EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

Ref. Ares(2015)3007794-16/07/2015 EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Directorate F - Food and Veterinary Office DG(SANTE) 2015-7465 - MR FINAL REPORT OF AN AUDIT CARRIED OUT IN THE FAROE ISLANDS FROM 10 MARCH 2015 TO 16 MARCH 2015 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.

Executive Summary This report describes the outcome of a FVO audit in the Faroe Islands carried out from 10 to 16 March 2015 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 authority can guarantee that the conditions of production of fishery products in the Faroe Islands 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 FVO fishery products audit report of 2011 have been implemented and enforced by the competent authority. The report concludes that the current organisation of competent authority and the control system implemented generally offers sufficient guarantees concerning the sanitary conditions of fishery products exported to the EU. However, in order to ensure that all fishery products exported to the EU comply with and were produced in accordance with requirements at least equivalent to the EU legislation, some improvements are needed, in particular concerning controls over the use of additives, implementation procedures based on the HACCP principles and certain official controls on fishery products (microbiological testing in cooked crustaceans and histamine sampling procedures). The report addresses to the Faroese competent authority a number of recommendations aimed at rectifying identified shortcomings and enhancing the control system in place. I

Table of Contents 1 Introduction...1 2 Objectives and scope of the audit...1 3 Legal Basis for the audit...2 4 Background...2 4.1 General background...2 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 National Provisions and Procedures for Listing Establishments exporting to the EU...7 5.4 Official controls...8 5.4.1 Official controls on production and placing on the market...8 5.4.2 Official controls of fishery products...13 5.5 Follow up of RASFF Notifications...15 5.6 Laboratories...15 6 Overall Conclusions...16 7 Closing Meeting...16 8 Recommendations...17 II

ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT Abbreviation CA Cd CCP DG SANTE EC EN EU EU listed EUROSTAT FBO FFVA FVO GRT HACCP Hg HPLC ISO OJ PAH Pb PCBs RASFF TVB-N Explanation Competent Authority Cadmium Critical Control Point Directorate General for Health and Food Safety European Community European Norm European Union Facility approved by the CA for EU fishery products export Statistical Services of the EU Food business operator Faroese Food and Veterinary Authority Food and Veterinary Office of the European Commission Gross Registered Tonnes Hazard Analysis Critical Control Points Mercury High Performance Liquid Chromatography International Organisation for Standardisation Official Journal of the EU Polycyclic Aromatic Hydrocarbons Lead Polychlorinated Biphenyls Rapid Alert System for Food and Feed Total volatile basic nitrogen III

1 INTRODUCTION The audit took place in the Faroe Islands from 10 to 16 March 2015 and was undertaken as part of the Food and Veterinary Office's (FVO) audit programme. The current audit was a joint audit covering two themes regarding fishery and aquaculture products intended for export to the European Union (EU), one evaluating the control systems and operational standards in the residues sector for aquaculture production and the other focusing on public health controls of the production system for fishery products. An individual report has been produced for both themes. This report covers an evaluation of the public health control system in place governing the production of fishery products intended for export to the EU. The report dealing with residues monitoring aspects bears the reference: DG (SANCO)/2015-7519.The audit team comprised one inspector from the FVO for each area audited. An opening meeting was held in Tórshavn on 10 March 2015 with the Competent Authority (CA), the Faroese Food and Veterinary Authority (FFVA). 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 objective of the audit covered by this report was to evaluate whether the official controls put in place by the CA can guarantee that the conditions of production of fishery products in the Faroe Islands destined for export to the EU are in line with the requirements laid down in EU legislation; In terms of scope the audit focused on the organisation and performance of the CA and the official control system in place covering production, processing and distribution stages applicable to fishery products to be exported to the EU. In pursuit of these objectives, the audit team visited the following sites: COMPETENT AUTHORITY Central level 1 LABORATORY VISITS FFVA laboratory 1 PRIMARY PRODUCTION Aquaculture farms 1 Fishing vessels 1 One trawler with fish preserved on ice LANDING AND FIRST SALE Landing sites 0 (no landing operations occurred at the time of the FVO visit) 1

FACILITIES HANDLING FISHERY PRODUCTS Factory vessels 2 Processing Plants 4 Cold stores 2 3 LEGAL BASIS FOR THE AUDIT The audit was carried out under the general provisions of EU legislation and, in particular, point 1 of article 9 of Chapter II of Decision No 1/2001, of 31 January 2001, of the EC- Faeroe Islands Joint Committee, laying down the provisions to implement the Protocol on veterinary matters supplementing the Agreement between the European Community, of the one part, and the Government of Denmark and the Home Government of the Faeroe Islands, of the other part. 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 The EU import conditions of products of animal origin originating from Faroe Islands are governed by the above mentioned Protocol on veterinary matters supplementing the Agreement between the EU, the Government of Denmark and the Home Government of the Faroe Islands 1 since 2001. Fishery products imports into the EU from the Faroe Islands are based on intra-eu trade conditions. The Faroes and the European Economic Community signed the first Free Trade Agreement (the Agreement) in 1991. This agreement was later revised, and in 2001, the Faroes and the EU finished negotiations on a Veterinary Protocol (the Protocol), which became part of the Agreement. The Protocol s intention is to ensure that the Faroes follow the same veterinary regulations for production and trade in animal products that are applicable in EU Member States. Therefore with the Agreement, the Faroes are within the external border of the EU in the veterinary area in relation to third countries. With regard to the legislation, the Protocol refers to some EU standards that are now repealed (e.g. Council Directives 91/493/EEC and 92/48/EEC) but remain relevant in the context of this audit. The report will refer to the current EU standards where equivalent to the old ones. The Faroe Islands is listed for aquaculture in the Annex to Commission Decision 2011/163/EU and therefore can export aquaculture fishery products to the EU. 1 See at: http://ec.europa.eu/food/safety/international_affairs/agreements/index_en.htm 2

A previous inspection took place in 2011 (ref. DG(SANCO)/2011-6145) which had highlighted deficiencies in relation to inspections of small fishing vessels, official controls on fishery products (organoleptic and parasite checks, chemical checks), official controls on scallops (microbiological and contaminants) and the use of non-authorised additives. That report made a number of recommendations in respect of the action required by the CA. Written guarantees were received from the CA in relation to the implementation of actions aimed at addressing those recommendations in a satisfactory way. The report (ref. DG(SANCO)/ 2011-6145) is published on the Health and Food Safety Directorate-General (SANTE) Internet site at http://ec.europa.eu/food/fvo/ir_search_en.cfm. 4.2 PRODUCTION AND TRADE INFORMATION According to information provided by the CA, the main fishery products exported to the EU are mackerel (Scomber scombrus), blue whiting (Micromesistis poutassou) salmon (Salmo salar) and cod (Gadus morhua). Table 1 summarises the exports from Faroe Islands of fishery products to the EU. Table 1 - Exports of fishery products from Faroe Islands to the EU (tonnes) (source CA) Common name Scientific name Quantity 2013 (in tonnes) Quantity 2014 (Jan. - Oct.) (in tonnes) Mackerel Scomber scombrus 20,072 29,695 Blue whiting Micromesistis poutassou 28,721 24,797 Salmon Salmo salar 25,176 19,488 Cod Gadus morhua 13,761 13,872 Saithe Pollachius virens 12,881 11,109 Hake Merlucciidae 3,860 4,777 Greater Silver Argentina silus 4,177 4,604 Smelt Ling Molva molva 3,589 3,198 Haddock Melanogrammus 3,381 2,603 aeglefinus Herring Clupea harengus 14,901 2,443 Others 44,307 37,647 Shrimp p.m. p.m. TOTAL 175,826 154,233 The main importing Member States are the Netherlands, United Kingdom, Denmark and Germany. According to the list established by the CA and available on the DG SANTE website, imports of fishery products from Faroe Islands into the EU are authorised from a total of 42 establishments (these include seven establishments processing only or partially materials derived from aquaculture), seven cold stores, twelve freezer vessels, and eight factory vessels. 3

There are currently 47 aquaculture farms, 27 of which are at sea stage (salmon) supplying raw materials to establishments exporting to the EU. A total of 86 fishing vessels over 20 Gross Registered Tonnes (GRT) are approved by the CA and roughly 600 vessels of lower capacity also participate in the production chain for EU export. This list is available on the SANTE website at the following address: http://ec.europa.eu/food/food/biosafety/establishments/list_en.htm. 4.3 RAPID ALERT SYSTEM FOR FOOD AND FEED (RASFF) NOTIFICATIONS Over the last four years, four Rapid Alert System for Food and Feed (RASFF) notifications were registered regarding fishery products produced or packaged in the Faroe Islands. Two notifications concerned allergens (undeclared milk ingredient) in frozen breaded prefried fish from Sweden (using Faroese raw material) and two cases of parasitic infestation with Anisakis of frozen and salted fish. 5 FINDINGS AND CONCLUSIONS 5.1 LEGISLATION Legal requirements Article 46(1)(a) of Regulation (EC) No 882/2004. Findings 1. The main legislation and standards in force in the Faroe Islands to control fishery products to be exported to the EU and its production chain have not changed since the previous audit report:- Act of Parliament No 58 of the 26 May 2010, on foodstuffs transposing into Faroese legislation Regulation (EC) No 178/2002; Executive Order No 122 of 24 August 2001, on the processing, purchase and placing on the market of fish and fishery products on land; Executive Order No 128 of 28 December 2010, laying down provisions on the authorisation and registration of food business operators; Executive Order No 161 of 18 December 1995, on hygienic operation, processing of fish and fishery products and authorisation on fishing vessels; Executive order No 114 of 15 August 2001, on own-controls; Executive Order No 9 of 5 February 2009, on microbiological criteria for foodstuffs; Executive Order No 147 of 1 December 2009, setting maximum levels for certain contaminants in foodstuffs; Executive Order No 148 of 1 December 2009, laying down methods of sampling and analysis for the official control of levels of certain contaminants in certain foodstuffs; 4

2. Executive Order No 127 of November 2013, laying down provisions for distribution and quality of water intended for human consumption, was published after the previous audit providing the EU equivalent legal base with regard to water quality assurances. 3. However the audit team noted that legal requirements on food additives used in fishery products have not yet been established by the CA, nor have binding procedures/ instructions been put in place to ensure that Food Business Operators (FBOs) using food additives comply with conditions at least equivalent to the ones prescribed in Regulation (EC) No 1333/2008 of the European Parliament and of The Council. In the previous FVO audit, the audit team was informed by the CA of their intention to translate into Faroese the main provisions of Regulations (EC) Nos 852, 853, 854 and 882 of 2004 of the European Parliament and of the Council, and to adopt a Faroese coversheet such as an executive order. These documents are now at a consultation stage with the production sector. According to the CA their adoption is expected to take place in the summer 2015. Conclusions on the Legislation 4. Faroese legislation in force dealing with fishery products and their production chain generally covers the requirements of the EU legislation with the exception of the requirements concerning additives permitted for use in foods. 5.2 COMPETENT AUTHORITY Legal requirements Article 46 of Regulation (EC) No 882/2004, in particular, points (1) (b) to (e), (g) and (h) of the aforementioned Article. Findings Structure and organisation 5. The CA, the FFVA, under the Ministry of Trade and Industry is empowered to enforce the food laws under the Executive Order No 83, from 30 June 2010. 6. The overall structure and organisation remains as it was at the time of the previous audit in 2011. However the Fish and Animal Health Department has been integrated into the Food Department. Of the fifteen officials integrated into this department, ten are currently involved in official controls of the fishery products production chain. Food safety, border inspection posts, animal health, and certification are some of the areas under their control. These inspectors are also responsible for carrying out official controls on other foodstuffs at production and retail level. 7. The CA has started to develop an in-house quality manual encompassing the procedures already in place. This manual will cover amongst other topics, the registration and approval of FBOs, regular official controls and official sampling of fishery products. 5

Powers, Independence and Supervision 8. The CA has the powers to enter and inspect premises, check hygiene conditions and relevant documentation, collect samples for analysis, seize products, apply penalties and order the suspension or withdrawal of establishments from the approved list. 9. During the audit the FVO team saw examples of the execution of these powers (inspection reports imposing corrective actions and requiring the destruction of products). 10. According to information provided by the CA, all officials are subject to the provisions relating to impartiality and independence defined in Chapter 2 of Parliamentary Act No 132 of June 10th 1993 (Parliamentary Act on Administration). Training of staff performing official controls 11. Internal and external training sessions have been organised for CA staff since 2011. The records of these training activities were reviewed by the audit team and included:- Better Training for Safer Food training on Hazard Analysis and Critical Control Points (HACCP) and food contact material; Nordic seminars on food safety with visits to similar organisations in other Nordic countries (sensory analysis, freshness of fish, spoilage, etc.). These training sessions include also audit performance (preparation of inspection, follow-up needed, checklists, partial audits and report writing); Internal seminars, with exercises in identification of nematodes in fish; Courses on aquaculture production technology, fish health and fish welfare; Participation in general courses, about project management and quality assurance. 12. In order to ensure that official tasks are performed in a uniform, consistent and adequate way newcomers should accompany more experienced staff in at least five official control actions (monitoring visits to the establishments, sampling, certification and other specific activities). Documented control procedures 13. The CA has in place a comprehensive set of written procedures and instructions which includes, the following:- Registration and approval - Instructions and templates for FBOs for the application process and checklists and forms used by staff in charge of evaluation of the process. Regular control Checklists that generally cover the EU requirements (structural and functional requirements, including hygiene and HACCP). There are checklists for official controls over aquaculture farms, vessels and landing operations and establishments. Templates of reports and letters requesting corrective actions are also in place. Feedback on inspections/audits to the CA hierarchy, and to the FBO; Actions to be taken following unsatisfactory results of analyses or nonconformities observed or/and reported during official inspections/audits 6

Conclusions on the Competent Authority 14. The CA responsible for official controls and fishery products is clearly designated, well structured and organised and has the necessary powers to implement the official control system. Documented procedures and instructions are in place to ensure adequate implementation of the provisions laid down in the legislation. 5.3 NATIONAL PROVISIONS AND PROCEDURES FOR LISTING ESTABLISHMENTS EXPORTING TO THE EU Legal requirements Article 31 (2) of Regulation (EC) No 882/2004 Findings 15. In order to be authorised to export to EU, fishery products establishments need to be approved. Under the provisions of Article 6 of Executive Order No 128 of 28 December 2010, establishments intending to be approved must submit an application to the CA. This application, together with a copy of the internal quality manual (including HACCP plan) and other relevant information, is assessed by the CA. 16. Approval is granted following a procedure which includes an on-site visit to verify whether the establishment complies with requirements established in the legislation mentioned above together with a preliminary assessment of the HACCP plan. A notification in writing, together with the allocation of an authorisation number, is sent to the FBO when authorisation is granted. Records of all the steps taken in the evaluation process and the exchange of documents with the FBO are kept in a database. 17. The authorisation issued sets out the activities within the scope of the approval, the legislation applicable to the activities under the authorisation, the legal provisions to appeal such decisions taken by the CA and the minimum analytical tests to be performed by the FBO on the final product. 18. Once granted the approval has no expiry date; however, renewal is required if major changes take place in the facilities, the layout or in the production process. In such cases the FBO should apply for a new authorisation to the CA and a new approval procedure takes place. 19. The CA has also provisions for approval of primary production fish farming facilities (broodstock farms, smolt ponds and aquaculture farms). An application is submitted to the CA, together with information related to facilities and activities. The approval is valid for up to five years. Fishing vessels with more than 20 GRT are also approved by the CA (these include refrigerated sea water (RSW) vessels, long liners and trawlers). 20. The audit team noted that:- Approval has been granted in accordance with the procedure in the establishments visited. An official notification of approval was available with the description of the activities authorised. 7

21. The audit team noted however, that lists of approved establishments are not properly drawn up and kept up-to-date with all the facilities that have been approved. In this regard the audit team noted delays of, in some cases, several months in the updating of the list published on the website. The CA had taken action in this regard during its preparation for the FVO audit and the lists, where reviewed by the audit team, were found up-to-date. Conclusions on provisions and procedures for listing establishments exporting to the EU 22. National provisions and procedures for listing establishments participating in the EU export of fishey products are in place and are followed by the CA. 5.4 OFFICIAL CONTROLS 5.4.1 Official controls on production and placing on the market Legal requirements Article 4 of Regulation (EC) No 854/2004 and Chapter I of Annex III to Regulation (EC) No 854/2004. Regulation (EC) No 2073/2005. Findings 5.4.1.1 Official control system in place 23. As described in the previous FVO audit the CA has a documented official control system in place that includes among others the following control actions:- Inspection of aquaculture farms the official control system over the aquaculture production chain include regular visits (4 times a year) and a systematic reporting, by the FBO to the CA, of data related to production, of the movement of animals between areas and to slaughter, of treatments and of abnormal mortalities. Movements between earlier stage production facilities and from an aquaculture farm to slaughter facilities are subject to the issuing of a Movement License by the CA. This license is valid for 40 days. Fish should be sent to slaughter accompanied by the food chain information document (declaration from the farmer to the slaughter facilities with details on the origins of animal, as well as assurances on the non-use of forbidden substances and on the respect of withdrawal periods for treatments). Aquaculture FBO s retain a private veterinarian who should regularly perform visits of the aquaculture farms (between once a month and once every two months depending on the production stage). The records of these visits as well as information on necropsies of fish and sampling for laboratory diagnosis should be kept at the farm. A checklist has been created to monitor aquaculture facilities and cover, amongst others, the verification of systematic reporting to the CA, identification of cages to allow traceability, biosecurity measures and animal health conditions. 8

Inspection of fishing vessels visits should be performed once every two years for all vessels above 20 GRT (the vessels approved by the CA) to check facilities, equipment, and general hygiene conditions. Smaller vessels are not approved by the FFVA but they are, nevertheless, registered by the Ministry of Fisheries (responsible for issuing fishing licenses) and kept on an up-to-date list available on the fisheries website. More detailed information about landing operations is made available to FFVA by request. These vessels are to be checked randomly by the CA during their controls on landing sites and reports are kept on a data base. Inspection of factory and freezer vessels inspections are foreseen to take place once and twice a year respectively for freezer and factory vessels. A checklist based on the existing legislation is used for this purpose. Checks on the hygiene conditions of landing are foreseen to take place twice a year. Partial inspection of fishery products processing plants is to take place twice a year. In addition a comprehensive audit should take place once every five years. The inspector responsible for the establishment organises the visit in order to cover different parts of the checklist on each visit. A checklist is in place based on the requirements of the legislation and cover, amongst other items, checks on maintenance and hygiene conditions of the facilities, compliance with temperature requirements, HACCP records, traceability and labelling. Inspection of cold stores - once a year, to check temperature requirements for storage, general hygiene and maintenance of the facilities. 24. Reports should be produced after each visit and sent to the FBO. A specific deadline for corrective actions should be included and follow-up is performed during the following visit. 5.4.1.2 Primary production Aquaculture farms 25. There are currently 46 approved aquaculture farms, of which 27 produce fish for slaughter (sea based aquaculture farms). 26. The audit team visited one of these farms and noted that:- There were comprehensive records in relation to the origin of feed and its rationing, health status of stock, a system to control the use of veterinary medicinal products and records of mortality. Detailed traceability data with records of harvesting dates, quantities harvested and dispatched and destination of the final product were also presented to the audit team. The aquaculture farm was visited according to the prescribed frequency, reports were sent to the FBO with reference to deficiencies to be corrected. Follow-up was generally performed during the subsequent scheduled visit. Prior to visits, inspectors consult the database available at the central level (with the above mentioned information reported by the farmer) in order to set priority areas to be controlled during that vistit. 9

This aquaculture farm was found to be largely in compliance with EU equivalent requirements. Vessels 27. There are currently 89 fishing vessels approved by the CA (over 20 GRT). These vessels mainly gut and preserve fish on ice (mostly cod, haddock and ling) or preserve whole fish in RSW tanks (mackerel and herring). 28. The audit team visited one fishing vessel over 20 GRT (a trawler preserving gutted fish on ice) and noted the following:- An approval notification has been issued by the CA. A report of the last visit was available (2012) covering the relevant points of EU legislation (including maintenance, cleaning of production areas, water intake and ice production and records of organoleptic inspection of landed products). Controls were carried out using a specific checklist. This vessel was found to be in generally in line with EU requirements, with some minor deficiencies in hygiene in the storage area (dirty conveyer belt used in the distribution of the fish to the bins inside the hold after cleaning operations before leaving the harbour) and rusty surfaces where the fish is landed on board. 29. The audit team was informed by the CA that vessels under 20 GRT are also under control. Taking into account the small dimensions of these vessels the requirements to be checked, which are included in a CA checklist for such vessels, are less comprehensive than those for vessels over 20 GRT but still equivalent to EU requirements. Checks on these small vessels are performed randomly during visits to landing sites. 30. A complete list of small vessels, frequency of landing in the last year and visits performed since the last audit was made available to the audit team together with samples of reports of visits done. Inspectors keep a list of vessels already visited in order to cover new vessels during subsequent visits to landing sites. According to data provided to the team by the CA, there are currently around 500 of these vessels (below 20 GRT) in the Faroe Islands, 28 of which operate full-time and the remainer only part-time (of which approx. 20% landed more than 10 times last year). Fifty nine of the registered vessels were checked by the CA over the last 3 years. The records of these visits are kept by the CA in a database. 5.4.1.3 Landing operations, landing sites and first sale 31. There are currently five landing sites approved by the CA. These landing sites are authorised to supply directly to the EU. None of these landing sites was visited by the audit team as no landing operations could take place due to adverse climate conditions. 32. Nevertheless, according to information provided by the CA during a visit to a processing establishment with such a landing site, the audit team was able to gather information and examples of the procedures in place:- The CA carries out inspections of the landing site using a specific checklist. All FBO managing landing sites (independent or belonging to an establishment) are obliged to keep records of organoleptic examinations of each batch landed by fishing vessels. The evaluation comprises, among others, the origin of the fish, 10

quantities, an assessment of freshness of the fish, temperature, ice content, storage conditions and an overall conclusion on the batch. This assessment is recorded in duplicate on a form defined by the CA and a duplicate is given to the vessel and should be kept on-board available for a CA review. Periodically the CA performs their own assessment simultaneously with the landing site FBO to verify the adequacy of their controls. 5.4.1.4 Facilities, including vessels, handling fishery products 33. The audit team visited six establishments (including two cold stores and one aquaculture processing establishment) and two factory vessels. One of the establishments was not in operation at the time of the visit due to seasonal break (a pelagic fish processing establishment). 34. Despite the fact that control visits were not always carried out according to the frequency set by the CA, reports of several visits over the last 3 years were present in all establishments visited. 35. Controls had been carried out using a specific checklist and examples of comprehensive and partial inspections were available on the spot. Copies of the reports were sent to the FBO and follow-up was generally carried out in the following visit. 36. The establishments visited were found, from a structural and hygiene point of view, generally in line with EU requirements. Some of the deficiencies noted by the audit team had already been detected by the CA during recent visits. Some others, however, have not been recorded in previous inspection reports (condensation in production areas over exposed product and brine, damaged coating on the walls and rusty surfaces of some equipment in production areas, non pest-proof doors or deficient separation from exterior of the areas used for thawing products, knife-grinders located over the areas of preparation of fillets in an establishment without a metal detector). 37. All the establishments visited had permanent procedures based on HACCP principles. Some significant shortcomings were noted in three out of six establishments i.e. relevant hazards were not properly identified and controlled (physical hazards not considered in facilities in which hooks, knifes and chain saw could pose a risk), monitoring procedures and verification procedures over the control points were not covered at all processing steps and deficient monitoring of some control points (lack of coverage of the use of additives, records not kept as foreseen, absence of control over temperature records in the storage process). 38. In all establishments visited comprehensive FBO own-check sampling plans are in place and results are routinely verified by the CA, which represents an improvement compared with the situation found during the 2011 audit. Currently the CA determines, at the moment of approval, the type and frequency of microbiological and chemical tests that should be included in each FBO s own-checks programme. These tests include the parameters foreseen in EU legislation and are generally carried out in accredited laboratories. Testing on histamine is carried out properly in establishments and factory vessels handling species associated with a high level of histidine. Microbiological tests are typically comprehensive and undertaken using the FFVA laboratory or other 11

accredited ones. In some of the establishments, contaminants such as heavy metals and/or dioxins are also part of the testing). 39. Comprehensive product and water tests are also undertaken routinely in establishments and also in the factory vessels visited. 40. With regard to the use of additives, the audit team noted that polyphosphates were used in both establishments visited processing salted fish. Brine with polyphosphates is injected into the fish and, in the cases reviewed by the audit team, a reference to these additives was found on the label of the final product. The audit team noted however that the inclusion of internal controls and records of the usage of these substances were only initiated very recently (February or March 2015) following the last visit by the CA and that in some cases those records were incomplete. 41. Control over the limits of additives in the final product is done by determination of the average volume of brine injected with a specifed concentration. Because this calculation is made, no analysis is done by the FBO in the final product to determine the concentration of residues of these additives, neither regularly nor during the validation of the process. 42. The audit team also noted that antifoaming substances were regularly included in the preparation of brine. The use of these substances was explained by one FBO as an essential step to guarantee that the required concentration of brine in the fillets is achieved and also to extend the use of brine. 43. It was noted however that the description of the "intended use" included in the technical specification of these products, as reviewed by the audit team, did not cover their use in brine to be injected in fish or any other food. 44. The detailed composition of these products was not found on either the product label or in the technical specification. In one case, no active substance was specified and in the other case Dimethyl polysiloxane (E 900) was indicated but technical specifications also stated A preservative to guard against antimicrobial growth is included in the product" but no information was provided identifying the preservative concerned. The same specification refers to the product as an additive, stating Antifoaming agents used in food processing applications are direct additives and thus remain in the food when it is consumed. 45. The audit team noted that Dimethyl polysiloxane is not authorised to be used as an additive in fishery products under Regulation (EC) No 1333/2008, its use is restricted primarily to: fats and oils, fruits, vegetables, jams but not fishery products. 46. None of the establishments visited had performed analytical tests on final product to verify the presence of residues of these substances nor could they present any health risk assessment with regard to their use. 47. The the use of these substances had only been detected by the CA in a very recent control (two to three weeks before the audit) despite the fact that, at least in one case, they had been regularly used over recent years. In both cases found by the CA, it requested that the FBO present the technical file on the substances. However the usage of the substances continued as the CA was assessing the files and investigating the legal framework within which they could be used (pending on their classification as either "additive" or "processing aid"). The audit team was informed that shortly after the FVO visit both FBOs decided to suspend the use of these products until further clarification from the CA. 12

48. The monitoring of the quality of drinking water by the FBO 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 were found to be satisfactory. Conclusions on official controls on production and placing on the market 49. A well-documented official control system covers all elements of the production chain and can provide the necessary guarantees that EU requirements are generally met at all stages of the chain. Some deficiencies were noted however, with regard to the implementation of official controls of the use of additives and HACCP. 5.4.2 Official controls of fishery products Legal requirements Article 7 of Regulation (EC) No 854/2004 Chapter II and III of Annex III to Regulation (EC) No 854/2004. Findings Official controls of fishery products are performed by the CA in accordance with the following:- 5.4.2.1 Organoleptic examinations 50. Organoleptic tests are carried out at all stages of the production chain. A comprehensive checklist is used for this purpose and in some cases these controls are performed in tandem with FBO own-checks in order to supervise the latter. The CA keeps records of these checks and a copy is given to the FBO. Examples of these records were made available to the audit team. 5.4.2.2 Freshness indicators 51. If needed, freshness indicator tests can be performed in the laboratory of FFVA. Examples of tests performed following an investigation of spoiled fish at landing, were provided to the audit team. 5.4.2.3 Histamine 52. The audit team noted that no official samples were collected in 2012 and 2013 for histamine testing. Official sampling started in 2014 with six samples in total collected in establishments and vessels and nine samples in 2015 to the date of the audit. 53. The audit team noted however, that those samples were not composed of nine units as required by the EU Regulation (EC) No 2073/2005. 13

5.4.2.4 Residues and contaminants 54. The audit team noted that official checks for environmental contaminants are carried out by the CA and include heavy metals (lead (Pb), Cadmium (Cd) and Mercury (Hg)), and dioxins and PCBs) for both aquaculture and wild fish. Tests were performed according to a Faroese monitoring plan for fish. Sampling is carried out by official inspectors for different species every year (size is one of the criteria taken into consideration for the evaluation) and are analysed by an external accredited laboratory. This programme is in place since 2009 and covers the main species exported to EU. 55. The team was provided with the CA test results for 2013 and 2014 on heavy metals, dioxins as well as dioxins like PCBs; all the results were found below the EU permitted levels. 5.4.2.5 Microbiological analysis 56. The audit team noted that fishery products exported to the EU are mainly raw chilled and frozen unprocessed products for which no microbiological criteria are set in EU legislation. 57. However some cooked shrimps are also exported but in small quantities. The audit team noted that no official tests on shrimp have been carried out by the CA to ensure compliance with EU requirements (Salmonella criteria) in particular results of microbiological tests performed in facilities producing cooked crustaceans as foreseen by Regulation (EC) No 2073/2005. 5.4.2.6 Parasites 58. Evidence was presented to the audit team that FBO own-checks include parasite controls and that these are carried out under CA supervision when visiting the establishments and factory vessels. Conclusions on official controls on fishery products 59. The CA implements official controls on fishery products exported to the EU that adequately covers most EU requirements (organoleptic check, parasites, freshness indicators, monitoring arrangements for environmental contaminants and more recently histamine). The official control systems has improved considerably since the previous audit but still some improvements are required in particular with regard to microbiological checks over the production on cooked crustaceans and the sampling procedures for histamine in order to be fully in line with EU requirements for the sector. 5.5 FOLLOW UP OF RASFF NOTIFICATIONS Legal requirements Article 11(4) of Regulation (EC) No 854/2004. Findings 60. The FFVA is the national contact point for RASFF notifications. 14

61. The audit team had the opportunity to review the follow-up of a RASFF notification, in one of the establishments visited. From the procedures implemented the audit team noted that:- Information related to the existence of the RASFF notification was speedily notified to the FBO with a requirement to provide information on the actions taken; A CA on-the-spot visit promply took place in good time, to collect relevant supplementary information and confirm the adequacy of the procedures put in place by the FBO to address the specific hazard (parasites in wet salted fillets). Results of investigations were transmitted in good time to the Commission services. Conclusions on follow up of RASFF notifications 62. There is a system in place to effectively investigate and take action in response to RASFF notifications. 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 26-1997. Chapter 1 of Annex I to Regulation (EC) No 2073/2005 and Section II of Annex II to Regulation (EC) No 2074/2005. Regulations (EC) No 333/2007 and Regulation (EU) No 589/2014. Findings 63. The FFVA laboratory visited by the audit team carries out TBV-N, histamine, heavy metals and microbiological determinations in fishery products and water and also animal health diagnostics. 64. The CA has also designated accredited laboratories in Member States for official analysis for dioxins and PCBs. 65. The audit team noted in visited the laboratory and that: It is accredited to ISO standard (ISO 17025) by DANAK (Danish accreditation scheme) for chemistry and microbiology. Both microbiological and chemical analyses relevant for EU exports have been included in the scope of accreditation. Corrective actions were implemented for the deficiencies identified in DANAK audit reports which were made available to the audit team.. The methods used for testing for heavy metals had been validated and the detection limits are in line with EU requirements. The laboratory participates regularly in internationally organised proficiency tests for heavy metals, histamine and microbiological tests and the results shown were satisfactory. 15

Conclusions on Laboratories 66. The designated laboratories performing official control analysis are accredited against ISO 17025 and work under satisfactory quality assurance schemes which allow them to provide adequate guarantees with regard to the reliability of the analysis results. 6 OVERALL CONCLUSIONS The current organisation of CA and the control system implemented offers generally acceptable guarantees concerning the sanitary conditions of fishery products exported to the EU. However, in order to ensure that all fishery products exported to the EU comply with and were produced in accordance with requirements at least equivalent to EU legislation, some improvements are needed, in particular concerning controls over the use of additives, implementation of procedures based on the HACCP principles and certain official controls on fishery products (microbiological testing in cooked crustaceans and histamine sampling procedures). 7 CLOSING MEETING During the closing meeting held in Tórshavn on 16 March 2015, the audit team presented the main findings and preliminary conclusions of the audit to the CA. During this meeting, the CAs acknowledged all the findings and preliminary conclusions presented by the audit team. The CAs pointed out that both establishments visited processing salted fish, had suspended the use of the antifoaming substances in brine preparation until further clarifications from the CA. The CA requested the assistance of Commission services in order to better address this situation. 16

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. No. Recommendation 1. The CA should ensure that standards equivalent to EU requirements regarding the food additives (as established in Regulation (EC) No 1333/2008) are applied to fishery products for EU export. In particular that only food additives that are included in the list of authorised additives are used in the production of such products. Recommendation based on conclusions No 4 and 49 Associated findings No 3 and No 42 to 46 2. The CA should ensure, that FBOs implement and maintain procedures based on HACCP principles that fully comply with Article 5 of Regulation (EC) No 852/2004. In particular, that all relevant potential hazards are identified and that monitoring procedures are adequately implemented. Recommendation based on conclusion No 49 Associated finding No 37 3. The CA should ensure that fishery products for EU export have satisfactorily undergone all the official controls laid down in Chapter II of Annex III to Regulation (EC) No 854/2004, in particular that microbiological checks take into account the specific EU requirements and that the official sampling plans of analysis for histamine are carried-out in accordance with Regulation (EC) No 2073/2005. Recommendation based on conclusion No 59 Associated findings 53 and 57 17

ANNEX 1 LEGAL REFERENCES Legal Reference Official Journal Title Dec. 2001/127/EC OJ L 46, 16.2.2001, p. 24-29 2001/127/EC: Decision No 1/2001 of the EC- Faeroe Islands Joint Committee of 31 January 2001 laying down the provisions to implement the Protocol on veterinary matters supplementing the Agreement between the European Community, of the one part, and the Government of Denmark and the Home Government of the Faeroe Islands, of the other part Dec. 2011/163/EU OJ L 70, 17.3.2011, p. 40-46 Dir. 98/83/EC OJ L 330, 5.12.1998, p. 32-54 Reg. 178/2002 OJ L 31, 1.2.2002, p. 1-24 Reg. 852/2004 OJ L 139, 30.4.2004, p. 1, Corrected and re-published in OJ L 226, 25.6.2004, p. 3 Reg. 853/2004 OJ L 139, 30.4.2004, p. 55, Corrected and re-published in OJ L 226, 25.6.2004, p. 22 Reg. 854/2004 OJ L 139, 30.4.2004, p. 206, Corrected and re-published in OJ L 226, 25.6.2004, p. 83 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 98/83/EC of 3 November 1998 on the quality of water intended for human consumption 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

Reg. 882/2004 OJ L 165, 30.4.2004, p. 1, Corrected and re-published in OJ L 191, 28.5.2004, p. 1 Reg. 2073/2005 OJ L 338, 22.12.2005, p. 1-26 Reg. 2074/2005 OJ L 338, 22.12.2005, p. 27-59 Reg. 333/2007 OJ L 88, 29.3.2007, p. 29-38 Reg. 1333/2008 OJ L 354, 31.12.2008, p. 16-33 Reg. 589/2014 OJ L 164, 3.6.2014, p. 18-40 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 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 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 589/2014 of 2 June 2014 laying down methods of sampling and analysis for the control of levels of dioxins, dioxin-like PCBs and nondioxin-like PCBs in certain foodstuffs and repealing Regulation (EU) No 252/2012