EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL

Transcription

1 EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL Directorate F - Food and Veterinary Office DG(SANCO)/7579/2005 MR Final REPORT OF A MISSION CARRIED OUT IN SOUTH AFRICA FROM 24 MAY TO 3 JUNE 2005 ASSESSING THE CONDITIONS OF PRODUCTION OF FISHERY PRODUCTS AND LIVE BIVALVE MOLLUSCS (AQUACULTURE ABALONE) INTENDED FOR EXPORT TO THE EUROPEAN UNION 24/10/

2 TABLE OF CONTENTS 1. INTRODUCTION Background to the mission Mission objectives and procedure FISHERY PRODUCTS MAIN FINDINGS Competent authority performance Laboratories AQUACULTURE ABALONE MAIN FINDINGS SAMSM&CP Classification of production areas Harvesting and transportation of aquaculture abalone Dispatch centres Requirements concerning end product Public health control and monitoring of production GENERAL CONCLUSION CLOSING MEETING RECOMMENDATIONS TO THE CA OF SOUTH AFRICA Fishery products Aquaculture abalone...15 ADDENDUM TO MISSION REPORT DG (SANCO)/7579/ ANNEX ANNEX

3 1. INTRODUCTION 1 The mission took place in South Africa from 24 May to 3 June The mission team comprised three inspectors from the Food and Veterinary Office (FVO), one inspector from the EFTA Surveillance Authority (ESA) and two National Experts from the Member States. This mission was scheduled as part of the FVO s planned mission programme for Background to the mission 2 South Africa is presently listed in part I of the Annex to Commission Decision 97/296/EC and authorised to export fishery products (FP) into the European Union (EU) by the specific Commission Decision 96/607/EC. Imports of FP from South Africa are authorised from a total of 69 establishments, 27 factory vessels and 196 freezer vessels. The total production exported to EU Member States 3 in 2003 and 2004 was, respectively, 74,631 and 75,380 tonnes. Various species of fresh/frozen/canned wild fish, cephalopods and wild crustaceans are exported to the EU. During 2003 and 2004 a total of four Rapid Alert System for Food and Feed (RASFF) notifications related to products imported from South Africa were recorded. Three notifications concerned high bacteriological counts and one related to the absence of labelling on live lobster crates Mission objectives and procedure The objectives of the mission were to: assess compliance with the special conditions governing imports of FP originating in South Africa, as laid down in Commission Decision 96/607/EC; assess the South African Molluscan Shellfish Monitoring and Control Programme (SAMSM&CP), in accordance with the requirements of Council Directive 91/492/EEC and Commission Decision 2002/225/EC, in the framework of South Africa s request for authorisation for aquaculture abalone (Haliotis midae) export to the EU market. In pursuit of these objectives, the mission team proceeded as follows: an opening meeting was held on 24 May with the Central Competent Authority (CCA). 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; 1 A list of abbreviations and special terms is drawn up in Part 1 of Annex 2 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 Annex 2 to this report. 3 EUROSTAT data. 3

4 the following sites were visited: COMPETENT AUTHORITY VISITS Competent authority central 1 SABS/FAI Cape Town/Western Cape Competent authority local 3 SABS/FAI West Coast, Hermanus and Port Elizabeth LABORATORY VISITS SABS 1 Microbiology analyses CSIR 1 Marine biotoxines, Heavy metals, Chemical analyses MCM 1 Phytoplancton PRIMARY PRODUCTION Fishing vessels 4 Equipped for FP ice chilling Freezer vessels 2 Factory vessels 1 Landing sites 3 FOOD PROCESSING FACILITIES Establishments 16 Fresh/frozen/canned FP / 1 Cold store Ice plants 3 representatives of the Competent Authority (CA) accompanied the inspection team during the whole mission. 2. FISHERY PRODUCTS MAIN FINDINGS 2.1. Competent authority performance Description The South African Bureau of Standards (SABS), Food and Associated Industries (FAI) Department, under the Ministry of Trade and Industry (MTI), in Cape Town, is the CCA. SABS/FAI is accredited to ISO (General criteria for the operation of various types of bodies performing inspection) by the South African National Accreditation System (SANAS). SABS/FAI is well organised being structured as follows: - Central level performs HACCP related six monthly inspections; - Local level carries out routine inspections on vessels and establishments; - Officers at the various export offices sample and verify each consignment of fishery products destined for Europe prior to the issuing of health guarantees; - Airport level does final checks on products, prior to export. Staff numbers are adequate for the task involved and officials appear to be well trained. Specific and detailed manuals, procedures, checks-lists, certificates and reports, e.g. for inspection of vessels and establishments, sampling and for inspection of product prior to export are available and uniformly used. The CA is only to a certain extent aware of Community requirements with regard to FP exports. Manuals and procedures used do not contain all the requirements of Community legislation and in some instances do not 4

5 correspond to Community requirements, e.g. absence of the requirement to use temperature recording devices in cold stores Verification of the CA control activities on FP production conditions (fishing vessels and establishments) Many of the deficiencies observed on-the-spot by the mission team and described below had also been included in CA inspection reports. However, recurring shortcomings have not been addressed by some establishments and no action had been taken by SABS, e.g. serious structure and hygiene deficiencies in some establishments such as broken floors, condensation on ceilings and rusty surfaces. Furthermore, some shortcomings identified by the mission team had not been previously identified by SABS inspectors, e.g. doors not pest proof, products kept in stagnant water, accumulation of products on processing tables/lines, poor traceability of products through processing, melting water contaminating products below and deficient collection system for waste water. During the visits to establishments and to the factory vessel, the CA could not provide any evidence that SABS inspectors are supervising the use of ingredients and additives and potentially toxic substances such as detergents, disinfectants, rodenticides and insecticides as described below 5. Fishing vessels The mission team visited four ice vessels, two freezer vessels and one factory vessel. During the visits the mission team noted that, apart from ongoing maintenance, the vessels were more or less in compliance with Community requirements. However, some shortcomings were detected during the visits: Ice vessels The mission team was told that ice vessels could stay at sea for up to seven days. In one vessel, the mission team noted that fresh gutted and de-headed fish were stored in containers with stagnant water due to the complete melting of the ice used. Freezer vessels In the freezer vessels visited the holds were not equipped with temperature recording devices. Factory vessel This vessel had no changing rooms; staff had one area with cubicles for clothes and boots. Packaging material was stored in non-hygienic conditions in the hold, together with finished products and open carton boxes covered 4 In their response to the draft report, the CA commented this point. 5 In their response to the draft report, the CA commented this point. 5

6 with dust. The use of repetitive fumigation was noticed. The CA could not provide evidence of the prevention of contamination of FP following this operation (product used, cleaning after fumigation). Establishments The mission team visited three ice plants that supply ice vessels. These plants generally complied with Community requirements. However, shortcomings related to contamination of ice were noted, e.g. absence of a complete pest and dust proof barrier from the external environment, paint flaking in areas where ice is stored and handling of ice from the plants to the vessels/establishments. Sixteen establishments on the list of establishments approved for export of FP to the EU were visited by the mission team. Thirteen establishments could be considered as in compliance with the provisions of Community legislation after correction of some deficiencies. The three remaining establishments were not in compliance and in need of correction of many serious deficiencies regarding layout, structure, equipment, maintenance and hygiene. A list of deficiencies were noted during the visits to establishments can be found in Annex 1 to this report. Regarding HACCP, all establishments visited presented a plan which is regularly audited by the CA. However, deficiencies were noted regarding their implementation in some establishments (see Annex 1) Verification of the official controls carried out on FP Organoleptic checks Organoleptic checks to assess the freshness of FP are not carried out by the CA during the offloading from the vessels or before first sale. However, establishments carry out organoleptic checks by sampling each batch Chemical checks Total Volatile Basic Nitrogen (TVB-N) and Trimethylamine-Nitrogen (TMA-N) analyses are not carried out 6. Histamine testing of end products from susceptible families is carried out by the CA on every batch to be exported to the EU. Additionally, histamine analyses are carried out on samples taken by the establishments according to a sampling programme. Maximum levels for heavy metals in FP, laid down in the Foodstuffs, Cosmetics and Disinfectants Act, are not equivalent to those specified in Community legislation (Commission Regulation (EC) No 466/2001 on Food Contaminants). The permitted levels for Cadmium and Lead are higher for some types of FP 7. 6 In their response to the draft report, the CA commented this point. 7 In their response to the draft report, the CA commented this point. 6

7 Results of analyses for Mercury, Lead and Cadmium on FP were provided to the mission team, some of which exceed the limits set in Commission Regulation (EC) No 466/2001 on food contaminants. The mission team saw evidences on the rejection of products intended to be exported to the EU following exceeding maximum levels of Mercury Microbiological analyses Microbiological criteria and limits for Enterococci in potable water, as in Council Directive 98/83/EC, are not established in the framework of the South African exports to the EU 8. Microbiological analyses are done on FP prior to export and on water and ice every month Laboratories Two laboratories dealing with FP, potable water and ice analyses were visited. The laboratory quality systems are, for a large number of tests, accredited to ISO 17025, as required by Council Directive 93/99/EEC on official control of foodstuffs. The Laboratories appeared to have good facilities, competent staff, and to be well equipped. The mission team was provided with the SANAS accreditation certificate and the schedule for the different government and private laboratories involved in the FP official control, including the SABS laboratory located in Pretoria which is responsible for the testing of heavy metals. 3. AQUACULTURE ABALONE MAIN FINDINGS 3.1. SAMSM&CP The SAMSM&CP was assessed by the mission team. The Marine Coastal Management (MCM), under the Department of Environmental Affairs & Tourism (DEAT), is the Regulatory Authority authorising the mariculture, harvesting and transport of molluscan shellfish for wholesale trading and is in charge of the monitoring activities of the SAMSM&CP in cooperation with SABS/FAI. The mission team was provided with the Memorandum of Understanding describing the relations between the two authorities with regard to the SAMSM&CP implementation. The mission team assessment of the SAMSM&CP applies exclusively to abalone aquaculture production as it is, as stated by the CA, the only product that is intended to be exported. This assessment includes considerations on whether aquaculture abalone are to be exported live or/and processed (without entrails), given that it will influence the controls, in particular for biotoxins and heavy metals, that are concentrated in the entrails. 8 In their response to the draft report, the CA commented this point. 7

8 Important aspects of the programme relating to wild abalone and other species were not assessed. Therefore, expansion of future exports to wild abalone and other species will require further detailed assessment of the control programme. The SAMSM&CP manual has been prepared by MCM and SABS/FAI. This manual includes the monitoring activities required for audit of growing areas and establishments in the interests of public health. In general, it includes the majority of the requirements of Council Directive 91/492/EEC and Commission Decision 2002/225/EC. Legal maximum levels for heavy metals in bivalve molluscs, as in the Foodstuffs, Cosmetics and Disinfectants Act, are not equivalent to those in Community legislation (Commission Regulation EC No 466/2001 on Food Contaminants). The level for Cadmium is higher and there is no level set for Lead Classification of production areas The SAMSM&CP gives three classes of area: Approved, Controlled and Prohibited. Controlled areas are further divided into Conditionally Approved and Restricted. A list of ten approved in-land farms that correspond to production areas was provided to the mission team. The classification appeared to be correctly assessed on the basis of the laboratory reports of faecal Coliform monitoring used in the programme. The list includes the addresses of the farms but not the information on the production area EU health status (A, B, C). Furthermore, the geographical co-ordinates and boundaries, inclusive of the seawater collection point, are not included. The classification of production areas could be determined without the testing of molluscan shellfish flesh: - Section only refers to microbiological testing of water; - Section does not require the microbiological classification of growing areas being made on the basis of compulsory analyses of shellfish flesh. One in-land abalone farm was visited by the mission team Harvesting and transportation of aquaculture abalone The registration/movement document model does not contain information regarding the address of the harvester and the production area EU health status (A, B and C). Movement documents assessed by the mission team were not completely filled in Dispatch centres One dispatch centre/live packer approved for export to the EU and three that were not approved, but which were interested to export live abalone, were visited. The approved dispatch centre visited can be considered in compliance with Community requirements. 8

9 In the three non-approved dispatch centres visited, several structural and hygiene deficiencies were noted by the mission team (similar to other visited FP establishments, see Annex 1) Requirements concerning end product End product testing is randomly done in processed abalone. However, end product testing is not carried out for live abalone as samples were not taken at, or immediately after, the packing stage Public health control and monitoring of production General aspects MCM/SABS do not have a mandate to issue agreements with the laboratories, relying on the accreditation of these laboratories by SANAS. No supervision/coordination of the testing laboratories is undertaken by MCM/SABS. No National Reference Laboratories (NRLs) are designated for marine biotoxins/bacteriological and viral contamination of bivalve molluscs, which adds to the lack of scientific coordination by MCM/SABS. Deadlines for receipt of analyses results from the testing laboratories are not defined in the SAMSM&CP manual Microbiology General Microbiological analyses of abalone are performed by two SABS laboratories located in Cape Town and Port Elizabeth. The Cape Town laboratory was visited by the mission team and appeared to have good facilities, competent staff, and to be well equipped. Deviations from the SAMSM&CP manual were noted as the sampling protocol, Appendix 1, 3.1. of the manual, states that between five and ten animals are to be taken per sample while the mission team was informed by the SABS sampling officer that only four animals are routinely taken for microbiology. Methods The faecal Coliform/Escherichia coli method specified by the SAMSM&CP manual is a 5 tube/3 dilution MPN method, as required by Council Directive 91/492/EEC. The methods used for general food products are accredited by SANAS. However, the methods specified for use in the SAMSM&CP (faecal Coliforms/Escherichia coli, Salmonella and Vibrio cholerae) differ from those used for general food products and are not currently accredited. Furthermore, this laboratory does not have Standard Operation Procedures (SOPs) for these methods. The standard methods are therefore not supplemented with the additional details necessary to ensure consistent application. Individual analysts had to take decisions relating to details of the methods that were not specified in the method, e.g. how much sample material to use in microbiological tests: 100 gr. being used in the SAMSM&CP and 25 gr. being used for compliance testing of abalone end product and other food products (including FP). 9

10 Quality system The laboratory undertook proficiency testing for presence/absence testing of pathogens. However, no formal assessment of results was undertaken by either the proficiency test provider or the laboratory itself. No system was in existence for undertaking corrective actions in the case of aberrant results. The laboratory did not take part in any proficiency testing for the quantitative faecal Coliform/Escherichia coli testing undertaken for the SAMSM&CP or for official control samples undertaken on abalone or FP. The SAMSM&CP manual sampling protocol (Appendix 1, 3.5.) sets requirements for sample transport temperature and elapsed time before analysis. However, no records of time and temperature are kept by the laboratory. These requirements are therefore not verifiable Marine Biotoxins General The frequency for marine biotoxin testing is monthly in the East of Cape point area for ASP, PSP and lipophilic toxins 9 (ex-dsp), with a bi-weekly variation for PSP in the West of Cape point. As in the case of potential toxic species, results of phytoplancton are not used to increase frequency of flesh testing (see chapter below), and as data on the kinetics of abalone contamination and purification were not seen by the mission team, MCM/SABS undertook to provide a written report justifying the choice for the referred sampling frequency for ASP, PSP and lipophilic toxins. In this context, the mission team was told that toxins (and also heavy metals) accumulate mainly in the abalone entrails and not the muscle, which is the edible part of the animal. The mission team visited the Council for Scientific and Industrial Research (CSIR), a semi-governmental laboratory, that is the only laboratory performing testing on marine biotoxins in South Africa. This laboratory also performs analyses for heavy metals and other chemical analyses for abalone and FP. Methods The CSIR performs the following analyses related to the monitoring of marine biotoxins: Lipophilic toxins: Yasumoto, 1984 modified on the whole flesh. PSP toxins: AOAC, 1990 on the whole flesh. ASP toxins: Quilliam, The SAMSM&CP manual prescribes the methods to be used for testing of marine biotoxins but deviations were noted as the methods mentioned for 9 The toxicity previously referred to as diarrhetic shellfish poisoning (DSP) is caused by several distinct groups of natural compounds, such as okadaic acid (OA) and dinophysistoxins (DTXs), yessotoxins (YTXs), azaspiracids (AZAs) and pectenotoxins (PTXs). Each has a different mode of action and each causes different types of toxicity. These groups of toxins are now sometimes referred to as lipophilic toxins, referring to their chemical characteristics rather than their toxic effect. 10

11 lipophilic and ASP toxins are Yasumoto, 1978 and AOAC, 1991, respectively. The laboratory is accredited in accordance with ISO for the Yasumoto, 1984 modified method (mussels and oysters) and for the AOAC, 1990 method (clams, mussels and oysters). The laboratory is not yet accredited for the method of Quilliam, 1995 but the mission team was told that it is expected that it will be accredited soon by SANAS. SOPs were observed for the three above methods. The accreditation scopes and SOPs state that the analyses are to be performed on the edible part of the animals. However, in the case of abalone, it is not clear whether this relates to the whole animal. The performances of the referred methods in abalone are not determined trough a validation process. One technician is in charge of the bioassays (lipophilic toxins and PSP) and one technician is in charge of the ASP analysis. The laboratory appeared to be adequately equipped for the number of analyses that are currently done. Should this quantity be increased, it would be necessary to adapt the laboratory to the new situation and to increase the number of staff. Quality system There is a quality system in place in the laboratory but some shortcomings were identified at three levels: Technical The laboratory has no written procedures to check the compliance of the samples received with some defined criteria that may influence the reliability of the result, e.g. number of specimen, freshness of samples for bioassay. The following factors appear to contribute to poor reproducibility of the analysis. The conditions for performing the bioassay (from the injection to the end of the observation time) were not adequate. After being injected, mice are kept in individual small glass pots in the same room where the extraction procedures take place. Deficiencies in the execution of the mouse bioassay for PSP were observed. The conversion factor for the PSP bioassay has been determined by one external staff once and has not been checked by the technician that performs the analysis regularly. The calculation of the PSP results was based on an average instead of a weighted mean. Even if it is allowed in the method, it is preferable to use mice having a weight as close as possible to 20 ± 2 gr. in order to assure the highest level of reproducibility of the PSP method. Quality control Internal quality controls for the ASP analysis by HPLC/UV method were in place for the determination of the recovery for each batch of analysis. However, there was no internal control for lipophilic toxins and PSP bioassays. The PSP conversion factor was not verified by the operator, for example by using a known concentration of standard. No negative sample (blank) is injected. Regarding external quality control, one sample for lipophilic toxins and one sample for PSP of West Coast abalone were tested in parallel with the CRL for marine biotoxins. The results obtained were both negative for lipophilic 11

12 toxins and both above the regulatory limit for PSP (134 for CSIR and 188 µgr./100 gr. of flesh for CRL). The laboratory indicated that this parallel testing would be done yearly. For ASP no ring test has been done so far. The laboratory also indicated that for ASP, participation in the Quasimeme programme 10 ring test would be carried out. The CSIR made an assessment of the reliability of the mouse bioassay for PSP toxins through a study performed in May 2004 by an external scientist. A report of a study 11 was shown to the mission team. The results of this study showed some discrepancies between results obtained from the CSIR technician and the scientist. To improve the reliability of the analyses, several significant recommendations were made in this report but at the time of the visit, only some of them had been put in place. Documentation/traceability As there was no procedure within the laboratory to check compliance of the samples to defined criteria, there is no way to trace back to the initial state of the sample whether a result is atypical or doubtful. In the bioassay, some points of the procedure are not recorded, e.g. the portion used for homogenisation, the weight of the test portion used and the symptoms of the mice Phytoplancton The mission team visited the MCM phytoplancton laboratory which is in charge of all analyses performed in South Africa. It is mainly involved in research programmes in order to understand the development of blooms in South African waters. Scientific publications were shown to the team during the visit. Given the scope of their research, the phytoplancton monitoring results are mainly used for the building up of a database and not as part of the public health protection system. The mission team was also told that even in the presence of potentially toxic phytoplancton, neither the frequency of shellfish sampling is intensified nor the harvesting areas closed. Furthermore, there are no defined thresholds for the different phytoplancton species in relation to the intensive sampling. The laboratory is well equipped and staff appeared to have good scientific knowledge on the harmful algal blooms in South African waters. A list of potential toxic species and a database with the results were available. Water sampling for phytoplancton testing is performed on a daily basis by farm staff using bottles of 200 ml. In the farm visited, the mission team was told that the samples are taken from the water inlet slipway at 50 cm depth. Water is fixed by the sampler. A composite weekly sample is analysed by MCM laboratory. The method of identification and numeration of the phytoplancton is the Utermöhl method. During the visit a list of potentially toxic species used by 10 Quasimeme = Quality Assurance Laboratory Performance Studies for Environmental Measurements in Marine Samples. 11 The comparative analysis of the MBA for the quantification of paralytic shellfish poisoning using different abalone samples and independent investigators (not published laboratory internal document). 12

13 the laboratory was produced. However, the laboratory does not pay any particular attention to epiphytic 12 phytoplancton species that may be found on kelp 13 and that, consequently, may represent a potential risk for abalone. 4. GENERAL CONCLUSION Fishery Products The SABS official controls take place regularly and on the basis of documented procedures ensuring a high degree of uniformity and consistency. However, Community requirements are not sufficiently and evenly enforced. The follow-up of the required corrective actions in some establishments (especially in products/processes with a high risk) and the use of sanctions, i.e. suspension of the FP export certification or withdrawal of an establishment s approval, are currently insufficient. Thus, the current export health attestation by SABS cannot be considered as in full compliance with the requirements of specific Commission Decision 96/607/EC. Aquaculture abalone The system of control and monitoring of aquaculture abalone has been developed since 2003 and many steps have been put in place with a view to obtaining the authorisation of South Africa for export to the EU. However, the mission team noted deficiencies regarding the coordination between MCM, SABS and the laboratories; the risk-based justification of the biotoxins monthly sampling frequency; the failure to use the phytoplancton monitoring results as part of the public health protection system, the performance of the requested analyses for microbiology and biotoxins; and the present legal limits for heavy metals. 5. CLOSING MEETING During the final meeting carried out in Cape Town, on 3 June 2005, the mission team presented the findings and preliminary conclusions of the mission to the CCA. MCM representatives also attended this meeting but only in relation to the aquaculture abalone SAMSM&CP. The CCA provisionally accepted the mission team s findings and stated that corrective actions would be put in place to guarantee the safety of the products to be exported and to strengthen the control system as currently implemented. The CA also stated that a meeting with industry representatives will be called in order to highlight the findings of the mission team and that Commission services will be regularly provided with follow-up information. 6. RECOMMENDATIONS TO THE CA OF SOUTH AFRICA The CA should provide the Commission services with an action plan including a timetable for its completion, within two months of receipt of the final report, in order to address the following recommendations for FP exported to the EU. However, the CA should forward, within 25 working days of receipt of the draft report, guarantees as to the actions that have already been taken to address 12 Living on the surface of plants, in this particular case, on the surface of kelp. 13 Large brown seaweeds (order Laminariales) upon which abalone feeds. 13

14 recommendation (2) related to inappropriate, or absence of, corrective actions and follow up, regarding repeated deficiencies in products/processes Fishery products Competent authority performance (1) In order to ensure full compliance with Community requirements, the CA should follow the requirements of Council Directive 91/493/EEC and Council Directive 92/48/EEC for FP and Fishing Vessels respectively. This relates in particular to Chapter V of the Annex to Council Directive 91/493/EEC. (2) Non-compliances identified and reported (by the CA during inspection visits), and in particular repeated issues, should be accompanied by the request for their correction with a deadline in order to guarantee a proper follow-up. (3) The CA should supervise the use of ingredients and additives according to the requirements of Council Directive 95/2/EC on Food additives, and of potentially toxic substances such as detergents, disinfectants, rodenticides and insecticides, as required by Chapter III, II, A, 2 and 5 of the Annex to Council Directive 91/493/EEC. (4) Each batch of FP should be submitted for inspection by the CA at the time of landing or before first sale to check whether they are fit for human consumption. This inspection should include an organoleptic check carried out by sampling, as required by Chapter V, II, 1 of the Annex to Council Directive 91/493/EEC 14. (5) The CA should ensure that the maximum levels set for heavy metals in FP in Commission Regulation (EC) No 466/2001 on Food Contaminants are respected. (6) The CA should ensure that microbiological criteria and limits for Enterococci in potable water set in Council Directive 98/83/EC are respected Fishing vessels (1) The CA should ensure that factory vessels are provided with adequate changing rooms as set out in Chapter I, I, 1 (h) of the Annex to Council Directive 91/493/EEC. (2) The CA should ensure that packaging materials are stored in good hygienic conditions in accordance with Chapter I, I, 1 (e) and Chapter VI of the Annex to Council Directive 91/493/EEC. (3) The CA should ensure that the use of any substance (rodenticides, insecticides) cannot lead to the contamination of the FP, as described in Chapter III, II, A 2 of the Annex to Council Directive 91/493/EEC. 14 The CA is aware that from 1 January 2006, the CA should enforce the requirements set by Regulation (EC) No 854/2004, laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption, in particular Chapter II, A of Annex III, where it is stated that random organoleptic checks must be carried out at all stages of production, processing and distribution. 14

15 (4) The CA should ensure that sections of vessels or containers reserved for the storage of FP must be designed as to allow them to ensure that melted water cannot remain in contact with the FP as required under Annex I, 1 to Council Directive 92/48/EEC Establishments (1) Ice plants supplying flaked ice to vessels should be designed and maintained in such a way that ice is not contaminated with pests and dust coming from the external environment and from foreign materials such paint flakes. (2) The CA should ensure that the structural, equipment, maintenance and hygiene shortcomings observed during the visits to the establishments, as described in chapter and Annex 1, are corrected according to the requirements of Chapters III and IV of the Annex to Council Directive 91/493/EEC Aquaculture abalone SAMSM&CP The CA should ensure that, when exporting aquaculture abalone to the EU in future, applicable maximum levels for heavy metals set in Commission Regulation (EC) No 466/2001 on Food Contaminants are respected Conditions for production areas (1) According to the requirements of Chapters I of the Annex to Council Directive 91/492/EEC the CA should publish a list of classified inland farms with the production area EU health status (A, B, C) and the locations of the classified in-land abalone farms with the use of geographical co-ordinates and the boundaries including the seawater collection point. (2) Sections and of the SAMSM&CP should be amended to only allow the classification of production areas following the testing of molluscan shellfish flesh Harvesting and transportation of aquaculture abalone (3) The registration/movement document model should contain specific fields on the address of the harvester and on the production area EU health status. (4) The CA should supervise the use of movement documents in order to ensure their correct implementation Requirements concerning live abalone Live abalone at the end product stage (at dispatch centre level and at, or immediately after, the packing stage) should be randomly tested in accordance with the requirements described in Chapter V of the Annex to Council Directive 91/492/EEC. 15

16 Public health control and monitoring of production General aspects (5) MCM/SABS should ensure the supervision and coordination of the testing laboratories. (6) Deadlines for the receipt of analyses results from the testing laboratories should be set in the SAMSM&CP manual or other associated document. Microbiology (7) Deviations from the SAMSM&CP manual sampling protocol (Appendix 1, 3.1.) should be corrected. The number of animals taken by the sampling officer should correspond to the number of animals stated in the SAMSM&CP manual. (8) The specific methods used in the framework of the SAMSM&CP (faecal Coliforms/Escherichia coli, Salmonella and Vibrio cholerae) should be included in the laboratory scope of accreditation in line with Council Directive 93/99/EEC on the official control of foodstuffs. Whenever the standard methods are being modified, laboratory SOPs should be established. (9) Proficiency testing should be followed by a formal assessment of results by either the proficiency test provider or the laboratory itself. In the case of aberrant results a system should be established for undertaking corrective actions as required by Council Directive 93/99/EEC. (10) The laboratory should participate in a proficiency testing scheme for the quantitative faecal Coliforms/Escherichia coli testing undertaken for the SAMSM&CP or for official control samples undertaken on abalone or FP. (11) SABS laboratories should keep records of the time and the temperature of the samples at laboratory arrival in order to verify the requirements set up in the SAMSM&CP manual sampling protocol (Appendix 1, 3.5.). Biotoxins (12) MCM/SABS should provide Commission services with a written report justifying the choice for the referred sampling frequency for ASP, PSP and lipophilic toxins. This report should also include the information on the accumulation of toxins and heavy metals in the different parts of the abalone body. (13) The SAMSM&CP manual should be amended to reflect the methods that are currently being used by the laboratory, in particular for lipophilic and ASP toxins. (14) The method of Quilliam, 1995 for ASP toxin should be included in the laboratory scope of accreditation in line with Council Directive 93/99/EEC. (15) In the SOPs for biotoxins, it should be clearly mentioned if the edible part of the animal relates to the whole animal or to the muscle. 16

17 (16) The performance of the biotoxins methods in abalone should be validated. (17) Deficiencies described in chapter on the laboratory quality system should be corrected. Phytoplancton (18) Phytoplancton monitoring should be used as part of the public health protection system in line with the requirements of Chapter VI of the Annex to Council Directive 91/492/EEC. (19) MCM/SABS should establish thresholds of the different phytoplancton species. (20) MCM/SABS should provide information to Commission services on studies made about the epiphytic phytoplancton species that may be found on kelp and that consequently may represent a potential risk for abalone. 17

18 ADDENDUM TO MISSION REPORT DG (SANCO)/7579/2005 South African CA response to report recommendations SABS/FAI sent its comments to the draft report which address all the recommendations of the report. Some recommendations have already been implemented while others are expected to be completed in the following months. Comments included: - Reply from SABS/FAI on individual recommendations pertaining to FP; - Clarification from SABS/FAI on report factual contents; - SABS/FAI and industry request for clarification on specific requirements related to fresh FP storage and frozen FP thawing; - Reply from MCM on individual recommendations pertaining to aquaculture abalone including the report on the SAMSM&CP justifying the sampling frequency for marine biotoxins tests in abalone; - Reply from CSIR laboratory; - Reply from SABS laboratory; - Reply from establishments. 18

19 ANNEX 1 List of general deficiencies noted during the visits to establishments Structure/Layout Layout deficiencies obliging raw material and processing products to pass through areas that are open to the exterior; parts of these areas were not covered and therefore not protected from the weather; trucks in the reception area; forklifts driving between presumably clean processing area (exposed products) and contaminated parts of the premises; cross-contamination of the product in these areas cannot be excluded; Layout deficiencies obliging the sorting area/equipment to be partially outside the building; premises open to the exterior leading to a high risk of crosscontamination (dust, smoke, dirt, birds, rodents, insects); exposed FP moved directly from the quay to the processing area/sorting machine; Layout deficiencies obliging staff already wearing working clothes to pass through areas that are open to the exterior; No clear segregation/separation between clean and dirty areas (high/low risk areas); Storage of packaging materials not organised/cleaned; storage area not sufficiently protected from contamination; doors not pest/dust proof; presence of flies; boxes open and unprotected; packaging materials contaminated; simultaneous storage of a truck and spare parts; Existence of mezzanines/dead spaces in production areas; not easy to clean and disinfect; Doors open to the exterior or not closing tightly to prevent the entry of pests, dust and smoke; presence of insects (flies) inside the premises, including processing rooms; Uneven flooring preventing sufficient drainage of waste water; Ceilings made of material not easy to clean, disinfect and maintain. Maintenance/Organisation Poor conditions of maintenance of premises, equipment and tools such as broken tiles on the floor and walls, flaking paint from walls and ceilings, damaged concrete and holes/cracks in the floors and rusted surfaces; poorly maintained conveyer belts; cutting tables heavily scored and not easy to clean and disinfect; Cold stores not organised; ice accumulating in the store and on packed and exposed products/raw material; presence of unlabelled products; presence of broken carton boxes with exposed products; Changing rooms: dust and dirt accumulation; lockers poorly maintained; Wellington/rubber boots observed in changing rooms where only private clothes were supposed to be kept; No separation between private clothes and working clothes; working clothes used during 2 consecutive days (no clean working clothes at the beginning of each working day); aprons and working gloves stored in a corridor in the production area in close contact with the walls; Cables/electrical wires not properly covered in processing rooms; Ceilings with rusted frames. 19

20 Equipment No hand wash basins in processing rooms; presence of hand-operable taps (by pressure, self closing but considered acceptable by the CA); Toilets; no toilet paper and no single use hand towels; Storage rooms for frozen products not equipped with a temperature recording device; Presence of dirty wooden pallets in processing areas; Equipment in processing areas dirty/dusty; Intense leaking of ammonia from a plate freezer in the processing area of one establishment; Rusty equipment used for handling of FP. Processing practices / Hygiene Poor conditions of hygiene; dirty floors, walls, ceilings, equipments; Fresh headed and gutted FP kept in a stagnant mixture of ice and water; inadequate drainage of melting water; FP being thawed/kept in melting/stagnant water 15 ; Accumulation of waste water; waste water from working tables not ducted into the drains; waste accumulating on the floor in the processing area; Presence of steam in processing areas; condensation of water on the ceiling, walls and equipments contaminating the raw material; condensation on the ceilings of processing areas above exposed products; Removal of blocks of frozen fish minced meat from master cartons carried out in such way that the products are in contact with the external part of the carton; Melting water coming from FP containers contaminating FP in containers below; Conditions observed during offloading of bulk frozen fish from a vessel to a cold store do not prevent contamination of the product; FP (inside a bulk net) in contact with the roof of the cold store; contamination by rusted equipment/surfaces; sorting on a big extremely dirty and poorly maintained wooden platform. Storage of frozen bulk FP in dirty and poorly maintained wooden containers (grids) that were stored outside in the open air; Water splashing (hosing near exposed products) contamination during processing; Gloves/hands dip in sanitizer s solution and no rinsing before use; FP temperature increasing during the processing (before freezing) due to piling up/accumulation on the lines/working tables; Products temperature during the processing above the establishment fixed limit of 10 C; no corrective actions observed. HACCP/Own-checks Deficiencies noted in the HACCP risk analyses: detection of metal fragments done visually, no metal detector used; 15 SABS/FAI and industry requested for clarification on this set of specific requirements. 20

21 Absence of CCP records; Critical limits not clearly identified/set; No corrective actions defined/recorded after critical limits being exceed; Flow diagram inconsistent with the actual on-site production. 21

22 ANNEX 2 1. Abbreviations and special terms used in the report AOAC ASP CA CCA CCPs CRL CSIR DEAT DSP EC EEC ESA EU FAI FP FVO HACCP HPLC/UV ISO MBA MCM MPN MTI NRLs PSP RASFF SABS SAMSM&CP SANAS SOPs TMA-N TVB-N Association of Analytical Communities Amnesic Shellfish Poison Competent Authority Central Competent Authority Critical Control Points Community Reference Laboratory Council for Scientific and Industrial Research Department of Environmental Affairs & Tourism Diarrhoeic Shellfish Poison European Community Economic European Community EFTA Surveillance Authority European Union Food and Associated Industries Fishery Products Food and Veterinary Office Hazard Analyses Critical Control Point High Performance Liquid Chromatography / Ultra Violet International Organisation for Standardization Mouse Bioassay Marine Coastal Management Most Probable Number Ministry of Trade and Industry National Reference Laboratories Paralytic Shellfish Poison Rapid Alert System for Food and Feed South African Bureau of Standards South African Molluscan Shellfish Monitoring and Control Programme South African National Accreditation System Standard Operation Procedures Total Volatile Basic Nitrogen Trimethylamine Nitrogen 22

23 2. References to Community Acts quoted in the report European legislation Official Journal Title Council Directive 91/492/EEC OJ N L 268, , p. 1 Council Directive 91/492/EEC of 15 July 1991 laying down the health conditions for the production and the placing on the market of live bivalve molluscs (as amended). Council Directive 91/493/EEC OJ N 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 (as amended). Council Directive 92/48/EEC OJ Nº L 187, , p. 41 Council Directive 92/48/EEC of 16 June 1992 laying down the minimum hygiene rules applicable to fishery products caught on board certain vessels in accordance with Article 3(1)(a)(I) of Directive 91/493/EEC. Council Directive 93/99/EEC OJ N L 290, , p. 14 Council Directive 93/99/EEC of 29 October 1993 on the subject of additional measures concerning the official control of foodstuffs (as amended). Council Directive 98/83/EC OJ Nº L 330, , p.32 Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption (as amended). European Parliament and Council Directive No 95/2/EC OJ Nº L 061, , p.1 European Parliament and Council Directive No 95/2/EC of 20 February 1995 on food additives other than colours and sweeteners (as amended). Commission Decision 96/607/EC OJ N L 269, , p.23 Commission Decision 96/607/EC of 11 October 1996 laying down special conditions governing the import of fishery and aquaculture products originating in South Africa Commission Decision 97/296/EC OJ N L 122, , p.21 Commission Decision 97/296/EC of 22 April 1997 drawing up the list of third countries from which the import of fishery products is authorised for human consumption (as amended). Commission Decision 2002/225/EC Commission Regulation (EC) 466/2001 European Parliament and Council Regulation (EC) No 854/2004 OJ N L 75, , p. 62 OJ N L 77, , p.1 OJ N L 139, , p.206 Commission Decision 2002/225/EC of 15 March 2002 laying down detailed rules for the implementation of Council Directive 91/492/EEC as regards the maximum levels and the methods of analysis of certain marine biotoxins in bivalve molluscs, echinoderms, tunicates and marine gastropods. Commission Regulation (EC) No 466/2001 of 8 March 2001 setting maximum levels for certain contaminants in foodstuffs. 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. 3. Legal basis for the mission The mission was carried out under the general provisions of Community legislation and, in particular: 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 (as amended), in particular its Article 11(2); Council Directive 91/492/EEC of 15 July 1991 laying down the health conditions for the production and the placing on the market of live bivalve molluscs (as amended), in particular its Article 9 (1); Commission Decision 98/140/EC 16 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. 16 OJ No L 38, , p