EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL

Directorate D - Food and Veterinary Office

DG (SANCO)/1082/99-MR Final

REPORT OF A MISSION CARRIED OUT IN THE REPUBLIC OF

FROM 14 TO 18 JUNE 1999

CONCERNING INSPECTION OF FISHERY PRODUCTS

AND

OF BIVALVE MOLLUSCS

18/10/99 - 23236 1. INTRODUCTION

This mission, which took place from 14 to 18 June 1999 in the Republic of Croatia, was carried out by a team of two veterinary inspectors from the Food and Veterinary Office. Initial and final meetings took place with the Central Competent Authority whose officials accompanied the mission team on all visits.

2. BACKGROUND OF THE MISSION

A preliminary evaluation mission, which partly covered fish and fishery products, was carried out in Croatia in July/August 1996 (mission report No.VI/7139/96). Subsequently, Croatia was included in list II of the Annex to Commission Decision 97/296/EC on 22 April 1997, which authorised for an interim period (31.12.2000), the import into the EU of fishery products originating in Croatia. A second mission for the evaluation of sanitary conditions concerning the production of bivalve molluscs was carried out in Croatia in October 1997 (mission report No.XXIV/2035/97). The mission concluded that the sanitary standards were inadequate in respect of such issue. Furthermore, Croatia is not included in any of the lists of third countries from which the Member States are authorised to import live bivalve molluscs, as laid down in the Annex of Commission Decision 97/20/EC.

3. SCOPE OF THE MISSION

The objective of the mission was to assess whether the conditions of production, storage and final export of fishery products in Croatia are equivalent to the requirements laid down in EU legislation and whether it would be possible to recommend the inclusion of Croatia in list I (permanent and harmonised list) of the Annex to Commission Decision 97/296/EC. Secondly, the conditions of production of bivalve molluscs were assessed in order to evaluate whether the import into the EU of those products could be considered.

4. LEGAL BASIS FOR THE MISSION

The mission was carried out under the general provisions of Community legislation and in particular: Council Directive 91/493/EEC of 22 July 1991, laying down the health conditions for the production and the placing on the market of fishery products. Council Directive 91/492/EEC of 15 July 1991, laying down the health conditions for the production and the placing on the market of live bivalve molluscs. Commission Decision 98/140/EC of 4 February 1998, laying down certain detailed rules concerning on-the-spot checks carried out in the veterinary field by Commission experts in third countries.

2 5. MAIN OBSERVATIONS

5.1. Competent Authority

The Veterinary Directorate, within the frame of the Ministry of Agriculture and Forestry of the Republic of Croatia, is an autonomous body and represents the Central Competent Authority. The Director of the Veterinary Directorate is appointed by the Government and acts both as Chief Veterinary Officer and as Assistant (Deputy) to the Minister. The headquarters in include five departments: Health Protection and Veterinary Practice, Veterinary Public Health, Veterinary Inspection, Health Protection Financing and Veterinary Legislation, Border Veterinary Inspection. At level 21 Veterinary Bureaux represent the regional branch of the Ministry of Agriculture and Forestry – Veterinary Directorate and their offices are located in the city of Zagreb and in each of the 20 that built up the Republic of Croatia. In addition, in each County are present the Veterinary Stations (100 in total in Croatia) in which Authorised Veterinary Inspectors, selected and appointed for specific official purposes by the Veterinary Directorate, carry out routine inspection of fishery product establishments, fish and bivalve molluscs farms and issue export health certificates.

5.2. Legislation

The Veterinary Service Act (Veterinary Law) of 18/6/1997 establishes competency and conditions for veterinary service operation regarding animal health, animal welfare and control of food of animal origin. It takes into account changes connected with privatisation of the veterinary stations and their functional and hierarchical link with the Veterinary Directorate. The Ministry of Agriculture and Forestry Regulation No.1311/97 lays down the obligation for the implementation of an HACCP system in all the approved plants that intend to export food of animal origin to the EU. The Ministry of Agriculture and Forestry Regulation 20/92 lays down the provisions for sanitary conditions to be complied with concerning plants which process food of animal origin. Two new (Draft) Veterinary Regulations made under the provision of the ‘Veterinary Service Act’ 1997 (articles 18 and 19), were at the time of the mission in the final stage (legal evaluation) before adoption and publication, foreseen for the end of August 1999. These two new Regulations would lay down health conditions for production and placing on the market of fishery products and of bivalve molluscs, equivalent to Council Directives 91/493/EEC and 91/492/EEC. Copy of legislation (version in ) regarding potable water - Regulation No.805/1994 - for which the Ministry of Health is responsible, was provided to the team at time of the visit and appeared to be equivalent to Council Directive 80/778/EEC.

3 5.3. Laboratories

Three laboratories were visited during the mission: the Croatian Veterinary Institute in Zagreb, the Veterinary Institute (branch) of Split and the Institute of Oceanography and Fisheries in Split. The Croatian Veterinary Institute (CVI) with headquarters in Zagreb is a scientific-research Government institution and represents the National Reference Laboratory for diagnostics of fish and bivalve molluscs’ diseases. The CVI comprises 14 departments; in addition as integral part of it, there are 5 peripheral branch offices in Split, , , Krizevci and the Poultry Centre in Zagreb. The Institute provides good facilities for the diagnostic of fish and bivalve molluscs diseases, with trained, competent staff. The CVI co- operate with and send comparative samples to the Community reference laboratory for diseases of bivalve molluscs – IFREMER, La Tremblade (F) and to the laboratories for fish diseases in Udine and Padova (I). The Institute does not organise inter-comparative tests within the country, with the exception of some inter-calibration tests for chemical and microbiological analysis. The Veterinary Institute (VI) of Split is a branch office of the CVI and its activity covers the central/southern coastal Counties of Croatia. The VI includes 5 departments amongst which the Foodstuff Hygiene and the Chemistry Departments. In both of these, microbiological and chemical analyses on foodstuff, including fishery products, are performed. For this purpose the expertise seen during the visit appeared to be adequate. The Institute of Oceanography and Fisheries (IOF) of Split is a scientific institution under the Ministry of Science. It includes 9 laboratories (departments) and conducts marine applied research regarding central/southern . The institute provides expertise for identification of toxic phytoplankton and participates in inter-laboratories tests with some Community laboratories: Vigo (ES), Jena (D), Cork (IRL), Trieste (I). It co- operates also with the University of Split on performing bio- essay for detection of alga biotoxins. The IOF has no legal obligation in providing routine analyses results to the Veterinary Directorate.

5.4. Residue Monitoring Plan

An annual residue plan is carried out on freshwater fish and marine animals, including all the substances required for this type of animals in Council Directive 91/493/EEC and in Council Directive 96/23/EC on measures to monitor certain substances and residues thereof in live animals and animal products. The responsibility for drawing up the yearly residue monitoring plan is assigned to the Veterinary Directorate in co-operation with the Croatian Veterinary Institute of Zagreb. Instructions regarding the number of samples and the products to be collected are sent to the Veterinary Bureaus of the Counties, which dispatch these instructions to the Veterinary Station. The Authorised Veterinarian of the Veterinary Stations takes the samples and sends them to the laboratory. The analyses are performed mainly in the Croatian Veterinary Institute in Zagreb.

4 The plan for the year 1999 includes monitoring of residues of antibiotics in freshwater aquaculture fish and the number of samples is in accordance with the figure of the total production. However no checks for such substances in saltwater aquaculture fish are foreseen for 1999. Regarding the substances included in Annex IV to Council Regulation No.2377/90/EEC, of which the administration to food-producing animals is prohibited within the EU, chloramphenicol and nitrofurans are monitored. The utilisation of both substances has been officially banned. As far as the use of veterinary drugs is concerned, antibiotics can only be prescribed and handled by Veterinarians. The therapy for aquaculture animals is carried out directly by the official veterinarians or under their strict supervision.

5.5. Histamine

Checks for controlling level of histamine are generally carried out on bluefish (mainly on canned products) either as official samples by the Authorised Veterinarians or as ‘own-checks’ by the companies. The Croatian Veterinary Institutes and the Public Health Departments (Ministry of Health) laboratories perform the analysis using Thin Layer Chromatography (TLC) method. Some results showed levels equivalent to the maximum limit foreseen for the Croatian Law (10mg. /100gr. for fresh fish and 20mg. /100gr. for canned products). In all cases the analysis method and the sample-unit taken were not in conformity with what is required under Chapter V of the Annex to Council Directive 91/493/EEC.

5.6. Approval of Establishments

At present, 47 fishery product establishments have been approved for export to the EU. A list of such plants was provided to the mission team. The approval to export to the EU is given by the Veterinary Directorate and the procedure applies to all establishments exporting food of animal origin. The procedure starts with a request for approval by the owner of the plant, which should submit a blueprint of the structural plan to the municipal authority. An ad hoc local commission, which includes also officials of the County Veterinary Bureau, evaluates if the project is in accordance with all the prescribed building, environmental and veterinary-sanitary requirements. If conditions are complied with, the County Veterinary Officer issues the preliminary veterinary approval that is sent, with all the documents annexed, to the Veterinary Directorate in Zagreb. Here, the Director (CVO) nominates an expert’s commission, which usually includes representatives of the Veterinary Directorate, of the County Veterinary Bureaus and of the Faculty of Veterinary Medicine. This commission has the duty of assessing the compliance of the plant with all legal requirements and with the veterinary-sanitary layout. When a favourable outcome from this evaluation is sorted out, the authorisation for building the structure is given. As soon as the plant is completed, officials of the Veterinary Directorate, accompanied by representatives of the relevant County Veterinary Bureau, verify compliance of the premises.

5 Finally, the Director of the Veterinary Directorate formally grants the approval and assigns the veterinary control number; the establishment is then registered in the list of plants authorised to export. The Veterinary Directorate keeps a register of approved establishments, since the list is not published in the Croatian Official Gazette. The approval Decision specifies the nature of activities for which the plant had been approved. Two originals of the approval Decision are issued: the first being sent to the company, the second kept as record by the Veterinary Directorate. Copy of the approval Decision (stamped in original) is sent to the County Veterinary Bureaus and to the Border Inspection Posts (BIPs). The implementation of HACCP system in the food-establishments that intend to export to the EU is compulsory in Croatia from January 1998. The withdrawal or suspension of the approval is pronounced by the Director of the Veterinary Directorate, following a proposal from the Authorised Veterinarians of the Veterinary Station, who carries out official inspection in the plant. Such proposal is dispatched to the Veterinary Directorate through the County Veterinary Bureaus. In the meanwhile, the Authorised Veterinarian has the power and the instruction to stop issuing the export (or local) health certificates in case of severe shortcomings. He also has to communicate the action undertaken to the relevant County Veterinary Bureau. As soon as the withdrawal decision becomes effective, the Veterinary Directorate has to inform the County Veterinary Bureaus, the BIPs and the European Commission.

5.7. Inspection of Establishments

Veterinary supervision of the fishery products processing plants is carried out at three different levels. · Veterinary Station Routine veterinary inspections in the establishments are carried out by the Authorised Veterinarians of the Veterinary Station, who also issue the health certificates. The Authorised Veterinarians has to inform the relevant County Veterinary Bureau about their monthly routine activity concerning the supervision of the plants filling in a form in which he/she has also to indicate if deficiencies are found. The Authorised Veterinarians can propose to the relevant County Veterinary Bureau a temporary suspension of the activities, in case of problems easy to correct or suggest, through the County Veterinary Bureau, for a proposal for withdrawal of approval to the Veterinary Directorate, in case of serious deficiencies. In the fishery product plants visited, the Authorised Veterinarian is part/full- time present during the operations, depending on the size of the activities. The evidence of the veterinary supervision by way of stamping and signing the documented ‘own-checks’ controls and results of analyses of the official sampling were found in the plants.

6 · County Veterinary Bureau The Veterinary Inspectors of the county units of the Veterinary Directorate carry out monthly or two-monthly visits to the establishments, for the purpose of inspecting the plant and controlling the activities of the Authorised Veterinarians of the Veterinary Station. On a monthly basis the Veterinary Inspector have to send to the Veterinary Directorate a report, using a standardised model, in which all the activities regarding the fishery product establishments and the fish farms are summarised. In addition a global report including all the activities taking place within the County is sent to the Veterinary Directorate every three months. · Veterinary Directorate The Veterinary Directorate regularly checks the activity of the County Veterinary Bureaus and organises a yearly meeting with all the County Veterinary Inspectors. The involvement of the central level in the supervision of the establishments does not follow a scheduled plan; nevertheless random visits are paid along the year in conjunction with the Veterinary Inspector of the County.

5.8. Export Health Certification

Model health certificates are drawn up by the Veterinary Directorate. The forms are printed and dispatched by the Veterinary Directorate, through the County Veterinary Bureaus, to the Authorised Veterinarians who issue the certificates. The Authorised Veterinarians of the Veterinary Stations can issue the health certificate for consignments originating from the plant that they are inspecting. A list of the Authorised Veterinarians entitled to sign health certificates, with their identification number, is available at central level and in the BIPs. For fishery products intended for export to the EU, a health certificate conforming to the model laid down in Commission Decision 95/328/EC is issued. Each certificate bears a unique reference number, a geographical lithograph of Croatia, with different colour (blue) to the one used for the text (black) and receives, when filled in by the Authorised Veterinarian, the official stamp reporting his/her identification number and the Veterinary Station of belonging. The consignor should notify to the relevant Veterinary Station at least 12/24 hours prior to loading of all consignments. Some irregularities in the completion of the export health certificates, such as the non-identification and listing of the species (scientific name) included in the consignments, were noted and pointed out to the Competent Authority.

5.9. Fishery product establishments

Four fishery product establishments approved to export to the EU were visited during the mission; all of them showed good facilities and structures. In all of them the HACCP system has been implemented and adequate records of the ‘own-checks’ monitoring and laboratory analysis were available. The official inspectors of the relevant Veterinary Station have a full-time supervision of the plants and have to be present when consignments for the

7 internal market or for export to the EU are loaded. If conditions are met they issue the export health certificate. For the Croatian Law the Official Inspectors issue a health certificate also for internal market consignments. The format and layout of this model certificate is completely different from the one used for export purposes. In three plants some minor deficiencies were noted in relation to the structures and to the hygienic handling and preparation of products.

5.10. Production of live bivalve molluscs

At present along the Croatian coastline, 4 production areas have been delimited: area surrounding the coast of Porec (Co.Istarska), Novigrad Sea (Co.Zadarska), Sibenik Fjord (Co.Sibensko-Kninska), and Maloston Bay (Co.Dubrovacko-Neretvanska). The main production being represented by mussels (Mytilus Galloprovincialis) clams (Tapes Decussatus) and a smaller quantity of oysters (Ostrea Edulis). The actual production (1998/99) is around 800 tonnes (mussels and clams) and 1 million pieces (oysters). There is no classification of the production areas as required by Chapter I of the Annex to Council Directive 91/492/EEC, even if a survey on seawater and shellfish (chemical, bacteriological and virological) is carried out. Research carried out by the Institute of Oceanography and Fisheries (Split) on toxic phytoplankton started in 1962. This survey led to the detection of Dinophysis spp. (from April to August), the critical period being usually from May till end of July. In 1998, the institute detected a new species of Dinophysis in Kastela Bay (Split). This species apparently was found to be the same discovered by the institute of Cork (IRL) and being responsible for a DSP (Diarrhoeic Shellfish Poisoning) intoxication. Alexandrium minutum and Pseudonitzschia Delicatissima were also identified. The institute is conducting autonomous research, on a monthly basis, on seawater and wild bivalve molluscs and covers the coastline starting from till (mid and south Adriatic Districts). In general, the samples are collected in pre- determined points, which in certain case coincide with the production areas of the farmed bivalve molluscs. Similar activity is performed by the marine institute “R.Boskovic” (Rovjni) for the northern Adriatic Districts, however the analyses are limited to evaluate the quality of seawater, including identification of phytoplankton. A new programme to monitor production areas will start as soon as the new Veterinary Regulation concerning the sanitary conditions for production and placing on the market of live bivalve molluscs, would be enacted. The programme would consist of: - Monitoring in the 4 production areas of the presence of Dinophysis spp., Alexandrium spp. and Psedonitzschia spp., with a weekly sampling starting at beginning of May and twice a month from the end of July to the end of September and from beginning of March to the end of April. Along the period starting from October to the end of February one sampling every 4/6 weeks has been foreseen. The institute in co-operation with the University of Biology of Split is also performing bio-essay for detection of biotoxins. This activity has started in 1992/93 and DSP and PSP (Paralytic Shellfish Poisoning) analysis are

8 performed. ASP (Amnesic Shellfish Poisoning) analysis will start as soon as new equipment is furnished (HPLC). No alert level has been determined in relation to the concentration of toxic phytoplankton in the seawater. The closing of the production area takes place when alga blooming is evident or when the result of the analysis is positive. In this cases the institute is formally involved in communicating the results to the Veterinary Directorate and to the competent County Veterinary Bureau. Nevertheless, even if not yet formalised, there is an exchange of information between the Institute of Oceanography and Fisheries and the Veterinary Directorate concerning this issue.

6. CONCLUSIONS

6.1. Legislation Following the evaluation process carried out by the Commission services, the Croatian legislation will be amended by new Veterinary regulations, which were in the final stage before adoption at the time of the mission, in order to be equivalent to the EU legislation regarding fishery products and bivalve molluscs. However, the new texts were not yet available in English and the mission team could not establish the equivalency of the legal texts.

6.2. Laboratories All the laboratories visited provide expertise and facilities for carrying out analyses on fishery products, bivalve molluscs, potable water and/or seawater. However, the Croatian Veterinary Institute and its branch perform some analyses that do not comply fully with EU requirements.

6.3. Residue Monitoring Plan The residue monitoring plan covers all the substances required for fish by Council Directive 96/23/EC. However, the plan for 1999 includes the monitoring of antibiotics only in freshwater aquaculture fish, and not in seawater aquaculture fish.

6.4. Histamine The number of samples per batch, the analytical method and the value of acceptability (maximum level limit) are not in accordance with Chapter V of the Annex to Council Directive 91/493/EEC.

6.5. Establishments A rational procedure for approval of fishery product establishments is in place. During the mission some minor deficiencies in three plants visited were pointed out.

6.6. Veterinary Supervision Veterinary supervision at plant level is carried out by Authorised Veterinarians from the Veterinary Station. Documented records and evidence of official sampling for analyses were available during the visit.

9 The Authorised Veterinarians of the Veterinary Station issue export health certificates conforming to the model laid down in Commission Decision 95/328/EC, however the species (scientific name) of fish to be exported is often not indicated.

6.7. Production of Live Bivalve Molluscs Official classification is not established for the four production areas. Some weak points were identified in the monitoring of phytoplankton and marine biotoxins, in particular as regards the sampling points, the bivalve molluscs to be sampled, the determination of alert level and the obligations of the Institute of Oceanography and Fisheries as regards the Veterinary Directorate. At present, the production and placing on the market of live bivalve molluscs in Croatia have not equivalence conditions to the requirements laid down by Council Directive 91/492/EEC.

7. RECOMMENDATIONS

7.1. For the Croatian Competent Authority

7.1.1. Legislation The new Veterinary regulations (English version) and evidence of their publication and entry into force should be forwarded to the European Commission.

7.1.2. Laboratories The Croatian Veterinary Institute should review some of its analytical methods (histamine, E. coli in mussel flesh) and perform them in accordance with EU requirements. The Institute of Oceanography and Fisheries of Split should be officially recognised as reference laboratory for marine biotoxins and be legally empowered to participate to the activity of the Veterinary Directorate regarding this issue.

7.1.3. Residue Monitoring Plan The monitoring of antibiotics in marine aquaculture fish should be systematically included in the annual residues monitoring plan.

7.1.4. Histamine The number of samples per batch, the analytical method and the value of acceptability (maximum level limit) for consignments to be exported to the EU should be in accordance with Chapter V of the Annex to Council Directive 91/493/EEC.

7.1.5. Establishments All the corrective measures for correcting the deficiencies identified during the EU visit should be put in place.

10 7.1.6. Veterinary Supervision The Veterinary Directorate should take the necessary measures to ensure the correct completion of export health certificates by the Authorised Veterinarians of the Veterinary Station.

7.1.7. Production of Live Bivalve Molluscs In order to be considered for inclusion in the lists of third countries from which the Member States are authorised to import live bivalve molluscs, the Croatian competent authority should establish an official list of production areas, with an indication of their location and boundaries and their classification in accordance with Chapter I of the Annex to Council Directive 91/492/EEC. A surveillance programme of these production areas should be finalised and forwarded to the EC, together with the results of the monitoring.

7.1.8. Written Assurances Written guarantees should be forwarded to the European Commission in respect of the rectification of all the points listed above, with a deadline of 1 October 1999 for the points 7.1.4.and 7.1.5. The Croatian competent authority should provide detailed information on the action that will be taken and on the deadlines by which this action will be completed. 7.2. For the Commission Services

– The Commission services should evaluate the written assurances received from the Croatian competent authority. If these guarantees appear to be satisfactory, the Commission services should consider to propose to Member States that Croatia be placed on list I of the Annex to the amended Commission Decision 97/296/EC, and that a Commission Decision laying down the health conditions for the importation of fishery products originating in Croatia be adopted. – With regard to bivalve molluscs, the Commission services should not consider to propose including Croatia in any of the lists of third countries contained in the Annex to Commission Decision 97/20/EC, prior to receiving from the Croatian Authorities information concerning the actions they have undertaken to address to point 7.1.7. of recommendations and before a follow-up mission has been carried out to verify the conditions of bivalve molluscs production and the surveillance programme of the production areas.

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