EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL

Transcription

1 Ref. Ares(2013) /09/2013 EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Directorate F - Food and Veterinary Office DG(SANCO) MR FINAL FINAL REPORT OF AN AUDIT CARRIED OUT IN VIET NAM FROM 03 TO 14 JUNE 2013 IN ORDER TO ASSESS THE CONTROL SYSTEMS IN PLACE TO CONTROL MICROBIOLOGICAL CONTAMINATION (SALMONELLA) OF HERBS AND SPICES INTENDED FOR EXPORT TO THE EUROPEAN UNION

2 Executive Summary This report describes the outcome of an audit carried out by the Food and Veterinary Office (FVO) in Vietnam from 3 to 14 June The objective was to assess the systems in place to control microbiological contamination of herbs and spices intended for export into the European Union (EU). The objective of the audit were met. This audit was included in the FVO 2013 audit programme due to the number of Rapid Alert System for Food and Feed (RASFF) notifications. Between 2011 and the time of the audit, thirty four notifications relating to salmonella in herbs and spices from Vietnam were issued through the RASFF. Overall, it can be concluded that the Vietnamese competent authorities have put in place certain official controls for the production and processing of herbs and spices. However there is no official control carried out for food hygiene requirements in those facilities which exclusively export their products. There is neither a mandatory nor official system of Salmonella analysis in place for herbs and spices for export to the EU. Only the phytosanitary aspects are checked prior to export. The official control system is based on an adequate legal framework and includes documented control procedures, obligations for food facilities to register and implement food safety requirements. However, there was a low take-up of Good Agricultural Practices and Good Hygiene Practices and poor information re microbiology. The effectiveness of the system is undermined by very limited official sampling for Salmonella contamination of herbs and spices. The laboratories visited were accredited and fit for the purpose for official analysis. However, the analysis of herbs and spices for Salmonella were never undertaken. There was no evidence of any of the thirty four RASFF notifications relating to Salmonella having been followed up. Consequently, there is a possibility that products cleared in Vietnam for export to the EU could be rejected at EU borders due to contamination with Salmonella. The report contains recommendations to Vietnam to address the shortcomings identified. I

3 Table of Contents 1 INTRODUCTION OBJECTIVES LEGAL BASIS LEGAL BASIS STANDARDS BACKGROUND FINDINGS AND CONCLUSIONS RELEVANT NATIONAL LEGISLATION COMPETENT AUTHORITIES OFFICIAL CONTROLS REGISTRATION OF ESTABLISHMENTS OFFICIAL CONTROLS CULTIVATION PROCESSING AND STORAGE NON- CONFORMING PRODUCTS PROCEDURES FOR EXPORTING TO THE EU METHOD OF SAMPLING LABORATORY SERVICES GENERAL ORGANISATION LABORATORIES VISITED THE NAFIQAD- BRANCH 1 LABORATORY QUATEST 3 LABORATORY RESPONSE TO RASFF NOTIFICATIONS OVERALL CONCLUSIONS CLOSING MEETING RECOMMENDATIONS...13 ANNEX 1 - LEGAL REFERENCES...14 II

4 ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT Abbreviation CA(s) CAC /GL CAC/RCP CB(s) CCA CODEX CPD EU FBO(s) FNAO FVO GAP GHP GMP HACCP HCMC ISO MARD NAFIQAD PPC PPD PPSD PT Explanation Competent Authority (ies) Codex Alimentarius Commission/Guideline Codex Alimentarius Commission/Recommended Code of Practice Certification Body(ies) Central Competent Authority Codex Alimentarius Commission of the Food and Agriculture Organization of the United Nations and World Health Organization Crop Production Department European Union Food Business Operator(s) Food of Non Animal Origin Food and Veterinary Office Good Agricultural Practices Good Hygiene Practice Good Manufacturing Practice Hazard Analysis and Critical Control Points Ho Chi Minh City International Organisation for Standardization Ministry of Agricultural and Rural Development The National Agro-Forestry-Fisheries Quality Assurance Department Plant Protection Centre Plant Protection Department Plant Protection Sub-Departments Proficiency Test QUATEST Quality Assurance and Testing Centre 3 RASFF UNIDO VietGAP TC(s) Rapid Alert System for Food and Feed United Nations Industrial Development Organization Vietnam Good Agricultural Practice Third Country(ies) III

5 1 INTRODUCTION This audit took place in Vietnam from 3 June 2013 to 14 June 2013 in order to assess controls on microbiological contamination (Salmonella) of herbs and spices intended for export to the European Union (EU). The audit team comprised two auditors from the Food and Veterinary Office (FVO). 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 Agriculture and Rural Development (MARD). An opening meeting was held on 3 June 2013 with the CCA, including the representatives of the laboratories and the EU Delegation to Vietnam. During the meeting, the audit objectives, itinerary, and the standard reporting procedures were confirmed. 2 OBJECTIVES The objective of the audit was to evaluate the official controls related to production and processing of herbs and spices intended for export to the European Union (EU) in the framework of Regulations (EC) No 178/2002 and No 852/2004. In terms of scope, the audit reviewed the controls on production, processing and export, including the national legislation in place, the organisation and operation of the competent authorities (CAs), and their controls over food business operators (FBO) compliance with the hygiene rules. In pursuit of this objective, the following sites were visited: Table 1. Audit visits and meetings Meetings/visits Competent authorities Comments Central 2 Opening and closing meeting was attended by representatives from the Ministry of Agriculture and Rural Development (MARD) including the National Agro-Forestry-Fisheries-Quality Assurance Department (NAFIQAD), the Crop Production Department (CPD), and the Plant Protection Department (PPD) Regional 3 Meetings with PPD and NAFIQAD inspectors Customs Airport Customs 1 Ho Chi Minh City (HCMC) Airport Customs Research Institutes Fruit and Vegetable Research Institute Laboratories 1 Publicly funded Public 2 The NAFIQAD Branch 1 laboratory in Haiphong City and Quality Assurance and Testing Centre 3 (QUATEST) from Ministry of Science and Technology 1

6 Producers Growers 6 Four small farms and two cooperative farms Processors/Exporters Pack houses 4 Four small pack houses. 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 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, Guidelines and Codes of Practice of the Codex Alimentarius Commission of the Food and Agriculture Organization of the United Nations and World Health Organization (CODEX) were taken into account in the context of the audit. 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 each section. 4 BACKGROUND Article 50 of Regulation (EC) No 178/2002 requires that information on foodstuffs and feed found to have public health implications is disseminated as notifications through the Rapid Alert System for Food and Feed (RASFF) to all MSs and to the exporting country. The finding of Salmonella is usually related to a foodborne outbreak after consumption of contaminated foodstuffs. From 2011 to the time of the audit there were some 34 notifications concerning Salmonella in herbs and spices from Vietnam. 5 FINDINGS AND CONCLUSIONS 5.1 RELEVANT NATIONAL LEGISLATION Legal requirements Article 46(1)(a) of Regulation (EC) No 882/2004 stipulates that EU controls are to have, inter alia, 2

7 particular regard to the legislation of the TCs. Article 10 of Regulation (EC) No 852/2004 requires that imported food meet the hygiene requirements laid down in Articles 3 to 6 of this Regulation. Findings The national legislation lays down the requirements for food hygiene, production, export, microbiological criteria for foodstuffs, registration of food establishments and food sampling. General food hygiene legislation is the responsibility of the Ministry of Health and specific requirements are laid down by the Ministry of Agriculture and Rural Development (MARD). The general requirements are given in the Food safety Law No 55/2010/QH 12 and by the Decrees No 38/2012/ND-CP, which detail the implementation of the Law. The law on Inspection No. 56/2010/QH12 and the Decree 86/2011/ND-CP specify some articles of the Law on Inspection and provide legal power to the Competent Authorities (CAs) including rights of access to the establishments and documents and powers to impose measures. Other relevant national legislation includes: Circular 15/2012/TT-BYT dated 12 September 2012 on general requirements for food safety to producers and businesses. Circular 07/2013/TT-BNNPTNT promulgating national technical standards for fresh fruit, vegetable and tea complying with food safety requirements in production. Circular 14/2011/TT-BNNPTNT on inspection and evaluation of agricultural materials and agro-fishery products business operators. Circular 59/2012/TT-BNNPTNT dated 9 November 2012 stipulating requirements and management of fruit, vegetable and tea production. Circular 05/2010/TT-BNNPTNT dated 22 January 2010 guideline on inspection and monitoring for food safety and hygiene of agricultural foodstuff before market circulation. Circular 74/2011/TT-BNNPTNT dated 31 October 2011 on tracing and recall of noncompliant agriculture products. Decision 379 /QD-BNN-KHCN dated 28 January 2008 promulgating the procedure of Good Agricultural Practice (GAP) for fresh fruit and vegetable in Vietnam. Decision 46/2007/QD-BYT of 17 December 2007 prescribing the maximum limits of chemical and biological contamination in food which are relevant to limits given in the EU regulations. Circular 05/2012/TT-BYT of 1 March 2012 promulgation of national technical regulation of microbiological contaminants in food The national legislation establishes the limits for microbiological contamination of plant products which are equal to the limits established in the EU legislation. The legislation is provided to the official inspectors in the form of letters and is publicly available on the web page of MARD. Conclusions: The Vietnamese legislation provides a basis for sufficient guarantees that vegetables including herbs and spices exported to the EU comply with the requirements at least equivalent to those set out by Articles 3 and 6 of Regulation No 852/2004 on food hygiene. 3

8 5.2 COMPETENT AUTHORITIES Legal requirements Article 46(1)(b) and (c) of Regulation (EC) No 882/2004 stipulates 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 MARD is the CCA within the context of this audit. The FVO team was informed by the central level of CAs that within the MARD there are several CAs competent in the context of this audit. The National Agriculture Extension Centre provides training and guidance to farmers on GAP and informs them about new developments. The Crop Production Department (CPD) is responsible for the official control at farm level as well as for the transport, storage and handling of primary products at the place of production, provided that this does not substantially alter their nature. In addition, the CPD is also responsible for the supervision of the Certification Bodies (CBs) which certify the implementation of GAP at farm level. The Plant Protection Department (PPD) is responsible for the official controls at the primary production level as well as the storage and transport of food of non-animal origin (FNAO). In addition the PPD has organised the implementation of the national monitoring program for food safety. It also inspects consignments for export and issues Health Certificates if these are required by the importing country. There is over 550 staff working in the areas of plant protection, plant quarantine, inspection, pesticide management and food safety. There are four Regional Plant Protection Centres (PPC) which direct and coordinate the Plant Protection Sub-departments' (PPSD) implementation of the monitoring, and official controls at the farms and in packing houses. The implementation of the official controls is undertaken by the 63 PPSD offices: working at local level (under the Provincial People s Committees). There are nearly 5,000 Plant Protection Officers and there are two laboratory centres for Pesticides Quality and Residue Analysis as well as microbiological contamination under the PPD. The National Agro-Forestry-Fisheries Quality Assurance Department (NAFIQAD) is responsible for carrying out investigations of non-compliant cases and proposing appropriate corrective actions. The structure of NAFIQAD is as follows: two Regional Authorities, six branches under which there are six NAFIQAD laboratories accredited according to ISO There are 63 provincial Agriculture Departments which are responsible for inspection and certification of food safety conditions for producers. The FVO team was informed that based on Circular 59/2012, the PPD is responsible for the official control of food hygiene in packing facilities which exclusively export their products. However the PPD inspectors met in Ho Chi Minh City (HCMC) were not aware of this duty and food safety controls in these facilities were not carried out. The CA stated that the NAFIQAD was tasked with carrying out random verification of food safety requirements in these facilities. Moreover in the Tien Giang province, the FVO team was informed that the official control of food safety on the farms is carried out by the NAFIQAD provincial inspectors and in the Long An province, the PPD carries out food safety inspections on farms, however in packing houses the NAFIQAD is the responsible CA. 4

9 The audit team was informed that all inspectors are required to have a university degree in any of the following disciplines: food technology, agronomy, veterinary medicine, plant health, food safety. All inspectors met had a relevant university degree and received additional training on food safety, Hazard Analysis and Critical Control Points (HACCP), auditing and sampling. The inspectors met in the Long An province stated that they would need further training on sampling for microbiological testing. Conclusions The CAs are designated by legislation, however in the pack houses which are exclusively exporting, the official control of food safety requirements is not carried out. The CAs have the authority to enforce the applicable legislation effectively and receive appropriate training, however staff require training on sampling for microbiological investigation. (See also Section 5.4). 5.2 OFFICIAL CONTROLS Legal requirements Article 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; The Codex Code of Hygienic Practice for Fresh Fruits and Vegetables (CAC/RCP , Rev. 2010) provides in Annex III 'Fresh Leafy Vegetables' recommended practices to prevent contamination of food from the key risks such as water, animals, workers and manure based soil amendments. Findings Registration of Establishments The registration of establishments is done by the Ministry of Investment and Planning. All CAs can receive data from this register on request Official Controls The PPD s Food Safety Division coordinates all activities with the four Regional PPC and the 63 PPSDs at Provincial level to carry out monitoring, official controls and sampling of FNAO. The National Technical Regulation on Microbiological Contamination in Food QCVN 8-3: 2012/BYT establishes the limits for microbiological contamination, which are equal to the limits in the EU legislation. The Circulars number 14 and number 59 include control procedures and checklists for inspections in different types of facilities. The FVO team confirmed that inspectors used these checklists during all observed visits. 5

10 Planning of the official controls is done by the provincial level of the PPD. The facilities are classified according to a checklist consisting of 47 criteria into three categories : Category A- 1 inspection per year Category B 2 inspections per year Category C - the frequency is established by the inspectors on the basis of results of previous inspections Each PPD and NAFIQAD provincial office is supervised once every five years by the central level of NAFIQAD. After verification, a report is issued which includes recommendations for improvement. The NAFIQAD also randomly supervises primary producers. The supervision is carried out by means of joint inspections with the PPSD inspectors. The NAFIQAD headquarters organises twice a year meetings with all provincial CAs. During the last meeting the representatives of the provinces were asked to focus their attention on primary production of herbs and spices. There are 17 private CBs which supervise the implementation of GAP. The certified farm receives the Vietnam GAP (VietGAP) certificate. However the number of certified farms is very low approximately 2-3 % of all growers/farmers. Since 2012 the NAFIQAD started to implement a national monitoring program covering a variety of issues, one of which is the post harvest microbiological control of herbs and spices for domestic consumption. However this programme is not completed yet Cultivation There is a booklet on GAP available for the production of fresh vegetables including herbs and spices and fruit which was provided to the trainers (e.g farm supervisors) by the National Agriculture Extension Centre. Farmers were provided with a leaflet on GAP. This leaflet provides information mainly on the use of pesticides and chemical fertilisers. From a microbiological point of view, the leaflet only covers the use of organic manure and procedures for the cleaning of boxes for the transportation of produce. The other potential sources of microbiological contamination were not addressed. All the farmers visited were aware of the existence of the Viet GAP scheme. Three out of five farms visited and the two cooperative farms were VietGAP certified. The FVO team was informed that there are approximately 5000 farmers producing leafy vegetables and herbs in the district of HCMC. The FVO team visited four farms in HCMC producing leafy vegetables and herbs and one cooperative farm. One visited farm was operated by one of the visited packers. The cooperative farm and two farms visited were VietGAP certified and one was in the process of being VietGAP certified. However the FVO team noted certain non-compliances which could affect the microbiological safety of produce. The main issues relate to insufficient protection of the source of 6

11 the irrigation water in all farms visited against cross contamination from the environment. The sources of water were not sufficiently protected against faecal contamination. The construction and layout of the toilet used by the staff on one visited farm was not adequate to prevent leakage and overflow. Moreover the irrigation water was never tested from a microbiological point of view on any of the visited farms. The visited farms were small ( square m) and medium sized (3000 square m). All farms visited were family run and families lived on site. In Tien Giang province there are hectares of land cultivated for vegetables and the average production is tons per year. In Tien Giang province, the FVO team visited one cooperative farm consisting of 28 farmers with 6.8 hectares of land which is VietGAP certified. The average daily production is two tons of leafy vegetables. The farmers bring their product daily to the collection centre. There, the produce is washed on site and packed in boxes and sold to another cooperative. The owners were not aware if their product is exported. The farms use river water for irrigation, which is pumped into man made ponds for storage nearer the place of use in the vegetable growing areas. These ponds are not protected against pollution from the environment. In the fields, the staff has no access to toilet facilities. The CA confirmed that samples were neither taken from the irrigation water nor from the produce for microbiological testing. In the Long An province there are 8000 hectares used for production of vegetables producing 40 tons of produce per hectare. The average size of farm is 0.2 hectares. In the Long An province the FVO team visited one cooperative farm, which has a membership of 50 farmers and also operates a pack house. The total land is 10 hectares. The produce is sold on the local market or to brokers. The cooperative farm is not VietGAP certified, however during the past year it had been certified by the PPD as compliant with food safety requirements. However, the FVO team noted that there were a number of non-compliances such as no hand drying facilities in the toilets, irrigation water was not protected against pollution from the environment and the packing house construction could not assure the prevention of pest access. In each province, the visited farmers keep records about their activities use of fertilisers, pesticides and harvest. The FVO team checked such records and considered them adequate. After harvest the produce is immediately delivered by farmers to the processing facilities. The main means of transport is motorbike. The produce is placed in open plastic bags or only partially covered by plastic sheets. The cooperative farm visited in HCMC collects produce from members of the cooperative daily. Produce is placed in plastic boxes and transported on a covered lorry. The plastic boxes were then cleaned on the cooperative farm with water from a public supply Processing and Storage The audit team visited four medium sized pack houses; one of them implemented a HACCP system with two critical control points, one of which addresses microbiological issues. With the exception of one, the hygienic standard of all visited facilities fulfilled the hygienic requirements set out in the relevant Codex alimentarius guide. In this particular facility, the construction could not assure the prevention of pest access as required by point of the Codex Alimentarius Code of Practice CAC/RCP General principles of food hygiene. The traceability in all facilities was adequate, 7

12 it was possible to trace produce back to the farms. Two packers used water from their own well; one was supplied by the public water system. The water from own wells was regularly checked from a microbiological point of view. One out of four visited facilities were regularly checked by the CA, however, at the time of the audit, no official sampling for microbiological investigation had been undertaken.( See also section 5.2). Two visited facilities started sampling the final product in 2011 and 2013 for microbiological testing. On the request of the laboratory, 1kg as sample was taken by the FBO. No non-compliant samples were detected. The visited facilities exported to Denmark, Austria, Norway, Germany, Belgium, France and Switzerland. In one visited facility, the FVO team was provided with the information, that its average export to the EU is 43 tons per year in another one ton daily. The customs could not provide the FVO team with specific information on the volume of exports of vegetables, including herbs and spices, to the EU. According to the information provided by customs, the main exports go to the Czech Republic, Germany, Belgium and the Netherlands. The FVO team noted that at one visited facility and at the cooperative farm, the produce was transported under conditions which would not minimise the potential for microbial contamination. (See also section 5.2.3). In HCMC the FVO team was provided with information that there are 19 exporters of vegetables to the EU and two of them have implemented HACCP. In the Long An province there are four pack houses and, according to the information provided by the CAs, all have implemented GHP Non- conforming products No non-compliant products were detected by the CAs at time of the audit. Conclusions There is information on GAP available to producer s growers and processors of fresh herbs and vegetables. However, the information does not contain all relevant details concerning microbiological contamination. The farmers, processors and exporters are covered by official food hygiene control. However the facilities which exclusively export their produce are not regularly checked from the point of view of food hygiene. Therefore there is no CA to ensure that those establishments comply with the requirements of Article 4 of Regulation (EC) No 852/2004 in conjunction with Article 10 of the same Regulation and the exact level of implementation of procedures based on HACCP principles and GMP in the above mentioned establishments is not known to the CA. Traceability of the products was ensured as required by Section IX product information and 8

13 consumer awareness of the Codex Alimentarius Code of Practice CAC/RCP General principles of food hygiene. In the visited farms not all the principles established in the Codex Alimentarius Code of Practice CAC/RCP for fresh fruits and vegetables were implemented. In the visited processors, Good Manufacturing Practice (GMP) principles established in the Codex Alimentarius Code of Practice CAC/RCP General principles of food hygiene were followed with some shortcomings concerning transportation of produce which is not in compliance with the requirements set out in Section VIII of the above mentioned standard and prevention of the pest access which is not in compliance with the requirements set out in Point of the above mentioned standard. 5.3 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. Findings Currently when a consignment is ready for export, the FBO notifies the relevant PPD for a preexport check. This check is done on spot by the PPD official and only addresses phytosanitary aspects. The PPD issues a phytosanitary certificate and this is the basis on which the product is released by customs. No food safety checks are carried out. The produce is exported by air in polystyrene boxes with added ice to maintain temperature. The transportation to the EU takes approximately hours. Conclusions There is at present there is neither a mandatory, nor an official system of Salmonella analysis in place for fresh herbs and spices for export to the EU. 5.4 METHOD OF SAMPLING Findings In 2012 the results of analysis of 50 official samples of herbs, spices and vegetable s taken by food inspectors in HCMC and Hanoi confirmed that all samples are in line with the microbiological limits given in the Vietnamese legislation. The FVO team observed a demonstration of sampling for microbiological investigation on a cooperative farm in Tien Giang province. The inspectors confirmed that this sampling for 9

14 microbiology was the first ever undertaken by them. The sampling was undertaken using a sterile scissors and a plastic bag, which was not labelled as sterile. The sample was taken randomly from the growing area. The sample was not weighed, the inspector stated 250 grams are required by laboratory and according to her experience the weight was sufficient. The sample was labelled and sealed, placed in a polystyrene cool box and sent to the laboratory without any protocol. There was no sampling protocol left with the FBO. The temperature of the sample was not checked and the inspector was not equipped with a thermometer. Conclusions The observed sampling for microbiological testing did not guarantee the analytical validity of the sample taken. 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 on the Design, Operation, Assessment and Accreditation of Food Import and Export Inspection and Certification Systems lay down that inspection services should utilize laboratories that are evaluated and/or accredited under officially recognized programmes to ensure that adequate quality controls are in place to provide for the reliability of test results. In accordance with Guidelines of CODEX CAC/GL , point 3, the laboratories should comply with ISO Findings General Organisation Currently, there are two PPD and six NAFIQAD official laboratories for performing microbiological analysis. All official laboratories are accredited to ISO by the Vietnam Bureau of Accreditation. The FVO team was informed, that the Pasteur Institute in Hanoi plays the role of the National Reference Laboratory for microbiological testing Laboratories visited The FVO team visited two laboratories, namely the NAFIQAD- branch 1 in Haiphong City and Quality Assurance and Testing Center 3 (QUATEST) laboratory which is under the Ministry of 10

15 Science and Technology. Both visited laboratories were well equipped, sufficiently staffed and accredited to ISO The NAFIQAD- branch 1 laboratory A general evaluation was made of the laboratory's systems for sample reception, processing and reporting. In the sample reception area, samples are brought in by the inspection staff either in polystyrene boxes or in cool boxes with a label. The laboratory has a laboratory information management system in place. In the reception area the samples are labelled and immediately transferred to the microbiological laboratory. The temperature of the sample is neither checked on arrival nor in the laboratory. The procedure for the sample reception includes criteria for the reception of samples however it does not include instructions on how to proceed in cases when the sample does not fulfil acceptance criteria. The laboratory is accredited to ISO and has also been accredited by the Norwegian accreditation body under the aegis of the United Nations Industrial Development Organisation (UNIDO) until August The laboratory has in place a quality manual. The laboratory has six staff including the head of the department, three of whom have a university degree. Training sessions have been organised by the laboratory. Three members of the staff participated in microbiology training in the EU and Thailand. Evidence of these training sessions was shown to the audit team. The laboratory uses the international standard method for Salmonella (ISO6579:2002). The laboratory has participated in international proficiency test (PT) schemes (eg. Australia) with good results. The FVO team was informed that this laboratory has not tested any samples of herbs or spices during the previous two years. The FVO team was informed that the laboratory had only analysed one non compliant sample of leafy vegetable Quatest 3 laboratory A general evaluation was made of the laboratories' systems for sample reception, processing and reporting. In the sample reception area, samples are brought in by the inspection staff either in polystyrene boxes or in cool boxes with a label. In the reception area the samples receive identification numbers, are labelled and immediately transferred to the microbiological laboratory. The temperature and weight of the sample is checked on arrival. The clients sign a protocol, agreeing with the investigation being undertaken even when the acceptance criteria are not in line with the legal requirements. The laboratory is accredited to ISO since 1996 and has also been accredited by the Norwegian accreditation body under the aegis of UNIDO until August The laboratory has 11 staff including the head of the department, seven of whom have a university degree. Training sessions have been organised by the laboratory. One member of the staff participated on a training in Malaysia for a method of validation of measurement of uncertainty in a microbiological laboratory. Evidence of these training sessions was shown to the audit team. The laboratory uses the international standard method for Salmonella (ISO6579:2002). The laboratory has participated in international PT schemes with good results. The FVO team was informed that the laboratory has tested approximately 770 samples of vegetables in The FVO team was informed that the laboratory had detected no non compliant sample of vegetable and this laboratory has not tested any samples of herbs or spices in

16 The audit team were informed that only 50 official samples of herbs and spices were analysed for Salmonella in Vietnam since Conclusions Both laboratories are accredited to ISO and have adequate systems for traceability of received samples. The methods used by the official laboratories for Salmonella detection are accredited. Small shortcomings concerning sample reception were noted. No samples of herbs or spices were analysed for Salmonella by the two laboratories visited in the past year. 5.6 RESPONSE TO RASFF NOTIFICATIONS Legal requirements Point 6 of Codex Guidelines CAC/GL 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 procedure for handling RASFF notifications is not clearly defined; the Sanitary and Phytosanitary office of the Internal Cooperation Department of the MARD is the designated contact point for receiving RASFF notifications. Notifications are subsequently handled by PPD or NAFIQAD. The FVO team was informed at the central level that there is no written procedure in place for RASFF follow-up. However, the NAFIQAD official met in HCMC stated that a procedure is described in Circular 74/2011. The first RASFF notification was received by the HCMC NAFIQAD district office on 23 and 27 May One RASFF notification concerned a visited FBO, however the FBO had not received any written information at the time of the audit and was informed by telephone on the morning of the audit team's visit. The NAFIQAD inspector met in HCMC stated that it is planned to carry out follow-up investigations of received notifications in the 3rd or 4th quarter of At the time of the audit, there was no evidence of any of the 34 RASFF notifications relating to Salmonella having been followed up. Conclusions The system in place for the follow-up of RASFF notifications by the CAs is inadequate. 12

17 6 OVERALL CONCLUSIONS Overall, it can be concluded that the Vietnamese CAs have put in place certain official controls for the production and processing of herbs and spices. However there is no official control carried out for food hygiene requirements in those facilities which exclusively export their products. There is neither a mandatory nor official system of Salmonella analysis in place for herbs and spices for export to the EU. Only the phytosanitary aspects are checked prior to export. The official control system is based on an adequate legal framework and includes documented control procedures, obligations for food facilities to register and implement food safety requirements. However there was a low take-up of GAP and GHP and poor information re microbiology. The effectiveness of the system is undermined by very limited official sampling for Salmonella contamination of herbs and spices. The laboratories visited were accredited and fit for the purpose for official analysis. However, the analysis of herbs and spices for Salmonella were never undertaken. There was no evidence of any of the thirty four RASFF notifications relating to Salmonella haveing been followed up. Consequently, there is a possibility that products cleared in Vietnam for export to the EU could be rejected at EU borders due to contamination with Salmonella. 7 CLOSING MEETING A closing meeting was held on 14 June 2013 with representatives of the CCA. The audit team presented the main findings and preliminary conclusions of the audit. The CA s 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 herbs and spices intended for export to the EU comply with the relevant requirements of food law, as laid down in Article 11 of Regulation (EC) No 178/2002, or their equivalent, ensuring in particular that such herbs and spices do not contain Salmonella. 2. Ensure the establishment of a system for the reception and follow up of RASFF notifications on herbs and spices exported from Vietnam to the EU to satisfy the requirements of point 6 of CODEX Guidelines CAC/GL The competent authority's response to the recommendations can be found at: 13

18 14

19 ANNEX 1 - LEGAL REFERENCES Legal Reference Official Journal Title Reg. 178/2002 OJ L 31, , p Reg. 852/2004 OJ L 139, , p. 1, Corrected and re-published in OJ L 226, , p. 3 Reg. 882/2004 OJ L 165, , p. 1, Corrected and re-published in OJ L 191, , p. 1 Reg. 2076/2005 OJ L 338, , p Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules Commission Regulation (EC) No 2076/2005 of 5 December 2005 laying down transitional arrangements for the implementation of Regulations (EC) No 853/2004, (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council and amending Regulations (EC) No 853/2004 and (EC) No 854/

20 Annex 2 Recommendations and Standards Quoted In The Report Reference Number Full title CAC/RCP CAC/RCP CAC/GL CAC/GL CAC/GL Code of Hygiene Practice for Fresh Fruits and Vegetables (CAC/RCP , Rev General Principles of Food Hygiene (CAC/RCP ) Guidelines for the exchange of information between countries on rejections of imported food (CAC/GL ). Guidelines on the design, operation, assessment and accreditation of food import and export inspection and certification systems (CAC/GL ) Guidelines for the Assessment of the competence of testing laboratories involved in the import and export control of food (CAC/GL ) Publication details org/standard/en org/standard/en org/standard/en org/standard/en org/standard/en 16