EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL

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1 EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Directorate F - Food and Veterinary Office Ares(2012) DG(SANCO) MR FINAL FINAL REPORT OF AN AUDIT CARRIED OUT IN BRUNEI FROM 25 TO 28 APRIL 2012 IN ORDER TO EVALUATE THE CONTROL SYSTEMS IN PLACE GOVERNING THE PRODUCTION OF FISHERY PRODUCTS INTENDED FOR EXPORT TO THE EUROPEAN UNION

2 Executive Summary This report describes the outcome of a Food and Veterinary Office audit in Brunei carried out from 25 to 28 April 2012, as part of its programme of inspections in third countries. The primary objective of the audit was to evaluate whether the official control system in place can guarantee that the conditions of production of fishery products in Brunei destined for export to the European Union are in line with the requirements laid down in EU legislation, and in particular with the health attestations contained in the health certificate contained in Commission Regulation (EC) No 2074/2005. The audit covered the relevant EU legislation for the public health sector. The audit also reviewed progress made in implementing the action plan submitted by Brunei in response to the recommendations contained in the report of a previous audit carried out for the sector in 2009 The report concludes that improvements in the implementation of official control systems since 2009 have been made. Aquaculture products intended for EU export respect the requirements set out in the health certificate in line with the model defined in Regulation (EC) No 2074/2005. Most of the recommendations of the previous audit report have been addressed. However the audit team identified a potential risk of contamination of fishery products in the vessel and the landing site visited which would currently preclude the export of wild caught fishery products to the EU. The report addresses to the competent authority of Brunei a number of recommendations aimed at rectifying identified shortcomings and enhancing the control system in place. I

3 Table of Contents 1 INTRODUCTION OBJECTIVES 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 OF ESTABLISHMENTS FOR EXPORT TO THE EU OFFICIAL CONTROLS OF PRODUCTION AND PLACING ON THE MARKET OFFICIAL CONTROL SYSTEM IN PLACE PRIMARY PRODUCTION LANDING SITES FISHING VESSELS FACILITIES HANDLING FISHERY PRODUCTS IMPORT CONTROLS OF FISHERY PRODUCT OFFICIAL CONTROLS OF FISHERY PRODUCTS OFFICIAL CERTIFICATION LABORATORIES OVERALL CONCLUSIONS CLOSING MEETING RECOMMENDATIONS...11 ANNEX 1 - LEGAL REFERENCES...13 II

4 ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT Abbreviation CA EC EU EU listed FBO FIQC FVO HACCP MTU PAH RASFF SANCO TPC TVB-N Explanation Competent Authority European Community European Union Facilities approved by the CA for EU fishery products export and listed on the internet site of DG SANCO Food Business Operator Food Inspection and Quality Control section Food and Veterinary Office of the European Commission Hazard Analysis Critical Control Points Mobile technical units Polycyclic Aromatic Hydrocarbons Rapid Alert System for Food and Feed Health and Consumers Directorate General of the European Commission Total plate count Total volatile basic nitrogen III

5 1 INTRODUCTION This audit took place in Brunei from 25 to 28 April 2012 and was undertaken as part of the Food and Veterinary Office's (FVO) audit programme. The audit team comprised two inspectors from the FVO. Representatives from the competent authority (CA) accompanied the audit team during the whole audit. 2 OBJECTIVES Brunei is not in the list of Annex II of Commission Decision 2006/766/EC as a third country approved for fishery products exports to the EU. The objectives of the audit were: to evaluate whether the official control system in place can guarantee that the conditions of production of fishery products in Brunei 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 health certificate laid down in Appendix IV to Annex VI to Commission Regulation (EC) No 2074/2005; to verify the extent to which the guarantees and the corrective actions submitted to the Commission services in response to the recommendations of the previous FVO audit report DG(SANCO) have been implemented and enforced by the CA. In terms of scope the audit focused on the organisation and performance of the CA, the export certification procedure, the official control system in place covering production, processing and distribution chains applicable to fishery products to be exported to the EU. Accordingly, relevant aspects of the EU legislation referred to in Annex 1 were used as technical basis for the audit. In pursuit of these objectives, the audit team proceeded as follows: an opening meeting was held in Bandar Seri Begawan on 25 April 2012 with the CA. At this meeting the audit team confirmed the objectives of, and itinerary for the audit, and requested additional information required for the satisfactory completion of the audit; the following sites were visited: Competent authority Central level 1 CA in Bandar Laboratory visits Official laboratory 1 The Seafood Analytical Laboratory section of the Fisheries Biosecurity Division of the Department of Fisheries. Primary production Aquaculture farms 1 Performing harvesting activities at the time of the FVO audit. Landing and first sale Landing sites 1 Facilities handling Fishery Products Freezer vessels 1 Not EU listed. Processing plant 1 Not EU listed 1

6 3 LEGAL BASIS The audit was carried out under the general provisions of EU legislation and, 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 feed and food laws, animal health and animal welfare. Full legal references are provided in Annex 1. EU legal acts quoted in this report refer, where applicable, to the last amended version. 4 BACKGROUND 4.1 GENERAL BACKGROUND In May 2009, Brunei requested Commission approval to export fishery products to the EU, following which a audit took place in October However the outcome did not allow the inclusion of Brunei in the list of Annex II of Commission Decision 2006/766/EC as a third country approved for exports to the EU. Furthermore, at this time Brunei was not yet included in the list of third countries with an approved residue monitoring plan as per Commission Decision 2004/432/EC. Since 2010 Brunei has been listed in the Annex to Commission Decision 2011/163/EU as having an approved residues monitoring plan for aquaculture products. Article 11(4)(k) of Regulation (EC) No 854/2004 establishes that EU controls carried out in the context of drawing up or updating lists of third countries from which imports of products of animal origin are permitted, shall have regard to the results of EU controls carried out in the third country, in particular the results of the assessment of the CAs, and the actions they have taken in the light of the recommendations addressed to them following a EU control. The 2009 FVO fishery products audit highlighted deficiencies in relation to the official control system for sampling and supervision of vessels and landing sites. The report DG(SANCO) published on the Health and Consumers Directorate-General (SANCO) Internet site at - made a number of recommendations in respect of the actions required of the CA. Written guarantees were received from the CA in relation to the implementation of actions aimed at addressing those recommendations. These written guarantees were evaluated by the FVO as satisfactory. 4.2 PRODUCTION AND TRADE INFORMATION Currently Brunei does not export export any fishery products to the EU. The FVO audit team was informed by the CA that Brunei initially would like to export farmed shrimp to the EU which would be processed in two land based establishments (one of them was not yet equipped for processing at the time of the audit). The main aquaculture farm produced in 2011 about 120 tons of shrimp from a total national production of 156 tons. In addition to the farmed shrimp Brunei intents at a later stage to seek to export wild caught tuna to the EU. 4.3 RAPID ALERT SYSTEM FOR FOOD AND FEED (RASFF) NOTIFICATIONS No RASFF notifications were issued as Brunei does not yet export fishery products to the EU. 5 FINDINGS AND CONCLUSIONS 5.1 LEGISLATION Legal requirements 2

7 Article 46(1)(a) of Regulation (EC) No 882/2004 states that Commission experts may carry out official controls in third countries in order to verify the compliance or equivalence of third countries legislation with the relevant EU legislation. Article 11(4)(a) of Regulation (EC) No 854/2004 Findings The audit team noted that the main legal texts governing the application of food safety policies in Brunei are the Public Health (Food) Act 2000 and the Public Health (Food) Regulations The main legislation governing the work of the CA is the Fisheries Order It stipulates that The Director shall have the general supervision of all matters relating to fisheries throughout Brunei. The Fisheries Order 2009 is enforced through Fisheries Regulations as follows: Regulation 8, Conditions of fish processing establishment of the Fisheries (Fish Processing Establishments) Regulations 2002 states that premises used as a fish processing establishment shall comply with such conditions as the Director may determine. This statement implies that the Director of Fisheries is empowered to decide on the requirements the Food Business Operators (FBOs) have to follow to be allowed to operate (licensed), and in particular to engage in the export of fishery products. Fisheries (Fish Culture Farms) Regulations 2002 provide for the registration of farms, the power of the Director of Fisheries to designate areas and issue licences, the possibility for authorised officers to inspect and if necessary, place restrictions on a farm and take any necessary action as appropriate to prevent the spread of disease. Fisheries (Fish Landing Complexes) Regulations 2002 regulate the access to fish landing sites by vessels and vehicles. In order to implement certain provisions of the Public Health (Food) Act 2000 and the Fisheries Order 2009 and to ensure the safety of fishery product exports, the Director of Fisheries has adopted the following Conditions :- Official Controls for Exported Fishery Products. Good Aquaculture Practices, Fishing Vessels and Landing Sites, Hygiene Requirements for Processing Establishments, and Fishery Products Exported to the EU. These "Conditions" are set out in manuals and are the main rules which regulate the official control of fishery products intended for EU export. Although these manuals are not formal legal texts they contain the requirements to be followed if an establishment in the sector wants to obtain a licence to export to the EU. This licence is issued subject to the "Conditions" which are specified in the manuals and which must be followed by the establishment. These manuals cover the main requirements of EU legislation for fishery products. However the audit team noted that these manuals lack certain minor elements in order to achieve equivalence with EU rules i.e.:- The direction of the airflow of ventilation in establishments The use of chlorine in fishery products. 3

8 Conclusions Generally, legislation is in line with EU requirements. However some specific requirements are not fulfilled. Recommendation No 5 of the previous audit report has not been addressed due to the permitted use of chlorine. 5.2 COMPETENT AUTHORITY Legal requirements Article 46 of Regulation (EC) No 882/2004 stipulates that EU Controls in third countries shall verify compliance or equivalence of third countries systems with EU food law. These controls shall have particular regard to points b) to (e), (g) and (h) of the aforementioned article. Points (g) and (h) are covered in section 5.4 of this report. Findings The Department of Fisheries under the Ministry of Industry & Primary Resources is the CA responsible for fishery products intended for export to the EU. It has jurisdiction and capacity - both technical and organisational - to implement controls over the entire food chain from primary production to distribution. The Food Inspection and Quality Control Section (FIQC) of the Fisheries Biosecurity Division of the Department of Fisheries carries out the official control tasks (inspections, sampling, issuing of corrective action requests) in aquaculture farms, vessels and establishments. The Section is comprised of a Head of Section and six inspectors (two dealing with vessels, two with aquaculture farms and two with establishments). The Licensing Section of the Department of Fisheries issues licences for processing and export of fishery products. It is planned that this section will sign the health certificates for export to the EU. In addition to these services, Mobile Technical Units (MTU) of the Aquaculture Industry Development Division of the Department of Fisheries take samples at aquaculture farms for animal health issues. The audit team noted that through these services a comprehensive control system for fishery products for export to the EU is in place. Written manuals on procedures and protocols for the official control of establishments and aquaculture farms are available and checklists are used during the inspection visits. The CA has the power to apply sanctions for non-compliances (infringement procedures) to FBOs and to seize fishery products all along the production and distribution chain. This power is provided by the Fisheries Order This legislation also enables the CA to suspend an establishment from export, to delist an establishment from the list of approved establishments and to impose fines. There is however, no body charged with, or a system in place for, the supervision on the technical performance of the CA. The audit team noted that the staff of the CA has received training: on hygiene in processing plants (according to EU legislation); for fish inspectors regarding audits of aquaculture farms, vessels, and establishments; on quality control; on HACCP Systems; on traceability and product recall. 4

9 Conclusions The current structure and organisation of the CA, including its powers and authority, are adequate to perform the official controls of the production chain of fishery products intended for EU export. These official controls are based on national legislation that can be considered as being broadly in line with EU requirements. However, in the absence of a system of supervision of the CA, the system cannot ensure the effectiveness of official controls. 5.3 NATIONAL PROVISIONS AND PROCEDURES FOR LISTING OF ESTABLISHMENTS FOR EXPORT TO THE EU Legal requirements Article 12(1) and (2) of Regulation (EC) No 854/2004. Part I.11. 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 The audit team noted that at present there are no establishments in Brunei approved and listed for fishery products export to the EU. All establishments, vessels and farms must have a licence for fisheries operations from the Licensing Section. Title 14 B of the Manual of Official Control for Exported Fishery Products describes the procedure to be followed by the operator to compile the necessary documents for the application. This procedure also describes the evaluation and audit steps to be carried out by the CA. The CA should carry out two inspection visits, one on the structure of the establishment followed by an inspection report and the second once the establishment has begun processing. The inspectors must produce a report (minutes) of these visits. The licence document for processing does not mention the type of fishery products processed or the type of processes authorised. Establishments must be approved by the CA for fishery products export (at present mainly to Asian countries). The Licensing Section issues an export licence which is valid for one month. Each individual export consignment must be licenced. Conclusions The CA has rules and procedures to list establishments wishing to export to the EU in line with EU requirements which are followed in the establishment visited by the audit team. 5.4 OFFICIAL CONTROLS OF PRODUCTION AND PLACING ON THE MARKET Legal requirements Article 12(2) of Regulation (EC) No 854/2004 Requirements contained in point II.1 and point II.2 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. Article 11(4) of Regulation (EC) No 854/2004 establishes that EU controls carried out in the context of drawing up or updating lists of third countries from which imports of products of animal origin are permitted, shall take particular account of the extent and operation of official controls on imports of animals and their products (Article 46(1) (g) (h) of Regulation (EC) No 882/2004). Article 11(4) (j) of Regulation (EC) No 854/2004 establishes that EU controls carried out in the context of drawing up or updating lists of third countries from which imports of products of animal origin are permitted, shall have regard to any experience of marketing of the product from the third countries and the results of any import control carried out and the assurances, which the third countries can give regarding equivalence to EU requirements. 5

10 Findings Official control system in place The audit team noted that the official control system in place is based on the Fisheries Order This legislation is supported by the manuals referred to above. Official controls cover the entire fishery products production chain (aquaculture farms, land based establishments, vessels and landing sites) Primary production The audit team visited one aquaculture farm. The rules in Brunei prescribe that for biosecurity reasons there must be a 72 hour interval before visiting a second aquaculture farm. The audit team noted that inspectors of FIQC inspect farms once per year, normally before issuing a new production licence. Comprehensive inspection reports based on checklists are produced following these visits and a list of the non-compliances is submitted to the FBO for corrective action within 15 days. After this period a follow-up inspection is carried out and if the operator has corrected the deficiencies the licence for production is issued. These inspectors take, once per year, samples of shrimp for analyses for food hygiene purposes and for the national residues programme. All the results of the analyses reviewed by the audit team were within the limits permitted under EU legislation. MTU carries out inspection visits to the farms. They carry out random pre-stocking visits for animal health issues and they take samples for analyses of animal health. The audit team noted that in the aquaculture manual of procedures the treatment of harvested shrimp with a chlorine solution (10 ppm) is permitted which is not in line with EU requirements. The audit team was informed that on the farm visited which supplies shrimp to the establishment foreseen for EU export, the shrimp are not treated with antibiotics, metabisulphite or chlorine. Chlorine is only used after harvesting on this farm to disinfect ponds in which outbreaks of fish diseases had occurred. The shrimp fry, Litopenaeus Stylirostris, used to stock ponds originates from hatcheries within Brunei Landing sites The CA carries out inspections of landing sites, verifies the hygiene of the unloading of fishery products and verifies that no poisonous fish has been landed. Twice per month the inspectors check the temperature of the frozen unloaded fishery products. The audit team was informed that samples of water were taken from the tap on the landing site twice per month for analyses. The structural and hygiene conditions of the landing site visited by the audit team do not preclude the risk of contamination of fishery products during unloading. The CA currently does not foresee using this particular landing site as part of the EU fishery products exports chain Fishing vessels The audit team visited one freezer vessel. Hydraulic equipment was installed close to the spot where fish is unloaded from the fishing nets (risk of contamination with mineral oils). Staff was walking on the frozen tuna at the time of the visit. This vessel had no HACCP plan or temperature recording device. The CA began inspecting vessels in 2010 and, since then, prepares reports which identify important deficiencies and set timetables for their correction Facilities handling fishery products The audit team noted that the FIQC inspectors visit establishments at least once per year or more often if the Director of Fisheries considers it necessary. On average, premises are inspected twice 6

11 per year by FIQC. The inspection visits are carried out generally at the frequency set in the manuals. Inspections are based on a comprehensive checklist and detailed reports are produced. Corrective action plans are drawn up by the inspector which must be addressed by the FBO within 15 days after which a follow-up visit is carried out. The audit team visited the establishment which the CA foresees for listing for EU export if Brunei receives the necessary approval to export. This establishment replaces one visited by the FVO audit team in 2009, which had severe hygiene deficiencies. The establishment is new and has a good structure and shrimp were processed hygienically. On the day of the FVO visit this establishment commenced processing shrimp for the first time. In this establishment some minor deficiencies were noted. A temperature recording device had, at the time of the visit, not yet been installed in the cold store and the temperature sensor itself was not placed in the location where the temperature is highest. The FBO did make a trial with several thermometers placed in the cold store and found that close to the door the temperature was on average 1 2 C higher than in other parts of the store. The establishment has an ice producing unit for flake ice and one for block ice. The ice is provided to both vessels and the aquaculture farm belonging to this FBO. The structure of these units permits the hygienic production of ice. The conditions of ice production have improved since the 2009 audit. As the establishment visited in 2009 has been replaced by a new one, recommendation No 1 of the previous FVO audit report regarding potential EU exporting establishments can be considered as adequately addressed. The audit team was informed by the CA that another newly built establishment may be proposed by the CA for addition to an EU list. However at the time of the visit this second establishment was not equipped for processing. A HACCP plan, generally following HACCP principles, was available in the establishment which was in operation at the time of the visit. This plan had been revised by the CA and improvements requested. No formal record of this request was made available to the team. The audit team reviewed this revised plan and noted a small number of inconsistencies between it and the relevant manual. This new establishment visited is intended as a replacement for an older establishment owned by the same FBO which was the subject of negative findings during the 2009 audit. The audit team reviewed documents of the older establishment. In this establishment own-checks for microbiology on shrimp had been performed three times per year for Total Plate Count (TPC), Total Faecal Coliforms, Salmonella, Vibrio, Staphylococcus aureus and E. Coli. Official samples had been taken twice per year for microbiology checks. Own-checks on water and ice had been carried out once per year and official checks four times per year. The audit team was informed that shrimp foreseen for export to the EU will not undergo treatment with metabisulphites. All laboratory results reviewed by the audit team were found to be within the tolerances set in EU legislation The establishment receives the shrimp from the farm owned by the same FBO and the records system permits trace-back of the product Import controls of fishery product The audit team noted that imports of fishery products are permitted by the Department of Fisheries. The Licensing Section issues a licence for these imports. However the CA has ruled that no 7

12 imported fishery products are to be used in the fishery products EU export chain. Conclusions The CA has an efficient official control system in place for the production of fishery products intended for export to the EU that covers fish processing establishments. Primary production is under the effective control of two divisions of the same CA and is generally equivalent to EU requirements. However the vessel and the landing visited site were not in line with EU requirements. 5.5 OFFICIAL CONTROLS OF FISHERY PRODUCTS Legal requirements 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 II of Reg. (EC) No 854/2004. Findings The audit team noted that random organoleptic checks are carried out by the inspectors at the time of landing and in the processing establishments. During these checks the inspectors also verify that no poisonous fish is landed. In the land based establishments similar checks are also carried out. The audit team noted that one official analyse had been carried out for TVB-N in an accredited laboratory in Singapore. A monitoring system to control the level of contaminants has been set up by the CA. The Seafood Analytical Laboratory Section carries out these analyses. The audit team noted that testing for heavy metals is integrated in the National Residue Monitoring Plan for shrimp. At least one sample per establishment per year is analysed. In 2009 one test result for lead was slightly above the EU limit but under the limit set in national legislation. Official controls for dioxin and Polycyclic Aromatic Hydrocarbons (PAH) are carried out in an accredited laboratory outside Brunei. Official controls for histamine in tuna (nine samples) are also carried out in an accredited laboratory outside Brunei. Official checks are carried out for metabisulphites when fishery products have been treated. An accredited laboratory in Malaysia carries out these analyses. Microbiological checks on fishery products are carried out at least twice per year by the CA. Analyses are carried out for TPC, Total Faecal Coliforms, E. Coli, Staphylococcus aureus, Salmonella and Vibrio. During the inspection visits the inspectors also do random tests for parasites. Official controls are carried out almost every month on water and ice and analyses are carried out for Total Coliform count, Total Faecal Coliform count and E-Coli. Conclusions The official controls of fishery products are performed adequately along the entire fishery products chain and include organoleptic checks, histamine testing, monitoring arrangements for contaminants, parasite checking and microbiology analyses. 5.6 OFFICIAL CERTIFICATION Legal requirements Article 14 of Regulation (EC) No 854/

13 Article 6 of Regulation (EC) No 2074/2005, in particular the model health certificate for imports of fishery products intended for human consumption established in its Appendix IV to Annex VI. Article 6 of Directive 96/93/EC establishes that the Commission shall ensure that the rules and principles applied by third countries certifying officers offer guarantees at least equivalent to those laid down in this Directive. Findings To-date the CA has not yet issued an EU export health certificate. However a procedure is in place (procedure 4B) to generate such certificates and the template to be used is in compliance with EU requirements. Conclusions The certification procedures in place can be considered as equivalent to the requirements of Directive 96/93/EC. 5.7 LABORATORIES Legal requirements Article 46(1)(d) and (c) of Regulation (EC) No 882/2004 stipulate that EU controls shall have particular regard to the resources including diagnostic facilities available to CAs and the training of staff in the performance of official controls. Points 41 and 42 of Guidelines of Codex Alimentarius CAC/GL on the Design, Operation, Assessment and Accreditation of Food Import and Export Inspection and Certification Systems Chapter 1 of Annex I to Regulation (EC) No 2073/2005 Section II of Annex II to Regulation (EC) No 2074/2005 Regulations (EC) Nos 1883/2006 and 333/2007. Findings The audit team visited the Seafood Analytical Laboratory Section in which official analyses are carried out. This laboratory also analyses own-check samples from the FBOs. The audit team noted that the situation in this laboratory has considerably improved since the previous FVO visit and it is now accredited for testing for microbiology and heavy metals (mercury, lead and cadmium). Proficiency tests have been carried out since 2009 for Vibrio, Salmonella, E. Coli, Staphylococcus and heavy metals with satisfactory outcomes. Analyses for metabisulphites, histamine, dioxin, PAH, antibiotics, malachite green pesticides are carried out in accredited laboratories outside Brunei. At the time of the visit the laboratory was found to have a good structure and layout and was very well equipped (the building was completed in 2010). The staff has participated in several relevant training courses. No analyses are carried out for Listeria monocytogenes as Brunei does not intend to export "ready to eat" fishery products to the EU. The laboratory carries out analyses on water for E. Coli, Clostridium perfringens, Enterococci, TPC and coliforms. Conclusions The CA has a designated laboratory for official controls of fishery products. This laboratory has shown a satisfactory performance and can provide reliable results for the tests for which it is 9

14 accredited. 6 OVERALL CONCLUSIONS Improvements in the implementation of official control systems since the last audit and in 2009 have been made. Aquaculture products intended for EU export respect the requirements set out in the health certificate in line with the model defined in Regulation (EC) No 2074/2005. Most of the recommendations of the previous audit have been addressed. However the audit team identified a potential risk of contamination of fishery products in the vessel and the landing site visited which currently would preclude the export of wild caught fishery products to the EU. 7 CLOSING MEETING During the closing meeting held in Bandar Seri Begawan on 28 April 2012, the audit team presented the main findings and preliminary conclusions of the audit to the CA. During this meeting, the CA acknowledged all the findings and preliminary conclusions presented by the audit team and provided commitment to correct the deficiencies. 8 RECOMMENDATIONS The CA should provide Commission services with an action plan, including a timetable for its completion, within one month of receipt of this report, in order to address the following recommendations for fishery products intended for EU export. N. Recommendation 1. The CA should ensure that harvested fishery products are not in contact with water which does not meet the criteria for potable/clean water as laid down in point II 4, Part A, Annex I to Regulation (EC) No 852/2004 (chlorine). 2. The CA should ensure that unloading of fish and fishery products are carried out in line with standards equivalent to point 1, Chapter II, Section VIII of Annex III to Regulation (EC) No 853/ The CA should ensure that freezer vessels will only be approved for participation in the fishery products EU export chain if they meet conditions equivalent to those laid down in the relevant EU legislation. In particular freezer vessels should be equipped with temperature recording devices and have an appropriate HACCP plan as required in Chapter I, Section VIII, of Annex III to Regulation (EC) No 853/2004 and in Article 5 of Regulation (EC) No 852/ The CA should ensure that standards applied to fishery products for EU export are fully equivalent to EU requirements in particular regarding the equipment of cold stores as laid down in part B, Chapter III, Section VIII, Annex III to Regulation (EC) No 853/

15 N. Recommendation 5. The CA should ensure that there is a mechanism (official controls, service supervision, service audit) for verifying that only establishments which are in line with the requirements of Section VIII, Chapters III and IV, of Annexe III to Regulation (EC) No 853/2004 are allowed to participate in the fishery products EU export chain. The competent authority's response to the recommendations can be found at: 11

16 ANNEX 1 - LEGAL REFERENCES Legal Reference Official Journal Title Dec. 2004/432/EC OJ L 154, , p , corrected and re-published in OJ L 189, , p. 33 Dec. 2006/766/EC OJ L 320, , p Dec. 2011/163/EU OJ L 70, , p Dir. 96/23/EC OJ L 125, , p Reg. 852/2004 OJ L 139, , p. 1, Corrected and re-published in OJ L 226, , p. 3 Reg. 853/2004 OJ L 139, , p. 55, Corrected and re-published in OJ L 226, , p. 22 Reg. 854/2004 OJ L 139, , p. 206, Corrected and re-published in OJ L 226, , p /432/EC: Commission Decision of 29 April 2004 on the approval of residue monitoring plans submitted by third countries in accordance with Council Directive 96/23/EC 2006/766/EC: Commission Decision of 6 November 2006 establishing the lists of third countries and territories from which imports of bivalve molluscs, echinoderms, tunicates, marine gastropods and fishery products are permitted 2011/163/EU: Commission Decision of 16 March 2011 on the approval of plans submitted by third countries in accordance with Article 29 of Council Directive 96/23/EC Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption 12

17 Legal Reference Official Journal Title Reg. 882/2004 OJ L 165, , p. 1, Corrected and re-published in OJ L 191, , p. 1 Reg. 2073/2005 OJ L 338, , p Reg. 2074/2005 OJ L 338, , p Reg. 1881/2006 OJ L 364, , p Reg. 1883/2006 OJ L 364, , p Reg. 333/2007 OJ L 88, , p Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs Commission Regulation (EC) No 2074/2005 of 5 December 2005 laying down implementing measures for certain products under Regulation (EC) No 853/2004 of the European Parliament and of the Council and for the organisation of official controls under Regulation (EC) No 854/2004 of the European Parliament and of the Council and Regulation (EC) No 882/2004 of the European Parliament and of the Council, derogating from Regulation (EC) No 852/2004 of the European Parliament and of the Council and amending Regulations (EC) No 853/2004 and (EC) No 854/2004 Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs Commission Regulation (EC) No 1883/2006 of 19 December 2006 laying down methods of sampling and analysis for the official control of levels of dioxins and dioxin-like PCBs in certain foodstuffs Commission Regulation (EC) No 333/2007 of 28 March 2007 laying down the methods of sampling and analysis for the official control of the levels of lead, cadmium, mercury, inorganic tin, 3-MCPD and benzo(a)pyrene in foodstuffs 13

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