EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL

31/03/08 - 59839

EUROPEAN COMMISSION

HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL Directorate F - Food and Veterinary Office

DG(SANCO)/2007-7355 – MR Final

FINAL

REPORT OF A FOLLOW-UP MISSION CARRIED OUT IN

CROATIA

FROM 9 TO 17 OCTOBER 2007

IN ORDER TO EVALUATE THE CONTROL SYSTEMS IN PLACE GOVERNING THE PRODUCTION OF FISHERY PRODUCTS AND LIVE BIVALVE MOLLUSCS

INTENDED FOR EXPORT TO THE EUROPEAN UNION

TABLE OF CONTENTS

1. INTRODUCTION... 3

2. MISSION OBJECTIVES... 3

3. LEGAL BASIS FOR THE MISSION ... 4

4. BACKGROUND TO THE MISSION ... 4

4.1. Historical background ... 4

4.2. Production and trade information... 4

4.3. The Rapid Alert System for Food and Feed (RASFF) notifications... 5

5. MAIN FINDINGS ... 5

5.1. Legislation ... 5

5.2. Competent Authority... 6

5.3. Laboratories... 8

5.4. Official controls on FP-PH... 12

5.5. LBM ... 15

5.6. Trade and health certification... 18

5.7. Visits carried out by the MT ... 19

5.8. Follow-up of RASFF notifications... 21

6. GENERAL CONCLUSION ... 21

7. CLOSING MEETING ... 22

8. RECOMMENDATIONS TO THE CA OF CROATIA... 22

8.1. Legislation ... 22

8.2. Competent Authority... 23

8.3. Laboratories... 23

8.4. Official supervision of FP ... 23

8.5. LBM ... 23

8.6. Visits carried out by the MT ... 24

9. COMPETENT AUTHORITY'S RESPONSE TO THE RECOMMENDATIONS.. 24

ANNEX ... 25

1. I NTRODUCTION

The mission took place in Croatia from 9 to 17 October 2007 and was undertaken as part of the Food and Veterinary Office's (FVO) planned mission programme.

The mission team (MT) comprised four inspectors from the FVO and two national experts from Member States.

2. M ISSION OBJECTIVES

The objectives of the mission were:

− to verify the extent to which the guarantees and the corrective actions submitted to Commission services have been implemented, controlled and enforced by the Competent Authority (CA) following a previous FVO mission (PFVOM) concerning the conditions of production of fishery products (FP) and live bivalve molluscs (LBM) (see report DG(SANCO)/7586/2005). For logistical reasons recommendations relating to animal health aspects of the PFVOM were not followed up in the current mission.

− to assess whether the organisation of the CA and the implementation of national provisions, against which the CA controls FP and LBM intended for export to the European Union (EU), can still be considered as at least equivalent to Community requirements.

In order to achieve these objectives, the MT evaluated the organisation of the CA and its capacity for implementing provisions considered at least equivalent to the relevant Community requirements.

In pursuit of these objectives, the MT proceeded as follows:

− an opening meeting was held on 9 October 2007 with the Central Competent Authority (CCA) – the Veterinary Directorate of the Ministry of Agriculture, Forestry and Water Management (MoAFWM). At this meeting the MT confirmed the objectives of and itinerary for the mission, and requested additional information required for the satisfactory completion of the mission.

− the following sites were visited:

C

Central Office 1 Zagreb

County Veterinary Inspectors (CVIs)

10 Approved Veterinarians 10

L

Central 1 Croatian Veterinary Institute (HRVI), Zagreb Central 1 Institute of Oceanography and Fisheries, Split Regional 2 Croatian Veterinary Institute, Rijeka and Split

FP Establishments (processing) 6 from seven selected LBM purification/dispatch

centres

6 2 purification/dispatch centres 4 dispatch centres (3 platforms, 1 boat) O

Landing sites 1

1

List of abbreviations and special terms is drawn up in Part 1 of the Annex to this report.

Fishing vessels 5

LBM production areas 3

Fish farms 1

− representatives from the CCA accompanied the MT during the whole mission.

3. L EGAL BASIS FOR THE MISSION

The mission was carried out in agreement with the Croatian authorities under the general provisions of Community 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 rules;

• 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.

4. BACKGROUND TO THE MISSION

4.1. Historical background

Croatia is presently listed in the Annex II of Commission Decision 2006/766/EC establishing the lists of third countries and territories from which imports of FP are permitted. From 1 May 2007, the model of the health certificate to accompany such imports is given in Appendix IV to Annex VI of Commission Regulation (EC) No 2074/2005, as amended by Commission Regulation (EC) No 1664/2006. To date, Croatia is not authorised to export LBM to the EU.

This mission was a follow up of a PFVOM to Croatia carried out from 28 November to 7 December 2005 (ref. DG(SANCO)/7586/2005). During this PVOFM serious deficiencies were identified in the official control system in place at that time and shortcomings were observed all along the production chain in relation to both FP and LBM. The report of this mission included a number of recommendations to which the Croatian Authorities responded providing some written guarantees and implementing certain corrective actions. This report is published on the Internet at:

http://europa.eu.int/comm/food/fvo/ir_search_en.cfm.

4.2. Production and trade information FP-Public Health (PH)

Imports of FP from Croatia are authorised from a total of 72 land based establishments (three involved in the production of canned FP, mainly sardines). In 2006, according to EUROSTAT, 16,476 tonnes of fish and FP, including 9,005 tonnes of fresh and salted anchovies, were exported to the EU market, mainly to Italy.

LBM-PH

Croatian production of oysters and mussels (Ostrea edulis and Mytilus galloprovincialis), according to information provided by the CA, amounted to an estimated 3,000 and 4,000 tonnes in 2005 and 2006, respectively.

2

References to Community Acts quoted in the report are mentioned in Part 2 of the Annex to this report. All legal

references refer, where applicable, to the latest amended version.

4.3. The Rapid Alert System for Food and Feed (RASFF) notifications FP-PH

Three RASFF notifications were reported regarding FP originating in Croatia since the PFVOM, two of them concerning levels of histamine (salted and fresh anchovies) and one on unsuitable transport conditions for chilled anchovies.

LBM-PH

One RASFF notification reported on illegal trade of clams.

5. M AIN FINDINGS

- Assurances given by the CA dated on 4 April and 24 November 2006 in response to each Recommendations from the DG(SANCO)/7586/2005 mission are transcribed in “italic letter type and between quotation marks”.

The PFVOM report (PFVOMR) included 19 recommendations addressed to the CA related to FP and LBM. Information on implementation of some recommendations was submitted by the CA to the Commission services.

The layout of the current mission report follows the structure of the PFVOMR and Croatia's response thereto.

5.1. Legislation

5.1.1. Recommendations from the DG (SANCO)/7586/2005 mission and assurances given by the CA

FP-PH

The HR legislation on PH control for FP intended for export to the EU should be reviewed in order to include certain provisions at least equivalent to those required in Council Directive 91/493/EEC3, in particular concerning the temperature of transport of FP (Directive 91/493/EEC, Annex, Chapter VIII, Point 1, 1st indent)4 and the requirements for RSW vessels (Directive 92/48/EEC, Annex 2, point 8)5.

"It is foreseen that the «new hygiene package» will be transposed until the end of the year 2006. Thus, all legislation related to PH control for FP will be part of Croatian legislation."

LBM-PH

The HR legislation on PH control for LBM intended for export to the EU should be reviewed in order to ensure equivalence to Community requirements as described in Council Directive 91/492/EEC6 and that discrepancies such as the ones described in point 2.1 are removed; in particular,

• only LBM from areas included in the monitoring programme should be accepted by purification centres;

3

Repealed by Directive 2004/41/EC. Please refer to Regulation (EC) No 853/2004, Annex III, Section VIII.

4

Please refer to Regulation (EC) No 853/2004, Annex III, Section VIII, Chapter VIII.

5

Repealed by Directive 2004/41/EC. Please refer to Regulation (EC) No 853/2004, Annex III, Section VIII, Chapter I, Part I (B).

6

Repealed by Directive 2004/41/EC. Please refer to Regulation (EC) No 853/2004, Annex III, Section VII.

• all the requirements for LBM as laid down in chapter V of Annex to Council Directive 91/492/EEC have to apply for LBM after relaying should be met;

• dispatch centres should keep dispatch details, including names and addresses of consignees, date and quantity of LBM dispatched, together with the corresponding entry registration document numbers.

"The legislation on LBM will be reviewed within the first quarter of 2007."

5.1.2. Findings regarding the assurances given by the CA FP-PH

At the initial meeting, the MT was informed on the recent adoption and entry into force with immediate effect of the "Ordinance transposing the EU hygiene package"

(published in the Official Gazette on 8 October 2007) which includes provisions at least equivalent to Regulations (EC) Nos 852/2004, 853/2004, 854/2004 and 882/2004 of the European Parliament and of the Council. This new legislation governs the requirements applicable for FP-PH. The MT was not provided with a copy of this document during the FVO mission and could not evaluate it.

In view of this finding the implementation of this recommendation could not be assessed at the time of the mission.

Additionally, the MT was informed of Croatia's intention to transpose remaining outstanding Community legislation in this field, in particular Commission Regulations (EC) Nos 1883/2006 and 2073/2005.

However, the MT evaluated some legislation still in force and found that the SLUZBENI LIST SFRJ No 68 from 3 November 1989 does not include provisions prescribed in Council Regulation (EC) No 2406/96, for instance categorisation of freshness of FP, detailed description and criteria to determine the freshness for certain FP products (e.g. anchovies and sardines).

The maximum permitted level of lead in certain species of fish and FP, according to the "Ordinance of toxins, metalloids and other harmful substances in food" (Official Gazette 16/05) is 0.4 mg/kg wet weight, is too high compared to the level set in Annex, Section III, point 3.1.5 of Commission Regulation (EC) No 1881/2006 (0.3 mg/kg wet weight).

LBM-PH

The MT was informed that the "Ordinance transposing the EU hygiene package"

would also include requirements applicable to LBM. However as a copy was not provided to the MT, no assessment of this piece of legislation could be made.

5.2. Competent Authority 5.2.1. Training

5.2.1.1. Recommendations from the DG (SANCO)/7586/2005 mission and assurances given by the CA

The CA should ensure that the inspection staff authorised to perform official check receive appropriate training to allow them to assess the own-checks system set up by

7

FVO was provided with a copy of this legislation in Croatian following the mission on 16.11.2007.

the person responsible for the establishment (Commission Decision 94/356/EC, Article 7)8.

Training seminar addressed to 30 county veterinary inspectors concerning the new EU legal framework on food safety which include even assessment of the own- checks system already started. Further activities related to the assessment of the own-checks system will be included as one of the topics within the CARDS 2004 Twinning project “«Capacity building in the area of agriculture, live animals and food products».

5.2.1.2. Findings regarding the assurances given by the CA

The MT was informed of the number of training courses held for the CCA and the regional CA. Courses were held concerning, in particular, general principles of HACCP in food of animal origin and auditing of HACCP plans, understanding of

"EU Hygiene Package" legislation, Community legal framework for food safety and inspection techniques, assessment of establishments with the aim of their categorisation and conducting of upgrading process. Lists of participants of some training courses were shown to the MT. The CA briefed the MT on plans to perform study visits to EU countries on monitoring programmes for LBM and implementation of the "EU Hygiene Package". The MT, however, saw no evidence of specific training for the assessment of the application of HACCP procedures for FP put in place by Food Business Operators (FBOs) or evidence of training for private authorised veterinarians (PAVs) carrying out delegated official control tasks, except of a few PAVs which had been invited to participate in one HACCP course organised for the CA.

In view of these findings this recommendation is considered as only partially satisfactorily addressed.

5.2.2. Control by the CCA over the other levels

5.2.2.1. Recommendations from the DG (SANCO)/7586/2005 mission and assurances given by the CA

The CA should ensure that no conflict of interest exists when private veterinarians carry out official tasks.

"Plan of action of reorganisation of Veterinary Service is under proposal. It is foreseen to increase number of veterinarians and split responsibilities in two areas:

food safety and animal health & animal welfare. New reorganisation will strengthen the Veterinary Services and assure that requirements will be fully and correctly implemented. Role of county veterinary inspector will be to appoint authorised veterinary inspector to perform specific tasks and controls in certain establishment.

It is foreseen to be ended until the 2008. The new Veterinary Act is planned to be published by the end of 2006. "

5.2.2.2. Findings regarding the assurances given by the CA

According to Article 42 point (1) of the recently adopted Veterinary Act (official Gazette No. 41/07), the CCA may delegate specific tasks of official control of food of animal origin to veterinary organisations as control bodies, which according to

8

Repealed. Please refer to Article 6 of Regulation (EC) No 882/2004, in particular Annex II, Chapter I, Point 7.

point (2) of the Article (must be impartial and may not be in any form of conflict of interest in relation to the delegated tasks.

The MT found that private veterinary organisations, which employ PAVs, are paid by FBOs. PAVs issue health certificates for export of FP to the EU, which is the official document delivering the attestation that all controls pertaining to Community requirements are in place. Some PAVs were not aware of these requirements or of the implications of such attestation. Employees of the same private veterinary organisation carry out tasks for FBOs such as pest control and are controlled by the PAVs working in the same organisation. As a result of the above, a potential conflict of interest cannot be excluded. The issue of conflict of interest of PAVs is presently not included in the supervisory task of the CVI or CCA, despite the requirement of Article 42 point (4) of Veterinary Act.

In view of these findings this recommendation is considered as only partially satisfactorily addressed.

5.2.3. CA Human resources FP-PH and LBM-PH

Since the previous mission, the CA has recruited one veterinarian to the Veterinary Public Health Department of the CCA in particular responsible for the drafting of legislation and coordination of official controls on FP and LBM.

One other inspector in the Veterinary Inspection Department deals particularly with the inspection of FP establishments approved by the CA for export to the EU (EU export establishments).

Official control of FP exported to the EU is being performed by some of the 98 CVIs and 992 PAVs in 158 authorised veterinary organisations.

At the opening meeting the CA stated that since the adoption of the Veterinary Act, 30 new staff had been recruited for the enforcement of this legislation. The MT was informed that a total of 184 official veterinarians will be employed by the end of 2009 by the CA for enforcement of the Veterinary Act.

The MT found, that none of the CVIs deals specifically with official controls of FP and LBM. The number of CVIs currently employed is very limited, taking into account the broad field of their responsibilities, in particular all aspects of PH controls on food of animal origin, controls on animal health and welfare, market places, complaints etc. This was acknowledged by some of CVIs.

The MT found that the CVIs are motivated in their work.

5.3. Laboratories

FP-PH and LBM-PH

5.3.1. Recommendations from the DG (SANCO)/7586/2005 mission and assurances given by the CA

(1) The CA should ensure that laboratories performing official samples for products (FP, LBM) to be exported to the EU are accredited to ISO 17025 standard.

Furthermore, establishments intending to export FP to the EU must have access to laboratories that can carry out all the analyses required under Community legislation and using suitable methods (including histamine).

"All laboratories performing official samples for products to be exported to the EU

are currently working towards accreditation."

(2) The CA should ensure that laboratories in charge of official controls and monitoring for LBM carry out analyses in accordance with methods laid down in Council Directive 91/492/EEC and Commission Decision 2002/225/EC9.

"All the laboratories in charge of official controls and monitoring for LBM carry out analyses in accordance with the methods laid down in Regulations 2073/2005 and Regulation 2074/2005."

5.3.2. Findings regarding the assurances given by the CA (1) FP-PH

The MT visited the laboratory of the Veterinary Institute of Rijeka, which has been authorised, since 1996, by MoAFWM to perform basic organoleptical, microbiological, physico-chemical laboratory analyses of foodstuffs and other products of animal origin and potable water with the aim to assess food safety.

Currently, the laboratory carries out microbiological tests on FP and potable water.

The laboratory performs both official tests for the CA and private ones for FBOs.

The MT noted that a Quality Manual was approved on 21/09/2006. This has already been revised once on 6/09/2007. The laboratory was inspected by the Croatian Accreditation Agency (CAA) on 13/09/2007 accompanied by an external expert. The foreseen accreditation according to EN/ISO 17025 concerns microbiology laboratory for food and laboratory methods for Salmonella spp. and Escherichia coli (E. coli), MPN for LBM but not for FP and potable water.

The MT saw evidence of training for laboratory personnel. During the visit to the microbiology department some deficiencies were noted as follows:

• Presence of food samples (meat) without identification label in refrigerator used for the storage of samples received;

• No indication of the methods of laboratory analyses in the reports;

• Acceptable temperature of reception of samples is not indicated in the Standard Operating Procedure (SOP) for sample reception;

• Temperature at the reception of samples is not always recorded;

• Results of histamine testing are being issued by this laboratory despite the fact that these histamine tests have been carried out in the Public Health Laboratory in Rijeka. However, sampling for these tests was not done in accordance with Annex I, Chapter I, points 1.25 and 1.26 of Regulation (EC) No 2073/2005 as only one sample unit was taken instead of nine per batch.

The MT visited the Croatian Veterinary Institute laboratory (HRVI) in Zagreb which is the central laboratory of MoAFWM. This laboratory supervises and coordinates the activities of branch laboratories located in Krizevci, Rijeka, Split, Vinkovci and a poultry centre in Zagreb. All these laboratories are in the process of accreditation, which is coordinated by HRVI Zagreb and carried out by the CAA. The MT saw evidence of audits of activities of branch laboratories carried out by the HRVI Zagreb.

9

Repealed. Please refer to Commission Regulation (EC) No 2074/2005, Annex III.

The HRVIs perform laboratory tests on contaminants (Pb, Cd, Hg and As) and microbiology for FP. Both private and official tests are carried out.

A Quality Manual was initially approved on 21/09/2006 and has been amended once since then The MT was informed that a second amendment is in progress. A request for accreditation to CAA was made on 19/12/2006 and in September 2007 the laboratory was inspected by this body.

Parts of the HRVI's premises are currently under renovation. The food microbiology laboratory has already been renovated.

In view of these findings this recommendation is considered as partially satisfactorily addressed pending on the final granting of accreditation to ISO 17025 for the analyses carried out in the framework of FP production and completion of the upgrading works.

LBM-PH

Microbiology laboratories

Two laboratories are authorised to undertake microbiological analyses on LBM for official control purposes, The HRVIs of Rijeka and Split.

Both laboratories were visited by the MT. The MT was provided with the laboratories' quality documents and observed laboratory activities. Managerial and technical staff were on hand for consultation and provided the requested documentation and responded to all requests for information.

Both laboratories are in the process of becoming accredited according to EN/ISO 17025 for analyses for E. coli and Salmonella spp. in LBM. Accreditation inspection visits were carried out recently and the laboratories were in the process of clearing non-conformities. The accreditation body is the CAA, which the MT was told is a member of the European Accreditation Association.

At both laboratories, a programme of internal audit carried out by representatives of the HRVI Zagreb was in place, recent audit reports were scrutinised at both laboratories. Agreed correction plans with timescales were noted. The MT identified no significant non-conformities.

Both laboratories participate in specific proficiency tests for bivalve shellfish through participation in the joint UK Health Protection Agency/Community Reference Laboratory (CRL) Shellfish Scheme. Both laboratories had participated in five distributions of such tests in 2006/2007.

Both laboratories had achieved maximum scores (100%) for both enumeration of E.

coli and detection of Salmonella spp.

In addition, both laboratories had participated in the CRL whole animal (mussels) External Quality Assessment distribution carried out in September 2007 designed to examine aspects of the methodology covered by the standard shellfish scheme. i.e.

initial sample preparation and dilutions. The results of the distribution were not yet available for scrutiny.

A programme of formal staff training was in place at both laboratories involving mentoring and, in Rijeka, parallel analyses of LBM samples and external quality assessment distributions.

Technical managers from laboratories at Rijeka and Split had undergone training at

the CRL through attendance at the annual workshops in 2006 and 2007.

In both laboratories methods for the enumeration of E. coli and Salmonella spp are based upon the Community reference methods ISO TS 16649-3 and EN/ISO 6579, respectively.

Staff at all levels was technically knowledgeable and able to explain in detail aspects of the analyses when requested to do so. In both laboratories the facilities and equipment were appropriate for the analyses undertaken.

Phytoplankton / Biotoxins laboratory

One laboratory, the Institute for Oceanography and Fisheries in Split, is authorised to undertake phytoplankton/ biotoxins analyses on LBM for official control purposes.

The laboratory was visited by the MT.

The laboratory is in the process of becoming accredited according to EN/ISO 17025 for analyses for phytoplankton in seawater and biotoxins in LBM. To achieve accreditation, a designed quality system has been put in place, including the necessary documentation. The laboratory is presently waiting for the accreditation visit by the CAA.

Proficiency tests were recently carried out with the Italian NRL for Paralytic Shellfish Poisoning (PSP) and Amnesic Shellfish Poisoning (ASP) with good results.

A proficiency test with Quasimeme (proficiency scheme) for ASP is ongoing and results are awaited.

Diarrhetic Shellfish Poisoning (DSP) proficiency tests have not been done yet but the MT was informed that the laboratory will participate in testing organized by the CRL for biotoxins.

Phytoplankton analyses

The monitoring covers most of the relevant dinoflagellates of the Croatian coast and was considered as adequate.

Biotoxins analyses

Biotoxin analyses are performed following well designed protocols. Bioassay analyses are performed with mice provided by a facility in Zagreb. The animals undergo a quarantine period in Split. Animal weight range and numbers used are in accordance with the Community prescribed methods.

The lipophilic group bioassay analysis is appropriate and equivalent to the approved harmonized SOP provided by the CRL. The extracts for DSP and yessotoxin (YTX) are always performed in parallel, so that two different bioassays are performed with different observation periods (24 h for DSP and 6 h for YTX).

The PSP bioassay was considered adequate but performed with only two mice. This is due to the historic lack of presence of these toxins, and therefore the use of the minimum amount of mice is intended to minimise animal suffering. This method was calibrated according to certified reference solution.

The ASP analysis was considered adequate and carried out by the High Performance

Liquid Chromatography (HPLC) - UV International Association of Analytical

Communities (AOAC) method which is implemented according to the AOAC

standard and for that a calibration curve was used with certified material (shellfish

tissue). This method, although well performed, relies on daily calibration which is

done with non-certified domoic acid solution. Occasionally the equipment

calibration is made using the certified material (shellfish tissue).

In view of these findings this recommendation is considered as satisfactorily addressed subject to the final granting of accreditation to ISO 17025 for the analyses carried out in the framework of LBM production.

5.4. Official controls on FP-PH 5.4.1. Official control activities

5.4.1.1. Recommendations from the DG (SANCO)/7586/2005 mission and assurances given by the CA

(1) The CA should ensure that only establishments that fully comply with the requirements laid down in Annex to Council Directive 91/493/EEC are placed on the list of establishments approved for export to the EU, with an accurate description of the activities for which the establishment is approved.

"Verification of the compliance the above mentioned requirements in all establishments already listed in SANCO list will be performed until the end of the year 2007."

(2) The CA should ensure that deficiencies in establishments are properly addressed within a reasonable timeframe and that a proper follow-up is effectively ensured.

"As the Veterinary Act is planned to be amend this year the provision related to assessment of removal of shortcomings will be foreseen after within the reasonable timeframe."

(3) In the context of the export of FP to the EU, the CA should ensure that fishing vessels are controlled and in compliance with the requirements of Council Directive 92/48/EEC.

"Provisions for the official control of fishing vessels will be adopted in 2007 and the revision of the list of fishing vessels supplying fishery products to EU approved establishments will be carried out."

5.4.1.2. Findings regarding the assurances given by the CA

(1) The MT was informed by the CA that categorisation (using a new checklist) on compliance with Community requirements of all establishments (including EU export FP establishments) processing food of animal origin had been started in July 2007 according to the Decree of MoAFWM from 21 June 2007 and will continue until the end of 2007. The MT was provided with written results of the assessment results of 24 from a total of 72 EU export FP establishments. Twelve of the 24 establishments were assessed as category I (compliant). One of these establishments was visited by the MT which found that the assessment by the CA only covered cold storage activity and did not include other activities such as freezing and salting.

Furthermore, the facilities where these latter operations are normally carried out were under renovation. A further eleven of the 24 establishments had been assessed as category II (to be brought into compliance within six months). The final establishment had been assessed as category III (to be brought into compliance within three years).

In view of these findings this recommendation is considered as only partially satisfactorily addressed.

(2) The MT visited seven establishments processing FP (one of them was found to

have relocated but still appears on its original site in the EU export establishment list

submitted to the Commission by Croatia). The inspection reports produced by CVIs and the CCA detail various shortcomings identified in establishments. The MT was informed there is no written procedure for follow up of shortcomings identified in establishments. The MT noted that the timeframe set for the correction of shortcomings varied between immediate and 60 days for the elimination of structural shortcomings or the installation of necessary equipment such as sinks, thermographs or new work surfaces in premises. Follow-up was found acceptable in establishments visited other than in one premise where major non-conformities in relation to Community standards were found regarding the structures, equipment and hygiene of operations. This establishment had not recently been inspected by the CCA.

In view of these findings this recommendation is considered only as partially satisfactorily addressed.

(3) Fishing vessels are not currently centrally registered according to the Directorate of Fisheries of MoAFWM. A central database for vessels is expected to be ready by 1 January 2008. There are an estimated 3000 fishing vessels of between 4 and 40 meters in Croatia.

The CCA of Croatia explained that at present there is no official inspection of vessels supplying FP to EU export establishments as required by Annex III, Chapter I, point 1(b) of Regulation (EC) No 854/2004, however it is foreseen in 2008 due to the recent transposition of Regulations (EC) Nos 852/2004, 853/2004 and 854/2004.

In view of the above findings this recommendation is considered as not addressed.

5.4.2. New findings

5.4.2.1. Inspection of establishments

An annual inspection plan has been approved by the CCA, establishing quarterly frequency of visits to be done by the CVIs. This frequency of visits was found to be respected in the establishments visited. In general, the frequency of inspections was found to be increased if a deficiency is found. Standardised report forms are used and copies were provided in establishments visited.

The MT was informed that additionally establishments would be visited by the CCA at least once a year. However, no written instruction/plan was available on this issue.

Furthermore, some establishments were not visited by the CCA due to the large number of food premises and the resulting heavy workload of CCA inspectors.

On a local level establishments are routinely supervised by PAVs. No frequency has been set for such supervision, however it relates to registration of incoming and outgoing fish and FP, taking of samples for laboratory tests, issuing of export health certificates and certificates for consignments of fish and FP for internal trade. One PAV explained that he had recently started doing parasitological and organoleptic checks; however only very limited records of these checks were shown to the MT.

Official supervision of an establishment's production activities is not done.

5.4.2.2. Approval of establishments

All inspected establishments were approved by the CA for export to the EU and

approval documents were presented to the MT. However, some establishments

visited were approved for activities for which the necessary equipment/facilities

were not in place, i.e. salting of FP, and, freezing without having adequate freezing

equipment with sufficient capacity to lower the temperature rapidly so as to achieve

a core temperature of not more than -18°C.

The CCA issues EU export approval decisions using a standard form on the basis of an official letter submitted by a CVI. The EU export approval procedure was explained to the MT who was shown written evidence of the procedural steps taken by the CA for a recently approved EU export establishment; however no written approval procedure was found.

5.4.2.3. Monitoring of hygiene and temperature requirements

There was no written evidence found of control of temperature for the handling of FP neither at PAV nor CVI level. An exception was the veterinary transport document issued by PAV during offloading from boats to means of transport, where the temperature of offloaded FP is indicated showing variations between -4°C to +4°C and in two cases indicating +5°C. In one of these cases the fish was destined for a recently approved EU export establishment.

The MT noted evidence of swab tests done in some establishments visited. However no evidence of follow-up was found in one case with positive laboratory results from tests on hands of personnel. Cleanliness of facilities and equipment and staff hygiene were found to be generally acceptable, other than in one establishment visited.

However, no written evidence of controls of these items was found.

5.4.2.4. Organoleptic examinations and freshness indicators

In general, FP assessed by the MT in vessels and establishments visited was found to be of a good freshness quality.

The MT was told that organoleptic examinations are done by the FBOs in some establishments. This is done on the basis of general knowledge and experience and no written procedures or records on these controls were available.

PAVs in some establishments visited informed the MT that they perform organoleptic examinations in accordance with Articles 135-138 of Croatian SLUZBENI LIST SFRJ 68/89 which prescribes general freshness criteria for fresh and frozen FP. No records of these controls were available either.

No written evidence of laboratory examinations of freshness indicators of FP were found in establishments visited.

5.4.2.5. Histamine

The MT found a considerable amount of samples taken for histamine testing by PAVs at least every three months, and in one establishment visited every two weeks.

In some cases this is done with the participation of laboratory staff for histamine sensitive fish species, mainly anchovies and sardines.

However, in two establishments visited only one histamine sample was taken from each production batch (i.e. in one establishment the first single sample of anchovies was taken on 15.06.2007 and the last one on 20.08.2007 giving a total of 9 samples but each one from different production batches, which is not in accordance with point 1.25, Chapter I, Annex I to Commission Regulation (EC) No 2073/2005.

According to information provided a Thin Layer Chromatography (TLC) test is used

in two laboratories. However, no information was available on the validation of this

method against the HPLC method. Some results were shown to the MT of histamine

tests carried out using the HPLC method in the Institute of Public Health (Zagreb),

however the number of units to be tested (9) was not always respected.

5.4.2.6. Contaminants

The MT was informed that no laboratory tests for dioxins/Polycyclic Aromatic Hydrocarbons (PAHs) are carried out on either FP or LBM.

The MT found that tests for heavy metals (Pb, Cd, As and Hg) were performed on a regular basis usually at least four times a year as prescribed by Ordinance 152 of MoH of 26 September 2003. Results were normally below the maximum levels.

In one case of exceeded levels of Cadmium (0.38 mg/kg) in farmed sea bass the corrective actions were undertaken by the CA, however no samples of fish feed were taken and no evidence was shown to the MT that samples of fish were taken shortly after the positive results were reported.

5.4.2.7. FP microbiological tests

The MT found that microbiological analyses tests are performed on a regular basis usually at least four times a year as prescribed by Ordinance 152 of MoH including tests for aerobic mesophile bacteria, Enterococcus spp., Staphylococcus aureus, E.coli, Listeria monocytogenes etc.

5.4.2.8. Parasites

All establishments visited had adequate facilities for parasite inspection.

The MT was informed by some establishment visited by the FBOs that tests for parasites are done by designated FBO personnel. However, no written evidence of this was seen. In other establishments visited it is the PAVs who allegedly do these tests but again only limited written evidence of this was presented to the MT.

5.5. LBM

5.5.1. Recommendations from the DG (SANCO)/7586/2005 mission and assurances given by the CA

(1) Production areas for LBM should be classified in accordance with the requirements of Chapter I of Annex to Council Directive 91/492/EEC;

"Production areas for LBM will be classified in accordance with the requirements of regulation 854/2004 in amendments to Plan for monitoring of sea water and bivalve molluscs quality in the production and harvesting areas for 2007 (Official Gazette No. 49/07)."

(2) The registration document model should mention the production area health status as required by Chapter II of annex to Council Directive 91/492/EEC;

"The registration document model will mention the production area health status as required by 854/2004 in amendments to Plan for monitoring of sea water and bivalve molluscs quality in the production and harvesting areas for 2007 (Official Gazette No. 49/07)."

(3) In the context of a future export of LBM to the EU, the CA should only approve purification and/or dispatch centres that can be considered as meeting at least the requirements of Chapter IV of the Annex to Council Directive 91/492/EEC. In particular, the approval for purification centres should be subjected to the validation of the efficiency of the purification system, taking into account the results of microbiological analyses of LBM before and after purification;

"As part of a CARDS 2004 project on upgrading of establishments, an evaluation

process is currently taking place to categorise establishments according to whether they meet EU requirements, plan to upgrade or need to be closed."

(4) The CA should ensure that LBM intended for export to the EU are subject to all the checks foreseen in Chapter V of Annex to Council Directive 91/492/EEC;

"This will be included in the Ordinance transposing the EU ‘Hygiene Package’, which is due for publication in the Official Gazette during September 2007. Thus, the checks will be in line with EU rules."

(5) The CA should ensure that the monitoring plan for LBM is in compliance with the provisions of Chapter VI of Annex to Council Directive 91/492/EEC and evenly implemented throughout the country;

"Plan for monitoring of sea water and bivalve molluscs quality in the production and harvesting areas for 2007 is published 16

May 2007 (Official Gazette No.

49/07). It is based on provision of Regulation 854/2004 as well as on recommendation from CEFAS experts."

(6) The CA should ensure that when results of sampling plan of Chapter VI Annex to Council Directive 91/492/EEC for LBM show that the health standards are not met, the production area concerned is closed and harvesting of LBM is prevented.

"Complete procedure for sampling as well as reporting is described in Plan for monitoring of sea water and bivalve molluscs quality in the production and harvesting areas for 2007 (Official Gazette No. 49/07)."

5.5.2. Findings regarding the assurances given by the CA

(1) Production areas location, boundaries and sampling points for seawater and LBM have been established in the framework of the "Plan for monitoring of seawater and bivalve molluscs quality in the production, harvesting and relaying areas", referred hereafter as The Plan, which was published in May 2007.

The MT saw evidence of the implementation of The Plan, since June 2007, which included at least monthly results for microbiological contamination of LBM in production areas.

However, the classification has not yet been formally adopted.

This is due to the lack of adequate regular data (only four months) and due to the fact that prior to the implementation of The Plan, results were only available on a quarterly basis, not for all production areas and laboratory analyses were not carried out in accordance with the prescribed methods.

(2) In the case of a batch of LBM sent from a production area, the Registration Document did not contain a section in which to indicate the health status of the production area. On some occasions, the information pertaining to the destination of the batch was not recorded by the producer.

In the case of a batch of LBM sent from a purification centre, the Registration Document did not contain sections detailing information on the duration of purification and the dates on which the batch entered the purification centre.

(3) Purification/dispatch centres are awarded an approval document by the CA based

on national standards and legislation. This document includes a description of

activities which can include the harvesting, cleaning, washing, sorting, packaging,

storage and putting on the market of LBM. Additionally, purification activity is also

stated in the purification centres approval document.

Reports of visits carried out prior to approval were not available at establishments or at CVI level. The MT was shown some of these reports at central level during the closing meeting.

Despite being available, inspection visit reports did not specify deadlines for the correction of deficiencies found by the CA nor did they include some of the deficiencies found by the MT, e.g. concerning HACCP.

For one particular dispatch centre a recent categorisation check-list was available which was also intended to cover the Community requirements for such type of establishment.

Results of own-checks microbiology analyses on LBM (E. coli and Salmonella) were available at purification/dispatch centres level and also following the purification treatment.

(4) LBM are subject to the following checks:

– microbiology, monthly sampling frequency in the framework of The Plan (E.

coli), randomly as own-checks (E. coli and Salmonella);

– biotoxins, weekly, fortnightly or monthly sampling frequency in the framework of The Plan;

– chemical contaminants, in particular heavy metals.

Checks on PAHs contamination are not performed.

(5) Production areas are periodically monitored for:

– the microbiological quality of LBM;

– the presence of toxin-producing phytoplankton in production waters and biotoxins in LBM; and

– the presence of chemical contaminants in LBM.

Sampling plans for the above mentioned checks have been established within The Plan. Sampling frequencies are monthly for microbiological contamination (E. coli).

Phytoplankton monitoring is based on a weekly/fortnightly/monthly testing depending on the location of the production area and the period of the year.

Whenever toxin-producing phytoplankton population increases are found which could lead to toxin accumulation, the sampling frequency of molluscs is increased to every 48 to 72 hours.

For biotoxins, The Plan does not always provide for a weekly sampling frequency, which can be during some periods of the year (winter), monthly or fortnightly.

Furthermore, in some production areas, mainly in the south, sampling frequency is never weekly. Data used to support a risk study for the choice of a non-weekly sampling frequency was passed to the MT. This data was based on results (LBM biotoxins toxic episodes) of official monitoring carried out since the year 2000.

However, this earlier (pre The Plan) official monitoring did not include all presently identified production areas and was not carried out on a weekly basis. Data for ASP is only available since the beginning of 2005. Furthermore, analyses of the above mentioned data showed that LBM biotoxin toxic episodes occurred during the periods of the year when sampling is now set as monthly.

Checks for the presence of chemical contaminants were made for heavy metals (Hg,

Cd and Pb) in the framework of a residues control monitoring plan. The MT was informed that checks for these heavy metals would start in the framework of The Plan.

(6) When the results of sampling showed that the health standards for LBM are compromised, or that there may otherwise be a risk to human health, the CA closes the production area concerned, preventing the harvesting of LBM.

The production areas were closed for shellfish biotoxin toxic episodes. Shellfish were generally sent for purification when levels of microbiological contamination exceed those of A areas (230 E. coli/ 100 gr.).

Re-opening occurred after two consecutive results below the regulatory limit which were separated by at least 48 hours.

No formal written procedures/instructions for the communication of results from the laboratories to all relevant counterparts (CCA, CVIs, PAVs and FBOs) are in place.

Furthermore, procedures for the dissemination of decisions taken by CVIs in relation to actions to take at production areas level have not been established yet. The MT noted that on some occasions results were delivered to the CVIs between three weeks and one month after testing. On one of these occasions, results for microbiology exceeded the parameter established for A production areas.

5.6. Trade and health certification

5.6.1. Recommendations from the DG (SANCO)/7586/2005 mission and assurances given by the CA

(1) The CA should ensure that certifying officers have a satisfactory knowledge of the specific Community requirements for the export of live fish and FP, and are informed as to the rules to be followed for drawing up and issuing the certificates (Art. 3, 1 of Council Directive 96/93/EC). Where necessary, they should organise additional training and oblige AVs to attend it;

"A training workshop on procedures for certifying live fish and FP for export was carried out in December 2006. c.100 county and approved veterinary inspectors attended."

(2) The CA should ensure that the form used for the certificate for imports to the EU of live fish, their eggs and gametes and fishery products of aquaculture origin, is in compliance with the last amendment of Commission Decision 2003/858/EC (Commission Decision 2004/914/EC).

"The FVO was provided with a copy of Model health certificate for imports to the EU of FP intended for human consumption as part of the permission questionnaire on 12/09/2007"

5.6.2. Findings regarding the assurances given by the CA

(1) The MT was provided with evidence of training in the form of the presentation for CVIs and PAVs regarding "Provisions of EU export certification for FP regulated by rules on issuing of veterinary health certificates (134/05)", which was prepared on the basis of Council Directive 96/93/EC. The presentation included some information based on Commission Regulation (EC) No 1664/2006. However, the MT was not provided with the list of participants in this training.

(2) The MT was provided with a copy of the model health certificate for exports to

the EU of FP intended for human consumption as it is prescribed by Appendix IV to

Annex V to Regulation (EC) No 1664/2006. The proper form of health certificate was found during visits to the establishments. However, some PAVs issuing health certificates were not familiar with the provisions of the relevant Community legislation.

5.7. Visits carried out by the MT FP-PH

Establishments

Four of seven establishments pre-selected by the CCA for the mission were visited by the MT. A further three establishments were selected by the MT itself and added to the itinerary. Of the seven selected, two were found not to be fully in operation at the time of the MT visit but were only functioning as cold stores.

One EU export establishment intended for a visit was found to have moved to other facilities and to have changed its commercial name. No inspection of this operation was done by the MT.

The four establishments pre-selected by the CCA to be visited had previously been visited by the CVIs and CCA and major structural shortcomings were identified.

However, on the operational side, only limited deficiencies in hygiene of operation had been found by the CCA and CVIs in these establishments.

However, the three establishments chosen by the MT on the spot had not been visited by the CCA and presented major structural, maintenance and hygiene deficiencies. CVIs in their previous visits to these premises had only identified a limited number of structural deficiencies.

Of the six establishments actually inspected by the MT one establishment (recently approved by the CA) was found up to Community standards, two were found with easy to rectify shortcomings, two were well below Community requirements (one of them producing canned products) and one establishment could not be assessed as it was under partial reconstruction.

Deficiencies were noted in most of establishments such as the cold/ambient temperature of running water for washing of hands, temperature in storage rooms for frozen FP often above -18 °C (between -13 and -18 °C), automatic temperature recording devices missing in freezer stores in some establishments.

In one establishment (FP canning factory), the MT noted significant deficiencies in relation to floors, walls, ceilings and other surfaces of the production premises and operational hygiene. Some of these deficiencies had been reported by the CVI following the recent inspection.

HACCP plans approved by the CCA, were however not implemented in general by FBOs or assessed by CAs in establishments visited by the MT.

Landing sites

The MT was informed by the Directorate of Fisheries of MoAFWM during the initial meeting, that all ports (around 300 at present) can be considered as landing sites. According to the MoAFWM Regulation

No 136 of 18.12.2006 all landing sites should be officially designated by 1 January 2008, however this could be delayed due to the lack of established criteria for designation for such sites.

10

Pravilnik

The MT visited one landing site located in Rovinj where FP are landed, then loaded directly for transport to EU export establishments. The MT was informed that there are 10 to 30 fishing vessels landing with FP at this place.

Access to this landing site was not controlled. This landing site was in an acceptable condition of cleanliness.

The MT was informed that official controls during the landing of FP are carried out by PAVs, however written evidence of such controls is limited to veterinary transport control documents issued (indicating transport temperature of FP) during the loading of FP to means of transport. Adequate traceability of FP is ensured using this document.

Fishing vessels

The MT inspected five fishing vessels (sardines).

According to explanations given to the MT, the sardines are caught during the night and delivered to port the following morning where they are unloaded from the vessels directly to the means of transport for delivery to establishments.

Ice for vessels is either provided from an ice production facility or from a large fish processing plant both of which are located close to the landing site. The MT found four of the vessels in acceptable hygiene conditions (construction of vessel, storage of ice and fish). The fifth vessel visited was found to not to meet Community standards (plastic boxes with ice were dirty, some polystyrene boxes located in dirty hold on floor close to spare mechanical parts, boxes with engine oil; main store for polystyrene boxes was dirty; poor hygiene at the wash basin facilities near the toilet;

dirty towel for drying of hands stored with dirty clothes).

Fish farms

There are 62 farms registered by the CA for fish farming (five for tuna, 13 for carp, 16 for trout and 28 for sea bass and sea bream).

The MT visited one farm located in sea waters producing sea bream and sea bass.

Fish is produced in cages. Feed is sourced from an EU Member State and routinely tested for the relevant microbiological parameters. Harvested fish is caught by net and placed in plastic containers with ice and delivered to a coastal FP establishment for further processing. The MT found the conditions for handling of fish on this farm, prior to delivery to FP processing establishments, acceptable. The farm is routinely supervised by a PAV and regularly inspected by the CVI. The latest tests for antibacterial substances were carried out on 19.03.2007.

LBM establishments (purification/dispatch centres)

LBM are placed on the retail market via a dispatch centre. Applied identification marks are in accordance with Annex III, Section VII, Chapter VII of Regulation (EC) No 853/2004.

The MT visited two purification/dispatch centres. Four dispatch centres were also visited, three of which consisted of platforms with the fourth being a boat.

The purification/dispatch centres and dispatch centres can be considered as

generally meeting standards equivalent to those of the Community concerning their

structure, layout, equipment, maintenance and hygiene

Records were available covering the receipt and dispatch of LBM. The MT found some inconsistencies in these records such as missing information and absence of some records in the establishments.

Results of own-checks analyses on LBM microbiology (E. coli and Salmonella) were available at purification/dispatch centres level and also following the purification treatment.

Purification/dispatch centres had so-called "HACCP plan" which cannot be considered as being in line with HACCP principles. Furthermore, these plans were not being implemented. Dispatch centres did not have any HACCP plans.

5.8. Follow-up of RASFF notifications FP-PH

Written evidence of follow-up action was only available for one of the two RASFF notifications on levels of histamine. This follow-up involved analysis on the same production batch with a negative result, however, only one sample unit was tested using a semi-quantitative TLC method. The investigation carried out by the CA did not provide enough information on the origin of the problems. The CA was unaware of the RASFF notification on unsuitable transport conditions for chilled anchovies from Croatia reported on 24/09/2007

.

6. GENERAL C ONCLUSION

FP-PH

The MT found improvements in training of official inspectors at CCA and county level.

The MT noted the implementation of a quality system by the laboratories involved in official controls with a view to their accreditation according to ISO 17025 as well as the training of laboratory personnel and the follow-up of shortcomings identified in establishments.

However, some major deficiencies remain as follows:

– no safeguard against possible conflict of interest when PAVs carry out official tasks;

– lack of awareness of Community standards among PAVs;

– absence of documented official controls on vessels and landing of FP;

– absence/poor records of official controls concerning organoleptic examinations, temperatures for fresh and frozen FP;

– histamine testing is not done in accordance with Community requirements in establishments visited;

– some EU export establishments not meeting Community standards;

– absence/poor implementation and assessment of HACCP principles in establishments.

As a consequence, official controls do not deliver guarantees at least equivalent to those provided for under Community requirements.

11

FVO was provided with some additional information on investigation regarding RASFF notifications on

23.11.2007.

LBM-PH

Despite major improvements which were seen by the MT in relation to the performance of all laboratories involved in the monitoring of LBM production areas, some deficiencies still remain:

– due to the lack of regular results on microbiology contamination in production areas, no classification of these areas exists;

– for biotoxins, current available data does not support the less than weekly frequency of sampling;

– no formal written procedures/instructions for the communication of results from the laboratories to all relevant stakeholders (CCA, CVIs, approved veterinarians and FBOs). No formal instructions are available either, for decisions taken by CVIs for actions to be taken in production areas;

– some deficiencies were seen at the level of the Registration Document, notably concerning the health status of the production areas;

– standards in purification and dispatch centres cannot be considered yet as being fully equivalent to those of the Community as HACCP based procedures are not used.

7. C LOSING MEETING

During the final meeting held in Zagreb, on 17 October 2007, the MT presented the findings and preliminary conclusions of the mission to the CCA.

The CCA acknowledged the deficiencies pointed out by the MT and provided oral and written guarantees on the actions to be taken to tackle the remaining deficiencies to comply with Community requirements. In particular the CA presented written evidence on the ban for export to the EU for establishments visited which presented major shortcomings as well as the deletion of some activities such as filleting and packing for one establishment. The CCA explained that shortcomings identified are related to the shortage of official control staff and informed the MT of their plans to recruit additional new staff.

8. R ECOMMENDATIONS TO THE CA OF C ROATIA

The CA should provide Commission services with

a) an action plan, including a timetable for its completion, within one month of receipt of the report, in order to address the following recommendations concerning FP for export to the EU;

b) a six-monthly report (starting from the date of receipt of the report), which should include the progress with, and the results of, the above mentioned action plan, until all deficiencies have been corrected.

Should the Croatian authorities wish to export LBM to the EU, they should submit, at their convenience, a comprehensive action plan to address the recommendations set out below in relation to LBM.

8.1. Legislation

8.1.1. The Croatian legislation on PH control of FP intended for export to the EU should be reviewed in order to include provisions at least equivalent to those required in Regulations (EC) No 2406/96 and No 1881/2006.

8.1.2. The CA should provide a copy of the new Croatian legislation, "Ordinance

transposing the EU hygiene package" as published in the Official Gazette on

8 October 2007.

8.2. Competent Authority

8.2.1. PAVs performing official control tasks in FP establishments should be aware of Community standards for export to the EU, in particular those specified in the health certificate for import of FP to the EU in accordance with Appendix IV to Annex VI to Regulation (EC) No 2074/2005.

8.2.2. The CA should ensure that no conflict of interest exists when PAVs carry out official tasks to achieve equivalence with point 2 (b) of Article 4 of Regulation (EC) No 882/2004.

8.3. Laboratories

8.3.1. The CA should ensure that any laboratories, performing analyses for official controls of FP and LBM are assessed and accredited in accordance with standards providing guarantees at least equivalent to the requirements of Article 12 of Regulation (EC) No 882/2004, taking into consideration Article 18 of Regulation (EC) No 2076/2005.

8.3.2. Histamine testing should be carried out in accordance with the requirements of points 1.25 and 1.26, Chapter I, Annex I of Regulation (EC) No 2073/2005.

8.4. Official supervision of FP

8.4.1. The CA should ensure that only establishments that equivalent with the requirements laid down in Annex II of Regulation (EC) No 852/2004 and Section VIII of Annex III of Regulation (EC) No 853/2004 are placed on the list of EU export establishments.

8.4.2. In the context of the export of FP to the EU, the CA should ensure that fishing vessels are controlled in line with the requirements of Part A, Annex I of Regulation (EC) No 852/2004 and Chapter I of Section VIII of Annex III of Regulation (EC) No 853/2004.

8.4.3. In the context of the export of FP to the EU, the CA should establish a list of approved landing sites and ensure that landing of FP are controlled in line with the requirements of Part A, Annex I of Regulation (EC) No 852/2004 and Chapter II of Section VIII of Annex III of Regulation (EC) No 853/2004.

8.4.4. The CA should carry out official controls on the FP production chain including, at a minimum, the elements required by Annex III Chapter I and II to Regulation (EC) No 854/2004 with records available.

8.4.5. Particular attention should be paid to the implementation and assessment of the HACCP system and to the understanding of the HACCP principles by CA officials (Regulation (EC) No 854/2004, Article 4).

8.5. LBM

8.5.1. The CA should classify the production areas for LBM in accordance with Annex II, Chapter II, Part A of Regulation (EC) No 854/2004.

8.5.2. The CA should ensure that the Registration Document accompanying LBM

sent from a production area or a purification centre contains is completed,

with the information described in Annex III, Section VII, Chapter I, Part 4

and 5 of Regulation (EC) No 853/2004.

8.5.3. CA enforcement should be strengthened following inspection visits to LBM establishments (purification/dispatch centres) in order to ensure that irregularities are fully corrected within an agreed deadline and that a proper and timely CA follow-up is done as required by Article 12.2 of Regulation (EC) No 854/2004.

8.5.4. In addition, when approving and inspecting LBM establishments, the CA should include an evaluation of the implementation of HACCP based procedures, in accordance with Article 4 (3)(a) of Regulation (EC) No 854/2004.

8.5.5. The CA should ensure that analyses for PAH (Benzo(a)pyrene) are carried out in line with the requirements of Commission Regulation (EC) No 1881/2006 and Commission Regulation (EC) No 333/2007.

8.5.6. The CA should ensure that the sampling frequency for biotoxins analyses in LBM is weekly during the periods at which harvesting is allowed in accordance with the requirements of Annex II, Chapter II, Part B, paragraph 5 of Regulation (EC) No 854/2004. The CA should only reduce the sampling frequency if a risk assessment on toxins and phytoplankton occurrence (historical/seasonal data by production area and LBM species) suggests a very low risk of toxic episodes.

8.5.7. The CA should formalise the written procedures/instructions for the communication of results from the laboratories to all relevant counterparts (CCA, CVIs, approved veterinarians and FBOs) and of decisions taken by CVIs in relation to actions to take at production area level in accordance with Annex II, Chapter II, Part E of Regulation (EC) No 854/2004.

8.6. Visits carried out by the MT

The CA should ensure that shortcomings observed during the visits to fishing vessels, landing sites and FP and LBM establishments, are corrected to meet standards equivalent to Community requirements, in particular those of Regulation (EC) No 852/2004 and Annex III of Regulation (EC) No 853/2004, in its Section VII, Chapter I, Part 4 and 5 for LBM and Section VIII, Chapter V for FP.

9. C OMPETENT A UTHORITY ' S RESPONSE TO THE RECOMMENDATIONS

Competent Authority's response to the recommendations can be found at:

http://ec.europa.eu/food/fvo/ap/ap_croatia_7355_2007.pdf

ANNEX 1. Abbreviations and special terms used in the report

AOAC The International Association of Analytical Communities ASP Amnesic Shellfish Poisoning

CA Competent Authority CCA Central Competent Authority Community European Community

CRL Community Reference Laboratory CVI/s County Veterinary Inspector/s

DSP Diarrhetic Shellfish Poisoning EC European Community EU European Union

EU export establishment Establishments approved by the CA for export to the EU FBO/s Food Business Operator/s

FP Fishery Products

HACCP Hazard Analyses Critical Control Point HPLC High-performance liquid chromatography

HR Croatia/n

HRVI Croatian Veterinary Institute

ISO International Organisation for Standardisation LBM Live Bivalve Molluscs

MoAFWM Ministry of Agriculture, Forestry and Water Management MoH Ministry of Health

MPN Most Probable Number MT Mission Team

NRL National Reference Laboratory PAH/s Polycyclic Aromatic Hydrocarbons

PAVs Private Authorised Veterinarians PFVOM Previous FVO Mission

PFVOMR Previous FVO Mission Report PH Public Health

ppm parts per million

PSP Paralytic Shellfish Poisoning RASFF Rapid alert system for food and feed

SANCO Consumer’s Health Protection Directorate General SOP/s Standard Operating Procedure/s

TLC Thin Layer Chromatography TMA-N Trimethylamine Nitrogen

TVB-N Total Volatile Basic Nitrogen

YTX/s Yessotoxin/s