EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL

Transcription

1 Ref. Ares(2014) /09/2014 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 GREENLAND FROM 19 TO 28 MAY 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 Greenland carried out from 19 to 28 May 2014 as part of its programme of audits in third countries. The objectives of the audit were to evaluate whether the official controls put in place by the competent authorities can guarantee that the conditions of production of fishery products in Greenland destined for export to the EU are in line with the requirements laid down in EU legislation, and to verify the extent to which the guarantees and the corrective actions submitted to the Commission services in response to the recommendations of the previous fishery products audit report of 2010 have been implemented and enforced by the competent authority. The report concludes that over time, the Danish Veterinary and Food Administration have developed an effective, (broadly) risk based official control system, which with the advent of controls on primary production (i.e. fishing vessels) by the Greenland Fisheries Licence Control Authority, and enhanced controls on imports to Greenland via their newly appointed Border Inspection Posts - covers the entire fishery product production chain. Furthermore this system is adapted to deal with the significant geographic and climatic challenges posed by Greenland, and relies more than usual on the reliability of the food business operators own-check results and the use of dedicated trade routes to ensure official controls (particularly microbiology and contaminant tests) can be performed before the fishery products are released onto the Union internal market. Future changes are likely in relation to the volumes and type of fish caught (quota/availability), their origin and distribution, and the position adopted by the Greenland government in relation to their trade patterns and official controls. This may have an impact on the suitability of the current control system which should be kept under constant review by the relevant Commission Services and the competent authority. All recommendations in the previous report have been addressed in a satisfactory way or are, as in the case of the recommendation on certification, no longer relevant. The report addresses to the competent authority of Greenland 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 OFFICIAL CONTROLS OF PRODUCTION AND PLACING ON THE MARKET...6 PRIMARY PRODUCTION...7 LANDING OPERATIONS, LANDING SITES AND FIRST SALE...7 FACILITIES, INCLUDING VESSELS, HANDLING FISHERY PRODUCTS OFFICIAL CONTROLS OF FISHERY PRODUCTS FOLLOW-UP OF RASFF NOTIFICATIONS LABORATORIES OFFICIAL CERTIFICATION OVERALL CONCLUSION CLOSING MEETING RECOMMENDATIONS...11 ANNEX 1 - LEGAL REFERENCES...13 II

4 ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT Abbreviation BIP CA/CCA Cd DVFA DG SANCO EC EU EU Listed FBO FTE FV/ZV FVO GFLK HACCP Hg ISO MFAF PAH Pb PCBs RASFF RVFA TMA-N TVB-N TVC Explanation EU Border Inspection Post Central/Competent Authority Cadmium Danish Veterinary and Food Administration 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 Full Time Equivalent Factory/ Freezer Vessel Food and Veterinary Office of the European Commission Greenland Fisheries Licence Control Authority Hazard Analysis Critical Control Points Mercury International Organisation for Standardisation Ministry of Food Agriculture and Fisheries Polycyclic Aromatic Hydrocarbons Lead Polychlorinated Biphenyls Rapid Alert System for Food and Feed Regional Veterinary and Food Administration Trimethylamine nitrogen Total volatile basic nitrogen Total Viable Count III

5 1 INTRODUCTION The audit took place in Greenland from 19 to 28 May 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. An opening meeting was held in Kangerlussuaq, Greenland on 19 May 2014 with the competent authority (CA) the Danish Veterinary and Food Administration (DVFA). 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. 2 OBJECTIVES AND SCOPE OF THE AUDIT The objectives covered by the audit were: to evaluate whether the official control system put in place by the CA can guarantee that the conditions of production of fishery products in country destined to be imported into the European Union (EU) are in line with the requirements laid down in EU legislation, and with the health attestations contained in the health certificate laid down in Appendix IV to Annex VI to Regulation (EC) No 2074/ ; to verify the extent to which the guarantees and the corrective actions submitted to the Commission services in response to the recommendations of the previous FVO audit report of 2010 have been implemented and enforced by the CA. 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 stages applicable to fishery products to be exported to the EU and the export certification procedure. Accordingly, relevant aspects of the EU legislation referred to in Annex 1 were used as audit criteria for the audit. In pursuit of this/these objective(s), the audit team visited the following sites: COMPETENT AUTHORITY Central level 2 LABORATORY VISITS Public 1 Government of Greenland Laboratory Nuuk Private 2 PRIMARY PRODUCTION Fishing vessels >5 LANDING AND FIRST SALE Landing sites 5 Including 2 establishment piers 1Given legislative changes and the opening of two BIPs in Greenland this piece of EU legislation is not relevant to Greenlandic production post 5 May

6 FACILITIES HANDLING FISHERY PRODUCTS Factory vessels 2 EU-listed Processing Plants 3 representatives from the (CCA) accompanied the audit team during the whole audit. 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. Full EU legal references are provided in Annex I. EU legal acts quoted in this report refer, where applicable, to the last amended version. 4 BACKGROUND 4.1 GENERAL BACKGROUND Greenland is currently listed in Annex II of Commission Decision 2006/766/EC (list of third countries and territories from which imports of fishery products are permitted). There is no aquaculture in Greenland. 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 an EU control. As a consequence, the FVO team made an assessment of the assurances provided by the CA following the last fishery products audit to Greenland that took place in The report (ref. DG(SANCO)/2010/8538) is published on the Health and Consumers Directorate-General (SANCO) Internet site at This report highlighted deficiencies in relation to reporting and follow-up (official controls), hygiene conditions in one establishment, frequency of vessel inspections and elements of certification. Written guarantees were received from the CA in relation to the implementation of actions aimed at addressing those recommendations. The FVO follow-up of these recommendations are reported under the relevant sections of this report. 4.2 PRODUCTION AND TRADE INFORMATION Greenland is currently authorised to export fishery products to the EU from 51 land-based establishments, 17 factory vessels (FV) 2 freezer vessels (ZV) and 5 cold-stores (listed under Article 12 of Regulation (EC) No 854/2004). Only fishing vessels registered and inspected by the Greenland Fisheries Licence Control Authority (GFLK) can provide raw material to the listed 2

7 facilities. Direct landings to the EU occur from eight vessels and two vessels are currently under inspection in Iceland for potential inclusion on the Greenland list and re-flagging. According to data provided by the CA, fishery products exported to the EU in 2013 amounted to around 112,000 tonnes, comprising comprising 46,000 tonnes processed in Greenland, 7,000 tonnes landed directly in the EU, 10,000 tonnes landed in Greenland to be processed in another country and 49,000 tonnes processed on factory vessels and thereafter exported to the EU. Shrimps represent the major export product (with significant quantities cooked at sea in sea water sea cooked prior to freezing) along with significant quantities of herring, halibut, cod, mackerel, redfish and haddock. Smaller quantities of snow crab, lump fish roe and other species are also exported.. According to the information provided by the CA, 1,400 tonnes of shrimp were imported in 2013 as raw material and were later on exported to the EU. Fishery products obtained from EU vessels (Denmark and Estonia in 2013) are no longer recorded as imports. A decision by the government of Greenland to fix for itself a mackerel quota in the North-East Atlantic means, that Greenland intends to harvest 100,000 tonnes of mackerel a year from this area. Of the 100,000 quota just over half will be fished directly by Greenlandic vessels, the remainder will be caught by contracted third country vessels (e.g. Russian Federation) and are unlikely, according to the CA, to be landed in Greenland. Approximately 70% of production originates from a state owned company - Royal Greenland. Under Greenland Law, 25 % of the volume of ZV and FV catches of shrimp and Greenland halibut from West Greenland shall be landed for further processing in the country 4.3 RAPID ALERT SYSTEM FOR FOOD AND FEED (RASFF) NOTIFICATIONS There have only been 6 RASFF since 2012, all resulting from poor temperature control during transport (i.e. outside the control of the processors) with the destruction of the product at the EU Border Inspection Posts (BIP) and the importer notified. 5 FINDINGS AND CONCLUSIONS 5.1 LEGISLATION Legal requirements Article 46(1)(a) of Regulation (EC) No 882/2004. Article 11(4)(a) of Regulation (EC) No 854/2004. Findings While Greenland has a system of self-government (on 21 June 2009, the Act on Greenland Self- Government came into force), it remains part of the Danish Realm. Greenland has not taken over responsibilities for the export of food of animal origin which is still administered by the Danish Ministry of Food, Agriculture and Fisheries (MFAF). Greenland and Denmark have essentially the same legislation for fish and fishery products; which is introduced in parallel, albeit with some short 3

8 delays[1] in the entry into force in Greenland. The relevant legislation for the fishery products official control system is described in the previous report DG(SANCO)/ and the CA provided a detailed table outlining all relevant Greenlandic legislation prior to the audit. To clarify the DVFA s responsibility and authority in Greenland, new legislation covering only Greenland, has been put into force Bekendtgørelse nr af 13. December 2012 om Fødevarestyrelsens og Grønlands Selvstyres opgaver og beføjelser på den del af fødevare- og veterinærområdet, der administreres af fødevareministeren. In brief, the DVFA authority continues to issue legislation and enforce the rules in relation to fishery products. The Government of Greenland has assumed legislative and administrative responsibility for the rules governing water supplies and disposal of waste and waste-water. [1] Due to time taken for translation of the text into Greenlandic Conclusions Greenland legislation and standards applicable to fishery products and their production chain for EU exports, mirror the equivalent Danish rules and are essentially the same as EU rules. These laws provide an adequate basis to implement an official control system. 5.2 COMPETENT AUTHORITY Legal requirements Article 46 of Regulation (EC) No 882/2004, in particular points b) to (e), (g) and (h) of the aforementioned article. Points g) and h) are covered in Sections 5.4 of this report. Findings The Danish Veterinary and Food Administration (DVFA) have five food control offices and three veterinary control offices. The food control offices are responsible for food inspections from raw materials to finished products. Inspections at food establishments include checks of internal control schemes, hygiene and labelling. The Food Control Office in North Jutland is responsible for official control visits in Greenland. The RVFA use approximately two Full Time Equivalents (FTEs) for inspection purposes in Greenland on fishery products and bivalve molluscs products, divided among four persons (three fishery inspectors and a senior consultant). Since 1 January 2013 the DVFA has delegated the inspection of the hygiene conditions of all fishing vessels to GFLK. The DVFA also man the two new BIPS situated in Nuuk and Sisimut and first listed on 3 April These two BIPs will monitor the EU eligibility of imported raw material supplied at present by foreign vessels flagged in Canada and allow these imports along with FPs landed by MS vessels to fill any shortfall in catch or domestic quota. With the implementation of Council Decision 2011/408/EU establishing these BIPS, fishery products produced in Greenland are de-facto deemed to be of EU origin and products previously landed from Danish and Estonian vessels are no longer classified as imports. Other than the above recent changes, powers, independence and supervision (including documented control procedures and enforcement) are largely as described in audit report DG(SANCO)/2010-4

9 8538. In response to the pre-audit questionnaire, the CA provided a copy of the current procedures in the general inspection manual Kontrolvejledningen, where chapter 14 deals specifically with Greenland. They also provided updated guidelines on own-checks in food establishments, audits in food establishments, food hygiene and specific guidelines for fishery products among other documents. Conclusions The CA has competencies, powers and independence to carry out official controls. Their structure and organisation and documented procedures cover the entire production chain and are in general adequate for the performance of official control tasks. 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 The audit team noted that Establishments, factory vessels, freezer vessels in Greenland are approved according to section 9 of Bekendtgørelse nr. 396 af 24. april 2014 for Grønland om fødevarevirksomheder. Bekendtgørelse no. 396, Section 9-18, lay down rules for approval of food businesses and for withdrawal of the approval. Bekendtgørelse nr. 395 af 24. April 2014 for Grønland om særlige bestemmelser for tilrettelæggelsen af den offentlige kontrol med animalske produkter til konsum, Chapter 5, sets out the requirements for the approval procedure. When applying for approval, a food business operator (FBO) must send an application to the RVFA. The application must include a plan for the food business and a description of the projected activities. If the activities in the establishment warrant an own-check system based on HACCP principles, this system must be included in the application as well. If the RVFA finds that the plan and the own-check system are adequate to cover the described activities, the RVFA will perform a control visit to the establishment. If the establishment is found to fulfil the infrastructure and equipment requirements, the RVFA issues a letter to the FBO stating that the establishment is approved, and that activities can commence. Approval, in the first instance, will in most cases be conditional. This is to allow the FBO the possibility to demonstrate, that the own-check system works in practice. Within three months of conditional approval the RVFA will perform another control visit to determine, whether it can be made permanent. Conditional approval may be prolonged for a further three months. If there are minor non-compliances in the establishment, conditional approval may be prolonged, but if there are major non-compliances, the approval must be withdrawn. A conditional approval must not be effective for more than six months. However, for factory vessels and freezer vessels conditional approval may be effective for 12 months. All fully and conditionally approved food businesses are given an approval number. This number is stated in the approval letter. 5

10 Approval may be withdrawn by the RVFA if the FBO does not fulfil the conditions for approval, if the premises for approval are considerably changed or for hygienic, marketing or other reasons. All Greenlandic fishing vessels have to be registered in the Greenlandic vessel register and have a license in order to be allowed to fish on a commercial basis. The audit team noted that in general, conditions for approval were complied with (see chapter 5.4) with the minor exception that in some cases the DVFA had not identified external premises used to store wrapping and packaging material. The audit team confirmed that there were no stand-alone ice plants, wholesale markets or auction halls handling EU eligible fishery products. The list for establishments in Greenland producing fishery products has recently been moved to those for countries with a special agreement (see Council Decision 2011/408/EU). This list is available on the SANCO web site at the following address: Conclusions Registration and approval procedures are generally in line with EU requirements, albeit the approval does not always cover the entire FBO premises. 5.4 OFFICIAL CONTROLS Official controls of production and placing on the market Legal requirements Article 12(2) of Regulation (EC) No 854/2004. Requirements contained in 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 I of Regulation (EC) No 854/2004. Article 11(4) of Regulation (EC) No 854/2004 establishes that EU controls shall take particular account of the extent and operation of official controls on imports of animals and their products and the assurances which the third countries can give regarding equivalence to EU requirements (Article 46(1)(g) (h) of Regulation (EC) No 882/2004). Findings Official control system in place There is a well-documented risk based official inspection system in place for the DVFA Food Control Office responsible for official control functions in Greenland. This prescribes inspection frequencies (three times/year for larger establishments, annually for other establishments and ZV/FV) to ensure approval conditions continue to be met and to ensure regular checks on the hygiene conditions of landing and first sale. Reporting is based on the facility being inspected and follow-up is based on the nature/severity of the findings made. As regards laboratory testing (particularly in relation to microbiological checks, residues and 6

11 contaminants), annual Danish sampling projects cover the relevant parameters, albeit testing is restricted to products examined at the Aalborg BIP in Denmark. All incoming consignments utilise a state subsidised sea transport provided by Royal Arctic Line, with Aalborg being the main recipient of all traffic from Greenland. The DVFA undertook to review the potential need for histamine testing in view of the mackerel catch-share allocations. The Food Control Office is subject to supervision including scrutiny of inspection reports and follow-up documents. For example, in 2012, 60 inspection reports and follow-up documents for 30 food establishments in Greenland were checked. DVFA perform internal audits, however, to-date the audit programme has not included the fishery product sector in Greenland. See: for The administration and supervision of the control system is described in further detail in the Danish country profile at: The GFLK undertake regular checks on the hygiene conditions of fishing vessels. This has required the development of guidelines and checklists with the participation of staff in extensive training to provide an understanding of the regulatory basis for controls on fresh fish after landing (i.e. in addition to quota, catch certificates and licencing issues) and the inspection of vessels and establishments. The target is to carry out hygiene control of 10% of the total quantity of landed amounts of fresh fish from registered fishing vessels (data provided to demonstrate this). The system that DVFA and GFLK have put into place aims to ensure that the same fishing vessels will not be inspected each year, unless subject to follow-up, and will make sure that vessels of all sizes will be inspected and not just the bigger fishing vessels. Water testing at land based establishments is organised by the Greenlandic Government and samples are submitted to a laboratory within the Greenland Department for Health and Infrastructure. Monthly samples are tested (for free) for establishments based in populated areas and less frequently on more distant settlements. While food business operators (FBOs) test potable water used on ZV and FV (mostly derived from desalination processes), there are no official controls by either the Greenlandic Government or the DVFA. Primary production Most fishing vessels delivering fish to establishments in Greenland are under 10 metres (dinghies) and one or two man operations using long-lines. Fishing vessel inspections, varying in depth, are undertaken by the GFLK using a standard checklist. The CA indicated that that there is ongoing training in this area as a result of the devolution of these controls to the island. Overall, the audit team noted that the vessels observed, maintained hygienic conditions on board, and the inspection carried out by a fully trained inspector correctly identified minor problems such as inadequate separation of an inboard engine and an inadequate supply of fish trays. Due to the speed of the vessels and the location of the inshore fisheries in operation, the audit team noted that the fish were extremely fresh or still alive on arrival. Landing operations, landing sites and first sale The audit team noted that while most fishery products are landed at dedicated establishment landing sites in the major centres, public quays are also used albeit, where observed, product was unloaded and handled in a hygienic way (in carton boxes or sealed big bags ) prior to being transferred to an adjacent cold-store or refrigerated container for onward transit. Where observed, 7

12 landed fresh fish was transferred immediately to adjacent premises in fish trays with ice or by crane in large double walled insulated boxes with lids. Facilities, including vessels, handling fishery products Of the 105 inspection visits foreseen for 2013, all were concluded but for two where extreme weather conditions prevented the visit despite repeat travel attempts. Reports Kontrolrapport were reviewed (including general access to other reports and examples via their IT system portal) and DVFA samples were taken as foreseen (with 255 compliant results). Except for one case, inspection reports and follow-up data reflected the situation observed on-the-spot by the audit team. In a few cases, additional problems were identified with the HACCP plan by the audit team (lack of raw data, or incomplete monitoring records at a critical control point for additives). For the one establishment seen with significant structural and maintenance problems (not in operation at the time of the visit), the DVFA on its own initiative requested corrective measures and an action plan to be submitted by 14/06/2014 (with deadlines for correction of irregularities found) for their approval. The operator undertook to conduct a full internal audit of their own to ensure the action plan fully addressed the concerns relayed at the exit meeting at the FBO. The DVFA routinely verifies FBOs own-check results and the action taken in the light of these. The tests are typically comprehensive and undertaken using reputable methods (including rapid tests) and laboratories. The audit team noted the long term storage of gutted Greenland halibut (up to 5 days) in large plastic tanks with chilled water to which ice is added from time to time (i.e. ice/melt-water mix) in two establishments visited and the CA acknowledged that this practice was now commonplace. Otherwise, product was typically stored frozen in cartons or bags well below the current EU temperature requirement of -18 C. The audit team noted the food safety criteria were not assessed using the reference methods laid down in Regulation (EC) No 2073/2005. This is described in chapter 5.6 (laboratories). However, product tests were undertaken routinely (e.g. for listeria monocytogenes - once per sailing at random for factory vessels and daily for land based establishments). The FBOs visited reported no listeria positive tests (in product) for a number of years, albeit they reported occasionally positive results following what were regarded as targeted surface swab testing. Conclusions A well-documented official control system now covers all elements of the production chain. Overall, the structure, maintenance and hygienic conditions were acceptable in the establishments and vessels visited (except in one instance) and as described in the control reports. The use of a melt-water/ice mix for chilling fishery products in establishments prior to processing is common place. In relation to the own checks, HACCP plans were not implemented correctly in all cases. Recommendation No 1, 2 and 3 of the previous audit report (concerning official controls, a processing plant visited in 2010 and an inspection programme for smaller vessels respectively) can be considered addressed 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 8

13 Official controls are in general, performed as described in EU legislation and include thorough organoleptic examinations (fresh, frozen and processed product) and checks on residues, contaminants (heavy metals (Mercury, Lead, and Cadmium ) as well as PAH, PCBs and dioxin) and microbiological parameters (particularly Listeria monocytogenes and Salmonella). Freshness indicator tests (i.e. TVB-N and TMA-N) are not done. The CA acknowledges that histamine testing may become necessary, with the likely inclusion of mackerel in their export products. Evidence was presented to the audit team that FBO own-controls include parasite controls and that these controls are under CA supervision. All testing is done on consignments at arrival in Denmark. In relation to the monitoring of the quality of drinking water by the Greenlandic Government, where this is undertaken (see section on the official control system in place), it is performed in line with Council Directive 98/83/EC. Samples are generally taken monthly for microbiological checks (Total Viable Count, E. coli, Enterococci, coliform bacteria) and at least annually for chemical checks. The audit team reviewed some of the results of these water tests in the establishments visited and in all cases but one (an ice sample with excessive TVC), they were found to be satisfactory. The CA provided a link to the approved food additives list on the DVFA s website: Two types of anti-oxidant additive for shrimps were checked on-the-spot and the ingredients (E223, E451, E301, E452) found to be those permitted in Annex II of Regulation (EC) No 1333/2008. Conclusions Official controls on fishery products exported to the EU adequately cover most EU requirements (organoleptic check, parasites, microbiology, heavy metals and residues). 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 take particular account of amongst other factors: any experience of marketing of the product from the third country and the results of any import control carried out. Findings In the context of the exports to the EU, the CA provided a list of the actions taken by the CA in relation to a limited number of RASFF notifications (only 6 since 2012). As the damage occurred during transport from Greenland to Denmark the procedure in place requires that the Aalborg BIP informs the importer and where the cold chain is broken, destroys the fishery products. Where relevant, the CA records that the manufacturer is not responsible for the damage. To-date, there have been no RASFF identified at the two new BIPs in Greenland. Conclusions The CA had an effective system to follow-up EU border rejections at Aalborg. 9

14 5.6 LABORATORIES Legal requirements Article 46(1)(d) and (c) of Regulation (EC) No 882/2004. 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 two private laboratories visited (both major players in fishery product exports) worked to similar standards with regard to establishment own-check samples, albeit they were certified rather than accredited due to the fact they are not independent. The audit team noted that certain samples (for Listeria and Salmonella) were pooled and the reference methods laid down in Regulation (EC) No 2073/2005 were not used in the examples provided. In one laboratory visited, it was explained that when Listeria was cultured, rapid chemical exclusion tests were used to rule out the presence of Listeria monocytogenes. The initial response of the DVFA was that pooling was not appropriate in the circumstances described, citing the Commission non-paper on this subject. However, they undertook to see if the analytical methods being used by FBOs could be considered at least equivalent to the EU reference methods. The CA also provided information to show that guidelines on the provisions in Regulation (EC) No 2073/2005, are being revised in 2014 and their own guidelines on the growth of Listeria monocytogenes, and the criteria that apply to products in relation to the rules in Regulation (EC) No 2073/2005. The CA also provided a copy of the a Commission non-paper on the pooling samples with their understanding that it will be revised in 2014 and that a meeting will be held on this issue soon at the Commission. Conclusions The Laboratory designated by the Greenlandic Government to carry out official controls on water is accredited to ISO and uses the EU reference methods. External and internal quality controls are carried out regularly with satisfactory results. Laboratories performing own-check analyses work to similar standards. However, where samples are analysed in the context of FBO food safety criteria, these were not undertaken as foreseen in Regulation (EC) No 2073/ 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. 10

15 Findings Certification procedures were amended following the previous audit to address the concerns at that time. However, with the application of Council Decision 2011/408/EC (from date of first BIP listing), certificates are no longer required for fishery products entering the Union from Greenland. Conclusions Recommendation No 4 of the previous audit report, in relation to the requirements in Article 3 of Directive 96/93/EC has been addressed satisfactorily. 6 OVERALL CONCLUSION Over time, the DVFA has developed an effective, (broadly) risk based official control system, which with the advent of controls on primary production by GFLK (i.e. fishing vessels), and enhanced controls on imports to Greenland via their newly appointed BIPs - covers the entire fishery product production chain. Furthermore this system is adapted to deal with the significant geographic and climatic challenges posed by Greenland, and relies more than normal on the reliability of the food business operators own-check results and the use of dedicated trade routes to ensure official controls (particularly microbiology and contaminant tests) can be performed before the fishery products are released onto the EU internal market. Future changes are likely in relation to the volumes and type of fish caught (quota/availability), their origin and distribution, and the position adopted by the Greenland Government in relation to their trade patterns and official controls. This may have an impact on the suitability of the current control system which should be kept under review by the relevant Commission Services and the DVFA. All recommendations in the previous FVO report have been addressed in a satisfactory way or are, as in the case of the recommendation on certification, no longer relevant. 7 CLOSING MEETING During the closing meeting held in Copenhagen on 28 May 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 a commitment to respond constructively and look further into the issue of laboratory testing methods in relation to food safety criteria in particular. 8 RECOMMENDATIONS The CA should provide Commission services with an action plan, including a timetable for its completion, within twenty-five working days of receipt of the report, in order to address the following recommendations for fishery products exported to the EU: 11

16 N. Recommendation 1. The CA should ensure that all parts of the food business operators premises (including external packaging stores) are inspected and included in the establishment approval, so that the CA can provide the guarantees listed under Article 12 (2) of Regulation (EC) No 854/ The CA should ensure that establishments from which fishery products have been prepared, particularly in relation to construction, design and maintenance, remain approved only where they maintain compliance with requirements at least equivalent to the applicable ones referred to in Annex II to Regulation (EC) No 852/ The CA should ensure that that when fishery products reach an establishment on land and are not prepared or processed immediately, they are stored under ice in appropriate facilities, with re-icing as often as necessary and ensuring and that the containers ensure that melt water does not remain in contact with the product in line with Regulation (EC) No 853/2004, Annex III, Section VIII, Chapter III, Part (A) 1 and The CA should ensure that HACCP systems implemented by FBOs, are in line with Article 5 (2) of Regulation (EC) No 852/2004 and in particular that they establish and implement effective monitoring procedures at critical control points. 5. The CA should ensure that foodstuffs comply with the relevant microbiological criteria and in particular, that FBOs apply the testing methods laid down in Annex I to Regulation (EC) No 2073/2005 or equivalent alternatives authorised by the CA (in line with Article 5.5 of Regulation (EC) No 2073/2005). The competent authority's response to the recommendations can be found at: 12

17 ANNEX 1 - LEGAL REFERENCES Legal Reference Official Journal Title Dec. 98/179/EC OJ L 65, , p Dec. 2006/766/EC OJ L 320, , p Dec. 2011/408/EU OJ L 182, , p Dir. 96/23/EC OJ L 125, , p Dir. 96/93/EC OJ L 13, , p Dir. 98/83/EC OJ L 330, , p Dir. 2000/13/EC OJ L 109, , p /179/EC: Commission Decision of 23 February 1998 laying down detailed rules on official sampling for the monitoring of certain substances and residues thereof in live animals and animal products 2006/766/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 2011/408/EU: Council Decision of 28 June 2011 laying down simplified rules and procedures on sanitary controls of fishery products, live bivalve molluscs, echinoderms, tunicates, marine gastropods, by-products thereof and products derived from these by-products coming from Greenland Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC Council Directive 96/93/EC of 17 December 1996 on the certification of animals and animal products Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs 13

18 Legal Reference Official Journal Title Reg. 2406/96 OJ L 334, , p 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. 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 Council Regulation (EC) No 2406/96 of 26 November 1996 laying down common marketing standards for certain fishery products 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 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. 1881/2006 OJ L 364, , p Reg. 333/2007 OJ L 88, , p Reg. 1333/2008 OJ L 354, , p Reg. 252/2012 OJ L 84, , 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 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs Commission Regulation (EC) No 333/2007 of 28 March 2007 laying down the methods of sampling and analysis for the official control of the levels of lead, cadmium, mercury, inorganic tin, 3-MCPD and benzo(a)pyrene in foodstuffs Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives Commission Regulation (EU) No 252/2012 of 21 March 2012 laying down methods of sampling and analysis for the official control of levels of dioxins, dioxin-like PCBs and non-dioxin-like PCBs in certain foodstuffs and repealing Regulation (EC) No 1883/