EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL

Transcription

1 EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Directorate F - Food and Veterinary Office Ares(2014) DG(SANCO) MR FINAL FINAL REPORT OF AN AUDIT CARRIED OUT IN MAURITIUS FROM 22 TO 30 JANUARY 2014 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 Mauritius carried out from 22 to 30 January 2014, as part of its programme of audits in third countries. The primary objective of the audit was to evaluate whether the official controls put in place by the competent authorities can guarantee that the conditions of production of fishery products in Mauritius destined to be imported into the European Union are in line with the requirements laid down in European Union legislation. The audit also verified the implementation of the recommendations of the previous 2009 audit visit covering the same subject. In principle the current organisation of the competent authority and the control system implemented offer sufficient guarantees concerning the sanitary conditions of fishery products for European Union export other than those derived from aquaculture. Furthermore the competent authority has implemented actions to address three out of seven recommendations of the previous Food and Veterinary Office audit report. The remaining four are still in the process of being fully addressed. In order to fully ensure that all fishery products exported to the European Union respect European Union requirements, corrections and improvements are needed, in particular concerning the legislation/standards, the food business operators implementation of Hazard Analyses of Critical Control Points and its assessment by the competent authority, verification of the eligibility of imported fishery products and the storage of frozen final products. The report addresses to the Mauritian competent authority a number of recommendations aimed at rectifying identified shortcomings and enhancing the control system in place. I

3 Table of Contents 1 INTRODUCTION OBJECTIVES AND SCOPE OF THE AUDIT LEGAL BASIS FOR THE AUDIT BACKGROUND GENERAL BACKGROUND PRODUCTION AND TRADE INFORMATION RAPID ALERT SYSTEM FOR FOOD AND FEED (RASFF) NOTIFICATIONS FINDINGS AND CONCLUSIONS LEGISLATION COMPETENT AUTHORITY NATIONAL PROVISIONS AND PROCEDURES FOR LISTING ESTABLISHMENTS EXPORTING TO THE EU OFFICIAL CONTROLS OFFICIAL CONTROLS OF PRODUCTION AND PLACING ON THE MARKET OFFICIAL CONTROLS OF FISHERY PRODUCTS CONTROLS ON THE DISTRIBUTION AND USE OF VETERINARY MEDICINAL PRODUCTS LABORATORIES FOLLOW-UP OF RASFF NOTIFICATIONS OFFICIAL CERTIFICATION OVERALL CONCLUSION CLOSING MEETING RECOMMENDATIONS...20 ANNEX 1 - LEGAL REFERENCES...22 II

4 ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT Abbreviation CA DG SANCO EC EU EU listed EUROSTAT FBO FVO HACCP HPLC ISO OJ RASFF Explanation Competent Authority Health and Consumers Directorate General of the European Commission European Community European Union Facility 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 business operator Food and Veterinary Office of the European Commission Hazard Analysis Critical Control Points High Performance Liquid Chromatography International Organisation for Standardisation Official Journal of the European Union Rapid Alert System for Food and Feed III

5 1 INTRODUCTION The audit took place in Mauritius from 22 to 30 January 2014 and was undertaken as part of the Food and Veterinary Office's (FVO) audit programme. The audit team (hereinafter the FVO team) comprised two inspectors from the FVO. An opening meeting was held in Port Louis on 22 January 2014 with the Mauritian competent authority (CA), the Competent Authority Seafood (CA-SF) within the Ministry of Fisheries. At this meeting the FVO team confirmed the objectives of, and the itinerary for the audit, and requested additional information regarding the specific elements of the control system in place. 2 OBJECTIVES AND SCOPE OF THE AUDIT 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 Mauritius destined for export to the European Union (EU) are in line with the requirements laid down in EU legislation, and in particular with the health attestations contained in the health certificate laid down in Appendix IV to Annex VI to Commission Regulation (EC) No 2074/2005. To verify the extent to which the guarantees and the corrective actions submitted to the Commission services in response to the recommendations of the previous fishery products FVO audit report of 2009 (ref. DG(SANCO)/ MR Final), published on DG SANCO's website have been implemented and enforced by the CA. In terms of scope the audit focused on the organisation and performance of the CA, the export certification procedure, the official control system in place covering production, processing and distribution chains applicable to fishery products to be exported to the EU, and also some elements of the control system for veterinary medicinal products 1. Accordingly, relevant aspects of the EU legislation referred to in Annex 1 were used as technical basis for the audit. Full references to EU legal acts quoted in this report are provided in that Annex and refer, where applicable, to the last amended version. In pursuit of these objectives, the FVO team visited the following sites:- COMPETENT AUTHORITY Central level 1 LABORATORY VISITS Private Laboratory in charge of official control analyses for fishery products PRIMARY PRODUCTION 1 1 This part of the scope was included in the audit following the findings detected during the visit to the aquaculture farm (see section Primary production). 1

6 Aquaculture farms 1 Fishing vessels 3 Not in operation at the time of the FVO visit. LANDING AND FIRST SALE Landing sites 4 Includes two landing points (no quay) and one landing site (with a quay) not in operation at the time of the FVO visit. FACILITIES HANDLING FISHERY PRODUCTS Reefer vessels 1 Processing Plants 7 Includes one processing establishment for the production of fish oil currently suspended from EU exports. Cold stores 1 Independent cold store facilities. Wholesale Pharmacy 1 Representatives from the CA accompanied the FVO team during the whole audit. 3 LEGAL BASIS FOR THE AUDIT The audit was carried out under the general provisions of EU legislation and, in particular Article 46 of Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004, on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare. 4 BACKGROUND 4.1 GENERAL BACKGROUND Mauritius is currently listed in Annex II to Commission Decision 2006/766/EC, List of third countries and territories from which imports of fishery products are permitted. It is also listed in the Annex to Commission Decision 2011/163/EU as having an approved residues monitoring plan for aquaculture products and therefore it can export those fishery products to the EU. Mauritius is currently authorised to export fishery products to the EU from one freezer vessel (which is in fact a reefer vessel that transports frozen fishery products in bulk), two cold stores and eleven processing establishments (two of them processing fishery products of aquaculture origin) as set out in the Mauritian establishment list published on 17/12/2013 on DG SANCO's website. Article 11(4)(k) of Regulation (EC) No 854/2004 states that in the context of drawing up or updating lists of third countries from which imports of products of animal origin are permitted, regard shall be had to the results of EU controls carried out in the third country, in particular the results of the assessment of the CAs, and the actions they have taken in the light of the recommendations addressed to them following an EU control. As a consequence, the FVO team made an assessment of the assurances provided by the CA following the last fishery products audit to Mauritius that took place in November The 2009 FVO audit report highlighted the improvements made since the previous (2008) audit and 2

7 also identified deficiencies with regard to the legal mandate of the CA, the level of implementation of official controls of facilities, quality and implementation of HACCP and the control and verification of the EU eligibility of imported raw materials. The FVO received written guarantees in relation to the recommendations of the 2009 audit which, at the time, were deemed satisfactory. The FVO follow-up of those recommendation is reported under the relevant parts of this report. 4.2 PRODUCTION AND TRADE INFORMATION According to the CA, fishery product exports to the EU amounted to approximately 63,000 tonnes in 2011 and 71,000 tonnes in 2012, mainly tuna species (approximately 99,5% of all fishery products exports). According to EUROSTAT the amount exported in 2011 presents a negligible difference and a 10% difference (less) for Also according to EUROSTAT 90% of the products exported belong to TARIC code 1604 (canned fishery products). The main importing EU members states are by decreasing order UK, SP, IT, NL and BE (representing 86% of the total imports from Mauritius). According to the list established by the CA imports of fishery products from Mauritius into the EU are authorised from a total of fourteen establishments (these include two establishments processing materials only or partially derived from aquaculture, two cold stores, and one freezer vessel (reefer vessel for transport in bulk)). This list (published on 17/12/2013 and valid as of 30/12/2013) is available on the SANCO website at the following address: RAPID ALERT SYSTEM FOR FOOD AND FEED (RASFF) NOTIFICATIONS Since the last FVO audit seven RASFF notifications were issued for fishery products of Mauritian origin. Four of the notifications were due to bad temperature control rupture of the cold chain of frozen products (tuna and mackerel), one due to the presence of mercury above the EU limits in chilled products (grouper), one due to defective packaging of pouched tuna and the last one due to unsuitable organoleptic characteristics of canned products (tuna). A short description on how these notifications were handled is presented in section 5.6 of the report. 5 FINDINGS AND CONCLUSIONS 5.1 LEGISLATION Legal requirements Article 46(1)(a) of Regulation (EC) No 882/2004 states that Commission experts may carry out official controls in third countries in order to verify the compliance or equivalence of third countries legislation with the relevant EU legislation. Article 11(4)(a) of Regulation (EC) No 854/2004. Findings Since the last audit Government Notice No. 147 of 2009, the Fisheries and the Marine Resources (Export of Fish and Fish Products) Regulations 2009, made under section 74 of the Fisheries and Marine Resources Act 2007, was amended by new legislation (hereinafter Regulations 2009):- Government Notice No. 204 of 2010 (signed on 21 October 2010) with regard to the legal 3

8 mandate of the CA. Government Notice No. No. 209 of 2012 (signed on 23 November 2013) with regard to fishery products (including its production chain). In addition to the above mentioned legislation Mauritius also has:- Government Notice No 193 of 2004, the Fisheries and the Marine Resources (Toxic Fish) Regulations 2004, that regulates fish species that can be considered poisonous due to ciguatoxin. This regulation is applicable to all fishery products produced in Mauritius. The Pharmacy Act of 1983 (as last amended), which defines the national rules on manufacture, importation, distribution and use of medicinal products (both human and veterinary). The CA also provided the FVO team with a copy of the draft Fisheries and the Marine Resources (Aquatic Animal Farming) Regulations 2013, that will cover, amongst others, the following aspects related to aquaculture:- Animal Health. Use of veterinary medicines at farm level. Feed. Record keeping. Prohibited pharmacologically active substances. Maximum residue limits for authorized pharmacologically active substances. Sampling of products. Registration and official controls over FBOs. Good hygiene practices. To note that during the FVO audit of 2008 to Mauritius (audit report ref. DG(SANCO)/ MR Final) the CA provided the FVO team with a draft of Regulations on Export and Control Diseases of Farmed Fish and Fishery Products. This regulation was never published or adopted. The CA also drafted an internal Manual of Procedures (Edition 5 of January 2013) and a Sampling Manual that includes the parameters to be checked during the official controls of fishery products and their applicable limits. Additionally, this document identifies the responsibilities of the FBOs producing fishery products that include the testing of those products for organoleptic characteristics, microbiological parameters (including water and ice), additives (for crustaceans), histamine and freshness parameters. However, as already mentioned, these are internal CA documents that are not made available to the FBOs. The FVO team noted that:- The Regulations 2009, as last amended, include standards that largely encompass the applicable EU rules with regard to the requirements of Regulations (EC) Nos 852/2004 and 853/2004 for fishery products and their production chain. However, for organoleptic evaluation and histamine testing Regulations 2009 indicate that the FBO must comply with the criteria defined by the importing country. No other reference to a fixed standard or EU rules is made in the relevant sections. 4

9 The CA Manual of Procedures and the Sampling Manual include standards to be followed by the CA when it carries out official controls of fishery products. Those standards can be considered as equivalent to the EU rules. The Pharmacy Act of 1983 deals with both human and veterinary medicines and does not distinguish between them. Conclusions It contains provisions on, inter alia, responsible bodies at the Ministry of Health and Quality of Life, conditions for imports and sale of various pharmaceutical products (categories as defined in the Act e.g. drugs, poisons, therapeutic substances), operating of pharmacies and wholesalers, record keeping, prescription requirements and official controls (inspector's powers). Regarding the use of medicines, the Pharmacy Act only stipulates that therapeutic substances may be administered for treatment only by, or under directions of, an authorised person (the definition of the latter includes also veterinary surgeons). Annexes to the Act provide lists of substances which can be imported/sold in Mauritius. As these lists are common for the human and veterinary part, it is not clear whether some of the listed substances which are explicitly banned for use in animals in the EU (e.g. stilbenes) are permitted for use in food producing animals in Mauritius and the CA could not clarify this particular point. Although requested, the clarification of provisions on, inter alia, prohibitions of substances for use in food producing animals has not been provided to the FVO team. From a summary review of the legal documents provided by the CA it can be concluded that they include standards applicable to fishery products and their production chain, including FBOs, at least equivalent to the EU rules and, except for the areas where deficiencies were noted, provide an adequate basis for the CA to implement an official control system aimed at providing the necessary guarantees with regard to EU requirements. However, this set of legal documents do not give a clear indication of the rules which the FBOs need to follow with regard to limits for histamine in fishery products and organoleptic criteria for fresh fishery products. Recommendation No. 1 of the previous audit report concerning the legal mandate of the CA can be considered satisfactorily addressed. 5.2 COMPETENT AUTHORITY Legal requirements Article 46 of Regulation (EC) No 882/2004 stipulates that EU Controls in third countries shall verify compliance or equivalence of third countries' systems with EU food law. These controls shall have particular regard to points b) to (e), (g) and (h) of the aforementioned article. Points g) and h) are covered in Sections 5.4 of this report. Findings Structure and organisation 5

10 In accordance with the information provided in the response to the FVO's Pre-Audit Questionnaire and during the audit, the CA for the official controls of fishery products for EU exports and their production chain is the Competent Authority Seafood, which is a Fisheries Technical Service under the Ministry of Fisheries. Since the last FVO audit an amendment was made to the Regulations 2009 in order to clearly identify this service as the CA. In accordance with information provided to the FVO team by the CA the organisational chart for the CA is represented in figure 1. Figure 1 Organisational chart of the CA The CA offices are located in Port Louis and different staff categories have different tasks assigned (e.g. - non-exhaustive):- Acting Officer-In-Charge: organisation, supervision and monitoring of all officers; budget; signature of official documents granting approval and/or registration; export certification and signature of export health certificates; liaison with DG SANCO. Veterinary Officers: performing, planning and coordination of official controls; sampling; organisation, supervision and monitoring of technical officers; export certification and signature of export health certificates; technical and administrative support for the grant of approval and/or registration; prepare the national residue monitoring plan. Technical Officers: performing official controls; sampling; export certification. Powers, Independence and Supervision The powers and duties of the CA can be found in the legal framework mentioned in section 5.1, in particular, regulations 4.(8), 5.(1) and 8. of Regulations During the audit the FVO team saw evidence of export certification suspension of establishments considered non-compliant with rules equivalent to the EU ones and also the cancellation of approval. All staff of the CA are Mauritian civil servants, and as such they are bound by the Code of Ethics 6

11 for Public Officers of the Ministry of Civil Service & Administrative Reforms. This code includes, amongst others, requirements with regard to the professional behaviour, conflict of interest and disclosure of information. The CA informed the FVO team that a plan is drafted every year setting out the planned official controls for each establishment (audits and sampling) which is then used to monitor staff activity. The CA also stated that weekly meetings take place with all staff to follow-up all activities related to official controls in order to ensure a harmonised approach between all staff. Minutes of those meetings are drafted and signed by all participants and circulated to all relevant staff. The FVO team reviewed the plans for 2011, 2012 and 2013 and noted that, in general, the planned audits took place as scheduled. The FVO team also had access to some minutes of meetings where relevant issues were discussed. Training The CA provided the FVO team with information regarding the training attended by official control staff. Some of the training sessions included relevant subjects related to, amongst others, auditing and inspection, seafood safety (by Norwegian Food Safety Authority), ISO 9001, Better Training for Safer Food (DG SANCO initiative) for fishery products and live bivalve molluscs and HACCP. In general, official staff interviewed by the FVO team showed an adequate level of knowledge concerning the applicable EU legal requirements. Resources Available to the CA The CA has a specific budget from the Ministry that allows it to implement the planned official controls. The available offices (accessible only to CA staff) are equipped with the necessary equipment for the performance of their tasks. The CA also has two vehicles to be used by staff. Where necessary, the costs of private transport used for official tasks is supported by the CA. The CA has a service contract with a private laboratory (ISO accredited) for the testing of official control samples. For certain parameters that laboratory outsources the services to other laboratories (also ISO accredited). Documented Control Procedures The CA drafted and adopted the Manual of Procedures for Export of Fish and Fishery Products (Edition 5 of January 2013) (hereinafter CA Manual of Procedures) and the Sampling Procedures Manual for Fish and Fishery Products (Revision of January 2013). Since the last FVO audit the CA no longer uses the Inspection manual for fish, fishery products and aquaculture and the Official Certification and listing procedures for export of fish and fishery products to the EU and non-eu Markets and incorporated all relevant elements into the CA Manual of Procedures. The CA Manual of Procedures covers the following areas:- Establishment approval and approval renewal. Vessels approval/registration and vessels monitoring. Official controls (covering both facilities and products). Export Certification. 7

12 Staff training. RASFF follow-up and crisis management. HACCP Guidelines. The CA Manual of Procedures also has annexed application forms (for FBOs) and checklists (for the performance of official controls). The FVO team noted that while the CA Manual of Procedures presents a detailed description of facility audits, official controls of fishery products and follow-up of deficiencies the same cannot be said with regard to some official control activities like facilities inspections and ad-hoc inspections. The FVO team also noted that a procedure regarding the eligibility of imported raw materials for further EU export was not drafted by the CA. This last finding was already mentioned in the last FVO audit report and, as mentioned there, although the CA staff perform controls on the EU eligibility of imported raw materials those controls are not always carried out adequately (see report section Checks on EU eligibility of imported raw materials). To address the report recommendation No. 6 of the previous audit report the CA updated all references to EU legislation in the CA Manual of Procedures. Conclusions The CA designated for the official control of fishery products present a structure, organisation and legal powers that allow for an adequate official control and enforcement across the full production chain of fishery products for EU export. The resources made available to the CA allow for the satisfactory execution of official tasks and official staff presented adequate knowledge of the relevant EU rules and requirements. Written procedures developed by the CA, provide an acceptable basis for the CA to guarantee the implementation of acceptable official controls of the sector. However, the absence of clear instruction/procedures in some areas weaken those guarantees. Recommendation No. 6 of the previous audit report concerning the references to outdated EU legal references can be considered satisfactorily addressed. 5.3 NATIONAL PROVISIONS AND PROCEDURES FOR LISTING ESTABLISHMENTS EXPORTING TO THE EU Legal requirements Article 12(1) and (2) of Regulation (EC) No 854/2004. Part I.11. of the model health certificate for imports of fishery products intended for human consumption established in Appendix IV to Annex VI to Regulation (EC) No 2074/2005. Findings The CA Manual of Procedures has clear instructions for listing facilities (establishments, freezer and factory vessels) authorised for EU export. These instructions allow the CA to provide the guarantees required by point 2 of Article 12 of Regulation (EC) No 854/

13 In accordance with the CA Manual of Procedures any FBO that intends to export fishery products to the EU needs to apply to the CA for registration and subsequent approval of the facility concerned. As part of the application, the FBO is required to provide a defined set of documents for evaluation. That set of documents includes, amongst others:- The HACCP manual. Layout plan. Scope of operations. Written guarantees that a HACCP system will be implemented and maintained, water and ice need to comply with the requirements of Council Directive 98/83/EC and cannot be hyper-chlorinated, raw materials are only sourced from approved facilities (CA listed) and that any additive used shall comply with the EU limits. In the case of a satisfactory documentary assessment a preliminary inspection is carried out to the facility to evaluate infrastructures, equipment and layout. A conditional approval is granted if the preliminary inspection had a satisfactory outcome that allows the FBO to start production. Once in production a final inspection is carried out (includes evaluation of HACCP implementation and official sampling) with a view to final approval. When the result of the final inspection is satisfactory the CA grants the approval and requests the Commission services to include the facility concerned in the EU list of Mauritian approved establishments. A facility can only export fishery products to the EU after its inclusion in the EU list. The CA also requires from the FBOs of EU listed establishment their list of raw material suppliers with a view to approving those suppliers. The CA made available to the FVO team a list of approved suppliers (fishing vessels) to EU listed establishments. Recently the CA has also started to approve those fishing vessels. The FVO team assessed the complete file of a recently approved freezer vessel (at the time of the audit the listing request was being processed by the Commission services) and noted that the set procedure was followed. However, the FVO team noted that there was no evidence of HACCP assessment and the freezer vessel had been approved by the CA for the production of brine frozen and deep frozen fishery products under conditions which cannot be considered as equivalent to EU rules. According to the documents provided by the CA the FVO team noted that:- The deep freezing of tuna consist of a three step process with two freezing stages:- Stage 1 freezing in brine this operation does not ensure at the end of freezing that a core temperature of not more than -9 C is achieved; the duration of the process ranges from 20 to 65 hours. Interruption of freezing for not more than 30 minutes to transfer fish to the next stage 2. Stage 2 dropping of the temperature of fish to reach a core temperature at the end of the stage of not more than -18 C; duration of 20 hours. These operations are well described in the HACCP plan of the vessel and the stages are identified by the operator as Pre-freezing in Brine and Placing in deep freezing dry storage. Approval granted to this vessel permits supply to a processing establishment that only 2 In their response to the draft report the Competent Authority noted that updated information provided by the FBO is currently being assessed by the CA and the same information has been passed to SANCO services for consideration. 9

14 produces frozen tuna for EU export at core temperatures of not more than -18 C. The FVO team is of the view that this vessel should only supply frozen fishery products at not more than -18 C where the first stage is able to ensure that fishery products temperature is lowered rapidly so as to achieve a core temperature of not more than -18 C, as required by point I.C.1 of Chapter I of Section VIII of Annex III to Regulation (EC) No 853/2004. Furthermore, as currently described, freezing in brine to achieve -8 C, does also not comply with point I.7 of Chapter I of Section VIII of Annex III to Regulation (EC) No 853/2004 which is why the product is not eligible to be used for canning. During a visit to an EU listed establishment the FVO team verified that exported consignments of fresh fish have been produced from raw materials provided by CA listed fishing vessels. The FVO team verified that the CA, during an official control, detected that the establishment was being supplied by fishing vessels not included in the authorised list and requested immediate measures from the FBO to correct the non-compliance. The FBO requested the CA to add the fishing vessels to the CA list of approved suppliers. The CA included the vessels in the CA list after an assessment and approval of those vessels as compliant with standards equivalent to EU rules. Conclusions The provisions and procedures for listing facilities for EU export adopted by the CA are, in principle, adequate and provide satisfactory guarantees. However, their implementation allowed the approval of a freezer vessel that performs operations that do not respect standards equivalent to EU rules for the freezing of fishery products. 5.4 OFFICIAL CONTROLS Official Controls of Production and Placing on the Market Legal requirements Article 12(2) of Regulation (EC) No 854/2004. Requirements contained in point II.1 of the model health certificate for imports of fishery products intended for human consumption established in Appendix IV to Annex VI to Regulation (EC) No 2074/2005. Article 11(4) of Regulation (EC) No 854/2004 establishes that EU controls carried out in the context of drawing up or updating lists of third countries from which imports of products of animal origin are permitted, shall take particular account of amongst other factors:- The extent and operation of official controls on imports of animals and their products (Article 46(1)(g) of Regulation (EC) No 882/2004). The assurances which third countries can give regarding equivalence to EU requirements (Article 46(1)(h) of Regulation (EC) No 882/2004). Findings Official control system in place 10

15 The official control system in place, which is based on the CA Manual of Procedures, covers the entire production chain and includes:- Audits (announced, of one to two days duration) which are performed:- Quarterly in land establishments, based on a specific checklist that covers environs and built infrastructure, layout and equipment, pre-requisite programmes, specific design of the process, fishery products health standards, own-checks, HACCP and its implementation. Twice per year in freezer vessels (reefer vessels are included in the category of freezer vessels) also based on a specific checklist that covers structures, equipment, hygiene practices, HACCP and its implementation. With no defined frequency on aquaculture farms and using a specific checklist covering structures, records and training. At the end of each audit, or the following day, a report is drafted by CA staff and the FBO signs it. The FBO is required to present an action plan to address any deficiency noted during the audit within seven days if the deficiencies are considered minor and immediately in case of major deficiencies. During each audit CA staff take samples of water, ice and fishery products for official control purposes. Ad hoc inspections (unannounced) carried out based on past and current performance of the FBO, to evaluate specific areas and to follow-up any complaint or RASFF notification. There are no checklist for these controls but a report is drafted following the same procedures as for audits. Inspections (announced) carried out to assess fishing vessels (without any frequency defined) and to inspect particular aspects of an establishment's operations, such as, unloading of fishery products from vessels and/or containers, loading of containers for export and organoleptic checks at landing sites. Specific checklists are used in accordance with the operation that is taking place. Follow-up inspections (announced) focused on the correction of deficiencies noted during any official control. A report is issued at the end of the inspection. The CA Manual of Procedures has instructions and guidance for the use of the checklists, the drafting of the report, the deadlines to be followed and a full chapter on HACCP assessment (specifically to address recommendation No. 2 of the previous audit report). The checklists are used as documentary support for drafting the reports, which are communicated to the FBOs and signed by them. The instructions with regard to the classification of deficiencies as major or minor are based on the direct impact on food safety but are not supported with clear guidance. All EU listed facilities are granted with an approval document (following an audit with a satisfactory outcome) which is valid for one year. The current version of the approval document states the types of products which are included in the approval for EU exports. Primary production The FVO team visited an aquaculture farm and hatchery (under reconstruction) which belong to an integrated production unit that also includes a processing establishment. The farm had been visited by the CA in accordance with the CA procedures and the frequencies defined by the CA for the processing establishment. Relevant records were made available to the FVO team and the premises were found by the FVO team compliant with standards at least equivalent to EU rules. 11

16 The FBO of the unit visited informed the FVO team that pharmacologically active substances have never been used in aquaculture facilities and therefore there were no treatment records. The CA also stated that the FBO always informed them that no treatment have been applied. However, during FVO team's visit, packages of malachite green, oxytetracycline, levamisole and acriflavine were found in the hatchery building. At the time of the visit these packages were stored on open shelves/refrigerator without restricted access. According to the FBO, oxytetracycline was purchased for diagnostic treatment of larvae in May 2013 whilst the other products had been on the site for at least the last ten years. The veterinary medicines found (oxytetracycline, levamisole) were not authorised for use in aquaculture. Neither levamisole nor acriflavine are listed as allowed substances in the Pharmacy Act. The CA had not remarked upon the the presence of these products in the records of its previous official control visits. The FVO team also noted that a risk analysis document for a viral disease was in place on farm and according to the FBO it serves as a general contingency plan in case of health problems. This document contains guidelines for treatment (from professional literature) covering, inter alia, the use of some substances which are not permitted for use in food producing animals in the EU (chloramphenicol and furaltadone). There was no evidence that either of these substances had been used. Following the FVO team's visit, the CA seized the above mentioned products and suspended the farm from any exports pending results of investigations to clarify whether the substances had been used or not. Analyses of samples taken from this farm under the national residue monitoring plan did not reveal any non-compliant results for the analytes tested for (although levamisole and acriflavine are not included in the scope of testing of the residue monitoring plan). Fishing vessels are controlled by the CA at least once a year and in general during a planned visit to the establishment that is supplied by them. The FVO team visited three small fishing vessels and found them in line with standards equivalent to the EU requirements of Chapter I of Section VIII of Annex III to Regulation (EC) No 853/2004. Files of two other fishing vessels were reviewed and the FVO team noted that they had been approved by the CA to supply fishery products for EU export following an on-the-spot inspection. The CA had used during its inspections the checklist defined in the CA Manual of Procedures. Landing In Mauritius fishery products can be landed in designated landing points (beaches without a quay), or at landing sites (quay annexed to an establishment or an independent landing quay). Fishery products are then transported to EU listed facilities by closed insulated trucks. The FVO team visited two landing points and two landing sites and observed the landing operations in one of each category. The FVO team noted that the unloading operations were carried out under conditions in line with the EU requirements defined in Chapter II of Section VIII of Annex III to Regulation (EC) No 853/2004. The FVO team also saw evidence of the controls (inspections) performed by the CA during landing operations. Checklists were filled in and reports issued where necessary. 12

17 Facilities, including vessels, handling fishery products The FVO team visited one freezer vessel (transport reefer), one establishment for fish oil, one cold store, two canneries, one establishment for frozen products, one establishment for processed products (salted), one establishment for fresh wild caught fishery products and one establishment for fresh/frozen aquaculture products. During the visits the FVO team noted that:- Audits had been carried out by the CA in accordance with the CA Manual of Procedures and following the defined frequencies. For all audits, checklists were filled and audit reports were drafted and delivered to the FBOs. Where necessary, action plans to correct deficiencies detected during audits were submitted by the FBOs to the CA and these were followed up by the latter. Inspections and follow-up inspections were carried out where needed. For all visits a report was drafted and made available to the FBO concerned. For the fish oil establishment, following an audit and other inspections, the CA decided to suspend the export to the EU of fish oil for human consumption suspension still in place at the time of the FVO's visit. The deficiencies detected were related to the unclear separation between raw materials that were considered either foodstuffs or feedstuffs. In another establishment the CA had detected several deficiencies as regards the freezing process and the HACCP plan and imposed a sanction of suspension of exports. There have been no exports of frozen fishery products to the EU from that establishment since then (confirmed in TRACES). However, during the FVO visits to the facilities deficiencies were noted that have not been previously identified/recorded by the CA:- In the reefer vessel the HACCP plan was not in line with the HACCP principles with regard to the description of the operations and the records. The version presented to the FVO team was of January 2014 which is currently being assessed by the CA. The previous version was not made available to the FVO team. However, from the discussion with the FBO, the FVO team concluded that the same shortcomings had been present in the previous version of the plan. In one establishment the workflows and the layout of equipment do not prevent the contamination of fishery products; e.g. possible contamination due to manipulation of exterior packaging material and cross-contamination between raw materials and filleted products. In the same establishment it was noted that frozen raw materials stored in its cold-room (with a door to the exterior) was not at the required temperature for the products involved (temperature measured ranging from -13,6 C to -17 C). This finding is a repetition of the situation observed in this establishment by the FVO during the 2009 FVO audit. In another establishment the FVO team noted that, since July 2013, the temperature records for the cold storage of frozen fishery products were not all available. Parts of the daily records were missing or complete records were missing for some days. In a third establishment it was noted that transport reefer containers, not equipped with temperature recording devices, are used for the storage of frozen products for EU export. This situation had previously been noted by the FVO during the 2009 FVO audit. 13

18 In a forth establishment the stacked crates of fresh fish kept on ice do not prevent the dripping of water from the melting ice to other crates. Of the six HACCP plans evaluated by the FVO team at the establishments two could be considered as in line with the applicable standards. One plan had already been identified by the CA as non-compliant and is currently being revised while for another, the document presented to the FVO team was not the one assessed by the CA (the FBO prepared a new copy that had not at the time been submitted to the CA). The remaining two HACCP plans presented shortcomings with regard to the complete identification of the steps, hazard identification, no evidence of use of a logical approach to decide on critical control points and some elements concerning traceability. The FVO team noted that an establishment exporting frozen fishery products (tuna for sushi/sashimi) to the EU, at a temperature not more than -18 C, plans to be supplied by the Mauritian freezer vessel indicated in report section 5.3. with raw material that was not frozen in accordance with EU rules. This raw material does not qualify under EU rules to be used for EU exports. This same establishment exported to the EU frozen fishery products that were produced from raw materials unloaded in Mauritius at a core temperature at a temperature not more than -18 C and produced on board flagged and approved EU MS vessels. The FVO team considers that four establishments (out of six currently exporting to the EU) visited can be considered largely in line with standards equivalent to the EU rules with regard to their structures and hygiene practices. However, the remaining two presented deficiencies that can be considered important and most importantly they are a repetition of the 2009 FVO audit findings. Checks on EU eligibility of imported raw materials The CA does not have in place formal procedures or instructions concerning the checks on the eligibility of imported raw materials for EU export. However, as also mentioned in the previous audit report, such checks are carried out for every consignment imported. The CA requires from the FBO a set documents that demonstrate that the products were produced in an EU listed facility of an EU approved country. An export certificate is also required to accompany the consignment entering Mauritius. After reviewing the documentation provided, the CA endorses the import request that the FBO submitted to the Import Control services of the Ministry of Fisheries. The CA informed the FVO team that without that endorsement the Import Control services of the Ministry of Fisheries will not allow the import, however, no formal document indicating these requirements have been drafted/issued. To check the information provided with regard to the establishments/vessels of origin the CA uses the SANCO web-page with the links to the non-eu countries list of establishments approved for EU export ( and the EU fleet register for EU flagged vessels ( The FVO team noted that even without written instructions the procedures are applied. However, the FVO team found two instances where the export certificates provided did not mention any attestation with regard to EU requirements. In one case the approval number mentioned on the certificate could not be found in the list of EU approved establishments for that country 3. 3 Although the name of the establishment identified in the certificate was included in the list of EU approved establishments for that country the approval number mentioned in the certificate for that establishment was completely different from the one indicated in the list of EU approved establishments. 14

19 This issue was the subject of a recommendation in the previous audit report, recommendation No. 3, and whilst the actions taken by the CA can be considered as an improvement, shortcomings still persist. Conclusions The detailed control system in place covers the entire production chain of fishery products for EU export and allows the CA to provide guarantees with regard the application of rules equivalent to those of the EU for the official control of production of fishery products. However, the reliability of those guarantees are weakened by the shortcomings noted with regard to HACCP implementation by FBOs and its assessment by the CA, the use of reefer containers not equipped with temperature recording devices for the storage of frozen fishery products, the temperature of stored frozen fishery products and the workflow and layout of equipment that allows for cross contamination of fishery products. The control of the eligibility of imported raw materials is mostly performed adequately, however, it cannot provide full guarantees that those materials are always eligible for EU exports due to the shortcoming related to the absence of health attestations of some imported consignments. Although the improvements made to the CA Manual of Procedures, recommendation No. 2 concerning the maintenance of the approval conditions can only be considered as partially addressed. Recommendation No. 3 of the previous audit report concerning the controls on imported raw material can only be considered as partially addressed. Recommendation No. 5 of the previous audit report concerning the deficiencies found at the establishments visited during the 2009 audit can only be considered as partially addressed Official controls of fishery products Legal requirements Point II.1 of the model health certificate for imports of fishery products intended for human consumption established in Appendix IV to Annex VI to Regulation (EC) No 2074/2005, in particular official controls laid down in Annex III, Chapter II of Regulation (EC) No 854/2004. Findings The CA has an annual sampling plan that covers water, ice and fishery products for the relevant parameters indicated in Chapter II of Annex III to Regulation (EC) No 854/2004. Samples are taken every quarter. The CA official controls for fishery products include, where applicable, organoleptic examinations, histamine testing, heavy metals testing (lead, mercury, cadmium and tin), dioxins testing, microbiological checks and parasite controls. Records of examinations, sampling and analyses results were provided to the FVO team and the results were, in general, in line with the applicable EU rules. The FVO team also noted that the frequencies set were followed. The official controls performed by the CA regarding poisonous fishery products ensure that those 15

20 products are not exported to the EU. With regard to ciguatoxin Mauritius has specific legislation that covers all fishery products placed on the Mauritius market (including products for export). That legislation is enforced by Fishery Control Officers of the Ministry of Fisheries. The same officers carry out controls to ensure that no fishery products containing ciguatoxin are placed on their domestic market. The official controls 4 for water and ice include the relevant EU microbiological parameters which are tested every quarter (except Enterococcus which is done yearly). A full physical-chemical analysis of water is carried out once a year and includes all EU relevant parameters. Conclusions The official controls of fishery products generally address EU rules, which allows the CA to provide adequate guarantees regarding their fulfilment of EU requirements Controls on the distribution and use of veterinary medicinal products and on residues thereof Legal requirements Article 29 of Council Directive 96/23/EC states that guarantees offered by residue monitoring plans submitted by third countries must have an effect at least equivalent to those provided for in the Directive and must, in particular, meet the requirements of Article 4 and specify the particulars laid down in Article 7 which provides for legislation on the use of (pharmacologically active) substances listed in Annex I to the Directive and, in particular, provisions on their prohibition or authorisation, distribution and placing on the market and the rules governing their administration. Article 10 of Council Directive 96/23/EC lays down the veterinary medicines record keeping requirements for stock-owners and veterinarians. Findings In spite the existence of a legal framework which could be used to implement controls on the distribution chain of veterinary medicinal products, the FVO team could not confirm that such controls were being routinely carried out and the CA was unable to clarify this point. The Pharmacy Act provides also for official controls of licensed premises. However, according to the wholesale pharmacy visited by the FVO team, since the initial inspection for granting its license no other official controls have been carried out to date (i.e. over the past four years). The FVO team was informed by the aquaculture FBO and by the wholesaler pharmacy that the prescription system laid down in the Pharmacy Act has not been implemented and all veterinary medicinal products are available over-the-counter. The FVO team was also informed by the CA and by the wholesale pharmacy that there are no manufacturers of veterinary medicinal products in Mauritius and that for every consignment of pharmaceutical products a permit for importation has to be obtained from the Ministry of Health and Quality of Life. The conditions for import are provided for in the Pharmacy Act. The Pharmacy Act does not foresee any veterinary input into decisions on importation of veterinary medicinal products, though the CA stated that Veterinary Services of the Ministry of Agriculture have 4 The CA uses Council Directive 98/83/EC to define the parameters to be tested in water and ice. The CA also requires that FBOs follow the same standard when performing the own-check controls. 16