deficiencies in one of them (some wall and floor damages in the milking room, water dripping from the window in the roof). The FBO was requested by the CA to carry out refurbishment, and committed to it, but have not addressed the deficiency in a satisfactory way (see section 5.6.1) Adequate records were kept with regard to medical treatments administered to animals; treated animals were milked separately, and their milk was stored in a separate tank before its disposal for feeding calves. Milk temperature records and written procedures for cleaning and disinfection of refrigerated tanks for storage of milk were present on all holdings visited. 5.4.2 Criteria for raw milk and controls upon collection Currently, according to the national standard STB 1598-2006, there are four milk quality categories ("extra", "higher", "first" and "second"): only one, "extra", fulfils the EU requirements concerning Somatic Cell Count (SCC) and Total Plate Count (TPC), hereinafter called milk of EU-eligible quality. The percentage of such milk in the establishments visited varied from 5% to 12%. At least every ten days raw milk is tested from each supplier at arrival in the plant by the FBO for parameters relevant for export (TPC, SCC and inhibitors). Moreover, SCC were tested for each consignment in two out of three holdings visited at dairy holding level. The FBO tests every consignment for antibiotics using quantitative rapid tests and for physical-chemical parameters prior to out-loading. Official samples are taken twice a year by the PHS at dairy holding level. Observations: TPC control was performed counting the units forming colonies in Petri dishes, while a rapid method was used to establish the SCC and rapid tests were also performed to detect residues of antibiotics. In one dairy establishment, automatic equipment for SCC and TPC had recently been purchased, and was currently tested. No procedures for the calculation of rolling geometrical average were used. Non-compliant raw milk (exceeding national standards for the acceptable level of antibiotics, SCC, acidity or density) is sent back to the holding of origin for disposal, which needs to be confirmed in writing by the farm to the FBO; however, the written procedure has been implemented very recently and, in one case, written confirmation to the FBO could not be provided. In all establishments visited, when residues of antibiotics were detected in the raw milk, the FBO informed the OV in the establishment by phone. In one establishment, evidence of written notification was provided. Also this procedure has been introduced very recently. No evidence was found of written communication on feedback of investigations carried out by the Veterinary Services in the holdings concerned. In one milk processing establishment visited raw milk of "extra" quality originating from one holding, together with another three farms which were close to reaching the EU requirements for their milk, was tested every day for TPC and SCC. 8
Dairy holdings are not informed about the results of tests (TPC, SCC) carried out on raw milk by the FBO of the processing establishment. 5.5 APPLICATION OF HYGIENE RULES ON DAIRY ESTABLISHMENTS 5.5.1 Dairy Plants Three dairy establishments, proposed for listing were visited. They intend to export to the EU fermented milk-based products, tvorog - a cottage cheese-like product, butter, semi hard cheese, whey powder and ice cream. Observations Two of these plants were found to be in line with EC requirements from the point of view of structure, lay-out, maintenance, equipment, cleanliness and FBO own checks system, including HACCP, with only minor deficiencies noted. In particular, in the ice cream establishment, in two out of three cold stores for the storage of final product, there was leakage from the cold units, with ice build up on the cartons stored. In the third establishment a new automatic cheese production line was put in place and this cheese production facility was in line with EC requirements. However, in other departments substantial deficiencies, mostly related to structure and maintenance were found: The salting room and other departments are difficult to maintain. In storage, drying and maintenance rooms cheese is kept on racks with flaking paint and rust. Some walls are not easy to clean, the air blowers are ancient models and are not easy to keep clean and not clean. Some equipment (in particular packing unit of the whey powder factory and in the butter factory) is used a lot, rust painted over, with cables and wires acting as dust trap, flaking paint, etc. In the cold store all of the ceiling consists of exposed insulation. In almost all of the storage and packaging rooms of the cheese factory, there are traces of leakage in the ceiling, and staff confirmed to the mission team, that the roof is in poor condition and leaks every time it rains. The FBO, in reply to the CA's request, has prepared an action plan, to be addressed during 2009. However, the problem with the leaking roof was not formally identified or included in the action plan. The ceiling is whitewashed every six months, but flakes off again after the next rain. Observations 5.5.2 Separation of EU eligible raw material and products 9
Two of the establishments visited process raw milk. The percentage of EU compliant milk varied from 5 to 12% in each of them. Both establishments were technically prepared for the separate reception and processing of such milk and had physically separated reception and storage areas. Processing could be separated on time. Traceability exercises carried out in both establishments were satisfactory. In one establishment, a detailed working instruction for the separate reception and storage of EU-compliant milk, developed by the FBO, was provided to the mission team. This instruction, however, did not cover the production and storage of final products intended for export to the EU. The other two establishments did not have any instruction or procedure for separation of EU eligible raw material and products. The third establishment visited, producing ice cream, used milk powder and butter of national origin as main ingredients as their origin is from non EU-approved establishments. These raw materials are not EU eligible. The VS confirmed that to date imported milk based raw materials are not used in Belarus. Observations 5.5.3 Heat Treatment The FBOs in the establishments visited declared, that they would be technically able to comply with the requirements of double pasteurisation or other relevant treatment (sterilisation, UHT treatment) as requested by Decision 2004/438/EC for countries listed in Column C (countries, where there is the threat of FMD). This treatment is currently not applied as no export to the EU takes place. Moreover, neither an official nor an FBO instruction for this procedure exists. Control of pasteurisation is set up as ### in all establishments. Temperature, time and the return valve are monitored. Efficiency of pasteurisation is controlled microbiologically at least once every ten days. The phosphatase test is routinely performed after pasteurisation of each batch. 5.5.4 Water supply Water is examined by the FBO and by the PHS according to national legislation (SanPiN 10-124 RB 99 and STB 1188-99), which requires somewhat different parameters than those in Annex I to Council Directive 98/83/EC. In particular, total coliforms, thermotolerant coliforms, and total bacterial count are checked but not specifically Enterococci. Observations In the establishments visited, the water used was municipal, or own (artesian well) or both. In all establishments, comprehensive sampling plans and water distribution plans were available. The frequency of sampling was extensive. In one establishment, fourteen identified sampling points were tested every month for microbiological parameters. Monthly 10
testing of all sampling points was also noted in two other establishments. The PHS takes three samples of cold, hot and icy water for official examination once a year. 5.5.5 In-house laboratory facilities In-house laboratories of the FBOs perform analyses on raw milk and some other ingredients, final products and controls on the hygiene process. Observations: The in-house laboratories of the establishments visited were properly equipped and staffed, used accredited methods and kept adequate records. They were not allowed to carry out certain analyses (for example, radionuclides and pathogens such as Salmonella and Listeria), and had contracts with external accredited laboratories for the performance of such analyses. They also controlled efficiency of the pasteurisation process by means of evaluation of the TPC, presence of coliforms, and alkaline phosphatase and peroxidase tests. The laboratories visited participated in the proficiency test organised by Gosstandart on SCC detection methods in June 2006. Observations: 5.5.6 FBOs' own check procedures All three establishments had implemented procedures based on the HACCP principles and a comprehensive system of own checks. In particular, control of pasteurisation parameters was found to be satisfactory. The HACCP-principles based procedures were audited and certified every five years by the Gosstandart. All three establishments visited had in-house laboratories (see section 5.5.5) in which final products are also regularly tested. In case of export each consignment is tested for all relevant microbiological and physico-biological parameters including efficiency of heat treatment. In particular, total mesophiles and coliforms are tested but not Enterobacteriaceae, which is required by Council Regulation (EC) No 2073/2005. The mission team noted that the FBO checked the final products for parameters laid down in the legislation of the country they currently export to. No similar checks for the compliance with EU legislation were performed. A small in-house laboratory was present on the farms, allowing evaluation, amongst other parameters, of SCC and, in one case, of the presence of residues of antibiotics by means of rapid tests. The records kept by these laboratories were in principle adequate. However, in one case, the records in the journal for milk examination showed abnormal uniformity as it indicated exactly the same figures for milk temperature and SCC for several consignments. The FBO did not provide any explanation for this uniformity. 11
5.6 OFFICIAL CONTROLS OF DAIRY FARMS AND ESTABLISHMENTS 5.6.1 Official Controls of Dairy Farms All three CAs carry out official controls at dairy holdings. The VS is in charge of monthly certification of animal health situation, and of quarterly routine supervision according to the checklist annexed to the Veterinary Supervision Rules, which lists the veterinary requirements for the food businesses. The PHS is in charge of controls on raw milk, potable water, supervision of the FBO's own checks control plan (which needs to be agreed by the head of the PH district office), hygiene of structures and equipment (including pest control programme) and medical checks on staff. It is also in charge of sampling along the entire production chain from raw milk to final product. Staff at the Metrology Section of Gosstandart is in charge of yearly calibration and supervision of chilling equipment. Following inspections, a copy of the inspection report is delivered to the FBO and, when deficiencies were noted, a request for corrective action is issued, indicating deadlines and requesting a confirmation by the FBO; finally, a follow up inspection is carried out by the relevant CA. Observations: In the three holdings visited inspection reports by the CAs and action plans presented by the FBO were available. Official controls were in principle efficient and effective; however, in two cases, poor enforcement of the request for corrective action was noted by the mission team. At one farm, the request for the refurbishment of milking room was not addressed adequately, but accepted by the CA as done. In another, the request for separation of animals with clinical signs of diarrhoea was systematically not respected, as the same remarks were repeated in three consecutive reports from April to November 2008. There were no official control nor instruction and procedure in place in order to ensure separation of EU-eligible milk intended as raw material for the export approved dairy establishments. This control was only performed by the FBO (separate collection, storage, laboratory control and transport). 5.6.2 Official Controls of Dairy Establishments The same services as indicated for dairy farms are involved in the dairy establishments and the same relevant rules apply. The frequency of official controls is risk based for both the PHS and the VS. However, for the PHS, at least one visit per year to each food business is compulsory. For VS, the frequency is based on the category of establishment, calculated from one to four on the base of the score received at the last inspection, with category one being the best and requiring at least one visit per year. Also for the Gosstandart, the minimum of official controls is once a year. Observations 12
All the establishments visited were classified as category one. In all of them, the frequency of official controls was much higher that the minimum indicated above. For example, in one establishment, there were four visits by the VS, and five visits by the PHS in 2008. After inspections, the reports were drawn up. When deficiencies were identified, the CA issued a request for corrective action, with deadlines. The FBO was requested to reply in writing. The efficiency of corrective action was checked at the next regular inspection or a special follow-up inspection was performed. In addition, in all establishments visited, an OV was permanently present during the production hours. His/her main task is to control incoming raw materials, general hygiene requirements and to issue veterinary certificates including pre-certificates for export. The OV did not participate in the inspections carried out by the VS and had no power to apply sanctions. In case of any deficiency the OV had to contact the DVO. No documentation of his supervisory activity was kept. Joint inspections with the participation of all three services are performed in particular situations. The mission team saw reports of such inspections for the confirmation of approval for export to the Russian Federation. The official controls were in principle effective and efficient: the CAs identified most of the relevant issues, documented their findings and enforced the corrective action. However, some deficiencies, noted by the mission team, were not identified by the CAs. In particular, in one establishment, both services noted, in their separate and very detailed reports, a number of maintenance and structural deficiencies. However, each of them noted different deficiencies, none of them provided the full picture and none noted one of the most relevant deficiencies: the leaking roof. There was no evidence of any exchange of information between the CAs concerned. The refurbishment the CAs requested was superficial and did not address the real issue. In addition, the FBO did not address all the deficiencies in a satisfactory way or did not address some of them at all. This was not identified by the CAs concerned. No official procedures or instructions exist for the official control of eligibility of incoming raw material with the EU requirements, and its separate reception, storage, processing and storage of final products. Concerning final product, the CA stated that the products must comply with the requirements of the importing country, but no official procedures to control this fact could be provided. 5.7 OFFICIAL LABORATORIES 5.7.1 Public health controls Each of the three CAs has its own central laboratory and a network of regional branches. The VS also have a network of laboratories ("Diagnostic departments") at district level, performing diagnostic tests in the field of animal health; in addition, in the framework of 13
the National Residues Control Plan, 307 samples are taken nationwide from raw milk at processing establishments to be analysed at the Central Veterinary Laboratory. PHS has to agree with the programme of testing of the in-house laboratories of the processing establishments; they are also in charge of official sampling along the full chain, from the raw milk up to the final products. Gosstandart is in charge of yearly calibration of equipment of both official (including its own) and in-house laboratories; its staff also carries out sampling of final products in order to verify their compliance with the national standards. Observations: The two laboratories visited - Gosstandart and PHS - are well equipped and staffed, keeping adequate records and using methods accredited by the national Accreditation Authority (based on the GOST standards, as well as on national or ISO/EN standards). Official samples are taken on a regular basis by the PHS and Gosstandart for analyses of radionuclides (Ce 137 and Sr 90). The raw milk and final products were regularly tested for radioactivity, with low level of radioactivity detected. Final products were tested against national standards and standards of the importing country (Russian Federation). In all laboratories visited evidence of testing against most of the standards of Regulation (EC) No 2073/2005 was provided, except for enterobacteriaceae. Proficiency tests were regularly organised by Gosstandart on the basis of an annual plan: SCC detection methods were tested in June 2006 with twenty accredited laboratories (including the in-house laboratories of two establishments visited), detection of radionuclides (Ce 137) in 2007 and safety parameters of milk in 2008. In 2007 a test was also organised to confirm competence of PHS laboratories in analyses of aluminium in drinking water. A series of seven different proficiency tests (heavy metals, TPC and coliform bacteria, antibiotics including chloramphenicol, chloro-organic pesticides, etc.) organised by the central laboratory of the PHS were carried out in 2007 and are also planned for 2009 for different commodities, including milk powder. 5.8 OFFICIAL CERTIFICATION The team examined the certification system for products exported. The OV in the exporting establishment issues a pre-certification document which accompanies the consignment to the border inspection point, where another OV issues the final export certificate. The mission team was informed by the CCoA that the same procedure would be used for milk and milk-based products to be exported to the EU. Observations: The pre-certificate states the origin of the certified products from holdings and areas which are not under restrictions for animal health reasons. The requirements of the importing country may also be introduced in the pre-certificate, but this was not the case in the example seen by the mission team. Moreover, the section "origin of 14
products (holding or area)" was not filled in. The mission team understood, that the OV at the border inspection point, issuing the final certificate on the basis of the pre-certificate seen, has to certify data not present on the pre-certificate. 6 CONCLUSIONS 6.1 LEGISLATION The Byelorussian legislation relevant for the scope of the mission ensures a level of food safety which is similar to that required by the relevant EU legislation. However, several aspects related to listing of establishments for export to the EU, certification procedures, granting of official TB status of herds, TB testing procedures, Brucellosis testing regime, raw milk criteria, water and final product testing differ from the EU legislation. 6.2 COMPETENT AUTHORITIES PERFORMANCE Three CAs are involved in the chain of controls over the production of milk and milk-based products, with the Veterinary Service as CCoA at central level. All three CAs have extensive powers and resources and many experienced and motivated staff, well positioned to enforce legislation. There was little cooperation seen in the field but no gaps in the control chain were noted. Approval of establishments for export to the EU is carried out on the basis of national legislation and is not in line with the procedure laid down in Article 12 of Regulation (EC) No 854/2004 as EU requirements, in particular those of Regulations (EC) No 853/2004, 2073/2005 and Council Directive 64/432/EEC are not used as a basis for approval. Despite extensive training programmes run by all three CAs, the officials involved in the supervision of milk sector have not received specific training related to the EU requirements for the control over the production of milk and milk-based products intended for export. 6.3 ANIMAL HEALTH CONTROLS The general animal health situation is satisfactory. The country is recognised by the OIE as free from FMD and Rinderpest. The testing regime for brucellosis, granting of officially TB free status of herds and performance of the TB testing differs from the requirements laid down in Annexes A and # to Directive 64/432/EEC. 6.4 APPLICATION OF HYGIENE RULES ON DAIRY HOLDINGS 15
Application of hygiene rules on dairy holdings was in line with the EC requirements and hygienic conditions laid down in Chapter II and Annex I to Regulation (EC) No 852/2004 and in Annex III, Section IX, Chapter I of Regulation (EC) No 853/2004. Structures, equipment, staffing and procedures were adequate, with relatively few shortcomings. 6.5 APPLICATION OF HYGIENE RULES ON DAIRY ESTABLISHMENTS Application of hygiene rules on dairy establishments was in line with EC requirements and hygienic conditions laid down in Chapter II and Annex II to Regulation (EC) No 852/2004 and in Annex III, Section IX, Chapter II of Regulation (EC) No 853/2004 in two establishments visited. Structures, equipment, staffing and procedures, were adequate, with relatively few shortcomings. In the third establishment, more substantial deficiencies related to structure and maintenance were noted. All three establishments had implemented HACCP based programmes, adequate own check systems and efficient in-house laboratories. The supply of raw milk of EU eligible quality was limited and other milk-based raw materials were not of EU eligible quality. All FBOs visited had the possibility to process EU eligible milk separately and to apply heat treatment as required by Decision 2004/438/EC. However, no written procedures for this purpose have yet been developed. Some parameters required by Regulation (EC) No 2073/2005 for testing of final product were not applied. 6.6 OFFICIAL CONTROLS The official controls by all three CAs involved were in principle efficient and effective, with frequent documented checks, official sampling and follow- up procedures. However, in some cases, the CAs did not identify all the deficiencies noted by the mission team. Moreover, the follow-up action was not always effective. Supervision was based on the national legislation and no evidence of official control of the compliance of procedures, raw materials and products with the EU requirements could be provided, as required by Article 12 of Regulation (EC) No 854/2004. 6.7 OFFICIAL LABORATORIES The official laboratories were adequately staffed and equipped, using accredited methods, keeping adequate documentation and participating in proficiency tests with satisfactory results. No evidence of testing against EU standards was provided. 6.8 OFFICIAL CERTIFICATION The system of official certification for export does not fulfil the requirements of Article 3.2 of Directive 96/93/EC, as the certifying officers certify data of which they have no personal knowledge or which cannot be ascertained by them. 16
6.9 OVERALL CONCLUSION The current system of official controls over the production of milk and milk based products in Belarus is largely adequate and close to fulfilling the requirements of the relevant EU legislation with regards to public health aspects. The existing deficiencies noted by the mission team may be relatively easily addressed. However, to date, the CCA cannot guarantee all the conditions required in the certificate laid down in Decision 2004/438/EC. 7 CLOSING MEETING A final meeting was held on 30 January 2009 with representatives of the CCoA. At this meeting, the mission team presented the main findings and preliminary conclusions of the mission. The CCoA informed the team of a number of measures which will be taken in response to the issues identified during the mission. 8 RECOMMENDATIONS An action plan describing the action taken or planned in response to the recommendations of this report and setting out a timetable, and a description of action taken to correct the deficiencies found should be presented to the Commission within 25 working days of receipt of the report. No. 1 2 3 4 Recommendation To review approval of dairy establishment for export to the EU in the light of the requirements of Article 12.2 (a) of Regulation (EC) No 854/2004, in order to ensure standards that are at least equivalent to, or comply with, the relevant EU requirements. To ensure that officials involved in the supervision of the milk sector have adequate knowledge of EU requirements for the control over the production of milk and milk-based products intended for export in order to be able to fulfil the conditions requested in the certificate HTC laid down in Annex II, part 2 of Commission Decision 2004/438/EC are met. To bring the granting of officially TB free status of herds, TB testing procedures and the testing regime for brucellosis on holdings supplying milk for EU export in line with the requirements of Annexes A and B to Council Directive 64/432/EEC, in order to ensure that the provisions of point 9.1 c of the certificate HTC laid down in Annex II, part 2 of Commission Decision 2004/438/EC are met. To correct the deficiencies found by the mission team in the establishments visited, and to ensure that deficiencies are corrected in all establishments the CAs approve for export to the EU in order to bring them in line with EU requirements, 17