EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

Transcription

1 Ref. Ares(2016) /07/2016 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 27 TO 06 NOVEMBER 2015 IN ORDER TO EVALUATE THE OFFICIAL CONTROLS ON CONSIGNMENTS IN TRANSIT 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 by DG Health and Food and Safety in Germany from 27 October to 6 November 2015, in order to evaluate the system of official controls implemented by the competent authorities on specific consignments transiting the EU. The responsibilities of competent authorities have been designated and communication, cooperation and coordination exist between veterinary authorities and Customs at national and Länder level. These systems, combined with the provision of a range of resources including appropriate written procedures and relevant training, support the implementation of the official controls on transits. The three Länder visited have set up systems for official controls at BIPs which generally ensure that only consignments eligible for transit are allowed to be introduced into EU territory. The systems for implementing official exit controls on transits had only been established or were totally modified just prior to the audit at two of the three BIPs visited. Therefore, their effectiveness could not be fully assessed. Compliance with legal requirements and the effectiveness of official controls differed between the warehouses visited. The official controls largely complied with EU requirements at one of the approved warehouses visited and the competent authority was acting to improve their effectiveness to ensure the prompt confirmation of receipt of goods at destination. The other warehouse was approved under veterinary legislation for storage of non-conforming goods although it was not approved as customs warehouse and most of the official controls required under EU legislation were not being implemented. The Länder are responsible for the implementation of verification procedures which are mainly based on the implementation of internal audits of each Land s Quality Management System (QMS). The extent to which internal audits include transits varied greatly between Länder mainly because of the variation in the amount of transit related procedures in each QMS. Verification activities related to transits are usually linked to verification activities for import controls at BIPs and therefore do not always include official controls at approved warehouses. Furthermore, action to address a recommendation from a 2013 DG Health and Food Safety audit report related to transits has still not been implemented. The report includes three recommendations addressed to the competent authority of Germany, aimed at rectifying the shortcomings identified and further enhancing the official control system on transit consignments. I

3 Table of Contents 1 INTRODUCTION OBJECTIVES AND SCOPE LEGAL BASIS BACKGROUND FINDINGS AND CONCLUSIONS Organisation of the controls, designation of competent authorities and operational criteria Official controls on non-conforming goods Controls at the entry Border Inspection Posts Pre-notification of consignments Documentary, identity and physical checks Follow-up of transiting goods by entry Border Inspection Posts Controls at approved warehouses Approval and listing Documentary, identity and physical checks Follow-up of consignments from the free zones or free/customs warehouses to exit Border Inspection Post or ship Controls at the exit Border Inspection Posts Documentary, identity and physical checks Verification and Review Follow-up of a previous recommendation from report DG(SANCO)/ OVERALL CONCLUSIONS CLOSING MEETING RECOMMENDATIONS...15 II

4 ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT Abbreviation AEO BGV BIP BMEL BVL Explanation Authorised economic operator, i.e., an economic operator established in the EU who is authorised by Customs authorities to benefit from various simplifications specifically provided for under the Customs legislation as they have met certain standards in relation to their security, management systems, compliance with Customs rules and ongoing solvency. The Hamburg Health and Consumer Protection Authority (Behörde für Gesundheit und Verbraucher- schutz (BGV) Hamburg) Border inspection post The Federal Ministry of Food and Agriculture (Bundesministerium für Ernährung und Landwirtschaft) The Federal Office of Consumer Protection and Food Safety (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit) COACH IT system used for all types of official control procedures, applied by 8 German BIPs, for live animals and products of animal origin Customs CVED CVEDA CVEDP Decision on the consignment FLI National Customs authority Common Veterinary Entry Document Common Veterinary Entry Document for Animals Common Veterinary Entry Document for Products The decision made by the Official Veterinarian at the BIP and entered on the CVED, as to the outcome of veterinary checks and the resulting fate of consignments. Friedrich Löfler Institute HS nomenclature Harmonised System Nomenclature, the international multipurpose nomenclature elaborated under the auspices of the World Customs Organisation LAV AG EAD The Länder working group for Import, Export and Transit (Länderarbeitsgeselschaft Ein-, Aus- und Durchfuhr) LVU QMS SLVU SOPs TRACES Local veterinary unit Quality Management Systems Super local veterinary unit Standard operational procedures Trade control and expert system III

5 Abbreviation VEA Explanation Veterinary and Import Authority (in Hamburg) (Veterinär- und Einfuhramt) IV

6 1 INTRODUCTION This audit took place in Germany from 27 October to 6 November The audit team comprised two auditors from the DG Health and Food Safety and a national expert. The audit was undertaken as part of the DG Health and Food Safety planned audit programme. This audit was conducted in parallel with audit DG(SANTE)/ (in order to evaluate the application of re-enforced checks on imported products of animal origin), for which a separate report was issued. An opening meeting was held on 27 October with representatives of the Federal Ministry of Food and Agriculture (Bunesministerium für Ernährung und Landwirtschaft BMEL), the Federal Office of Consumer Protection and Food Safety (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit - 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. A representative from BVL accompanied the audit team during the entire audit. 2 OBJECTIVES AND SCOPE The main objective of the audit was the evaluation of the official control system implemented by the competent authorities on consignments transiting the EU, in particular: whether the controls are implemented in compliance with the requirements, whether the implementation of these controls is effective and suitable in ensuring that (i) only consignments eligible for transit are accepted, and that (ii) transiting consignments always leave the Union. In addition to the main objective, the audit also evaluated the implementation of corrective actions foreseen in the action plan addressing recommendation 1 in report DG(SANCO)/ 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 BMELV BVL Relevant Länder FLI Customs Hessisches Ministerium für Umwelt, Klimaschutz, Opening and closing meetings Audit of official controls on transits at the Border 1

7 Frankfurt/Main BIP Land Hamburg Hamburg port BIP Land Bremen Bremerhaven BIP Landwirtschaft und Verbraucherschutz Ministry of Environment, Energy, Agriculture and Consumer Protection Hessen Veterinär- und Einfuhramt Hamburg Veterinary and Import Authority Hamburg Behörde für Gesundheit und Verbraucherschutz (BGV) Hamburg Health and Consumer Protection Authority Hamburg Lebensmittelüberwachung, Tierschutz und Veterinärdienst des Landes Bremen (LMTVet) Ministry of Foodstuffs, Animal Welfare and Veterinary Service of the Land of Bremen Inspection Posts (BIPs) Two warehouses approved under Articles 12 and 13 of Directive 97/78/EC The scope of the audit covered the implementation of the controls at entry and exit BIPs, warehouses approved for storing non-conforming goods and ship suppliers, including operational criteria, ability of staff implementing the controls and verification procedures, in relation to: commercial consignments originating in third countries, transiting the Union, intra-community movements of EU goods moving via third countries ("external transits" for the purpose of this report, not to be confused with the T1 external transit procedure of Customs), movements of goods taking place by road and railway. The following were excluded from the scope: transhipments, personal consignments and movements of pet animals, and external transits via EFTA countries. 2

8 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 to this report comprises a list of legislation used as audit criteria for this report. Legal acts quoted refer, where applicable, to the last amended version. The European Commission has created a set of manuals for the Member States, to facilitate the work of officials using TRACES (Trade Control and Expert System) and to avoid inaccuracies. TRACES is a trans-european network for veterinary health which notifies, certifies and monitors imports, exports and trade in animals and animal products. The TRACES toolkit includes guidance on the movement of transit consignments from BIPs to US military bases in several Member States which is based on an agreement between the European Commission and the US Public Health Command for Europe region. User manuals, release notes, tools, etc., are part of the TRACES toolkit, available at: The European Commission has also published a General Guidance for consignments of live animals and animal products from third countries in transit and transhipment in order to assist the competent authorities carrying out veterinary checks on consignments of live animals and animal products from third countries which are destined for transit or transhipment through the Union territory (SANCO/10844/2011, Revision 3, , hereafter Guidance on transit), available at: When relevant, guidance provided in these documents has been taken into consideration in evaluating the official controls on consignments in transit. 4 BACKGROUND Council Directives 97/78/EC (for animal products) and 91/496/EEC (for live animals) set out the veterinary procedures and requirements for importing into the EU commercial consignments of live animals and animal products. While consignments to be imported must meet both animal and public health requirements, consignments of animal products in transit are only required to meet the animal health requirements. It is therefore necessary that the competent authorities ensure that those consignments, for which public health guarantees have not been provided, do not enter the EU market. Live animals physically entering the territory of the EU must always fulfil EU animal and public health import requirements, whether for import or transit. The Commission General Guidance for consignments of live animals and animal products from third countries in transit, referred to above, includes the following definitions: 3

9 Non-conforming consignments: animal products that do not meet EU public health requirements. As they do not meet these requirements, they may not be imported into the Union/EEA or intended for the Union/EEA market. Non-conforming consignments are destined or intended for free zones, free/customs warehouses, ship suppliers or ships leaving the coastal waters of the Union/EEA territory; they may be in transit from one third country to another through the Union/EEA territory by road, rail or waterways or they may be transhipped from an EU port/airport to a third country. Transit: the movement of non-conforming consignments or the movement of live animals conforming to EU requirements across Union/EEA territory by road, rail, or waterway transport from one third country to another. The transit may be direct or indirect (involving a period of storage). An overview of the control systems in Germany can be found in the country profile for Germany which is available at: There are 14 BIPs in 10 Länder in Germany approved in Commission Decision 2009/821/EC. There are 42 warehouses in Germany approved to store non-conforming products of animal origin. 32 of these are approved under Article 12 of Directive 97/78/EC for the temporary storage of non-conforming products of animal origin (2 of which are located in free zones). 16 warehouses are approved under Article 13 of the Directive 97/78/EC for the temporary storage of products of animal origin destined for the supply of ships (with six being approved also under Article 12). Details of the approved warehouses are available on the DG SANTE website at: The issuing of Common Veterinary Entry Documents (CVEDs) within TRACES for consignments leaving warehouses is managed via BIP in the case of Bremen Land and super local veterinary unit (SLVU) at all other Länder. The following movements of transiting goods relevant to Germany were recorded in TRACES for 2014: Out of the 72,680 Common Veterinary Entry Documents for products (CVEDPs) issued in Germany, 2,276 were for transiting consignments of products of animal origin. Out of the 17,403 Common Entry Documents for live animals (CVEDAs), 3,787 were consignments of transiting live animals. 808 transit consignments exited the EU via German BIPs after entering in other Member States. 4

10 5 FINDINGS AND CONCLUSIONS 5.1 ORGANISATION OF THE CONTROLS, DESIGNATION OF COMPETENT AUTHORITIES AND OPERATIONAL CRITERIA Legal requirements Articles 4, 6, 8 and 24 of, and Annex II to Regulation (EC) No 882/2004; Article 3(1)(c) of Commission Decision 2004/292/EC. Findings 1. In accordance with Article 4(1) of Regulation (EC) No 882/2004, the BMELV has been designated as the central competent authority with responsibility for issuing federal legislation for import/transit controls of live animals and food of animal origin. The Länder implement federal legislation and the directly applicable legislation of the EU. The Friedrich Löfler Institute (FLI) is the national coordinating office for TRACES and serves as the national administrator and technical coordinator. The Länder are responsible for the use of TRACES. 2. In accordance with Article 4(3) of Regulation (EC) No 882/2004, there are regular contacts between the representative of relevant Länder via the inter-länder working group for Import, Export and Transit (Länderarbeitsgeselschaft Ein-, Aus- und Durchfuhr - LAV AG EAD). The objectives of this subgroup include aligning import/transit procedures across all Länder, updating the national "border inspection posts manual (Handbuch) and establishing a training programme for BIP staff. There is also cooperation and coordination within competent authorities at individual Land level with regular exchange of information between central office and BIPs via , the intranet and telephone when necessary. 3. In accordance with Article 24(1) of Regulation (EC) No 882/2004, a legal basis for coordination and cooperation between the veterinary authorities and Customs is laid down in various Customs administrative orders and circulars at national level. At federal and Land levels, there was evidence of regular contacts between veterinary and Customs authorities. 4. In accordance with Article 8(1) of Regulation (EC) No 882/2004, official controls on consignments in transit are carried out in accordance with documented procedures set out in various sections of the Handbuch. The Handbuch is complimented by a range of procedures developed at Land level which can be incorporated into the Länder Quality Management System. 5. In accordance with Article 6 of Regulation (EC) No 882/2004, training covering official controls on transit consignments is provided to officials, and often forms part of wider training related to imports controls. The most frequently provided training includes that which is obtained on the job, from relevant issues discussed with all staff during local management meetings, attendance at Better Training for Safer Food courses and specific 5

11 training on transits at some locations visited. Officials met during the audit displayed a high level of knowledge on the relevant rules for transit consignments. 6. As required by Article 3(1)(c) of Decision 2004/292/EC, TRACES is being used for communication between authorities and for recording the outcome of official controls related to consignments in transit. TRACES is not used directly at eight German BIPs where information is first entered into another computerised BIP data and expert system, "COACH", before it is transferred via an interface to TRACES. If the interface does not work correctly for a consignment, the BIP receives an on-screen error message and BIP staff enters data directly in TRACES. All officials met were competent users of TRACES (see section 5.4). Conclusion on the organisation of the controls, designation of competent authorities and operational criteria 7. The responsibilities of competent authorities have been designated and a system of communication, cooperation and coordination exists within and between veterinary authorities at federal and Land level and with Customs. This system combined with the provision of appropriate written procedures and relevant training, supports the implementation of the official controls on transits. 5.2 OFFICIAL CONTROLS ON NON-CONFORMING GOODS Legal requirements Articles 3, 4, 11 and 12 of Council Directive 97/78/EC; Article 3 of Council Directive 91/496/EEC; Articles 1, 2, 3 and 4 of Commission Decision 2000/571/EC; Article 4(2) of Regulation (EC) No 853/2004; Articles 2, 7 and Annex III to Commission Regulation (EC) No 136/2004; Article 3 of Commission Decision 2000/208/EC; Articles 1 and 6 of Commission Regulation (EC) No 282/2004; Article 3(1) of, and Annex I to Commission Decision 2007/275/EC. Findings Controls at the entry Border Inspection Posts Pre-notification of consignments 8. Frankfurt/Main BIP receives the notification required under Article 2 of Regulation (EC) No 136/2004 electronically using part 1 of the CVED in TRACES. Bremerhaven and Hamburg ports BIPs receive the required notification electronically via COACH. 9. The competent authority needs to ensure that all products of animal origin entering the Community undergo veterinary checks, as required by Article 6 of Regulation (EC) No 136/2004 for products and as required by Article 3 of Council Directive 91/496/EEC for live animals. For this purpose: 6

12 Bremerhaven and Hamburg BIPs use the COACH-Manifest programme to verify that all consignments subject to veterinary checks are notified to the BIP. Frankfurt/Main BIP does not have access to relevant databases to verify that all consignments of products of animal origin subject to veterinary checks are notified to the BIP, e.g. the Customs' or Airport Authority's databases contrary to Article 6 of Regulation (EC) 136/2004. BIP staff stated that manifests were spot-checked in the past but the practice had ceased due to time constraints and the fact that they never found any consignment not presented for controls. BIP staff also stated that consignments of live animals arriving at the airport are delivered by ground staff of the airport operator with a consignment note to the building of Frankfurt Animal Lounge in which the BIP is located ensuring that they undergo the veterinary checks Documentary, identity and physical checks 10. BIP staff check in part 1 of the CVED the information submitted by the economic operator against the health certificate which accompanies the consignment, as required by Article 4(3)(a) of Directive 97/78/EC. BIP staff keep a copy of the certificate and the original accompanies the consignment when it leaves the BIP, as required by Article 1(4) of Decision 2000/571/EC. 11. The implementation of identity checks of consignments in transit varied between the BIPs visited: Bremerhaven BIP: identity checks are usually based on a check of the seal on the means of transport, in line with Article 4(4)(a)(i) of Directive 97/78/EC. The CVED issued for these consignments indicated correctly that a seal check had been performed. Hamburg port BIP: identity checks are usually based on opening all containers and checking that the product tallies with the certificate. The identity check usually does not involve unloading and is limited to products visible from the back door 1. The CVED issued for these consignments indicated that a full identity check had been performed. The BIP highlighted the fact that there is no definition for full identity check as opposed to identity check in EU legislation and that the current approach satisfies the requirements of Annex III to Regulation (EC) No 136/2004. Frankfurt/Main BIP: seal checks and full identity checks are both implemented depending on how the product is presented, e.g. seal checks for germinal products (frozen semen) being transported in sealed flasks and full identity checks for the rest of consignments. 12. Physical checks are very rare and would be carried out in cases of suspicion, which is in line with the requirements of Article 12(2) of Directive 97/78/EC. 1 In its response to the draft report the competent authority noted that individual packages are always unloaded and, where necessary (e.g. different lot numbers), may be taken from different areas of the container. 7

13 Follow-up of transiting goods by entry Border Inspection Posts 13. Article 11(2) of Directive 97/78/EC requires BIP staff to ensure that they receive confirmation of arrival (from an approved warehouse) or confirmation of exit from the EU (from the exit BIP) within 30 days after a transit consignment leaves their BIP. If no confirmation is received, official staff should seek confirmation either by contacting the officials in charge of controls at the warehouse or the BIP, or by asking Customs. Bremerhaven BIP: a register was maintained for follow-up. If no confirmation was received in time, the BIP sought confirmation of exit via Customs documentation. The follow-up was completed for the vast majority of consignments. Hamburg port and Frankfurt/Main BIPs: these BIPs did not have a system put in place to follow up the consignments in transit contrary to the requirements of Article 11(2) of Directive 97/78/EC. A system for follow-up was introduced prior to the audit and its ability to follow up the consignments could not yet be demonstrated. 14. Both Hamburg port and Frankfurt/Main BIPs had retrospectively confirmed the receipt at destination (either exit BIP or approved warehouse) prior to the audit for consignments in 2014 and 2015). Conclusion on the official controls at entry Border Inspection Posts 15. In the three BIPs visited, consignments in transit are checked as required but in Frankfurt/Main BIP staff have no access to the information from the relevant databases which would enable them to verify that consignments are always presented for the controls. Veterinary checks generally ensure that only eligible consignments are accepted for transit. 16. The system for the follow-up of the consignments in transit entering via Bremerhaven BIP complies with the requirements. In Hamburg port and Frankfurt/Main BIPs, the system had only been put in place before the audit and its effectiveness could not be assessed Controls at approved warehouses Approval and listing 17. The competent authority in each Land inspects and approves warehouses in line with the requirements of Article 4(2) of Regulation (EC) No 853/2004, Article 12 of Directive 97/78/EC and Decision 2000/571/EC. Warehouses are controlled by staff from BIP in the Bremen 2 Land and by staff from SLVUs in all other Länder. 2 In its response to the draft report the competent authority noted that SLVU was established at LVU in the Bremen Land. 8

14 18. Warehouse 1: The Land authority approved the warehouse under Article 12 of Directive 97/78/EC. The competent authority also confirmed that it is also approved under Article 4(2) of Regulation (EC) No 853/2004. The audit team noted that this warehouse only handles non-conforming consignments destined for NATO bases. The warehouse is not a customs warehouse within the meaning of EU Customs legislation, but consignments are under Customs supervision following the particular provisions of Customs law which are related to the international agreement of NATO Status of Forces Agreement (SOFA) and the Supplementary Agreement thereto. According to the information provided by Customs authorities, these consignments are brought from the Member State of entry to Germany under a transit procedure using "Form 302", presented at the Customs office of destination and upon being handed over to a representative of the foreign armed forces in Germany, placed under the Customs procedure for non-community goods used by military forces (Truppenverwendung). According to the information provided by Customs authorities, the goods do not need to be placed under a Customs warehousing procedure, since they have already placed under Truppenverwendung Customs procedure of the foreign armed forces. 19. Warehouse 2: The warehouse was correctly approved under Articles 12 and 13 of Directive 97/78/EC, and under Article 4(2) of Regulation (EC) No 853/2004 as required. It was a customs warehouse operated by an authorised economic operator (AEO) Documentary, identity and physical checks 20. Warehouse 1: According to the competent authority, the official veterinarian visited the warehouse once every two or three months. The audit team noted that: a check was not performed on entries and exits to/from the warehouse contrary to the requirements of Article 12(5) of Directive 97/78/EC; the consignments of non-conforming products stored in warehouses were not marked on each unit with the unique number of the CVED contrary to the requirements of Article 1(5) of Decision 2000/571/EC; documentary and identity checks were not made on consignments during storage and before exit to verify their source and destination contrary to the requirements of Article 4 of Decision 2000/571/EC. Consignments could enter and leave between visits of the official veterinarian, without control; there was no register of entries and exits of the consignments, which is required by Article 12(4)(b) of Directive 97/78/EC and Article 3(2) of Decision 2000/571/EC; non-conforming products entering or leaving the warehouse were not accompanied by the CVED required by Art 1(1) of Decision 2000/571/EC. The audit team noted that no official documents accompanied the consignments leaving the warehouse. A system to confirm receipt at the warehouse has been established in June The system is based on information provided by the economic operator. The competent authority does not routinely inspect the consignments before confirming their arrival to the warehouse. 9

15 21. Warehouse 2: According to the competent authority, the official veterinarian usually visited the warehouse once per week. The audit team noted the following with respect to implementation of the official controls: The AEO performs the documentary and identity checks before a consignment is allowed to enter the warehouse including breaking the seal following a standard operating procedure (SOP) on which the competent authority provided input. If there was any issue with the seal or documents, then the warehouse should inform the official staff responsible for the warehouse. If the outcome of the seal and documentary checks was satisfactory, then the AEO marked the individual units of non-conforming products with the reference number of the incoming CVED before the goods entered the storage rooms in compliance with requirements of Article 1(5) of Decision 2000/571/EC. The audit team confirmed that the CVED number was marked on all products during an inspection of the storage facilities. The warehouse operator maintains an electronic database of all consignments which are stored at the warehouse, as required by Article 3(2) of Decision 2000/571/EC. The official veterinarian during the visit to the warehouse carries out a check on the recently entered consignments using a checklist. This involves an assessment of the AEO s entry checks and periodically the official veterinarian performs checks on consignments in storage and cross checks them with the AEO's database to verify the correctness of the data. The competent authority stated that the arrival of the consignment to the warehouse is confirmed as soon as possible following the visits when the official veterinarian returns to the office of the competent authority. All consignments stored in the warehouse are destined for ship supplies. Therefore, they leave with a veterinary certificate as laid down in the Annex to Decision 2000/571/EC. The audit team conducted a successful traceability exercise between the stored goods and the operator's database Follow-up of consignments from the free zones or free/customs warehouses to exit Border Inspection Post or ship 22. Warehouse 1: There was no official control system in place to ensure that all nonconforming consignments that left the warehouse reached their intended destination within 30 days of despatch contrary to Article 2 of Decision 2000/571/EC. 23. Warehouse 2: According to the competent authority, about 10% of the veterinary certificates issued for consignments leaving the warehouse are not returned completed within the 30 days legal deadline. The competent authority contacted Customs as required by Article 2 of Decision 2000/571/EC in May 2015 requesting confirmations of receipt for certificates issued in Confirmation was obtained in the vast majority of cases. A similar request for 2015 certificates was sent in November The competent authority stated that they intend to increase the frequency of follow-up for 10

16 non-returned certificates in order to ensure the effective implementation of Article 2 of Decision 2000/571/EC. Conclusion on the official controls at approved warehouses 24. Compliance with the requirements and effectiveness of the controls differ between the warehouses visited: In one of them the official controls comply with the EU requirements and the competent authority was acting to improve their effectiveness. In the other warehouse, the control system failed to comply with the minimum requirements (verification of traceability, labelling, and certification) and could not provide guarantees that products reached their intended destination. The warehouse is not approved/authorised as a customs warehouse, but it is under Customs supervision (on the basis of the particular provision of Customs law related to the foreign military forces). This supervision could provide sufficient guarantees for the goods intended for military forces if effective veterinary controls were in place Controls at the exit Border Inspection Posts Documentary, identity and physical checks 25. Hamburg port BIP: The BIP receives a TRACES notification indicating that a consignment intends to exit via their port. The transit consignments exiting in Hamburg without intermediate storage in the warehouse are under responsibility of the BIP. Before and during the audit, the competent authority informed the Commission that they have difficulties controlling consignments that entered via road BIPs in other Member States and are repacked in containers in Hamburg warehouses. These consignments are erroneously registered with Hamburg port BIP as direct transit exits without indicating the number of the Customs document required under Customs law. The VEA nonetheless managed to find and check four out of seven consignments in This was not possible in the case of three consignments because incorrect information (e.g. non-existent warehouse) was provided in the CVED. The LVU under subordination of VEA controls the consignments dispatched from the warehouses and prepare the accompanying documents. The port IT system is used to this end. The LVU does not confirm the actual exit of the consignment from the EU, as it is the unit responsible for checking the exit and thus does not notify itself. However, this causes that CVEDs remain in TRACES incomplete and do not show that consignments have, indeed, left the Union territory. 11

17 26. Bremerhaven BIP: The BIP was confirming exits using checks at the BIP (about 20%) and information from the port database (about 80%). The confirmation using the port database did not comply with the requirements of Article 3 of Decision 2000/208/EC. To achieve compliance with the Decision, the BIP changed the system prior to this audit, therefore, the functioning of the newly established system was not assessed. Since then, the BIP contacts the persons responsible for the load and instructs them to present the consignment in transit at the BIP for exit checks. 27. Frankfurt/Main BIP: Exit of products: The competent authority introduced a system in September The BIP contacts Customs when they receive via TRACES a notification of an exit. Customs would then inform the BIP when the consignment has exited. Exit of live animals: Nearly all consignments of live animals in transit, which exit the Union via Frankfurt/Main airport, entered the EU via the same airport, i.e. they change aeroplanes. All animals are checked by the BIP but, in accordance with Article 4 of Regulation (EC) 282/2004, part III of the Common Veterinary Entry Document for Animals (CVEDA) in TRACES is completed only when the entry BIP is not the same as the exit BIP (only 6 out of 3,656). As a consequence, TRACES is not provided with the data which can be properly managed and processed in order to ensure that all live animal consignments in transit have left the EU territory. Conclusion on the official controls at exit Border Inspection Posts 28. The controls at exit have not complied with the minimum requirements until recently. A variety of weaknesses in the BIPs lead to a lack of adequate confirmation of exits. Before the audit, the competent authority detected weaknesses in Hamburg BIP, established a new control system in Frankfurt/Main BIP, and modified the controls in Bremerhaven BIP. The actions put in place would comply with the legal requirements if implemented accordingly. 5.3 VERIFICATION AND REVIEW Legal requirements Articles 4 and 8(3) of Regulation(EC) No 882/2004. Findings 29. The Länder are responsible for the implementation of verification procedures which are mainly based on the implementation of internal audits of each Land s Quality Management System (QMS). The extent to which internal audits include transits varied greatly between Länder mainly because of the variation in the amount of transit related procedures in each QMS. 12

18 30. Hessen: Internal audits are conducted at the Frankfurt/Main BIP on an annual basis. For products, they have not covered transit controls to date. For live animals, the audits on certification covered transits. There has been no verification of official controls at approved warehouses to date. 31. Hamburg (Hamburg port BIP and warehouses): The Hamburg Health and Consumer Protection Authority (BGV) arranges: annual internal audits; external audits on a 5-year cycle and one was conducted in 2014 which assessed all aspects of the VEA including procedures (including transits) and facilities; risk-based inspections on specific issues. For example, official controls on transits were assessed in Verification led to recommendations which triggered action plans. Some actions were completed and some were still ongoing at the time of the audit. For example, recommendations related to the need for further SOPs were issued and that exit checks on transits should be documented. 32. Bremen: Internal audits are conducted at Bremerhaven BIP on an annual basis. The October 2015 audit reported on problems in receiving confirmation of receipt at destination for transit consignments destined for military bases. The Land also has a plan to introduce "expert supervision" in 2016 where specific activities could be reviewed on a risk basis. This could include transits. There has been no verification of official controls at approved warehouses to date. Conclusion on the verification and review 33. The Länder are responsible for verification, but the extent to which verification activities covered transits varied between Länder. Verification activities related to transits are covered in BIPs but not always at warehouses. In Bremen and Hamburg the verification detected shortcomings in the transit controls and relevant recommendations were triggered. 5.4 FOLLOW-UP OF A PREVIOUS RECOMMENDATION FROM REPORT DG(SANCO)/ In their response to recommendation No 1 from report DG(SANCO)/ (described in finding 36), the competent authority stated that: Super Local Veterinary Unit (SLVU) accounts would be made available to competent authorities issuing CVEDs for non-conforming consignments leaving approved warehouses, and written instructions would be provided in the form of frequently asked questions on the TRACES administrator's (FLI) website. 13

19 Both these actions had been completed but no SLVU has issued a CVED in Germany at the time of the audit. The competent authority presented to the audit team the missing functionalities in TRACES as the reason for failing to use it. 35. In relation to the issuance of subsequent CVEDs in the warehouses, the audit team noted that: in warehouse 1 the exiting consignments were not accompanied by subsequent CVEDs, therefore there was no documentary traceability of the goods. This is a consequence of the absence of an official control system in warehouse 1 contrary to the requirements of Article 12 of Directive 97/78/EC; in warehouse 2 the consignments were intended for ship supplies and left accompanied by the veterinary certificates in compliance with the requirements of Article 5 of Decision 2000/571/EC; the representative of another Land, in which the audit team did not visit a warehouse, stated that the subsequent CVEDs accompanying consignments exiting the warehouse are created in COACH. They have the reference number of the original ("mother") CVED in box 11 under "Documentary reference". When the interface transfers information into TRACES, the CVEDs appear as new transits and the link between entering and exiting split consignments is lost. 36. The table below summarises the situation of the recommendation: No Recommendation Assessment 1 To implement actions to ensure that CVEDs issued for nonconforming consignments leaving approved customs warehouses are cross referenced to the original incoming CVEDs as required by Article 1(6) of Decision 2000/571/EC Not addressed See findings 34 and 35 See recommendation No 4 of the current audit report Conclusion on the follow-up of previous recommendations 37. The actions proposed to address recommendation No 1 from DG(SANCO)/ have not been effective and the recommendation remains unaddressed. 6 OVERALL CONCLUSIONS The responsibilities of competent authorities have been designated and communication, cooperation and coordination exist between veterinary authorities and Customs at national and Länder level. These systems, combined with the provision of a range of resources including appropriate written procedures and relevant training, support the implementation of the official controls on transits. 14

20 The three Länder visited have set up systems for official controls at BIPs which generally ensure that only consignments eligible for transit are allowed to be introduced into EU territory. The systems for implementing official exit controls on transits had only been established or were totally modified just prior to the audit at two of the three BIPs visited. Therefore, their effectiveness could not be fully assessed. Compliance with legal requirements and the effectiveness of official controls differed between the warehouses visited. The official controls largely complied with EU requirements at one of the approved warehouses visited and the competent authority was acting to improve their effectiveness to ensure the prompt confirmation of receipt of goods at destination. The other warehouse was approved under veterinary legislation for storage of non-conforming goods although it was not approved as customs warehouse and most of the official controls required under EU legislation were not being implemented. The Länder are responsible for the implementation of verification procedures which are mainly based on the implementation of internal audits of each Land s Quality Management System (QMS). The extent to which internal audits include transits varied greatly between Länder mainly because of the variation in the amount of transit related procedures in each QMS. Verification activities related to transits are usually linked to verification activities for import controls at BIPs and therefore do not always include official controls at approved warehouses. Furthermore, action to address a recommendation from a 2013 FVO report related to transits has still not been implemented. 7 CLOSING MEETING A closing meeting was held on 6 November with representatives from BMELV, BVL, the Länder of Bremen, Hamburg and Hessen, the Friedrich Loeffler Institute (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 on certain issues. In relation to finding 18 (warehouses storing non-conforming goods moving under "Form 302"), Customs reiterated that these goods are placed under the Truppenverwendung Customs procedure, which is subject to official Customs supervision. 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 ) and within the deadlines indicated in Article 6 of Decision 2001/812/EC where relevant. 15

21 No. Recommendation 1. To gather and analyse relevant information at Frankfurt/Main BIP to verify that eligible consignments in transit are subject to veterinary checks, as required by Article 6 of Regulation (EC) No 136/2004. Recommendation based on conclusion: 15. Associated finding: To ensure that controls at the warehouse are implemented in line with the EU requirements laid down in Decision 2000/571/EC and Directive 97/78/EC. Recommendation based on conclusion: 24. Associated finding: To implement actions to ensure that CVEDs issued for non-conforming consignments leaving approved customs warehouses are cross referenced to the original incoming CVEDs as required by Article 1(6) of Decision 2000/571/EC. Recommendation based on conclusion: 37 Associated findings: 34 and 35. The competent authority's response to the recommendations can be found at: 16

22 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 Dec. 2000/208/EC OJ L 64, , p Dir. 97/78/EC OJ L 24, , p Dir. 91/496/EEC OJ L 268, , p Dec. 2004/292/EC OJ L 94, , p Reg. 282/2004 OJ L 49, , p Reg. 136/2004 OJ L 21, , p /208/EC: Commission Decision of 24 February 2000 establishing detailed rules for the application of Council Directive 97/78/EC concerning the transit of products of animal origin from one third country to another third country by road only across the European Community 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 2004/292/EC: Commission Decision of 30 March 2004 on the introduction of the Traces system and amending Decision 92/486/EEC Commission Regulation (EC) No 282/2004 of 18 February 2004 introducing a document for the declaration of, and veterinary checks on, animals from third countries entering the Community 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

23 Dec. 2000/571/EC OJ L 240, , p Dec. 2009/821/EC OJ L 296, , p.1 Reg. 853/2004 OJ L 139, , p. 55, Corrected and re-published in OJ L 226, , p. 22 Dec. 2007/275/EC OJ L 116, , p /571/EC: Commission Decision of 8 September 2000 laying down the methods of veterinary checks for products from third countries destined for introduction into free zones, free warehouses, customs warehouses or operators supplying cross border means of sea transport 2009/821/EC: Commission Decision 2009/821/EC of 28 September 2009 drawing up a list of approved border inspection posts, laying down certain rules on the inspections carried out by Commission veterinary experts and laying down the veterinary units in Traces Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin 2007/275/EC: Commission Decision of 17 April 2007 concerning lists of animals and products to be subject to controls at border inspection posts under Council Directives 91/496/EEC and 97/78/EC