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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.
EUROPEAN COMMISSIONDIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY
Health and food audits and analysis
DG(SANTE) 2016-8947 - MR
FINAL REPORT OF AN AUDIT
CARRIED OUT IN
HONDURAS
FROM 10 OCTOBER 2016 TO 20 OCTOBER 2016
IN ORDER TO
EVALUATE THE CONTROL SYSTEMS IN PLACE GOVERNING THE PRODUCTION OF FISHERY PRODUCTS INTENDED FOR EXPORT TO THE EUROPEAN UNION
Ref. Ares(2017)2508539 - 17/05/2017
I
Executive Summary
This report describes the outcome of a Directorate-General for Health and Food Safety audit in Honduras carried out from 10 to 20 October 2016, as part of its programme for audits in non-EU countries.
The primary objective of the audit was to evaluate the public health conditions for the production of fishery products (mainly aquaculture) in Honduras destined for export to the EU. The audit covered the relevant EU legislation for the public health sector.
The report concludes that improvements have been made since the last audit and that most of the recommendations concerning fishery products have been addressed in a satisfactory way, except for the insufficient official controls on the use of additives and the reliability of validation/accreditation of some methods of analyses used for official controls of fishery products.
The competent authority has implemented an official control system for fishery products intended for export to the EU, which adequately covers the production, processing and distribution chain of fishery products. However, to guarantee that fishery products exported to the EU comply with all of the relevant elements of the export health certificate, improvements are needed mainly regarding the guarantees provided by the competent authority in relation to compliance with EU requirements of the listed establishments and implementation of procedures at the time of issuing health certificates.
The report addresses to the Honduras competent authority a number of recommendations aimed at rectifying the identified shortcoming and enhancing the control system in place.
II
Table of Contents1 INTRODUCTION..........................................................................................................................1
2 OBJECTIVES AND SCOPE .........................................................................................................1
3 LEGAL BASIS ..............................................................................................................................2
4 BACKGROUND............................................................................................................................2
4.1 General Background ..............................................................................................2
4.2 Production and Trade Information ........................................................................3
4.3 Rapid Alert System for Food and Feed (RASFF) Notifications ...........................45 FINDINGS AND CONCLUSIONS ..............................................................................................4
5.1 Legislation .............................................................................................................4
5.2 Competent Authority .............................................................................................55.2.1 Structure and organisation ...................................................................................................6
5.3 National Provisions and Procedures for Listing of Establishments for Export to the EU..........................................................................................................................9
5.4 Official Controls ................................................................................................105.4.1 Official Controls of Production and Placing on the Market...............................................10
5.4.5 Official Control of Fishery Products ..................................................................................17
5.5 Follow-up of RASFF Notifications .....................................................................19
5.6 Laboratories .........................................................................................................20
5.7 Official Certification............................................................................................23
5.8 Follow-Up of Previous Audit 2011-8892............................................................256 OVERALL CONCLUSION ........................................................................................................27
7 CLOSING MEETING .................................................................................................................27
8 RECOMMENDATIONS .............................................................................................................27
III
ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT
Abbreviation Explanation
CA Competent Authority
CENTREX Centro de Tramites de Exportación
DG Health and Food Safety
Directorate-General for Health and Food Safety of the European Commission
EU European Union
EU listedFacilities approved by the Honduran CA for participation in the production chain for fishery products for EU export and listed on the internet site of the EU Commission
EUROSTAT Statistical Services of the European Union
FBO Food Business Operator
HACCP Hazard Analysis Critical Control Points
IAPPAuxiliary Inspectors of Primary Production -Inspectores Oficiales Auxiliares de Producción Primaria
ISO International Organisation for Standardisation
IVO Official Veterinary Inspector - Inspector Veterinario Oficial
LANAR National Residues Analyses Laboratory
NVS National Veterinary Supervisors
PCBs Polychlorinated biphenyls
PT Proficiency Test
RASFF Rapid Alert System for Food and Feed
RMP Residues Monitoring Plan
SAG Secretaria de Agricultura y Ganadería
SENASA Servicio Nacional de Sanidad e Inocuidad Agroalimentaria
TRACES Trade Control and Expert System
TVB-N Total Volatile Basic Nitrogen
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1 INTRODUCTION
This audit took place in Honduras from 10 to 20 October 2016 and was undertaken as part of the Directorate-General for Health and Food Safety's (DG Health and Food Safety) planned audit programme. The audit team comprised two auditors from DG Health and Food Safety. The current audit was a joint audit covering broad areas regarding fishery products intended for export to the European Union (EU), one evaluating the control systems and operational standards in the residues sector and the other focusing on public health controls of the production system for fishery products. For each scope, an individual report is being produced. This report covers the evaluation of the control systems in place governing the production of fishery products intended for export to the EU. The report dealing with residues monitoring has the following reference DG (SANTE)/2016-8898.
An opening meeting was held in Tegucigalpa on 10 October 2016 with the competent authority (CA), the Servicio Nacional de Sanidad e Inocuidad Agroalimentaria (SENASA). This meeting was attended by the Minister of Agriculture and Livestock. At this meeting the audit team confirmed the objectives of, and the itinerary for the audit, and received additional information required for satisfactory completion of the audit.
2 OBJECTIVES AND SCOPE
The objectives of the audit covered by this report 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, and in particular with the health attestations contained in the certificate of Appendix IV to Annex VI to 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 fishery products audit report of 20111 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 and the official control system in place covering production, processing and distribution stages 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 audit criteria for the audit.
1 Report ref. DG(SANCO)/2011-8892 published in http://ec.europa.eu/food/audits-analysis/audit_reports/details.cfm?rep_id=2835
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In pursuit of these objectives the following sites were visited by the audit team:
COMPETENT AUTHORITYCentral level 1Regional level 1LABORATORY VISITS
National Residues Analyses Laboratory (LANAR)
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PRIMARY PRODUCTIONAquaculture farms shrimps 2Aquaculture farms tilapia 1FACILITIES HANDLING FISHERY PRODUCTSProcessing Establishment shrimp 3Processing Establishment tilapia 1FEED MILL
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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. EU legal acts quoted in this report refer, where applicable, to the last amended version.
4 BACKGROUND
4.1 GENERAL BACKGROUND
Honduras is presently listed in Annex II to Commission Decision 2006/766/EC establishing the list of third countries and territories from which imports of fishery products for human consumption are permitted, other than those covered by Annex I.
Honduras is also listed in the Annex to Commission Decision 2011/163/EC as having an approved Residues Monitoring Plan (RMP) for aquaculture products and therefore can export such products to the EU.
A previous audit took place in 2011 (ref: DG (SANCO) 2011-8892) which highlighted deficiencies in shrimp aquaculture products in relation to the chlorine content of processing water, the maximum limits permitted for heavy metals, compliance with requirements for Hazard Analysis Critical Control Points (HACCP) in processing establishments, lack of official monitoring for certain contaminants and additives, the quality assurance of some
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analytical techniques used in the official laboratory as well as some structural deficiencies in and maintenance of establishments.
The report of this earlier audit 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 guarantees were evaluated and considered satisfactory.
4.2 PRODUCTION AND TRADE INFORMATION
According to Trade Control and Expert System (TRACES), in 2015 just over 9,100 tonnes of fishery products were exported to the EU. These were mostly aquaculture shrimp (Litopenaeus vannamei) with small quantities of wild frozen squid and prepared octopus. Other fishery products that appear in Table 1 below were found during this audit to have been incorrectly coded or to have been exported illegally (see paragraphs 64 and 77). The main importers were UK, Spain, Germany, France, the Netherlands and Belgium. In addition, the CA informed the audit team that nearly 600 kg of tilapia (Oreochromis spp) skin and fish scales destined for the production of cosmetics and the manufacture of gel capsules for medicines were exported to the EU. The figures obtained from Statistical Services of the EU (EUROSTAT) were similar.
Table 1 summarises the exports from Honduras of fishery products to the EU. Table 1- Exports of fishery products from Honduras to the EU (tonnes)
(source TRACES)
Commodity Category 2014 2015Crustaceans (shrimp of the
genus Penaeus)7,331 6,322
Shrimps/ prawns prepared, preserved
2,618 2,734
Other shrimps and prawns farmed
40
Crabs 4.3Rock lobster and sea
crawfish excluding tails (Palinurus spp)
3
Squid (Loligo vulgaris) 2Octopus (Octopus vulgaris) 1.5
Total export to the EU 9,949 9,106.8
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4.3 RAPID ALERT SYSTEM FOR FOOD AND FEED (RASFF) NOTIFICATIONS
As regards Honduras , only two RASFF notifications regarding fishery products exported to the EU were issued in the period January 2015 to September 2016 both were for crustaceans and concerned primarily ruptures of the cold chain (subsequently found to be illegal exports, see paragraph 64).
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
1. The main pieces of legislation covering the production chain of fishery products intended for export to the EU currently in force are: The Executive Decree No PCM-038-2016 of July 2016 is the only new piece of
legislation since the previous fishery products audit in 2011. This Decree establishes the "new" SENASA, a decentralized/autonomous agency but always under the Ministry of Agriculture and Livestock (Secretaria de Agricultura y Ganadería, SAG), as the CA for fish and fishery products.
The Phytosanitary Law No 157/94 updated by the Decree No 344 – 2005 confers on SENASA the powers and faculties to be the CA for sanitary and phytosanitary issues, including the inspection and certification of products of agricultural origin of import and export destined for human consumption.
The Agreement 728-2008, "Regulation for the Inspection and Certification of Fishery and Aquaculture products" contains requirements for official controls in primary production and processing establishments producing fishery products for EU export including organoleptic characteristics and maximum levels of microorganisms, residues, contaminants and additives. It also recognises LANAR as responsible for official control analyses.
The Agreement No 084-1995 describes the "Technical standard for drinking water quality".
The RMP which sets out the monitoring system for residues, the maximum permitted limits and the verification procedures to be employed for the control of residues, contaminants and microbiology characteristics of fishery products and water.
2. The audit team noted that:- A legal framework covering the production of fishery products intended for EU
export is in place. The legislation described covers all the main elements of EU legislation concerning fishery products.
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The deficiencies identified in 2011 regarding maximum limits of heavy metals and the use of chlorine in processing water, have not resulted in changes in legislation (Agreement No 728-2008) as proposed in the CAs response to recommendations of the 2011 report. However, the maximum levels of heavy metals implemented are those outlined in the 2016 RMP and are in line with EU legislation. Regarding chlorine, the standards of potable water, as per Honduran legislation, are described in the IVO (Official Veterinary Inspector) Guide (see paragraph 13 below) and these are being implemented.
The competent authority stated to the audit team that, in their view, the RMP is the Honduran document that clearly indicates to all of those involved in the production chain of fishery products for EU export, the requirements to be verified during the official control tasks. These requirements are applied to all the fishery products exported from Honduras whether to the EU or not. In this regard, the maximum limits of contaminants that are enforced by the CA are the most restrictive ones amongst all those which have been set by the importing countries.
Auditors noted that the 2016 RMP does not include all the requirements of EU legislation in relation to maximum levels of the sum of dioxins, and dioxin-like polychlorinated biphenyls (PCBs) and the sum of PCBs in shrimp and tilapia. In addition, all the maximum levels of contaminants for fishery products being exported to the EU from Honduras (i.e. levels of cadmium in cephalopods) are not included in the RMP. However, none of the results of testing for dioxins and PCBs observed by the auditors was above the EU permitted maximum limits.
Conclusions on legislation
3. In general terms, Honduran fishery products legislation (and RMP) in force covering the exports of fishery products to the EU, gives an adequate basis to provide guarantees as to their equivalence with EU rules for the sector. The maximum levels implemented for heavy metals in fishery products and chlorine in water are now in line with EU and national legislation respectively, even though the national legislation has not been amended. However, the gaps in the inclusion of some contaminants in the RMP may weaken the ability of the competent authority to demonstrate that applied standards are at least equivalent to EU requirements.
5.2 COMPETENT AUTHORITY
Legal requirements
Article 46 of Regulation (EC) No 882/2004, in particular point 1 (b) to (e), (g) and (h) of the aforementioned Article. Points g) and h) are covered in section 5.4 of this report.
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Findings
5.2.1 Structure and organisation
4. SENASA is the CA responsible for control of the EU export fishery products production chain in Honduras. It operates under its Director General, through its Sub-Directorate General for Food Safety (Subdirección General Inocuidad Agroalimentaria) and through its Fishery Products and Aquaculture Section (Sección de Productos Pesqueros y Acuícolas) using National Veterinary Supervisors for Fishery Products (NVS). The CA headquarters is located in Tegucigalpa. The head of the Sub-Directorate General for Food Safety coordinates and supervises official controls including those done by the official laboratory LANAR. Two, one newly recruited, NVS supervise imports/exports and carry out one audit a year in EU approved processing establishments for verification of HACCP and prerequisite programmes.
5. Below national level is the regional CA, composed of three Official Veterinary Inspectors [Inspector Veterinario Oficial, (IVO)]. Two IVOs in a region visited, are assigned to approved shrimp processing establishments and one in another region visited, is assigned to two tilapia fish farms and an approved tilapia processing establishment. The IVOs carry out inspection and verification of compliance with both Agreement 728-2008 and the IVO Guide and sign export health certificates. One IVO is responsible for approving on line (TRACES system) EU export health certificates for shrimp and for the RASFF notifications follow up.
6. There are six official Auxiliary Inspectors of Primary Production (IAPP) in the shrimp farms and one hatchery inspector responsible for the inspection and verification of the hygiene process and official controls in accordance with the requirements of Agreement 728-2008 and procedures described in the Shrimp Manual (see paragraph 13).
7. The audit team was informed that, in addition, there are ten IAPP whose role is to supervise shrimp harvesting and issue transport certificates for the truck taking shrimp to processing plants.
5.2.2 Powers, Independence and Supervision
8. SENASA have powers under the Phytosanitary Law No 344-2005 to impose sanctions on Food Business Operators (FBOs) for infringements of the law. This legislation also allows for the delisting of EU exporting establishments, the closing of food business operations, the removal and the destruction of products. Agreement 728-2008 Chapter X, establishes the infringements and the type of sanctions. The audit team was provided with an example of actions taken in the case of a non-compliance that resulted in a court case (ongoing at the time of the audit).
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9. There is a documented system in place covering official staff supervision. The audit team was informed that in 2015/2016 official supervision over the technical performance of staff was not carried out. However, the audit team observed an instance where an IAPP's performance was reviewed/ inspected by an IVO.
10. The audit team was informed that as part of the certification of fishery products for EU export, Honduran official controls may be audited by the CAs of importing countries (e.g. USA and Mexico). Evidence of such audits having taken place was provided to the audit team.
11. The audit team was informed that testing of official samples is financed by the FBOs. The imposition of charges for official controls including hygiene inspections, running programmes of control of contaminants and other activities of the SENASA, are covered in the Phytosanitary Law No 344-2005.
5.2.3 Training
12. Regarding training of staff involved in official controls of fishery products, the audit team noted that:-
a. Veterinary staff at the CA headquarters had recently undergone and/or were undergoing training related to food safety and HACCP. On-the-job training takes place whereby newly recruited officials such as the NVS, are mentored by more experienced staff.
b. The IVO responsible for approving EU export health certificates had participated in 24 hours (3 days) of training on TRACES carried out by the EU.
c. Some IAPPs have participated in training provided by SENASA officials (e.g. antimicrobial resistance).
d. No specific training on EU requirements for fishery products had been organised lately.
5.2.4 Documented Control Procedures
13. There is one Guide for IVOs (2015) setting out the procedures and protocols for IVO inspector duties in the processing establishments and a Shrimp Manual (updated 2016) detailing IAPP duties for shrimp farms.
14. Regarding inspection reporting procedures in shrimp aquaculture farms, the audit team noted that inspection reports were available in the farms visited. Any deficiencies were registered and followed-up in the farm's logbook. Other documents include:- a form for reporting on the hygiene conditions at time of harvesting including the use of metabisulphites and potable water; a form for the submission of samples to LANAR and a form for recording the non-compliances found.
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15. Regarding inspection reporting procedures in tilapia aquaculture farms, the audit team noted that that a checklist was available and used.
16. Regarding inspection reporting procedures in shrimp processing establishments, the team noted that the annual audit of the HACCP system is documented using a checklist. Non-compliances are recorded in a document given to the FBO. The audit team noted that the IVO also uses a checklist for routine inspections and a document in which the programme of inspections for the following three months is outlined.
17. Regarding inspection reporting procedures in the tilapia processing plant, the audit team was informed that inspection reports are not routinely issued and that only non-compliances are recorded and followed-up via the plant's logbook. However, no major issues were identified during the visit of the audit team.
18. Regarding control activities, methods and techniques, the team noted that tasks related to official controls are, in general, carried out by SENASA officials, using appropriate control methods and techniques such as monitoring, surveillance, verification, audit, inspection, sampling and analyses.
Conclusions on Competent Authorities
19. The CA responsible for official controls on fishery products is clearly designated and has an adequate structure, organisation and powers for the performance of official controls of the production chain of fishery products intended for EU export.
20. In general, documented procedures are in place to support official staff with their
duties to guarantee the compliance of fishery products with EU equivalent standards in all the establishments visited. The gap identified on the general lack of supervision of the officials performing official controls together with finding 37 weakens the ability of the competent authority to guarantee compliance/equivalence with the relevant EU requirements.
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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
21. In order for an establishment to be listed for export to the EU, it is a pre-requisite that the establishment is approved and certified at national level by the Food Safety Division of SENASA and complies with EU requirements.
22. The national approval procedure and/or renewal of approval is set out in detail in Chapter IV of the "Approval Regime and Own-Check Systems" in the Agreement No 728-2008. The procedure includes an application submitted to the SAG by the interested FBO, accompanied by the documentation requested. The official veterinary inspector must endorse the sanitary aspects of the documentation presented under the requirements determined by SENASA. The establishment may only operate after inspection and approval for operation and when it receives a number that accredits that is an approved establishment. The establishment number must always be used for identification of the processed products that should have passed the inspection and approval of the veterinary services. The approval of an establishment is valid for two years when specific documentation has to be submitted to the CA. SENASA will keep up to date lists of approved processing plants including the product for which they are approved. The approved establishments will be under official control.
23. The control systems for EU listed facilities2"Approval procedure of establishments to be certified or renew their certification for export" is outlined in the IVO Guide. The procedure includes an application submitted to SENASA. The establishment must have an up to date registration in SAG, a HACCP manual and be officially supervised. The establishment must comply with the programme of microbiological and chemical residues related to the product and year. During an official inspection, the compliance with the requirements of the importing country will be evaluated. If approved, the CAs will inform the importing country. There is a system in place to re-export to Honduras products in the case of a sanitary alert. The CAs will be responsible for reprocessing or destruction of the product as appropriate.
2 facilities approved by the Honduran CA for participation in the production chain for fishery products for EU export and published on the internet site of the EU Commission
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24. 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 establishments (these include seven establishments processing only or partially materials derived from aquaculture shrimp and one processing materials derived from aquaculture tilapia).
The list, is available on the European Commission website at the following address:
https://ec.europa.eu/food/safety/international_affairs/trade/non-eu-countries_en
Conclusions on listing of establishments for export to the EU
25. There is a system in place for approval and listing of establishments authorised to export to the EU which gives a good basis for ensuring that the relevant EU requirements are met.
5.4 OFFICIAL CONTROLS
5.4.1 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.
Article 12 (2) and Article 11(4) of Regulation (EC) No 854/2004.
Findings
5.4.1.1 Official Control System in Place
26. Official controls of aquaculture fishery products are carried out by SENASA officials and cover the whole chain of production (feed meal, hatchery, aquaculture farms, processing establishments and transport).
27. The shrimp inspection schedule is based on the production cycle and the volume of production. There are two cycles of shrimp production per annum, according to the RMP the first cycle is March to June and the second is July to November. For shrimp farms, official inspections by the IAPP are scheduled every month during production. For tilapia farms, official inspections are planned at least annually by the NVS and twice a year by the IVO. Official controls in shrimp processing establishments are programmed to take place at least once a year by the NVS and once a week by the
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IVO. For the establishment processing tilapia, inspections are programmed at least once a year by the NVS and twice a week by the IVO.
28. The official control system is based on documented procedures described in the Agreement No 728-2008, the IVO Guide, the Shrimp Manual and the RMP. Standardised checklists are used to facilitate the performance and consistency of official controls in the shrimp sector. Inspections and audits are generally announced in advance. Reports and establishment logbooks are used for documentation of controls and those were available to the audit team at regional offices and at farms and establishments visited.
29. In the case of shrimp farms, non-compliances are registered in a logbook and are checked in the follow-up visit. If after three visits the non-compliances have not been resolved, the shrimp farm operator will not be allowed to send their products to a processing plant for later export. In the case of processing establishments, after each inspection a non-compliance report is given to the FBO who must submit a plan of corrective actions that includes deadlines for approval by the inspector. These are verified before closure. Results of inspections are written up in monthly reports prepared at regional level.
5.4.2 Primary Production
5.4.2.1 Shrimp Aquaculture Farms
30. Aquaculture farms must be listed by SENASA to be entitled to send their raw material to EU listed establishments for eventual export to the EU. In order to be listed, a farm has to comply with the following requirements:- o be identified by SENASA and have a geo-reference, o be supervised by SENASA, samples are taken as part of the RMP, samples are
taken as part of the epidemiological surveillance and o be recognised by SENASA as applying Good Aquaculture Practices (at least 90
% compliance awarded during the inspection, each area inspected is awarded a different score).
Once listed an individual identity code is allocated to each farm.
31. The audit team noted that:- o Unlisted farms can also send their raw materials to EU listed establishments for
markets other than the EU. o In Honduras there are 349 geographically identified shrimp farms of which 26 are
listed for export to the EU. o According to the CAs, 70% of shrimp production in Honduras comes from the
listed farms. o Some EU listed establishments have their own listed farms.
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32. The audit team visited two EU listed farms and observed that:-o Both had valid certificates of " Good Aquaculture Practices". o The IAPP monthly visits covered the following issues:- implementation of Good
Aquaculture Practices (four times a year a full inspection visit based on a checklist should be carried out), sample collection under the RMP, epidemiological surveillance or audits carried out by importing countries (e.g. Mexico).
o In both farms, in 2016, the IAPPs had carried out inspections and follow-up in line with the set procedures and established frequencies.
o Own-checks for microbiology are carried out in in-house laboratories.
33. Harvesting of shrimp takes place at night or very early in the morning. The audit team was not present at the time of harvesting but was informed that in the shrimp farms visited the procedure is as follows:-o Staff, specially trained in the use of additives (metabisulphites), are provided by
the processing establishment that is to receive the raw materials. The additive, water and ice used at the time of harvesting and for transport to the processing establishment, is also provided by them. “In situ” checks on the levels of additives are carried out. The protocols for the use of metabisulphites was updated after the 2011 audit.
o The treatment of shrimp with a chlorine solution is no longer allowed by the CAs. This practice was terminated in 2012. In response to a recommendation in the 2011 audit report, an official communication was issued banning the use of chlorine solutions and has been implemented ever since. The official communication states that only potable water is to be used in both the harvesting and processing of shrimp.
o IAPPs supervise the harvesting including hygiene conditions, use of water, ice, disinfectants and metabisulphites as well as verifying the traceability of the product. If everything is found compliant, a bill of lading (guía de embarque) authorising the transport of the product to the processing establishment will be issued. The audit team noted that this document is signed in advance by the IVO before being completed by the IAPP. In addition, a commercial certificate accompanies the product. Individually both documents guarantee the traceability of the materials being transported. The audit team observed SENASA traffic checks to ensure that shrimp being moved had the appropriate documentation.
5.4.2.2 Tilapia aquaculture farms,
34. In Honduras there are two tilapia farms in the same lake. Both farms have year round production. The current tilapia production system is integrated and the farms and processing establishment are owned by the same FBO. There is one IVO responsible for all official controls in the farms and the establishment. In 2015, there were no exports of tilapia for human consumption to the EU but they are EU listed for this should they so wish.
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35. In one farm visited, the team noted the following:-o The farm has a certificate of Good Aquaculture Practices issued by the CCA.
Minimum inspections visits are once a year.o The IVO carries out two official announced inspections a year using a
standardised checklist. The IVO also visits the farm to collect, together with FBO staff, samples under the annual RMP. Samples are taken two months before harvesting and are sent to LANAR for testing for heavy metals, dioxins and PCBs. Official IVO visits and their purpose are recorded in the logbook.
o Transport of tilapia to the plant is documented by a biomass harvest waybill (Guía de remisión de cosecha de biomasa) issued by the FBO, that allows for traceability of the product. There is no official control at this stage.
o Water and ice go from the processing plant to the tilapia farm for the harvesting and transport of live fish to the processing establishment.
o For feed security, the farm receives a certificate issued by the feed supplier stating that the feed is free of medicines, colorants, hormones and antibiotics.
o Farm own-checks cover pest control. According to the CA, the Honduran Ministry of Health is, since 2014, responsible for official control/ registration of chemical products for pest control having taken over this role from SENASA.
5.4.3 Facilities Handling Fishery Products
5.4.3.1 Shrimp processing establishmentsThree processing establishments were visited by the team.
36. The HACCP system and the implementation of Good Hygiene Practices for each establishment is audited annually by the NVS. The checklists used are quite comprehensive. When all is found compliant an " Official Recognition of the HACCP Programme" (Reconocimiento Oficial del Programa HACCP) will be issued. This certificate is valid for one year.
37. The audit team noted that:- o All eight approved processing establishments had up-to-date certificates. The
assessment of the HACCP plans in the processing establishments visited had taken place shortly before the current audit and most non-compliances identified had been resolved.
o According to the IVO Guide the evaluation of the HACCP plan should take place twice a year.
o In one of the plants visited (of seven shrimp plants approved for exports to the EU), the NVS had carried an annual audit of the HACCP plan in September 2016 and fifteen non-compliances had been identified. A plan of corrective actions had been issued and some corrective actions had been closed, others were still open. Some non-compliances identified during this HACCP audit were not covered by the corrective action plan. This had not been noticed by the IVO responsible for the follow up of the audit. Furthermore in 2016, up to the time of the audit, the
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local IVO had inspected the plant four times without identifying any non-compliance. The most recent IVO inspection occurred two days before the NVS inspection in September. While some of the points to be checked during the IVO inspections overlapped those covered during the HACCP audit (and for which several non-conformities were identified by the NVS), the checklists that were filled in during the IVO inspections did not contain any non-conformities, hence showing discrepancies in the outcome of the assessments conducted for areas that fell under the scope of both the NVS audit and the IVO inspections. These non-conformities included: lack of description of all the possible hazards in the HACCP plan, the number of samples taken for microbiological sampling being lower than required in the official programme, lack of register of calibration of thermometers, lack of register of temperature records during transport and structural deficiencies (adequate light in the processing area, sanitary installations for personnel).
38. IVO visits are carried out for two reasons, either for official sampling purposes or to verifying the condition of the facilities using the checklist.
39. The audit team noted that :-o Inspections are not systematically documented even though a checklist is available
(the IVO may only sign in the logbook to indicate that a visit had occurred).o One establishment had not been visited by the IVO weekly as required by the IVO
Guide.o The conditions were generally adequate in the establishments visited as regards
structure, equipment, maintenance and hygiene.
40. Own-checks (sampling and testing) performed in establishments were carried out regularly in in-house laboratories including:-o Organoleptic tests. Both on farm and in the processing establishments. o Microbiology. Comprehensive list of pathogens were being tested for in raw and
cooked end-product including testing for Listeria monocytogenes in cooked shrimp (ready to eat). Positive samples are sent for confirmation either to LANAR or the government's Laboratory of Aquatic Pathology and Water Quality (Laboratorio de Patología Acuática y Calidad de Agua) in Choluteca. This latter laboratory is the result of an agreement on inter-institutional cooperation between the SAG and the National Association of Aquaculture Producers of Honduras (Asociación Nacional de Acuicultores de Honduras). In one establishment visited, microbiological analyses are carried out every production day.
o Additives (metabisulphites): In one of the processing establishments visited 10% of the product coming from each pond is checked. In another establishment the audit team was informed that in three years they have not had any result above the permitted levels. All the analysis results reviewed by the audit team in the three plants visited were under the maximum limits set in the EU legislation.
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o Heavy metals: These are tested for in LANAR as part of official controls, the results seen were always below the maximum limits set in EU legislation.
o Water and ice: All processing establishments visited were using well water filtered and treated with chlorine. All the plants had sampling plans covering microbiological parameters (Total coliforms and E. coli) and chlorine. The maximum level of chlorine accepted is that stipulated in the national legislation for potable water.
41. Under the RMP, LANAR should audit annually FBO private laboratories. The audit team was informed that this has not happened since 2011. One “in-house” laboratory has some microbiological rapid methods accredited to ISO 17025.
42. The audit team noted that water and ice samples taken by SENASA are tested every three months against the microbiological requirements of Agreement No 084 of 31 July 1995, including total and faecal coliforms. Twice a year (once per production cycle) water is tested for the physico-chemical parameters in national legislation. All the analyses are carried out by LANAR.
43. The audit team reviewed the traceability system in the three shrimp establishments visited. End products could be traced back to the level of aquaculture farms, ponds and feed batches used.
5.4.3.2 Tilapia processing establishment
44. The team noted that:-o Fish are slaughtered in the establishment. Only incoming fish that are alive are
processed. The end products will be stored at either -5 °C ("fresh") or -18°C ("frozen").
o The IVO inspects the plant twice a week accompanied by FBO staff responsible for HACCP. The IVO requests corrective actions where needed but no checklist is used in these inspections. No formal records of what was actually inspected were available to the audit team.
o LANAR carries out official sampling and testing every quarter for microbiological parameters in fish, water and ice (in July 2016, all the results were negative). Samples are taken of the final product (only one sample will be tested for Salmonella, this is not in line with Agreement 728-2008 that indicates that 5 samples should be tested).
o FBO sampling and testing takes place as part of own-checks as follows:- A private laboratory carries out monthly microbiological tests of fish water
and surfaces samples. This laboratory is accredited for some of the tests performed. The establishment's ”in-house” laboratory analyses daily microbiological samples covering equipment, ice, water and staff hands.
Water is checked for chlorine in the tilapia washing tanks of the plant every 30 minutes using a rapid test kit. In all the records observed by the audit team, the
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levels of chlorine were all 1 ppm. The maximum limits accepted by the FBO were from 0.5 to 1.5 ppm.
Visual checks for parasites were stopped in December 2014 as parasites were never found after continuous thorough examinations.
o In general, the establishment presented good conditions regarding structure, equipment, maintenance and hygiene even though some deficiencies were noted relating to the flow of personnel in the changing area, incomplete closure of a door and location of a hand dryer. The FBO undertook to rectify these.
o The CA (NVS) had carried out two inspections in September 2016. One was related to the HACCP plan and pre-requisite programmes during which no non-compliances were found; and the other to Good Hygiene Practices where 16 non-compliances were found. All 16 non-compliances had been closed by the time of the audit team's visit.
5.4.4 Checks on the EU eligibility of imported raw materials
45. Imports of fishery products are permitted by SENASA some of which undergo further processing in EU listed establishments prior to export to the EU. The CA headquarters checks the health certificate, the certificate of origin and invoice before permitting such imports. These imports are not routinely officially physically supervised. This is not complying with the IVO Guide that indicates that after the health certificate inspection, fishery products should be inspected to verify the amounts imported, match the label to the certificate, origin of the lot and any other verification. Only one EU listed establishment currently imports. Adequate documentation was available for imports that had taken place in 2015.
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Conclusions on official controls on production and placing in the market
46. There is an official control system covering the whole production chain of aquaculture fishery products intended for export to the EU.
47. The official controls over primary production of EU listed shrimp farms can be considered in line with EU requirements. Only listed farms can have their products exported to the EU. Only water and ice of potable quality are allowed during harvesting and transport. The controls over the use of additives appear to have improved since the previous audit with trained staff applying the additives during harvesting.
48. The system in place for official controls over EU listed shrimp processing establishments can be considered in line with EU requirements. However, its implementation shows weaknesses as IVO inspections have gaps in their assessment of compliance of establishments, as evidenced by the differences in outcome of NVS and IVO controls on the same requirements. The fact that part of the system designed by the CA to ensure that these gaps do not occur in other establishments is not being implemented (see paragraph 9) does not help provide the assurance that the control system over EU listed establishments is effective.
49. The system of official controls over the integrated tilapia production system, farms
and processing establishment, is in general adequate and in line with EU requirements.
50. The official control of fishery products imported for processing and later exported to the EU permits traceability.
5.4.5 Official Control of Fishery Products
Legislation
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, in particular official controls laid down in Annex III, Chapter II of Regulation (EC) No 854/2004. Regulation (EC) No 1881/2006 sets the maximum limits for contaminants.
Findings
51. Testing for Total Volatile Basic-Nitrogen (TVB-N), organoleptic characteristics, metabisulphites, heavy metals, dioxins, PCBs, microbiology of end-product, processing water and ice are integrated into the RMP.
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52. The sampling programme is organised by the CCA in liaison with LANAR and the local IVOs. The number of samples taken is based on total national production but samples are only taken from listed farms and EU listed establishments (number of samples based on the previous year's production).
53. TVB-N a freshness indicator, is monitored for tilapia fillets. The audit team noted that tilapia arrives alive at the processing establishment, where it is slaughtered and processed immediately.
54. Organoleptic checks are done at random for shrimp including cooking the product and assessing the taste.
55. Official samples for residue and contaminant testing are taken, on average, three times a year at shrimp farm level. In 2015, 36 samples were tested for heavy metals (cadmium, lead and mercury) in shrimp muscle, all the results proved negative (below the EU maximum permitted limits).
56. Official samples are taken for testing for dioxin and PCBs in shrimp and tilapia at least once a year. Samples are tested in a foreign private laboratory not accredited for these tests, see paragraph 68. None of the results observed was above the EU maximum permitted limits.
57. Samples are not being taken with the regularity set in the RMP for metabisulphites in shrimp aquaculture. The RMP indicates that samples should be taken once a month of end product in each processing plant (there are seven EU approved establishments and mainly two cycles of production each averaging 4 months according to the RMP). In 2015 the testing was limited to eight official samples of approximately 56 that were to be collected, the results of which were all below the maximum permitted EU limits. The CAs continue relying on the tests carried out in the FBOs in-house laboratories even though the reliability of the test results is not verified As indicated in paragraph 41, private laboratories should be audited by LANAR but this has not happened since 2011. Over 9000 tons of shrimps were exported to the EU in 2015 most of them undergo a treatment with metabisulphite, however, since 2014 there has been no RASFF notifications for Honduras related to high levels of the additive.
58. Official samples are to be taken of the end-product for microbiological checks according to Article 93#2 of Agreement No 728-2008. The IVO Guide indicates that samples are to be taken every three months in registered processing establishments taking into consideration the production cycle and previous results. If non-compliant results are found, monthly sampling will take place until three consecutive months are compliant.
59. The audit team was informed that samples are taken for every 100 tonnes processed. In the shrimp processing establishments, testing includes the following parameters:-
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Total plate count, E. coli, Staphylococcus aureus, faecal coliforms, Salmonella spp and Listeria monocytogenes in raw and cooked product.
60. In the tilapia processing plant, testing includes the following parameters:- Staphylococcus aureus, E. coli, Salmonella spp and Total coliforms.
61. Parasites are no longer checked for in tilapias fillets as indicated in finding 49 Ectoparasites are checked for in the tilapia farms.
Conclusions on official controls of fishery products
62. Official controls of fishery products intended for EU export (shrimp and tilapia) cover all the EU requirements. The lack of compliance with the additives testing official control programme together with the lack of verification of the reliability of the FBO own checks results, weakens the guarantees that EU listed establishments in Honduras comply with Article 12 (2) of Regulation EC (No) 854/2004.
5.5 FOLLOW-UP OF RASFF NOTIFICATIONS
Legal requirements
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 non-EU countries from which imports of products of animal origin permitted, shall take particular account amongst other factors any experience of marketing of the product from the third country and the results of any imports carried out.
Findings
63. Instructions and procedures for the follow-up on RASFF notifications are in place in the IVO Guide. The procedure includes weekly surveillance at CA headquarters level of the RASFF website during the shrimp production cycle. When a notification is found the local IVO is informed immediately and he/she must visit the plant to trace the product, which includes checks on production and export registers, boxes and weight of the lot and the location. If linked product is still in the processing establishment it will be put under official control. The FBO should investigate the cause of the RASFF notification and carry out corrective actions. The IVO must verify the closure of any related non-compliances. This procedure is currently being implemented by the local IVO.
64. Since 2014 there have been two RASFF notifications for Honduras both related to exports of wild crustaceans to the same country and the rupture of the cold chain. The audit team verified that the CAs had followed-up both notifications that showed that
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the health certificates for both exports had been issued illegally. One of the cases had resulted in court case and a private veterinarian being suspended from his duties.
Conclusions on RASFF notifications
65. The competent authority investigates adequately RASFF notifications and takes adequate measures when investigations identify Honduran private veterinarians as responsible for issuing illegal health certificates.
5.6 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. Points 41 and 42 of Guidelines of Codex Alimentarius CAC/GL 26-1997 on the Design, Operation, Assessment and Accreditation of Food Import and Export Inspection and Certification Systems.
Findings
66. Two laboratories carry out official analyses of samples taken during official controls. Both laboratories also carry out testing for the FBOs. These are:-
o LANAR, the state laboratory. This is SENASA's official laboratory. In this laboratory microbiological testing of fishery products is carried out including detection of Salmonella spp, isolation and identification of Listeria monocytogenes, total plate count, Faecal coliforms, E. coli, Total coliforms and Staphylococcus aureus. In addition, water is tested for some microbiological parameters (E.coli and Enterococci) and some chemical analyses are done including testing for chlorine. Shrimp are tested for additives (metabisulphite).
o A private laboratory tests official samples of fishery products for heavy metals (mercury, cadmium and lead), PCBs and dioxins.
Official samples are collected at processor level either by LANAR staff or the IVOs. In the shrimp farms samples are collected by the IAPP and in the tilapia farm by the IVO.
67. The LANAR laboratory was visited by the audit team.
The team noted that:-
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The laboratory is accredited to INTE-ISO/IEC 17025:2005 since 2010 by The Costa Rican Accreditation Institute ECA (Ente Costarricense de Acreditación) for some analytical methods relevant for EU exports (see www.eca.org.cr). ECA is a full member (MRA Signatory) of ILAC (International Laboratory Accreditation Cooperation).
The laboratory is accredited for USDA/FSIS MLG method for the isolation of Salmonella covering meat and meat products, poultry and eggs but not for fish. The audit team was informed that the method used for testing shrimp muscle either raw or cooked for Salmonella, is the EU reference method EN/ISO 6579 which has neither been accredited nor validated at LANAR.
As regards fishery products, LANAR's scope of accreditation includes:o Isolation and identification of Listeria monocytogenes in fishery and
aquaculture products using the EU reference method NTC 4666 (ISO-11290-1). Under national legislation (Agreement No 728-2008, Article 93#2) and LANAR's laboratory procedures, the number of sample units specified in the criterion sampling plan is n=5 for Salmonella spp and Listeria monocytogenes. The audit team learnt that LANAR only tests one sample unit. This issue was identified as a non-compliance in a HACCP audit carried out by the CAs (NVS) at a shrimp processing establishment in September 2016 (see paragraph 37).
o Detection of heavy metals (lead, cadmium and mercury) in fishery and aquaculture products is done using Atomic Absorption Spectroscopy methods. EU MLs are satisfied. The laboratory analyses some shrimp FBO own-check samples for these parameters, all official samples are sent to a private laboratory for testing, see paragraph 68.
o Testing for metabisulphites is done using the AOAC 990.28 Monier Williams modified, 18th edition 2005 in fishery and aquaculture products. Eight official results reports of samples taken in three establishments in 2015 proved negative.
With regard to testing for total plate count, Faecal coliforms, E. coli, Total coliforms, and Staphylococcus aureus in fishery products methods used are neither accredited nor validated.
With regard to TVB-N, the method used is neither accredited nor validated. As regards testing of water and ice, the scope of accreditation does not include
methods for E. coli, Enterococci or Clostridium perfringens (surface water). The audit team was informed that these methods have also not been validated. Surface water is not used in processing plants, all the water in the establishments visited came from wells so testing for C. perfringens is not required. Some water chemical analyses are included in LANAR's scope of accreditation (copper, manganese, lead, and zinc, pH and nitrogen) but not chlorine.
Results of analyses are reported to the CA headquarters, to the official veterinarian that took the samples and to the FBO concerned.
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LANAR regularly participates in proficiency testing (PT) and inter-laboratory comparative testing schemes. They have three PTs providers. The summary provided for 2015 indicates that,
o The results for sulphites in shrimp, lead and cadmium in tuna paste were satisfactory. The results of mercury in tuna paste were unsatisfactory.
o In relation to Salmonella spp and Listeria monocytogenes in food, the three participations were satisfactory. For E. coli, Total coliforms and Enterobacteriaceae in food one participation was satisfactory. E. coli, Total coliforms and Enterococcus in water was also satisfactory.
o In 2016 the results of heavy metals in water were satisfactory other than for zinc.
The laboratory provided a summary of the corrective actions taken in the case of unsatisfactory results.
The annual evaluation carried out by the accreditation body ECA took place in March 2016. Five major non-compliances were identified, four of them were closed at the time of this audit. These were as follows,
o Three non-compliances related to PTs including: lack of accreditation to ISO 17043 (general requirements for the competence of providers of proficiency testing schemes and for the development and operation of proficiency testing schemes); failure to inform and provide a follow up to the accreditation body that they had obtained unsatisfactory results in a PT for mercury and sulphite testing in fishery products and inadequate follow up of unsatisfactory results for the detection of zinc and copper in water.
o It is a requirement of the method for the detection of Listeria monocytogenes to confirm the isolation using two tests. These are not carried out without a technical justification or validation of the changes.
o The laboratory was not able to show that the validation of the microbiological methods complied with minimum ECA requirements. This major non-compliance was not closed at the time of this audit.
68. The private laboratory carries out some official controls analyses. The audit team noted that:-
The laboratory carries out heavy metals testing on behalf of SENASA. Testing for cadmium, lead and mercury in food and feed using the ICP-MS method (AOAC) which is included in their scope of ISO 17025 accreditation.
The laboratory performs dioxin and PCB testing on behalf of SENASA.The scope of accreditation does not include these parameters. Furthermore, the CAs were not aware of whether the methods used for these tests had been validated or not.
The CAs have no measures in place to guarantee that the methods of analysis and reliability of the methods of the external laboratory complies with
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relevant requirements. At the time of the audit, the CAs did not have a formal contract with them.
Conclusions on official laboratories
69. LANAR now has several methods under the scope of this audit accredited but in general, these methods are not used to test official fishery products samples (Salmonella, heavy metals, metabisulphites). Not all laboratory methods used in the analysis of official controls are validated and/or accredited. Furthermore, at the time of the current audit the laboratory was not able to show that the validation of microbiological accredited methods complied with minimum ECA requirements. Therefore, the reliability of some analytical results could not be demonstrated.
70. The CA has not specified its requirements for the methods of analyses and the reliability of the results in the private laboratory used for the purpose of official controls. This does not enable the CA to ensure that the analyses are carried out in accordance with EU requirements for the methods which are not accredited.
71. The number of samples tested for certain microbiological parameters is lower than
that stipulated in the national legislation which undermines the reliability of the results
5.7 OFFICIAL CERTIFICATION
Legislation
Requirements laid down in Article 14 and Annex VI to Regulation (EC) No 854/2004.
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 Appendix IV to Annex VI.
Article 6 of Directive 96/93/EC.
Findings
72. The IVO Guide indicates that when an export health certificate is to be issued for export to the EU, the IVO together with FBO staff responsible for exports will go over all the relevant documents including the consignment manifest, certificate of origin and microbiological results. After this step, the EU health certificate will be printed and then reviewed against the documents presented by the FBO, number of the container and inviolable stamp. Once the above is verified, the public health
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attestation will be marked on the certificate and the report signed and stamped. The health certificate is then sent by courier to the importer.
73. The audit team noted that the above procedure was not followed. The team was informed that the EU export health certificates are being signed and issued without the officials checking any supporting evidence or being present in the establishment at the time of loading the containers for export.
74. Health certificates are issued using TRACES. The procedure is as follows, The EU listed establishment fills in the model health certificate on-line. The IVO responsible for the processing establishment signs it. The IVO responsible for TRACES approves it on-line and requests a Zoosanitary
Certificate from CENTREX, part of the Ministry of Industry and Commerce (Secretaria de Industria y Comercio de Honduras) and demanded by the CAs in Honduras for all exports.
75. The audit team noted that with the above procedure, the certifying officer is certifying data which he has not ascertained on the basis of reliable documents and/or inspected. This procedure cannot be considered in line with the EU rules in particular with the requirements of Council Directive 96/93/EC.
76. The CAs have made an effort to rectify the above situation. On 6 October 2016, SENASA sent an official note to the processing establishments highlighting its approved list of farms permitted to supply export raw material to EU listed establishments, see paragraph 31. This list is to be updated each month. In order for the IVO to sign export certificates, evidence has to be presented that the raw material comes from approved farms. This system had not yet been implemented at the time of this audit.
77. The audit team noted that in 2015:- Three consignments of aquaculture shrimp were issued with the wrong commodity
code on export health certificates indicating that they were aquaculture shrimp of a species not farmed in Honduras.
The figures for fishery product exports to the EU in 2015 received from the CA were clarified during the audit. The final CA figures for aquaculture shrimp were very similar to the TRACES figures.
78. The model of the health certificate used for EU exports is the one set out in Regulation (EC) No 2074/ 2004.
79. Only SENASA official veterinarians are authorised to sign health certificates for fishery products exported to the EU.
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80. A private carrier is hired to transport the product from the processing establishments to the EU. The audit team was informed that the consignment leaves the plant by truck with an inviolable stamp to Puerto Cortes in the Caribbean.
Conclusions on official certification
81. As the required procedure for official certification is not implemented in practice, the current system does not provide guarantees at least equivalent to EU rules for certification of fishery and aquaculture products exported to the EU
5.8 FOLLOW-UP OF PREVIOUS AUDIT 2011-8892
No Recommendation Assessment
8.1 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.
Partially addressed
This recommendation is now incorporated into recommendation No 1 of this report.
See findings Nos 2, 33, 40 and 44
8.2 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 3.
Recommendation satisfactorily addressed
See findings Nos 30 and 32
8.3 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 4.
Recommendation satisfactorily addressed
See findings No 2 and 33
8.4 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
This recommendation is now incorporated into recommendation No 2 of this report
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least equivalent to those of the EU, in particular, those of Article 5 of Regulation (EC) No 852/2004.
8.5 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 853/2004.
This recommendation is now incorporated into recommendation No 2 of this report.
See finding No 39
8.6 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).
Recommendation addressed as regards the monitoring of contaminants (dioxins and Listeria monocytogenes)
See findings Nos 56, 59 and 66
Recommendation not addressed as regards the official monitoring of additives (metabisulphites)
See finding No 57 and recommendation 4.
8.7 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.
Recommendation not addressed as regards validation/accreditation of some methods of analyses used for official controls of fishery products under the scope of this audit.
See findings Nos 67 and 68 and recommendation 3.
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6 OVERALL CONCLUSION
Improvements have been made since the last audit and it can be concluded that most recommendations of the previous audit report on fishery products have been addressed in a satisfactory way, other than for the official monitoring of the use of additives, maximum limits for heavy metals (cadmium) and the validation/accreditation of some methods of analyses used for official controls.
The competent authority has implemented an official control system for fishery products intended for export to the EU, which adequately covers the production, processing and distribution chain of fishery products. However, to guarantee that fishery products exported to the EU comply with all of the relevant elements of the export health certificate, improvements are needed mainly regarding the guarantees provided by the competent authority in relation to compliance with EU requirements of the listed establishments and implementation of procedures at the time of issuing health certificates.
7 CLOSING MEETING
During the closing meeting held in Tegucigalpa on 20 October 2016, the audit team presented the main findings and preliminary conclusions of the audit to the CAs.
During this meeting, the CAs offered some clarifications and acknowledged the findings and preliminary conclusions presented by the audit team stating that they intend to undertake actions to rectify all the shortcomings identified.
8 RECOMMENDATIONS
No. Recommendation
1. The CAs should lay down clear rules in relation to maximum limits for contaminants in fishery products in line with maximum EU limits set in Regulation (EC) No 1881/2006.
Recommendation based on conclusion 3
Associated finding 2
2. The competent authority should ensure that the planned arrangements for supervision of official controls are implemented, in order to ensure that the gaps observed in the performance of IVO controls are identified and addressed, with a view to providing the guarantees of Article 12 (2) of Regulation (EC) No 854/2004 as regards establishments listed for export of fishery products to the EU.
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No. Recommendation
Recommendation based on conclusions 20 and 48
Associated findings 9, 37 and 44
3. In order to be able to provide guarantees set out in the public health attestations of the EU health certificate the competent authority should ensure that laboratories involved in official samples analyses 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 17025, to ensure the reliability of analytical results. The methods of analyses, performance criteria and validation should be in line with EU requirements.
Recommendation based on conclusions 69, 70 and 71
Associated findings 67 and 68
4. The competent authority should verify the reliability of the results of the FBOs regarding levels of metabisulphites and achieve their targets of official testing in their programme in order to guarantee that EU listed establishments comply with Article 12 (2) of Regulation (EC) No 854/2004
Recommendation based on conclusion 62
Associated findings 41 and 57
5. The CA should ensure that export certification of fishery and aquaculture products to the EU offers guarantees as least equivalent to those laid down in Directive 96/93/EC.
Recommendation based on conclusion 81
Associated findings 31, 73, 75, and 77
ANNEX 1 – LEGAL REFERENCES
Legal Reference Official Journal TitleDec. 2006/766/EC OJ L 320,
18.11.2006, p. 53-57 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
Dec. 2011/163/EU OJ L 70, 17.3.2011, p. 40-46
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
Dir. 96/93/EC OJ L 13, 16.1.1997, p. 28-30
Council Directive 96/93/EC of 17 December 1996 on the certification of animals and animal products
Reg. 852/2004 OJ L 139, 30.4.2004, p. 1, Corrected and re-published in OJ L 226, 25.6.2004, p. 3
Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs
Reg. 853/2004 OJ L 139, 30.4.2004, p. 55, Corrected and re-published in OJ L 226, 25.6.2004, p. 22
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
Reg. 854/2004 OJ L 139, 30.4.2004, p. 206, Corrected and re-published in OJ L 226, 25.6.2004, p. 83
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
Reg. 882/2004 OJ L 165, 30.4.2004, p. 1, Corrected and re-published in OJ L 191, 28.5.2004, p. 1
Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules
Reg. 2073/2005 OJ L 338, 22.12.2005, p. 1-26
Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs
Reg. 2074/2005 OJ L 338, 22.12.2005, p. 27-59
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
Reg. 1881/2006 OJ L 364, 20.12.2006, p. 5-24
Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs
Reg. 1883/2006 OJ L 364, 20.12.2006, p. 32-43
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
Reg. 333/2007 OJ L 88, 29.3.2007, p. 29-38
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