EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL

Transcription

1 EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL Directorate F - Food and Veterinary Office DG(SANCO)/ MR Final REPORT OF A FOLLOW-UP MISSION CARRIED OUT IN PANAMA FROM 12 TO 19 SEPTEMBER 2007 TO EVALUATE THE CONTROL SYSTEMS IN PLACE GOVERNING THE PRODUCTION OF FISHERY AND AQUACULTURE PRODUCTS INTENDED FOR EXPORT TO THE EUROPEAN UNION 28/01/

2 TABLE OF CONTENTS 1. INTRODUCTION Background to the mission Mission objectives and proceeding MAIN FINDINGS Legislation Competent authority performance Laboratories CONCLUSIONS GENERAL CONCLUSION CLOSING MEETING RECOMMENDATIONS TO THE CA OF PANAMA Legislation Competent authority performance Laboratories COMPETENT AUTHORITY RESPONSE TO RECOMMENDATIONS ANNEX

3 1. INTRODUCTION 1 The mission took place in Panama from 12 to 19 September 2007 and was undertaken as part of the Food and Veterinary Office's (FVO) planned mission programme. The mission team comprised two inspectors from the FVO Background to the mission Historical background Panama is presently listed in Annex II to Commission Decision 2006/766/EC, which lists the third countries and territories from which imports of fishery products (FP) are permitted. Until 1 May 2007, Commission Decision 1999/526/EC laid down the special conditions governing the import of FP and aquaculture products (AP) originating in Panama 3. The conditions governing these imports are now laid down in the model health certificate in Appendix IV to Annex VI of Commission Regulation (EC) No 2074/2005 and include a public health and where relevant, an animal health attestation. This mission was a follow up of a previous FVO mission to Panama carried out from 11 to 15 June 2004 (ref. DG(SANCO)/7268/2004). During this earlier mission, a number of deficiencies were identified in the official control system put in place by the Competent Authority (CA), and standards in establishments varied considerably. Furthermore factory vessels (FV) and freezer vessels (ZV) were not available for inspection by the MT. In particular, it was noted that the CA had a limited knowledge and understanding of Community requirements. This report is published on the Internet at: Production and trade information At the time of the mission imports of FP from Panama were authorised from a total of sixteen establishments (seven processing materials only or partially derived from aquaculture), as well as from forty nine FV and ZV 4. According to revised information provided by the CA prior to the mission, the total exports of FP and AP to the European Union (EU) in 2006 was 11,980 tonnes. According to EUROSTAT data, the total exports to EU of FP and AP from Panama in 2006 was 34,535 tonnes. Over 85% of these exports were frozen fish (excluding fish fillets). The CA acknowledged that the large discrepancy is probably attributable to direct landings (fishing vessels landing directly in Community ports or landing in third country ports, the catches being exported to the EU via reefer vessels/containers and accepted by EU Member States (MS) as direct landings). 1 List of abbreviations and special terms is drawn up in Part 1 of the Annex to this report. 2 References to Community Acts quoted in the report and legal basis for the mission are mentioned in Part 2 and Part 3 of the Annex to this report. All legal references refer, where applicable, to the latest amended version. 3 Commission Decision 1999/526/EC is repealed, with effect from 1 May 2007, by Commission Regulation (EC) No 1664/2006, which amends Regulation (EC) No 2074/2005. This Regulation includes the new joint public and animal health model of certificate for imports of FP intended for human consumption. 4 The details of these vessels have been submitted to the Commission and are included on a consolidated list (effective from ) published on the Internet at: 3

4 The Rapid Alert System for Food and Feed (RASFF) notifications Since January 2005, sixteen notifications have been received (as of 06/09/2007) linked to five establishments. These notifications are mainly due to contamination with histamine, mercury, sulphites and carbon monoxide (CO) treatment. One establishment associated with five RASFF notifications for sulphites had been removed from the consolidated list and in the other cases, written reprimands were issued or exports suspended. Where checked, the mission team (MT) noted that there was limited documented follow-up to the RASFF notifications other than written reprimand/suspension. In one case the Food Business Operator (FBO) had been instructed by the CA not to export the specific species Moro Mora for six months following a RASFF notification for mercury, but was not aware of a second RASFF related to CO contamination. During the mission, the CA initiated the de-listing of a FV on account of a fourth RASFF for contamination of FP with mercury Mission objectives and proceeding The objectives of the mission were to: re-assess whether the CA is capable of guaranteeing that the special conditions governing imports of FP and AP originating in Panama, as laid down in Decision 1999/526/EC 5 and in the Community's new hygiene legislation 6 are met; verify the extent to which the guarantees and the corrective actions submitted to the Commission services, following the recommendations of the previous FVO mission report, have been implemented, enforced and controlled by the CA. In order to achieve these objectives, the mission team evaluated the organisation of the CA and its capacity for implementing provisions considered as at least equivalent to the relevant Community legislation. In pursuit of these objectives, the mission team proceeded as follows: an opening meeting was held on 12 September 2007 with the CA. At this meeting the inspection team confirmed the objectives of and itinerary for the mission, and requested additional information required for the satisfactory completion of the mission. representatives from the CA accompanied the inspection team during the whole mission. the following sites were visited: 5 Decision 1999/526/EC was repealed as of by Commission Regulation (EC) No 1664/2006. Furthermore, this Decision makes reference to Council Directives 91/493/EEC and 92/48/EEC, which were repealed by Directive 2004/41/EC of the European Parliament and of the Council. 6 The Community's new hygiene legislation is applicable from 1 January 2006 and includes Regulations (EC) Nos 852/2004, 853/2004, 854/2004 and 882/2004 of the European Parliament and of the Council. 4

5 COMPETENT AUTHORITY Central office 1 LABORATORIES INVOLVED IN THE OFFICIAL CONTROL Central 2 For one laboratory (conducting all test on official samples for FP) a meeting took place with the laboratory representatives as the facility is based in Ecuador FACILITIES Establishments 5 OTHER FACILITIES Landing sites 1 Vessel Monitoring System 1 operator 2. MAIN FINDINGS The previous mission report included eight recommendations addressed to the CA. A corrective action plan was received on 25 November In addition, two letters have been received in response to requests for further information on 14 January and 16 March A further update dated 2 August 2007 was included as part of Panama's response to a pre-mission questionnaire for the current mission. The findings of the current mission follow the structure of the above mentioned action plan, and cover all the recommendations of the previous mission report Legislation Recommendation number 1 (5.1.1) of the previous mission report stated that the CA should clarify, either by amending the legislation or by other appropriate means, the limits for heavy metals in line with Community legislation. In the CA letter dated 14 January 2005 it was stated that the limits for heavy metals and other contaminants (e.g. histamine) have been revised and brought in line with Community requirements (i.e. those cited in Commission Regulation 466/2001 and Council Directive 91/493/EC respectively). In the latest action plan, the CA confirmed that the relevant legislation (Resolution 92) was adopted on 10 February A review of this text confirmed that the revised limits for heavy metals laid down in Resolution 92 are in line or stricter than the Community limits established in Commission Regulation (EC) No 1881/2006. However, no limits have been established for polycyclic aromatic hydrocarbons (PAH). The mission team was provided with a draft resolution dated 18 September 2007 which establishes limits for PAH and also a sampling plan, limits and analytical reference method (high performance liquid chromatography - HPLC) for histamine testing in Scombridae and Clupeidae omitting four species that are also associated with a high amount of histidine (Engraulidae, Coryfenidae, Pomatomidae and Scombresosidae). The CA informed the mission team that they were aware of Regulations (EC) No 333/2007 and 1883/2006 and is considering the necessary elements for adoption in National legislation. Resolution 227 of 15 March 2007 was adopted to take account of such legal gaps pertaining to Community requirements and establish a "legal 5

6 framework" which would allow national standards to be adjusted to EU export requirements Competent authority performance Knowledge of Community requirements (CA) Recommendation number 2 ( ) of the previous mission report stated that the knowledge of Community requirements for FP should be improved by training on legislation, specific procedures for EU exports (special checks such as histamine and heavy metals, etc.) and hygiene of production. In the CA letter dated 14 January 2005 it was stated that Community legislation had been reviewed and training provided for FBOs and staff from the Food Protection Department (i.e. Departamento de Proteccion de Alimentos, DEPA the CA) of the Ministry of Health, the Central Public Health Reference Laboratory, the Toxic Residues Laboratory of the Ministry of Agricultural Development, the private laboratories serving the processing establishments and the Deputy Minister for Foreign Trade. Further training was provided in February 2005 for DEPA staff on contaminant sampling and organoleptic examinations. The CA forwarded detailed information on the implementation of the training programme. The mission team was provided with records to show that the CA and FBOs had participated in training organised at both the national and international level. The frequency of this training has been increasing since the mission in 2004 and has been enhanced by the number of training opportunities available. Future participation is planned in a workshop on RASFF in Buenos Aires at the end of 2007, and a seminar in Guatemala in October 2007 on food safety and sanitation in aquaculture. There was evidence that both CA staff and FBOs visited were broadly aware of the relevant Community requirements and had copies of, or access to the relevant legal texts. Health Certification The model health certificate in Appendix IV to Annex VI of Commission Regulation (EC) No 2074/2005 includes an animal health attestation, which for AP requires that "they are clinically healthy on the day of harvest". Aquaculture farm inspections are carried out at present by the animal health services - DINASA (i.e. Direccion Nacional de Salud Animal) from the Ministry of Agriculture. The CA is seeking to establish formal co-ordination with DINASA to ensure that this condition of certification is met. The CA confirmed that if necessary, an inspection could be made on the day of harvest by either DINASA or DEPA staff Knowledge of Community requirements (FBO) Recommendation number 3 ( ) of the previous mission report stated that the Panamanian CA should ensure that the standards used for achieving equivalent guarantees to Community requirements are known and understood by the managers of vessels/establishments. The CA comments were as for point above. 6

7 CA controls over fishing vessels Recommendation number 5 ( ) of the previous mission report stated that fishing vessels providing FP to EU exporting establishments (i.e. those on the domestic register) should also be controlled against the requirements set out in Council Directive 92/48/EEC 7. In the corrective action plan received on 25 November 2004, the CA stated that shrimp vessels supplying FP to the EU were being controlled against the requirements set out in Council Directive 92/48/EEC and they are issued with a health permit valid for one year's operations. The CA stated, however, that establishments do not export these shrimp to the EU. The CA provided the list of vessels on the domestic register providing FP to the EU approved establishments in Panama. The CA informed the mission team that at present, there are no exports of sea caught shrimp to the EU. However, other FP are exported from establishments supplied by vessels on the domestic register. The domestic register and the list of vessels supplying one of the establishments visited (with inspection dates) were provided to the MT at the final meeting. However, no vessels were available for inspection Inspection of FV/ZV Recommendation number 6 ( ) stated that the CA should provide the Commission Services with information regarding the usual time and location of Panamanian FV/ZV when mooring in harbours (in particular in MS harbours) in order to make an FVO inspection possible in satisfactory conditions. In the CA letter dated 14 January 2005 the CA stated that FV/ZV flying the Panamanian flag are inspected in situ on arrival at landing ports within and outside the MS by their inspectors. This inspection usually takes two to three days. A health certificate valid for one year is issued under Decree 84 of 10 June 1996, which takes account of Community requirements. In the latest action plan, the CA confirmed that most vessels flying the Panamanian flag unload their product outside Panamanian ports. An instruction has, however, been issued to all ship owners to notify the CA when the vessels are in port. Since the last mission, no information was provided to the FVO on the date, time or mooring location of fishing vessels landing in Community ports. Data on Panamanian vessels when mooring The authority for aquatic resources in Panama (AARAP) demonstrated their vessel monitoring system to the MT and provided a graphic representation of the location/movement/activity of 150 vessels with Panamanian flag, with international fishing licence (i.e. operating beyond the 200 mile territorial limit). According to the information provided to the MT, the majority of listed fishing vessels (external list) and all the vessels on the internal list are covered by this monitoring. However, AARAP acknowledged that some vessels did not show up on their tracking system as a) some boats are given three months to acquire the system and b) technical reasons linked to the vessel beacon code not being available. At the time of the mission there was no established relationship between the CA and AARAP, which would facilitate the geographical location of the FV/ZV, and provide 7 Now replaced by the Community's new hygiene legislation. See footnote 6 7

8 landing data. The mission team was provided with the draft of an Executive Decree which seeks to improve co-operation/co-ordination through the creation of a "National Technical Commission for the Health of FP". AARAP could not (as initially agreed) provide the MT with unloading data (quantity of FP unloaded directly in Community ports and the names of the vessels concerned). Inspection of FV/ZV in-situ (Procedure) From the records the MT confirmed that vessels on the consolidated list have been inspected once per year in-situ (e.g. in Spain (Vigo and Coruña), Japan, Uruguay, Peru, South Africa (Durban) and Panama), with a few exceptions (seven pending). It was explained that the seven vessels will be inspected at the next port of call following the expiry of the health permit. The CA stated that a health permit is issued if a vessel is compliant (typically small deficiencies are rectified before the departure of the inspector). If the vessel is noncompliant, no permit is issued and a re-visit is scheduled. In one case a permit was issued on the basis of guarantees submitted. In May 2007 a new plant and vessel form/check list was adopted with categorisation of deficiencies (compliant, partially compliant, and non-compliant). So far it has only been used on one vessel and the CA is still validating the format. Criteria to establish that a vessel is non-compliant/partially compliant/ compliant on the basis of the new forms and subsequent actions have not yet been finalised CA controls over establishments and FV/ZV (including HACCP) Recommendation number 7 ( ) stated that the CA should ensure that all establishments and vessels proposed for listing, should comply with standards equivalent to Community requirements. In particular HACCP plans should be updated and properly assessed and validated. In the CA letter dated 14 January 2005 the CA stated that establishments had been inspected to ensure that they took corrective action and adapted their HACCP plans, no reference however was made to vessels. In their most recent action plan the CA stated that vessels had also been inspected to ensure that they met Community requirements and have a HACCP plan. Establishment visits The establishments all had valid approval documents and had been subject to regular supervision (particularly in 2007). Written reports were available for formal plant inspection visits; however, the MT did not see documentary evidence for the routine visits made by local inspectors based at the port of Vacamonte. Since May 2007, the inspectors based in Panama have used new models of checklists (e.g. forms F1 to F4 deal with establishment structure, Good Hygiene Practice (GHP) pre-requisites, the HACCP plan and implementation of HACCP respectively). In many cases, the CA did not clearly document on forms F1 to F3 the objective evidence resulting in the partial/non-compliance identified, or obtain written assurances from the FBO with a timetable for corrective action by the FBO (descried in form F 12), or verify that the necessary corrective action had been taken (form F 13). Form F3 was not always available and form F4 had not been used in the establishments visited. When inspected on-the-spot some recent HACCP plans were found to contain deficiencies (e.g. FP could be accepted at temperatures in excess of Community limits and aquaculture shrimp could be rinsed with hyper-chlorinated water). It was noted that few/no official samples were taken by the official services for microbiology 8

9 (FP/water) or histamine and organoleptic checks in aquaculture shrimp are confined to a check on the records maintained by the FBO. Where water analysis results were provided (typically "own-checks"), these did not include results for Enterococci or all the physico-chemical parameters foreseen in Community legislation. Some deficiencies had not been detected by the CA and it was found that of the five establishments visited, three were partially compliant (minor deficiencies that can be readily rectified) and two were non compliant (more significant deficiencies noted, some requiring urgent attention). The deficiencies in the FBOs ranged from problems with the structure (e.g. walls/floors in need of repair), maintenance and equipment, to specific deficiencies in pest and product temperature control. In the case of the two non compliant establishments the MT noted that the CA took immediate steps to a) stop exports of cooked product in one establishment until the relevant deficiencies have been rectified (including a programme for microbiological testing in the cooked product) and b) in the second establishment, obtained guarantees from the FBO that the necessary corrective action would be taken within the next 60 working days. Inspection of vessels by the CA Despite repeated requests prior to and during the mission, it was not possible to visit any FV/ZV. The CA was slow to provide data on the vessels supplying establishments in Panama and could not obtain data on product they exported to the EU for FV/ZV on the consolidated list. No data on EU exported product was available in part because the ship's captain signs official export certificates without prior CA approval, and because copies of these or the relevant data is neither collected from the captain during the annual inspection or from the ship's agent. As the vessels do not typically visit/discharge in Panama, the CA to-date has not been able to obtain official samples (e.g. chemical contaminants/microbiology) as planned. A file for the vessel associated with three RASFF notifications was checked and it was found to have a certificate valid until 19 December There was no documented evidence of follow-up to the RASFF notifications, there was no export data available and no official samples had been taken. This vessel was inspected using the old checklists (last inspected in Durban in December 2006). No objective evidence or corrective action was described when a deficiency was identified (i.e. an item with a score less than 100%). For example, specific deficiencies were identified in the HACCP plan (the flow chart did not include washing fish after de-heading, nor the final storage phase), however, this was not documented nor any corrective action described. The MT noted that the Residue Control Plan (which covers both AP and FP) for the year 2007 foresees 282 samples on the external list of vessels (i.e. based on 47 vessels on the external list and 3 samples taken twice/year). The CA has yet to decide how these samples are to be taken Official controls (FP) Recommendation number 8 ( ) stated that the CA should ensure that official controls and monitoring of the production of FP intended for EU export should be improved. The specific recommendations (i.e. points 1 to 4) and the responses from the CA were as follows: 1) Each batch of FP should be subject to organoleptic inspection by the CA at the time of landing or before first sale in order to establish whether they are fit for 9

10 human consumption, as is laid down in Annex V of Council Directive 91/493/EEC 8. These checks should be documented. In the letter dated 14 January 2005 the CA stated that staff has been trained in performing organoleptic examination of each batch of FP at the time of landing. A log book was introduced to document the examinations carried out for each plant at the time of landing or before first sale. In particular, the CA stated that organoleptic checks were to be made by trained officials from the Food Protection Department, permanently assigned at the landing ports in Panama. This official should record the date and time of performance and the details of the checks, in the plant s log book. Such checks should also be carried out at the landing quays for shrimp vessels, and recorded in the same way. These controls were to be formally put in place as from 1 February For aquaculture shrimp, the MT noted that the CA ensured that the FBO had documented controls in place; however, there were no documented records to show that random organoleptic checks had been performed by the CA to verify compliance with freshness criteria established in Executive Decree No 84 of 3 January The CA informed the MT that this check would be included in future inspections as detailed in checklist F 14. The mission team noted that when inspected, shrimp had been transported short distances with good temperature control and arrived at the establishments in good condition, qualifying as category "extra" or "A" under Community rules. 2) Checks for histamine should be carried out according to the requirements of Council Directive 91/493/EEC (Chapter V, II, 3 A {b} of the Annex); In the letter dated 14 January 2005 the CA stated that checks for histamine would be carried out according to Council Directive 91/493/EEC. In 2006, only six official samples were taken for histamine and these were analysed by ELISA test. As indicated above (see section 2.1), the CA has provided a copy of a draft resolution establishing HPLC as the reference method and laying down a sampling plan and limits for certain fish as set out in Community legislation. The mission team visited an establishment which processes mainly tuna and is associated with two previous RASFF notifications for histamine. It was noted that although the FBO carried out regular checks (all negative) using a screening test (a colorimetric assay with lower detection limit of 20 ppm in fresh fish), there were no records of any official histamine test on file. 3) Checks on water and ice should be carried out according to the requirements of Council Directive 98/83/EC; In the letter dated 14 January 2005 the CA stated that a sampling and analysis of water and ice according to Council Directive 98/83/EC have been introduced. Where checked by the MT, the FBOs had taken regular samples of water and ice for testing, both at in-house and external laboratories. These samples were not always taken in a way that ensured all relevant outlets were tested. Results were provided for microbiology (including total coliforms and E.coli) and in some cases results were also available for certain physico-chemical parameters. 8 See footnote 6 10

11 In some establishments no results were available for official control on water. A number of legal references were provided for the criteria for classifying potable water; however, the CA confirmed that a national norm COPANIT applies. This norm does not cover all of the parameters referred to in Community legislation and in particular, there is no requirement to test for Enterococci. 4) only potable water should be in contact with FP, and no disinfectant should be used on fish in food establishments, as laid down in Council Directive 91/493/EEC (Chapter III, II, 3, 4 A of the Annex). In the letter dated 14 January 2005 the CA stated that the use of disinfectants has been eliminated and checks are being carried out to make sure that only potable water comes in contact with FP. The use of disinfectants was not observed by the mission team Laboratories Recommendation number 4 ( ) of the previous mission report stated that the deficiencies and shortcomings detected during the visit by the mission team with regard to laboratories and analysis methods used should be addressed in the shortest delay possible to assure full reliability of the results of analyses. In the latest action plan, the CA confirmed that laboratories (including the Residues Laboratory of the Ministry of Agricultural Development) have begun the accreditation process. In the meantime, to overcome the deficiencies noted in the previous report, the CA send official samples of FP and AP to a private laboratory in Ecuador. The mission team noted that this laboratory has ISO accreditation provided by a body recognised at international level and this is valid until April 30, 2009 for both chemistry and biology. The chemical tests covered by the scope of accreditation include: lead, cadmium and mercury. Histamine testing is by ELISA and they can, if required, perform HPLC tests, however, neither test is included in the scope of accreditation at present. The biological tests covered by the scope of accreditation include: Staphylococcus aureus, Salmonella, aerobic plate counts, and faecal/total coliforms. The mission team also noted: Efficient shipping and customs clearance (samples arrive in one day). In some of their test reports, incorrect Community limits are cited. Samples for dioxin/pah have not been submitted to date. If received, PAH (benzo(a)pyrene) could be analysed but samples for dioxin would be redirected to laboratories within the laboratory group with the appropriate accreditation. The 2006 Residue Control Plan 9 included a limited number of results for heavy metals in fish (there have been six RASFF notifications since 2005 for mercury and much of the sea catch comprises large predatory fish). In total, 9 The residue monitoring plan for 2006 was divided into two parts for the year One part from April to December 2006 (rainy season) and the second part, from January to March 2007 (dry season). 11

12 3. CONCLUSIONS eight samples were analysed for fish, twenty-two for shrimp from aquaculture, three feed and one water sample. The MT noted five unsatisfactory results from the 88 tests for heavy metals (four for lead and one for cadmium in aquaculture shrimp) with no follow-up by the CA. Malachite/Leucomalachite green With regard to this substance, the MT noted the following: The CA started testing for malachite/leucomalachite green as part of the Residue Control Plan for The analyses were performed by a private laboratory in Ecuador, which is preparing to include this test within its scope of accreditation (a ring test is foreseen in January 2008). Their limit of detection is quoted as 0.25 ppb and limit of quantification 0.5 ppb, which is satisfactory as regards Community requirements. Of the 34 samples tested between December 2006 and January 2007, 15 were found to be unsatisfactory i.e. non negative (presence of traces, but some exceeding Community limits). Meetings took place on 4 and 25 April 2007 between the CA and FBOs and the latter was instructed to investigate the source of malachite green. The CA adopted Resolution No 514 of 2 July 2007, requiring the exclusion of this substance from the food chain (it had not previously been covered by Panamanian legislation) A Draft Executive Decree is under preparation to give further weight to complete prohibition of the use of colorants in feed stuffs. A further six samples were taken in shrimp in August 2007 as part of the 2007 Residue Control Plan and all results are negative. The mission team observed that since the last FVO mission in 2004, there have been ongoing corrective measures and improvements (regular training for the CA and FBOs, analyses of official samples in an accredited laboratory, adoption of new legislation, and the introduction of a revised manual of procedures (draft) with detailed check lists and sampling programme. Despite these improvements, however, the mission team considers that there are still gaps in the legislation, significant deficiencies remain in official controls (e.g. in sampling, incomplete implementation of the manual of procedures, supervision in establishments and effective follow-up of RASFF notifications/contamination of foodstuffs). Furthermore the CA is not in a position to provide accurate information on the nature and extent of exports to the EU. With specific regard to vessels, it should be noted that despite repeated requests prior to and during the mission, it was not possible to visit any FV/ZV. The CA was slow to provide data on the vessels on the domestic register supplying establishments in Panama and could not obtain data concerning listed FV/ZV on the quantity or type of product they export to the EU. 12

13 4. GENERAL CONCLUSION The official controls in place cannot be deemed as being in full compliance with the requirements of Community legislation and in particular the certification of the conditions as now laid down in the model health certificate in Appendix IV to Annex VI of Commission Regulation (EC) No 2074/2005. Despite the prompt assurances, significant further efforts are required to address some of the longstanding issues, particularly those related to the vessels flying the Panamanian flag in international waters. A risk exists for consumers in relation to the contamination of FP and AP by heavy metals, histamine in certain fish species and micro-organisms or their contaminants (particularly in cooked product). The degree of risk is difficult to assess in the absence of adequate/reliable data. 5. CLOSING MEETING During the final meeting held in Panama City on 19 September 2007, the mission team presented the findings and preliminary conclusions of the mission to the CA. At the meeting, in Panama City the CA acknowledged the deficiencies identified by the mission team and reiterated the commitment of the country to improving the official sanitary export controls. In particular the CA provided an initial written assurance (Ref. No 773/DEPA/INPLA dated 19 September 2007) that they would make every effort to address the deficiencies noted. They also provided copies of a circular to be sent to vessel operators to provide data on landing quantities and port of unloading (circular 040/DEPA/INPLA), a letter requesting the same data from AARAP (Ref. 777/DEPA/INFLA dated 19 September) and a letter delisting a FV (Ref. 776/DEPA/INPLA dated 19 September) which was the subject of a fourth RASFF for mercury since RECOMMENDATIONS TO THE CA OF PANAMA Further to the commitment provided by the CA, they should provide the Commission services with an action plan, including a timetable for its completion in order to address the recommendations set out below: 6.1. Legislation The CA should ensure that the following Community standards, or requirements equivalent to those standards, are applied: a. Contaminants (including limits for PAH), according to Commission Regulation (EC) No 1881/2006. b. Histamine according to Regulation (EC) No 2073/2005; c. Potable water (including physico-chemical parameters) according to Directive 98/83/EC; d. Methods of sampling and analysis of contaminants according to Commission Regulations (EC) Nos 333/2007 and 1883/ Competent authority performance RASFF The CA should ensure that when non-compliance is identified, it shall take action to ensure that the operator remedies the situation as foreseen in Title VII, Chapter I, Article 54 of Regulation (EC) No 882/2004; 13

14 Certification a) For AP, the CA should ensure that the necessary on farm supervision is put in place so that officials are in a position to sign the animal health attestation in the health certificate for the EU exports of FP intended for human consumption as laid down in appendix IV to Annex VI to Regulation (EC) No 2074/2005. b) the CA should ensure that certification of the FP landed directly in EU ports from FV comply with the relevant Community requirements; the CA should either provide FV's captains with the necessary authorisation to sign official health certificates in accordance with Annex VI, point 1 of Regulation (EC) No 854/2004 or implement an equivalent procedure; Inspection of vessels The CA should ensure that the vessel monitoring system covers all listed vessels, and ensure effective communication between the relevant services (i.e. the CA and AARAP) so that the CA can reliably provide Commission services with information regarding their location and thus facilitate an FVO inspection CA controls over establishments and FV/ZV (including HACCP) a) The CA should ensure that FV/FZ vessels directly exporting FP to the EU are subject to improved controls with regard to their compliance with vessel requirements equivalent to Regulation (EC) No 853/2004, Section VIII, and for HACCP, Chapter II, Article 5 of Regulation (EC) No 852/2004. b) The CA should ensure that the shortcomings found during the visits to the different sites are corrected in order to meet standards equivalent to Chapter II, Article 5 (HACCP) and with regard to general hygiene requirements, Annex II of Regulation (EC) No 852/2004. c) The CA should ensure that official controls (in both establishments and vessels) cover the checks foreseen in Annex III to Regulation (EC) No 853/2004. In particular, the CA should fully implement a) their new manual of procedures, b) the monitoring programme foreseen in the 2007 Residue Control Plan and obtain c) the relevant export data requested in their circulars sent to AARAP and the vessel operators. d) The CA should ensure that microbiological tests are performed with an adequate frequency on cooked crustaceans on the basis of requirements at least equivalent to Annex I, Chapter II, point of Regulation (EC) No 2073/2005. e) The CA should review establishments, FV/FZ and vessels on the domestic register so that only those in compliance with the requirements of Community legislation are approved to supply establishments on the consolidated list (i.e. those approved to export to the EU). The list of these establishments should be provided to the Commission services Official controls (fishery products) a) Random organoleptic checks should also be carried out by the CA at all stages of production, processing and distribution of aquaculture shrimp in line with Annex III, Chapter II (A), of Regulation (EC) No 854/2004. b) The CA should confirm when the HPLC (following the reference method of Regulation (EC) No 2073/2005) will be introduced. 14

15 c) The CA should ensure that the quality of water used in establishments is checked on the basis of requirements at least equivalent to the relevant sampling, microbiological and chemical parameters of Directive 98/83/EC Laboratories a) The CA should ensure that all testing methods (e.g. for histamine analysis) used in laboratories meet standards equivalent to those laid down in Regulation (EC) No 2073/2005. b) Panamanian laboratories that carry out any future analyses of FP, AP and water samples taken during official controls should be formally designated by the CA and in line with the requirements of Article 12 of Regulation (EC) No 882/2004. In particular, the CA should maintain progress towards the accreditation of these laboratories in accordance with the standard EN ISO/IEC COMPETENT AUTHORITY RESPONSE TO RECOMMENDATIONS The Competent Authority's response to the recommendations can be found at: 15

16 ANNEX 1. Abbreviations and special terms used in the report AARAP Administrador de la Autoridad de los Recursos Acuáticos AP Aquaculture Products CA Competent Authority CO Carbon monoxide DEPA Departamento de Protección de Alimentos DINASA Dirección Nacional de Salud Animal (del Ministerio de Desarrollo Agropecuario). DG Directorate General EC European Community ELISA Enzyme Linked Immuno Sorbent Assay EU European Union EUROSTAT Statistical Office of the European Communities FP Fishery Products FBO/s Food Business Operator/s FV Factory Vessel FVO Food and Veterinary Office GHP Good Hygiene Practice (as described in Article 4 of Regulation (EC) No 854/2004). HACCP Hazard Analyses Critical Control Point HPLC High Performance Liquid Chromatography ISO International Organisation for Standardisation MS Member States MT Mission Team PAH Polycyclic Aromatic Hydrocarbons ppb Parts per billion ppm Parts Per million RASFF Rapid Alert System for Food and Feed SANCO Health and Consumer Protection DG (European Commission) ZV Freezer Vessel 2. References to Community Acts quoted in the report European legislation 10 Official Journal (OJ) Title Commission Decision 94/356/EC Repealed as of by Commission Decision 2006/356/EC Commission Decision 98/140/EC Commission Decision 99/526/EC - Repealed as of by Commission Regulation (EC) No 1884/2006 L 156, , p L 138, , p.14 L 203, , p. 58 Commission Decision of 20 May 1994 laying down detailed rules for the application of Council Directive 91/493/EEC, as regards own health checks on fishery products 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. Commission Decision 99/526/EC of 14 July 1999 laying down special conditions governing imports of fishery and aquaculture products originating in Panama. 10 Community legislation (Internet): 16

17 Commission Decision 2006/766/EC L 320, , p. 53 Commission Decision 2006/766 of 6 November establishing the lists of third countries and territories from which imports of bivalve molluscs, echinoderms, tunicates, marine gastropods and fishery products are permitted. Council Directive 91/493/EEC OJ L 268, , p. 15 Council Directive 91/493/EEC of 22 July 1991 laying down the health conditions for the production and the placing on the market of fishery products Directive 95/2/EC L 61, , p. 1 European Parliament and Council Directive Nº 95/2/EC of 20 February 1995 on food additives other than colours and sweeteners. Council Directive 96/23/EC L 125, , p. 10 Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC Council Directive 98/83/EC L 330, , p.32 Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption. Commission Regulation (EC) L 77, , p.1 No 466/2001 -Repealed as of by Regulation (EC) No 1881/2006 Regulation (EC) No 852/2004 L 139, , p. 1 Corrigendum OJ L 226, , p. 3 Regulation (EC) No 853/2004 L 139, , p. 55 Corrigendum OJ L 226, , p. 22 Regulation (EC)No 854/2004 L 139, , p. 206 Corrigendum OJ L 226, , p. 83 Regulation (EC) No 882/2004 L 165, , p. 1 Corrigendum OJ L 191, , p. 2 Commission Regulation No L 338, , p. 1 (EC) 2073/2005 Commission Regulation No L 338, , p. 27 (EC) 2074/2005 Commission Regulation No (EC) 1664/2006 Regulation (EC) No 1881/2006 Commission Regulation (EC) No 1883/2006 Commission Regulation (EC) No 333/2007 L 320, , p. 13 L 364, , p..5 L 364, , p. 32 L 88, , p..29 Commission Regulation (EC) No 466/2001 of 8 March 2001 setting maximum levels for certain contaminants in foodstuffs 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. Commission Regulation (EC) Nº 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs. Commission Regulation (EC) Nº 2074/2005 of 5 December 2005, laying down implementing measures for certain products under Regulation (EC) No 853/2004 of the European Parliament and of the Council and for the organisation of official controls under Regulation (EC) No 854/2004 of the European Parliament and of the Council and Regulation (EC) No 882/2004 of the European Parliament and of the Council, derogating from Regulation (EC) No 852/2004 of the European Parliament and of the Council and amending Regulations (EC) No 853/2004 and (EC) No 854/2004. Commission Regulation (EC) Nº 1664/2006 of 6 November 2006 amending Regulation (EC) No 2074/2005 as regards implementing measures for certain products of animal origin intended for human consumption and repealing certain implementing measures. Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs. Commission Regulation (EC) of 19 December 2006 laying down methods of sampling and analysis for the official control of levels of dioxins and dioxinlike PCBs in certain foodstuffs. Commission Regulation of 28 March 2007 laying down the methods of sampling and analysis for the official controls of the levels of lead, cadmium, mercury, inorganic tin, 3-MCPD and benzo(a)pyrene in foodstuffs. 3. Legal basis for the mission The mission was carried out under the general provisions of Community legislation and, in particular: - 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, Article 46; - 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. 17