EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL

Ref. Ares(2014)2907371-05/09/2014 EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Directorate F - Food and Veterinary Office DG(SANCO) 2014-7169 - MR FINAL FINAL REPORT OF AN AUDIT CARRIED OUT IN MYANMAR FROM 24 FEBRUARY TO 06 MARCH 2014 IN ORDER TO ASSESS THE CONTROL SYSTEMS IN PLACE TO CONTROL MICROBIOLOGICAL CONTAMINATION IN SEEDS FOR HUMAN CONSUMPTION INTENDED FOR EXPORT TO THE EUROPEAN UNION

Executive Summary This report describes the outcome of an audit carried out by the Food and Veterinary Office (FVO) in Myanmar from 24 February to 06 March 2014. The objectives of the audit were to evaluate the official controls related to production and processing of seeds for human consumption (in particular, seeds for sprouting eg. mung beans and other seeds for sprouting) intended for export to the European Union (EU) in the framework of Regulation (EC) No 178/2002 and Regulation (EC) No 852/2004 and to evaluate procedures in place for the certification for imports into the EU of seeds for the production of sprouts as required by Regulation (EU) No 211/2013. The objectives of the audit were met. Myanmar was selected to be audited as part of the 2014 FVO audit programme due to a number of outbreaks in the EU connected with the consumption of sprouted seeds and the volume of imports from Myanmar. Official food safety controls on primary production, collection and processing of seeds for human consumption (in particular, seeds for sprouting) do not take place. This was acknowledged by the Myanmar Competent Authorities. The CAs of Myanmar are aware of the requirements of EU legislation on sprouts and seeds for sprouting. There are currently no official controls carried out to attest the implementation of general hygiene requirements as laid down in Annex I to Regulation 852/2004. However, in the regions visited the above-mentioned requirements were implemented by primary producers. The hygiene practices in the processing facilities and collectors visited by the FVO audit team were generally in line with the relevant EU requirements. The system of official food safety controls currently in place cannot ensure that the seeds for human consumption (in particular, seeds for sprouting) were produced under conditions which meet the general hygiene provisions for primary production and associated operations as set out in Part A of Annex I to Regulation (EC) No 852/2004 and therefore the CA is not able to certify conformity with these requirements as required by Article 3 of Regulation (EU) 211/2013. The report contains recommendations to Myanmar to address the shortcomings identified. I

Table of Contents 1 INTRODUCTION...1 2 OBJECTIVES...1 3 LEGAL BASIS...2 3.1 LEGAL BASIS...2 3.2 STANDARDS...2 4 BACKGROUND...2 5 FINDINGS AND CONCLUSIONS...3 5.1 NATIONAL LEGISLATION...3 5.2 COMPETENT AUTHORITIES...4 5.3 OFFICIAL CONTROLS...5 5.3.1 DOCUMENTED CONTROL PROCEDURES...6 5.3.2 REGISTRATION OF FOOD BUSINESS OPERATORS...6 5.3.3 CULTIVATION...6 5.3.4 PROCESSING AND STORAGE...8 5.3.5 NON- CONFORMING PRODUCTS...10 5.4 METHOD OF SAMPLING...10 5.5 LABORATORY SERVICES...11 5.6 CERTIFICATION PROCEDURES FOR EXPORTING TO THE EU...13 5.7 RESPONSE TO RASFF NOTIFICATIONS...14 6 OVERALL CONCLUSIONS...14 7 CLOSING MEETING...15 8 RECOMMENDATIONS...15 ANNEX 1 - LEGAL REFERENCES...16 ANNEX 2 STANDARDS...17 II

ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT Abbreviation BAM CA(s) CCA CN CODEX DA EFSA EU FBO(s) FDA FDSC FNAO FVO GAP GMP GPA HACCP ISO MFDBA MITS MOAI MOC MOH MS(s) RASFF STEC TC(s) Explanation Bacteriological Analytical Manual Competent Authority(ies) Central Competent Authority Combined Nomenclature Codex Alimentarius Commission of the Food and Agriculture Organization of the United Nations and World Health Organization Department of Agriculture European Food Safety Authority European Union Food Business Operator(s) Food and Drug Administration Food and Drug Supervisory Committee Food of Non Animal Origin Food and Veterinary Office Good Agricultural Practices Good Manufacturing Principles Good Practices of Agriculture Hazard Analysis and Critical Control Points International Organisation for Standardization Myanmar Food and Drug Board Authority Myanmar Inspection and Testing Services Ministry of Agriculture and Irrigation Ministry of Commerce Ministry of Health Member State(s) Rapid Alert System for Food and Feed Shiga Toxin-Producing Escherichia Coli Third Country(ies) III

1 INTRODUCTION This audit took place in Myanmar from 24 February to 06 March 2014 to assess the official control systems in place on seeds for human consumption (in particular, seeds for sprouting eg. mung beans and other seeds for sprouting) for export into the European Union (EU). The audit team comprised two auditors from the Food and Veterinary Office (FVO) and one National Expert from an EU Member State (MS). The audit was undertaken as part of the FVO s annual audit programme. The audit team was accompanied throughout the audit by representatives of the Central Competent Authority (CCA) the Ministry of Commerce (MOC) and the Department of Trade Promotion. The opening meeting was held on 24 February 2014 with the CCA, Competent Authorities (CAs) including the representatives of a laboratory, private sector representatives and the EU Delegation to Myanmar. During the meeting, the objectives of the audit, itinerary and the standard reporting procedures were confirmed. 2 OBJECTIVES The objectives of the audit were to evaluate: 1) the official controls related to the production and processing 1 of seeds for human consumption (in particular for sprouting) intended for export to the EU in the framework of Regulation (EC) No 178/2002 and Regulation (EC) No 852/2004 2) procedures in place for the certification for imports into the EU of seeds for the production of sprouts as required by Regulation (EU) No 211/2013 In terms of scope, the audit reviewed the controls on production, processing and export, including national legislation in place, the organisation and operation of the CAs and their controls over Food Business Operators (FBOs) compliance with hygiene rules. Table 1: Audit visits and meetings Meetings/visits Competent authorities Comments Central 3 Opening meeting, closing meeting and an information meeting were attended by representatives from the MOC, Ministry of Agriculture and Irrigation (MOAI), and representatives of the exporting companies Regional 1 Meeting with the MOAI Laboratories Official 3 Laboratory under the MOAI, Microbiological laboratory services of the Ministry of Livestock 1 Processing of seeds for sprouting consists for the purpose of this report of cleaning, sorting, grading and storage of the seeds, unless otherwise specified. 1

and Fisheries and Food and Drug Administration (FDA) laboratory Private 1 Private laboratory in Yangon Processors /Exporters/Farms Processors/Packers/Exporters 5 The five main exporting enterprises were visited Collector of seeds for sprouting 3 Collectors connected to the farms were visited Farms producing seeds for sprouting 3 The farms visited were based in Yangon Region and Bago Region 3 LEGAL BASIS 3.1 LEGAL BASIS The audit was carried out under the general provisions of EU legislation, in particular, Article 46 of Regulation (EC) No 882/2004 of the European Parliament and the Council which stipulates that EU controls in Third Countries (TCs) may verify compliance or equivalence of TC legislation and systems with EU feed and food law. These controls shall have particular regard to the assurances which the TC can give regarding compliance with, or equivalence to the relevant EU requirements. A full list of the EU legal instruments referred to in this report is provided in Annex 1. EU legal acts quoted in this report refer, where applicable, to the most recently amended version. 3.2 STANDARDS Additionally, the Guidelines and Codes of Practice of the Codex Alimentarius Commission of the Food and Agriculture Organisation of the United Nations and World Health Organisation (CODEX) were taken into account in the context of the audit, where relevant. A full list of applicable standards referred to in this report is provided in Annex 2. Reference to specific provisions of these texts is provided at the beginning of relevant sections. 4 BACKGROUND The European Food Safety Authority (EFSA) adopted a scientific opinion on the risk posed by Shiga toxin-producing Escherichia Coli (STEC) and other pathogenic bacteria in seeds and sprouted seeds, after the outbreaks of STEC in May 2011 in the EU. The EFSA report can be found at: http://www.efsa.europa.eu/en/efsajournal/pub/2424.htm. The EFSA indicated that as sprouted seeds are ready-to eat foods, the presence of pathogenic bacteria in seeds used for sprouting or in sprouted seeds represents a public health risk. 2

Microbiological testing alone may convey a false sense of security due to the statistical limitation of sampling plans. A negative sample result does not ensure the absence of the pathogen in the tested lot, particularly where it is present at low or heterogeneous prevalence. In order to ensure an adequate level of protection of public health, it is appropriate that sprouts and seeds intended for the production of sprouts imported into the EU comply with the requirements as laid down in Regulation (EC) No 852/2004. Appropriate certification requirements are therefore laid down for such commodities imported into the EU. In view of the number of large outbreaks and the volume of imports from Myanmar, the FVO decided to undertake an audit to Myanmar in order to assess the control systems in place to control microbiological contamination in seeds for human consumption (in particular seeds for sprouting) intended for export to the EU. Table 2 : Imports of seeds for human consumption from Myanmar to the EU (Eurostat) Year Imports of dried leguminosae (Combined Nomenclature [CN] 0713) in tonnes 2012 17862 11863 2013 7337 5071 Imports of dried mung beans (CN 0713310) in tonnes 5 FINDINGS AND CONCLUSIONS 5.1 NATIONAL LEGISLATION Legal requirements Article 46(1)(a) of Regulation (EC) No 882/2004 stipulates that EU controls are to have, inter alia. particular regard to the legislation of the TCs. Findings Legislation related to food safety in Myanmar are the Food and Drug Act (1928), the Public Health Law (1972), the National Drug Law (1992), the National Food Law (1997), the Pesticide Law (1991) and the Plant Pest Quarantine Law (1993). The Consumer Protection Law defines specific tasks of the MOC. Requirements for official controls on imported and exported food are laid down in the Export and Import Law of 2012. This law is administered by the MOC. The MOC issues necessary orders, notifications and directives pertaining to all export/import activities. The authority to issue export/import licenses and permits is delegated to the Department of Commerce and Consumer Affairs under the MOC. However, to export seeds for sprouting to the EU an export license is not needed. The Pest Quarantine Law describes several duties for the Department of Agriculture (DA) under the 3

MOAI, division of Plant Protection, related to the control of quarantine pests for food imports and exports including the issuing of phytosanitary certificates. However, at the time of the audit there were no food safety requirements applicable to producers of seeds for sprouting to be exported to the EU (equivalent to the requirements of Annex I to Regulation (EC) No 852/2004). No legislation existed for official controls at primary production for both foods of animal and non-animal origin. Conclusions There is a legal framework for food safety in place that defines the CAs and their competences. However, the legal requirements in national legislation do not cover the production of seeds for sprouting to be exported to the EU. 5.2 COMPETENT AUTHORITIES Legal requirements Articles 46(1)(b) and (c) of Regulation (EC) No 882/2004 stipulate that EU controls shall have, inter alia, particular regard to the organisation of the TC's CAs, their powers and independence, the authority they have to enforce the applicable legislation effectively, and the training of staff in the performance of official controls. Findings The resolution of the Cabinet of Ministers of Myanmar 3/2011 is the legal basis for the conversion of the Myanmar Agricultural Service into the DA under the MOAI. It stipulates the total staff number of 16416 (989 officials and 15427 non-official staff). The agreement also defines the structure of the department. The department is made up of 8 divisions. In addition to the headquarters there are 15 regional offices and around 60-70 district offices. The MOAI is responsible for the administration of the supervision of primary production of Food of Non Animal Origin (FNAO). The audit team was informed by the MOAI that no food safety controls on primary production of seeds for human consumption and seeds for spouting for export to the EU are currently being carried out. The audit team observed that several principles of GAP for the production of seeds for sprouting as described in Annex I to Regulation 852/2004 were followed at the farms visited and these practices are named in this report Good Practices of Agriculture (GPA) (see also chapter 5.3). The DA provides training on GPA to regional staff. This knowledge is then transmitted via a cascade procedure to local staff, who in turn are responsible for the training of farmers. In September 2013, local farmers received training on the production of seeds for sprouting. However, no specific training on hygiene was provided. The MOAI and, in particular, its Plant Protection Division is responsible for the supervision of the safety of food and agricultural products for export. 4

The National Food Law of Myanmar established in 1997 that the CA responsible for official food safety control is the Ministry of Health (MOH). The Myanmar Food and Drug Board Authority (MFDBA) was formed in 1997 in accordance with the National Drug Law. It is chaired by the Minister of Health and its members come from related departments/professionals and from relevant fields of expertise. The MFDBA has to ensure efficient and uniform official control on the safety of food and food additives throughout Myanmar. The Food and Drug Supervisory Committee (FDSC) is responsible for the supervision of domestic processed food products in terms of processing, distribution and consumption. The FDSC has to ensure efficient and uniform official control on food safety throughout Myanmar. The Myanmar FDA of the MOH is responsible for the supervision of processed food products in terms of import, export, processing, distribution and consumption. At exporters' facilities, sampling of consignments for export including to the EU is done by Myanmar Inspection and Testing Services (MITS) (a company owned by the MOC) and a private international inspection company. Samples are tested for Salmonella spp. and E. coli at the request of clients. Before the audit took place MITS was in charge of the issuing and signing of certificates for exporting seeds for sprouting to the EU. However, it was not clear for the CAs of Myanmar that it is the task of a CA to issue the certificates for exporting seeds for sprouting to the EU. Therefore the CAs of Myanmar decided during the opening meeting of this audit that the DA is the CA in charge of signing the certificates for exporting seeds for sprouting to the EU. Conclusions The CAs are designated and their responsibilities are defined in national legislation. The CAs of Myanmar decided that the DA is the CA in charge of attesting the compliance with EU requirements of seeds for sprouting for export to the EU. The CAs have the authority to enforce the applicable legislation. CA staff have not received training on food safety requirements for the production of seeds for sprouting. 5.3 OFFICIAL CONTROLS Legal requirements Articles 46(1)(e) and (b) of Regulation (EC) No 882/2004 stipulates that EU controls shall have, inter alia, particular regard to the existence and operation of documented control procedures and control systems based on priorities, and the CA's capability to enforce applicable legislation. Requirements contained in part II of the model health certificate for the import of seeds for sprouting established in the Annex to Regulation (EC) No 211/2013. Articles 3,4 and 6 of Regulation (EC) No 852/2004 in connection with its Article 10. 5

The Codex Code of Hygienic Practice for Fresh Fruits and Vegetables (CAC/RCP 53-2003, Rev. 2010) provides in Annex II recommended practices to prevent contamination of seeds from key risks such as water, animals, workers and manure. Codex Alimentarius General principles of food hygiene (CAC/RCP 1-1969). Findings The Plant Protection Service of the MOAI is responsible for the official safety controls on agricultural food products, including seeds for human consumption and seeds for sprouting for domestic consumption. The controls are performed by taking around 1200 samples per annum. However, no specific samples of seeds for sprouting intended to be exported to the EU are analysed for microbial contamination. Currently there are no official food safety controls carried out in primary production, at collectors or processors/packers/exporters of seeds for sprouting for export to the EU. 5.3.1 Documented Control Procedures Documented control procedures are in place for the plant health inspections of consignments of seeds for sprouting for export (General Working Procedures and templates for the Inspection and Quarantine of Export of Plants and Plant-Derived Food). However, there are no procedures in place for hygiene controls. 5.3.2 Registration of Food Business Operators The CA stated that all processors/packers/exporters are registered with the Municipality of Yangon. The processors/packers/exporters of seeds for human consumption, including seeds for sprouting, visited during the audit are registered by the Municipality of Yangon following an inspection at their premises on occupational health. Registration needs to be renewed every two years following an inspection of the facilities. The inspection is carried out by a team of representatives of the City Council, the General Municipality Development Council, the Ministry of Health (Township Medical Doctor) and the Department of Labour. However, such inspections do not cover general food hygiene requirements. Currently eight processors/packers/exporters of seeds for sprouting to the EU are registered. The MOAI informed the audit team that all collectors were registered at the local municipality. The municipality grants a license for their operations without any inspection of the facilities. The MOAI informed the audit team that all farmers including the farmers producing seeds for sprouting for export to the EU are currently registered by the MOAI. For registration purposes, only facilities producing processed food in the sense of Article 2.1 of Regulation (EC) No 852/2004 are assessed under the hygiene criteria. For these facilities criteria equivalent to Annex II of Regulation (EC) No 852/2004 are applied. 5.3.3 Cultivation The main production areas in Myanmar for mung beans intended for export to the EU are about 50 km north of Yangon in the Yangon and Bago Region. The audit team visited three townships. 6

Khayan township consists of 13554 farmers that grow produce on 96896 acres. The township of ThoneKwa consists of 18874 farmers that grow on 124871 acres. The KaWa township in Bago region consists of 26032 farmers that grow produce on 208174 acres. The yield of mung beans is considered this year to be in the mid-range with about 300 kg per acre. The main types are Shwewahmung beans and Yezinmung beans. At the time of sowing and growing, the future use of seeds (such as seeds for sprouting intended to be exported to the EU) is already specified because collectors usually buy from the same farmers and processing facilities buy from the same collectors. The collectors provide the farmers with seeds, fertilizers and pesticides. The audit team was informed that GAP implementation started in 2005 for mango and watermelon production and had not commenced at the time of the audit for seeds for sprouting. The Myanmar GAP for mango and watermelon is based on Asean GAP and consists of modules for produce quality, food safety, environmental management and workers welfare. However, the audit team observed that principles of GAP for the production of seeds for sprouting such as measures to reduce the risks of contamination as described in Annex I to Regulation (EC) No 852/2004 were followed at the farms visited and these practices are named GPA in this report (see also chapter 5.2). Since 1948, the government has actively supported the development of farmers' skills. Technicians of the local MOAI branch have training facilities in the villages to instruct and train the farmers and explain to them good practice for seed selection, fertilization, the use of pesticides, harvest and drying according to the requirements of GPA. They also provide GPA guides to the farmers. However, these guides do not include specific hygiene practices for production of seeds for sprouting. The audit team was provided with the guides. Farmers visited stated that they regularly (before planting) receive training and advice on GPA. The agronomist of the MOAI is responsible for supporting roughly 500 farmers. Based on the farmers register, he visits all farmers several times a year to provide individual advice. The audit team met three mung bean farmers in the three different townships and two regions. The first farm visited was 50 acres, the second 300 acres and the third 40 acres. The audit team noted that there is no official controls (inspections) of mung bean growers. The farmers and the advisers of the MOAI stated that most recommended practices regarding, for example, sowing, fertilization and pesticide use, based on GPA are followed during the growing season. Mung beans are sown in the dry season after rice. In Yangon region (the main growing area for seeds for sprouting to be exported to the EU) fertilizer was not applied before sowing. A technician stated that the farmers should also have used one more pesticide application. The audit team was informed by the MOAI that during growing the crop is neither fertilised nor irrigated. In Kawa region the soil is of a lower quality and the farmer reported that he used mineral fertilizer before sowing and that he had used the mineral foliar feed three times during the vegetation period. Irrigation was not used in either of the regions visited. At all farms visited, there was no regular access of animals to the mung bean fields. Field work is done mechanically. 7

Harvesting takes place from mid-february to mid-march. Mung beans are harvested in one to three hand picking campaigns. The audit team observed full picking at two farms. After the harvest, mung beans are collected and dried on open places on the soil which is not in line with CODEX CAC/RCP 53-2003. Threshing takes place after one to three days. After threshing, the bags of mung beans are transported to a collector. On one farm visited, the beans were dried close to a place where animals were kept and no measures were taken for protecting the produce against potential cross-contamination which is not in line with Annex I, A, II.2 and II.5.e of Regulation (EU) No 852/2004. At present there are no special hygiene requirements in the legislation of Myanmar at primary production level covering the safety of mung beans for export to the EU and the producers of seeds for sprouting are not checked from the point of view of food hygiene. Therefore the CA does not ensure that those establishments meet the requirements equivalent to Article 4 of Regulation (EC) No 852/2004 in conjunction with Article 10 and Annex I of the same Regulation. However, field management is in line with the requirements of Codex Alimentarius Code for fresh fruit and vegetables (CAC/RCP 53-2003), Annex II. Point 3.2.1.2. and Annex I point 5e) of Regulation (EU) No 852/2004. The audit team observed that hygiene and sanitary facilities are often in close proximity to the fields as required by the Codex Alimentarius Code for fresh fruit and vegetables (CAC/RCP 53-2003) chapter 3.2.3. However, potable water for hand washing was not always available. 5.3.4 Processing and Storage The audit team visited 3 collectors of seeds for sprouting which are based in the same townships of the growers. The collectors buy the mung beans from the farmers and divide the incoming bags in high quality and low quality. The high quality bags are sent within five days by truck to the exporter. The collectors stated to the audit team that they buy and sell between 10000 and 15000 tonnes of mung beans per year. They usually buy around 50-70% of the produce from smaller collectors and the rest from roughly 1500 3000 small farmers. One collector visited received training and advice provided by a representative of the importer in Europe once a year. The audit team assessed the facility visited and found it was, in general, in compliance with the requirements of Annex II of Regulation (EU) No 852/2004 and Codex Alimentarius General principles of food hygiene (CAC/RCP 1-1969). However, one FBO stored part of his produce on an open pile and the personnel who filled the produce from the pile into sacks passed through the produce with bare feet. Additionally, the nets for protection against birds had holes. The audit team visited five processors/packers/exporters of seeds for sprouting in the Yangong region. The first visited processor/packer/exporter, exports since this year approximately 300 tonnes of mung beans for sprouting to the EU. The company bought the produce from five brokers in the same county. The brokers buy direct from the farmers and organise the transport to the company. Mung bean seeds are stored after harvest in intermediate storage facilities at the broker for up to 8

two weeks. The processing includes machine cleaning, sorting and packing. At the request of clients the processor carries out microbiological testing of seeds for sprouting (Salmonella, E. coli). The processor was not inspected on food hygiene by a CA. The processor was not fully able to trace back seeds internally to the intermediate storage. The audit team assessed the facility visited and found it was, in general, in line with the requirements of Annex II of Regulation (EU) No 852/2004 and Codex Alimentarius General principles of food hygiene (CAC/RCP 1-1969). However, the FBO was not aware of the risks associated with birds and rodents and measures taken were considered poor. The second processor/packer/exporter exports annually to the EU approximately 1000 tonnes of mung beans and another 15000 tonnes to other destinations. The Company buys the produce from three brokers in the same county. The processor was not inspected on food hygiene by a CA. The processor was not able to fully trace internal produce back to the intermediate storage of the broker. The audit team assessed the facility visited and found it was, in general, in line with the requirements of Annex II of Regulation (EU) No 852/2004 and of Codex Alimentarius General principles of food hygiene (CAC/RCP 1-1969). However, the FBO was not aware of the risks associated with birds and rodents and measures taken were considered to be poor. Bags with produce were partly stored directly on the floor, for short time storage. The third processor and exporter of seeds for sprouting, exports annually approximately 1,000 tonnes of mung beans to the EU. This FBO buys raw material from three brokers in the same county. The FBO was not inspected on food hygiene by a CA. The processor was not able to fully internally trace produce back to the intermediate storage of the broker. It was observed that the coding form on the incoming bags could not be connected to the lot number and batch number for the big packs to be exported. The audit team assessed the facility visited and found it was, in general, in line with the requirements of Annex II of Regulation (EU) No 852/2004 and of Codex Alimentarius General principles of food hygiene (CAC/RCP 1-1969). The fourth processor and exporter of seeds for sprouting, exported 400 tonnes of mung beans in 2013 to the EU and the representative of the company stated that he had contracts for 300 tonnes for 2014. Another 15000 tonnes are sold to other destinations. However, at the time of the audit no produce intended to be exported to the EU was physically present at the exporters premises. The FBO stated that he buys the raw material from four brokers in the same county. He also stated that for the consignment of 300 tonnes he needs to buy 1000 tonnes. The remaining 700 tonnes are exported to other destinations. The processor was not inspected on food hygiene by a CA. The processor was not able to fully trace internally produce back to the intermediate storage of the broker. It was observed that the coding form of the incoming bags could not be connected to the lot number and batch number of the bags to be exported. The audit team assessed the facility visited and found it was, in general, in line with the requirements of Annex II of Regulation (EU) No 852/2004 and of Codex Alimentarius General principles of food hygiene (CAC/RCP 1-1969). However, some produce for short time storage was stored directly on the floor. The fifth processor/packer/exporter exports annually to the EU approximately 1,000 tonnes of mung 9

beans and another 19000 tonnes to other destinations. The main importing MS is the United Kingdom. The Company buys the produce from 3 brokers in the same county. The processor was not inspected on food hygiene by a CA. The processor was not able to fully trace produce back to the intermediate storage of the broker. The audit team assessed that the facility visited was, in general, in line with the requirements of Annex II of Regulation (EU) No 852/2004 and of Codex Alimentarius General principles of food hygiene (CAC/RCP 1-1969). However, some produce for short time storage was stored directly on the floor. 5.3.5 Non- Conforming Products No non-compliant consignments of the seeds for sprouting intended to be exported to the EU had been detected by a CA up to the time of the audit. Conclusions The collectors and processors/packers/exporters of seeds for sprouting are not covered by official food hygiene control. There is no specific information on hygiene requirements in the GPA available to growers of seeds for sprouting. The producers of seeds for sprouting are not checked from the point of view of food hygiene. Therefore, there is no CA to ensure that these establishments comply with the requirements of Article 4 of Regulation (EC) No 852/2004 in conjunction with Article 10 and Annex I of the same Regulation. At the collectors and processors/packers/exporters visited, Good Manufacturing Principles (GMP) established in the Codex Alimentarius Code of Practice CAC/RCP 1-1969 General principles of food hygiene were followed with minor deficiencies concerning storage of produce which is not in compliance with the requirements set out in Section IV of the above-mentioned standard and prevention of pest access which is not in compliance with the requirements set out in section 6.3.2. of the same standard. 5.4 METHOD OF SAMPLING Legal Requirements The Codex General Guidelines on sampling (CAC/GL 50-2004) provides fair and valid sampling procedures to be used when food is being tested for compliance with Codex commodity standards. Regulation (EC) No 2073/2005 amended by Regulation (EU) No 209/2013. Findings Sampling is carried out at the exporters by MITS and by an international private organisation. According to MITS, written sampling procedures following International Organisation for Standardization (ISO) 950:1979 are in place. However, ISO 950:1979 was withdrawn and is 10

replaced by ISO 13690:2007. These sampling protocols are designed for the assessment of quality traits and for chemical analysis. They cannot be applied for microbial tests due to the nonhomogeneous nature of microbial contaminations. Procedures ensuring that the sample is representative for the consignment such as described for example in Regulation (EU) No. 2073/2005 have not been taken into account. According to the information provided, MITS will take this into account and amend their sampling procedures accordingly very soon. Conclusions The sampling procedure in place for samples taken on request of exporters for Salmonella and Escherichia coli analysis does not address the non-homogeneous nature of microbiological contaminations and does not ensure that the sample taken is representative of the consignment or of the lot as provided for by Regulation (EU) No 2073/2005 and Codex Alimentarius General Guidelines on sampling CAC/GL 50-2004 sections 2.1.2.and 2.3.3. 5.5 LABORATORY SERVICES Legal requirements Article 46(1)(d) of Regulation (EC) No 882/2004 stipulates that EU controls shall have, inter alia, particular regard to the resources, including diagnostic facilities, available to CAs in the performance of official controls. Points 41 and 42 of CODEX Guidelines CAC/GL 26-1997 on the Design, Operation, Assessment and Accreditation of Food Import and Export Inspection and Certification Systems. Findings General At present in Myanmar, there is no laboratory accredited for internationally recognised tests for Enterobacteriaceae such as ISO 21528-2:2009. A national accreditation organisation does not exist in Myanmar. Microbiological criteria defining conforming and non-conforming lots of green mung beans were not issued at the time of the audit. In general, there are several laboratories involved in food analysis: Laboratory under the MOAI. This laboratory is not equipped for microbiological analysis Microbiological laboratory services of the Ministry of Livestock and Fisheries, Department of Fisheries, Analytical Laboratory Section Private Microbiological Laboratory FDA laboratory 11

Laboratory services of the Ministry of Livestock and Fisheries, Department of Fisheries, Analytical Laboratory Section This official laboratory is the only laboratory in Myanmar accredited according to ISO 17025:2005 as an analytical laboratory by the Bureau of Laboratory Quality Standards, Department of Medical Science, Ministry of Public Health, Thailand, in 2012, and re-audited in February 2014. Methods in place comprise total plate count, faecal coliforms, Escherichia coli, Staphylococcus aureus and Salmonella spp.. All methods are based on methods published by an internationally recognised organisation and Bacteriological Analytical Manual (BAM) methods. Since 2009, the laboratory participated annually in international proficiency tests for these five methods of analysis. Approximately 100 samples of fish and fishery products are analysed per month. The equipment in place and the staffing situation meet the requirements for this number of samples. The sample recording system, based on laboratory files, allows tracing the samples through the analytical procedure. Private Microbiological Laboratory This private laboratory acts as a non-profit organisation with funding by MFPEA, it is not accredited. The laboratory carries out microbiological tests for Salmonella spp. and Escherichia coli of green mung beans required by Codex Alimentarius standard CAC/RCP 53-2003, Annex II, point 3.4. Both methods follow written laboratory procedures based on AOAC methods. A method for Enterobacteriaceae such as ISO 21528:2009 is not being established. The number of samples analysed increased significantly from 352 in 2011 to 798 in 2013. In the first two months of 2014 around 335 samples were analysed. In 2013 about 121 samples consisted of green mung beans and in 2014 around 220 were green mung beans. The audit team noted that serological tests for Salmonella were not applied on a regular basis, E. coli quantification is done in only one replicate instead of two. The laboratory staff is aware of the methodological shortcomings due to budget and laboratory space limitations. Proficiency tests in microbiology have not yet been carried out. The collection of reference strains is limited to one strain each of E. coli, Salmonella ser. Typhi, and Staphylococcus aureus, making method verification and the establishment of new methods difficult. For the analysis of green mung beans, a sophisticated procedure including a three day sprouting process is been applied. To date, E. coli was found in three private samples of green mung beans. Salmonella spp. has not yet been detected. Yangon Microbiological Laboratory of the Food and Drug Administration under the Ministry of Health This governmental laboratory is responsible for the analysis of food products from the domestic market, imported food and food to be exported. However, according to the Myanmar legislation in force, green mung beans for sprouting, are not considered as processed food and therefore mung beans intended for export to the EU are not tested. The Yangon Microbiological Laboratory is one of three laboratories responsible for food analysis. The other laboratories are based in Mandalay and Naypyidaw. The staffing situation in the laboratory in Yangon with only four technicians is not sufficient for the number of samples to be analysed. A staff of seven technicians is planned for the future. The laboratory layout does not meet the requirements regarding the medium preparation and sample analysis in different rooms. The laboratory is not accredited. The laboratory carries out the following microbiological tests: total 12

plate count, faecal coliforms and E. coli, Staphylococcus aureus, Salmonella spp., yeasts and moulds, Clostridium perfringens, Listeria monocytogenes, Vibrio cholerae, Vibrio parahaemolyticus. A method for Enterobacteriaceae such as ISO 21528:2009 is not established. Proficiency tests are not carried out on a regular basis. In 2013 the laboratory participated in a proficiency test for Staphylococcus aureus in milk powder. There is no collection of reference strains, however, the food microbiological laboratory has access to the strain collection of the National Health Laboratory in the same premises. In 2013, 10387 samples were analysed, this included 54 samples of processed black mung beans and three samples of processed green mung beans. From these mung bean samples, no noncompliances were reported. The audit team noted that the Salmonella method is based on the BAM protocol, as selective agar plate, Xylose lysine deoxycholate agar only is being used. Conclusions At present, there is no accredited laboratory for microbiological tests of beans for sprouting in Myanmar. Laboratory tests for Salmonella and Escherichia coli are carried out on a regular basis. However, no analysis are carried out on STEC and some shortcomings in applying the relevant standards were noted. Method validation and method verification could be compromised by the limited number of reference strains available in the laboratories. 5.6 CERTIFICATION PROCEDURES FOR EXPORTING TO THE EU Legal Requirements Article 46(1)(h) of Regulation (EC) No 882/2004 stipulates that EU controls shall have, inter alia, particular regard to the assurances which the TC can give regarding compliance with, or equivalence to, EU legislation. Article 3 of Regulation (EU) No 211/2013. Findings Before export, the Plant health Division of the MOAI, upon reception of all the necessary documentation, carries out an on-site inspection of the consignment intended for export at the premises of the exporter. On condition that the result of the official control is in compliance with the requirements of the Plant Pest Quarantine Law it issues a phytosanitary certificate. The containers are loaded and sealed at the processor's site, during which an MOAI inspector is present. The seeds for sprouting exporters submit an export declaration for customs. The application will pass if all documents have been provided. 13

In 2013 the exporters of seeds for sprouting in Myanmar requested the MITS to issue certificates for export, based on Regulation (EU) No 211/2013. The audit team examined a certificate issued in October 2013. The certificate for export was issued by MITS staff on the basis of an inspection of the produce carried out in the processing/packing/exporting facility. The procedure in place at the time of the audit did not require any verification activities to check the hygienic production of seeds for sprouting. Therefore the procedure for certification does not ensure that certified seeds meet the requirements contained in the health attestation laid down in Regulation (EU) No 211/2013. The CA of Myanmar provided the audit team with templates of farm records and a concept for the control of farms, they stated that in the near future they would fully implement all EU requirements. Conclusions There is a general export procedure in place for all exported goods; however, there was no specific verification procedure to attest the hygienic production for seeds for sprouting required by Regulation (EU) No 211/2013. The CA plans to establish procedures for seeds for sprouting to be exported to the EU including controls at primary production. 5.7 RESPONSE TO RASFF NOTIFICATIONS Legal requirements Point 6 of Codex Guidelines CAC/GL 25-1997 requires exchange of information between countries on rejections of imported food. In particular, the food control authorities in the exporting country should undertake the necessary investigation to determine the cause of any problem that has led to a rejection of the consignment. If requested, the food control authority in the exporting country should provide the authorities in the importing country with available information on the outcome of the necessary investigation. Bilateral discussions should take place as necessary. Findings The MOH is responsible for receiving and responding to Rapid Alert System for Food and Feed (RASFF) notifications. The CAs of Myanmar received in total sixteen RASFF notifications related to fish and fishery products. However, at the time of the audit there were no notifications issued concerning FNAO including seeds for sprouting from Myanmar. Conclusion There is a CA responsible for follow-up of RASFF notifications. 6 OVERALL CONCLUSIONS Official food safety controls on primary production, collection and processing of seeds for human consumption (in particular, seeds for sprouting) do not take place. This was acknowledged by the Myanmar Competent Authorities. 14

The CAs of Myanmar are aware of the requirements of EU legislation on sprouts and seeds for sprouting. There are currently no official controls carried out to attest the implementation of general hygiene requirements as laid down in Annex I to Regulation 852/2004. However, in the regions visited the above-mentioned requirements were implemented by primary producers. The hygiene practices in the processing facilities and collectors visited by the FVO audit team were generally in line with the relevant EU requirements. The system of official food safety controls currently in place cannot ensure that the seeds for human consumption (in particular, seeds for sprouting) were produced under conditions which meet the general hygiene provisions for primary production and associated operations as set out in Part A of Annex I to Regulation (EC) No 852/2004 and therefore the CA is not able to certify conformity with these requirements as required by Article 3 of Regulation (EU) 211/2013. 7 CLOSING MEETING A closing meeting was held on 06 March 2014 with representatives of the CCA, CAs, private sector representatives and the EU Delegation to Myanmar. The audit team presented the main findings and preliminary conclusions of the audit. The CAs made initial comments and provided some additional information. 8 RECOMMENDATIONS An action plan in response to the recommendations should be forwarded to the Commission within 25 days of receipt of the report. This action plan should clearly set out the manner and deadline by which the CAs will address each of the following recommendations. N. Recommendation 1. Ensure that all farms where seeds for sprouting for export to the EU are produced are under official food safety controls, to ensure that produce exported to the EU meets the requirements in the certificate laid down in Regulation (EU) No 211/2013. 2. Ensure that the storage conditions and the prevention of pests entering processing and storage facilities for seeds for sprouting meet the requirements set out in particular in Annex I and Annex II, Chapters I. 2. (c), II. 1. (d) and IX. 4. of Regulation (EU) No 852/2004 and the CODEX Code of Practice CAC/RCP 1-1969 General principles of food hygiene section 6.3.2. 3. Ensure that the procedure for export certification of seeds for sprouting attests that the seeds for sprouting were produced under conditions which meet the general hygiene provisions for primary production and associated operations as required by certificate laid down in Regulation (EU) No 211/2013. 4. Ensure that sampling procedures for microbiological analysis of seeds for sprouting intended for export to the EU, in particular, the representativeness of the laboratory sample, meet requirements at least equivalent to those laid down by CODEX Alimentarius General Guidelines on sampling CAC/GL 50-2004 chapters 2.1.2. and 15

N. Recommendation 2.3.3. The competent authority's response to the recommendations can be found at: http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_inspection_ref=2014-7169 16

ANNEX 1 - LEGAL REFERENCES Legal Reference Official Journal Title Reg. 178/2002 OJ L 31, 1.2.2002, p. 1-24 Reg. 882/2004 OJ L 165, 30.4.2004, p. 1, Corrected and re-published in OJ L 191, 28.5.2004, p. 1 Reg. 852/2004 OJ L 139, 30.4.2004, p. 1, Corrected and re-published in OJ L 226, 25.6.2004, p. 3 Reg. 2073/2005 OJ L 338, 22.12.2005, p. 1-26 Reg. 211/2013 OJ L 68, 12.3.2013, p. 26-29 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs Commission Regulation (EU) No 211/2013 of 11 March 2013 on certification requirements for imports into the Union of sprouts and seeds intended for the production of sprouts 17

ANNEX 2 STANDARDS Reference number Full title Publication details CAC/GL 25-1997 CAC/GL 26-1997 CAC/GL 27-1997 CAC/GL 50-2004 CAC/RCP 53-2003 CAC/RCP 1-1969 Guidelines for the exchange of information between countries on rejections of imported food (CAC/GL 25-1997). Guidelines on the design, operation, assessment and accreditation of food import and export inspection and certification systems (CAC/GL 26-1997). Guidelines for the Assessment of the competence of testing laboratories involved in the import and export control of food (CAC/GL 27-1997). General Guidelines on Sampling (CAC/GL 50-2004). Code of hygienic practice for fresh fruits and vegetables (CAC/RCP 53-2003). General principles of food hygiene (CAC/RCP 1-1969). http://www.codexalimentarius.n et/web/standard_list.jsp http://www.codexalimentarius.n et/web/standard_list.jsp http://www.codexalimentarius.n et/web/standard_list.jsp http://www.codexalimentarius.n et/web/standard_list.jsp http://www.codexalimentarius.n et/web/standard_list.jsp http://www.codexalimentarius.n et/web/standard_list.jsp 18