EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL

Transcription

1 EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Directorate F - Food and Veterinary Office Ares(2014) DG(SANCO) MR FINAL FINAL REPORT OF AN AUDIT CARRIED OUT IN IRELAND FROM 06 TO 16 MAY 2014 IN ORDER TO EVALUATE THE FOOD SAFETY CONTROL SYSTEMS IN PLACE GOVERNING THE PRODUCTION AND PLACING ON THE MARKET OF FISHERY PRODUCTS 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 Ireland carried out from 6 to 16 May 2014, as part of its programme of audits in Member States. The objective of the audit was to assess whether the organisation of the CA and the implementation of national provisions, against which the CA controls fishery products is compliant with EU requirements. The report concludes that the CA has in place an official control system based on EU requirements and national legislation. It is supported by an extensive number of instructions and checklists. All laboratories participating in official controls are accredited. This control system covers the entire fishery products production chain but is not always consistently applied. The control system presents some gaps with regard to registration/approval of cold stores, inspection of vessels, temperature recording devices (identified in the previous audit), drafting and implementing food safety management systems based on HACCP principles and analyses of PAH. The report addresses to the Irish competent authority a number of recommendations aimed at rectifying identified shortcomings and enhancing the control system in place. I

3 Table of Contents 1 INTRODUCTION OBJECTIVES AND SCOPE OF THE AUDIT LEGAL BASIS FOR THE AUDIT BACKGROUND GENERAL BACKGROUND PRODUCTION AND TRADE INFORMATION RAPID ALERT SYSTEM FOR FOOD AND FEED (RASFF) NOTIFICATIONS FINDINGS AND CONCLUSIONS COMPETENT AUTHORITY REGISTRATION/APPROVAL OF FOOD BUSINESS OPERATORS ESTABLISHMENTS OFFICIAL CONTROLS OFFICIAL CONTROL OF PRODUCTION AND PLACING ON THE MARKET OFFICIAL CONTROL OF FISHERY PRODUCTS FOLLOW UP OF RASFF NOTIFICATIONS LABORATORIES OVERALL CONCLUSION CLOSING MEETING RECOMMENDATIONS...12 ANNEX 1 - LEGAL REFERENCES...13 II

4 ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT Abbreviation CA CCP DAFM DG SANCO EC EN EU EUROSTAT FSAI FVO HACCP IFIS ISO OJ PAH PCBs RASFF RSW SFPA SFPO SPO TVB-N Explanation Competent Authority Critical Control Point Department of Agriculture, Food and the Marine Health and Consumers Directorate General of the European Commission European Community European Norm European Union Statistical Services of the European Union Food Safety Authority of Ireland Food and Veterinary Office of the European Commission Hazard Analysis Critical Control Points Integrated Fisheries Information System International Organisation for Standardisation Official Journal of the European Union Polycyclic Aromatic Hydrocarbons Polychlorinated Biphenyls Rapid Alert System for Food and Feed Refrigerated Sea Water Sea Fisheries Protection Authority Sea Fisheries Protection Officer Senior Port Officer Total volatile basic nitrogen III

5 1 INTRODUCTION The audit took place in Ireland from 6 to 16 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 Clonakilty on 6 May 2014 with the central competent authority, the Food Safety Authority Ireland (FSAI) and the competent authority (CA) the Sea Fisheries Protection Authority (SFPA). 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 was to assess whether the organisation of the CA and the implementation of national provisions, against which the CA controls fishery products is compliant with EU requirements. In terms of scope the audit focused on the organisation and performance of the CA, the official control system in place covering production, processing and distribution stages applicable to fishery products placed on the market. Accordingly, relevant aspects of the EU legislation referred to in Annex 1 were used as technical basis for the audit. In pursuit of this objective, the audit team visited the following sites: COMPETENT AUTHORITY Central level 1 Regional level 4 LABORATORY VISITS Official control 1 PRIMARY PRODUCTION Fishing vessels 2 Refrigerated Sea Water (RSW) LANDING AND FIRST SALE Landing sites 5 FACILITIES HANDLING FISHERY PRODUCTS Freezer vessels 1 Processing Plants 7 Cold stores 2 OTHERS Ice factories 1 Representatives from the CA and the FSAI accompanied the FVO team during the whole audit 1

6 3 LEGAL BASIS FOR THE AUDIT The audit was carried out under the general provisions of EU legislation and, in particular, Article 45 of Regulation (EC) No 882/2004. Full legal references to EU legal acts quoted in this report are provided in Annex 1 and refer, where applicable, to the last amended version. 4 BACKGROUND 4.1 GENERAL BACKGROUND A previous audit concerning fishery products took place in 2008 (ref. DG(SANCO)/2008/7641) which highlighted deficiencies in relation to compliance with the requirements for vessels and establishments including absence of temperature recording devices, training of staff on public health issues, designation of accredited laboratories for official controls and official controls of fishery products. The report published on the Health and Consumers Directorate-General (SANCO) internet site at 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. 4.2 PRODUCTION AND TRADE INFORMATION According to information provided by the CA, around 296,000 tonnes of fishery products were landed in Ireland in 2012, mainly fresh fishery products. Almost 80% are pelagic species landed from Irish vessels - mackerel, herring, horse mackerel and blue whiting. Vessels from Norway and Faeroe Islands also land blue whiting. These pelagic fishery products are all frozen in Ireland. Most of these products are exported to third countries, sold to other Member States or used in the Irish fish meal industry. The demersal fishing targets mainly cod, haddock, monkfish and crustaceans. Vessels from other Member States, particularly France and Spain, land demersal fishery products (prepared and packed on board) in Ireland, for onward transport to the continent. Approximately 3,900 tonnes of fishery products of various finfish species and crustaceans were imported into Ireland, according to the information provided by the CA. According to the list set up by the CA and available on the CA website in April 2014, there are a total of 162 establishments, 32 freezer vessels and two factory vessels authorised to place fishery products on the market. Cold stores are listed on the FSAI website - see Chapter 5.2 Registration/Approval. Table 1 summarises the quantity of fishery products landed in Ireland. Table 1 - Fishery products landed in Ireland (source CA); tonnes Commodity 2012 Pelagic 230,000 Demersal 30,000 Crustaceans 36,000 Total 296,000 2

7 4.3 RAPID ALERT SYSTEM FOR FOOD AND FEED (RASFF) NOTIFICATIONS There has been in total six notifications in for Irish fishery products. Listeria monocytogenes was found in smoked salmon on four occasions and once in crab meat during this period. The sixth notification concerned the presence of parasites in mackerel. See Chapter FINDINGS AND CONCLUSIONS 5.1 COMPETENT AUTHORITY Legal requirements Articles 3 to 10, 54 and 55 of Regulation (EC) No 882/2004. Findings Designation of competent authorities and operational criteria FSAI, which is the central competent authority with responsibility for enforcement of food safety legislation in Ireland, has a service contract agreement with SFPA to be the CA and implement and enforce national and EU legislation covering production and placing on the market of fish and fishery products. SFPA official controls include fishery products and all its stages of production, processing, storage and transport within the remit of Regulation (EC) Nos 853/2004 and 854/2004. However they do not cover storage carried out outside processing plants (hereinafter identified as independent cold stores ). These independent cold stores are under the control of the Department of Agriculture, Food and the Marine (DAFM). The SFPA is an independent statutory authority under the corporate governance of the Department of Agriculture, Food and the Marine with the remit to enforce national and EU regulations on seafisheries conservation and seafood safety. The structure and organisation of the CA, as well as the control system for fishery products is well described in the Country Profile of Ireland at and in the FVO report from October 2013 (DG(SANCO) MR FINAL)) of an audit of systems put in place to implement article 8(3) of 882/2004. Within the CA the Food Safety Unit is the one with the lead role with regard to the service contract agreement with FSAI. It is managed by a National Director who is assisted by headquarter's staff, some of whom work exclusively on food safety matters. This unit supports and coordinates activities within the food safety sector. The CA has, beside the headquarters in Clonakilty, seven Fishery Harbour Centres managed by Senior Port Officers (SPO) who are in charge of 62 Sea Fisheries Protection Officers (SFPO) that cover primary production (fishing vessels), landing sites, auction halls and establishments. The primary role of SFPOs is inspection, i.e. as inspectors they routinely carry out official controls in fishery facilities in relation to both fisheries conservation and food safety. SPO participate in fortnightly management meetings one meeting as video conference, and the next one in person. Every Monday morning a telephone meeting is held between the CA headquarters and the Fishery Harbour Centres in which all staff can participate. This meeting is recorded so staff not attending can listen to it afterwards. SPO read and sign inspection reports and can then give feed-back to SFPOs. All CA staff have access to an intranet where information regarding control objectives within their 3

8 region is available. Information regarding tasks to be performed such as inspection report templates and checklists, as well as the results of analyses and protocols are accessible on this intranet. The CA commissioned an internal audit in 2013 by an external auditor. At the time of the FVO audit, the CA was in the process of launching a tender for two further internal audits in The FSAI performs audits of the CA twice every three years. An audit of the CA was performed by the FSAI in 2013 and the report is published on the FSAI website. There can also be cross-agency audits carried out by the FSAI, (e.g. traceability), that may include the CA. Training of staff performing official controls A number of relevant training courses have been delivered to CA staff to enable and enhance their work. The CA showed documentation of regional meetings and workshops held and training sessions provided including the number of participants. During the last three years training, conferences and workshops covered various fishery product related topics and food safety (e.g. Listeria, microbiological criteria, smoking of fishery products, food contact materials, water quality, heat treatment, shelf-life, auditing, food law, animal by-products, sampling techniques) have been attended by staff. Officials from the CA have also attended different training sessions including fishery products under the SANCO training programme Better Training for Safer Food. The CA headquarters decides, in consultation with the SPO on the participants in these courses. Documented control procedures Documented control procedures drafted by the CA are available and used by staff. They include amongst others various checklists, forms, report templates and guidelines related to the official control of fishery products. There is an annual Food Safety Control Plan issued by headquarters with instructions for controls (inspections, sampling) and reporting procedures. The latest version issued in May Up until the beginning of 2014 all completed official controls were recorded in excel sheets completed by each port. The CA headquarters collated data (number of inspections, approvals and non-compliances etc.) and supplied it to FSAI on a quarterly basis. The data was also shared with ports along with official control activity carried out in the same quarter of the previous year to facilitate a review of official control work done. Since March 2014 an IT system supported by FSAI facilitates direct reporting by inspecting officers. Control activities, methods and techniques Official controls are carried out by audits, inspections and follow-up visits. (See also Chapter 5.3.1) There is a Code of Practice for the Risk Assessment of Approved Establishments to facilitate and standardise risk assessment. Risk assessment is based on the type and size of production, activities performed and number of employees, Hazard Analysis Critical Control Point (HACCP) plans and the past performance of the food business operator. Score points are given for the different factors and the sum of the scores determines the number of yearly visits to individual facilities. Risk assessments are reviewed on an annual basis by each port, amended if necessary and recorded. Enforcement measures The CA has the power to suspend establishments under their supervision. Non-compliances may lead to follow-up inspections and or penalties. There are procedures specified in the Irish Statutory Instrument (SI) No 432/2009, a legal act, for different steps of enforcement and penalties when requirements are not complied with. The audit team saw documentation of the communication between the CA and food business 4

9 operators concerning withdrawal of approvals in three cases due to ceased operations and two examples of suspensions (one factory vessel due to ceased production, one food business operator temporary suspension due to a report with non-compliances). Conclusions The CA for official control of activities within the scope of this FVO audit is designated as required in Article 4 of Regulation (EC) No 882/2004. Official controls are carried out on a risk basis, according to documented procedures, and comply with requirements laid down in Articles 3 to 10, 54 and 55 of Regulation (EC) No 882/ REGISTRATION/APPROVAL OF FOOD BUSINESS OPERATORS ESTABLISHMENTS Legal requirements Article 6 of Regulation (EC) No 852/2004, Article 4 of Regulation (EC) No 853/2004, Article 3 of Regulation (EC) No 854/2004 and Article 31 of Regulation (EC) No 882/2004 Findings The CA has established procedures for approval of facilities in the "Code of Practice for Approving Land based establishments" and the "Procedure for Approval of Freezer and Factory Vessels". All approvals are issued by the CA headquarters based on inspection reports from regional offices. Conditional approval for three months can be given to processing establishments with the possibility of prolongation for a further three months. An approval document is issued by the CA and given to the FBOs. This document specifies the fish species and activities for which the establishment has been approved and states that the approval is based on Regulations (EC) Nos 852 and 853 of The audit team checked the procedure applied for a recently approved facility. The establishment had received a conditional approval for three months dated 16 March 2014 based on a structural assessment, a HACCP plan as part of a food safety management system and an inspection report. The CA had received additional information for further assessment and a follow-up inspection was planned before the conditional approval expired. The audit team noted that all fishery product establishments visited during the audit were approved and the approval documents were present. Freezer and factory vessels can also be given three months conditional approval that can be prolonged for another three months. This practice is not defined in the CA procedures for vessels, but is mentioned in approval certificates. The CA does not use the possibility of giving vessels six months conditional approvals with prolongation for another six months. Files of freezer vessels were assessed and the audit team found that the inspection frequency for conditional approval was not always respected. In their response to the draft report the CA noted that FSAI is reviewing the guidance document.. The CA procedures mentioned above do not cover the approval of independent cold stores. The FSAI has drafted a guidance document where it is indicated when to approve a cold store and which Irish official entity is to be in charge of its supervision (Guidance for determining the supervision agency for Food Businesses, Rev. 6 of January ). In accordance with this document, independent cold stores that store wrapped/packaged products and do not rewrap/repack do not need to be approved. Registration and compliance with applicable temperature requirements of 1 In their response to the draft report the central CA noted that it is reviewing this guidance document. 5

10 Regulation (EC) No 853/2004 will suffice, which is not in line with the approval requirements of Article 3 of Regulation (EC) No 854/2004 and Article 31(2) of Regulation (EC) No 882/2004. However, the FSAI representatives informed the audit team that independent cold stores under the control of DAFM and storing meat are subject to approval following the applicable EU regulations. During the approval process the independent cold stores are assessed (including an on-the-spot visit) and the approval granted may cover meat with the indication of species allowed and fish. Additionally the FSAI provided the audit team with a written statement explaining that their policy is that cold stores approved for storage of meat, which under EU law require a maximum storage temperature of -12 C, are considered as suitable for the storage of all food of animal origin, including fishery products which should be stored at a maximum of -18 C. The audit team visited two independent cold stores used to store fishery products and noted that although they have been approved by DAFM, their approval did not include the storage of fishery products. Moreover, the conditions for the approval (temperature regime and HACCP plans) cannot be considered as satisfactory with regard to the storage of fishery products as -18 C was not an approval requirement. During the visits, the audit team noted that one cold store maintained -18 C, while the second one did not. Conclusions There are procedures in place for registration and approval of food business operators that are compliant with EU regulations except for independent cold stores which store fishery products. However, re-inspection of vessels within the timeframe for conditional approvals may not always be respected. 5.3 OFFICIAL CONTROLS Official Control of production and placing on the market Legal requirements Article 4 and 5 of Regulation (EC) No 852/2004, Article 3 and Section VIII of Annex III to Regulation (EC) No 853/2004 and 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 Official control system in place The overall control system is described in Chapter 5.1 and more details are covered in relevant sections below. The policy for fishing vessels inspection is at least once a year with priority for vessels over 15 metres. However, vessels are not always inspected within that timeframe when they land fish in other Member States. All approved premises have to be inspected at least once a year with a full audit. Depending on the risk assessment the number of visits per year can vary between one and four. The annual full audits are usually done by a team of two SFPO. Primary production The CA informed the audit team that there are at present 2,160 registered fishing vessels. Over 1,600 of them are less than 10 metres in length of which approximately half operate on either a part- 6

11 time basis or seasonally. The pelagic (mackerel, herring, horse mackerel, blue whiting) fishing vessels ( both pelagic and demersal) are active during the pelagic fishing season from October through March. Most pelagic fish are landed in Killybegs and all landed fish are processed in Ireland. Most pelagic fishing vessels use RSW tanks. Two RSW vessels were visited by the audit team and can be considered in line with the EU requirements. Landings are recorded in the Integrated Fisheries Information System (IFIS) where species, quantity, organoleptic checks and landing conditions are documented. Vessel hygiene inspections are also registered in IFIS. When fishing vessels are inspected, a standard checklist is used and reports are written. In one ice factory visited, the audit team noted that the hopper used for the ice was made of uncoated wood (surface not easy to clean). It was not covered which by its absence did not prevent accumulation of dust and dirt that was observed on the ice. Landing operations, landing sites and first sale The seven major ports have inspectors present at the time of landing for EU and national fish policy checks (quotas, fish size etc.) and the hygiene conditions of landing are checked at the same time. The audit team visited two main ports with landing sites, one secondary port and two landing piers. Although none of these were in operation at the time of the FVO visit, those places would allow the unloading of fish in accordance with the EU requirements. Facilities, including vessels, handling fishery products The CA stated its commitment to visit approved facilities within the set frequencies. However, from an assessment of the information at CA port offices and at the establishments visited the audit team noted that some of the premises had not been inspected with the stipulated frequency. This was explained by the CA to be due to staff constraints. The FVO team also noted that some reports have not yet been drafted for audits/inspections carried out in 2013 and that the forms used in different port offices were not the ones available in the CA intranet. Nevertheless, the relevant information with regard to those audits/inspections was made available and the differences between the different forms are minimal. One freezer vessel was visited by the audit team, which can be considered compliant with EU requirements concerning structures and equipment. A generic Good Manufacturing Practice manual was made available, but this document did not cover all relevant aspects of the operations performed on board this vessel. The food business operator informed the audit team that a Food Safety Management System based on HACCP principles had been developed but that the complete manual was not on board at the time of the visit. This vessel uses an additive on prawns and three different procedures for its use were available on board. It was not clear which procedure to apply and this could result in exceeding the maximum permitted levels in the products. Temperature records of storage of frozen fishery products were not available, but a recording device was present on board. Files of freezer vessels were assessed and the audit team found that yearly inspections were not always possible to carry out when vessels were not available. Cold stores and processing establishments visited broadly respect the hygiene and structural conditions required in EU legislation. However, one establishment could not be considered compliant with EU requirements. There were structural deficiencies (reception area not preventing contamination, condensation water dripping onto exposed products, records of up to -12 C in cold storage) and it was in a poor state of maintenance, which was not reflected in several CA inspection 7

12 reports reviewed by the audit team. In addition during the visit the audit team noted that frozen products are received from several freezer vessels without the required identification mark and without an indication of the freezing date. These products were subsequently marked with this establishment's approval number and given the date of reception as the production/freezing date. With regard to the remaining establishments visited some shortcomings were detected: Storage of both exposed and packaged products in the same room and pallets in a cold store directly against the wall which hampers air circulation and inspection possibility. In one establishment one product was labelled "Keep chilled" and a frozen product had no temperature requirement on the label. This was brought to the attention of the food business operator by the CA and corrective actions were put in place. Temperature recording devices are not used in all cold stores on board vessels and in establishments (this finding was previously noted during the last 2008 fishery products FVO audit in Ireland). Switching off the power supply during daytime in one independent cold store which allowed the air temperature to rise up to -11 C. Inspection reports were available in all premises visited and had been performed with the set frequency. Non-compliances found were noted and followed-up which also was documented. HACCP plans were implemented in the establishments visited. However, some shortcomings were identified during the audit. One plan did not reflect all aspects of the production or the actual processes applied by the food business operator. Four out of seven HACCP plans had temperature limits for chilled raw material up to +5 C (0-3 C, 0-4 C, 0-5 C) and one plan had a limit -12 C for frozen products. Two establishments where smoking takes place did not consider Polycyclic Aromatic Hydrocarbons (PAH) as a potential risk and consequently it was not included in the HACCP plans and not analysed for as part of the own-check programme. Own-check analyses include microbiological parameters for raw material, total volatile basic nitrogen (TVBN), histamine for susceptible species, cadmium, mercury and lead and Salmonella, L. monocytogenes, S. aureus and Total Viable Count for ready-to-eat fishery products. Parasites are checked for at reception of raw material and when filleting takes place. Records of those checks were available to audit team. PAH and dioxins are not included in the own-check programmes seen by the audit team. Water and ice are checked by the food business operators in all visited establishments for microbiological parameters in accordance with national and EU provisions for potable water. Chemical analyses are also either performed by the food business operators or the results of such analyse are retrieved from the local authority's examinations. None of the visited land-based establishments currently used additives in their production. Conclusions Official control of production and placing on the market covers all stages of production and is carried out in accordance with EU requirements. The control system does not give guarantees that all the requirements are met. In particular, the shortcomings noted during the audit concerning vessel inspection frequency, temperature controls, the implementation of procedures based on HACCP principles, non-compliant labelling procedures for frozen products, own-check programmes omitting certain contaminants, storage of ice and the serious deficiencies noted in one establishment raises concerns about the effectiveness of the current system. 8

13 5.3.2 Official control 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 Organoleptic examination the audit team was informed that organoleptic checks are carried out by SFPO at landing sites and in establishments at the time of the inspections. Records are kept, and were made available to the audit team, to verify that organoleptic checks are carried out in accordance with freshness criteria in line with Regulation (EC) No 2406/96. Freshness indicators - samples are taken for analysis of TVBN and satisfactory results were available to the audit team in the establishments visited. The CA reported that one out of 16 analyses in 2013 showed unsatisfactory result. The unsatisfactory result was reported as if it had been fresh fishery products, when the follow-up showed that it was found in a smoked fishery product and the result was discarded as EU limits do not apply to processed products. Histamine - official samples for analysis of histamine are taken by SFPO at establishment level and the audit team saw satisfactory results in the establishments visited. The CA reported that one out of 245 analyses in 2013 was non-compliant. When an unsatisfactory result is found, the CA performs a follow-up to identify the cause of the problem, e.g. broken cold chain, and the product is withdrawn from the market. Contaminants - official samples for analysis of cadmium, mercury and lead are taken by the CA at establishment level. The CA reported that one non-compliant result for cadmium was found in 2012 and one in These analyses form part of a monitoring programme and when results are available, the product may not be on the market any longer. Results available at visited establishments were satisfactory. There are also analyses for trace metals in samples of wild finfish as part of a national seafood database project. Dioxins/Polychlorinated Biphenyls (PCBs) are analysed for in samples taken within projects initiated by the FSAI. In 2012, 12 analyses for the six indicator PCBs were performed with satisfactory results. The results for samples taken during 2013 are not yet reported. There is no official control of PAH in smoked products. Microbiological checks Official samples for microbiology in fishery products are taken by the CA at establishment level and results were available in visited premises. Fishery products are tested for E.coli Total Viable Count, Coliforms, Salmonella, S. aureus and L. Monocytogenes with satisfactory results in the establishments visited. Drinking water The water quality is part of the official control at establishment level and E.coli and Enterococci are tested for once per year. Potable water is checked by the local authority at supplier level and can be checked at establishment level too. Their results are published on the internet site of the local authority. In one establishment the audit team saw letters sent by the local authority to the food business operator to inform them of the results of such testing. Results of water testing was satisfactory in the establishments visited. Parasites - the CA carry out official controls on parasites at landing sites and in establishments and records of the controls are kept. Additives 9

14 In the yearly control plan analyses for bisulphites and 4-hexylresorcinol in prawns are foreseen. In samples and in samples were taken for analysis of these additives. Three noncompliant results were reported in 2012 and eight in According to the CA, all cases of noncompliant results are investigated to determine the cause and additional samples may be taken and if deemed necessary, the product is withdrawn from the market. With respect to non-compliant bisulphite and 4-hexylresorcinol results, vessel owners are also contacted to review their dipping procedures and advised as appropriate. Conclusions Official controls of fishery products are carried out adequately and include most of the parameters in the EU requirements. However, monitoring for PAH is not carried out. 5.4 FOLLOW UP OF RASFF NOTIFICATIONS Legal requirements Articles 50 and 52 of Section I, Chapter IV to Regulation (EC) No 178/2002. Findings There is a procedure in place to respond to RASFF notifications. During the visit to one establishment, the audit team saw evidence of prompt and adequate measures taken by the CA in response to an alert. Documentation of the communication between the FSAI, the CA, the local inspectors and the food business operator was available. Conclusions There is a system in place to investigate occurring problems and to take appropriate action in response to RASFF notifications. 5.5 LABORATORIES Legal requirements Articles 11, 12 and 33 of Regulation (EC) No 882/2004, Article 1 and Annex I to Regulation (EC) No 2073/2005 and Article 2 and Section II of Annex II to Regulation (EC) No 2074/2005. Regulation (EC) No 1881/2006. Regulation (EC) No 333/2007. Regulation (EU) No 252/2012. Findings There are at present 11 laboratories participating in official controls of fishery products in Ireland. All the laboratories are accredited against the ISO standard. The audit team visited one laboratory and another laboratory's involvement in official controls was presented at the opening meeting. For the visited laboratory, the scope of accreditation by the Irish National Accreditation Board includes relevant methods for microbiological analyses for Enterococci and E. coli in water and ice and Salmonella and Listeria monocytogenes in fishery products, as well as an HPLC method for histamine analysis of official samples. All analytical methods in use were the EU reference ones. The laboratory is subject to internal audit and external audit once a year. Approximately 5,000 microbiological analyses are performed every year in this laboratory % of them are of fishery products including water and ice. 20% of those samples are taken by the CA and the rest are submitted by food business operators. 10

15 At reception, the samples are assessed for suitability for analyses. There is a standard operating procedure developed covering this point. Refusal of samples is recorded. In general, analysis should start within 24 hours from sampling. If samples arrive before 16:00, the analysis is started the same day. Samples are accompanied by a form where the sampler indicates what analyses are requested. Information of the sample, from where it was taken and by whom is entered into the internal data system and the sample is given an identity number that follows it through the analysis. The information in the data system is not accessible to all staff. A logbook with daily records is kept for the use of media by batch numbers and positive and negative controls are noted. Each batch of media is checked weekly. Temperatures of incubators are checked daily and the thermometers are calibrated against a reference thermometer Histamine analyses are done in nine samples in line with EU requirements and the results are reported separately. Records of training of staff are kept and showed what methods each person was trained to perform and other courses attended. The laboratory regularly, usually twice per year, participates in proficiency testing for histamine and microbiological methods. The results of the proficiency testing carried out in the last two years were satisfactory. Conclusions Laboratories designated to carry out official control are accredited to ISO and use EU reference methods. External and internal quality controls are carried out regularly with satisfactory results. 6 OVERALL CONCLUSION The CA has in place an official control system based on EU requirements and national legislation. It is supported by an extensive number of instructions and checklists. All laboratories participating in official controls are accredited. This control system covers the entire fishery products production chain but is not always consistently applied. The control system presents some gaps with regard to registration/approval of cold stores, inspection of vessels, temperature recording devices (identified in the previous audit), drafting and implementing food safety management systems based on HACCP principles and analyses of PAH. 7 CLOSING MEETING During the closing meeting held in Dublin on 16 May 2014, the audit team presented the main findings and preliminary conclusions of the audit to the CAs. During this meeting, the CAs acknowledged the findings and preliminary conclusions presented by the audit team and provided commitment to correct the deficiencies. 11

16 8 RECOMMENDATIONS The CA should provide Commission services with an action plan, including a timetable for its completion, within a month of receipt of the report, in order to address the following recommendations. N. Recommendation 1. The CA should ensure that all fishing vessels are regularly inspected as required under Annex III, Chapter I, part 1(b) of Regulation (EC) No 854/2004 and that requirements of Chapter I, Section VIII of Annex III to Regulation (EC) No 853/2004 are met. 2. The CA should ensure that all food business operators put in place, implement and maintain procedures based on HACCP principles as required in Article 5 of Regulation (EC) No. 852/2004. In particular, that limits set for critical control points are in line with EU requirements and all relevant potential hazards are identified. 3. The CA should ensure that only facilities, including establishments, freezer and factory vessels, which comply with the requirements in Regulations (EC) Nos 852/2004 and 853/2004, including temperature recording devices in cold stores, are approved in accordance with Article 3 of Regulation (EC) No 854/ The CA should ensure that fishery products are stored in cold stores which comply with the requirements in Regulations (EC) Nos 852/2004 and 853/2004, including temperature recording devices, and which are approved in accordance with Article 3 of Regulation (EC) No 854/ The CA should ensure that fishery products satisfactorily undergo all the official controls laid down in Chapter II of Annex III to Regulation (EC) No 854/2004, in particular PAH. 6. The CA should ensure that packaged fishery products leaving an approved establishment (including freezer vessels) bear an identification mark as required in Section I of Annex II to Regulation (EC) No 853/2004 and that the date of production /freezing is indicated as required in Points 1(c) and 2(a,b) in Section IV of Regulation (EC) No 853/2004. The competent authority's response to the recommendations can be found at: 12

17 ANNEX 1 - LEGAL REFERENCES 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 13

18 Legal Reference Official Journal Title Reg. 2074/2005 OJ L 338, , p Reg. 333/2007 OJ L 88, , p Reg. 1169/2011 OJ L 304, , p Reg. 252/2012 OJ L 84, , p Contaminants Reg. 1881/2006 OJ L 364, , p Commission Regulation (EC) No 2074/2005 of 5 December 2005 laying down implementing measures for certain products under Regulation (EC) No 853/2004 of the European Parliament and of the Council and for the organisation of official controls under Regulation (EC) No 854/2004 of the European Parliament and of the Council and Regulation (EC) No 882/2004 of the European Parliament and of the Council, derogating from Regulation (EC) No 852/2004 of the European Parliament and of the Council and amending Regulations (EC) No 853/2004 and (EC) No 854/2004 Commission Regulation (EC) No 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 (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, an 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 1883/2006 Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs 14

19 Legal Reference Official Journal Title Dec. 98/179/EC OJ L 65, , p Dir. 96/23/EC OJ L 125, , p Dir. 98/83/EC OJ L 330, , p Reg. 1333/2008 OJ L 354, , 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 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 98/83/EC of 3 November 1998 on the quality of water intended for human consumption Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives 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 15