EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL

Transcription

1 EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Directorate F - Food and Veterinary Office Ares(2014) DG(SANCO) MR FINAL FINAL REPORT OF AN AUDIT CARRIED OUT IN SINGAPORE FROM 14 TO 21 JANUARY 2014 IN ORDER TO EVALUATE THE CONTROL SYSTEMS IN PLACE GOVERNING THE PRODUCTION OF FISHERY PRODUCTS INTENDED 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 a footnote.

2 Executive Summary This report describes the outcome of a Food and Veterinary Office audit in Singapore carried out from 14 to 21 January 2014, as part of its programme of audits in third countries. The objective of the audit was to evaluate the public health conditions for the production of fishery products intended to be imported into the EU. The audit covered the relevant EU legislation for the public health sector. This audit was conducted in the context of a desk study on smaller third country trading partners for fishery products. The report concludes that overall, the structure and standards set and their documented operational procedures provide for an acceptable official control system for fishery products, which is implemented in a satisfactory way. Since the last Food and Veterinary Office audit in 2004 improvements have been noted in relation to the traceability of raw materials, frequencies of inspections and analytical methods used. Nevertheless at one establishment competent authority inspectors had not ensured that EU requirements were being met in relation to operational hygiene, maintenance and process flow despite being aware of these problems for some time. The report addresses to the Singaporean competent authority a number of recommendations aimed at rectifying identified shortcomings and enhancing the control system in place. I

3 Table of Contents 1 INTRODUCTION OBJECTIVES AND SCOPE OF THE AUDIT LEGAL BASIS FOR THE AUDIT BACKGROUND GENERAL BACKGROUND PRODUCTION AND TRADE INFORMATION RAPID ALERT SYSTEM FOR FOOD AND FEED (RASFF) NOTIFICATIONS FINDINGS AND CONCLUSIONS LEGISLATION COMPETENT AUTHORITY NATIONAL PROVISIONS AND PROCEDURES FOR LISTING ESTABLISHMENTS EXPORTING TO THE EU OFFICIAL CONTROLS OF PRODUCTION AND PLACING ON THE MARKET OFFICIAL CONTROLS OF PRODUCTION AND PLACING ON THE MARKET...6 PRIMARY PRODUCTION...7 LANDING AND FIRST SALE...7 FACILITIES...7 CHECKS ON THE EU ELIGIBILITY OF RAW MATERIALS...8 OFFICIAL CONTROLS ON WATER SUPPLY OFFICIAL CONTROLS OF FISHERY PRODUCTS FOLLOW-UP OF RASFF NOTIFICATIONS OFFICIAL CERTIFICATION LABORATORIES OVERALL CONCLUSION CLOSING MEETING RECOMMENDATIONS...12 ANNEX 1 - LEGAL REFERENCES...14 II

4 ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT Abbreviation AERG AVA CA DG SANCO EC EU EU listed FBO FERG FVO FRSG HACCP IFAST ISO/IEC LG OJ QIG RAG RASFF SOP TRACES TVB-N VPHL Explanation Agri Establishment Regulation Group - AVA Agri-Food and Veterinary Authority of Singapore Competent Authority Health and Consumers Directorate General of the European Commission European Community European Union Facility approved by the CA for EU fishery products export and listed on the internet site of DG SANCO Food business operator Food Establishment Regulation Group - AVA Food and Veterinary Office of the European Commission Food Supply Resilience Group AVA Hazard Analysis Critical Control Points AVA database for registration, approval and inspection results International Organisation for Standardisation Laboratories Group - AVA Official Journal of the European Union Quarantine and Inspection Group - AVA Regulatory Administration Group - AVA. Rapid Alert System for Food and Feed Standard Operating Procedure Trade Control and Expert System Total volatile basic nitrogen Veterinary Public Health Laboratory III

5 1 INTRODUCTION The audit took place in Singapore from 14 to 21 January 2014 and was undertaken as part of the Food and Veterinary Office's (FVO) audit programme. The audit team comprised two inspectors from the FVO. Representatives from the Competent Authority (CA) accompanied the audit team during the whole audit. 2 OBJECTIVES AND SCOPE OF THE AUDIT The objective of the audit was to evaluate whether the official controls put in place by the CA can guarantee that the conditions of production of fishery products in Singapore destined to be imported into the European Union (EU) are in line with the requirements laid down in EU legislation, and in particular with the health attestations contained in the health certificate laid down in Appendix IV to Annex VI to Commission Regulation (EC) No 2074/2005. In terms of scope the audit focused on the organisation and performance of the CA, the export certification procedure, the official control system in place covering production, processing and distribution chains applicable to fishery products to be exported to the EU. Accordingly, relevant aspects of the EU legislation referred to in Annex 1 were used as technical basis for the audit. In pursuit of this objective the audit team proceeded as follows: an opening meeting was held in Singapore on 14 January 2014 with the CA. At this meeting the audit team confirmed the objectives of, and itinerary for the audit, and requested additional information required for the satisfactory completion of the audit; the following sites were visited: COMPETENT AUTHORITY Central and inspection levels 3 Agri-Food and Veterinary Authority (AVA) LABORATORY VISITS Official Laboratory 1 AVA's official laboratory at the Veterinary Public Health Centre LANDING AND FIRST SALE Landing site 1 Jurong Fishery Port FACILITIES HANDLING FISHERY PRODUCTS Processing Plants 4 with attached cold-rooms Stand alone Cold-stores 1 3 LEGAL BASIS FOR THE AUDIT The audit was carried out under the general provisions of EU legislation and, in particular: Article 46 of Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004, on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare. 1

6 Full EU legal references are provided in Annex 1 EU legal acts quoted in this report refer, where applicable, to the last amended version. 4 BACKGROUND 4.1 GENERAL BACKGROUND Singapore is presently listed in Annex II to Commission Decision 2006/766/EC establishing the list of third countries and territories from which imports are permitted of fishery products for human consumption, other than those covered by Annex I. Singapore is also listed in the Annex to Commission Decision 2011/163/EU and therefore can export aquaculture fishery products to the EU. The last export of fishery products derived from aquaculture from Singapore to the EU was in Article 11(4)(k) of Regulation (EC) No 854/2004 establishes that EU controls carried out in the context of drawing up or updating lists of third countries from which imports of products of animal origin are permitted, shall have regard to the results of EU controls carried out in the third country, in particular the results of the assessment of the CAs, and the actions they have taken in the light of the recommendations addressed to them following a EU control. The last fishery products audit took place in 2004 (ref. DG(SANC0)/2004/7340) had highlighted in particular deficiencies in relation to import controls, and the report - published on the Health and Consumers Directorate-General (SANCO) Internet site - made a number of recommendations in respect of the action required to the CA. Written guarantees were received from the CA in relation to the implementation of actions aimed at addressing those recommendations. The current audit was conducted following a 2013 FVO desk study carried out on smaller third country trading partners (export volume below 5,000 tonnes/year). 4.2 PRODUCTION AND TRADE INFORMATION According to information provided by the CA Agri-Food and Veterinary Authority of Singapore (AVA) and DG SANCO's trade database TRACES the main fishery products exported to the EU are Swordfish (Xiphias Gladus) and Surimi. The main importing Member States are Italy, Spain, and Greece. According to the information provided by the CA, all fishery products were imported into Singapore as raw material, processed and later on exported to the EU. According to the list established by the CA and available on the DG SANCO website (list valid as of 15/01/2013), imports of fishery products from Singapore into the EU are authorised from a total of five processing establishments and one cold store. No freezer or factory vessels are listed. This list is available on the SANCO web site at the following address: Table 1 summarises the exports from Singapore of fishery products to the EU. 2

7 Table 1 - Exports of fishery products from Singapore to the EU in tonnes 2013 (source TRACES/AVA) Species (Common name) Scientific Name 2013 Sword Fish Xiphias Gladius Surimi based products Nemipterus Japonicus, Sepia spp TOTAL RAPID ALERT SYSTEM FOR FOOD AND FEED (RASFF) NOTIFICATIONS Since 2010 there has been one RASFF alert for fishery products originating from Singapore. In 2012 the EU limits for mercury were exceeded in frozen Shortfin Mako (Isurus Oxyrhynchus). There have been no imports of this species since FINDINGS AND CONCLUSIONS 5.1 LEGISLATION Legal requirements Article 46(1)(a) of Regulation (EC) No 882/2004 states that Commission experts may carry out official controls in third countries in order to verify the compliance or equivalence of third countries legislation with the relevant EU legislation. Article 11(4)(a) of Regulation No 854/2004 states that regard shall be given on the legislation of a third country exporting to the EU. Findings The audit team reviewed the information provided by the CA in response to the pre-audit questionnaire and handed over during the FVO audit. The legislation and standards to ensure the food safety for exported fishery products include: the Agri- Food and Veterinary Authority Act establishes AVA and sets out its powers; the Wholesome Meat and Fish Act regulates the processing, packing, inspection, import, distribution, sale, transshipment and export of fishery products; the Fisheries Act makes, inter alia, provisions for the control of marketing and distribution of fish and the use and control of fishing harbours/landing sites; the Sale of Food Act fixes standards for foodstuffs and regulates food processing establishments. The Feeding Stuff Act provides the legal base for controls on feeding stuffs for animals. For exports to the EU a set of standards for maximum limits in fishery products concerning microbiological 3

8 limits, residues and contaminants is in place in line with the EU requirements. Conclusions From the limited review of the Singaporean legislation and standards applied to EU exports the FVO team concluded that they are largely in line with EU rules. They provide an adequate framework for CA controls to provide the necessary guarantees with regard to EU requirements. 5.2 COMPETENT AUTHORITY Legal requirements Article 46 of Regulation (EC) No 882/2004 stipulates that EU Controls in third countries shall verify compliance or equivalence of third countries' systems with EU food law. These controls shall have particular regard to points b) to (e), (g) and (h) of the aforementioned article. Findings Structure and organisation AVA is the only competent authority for the control chain for fishery products for EU export. AVA is responsible for the food safety of all primary production chain. It is composed of two main sections, each of which is comprised of five groups which are further divided into a number of departments/ sections. The relevant groups for fishery products are: Food Establishment Regulation Group (FERG), Food Supply Resilience Group (FRSG), Laboratories Group (LG), Agri Establishment Regulation Group (AERG) and the Regulatory Administration Group (RAG), Quarantine and Inspection Group (QIG). FERG regulates and grades processing establishments, issues licences and conducts surveillance inspections and sampling; FSRG oversees the operations of Singapore's fishery ports; LG analyses official samples; AERG regulates and supervises primary production including aquaculture farms, landing sites and wholesale markets for fishery products; RAG coordinates international relations and standards, carries out risk assessments, investigations and legal enforcement; QIG is responsible for import control and inspection. There are no regional or local branches due to the size of Singapore (land area 712 km 2 ). Powers, Independence and Supervision The legal base empowers the CA to have access to establishments. The CA can grant, seize and withdraw licences and approvals in their field of competence. The audit team saw evidence that the CA can approve and withdraw approvals from establishments. All AVA staff are civil servants and must follow a specific code of conduct for impartiality, independence and transparency and notify 4

9 any conflict of interest concerning their official tasks. For inspectors there is a two-year rotation system in place to enhance their independence. Audits for renewal of approvals are carried by the staff other than those who do the routine inspection of the establishment concerned. Staff are subject to monthly and annual reports and cross-checks on their inspection reports. Training AVA provided the audit team with information of a continuous training programme for their staff. The courses are obligatory and comprise auditing, sampling and inspection. There are modules for European Food and Feed law and applicable EU standards for fishery products, certification systems, poisonous fish, parasites, hygiene and technology. The FVO team examined several AVA staff training files which showed evidence of regular participation in such training courses. The minimum level of qualification for inspectors is a bachelor degree. Documented Control Procedures Documented control procedures were drafted by FERG and are used by the inspectors at the premises visited by the audit team. They comprised checklists and Standard Operation Procedures (SOPs) for approval and routine inspections at establishments. They covered also the specific requirements and standards for export to the EU. The audit team could verify that the procedures were updated. For fish farms (primary production) AERG have issued procedures for approval requirements, water quality, veterinary drug and feed use, residue testing and traceability. The audit team noted that the staff followed the procedures as prescribed. Conclusions The CA responsible for official controls on fishery products is clearly designated with adequate powers to perform official controls and enforcement. The staff knowledge of EU requirements was found satisfactory and adequately maintained by regular training. Updated documented procedures are in place to support official staff with their duties to guarantee the compliance of fishery products with EU equivalent standards. 5.3 NATIONAL PROVISIONS AND PROCEDURES FOR LISTING ESTABLISHMENTS EXPORTING TO THE EU Legal requirements Article 12(1) and (2) of Regulation (EC) No 854/2004. Part I.11. of the model health certificate for imports of fishery products intended for human consumption established in Appendix IV to Annex VI to Regulation (EC) No 2074/2005. Findings AVA has a procedure in place to register and list processing establishments and cold stores. There are no freezer vessels or factory vessels under Singaporean flag for EU exports. Landing sites are approved and inspected by FSRG. Food business operators (FBOs) must apply for an approval to run a food establishment as well as for EU export. The approval is given by the CA based on a documentary assessment and an inspection visit to evaluate the level of compliance with the rules for food processing establishments. FBOs must have a HACCP plan, own checks system and a quality assurance system in place. Approval is valid for one year. To maintain their approval and listing for EU 5

10 exports, FBOs must apply for renewal every year. The list of EU approved facilities is sent to Commission Services and updated regularly. Approval documentation was available at all establishments visited by the audit team. The documentation identified the activities for which each establishment was approved. Conclusions The rules and procedures in place for listing of facilities for the EU export are appropriate and provide satisfactory guarantees in line with EU requirements. 5.4 OFFICIAL CONTROLS OF PRODUCTION AND PLACING ON THE MARKET Legal requirements Article 5 of Regulation (EC) No 852/2004. Article 12(2) of Regulation (EC) No 854/2004. Requirements contained in point II. 1 and point n.2 of the model health certificate for imports of fishery products intended for human consumption established in Appendix IV to Annex VI to Regulation (EC) No 2074/2005. Article 11(4) of Regulation (EC) No 854/2004 establishes that EU controls carried out in the context of drawing up or updating lists of third countries from which imports of products of animal origin are permitted, shall take particular account of the extent and operation of official controls on imports of animals and their products amongst other factors: the extent and operation of official controls on imports and their products (Article 46(1)(g) of Regulation (EC) No 882/2004; the assurances which third countries can give regarding equivalence to EU requirements (Article 46(1)(h) of Regulation (EC) No 882/2004); the requirements set out in Section VIII of Annex III of Regulation (EC) No 853/2004; Regulation (EC) No 1333/2008 on food additives. Requirements of Chapter VII in Annex II of Regulation (EC) No 852/2004. Requirements of Council Directive 98/83/EC on water for human consumption. Findings Official controls of production and placing on the market Official control system in place The official control system is implemented by the CA by administrative orders, work instructions and an annual sampling plan. The system covers the entire production chain including imports. FSRG is responsible for the control of the two fishery harbours in Singapore, the fish auctions and 6

11 aquaculture farms. Aquaculture farms must be approved and undergo regular inspections. FERG is responsible for the grading and surveillance inspections of food establishments. All food processing establishments are inspected and audited according to their grading A - D. The categories are determined by a points system based on several criteria. The inspection frequency for grade D (insufficient) is monthly. Grade A with no or only minor shortcomings are inspected once in four months. Category D is considered to be monitored closely to improve the situation immediately. The grading exercise is carried out every year. All inspection and analysis results are fed into a data-base called IFAST. The audit team reviewed more than thirty inspection and analytical reports on the spot and all were correctly stored in the system. Primary production The audit team did not visit an aquaculture farm. The audit team assessed at the central office the control system for aquaculture farms with following findings. Aquaculture farms must be approved and undergo regular inspections. The audit team received documentary evidence that these controls are carried out four times a year by AVA. The analyses carried out covers contaminants and residues of, among others, veterinary drugs, heavy metals as well as plant protection products in fish and feed samples. One farm is approved for EU export. It produces Barramundi (Lates calcarifer). There have been no exports to the EU since No EU exports of aquaculture produce are planned for the next future. Landing and first sale The audit team visited the Jurong fishery harbour. The landing site is divided into three parts: one part is for the domestic market with an fish auction site while another part is for freezer vessels mainly landing frozen fish for export establishments. AVA staff is present there permanently round the clock and has its own offices. Approximately 25% of the landings are physically checked by AVA during unloading. The third part is a private, used by one EU approved processing establishment exclusively for their own production. There are no official checks at landing. Checks of primary material are conducted at the establishment during inspections. The audit team noted that one bulk reefer carrier landed there with frozen swordfish which was exported later to the EU. Temperature control checks were conducted for this consignment and were in compliance with the requirement of -18 C or lower. Facilities The audit team visited four production establishments with cold-rooms attached and one standalone cold store listed for export to the EU. In all facilities an EU export approval document was present. The audit team noted that EU listed facilities are inspected with the stipulated frequency. During these visits a checklist based on EU requirements is used as a guidance to verify if the FBOs operate according to EU legislation. Lists of approved EU establishments were available to AVA staff. The audit team reviewed several reports of inspections and verified that non-conformities had been identified and follow-up carried out in most cases. Reports showed also that the set inspection frequency was met. When deficiencies are identified the FBO is required to present an action plan with corrective actions within a set deadline. 7

12 In three establishments the level of compliance was satisfactorily. Notable deficiencies were found in one processing establishment and at the cold-store. At the cold-store the temperature of incoming goods was not measured and recorded in contravention of their HACCP programme. The cold store did not have automatic temperature records. Condensation was dripping from the ceiling under which containers of frozen raw fish had to pass when heading to a production unit. At one processing establishment the space for operations was restricted in relation to the daily turnover. As a result the product flow, as per HACCP/ drawings was not being has not been respected as frozen products were transferred from one cold room to processing rooms outside the main premises. Raw material was handled in a clean production area. Some materials used in the production such as containers, plastic crates, packaging material, small equipment, were stored outside the establishment. Some doors to the outside were open and not pest proof and floor and ceilings had structural defects. Water was pooling in some areas. In the cold room attached to this processor, raw material and final products were stored together without clear separation and some of the fishery products therein were unprotected. The temperature was not recorded automatically and the ad hoc thermometer showed -8 C. Manual records showed that -16 C was the normal level maintained. In another cold store -14 C was measured during the audit. Following a review by the audit team of AVA inspection reports going back several years it was noted that most of the above short-comings had previously been recorded by inspectors without appropriate follow-up. The A-grade level has been maintained. HACCP plans at the establishments visited were generally satisfactory. In one establishment the audit team found that the required temperature for raw material in finished products was -16 C and not -18 C as stipulated in national and EU standards. In another facility the HACCP system did not describe any critical limits for the Critical Control Point for the temperature of frozen goods. In three of the four establishments visited there were either no automatic temperature recorders or the paper records were not available. Own-checks were performed by the establishments and found in general to be adequate. They included testing of microbiological parameters in products (total viable count, E coli, S Aureus, Salmonella) as well as analyses of water and ice and environmental checks (air, contact surfaces). Testing of chemical parameters like histamine and heavy metals are also carried out by the FBOs with the exception of lead. In one establishment with production of ready-to-eat products the quality system described Listeria monocytogenes as a hazard, but no own-checks or official sampling was performed to detect this hazard. Checks on the EU eligibility of raw materials QIG carries out import inspections. Imported fishery products/ materials are divided in two categories. High risk products undergo a documentary, identity and physical check. Items include live and frozen oysters, live cockle, frozen cooked crabmeat and prawn meat for the domestic market. They require a health certificate for importation. Other fishery products such as frozen finfish are not checked on import. There is only an import permit required for each consignment which is delivered upon a documentary check by AVA. Imported fishery products are randomly analysed based on an annual sampling plan. The EU eligibility of imported raw material is confirmed via official health certificates or catch certificates. The audit team checked the origin of the raw material for all EU exports for the year Although the catch certificates showed that the raw material (mainly sword fish) was originating from EU approved export establishments or vessels, in several cases a declaration in relation to EU food safety status of the raw material was missing. This 8

13 is in contrary to the AVA SOP which states that, for export, a health certificate for the raw material must always be present. AVA declared that consignments transshipped in Singapore would not be certified by them for EU export. The audit team compared all 2013 fishery products consignment documents filed in the customs database as exported to the EU with the inspection database. There were no notable discrepancies. A few small consignments were exported without health certificate as 'commercial samples'. Official controls on water supply Water and ice are tested at establishments at least once a year for chemical and microbiological parameters in line with EU standards. Tests for Enterococcus were not carried out. Records of the analyses in 2013 were available in the IFAST system and showed no non-compliances. Conclusions The detailed control system in place covers the entire production chain of fishery products for EU export and allows the CA to provide reliable guarantees with regard the EU rules applicable to the official control of production of fishery products. However, these guarantees are weakened by the shortcomings noted with regard to the lack of follow-up and inadequate grading of an establishment with serious persistent hygiene problems. The lack of automatic temperature registration and shortcomings in the cold chain could lead to increased risks for the food safety of export consignments. The monitoring system for water is in place but does not cover analyses for Enterococcus. The HACCP systems were worked out in detail and has been satisfactorily implemented but some errors concerning temperature control in the HACCP plans at two facilities weakens their reliability. The control of the EU eligibility of imported raw materials is performed comprehensively but the required supporting documentation was incomplete in some cases Official Controls of fishery products Legal requirements Point II.1 of the model health certificate for imports of fishery products intended for human consumption established in Appendix IV to Annex VI to Regulation (EC) No 2074/2005, in particular official controls laid down in Annex III, Chapter II of Regulation (EC) No 854/2004. Findings The CA monitoring plan covers freshness indicators (TVB-N), histamine, pesticides, heavy metals, benzo(a)pyrene, radionuclides and dioxins. In addition to the monitoring plan, AVA takes samples of consignments of final products before export. They are always checked for freshness indicators, histamine, microbiological criteria, parasites, heavy metals, benzo(a)pyrene and dioxins. Lead content is not included as part of pre-export analysis but covered by the annual sampling plan. The results of these tests reviewed by the audit team were compliant with EU requirements. Organoleptic checks are carried out in case of suspicion during routine or export inspections. At the establishments visited there was no risk of the presence of poisonous species. The summary of analyses results made available to the FVO team showed that in general all EU required parameters, other than lead, were checked, the results were in line with EU requirements and the frequencies of checks were appropriate. Testing fishery products for dioxins has been implemented during 2013 and four samples were tested for dioxins with results in line with EU requirements. 9

14 Conclusions The official controls on fishery products intended for EU export can be considered as adequate. 5.5 FOLLOW-UP OF RASFF NOTIFICATIONS Legal requirements Article 11(4) of regulation (EC) No 854/2004 establishes that EU controls carried out in the context of drawing up or updating lists of third countries from which imports of products of animal origin are permitted, shall particular account of amongst other factors: any experience of marketing of the product form the third country; the results of import controls carried out. Findings The audit team noted that incoming RASFF notifications were dealt by a specific unit. The audit team examined the 2012 RASFF notification for mercury in Shortfin Mako. The consignment was traced back to the original establishment and the root-cause investigated. This results of the investigation were transmitted to the EU RASFF contact point. Conclusions The system to follow-up RASFF notifications is implemented and functional to identify and rectify the root cause of non-compliant consignments exported to the EU. 5.6 OFFICIAL CERTIFICATION Legal requirements Article 14 of Regulation (EC) No 854/2004. Article 6 of Regulation (EC) No 2074/2005, in particular the model health certificate for imports of fishery products intended for human consumption established in its Appendix IV to Annex VI. Article 6 of Directive 96/93/EC establishes that the Commission shall ensure that the rules and principles applied by third countries certifying officers offer guarantees at least equivalent to those laid down in this Directive. Findings A detailed SOP is in place to certify fishery products to be exported to the EU. FERG conduct preexport checks on all export consignments at the establishments. The official inspectors at the premises visited apply a uniform approach in export controls. The reports of such inspection are entered in the IFAST system. The analytical results are put as well into the system. After a favourable assessment by AVA, export certificates are issued. The certificates examined by the 10

15 audit team were available in the IFAST system. The model of export health certificate currently in use is in line with Regulation (EC) No 2074/2005. It was noted that not in all cases the necessary deletions were made by AVA staff. The alternative health declarations on export certificates were not always correctly deleted. Conclusions The general procedures in place for the health certification of EU export fishery products from Singapore give adequate guarantees concerning EU requirements. However, the shortcomings identified above with regard to the health declaration weaken the reliability of the information provided in the health certificate that accompanies the consignments exported to the EU. 5.7 LABORATORIES Legal requirements Article 46(1)(d) and (c) of Regulation (EC) No 882/2004 stipulate that Community controls shall have particular regard to the resources including diagnostic facilities available to CAs and the training of staff in the performance of official controls. Points 41 and 42 of Guidelines of Codex Alimentarius CAC/GL on the Design, Operation, Assessment and Accreditation of Food Import and Export Inspection and Certification Systems. Chapter 1 of Annex I to Regulation (EC) No 2073/2005 and Section II of Annex II to Regulation (EC) No 2074/2005; Regulation (EC) No 333/2007 and Regulation (EU) No 252/2012. Findings The Veterinary Public Health Laboratory (VPHL) analyses official samples of fishery products. The VPHL is accredited by the Singapore Accreditation Council's Laboratory Accreditation Scheme for compliance under the ISO/IEC Guide "General Requirements for the Competence of Calibration and Testing Laboratories." The audit team visited the VPHL. The scope of accreditation includes, amongst others, methods for the determination of Salmonella, Listeria monocytogenes, Staphylococcus aureus coagulase positive, E. coli, TVB-N, heavy metals (mercury, lead, cadmium and inorganic tin) and histamines. The laboratory has participated in proficiency tests for contaminants and microbiology with good results. The performance criteria of the methods used for heavy metals testing is in line with the EU rules. Accredited and validated methods are in use which are at least equivalent to EU methods. The laboratory performs quality controls using blank and spiked blank samples and calculates recovery. The laboratory had adequate facilities and staff showed an adequate knowledge. Conclusions The laboratory responsible for official control has analytical methods and quality assurance systems in place in order to provide the necessary guarantees to ensure that the sampling results are consistent and reliable for fishery products exported to the EU. 11

16 6 OVERALL CONCLUSION The structures and documented operational procedures in place and the standards applied by the Singaporean competent authority ensures that the official control system provides appropriate guarantees as to the conformity of fishery products exported to the EU with EU equivalent standards Since the previous audit in 2004 improvements have been made in relation to the traceability of raw materials, frequencies of inspections and analytical methods used. Nevertheless one of the four establishments visited had long-standing operational hygiene, maintenance and process flow deficiencies which although noted by the competent authority had not been corrected which undermines confidences in the reliability of export health certificates. Other than the above deficiencies and taking into account the pre-export laboratory checks which ensures that sampling results are consistent and reliable for fishery products exported to the EU, the competent authority is in a position to guarantee that fishery products exported to the EU comply and were produced in accordance with the sanitary conditions for fishery products indicated in the export health certificate. 7 CLOSING MEETING At the closing meeting held in Singapore on 21 January 2014, the audit team presented the main findings and preliminary conclusions of the audit to the CA. During this meeting, the CAs acknowledged the findings and preliminary conclusions presented by the audit team and provided commitment to correct the deficiencies. In particular the CA stated that the non-conforming establishment would be suspended from EU export until such time as all identified shortcomings had been resolved and the corrections verified. 8 RECOMMENDATIONS The CA should provide Commission services with an action plan, including a timetable for its completion, within one month of receipt of the report, in order to address the following recommendations for fishery products exported to the EU. N. Recommendation 1. The CA should ensure that establishments approved for EU export produce fishery products in compliance with standards equivalent to the requirements of Annex II of Regulation (EC) No 852/2004 in order to provide guarantees that these establishments comply with rules at least equivalent to those of the EU, as required by Article 12, point 2 (a) of Regulation No 854/ The CA should improve the official control system with regard to the effective followup of deficiencies noted during such controls of facilities in order to provide the guarantees required by Article 12, point 2 (a) of Regulation (EC) No 854/ The CA should ensure that permanent automatic temperature recorders are present and functioning at cold-rooms to ensure that products exported to the EU comply with Annex II of Regulation (EC) 852/2004 and Annex VII of Regulation (EC) No 12

17 N. Recommendation 853/ The CA should ensure that all imported raw materials used for EU export are produced in accordance with applicable EU rules in order to provide the guarantees required by point 11.1 of the export health certificate in annex to Regulation (EC) No 2074/2005, in particular that the imported products comply with such EU rules. 5. Ensure that HACCP criteria used in establishments' quality assurance systems comply with the requirements of Article 5 of Regulation (EC) No 852/2004 in order to provide guarantees that all establishments comply with rules at least equivalent to those of the EU, as required by Article 12, point 2 (a) of Regulation No 854/ Ensure that water is tested on all necessary parameters, including Enterococcus faecalis in line with Annex 1 point A of Council Directive 98/93/EC. 7. Ensure that export health certificates are correctly filled in and necessary deletions are carried out to provide clear health declarations in line with the export health certificate in annex to Regulation (EC) No 2074/2005. The competent authority's response to the recommendations can be found at: 13

18 ANNEX 1 - LEGAL REFERENCES Legal Reference Official Journal Title Dec. 2006/766/EC OJ L 320, , p Dec. 2011/163/EU OJ L 70, , p Dir. 96/93/EC OJ L 13, , p Reg. 852/2004 OJ L 139, , p. 1, Corrected and re-published in OJ L 226, , p. 3 Reg. 853/2004 OJ L 139, , p. 55, Corrected and re-published in OJ L 226, , p. 22 Reg. 854/2004 OJ L 139, , p. 206, Corrected and re-published in OJ L 226, , p. 83 Reg. 882/2004 OJ L 165, , p. 1, Corrected and re-published in OJ L 191, , p. 1 Reg. 2073/2005 OJ L 338, , p /766/EC: Commission Decision of 6 November 2006 establishing the lists of third countries and territories from which imports of bivalve molluscs, echinoderms, tunicates, marine gastropods and fishery products are permitted 2011/163/EU: Commission Decision of 16 March 2011 on the approval of plans submitted by third countries in accordance with Article 29 of Council Directive 96/23/EC Council Directive 96/93/EC of 17 December 1996 on the certification of animals and animal products Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs 14

19 Legal Reference Official Journal Title Reg. 2074/2005 OJ L 338, , p Reg. 1883/2006 OJ L 364, , p Commission Regulation (EC) No 2074/2005 of 5 December 2005 laying down implementing measures for certain products under Regulation (EC) No 853/2004 of the European Parliament and of the Council and for the organisation of official controls under Regulation (EC) No 854/2004 of the European Parliament and of the Council and Regulation (EC) No 882/2004 of the European Parliament and of the Council, derogating from Regulation (EC) No 852/2004 of the European Parliament and of the Council and amending Regulations (EC) No 853/2004 and (EC) No 854/2004 Commission Regulation (EC) No 1883/2006 of 19 December 2006 laying down methods of sampling and analysis for the official control of levels of dioxins and dioxin-like PCBs in certain foodstuffs 15