Subject: Mission reference number: DG (SANCO)/

Transcription

1 REPUBLIKA E SHQIPËRISË MINISTRIA E BUJQËSISË,USHQIMIT DHE MBROJTJES SË KONSUMATORIT DREJTORIA E PERGJITHSHME E SIGURISE USHQIMORE E MBROJTJES SE KONSUMATORIT DREJTORIA E SHENDETIT TE KAFSHEVE E MBROJTJES SE BIMEVE Adresa: Sheshi Skenderbej, Nr. 2, Tirane Tel/Fax: Nr Prot. Tirana, Subject: Mission reference number: DG (SANCO)/ To: Dr. Colm GAYNOR DIRECTOR EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE GENERAL DIRECTORATE F-FOOD AND VETERINARY OFFICE GRANGE, DUNSANY, Co. Meath IRELAND Fax: Sanco-fvo-inspections@cec.eu.int Referring to draft report recommendations of the Mission, carried out in Albania from 04 To 08 June 2007, concerning the evaluation of the control systems in place governing the production of fishery products and live bivalve molluscs intended for exports to the European Union, the Albanian Competent Authority send to this mission the administrative measures and action undertaken in order to accomplish all given recommendations of EU-mission. Below we have explained all administrative measures, action plan and adoptions of Albanian legislations regarding as well completing of other duties of AHPPD (Animal Health & Plant Protection Directory), RAH (Regional Animal Health sector) and other institutions that are included in implemented control system on fishery products, animal health, etc. to ensure the Albanian consumers and EU-countries. Reflections of Albanian CA to the EU-mission recommendations: Notice: The index is used according to draft report of EU-mission In the light of findings of the mission during inspections carried out in Albania from 04 to 08 June 2007 Competent Authority (AHPPD) started to work on corrective measures

2 deficiencies in the operation of the official controls on fishery products and we started with an action plan just the mission left. We appreciate the help of the mission even the preliminary report was submitted not in 25 working days to us. The Central Veterinary Authority (AHPPD) has evaluated positively the EU Mission findings and recommendations in Albania and thanks it for its evaluation and very important realistic recommendations written down in the draft-report. The Albanian Central Competent Authority (AHPPD), the Food Safety and Veterinary Institute (FSVI), the Local Competent Authority (RAH), the establishments inspected, have evaluated seriously this opportunity to implement all Mission recommendations and technical suggestions, regarding PH, FP and LBM intended for export to EU. Response of the Competent Authorities of Albania to the recommendations of Mission report ref. GD (SANCO) 7293/2007- A FOLLOW-UP MISSION in order to evaluate the control system in place governing the production of fishery products and live bivalve molluscs intended for export to European Union. 5. Recommendations to the Competent Authority 5.1. Legislation The relevant Albanian standards on potable water and contaminants are to be brought in line with UE ones (respectively Directive 98/83/EC and Regulation (EC) No 1881/2006 Relating the Albanian legislation on potable water, it is still in force the Regulation approved by Council of Ministers Decision Nr 145, date 26/02/1998 Hygienic-Sanitary Regulation for the control of quality of potable water, State Standards STAZH , for potable water, approved by Albanian Committee of Standards. The Regulation is based on: - Guidelines for Drinking Water Quality- second edition, volume 2 Recommendations 1996 WHO, - Directive of EU Community EAUX DESTINEESA LA CONSOMATION HUMAINE No 80/778, 15/08/1980, - The Albanian law Nr 7643 date 02/12/1992 For State Sanitary Inspectorate The contacts done recently by AHPPD with experts of Ministry of Health, confirmed that the draft law on potable water is just prepared according the Directive No. 98/83/ EC and will be distributed to other Ministries for comments and then will be approved by Council of Ministers for entering in force. That will be finished by the end of December Also regarding the Regulation (EC) No 1881/2006 and the parts identified by the mission team, that are missing in the Albanian version of Regulation (EC) No 1881/2006, the Albanian HAPPD has prepared an order For some changes in regulation On setting maximum levels for certain contaminants in foodstuffs approved with Order no. 182 date This Order prepared by us, modifies the annex of the Albanian

3 regulation with the parts that are missing and which were identified by the mission team. That regulation is sent to ISUV for applying to other tests. On the other hand AHPPD and ISUV have done an agreement with Food Institute of Skopje to do the residues analyses for Thyerostats, Ivermectin, Carbamates, Pyrethroids, Promasines, Fenylbutazon to food samples send by ISUV The CA should ensure that there is a sufficient number of trained and experienced staff so that official controls and control duties in relation to EU exports can be carried out efficiently and effectively. In this regard, all staff performing official controls should receive appropriate and regular training that should cover, as appropriate, the areas referred to in Annex II, Chapter I of Regulation (EC) No 882/2004. The AHPPD have planed to train and retrain all veterinary inspectors (central and regional) that performs official controls based on Regulation 852/2004, 853/2004; 854/2004; 882/2004 during December 2007 and January 2008, supported by GTZ foundation. There are prepared all the issues relating with those Regulations and the training will be repeated again during 2008 strengthening to hygienic packet In the context of any future possible export of LBM to the EU, the CA should ensure that the chain of command and the delivery of results of analyses permits a prompt adoption of the measures necessary to prevent the placing on the market of LBM found to be unsuitable for human consumption as foreseen by Regulation (EC) No 854/2004, Annex II, Chapter II, Parts C, D and E. After mission left the AHPPD change and reinforce the chain of command and delivery of results of analyses to permit a prompt adoption of the measures necessary to prevent the placing on the market of LBM found unsuitable for human consumption as foreseen by Regulation (EC) No. 854, Annex II, Chapter II, Parts C,D, and E. The results and the orders relating the results are sending immediately to veterinary inspectors and to the Purification Center to prevent or give permission for LBM consumption. The AHPPD strengthened the implementation of the feedback system for opening and closing of the LBM production areas based on laboratory results carried out by FSVI, based on sampling according to National Monitoring Plan for LBM production areas. Where the results of sampling show that the health standards for mollusks are exceeded, or that there may be otherwise a risk to human health, or because of the presence of plankton or excessive levels of toxin in mollusks the AHPPD close the production area. The AHPPD re-opens the area based on the results of laboratory analyses taking in account of information on phytoplankton trends. All that procedure is and will be under the control of inspectors ensuring and preventing the placing on market of LBM unsuitable for human consumption. The inspectors will be train again on December 2007-January The AHPPD communicated the situation of the production area of Butrinti to the interested parties such as producers, and operators of purification centre.

4 According to the Albanian legislation, for the production and processing of bivalve mollusks, is still in force the Minister Order, No. 407 date , Strengthening of the sanitary and veterinary measurements for the control of production, collecting, purification and dispatching centres of bivalve molluscs as well as monitoring Laboratories The CA should ensure that laboratories responsible for official controls are designated in accordance with Article 12 of Regulation (EC) No 882/2004, taking into consideration Article 18 of Regulation (EC) No 2076/2005. The AHPPD has designated the Veterinary Research Institute like National Reference Laboratory to carry out all the tests according to article 18 of Commission Regulation (EC) No 2076/2005. The last is included to Minister Order No 382, date Approving Regulation On official controls to ensure the verification of compliance with feed and food law, animal health and animal welfare rules The FSVI has initiated and is pursuing the necessary accreditation procedures in accordance with (EC) No 882/2004 as well as the FSVI gives to the AHPPD the guaranty that quality control schemes for the analyses are applied for the purpose of official controls. The last information given by FSVI is that in framework of CARDS 2005 project Monitoring the health of small ruminants, experts from EU (Istituto Superiore di Sanita, Roma and Istituto Zooprofilattico Sperimentali di Torino) come to assess FSVI and have given support in the procedure for starting the accreditation of laboratories. The staff of the FSVI has nominated responsible people to prepare all the general procedures for accreditation of the Institute based on the suggestions given by experts. They have prepared and approved the Manual of Quality. On the other hand Italian Cooperation will start to implement on 2008 a project for accreditation of the FSVI with financial cost 2,000,000 EURO The CA should ensure that laboratories responsible for official controls and monitoring for LBM carry out analyses with validated methods and in accordance with Regulations (EC) No 2073/2005 and 2074/2005), and in accordance with the general requirements of Article 11 to Regulation (EC) No 882/2004. The proper handling and transport of samples should guarantee that their analytical validity is ensured; in particular, an appropriate temperature during handling and transport should be ensured, and its suitability should be properly documented. FSVI has updated the methodology for E. Coli according to the Regulation 2073/2005, annex II,Cap. I, Part A, 4, 5. and for salmonella tests the FSVI has adopted the Donovan method as foreseen by Regulation No. 2073/2005, Annex II Chapter I, Part A, points 4, 5. FSVI will take from ATCC USA reference cultures to ensure the quality and reliability of the laboratory results. It is approved and enters in force the manual for proper sampling procedure and the manual on modern sampling techniques, conservation and transportation.

5 FSVI has prepared all the measures for the receipt of samples: human recourses, location, temperature records of samples on their arrivals, documentation and computerizing of the data. For calibrations of all equipments AHPPD and FSVI has contacted the companies that have produced the equipments that FSVI have in use, to come and calibrate them. The other equipments will be calibrated by Albanian company The CA should ensure that laboratories responsible for official controls and monitoring for LBM carry out analyses in order to cover all the possible harmful species of toxic phytoplankton as foreseen by Regulation (EC) No 854/2004, Annex II, Chapter II, Part B, point 1(c), in particular: Gymnodinum catenatum (PSP), Protoceratium reticulatum (Yessotoxin) and Ostreopsis species (for Palytoxin). FSVI give guaranty that for Ostreopsis species (for Palytoxin) the method is approved and the analyses will start immediately, for the other Gymnodinum catenatum (PSP) and for Protoceratium reticulatum (Yessotoxin) method is in process and soon it will be available. Official supervision of FP In the context of the export of FP to the EU, the CA should ensure that landing sites comply with Community legislation at least equivalent to the requirements of Regulations (EC) No 852/2004, Annex I, Part A, II, point 3 (a) and Regulation (EC) No 853/2004, Annex III, Section VIII, Chapter I, point 1. Relating the landing sites AHPPD have put in force the Community legislation equivalent to requirements of Regulation (EC) No. 852/2004, annex I, Part A, II, point 3 (a) and Regulation 853/ 2004, Annex III, Section VIII, Chapter I, point 1. The AHPPD and RAH is controlling and stressing to business operator to apply measures to control product contamination arising from air, soil, water, feed, veterinary medicinal products, plant protection products and biocides, handling and disposal of waste and to ensure that vessels used to harvest fishery products from their natural environment is in compliance with structure and equipped as standards foreseen 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) and by the FBOs (Regulation (EC) No 852/2004, Article (5)). Relating the HACCP implementation, MoAF&CP and AHPPD have set particular attention relating the implementation and assessment of the HACCP system and for understanding the principles first by official MoAFCP have organize seminar in collaboration and supported by FAO, TCP/RER/3002d-GHP/HACCP component on SEE regional project. The subjects treated in the seminar where: Principle of Food Hygiene, Principle of HACCP, Principle of HACCP Auditing, Product

6 traceability, Application of HACCP in different field, etc. AHPPD has sent to RAH and to establishments Regulation No 854/2004 for application and to FBOs Regulation (EC) No 852/2004, article 5. Regulation 852/2004 is adopted in Albanian Legislation as Regulation No 3, date On the hygiene of food products Approved by Minister of MoAF&CP. AHPPD has foreseen that the HACCP system will be compulsory implement for all establishments during the AHPPD will organize on of December 2007 and in April 2008, training of all regional inspectors and especially to those controlling the fish processing plants on HACCP issues supported by CARDS 2005 project. That will help for a better control to the establishments for HACCP implement. Food business operators are ordered to put in place, implement and maintain a permanent procedure/s based on the HACCP principles. The situation is improved and the AHPPD is stressing to the establishments to follow step by step the implementation of the HACCP and will certify them for that at the end of this year. After that we will send to DG SANCO the final list of FPP establishments that fulfils all the requested conditions for export to EU The CA should carry out official controls on FP including at least the elements required by Annex III Chapter II to Regulation (EC) No 854/2004. The AHPPD and RAH will put in place the organoleptic examinations of fishery products to all stages of production, processing and distribution to verify compliance with freshness criteria in accordance with Community legislation and when organoleptic examination reveals any doubt to freshness of fishery products, will send samples to ISUV laboratory for determining the levels of TVB-N. The AHPPD will train the inspectors for that on February 2008 and actually ISUV have responsibility and capability to carry out the TVB-N test The CA should ensure that official analyses of water and ice are carried out in accordance with requirements at least equivalent to the ones of Directive 98/83/EC. The new Council of Ministers Decision for Water Potable, based on the Directive 98/83/EC, which is in line to be approved till the end of the year 2007, will enter in force to apply that new decision to all the food establishments. LBM Production areas for LBM should be classified in accordance with the requirements of Annex II, Chapter II, A to Regulation (EC) No 854/2004; in particular, the classification criteria must take into account the characteristics of the production area in accordance with point 6 of Annex II, Chapter II, A to Regulation (EC) No 854/2004.

7 AHPPD based on requirements of Annex II, chapter II, A to Regulation (EC) No. 854/2004 and in particular with the characteristic of the production area in accordance with point 6 of Annex II, Chapter II, A to Regulation (EC) No 854/2004 and on Mission recommendation for classification of production area have done the new classification The registration document model should include the information cited in Annex III, Section VII, Chapter I, point 4 to Regulation (EC) No 853/2004; if the CA intends to apply the derogation foreseen in Regulation (EC) No 853/2004, Annex III, Section VII, Chapter I, point 7, a clear authorisation from the CA in accordance with the same point has to be issued. The AHPPD approved a new registration document model, including all information cited in Annex III, Section VII, Chapter I (point 4 a, b, c) to Regulation (EC) No 853/2004, and according to the Albanian Regulation No. 2, date On the specific hygiene conditions for LBM based on Regulation No 853/2004/EC. The registering document coming with LBM from production area is hold and registered in Purification Center (Butrinti- Saranda), and for each area of production in the lake of Butrinti, contain: a)- the gatherer s identity and address; - the date of harvesting; - the location of the production area described in as precise detail by code number; - the health status of production area; - the shellfish species and quantity; - the destination of the batch. b) the live bivalve mollusks sent to market from that purification centre in Butrinti contain a batch with information referred to in (a) and the following information: - the address of purification centre; - the duration of purification; - the dates on which the batch entered and left the purification centre. The LBM are associated with moving health certificate approved by CVO within standards In the context of a future export of LBM to the EU, the CA should ensure that approval of purification centres is subject to the validation of the efficiency of the purification system, taking into account the results of microbiological analyses of LBM before and after purification, and an assessment of the own-check system. Actually the production of LBM is to low. AHPPD in collaboration with FSVI will approve the purification centre, its validity and the efficacy, based in results of microbiological analyses of LBM before and after purification just the production of LBM will increased. The assessment of own-check system will be one objective of AHPPD.

8 In the context of a future export of LBM to the EU, the CA should ensure that official controls in the purification centres ensure that all the requirements mentioned in Regulation (EC) No 853/2004, Annex III, Section VII, Chapter IV, Part A are complied with. The Albanian AHPPD ensure the Commission that official controls in the purification centre will be focused in all the requirements mentioned in Regulation (EC) No 853/2004, Annex III, Section VII, Chapter IV, Part A and that the purification centre must fulfill all these requests, if they intend to have the right in the future to export LBM in EU member countries. According to Regulation (EC) No 853/2004, Annex III, Section VII, Chapter IV, Part A the Purification Centre, in Butrinti, has applied a manual for depuration of LBM using clean water for washing them before depuration, using all the operations to keep them alive, to avoid contamination and recontamination to achieve all the health standards before sending them to consumers (market). The purification Centre is applying the HACCP system too. The Purification Centre if equipped with a generator to be used in case of black out for continuing the purification procedure, analyses and other works at the centre The CA should ensure that the monitoring plan for LBM is in compliance with the provisions of Annex II, Chapter II, B to Regulation (EC) No 854/2004; in particular, the CA should ensure that: The Albanian AHPPD ensure the Commission that the monitoring plan for LBM is in compliance with the provisions of Annex II, Chapter II, Part B to Regulation (EC) No 854/2004 and in particular: The microbiological sampling plans to check the microbiological quality of LBM must take particular account of the likely variation in faecal contamination, and the parameters referred to in Regulation (EC) No 854/2004, Annex II, Chapter II, Part A, point 6; The Albanian AHPPD ensure the Commission that the microbiological sampling plans to check the microbiological quality of LBM take, particular account of the likely variation in faecal contamination, and the parameters referred to in Regulation (EC) No 854/2004, Annex II, Chapter II, Part A, point 6, also the AHPPD have planed to make an inventory of the source of pollution of human or animal origin; examine the quantities of organic pollutants which are released during the different periods of the year, according to the seasonal variations of both human and animal populations in the harvesting area, rainfall readings, waste water treatment, etc; determine the characteristics of the circulation of pollutants by virtue of current patterns, bathymetry and the tidal circle in the production area. Also we must say that our classification of BM1 production area is done not in principle but in base of a large number of data (analyses results) collected in this area The sampling frequency for biotoxins is weekly during the period of harvesting. This frequency may be reduced in specific areas, or for specific types of molluscs, if a risk assessment on toxins or phytoplankton

9 occurrence suggests a very low risk of toxic episodes as foreseen by Regulation (EC) No 854/2004, Annex II, Chapter II, Part B, point 5; After the mission left the Albanian AHPPD has applied by order that the sampling frequency for biotoxins must be weekly and actually the sampling frequency for biotoxins in BM1 area is weekly and will continue with this frequency The sampling frequency of LBM for biotoxins and seawater for phytoplankton is increased in case of results of analyses suggesting an accumulation of toxins as foreseen by Regulation (EC) No 854/2004, Annex II, Chapter II, Part B, point 4 (a). After the mission left the Albanian AHPPD has decided and ordered that the sampling frequency of seawater for phytoplankton to be weekly and actually the sampling frequency of seawater for phytoplankton in BM1 area is weekly and will continue with this frequency and also will be increased, in more intensive sampling, in case of results of analyses suggesting an accumulation of toxins as foreseen by Regulation (EC) No 854/2004, Annex II, Chapter II, Part B, point 4 (a). Trade and health certification 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 (Article 3(1) of Directive 96/93/EC). The AHPPD have approved the certificate according to Article 3(1) of the Directive 96/93/EC and all the certified inspectors in charge with issuing that certificate are and will be retrained to have a satisfactory knowledge of the specific Community requirements for export of live fish and FP and for the LBM if the export will start. For any further clarification or any documents be required I am at your disposal Once more thank you for your assistance and help to Albanian CVO (AHPPD). Lefter KLIMI DIRECTOR Animal Health & Plant Protection Directory Ministry of Agriculture, Food and Consumer Protection Skenderbej Square No. 2 Tirana Albania Tirana on