EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL

Transcription

1 Ref. Ares(2014) /06/2014 EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Directorate F - Food and Veterinary Office DG(SANCO) MR FINAL FINAL REPORT OF AN AUDIT CARRIED OUT IN POLAND FROM 12 TO 22 NOVEMBER 2013 IN ORDER TO EVALUATE THE OFFICIAL CONTROLS IN PRIMARY PRODUCTION OF FOOD OF NON-ANIMAL ORIGIN 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 Poland which took place from 12 to 22 November 2013 under the provisions of Regulation (EC) No 882/2004 of the European Parliament and the Council of 29 April The objectives of the audit were to evaluate the system of official controls in the area of food hygiene for primary production of Food of Non-Animal Origin (FNAO) and the system of official controls in the area of traceability and import of seeds intended for sprouting and sprouts, microbiological criteria and approval of sprout producing establishments. Although there are competent authorities designated for official controls in the sectors of primary production of FNAO, the official control system applied is not risk based and cover only production activities during and post harvest in a limited number of establishments. This means that the potential risks arising from microbiological contamination are not systematically taken into account in the planning of official controls. The Polish competent authorities plan to incorporate primary production of FNAO in the risk based official control system. The shortcoming identified in the capacity of the official control laboratories visited could affect the reliability of the analytical results for Verocytotoxin producing Escherichia coli testing. The Union legislation on seeds intended for sprouting and sprouts has not been adequately implemented. There are deficiencies concerning the approval of sprouting establishments as required by Regulation (EU) No 210/2013 and the own-check systems for monitoring of food safety criteria for sprouts as required by Regulation (EC) No 7023/2005. The report makes a number of recommendations to the competent authorities aimed at rectifying the shortcomings identified and enhancing the implementation of control measures. I

3 Table of Contents 1 INTRODUCTION OBJECTIVES AND SCOPE LEGAL BASIS BACKGROUND FINDINGS AND CONCLUSIONS RELEVANT NATIONAL LEGISLATION ORGANISATION AND IMPLEMENTATION OF OFFICIAL CONTROLS DESIGNATION OF COMPETENT AUTHORITIES REGISTRATION/APPROVAL OF FOOD ESTABLISHMENTS ORGANISATION AND SCOPE OF OFFICIAL CONTROLS IMPLEMENTATION OF OFFICIAL CONTROLS OVER FBO'S OBLIGATIONS SAMPLING LABORATORY PERFORMANCE PROCEDURES FOR PERFORMANCE AND REPORTING OF CONTROL ACTIVITIES CO-OPERATION BETWEEN AND WITHIN COMPETENT AUTHORITIES ENFORCEMENT MEASURES OVERALL CONCLUSION CLOSING MEETING RECOMMENDATIONS...17 ANNEX 1 - LEGAL REFERENCES...19 II

4 ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT Abbreviation AFQI ARMA CA(s) CCA(s) CSI DG (SANCO) EFSA EU EURL FBO(s) FNAO FVO GHP HACCP IEP ISO MARD MS(s) NIPH-NHI Explanation Agricultural and Food Quality Inspection Agency for Restructuring and Modernisation of Agriculture Competent Authority(ies) Central Competent Authority(ies) Chief Sanitary Inspectorate Health and Consumers Directorate-General European Food Safety Authority European Union European Union Reference Laboratory Food Business Operator(s) Food of non animal origin Food and Veterinary Office Good Hygiene Practice Hazard Analysis Critical Control Points Inspection of Environmental Protection International Organisation for Standardisation Ministry of Agriculture and Rural Development Member State(s) National Institute of Public Health - National Hygiene Institute III

5 NRL PCR PSES(s) RASFF SPHSIS SSI STEC VSES(s) VTEC National Reference Laboratory Polymerase Chain Reaction Poviat Sanitary and Epidemiological Station(s) Rapid Alert System for Food and Feedstuffs State Plant Health and Seed Inspection Service State Sanitary Inspection Shiga toxin-producing Escherichia coli Viovodship Sanitary and Epidemiological Station(s) Verocytotoxin producing Escherichia coli IV

6 1 INTRODUCTION The audit took place in Poland from 12 to 22 November The audit formed part of the Food and Veterinary Office (FVO) planned audit programme and formed part of a series of audits to Member States (MSs). The audit team comprised two auditors from the FVO, one national expert from a MS and an observer from European Free Trade Association Surveillance Authority. Representatives from the Central Competent Authority (CCA) within the context of this audit: the Chief Sanitary Inspectorate (CSI) within the State Sanitary Inspection (SSI) and from the Ministry of Agriculture and Rural Development (MARD) accompanied the audit team for the duration of the audit. An opening meeting was held on 12 November 2013 with the CCA, representatives from SSI laboratories and competent authorities (CAs) at regional and district level. There were also present representatives from the State Plant Health and Seed Inspection Service (SPHSIS) and the Agricultural and Food Quality Inspection (AFQI) both under the MARD, and representatives from the Inspection of Environmental Protection (IEP) under the Minister of Environment (for more details see the Table on page 2). At this meeting, the audit team confirmed the objectives of, and itinerary for, the audit, and additional information required for the satisfactory completion of the audit was requested. In addition, the standard reporting procedures were confirmed. 2 OBJECTIVES AND SCOPE The objectives of the audit were to: Evaluate the system of official controls in the area of food hygiene for primary production of food of non-animal origin (FNAO); Evaluate the system of official controls in the area of traceability and import of sprouts and seeds intended for sprouting, microbiological criteria for them and the approval of sprouting establishments. In terms of scope, the audit reviewed official controls on food hygiene at primary production of FNAO, including seeds intended for sprouting and sprouts, as well as the planning and implementation of official controls, control procedures, sampling performance and enforcement capability. In particular, the audit evaluated the implementation of: Regulation (EC) No 852/2004 on the hygiene of foodstuffs, in particular, Articles 4(1) and 6 and Annex I; Regulation (EC) No 882/2004 on official controls, in particular, Title II; Regulation (EC) No 178/2002, in particular, Article 18 regarding traceability; Regulation (EU) No 208/2013, Regulation (EU) No 210/2013 and Regulation (EU) No 211/2013 and Regulation (EC) No 2073/2005 regarding microbiological requirements for sprouts and seed for sprouting. In pursuit of these objectives, the following sites were visited: 1

7 Table: Audit visits and meetings Visits/meetings Comments Competent Authorities Central level 4 Opening and closing meetings with the CSI, SPHSIS, AFQI and IEP Regional level 5 Meetings with inspectors from the Viovodship Sanitary and Epidemiological Stations (VSES) and representatives from Viovodship Inspectorates of Plant Health and Seed Inspection Service in Lublin, Katowice and Lodz regions visited District level 5 Poviat Sanitary and Epidemiological Station (PSES) inspectors and representatives from the SPHSIS met during the establishments and farms visits Laboratories Public laboratories 2 Official control laboratories in Katowice and Lublin Establishments 2 Two farms producing green leafy vegetables 3 Three farms producing strawberries, raspberries, bulb and stem vegetables 2 Two approved sprout producing establishments 3 LEGAL BASIS The audit was carried out under the general provisions of European Union (EU) legislation, in particular, Article 45 of Regulation (EC) No 882/2004 of the European Parliament and the Council. A full list of the EU legal acts referred to in this report is provided in the Annex. EU acts quoted in 2

8 this report refer, where applicable, to the most recently amended version. 4 BACKGROUND Information on the existence of direct or indirect risk to human health deriving from food or feed is disseminated via notifications through the Rapid Alert System for Food and Feed (RASFF) to all MSs and to the exporting country. From 2011 up until the time of the audit there were 170 notifications concerning pathogenic micro-organisms in fruit and vegetables. The European Food Safety Authority (EFSA) adopted a scientific opinion on the risk posed by FNAO: The EFSA assessed that FNAO is consumed in a variety of forms, and is a major component of almost all meals. These food types have the potential of being associated with large outbreaks as seen in 2011 with verocytotoxin producing Escherichia Coli (VTEC) O104. A comparison of the incidence of human cases linked to the consumption of FNAO and of food of animal origin was carried out to provide an indication of the relative incidence between these two groups of foods. Using data from 2007 to 2011, FNAO was associated with 10% of outbreaks, 26% of cases, 35% of hospitalisations and 46% of deaths. If the data from the 2011 VTEC O104 outbreak is excluded, FNAO was associated with 10% of outbreaks, 18% of cases, but only 8% of hospitalisations and 5% of deaths. From 2008 to 2011 there was an increase in the number of reported outbreaks, cases, hospitalisations and deaths associated with FNAO. In order to identify and rank specific food/pathogen combinations most often linked to human cases originating from FNAO in the EU, a model was developed using seven criteria: strength of associations between food and pathogen based on the food-borne outbreak data from EU Zoonoses Monitoring ( ), incidence of illness, burden of disease, dose-response relationship, consumption, prevalence of contamination and pathogen growth potential during shelf life. The top ranking food/pathogen combinations were : leafy greens eaten raw as salads/salmonella spp. and norovirus; bulb and stem vegetables; tomatoes; melons; sprouts/salmonella spp; fresh pods, legumes or grain/pathogenic Escherichia coli. The EFSA adopted a scientific opinion on the risk posed by shigatoxin producing Escherichia coli (STEC) and other pathogenic bacteria in seeds and sprouts, after the outbreaks of STEC in May 2011 in the EU. The EFSA report can be found at: The consumption of sprouts was identified as the most likely origin of the outbreaks. Over human cases were reported and 55 people died. In its opinion EFSA concluded that the contamination of seeds with bacterial pathogens is the most likely initial source of sprout-associated outbreaks. Due to the high humidity and the favourable temperature during sprouting, bacterial pathogens present on dry seeds can multiply on the sprouts. The most recent EFSA scientific opinion on the VTEC-seropathotype and scientific criteria regarding pathogenicity assessment can be found at: In view of the number of large outbreaks and the high number of RASFF notifications concerning primary products of non-animal origin the FVO decided to undertake an audit series to MSs on 3

9 primary production of FNAO. 5 FINDINGS AND CONCLUSIONS 5.1 RELEVANT NATIONAL LEGISLATION Legal Requirements Article 291 of the Treaty on the Functioning of the EU establishes that MSs shall adopt all measures of national law necessary to implement legally binding Union acts. Findings The legal basis for the official controls in the food sector is described in the country profile for Poland which is accessible at: The national legal basis establishing the procedure for registration of primary producers of FNAO, including direct suppliers, entered into force in 2010 with the amendment of the Act on Food Safety and Nutrition of 25 August The Regulation of the Minister of Health on the model documents for the registration and approval of food establishments supervised by the SSI of 29 May 2007 sets out the procedure to be followed for registration and approval of establishments for primary production of FNAO. The Regulation of the Minister of Health on the direct supply of foodstuffs of 6 June 2007 specifies the activities laid down in Article 1(2)(c) of Regulation (EC) No 852/2004. The CAs make use of a definition of small quantities of FNAO (which is set out as the annual yield) produced by farmers for the direct supply to the final consumer or to local retail establishments directly supplying the final consumer. Under this national Regulation, primary producers of FNAO operating as direct suppliers should comply with the hygiene requirements laid down by Article 4(1) of Regulation (EC) No 852/2004. There are no national provisions for microbiological criteria for foodstuffs. All legislation is made available to the public on the websites of the Chief Sanitary Inspectorate ( Information on newly published legislation is prepared by the SSI and is provided to the VSESs and PSESs via circular letters. Conclusions Relevant legislation is publicly available and accessible to the CA's inspectors. 5.2 ORGANISATION AND IMPLEMENTATION OF OFFICIAL CONTROLS Designation of Competent Authorities Legal Requirements Article 4(1) of Regulation (EC) No 882/2004 requires MSs to designate the CAs responsible for official controls. Article 4 of Regulation (EC) No 882/2004 requires the CA to ensure that they have access to a 4

10 sufficient number of suitably qualified and experienced staff; that appropriate and properly maintained facilities and equipment are available. Article 6 of Regulation (EC) No 882/2004 requires CAs to ensure that staff performing official controls receive appropriate training, and are kept up-to-date in their competencies. Findings A detailed description of the CAs falling within the scope of the audit can be found in the country profile for Poland. The SSI within the Ministry of Health is the single CA responsible for official controls on FNAO from primary production to retail level, including controls on seeds intended for sprouting and sprouts. However, representatives from SSI stated that regarding primary production of FNAO, they do not have responsibility to carry out official controls at the stage prior to harvest, as they do not consider primary plant products as foodstuffs (see section 5.2.3). This is not in line with the requirements laid down by Article 17 of Regulation (EC) No 178/2002. The SSI has competences to perform official controls on primary production of FNAO after harvest during storage, handling and transport of primary plant products. Representatives from SSI stated that primary plant products are not considered food before harvest, according to the definition of food as laid down in Article 2 of Regulation (EC) No 178/2002. The SSI is organised in 16 VSESs (regional level) which have coordinating and supervising tasks. Official controls are carried out by the 318 PSESs (district level). The SSI consists of 2514 full time equivalent food inspectors responsible for official controls of FNAO, including primary production of FNAO. Within the scope of this audit, the PSESs are responsible for (a) registration of farms producing FNAO and importers of seeds for sprouting, (b) approval of sprout producing establishments and (c) official controls at farms and sprout producing establishments covering food safety. The SPHSIS within the MARD is responsible for official controls on plant health, plant protection products and seed materials. These controls cover inspections where compliance with phytosanitary and plant protection products legislations is checked and do not cover compliance with the hygiene requirements. The AFQI within the MARD is the CA for the supervision of the marketing quality of fresh fruit and vegetables at import, export, retail and wholesale level. Their controls are not carried out at primary production stage and do not cover food hygiene requirements. The IEP is responsible for official controls on the use of fertilizers as regards environmental issues. A representative of the CA stated that their controls are carried out only at farms that are most likely to have a significant impact on the environment and do not cover compliance with the hygiene requirements. According to the CSI, relevant training on primary production of FNAO, EU legislation on seeds for sprouting and sprouts, sampling for microbiological analysis and microbiological food contamination was provided to VSES and PSES inspectors. The audit team noted: The CA in charge of official controls on FNAO is designated and that the officials met had a clear understanding of their responsibilities and duties. In the regions and districts visited, evidence was provided to demonstrate that cascade training on primary production of FNAO and EU legislation on seeds for sprouting and sprouts had been provided to VSES and PSES inspectors. The majority of them received the 5

11 training prior to the audit. The PSES inspectors met were adequately equipped with sampling equipment. Conclusions The CAs responsible for the official controls on primary production of FNAO have been designated. However, the official controls (as required by Article 17(1) of Regulation (EC) No 178/2002) are only partially undertaken in the sector of FNAO at primary production stage prior to harvest concerning the hygiene provisions as laid down in Article 4 and in Annex I to Regulation (EC) No 852/2004. The training arrangements required by Article 6 of Regulation (EC) No 882/2004 are in place and assist PSES inspectors to be aware of the relevant EU and national legislation Registration/Approval of Food Establishments Legal Requirements Article 6 of Regulation (EC) No 852/204 requires that Food Business Operators (FBOs) shall notify the appropriate CA of each establishment under its control that carries out any of the stages of production, processing and distribution of food, with a view to its registration. It also requires that FBOs ensure that establishments are approved by the CA when approval is required under national law or by a decision adopted by the Commission. Article 2 of Regulation (EU) No 210/2013 requires that establishments producing sprouts are approved by the CA in accordance with Article 6 of Regulation (EC) No 852/2004. Article 31 of Regulation (EC) No 882/2004 requires MSs to establish procedures for FBOs to follow when applying for the registration/approval of their establishments. It also provides for reviewing compliance with conditions of approval and for the withdrawal of approvals. Findings According to SSI, the main source to identify primary producers of FNAO is the information gathered during the official controls on food processors, distributors and retailers. The CAs do not have access to existing databases of registered farmers. The SSI had undertaken actions to cooperate with the SPHSIS in order to get information on farmers producing FNAO and to advise farmers of their obligation to be registered with the relevant PSESs (see section 5.2.7). According to the data provided to the audit team during the audit, there were: 5473 registered primary producers and direct suppliers of FNAO. Five approved sprouting establishments out of 10 operational in the country. Six registered distributors of seeds intended for sprouting. One registered importer of seeds intended for sprouting. The audit team noted: The registration of primary producers and direct suppliers of FNAO started in 2010 and is not yet completed. The exact number of these FBOs remains unknown for SSI. Many farmers were registered because a registration was required for export to a third country. In the Lublin region visited, the PSESs registered 688 primary plant producers and 119 6

12 direct suppliers of FNAO. Representatives from the regional SPHSIS informed the audit team that according to the data of the Agency for Restructuring and Modernisation of Agriculture (ARMA), in the region there were farmers (producing FNAO and food of animal origin) registered in order to receive EU subsidies. For the Katowice region visited, these numbers were 83 registered primary producers and direct suppliers by the PSESs and farmers registered by the ARMA, and for the Lodz region visited registered primary producers and direct suppliers, and farmers registered by the ARMA. The CCA did not have information on businesses producing seeds for sprouting in operation. Sprout producing establishments were already approved under Regulation (EC) No 852/2004 before 1 July Compliance with the new requirements of Regulation (EU) No 210/2013 was checked through comprehensive inspections carried out by PSES inspectors since September As a result, half of the operational sprouting establishments were not approved at the time of the audit due to some deficiencies with long deadlines for corrective measures. According to the information provided by the SSI, one of these FBOs had a deadline in March The two sprouting establishments visited were approved by the CAs. However, they did not fully comply with the requirements for testing the seeds used for sprouting and the sprouts (see section ). In the approval decisions checked by the audit team there was no reference to Regulation (EU) No 210/2013. The inspectors met explained that they were not yet provided with a new template for the approval decision. Separate lists of registered primary plant production establishments and approved sprouting establishments are maintained at district (PSES) level. This was confirmed by the documents provided to the audit team by PSES inspectors met. Regional or national lists were not in place as this information was spread on the lists kept by the 318 PSESs (see section 5.2.6). Conclusions Although procedure for registration of establishments for primary production of FNAO is in place, the registration is incomplete. This results in farms being in activity without being subject to official controls. Therefore, the relevant requirements laid down by Article 6 of Regulation (EC) No 852/2004 are not fully met. Official controls cannot always ensure that approved sprouting establishments comply with the general hygiene requirements as laid down in Annex II to Regulation (EC) No 852/2004, requirements for approval as laid down in Annex to Regulation (EU) No 210/2013 and the requirements for testing of seed and sprout batches as required in Chapter 3.3 of Annex I to Regulation (EC) No 2073/ Organisation and Scope of Official Controls Legal Requirements Article 17 of Regulation (EC) No 178/2002 requires that MSs shall enforce and monitor and verify that the relevant requirements of the food law are fulfilled by the FBOs at all stages of production, processing and distribution. 7

13 Article 3 of Regulation (EC) No 882/2004 requires that official controls are carried out regularly, on a risk basis and with appropriate frequency, taking account of (a) identified risks; (b) the FBOs past record as regards compliance; (c) the reliability of any own checks that have already been carried out; and (d) any information that might indicate non-compliance. Findings According to CSI representatives, there is a risk categorisation system for food establishments. However, this system does not include establishments for primary production of FNAO. The risk assessment to determine the number of inspections to primary producers of FNAO is a decision for each PSES to make at district level without any instructions provided by the CCA. However, the audit team was informed by the CSI representatives that a new risk categorisation system for food establishments was under preparation and would include primary production of FNAO. The system is planned to be implemented by the end of There is an annual national sampling plan which is executed separately. The official sampling plan for microbiological testing of food samples is designed by the SSI in conjunction with the National Hygiene Institute (NHI). It is based on the requirements of Regulation (EC) No 2073/2005, RASFF notifications, previous results on microbial food contamination, notified outbreaks and food consumption patterns. The allocation of the number of samples per VSES, the parameter to be tested and the place of sampling is decided at central level. The distribution of samples between PSESs is decided by VSES. According to the information provided by the CSI, in 2013, under the official sampling plan, 400 samples of fresh vegetables were to be taken for testing the presence of Salmonella and E. coli O157, and enumeration of Listeria monocytogenes and E. coli. Another 500 samples of frozen fruit were planned to be analysed for the presence of Salmonella, mould and yeasts and enumeration of Listeria monocytogenes. Official controls of primary producers of FNAO, including sprout producers, are performed using the SSI general procedures for inspection of food establishments and for food sampling. The audit team noted: The CAs do not consider primary plant products as food before harvest, according to the definition of food as laid down in Article 2 of Regulation (EC) No 178/2002. The official controls carried out by the CAs do not cover all FBOs producing primary plant products and seeds intended for sprouting due to the fact that many of them are not registered (see section 5.2.2). The PSESs visited have established different inspection frequency for primary plant production establishments. In one region the inspection frequency was 10% of registered farms and was established mainly to take account of available resources rather than on a risk basis. In another region, the fixed inspection frequency was one comprehensive inspection every three years. There was some evidence for risk-based sample planning. For example, samples of fresh vegetables were included in the 2012 sampling plan, after the E. coli O104 outbreak in EU. However, the testing parameters included only detection of serotype E. coli O157 due to the lack of laboratory capacity. Although strains isolated from samples with high E. coli counts were examined for the presence of VTEC related genes, the sensitivity of the procedure is low due to the fact that only samples with high E. coli counts were checked and the procedure cannot be considered equivalent to the method prescribed in Regulation (EC) No 2073/2005 for VTEC detection. 8

14 According to the SSI instructions, samples from primary plant products were to be taken mainly at retail level. The 2013 sampling plan had instructions to take samples of sprouts and seeds for sprouting every time they appear on the retail market. There were no plans to sample fresh fruits for microbiological analysis despite the RASFF notifications for Polish products related to this food category (e.g. there were no planned samples from strawberries and raspberries for analysis for contamination with Hepatitis A virus or norovirus). Furthermore, there was no requirement to carry out E. coli enumeration testing in samples of frozen fruit, which could be used as an indicator of faecal contamination in the absence of testing for the presence of Hepatitis A virus or norovirus. PSES inspectors were not provided with instructions for official controls on primary production of FNAO and for implementation of approval measures contained in Regulation (EU) No 210/2013. The checklist used by PSES inspectors in the farms and sprout producing establishments visited did not cover specific questions for compliance with the provisions of Annex I to Regulation (EC) No 852/2004. PSES inspectors carrying out controls in farms visited paid very little attention to field visits and measures put in place by the farmers to implement GAP for irrigation and use of fertilizers. Conclusions Risks arising at primary production of FNAO including those at growing and harvesting stage are not taken into account in the development of risk-based planning of official controls and the risk categorization of FBOs does not cover primary producers of FNAO except establishments producing sprouts. Consequently the official controls do not cover the observance of hygiene requirements listed in Annex I of Regulation (EC) No 852/2004 relevant for pre-harvest and for harvesting and therefore FBO's compliance with those requirements cannot be ensured Implementation of Official Controls over FBO's Obligations Legal Requirements Article 10(2)(b)(i) of Regulation (EC) No 882/2004 requires that official controls on food include, the inspection of primary producers' installations, including their surroundings, premises, offices, equipment, installations and machinery, transport, as well as of food. Article 10(2)(c) of Regulation (EC) No 882/2004 requires that official controls on food include, inter alia, checks on hygiene conditions in food businesses. Article 10(2)(d) of Regulation (EC) No 882/2004 requires that official controls on food shall include the assessment of procedures on good farming practices, taking into account the use of guides established in accordance with Union legislation. Article 4(1) of Regulation (EC) No 852/2004 requires that FBOs carrying out primary production and associated operations listed in Annex I must comply with the general hygiene provisions as laid down in part A of Annex I to that Regulation. Article 7 of Regulation (EC) No 852/2004 requires that MSs encourage the development of national guides to good practice for hygiene in accordance with Article 8, which requires MSs to assess national guides and forward to the Commission national guides complying with the requirements of that Article. Article 8 of Regulation (EC) 852/2004 requires that if national guides to good practice are 9

15 developed, they shall be developed and disseminated by food business sectors and when they concern primary production and those associated operations listed in Annex I, they should take into consideration recommendations contained in Part B of Annex I to Regulation (EC) 852/2004. Article 18 of Regulation (EC) No 178/2002 establishes traceability requirements in food. Article 15(1) of Regulation (EC) No 882/2004 requires that official controls on food include regular official controls on FNAO imported into the EU. Article 3 of Regulation (EU) No 208/2013 establishes traceability requirements for all stages of production, processing and distribution of seeds intended for the production of sprouts and for the batches of sprouts. Regulation (EU) No 211/2013 establishes the certification requirements for import into the EU of sprouts and seeds intended for the production of sprouts. Annex I of Regulation (EC) No 2073/2005 establishes general rules for the sampling and testing of seeds and sprouts and spent irrigation water. Findings The audit team visited five growers of FNAO (strawberries, raspberries, green leafy and stem vegetables) and two sprout producing establishments. The PSES inspectors met were the inspectors who had carried out previous controls in the visited premises. Inspections at primary plant production level, including sprout producing establishments, can be either of a comprehensive or secondary type. During comprehensive inspections, a systematic verification of compliance with food hygiene legislation is carried out. Secondary inspections include sampling visits, follow-up visits and complaints or RASFF investigations. The PSES inspectors had no documented procedure and guidance documents in place for the implementation of official controls at primary plant production level, including sprouting establishments. During the inspections observed, they followed the general procedure and checklist for hygiene inspection of food establishments (see section 5.2.6) Official Controls on Primary Production Establishments All farmers visited except one, supplied their produce to supermarket chains with whom contracts were signed. The contracts included an obligation for strict compliance with hygiene requirements during harvest and post-harvest activities as well as for personnel hygiene of the staff. The inspections observed covered mainly post-harvest activities at farms for compliance with the hygiene requirements laid down in Annex II to Regulation (EC) 852/2004. The PSES inspectors met demonstrated knowledge of the relevant legislation and were able to check that farmers were aware of the hygiene measures that should be in place to prevent microbiological food contamination. The inspections observed at two of the primary producers were the first PSES inspection carried out at the farms following their registration. The audit team noted that PSES inspectors carried out documentary checks on some pre-harvest activities such as use of irrigation water and irrigation systems, provision of sanitary facilities at the production fields and cleanliness of the harvest equipment used. However, the official inspections did not include verification of the procedures for use of fertilisers and visits to the production fields. The traceability requirements were largely complied with by all farmers visited. Traceability checks were routinely included in official controls and were adequately checked by the inspectors met. 10

16 Reports on official controls performed by PSES inspectors were drawn up in all cases. In the files examined by the audit team there was evidence that follow-up had taken place and sanctions were imposed (see section 5.2.8) Official Controls on Imports and Sprouting Establishments The audit team visited one small (with capacity of kg of sprouts per week) and one large (with capacity of 5 tonnes of sprouts per week) sprout producing establishments. According to the CAs, these establishments are categorised as high risk food establishment with a fixed inspection frequency of one comprehensive inspection per year. The small sprout producer was in operation for 15 years and processes 7 types of seeds for sprouting radish, alfalfa, mung beans, lentils, chickpeas, broccoli, sunflower. The establishment was approved according to Regulation (EU) No 211/2013 by the relevant PSES on 12 November The FBO buys the seeds used from Polish producers, traders and importers. The origin of the seeds for sprouting was domestic, Italy and China. The FBO stated that all the imports of the seeds were carried out before 1 July The production of sprouts was delivered only to local retail shops. The observed inspection included checks on documentation for incoming seeds for sprouting, hygiene provisions, FBOs' own plans of sampling and testing for microbiological criteria, traceability requirements and labelling. During the traceability checks, the inspectors verified and confirmed that the import of the seeds took place before 1 July The inspectors and the FBO were aware of the provisions of Regulation (EU) No 211/2013. The audit team noted that PSES inspectors were not instructed to verify if the seed suppliers were registered as FBOs. However, they explained that the sourcing of the seeds is verified and when a Polish producer of seeds for sprouting had been identified, they inform the PSES of the district where the operator was situated. The audit team was provided with evidence of such case in the establishment visited. The FBO had implemented an own control system covering GHP. Own controls on each seed batch for sprouting and on the produced sprouts were not in place. The inspectors noted the deficiencies and prescribed corrective measures to be taken by the FBO. The FBO stated that in practice it was not possible to afford the costs of the required laboratory analysis. In the course of the official controls, 40 sprout samples in 2012 and 20 sprout samples in 2013 were taken to monitor FBO s compliance with Regulation (EC) No 2073/2005. All results were satisfactory. The large sprout producer processes several types of seeds for sprouting including radish, broccoli, alfalfa, mung beans, lentils, chickpeas. The establishment was approved as a sprout producer under Regulation (EC) No 852/2004 on 14 February In this case, the PSES inspectors were advised by the VSES to carry out an inspection for compliance with Regulation (EU) No 210/2013 but not to issue new approval decision. The FBO buys the seeds used from Polish and EU (Italy and the UK) producers or directly imports from the USA (radish and broccoli), Mexico (chickpeas), Moldova and Ukraine. The FBO stated that all the imports of the seeds were carried out before 1 July 2013 and that currently he had difficulties to find on the market imported seeds for spouting with an import certificate (issued in line with Regulation (EU) No 211/2013). The production of sprouts was delivered to supermarket chains in Poland and to a food processor in Germany. 11

17 The observed inspection included checks on documentation for incoming seeds for sprouting, hygiene provisions, FBOs' own plans of sampling and testing for microbiological criteria, traceability requirements and labelling. The FBO had own controls on each batch of seed for sprouting, produced sprouts and spent irrigation water. The PSES inspectors met did not note that the scope of the own controls did not include testing for STEC and that the FBO's procedure for sampling the seeds did not follow the rules as laid down in Section 3.3 of Annex I to Regulation (EC) No 2073/2005, regarding the weight of the samples taken. The FBO had implemented procedures based on Hazard Analysis and Critical Control Points (HACCP) principles, as required by customers and was GlobalGAP certified. The FBO was never subject to official sampling (see section 5.2.6). The observed official sampling was not planned and was carried out for the first time at this establishment. The audit team noted: In both establishments the production facilities in place were in line with the requirements of Regulation (EU) No 210/2013 and Annex I to Regulation (EC) No 852/2004. The incoming seeds of mung beans and chickpeas checked by the audit team during the visits to the sprout producers were not labelled as suitable for sprouting. The PSES inspectors met at the sprout producing establishments received training on the new EU legislation on seeds for sprouting and sprouts prior to the audit (in October and November 2013). However, they stated that they were not provided with any instructions from the CSI on the implementation of this legislation Other Control Systems Three of the farmers visited had in place own-checks for microbiological examination of the final products and were certified by a private sector scheme related to GAP. All farmers had in place GHP and two of them had implemented procedures based on HACCP principles on customers request. The large sprout producer visited had implemented procedures based on HACCP principles on customers request and was certified by a private sector scheme related to GAP. Conclusions The primary producers of FNAO visited were assessed against the general hygiene requirements as laid down in Annex II of Regulation (EC) No 852/2004, but not against provisions laid down in Annex I to the same Regulation. The assessment of the general hygiene conditions as laid down in Annex II of Regulation (EC) No 852/2004 was adequate. Official controls can largely ensure that primary producers of FNAO comply with traceability requirements of Regulation (EU) No 208/2013. Other control systems run by FBOs assist in ensuring the safety of foodstuffs Sampling Legal Requirements Article 11 of the Regulation (EC) No 882/2004 establishes requirements for sampling. Regulation (EC) No 2073/2005 establishes sampling rules and microbiological criteria for sprouts. Findings The audit team observed two official samplings of pre-packed sprouts and one official sampling of 12

18 frozen raspberries during the visits to sprout producers and one farmer. The inspectors met started the procedures with verification of the storage temperature. For each product five sampling units were taken. The samples were adequately sealed, labelled, placed into coolers with monitored temperature and transported to the laboratories by the PSES inspectors. The FBOs were informed for the right to have samples taken for a supplementary expert opinion. Conclusions The observed sampling procedures comply with the requirements of Article 11 of Regulation (EC) No 882/ Laboratory Performance Legal Requirements Article 4(2)(c) of Regulation (EC) No 882/2004 requires the CA to ensure that they have access to adequate laboratory capacity. Article 11(1) of Regulation (EC) No 882/2004 requires that sampling and analytical methods used in the context of official controls shall comply with relevant EU rules. Article 12(1) of Regulation (EC) No 882/2004 requires the CA to designate laboratories that may carry out the analysis of samples taken during official controls. Article 12(2) and (3) of Regulation (EC) No 882/2004 requires CAs to designate only laboratories accredited to European standards. Article 33 of Regulation (EC) No 882/2004 requires MSs to designate National Reference Laboratories (NRLs) for each EU Reference Laboratory (EURL) referred to in Article 32. The NRL shall collaborate with the EURL, co-ordinate activities, organise comparative tests, ensure dissemination of information, and provide scientific and technical assistance. Findings There is a network of 16 regional and 50 district official control laboratories for food analysis under the SSI. All of them perform testing for microbiological parameters of food samples. The NIPH- NHI in Warsaw is acting as an NRL for food pathogens, including Salmonella, Listeria monocytogenes and E. coli. The NIPH-NHI is accredited to ISO by the Polish Accreditation Body and the food microbiological parameters are included in a flexible scope accreditation which covers all microbiological criteria as laid down in Regulation (EC) No 2073/2005 with the exception of VTEC detection, as only E. coli O157 can be detected. In June 2012, the scope of NRL activities was extended to cover FNAO. The audit team visited the regional official control laboratories in Katowice and Lublin. Both laboratories visited were accredited to ISO by the Polish Accreditation Body and are subject to annual audits. The audit team verified the most recent audit reports from the accreditation body which did not contain major non-compliance. The laboratories undertake different types of analyses, including food microbiology. All microbiological testing conducted on official samples taken by the CAs are carried out using methods that are in the scope of the accreditation. The laboratories have adequate capacity for detection of the microbiological parameters as laid down in Regulation (EC) No 2073/2005 with the exception of VTEC detection as they can only cover E. coli O157. The analytical methods used are the current versions of the reference methods included in 13

19 Regulation (EC) No 2073/2005 or alternative methods that are certified as having been validated against the reference method according to an internationally accepted protocol. The official laboratories visited: Participated in regular training organised by the NRL every year. At these trainings, information from the EURL is presented. Participated in proficiency testing organised by the NRL or by providers accredited to ISO The outcome of the participation was satisfactory. Have procedures in place to ensure the quality of delivered samples. Have adequate capacity for the detection of microbiological parameters as laid down in Regulation (EC) No 2073/2005 with the exception of VTEC detection as they can cover only E. coli O157. One of the laboratories visited used a Polymerase Chain Reaction (PCR) based method for E. coli O157 detection. The positive PCR results were not followed up by isolation of strains and confirmation of the presence of VTEC. The positive result was reported on the basis of the PCR result alone which is not confirmatory of the presence of VTEC 1. In 2012, the laboratory in Lublin carried microbiological analysis of 40 samples of sprouts, 23 samples of fresh vegetables and 29 samples of frozen fruit and the laboratory in Katowice tested 30 samples of sprouts, 29 samples of fresh vegetables and 32 samples of frozen fruit. All samples had satisfactory results. The analytical reports checked by the audit team were comprehensive, with an indication of the maximum permitted limits to help the interpretation of results. These reports were sent back to the sampling PSES inspector. Conclusions The two laboratories visited were accredited to ISO and have the competence and capacity to analyse food samples for microbiological criteria as laid down in Regulation (EC) No 2073/2005. Although they did not have capacity for proper VTEC detection, they were designated to undertake such analyses Procedures for Performance and Reporting of Control Activities Legal Requirements Article 8 of Regulation (EC) No 882/2004 requires that CAs carry out their official controls in accordance with documented procedures, containing information and instructions for staff performing official controls. Article 9 of the above Regulation requires CAs to draw up reports on the official controls carried out, including a description of the purpose of official controls, the methods applied, the results obtained and any action to be taken by the business operator concerned. 1 In their response to the draft report the competent authority noted that the positive result for Escherichia coli O157 (using the technique of real time PCR) refers to samples of raw meat. With regard to this food group there were no recommendations from CSI as to the necessity of isolation of strains and confirmation the presence of VTEC (since these were monitoring tests). The audit scope did not include this kind of food. Regarding the analysis of sprouts samples (covered by Regulation (EU) No 209/2013), there were no positive results for Escherichia coli O157 and therefore, the laboratory did not have to confirm the presence of VTEC. 14

20 Findings The PSESs are required to report official control results to the VSES monthly, quarterly and annually. The VSES compiles these reports and submits the information to the CSI. Reports on the findings of official controls have always to be produced regardless of the purpose of the visit (inspection, sample collection or follow-up). Paper records of sampling and inspection reports, as well as the list of registered primary producers and approved sprout producers are kept at district (PSES) level. The audit team noted: The data concerning the registration of primary production and sprout producing establishments are only available at PSES level (see section 5.2.2). The reporting system for official controls does not provide the VSESs and the SSI with information about official controls carried out on primary production of FNAO, and, in particular, on registered primary producers and approved sprout producers, as this data is reported in the category 'Other food establishments'. In one of the regions visited, the VSES inspector responsible for the distribution of planned samples to the PSESs, was not aware that in one of the districts there was an approved large sprout producer. As a result, all samples for microbiological analysis of sprouts were planned to be taken at retail level. In the establishments visited, the audit team confirmed that operators had received copies of the inspection reports in which the results of the controls were specified. However, the reports seen did not include comments on FBO's compliance with relevant aspects of Regulation (EC) No 2073/2005 such as sampling methods used, test results and action taken in case of non-compliance (see section ). The CSI sent all PSESs a circular letter (dated ) to increase the official controls on the microbiological safety of primary produced FNAO in response to the information on recent Hepatitis A outbreaks in Italy and Ireland, potentially caused by Polish fruits. The CAs were required to pay particular attention to the quality of the used irrigation water and the appropriate use of fertilisers. Conclusions Centrally issued guidelines and checklist were used during the observed inspections. However, these documents did not contain the relevant information and instructions for performing official controls on primary production of FNAO as required by Article 8(1) of Regulation (EC) No 882/2004. Inspection reports are drawn up following all official inspections as required by Article 9 of Regulation (EC) 882/ Co-operation between and within Competent Authorities Legal Requirements Article 4(3) of Regulation (EC) No 882/2004 provides for efficient and effective co-ordination between CAs. Article 4(5) of Regulation (EC) No 882/2004 requires that, when, within a CA, more than one unit is competent to carry out official controls, efficient and effective co-ordination and co-operation shall be ensured between the different units. Findings Co-ordination between the CSI and the VSESs/PSESs is achieved through procedures, guidelines 15

21 and circular letters covering different aspects of the official control activities. These documents are issued by the CSI for implementation by the PSESs. Meetings take place between the Heads of Directorates from VSES and the CCA representative responsible for the specific sector coordination. The information received during these meetings is cascaded by the VSES to PSES level. The audit team was provided with evidence of meetings between the CSI and the VSESs to share information on official food controls including controls on primary production of FNAO. A good level of co-operation was in place between the VSESs and PSESs visited, in particular, in circumstances where enforcement was required. The audit team was provided with evidence of an exchange of information between PSESs, regarding an identified supplier of seeds for sprouting during official inspection at a sprout producer. For the identification and registration of the primary producers of FNAO, the CSI requested from SPHSIS access to their lists of primary producers. The request was denied with the explanation that this information contained personal data. However, there was evidence of good co-operation between CSI and SPHSIS. Upon request from the CSI, information on the obligation to register with the relevant PSES was routinely supplied by SPHSIS inspectors during their inspections of primary producers of FNAO. The system in place for co-ordination within the SSI in the case of RASFF notifications was used in the management of the cases assessed by the audit team. The CAs carried out verification checks to ensure that affected products were traced back. However, these checks did not cover the primary producers involved and visits on the spot were not carried out. Conclusions Overall, effective co-operation and co-ordination within and between the CAs involved as required by Article 4(3) and (5) of Regulation (EC) No 882/2004 has been achieved Enforcement Measures Legal Requirements Article 54 of Regulation (EC) No 882/2004 requires a CA which identifies a non-compliance to take appropriate action to ensure that the operator remedies the situation. Article 55 of Regulation (EC) No 882/2004 states that MSs shall lay down the rules on sanctions applicable to infringements of feed and food law and other EU provisions relating to the protection of animal health and welfare and shall take all measures necessary to ensure that they are implemented. The sanctions provided for must be effective, proportionate and dissuasive. Findings The Act on Food and Nutrition Safety of 25 August 2006, as amended, lays down the measures and sanctions which can be imposed following official controls. They include warning letters, administrative fines, penal sanctions, detention of products or withdrawal of approval. The enforcement actions taken by the CA for non-compliances with the relevant legislation were reviewed in the establishments visited. Evidence of adequate enforcement measures taken was provided to the audit team. In one of the regions visited, in 2012, one fine and in 2013, five fines were imposed on direct suppliers of FNAO for not complying with the obligation to be registered (Article 103 of Act on Food and Nutrition Safety). The level of the fines was 1000 PLN (about 240 Euro). One of the farmers visited was sanctioned in 2013 with a fine of 1000 PLN for not being registered and in 2012 with a fine of 500 PLN (about 120 Euro) for breaching the national provisions on 16