EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

Transcription

1 Ref. Ares(2017) /09/2017 EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Health and food audits and analysis DG(SANTE) FINAL REPORT OF AN AUDIT CARRIED OUT IN INDONESIA FROM 28 FEBRUARY 2017 TO 09 MARCH 2017 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

2 Executive Summary This report describes the outcome of an audit in Indonesia carried out from 28 February to 9 March 2017, 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 Indonesia 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 Regulation (EC) No 2074/2005, hereinafter referred to as the European Union export certificate. The current audit is the fifth in a series of audits dedicated to getting a clearer picture of the tuna industry as a whole and to verify 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. Indonesia 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 (Indian Ocean (Eastern) and Pacific Ocean (Western Central)). The report concludes that the official control system developed by the competent authority is based on adequate procedures and legislation aiming to provide the guarantees required by the public health attestations of the European Union export health certificate. The legislation presents important gaps, notably related to the absence of a Hazard Analysis and Critical Control Points plan for freezer vessels and the exemption of fishing vessels below 20 gross tonnage from sanitary controls. Those elements of the control system covering primary production and some establishments which are not EU listed (freezer vessels and fish suppliers) have not been adequately implemented by the Indonesian competent authorities. These deficiencies do not allow the Indonesian competent authority to provide adequately the guarantees required by the European Union export health certificate when exporting tuna products to the European Union. The report contains recommendations to address the 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...30 Annex 1 - Legal references Annex 2 List of tuna species and CN product codes II

4 ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT Abbreviation CN CPIB DG Capture Fisheries DG Health and Food Safety EC EU EU export certificate EU listed establishments FAO FBO(s) FQIA HACCP PCBs PCB's RASFF SIKPI SIPI SKH IPI SKPI SKPPI TIU TRACES Explanation Combined Nomenclature Certificate of Good Fishing Handling Method Directorate General of Capture Fisheries Directorate-General for Health and Food Safety of the European Commission 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 Establishments included in lists made in accordance with Article 12 of Regulation (EC) No 854/2004 and available at /safety/international_affairs/trade/non-eu-countries_en, from which imports into the EU are permitted Food and Agriculture Organization (United Nations) Food business operator(s) Fish Quarantine and Inspection Agency (Indonesian acronym BKIPM) Hazard Analysis and Critical Control Points Polychlorinated biphenyls Polychlorinated biphenyls Rapid Alert System for Food and Feed Permit letter to transport fishing vessels Permit letter to catching fishing vessels Unloading conditions inspection report Fisherman good handling practices certification Fishing vessels good handling and storage practices certification Technical Implementing Unit Trade Control and Expert System III

5 1 INTRODUCTION The audit took place in Indonesia from 28 February to 9 March 2017 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 auditors from DG Health and Food Safety. An opening meeting was held in Jakarta on 28 February with the competent authorities the Fish Quarantine and Inspection Agency (FQIA) and the Directorate General of Capture Fisheries (hereinafter referred to as DG Capture and Fisheries), both under the responsibility of the Ministry of Marine Affairs and Fisheries. 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 Indonesia destined for export to the European Union (EU) are in line with the relevant requirements laid down in EU legislation, and specifically with the health attestations contained in the model health certificate of Appendix IV to Annex VI to Commission Regulation (EC) No 2074/ (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/

6 In pursuit of this objective, the audit team visited the following sites: Competent Authority Central level 5 Main Headquarters (2). Landing Sites Port Authorities (2). Technical Implementing Unit (TIU) (1). Landing Areas 3 In operation at the time of the visit. Fishing vessels 5 Fishing vessels (2). Processing Facilities Transport vessels for fresh fish (3). Freezer Vessels 2 One of them not in operation at the time of the visit. Establishments on land (not EU listed 4 ) Establishments on land (EU listed) 1 Supplier of fresh fish. 8 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 Indonesia 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. Indonesia is authorised to export fishery products to the EU from 203 processing establishments and nine freezer vessels. 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, 3 EU legislation (Internet): 4 Establishments included in lists made in accordance with Article 12 of Regulation (EC) No 854/2004 and available at from which imports into the EU are permitted 2

7 between 2013 and 2015, the EU imported tuna fishery products from 71 processing establishments and one freezer vessel. According to the competent authority 77 EU listed establishments may produce tuna fishery products. The last audit by the Commission services to Indonesia covering fishery products took place from 25 February to 7 March 2013 (hereinafter the 2013 audit). The 2013 audit report 5 made eleven 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 relevant sub-sections of section 5. This audit is the fifth in a series of audits dedicated to obtaining a clearer picture of the tuna industry as a whole and to verify 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. Indonesia 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 sized tuna exporter potentially operating in two of the geographically important tuna catching areas (Indian Ocean (Eastern) and Pacific Ocean (Western Central)). 4.2 PRODUCTION AND TRADE INFORMATION According to EUROSTAT from 2013 to 2015 Indonesia supplied 7 to the EU circa tonnes of tuna fishery products (roughly tonnes per year). The majority of products received from Indonesia were processed tuna fishery products 8 falling under the Combined Nomenclature (CN) code 1604 (approximately 61 %). The remaining products were divided between frozen tuna belonging to the CN codes 0303 and 0304 (approximately 37.2 %) and fresh tuna belonging to CN codes 0302 and 0304 (approximately 1.8 %). These figures are not comparable to the ones provided by the competent authority ( tonnes). EUROSTAT and competent authority figures for fresh tuna present minor differences. However, for processed and frozen tuna the differences are significant. The audit team was not able to identify the cause of this discrepancy. From the information gathered from the competent authority and TRACES one can see the tuna products have been produced mainly from the following tuna species Katsuwonus pelamis, Tunnus albacares, Thunnus alalunga, and Thunnus obesus. However, the differences between the figures from the different sources do not allow us to quantify the contribution of each species to the total amount of tuna products exported from Indonesia to the EU. 5 Report reference DG(SANCO) The implementation of the corrective actions covering recommendations Nos 1, 5 and 10 of the 2013 audit report were not checked because they are not covered by the scope of the current audit. 7 EU fishery products imports from Indonesia. 8 Mainly canned products but also pre-cooked frozen tuna loins and a small quantity of pouched products. 3

8 From EUROSTAT, one can also note that during that period there was an increase in the quantity of processed products received (from 49 % in 2013 to 72 % in 2015), while frozen products decreased (from 49 % to 25 %). The competent authority provided to the audit team a detailed list of tuna raw material suppliers covering According to that list, during that period, the establishments producing fishery products of tuna species and exporting to the EU received approximately tonnes of domestic caught tuna species as raw materials potentially used for the manufacture of those products. Those raw materials were mainly frozen fish (97.9 %). Also according to that list and during the same period, fishing vessels provided frozen raw materials and 286 fishing vessels provided fresh raw materials. The competent authority informed the audit team that Indonesian establishments did not export to the EU tuna fishery products manufactured from raw materials imported from other non-eu countries. During an audit of this series to another non-eu country, Indonesia was identified by the audit team as supplying that non-eu country with raw materials for further processing and later exported to the EU. The amount provided for the period was circa tonnes, which represented 3.7 % of the imports of that country. From the data provided by the competent authority one can see that the majority of tuna is caught in the major FAO (Food and Agriculture Organization (United Nations)) fishing area 71 (Western Central Pacific Ocean); in the last years tuna was caught inside the exclusive economic zone of Indonesia of FAO fishing area 71. Tuna was also caught in the major FAO fishing area 57 (Eastern Indian Ocean). In terms of fisheries management and conservation measures these fishing areas are managed by the following Regional Fisheries Management Organisations covering tuna: Western and Central Pacific Fisheries Commission (WCPFC) FAO area 71. Commission for the Conservation of Southern Bluefin Tuna (CCSBT) FAO area 57. Indian Ocean Tuna Commission (IOTC) FAO area 57. According to the competent authority response to the pre-audit questionnaire, Indonesia has 22 main fishing ports where landing of tuna species can take place. During the audit, the competent authority stated to the audit team that tuna can also be landed or more commonly transhipped 9 in approximately 490 smaller fishing ports. 4.3 RAPID ALERT SYSTEM FOR FOOD AND FEED (RASFF) NOTIFICATIONS Members of the RASFF network 10 have issued five notifications for Indonesian tuna fishery products since the 2013 audit. Three were due to the presence of histamine above the EU regulatory limits and two were due to the rupture of the cold chain in frozen products. Section 5.5 below describes how the competent authority handled those RASFF notifications. 9 Transfer of frozen or fresh fishery products from a fishing vessel to another fishing vessel or to a transport vessel. 10 European Commission, EFSA, EFTA Surveillance Authority, EU member states, Iceland, Liechtenstein, Norway and Switzerland. 4

9 5 FINDINGS AND CONCLUSIONS 5.1 LEGISLATION Legal requirements Article 46(1)(a) of Regulation of the European Parliament and of the Council (EC) No 882/2004. Article 11(4)(a) of Regulation of the European Parliament and of the Council (EC) No 854/2004. Findings 1. According to the information provided by the competent authority, the Indonesian legislation applicable to the fishery products to be exported to the EU is divided between three tiers: (1) Laws and Governmental Regulations; (2) Ministerial Decrees and Regulations; and, (3) Directorate General Decrees and Regulations. 2. The main Laws and Governmental Regulations of relevance are: Government Regulation No 28/2004, concerning safety, quality and nutrition of food. It covers general food safety requirements for foodstuffs, the processes and premises for their production (including storage and transport). It also covers the export of foodstuffs, allowing the relevant competent authorities to establish specific export requirements (in accordance with the conditions laid down by the country of destination). Law No 31/2004, amended by Law No 45/2009, concerning fisheries. It covers fishing vessels, fish ports and fish quality (from a food safety perspective). It regulates the issuance of SIPI and SIKPI permits (respectively permit letter to catching fishing vessels and permit letter to transport fishing vessels ). It also requires that fishery products exported from Indonesia must be accompanied by a health certificate for human consumption. Law No 18/2012, concerning food safety. In particular, Part Four of Chapter IV covering exports, Chapter VII on food safety, Chapter IX on control activities, Chapter XIV on investigations and Chapter XV on penalties. Law No 23/2014 concerning local governance (transfer of duties between services see paragraph 22). Government Regulation No 57/2015, concerning the system of quality assurance and safety of fishery products. Establishes the general principles to ensure the safety of fishery products, covering products, facilities, production processes, staff and HACCP (Hazard Analysis and Critical Control Points). It also covers the general principles for the official control system and the different types of certification. Presidential Regulation No 02/2017 concerning the duties and function of ministries and also the structure, duties and functions of FQIA. 3. The main Regulations and Decrees of the Ministry of Marine Affairs and Fisheries are: 5

10 Regulation No PER.019/MEN/2010, concerning the official control of the quality assurance and safety of fishery products. Art. 4 designate FQIA as the competent authority for the official control system and for the issuance of the EU export certificate. Additionally, this regulation specifies other mandatory certifications given to: aquaculture farms (CBIB); to fishing and transport vessels, collection points, fish suppliers and distributers (CPIB Certificate of Good Fishing Handling Method ); and to processing establishments (HACCP Certificate for fish processing units (UPI); and SKP Certificate of Eligibility Processing ). This regulation also establishes the possibility for FQIA to delegate certain tasks related to CBIB and CPIB (including its issuance). Regulation No PER.23/MEN/2011, concerning the organisation and procedures of the TIUs of FQIA. Regulation No PER.08/MEN/2012 concerning the fish ports. It covers the activities to be performed at the fish ports (e.g. supervision of fisheries and fishing vessels (including food safety aspects) and unloading, marketing and distribution of fishery products). Decree No KEP.52A/MEN/2013, concerning the requirements applicable to the production of fishery products and covering the entire production chain (from fishing grounds to dispatch for export). It covers the requirements to be followed by the FBOs (food business operators) when participating in the production chain of fishery products (including the ones intended for export to the EU). This decree was issued in response to the 2013 audit report recommendations No 4 11 and No Regulation No PER.23/MEN/2015, concerning the structure of the Ministry of Marine Affairs and Fisheries, its tasks and responsibilities. Regulation No PER.74/MEN /2016, concerning imports of fishery products into Indonesia. 4. The main Regulations and Decrees of the FQIA within the scope of the audit are: Regulation No PER.03/BKIPM/2011, concerning the requirements and procedures to be followed by official staff of the competent authority (or delegated authorities) in the implementation of Regulation No PER.019/MEN/2010. It covers amongst other things, the designation of official laboratories, HACCP certification, official control visits of establishments, issuance of export certificates, and attribution of establishment approval number for exports. This regulation sets three different levels for the HACCP certification: levels A, B and C (in accordance with the number and significance of deficiencies identified). The frequency of control visits is linked to the HACCP certification level. 11 Recommendation No 4 of the 2013 audit report To ensure, as established in Part II.1 of the health certificate, that fishery products exported to the EU have been caught and handled on board freezer vessels implementing a programme based on HACCP principles in accordance with Article 5 of Regulation (EC) No 852/ Recommendation No 6 of the 2013 audit report To ensure that all establishments handling raw material used in the manufacture of fishery products intended for export to the EU are supervised by the CA as laid down in Article 12, point 2 (b) of Regulation (EC) No 854/

11 Decree No 259/KEP-BKIPM/2013, concerning the monitoring of fishery products. It covers sampling of fishery products, parameters to be checked and maximum admissible limits. This decree replaces decree No KEP.135/DJ-P2HP/2009 and it was adopted as part of the actions addressing the 2013 audit report recommendations Nos and Decree No 371/KEP-BKIPM/2014, concerning the official controls (inspections) of fish collectors/suppliers. Decree No 59/KEP-BKIPM/2016, concerning the health certification procedures. It updates and supplements Regulation FQIA No PER.03/BKIPM/2011 in relation to the issuance of export certificates, official control visits of establishments and product monitoring (including sampling, parameters to be checked and maximum limits). Decree No 63/KEP-BKIPM/2016 concerning potable water. It establishes criteria for potable water to be followed by the FBOs and also the procedures for the official controls by the competent authorities (including water and ice sampling). The adoption of this decree was part of the guarantees provided by the competent authority in relation to recommendation No 9 15 of the 2013 audit report. Regulation No 81/KEP-BKIPM/2016 concerning officials signing of health certificates. 5. The main Regulations and Decrees of the DG Capture Fisheries within the scope of the audit are: Decree No 18/KEP-DJPT/2013, concerning the implementation of guidelines for fish inspection at unloading. Decree No 84/PER-DJPT/2013, concerning the certification of good handling on fishing and/or carrier vessels. It covers the requirements and procedures for the issuance of CPIB and also the controls at landing. According to this decree only vessels above 20 GT (gross tonnage) are required to have a CPIB. This regulation was issued in response to recommendation No 3 16 of the 2013 audit report (aiming at requiring fishing vessels (including transport) to comply with standards equivalent to the EU rules and to certify vessels participating in the production chain of fishery products destined for the EU market). 13 Recommendation No 7 of the 2013 audit report To ensure that, as established in Part II.1 of the health certificate, that fishery products exported to the EU have satisfactorily undergone the official controls laid down in Annex III to Regulation (EC) No 854/2004, in particular concerning dioxins, PCBs and poisonous fish. 14 Recommendation No 8 of the 2013 audit report To ensure that, as established in Part II.1 of the health certificate, fishery products exported to the EU have satisfactorily undergone the official controls laid down in Annex III to Regulation (EC) No 854/2004, in particular that histamine testing is in line with Regulation (EC) No 2073/2005 and that maximum limits applied for heavy metals are in line with Regulation (EC) No 1881/ Recommendation No 9 of the 2013 audit report To ensure that only potable water is used as laid down in Chapter VII of Annex II to Regulation (EC) No 852/ Recommendation No 3 of the 2013 audit report To ensure that fishing vessels providing fishery products to EU listed establishments meet standards at least equivalent to the requirements laid down in Annex I to Regulation (EC) No 852/2004 and in Section VIII, Chapter I of Annex III to Regulation (EC) No 853/

12 Decree No 264/DJ-PT/2015, concerning the implementation of guidelines for certification of good handling of fishery products in fishing vessels and at landing. 6. While a comprehensive review of Indonesian legislation was not carried out by the audit team, it was noted the following findings related to discrepancies with the EU rules: a. The definition for fishing vessels of Decree No KEP.52A/MEN/2013 includes fishing and freezer vessels as defined in Regulation (EC) No 853/2004. Decree No KEP.52A/MEN/2013 also allows transport vessels to freeze fishery products. This decree requires the implementation of Good Handling Procedures based on HACCP for those fishing and transport vessels. This cannot be considered in line with Article 5 of Regulation of the European Parliament and of the Council No (EC) No 852/2004, which requires the existence, implementation and maintenance of a permanent procedure based on the HACCP principles. b. Decree No KEP.52A/MEN/2013 allows fish stockpiling/supplier facilities to freeze fishery products. However, it does not require that these facilities implement HACCP based procedures. This cannot be considered in line with Article 5 of Regulation No (EC) No 852/2004. c. Decree No 259/KEP-BKIPM/2013 and Decree No 59/KEP-BKIPM/2016 set maximum admissible levels of environmental contaminants in fishery products (lead, cadmium, mercury, benzo(a)pyrene and polychlorinated biphenyls (PCBs)). These levels are not in line with the EU rules, in particular Commission Regulation (EC) No 1881/2006, for the maximum admissible levels of dioxins and PCBs for all tuna species and for the maximum admissible levels of cadmium in the fish of Auxis species (bullet tuna). d. Decree No 259/KEP-BKIPM/2013 and Decree No 59/KEP-BKIPM/2016 also contain other maximum admissible levels which are not in line with the EU rules for fishery products other than tuna. Those discrepancies are related to the maximum admissible levels in fishery products of: (1) benzo(a)pyrene; (2) the sum of benzo(a)pyrene, benz(a)anthracene, benzo(b)fluoranthene and chrysene; (3) dioxins; (4) and PCBs. There is also a discrepancy related to the maximum admissible levels of cadmium in Xiphias gladius and Engraulis species. e. According to Decree No KEP.52A/MEN/2013 a valid CPIB is a pre-condition for vessels to be allowed to participate in the production chain of fishery products destined for the EU market. However, Decree No 84/PER-DJPT/2013 (setting up the procedures for the issuance of a CPIB to fishing vessels (including transport vessels) and the conditions required for that issuance) excludes this CPIB requirement for vessels with less than 20 GT. Considering the information provided by the competent authorities, that vessels with less than 20 GT provide raw materials to be used for further processing and later export to the EU, the competent authorities cannot demonstrate that all vessels participating in the production chain of fishery products destined for the EU market are required to comply with the requirements set out in Section VIII, of Annex III to Regulation of the European Parliament and of the Council No (EC) No 853/2004, in particular, point 3 and Chapter I of that section. 8

13 7. From paragraphs 6.a and 6.b the audit team notes that, the publication of Decree No KEP.52A/MEN/2013 does not allow the competent authorities to provide adequate assurances that recommendations Nos 4 and 6 of the 2013 audit report have been satisfactorily addressed. 8. Based on paragraph 6.e the audit team notes that, the publication of Decree No 84/PER- DJPT/2013 does not allow the competent authorities to provide adequate assurances that recommendations No 3 of the 2013 audit report have been satisfactorily addressed. 9. The publication of Decree No 63/KEP-BKIPM/2016 and its correct application would allow the competent authority to provide adequate assurances that recommendation No 9 of the 2013 audit report has been satisfactorily addressed. 10. The publication of Decree No 259/KEP-BKIPM/2013 and its correct application would allow the competent authority to provide adequate assurances that recommendation No 7 of the 2013 audit report has been satisfactorily addressed. However, for the relevant part of recommendation No 8 of the 2013 audit report this decree still does not offer all the guarantees requested (in particular with regard to the maximum admissible levels for certain environmental contaminants in tuna fishery products and also other fishery products). 11. From a limited review of the remaining Indonesian legislation the audit team notes that it is broadly in line with the EU applicable rules. Conclusions on Legislation 12. Globally the Indonesian legislation (and standards) in force covering the exports of fishery products to the EU gives an adequate basis to provide the guarantees required by the public health attestations of the EU export certificate. 13. However, important gaps have been identified with regard to HACCP based procedures for certain vessels and fish suppliers, the maximum admissible levels of certain contaminants in fishery products and obligation for all fishing vessels to comply with the EU rules. These gaps weaken certain guarantees given by the competent authority that products exported to the EU comply or are produced in compliance with the relevant EU requirements. 14. As regards the Indonesian legislation (and standards) issued and implemented to address certain recommendations of the 2013 audit report the audit team concludes that the new legislation addresses recommendations Nos 7 and 9. For recommendations Nos 4and 8 the new legislation did not adequately address the issues identified. 15. The Indonesian legislation (and standards) issued and implemented following the 2013 audit does not address adequately recommendation No 3 of that audit report. 9

14 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 16. FQIA is still the main competent authority with regard to the export of fishery products to the EU. 17. Article 4 of Regulation No PER.019/MEN/2010 designates FQIA as the competent authority for the official control system and for the issuance of the EU export certificate. 18. According to that regulation, the issuance of the CPIB for fishing and transport vessels and their control is carried out by DG Capture Fisheries on behalf of, and coordinated by, FQIA. DG Capture Fisheries also controls the landing of fishery products, which comprises checks on the hygiene of landing and sanitary control of fishery products. DG Capture Fisheries is responsible for the issuance of the catch certificate. 19. The structure and organisation of both FQIA and DG Capture Fisheries is detailed in different of the legal acts mentioned in section 5.1, in particular: Regulation No PER.23/MEN/2011. Regulation No PER.23/MEN/2015. Presidential Regulation No 02/ The Directorate General of Product Competitiveness issues the SKP, the import permits and also provides technical guidance and assistance to FBOs with regard to pre-requisite programs, structural requirements and hygiene practices. 21. Different services of FQIA are involved in the official control system, as follows: Centre for Quality & Safety Control, central service in charge of HACCP certification (initial certification and a sample of certification renewals) and for establishments' surveillance (in addition to the one performed by TIU). It provides technical assistance and guidance to FQIA TIUs and supervises them by verifying the implementation of the official control tasks. Centre for System Standardization and Compliance, central service in charge of harmonisation and publication of standards/procedures and also of supervision (internal audits) over FQIA TIUs. FQIA TIUs, located in the provinces and in charge of the implementation of the official control system, comprising the establishments' surveillance and the issuance 10

15 o of EU export certificates. From the 47 FQIA TIUs existent in Indonesia, 35 of them, located in 26 provinces, are dealing with fishery products. Typically, FQIA TIUs have a laboratory part, a certification part and an inspection part. The organisation and typology of the different TIUs is described in Regulation No PER.23/MEN/ Early 2016, the tasks described in section 5.2 of the 2013 audit report and attributed to the provincial services (Provincial Laboratory Fish Inspection and Quality Control) were transferred to FQIA TIUs. Exceptionally, laboratories from the provincial services can be used for official testing if the FQIA TIU laboratories are not able to perform the laboratory test requested. 23. Different services of DG Capture Fisheries are involved in the official control system, as follows: Directorate of Fishing Ports, central service responsible for the fish inspection at landing ( SKH IPI (unloading conditions inspection report) and with responsibilities on the issuance of the catch certificate for IUU issues. This directorate also regulates fishing ports. Directorate of Fishing Vessels and Fishing Gear, central service in charge of controlling fishing vessels and providing training on good handling practices to fisherman ( SKPPI (fishing vessels good handling and storage practices) and SKPI (fisherman good handling practices) certifications). DG Capture Fisheries also has TIUs which are located in 22 major fish ports that are managed by a Head of Fish Port. These TIUs implement the tasks of the different central directorates. 24. The competent authority provided the audit team in the answer to the pre-audit questionnaire the following organigramme showing the relationship of all competent authorities: 11

16 Powers, Independence and Supervision 25. Law No 18/2012 attributes to competent authorities the duty to set up food safety requirements and to establish a control system to check if FBOs implement the applicable food safety requirements. Law No 18/2012 also confers to competent authorities the powers to enter any food producing facility (including storage and transport) with a view to inspect (products and premises), check any relevant documentation and to sample foodstuffs. Enforcement actions and sanctions are also described in the law. 26. Law No 31/2004, as last amended, allows the relevant competent authority to establish requirements and standard operating procedures for handling fishery products (food safety perspective). Law No 31/2004 also establishes the duties of competent authority staff with regard to the quality control (food safety perspective) of fishery products on board fishing vessels and at landing. In that regard, Law No 31/2004 confers to the competent authority the powers to enter into and investigate vessels, facilities and locations engaged in fishery products business, as well as check any relevant documentation and perform product sampling. Sanctions and enforcement actions are also described in the law. 12

17 27. Government Regulation No 28/2004 describes sanctions and enforcement measures available to the relevant competent authorities (product recall/withdrawal and licence withdrawal) in cases where non-compliances to the general food law are detected. 28. All staff of the competent authorities are civil servants. Their impartiality and freedom of conflict of interest is covered by the Indonesian rules applicable to all civil servants. In addition, both Law No 31/2004 and Law No 18/2012 include specific sanctions to official staff involved in any contravention to the requirements set out in those laws. In addition, the competent authorities stated to the audit team that all staff signs an "integrity letter" covering conflict of interest issues. 29. The centre for Quality & Safety Control plays a supervisory role if the FQIA TIUs by verifying the activity reports provided by the TIU every quarter. Staff at central level regularly accompanies the HACCP certification visits (100% before 2016 and as team leader; randomly since 2017 as team member/supervisor). The central level also supervises the issuance of EU export certificates at least once a year in all FQIA TIUs. 30. Centre for System Standardization and Compliance is responsible for the audit once a year of the work of the FQIA TIUs. The audit team visited one FQIA TIU and noted that it has been audited by the centre in 2015 and The authorities provided to the audit team the reports of those audits and indicated the follow-up actions taken. Those audits also covered the laboratory part of the FQIA TIU. Training Knowledge of EU requirements 31. The competent authority presented detailed information concerning the training provided to official staff since the 2013 audit. The training covered several topics relevant to the performance of official controls of fishery products and their production chain. The most relevant of these were: basic HACCP; procedures for registration/approval/certification of establishments and vessels; EU requirements for fishing vessels, fish transport and fish landing (focus on good handling practices); CPIB on small scale fishing vessels (less than 20 GT); and catch certification and traceability. 32. In general, official staff interviewed by the audit team showed an adequate level of knowledge concerning the applicable EU requirements. Resources available to the competent authority 33. 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. 34. According to the competent authority, 196 staff from FQIA and 98 staff from DG Capture Fisheries are directly involved in the official controls of fishery products and their production chain, i.e. inspections, sampling and export certification. 13

18 35. For the purpose of official control testing of fishery products (tuna) and water the competent authority has access to its own laboratory network and to the laboratories of the provincial services (if necessary and more often for water and ice). Documented control procedures 36. The competent authorities adopted several procedures covering their main tasks. Those procedures are described in several of the legal documents referred to in section 5.1. The procedures cover: The licensing and certification of facilities (fishing vessels, fish supplier and fish processors). The official control of establishments EU listed and other establishments participating in the production chain of fishery products for export to the EU. The monitoring of fishery products for export to the EU. The monitoring of water and ice. The export certification of fishery products. 37. The main legal documents where these procedures can be found are: Regulation No PER.03/BKIPM/2011. Decree No 84/PER-DJPT/2013. Decree No 259/KEP-BKIPM/2013. Decree No 371/KEP-BKIPM/2014. Decree No 59/KEP-BKIPM/2016. Decree N0 63/KEP-BKIPM/ The audit team noted that the majority of the documented procedures are routinely used by official staff and they are updated as necessary. 39. The audit team noted that the procedures related to the official control of establishments (surveillance inspections) establish the frequency of the visits based on the classification of the HACCP certification (HACCP A once every three months; HACCP B once every two months; and, HACCP C once every month). In turn, the classification of the HACCP depends on the outcome of the inspection made to the establishment and based on the number and type of the deficiencies observed. As a generic rule, deficiencies can be classified as minor, major, serious or critical. However, that classification is not defined in the procedures (i.e. there is no indication of the criteria to be applied when deciding the classification of a deficiency). Moreover, the check-list used for the inspection restricts the classification of the deficiency to a pre-defined category. For certain items it does not allow the inspector to classify it in accordance with a risk based approach and/or its professional judgement (e.g. deficiencies that could be deemed critical would be recorded as major or serious). 40. The use of a pre-set classification for deficiencies and the absence of criteria defining the types of deficiencies undermine the ability of official staff to correctly classify the establishments during their official visits. Furthermore, during the audit visits to the EU listed establishments the audit team noted several cases where official staff did not 14

19 respect the pre-set deficiency classification and marked them less severe than defined by the check-list. The audit team noted that in some cases the correct use of the check-list could have as a consequence the downgrading of the HACCP certification from A to B (see paragraph 85). 41. The audit also noted that the procedures related to the follow-up of deficiencies were not always performed adequately (paragraph 86). Conclusion on competent authority 42. The competent authority has a structure, organisation, powers, staff (including provisions regarding freedom from conflict of interest) and resources available that can be considered appropriate for an official control system covering the production chain of tuna fishery products for EU export. 43. The competent authority also drafted procedures that if adequately followed and implemented, should allow the competent authority to provide adequate guarantees as regards compliance with the relevant EU requirements. However, the procedures related to the classification of deficiencies do not allow the competent authority to guarantee that official staff correctly classifies the deficiencies observed noted during the official visits to establishments. 44. This puts into question the ability for the competent authorities to guarantee adequately that only establishments compliant with the EU rules are EU listed and/or authorised to participate in the production chain of products destined to the EU market. 5.3 NATIONAL PROVISIONS AND PROCEDURES FOR LISTING ESTABLISHMENTS EXPORTING FISHERY PRODUCTS TO THE EU Legal requirements Article 12(1), (2) and (3) 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 45. The competent authority defined in Regulation No PER.03/BKIPM/2011 the requirements and procedures to assign an export approval number for the EU. The correct implementation of this procedure, in conjunction with the requirements of Decree No KEP.52A/MEN/2013, would allow the competent authority to provide the guarantees required by Article 12 of Regulation (EC) No 854/

20 46. The general description made on the 2013 audit report concerning of establishments in the inclusion on the EU list is still valid. The competent authority provided to the audit team a list of the processing establishments with a HACCP grade B (347 establishments that can supply the EU listed establishments) and C (140 establishments that cannot supply the EU listed establishments). 47. The HACCP certificate is granted after a satisfactory on-the-spot assessment (HACCP verification visit) and is valid for one year and for the manufacturing process and products indicated in the certificate. The HACCP certificate is issued by the central level of FQIA based on the report of the verification carried out by the central level or by the relevant FQIA TIU. 48. The audit team noted that for all EU listed establishments visited during the audit there was a valid HACCP certificate A indicating the products are allowed to be exported to the EU. 49. With regard to the other suppliers (fishing vessels and fish suppliers (establishment not EU listed and/or pre-processing establishments)) of raw materials to the EU listed establishments the audit team noted that different pieces of the Indonesian legislation requires that they need to have a valid CPIB to be able to participate in the production chain of fishery products destined for the EU market, in particular the Decree No KEP.52A/MEN/2013. As mentioned in paragraph 6.e Decree No 84/PER-DJPT/2013 exempts vessels with less than 20 GT from this obligation. 50. The issuance of a CPIB to a fish supplier (pre-processing establishment on land) is the responsibility of the relevant FQIA TIU and depends on the satisfactory outcome of an on-the-spot inspection to assess compliance with the requirements of Decree No KEP.52A/MEN/2013. This CPIB is valid for three years. 51. FQIA provided to the audit team a list of 92 fish suppliers with CPIBs issued during According to that list there are several suppliers for tuna fishery products, including fresh fish, frozen fish and loins. 52. The issuance of a CPIB to a fishing vessel (including freezer and transport vessels) is the responsibility of DG Capture Fisheries. The issuance of a CPIB is subject to the following requirements: a. The fishing vessel needs to have a fishing permit (see paragraph 2, second bullet point). b. The fishing vessel must have a valid SKPPI certificate (all SKPPI certificates are valid for 2 years). c. The vessel crew, or at least its captain, need to have a SKPI certificate (never expires). d. There was at least one satisfactory control of the unloading conditions in the last year SKH IPI report. 53. The CPIB for fishing vessels has the same validity period as the fishing license (typically one year). 16

21 54. DG Capture Fisheries provided the audit team lists of: CPIBs issued 13 during 2014, 26 during 2015 and 14 during SKPIs issued 924 SKPI certificates were issued during SKPPIs issued 44 during 2014 (currently expired), 57 during 2015 and 3 in During the audit, the competent authority stated to the audit team that roughly fishing vessels with more than 20 GT were active in 2015 (see paragraph 70). 56. The audit team noted during the visits to the EU listed establishments that raw materials used in the production of products destined for the EU market have been sourced from suppliers without a HACCP grade A or B, in the case of processing establishments, or a valid CPIB, in the case of pre-processing establishments and fishing vessels (see paragraphs 75, 76 and 91). This fact has been reported previously by the competent authority. This is not in line with the Indonesian requirements and does not allow the competent authority to guarantee that only establishments compliant with the EU rules in particular the requirements laid down in Section VIII, Chapters III and IV of Annex III to Regulation (EC) No 853/2004 are allowed to participate in the production chain for EU exports. 57. Furthermore, the assessment of the data provided by the competent authorities (indicated in paragraphs 54 and 55) shows that the competent authority is not a position to guarantee that only fishing vessels compliant with the relevant EU requirements, in particular the requirements laid down in Section VIII, Chapters I to III of Annex III to Regulation (EC) No 853/2004, participate in the production chain of fishery products destined for the EU market. This finding was further confirmed during the visits to the establishments (see paragraph 91). 58. The audit team noted that the competent authority maintains the EU list of establishment updated and communicates any change to the Commission services. Conclusions on national provisions and procedures for listing establishments exporting Fishery Products to the EU 59. The competent authorities have in place an adequate procedure for approval and listing establishments exporting directly to the EU. The competent authorities also have in place adequate procedures for the identification and control of establishments and vessels providing raw materials to the EU listed establishments. 60. However, the implementation of those procedures is not carried out adequately with regard to the fish suppliers (establishments not EU listed and fishing vessels), which does not allow the competent authority to provide the guarantees required by Article 12 (2) of Regulation (EC) No 854/2004 and by the health attestations of the EU export certificate. 17

22 5.4 OFFICIAL CONTROLS Official 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 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, in particular official controls laid down in Annex III, Chapter I of Regulation (EC) No 854/2004. Findings Official control system in place 61. The official control system in place is divided between two competent authorities as mentioned in paragraphs 16 to Fishing vessels (including freezer and transport vessels) and fish landing operations are checked by DG Capture Fisheries, and fish suppliers (pre-processing establishment and/or establishments not EU listed) and EU listed establishments are checked by FQIA. 63. Fishing vessels include primary production fishing vessels 17, freezer vessels 18 and transport vessels (transporting simultaneously fresh/chilled and frozen tuna fishery products). Certain of those fishing vessels need to have a valid CPIB to be allowed to participate in the production chain of fishery products destined for the EU market (see paragraph 3). The CPIB has the same validity period as the related SIPI of SIKPI (in general one year). After its expiry, the CPIB needs to be renewed on the basis that they continue to meet the requirements that allowed for the previous CPIB issuance. This means that DG Capture Fisheries is required to check the unloading conditions at least once a year (SKH IPI) and check the concerned vessels at least once every two years (SKPPI). 64. Fish suppliers participating in the production chain of fishery products destined for the EU market need to have a valid CPIB (pre-processing establishment) or a HACCP certificate A or B (for processing establishments). This means that FQIA TIUs is required to evaluate pre-processing establishment (surveillance inspections) at least once a year and processing establishments once every two months (HACCP certificate B) or once every three months (HACCP certificate A). 17 Defined in the EU as vessels (except freezer and factory vessels) handling fishery products (without changing their nature substantially) and their transport to the first establishment (including auction halls) on land. 18 Defined in the EU as any vessel on board which freezing of fishery products is carried out, where appropriate after preparatory work such as bleeding, heading, gutting and removal of fins and, where necessary, followed by wrap-ping or packaging. 18