EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL

EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Directorate F - Food and Veterinary Office Ares(2014)2441615 DG(SANCO) 2013-6668 - MR FINAL FINAL REPORT OF AN AUDIT CARRIED OUT IN GERMANY FROM 21 TO 30 OCTOBER 2013 IN ORDER TO EVALUATE THE FOOD SAFETY CONTROL SYSTEMS IN PLACE GOVERNING THE PRODUCTION AND PLACING ON THE MARKET OF BIVALVE MOLLUSCS 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 The report provides the results of an audit performed by the Food and Veterinary Office in Germany from 21 to 30 October 2013. The main purpose of the audit was to verify that the official controls of bivalve molluscs including echinoderms, tunicates and marine gastropods are implemented according to the requirements of EU rules. The report concludes that the two competent authorities have well organised and documented systems for official control of the production and placing on the market of live bivalve molluscs and fishery products derived therefrom, including classification and monitoring of production areas, laboratory testing and decisions after monitoring. However, the system is undermined by a number of non-compliances identified in relation to classification and monitoring of classified production areas and weaknesses in certain aspects of laboratory performance, including preparation/quality of samples, internal quality controls and the range of phytoplankton/marine biotoxin analogues tested. The report makes recommendations to the competent authorities aimed at addressing areas in which further improvements are required. I

Table of Contents 1 INTRODUCTION...1 2 OBJECTIVES AND SCOPE...1 3 LEGAL BASIS...2 4 BACKGROUND...2 4.1 PREVIOUS FVO REPORT...2 4.2 PRODUCTION AND TRADE INFORMATION IN TONNES...2 4.3 RAPID ALERT SYSTEM FOR FOOD AND FEED NOTIFICATIONS...3 5 FINDINGS AND CONCLUSIONS...3 5.1 COMPETENT AUTHORITIES...3 5.2 REGISTRATION/APPROVAL OF ESTABLISHMENTS...4 5.3 OFFICIAL CONTROLS ON LIVE BIVALVE MOLLUSCS FROM CLASSIFIED PRODUCTION AND RELAYING AREAS...5 5.3.1 CLASSIFICATION OF PRODUCTION AND RELAYING AREAS...5 5.3.2 MONITORING OF CLASSIFIED PRODUCTION AND RELAYING AREAS...7 5.3.3 DECISION AFTER MONITORING...9 5.3.4 ADDITIONAL MONITORING REQUIREMENTS...10 5.3.5 RECORDING AND EXCHANGE OF INFORMATION...10 5.3.6 FOOD BUSINESS OPERATORS' OWN CHECKS...11 5.4 OFFICIAL CONTROLS ON PECTINIDAE AND LIVE MARINE GASTROPODS NOT FILTER FEEDERS HARVESTED OUTSIDE CLASSIFIED PRODUCTION AREAS...11 5.5 OFFICIAL CONTROLS TO VERIFY FOOD BUSINESS OPERATORS' COMPLIANCE WITH THE REQUIREMENTS FOR THE PRODUCTION AND PLACING ON THE MARKET OF BIVALVE MOLLUSCS, ECHINODERMS, TUNICATES AND MARINE GASTROPODS...11 5.5.1 REQUIREMENTS FOR PLACING ON THE MARKET...11 5.5.2 OFFICIAL CONTROLS OF FOOD BUSINESS OPERATORS...12 5.5.3 FACILITIES HANDLING BIVALVE MOLLUSCS...12 5.6 LABORATORIES...13 6 OVERALL CONCLUSIONS...19 7 CLOSING MEETING...19 8 RECOMMENDATIONS...19 ANNEX 1 - LEGAL REFERENCES...22 II

ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT Abbreviation AKS ASP BfR BMELV BVL CA CCA DAkkS EC EU EU Guide EURL EURL generic protocol FLD FVO HACCP HPLC LAVES LC-MS LLUR MELUR ML MPN NLWKN NRL PSP SANCO Explanation Staatliche Akkreditierungsstelle Hannover Amnesic Shellfish Poisoning Federal Institute for Risk Assessment Federal Ministry of Food, Agriculture and Consumer Protection Federal Office of Consumer Protection and Food Safety Competent authority Central Competent Authority Deutsche Akkreditierungsstelle AmbH European Commission European Union Community Guide to the Principles of Good Practice for the Microbiological Monitoring of Bivalve Mollusc Harvesting Areas European Union Reference Laboratory EURL generic protocol for Enumeration of E. coli in bivalve molluscan shellfish by the most probable number technique (based on ISO16649-3) Fluorescence detection Food and Veterinary Office Hazard Analysis of Critical Control Points High Performance Liquid Chromatography Lower Saxony Office of Consumer Protection and Food Safety, Lower Saxony Liquid Chromatography Mass Spectrometry State Agency for Agriculture, Environment and Rural Areas, Schleswig- Holstein Ministry of Energy Transition, Agriculture, Environment and Rural Affairs, Schleswig-Holstein Ministry of Food, Agriculture and Consumer Protection, Lower Saxony Most Probable Number State Office for Water Management, Coastal Defence and Nature Protection, Lower Saxony National Reference Laboratory Paralytic Shellfish Poisoning General Directorate for Health and Consumers III

1 INTRODUCTION This audit took place in Germany from 21 to 30 October 2013 and was undertaken as part of the Food and Veterinary Office's (FVO) planned audit programme. The audit team comprised two auditors from the FVO and two national experts from EU Member States. An opening meeting was held in Berlin on 21 October with the Federal Ministry of Food, Agriculture and Consumer Protection (BMELV) of Germany which is the federal competent authority (CA) within the scope of this audit. This meeting was also attended by Federal Office of Consumer Protection and Food Safety (BVL) and Federal Institute for Risk Assessment (BfR). Representatives from the two länder to be visited also attended this meeting. The team confirmed the objectives of and the itinerary for the audit and requested additional information regarding the specific elements of the control system in place. A representative from the BVL accompanied the FVO team during the whole audit. 2 OBJECTIVES AND SCOPE The objectives of the audit were to:- Verify that official controls of bivalve molluscs, echinoderms, tunicates and marine gastropods are organised and carried out in accordance with the relevant provisions of Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules. Evaluate whether the control system in place for the production and placing on the market of bivalve molluscs, echinoderms, tunicates and marine gastropods is in compliance with EU requirements. In terms of scope, the audit focused on the organisation and performance of the CAs, the official control system in place covering the classification and monitoring of live bivalve molluscs production and relaying areas, and the production and placing on the market of bivalve molluscs, echinoderms, tunicates and marine gastropods. Accordingly, certain aspects of the legislation referred to in Annex 1 were used as technical basis for the audit. In pursuit of these objectives, the audit team visited the two länder that produce German bivalve molluscs - Lower Saxony and Schleswig-Holstein. The table below lists sites visited and meetings held in order to achieve those objectives. MEETINGS / VISITS no. COMMENTS Competent Authority Federal 3 Opening and closing meeting with representatives of the BMELV, the BVL and the BfR Länder 4 1) the Ministry of Food, Agriculture and Consumer Protection and the State Office of Consumer Protection and Food Safety of Lower Saxony; 2) the Ministry of Energy Transition, Agriculture, Environment and Rural Affairs and the State 1

Agency for Agriculture, Environment and Rural Areas of Schleswig-Holstein. Districts 4 1) Aurich and Zweckverband Veterinäramt Jade Weser veterinary offices in Lower Saxony; 2) Nordfriesland, the city of Kiel and Schleswig- Flensburg in Schleswig-Holstein National Reference Laboratories 2 BfR: 1) viruses and bacteria in bivalve molluscs; 2) marine biotoxins Laboratories 5 Cuxhaven (Microbiology, phytoplankton, marine biotoxins) and Neumünster (Microbiology, marine biotoxins) Vessels 1 Kiel Fjord Processing establishments 1 Nordfriesland 3 LEGAL BASIS 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 PREVIOUS FVO REPORT The previous FVO audit on this subject in Germany was carried out in October 2005 (ref. DG(SANCO)/2005/7583). The report of this audit is available on the Health and Consumers Directorate General website at: http://ec.europa.eu/food/fvo/ir_search_en.cfm. Recommendations made in the 2005 report of the FVO's inspection, relevant to the live bivalve mollusc sector, concerned laboratory techniques, interpretation of test results and adequate number of staff and procedures for classification of production areas. The FVO received written guarantees in relation to the recommendations of the 2005 audit which were found satisfactory. 4.2 PRODUCTION AND TRADE INFORMATION IN TONNES According to information provided by the CAs, the total annual production of mussels (Mytilus edulis) in Lower Saxony and Schleswig-Holstein amounts to between 5,000 and 7,000 tonnes. In 2011, which was considered an exceptional harvest, the bivalve mollusc production amounted to 23,250 tonnes of mussels. Less than 100 tonnes of oysters (Crassostrea gigas) were produced for placing on the market in Schleswig-Holstein per year during 2010 2012. The majority of the German mussel production is transferred to the Netherlands without handling or processing. Schleswig-Holstein has one dispatch centre and one processing establishment for mussels but in 2

Lower Saxony there are none. 4.3 RAPID ALERT SYSTEM FOR FOOD AND FEED NOTIFICATIONS Two notifications are reported in the RASFF portal since 2005, one in 2006 and one in 2009 concerning findings of lipophilic toxins in mussels from Germany and Norway, both results found in official control samples taken from products on the market. There was also a notification in 2008 concerning lipophilic toxin findings in cooked mussels of Irish origin detected by a food business operator in their own control and this was susequently confirmed by official samples taken at the company. 5 FINDINGS AND CONCLUSIONS 5.1 COMPETENT AUTHORITIES Legal Requirements Articles 3 to 10, 54 and 55 of Regulation (EC) No 882/2004. Findings The BMELV is the federal CA responsible for legislation concerning monitoring and control of bivalve molluscs. The BVL and the BfR cover risk assessment, risk management and implementation of controls. The official control of bivalve mollusc production placed on the market is the responsibility of each länd. In Lower Saxony the central CA (CCA) for monitoring and control of live bivalve molluscs is the Ministry of Food, Agriculture and Consumer Protection (ML) with headquarters in Hannover. The ML has responsibility for the evaluation and enforcement of bivalve mollusc regulatory requirements in fishing and harvesting areas. The ML enacts legally binding rules in the form of decrees and techanically supervises the Lower Saxony Office of Consumer Protection and Food Safety (LAVES) and the CAs. The ML's supervision is performed via reports, workshops and annual meetings where issues concerning bivalve molluscs are discussed and from which minutes are distributed to all staff. LAVES is responsible for approval of establishments (see 5.2) and for analysis and assessment of official control programmes. There is a quality management system in place with written work instructions. There are also written guidelines for the implementation of food hygiene controls for the local CAs for the classification of production areas and monitoring of bivalve molluscs. In Schleswig-Holstein the CCA is the Ministry of Energy Transition, Agriculture, Environment and Rural Affairs (MELUR) situated in Kiel. It has the same responsibility for monitoring and control of bivalve molluscs as ML in Lower Saxony. Together with the State Agency for Agriculture, Environment and Rural Areas (LLUR) the same functions are carried out. There is also a quality management system in place in Schleswig-Holstein. Official staff met during the audit has access to appropriate facilities and equipment to perform official controls on bivalve molluscs. Legal powers to carry out those controls and to take measures are foreseen under national legislation. The quality management system in place includes instructions for decisions and enforcement. All staff must sign a work instruction when employment starts where requirements to be impartial and free from conflict of interest are included. The State Fisheries Office in Bremerhaven, Lower Saxony and the Fisheries Authority, a part of MELUR in Kiel, Schleswig-Holstein are responsible for fishing licences and permits. They are also 3

responsible for the registration/demarkation of production areas including molluscs farms and confirm their location and boundaries and in Lower Saxony the fisheries office is also responsible for the release of mollusc farms for seed mollusc production. They register mollusc fishing vessels, check vessels' fishing activities via a black box (in Schleswig-Holstein) or the VMS system (in Lower Saxony) that all vessels must have, make inspections of production areas and perform random landing controls. This information can be cross-checked with copies of the bivalve registration documents that fishermen have to fill out and send in. (See 5.3.4) In both länder it is the local CA that has the responsibility for classification, monitoring and sampling of production areas and harvesting of bivalve molluscs. In Schleswig-Holstein this also includes approval of establishments (see 5.2). In Lower Saxony two districts 1 and in Schleswig- Holstein three districts have bivalve mollusc production. In Lower Saxony, the ML has developed a Bivalve Mollusc Guide and implemented food hygiene controls of bivalve molluscs. This guide contains instructions for determination, classification and monitoring of production areas and bivalve molluscs. One local CA has given training courses for fishermen, on behalf of both local CAs involved in bivalve mollusc production, on how to sample water for plankton counts and bivalve molluscs for analyses. This training is given yearly. The same fishermen operate across all of Lower Saxony. The audit team saw lists of participants and copies of certificates of participation from 2011 and 2012. Certificates indicate whether the training is the first one or a refresher course. Official samples are mandatory for classification purposes. In Schleswig-Holstein all bivalve mollusc samples are taken by the fishermen. There are written instructions for sampling procedures. The LLUR is responsible for the monitoring of coastal waters and water samples for toxin-producing plankton are taken by LLUR. The audit team visited two NRLs and one official laboratory in Lower Saxony performing microbiology, plankton and toxin analyses of bivalve molluscs and one in Schleswig-Holstein doing the analyses for microbiology and toxins. There is adequate laboratory capacity for official controls testing in both länder using the official laboratories that are designated by the CCA.(See chapter 5.6) Control of food business operators is carried out by the official inspectors. (see 5.5.2) There are procedures in place with written instructions for adequate reporting and enforcement actions, which in case of non-compliance, are implemented. The audit team saw examples of enforcement letters relating to classification changes to production areas. Technical supervision of local levels by the central level is carried out to ensure that the objectives of control programmes are correctly implemented. Conclusions CAs involved in controls relating to bivalve molluscs have been designated and their areas of responsability have been defined in line with EU requirements. 5.2 REGISTRATION/APPROVAL OF ESTABLISHMENTS Legal Requirements Articles 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 1 In their response to the draft report the CA noted that it is one rural district and one special-purpose association. 4

Findings Fishing vessels are registered and harvesters/fishermen have to be licensed by the fisheries authorities in both länder. There are no dispatch, purification centres or processing plants approved in Lower Saxony at present. There are procedures for approval in the quality management system of Lower Saxony. The food business operator sends an application for approval to the local CA. The application must contain blue prints, production data and flow charts. The application is forwarded from the local CA to LAVES for assessment. If no additional documentation is required, an on-the-spot inspection is performed with staff from LAVES and the local CA. A report of the inspection is sent to the food business operator and the local CA. Where corrective actions are deemed necessary an action plan is requested. Conditional approval is given for a maximum of three months to enable the food business operator to demonstrate his/her capability to produce. A prolongation for a further three months of conditional approval may be given. The period of conditional approval may not exceed six months in total. The approval decision is sent to the food business operator and the local CA. The local CA is responsible for supervision of hygiene requirements in establishments. LAVES periodically inspects to confirm that approval requirements continue to be met. Approval is indefinite but may be retracted if requirements are not met. The system in Schleswig-Holstein is similar to Lower Saxony. The national hygiene regulation has specific requirements for the approval process and the supporting documentation required. Dispatch centres and processing establishments are, since 2006, approved by the local CAs in Schleswig- Holstein. The food business operator has to apply for approval and send in blueprints, process descriptions, flow-charts and HACCP plans to the CA. For a new processing establishment an initial on-site inspection is necessary to trigger the start of production. An establishment can have a conditional approval for a maximum of six months and a follow-up inspection is required. In both länder the CCAs are informed and they forward the approval numbers to the BVL which maintains and updates lists of approved German establishments on its website. The audit team verified that the procedures in place are followed. Conclusions The procedures in place for registration and approval of food business operators are compliant with EU regulations. 5.3 OFFICIAL CONTROLS ON LIVE BIVALVE MOLLUSCS FROM CLASSIFIED PRODUCTION AND RELAYING AREAS Legal Requirements Article 6 of Regulation (EC) No 854/2004 and Chapter II of Annex II to Regulation (EC) No 854/2004. Findings 5.3.1 Classification of production and relaying areas The boundaries of production areas are approved by the fisheries authorities in Lower Saxony. In Schleswig-Holstein the fishing authority declares certain areas within shellfish waters to be mollusc farming districts (production areas). There are a number of bivalve mollusc farms identified with their geographical coordinates within the production areas. 5

The majority of the production is dredged mussels in both länder. Three classes of production area (class A, B and C) are used and the thresholds defining these comply with those set by the EU. There are no relaying areas in Lower Saxony or Schleswig-Holstein. In Lower Saxony there are four well delimited coastal production areas classified. A fifth area is identified but not classified because no bivalve molluscs for consumption are harvested there. The production areas are identified and the locations of all the farms within the areas are defined by their geographical coordinates. Production areas are monitored throughout the year. The CA classifies the production areas/mollusc farms on the basis of weekly analysis results for microbiology. The areas are classified in class A if the criterion of <230 most probable number (MPN) E.coli/100g is complied with. If, when severeal samples are taken in a production area, an individual value of between 230 and 1000 MPN E.coli/100g is determined, follow-up sampling takes place in accordance with instructions in the bivalve mollusc guide. All results of follow-up samples must be below 230 MPN E.coli/100g in order for the production area to be classified as class A. In Schleswig-Holstein nine well delimited production areas are classified, six of them on the North Sea coast and three in the Baltic Sea. The areas are identified and the locations of all the beds within the areas are defined by their geographical coordinates. Two of the areas have not been classified for a long time as there is no harvesting there. Currently individual mollusc farms within the production areas are monitored and classified, not the production areas previously defined. Samples are taken before harvest and when harvest occurs. The audit team was informed that samples are taken from all mollusc farms which are going to be harvested. The criteria used for permanent classification of areas are different from the specifications of the Community Guide to the Principles of Good Practice for the Microbiological Monitoring of Bivalve Mollusc Harvesting Areas (EU Guide) on sampling frequency and the data used is not from fixed monitoring points. There is a pool of data from different points, most of them collected from June to September at weekly frequency to establish the classification (on the basis of each analysis result), and not sufficient data from fixed sampling points as indicated in the EU Guide. Classification is maintained for areas for which the level of monitoring is inadequate regardless of the level of harvesting activity and the monitoring in the production area. Sanitary surveys Almost all areas were classified before 2006 in both Lower Saxony and Schleswig-Holstein. Bivalve molluscs can only be harvested from classified areas. In 2008/2009 a sanitary survey was conducted for an area to be newly classified in Lower Saxony. In Lower Saxony, sanitary surveys were performed between 2009 and 2011, in all areas following the recommendations of the EU Guide. All areas were re-classified after the sanitary survey, one area as class B and the other three as class A. The sanitary surveys included a desk study (the inventory of sources of faecal contamination, location and characterisation of the farms, assessment of circulation of pollutants and characteristics of mussel farming); a shoreline study (assessment of microbial loads in water and mussels); a bacteriological study based on results for the last ten years for two areas and sampling plans leading to the definition of representative monitoring points. One or two sampling points were selected, based on the studies, in all areas. In Schleswig-Holstein, one new area was established after 2006 in Kiel Fjord and a sanitary survey was conducted in cooperation between the food business operator and the local CA which classified the area as class A. It includes an inventory of sources of pollution, an assessment of microbial loads in the area, an assessment of circulation of pollutants but no sampling plan leading to the definition of representative monitoring points was established. 6

Conclusions The CAs have fixed the location and the boundaries of production areas in line with EU requirements. The CAs in both länder have classified the new production areas after 2006 in line with EU rules. The geographical distribution of sampling points is representive in Lower Saxony and is based on sanitary surveys and monitoring frequency for classification is in line with the EU guide. In Schleswig-Holstein, except in one area, the geographical distribution of sampling points and the frequency do not ensure that the results of the analyses are as representative as possible for the area concerned. Findings 5.3.2 Monitoring of classified production and relaying areas Microbiological monitoring of bivalve molluscs Lower Saxony: The monitoring requirements are specified in the Bivalve Mollusc Guide and can be summarised as follows: The on-going microbiological monitoring for E.coli and Salmonella of classified production areas is carried out at sampling points defined in the sanitary survey and the monitoring requirements are specified and based on the criteria of the EU Guide. For up to three years of monitoring the sampling frequency should be at least once monthly. If the area has been considered stable, the sampling frequency may be reduced, e.g. to every second month. The sampling point fixed following the sanitary survey is not always the point used for on-going monitoring because there may not always be molluscs to harvest there. Samples are therefore taken from a different point/farm which is to be harvested. The change of sampling point is assessed in the sanitary survey review for the production area. Schleswig-Holstein: Monitoring takes place before and during harvesting. According to data provided by the CCA, in the last three years most of the production areas were monitored weekly between June and September, other than those farms with a different seasonal production. Generally, samples are taken before harvesting and then once a week during summer time and monthly during the winter. There are no fixed sampling points in the production areas. The monitoring is done when and where harvesting takes place. Phytoplankton monitoring (Presence of toxin-producing plankton in waters) Lower Saxony: To monitor water quality, a phytoplankton monitoring programme is carried out by the Lower Saxony State Office for Water Management, Coastal Defence and Nature Protection (NLWKN). The seven different sampling points monitored are fixed and determined by the shellfish waters identified. The samples are taken every 14 days from July to October regardless of the length of the harvesting season. Depending on weather conditions a final sample can be taken in October. Results from the sampling points used during the summer by the NLWKN are used in order to obtain information on the presence of potentially toxic algae and to provide information for sampling for bivalve mollusc areas and is used as an early warning system for the presence of algae toxins. Independently of this programme, phytoplankton monitoring takes place during the harvesting season without a set sampling frequency. 2 The phytoplankton monitoring points in this instance are 2 In their response to the draft report the CA noted that the sampling and testing are carried out on the basis 7

not fixed and three species of Dinophysis are identified. Water samples are collected by the fishermen (official regulated samples) at the time and location of harvest and although some exceptions have been noted, generally at least one water sample is taken in a given production area at the time of harvest. However, water samples have not always been taken on all mollusc farms being harvested. Random checks are also carried out by the local CAs (official samples). According to the Bivalve Mollusc Guide, the local CAs take at least one water sample per mollusc area immediately prior to harvest. The audit team noted that these checks took place in 2011 and 2012 and, for the majority of the production areas being harvested in 2013. Schleswig-Holstein: Water samples are collected by the LLUR in the North Sea to monitor the water quality. The 15 sampling points are fixed and have no direct link to bivalve mollusc production areas. Samples are taken once a month in April, May and October and twice a month in June to September with the main purpose to produce information to the public concerning bloomforming species of phytoplankton during the summer. In the Baltic Sea, samples are also taken to give information to the public concerning blue algae in coastal waters. In addition, monthly phytoplankton monitoring samples are taken throughout the year. No count of further potencially toxic phytoplankton species is conducted within this framework. For the Kiel Fjord production area, water samples are taken weekly at two sampling points at the point of harvest by the harvester who also analyses the samples. Considering the sampling method and the equipment used, there is a concern that potentially toxic algae may be lost and that the sampling is not representative of all the relevant potentially toxic phytoplankton species. 3 The results of these analyses are used by the CA. The audit team was informed that, in the North Sea, samples are taken monthly in April, May and October and twice a month from June to September. In the Baltic Sea, samples are taken but there is no set frequency for phytoplankton monitoring. The phytoplankton monitoring programme stops at the end of October but harvest of bivalve molluscs may continue beyond this date. Biotoxin monitoring of bivalve molluscs In all areas visited, sampling for marine biotoxins takes place as and when harvesting occurs. There are no fixed monitoring points and samples are taken by the fishermen from the farms being harvested (one sample per farm). Lower Saxony: During the harvest season, samples are taken weekly to the end of October and every two weeks after 1 November. The audit team noted that, in general, these frequencies are respected and that on numerous occasions, individual samples were collected for a given week from different farms within the same production area. According to the Bivalve Mollusc Guide, all samples are tested for ASP, PSP and lipophilic toxins. The audit team, based on several randomly picked samples, confirmed at the laboratory that this was done. At the time of the visit, some production areas had not been monitored in 2013. The audit team was of risk, irrespective of the current climatic and hydrological conditions, and taking into account the results of the NLWKN information system on plankton blooms and toxic algae. As a rule one sample is taken on each mollusc farm. This means that there is a geographical demarcation of the sampling point within a spatially restricted area. Depending on the assessment of the location and size of the mollusc farms and the hydrographic conditions, the number of samples may be varied. 3 In their response to the draft report the CA noted that the plankton sieve used was adjusted immediatly after the audit. 8

informed that the lack of monitoring was because this year's harvesting had not begun. For one of these areas, the harvesting status was confirmed by the absence of registration documents for this particular production area when visiting the relevant local authority. Schleswig-Holstein: Training in sampling technique and sample packing is not organised for the fishermen. The local authorities do not supervise sampling or carry out any sampling themselves. 4 According to a MELUR decree, the testing schedule for bivalve mollusc samples for marine biotoxins should be as follows: lipophilic toxins weekly from July to September and monthly from October to June; ASP & PSP monthly. The audit team was able to verify the sampling frequency with the local CAs and found that the sampling plan was observed. In either land visited, the audit team was not provided with a risk assessment on the toxin occurrence that would justify a reduction in the monitoring frequency. Monitoring of contaminants in bivalve molluscs Samples from each production area are analysed for contents of mercury, lead, cadmium, dioxins and radioactivity at least once per year with acceptable results. Conclusions The monitoring for microbiology, phytoplankton and marine biotoxins put in place by the CAs is not consistently applied and cannot be considered as in line with EU requirements taking into account the geographical distribution of sampling points and the frequency do not ensure that the results of the analyses are as representative as possible for the area concerned, except in the cases described above. Furthermore in Schleswig-Holstein food business operators' own checks taken into account by the CA for the purpose of classification and monitoring are not supervised effectively. There is a system in place for official controls of contaminants in line with EU legislation. Findings 5.3.3 Decision after monitoring Decisions after monitoring of microbiological quality of live bivalve molluscs In Lower Saxony, monthly samples for micribiological tests are taken throughout the year. In Schleswig-Holstein, weekly samples for microbiology are taken when harvest occurs and decisions are taken by the local CA to keep the production area/farm open to harvest the coming week. If results of E.coli analyses show results above the regulatory limit of the classification, the fishermen are notified via telephone, e-mail and by letter of the classification by the CA. In Lower Saxony, when a class A area is re-classified to class B, it can regain class A status after two samples are taken with a week in between that show class A results. Decisions after monitoring for the presence of toxin-producing plankton in waters 4 In their response to the draft report the CA noted that training was carried out in November 2013 and will be carried out annually in the future. Samples will only be accepted from fishermen who have undergone the training. 9

In Lower Saxony, if more than 1,000 cells/l of Dinophysis spp. are detected by the NLWKN, the CAs and the official control laboratory are informed immediately. The audit team was informed that this limit has been established based on experience because historically, when counts of Dinophysis spp. around 1,000 cells/litre have been quantified by NLWKN in water samples, okadaic acid and dinophysis toxins have been identified in mussel samples. Trigger levels are not applied to other species of potentially toxic algae. In Schleswig-Holstein, there is one sampling point which is particulary suitable for assessing the toxic effect on molluscs in the presence of potentially toxic species in the North Sea coastal waters. This point has shown over the years that if Dinophysis occurs in levels above 700 cells/litre, lipophilic toxins may be detected in other parts of the production areas. This results in an increased frequency of sampling for toxin testing of bivalve molluscs, but not of water. The audit team did not observe any results above the trigger level established that had led to decisions taken. Decisions after monitoring for the presence of biotoxins in live bivalve molluscs Maximum permitted limits for marine biotoxins used in the national monitoring programme are those set in the relevant EU legislation. The audit team was informed that if a sample was positive for marine biotoxins, the local CAs would carry out a risk assessment and take appropriate action. If a closure is put in place, at least two consecutive results from samples taken 48 hours apart below the maximum permitted level are required to re-open the area. In Lower Saxony, if following own-checks, lipophilic toxins are detected above 20µg/Kg, an official sample is taken. The audit team did not observe any results above the trigger level established that had led to decisions taken. Conclusions Decisions are taken to prevent the harvesting of bivalve molluscs when monitoring sample results show that maximum limits for E.coli have been exceeded. They were found to be taken as soon as the results were available and were well documented and in line with national procedures and EU requirements. Findings 5.3.4 Additional monitoring requirements The Fisheries Office in Lower Saxony and the LLUR in Schleswig-Holstein randomly check positions of vessels at sea via recorded information from the black box (in Schleswig-Holstein) or the VMS system (in Lower Saxony) all vessels must carry. The black box is a GSM system with maritime maps where all production areas and mussel farms are plotted. The system can show where vessels are dredging and if lifting devices are used. The audit team reviewed registration documents at a local CA in Schleswig-Holstein from the summer 2013. They were matched with laboratory analysis results and decisions for harvesting taken by the local CA and compared with the information from the black boxes. Two registration documents showed harvesting in one mussel bed that was approved by the CA, but the black box recording showed for both these occasions harvesting in another bed which was neither approved nor monitored for harvest. 10

There are random samples taken for official control of end products. (See 5.5.2) Conclusions Both länder have additional monitoring requirements in place. However, the system with random checks of vessel activities cannot fully prevent harvest of bivalve molluscs in areas forbidden to be harvested. Findings 5.3.5 Recording and exchange of information Fishermen are informed by the local CAs, in writing, of the status of production areas. Results from analyses that change the classification of an area are communicated by telephone and written decisions. Results of toxin testing are sent out once a week when they are negative. When a positive sample is found, the result is communicated immediately via telephone and a separate letter is sent. Conclusions There is an efficient communication system in place and it is in line with EU legislation. Findings 5.3.6 Food Business Operators' own checks The official control system takes into account results of food business operator's water samples for analyses of toxin-producing plankton species in Lower Saxony and mussel samples for classification, opening and closure of production areas in Schleswig-Holstein and checks for marine biotoxins in both länder as described under points 5.3.1, 5.3.2 and 5.3.3 in this report. Samples taken by food business operators are analysed in laboratories designated by the CAs. Training in sampling procedures is given in Lower Saxony and in Schleswig-Holstein written instructions are available. Conclusions Results from food business operator's sampling are used by the CA in line with EU legislation. 5.4 OFFICIAL CONTROLS ON PECTINIDAE AND LIVE MARINE GASTROPODS NOT FILTER FEEDERS HARVESTED OUTSIDE CLASSIFIED PRODUCTION AREAS Legal Requirements Article 6 of Regulation (EC) No 854/2004 and Chapter III of Annex II to Regulation (EC) No 854/2004, having particular regard to the CA's official controls to verify FBOs' compliance with Chapter IX of Section VII of Annex III to Regulation (EC) No 853/2004; Council Decision 2002/226/EC. Findings There is no production of pectinidae or marine gastropods in Germany and there are no authorised establishments under the provisions of Commission Decision 2002/226/EC. 11

5.5 OFFICIAL CONTROLS TO VERIFY FOOD BUSINESS OPERATORS' COMPLIANCE WITH THE REQUIREMENTS FOR THE PRODUCTION AND PLACING ON THE MARKET OF BIVALVE MOLLUSCS, ECHINODERMS, TUNICATES AND MARINE GASTROPODS Legal Requirements Article 4 of Regulation (EC) No 854/2004, having particular regard to the CA's official controls to verify FBOs' compliance with Regulation (EC) No 852/2004, Regulation (EC) No 853/2004 (section VII and VIII of Annex III) and the microbiological criteria laid down in Regulation (EC) No 2073/2005. Findings 5.5.1 Requirements for placing on the market The audit team did not observe the harvesting and handling of live bivalve molluscs following harvest as it was not possible to visit the single dispatch centre in the länder visited. A harvesting vessel belonging to one aquaculture farm was present at quay. Conditions observed on board were adequate. Live bivalve molluscs are sold directly from this vessel to final consumers, including restaurants and retail shops. Provisions for doing so are regulated in the national legislation. The audit team was provided with a list of customers. The same practice is carried out with oysters harvested by hand in Schleswig-Holstein. Registration documents must accompany every batch of live bivalve molluscs. Information about species, amount, origin, destination and the status of the area from where they are harvested are filled in and signed by the fishermen and the document accompanies the batch. Copies are sent to both local and central CAs. The registration documents are issued by the länder CCAs. The audit team noted in Lower Saxony that registration documents for mussels destined for the Netherlands were written exclusively in German up to 2011. Conclusions Bivalve molluscs are placed on the market in line with EU requirements. Findings 5.5.2 Official controls of food business operators The official controls of establishments are carried out by the local CAs with a frequency based on risk assessment of the type of production and the inspection records concerning non-compliances. Paper checklists for inspections were used prior to the introduction of a computerised system where all control activities are now recorded. Verification covers structural and hygiene conditions and the HACCP plan. Reports are issued and sent to the food business operator. Deficiencies are identified and followedup. The audit team verified in the establishment visited that official controls follow the set frequency of once per year in this establishment. Official control samples are taken for analyses of end product testing for microbiology, marine biotoxins and heavy metals. Conclusions The official controls of food business operators are carried out based on risk and the frequency is 12

respected and includes testing of end products. Findings 5.5.3 Facilities handling bivalve molluscs The audit team visited one processing plant that was in operation at the time of the visit. Before cooking, incoming live bivalve molluscs are kept in containers under water pumped in from the sea for conditioning (de-sanding) for periods from a couple of hours in summer up to 48 hours in winter. This process has not been assessed or controlled by the CA in a way that ensures that recontamination of mussels cannot occur. A HACCP plan was available describing the processing and the heat-treatment steps included. There were four critical control points covering the origin of the raw material, cooking temperature, cooking pressure and glazing of the mussels. Under EU legislation cooking requires a minimum temperature of 90ºC for a minimum of 90 seconds. To ensure that those requirements are met, mussels are cooked above 100ºC for 140 seconds under a pressure of 2.1 2.2 bar. The temperatures are checked for compliance by loggers placed in the mussel flesh through the cooker. The process is also checked by manual measurements from three different parts of the cooker and readings of the water temperature, time in heat-treatment and the final product are registered. The audit team saw printed graphs of records of the cooking processes with satisfactory results. When visiting the establishment, the audit team noted that the standard of the facilities and equipment was good and that handling of products was performed in a hygienic manner. Microbiology testing is performed for every batch in the food business operator's in-house laboratory and also in an external laboratory for verification. Chemical analyses are performed externally. All batches are kept in a cold store until results are available following which the batches can be approved of and released. All results shown to the audit team had satisfactory results. A traceability exercise on the labelling of a finished product was performed during the visit and the food business operator could show from where the incoming raw material came. Conclusions Official inspections are carried out in accordance with the set frequency by the CA and hygiene requirements are complied with. However, the suitability of the conditioning (de-sanding) systems in use has not been evaluated and there are risks that current practice could lead to additional contamination of mussels. 5.6 LABORATORIES Legal Requirements Articles 11, 12 and 33 of Regulation (EC) 882/2004, and Article 3 of Regulation (EC) 2074/2005. Findings Besides the National Reference Laboratory (NRL) for microbiology and marine biotoxins, there is one official control laboratory in each land visited designated for the testing of bivalve molluscs. BfR laboratory NRL for Microbiology 13

The BfR Laboratory in Berlin was designated the national reference laboratory (NRL) for monitoring of bacterial and viral contamination of live bivalve molluscs in 2000. No official control analyses are performed by the NRL. The CCA in the länder and their official laboratories are in charge of sampling coordination and testing. The NRL has been accredited according to ISO17025:2005 by a German accreditation body AKS, Staatliche Akkreditierungsstelle Hannover. It is under a flexible accreditation for "Bacteriological and microbiological culture, isolation and quantification" and not for specific methods like the official one for E. coli (ISO16649-3). The laboratory has taken part in lenticules (Shellfish Scheme) and whole bivalve mollusc proficiency testing exercises for E. coli and Salmonella which were organised by the British Health Protection Agency. The NRL also participates in bivalve mollusc EU Reference Laboratory (EURL) ring tests for Norovirus, Hepatitis A virus and Vibrio spp. The results of this proficiency testing in 2012 and 2013 were satisfactory. The BfR laboratory fulfils the majority of the tasks with regard to Regulation (EC) No 882/2004 (Article 33) as NRL: participates in yearly EURL workshop; ensures that the official control laboratories participate in proficiency testing and ensures an appropriate follow up; provides information to laboratories and scientific support in new methods by participation in international organizations for standard methods (Vibrio spp. and Norovirus) and also providing SOPs and bacterial and viral strains; provides scientific and technical assistance to the CAs, with a meeting every two years. BfR laboratory NRL for Marine biotoxins The NRL for marine biotoxins carries out analysis of marine biotoxins, is not involved in phytoplankton testing and does not carry out any official control analysis. The audit team was informed that the NRL is accredited to ISO17025:2005 by the German accreditation body (DAkkS) under a flexible scope of accreditation. The laboratory regularly takes part in a number of proficiency testing exercises for ASP, PSP and lipophilic toxins (EURL, Quasimeme) as well as inter-laboratory method validation exercises. The majority of the results have been satisfactory. The NRL has a number of methods available for ASP, PSP and lipophilic toxins analysis (ASP by HPLC-UV, PSP by HPLC-FLD with pre-column oxidation, lipophilic toxins by LC-MS/MS). In addition, it is developing or rolling out additional procedures (e.g: PSP by LC-MS\MS, PSP by HPLC-FLD using post-column oxidation). Should the NRL require analysis of PSP using the current reference method, the sample(s) would be sent to the EURL for analysis. The NRL had collected information related to proficiency testing performance from the official control laboratories. Some of these z-scores were questionable or unsatisfactory and an explanation had been provided for a few of these. The NRL was not informed of follow-ups of other unsatisfactory results. The NRL did not have an up-to-date list of the methods currently in use for marine biotoxins testing in the official control laboratories. In 2012, all the BfR NRLs, which carry out chemical analyses, organised an one-day joint workshop. Subsequently a one-day work shop on marine biotoxins was offered. The laboratory has an on-line portal that it uses to communicate information (relevant legislation etc.) to the laboratories. 14

The NRL offers training on request. It has organised a training course on PSP by HPLC attended by colleagues from the laboratory in Lower Saxony and related certificates were available when the audit team visited that laboratory. The NRL has also been involved in European Food Safety Authority working groups, collaborated with the EURL and other European laboratories on the validation of methods. The NRL also advises the government ministries at federal and länder level. LAVES, Cuxhaven, Lower Saxony It is the official control laboratory responsible for the analysis of all water and bivalve mollusc samples taken in the context of the marine biotoxin monitoring programme in Lower Saxony and the analysis of all samples in connection with the microbiological monitoring of molluscs production areas. Microbiology It is the official laboratory for the enumeration of E. coli in bivalve molluscs in Lower Saxony. It receives samples from all production areas for microbiological tests and the results are reported by telephone to the local CA, before result documents are sent out. The laboratory carries out 60-65 E. coli analyses yearly in bivalve molluscs. Two staff members are involved in these official controls activities. The audit team was informed they have both been trained to perform the assays in the course of laboratory proficiency tests conducted by the EURL. The laboratory is accredited in accordance with ISO17025:2005 by the two German accreditation bodies, for the official method for E. coli, DIN ISO/TS 16649-3 in accordance with ISO 17025:2005. An audit will be conducted in the laboratory for reaccreditation by the DAkks in November 2013. The laboratory has taken part in Health Protection Agency proficiency tests for E. coli and Salmonella. In 2013, for E. coli, when unsatisfactory results were obtained, the finding was noted and follow-up actions have been put in place immediately demonstrating no deviation in the results of the laboratory. All bivalve mollusc samples submitted for microbiological analysis are generally received on Mondays, in sealed and refrigerated cool boxes. Samples must arrive to the laboratory within 24h and sample temperature is checked on arrival. The audit team verified some records in accordance with refrigeration requirements and was informed about the packaging of samples arriving at the laboratory. Concerning temperature requirements the audit team was told that samples should not exceed +8ºC, but in the Bivalve Mollusc Guide the range is stated as between +2 to +10ºC. The audit team was informed about the procedures for sample log in, preparation, stomaching and inoculation for E. coli analysis and positive and negative quality controls are included each day, all in line with the specifications of the EURL generic protocol for Enumeration of E. coli in bivalve molluscan shellfish by the most probable number (MPN) technique (based on ISO16649-3) (hereafter EURL generic protocol). Equipment is periodically calibrated and media control is adequately performed according to ISO11133-1 and 2 standards for microbiology analyses. The audit team verified the traceability of samples at the laboratory and the reports sent to the CA when results confirm the presence of E. coli above limits. Plankton The audit team was informed that the phytoplankton team at the laboratory dealt with 65 samples in 15