EUROPEAN COMMISSION HEALTH & CONSUMERS DIRECTORATE-GENERAL Directorate F - Food and Veterinary Office DG(SANCO)/ 2009-8042 - MR - FINAL FINAL REPORT OF A MISSION CARRIED OUT IN GREENLAND FROM 09 JUNE TO 12 JUNE 2009 IN ORDER TO EVALUATE THE CONTROL SYSTEMS IN PLACE GOVERNING THE PRODUCTION OF BIVALVE MOLLUSCS IN GREENLAND 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 an endnote.
Executive Summary This report describes the outcome of a Food and Veterinary Office mission to Denmark concerning Greenland carried out between 9 and 12 June 2009, as part of its programme of inspections in Member States and third countries. The objectives of the mission was to follow-up and evaluate how the action plan in 2008 provided by the Competent Authority has been implemented to guarantee public health conditions linked to the production of bivalve molluscs (scallops) in Greenland intended for export to the European Union. A new control system had been put in place prior to the previous mission, however at that time the sampling was not considered to fully meet the requirements of Chapter II, Annex II of 854/2004. Improvements were made during the autumn 2008 and the system now covers all required analyses. Microbiology analyses for E. coli are now performed in line with Community requirements (ISO 16649-3 standard). The report concludes that the official control system implemented by the Danish Veterinary and Food Administration (acting Competent Authority for Greenland) can be considered as providing guarantees equivalent to the Community requirements for raw, frozen scallops. i
TABLE OF CONTENTS 1 INTRODUCTION... 1 2 OBJECTIVES OF THE MISSION... 1 3 LEGAL BASIS FOR THE MISSION... 2 4 BACKGROUND... 2 4.1 Historical background... 3 4.2 Production and trade information... 3 4.3 Rapid Alert System for Food and Feed (RASFF) notifications... 4 5 FINDINGS AND CONCLUSIONS... 4 5.1 Legislation... 4 5.2 Competent Authority... 5 5.3 Official controls of production and placing on the market... 5 5.4 Official controls of fishery products... 6 5.5 Verification of application of relevant rules by the FBO... 7 5.6 Laboratories... 8 5.7 Official certification... 9 6 OVERALL CONCLUSION... 9 7 CLOSING MEETING... 10 8 RECOMMENDATIONS... 10 ii
ABBREVIATIONS & SPECIAL TERMS USED IN THE REPORT Abbreviation CA/s CRL DVFA EC EU EUROSTAT FBO/s FP FVO HACCP HM ISO L/BM MBA MT MT NRL OJ PAH PCBs PSP RASFF RVFA Explanation Competent Authority/ies Community Reference Laboratory Danish Veterinary and Food Administration European Community European Union Statistical Services of the European Union Food Business Operator/s Fishery Products Food and Veterinary Office of the European Commission Hazard Analysis Critical Control Points Heavy Metals International Organisation for Standardisation Live/ Bivalve Molluscs Mouse Bio Assay Mission Team Mission Team National Reference Laboratory Official Journal Polycyclic Aromatic Hydrocarbons Polychlorinated Biphenyls Paralytic Shellfish Poisoning Rapid Alert System for Food and Feed Regional veterinary and Food Administration iii
1 INTRODUCTION The mission concerning Greenlandic bivalve molluscs (BM), i.e. scallops, took place in Denmark from 9 to 12 June 2009 and was undertaken as part of the Food and Veterinary Office's (FVO) mission programme. Denmark is the acting competent authority (CA) for Greenland for fishery products (FP). Scallops are wild bivalve molluscs (BM) fished at open sea. The mission team (MT) comprised two inspectors from the FVO and onenational expert from the Community Reference Laboratory (CRL) for marine biotoxins in live bivalve molluscs. 2 OBJECTIVES OF THE MISSION The objectives of the mission were to: to evaluate whether the official controls put in place by the CA can guarantee that the conditions of production of BM (scallops) in Greenland destined for export to the European Union (EU) are equivalent to the requirements laid down in Community legislation, and in particular to the health attestations contained in the certificate of Appendix IV to Annex VI of Commission 2074/2005; 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 mission report have been implemented and enforced by the CA. In pursuit of these objectives, the MT proceeded as follows: an opening meeting was held on 9 June 2009 with the CA. At this meeting the MT confirmed the objectives of, and itinerary for the mission, and requested additional information required for the satisfactory completion of the mission; the following sites were visited: 1
Competent authority Central level 1 Danish Veterinary and Food Administration Regional level 1 Region North, RVFA Laboratory visits Microbiology 2 1 National reference Laboratory (NRL) Marine bio-toxins 2 1 NRL Region North, Microbiological Laboratory, Aalborg LAB Research (Scantox) Chemical 2 Region North, Chemical Laboratory, Århus Region East, Chemical Laboratory, Ringsted representatives from the CA accompanied the MT during the whole mission. As the objectives concerned the control system and laboratory procedures, no on site visits in Greenland were performed. 3 LEGAL BASIS FOR THE MISSION The mission was carried out in agreement with the Greenlandic Authorities and under the general provisions of Community legislation and, in particular: Article 46 of 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 Decision 98/140/EC of 4 February 1998, laying down certain detailed rules concerning on-the-spot checks carried out in the veterinary field by Commission experts in third countries. Full legal references are provided in Annex I. Legal acts quoted in this report refer, where applicable, to the last amended version. 4 BACKGROUND 2
4.1 HISTORICAL BACKGROUND Greenland is part of the Danish realm with an extensive type of self-government, but it is not part of the EU. Home Rule Act (Grønlands Hjemmestyre) was introduced in 1979 and Greenland has taken over all special administrative areas mentioned in the Home Rule Act. On 21st June 2009 Self-Government was inaugurated. There will be no immediate practical implications following the inauguration of Self-Government for the relationship between Greenland and the European Union. Greenland remains a part of the Kingdom of Denmark and export of food of animal origin is still administrated by the Danish Ministry of Food, Agriculture and Fisheries through the Danish Veterinary and Food Administration (DVFA) as acting CA for Greenland. Greenland is at present listed in Annex II of Commission 2076/2005, establishing the lists of third countries and territories from which imports of FP in whatever form for human consumption may be permitted (former List II countries). This mission was a follow-up of the FVO mission to Greenland carried out from 22 to 30 April 2008 (ref. DG(SANCO)/2008/7638). The previous mission highlighted deficiencies in relation to official controls of the whole production chain, methods used for analyses and giving guarantees that the products have been obtained in conditions equivalent to those governing the production and placing on the market of Community products. The report published on the Health and Consumers Directorate-General Internet site at http://ec.europa.eu/food/fvo/ir_search_en.cfm made a number of recommendations in respect of the action required by the CA. An action plan and written guarantees were received from the CA in relation to the implementation of those recommendations. 4.2 PRODUCTION AND TRADE INFORMATION According to information provided by the CA 150 tonnes of scallops were registered as exported to the EU during 2008. Figures from Eurostat show that 171 tonnes have been exported. The discrepancy between the figures could not be explained to the MT. However, the DVFA showed that there was consistency between the import figures extracted from the TRACES system and the export figures delivered from Greenland. All shipments enter the EU via Denmark and Aalborg is the only port of entry. The final destination is Denmark and France. Currently there is only one factory vessel fishing wild scallops in Greenland. In 2009 two consignments of 17 and 22 tonnes respectively have been exported so far. Table 1 - Exports of scallops from Greenland to the EU (source CA/Traces) Commodity Total amount (tonnes) 2007 2008 Scallops (Pectinidae) 310 150 3
4.3 RAPID ALERT SYSTEM FOR FOOD AND FEED (RASFF) NOTIFICATIONS There have not been any RASFF notifications for scallops from Greenland since the 2008 FVO mission took place and there have not been any notification for BM originating from Greenland since 1970. 5 FINDINGS AND CONCLUSIONS 5.1 LEGISLATION Legal requirements Article 46 of 882/2004 states that Commission experts may carry out official controls in third countries in order to verify the compliance or equivalence of third-country legislation and systems with the relevant Community legislation. Findings A number of regulatory texts covering the production of FP including wild scallops were issued prior to the mission in 2008. Order No 83 of 19 February 2008 (Bekendtgørelse nr. 83 af 19 februar 2008 for Grønland om muslinger m.m.) describes the rules applicable from 15 March 2008 for the export of BM from Greenland to the EU. Two other orders, based on the main relevant provisions of s 853/2004 and 854/2004, cover the official controls and the specific hygiene rules for scallops (Bekendtgørelse nr. 655 af 19 juni 2006 for Grønland om födevarevirksamheder and Bekendtgørelse nr. 656 af 19 juni 2006 for Grønland om saerlige bestemmelser for tilrettelaeggelsen af den offentlige kontrol med animaliske produkter til konsum). Executive Order No 120 of 26 February 2008 and Executive Order No 130 of 27 February 2008 describe the tasks and authority of the DVFA and the regional CAs. In 2008 it was noted that the Order 891 of 22 September 2005 was based on Commission 466/2001 which has been repealed and replaced by Commission 1881/2006. During the initial meeting of the current mission the CA informed the MT that the order now is changed and at present being circulated for consultation. Conclusions 4
The standards laid down in the legislation covering scallops can be considered as in line with the Community requirements. 5.2 COMPETENT AUTHORITY Legal requirements Article 46 of 882/2004 specifies that official controls carried out in third countries by Commission experts shall have particular regard to the organisation of the third country's competent authorities, their powers and independence, the supervision to which they are subject and the authority they have to enforce the applicable legislation effectively; the training of staff in the performance of official controls; the resources including diagnostic facilities available to competent authorities; the existence and operation of documented control procedures and control systems based on priorities; the extent and operation of official controls on imports of animals and their products. Findings The DVFA is the CA for both Denmark and Greenland. It was given the authority by the Danish Ministry of Food, Agriculture and Fisheries to draft the legislation and to enforce the rules concerning control of production and export of scallops from Greenland. The DVFA has delegated authority to the Regional Veterinary and Food Administration (RVFA) of Region North to approve and inspect establishments, factory vessels, etc. RVFA reports to DVFA. The CA has no permanent staff stationed in Greenland. Four RVFA inspectors based in Aalborg participate in the control activities concerning all FP in Greenland. The inspectors visit Greenland 10 times a year for periods of 14 days (140 days in total). The Greenland Home Rule Authority has a delegation to perform sampling for official controls (see 5.4). The CA provided the MT with tables of training for inspectors and lists of participants. Conclusions The organisation of the CA is appropriate and has been evaluated in the previous mission. 5.3 OFFICIAL CONTROLS OF PRODUCTION AND PLACING ON THE MARKET Legal requirements Article 12(1) of 854/2004 establishes that products of animal origin can be imported into the EU if they have been dispatched from, and obtained or prepared in, establishments that appear on lists drawn up and updated by the CA in accordance with this Article. Land based establishments/freezer and factory vessels should be approved and included on the list drawn up by the CA (Art 4(2) of 853/2004 and Art.12 of 854/2004). 5
They should be in line with the relevant requirements established in Annex II to 852/2004 and Section VIII of Annex III to 853/2004. Findings The factory vessel fishing scallops is approved and on the published list as well as the cold stores that can receive frozen scallops from the factory vessel. The MT saw evidence that the RVFA performs yearly on-the-spot inspections of the vessel and the establishments; corrective actions are demanded for and the implementation is followed-up. Vessels and establishments in Greenland are visited once a year by RVFA staff. In the production of scallops there is at present only one factory vessel and two cold stores involved. The MT was shown copies of inspection reports and a letter of corrective actions to be taken by the FBO. The checklist used by inspectors carrying out controls in Greenland will be revised continuously by the Food Control Office in Aalborg in accordance with changes in the legislation. Conclusions The CA conducts official controls based on legislation and procedures that can be considered as providing guarantees equivalent to Community requirements. 5.4 OFFICIAL CONTROLS OF FISHERY PRODUCTS Legal requirements In Part II.1 of the health certificate for imports of FP intended for human consumption in Appendix IV to Annex VI to 2074/2005 it is certified that FP have satisfactory undergone the official controls laid down in Annex III to (EC) No 854/2004. Chapter III of the Annex II to (EC) 854/2004 establishes that official controls of FP are to be carried out to verify compliance with the standards in Annex III, section VII, Chapter V to 853/2004 as well as other requirements of Annex III, Section VII, Chapter IX to that. Findings Recommendation 1 of the previous mission report, in relation to effective official controls stated that the sampling should be representative of the production volumes and harvesting areas, guarantee that products meet the same health standards as LBM harvested in class A production areas and that the controls should cover the whole production chain of frozen scallops. During 2008 a new monitoring programme of official controls for microbiology, chemical contaminants and marine biotoxins was launched by the CA. Raw, frozen scallops are sampled at the port in Greenland when they are landed from the vessel. All samples are taken randomly as a control of the own check system. Samples are taken by 6
officials from the Greenland Home Rule Authority. This programme of official controls is coordinated through the RVFA. The Home Rule Authority has a delegation from the CA to perform this sampling and instructions for the sampling are sent from Region North to the Home Rule Authority staff (see 5.2.). The samples are sent to laboratories in Denmark for the required analyses. The programme for 2009 consists of 50 samples to be analysed for marine biotoxins and microbiology. There will be 20 analyses for heavy metals (HM), 10 for PAH, Dioxins and PCB respectively. The samples will be taken from 10 different fishing areas which is the estimated number the vessel can harvest from this year. If less than 10 areas will be visited, more samples will be taken from the areas used, so that the total number of samples will be as foreseen in the programme. Official sampling is also performed at the border inspection post when the products are imported to Denmark. 10 % of the consignments are tested for marine biotoxins. Conclusions Scallops are wild Pectinidae fished at open sea. Testing of marine biotoxins has, besides one paralytic shellfish poisoning (PSP) positive analysis in 2003, a record of negative analyses and there have not been rapid alert notifications in several years. The monitoring programme can be considered as representative of the production volumes and the harvesting areas. Recommendation No 1 of the previous mission can be considered as addressed and the system of official controls can also be considered to provide guarantees that the products meet the health standards of the Community requirements. 5.5 VERIFICATION OF APPLICATION OF RELEVANT RULES BY THE FBO Legal requirements Point 4, Section VIII of the Annex III to 853/2004 states that primary production, in relation to FP, covers farming, fishing and collection of live FP with a view to their being placed on the market; and Part A of the Annex I to 852/2004 lays down the general hygiene provisions for primary production and associated operations. Findings In March 2008 the system for own checks by FBOs changed. During the 2008 mission the MT could see that guidelines and instructions were in place, but that sampling at that time concerned only biotoxins. The MT in the 2009 mission noted that now samples are taken by the FBO to check also microbiology and HM. The samples are to be taken the first day of fishing in every new production area every week for marine biotoxins and for HM once per year per production area. Microbiology analyses in the own check system are performed by a laboratory in Greenland and analyses of toxins are done in Denmark. The results from the FBO sampling for toxins and HM are sent to the RVFA. 7
Conclusions The part concerning the FBO's responsibilities in the Recommendation No 1 of the previous mission can be considered as addressed. 5.6 LABORATORIES Legal requirements Article 11 of 882/2004 establishes that sampling and analysis methods, used in the context of official controls, comply with relevant Community rules or with internationally recognised rules or protocols or, in the absence of these, with other methods fit for the intended purpose or developed in accordance with scientific protocols. Article 12 of 882/2004 requires CAs to only designate official laboratories that operate and are assessed and are accredited in accordance with several standard (e.g. EN ISO/IEC 17025), taking into account criteria for different testing methods laid down in Community legislation. 333/2007 lays down the methods of sampling and analysis for the official control of the levels of lead, cadmium, mercury, inorganic tin, and benzo(a)pyrene in foodstuffs. Point 1.2 of the Annex to Commission Decision 98/179/EC states that laboratories must prove their competence by regularly and successfully participating in adequate proficiency testing schemes recognised or organised by the national or community reference laboratories. Findings There are agreements between the CA and all laboratories performing analyses as part of the official controls for microbiology and marine biotoxins. The chemical laboratories have not yet signed similar agreements. The MT visited two NRLs and four other laboratories involved in the microbiological, chemical and toxicological control of the frozen scallops. There are no NRLs in Greenland so the Danish NRLs also act as the NRLs for Greenland. In general all six laboratories visited were adequately equipped and had knowledgeable staff. All laboratories carrying out official control analyses on BM are accredited and regularly participate in international and/or national proficiency tests. In one of the laboratories for marine biotoxins the MT noted that one analysis, according to the laboratory files, was performed where five results from the same sampling date were recorded with the RVFA coordinating unit. Following the mission the CA has provided a satisfactory explanation to the MT, including copies of the reports and the raw data from the testing. Recommendation No 2 of the previous mission report in relation to toxicological and microbiological analyses stated that Community reference methods or alternative methods validated against them should be used. 8
The mission team noted that: The plan from last year, provided by the CA, to have the Lawrence method validated and accredited by the end of 2009 is now prolonged to the end of 2010. The Lawrence method is an alternative to the mouse bioassay method that would reduce the number of mice to be killed. The situation concerning killing of mice remains unchanged due to animal welfare reasons. The method for detecting E. coli has changed to the Community reference method (ISO 16649-3). Conclusions The modification by killing mice as soon as they show signs of suffering makes the method for detecting PSP a qualitative test. This can give false positive results as there is no quantification of the level of toxins with this alteration. This does not increase the public health risk. As a consequence, scallops may be destroyed on false positive results, but the CA does not consider that as problem as there rarely are positive results. Recommendation No 2 of the previous mission can be considered as addressed. However, the validation of the Lawrence method has been prolonged to the end of 2010. 5.7 OFFICIAL CERTIFICATION Legal requirements Article 14 of 854/2004 states that a document meeting the requirements set out in Annex VI shall accompany consignments of products of animal origin when they are imported into the Community. The certificates shall meet the requirements set out in Annex VI to 854/2004. Appendix IV to Annex VI to 2074/2005 includes the model health certificate for imports of FP intended for human consumption. Findings Recommendation No 3 of the previous mission report in relation to giving guarantees to the Member State(s) of destination as describe in Article 17 of Commission regulation 2076/2005 has been addressed by the CA. The health certificate used for import of scallops to Denmark meets the requirements stated above. Conclusions The health certificate model used by the CA meets Community requirements. 6 OVERALL CONCLUSION 9
A new control system was developed before the previous mission took place in 2008, but the sampling was not considered to fully meet the requirements requested in Chapter II, Annex II of 854/2004. Improvements have been made to the control system for BM since the 2008 mission and the system now covers all required analyses. Microbiology analyses for E. coli are now performed according to the requirements (ISO 16649-3 standard). The control system now being implemented by the Danish Veterinary and Food Administration, as the acting CA for Greenland, can be considered as providing guarantees equivalent to Community requirements for raw, frozen scallops. 7 CLOSING MEETING During the closing meeting held in Søborg on 12/06/2009 the MT presented the findings and preliminary conclusions of the mission to the CA. During this meeting, the CAs acknowledged the findings and preliminary conclusions presented by the MT and provided commitment to give additional information concerning the missing laboratory results. 8 RECOMMENDATIONS No. 1 Recommendation The Lawrence method should be validated and accredited by the end of 2010 as stated in the updated action plan 2009 from the CA. The CA should provide the Commission Services with the result of this validation. The competent authority's response to the recommendations can be found at: http://ec.europa.eu/food/fvo/ap/ap_greenland_8042_2009.pdf 10
ANNEX 1 - LIST OF LEGISLATION REFERENCED IN THE REPORT Reference OJ Ref. Detail Audits by the Commission Services Decision 98/140/EC 882/2004 OJ L 38, 12.2.1998, p. 14 16 OJ L 165, 30.4.2004, p. 1, Corrected and re-published in OJ L 191, 28.5.2004, p. 1 Food Law and official controls 178/2002 852/2004 853/2004 854/2004 OJ L 31, 1.2.2002, p. 1 24 OJ L 139, 30.4.2004, p. 1, Corrected and re-published in OJ L 226, 25.6.2004, p. 3 OJ L 139, 30.4.2004, p. 55, Corrected and re-published in OJ L 226, 25.6.2004, p. 22 OJ L 139, 30.4.2004, p. 206, Corrected and re-published in OJ L 226, 98/140/EC: Commission Decision of 4 February 1998 laying down certain detailed rules concerning on-the-spot checks carried out in the veterinary field by Commission experts in third countries 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 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 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin 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 11
Reference OJ Ref. Detail 2074/2005 2076/2005 1664/2006 25.6.2004, p. 83 OJ L 338, 22.12.2005, p. 27 59 OJ L 338, 22.12.2005, p. 83 88 OJ L 320, 18.11.2006, p. 13 45 Microbiological criteria 2073/2005 Contaminants 1881/2006 1883/2006 OJ L 338, 22.12.2005, p. 1 26 OJ L 364, 20.12.2006, p. 5 24 OJ L 364, 20.12.2006, p. 32 43 OJ L 88, 29.3.2007, p. Commission 2074/2005 of 5 December 2005 laying down implementing measures for certain products under 853/2004 of the European Parliament and of the Council and for the organisation of official controls under 854/2004 of the European Parliament and of the Council and 882/2004 of the European Parliament and of the Council, derogating from 852/2004 of the European Parliament and of the Council and amending s 853/2004 and 854/2004 Commission 2076/2005 of 5 December 2005 laying down transitional arrangements for the implementation of s 853/2004, 854/2004 and 882/2004 of the European Parliament and of the Council and amending s 853/2004 and 854/2004 Commission 1664/2006 of 6 November 2006 amending 2074/2005 as regards implementing measures for certain products of animal origin intended for human consumption and repealing certain implementing measures Commission 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs Commission 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs Commission 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 Commission 333/2007 of 28 March 2007 laying down the methods of sampling 12
Reference OJ Ref. Detail 333/2007 29 38 and analysis for the official control of the levels of lead, cadmium, mercury, inorganic tin, 3-MCPD and benzo(a)pyrene in foodstuffs 13