EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL

Transcription

1 Ref. Ares(2014) /06/2014 EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Directorate F - Food and Veterinary Office DG(SANCO) MR FINAL FINAL REPORT OF AN AUDIT CARRIED OUT IN PANAMA FROM 04 TO 13 FEBRUARY 2014 IN ORDER TO EVALUATE THE CONTROL SYSTEMS IN PLACE GOVERNING THE PRODUCTION OF FISHERY PRODUCTS INTENDED FOR EXPORT TO THE EUROPEAN UNION

2 Executive Summary This report describes the outcome of a Food and Veterinary Office audit in Panama carried out from 4 to 13 February 2014, as part of its programme of audits in third countries. The primary objective of the audit was to evaluate whether the official controls put in place by the competent authority can guarantee that the conditions of production of fishery products in Panama, destined for export to the European Union, are in line with the requirements laid down in European Union legislation. The audit also verified the extent to which measures taken to address the recommendations of the previous Food and Veterinary Office audit report on fishery products of 2012 have been implemented and enforced by the competent authority. The report concludes that in principle the current organisation and implementation of official controls could guarantee that the conditions of production of fishery products in Panama intended for EU export meet standards equivalent to the requirements laid down in EU legislation. However, deficiencies identified, in particular concerning supervision of establishments and laboratory performance, undermine the guarantees given in the EU export health certificates. Improvements have been made since the last Food and Veterinary Office audit in 2012 and corrective actions have been implemented by the competent authority which address most of the recommendations of the 2012 audit report. The report addresses to the competent authority of Panama a number of recommendations aimed at rectifying identified shortcomings and enhancing the control system in place. I

3 Table of Contents 1 INTRODUCTION OBJECTIVES AND SCOPE OF THE AUDIT LEGAL BASIS FOR THE AUDIT BACKGROUND GENERAL BACKGROUND PRODUCTION AND TRADE INFORMATION RAPID ALERT SYSTEM FOR FOOD AND FEED (RASFF) NOTIFICATIONS FINDINGS AND CONCLUSIONS LEGISLATION COMPETENT AUTHORITY NATIONAL PROVISIONS AND PROCEDURES FOR LISTING ESTABLISHMENTS EXPORTING TO THE EU OFFICIAL CONTROLS OF PRODUCTION AND PLACING ON THE MARKET OFFICIAL CONTROL SYSTEM IN PLACE PRIMARY PRODUCTION LANDING AND FIRST SALE FACILITIES, INCLUDING VESSELS, HANDLING FISHERY PRODUCTS IMPORT CONTROLS OF FISHERY PRODUCTS OFFICIAL CONTROLS OF FISHERY PRODUCTS LABORATORIES FOLLOW-UP OF RASFF NOTIFICATIONS OFFICIAL CERTIFICATION OVERALL CONCLUSION CLOSING MEETING RECOMMENDATIONS...15 ANNEX 1 - LEGAL REFERENCES...16 II

4 ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT Abbreviation AMP ARAP AUPSA CA CCP DEPA DG SANCO EC EN EU EU listed Eurostat FVO HACCP ISO MRL MIDA MINSA OJ p.p.m. PAH PCBs RASFF RMP Explanation Maritime Authority of Panama (Autoridad Marítima de Panama) Authority for Aquatic Resources of Panama (Autoridad de los Recursos Acuáticos de Panama) Panamanian Food Safety Authority (Autoridad Panameña de Seguridad de Alimentos) Competent Authority Critical Control Point Department of Food Protection (Departamento de Protección de Alimentos) Health and Consumers Directorate General of the European Commission European Community European Norm European Union Facility approved by the CA for EU fishery products export and listed on the internet site of DG SANCO Statistical Services of the European Union Food and Veterinary Office of the European Commission Hazard Analysis Critical Control Points International Organisation for Standardisation Maximum residues limits Ministry of Agriculture (Ministerio de Desarrollo Agropecuario) Ministry of Health (Ministerio de Salud) Official Journal of the European Union Part per million Polycyclic Aromatic Hydrocarbons Polychlorinated Biphenyls Rapid Alert System for Food and Feed Panamanian Residue Monitoring Plan III

5 1 INTRODUCTION The audit took place in Panama from 4 to 13 February 2014 and was undertaken as part of the Food and Veterinary Office's (FVO) audit programme. The audit team comprised two auditors from the FVO. Two audit reports have been produced. This report covers fishery products while the other report covers residues aspects in aquaculture fishery products (ref. DG(SANCO)/ MR FINAL). 2 OBJECTIVES AND SCOPE OF THE AUDIT The objectives of the audit were: to evaluate whether the official controls put in place by the competent authority (CA) can guarantee that the conditions of production of fishery products in Panama destined to be imported into the European Union (EU) are in line with the requirements laid down in EU legislation, and in particular with the health attestations contained in the health certificate laid down in Appendix IV to Annex VI to Commission Regulation (EC) No 2074/2005; to verify the extent to which the guarantees and the corrective actions submitted to the Commission services in response to the recommendations of the previous FVO audit report on fishery products of 2012 have been implemented and enforced by the CA (ref. DG(SANCO)/ MR FINAL, published on DG Health and Consumers' website In terms of scope the audit focused on the organisation and performance of the CA, the export certification procedure, the official control system in place covering production, processing and distribution chains applicable to fishery products to be exported to the EU. Accordingly, relevant aspects of the EU legislation referred to in Annex 1 were used as technical basis for the audit. In pursuit of these objectives, the audit team proceeded as follows: An opening meeting was held in Panama City on 4 February 2014 with the CA, the Department of Food Protection (DEPA) within the Ministry of Health (MINSA). This meeting was also attended by the Ministry of Agriculture (MIDA), the Maritime Authority of Panama (AMP), the Authority of Aquatic Resources of Panama (ARAP) and the Panamanian Food Safety Authority (AUPSA). At this meeting the audit team confirmed the objectives of, and the itinerary for the audit, and received additional information required for the satisfactory completion of the audit. The following sites were visited: COMPETENT AUTHORITY Central level 5 DEPA (MINSA), AMP, ARAP, AUPSA and MIDA Regional level 3 2 DEPA, 1 MIDA LABORATORY VISITS PRIMARY PRODUCTION Feed mill 1 1 The official laboratory in Panama city 1

6 Aquaculture farms 4 Fishing vessels 2 (including 1 harvest vessel) LANDING AND FIRST SALE Landing sites 1 FACILITIES HANDLING FISHERY PRODUCTS Processing Plants 3 OTHERS Wholesalers of medicines 2 representatives from the CA accompanied the audit team during the whole audit. 3 LEGAL BASIS FOR THE AUDIT The audit was carried out under the general provisions of EU legislation and, in particular: Article 46 of Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004, on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare. Full EU legal references are provided in Annex I. EU legal acts quoted in this report refer, where applicable, to the last amended version. 4 BACKGROUND 4.1 GENERAL BACKGROUND Panama is presently listed in Annex II to Commission Decision 2006/766/EC establishing the list of third countries and territories from which imports of fishery products for human consumption are permitted, other than those covered by Annex I. Panama is also listed in Annex to Commission Decision 2011/163/EU, indicating that the Panamanian Residue Monitoring Plan (RMP) for aquaculture is approved in accordance with Directive 96/23/EC and can therefore export aquaculture fishery products to the EU. The 2012 FVO audit report highlighted deficiencies in relation to maximum limits of heavy metals and histamine in fishery products, structure and maintenance of vessels and establishments and issuing of health certificates for products landed in Panama. The report made a number of recommendations in respect of the action required of the CA. Written guarantees were received from the CA in relation to the implementation of actions aimed at addressing those recommendations. 4.2 PRODUCTION AND TRADE INFORMATION According to information provided by the CA, the main fishery products exported to the EU are raw, frozen tuna (Thunnus alalunga, Thunnus albacares) and shrimp (Litopeneaus vannamei) and fish oil for feed purposes. The main importing Member States are Spain, Italy, UK and Greece for tuna and shrimp and Denmark for fish oil. 2

7 According to the list drawn up by the CA and available on the DG SANCO web site (list valid as of 08/01/2014), imports of fishery products from Panama into the EU are authorised from a total of nine establishments including seven establishments processing only or partially materials derived from aquaculture. On the list are 47 freezer vessels, 17 reefer vessels and seven factory vessels. The CA notified the Commission services of the delisting of one non-exporting establishment shortly before the audit and informed the audit team that another establishment had been delisted the week before the audit due to legal problems. After the audit, the FVO received a letter concerning the delisting of a further 14 freezer vessels. This list is available on the SANCO web site at the following address: Table 1 summarises the exports from Panama of fishery products to the EU. Table 1 - Exports of fishery products from Panama to the EU (tonnes) (source Eurostat) Commodity Fish, chilled and frozen (0303, 0304) 18,413 14,947 Shrimp (0306) 2,355 2,495 Oil (1504) 2,103 5,053 Total exports to the EU 22,871 22,495 Almost all fishery products exported to the EU, besides shrimp, are processed on board freezer and factory vessels and landed in Panama before being shipped to the EU. In addition, approximately 56,400 tonnes of frozen tuna are landed directly in EU Member States by Panamanian vessels according to statistics provided by the CA. 4.3 RAPID ALERT SYSTEM FOR FOOD AND FEED (RASFF) NOTIFICATIONS In 2012 there was one RASFF notification concerning the presence of Salmonella and Vibrio in frozen shrimp reported by Denmark. In 2013 there was one RASFF notification from Spain concerning high levels of mercury in swordfish. (See also Chapter 5.7) 5 FINDINGS AND CONCLUSIONS 5.1 LEGISLATION Legal requirements Article 46(1)(a) of Regulation (EC) No 882/2004 states that Commission experts may carry out official controls in third countries in order to verify the compliance or equivalence of third countries' legislation with the relevant EU legislation. 3

8 Article 11(4)(a) of Regulation (EC) No 854/2004. Findings The audit team noted that the main pieces of legislation covering the production chain of fishery products intended for export to the EU are the same as when the previous FVO audit took place in 2012, although some amendments have been made, and are the following: The Health Code Law No 66 of 10 November 1947, is the fundamental law for Panamanian public health which regulates the sanitary control of food, raw material and by-products. It includes hygienic food conditions, production, sanitation, distribution, preservation, consumption and obligatory controls of food. Also imports are included. Executive Decree No 1 of 3 January 1996, settles the sanitary regulation of fishery products, including aquaculture, for human consumption. Rules for the use of additives for aquaculture products are included. Executive Decree No 84 of 10 June 1996, contains requirements that cover, in general, the EU hygiene requirements for fishery products. Executive Decrees No 352 of 10 October 2001, and No 81 of 31 March 2003, require the implementation of HACCP in establishments. Resolution No 227 of 15 March 2007, establishes that a national sampling plan must be fulfilled by fishery and aquaculture products intended for export to the EU. Resolution No 368 of 15 May 2009, establishes maximum levels of residues and contaminants allowed in fishery products. There has been one modification, Resolution No 120 of 22 February 2013, to settle Maximum Residue Limit (MRL) for mercury and histamine. (See also Chapter 5.5) Resolution No 765 of 27 July 2010, establishes maximum microbiological levels for fishery products intended for human consumption. Resolution No 765 of 1 August 2012, prohibits the use of carbon monoxide in the processing of fishery products. Resolutions No 596 and No 597 of 12 November 1999, cover requirements for potable water. Resolution No 017 of 16 January 2014, sets parameters for freshness classification. Conclusions From a limited review of the national laws and the standards applied to fishery products and their production chain, they can be considered as broadly in line with the relevant EU requirements. Recommendations No 1 in the previous FVO report from 2012 have been addressed by the modification of the MRLs for mercury and histamine. 5.2 COMPETENT AUTHORITY Legal requirements Article 46 of Regulation (EC) No 882/2004 stipulates that EU Controls in third countries shall verify compliance or equivalence of third countries' systems with EU food law. These controls shall have particular regard to points b) to (e), (g) and (h) of the aforementioned article. 4

9 Findings Structure and organisation The structure and organisation of the CA has not changed since the 2012 fishery products audit. The CA remains the DEPA which has a central office in Panama City, 12 regional and 15 local offices with a total of 244 staff for controls of all food commodities. Official control tasks of fishery products are performed by the central CA, eight regional and two local offices with a total of 35 staff. Three regions have establishments approved for export to the EU. The CA staff is assigned to different control tasks according to training and experience. Control tasks include inspections of aquaculture farms, feed mills, landing sites, vessels and establishments and sampling within the RMP. The audit team noted that the CA staff is located in adequate offices and have the necessary means available for the performance of their tasks, such as vehicles, communication equipment/computers, material for sample collection, etc. to perform their tasks. At national level DEPA and MIDA have meetings every six months to discuss inspection and sampling programmes and results for aquaculture products, including findings and measures to be taken. The ARAP is responsible for technical approvals of fishing vessels and their registration and for issuing licenses (valid for one year). ARAP staff performs landing inspections to check the fishing equipment, fishery products and tracking devices that are compulsory to have on board and performs random checks at sea for legal aspects on fishing. ARAP issues catch certificates based on the vessel tracking system that records where the fishing has taken place. ARAP also registers aquaculture farms and participates in joint inspections of them together with MINSA and MIDA. MIDA is responsible for border controls, quarantine, import licenses for therapeutic substances and medicines and the registration of those products. MIDA staff is present when harvesting of aquaculture products occurs and issue harvest certificates that accompany the products to the processing plants. (See also Chapter 5.4.2) AMP is responsible for ports and has staff present to register landings. AMP issues five-year permits to foreign vessels allowing them to fly the Panamanian flag. AUPSA is responsible for import licenses concerning food and feed from a sanitary and phytosanitary point of view. Powers, Independence and Supervision The CA has powers to enter and inspect premises and vessels to check hygiene conditions and relevant documentation, collect samples for analysis, suspend approval, seizure or disposal of products and launch sanctions for non-compliances against food business operators under the Health Code Law No 66 of 10 November 1947, amended by Law No 40 of 6 November Executive Decree No 352 of 10 October 2001, gives possibilities for penalties for offences. (See also Chapter 5.3) There are legal provisions and a Code of Ethics for public servants to avoid conflicts of interest for staff. 5

10 The central CA supervises regional and local levels by visits to each region once or twice per year. During these visits documentation and sampling procedures are checked and inspections of vessels, establishments and aquaculture farms are performed jointly with the regional and local CAs. Inspection reports are written as are visit reports which are sent to the Director General of DEPA and the regional and local staff involved. However, in the West Panama regional office no visit reports were available. The audit team was informed that this office is close to Panama City and therefore the central inspectors go there several times per year to assist and visit reports have not been written. A monthly activity report and copies of all inspection reports are sent by the regional offices to the central CA. Training Training is documented by lists of participants and presentations given. During 2013 training sessions in HACCP evaluation, processing requirements, residues, sampling techniques and TRACES were given. Meetings with laboratories to coordinate sampling programmes and with regional offices for planning and implementation of controls are held. Agendas and minutes of these meetings are kept. The audit team noted that official staff presented knowledge of EU requirements which in general was shown to be adequate for the duties performed. Documented Control Procedures There is a comprehensive Manual of Procedures with instructions for monitoring and sampling for contaminants and toxic residues including instructions for non-satisfactory results, water and ice, microbiological checks, organoleptic examinations and procedures for export health certificates. There are checklists for inspections of farms, vessels and establishments. Conclusions The CA, designated for the official control of fishery products, has a structure and organisation that is adequate for the performance of their official control tasks. The CA has been given enforcement powers, resources and has put in place written procedures for the performance of their role. 5.3 NATIONAL PROVISIONS AND PROCEDURES FOR LISTING ESTABLISHMENTS EXPORTING TO THE EU Legal requirements Article 12(1) and (2) of Regulation (EC) No 854/2004. Part I.11. of the model health certificate for imports of fishery products intended for human consumption established in Appendix IV to Annex VI to Regulation (EC) No 2074/2005. Findings The CA has procedures in place for listing of facilities exporting to the EU (freezer vessels, factory vessels and establishments). There is an approval procedure in Panamanian legislation (Resolution 766/2010 and detailed requirements in Decree No 84/1996). In the inspection reports for both vessels and establishments 6

11 references are made to the EU Regulations (EC) Nos 852/2004, 853/2004 and 854/2004. Approvals are always given by the CA at central level. Some of the regional offices have been delegated the task of auditing establishments to certify that they fulfil requirements for approval. The approval states that the establishment may produce fishery products and that they can export to the EU and includes requirements for Good Manufacturing Practices, cleaning and sanitary procedures and HACCP plans. All establishments must have a business certificate from the Ministerio de Comercio e Industrias which allows them to operate. The CA at central level also issues a sanitary permit concerning operational requirements for storing and production of fishery products. These documents are valid one year and all establishments have to be re-approved every year. All establishments visited had their approvals/certificates available. Freezer and factory vessels that operate internationally are visited once a year by the CA for renewal of their approvals. The audit team saw letters where the CA demands that the vessels must unload the cargo in the presence of a CA inspector, that temperature recording devices must be installed for cold storage on board and that an interpreter, if required, has to be present at the time of inspection to be able to approve them. The audit team was informed by the ARAP that the vessels are inspected also by them in foreign harbours for renewal of their fishing licenses. Executive Decree of 10 June 1996, and Resolution No 766 of 27 July 2010, contain requirements and measures for inclusion or exclusion from the list of vessels and establishments authorised for export to the EU. The audit team saw examples of these powers in form of inspection reports, records of sampling, and letters to food business operators with requirements to be fulfilled before approval and withdrawal from the EU list due to non-compliances. Conclusions The provisions and procedures for listing facilities for EU export adopted by the CA are, in principle, adequate and provide satisfactory guarantees as required by point II.1 of the health certificate defined in Regulation (EC) No 2074/ OFFICIAL CONTROLS OF PRODUCTION AND PLACING ON THE MARKET Legal requirements Article 12(2) of Regulation (EC) No 854/2004. Requirements contained in point II.1 and point II.2 in case of aquaculture products of the model health certificate for imports of fishery products intended for human consumption established in Appendix IV to Annex VI to Regulation (EC) No 2074/2005. Article 11(4) of Regulation (EC) No 854/2004 establishes that EU controls carried out in the context of drawing up or updating lists of third countries from which imports of products of animal origin are permitted, shall take particular account of the extent and operation of official controls on imports of animals and their products (Article 46(1)(g) (h) of Regulation (EC) No 882/2004). Findings Official control system in place The official control system in place covers the entire fishery products production chain. Official 7

12 controls on the production and placing on the market of fishery products are foreseen to include the following: A regular check on the hygiene conditions of landing performed during visits to fishing vessels when landing takes place, but these checks are not documented. Inspections are performed once per year of all vessels using checklists on the hygiene conditions on board and temperature requirements. Inspections at regular intervals of aquaculture farms to check hygiene conditions, adequate use of veterinary medicinal product and record keeping performed at a minimum once a year. Inspections at regular intervals of establishments on land, to check in particular whether the structural and hygiene conditions for listing remain fulfilled, whether the fishery products are handled correctly, for compliance with hygiene and temperature requirements, traceability and the implementation of HACCP systems. Staff from the CA's central level visits all establishments at least once, sometimes twice, per year together with regional/local staff for renewal of the approval and the supervision of staff. Routine inspection frequency can vary between regions. In one region where staff is locally based, establishments are visited daily or twice a week. In another region the inspection frequency is two to three times per year. If non-compliances need to be followed-up, extra inspections are performed. When non-conformities are detected in all types of facilities described above, they are noted in the checklist and transferred to a separate document. This document includes also a timetable for corrective actions and has to be signed by the captain or the food business operator Primary production The audit team visited four aquaculture farms providing raw material to establishments listed for export to the EU, three shrimp and one finfish farm. There are two cycles per year for shrimp production. A Good Aquaculture Practice manual developed by the aquaculture industry was used by shrimp farmers. There were adequate records of each pond kept where starting date, feed, treatment and mortality were noted. The use of veterinary medicinal products was indicated as well as withdrawal periods. Documentation concerning substances used and invoices from feed mills were available. However, one shrimp farm had in 2011 recorded that harvesting took place in three ponds 27 and 28 days after treatment where 30 days withdrawal time should have been respected. This is described in detail in the residue report, DG(SANCO)/ MR FINAL. The audit team was informed by the CA that official visits are unannounced and this was confirmed by the farmers. MIDA inspectors visit two to three times per year. Inspection reports from MIDA using a farm inspection checklist were available as well as reports of the yearly joint visit by MINSA-MIDA-ARAP. Non-compliances were noted in the inspection reports. The CA visits farms three times per year for sampling under the RMP. Results of tests on those samples are sent out to the farms and the regional CA offices and they were made available to the audit team. MIDA staff is present when harvesting occurs and issue harvest certificates each day of the harvest. Copies of harvest certificates were also available to the audit team. The audit team visited two fishing vessels - one long liner with a refrigerated seawater (RSW) chilling system and one fish harvest vessel that pumped the fish on board, stunned and bled them prior to storage in closed, insulated plastic containers on ice during transport to the establishment. Both vessels showed acceptable hygiene conditions. In the long liner, the audit team was informed 8

13 that the temperature of the refrigerated seawater was measured every three hours, but was not recorded, which means that the chilling efficiency could not be demonstrated. Vessel files are kept at the central CA office and the audit team made a limited review by checking randomly selected files for two fishing vessel. Visits to vessels take place once a year and previous reports were available. The use of checklists and a separate non-compliance form with agreed time tables for corrective actions was confirmed by the audit team. However, in the case of one fishing vessel, the follow-up of corrective actions had not been documented Landing and first sale The audit team visited one landing site in a port where the CA has three inspectors permanently present to supervise landing operations. The audit team was informed by the CA that the inspectors check the freshness of the fish and the hygiene conditions during landing and loading onto the collecting trucks, but those checks are not documented. Containers with ice are brought from the receiving establishments with the trucks collecting the fish. No landing took place at the time of the audit team's visit Facilities, including vessels, handling fishery products The audit team reviewed the files of three freezer vessels and two factory vessels in the central CA office. The audit team requested the CA to have vessels available for on-the-spot visits, but no such vessels were provided for inspection. The files contained yearly inspection reports and completed checklists, certificates of approval, fishing licences, correspondence with the CA, hygiene controls, pest control, water testing, temperature registration, HACCP plans, photos and copies of food business operators' own-check documents, which respected the CA procedures. The audit team visited three establishments. These establishments had been visited with the stipulated frequency, checklists were used and inspection reports were available. Findings were noted and follow-up of deficiencies was carried out on the following inspection if not urgent. Results from official samples of water, ice and fishery products were sent out to the food business operator. Records of official sampling and own-checks were available to the audit team. Each establishment had its own ice production for use during production and for the transport of incoming raw material. Records of incoming raw material were kept including accompanying documents signed by the farmers stating that veterinary medicines had not been used or that withdrawal periods had been respected. Also official harvest certificates from MIDA were available. Traceability checks from finished products and from export health certificates were performed and the origin of the raw material (vessels or farms and ponds) was shown by a unique lot number given to each batch of raw material. However, in one example from the day of the FVO visit, the lot number, based on reception day and fishing vessel, for the incoming raw material had been changed as the same lot was used during more than one production day. In this particular case it was possible to identify the vessel providing the fish because it was the last lot received. The audit team noted that all three establishments could be considered as in line with EU requirements as regard the general structure and the flow of products. However, two of them processing shrimp were in need of maintenance concerning floors, walls and doors (broken surfaces, pooling of water, cracked door frames and doors, peeling paint, ice build-up in a cold storage) in transport corridors and loading and storage areas. Both the CA and the food business 9

14 operators were aware of the deficiencies. The audit team was informed that due to the cyclical nature of shrimp production, maintenance was planned to be undertaken when the production cycle was over. However, repairs were in progress in one of the establishments which had already completed the production cycle. Two establishments had not fitted doors leaving gaps to the outside between doors, floors and walls and one had doors (in the reception area) that were constructed with a lattice in the middle and above potentially allowing dust and pest entry, which had not been noted by the CA. In one establishment, the records of temperatures in a cold storage showed that -18ºC had not been reached for most of the time over two months. During this period the food business operator checked and documented temperatures of fishery products and moved products to containers to keep the required temperature. This had not been noted by the CA inspector in the checklist used for an inspection during this period where all the boxes had been ticked as acceptable. The visited establishments had own-check programmes covering reception controls of temperature and organoleptic examinations, staff training, cleaning and sanitation programmes, pest control, additives, packaging material, labelling and water and product quality. All establishments visited have a public water supply. There is a national requirement for free residual chlorine to be between 0.8 and 1.5 ppm. Incoming water is tested by the establishments with satisfactory results and records are kept. All three food business operators rely on the CA's sampling within the RMP for checks for heavy metals, dioxins/polychlorinated Biphenyls (PCBs) and Polycyclic Aromatic Hydrocarbons (PAH) HACCP-based procedures There were HACCP plans implemented and kept updated that addressed the significant hazards identified for the activities being performed. HACCP plans are assessed by the CA as part of their inspections and are included in the checklist used. One shrimp establishment did not consider veterinary medicine residues as a Critical Control Point (CCP) because they demand written guarantees of freedom from them from the farmers. Metabisulphite is an allergen and the labelling is considered as a CCP and packaging material is checked for the correct printing. One establishment had histamine in tuna as a CCP and controlled the temperature of incoming raw material from refrigerated seawater vessels (0ºC) and during the process (< 4ºC). The food business operator informed the audit team that own-checks have been performed on exported products on arrival in Spain. This year an in-house own-check testing by rapid test kits will commence. Heavy metals are not considered a hazard in wild caught fish Checks on the EU eligibility of imported raw materials The audit team was informed by the CA that in Panama there is no import of fishery products for further processing and onward export to the EU. Vessels from other third countries can unload their catch into shipping containers for transit through Panama and export to the EU. These landings are supervised by several authorities as described in the previous FVO report for fishery products and the CA issues the required health certificates. Conclusions The control system in place covers the entire production chain of fishery products intended for export to the EU. It allows the CA to provide guarantees with regard to the application of EU equivalent rules to the official control of fishery products. However, these guarantees are undermined by the shortcomings noted with regard to: lack of documentation of controls at the point of landing and the follow-up corrective 10

15 actions on board vessels; monitoring of chilling of fishery products and recording of temperature-controlled storage (RSW); not all relevant hazards are assessed in the HACCP plans; structural deficiencies in the establishments and not maintaining the required storage temperature which had not been observed by the CA. Recommendation No 2 of the last FVO report concerning structure and maintenance of establishments can be considered as partly addressed. No conclusion can be drawn with regard to recommendation No 3 concerning structure and maintenance of vessels due to the limited number of vessels seen by the audit team. Recommendation No 4 concerning issuing of health certificates for fishery products in transit via Panama can be considered addressed. 5.5 OFFICIAL CONTROLS OF FISHERY PRODUCTS Legal requirements Point II.1 of the model health certificate for imports of fishery products intended for human consumption established in Appendix IV to Annex VI to Regulation (EC) No 2074/2005, in particular official controls laid down in Annex III, Chapter II of Regulation (EC) No 854/2004. Findings Since the previous FVO audit analyses of dioxins are included in the RMP and maximum limits for mercury and histamine have been changed in the Panamanian legislation. (See also Chapter 5.1) The audit team noted that organoleptic examinations are performed by the CA inspectors at establishments as part of their inspection routines and they check the documentation of the food business operator controls. Checks at landing sites are not documented. Histamine controls are performed and samples consisting of nine units are taken and sent to an accredited laboratory in Ecuador for analysis. The nine results are now reported separately. In 2013 a total of 29 samples were taken and all showed acceptable results. However, in May 2013 only one analysis was made from the nine units in one sample. This mistake was pointed out by the CA in a letter sent in October 2013 five months later to the laboratory. Mercury, lead and cadmium are included in the RMP and 13 analyses were made in Two of them showed unsatisfactory results for mercury in wild caught fish that was not exported to the EU. PCBs are also included in the RMP. 28 samples were analysed during 2013 and all of them showed results under the EU maximum limits. PAH was analysed in 21 samples taken during 2013 and all results were satisfactory. No smoked products are exported to the EU. Microbiological analyses of 18 official samples of fishery products were performed in 2013 for E.coli, Salmonella and S. Aureus with acceptable results. All fishery products exported to the EU are raw, frozen products. 11

16 Parasites are checked for by the food business operators and randomly checked for by the CA inspectors by visual inspection at landing sites and in the establishments. Escolar (Lepidocybium flavobrunneum) can be exported to the EU and if so, the labelling is done in line with EU requirements. Poisonous fish is not of commercial interest in Panama. Residues of veterinary medicinal products are analysed for within the RMP. Samples are taken from both farms and establishments. (ref. DG(SANCO)/ MR FINAL) Water and ice is sampled both by the food business operators and minimum once a year by the CA for chemical and microbiological analyses. However, during 2013 there were no samples taken in two regions. Microbiological parameters analysed are E.coli, Enterococci, coliforms and colony count 22ºC, which cover EU requirements. Results are sent to the food business operators. The audit team reviewed analyses results in the three establishments visited. In one instance reviewed by the audit team, a water sample taken in an establishment on 3 June 2013 was received in the Panama City laboratory 4 June. A result report was issued on 13 June with a non-satisfactory result and the central CA office dated the report 24 June, eleven days later. On 30 July the central CA sent a letter to the food business operator where they demanded follow-up samples be taken in September. The food business operator took new samples for analysis and sent them to a different laboratory on 24 September. The food business operator sent a letter to the CA in October 2013 with analysis results and information of actions taken. The regional CA visited the establishment to initiate an investigation and photos of the visit were available but they were not dated and there were no minutes of the meeting. The food business operator informed the audit team that the nonsatisfactory result was due to the fact that the first laboratory had analysed the sample as if it was bottled water, not tap water. The results report of this first analysis showed that there was a mixture of parameters tested, not fully applicable to either bottled or tap water Additives Metabisulphite is used in shrimp production, mixed in the ice chilling the shrimp after harvest. The establishments' own-checks are performed at arrival by rapid tests and samples are also sent to external laboratories for analysis. The CA verifies the own-checks by random samples and results of those verifications were satisfactory for the last two years. Conclusions The CA implements official controls on fishery products exported to the EU that adequately cover most EU requirements (organoleptic checks, parasites, microbiology, additives, environmental contaminants and residues). However, the long delays from sampling to reporting results of analyses of histamine and water and ice would not allow the CA to take timely and adequate measures, should this be required. Recommendations No 5 in the previous FVO report from 2012 have been addressed by the modification of the MRLs for histamine. 5.6 LABORATORIES Legal requirements 12

17 Article 46(1)(d) and (c) of Regulation (EC) No 882/2004 stipulate that Community controls shall have particular regard to the resources including diagnostic facilities available to CAs and the training of staff in the performance of official controls. Points 41 and 42 of Guidelines of Codex Alimentarius CAC/GL on the Design, Operation, Assessment and Accreditation of Food Import and Export Inspection and Certification Systems. Chapter 1 of Annex I to Regulation (EC) No 2073/2005, Section II of Annex II to Regulation (EC) No 2074/2005 Regulations (EC) Nos 1883/2006, 333/2007 and (EU) No 252/2012. Findings The CA of Panama sends all samples for histamine analysis and contaminants within the RMP to an accredited laboratory in Ecuador. As part of an FVO audit to that country, this laboratory was visited in November (See ref. DG(SANCO)/ MR FINAL) The audit team visited a laboratory in Panama City designated to participate in official controls of water/ice and fishery products. The laboratory is not accredited. The laboratory stated that the process of accreditation will start this year. An initial visit by the accreditation body, Pracam, was carried out in September During microbiological (E.coli, Salmonella, coliforms, colony count 22ºC) and 22 chemical analyses of water and ice were performed. 18 microbiological analyses (E.coli, Salmonella and S. Aureus) of fishery products were also performed. In the laboratory visited there was no documented quality management system in place yet and work instructions were found to be out-dated. The latter problem, it was claimed, was due to a shortage of staff. At reception of the samples, the information is entered into a database. On the accompanying document from the sampler a consecutive identity number is written. This document follows the sample through the analysis. There is no written procedure in place for reception controls (i.e. temperature, packaging, time, conditions, etc.) However, the CA stated that rejection of samples had occurred during 2013 for failure to maintain the cold chain. The audit team saw records of microbiological analyses. A log book is kept where all samples received each day are recorded together with the starting date for the analyses and reading dates for each parameter. In every batch of samples, a non-inoculated sample of the media used and a sample with a control strain were added, to check that the method worked. Controls were made each day of all steps of the methods used. Controlled strains are acquired and kept at -70ºC, but they may be used after their expiry date. Results reports are sent out to both the CA and the food business operator. The staff are knowledgeable and specialised and there is a system for back-up of absent staff. Training in-house by seniors is not documented. Other training is documented by keeping lists of participants and topics covered. The laboratory has adequate facilities and equipment adequate for their tasks. Temperature controls of incubators and refrigerators are documented and balances are checked every day. An external company calibrates balances once a year, but not thermometers. 13

18 Inter-laboratory testing takes place every year for Salmonella organised from Denmark. The results of these tests were satisfactory. The laboratory had also participated in one proficiency testing for Salmonella in powdered milk with satisfactory result. Conclusions The laboratory performing official control analysis of water/ice and fishery products visited by the audit team is not evaluated and/or accredited under officially recognised quality management and assurance programmes equivalent to intenational standards and thus cannot demonstrate the reliability of the analysis results. 5.7 FOLLOW-UP OF RASFF NOTIFICATIONS Legal requirements Article 11(4) of Regulation (EC) No 854/2004 establishes that EU controls carried out in the context of the drawing up or updating of lists of third countries from which imports of products of animal origin are permitted, shall take particular account of amongst other factors the result of any import control carried out. Findings When a RASFF notification is received, the food business operator is asked for an investigation to find the source of the problem and an action plan with corrective measures to prevent re-occurrence. The CA may intensify the inspection frequency for the establishment and additional samples may be analysed to check the status. From the review of one case concerning microbiological findings in shrimp the audit team concluded that the set procedures had been followed. The audit team saw a letter sent by the CA to the food business operator with instructions for measures to be taken. The CA informed the audit team that their investigation of the notification of mercury in swordfish in 2013 showed that the fish was from South Korea, not Panama. Conclusions The measures taken by the CA following RASFF notifications were adequate and led to strengthening the mechanisms in place to ensure that fishery products exported to the EU from Panama comply with the health attestations mentioned in the health certificate of Regulation (EC) No 2074/ OFFICIAL CERTIFICATION Legal requirements Article 14 of Regulation (EC) No 854/2004. Article 6 of Regulation (EC) No 2074/2005, in particular the model health certificate for imports of fishery products intended for human consumption established in its Appendix IV to Annex VI. Article 6 of Directive 96/93/EC establishes that the Commission shall ensure that the rules and principles applied by third countries certifying officers offer guarantees at least equivalent to those laid down in this Directive. 14

19 Findings The CA has procedures for certification in place that includes an on-the-spot visit to check the consignment and the loading of containers. These checks are reported to the central CA before the certificates may be signed. All health certificates are signed at central level. The most recent model health certificate, in line with Regulation (EC) No 2074/2005, as amended is used. Panama had training in TRACES in November 2013 and has this year started to use the system. Catch certificates are issued by ARAP. The food business operator sends a request to ARAP when a consignment is ready for export. The production lot numbers corresponding to vessels delivering raw material are used for traceability checks in the vessel tracking system at ARAP. Copies of catch certificates were kept at the establishment visited together with copies of export health certificates and production data. Conclusions There is a system in place for export health certification that is in line with EU requirements. 6 OVERALL CONCLUSION In principle the current organisation and implementation of official controls could guarantee that the conditions of production of fishery products in Panama intended for EU export meet standards equivalent to the requirements laid down in EU legislation. However deficiencies identified, in particular concerning supervision of establishments and laboratory performance undermine the guarantees given in the EU export health certificates certificates (model defined in Regulation (EC) No 2074/2005). Improvements have been made since the last FVO audit in 2012 and corrective actions have been implemented by the CA, which address most of the recommendations of the 2012 audit report. 7 CLOSING MEETING During the closing meeting held in Panama City on 13 February 2014, the audit team presented the main findings and preliminary conclusions of the audit to the CA. During this meeting, the CAs acknowledged the findings and preliminary conclusions presented by the audit team and provided commitment to correct the deficiencies. 8 RECOMMENDATIONS 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 fishery products exported to the EU. 15

20 N. Recommendation 1. The CA should ensure that for vessels equipped for chilling fishery products in cooled clean seawater, tanks must incorporate devices that achieve a chilling rate that ensures that the mix of fish and clean seawater reaches not more than 0 C after 16 hours, and that allow monitoring and recording of temperatures in line with requirements in Point I.B.3 of Chapter I, Section VIII of Annex III to Regulation (EC) No 853/2004 and Point 2(d) of Chapter I of Annex II to Regulation (EC) No 852/ The CA should ensure that official controls of production and placing on the market of fishery products are performed, in particular the hygiene conditions of landing, in line with requirements in Point 1(a), Chapter I of Annex III to Regulation (EC) No 854/ The CA should ensure that all relevant hazards related to fishery products exported to the EU are assessed when food business operators put in place, implement and maintain procedures based on HACCP principles in line with requirements in Article 5, point 2(a) of Regulation (EC) No 852/ The CA should ensure that all facilities placed on the EU list have been approved only if they comply with requirements at least equivalent to the applicable ones referred to in Section VIII of Annex III to Regulation (EC) No 853/2004, and Annex II to Regulation (EC) No 852/2004 and that these listed facilities maintain compliance with those requirements, in order to be able to provide the guarantees required in point II.1 of the export health certificate defined in Regulation (EC) No 2074/ The CA should ensure timely access to laboratory results of official control analyses for histamine and water and ice in order to take timely and appropriate measures and provide the guarantees required in point II.I of the export heath certificate defined in Regulation (EC) No 2074/ The CA should ensure that laboratories performing official control analyses apply the principles of internationally recognised quality assurance techniques and are evaluated and/or accredited under officially recognised quality management and assurance programmes equivalent to international standards, such as ISO/IEC 17025, to ensure the reliability of analytical results. The competent authority's response to the recommendations can be found at: 16

21 ANNEX 1 - LEGAL REFERENCES Legal Reference Official Journal Title Dec. 2006/766/EC OJ L 320, , p Dec. 2011/163/EU OJ L 70, , p Dir. 96/23/EC OJ L 125, , p Dir. 96/93/EC OJ L 13, , p Reg. 852/2004 OJ L 139, , p. 1, Corrected and re-published in OJ L 226, , p. 3 Reg. 853/2004 OJ L 139, , p. 55, Corrected and re-published in OJ L 226, , p. 22 Reg. 854/2004 OJ L 139, , p. 206, Corrected and re-published in OJ L 226, , p /766/EC: Commission Decision of 6 November 2006 establishing the lists of third countries and territories from which imports of bivalve molluscs, echinoderms, tunicates, marine gastropods and fishery products are permitted 2011/163/EU: Commission Decision of 16 March 2011 on the approval of plans submitted by third countries in accordance with Article 29 of Council Directive 96/23/EC 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 96/93/EC of 17 December 1996 on the certification of animals and animal products 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 17