EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

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1 Ref. Ares(2017) /04/2017 EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Health and food audits and analysis DG(SANTE) MR FINAL REPORT OF AN AUDIT CARRIED OUT IN GERMANY FROM 2 TO 13 MAY 2016 IN ORDER TO EVALUATE THE SYSTEMS FOR ENHANCED IMPORT CONTROLS 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 in Germany, carried out from 2 to 13 May 2016, as part of the published DG Health and Food Safety audit programme. The objective of the audit was to evaluate the official control systems implemented by the competent authorities when specific import controls (hereinafter: enhanced controls) are required. In this respect, it examined whether the controls are implemented in compliance with the applicable requirements, and evaluated the system's effectiveness and suitability for ensuring that, when special import requirements are required, only compliant goods can enter the European Union (EU) market. Overall, the report concludes that the competent authorities have appropriately qualified staff to carry out official controls supported by the cooperation with Customs authorities ensuring that relevant consignments are presented for official controls. The administrative framework provides information and instructions to border inspection posts (BIPs) and designated points of entry (DPEs). The official controls of products subject to enhanced controls are performed in good conditions in both BIPs and DPEs visited. Documentary, identity and physical checks contribute to ensuring that imported goods fulfil the guarantees set up in the certificates but the effectiveness of this system is, to some extent, compromised by some inconsistencies in the implementation of sampling procedures. In general, with the exception of one BIP, the competent authority uses the trade control and expert system (TRACES) correctly. Although not a legal requirement, TRACES is also used at DPEs to facilitate exchange of information on rejected consignments. This report makes recommendations addressed to the competent authorities of Germany, aimed at rectifying the shortcomings identified and/or further enhancing the official controls system. I

3 Table of Contents 1 Introduction Objectives and scope Legal Basis Background Findings and Conclusions General requirements regarding the controls system Competent authorities Facilities Mechanisms to ensure that consignments are presented for import controls Implementation of the import controls Documentary checks Identity and physical checks Decision on the consignments and enforcement measures Use of TRACES Overall Conclusions Closing Meeting Recommendations...12 II

4 ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT Abbreviation Approval categories BIP BMEL BVL CED COACH CVED DPE DPI EU RASFF TRACES Explanation Categories of products of animal origin 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. 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 common entry document : the document to be completed by the feed and food business operator or its representative as provided for in Article 6, a model of which is set out in Annex II to Regulation (EC) No 669/2009, and by the competent authority confirming completion of official controls the IT system for managing import controls Common Veterinary Entry Document designated point of entry: under Regulation (EC) No 669/2009, the point of entry into the Union designated by the competent authority designated points of import: any point designated by the competent authority, through which the feed or food referred to in Article 1 of Council Regulation (EU) No 884/2014 may be imported into the Union European Union Rapid alert system for food and feed Trade control and expert system III

5 1 INTRODUCTION The audit took place in Germany from 2 to 13 May 2016, as part of the published DG Health and Food Safety audit programme. The audit team comprised three auditors from DG Health and Food Safety. An opening meeting was held on 2 May 2016 with representatives from the Federal Ministry of Food and Agriculture (Bundesministerium für Ernährung und Landwirtschaft BMEL), the Federal Office of Consumer Protection and Food Safety (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit BVL), the Länder visited during the audit, i.e. Bavaria, Hessen, Saxony and Bremen, and Customs authorities. The audit team was accompanied during the audit by representatives of the BVL. In addition, the availability of representatives of local or Länder authorities involved in the control systems, including Customs authorities, was ensured during the relevant parts of the audit. 2 OBJECTIVES AND SCOPE Specific requirements for veterinary checks of food and feed of animal origin are set out in Council Directive 97/78/EC. Additional rules on official controls on the introduction into the EU of all feed and food, both of animal and non-animal origin, are laid down in Regulation (EC) No 882/2004 of the European Parliament and of the Council. Moreover, certain special conditions have been adopted for import controls of feed and food for which there may be an increased risk to human, animal health or the environment. For the purpose of this audit, when the text refers to enhanced import controls, this term includes: the controls implemented under emergency measures put in place by the Commission in accordance with Article 53 of Regulation (EC) No 178/2002 of the European Parliament and the Council. The emergency measures under the scope of this audit are included in the Annex 1 to this report; for feed and food of non-animal origin, also the controls implemented at the point of entry on goods as laid down in Commission Regulation (EC) No 669/2009, and the controls implemented following Council Regulation (EC) No 733/2008 on the conditions governing imports of agricultural products originating in third countries following the accident at the Chernobyl nuclear power station. The objective of the audit was the evaluation of the enhanced import controls and other related activities of the import control system, 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, when special import requirements are required, only compliant goods can enter the EU market. 1

6 The audit also evaluated, when relevant, the compliance of the facilities, equipment and hygiene conditions of the border inspection posts (BIPs) and the designated points of entry (DPEs) visited. In terms of scope, the audit covered: the organisation of the official control systems, including, amongst others things, the general obligations and operational criteria; the implementation of the controls at the BIPs, DPEs and designated points of import (DPI), including identification of consignments, documentary controls and sampling procedures, and the enforcement procedures; the use of the Trade Control and Expert System (TRACES), when relevant, and the control and verification activities. The analytical performance of the laboratory network and enhanced controls on live animals were excluded from the scope. 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 airport DPE Land Bremen Bremerhaven DPE Land Bavaria port Munich airport BIP BMEL (via videolink) BVL Relevant Länder Customs authorities Hessisches Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz Ministry of Environment, Energy, Agriculture and Consumer Protection, Hessen Lebensmittelüberwachung, Tierschutz und Veterinärdienst des Landes Bremen Ministry of Foodstuffs, Animal Welfare and Veterinary Service of the Land of Bremen Customs authorities Bayerisches Staatsministerium für Umwelt und Verbraucherschutz Ministry of Environment and Consumer Protection, Bavaria Opening and closing meetings Audit of official controls on enhanced controls at DPE Audit of official controls on enhanced controls at DPE Audit of official controls on enhanced controls at the BIP 2

7 Land Saxony Leipzig Halle airport BIP and DPE Sächsisches Staatsministerium für Soziales und Verbraucherschutz Ministry of Social affairs and Consumer Protection, Saxony Customs authorities Audit of official controls on enhanced controls at BIP and DPE 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. Annex 1 comprises a list of legislation as criteria for the audit. Legal acts quoted refer, where applicable, to the last amended version. 4 BACKGROUND The country profile for Germany provides an overview of how the control systems are organised, based on information supplied by the competent authorities, and is available at the following link: 5 FINDINGS AND CONCLUSIONS 5.1 GENERAL REQUIREMENTS REGARDING THE CONTROLS SYSTEM Legal requirements Articles 4(1), 4(6), 6, 8(1), 8(3)(a) and 24(1) of Regulation (EC) No 882/2004, Articles 4 and 5 of Regulation (EC) No 669/2009, Article 6 of Commission Regulation (EC) No 136/2004, Annex II to Council Directive 97/78/EC, Annex to Commission Decision 2001/812/EC, Article 8 of Commission Regulation (EC) No 884/2014. Findings 5.1.1Competent authorities 1. Competent authorities responsible for enhanced import controls are designated, in compliance with Article 4(1) of Regulation (EC) No 882/2004. The BMEL is the competent authority at federal level for import of food and feed of animal and nonanimal origin. The BVL provides data and works in cooperation with BMEL. The responsibility for implementing official controls, and for enforcement of relevant 3

8 legislation lies with the Länder. The competencies and responsibilities of the competent authorities are laid down in the federal Food and Feed Code. 2. The BVL maintains and publishes the lists of DPEs and DPIs, designated by the Länder as required by Article 5 of Regulation (EC) No 669/2009 and Article 8 of Regulation (EU) No 884/2014 respectively. 3. BIP staff are responsible for import controls on products of animal origin (at the BIPs). BIP staff are also partly responsible for products of non-animal origin (at the DPEs). Staff met were sufficiently trained and experienced. 4. In line with Article 6 of Regulation (EC) No 882/2004, official staff at the BIPs visited have received training covering, amongst other topics, official controls on import of products of animal and non-animal origin and the use of TRACES. Training for the BIP staff is organised at various levels, for example at federal, Länder, and BIP level. In certain cases Customs authorities participate in training courses organised by BIP staff, e.g. in Bremerhaven. The knowledge gained by the BIP staff at Better Training for Safer Food (BTSF) sessions was further disseminated. 5. In line with Article 8(1) of Regulation (EC) No 882/2004, instructions are provided to the official staff. General instructions are issued at the Land level for their respective BIPs. The degree of detail varied, depending on the Land. In the Länder visited, quality management systems are in place and include work instructions on official controls (e.g. BIP Manual). 6. All BIPs visited have instructions indicating to which laboratories samples taken during official controls shall be sent. 7. In two DPEs visited, where large numbers of small consignments are received, the instructions did not establish criteria to determine which small sized consignments are subject to sampling for enhanced controls. 8. In another DPE visited, the instructions do not require staff to indicate on the sampling form the purpose and legal reference under which the sample is taken, allowing the laboratory to quickly identify analytes to be tested. However, the competent authority informed the audit team that laboratories follow the agreed protocol for testing. 9. In all places visited there was good cooperation between the BIP/DPE staff and Customs authorities, which is in compliance with Article 24(1) of Regulation (EC) No 882/ Customs authorities are informed about consignments subject to enhanced controls through an electronic system where relevant consignments are flagged. The system also flags whether a common entry document (CED) or common veterinary entry document (CVED) are required. 11. Customs authorities confirmed that, where required by EU legislation, consignments cannot be released for free circulation or re-dispatched without being accompanied by a 4

9 completed CED or CVED. DPE staff inform Customs authorities electronically when such a consignment is released in order to maintain the flow of information. 12. In line with Articles 4(6) and 8(3)(a) of Regulation (EC) No 882/2004, the internal audits and verification inspections are carried out at the BIPs/DPEs visited with the frequency set up in the Länder quality management systems. 13. In the Land Saxony, internal audit activities of the Ministry of Social Affairs and Consumer Protection identified a non-compliance with Article 6 of Regulation (EC) No 136/2004 (using intelligence available at the Customs authorities) in 2015 which was still not addressed during the internal audit in 2016, indicating that corrective actions had not been taken in a timely manner. The follow-up actions in this matter were not completed at the time of this audit Facilities 14. In general, the BIPs visited have appropriate facilities and equipment for carrying out import checks in accordance with the requirements of Annex II to Directive 97/78/EC and Annex of Decision 2001/812/EC. BIP facilities visited and used for the activities of DPEs are in line with Article 4 of Regulation (EC) No 669/2009 and Article 8 of Regulation (EC) 884/ At Leipzig airport the same facilities are used for unloading, inspection and storage of consignments of products of animal origin arriving at the BIP and products of nonanimal origin arriving at the DPE. Procedures for cleaning and disinfection are in place. Despite the facilities being large enough to store products of animal and non-animal origin separately, these were seen to be stored together. Stored products were properly packed which minimises any possible cross-contamination. Conclusions on the general obligations of the official controls system 16. The competent authority has organised the specific import controls in an efficient way supported by operational electronic tools and appropriate facilities. Moreover, the competent authorities make efficiency gains by allowing BIPs and DPEs to share their facilities. 17. There is an administrative framework for providing information and instructions to BIPs and DPEs, which contributes to the implementation of the enhanced controls. 1 In their response to the draft report, the competent authority noted that consignments from passenger aircraft have to be registered through enquiries with the airline. Measures are being agreed with the airlines at Leipzig airport for the communication of loading lists (Q1 2017). 5

10 5.2 MECHANISMS TO ENSURE THAT CONSIGNMENTS ARE PRESENTED FOR IMPORT CONTROLS Legal requirements Articles 6 and 7 of Regulation (EC) No 136/2004, Article 6 of Regulation (EC) No 669/2009, Article 7 of Regulation (EC) No 884/2014. Findings 18. In accordance with the requirements of Regulation (EC) No 136/2004 and Regulation (EC) No 669/2009, prior notification of consignments of products of animal and nonanimal origin is done by the persons responsible for the load/operators one day before their physical arrival at BIPs or DPEs. In addition, the Customs authorities operate a risk-based system to identify consignments subject to official controls and not prenotified by the operator. 19. At Leipzig airport DPE, however, a prior notification of products of non-animal origin is in some cases received on the morning of the expected arrival of the consignment contrary to Article 6 of Regulation (EC) 669/2009 and Article 7 of Regulation (EC) 884/2014. The competent authority stated that this does not affect the organisation of official controls In the BIPs, prior notification of consignments of products of animal origin is generally performed electronically (using COACH - the national IT system, TRACES or ). Both BIPs visited used COACH which automatically flags consignments of products of animal origin subject to enhanced controls. In the BIPs where COACH is not used, alternative systems are in place. 21. Although it is not a legal requirement for products of non-animal origin, the staff of DPEs visited perform checks of manifests randomly or daily. For instance, random checks of manifests are carried out at Bremerhaven port DPE and daily checks at Leipzig airport DPE. 22. At BIP (and DPE) Leipzig, 98% of consignments are handled by the same operator who provides information concerning consignments prior to arrival for both products of animal and non-animal origin. For this operator, import manifests are checked by the official staff on a daily basis. No checks of manifests by the official staff or alternative systems are in place at the BIP for consignments handled by the other operators, which is not in line with Articles 6 and 7 of Regulation (EC) 136/2004. The competent authority informed the audit team that corrective actions will be initiated to include these checks on the consignments handled by the other operators (2%). 3 2 In their response to the draft report, the competent authority noted that they agreed to this procedure because the freight companies and the authorities have different working hours. 3 In their response to the draft report, the competent authority noted that consignments from passenger aircraft have to be registered through enquiries with the airline. Measures are being agreed with the airlines at Leipzig 6

11 23. At BIP Munich, checks of manifests have not been carried out by the official staff since 2014 contrary to the requirements laid down in Articles 6 and 7 of Regulation (EC) No 136/2004. The competent authority stated that a new IT tool is being developed to include such checks. It is planned that this system will be finalised and implemented by end Conclusions on the mechanisms to ensure that consignments are presented for import controls 24. Mechanisms are in place, supported by the system applied by the Customs authorities, to ensure that consignments requiring enhanced controls are presented for official controls. In one BIP visited such a mechanism is still under development and does not yet ensure that all consignments subject to enhanced controls will be identified. 5.3 IMPLEMENTATION OF THE IMPORT CONTROLS 5.3.1Documentary checks Legal requirements Article 4(3) of Directive 97/78/EC, Article 8 of Regulation (EC) No 669/2009. Findings 25. In accordance with Article 4(3) of Directive 97/78/EC the competent authorities carry out documentary checks on each consignment presented by the operators at the BIPs visited. 26. The competent authority at the DPEs visited stated that documentary checks are carried out without undue delay on all consignments within two working days from the time of arrival. Checks of selected files of products of non-animal origin subject to enhanced controls confirmed that the documentary checks are carried out in line with the requirements laid down Article 8 of Regulation (EC) No 669/ During documentary checks, the competent authority verifies the documents accompanying the consignments required by EU legislation on enhanced controls such as health certificates, laboratory results, and declarations of the competent authority of non-eu countries where relevant. The competent authorities check in addition other documents provided by the operator such as bills of lading, airway bills, packing lists etc. airport for the communication of loading lists. (Q1 2017) 4 In their response to the draft report, the competent authority stated that the IT tool for the central registration of manifests at BIPs is expected to be fully installed and operational at the relevant storage companies in the second quarter of Checks can therefore probably also start in the second quarter. Until the IT tool is operational, no manifest checks can be conducted. 7

12 Conclusions on the implementation of documentary checks at the border 28. Documentary checks of all consignments arriving to BIPs and DPEs visited subject to enhanced controls were carried out in satisfactory way Identity and physical checks Legal requirements Article 8(1)(b) of Regulation (EC) No 669/2009, Commission implementing Regulation 885/2014, Articles 11, 12, 18, 22 and 24(3) of Regulation (EC) No 882/2004, Article 1(2) of Regulation (EC) No 136/2004 Article 16(1)(e) and (f) of Directive 97/78/EC Findings 29. There is a procedure to carry out identity and physical checks, including sampling, of consignments subject to enhanced controls. The competent authorities at the DPEs visited use various tools to select consignments for sampling in order to ensure that the required frequency of sampling was achieved. 30. The identity and physical checks, including laboratory analyses, at DPEs visited were carried out without undue delay as required by Article 8(1)(b) of Regulation (EC) 669/ In the DPEs visited, official detention of the relevant consignment is appropriately conducted when a sample is taken, which is in line with requirements laid down in Article 18 of Regulation (EC) No 882/ In line with Article 24(3) of Regulation (EC) 882/2004 the competent authorities in the BIPs and DPEs visited (with the exception of DPE Frankfurt) have a system in place to inform Customs authorities and the operators of the detention of the consignments in case of sampling. DPE Frankfurt does not directly transmit such information to the Customs authorities but the competent authority stated that the Customs authorities do not release for free circulation consignments that require a CED to be eligible for import if a CED has not been completed. 33. In relation to the frequency of physical checks: In Frankfurt DPE, some products were sampled at a lower frequency than required e.g. okra from India subject to enhanced controls according to Regulation 885/2014. The competent authority stated that, in 2015, the required frequency of identity and physical checks were not met due to a lack of resources and the small size of the consignments. 8

13 At Leipzig airport DPE, only tea from China is imported. From the approximately 60 commercial consignments which were imported in 2015 only two samples were taken. The competent authority in this case could not demonstrate that the required frequency of sampling 10% of consignments was met. The competent authority stated that the electronic system does not distinguish between regular tea and 'blooming tea'. 34. At the BIPs visited, the following was noted: At Leipzig BIP, all consignments are subject to documentary checks, after which a risk-based decision is taken on which of them should be subject to further checks. The competent authority stated that physical checks are not carried out because the majority of consignments were trade samples or intended for analysis in line with Article 16(1)(e) and (f) of Directive 97/78/EC. Contrary to requirements of Article 1(2) of Regulation (EC) No 136/2004, the staff at BIP Munich has not taken any samples under the import monitoring plan during the last year. The competent authority explained that the main reason was a lack of resources. 35. In order to ensure the legal and analytical validity of official samples, these are correctly packed and labelled, and then transported to the state laboratories either by the competent authority (e.g. Leipzig) or the courier (e.g. Bremerhaven) of the laboratory. At Frankfurt airport DPE, the sample is handed to the importer or their representative to take it to the laboratory. The bags used for transport and storage of sample whilst sealed were not tamper proof. Thus the legal and analytical validity of the sample cannot be ensured as required by Article 11 of Regulation (EC) No 882/ Regarding the sampling of products of non-animal origin the audit team noted a good practice at the DPE Bremerhaven where seals with a unique number are used to ensure traceability of the samples. 37. The competent authority stated that all official laboratories and private laboratories which are designated to be used for testing are accredited as required by Article 12 of Regulation (EC) 882/ Operators pay for testing of samples taken for enhanced controls as required by Article 22 of Regulation (EC) No 882/ All DPEs visited received the test results from the laboratories without undue delay. This is in line with Article 8(1)(b) of Regulation (EC) No 669/2009. Conclusions on the implementation of identity and physical checks 40. There is an established system that allows identity and physical checks of consignments subject to enhanced controls to be carried out as required and which ensures that 9

14 consignments are not released before satisfactory laboratory tests results are received Decision on the consignments and enforcement measures Legal requirements Articles 19, 21(3) and 54(3) of Regulation (EC) No 882/2004, Article 5(1) of Directive 97/78/EC, Article 7 of Regulation (EC) No 884/2014, Articles 8(2) and 13 of Regulation No 669/2009, Article 3 of Regulation (EC) No 136/2004, Article 12 of Regulation (EU) No 885/2014. Findings 41. The decision on the consignment is taken only after the results of the laboratory analyses are received by the DPEs visited. BIPs and DPEs issue a CVED or CED respectively after completion of all the checks. 42. In the case of favourable results and in compliance with the requirements of Article 5(1) of Directive 97/78/EC, Article 8(2) of Regulation (EC) No 669/2009 and Article 7 of Regulation (EU) No 884/2014 the staff ensure that the CVED or CED accompanies the consignments to the place of destination. 43. When non-compliances are identified, the competent authority completes part II of the CVED as required by Article 3 of Regulation (EC) No 136/2004 or part III of the CED in accordance with Article 13 of Regulation (EC) No 669/2009 or Article 12 of Regulation (EU) No 885/2014, and the consignments are rejected. Thereafter, the actions laid down in Article 19 of Regulation (EC) No 882/2004 are implemented. 44. The competent authority informs the operators about the rejection of the consignment as required by Article 54(3) of Regulation (EC) No 882/ The consignments pending re-dispatch or destruction remain under the responsibility of the competent authority as required by Article 21(3) of Regulation (EC) No 882/ Staff at DPE Bremerhaven follow up the decisions taken for all non-compliant consignments, including the confirmation when the consignment was destroyed or left the port in the case of re-dispatch. 47. Leipzig BIP and DPE do not systematically request evidence of the physical departure of the consignments in the case of re-dispatch (e.g. airway bill of the consignments). The competent authority stated that this practice will be re-introduced soon. 48. Onward transportation in accordance with Article 8(2) of Regulation No 669/2009 and transfer of the consignment to a DPI is authorised at the places visited but this option is 10

15 not used in DPE Leipzig. Relevant competent authorities in Germany and in other Member States are informed via . At DPE Bremerhaven evidence was provided of such exchanges. Conclusions on the decision on the consignments 49. Decisions on consignments under enhanced controls (favourable or rejected) and procedures relevant to them are correctly applied resulting in placing on the EU market only compliant consignments Use of TRACES Legal requirement Article 3 of Decision 2004/292/EC. Findings 50. Operators give prior notification of consignments using part I of CEDs and CVEDs depending on the type of commodity. The staff at BIPs visited were trained and aware of the requirements for the use of TRACES laid down in Decision 2004/292/EC. 51. The competent authority at BIP Leipzig uses TRACES only for rejected consignments and commercial consignments. 52. Although it is not required by EU legislation to register consignments of products of non-animal origin in TRACES, most DPEs visited use TRACES to register rejected consignments. Conclusions on the use of TRACES 53. The competent authorities of the BIPs visited are using TRACES and/or the national IT system COACH for products of animal origin, but still not all consignments are registered in TRACES. The competent authority at DPEs also uses TRACES for consignments of products of non-animal origin, in particular for rejected consignments and this facilitates the exchange of information on non-compliant consignments between competent authorities and the Commission. 6 OVERALL CONCLUSIONS Overall, the report concludes that the competent authorities have appropriately qualified staff to carry out official controls supported by the cooperation with Customs authorities ensuring that relevant consignments are presented for official controls. The official controls of products subject to enhanced controls are performed in good 11

16 conditions in both BIPs and DPEs visited. Documentary, identity and physical checks contribute to ensuring that imported goods fulfil the guarantees set up in the certificates but the effectiveness of this system is, to some extent, compromised by some inconsistencies in the implementation of sampling procedures. In general, with the exception of one BIP, the competent authority uses the trade control and expert system (TRACES) correctly. Although not a legal requirement, TRACES is also used at DPEs to facilitate exchange of information on rejected consignments. This report makes recommendations addressed to the competent authorities of Germany, aimed at rectifying the shortcomings identified and/or further enhancing the official controls system. 7 CLOSING MEETING A closing meeting was held on 13 May with representatives from BMEL, BVL, the Länder of Bavaria, Hessen, Saxony and Bremen, and the Customs authorities authority. At this meeting, the main findings of the audit were presented by the audit team. The BMEL provided some clarification in relation to some issues but did not express disagreement with the findings. 8 RECOMMENDATIONS The competent authorities are invited to provide details of the actions taken and planned, aimed at addressing the recommendations set out below, within 25 working days of receipt of this audit report, including deadlines for their completion ("action plan"). No. Recommendation 1. To ensure that import manifests are checked at the BIPs Munich and Leipzig as required by Articles 6 and 7 of Regulation (EC) No 136/2004. Recommendation based on conclusions: 24. Associated findings: 22, To ensure that sampling takes place at Frankfurt and Leipzig DPEs and Munich BIP when required by the EU legislation (Article 8(2) of Regulation (EC) No 885/2014 and Article 1(2) of Regulation (EC) No 136/2004). Recommendation based on conclusions: 40 Associated findings: 33, 34. The competent authority's response to the recommendations can be found at: 12

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18 ANNEX 1 LEGAL REFERENCES Legal Reference Official Journal Title Reg. 178/2002 OJ L 31, , p Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety Reg. 882/2004 OJ L 165, , p. 1, Corrected and re-published in OJ L 191, , p. 1 Reg. 669/2009 OJ L 194, , p Dir. 97/78/EC OJ L 24, , p Dec. 2011/884/EU OJ L 343, , p Reg. 733/2008 OJ L 201, , p. 1-7 Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules Commission Regulation (EC) No 669/2009 of 24 July 2009 implementing Regulation (EC) No 882/2004 of the European Parliament and of the Council as regards the increased level of official controls on imports of certain feed and food of non-animal origin and amending Decision 2006/504/EC 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 2011/884/EU: Commission Implementing Decision of 22 December 2011 on emergency measures regarding unauthorised genetically modified rice in rice products originating from China and repealing Decision 2008/289/EC Council Regulation (EC) No 733/2008 of 15 July 2008 on the conditions governing imports of agricultural products originating in third countries following the accident at the Chernobyl nuclear power station (Codified version)

19 Reg. 884/2014 OJ L 242, , p Reg. 885/2014 OJ L 242, , p Reg. 322/2014 OJ L 95, 29/03/2014, p Dec. 2010/381/EU OJ L 174, , p Dec. 2008/866/EC OJ L 307, , p Dec. 2008/630/EC OJ L 205, , p Dec. 2007/642/EC OJ L 260, , p Commission Implementing Regulation (EU) No 884/2014 of 13 August 2014 imposing special conditions governing the import of certain feed and food from certain third countries due to contamination risk by aflatoxins and repealing Regulation (EC) No 1152/2009 Commission Implementing Regulation (EU) No 885/2014 of 13 August 2014 laying down specific conditions applicable to the import of okra and curry leaves from India and repealing Implementing Regulation (EU) No 91/2013 Commission Implementing Regulation (EU) No 322/2014 of 28 March 2014 imposing special conditions governing the import of feed and food originating in or consigned from Japan following the accident at the Fukushima nuclear power station 2010/381/EU: Commission Decision of 8 July 2010 on emergency measures applicable to consignments of aquaculture products imported from India and intended for human consumption 2008/866/EC: Commission Decision of 12 November 2008 on emergency measures suspending imports from Peru of certain bivalve molluscs intended for human consumption 2008/630/EC: Commission Decision of 24 July 2008 on emergency measures applicable to crustaceous imported from Bangladesh and intended for human consumption 2007/642/EC: Commission Decision of 4 October 2007 on emergency measures applying to fishery products imported from Albania and intended for human consumption

20 Dec. 2006/27/EC OJ L 19, , p Dec. 2004/225/EC OJ L 68, , p Dec. 2002/994/EC OJ L 348, , p /27/EC: Commission Decision of 16 January 2006 on special conditions governing meat and meat products of equidae imported from Mexico and intended for human consumption 2004/225/EC: Commission Decision of 2 March 2004 on protective measures with regard to certain live animals and animal products originating in or coming from Albania 2002/994/EC: Commission Decision of 20 December 2002 concerning certain protective measures with regard to the products of animal origin imported from China Reg. 175/2015 N/A N/A Dec. 2014/88/EU OJ L 45, , p /88/EU: Commission Implementing Decision of 13 February 2014 suspending temporarily imports from Bangladesh of foodstuffs containing or consisting of betel leaves ( Piper betle ) Reg. 943/2015 N/A N/A Dec. 2007/82/EC OJ L 28, , p /82/EC: Commission Decision of 2 February 2007 on emergency measures suspending imports from the Republic of Guinea of fishery products intended for human consumption