EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

Transcription

1 Ref. Ares(2017) /05/2017 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 ECUADOR FROM 15 NOVEMBER 2016 TO 24 NOVEMBER 2016 IN ORDER TO EVALUATE THE CONTROL SYSTEMS IN PLACE GOVERNING THE PRODUCTION OF FISHERY PRODUCTS DERIVED FROM TUNA SPECIES INTENDED FOR EXPORT TO THE EUROPEAN UNION 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 Ecuador carried out from 15 to 24 November 2016, as part of the published Directorate-General for Health and Food Safety audit programme. The objective of the audit was to evaluate whether the official controls put in place by the competent authority can guarantee that the conditions of production of fishery products derived from tuna species in Ecuador destined for export to the European Union are in line with the requirements laid down in European Union legislation, and in particular with the health attestations contained in the model health certificate of Appendix IV to Annex VI to Commission Regulation (EC) No 2074/2005, hereinafter referred to as the European Union export certificate. The current audit is the third in a series of audits dedicated to getting a clearer picture of the tuna industry as a whole and determine if the tuna imported into the European Union meets the applicable requirements concerning public health standards (in particular limits for histamine and heavy metals) also in the context of fish policy requirements and customs rules. The scope of the audit series extends to geographically identified hubs, where tuna and tuna-like species caught are landed and/or processed (all forms) for export to the European Union. Ecuador was selected following a Directorate-General for Health and Food Safety in-depth review of European Union tuna imports in which it was identified as a medium tuna exporter potentially operating in two of the geographically important tuna catching areas (Eastern and Central & Southeast Pacific Ocean). The report concludes that the official control system developed and implemented by the competent authority is based on adequate procedures and legislation aiming to provide the guarantees required for European Union export health certification. Most of the components of that control system provide those guarantees. However, the implementation of the control system presents weaknesses that may allow the export to the European Union of fishery products contaminated with diesel, mainly due to the dual use of storage tanks and food business operators' quality control procedures. The control system also presents serious weaknesses with regard to the control of raw materials used for the production of fish oil (in general and derived from tuna species). These weaknesses do not allow the competent authority to provide with confidence the guarantees required by the European Union export certificate when exporting tuna fishery products to the European Union. The report addresses to the Ecuadorian competent authority recommendations aimed at rectifying identified shortcomings and enhancing the control system in place. I

3 Table of Contents 1 Introduction Objective and scope Legal Basis Background General Background Production and Trade Information Rapid Alert System for Food and Feed (RASFF) Notifications Findings and Conclusions Legislation Competent Authority National provisions and procedures for listing establishments exporting Fishery Products to the EU Official controls Official controls of production and placing on the market Official controls of fishery products Follow up of RASFF Notifications Laboratories Official certification Overall Conclusions Closing Meeting Recommendations...25 Annex 1 Legal References Annex 2 - List of tuna species and CN product codes II

4 ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT Abbreviation ACPAA DG Health and Food Safety DPI EC EU EU export certificate EU listed FAO FBO HACCP INP MAGAP NCP PAH PCB's RASFF TRACES TVB-N Explanation Quality Assurance for Fisheries, Aquaculture and Environment (Aseguramiento de la Calidad Pesquera, Acuícola y Ambiental) Directorate-General for Health and Food Safety of the European Commission Directorate of Industrial Fisheries (Dirección de Pesca Industrial) European Community European Union Model health certificate for imports of fishery products intended for human consumption as defined in Appendix IV to Annex VI to Commission Regulation (EC) No 2074/2005 The facilities approved and registered by the Ecuadorian authorities for participation in the fisheries products for EU export production chain which are communicated to the EU in list form Food and Agriculture Organization (United Nations) Food business operator Hazard Analysis and Critical Control Points Fisheries National Institute (Instituto Nacional de Pesca) Ministry of Agriculture, Livestock, Aquaculture and Fisheries (Ministerio de Agricultura, Ganadería, Acuacultura y Pesca) National Control Plan Polycyclic aromatic hydrocarbons Polychlorinated biphenyls Rapid Alert System for Food and Feed Trade Control and Expert System Total volatile basic nitrogen III

5 1 INTRODUCTION The audit took place in Ecuador from 15 to 24 November 2016 and was undertaken as part of the Directorate-General for Health and Food Safety (DG Health and Food Safety) planned audit programme. The audit team comprised two inspectors from DG Health and Food Safety. An opening meeting was held in Guayaquil on 15 November with the competent authority within the scope of this audit, the Fisheries National Institute (INP Instituto Nacional de Pesca) of the Ministry of Agriculture, Livestock, Aquaculture and Fisheries (MAGAP Ministerio de Agricultura, Ganadería, Acuacultura y Pesca) and the Vice-Minister for Aquaculture and Fisheries. Other relevant services of the Aquaculture and Fisheries Vice- Ministry were also present. At this meeting the audit team confirmed the objective of, and the itinerary for the audit, and requested additional information on specific elements of the control system in place. Representatives from the competent authority accompanied the audit team throughout the audit. 2 OBJECTIVE AND SCOPE The objective of the audit was to evaluate whether, the official controls put in place by the competent authority can guarantee that the conditions of production of fishery products derived from tuna species 1 in Ecuador destined for export to the European Union (EU) are in line with the requirements laid down in EU legislation, and in particular with the health attestations contained in the model health certificate of Appendix IV to Annex VI to Commission Regulation (EC) No 2074/2005 2, hereinafter referred to as the EU export certificate. In terms of scope, the audit focused on the following elements applicable to fishery products derived from the various tuna species to be exported to the EU: The organisation and performance of the competent authority. The official control system in place covering fishing, production, processing and distribution chains. The export certification procedure. Additionally, the scope included certain elements indirectly reflected in the EU export certificate, such as labelling (also linked with food fraud and fish substitution) and traceability covering the full fishery products production chain (also benefiting from some elements of the rules on illegal, unregulated and unreported fisheries from fishing ground to the consignment for export). Accordingly, certain aspects of the EU legislation 3 referred to in Annex 1 were used as a technical basis for the audit. Full legal references to EU legal acts quoted in this report are provided in that Annex and refer, where applicable, to the last amended version. 1 A list of species and the Combined Nomenclature (CN) product codes covered are indicated in Annex 2. 2 Model health certificate for imports of fishery products intended for human consumption as defined in Appendix IV to Annex VI to Regulation (EC) No 2074/ EU legislation (Internet): 1

6 In pursuit of this objective, the audit team visited the following sites: Competent Authority Central level 2 Main Headquarters. Regional level 1 Certification Office - Manta. Landing Sites Landing Areas 3 Two of which were an integral part of the processing establishments. Processing Facilities Freezer Vessels 4 Additional information was gathered with regard to three other vessels. Cold stores (not EU listed) 1 Processing (EU listed) establishments 8 Seven of them manufacturing canned tuna and the remaining one fish oil. 3 LEGAL BASIS The audit was carried out under the general provisions of EU legislation, in particular Article 46 of Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules. 4 BACKGROUND 4.1 GENERAL BACKGROUND As far as the scope of the current audit is concerned, Ecuador is included in Annex II to Commission Decision 2006/766/EC which sets out the list of third countries and territories from which imports of fishery products are permitted. Ecuador is authorised to export fishery products to the EU from 87 processing establishments and 115 freezer vessels 4. The list of those authorised facilities is available on the European Commission website: ( trade/non-eu-countries_en). According to TRACES (Trade Control and Expert System) data, between 2013 and 2015, the EU imported tuna fishery products from twenty-seven processing establishments and from four freezer vessels. The last audit by the Commission services to Ecuador covering fishery products took place from 26 November to 5 December 2013 (hereinafter the 2013 audit). The 2013 audit report 5 made seven recommendations to the competent authority, which, in response, provided an action plan with corrective actions to address those recommendations. The current audit report describes, where applicable, the implementation of those corrective actions 6 in the 4 The current list has 117 freezer vessels but it contains two repeated entries. 5 Report reference DG(SANCO) which is available at:- 2

7 relevant sub-sections of section 5. This audit is the third in a series of audits dedicated to obtaining a clearer picture of the tuna industry as a whole and to determine whether tuna imported into the EU meets the applicable requirements concerning public health standards (in particular limits for histamine and heavy metals) also in the context of fish policy requirements and customs rules. The scope of the audit series extends to geographically identified hubs, where tuna and tuna-like species caught are landed and/or processed (all forms) for export to the EU. Ecuador was selected following a DG Health and Food Safety in-depth review of EU tuna imports in which the country was identified as a medium tuna exporter potentially operating in two of the geographically important tuna catching areas (Eastern and, Central & Southeast Pacific Ocean). 4.2 PRODUCTION AND TRADE INFORMATION According to EUROSAT from 2013 to 2015 Ecuadorian exports of fishery products from tuna species amounted to circa 362,900 tonnes of tuna fishery products (roughly 120,000 tonnes per year). The vast majority (approximately 95.6%) of the exported products were processed fishery products belonging to the Combined Nomenclature (CN) code 1604 and the remaining 4.4% frozen fishery products belonging to the CN code 0303 and The competent authority was not able to provide to the audit team reliable data with regard to the production (caught fishery products), imports and exports of tuna fishery products to the EU. From the information collected during the visits to the processing establishments the audit team noted that fishery products exported from Ecuador originated from fishing activities that took place in the major FAO (Food and Agriculture Organization (United Nations)) fishing areas 77, 81 and 87 (Pacific Ocean). In terms of fisheries management and conservation measures these fishing areas are managed by the following Regional Fisheries Management Organisations covering tuna: Commission for the Conservation of Southern Bluefin Tuna (CCSBT) FAO area 81. Inter-American Tropical Tuna Commission (IATTC) FAO areas 77, 81 and 87. Western and Central Pacific Fisheries Commission (WCPFC) FAO areas 71 and RAPID ALERT SYSTEM FOR FOOD AND FEED (RASFF) NOTIFICATIONS Members of the RASFF network 7 have issued eight notifications for Ecuadorian tuna fishery products since the 2013 audit. Seven were due to levels of heavy metals above the EU regulatory limits and one was due to levels of histamine also above the EU regulatory limits. 6 In particular recommendations Nos 1, 2, 4 and 7. 7 European Commission, EFSA, EFTA Surveillance Authority, EU member states, Iceland, Liechtenstein, Norway and Switzerland. 3

8 Section 5.5 below describes how the competent authority handled those RASFF notifications. 5 FINDINGS AND CONCLUSIONS 5.1 LEGISLATION Legal requirements Article 46(1)(a) of Regulation (EC) No 882/2004. Article 11(4)(a) of Regulation (EC) No 854/2004. Findings 1. According to the information provided by the competent authority the main legislation applicable to fishery products (including those derived from tuna species) has not changed since the 2013 audit and can be found in that audit report, i.e. the Ministerial Agreement No 241 (Official Gazette No 228 of July 5, 2010), establishing the minimal sanitary requirements to be fulfilled by the fish and aquaculture industry and other subsidiary legislation. 2. In addition to the Ministerial Agreement No 241 the competent authority issued Resolutions and Notifications (Oficios) establishing additional rules or requirements to be followed by the operators when involved in the production chain of fishery products intended to be exported to the EU. Examples of those are: Resolution ADM-INP , of 31 January 2013 defining the procedures that food business operators (FBOs) must follow in order to be included or withdrawn from the official list of INP. Notification MAGAP-INP OF, of 16 April 2014 requiring FBOs of establishments and freezer vessels involved in the production chain of fishery products intended to be exported to the EU to implement permanent procedures based on Hazard Analysis and Critical Control Points (HACCP) principles and also to install temperature recording devices where needed (storage of frozen fishery products). Resolution MAGAP-INP R, of 26 July 2016 defining the technical requirements for the authorisation of external laboratories to perform official control tests. 3. The issuance of the Notification MAGAP-INP OF by the competent authority is related to the implementation of the guarantees provided with regard to the recommendation No 2 8 of the 2013 audit report. 4. The legislation establishing INP as the competent authority and describing its authority, powers and duties has not changed since the 2013 audit. The 2013 audit report describes that legislation in its section 5.1, in particular, the Supreme Decree No 2026 (Official Gazette No 486 of December 19, 1977). 8 Recommendation No 2 of the 2013 audit report The CA should ensure that establishments from which fishery products have been dispatched, obtained or prepared, in particular those not exporting directly to the EU, comply with standards equivalent to the requirements of Article 5 of Regulation (EC) No 852/2004 and Section VIII of Annex III to Regulation (EC) No 853/2004, in order to be able to provide all the necessary guarantees required in Article 12 (2) of Regulation (EC) No 854/

9 5. The competent authority requires FBOs participating in the production chain of fishery products intended for EU export to agree to be subject to the above mentioned legislation and any rules defined by the competent authority derived from that legislation. 6. In addition to the above mentioned legislation, since 2013, the competent authority issued the Ministerial Agreement No 227 (published in 1 September 2015) which adopts the National Control Plan (NCP). 7. This NCP includes a description of all elements of the official control system and establishes the requirements for its implementation. It covers, amongst others, the following elements: Operational organisation of INP. Listing procedures (for the EU list and for lists of other facilities participating in the production chain of fishery products for EU export (called internal lists by the competent authority)). Export certification for the EU market. Sanitary alert system and its management. Monitoring of fishery products (Monitoring Plan). Official control of establishments (verification in Ecuadorian documentation hereinafter inspection). Additional legal requirements (according to the NCP directly applicable). 8. The competent authority stated to the audit team that, in their view, the NCP is the Ecuadorian document that clearly indicates to all those involved in the production chain of fishery products for EU export, the requirements to be followed and also the requirements to be verified during the official control tasks. This position is supported by the fact that the NCP was published as part of a ministerial agreement which is made publicly available on the INP webpage ( 9. The audit team is of the opinion that the NCP clarifies and supplements the Ecuadorian applicable legislation and provides valuable guidance to both the FBOs and official staff. However, the audit team noted that the NCP section on additional requirements does not refer to the last amended versions of the EU legislation and also contains several references to repealed EU legislation. 10. The audit team is of the opinion that making reference in the NCP to repealed EU legislation, either updated or replaced, could undermine in certain cases, the ability of the competent authority to demonstrate that applied standards are at least equivalent to the EU rules in force. The discrepancies were indicated to the competent authority, in particular the reference to Regulation (EC) No 466/2001 instead of Regulation (EC) No 1881/2006. Conclusions 11. The audit team concludes that globally the Ecuadorian legislation (and standards) in force covering the exports of fishery products to the EU gives an adequate basis to provide guarantees as to their equivalence with EU rules for the sector. Nevertheless, the reference in the NCP to repealed/modified EU regulations has the potential to weaken the guarantees given by the competent authority that products exported to the EU comply or are produced in compliance with standards at least equivalent to current EU rules. 5

10 12. The audit team concludes that the competent authority has implemented satisfactorily the action proposed to address recommendation No 2 of the 2013 audit report. 5.2 COMPETENT AUTHORITY Legal requirements Article 46(1) of Regulation (EC) No 882/2004, in particular points (b) to (e) of the aforementioned Article. Findings Structure and organisation 13. The competent authority for the official control of fishery products destined for EU export and their production chain is still the INP (as per the 2013 audit report). 14. The Quality Assurance for Fisheries, Aquaculture and Environment (Aseguramiento de la Calidad Pesquera, Acuícola y Ambiental - ACPAA) within the Scientific Sub-Directorate of INP is the service directly in charge of the official control of fishery products destined for EU export and their production chain. For operational reasons, and in spite of the different organisational arrangements (see figure 1 below INP organigram (source December 2016)), this service is divided into three main areas: Verification area in charge of the official controls of fishery products and their production (e.g. freezer vessels, cold stores and processing establishments). Located in INP`s Guayaquil head-quarters. Certification area in charge of certification for EU exports. Located in Guayaquil headquarters and with an additional office in Manta. Laboratory area official laboratory for testing of fishery products. Also located in Guayaquil. 15. As indicated in section 1 above, other relevant services of the Aquaculture and Fisheries Vice-Ministry, the Directorate of Industrial Fisheries (Dirección de Pesca Industrial - DPI) of the Sub-Secretary of Fishery Resources, were also present at the opening meeting and also during part of the audit. DPI is in charge, amongst others, of the issuance of the catch certificates and processing statements (model in Annex IV of Council Regulation (EC) No 1005/2008) for EU exports. Other directorates of the Sub-Secretary of Fishery Resources also take part in the control of the fisheries policy to enable DPI to issue the EU catch certificates or processing statements mentioned above. These authorities do not have any involvement in the food safety aspects of fishery products exported to the EU but they possess elements that allow for the verification of the traceability of fishery products and the description of the fishing fleet (mainly freezer vessels). Both DPI and INP informed the audit team that frequent meetings to exchange information take place between them. 6

11 Powers, Independence and Supervision Figure 1 INP organigramme 16. The Ecuadorian legislation mentioned in section 5.1 and in particular Articles 1 to 5 of the Ministerial Agreement No A set out the powers of the competent authority to perform official controls. Those powers include amongst others, unrestricted access to premises and documentation related to the production of fishery products, product sampling, suspension of export certification and approval withdrawal (including removal from the EU list or the internal lists as applicable). 17. During the audit the competent authority provided to the audit team an example of export certification suspension of an EU listed establishment involved in several RASFF notifications. In addition, the competent authority suspended the export certification of an establishment during the current audit due to the seriousness of the deficiencies observed during the visit to that establishment (see paragraphs 76 to 80 of section below). 18. The provisions as regards conflict of interest of official staff while performing their duties (P-VRF-15 and P-VRF-16) remain as described in the 2013 audit report. 7

12 19. To enhance the supervision mechanism described in the 2013 audit report the competent authority has implemented random supervision visits which are performed by specifically appointed staff. These supervision visits, carried out in accordance with Article 55 of the NCP, assess the level of compliance of the establishment (covering the whole establishment or a selected part of it) as well as the performance of the official staff in previous visits and the current visit. 20. During 2015 and 2016 the competent authority performed, respectively, seven and ten random supervision visits. The results of those visits were considered satisfactory in the majority of the cases. 21. The competent authority provided the audit team with reports of those supervisory visits. The audit team noted that the reports are detailed and in certain cases deficiencies had been recorded. In those cases, the report contains recommendations addressed to the services to correct the deficiencies detected. Training Knowledge of EU requirements 22. In their answer to the pre-audit questionnaire the competent authority presented detailed information concerning the trainings provided to official staff since the 2013 audit. The trainings covered several topics relevant to the performance of official controls of fishery products and their production chain. The most relevant of these are: sanitary legislation and good manufacturing practices; food safety; auditing; sampling; inspection; HACCP based procedures; and EU legal requirements. 23. The audit team noted also that, as already mentioned in the 2013 audit report, new staff receive on-the-job mentoring from senior inspectors when performing their first official control visits. 24. In general, official staff interviewed by the audit team showed an adequate level of knowledge concerning the applicable EU requirements. However, and despite the improvements noted since the 2013 audit, official staff met still present gaps with regard to their ability to assess the HACCP based procedures and in particular HACCP principle The audit team noted that official staff have difficulties understanding and interpreting the last step of HACCP principle 1 (risk assessment) and the approach to be followed to decide whether or not a certain production step should be defined as a critical control point. This knowledge gap contributed significantly to the findings described in paragraph 66 of section The weaknesses with regard to the knowledge on HACCP by officials had already been identified in the 2013 audit report which made a recommendation in that regard (recommendation No 1 9 ). Despite the training provided since 2013, some gaps on this subject persist. Resources available to the competent authority 27. The audit team noted that competent authority officials have access to adequately equipped offices and also have the necessary means, materials and equipment to perform their official tasks. 9 Recommendation No 1 of the 2013 audit report The CA should ensure that staff in charge of performing official controls is adequately trained to perform the assessment of standards equivalent to the requirements of Article 5 of Regulation (EC) No 852/

13 28. According to the competent authority twenty-three staff (including a national coordinator and two clerical officers) at central level are directly involved in the official controls of fishery products and their production chain, i.e. inspections. 29. The competent authority has another five staff assigned to export certification; four are located in the headquarters and one in Manta office. These certifying officers are assisted by three clerical staff in the headquarters and one assistant and two clerical staff in Manta office. 30. For the purpose of official control testing of fishery products (tuna) and water the competent authority has access to its own laboratory and to a foreign laboratory (for testing of dioxins and polychlorinated biphenyls (PCB's)). Both laboratories are accredited to ISO/IEC 17025:2005 for the parameters tested. Documented control procedures 31. The competent authority has drafted and adopted several documents to assist them in the performance of the official controls of tuna fishery products to be exported to the EU. 32. Those documents include procedures and an instruction manual for: The export certification (P-PC-1, P-PC-2 and PC-013). The approval and listing of establishments (EU list and internal list) (P-VRF-1-A, P-VRF-1-C and P-VRF-06). The inspection of facilities involved in the production chain for EU exports (EU list and internal list) (P-VRF-03, P-VRF-05, P-VRF-14). The evaluation of HACCP based procedures (P-VRF-04). The reporting of inspection results (P-VRF-07). The follow-up of deficiencies identified during inspections. The official sampling (P-VRF-08), the assessment of the test results (P-VRF-09) and the follow-up of non-conforming results (P-VRF-10). The recording of official control activities (P-VRF-12). The sensory evaluation of fishery products (P-VRF-19). The verification of traceability (P-VRF-20) and labelling (P-VRF-21). The User Instruction Manual for the use of ACPAA software (replacing manual completion of checklist, forms, etc.). 33. The above mentioned documentation is further complemented by the relevant part of the NCP that includes the forms (check-lists) to be used by official staff during inspections of facilities. 34. The audit team noted that the procedures drafted cover, in general, the role and mandate of the competent authority with regard to the official control of fishery products for EU export and their production chain and that the requirements mentioned therein are in line with the applicable EU requirements. The audit team also noted that, in general, the written procedures are adequately implemented. 9

14 Conclusions 35. The competent authority has a structure, organisation, powers, staff (including freedom from conflict of interest), documented control procedures and resources available that can be considered appropriate for an official control system covering the production chain of tuna fishery products for EU export. These should allow the competent authority to provide adequate guarantees as regards compliance with the relevant EU requirements. 36. However, the gap identified in the knowledge of official staff of HACCP principles undermines the ability of the competent authority to guarantee that facilities participating in the production chain of tuna fishery products for EU export comply with requirements at least equivalent to the EU rules concerning the implementation of HACCP based procedures. 37. The audit team concludes that the implementation by the competent authority of the action proposed to address recommendation No 1 of the 2013 audit report is not fully satisfactory. 5.3 NATIONAL PROVISIONS AND PROCEDURES FOR LISTING ESTABLISHMENTS EXPORTING FISHERY PRODUCTS TO THE EU Legal requirements Article 12(1), (2) and (3) and Article 13 of Regulation (EC) No 854/2004. Parts I.8., I.11. and I.28. of the model health certificate for imports of fishery products intended for human consumption established in Appendix IV to Annex VI to Regulation (EC) No 2074/2005. Findings 38. The competent authority has in place written procedures for the listing of facilities permitted to export fishery products directly to the EU (see paragraphs 7 and 32 above). The EU list is made available to European Commission services and it is also published on the competent authority's website, at This list includes all processing establishments exporting directly to the EU and all freezer vessels involved in the production of fishery products destined for the EU market. The competent authority informed the audit team that the EU list had been recently updated concerning the freezer vessels involved in the production chain of fishery products for EU export. 39. Similar procedures cover the listing of other facilities ( internal list ) not exporting directly to the EU but participating in the production of fishery products destined to the EU. These internal lists are available on the competent authority s website at As regards the scope of the current audit, these lists include independent cold stores and facilities producing crude fish oil. 40. The inclusion in the internal list is a pre-requisite for an FBO to request the EU listing of its facility. 41. The listing procedure (both for EU and internal listing) includes an application submitted by the interested FBO, accompanied by the relevant documentation, which is then followed by a desk evaluation of the file and an on-the-spot check of the facilities by the competent authority. 10

15 42. Where the desk evaluation and the on-the-spot check demonstrate that the concerned facility conforms (hereinafter, in compliance) with the applicable requirements, the competent authority issues an approval and proceeds with the listing. 43. The approval granted does not expire, instead, all listed establishments (both EU and internal lists) are subject to regular inspections to assess their level of compliance with the requirements that allowed for their listing. If during a regular inspection an establishment is found non-conforming (hereinafter, non-compliant) the competent authority may suspend the export certification (only for EU listed establishments) and/or withdraw the approval (with subsequent delisting of the facility concerned). 44. The audit team noted that since the last audit no additions of processing establishment to the EU list occurred. 45. As mentioned above in paragraph 38, recently the competent authority included in the EU list all freezer vessels involved in the production of fishery products for EU export based on the results of inspections made throughout 2016 and only for those vessels that comply with requirements at least equivalent to the EU rules. The competent authority provided to the audit team a list of the vessels inspected. The audit team noted that all EU listed vessels had been inspected and that the competent authority paid particular attention to the implementation of procedures based on the HACCP principles and the presence of a temperature recording device. 46. Considering the scope of the current audit, the audit team also noted that while inspecting cold stores the competent authority also assesses the implementation of the procedures based on the HACCP principles and the presence of a temperature recording device. 47. The actions taken by the competent authority described in paragraphs 45 and 46 have been implemented to address the recommendation No 2 of the 2013 audit report. 48. The audit team noted, as described in section below, that facilities involved in the production of fishery products for EU export included in the EU list and in the internal lists have been regularly inspected by the competent authority to verify their level of compliance with the applicable requirements. The audit team also noted that the competent authority updates the EU list and communicates to the EU Commission those changes. These procedures follow adequately the requirements of Article 12 of Regulation (EC) No 854/2004. Conclusions 49. The competent authority has developed and implements procedures to list and approve both establishments exporting fishery products directly to the EU as well as establishments supplying these exporters. The procedures can be considered as providing adequate guarantees with regard to the requirements of Article 12 of Regulation (EC) No 854/ OFFICIAL CONTROLS 5.4.1Official controls of production and placing on the market Legal requirements Article 11(4) and 12(2) of Regulation (EC) No 854/2004. Point II.1 (and point II.2 in case of aquaculture products) of the model health certificate for imports of fishery products intended for human consumption established in Appendix IV to 11

16 Annex VI to Regulation (EC) No 2074/2005, in particular official controls laid down in Annex III, Chapter I of Regulation (EC) No 854/2004. Findings Official control system in place 50. The competent authority in their answer to the pre-audit questionnaire stated that the vast majority of the tuna fishery products exported to the EU are produced from frozen raw materials caught by freezer vessels (purse-seiners and long-liners). As such the audit focused on this part of the production chain. 51. The competent authority has an official control system, based on the legislation and the written procedures mentioned in sections 5.1 and 5.2, with a view to verifying that all facilities involved in the production chain of fishery products destined to EU export comply with requirements at least equivalent to the applicable EU rules. This official control system is described in detail in the NCP. 52. The NCP indicates the frequencies for the inspections and the check-lists to be used. The conditions during unloading are assessed during the inspections to freezer vessels. 53. Facilities included in the internal list and freezer vessels are inspected once a year while the EU listed facilities are inspected every six months. 54. The inspections are performed using different checklists depending on the facility type and the activities performed. The level of compliance of the establishment based on the percentage of compliance must be indicated at the end of each checklist. The thresholds and criteria to determine the levels of compliance (i.e. fully, partly or non-compliant), are defined in the NCP and are also set out in the checklists. 55. Where deficiencies are detected, official staff is required to signal them in the checklist and provide a brief explanation of each deficiency. FBOs are provided with a copy of the completed checklist and are required to provide an action plan to address the deficiencies and to correct them within an agreed deadline. The follow-up of the correction of the deficiencies by the competent authority is performed in accordance with the final classification of the establishment and as follows: Establishment compliant all deficiencies must be corrected before the next inspection. Establishment partially compliant the deficiencies must be corrected within the deadlines established in the action plan. Establishment non-compliant all deficiencies must be corrected immediately. 56. Inspections to processing establishments can cover all the applicable requirements (full inspection carried out at least once a year) or certain specific parts of the production and/or facility (partial inspection designed in particular for the follow-up of deficiencies or of previous inspections). These inspections are announced. Aspects covered during the inspections have been divided into: Structural requirements. Pre-requisites and hygiene requirements. Procedures based on the HACCP principles and its implementation. Providers of raw materials. Traceability. 12

17 57. The competent authority also carries out unannounced inspections, aimed at assessing both the premises and the performance of official staff (random supervision visits). 58. In general, inspections are carried out by a team of two inspectors. Landing operations 59. In accordance with the NCP, an assessment of landing operations is carried out as part of the inspection visits to establishments and to freezer vessels. 60. The audit team visited three landing areas, two of them were associated with processing establishments and the third was independent. The audit team noted that those landing areas, in principle, met EU equivalent standards as regards structural and hygiene requirements. 61. The audit noted that the competent authority assessed the landing conditions during the visits to the freezer vessels and to the processing establishments. The competent authority made available to the audit team reports of those visits which showed that in general the landing operations had been carried out in accordance with the applicable rules. 62. During the audit it was not possible to witness an unloading at port but the competent authority made available to the audit team records of previous inspections of landing operations. Those records showed that landing operations were carried out hygienically. 63. The audit team observed in one establishment the reception and sorting of recently unloaded fish. The fish had been transported from the landing area to the establishment by a truck (shortcomings identified at reception can be found in paragraph 75 below). Facilities, including vessels, handling fishery products 64. The audit team visited four freezer vessels and eight processing establishments included in the EU list. The audit team also visited one cold store not included in the EU list but participating in the production chain of fishery products for EU export. In addition, the audit team gathered additional information with regard to three other EU listed freezer vessels. 65. During our visits to the freezer vessels the various FBOs informed the audit team that: All vessels have been constructed or adapted to use storage holds (or tanks), initially intended to freeze and store frozen fishery products, to store diesel (hereinafter referred to as dual use holds). This practice consists in using those holds to store diesel during part of the fishing trip allowing the FBO to extend the duration and/or range of fishing trips beyond the normal travel capacity of the vessel. The holds storing fuel are subject to a washing, rinsing and ventilation to remove any residues of diesel before being used for fishery products. They have drafted procedures for cleaning, which include cleaning records. The dual usage of storage holds had been communicated to and approved by the Ecuadorian Ministry of Transports and Public Works (hereinafter Ministry of Transports) covering seaworthiness conditions and MARPOL (International Convention for the Prevention of Pollution from Ships) rules. 66. During the same visits the audit team observed: The dual use holds are clearly identified within vessels` documentation. Approval for dual use is issued by a service of the Ecuadorian Ministry of Transports. 13

18 FBOs drafted cleaning procedures and the cleaning reports were available. Those cleaning procedures neither detail the use of chemicals approved for use on surfaces in direct contact with foodstuffs nor provide information on the validation of the cleaning process to prevent the contamination of fishery products with residues of the cleaning chemicals. Moreover, the audit team observed in one case that the chemicals used for the cleaning were not authorised for use in the food industry and in another case the chemicals used were authorised for the food industry but not for use on surfaces in direct contact with foodstuffs. In one vessel, recently arrived from a fishing trip, the dual use holds which were empty at the time (the fish having been unloaded) presented a strong smell of diesel. In three of the vessels, the surface of the storage holds does not allow a proper cleaning due to the pipework of the cooling system (a serpentine construction). In two cases the HACCP plans presented by the FBOs were not in line with the EU rules, in particular with the process used for the identification of the critical control points (principle 2 of the HACCP). In one vessel visited the temperature recording device of one storage hold had stopped working almost ten days before the completion of the fishing trip and the FBO has neither recorded the non-compliance nor defined the corrective actions to ensure that despite the malfunctioning of the device the correct temperature of the products could be maintained. Furthermore, the audit team noted that the FBO did not have in place a documented system to record non-compliances observed and the respective corrective actions taken. 67. All freezer vessels visited had been inspected by the competent authority in line with the set frequency. The reports provided to the audit team indicated that the deficiencies mentioned above had not been detected by the competent authority. The competent authority stated to the audit team that they were not aware of the practice of dual use of storage tanks. 68. The information gathered for the other three freezer vessels contained similar evidences to the ones indicated above. 69. The audit team requested of the competent authority a complete description of the situation of the 115 EU listed freezer vessels with regard to the dual use practice. The competent authority passed to the audit team the following information provided by the services of the Ecuadorian Ministry of Transports: Two of the freezer vessels included in the EU list had sunk (the request for their removal from the EU list had already been submitted). There was no information available on dual use of storage holds or its authorisation for nine freezer vessels (eight long-liners and one purse-seiner). There were fifteen freezer vessels without authorisation for dual use of holds (the audit team did not have enough information to ascertain whether or not they were engaged in such a practice). Six freezer vessels had not requested authorisation for dual use (the audit team did not have enough information to ascertain whether or not they were engaged in such a practice). The remaining 83 freezer vessels are authorised for the dual use of storage tanks. 14

19 The percentage of storage holds authorised for dual use ranges from 10% to 53% (36 vessels have more than 30% of their storage holds authorised for dual use). 70. Based on the above the audit team finds that the freezer vessels visited, and all the others engaged in the dual use practice, cannot be considered in line with the EU rules, in particular with point I.A.1. of Chapter I, Section VIII of Annex III to Regulation (EC) No 853/2004 (structural and equipment requirements for vessels) and point 2 of Chapter IV of Annex II to Regulation (EC) No 852/2004 as the vessels are not designed and constructed so as not to cause contamination of the products with fuel and the storage holds where the fish is transported are used for the transport of substances other than foodstuffs that may result in contamination (see paragraphs 78 to 80 below for evidences of contamination). 71. The audit team visited one cold store (only included in the Ecuadorian internal list) and noted that the competent authority performed regular inspections within the set frequencies. During the visit the audit team noted two important shortcomings, previously not detected by the competent authority, which were related to hygiene practices (storage of packaged products in the vicinity of exposed products) and equipment requirements (the location of the temperature sensor was not in line with the EU rules, namely point B of Chapter III of Section VIII of Annex III to Regulation (EC) No 853/2004). 72. The audit team visited eight processing establishments, seven mainly for canned tuna fishery products and one for fish oil. 73. With regard to the establishments producing mainly canned tuna fishery products the audit team noted that all of them had been inspected by the competent authority in accordance with the set frequencies. During those inspections visits official staff used adequately the relevant forms and the deficiencies observed were duly noted. In this regard the audit team noted that the records related to the deficiencies were minimal and would not allow for a proper and complete follow-up of the situation as verified on the spot. 74. Two of the establishments visited by the audit team could be considered as broadly in line with the EU rules. 75. The audit team found four of the seven establishments as partially compliant (one of the establishments presented poorer conditions than the other three) with EU equivalent requirements due to the deficiencies noted during our visits. Those deficiencies, previously not detected by the competent authority, include the following: Main deficiencies related to structural requirements: o o o o o o Sorting (classification) and cooling areas not pest-proof and ceiling not allowing for adequate cleaning. Floors allowing the pooling of water. Pipes with non-potable water in production rooms not identified as indicated in FBO documentation (colour coded). Changing rooms for workers located outside premises workers need to walk in the open air between changing rooms and production areas. Ceilings of production areas with condensation. Poorly maintained concrete tanks used for thawing. Main deficiencies related to hygiene requirements and HACCP: 15

20 o o o o o o Water used for thawing of frozen fishery products not in line with Ecuadorian and EU requirements dark colour and putrid smell (possible source of contamination). Cooking trays inadequately cleaned. Storage of discarded fishery products (waste) not clearly separated from raw materials. Own-check controls, as defined by the FBO, not adequately followed. Temperature control at reception not carried-out as planned and not adequately recorded. Procedures for the control of raw materials at reception that can allow the production of fishery products from raw materials with a high probability of being contaminated with diesel. 76. In one establishment the audit team found some of the deficiencies identified above but also detected the presence in that establishment of raw materials contaminated with diesel. 77. Moreover, during the visit the audit team also noted that procedures in place to manage the placement of the bins with fishery products inside the cold stores did not allow the correct location of the bin to be identified accurately (located in places different from those initially defined in the same cold room and bins located in cold rooms different from those indicated). Despite the deficiency related to their location, the traceability of fishery products to the vessel was maintained due to the bin labelling system in place. 78. With regard to the raw materials contaminated with diesel the audit team noted that: Circa 193 tonnes of fish presenting signs of contamination with diesel (different degrees of smell ranging from light to strong) had been received from a total of circa tonnes fishery products caught by a freezer vessel. When the diesel smell was detected the raw material received was blocked and stored in the cold stores and the unloading of additional fishery products from that vessel was suspended. The FBO informed the audit team that they had the suspicion that all fishery products of that vessel were contaminated with diesel. The blocked batch (193 tonnes) was then submitted to a special production procedure based on organoleptic evaluation of each individual fish (smell and taste) at different production steps (i.e. selection, thawing and evisceration, cooking and trimming) and of finished products (after sterilization). This procedure is documented and is part of the standard operating procedures of the FBO. Under this procedure the parts of the fish that have diesel smell are removed (scraping of skin and meat) until the products no longer present such smell. A final sensory test is performed on the canned product which will be fully rejected if a diesel taste or smell is detected. In summary, the procedure allows the production and placing on the market of fishery products from fish initially contaminated with diesel that does not present smell or taste in specific steps of the production, i.e. selection, thawing and evisceration, cooking, trimming and sterilization. According to the information provided by the FBO the rejected contaminated fishery products are sent to the fish meal and fish oil processing establishments (plantas harineras y produtoras de aceite). 79. The audit team is of the view that the entire batch of raw materials where diesel smell was detected cannot be used for the production of fishery products to be exported to the EU due 16