EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

Transcription

1 Ref. Ares(2016) /04/2016 EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Directorate F - Health and food audits and analysis DG(SANTE) MR FINAL REPORT OF AN AUDIT CARRIED OUT IN GERMANY FROM 27 OCTOBER 2015 TO 06 NOVEMBER 2015 IN ORDER TO EVALUATE THE APPLICATION OF RE-ENFORCED CHECKS ON IMPORTED PRODUCTS OF 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 an audit carried out in Germany from 27 October to 6 November 2015, as a part of the published DG Health and Food Safety audit programme. The objective of the audit was to evaluate the official control system implemented by the competent authorities on re-enforced checks on imported products of animal origin. In this respect, it covered also the import monitoring plan, sampling in the case of suspicion and the use of the Rapid Alert System for Food and Feed (RASFF). The risk-based import monitoring plan is elaborated taking into consideration relevant data on animal and public health in a timely manner. The import monitoring plan is implemented in accordance with planned arrangements. The implemented official control system allows suspicious consignments to be effectively identified and triggers re-enforced checks. In general the facilities and equipment of BIPs visited during the audit fulfil the EU requirements and are appropriate for the categories included in the approval, except for shortcomings in the Reiherdamm inspection centre at Hamburg port BIP and Frankfurt/Main BIP. The report includes one recommendation addressed to the competent authority of Germany, aimed at rectifying the shortcomings identified and/or further enhancing the official control system. I

3 Table of Contents 1 Introduction Objectives and scope Legal Basis Background Findings and Conclusions Monitoring plan Development of the monitoring plan Implementation of the monitoring plan Actions in case of suspicion Use of the rapid alert system for food and feed Implementation of the re-enforced checks regime Compliance of the facilities, equipment and hygiene conditions of the BIPs/inspection centres visited Bremerhaven BIP (approval categories HC, NHC) and the inspection centre Reiherdamm at Hamburg port BIP (approval categories HC, NHC-T(FR), NHC-NT) Frankfurt/Main BIP (approval categories HC, NHC, U, E, O) Overall Conclusions Closing Meeting Recommendation...15 II

4 ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT Abbreviation Approval categories BIP BMEL BVL IMP RASFF SOP TRACES QMS Explanation Categories of live animals and animals products for the receipt of which BIPs are approved in accordance with Commission Decision 2009/821/EC as follows: HC: all products for human consumption, NHC: all products for non-human consumption, NT: no temperature requirement, T(FR): frozen products, U: ungulates (cattle, pigs, sheep, goats, wild and domestic solipeds), E: registered equidae as defined in Council Directive 90/426/EEC, O: other animals (including zoo animals) Border inspection post Federal Ministry of Food and Agriculture, Bundesministerium für Ernährung und Landwirtschaft Federal Office of Consumer Protection and Food Safety, Bundesamt für Verbraucherschutz und Lebensmittelsicherheit Import monitoring plan Rapid alert system for food and feed Standard operating procedure Trade control and expert system Quality management system III

5 1 INTRODUCTION The audit took place in Germany from 27 October to 6 November 2015, as part of the published DG Health and Food Safety audit programme. The audit was conducted in parallel with audit DG(SANTE)/ , which evaluated the official controls on consignments in transit, and for which a separate report was issued. The audit team comprised two auditors from DG Health and Food Safety and a national expert from a European Union (EU) Member State. The audit team was accompanied during the whole audit by representatives of the Federal Office of Consumer Protection and Food Safety (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit BVL). An opening meeting was held on 27 October with representatives from the Federal Ministry of Food and Agriculture (Bundesministerium für Ernährung und Landwirtschaft BMEL), BVL, the Länder to be visited during the audit, i.e. Bremen, Hamburg and Hessen, the Friedrich Loeffler Institute (FLI) and Customs. At this meeting, the objectives of, and itinerary for, the audit were confirmed and the control systems were described by the authorities when necessary. 2 OBJECTIVES AND SCOPE The main objective of the audit was the evaluation of the official control system implemented by the competent authorities to comply with the requirements of Articles 20 and 24 of Directive 97/78/EC, of Article 30 of Directive 96/23/EC, and of Annex II to Commission Regulation (EC) No 136/2004, specifically: whether the controls are implemented in compliance with the applicable requirements, and whether the implementation of those controls is effective and suitable in ensuring that (i) the import monitoring plan contributes to overseeing that imported goods comply with the EU requirements; (ii) the official veterinarians at the border inspection posts (BIPs) raise suspicion on consignments for which the veterinary legislation might have been not complied with or where there is doubt; (iii) Member States take the appropriate measures to enable the launching of reenforced checks when required, and (iv) the re-enforced checks regime is applied consistently to the relevant consignments and the sampling procedures. In addition to the main objective, the audit also evaluated the compliance of the facilities, equipment and hygiene conditions of the BIPs and/or the inspection centres visited, with the requirements of Council Directive 91/496/EEC, Directive 97/78/EC and Commission Decision 2001/812/EC. 1

6 In terms of scope, the audit covered: - the organisation and implementation of the import monitoring plan at the BIPs; - the level of awareness for possible non-compliances with veterinary legislation for consignments intended for import (suspicion); - the system to trigger Rapid Alert System for Food and Feed (RASFF) alerts when testing of consignments intended for the EU market has indicated the presence of unauthorised or prohibited substances; - the implementation of the re-enforced checks regime at the BIPs, including identification of consignments and sampling; - the use of TRACES and specifically the timeframe for introducing test results; - the verification activities on the re-enforced checks and import monitoring plan, operational criteria and relations between authorities and their ability to improve the controls. The table below lists the sites visited and the meetings held in order to achieve the above objectives: Location Competent authority Comments Berlin Land Hessen Frankfurt/Main BIP Land Hamburg Hamburg port BIP Land Bremen Bremerhaven BIP BMEL BVL Relevant Länder FLI Customs Hessisches Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz Ministry of Environment, Energy, Agriculture and Consumer Protection Ministerium für Gesundheit und Verbraucherschutz Schutz Hamburg Ministry of Health and Consumer Protection Hamburg Lebensmittelüberwachung, Tierschutz und Veterinärdienst des Landes Bremen Ministry of Foodstuffs, Animal Welfare and Veterinary Service of the Land of Bremen Opening and closing meetings Audit of official controls on re-enforced checks at the BIP Audit of official controls on re-enforced checks at the BIP Audit of official controls on re-enforced checks at the BIP 2

7 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 of the European Parliament and of the Council on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules. The Annex to this report comprises a list of legislation as audit criteria. Legal acts quoted refer, where applicable, to the last amended version. 4 BACKGROUND Member States must submit consignments of products presented for importation to physical checks, including laboratory checks, to detect residues, pathogens, contaminants or evidence of alteration. These monitoring plans must be based upon the nature of the products and the risk they represent, taking into account all relevant monitoring parameters such as frequency and number of incoming consignments and results of previous monitoring. The aim of the physical check is to ensure that the products still meet the guarantees of origin certified by the third country while ensuring that the subsequent transport of the product has not altered the original guaranteed condition. In addition, the legislation describes the actions expected from the competent authorities when there is a suspicion that veterinary legislation has not been complied with. Member States must apply more stringent checks on consignments from an origin for which there are grounds for believing that Community veterinary legislation has been seriously or repeatedly infringed. The Commission General Guidance on implementation and interpretation of Article 24 of Council Directive 97/78/EC (Re-enforced checks (SANCO/11255/2012 of 24 May 2012, hereafter the Guidance) was published in 2012 after Member States agreed to apply the procedures laid down in it. The Guidance was prepared with the aim of harmonising the approach in the Member States on the interpretation and implementation of the relevant legal requirements. TRACES (Trade and Control and Expert System) includes a specific module to support the Member States in complying with these requirements. Article 50 of Regulation (EC) No 178/2002 establishes a rapid alert system for the notification of a direct or indirect risk to human health deriving from food or feed, which operates as a network known as the RASFF. Member States shall immediately notify the Commission under this system (among others) of any rejection, related to a direct or indirect risk to human health, of a batch, container or cargo of food or feed by a competent authority at a border post within the EU. 3

8 DG Health and Food Safety carried out an audit in order to evaluate the follow-up action taken by the competent authorities with regard to the import/transit control system and BIPs (report No DG(SANCO) ). The report is available at: An overview of the control systems in Germany and a more detailed description of the relevant competent authorities can be found in the country profile for Germany available at: 5 FINDINGS AND CONCLUSIONS 5.1 MONITORING PLAN Legal requirements Articles 3, 4, 6, 8, 11, 12, 24 and 26 of Regulation (EC) No 882/2004, Annex II of Commission Regulation (EC) 136/2004, Article 4, Annex II and III of Council Directive 97/78/EC and Article 3 of Commission Decision 2004/292/EC. Findings Development of the monitoring plan 1. The import monitoring plan (hereafter IMP) is developed and updated by the Länder working group for import and transit (Arbeitsgruppe Ein- und Durchfuhr der Länderarbeitsgemeinschaft ) in co-operation with representatives of the BMEL and the BVL. The IMP is published together with the national residue control plan. This working group considers the information on previous IMP results, RASFF notifications, the applicable EU legislation, results of studies provided by other authorities, information from EU working groups (i.e. residue controls, veterinary checks), training, and other relevant risk factors, in accordance with Article 3(1) of Regulation (EC) No 882/ The risk-based approach is applicable for all products of animal origin imported via German BIPs, ensuring that products intended for release into free circulation in another Member State are also controlled, in compliance with Article 3(5) of Regulation (EC) No 882/ The IMP covers residues of veterinary medicines, pathogens, contaminants, hormones and other substances dangerous for humans, animals or the environment, in compliance with Annex II to Regulation (EC) 136/ The IMP is adopted by the Länder working group for import and transit of the Länder joint operations body on consumer protection (Länderarbeitsgemeinschaft Verbraucherschutz Arbeitsgruppe Ein- und Durchfuhr der Länderarbeitsgemeinschaft) 4

9 and then it is forwarded to the BIPs, which are responsible for its implementation. The plan is implemented throughout the calendar year. 5. The audit team noted that the implementation of the plan differs in the Länder visited: Hessen: Frankfurt/Main BIP registers all consignments of animal origin in a local database. The BIP follows the general rule of 5% sampling of all different origin and types of products of animal origin without being prescriptive in how to achieve this. Analytes considered for testing are based on information available in the database and the BIP takes a flexible approach to the selection of consignments for sampling. The audit team noted that the system in place allows BIP staff to take samples in line with the IMP. Hamburg and Bremen: Hamburg port and Bremerhaven BIPs prepare the annual plan indicating the number of samples to be taken for different types of products of animal origin and analytes for laboratory tests. The annual IMP is split into monthly plans ensuring the sampling is spread throughout the year. In Hamburg, the IMP includes the possibility of sampling in case of new hazards and samples are selected ensuring that different origins are covered. 6. An annual budget for the implementation of the IMPs is allocated by the Länder competent authorities in accordance with Article 26 of Regulation (EC) No 882/2004. The Länder competent authorities indicated that BIPs can re-allocate the finances for the different tests within the annual budget for implementation of the import monitoring plan. 7. All BIPs visited have instructions on which laboratories are to be used for different laboratory tests. Official laboratories are used for testing samples taken under the import monitoring plan, re-enforced checks or in case of suspicion, as required by Article 12 of Regulation (EC) No 882/2004. After consultation with the official laboratories, BIPs can send samples to private laboratories if the methods for testing are not within the scope of accreditation of official laboratories. 8. Training covering official import controls including physical checks and sampling has been provided to BIP staff, in accordance with Article 6 of Regulation (EC) No 882/2004. During the visit to Hamburg port BIP, BIP staff demonstrated appropriate knowledge on practical sampling. 9. In accordance with Article 8(1) of Regulation (EC) No 882/2004, the official controls on physical checks including sampling are carried out in accordance with documented procedures contained in the BIP manual (Handbuch). 10. The audit team noted that the BIP manual is complimented by a range of procedures developed at Länder level, usually in the form of standard operational procedures (SOPs) incorporated into Länder Quality Management Systems (QMS). At the time of 5

10 the audit, Bremen Land had the most developed system of procedures covering sampling. 11. The IMP is only for official use and the import monitoring plans developed by the Länder are not made available to the public/operators. Official controls are carried out without prior warning, as required by Article 3(2) of Regulation (EC) No 882/2004. Conclusion on the development of the monitoring plan 12. The import monitoring plan is developed in accordance with all the requirements to verify that products fulfil the guarantees of origin established in the accompanying certificate/document and meet the requirements for their intended use Implementation of the monitoring plan 13. The BIPs visited have sufficient staff to take planned samples in accordance with Annex II to Directive 97/78/EC. 14. The audit team noted that Bremen Land delegated the official sampling of fishmeal intended for import to a sampling company which has expertise and equipment to carry out the fishmeal sampling. The Bremen Land competent authority provided instructions to the sampling company with an accurate description of tasks. The competent authority performs annual supervision of the sampling company. Bremerhaven BIP staff stated that sampling of fishmeal is performed in the facilities located in the port area, but not in the BIP and not in the presence of BIP staff, contrary to the requirement of Article 4(1) of Directive 97/78/EC. 15. The Länder competent authorities stated that the sampling is performed following the requirements of the relevant EU legislation. The audit team noted that the instructions for sampling are correctly specified in a sampling submission document accompanying the samples to the laboratory, in accordance with Annex III(e) to Directive 97/78/EC. The samples in most of the cases seen are tested for several hazards within the same group following the laboratories' methods (i.e. for a group of antibiotics, several heavy metals, a range of pesticides, etc.). 16. The BIPs visited have the appropriate facilities and equipment to ensure that the samples are taken in a hygienic way, as required by Annex II to Directive 97/78/EC. The samples are labelled and collected in BIP facilities prior to transportation to the laboratory, in accordance with Article 11(6) and (7) of Regulation (EU) No 882/2004. Daily transportation of samples to laboratories is arranged. The laboratories provide the interpretation of the test results together with the results to the BIP staff. The results of laboratory tests are recorded in TRACES in a timely manner, as required by Article 3(2) of Commission Decision 2004/292/EC. 6

11 17. Consignments sampled under the import monitoring plan were correctly released into free circulation before the laboratory results were obtained, as foreseen in paragraph 2 of Annex II of Regulation (EC) No 136/ The audit team noted that Bremerhaven BIP is implementing a project on testing of products for forbidden additives. The laboratory provides the results of these tests to the BIP staff which record the results in TRACES. At the time of the audit, the BIP had received one non-satisfactory result of the laboratory tests which was communicated to the Commission services. Bremerhaven BIP staff informed the audit team that the consignment was recalled from the market and destroyed. 19. All BIPs visited have a system in place to inform Customs and the operators concerned of the detention of the goods when sampling is performed on the basis of suspicion or the re-enforced checks regime, in line with Article 24(3) of Regulation (EC) 882/ Länder authorities are responsible for the implementation of verification procedures. The verification system is based on evaluating the compliance with the QMS. Consequently, the verification activities assess the import-related controls as far as those are covered by the QMS. Hessen: Verification procedures do not cover sampling and the implementation of the import monitoring plan. Hamburg: An external audit had been performed in 2014 which covered the implementation of the requirements of Directives 97/78/EC and 91/496/EEC including physical checks and sampling. The external audit did not report irregularities for physical checks including sampling. Bremen: Annual internal audits are performed at the BIP and they cover the procedures on physical checks, including sampling. The internal audit did not report irregularities in these activities. Conclusion on the implementation of the monitoring plan 21. The import monitoring plans are implemented in accordance with the planned arrangements and contribute to ensuring that imported goods comply with the EU requirements. 5.2 ACTIONS IN CASE OF SUSPICION Legal requirements Article 18 of Regulation (EC) No 882/2004, Articles 20, 24 and Annex III of Directive 97/78/EC. 7

12 Findings 22. When samples are taken in case of suspicion, the BIPs visited have established procedures to ensure that consignments are not released into free circulation before the results of the laboratory tests are received, in compliance with Article 18 of Regulation (EC) No 882/2004 and Annex III(f) to Directive 97/78/EC. In Frankfurt/Main BIP, detained consignments are placed in the BIP facilities until the results are received. In Hamburg port and Bremerhaven BIPs, detained consignments are stored in the containers and they are unloaded into BIP storage facilities only in exceptional cases. 23. Procedures are in place in all BIPs visited to ensure that consignments are sampled when suspicion is based on safeguard measures foreseen in the EU legislation or when the imposed checks are triggered in TRACES, in accordance with Article 20 of Directive 97/78/EC. 24. The audit team noted that the BIP staff are also proactive in raising suspicion of noncompliance, sampling and testing those consignments, in line with the Article 20 of Directive 97/78/EC. For example, Frankfurt/Main BIP detained and sampled consignments originating in Japan before EU legislation was adopted following the accident at the Fukushima nuclear power station; Bremerhaven BIP took actions when documents accompanying a consignment of pet food gave grounds to suspect that veterinary legislation had not been complied with. 25. A sampling submission document, which is issued by the BIP and accompanies the sample to the laboratory, indicates if the sample is based on re-enforced checks or suspicion. Therefore, the laboratory is aware of the urgency of the tests. The representatives of Frankfurt/Main indicated that samples are taken for all types of consignments, including fresh/chilled products, as required by Article 20 or Article 24 of Directive 97/78/EC. The representatives of Hamburg port and Bremerhaven BIPs indicated that regular consignments received in BIPs are tested urgently. Conclusion on the sampling in case of suspicion 26. Sampling in case of suspicion is correctly applied to follow safeguard measures or imposed checks and it is proactively triggered when a risk to animal or public health is suspected. Therefore, the official control system allows the detection of the consignments for which the veterinary legislation might not have been complied with. 8

13 5.3 USE OF THE RAPID ALERT SYSTEM FOR FOOD AND FEED Legal requirements Articles 2 and 5 of Commission Regulation (EU) No 16/2011, Article 23 of Regulation of the European Parliament and of the Council (EC) No 470/2009. Findings 27. The BMEL has issued the national instructions on the use of RASFF, in compliance with Article 2 of Commission Regulation (EU) No 16/2011. Every Land visited has working instructions on the use of RASFF. Those instructions are included within the QMS of each Land. BIPs have access to the RASFF system. 28. BIPs trigger RASFF alerts in TRACES as soon as they receive the non-satisfactory laboratory test results, in line with their work instructions. The BVL provides information to the Commission, in compliance with Article 5 of Regulation (EU) No 16/2011. The audit team confirmed that non-compliant laboratory tests' results trigger the RASFF notifications when necessary. 29. The audit team noted that a number of RASFF notifications provided by German BIPs were rejected by the Commission services due to the absence of a documented public health risk (e.g. traces of antibiotics found in honey and aquaculture fish, forbidden food additives). Therefore, other Member States could not be informed about consignments of animal origin which are not fit for placing on the market pursuant to Article 23 of Regulation (EC) No 470/2009. The representatives of the Länder expressed their opinion that the rest of the Member States should be made aware of such findings, either by RASFF or by other means. Since 2015, the notifications are accepted by Commission RASFF contact point with a national risk assessment indicating a proven health risk for the specific finding. Conclusion on the use of Rapid Alert System for Food and Feed 30. RASFF is used correctly, enabling other Member States to take action by allowing the rapid exchange of information on risks and on measures taken to counter them. 5.4 IMPLEMENTATION OF THE RE-ENFORCED CHECKS REGIME Legal requirements Article 3 of Decision 2004/292/EC, Articles 20 and 24 of Directive 97/78/EC, Article 30 of Council Directive 96/23/EC, Articles 4 and 18 of Regulation (EC) 882/

14 Findings 31. Samples are taken under the re-enforced checks regime in all BIPs visited when required, in accordance with Article 24 of Directive 97/78/EC and Article 30 of Directive 96/23/EC. Different examples of implementation of the re-enforced checks were presented that follow the Guidance on re-enforced checks: Frankfurt/Main BIP apply re-enforced checks also when the size/volume of the consignment is less than 10% of the original consignment that triggered the re-enforced checks. Hamburg port BIP correctly requests for derogations from testing in cases of transhipped consignments, or when the hazard is not applicable to the product. Bremerhaven BIP requested a derogation from the re-enforced checks regime when a second analyte triggered new reenforced checks. 32. All BIPs visited use TRACES for the consultation of re-enforced checks in force in accordance with the requirements of Article 24(1) of Directive 97/78/EC. Hamburg port and Bremerhaven BIPs have a parallel system to ensure that all consignments under reenforced checks are properly controlled. Both BIPs use the national IT system (Coach) which informs BIP staff about the re-enforced checks regime applicable for that consignment as soon as part I of the Common Veterinary Entry Document (CVED) is delivered via an interface to TRACES. 33. All BIPs visited confirmed that when a re-enforced check is ongoing, they would detain (and sample, if requested by the person responsible for the load) from 11 th to 30 th consignments until the results of the first ten became available. This procedure is in compliance with point 8.6 of the Guidance on re-enforced checks and it is based on Article 20 of Directive 97/78/EC. 34. The national laboratory network is able to perform the laboratory tests required by the EU legislation in compliance with the requirements of Article 4(2)(c) of Regulation (EC) No 882/2004 (see finding 7). 35. The audit team noted that consignments subject to re-enforced checks are detained until the laboratory results are received (see finding 19) in accordance with the requirements of Article 18 of Regulation (EC) No 882/2004. There were no cases indicating that imports were allowed before the BIP had received the laboratory test results. 36. BIP staff introduce the information into TRACES as soon as the laboratory test results are received, in compliance with the requirement of Article 3(2) of Decision 2004/292/EC. The audit team noted some deficiencies in Frankfurt/Main and Bremerhaven BIPs in recording the data of laboratory results in TRACES. These deficiencies led to the TRACES system showing that the results of the laboratory tests were still pending. 37. All BIPs visited apply multi-residue methods to the testing of consignments subject to re-enforced checks. The representatives of the BIPs highlighted that this approach is taken since laboratories apply the methodology for testing all groups of hazards (e.g. all 10

15 group of tetracyclines or heavy metals, or serotyping microbiological hazards) (see finding 15). Conclusion on the implementation of the re-enforced checks regime 38. The re-enforced checks regime is implemented in compliance with the applicable requirements, contributing to harmonised and effective EU import controls. 5.5 COMPLIANCE OF THE FACILITIES, EQUIPMENT AND HYGIENE CONDITIONS OF THE BIPS/INSPECTION CENTRES VISITED Legal requirements Article 6 and Annex A to Council Directive 91/496/EEC, Articles 3 and 4 of Commission Decision 97/794/EC, Article 3 and Annex II to Directive 97/78/EC, Articles 3, 4 and Annex to Commission Decision 2001/812/EC. Findings Bremerhaven BIP (approval categories HC, NHC) and the inspection centre Reiherdamm at Hamburg port BIP (approval categories HC, NHC-T(FR), NHC-NT) 39. BIP staff have sufficiently large and equipped offices and social rooms in both locations visited in line with Annex II to Directive 97/78/EC and Article 4(2)(a) and (b) of Decision 2001/812/EC. 40. The unloading areas for the means of transport are enclosed and protected from the external environment in both locations in accordance with the requirements of Article 4(2)(c) of Decision 2001/812/EC. 41. The inspection rooms are equipped with the necessary tools for performing identity and physical checks in compliance with the requirements of Annex II of Directive 97/78/EC and Article 4(2)(d) of Decision 2001/812/EC. 42. There are sufficiently large storage rooms to detain consignments at frozen, chilled and ambient temperature at the same time for different approval categories, in accordance with the requirements of Annex II to Directive 97/78/EC and Article 4(2)(e) of Decision 2001/812/EC. 43. At the Reiherdamm inspection centre at Hamburg port BIP, an old photocopying machine and cleaning equipment were stored in a storage room for products intended for human consumption. The inspection centre does not have a space to adequately house the cleaning equipment contrary to the requirements of the third indent of point 1(a) of Annex to Decision 2001/812/EC. This non-compliance had been noted in the external audit report performed in Hamburg port BIP in The actions to remove the equipment have not been implemented yet. 11

16 5.5.2 Frankfurt/Main BIP (approval categories HC, NHC, U, E, O) 44. The inspection facilities and housing area for live animals and the NHC-NT inspection room intended to check consignments of game trophies are located in the Live Animal Centre. The inspection facilities for products of animal origin are located in another building called the Perishable Centre. Both buildings are located in the Customs area of the point of entry into the EU in accordance with the requirements laid down in Article 6(2)(a) and (b) of Directive 91/496/EEC and Article 6(1)(a) of Directive 97/78/EC. 45. BIP staff have sufficiently large and equipped offices in line with Article 4(2)(a) of Decision 2001/812/EC and point 4 of Annex A to Directive 91/496/EEC. 46. The audit team noted the following regarding the facilities for official controls of live animals at the Live Animal Centre: there are sufficiently large premises at the disposal of staff responsible for carrying out veterinary checks of live animals as required by point 4 of Annex A to Directive 91/496/EEC, the unloading area is adequate for the animal species expected, as required by point 2 of Annex A to Directive 91/496/EEC, the inspection room is suitable for different species of animals and it is equipped with the necessary tools that would allow staff to perform identity and physical checks (e.g. refrigerator for storing samples, equipment to restrain, equipment to check their identification, i.e. microchip reader) as required by Articles 3 and 4 of Decision 97/794/EC, the facilities and equipment to guarantee the safety and welfare of the animals during handling (i.e. feeding and watering of animals, a tank of oxygen for ornamental fish) are available in accordance with point 8 of Annex A to Directive 91/496/EEC. procedures for cleaning and disinfection are in place as required by point 10 of Annex A to Directive 91/496/EEC. 47. The audit team noted the following regarding the facilities for official controls of NHC- NT at the Live Animal Centre: a changing room is not available contrary to the requirements of Article 4(2)(b) of Decision 2001/812/EC 1. This issue was noted in section of the DG Health 1 In its response to the draft report the competent authority noted that following a discussion with the operator of the Live Animal Centre, a plan is being drawn up with proposals for refurbishment measures to set up changing and storage rooms. The proposal from the audit team to submit the amendment plan before carrying out the works has been accepted. The operator has agreed to have the renovation plans drawn up by a consultancy and submit them within four weeks. After being evaluated by Commission services, the operator will implement the refurbishment measures immediately. 12

17 and Food Safety report on the evaluation of the import/transit controls system and border inspection posts in 2011 (ref. DG(SANCO)/ ); there is an adequate inspection room, in compliance with the requirements of Article 4(2)(d) of Decision 2001/812/EC; the storage room is not available contrary to the requirements of Article 3 of Decision 2001/812/EC 1. This issue was noted in section of the DG Health and Food Safety report on the evaluation of the import/transit controls system and border inspection posts in 2011 (ref. DG(SANCO)/ ); procedures for cleaning and disinfection are in place as required by point 1 of Annex to Decision 2001/812/EC. 48. The audit team noted the following regarding the facilities for products of animal origin at the Perishable Centre: BIP staff have sufficiently equipped social rooms in line with Annex II to Directive 97/78/EC and Article 4(2)(b) of Decision 2001/812/EC; the unloading area for the means of transport is enclosed and protected from the external environment in accordance with the requirements of Article 4(2)(c) of Decision 2001/812/EC; the inspection rooms are equipped with the necessary tools for performing identity and physical checks in compliance with the requirements of Annex II of Directive 97/78/EC and Article 4(2)(d) of Decision 2001/812/EC. However, the inspection room for NHC products of animal origin does not comply with the hygiene rules (i.e. the wall is covered with condensation water which is leaking on the floor). The competent authority provided informed the audit team that the operator responsible for the maintenance of the facilities had been informed and this deficiency was planned to be rectified in the near future 2 ; a storage room for HC-NT is absent contrary to the requirement of Article 4(3) of Decision 2001/812/EC 3 ; 2 In its response to the draft report the competent authority noted that according to information from the competent authority, the deficiency has been rectified; the wall in question was insulated. There is no more condensation. 3 In its response to the draft report the competent authority noted that the room marked as a storage room for polystyrene boxes in the building plan has been converted into a storage room for HC-NT. 13

18 two stand-alone containers are used for storage of NHC-T(FR), but they are not linked to the unloading area in such a manner that the unloading process is under shelter and protected from the weather contrary to the requirements of Article 4(3) of Decision 2001/812/EC 4. This issue was noted in section of the DG Health and Food Safety report on the evaluation of the import/transit controls system and border inspection posts in 2011 (ref. DG(SANCO)/ ). Conclusion on the compliance of the facilities, equipment and hygiene conditions of the inspection centres visited 49. The facilities at Bremerhaven BIP and the Reiherdamm inspection centre at Hamburg port BIP comply with EU requirements (with the exception of the housing of cleaning equipment at the inspection centre) and are appropriate for the purpose of the categories included in their approval. 50. The facilities at Frankfurt/Main BIP for live animals comply with EU requirements. However, the facilities for products of animal origin at Frankfurt/Main BIP are not fully compliant with the requirements of relevant EU legislation and may compromise the hygienic handling of the consignments subject to the veterinary checks. 6 OVERALL CONCLUSIONS The risk-based import monitoring plan is elaborated taking into consideration relevant data on animal and public health in a timely manner. The import monitoring plan is implemented in accordance with planned arrangements. The implemented official control system allows suspicious consignments to be effectively identified and triggers re-enforced checks. In general the facilities and equipment of BIPs visited during the audit fulfil the EU requirements and are appropriate for the categories included in the approval, except for shortcomings in the Reiherdamm inspection centre at Hamburg port BIP and Frankfurt/Main BIP. 7 CLOSING MEETING A closing meeting was held on 6 November with representatives from BMEL, BVL, the Länder of Bremen, Hamburg and Hessen, FLI and Customs. At this meeting, the main findings and the preliminary conclusions of the audit were presented by the audit team. The competent authority provided some clarifications in relation to some issues but did not express disagreement with the findings and conclusions presented. 4 In its response to the draft report the competent authority noted that a deep-freeze container for NHC-T(FR) is being installed on trailer dock No 2 and connected with the building and the temperature monitoring system of the Perishable Centre. Unloading is in the Perishable Centre allowing the products to be placed in the container under shelter from the weather. 14

19 8 RECOMMENDATION The competent authorities are invited to provide details of the actions taken and planned aimed at addressing the recommendation set out below, including deadlines for their completion ('action plan'), within 25 working days of receipt of the translated draft audit report. No. Recommendation 1. To ensure the compliance of the Reiherdamm inspection centre at Hamburg port BIP and Frankfurt/Main BIP facilities with the requirements set out in Annex II to Directive 97/78/EC and Decision 2001/812/EC Recommendation based on conclusions 49 and 50. Associated findings: 43, 47 and 48. The competent authority's response to the recommendations can be found at: 15

20 ANNEX 1 LEGAL REFERENCES Legal Reference Official Journal Title Reg. 882/ Article 45 (MS) OJ L 165, , p. 1, Corrected and re-published in OJ L 191, , p. 1 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 Reg. 136/2004 OJ L 21, , p Reg. 882/2004 OJ L 165, , p. 1, Corrected and re-published in OJ L 191, , p. 1 Reg. 16/2011 OJ L 6, , p Dir. 97/78/EC OJ L 24, , p Dir. 91/496/EEC OJ L 268, , p Dir. 96/23/EC OJ L 125, , p Commission Regulation (EC) No 136/2004 of 22 January 2004 laying down procedures for veterinary checks at Community border inspection posts on products imported from third countries Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules Commission Regulation (EU) No 16/2011 of 10 January 2011 laying down implementing measures for the Rapid alert system for food and feed Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organization of veterinary checks on animals entering the Community from third countries and amending Directives 89/662/EEC, 90/425/EEC and 90/675/EEC Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC

21 Dec. 97/794/EC OJ L 323, , p Dec. 2004/292/EC OJ L 94, , p Dec. 2001/812/EC OJ L 306, , p Reg. 470/2009 OJ L 152, , p /794/EC: Commission Decision of 12 November 1997 laying down certain detailed rules for the application of Council Directive 91/496/EEC as regards veterinary checks on live animals to be imported from third countries 2004/292/EC: Commission Decision of 30 March 2004 on the introduction of the Traces system and amending Decision 92/486/EEC 2001/812/EC: Commission Decision of 21 November 2001 laying down the requirements for the approval of border inspection posts responsible for veterinary checks on products introduced into the Community from third countries Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council