EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL

Transcription

1 Ref. Ares(2012) /02/2012 EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Directorate F - Food and Veterinary Office DG(SANCO) MR FINAL FINAL REPORT OF AN AUDIT CARRIED OUT IN HONDURAS FROM 16 TO 23 NOVEMBER 2011 IN ORDER TO EVALUATE THE CONTROL SYSTEMS IN PLACE GOVERNING THE PRODUCTION OF FISHERY PRODUCTS 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 a Food and Veterinary Office audit in Honduras carried out from 16 to 23 November 2011, as part of its programme of inspections in third countries. The primary objective of the audit was to evaluate the public health conditions for the production of fishery products intended for export to the EU. The audit covered the relevant EU legislation for the public health sector. The report concludes that improvements in the implementation of official control have been made. However, to fully ensure that all fishery and aquaculture products exported to the EU respect the requirements mentioned in the health certificate as set out in the model defined in Regulation (EC) No 2074/2005 corrections and improvements are needed, in particular concerning the deficiencies identified in the treatment of shrimp as well as in the laboratory analyses for contaminants and additives. Once the identified deficiencies have been addressed the competent authority should be in a position to guarantee that the required sanitary conditions of fishery and aquaculture products for EU export can be met. The report addresses to the competent authority of Honduras 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 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 FACILITIES HANDLING FISHERY PRODUCTS IMPORT CONTROLS OF FISHERY PRODUCTS FOLLOW UP OF RASFF NOTIFICATIONS 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 Abbreviation CA CCP SANCO DIA EC EU EU listed EUROSTAT FVO HACCP ISO IVO LANAR PAH PCB RASFF SENASA TPC TVB-N Explanation Explanation Competent Authority Critical Control Point Health and Consumers Directorate General of the European Commission División de Inocuidad de Alimentos European Community European Union Facilities approved by the CA for EU fishery products export and listed on the internet site of DG SANCO Statistical Services of the European Union Food and Veterinary Office of the European Commission Hazard Analysis Critical Control Points International Organisation for Standardisation Inspector Veterinario Oficial Laboratorio Nacional de Análisis de Residuos Polycyclic Aromatic Hydrocarbons Polychlorinated biphenyls Rapid Alert System for Food and Feed Servicio Nacional de Sanidad Agropecuaria Total plate count Total volatile basic nitrogen III

5 1 INTRODUCTION This audit took place in Honduras from 16 to 23 November 2011 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 CA accompanied the audit team during the whole audit. An opening meeting was held in Tegucigalpa on 16 November 2011 with the competent authority (CA). At this meeting the FVO team confirmed the objectives of, and itinerary for the audit, and requested additional information required for its satisfactory completion. 2 OBJECTIVES The objectives of the audit were: to evaluate whether the official controls put in place by the CA can guarantee that the conditions of production of fishery products in Honduras destined for export to the EU are in line with the requirements laid down in EU legislation; 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 mission report of 2006 have been implemented and enforced by the CA; The following sites were visited: Competent authority Central level 1 CA at Tegucigalpa District level 1 CA in Choluteca Laboratory visits Official laboratory 1 Tegucigalpa Facilities handling fishery products Aquaculture farms 2 San Bernardo Processing Plants 5 Choluteca and San Lorenzo 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 verify the equivalence of third-country rules with EU feed and food laws, as well as with animal health and animal welfare legislation. Full legal references are provided in Annex I. Legal acts quoted in this report refer, where applicable, to the last amended version. 1

6 4 BACKGROUND 4.1 GENERAL BACKGROUND Honduras is presently listed in Annex II of Commission Decision 2006/766/EC establishing the list of third countries and territories from which imports are permitted of fishery products for human consumption, other than those covered by Annex I. Honduras is also listed in the Annex to Commission Decision 2004/432/EC as having an approved residues monitoring plan for aquaculture products. A previous FVO fishery products mission took place in 2006 (ref. DG(SANCO)/2006/8161) which highlighted deficiencies in relation to the official control system for vessels, analytical methods used in laboratories, EU list of facilities, levels of sulphites in fishery products, the residue plan, issuing of health certificates as well as some deficiencies in establishments. The report 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. Those paper guarantees were evaluated by the FVO as satisfactory except the one about the scope of the laboratory. 4.2 PRODUCTION AND TRADE INFORMATION According to information provided by EUROSTAT the main fishery products imported into the EU in 2010 were about 8,200 tons of farmed shrimp, 96 tons of tilapia skins and about 80 tons of squid. The main importing Member States are (by decreasing order): Spain, the UK, France and Germany. The figures for fishery product exports to the EU received from the CA were very similar to the EUROSTAT figures. According to the information provided by the CA, the squid were imported into Honduras as raw material from EU listed sources, then processed and were later on exported to the EU. According to the list established by the CA imports of fishery products from Honduras into the EU are authorised from a total of eight land based processing plants. This list valid as of 08/05/2011 is available on the SANCO web site under: 5 FINDINGS AND CONCLUSIONS 5.1 LEGISLATION Legal requirements Requirements laid down in Article 46(1)(a) of Regulation (EC) No 882/2004 and Article 11(4)(a)(i) of Regulation (EC) No 854/2004. Findings The legal basis concerning the set up and organization of the National Service for Agricultural Health (Servicio Nacional de Sanidad Agropecuaria -SENASA) as the competent authority for fish, fishery and aquatic products in Honduras is the Phytosanitary Law No 157/94. This piece of legislation was updated by the Decree No providing for it the organisation, duties and 2

7 functions, competencies, prerogatives and powers. The main legal texts which regulate the official control of fishery products for EU export are the Agreement for the Inspection and Certification of fishery and aquaculture products No This governs the organization and implementation of official controls on fishery and aquatic products for human consumption intended for export, including to the EU market. It also identifies the National Residues Analyses Laboratory (Laboratorio Nacional de Análisis de Residuos - LANAR) as the laboratory responsible for official control analyses. This legislation covers all the main elements of EU legislation concerning fishery products. However the audit team noted some discrepancies: Maximum values for cadmium in fish meat are not in line with EU requirements. Agreement No indicates in its Article 77 that in a processing establishment the water in the reception bin for washing shrimps can contain up to 10 ppm of chlorine. This is not in line with EU legislation as fishery products have to be treated only with potable water and water with 10 ppm of chlorine is not considered as potable water under Honduran legislation. Conclusions Legislative improvements have been made since the previous mission in 2006 and the recommendation on this issue of that report is mostly addressed. Generally, legislation is in line with EU requirements. However to ensure full equivalence, some adjustments are needed to deal with the deficiencies noted concerning heavy metals and the use of chlorine in processing water. 5.2 COMPETENT AUTHORITY Legal requirements Requirements laid down in Article 46(1)(b) to (e), (g) and (h) of Regulation (EC) No 882/2004. Findings SENASA is the CA through its Food Safety Division (División de Inocuidad de Alimentos- DIA) and through the National Veterinary Supervisor for fishery products. SENASA is part of the Ministry of Agriculture and Livestock (Secretaría de Agricultura y Ganadería). The CA at regional level is composed of three Official Veterinary Inspectors (Inspector Veterinario Oficial - IVO) who carry out weekly inspections in the establishments, sign the export health certificates and supervise auxiliary inspectors. The auxiliary inspectors, five in total, supervise the aquaculture farms. The audit team noted that through these services a comprehensive control system for fishery products for export to the EU is in place. The team noted also that there is no system in place to carry out internal audits on the technical performance of the CA. But the DIA coordinator supervises the other inspectors following a procedure which is described in detail in Annex I of the IVO Guide. Written manuals/guides (Guías) on procedures and protocols on how the inspector's duties are carried out in the establishments and aquaculture farms are available and followed. The CA has the power to launch sanctions for non-compliances (infringement procedures) against food business operators and to seize fishery products at production and distribution levels. This power is provided under Phytosanitary Law No This piece of legislation also enables 3

8 the CA to suspend an establishment from export, to delist an establishment from the list of approved establishments and to impose fines. The impartiality and conflict of interest is covered by the laws applicable to civil servants in Honduras. 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 and associated manuals of procedures that can be considered to be in line with EU requirements. 5.3 NATIONAL PROVISIONS AND PROCEDURES FOR LISTING OF ESTABLISHMENTS FOR EXPORT TO THE EU Legal requirements Requirements laid down in Article 12(1) and (2) of Regulation (EC) No 854/2004 and contained in 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 Aquaculture farms must be registered with SENASA. At present 49 aquaculture farms are entitled to send their raw material to EU listed establishments. The registration of these farms is not formalised in writing but the CA applies the following system: before an aquaculture farm can be registered an auxiliary inspector visits the farm and explains to the operator which documents have to be provided. During this farm visit the auxiliary inspector verifies that good aquaculture practices are applied and a geo-reference code is attributed to the farm. After this visit the CA attributes an identity number to the farm and it may then sell its products to the EU listed establishments. Fish processing establishments must be approved by the CA in order to export fishery products to the EU. The approval procedure is set out in detail in the 17 points of Article 17 of Agreement No The approval of an establishment is valid for two years. The audit team noted that the approval document does not mention the kind of processing being carried out or the fact that the establishment is allowed to export to the EU. In addition to this approval document the CA issues every year a further document which certifies that a HACCP system is in place and has been verified. The HACCP plan describes both the species and processes involved. The audit team noted that the EU list of establishments allowed to export to the EU was up to date at the time of the audit. Conclusions The CA has rules and procedures to list establishments exporting to the EU in line with EU requirements which has been followed in the establishments visited by the audit team. There is also adequate provision for the registration of aquaculture farms providing raw material to EU listed establishments. 4

9 5.4 OFFICIAL CONTROLS OF PRODUCTION AND PLACING ON THE MARKET Legal requirements Requirements contained in 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. Findings Official control system in place The official control system in place is based on the Agreement No Subsidiary to this legislation a more detailed and practical description of the tasks involved is included in two codes of practice, an "Inspection Manual for Shrimp Farms" (Manual de Inspección de Fincas de Producción Primaria de Camarón de Cultivo) and the "IVO Guide -Fishing and Aquaculture Section" (Guía del IVO, Sección Pesca y Acuícola). Official controls cover the entire fishery products production chain (aquaculture farms, processing establishments and transport). The inspection visits to registered farms and EU listed establishments are carried out generally at the frequency which is laid down in the national legislation Primary production An auxiliary inspector inspects aquaculture farms once a month and notes the deficiencies in the logbook maintained on the farm. Four times a year he carries out a full inspection visit based on a checklist. Deficiencies are described in the inspection report but neither deadlines for their correction are set by the CA nor is a corrective action plan put in place by the food business operator. The audit team found no written evidence of a follow-up of the deficiencies recorded in the inspection reports. The audit team noted during a visit to a farm that oxytetracycline had been used for the treatment of shrimp. The withdrawal period for this antibiotic was respected and records of the administration of the drugs well kept. In another farm visited the audit team noted inconsistencies in the record keeping concerning the use of additives (sodium metabisulphite) and also between the practical use of additives and its use as foreseen in the FBO's own Good Practice Guide. Official samples for residues are taken, on average, three times a year. Own-checks for microbiology are carried out and the samples are analysed in the in-house laboratory of the processing plant which is to receive the shrimp. Directions for the preparation of the metabisulphite solution were available on the farms. However the audit team noted that the internal documents of the control on the quantities of metabisulphite used were sometimes not reliable. Pest control in one feed store was noted as very deficient by the audit team. The team also noted in one farm visited that shrimps immediately after being harvested are treated with a chlorine solution of 50 ppm or even higher Facilities handling fishery products The national veterinary supervisor of SENASA carries out at least once per year an audit in the processing establishments. During these visits a checklist is used for the audit of the HACCP system. In addition to this checklist the inspector uses the IVO Guide for the inspection of the 5

10 processing area and the other related facilities. The audit team found that reports of inspection visits were quite comprehensive. These visits are the basis for the renewal of approval of establishments. Renewal is also dependent on the findings noted during the weekly inspection visits of the IVO. However the audit team found that some deficiencies noted by them during their visits had not been mentioned in official control inspection reports. These deficiencies render the relevant part of the establishment at variance with EU equivalent standards. After each inspection visit the food business operator establishes a corrective action plan with a time-frame which he submits to the IVO for agreement. If the IVO agrees with the time-frame the food business operator carries out the required corrections. At the end of the time-frame the regional inspector verifies during his next visit whether the deficiencies have been corrected or not and records his findings. However the audit team noted that the inspector responsible for the establishment is not in receipt of a copy of the action plan. This fact limits the reliability of the follow up of the deficiencies. Regional IVOs carry out weekly inspection visits in the establishments. These visits can be divided into three types: One aimed to documentary checks, regarding the export health certification and the raw material reception. A second for official sampling. The third is an inspection visit to the establishment verifying condition of the facilities from a hygiene and maintenance perspective. The IVO does not write a report after these visits, merely a "Corrective Action Request" (Demanda de Acciones Correctivas) indicating the deficiencies noted. In response to this request the food business operator proposes a timeframe for the correction of the deficiencies. The IVO follows-up the correction of the deficiencies and records when the deficiency is considered as having been corrected. There is no risk based classification of establishments in Honduras so all are officially inspected with the same frequency. The audit team visited five land based establishments processing shrimp from aquaculture. Four of the five freeze their product of which two cook the shrimp before freezing. The fifth establishment merely deheads the shrimp. During the visits the audit team noted that in general the structural maintenance was generally satisfactory, nevertheless some deficiencies were found. The fishery product itself was processed hygienically. HACCP procedures were in place in all establishments visited and are approved by the CA on an annual basis. In general the HACCP plans reviewed were acceptable; however it was noted in two out of three plans that there was no evidence of the use of a logical process for the definition of Critical Control Points (CCPs). In one establishment all possible CCPs were ruled out with the use of a decision tree based on the principle that a subsequent step would eliminate or reduce the hazard to acceptable levels; however, the final step of the evaluation in this plant stated that the first step in processing carried out in the next establishment could be used to disregard that final step as a CCP. Own-checks performed in establishments were carried out regularly for all relevant fishery products (microbiology, heavy metals, PAH, PCB, some residues and metabisulphite). In one establishment visited microbiological analyses are carried out even every day of production. No own-checks are carried out here on ready to eat food (cooked shrimp) for Listeria monocytogenes, however this analysis is carried out for raw shrimp. All the analysis results reviewed by the audit team were 6

11 under the limits required in the EU legislation other than one result for metabisulphite and one for Salmonella. The audit team found evidence that the food business operators have taken corrective actions following theses high values. The audit team carried out some exercises on traceability in establishments and noted that a reliable system of traceability was in place. However the audit team noted in one establishment that shrimp originated from one farm which is not on the list of farms allowed to provide fishery products to the establishments exporting to the EU. The findings noted in the establishments visited by the audit team were as follows (not all present in every establishment):- Flakes of paint which could contaminate fishery products. Temperatures in one freezer tunnel functioning as a cold store were often above -18 C. Gaps under doors rendering them not pest-proof. Staff changing rooms not in the same building as processing rooms. Ice machine not covered (risk of contamination of the ice). Treatment of the water for processing fishery products not reliable (chlorination: time for contact chlorine water too short, no filtration). Absence of temperature recording devices in cold stores. The audit team noted in one establishment that seven of ten deficiencies recorded during the previous FVO inspection visit in 2006 had never been addressed. Most of these unaddressed deficiencies, some of them major, could have been easily resolved in this time span. The CA inspectors accompanying the audit team acknowledged these deficiencies and at the final meeting the CA assured the audit team that they would all be addressed Import controls of fishery products Imports of fishery products are permitted by SENASA some of which undergo further processing in EU listed establishments prior to export. The CA verifies the health certificate and the certificate of origin before permitting the import. Establishments importing fishery product must have an importer's authorisation from SENASA. One establishment visited imports squid for processing from EU listed sources. While in 2010 it exported 80 tons of squid to Spain, the audit team was informed that all squid imported and processed in 2011 was only for the regional market and not for the EU Follow up of RASFF notifications The audit team reviewed the CA procedure for follow-up of RASFF notifications. The CA checks every week the RASFF website for rapid alert notifications. In case of a notification the IVO responsible for the establishment traces back, on site, the batch of fishery product to its origin and enquires on destination of the product already delivered to customers. If parts of this batch are still in the establishment they will be detained, samples are taken and, where necessary, corrective actions carried out. Should it prove necessary the FBO must recall the product already delivered. The CA informs the relevant EU services on these follow-up activities. Since 2007 there has only been one RASFF for Honduras: interruption of the cold chain on a shipping container in a vessel. The audit team investigated this case where higher temperatures than 7

12 18 C were notified in the alert. The food business operator carried out an investigation and the reason could be explained to the audit team (interruption of power supply on the container vessel concerned). Conclusions The CA has an adequately functioning official control system in place for the production of fishery products intended for export to the EU that covers the entire production chain. Primary production is under its control and mostly in line with EU requirements. The treatment of fishery products with hyper-chlorinated water is not in line with EU legislation. The CA has a system for control of imports of fishery products in place which permits traceability. The official control system for establishments listed for EU export is adequate and the establishments visited generally meet EU equivalent standards even though some deficiencies were noted. Notably, given that some of the HACCP plans do not adequately address the risks involved and that the system of own-checks is deficient as regards microbiological testing of ready-to-eat foods, standards equivalent to EU legislative requirements are not met. 5.5 OFFICIAL CONTROLS OF FISHERY PRODUCTS Legal requirements Requirements contained in 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. Regulation (EC) No 1881/2005 sets the maximum limits for contaminants. Findings The audit team noted that random organoleptic checks are carried out by the regional inspectors at several levels of production. The audit team was informed that testing for TVB-N was carried out only for tilapia filets. A control system to monitor the level of contaminants has been set up by the CA and the LANAR takes and analyses samples. The coordinator of the DIA and the general manager of the laboratory establish a yearly monitoring plan (numbers of samples to take, methods of analysis to employ, define the detection limits and review the results of the previous year). The audit team noted that testing for heavy metals is integrated in the Honduran residues monitoring plan. The monitoring arrangements are integrated in the supervision of establishments. Official checks for heavy metals are carried out at least once a year in the establishments. The audit team saw no result above the limits laid down in EU legislation. No official controls are carried out for dioxins. No official analyses are carried out for sulphites in shrimp. The CA relies solely on the food business operator's own-check analyses for sulphites and their test results for which the CA does not perform any control to verify that the test methods and results are reliable. Most of the 8200 tons of shrimp exported every year to the EU undergo a treatment with metabisulphite. Microbiological checks are carried out at least once per year by the CA. Analyses are carried out for Total Plate Count (TPC), faecal coliforms, E. Coli, Staphylococcus aureus, Salmonella, Listeria monocytogenes inn fresh shrimp and total coliforms. However the audit team noted that no tests are carried out for Listeria monocytogenes on cooked ready to eat products. During the inspection visits SENASA inspectors do random testing for parasites. 8

13 As Honduras exports only products from aquaculture and squid to the EU there is no risk that poisonous fish species are exported to the EU. Conclusions The official controls of fishery products implemented by the CA do not cover all the requirements mentioned in the health certificate and in Chapter II of Annex III to Regulation (EC) No 854/2004. They do not include testing for dioxins or for Listeria monocytogenes in cooked fishery products. The CA does not have in place an official control system to ensure that fishery products exported to the EU comply with the admissible levels for additives, in particular for sulphites. 5.6 OFFICIAL CERTIFICATION Legal requirements Requirements laid down in Article 14 and Annex VI to Regulation (EC) No 854/2004 and 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. Certification procedure has to be at least equivalent with the requirements of Directive 96/93/EC. Findings Article 101 of Agreement No prescribes the information to be included in the export health certificate. Before issuing a health certificate, the IVO jointly with the food business operator gathers the packing list, the certificate of origin, the bill of lading, the test results of the own microbiological checks and the invoice. In Honduras the IVO in charge of the inspection of the exporting establishment issues the health certificate. The audit team noted that the deficiency in this area detected during the last FVO mission (more than one original of the certificate issued) has been addressed. Conclusions The certification procedures designed by the CA can be considered as equivalent to the requirements of Directive 96/93/EC. 5.7 LABORATORIES Legal requirements Requirements laid down in Article 46(1)(d) of Regulation (EC) No 882/2004, Chapter 1 of Annex I to Regulation (EC) No 2073/2005, Section II of Annex II to Regulation (EC) No 2074/2005 and Regulations (EC) Nos 1883/2006 and 333/2007. Findings The audit team visited the LANAR laboratory in which official analyses are carried out. This laboratory also analyses samples for the food business operators' own-checks systems. The conditions in this laboratory has considerably improved compared to the mission in 2006 and is now in a new building with new equipment available to carry out the relevant tests. At the time of the visit the laboratory was in a good state of maintenance and well equipped. The staff has undergone regularly training. However the laboratory is only accredited for testing for Salmonella and reassessment for this scope 9

14 is done every year. Accreditation is in progress for aflatoxins, heavy metals, Ivermectin and Nitrofurazones. In February 2011 the laboratory participated with satisfactory results in a proficiency tests for E. Coli, coliforms, Staphylococcus aureus, Salmonella and Listeria monocytogenes in meat. Also in May 2010 it participated in a proficiency test for microbiology in canned tuna with only one result being unsatisfactory. LANAR was at the time of the audit participating in a proficiency test for lead and cadmium in rice. Water is analysed for TPC, E. Coli, coliforms as well as for Enterococci but not for Clostridium perfringens as no surface water is used in the establishments exporting to the EU. The audit team found only on test result (Salmonella) which was above the limits defined in EU legislation. The audit team noted that for metabisulphite testing the laboratory uses a method which has not been validated. Conclusions The CA has designated a laboratory for official controls of fishery products. However, the methods used in the context of the controls for metabisulphites and heavy metals are neither accredited nor validated. Consequently, the tests currently used to monitor fishery products with regard to these substances cannot be considered as fully meeting EU equivalent standards and the results may be unreliable. 6 OVERALL CONCLUSIONS Improvements in the implementation of official control system since the last mission in 2006 have been made. However, to fully ensure that all fishery and aquaculture products exported to the EU respect the requirements mentioned in the health certificate as set out in the model defined in Regulation (EC) No 2074/2005 corrections and improvements are needed, in particular concerning the deficiencies identified in the treatment of shrimp as well as in the laboratory analyses for contaminants and additives. Once the identified deficiencies have been addressed the competent authority should be in a position to fully guarantee that the required sanitary conditions of fishery and aquaculture products for EU export are being met. 7 CLOSING MEETING During the closing meeting held in Tegucigalpa on 23 November 2011, the audit team presented the main findings and preliminary conclusions of the audit to the CA. During this meeting, the CAs acknowledged all the findings and preliminary conclusions presented by the audit team and provided a written plan for ten activities which they intend to undertake in order to address the deficiencies found. 8 RECOMMENDATIONS The CA should provide Commission services with an action plan, including a timetable for its completion, within one month of receipt of the report, in order to address the following recommendations for fishery products exported to the EU. 10

15 N. Recommendation 1. The CA should ensure that standards applied to fishery products exported to the EU are fully equivalent to EU requirements in particular regarding maximum limits of heavy metals as laid down in Regulation (EC) No 1881/2006 and the content of chlorine in the processing water as laid down in national legislation. 2. The CA should ensure that aquaculture farms providing fishery products to EU listed establishments meet provisions at least equivalent to the requirements laid down in Regulation (EC) No 852/2004 Annex I, Part A, Point II The CA should ensure that harvested fishery products are in contact with water which meets the criteria of potable water as laid down in (EC) No 852/2004 Annex I, Part A, Point II The CA should ensure that all establishments involved in the production chain of fishery products for EU export are in compliance with requirements for HACCP at least equivalent to those of the EU, in particular, those of Article 5 of Regulation (EC) No 852/ The CA should ensure that all establishments involved in the production chain of fishery products for EU export are, as far as structure and maintenance of facilities are concerned, in compliance with requirements at least equivalent to those of the EU, in particular, those of Section VIII of Annex III to Regulation (EC) No 853/ The CA should provide guarantees that fishery products for export to the EU have satisfactorily undergone all official controls laid down in Chapter II of Annex III to Regulation (EC) No 854/2004, in particular, monitoring of certain contaminants (dioxin and Listeria monocytogenes) and additives (metabisulphite). 7. The CA should ensure that laboratories involved in official controls apply the principles of internationally recognised quality assurance techniques and are evaluated and/or accredited under officially recognised quality management and assurance programmes equivalent to international standards, such as ISO/IEC 17025, to ensure the reliability of analytical results. 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 Dir. 96/93/EC OJ L 13, , 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. 83 Reg. 882/2004 OJ L 165, , p. 1, Corrected and re-published in OJ L 191, , 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 Council Directive 96/93/EC of 17 December 1996 on the certification of animals and animal products 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 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 12

17 Legal Reference Official Journal Title 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 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