EUROPEAN COMMISSION

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

DG (SANCO)/2007 7308 MR Final

FINAL REPORT OF A MISSION CARRIED OUT IN AZERBAIJAN FROM 10 TO 17 SEPTEMBER 2007 IN ORDER TO EVALUATE THE CONTROL SYSTEMS IN PLACE GOVERNING THE PRODUCTION OF FISHERY PRODUCTS INTENDED FOR EXPORT TO CERTAIN MEMBER STATES OF THE EUROPEAN UNION

21/12/07 - 20817

TABLE OF CONTENTS 1. 2. INTRODUCTION....................................................................................................... 3 BACKGROUND TO THE MISSION ........................................................................ 3 2.1. Historical background ....................................................................................... 3 2.2. Production and trade information...................................................................... 3 2.3. The Rapid Alert System for Food and Feed notifications................................. 3 3. 4. MISSION OBJECTIVES ............................................................................................ 3 MAIN FINDINGS....................................................................................................... 4 4.1. Legislation ......................................................................................................... 4 4.2. Competent authority performance ..................................................................... 4 4.3. Official controls................................................................................................. 5 4.4. Laboratories....................................................................................................... 6 4.5. Visits carried out by the MT.............................................................................. 7 5. 6. 7. GENERAL CONCLUSION........................................................................................ 8 CLOSING MEETING................................................................................................. 8 RECOMMENDATIONS TO THE CA OF AZERBAIJAN ....................................... 9 7.1. Legislation ......................................................................................................... 9 7.2. Knowledge of Community requirements .......................................................... 9 7.3. Official controls................................................................................................. 9 7.4. Laboratories..................................................................................................... 10 7.5. Visits carried by the MT.................................................................................. 10 8. COMPETENT AUTHORITY RESPONSE TO RECOMMENDATIONS.............. 10

ANNEX ............................................................................................................................. 11

1.

INTRODUCTION1 The mission took place in Azerbaijan from 10 to 17 September 2007 and was undertaken as part of the Food and Veterinary Office's (FVO) planned mission programme. The mission team (MT) comprised two inspectors from the FVO.

2.

BACKGROUND TO THE MISSION2 2.1. Historical background Azerbaijan is presently listed in Annex II of Commission Regulation (EC) No 1666/2006, establishing the list of third countries and territories from which imports of fishery products (FP) may be permitted (former list II countries). Imports from Azerbaijan are currently only authorized for caviar. This means that FP exports from Azerbaijan are not yet totally harmonised. Consequently Competent Authorities (CAs) of Member States importing FP from Azerbaijan have to get assurances from the Azerbaijan CA that the requirements of the health certificate laid down in Commission Decision 95/328/EC are met. At the time of the mission, according to the information provided by the CA, no establishment is currently authorised to export FP from Azerbaijan. The last mission to Azerbaijan on FP was carried out in November 2002 (DG SANCO/8733/2002). 2.2. Production and trade information In 2006, about 500 kg of caviar (EUROSTAT data) were exported from Azerbaijan to France. 2.3. The Rapid Alert System for Food and Feed notifications No Rapid Alert System for Food and Feed (RASFF) notifications were produced in relation to FP imported from Azerbaijan.

3.

MISSION OBJECTIVES3 The objective of the current mission was to evaluate whether the official controls put in place by the CA to export FP, produced in Azerbaijan and destined to certain Member States (MS) of the EU, provide guarantees that can be considered as at least equivalent to the requirements laid down in Commission Decision 95/328/EC. In pursuit of this objective, the MT proceeded as follows: - an opening meeting was held on 10 September with the CA, the State Office on Control of Consumer Market (SOCCM) from the Ministry of Economic Development (MED). At this meeting the inspection team confirmed the objective of and itinerary for the mission, and requested additional information required for the satisfactory completion of the mission;

1 2 3

List of abbreviations and special terms is drawn up in Part 1 of the Annex to this report. 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. The legal basis for the mission is mentioned in part 3 of the Annex to this report.
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- the following sites were visited:

COMPETENT AUTHORITY VISITS 1 CA LABORATORY VISITS FP, potable water 2 PRIMARY PRODUCTION Landing sites 1 FOOD PROCESSING FACILITIES Traditional fishing vessels 4 Storage facilities 1 Establishments 1 SOCCM within MED Private laboratories performing official analyses Fresh FP preserved on ice; live sturgeon Fresh FP preserved on ice Fresh FP preserved on ice processing FP, including caviar

- representatives from the CA accompanied the MT during the whole mission. 4. MAIN FINDINGS4 4.1. Legislation The Decree of the President of Azerbaijan Republic N 218, dated 1 April 2005, appointed the SOCCM within the MED as the CA responsible for the controls of FP, produced in Azerbaijan and destined to MS. This Decree gives the power to the CA to implement and enforce Community requirements. The Decision of Cabinet of Ministries N 135, of 13 July 2005 and the legislative Act N 644, of 26 December 2006, provide the main provisions for the certification and the control of FP intended for export to certain MS of the EU, including check-lists for the inspection of fishing vessels, landing sites and establishments, organoleptic criteria for FP and microbiological/ chemical parameters for FP and water. However, the MT noted that the standards for the quality of water intended for human consumption were not based on the requirements of Council Directive 98/83/EC. 4.2. Competent authority performance Compared to the last FVO mission in 2002, where many authorities were involved in FP controls with different aims, procedures and methods, there is now a sole CA, which is the SOCCM within the MED. As described previously, the CA was appointed by Presidential Decree on 1 April 2005. However, the CA started officially control activities in May 2007 following the publication of legislative Act N 644, which was approved by the Ministry of Justice on 12 January 2007. Currently 18 officials, including two veterinarians, four engineers, seven laboratory staff and five administrative staff are involved in the official control of the production chain of FP intended for export to certain MS.

Missions findings are based on Regulations (EC) N 852/2004 (especially its Annex II), 853/2004 (especially its Annex III, section VIII), 854/2004 (especially its Annex III) and 882/2004, and other Community texts.
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CA officials received training on: Hazard Analyses Critical Control Points (HACCP); Community legislation; some officials participated in the workshop on Community fishery and aquaculture standards, which took place in the United Arab Emirates in May 2007; Other trainings on food hygiene and technology. The MT found that the knowledge of Community requirements of the officials in charge of the controls was adequate from a general point of view, but needed to be improved in some areas (HACCP, health standards for FP and potable water, temperatures of preservation of fresh or frozen FP, etc). 4.3. Official controls 4.3.1. 4.3.1.1. General monitoring on production conditions Registration and approval procedures

Fishing vessels are currently registered and a list was available. Written procedures to approve establishments have been established. Approval files for the establishments which intend to export FP to certain MS were available. Currently, no establishment has been officially approved to export FP due to the recent start of control activities by the CA. One establishment processing FP and producing caviar is in the process of approval. HACCP plans of the above two mentioned establishment have been fully evaluated by the CA. However, deficiencies in the HACCP plans were noted, such as: HACCP manual not dated; HACCP plans not reflecting the reality of operations carried out. No description of controls at reception of FP such as organoleptic checks and temperature controls; limits of temperature for fresh (8C to 10 C) and frozen (- 2C to - 8 C) FP during processing and storage not in accordance with Community requirements. 4.3.1.2. Inspection at regular intervals of fishing vessels, landing sites and establishments

According to the information provided by the CA, fishing vessels, landing sites and establishments should be inspected every month, using check-lists. Due to the recent start of control activities, very few inspection reports have been issued. No follow-up of these reports was available. 4.3.2. Health Standards for FP

Very limited official analyses on FP have been carried out by the CA.

The MT noted that: official analyses on caviar, in particular testing for boric acid, have never been carried out despite the fact that Azerbaijan is only authorised to export caviar; only the results of three recent random tests for environmental contaminants and microbiology were available. The tests for heavy metals were not assessed according to Community requirements. Furthermore, one analysis showed a level of lead exceeding the maximum level set in Commission Regulation 1881/2006 and no corrective action was taken; testing for freshness indicators (TVB-N and TMA-N) and histamine was not performed. 4.3.3. Health Standards for potable water

The MT noted that two microbiological analyses and three chemical analyses on water were available; these tests were not carried out in accordance with requirements of Council Directive 98/83/EC. 4.3.4. Official certification

The model of health certificate adopted by the CA is the appropriate one, in accordance with Commission Decision 95/328/EC. No health certificate has been issued by the CA since its recent appointment in March 2007. 4.4. Laboratories Two private laboratories performing official analyses for the CA were visited by the MT. Both laboratories have been approved by the CA to carry out official analyses on FP intended for export to certain MS and on water. These laboratories do not carry out own-checks analyses for Food Business Operators (FBOs). 4.4.1. Laboratory A

The laboratory was founded in 2004 and presented good premises and was well equipped. Staff appeared well trained and qualified but was not always aware of or following Community requirements. The laboratory performs microbiological analyses on FP, including Listeria on ready to eat products, and water. However, analyses on potable water are not carried out following the requirements of Directive 98/83/EC. Chemical analyses are performed only on heavy metals but not carried out following requirements of Commission Regulation 1881/2006 and Commission Regulation 333/2007. Furthermore, no testing for freshness indicators (TVB-N and TMA-N), histamine and boric acid was carried out. The laboratory is not accredited according to ISO 17025 standards. The laboratory applied recently for accreditation with Turkish Accreditation Agency (TRKAK) for some microbiological analyses (Total Plate Count, E. coli, Staphylococcus aureus and Salmonella) and heavy metals chrome (Hg), cadmium (Cd), lead (Pb) on FP. No accreditation is foreseen for water analyses.
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The laboratory has a quality management manual in place but no Standard Operation Procedures (SOPs) have been established. No proficiency tests on microbiological and chemical analyses have been carried out. Testing for heavy metals is carried out for Cd, Pb and Hg using Inducted Coupled Plasma (ICP) and not Atomic Absorption Spectrometry (AAS). The MT noted that results of analyses showed always a complete absence of Hg and high levels of contamination by Pb. 4.4.2. Laboratory B

The laboratory presented good premises and was well equipped. Staff appeared well trained and qualified. The laboratory performs microbiological analyses on FP, excluding Listeria, and potable water, excluding Enterococci. The MT noted that only one official chemical analyse on potable water, with very few chemical parameters, was available. Furthermore, this analyse was not performed according to Community requirements (Directive 98/83/EC). No analyses were available for FP. The laboratory is not accredited according to ISO 17025 standards; it recently applied for accreditation with TRKAK. The Laboratory has a quality management manual in place and SOPs have been established. Proficiency tests on microbiological and chemical analyses have been carried out with acceptable results. 4.5. Visits carried out by the MT 4.5.1. Fishing vessels and landing sites The MT visited one landing site for unloading of live sturgeon intended for caviar production and fresh FP preserved on ice. Fishing vessels are small traditional wooden boats. The fishing period is less than 24 hours and takes place normally during the night. The MT was present at one unloading of FP and noted that: FP were kept on ice inside plastic crates which were protected from the environment with a plastic cover; temperatures of FP were between 0 and 1 C. Ice was provided by the establishment and is transported on board using closed polystyrene boxes; unloading was quickly carried out and FP were transported in an appropriate truck to a nearby chilling facilities belonging to the establishment; these facilities were found to be in compliance with Community requirements, including the temperatures of storage of fresh FP. 4.5.2. Establishments

The MT visited one processing establishment, which can be considered in general in compliance with Community requirements regarding structure, layout and hygiene of operation.
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However, the MT noted the following deficiencies: doors to the exterior not pest proof; temperature of fresh FP during processing up to 10C; absence of recording device for registration of cold stores temperatures. With regards to own-checks, the MT noted the following: HACCP plans presented some deficiencies (see point 4.3.1.1.); organoleptic examinations are mainly carried out at reception of FP in the establishment; microbiological and chemical analyses of FP and water are carried out either in the establishment's laboratory or in the Veterinary Services laboratory. These analyses are carried out according to national standards but not according to Community requirements; pest control programme, health certificates for staff were available. 5. GENERAL CONCLUSION Some recommendations described in the previous mission report (DG SANCO/8733/2002) have been satisfactorily addressed: the SOCCM within the MED has been appointed as CA by presidential Decree. This Decree gives the power to the CA to implement and enforce Community requirements; a legal basis lays down the main provisions for the certification and the control of FP intended for export to certain MS. However, due to the fact that the structure and organisation of the new CA was only recently put in place (March 2007), the official controls in the framework of the export of FP to certain member states of the EU only started recently. Therefore, the official controls put in place by CA cannot be considered yet as fully equivalent to Community requirements. Therefore, the CA is currently not in a position to fully verify and certify the conditions prescribed by the export Health certificate attached to Commission Decision 95/328/EC. However, the fishing vessels and the landing site visited were found to be compliant with Community requirements. In addition, despite that HACCP plans presented some deficiencies and own-check analyses on FP and water were not carried out following Community requirements, the two establishments visited were found to have in general good structure, layout, maintenance and hygiene of operation. Consequently, and due to the kind of FP produced in these establishments, immediate and serious risks for consumer health are unlikely to occur. 6. CLOSING MEETING During the final meeting held in Baku, on 17 September 2007, the MT presented the findings and preliminary conclusions of the mission to the CA. During this meeting the CA acknowledged the deficiencies pointed out by the MT and provided oral guarantees on the actions planned to tackle the deficiencies in order to fully comply with Community requirements.

7.

RECOMMENDATIONS TO THE CA OF AZERBAIJAN The CA should provide Commission services with an action plan, including a timetable for its completion, within one month of receipt of the report, in order to address the following recommendations for FP exported to MS: 7.1. Legislation The CA should ensure that Community standards on quality of water intended for human consumption (Council Directive 98/83/EC) or requirements at least equivalent to those standards are applicable. 7.2. Knowledge of Community requirements The CA should ensure that the training of all staff performing official controls in relation to Community FP export requirements is further enhanced in order to ensure adequate knowledge, in line with standards at least equivalent to all the requirements of Annex II, Chapter I to Regulation (EC) N 882/2004 of the European Parliament and of the Council. 7.3. Official controls 7.3.1. General monitoring on production conditions HACCP plans should reflect the Community requirements for fresh and frozen FP cold chain/storage in accordance with Annex III, Section VIII, and Chapter VII to Regulation (EC) No 853/2004 of the European Parliament and of the Council. 7.3.2. (1) Caviar The CA should implement official analyses on caviar including Listeria (Regulation (EC) N 2073/2005), boric acid (Directive 95/2/EC) and environmental contaminants (Regulation (EC) No 1881/2006 and Regulation (EC) No 333/2007). (2) Freshness indicators The CA should ensure that chemical checks (TVB-N and TMA-N) are done on FP intended for export to MS in line with the requirements of Regulation (EC) No 2074/2005. (3) Histamine The CA should ensure that analyses for histamine are randomly carried out in establishments/cold stores in line with Annex III, Chapter II, and Point C of Regulation (EC) No 854/2004 to verify compliance with the requirements of Regulation (EC) No 2073/2005. (4) Environmental contaminants The CA should ensure that monitoring arrangements are set up to control the levels of contaminants in line with Annex III, Chapter II and Point D to Regulation (EC) No 854/2004. In particular, in line with the requirements of Regulation (EC) No 1881/2006 and Regulation (EC) No 333/2007, the CA should ensure that analyses are carried out for: Health Standards for FP

- heavy metals; - PAH (benzo(a)pyrene); and, in line with the requirements of Regulation (EC) No 1881/2006 and Regulation (EC) No 1883/2006, for: - dioxins and PCBs. 7.3.3. Health Standards for water

The CA should ensure that microbiological and chemical analyses of potable water/ice are carried out in line with the requirements of Directive 98/83/EC. 7.4. Laboratories The CA should ensure that laboratories performing official analyses 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 of the European Parliament and of the Council, taking into consideration the requirements of Article 18 of Regulation (EC) No 2076/2005. The CA should also ensure that these laboratories take into account criteria for the different testing methods laid down in Community legislation, in particular those laid down in Regulation (EC) No 2073/2005, Regulation (EC) No 333/2007, Regulation (EC) No 1883/2006 and Directive 98/83/EC. 7.5. Visits carried by the MT The CA should ensure that the shortcomings observed in the establishment visited, as described in chapter 4.5.2 are corrected to meet the Community requirements laid down in Regulation (EC) No 852/2004 and Annex III, Section VIII to Regulation (EC) No 853/2004. 8. COMPETENT AUTHORITY RESPONSE TO RECOMMENDATIONS The Competent Authority's response to the recommendations can be found at: http://ec.europa.eu/food/fvo/ap/ap_azerbaijan_7308_2007.pdf

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ANNEX 1. Abbreviations and special terms

AAS CA/s Cd DG EC EU FBO(s) FP FVO HACCP HG HPLC ICP ISO MED MR MS MT PAH Pb PCBs RASFF SANCO SOCCM SOPs TVB-N TMA-N TRKAK Atomic Absorption Spectrometry Competent Authority/ies Cadmium Directorate General European Community European Union Food Business Operator(s) Fishery Products Food and Veterinary Office Hazard Analyses Critical Control Point Chrome High Performance Liquid Chromatography Inducted Coupled Plasma International Organisation for Standardisation Ministry of Economic Development Mission Report Member State of the EU Mission Team Polycyclic Aromatic Hydrocarbons Lead Polychlorinated Biphenyls Rapid Alert System for Food and Feed Health and Consumers Protection Directorate General State Office on Control of Consumer Market Standard Operation Procedures Total Volatile Basic Nitrogen Trimethylamine Nitrogen Turkish Accreditation Agency

2.

Community Acts quoted in the report

Official Journal
L 191, 12.8.1995, p. 32

European legislation5
Commission Decision 95/328/EC Commission Decision 98/140/EC

Title
Commission Decision 95/328/EC of 25 July 1995 establishing health certification for fishery products from third countries which are not yet covered by a specific decision. 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.

L 38, 12.2.1998, p. 14

Community legislation (Internet): http://europa.eu.int/eur-lex/en/search/search_lif.html

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Commission Decision 2007/240/EC

L 104, 21.4.2007, p. 37

Council Directive 98/83/EC Directive 95/2/EC Regulation (EC) No 852/2004 of the European Parliament and of the Council Regulation (EC) No 853/2004 of the European Parliament and of the Council Regulation (EC) No 854/2004 of the European Parliament and of the Council Regulation (EC) No 882/2004 of the European Parliament and of the Council Council Regulation (EC) No 2406/96 Commission Regulation (EC) No 2073/2005 Commission Regulation (EC) No 2076/2005

L 330, 5.12.1998, p.32 L 61, 18. 3. 1995, p.1 L 139, 30.4.2004, p. 1 Corrigendum OJ L 226 , 25.06.2004, p. 3 L 139, 30.4.2004, p. 55 Corrigendum OJ L 226 , 25.06.2004, p. 22 L 139, 30.4.2004, p. 206 Corrigendum OJ L 226 , 25.06.2004, p. 83 L 165, 30.4.2004, p. 1 Corrigendum OJ L 191, 28.5.2004, p. 1 L 334, 23.12.1996, p.1 L 338, 22.12.2005, p. 1 L 338, 22.12.2005, p. 83

Commission Decision 2007/240/EC of 16 April 2007 laying down new veterinary certificates for importing live animals, semen, embryos, ova and products of animal origin into the Community pursuant to Decisions 79/542/EEC, 92/260/EEC, 93/195/EEC, 93/196/EEC, 93/197/EEC, 95/328/EC, 96/333/EC, 96/539/EC, 96/540/EC, 2000/572/EC, 2000/585/EC, 2000/666/EC, 2002/613/EC, 2003/56/EC, 2003/779/EC, 2003/804/EC, 2003/858/EC, 2003/863/EC, 2003/881/EC, 2004/407/EC, 2004/438/EC, 2004/595/EC, 2004/639/EC and 2006/168/EC. Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption. European Parliament and Council Directive No 95/2/EC of 20 February 1995 on food additives other than colours and sweeteners Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs.

Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin.

Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption. Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules. Council Regulation (EC) No 2406/96 of 26 November 1996 laying down common marketing standards for certain fishery products. Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs. Commission Regulation (EC) No 2076/2005 of 5 December 2005 laying down transitional arrangements for the implementation of Regulations (EC) No 853/2004, (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council and amending Regulations (EC) No 853/2004 and (EC) No 854/2004. Commission Regulation (EC) No 1666/2006 of 6 November 2006 amending Regulation (EC) No 2076/2005 laying down transitional arrangements for the implementation of Regulations (EC) No 853/2004, (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council. Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs. Commission Regulation (EC) No 1883/2006 of 19 December 2006 laying down methods of sampling and analysis for the official control of levels of dioxins and dioxin-like PCBs in certain foodstuffs. Commission Regulation (EC) No 333/2007 of 28 March 2007 laying down the methods of sampling and analysis for the official control of the levels of lead, cadmium, mercury, inorganic tin, 3-MCPD and benzo(a)pyrene in foodstuffs.

Commission Regulation (EC) No 1666/2006

L 320, 18.11.2006, p. 47

Commission Regulation (EC) No 1881/2006 Commission Regulation (EC) No 1883/2006 Commission Regulation (EC) No 333/2007

L 364, 20.12.2006, p. 5 L 364, 20.12.2006, p. 32

L 88, 29.3.2007, p. 29

3.

Legal basis for the mission The mission was carried out in agreement with the Azerbaijan Authorities and under the general provisions of Community legislation and, in particular: Article 46 of Regulation (EC) No 882/2004 Commission Decision 98/140/EC.

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