HEALTH & CONSUMERS DIRECTORATE-GENERAL

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1 EUROPEAN COMMISSION HEALTH & CONSUMERS DIRECTORATE-GENERAL Directorate F - Food and Veterinary Office DG(SANCO)/ MR - FINAL FINAL REPORT OF A MISSION CARRIED OUT IN ECUADOR FROM 15 OCTOBER TO 23 OCTOBER 2008 IN ORDER TO EVALUATE THE CONTROL OF RESIDUES AND CONTAMINANTS IN LIVE ANIMALS AND ANIMAL PRODUCTS, INCLUDING CONTROLS ON VETERINARY MEDICINAL PRODUCTS In response to information provided by the Competent Authority, any factual error noted in the draft report has been corrected;any clarification appears in the form of an endnote.

2 Executive Summary This report describes the outcome of a mission carried out by the Food and Veterinary Office (FVO) in Ecuador, from 15 to 23 October 2008 as part of the published programme of FVO inspections on residue controls in third countries. The objective of the mission was to evaluate the implementation of national measures, aimed at the control of residues and contaminants in live animals and animal products exported to the EU, including the controls on the distribution and use of veterinary medicinal products and feed additives, the use of which may give rise to residues in such products. As Ecuador is only authorised to export fishery and aquaculture products to the EU, the mission focussed on residues controls in this commodity. The evaluation was based on the standards set out in Council Directive 96/23/EC, and other relevant Community legislation in this field, including legislation on the control and distribution of veterinary medicinal products. The mission assessed the performance of the competent authorities and other officially authorised entities involved in residues and veterinary medicinal product controls and the legal and administrative measures put in place to give effect to the relevant Community requirements with regard to import of food of animal origin into the EU. The report concludes that the Ecuadorian national residues plan goes beyond minimum EU requirements in relation to the number of samples programmed and the testing for non-essential groups of substances. In general its implementation, both in terms of sampling and testing is satisfactory. A procedure for registration, approval, inspection and sampling controls on the food business operators eligible to export products to the EU has been developed. However, the absence of effective controls on the retail distribution of veterinary medicinal products and the presence on the market of several EU-banned substances weakens competent authority guarantees on the residues status of the products exported to EU. It must be stated however that there was no evidence observed of the use of any EU-banned substances in the approved farms visited by the mission team. The report makes a number of recommendations to the Ecuadorian competent authorities, aimed at rectifying the shortcomings identified and enhancing the control measures in place. i

3 TABLE OF CONTENTS 1 INTRODUCTION OBJECTIVES OF THE MISSION LEGAL BASIS FOR THE MISSION BACKGROUND COUNTRY STATUS IN RELATION TO SUBMISSION OF RESIDUES CONTROL PLANS INFORMATION ON TRADE AND PRODUCTION MAIN FINDINGS NATIONAL RESIDUE CONTROL PLAN Planning of the national residue control plan Implementation of the national residue control plan Supervision of implementation of the national residue control plan Follow-up of non-compliant results OTHER RESIDUES CONTROL PROGRAMMES Pre-export testing Testing for melamine in feed Establishments' own-checks LABORATORIES VETERINARY MEDICINAL PRODUCTS AND MEDICATED FEEDINGSTUFFS Authorisation of veterinary medicinal products Distribution and use of veterinary medicinal products Controls on the distribution and use of veterinary medicinal products CONCLUSIONS NATIONAL RESIDUE CONTROL PLAN OTHER RESIDUES CONTROL PROGRAMMES LABORATORIES VETERINARY MEDICINAL PRODUCTS AND MEDICATED FEEDINGSTUFFS OVERALL CONCLUSION CLOSING MEETING RECOMMENDATIONS ii

4 ABBREVIATIONS & SPECIAL TERMS USED IN THE REPORT Abbreviation AOZ and AMOZ, AHD and SEM CCß CC# Competent Authority DG(SANCO) ELISA EU EU FVO HACCP HPLC-DAD INP ISO LC LC-UV MAGAP ML MRL MRPL MS-MS National residues plan RASFF Explanation Marker residues of the nitrofuran drugs furazolidone, furaltadone, nitrofurantoin and nitrofurazone respectively Detection Capability Decision Limit The Ecuadorian central competent authority for aquaculture, the Instituto Nacional de Pesca (INP) Health and Consumers Directorate-General Enzyme-linked immunosorbent assay European Union European Union Food and Veterinary Office Hazard Analysis and Critical Control Points High Performance Liquid Chromatography-Diode Array Detector National Institute for fisheries (Instituto Nacional de Pesca) National Residue Control Plan International Organisation for Standardisation Liquid Chromatography Liquid Chromatography-Ultraviolet detector Ministry of Agriculture, Animal Husbandry, Aquaculture and Fisheries (Ministerio de Agricultura, Ganadería, Acuacultura y Pesca) Maximum Level Maximum Residue Limit Minimum Required Performance Limit (Tandem) Mass Spectrometry National Residue Control Plan Rapid Alert System for Food and Feed iii

5 Abbreviation SESA SOP Explanation Ecuadorian Service of Animal Health (Servicio Ecuatoriano de Sanidad Agropecuaria). From December 2008, SESA becomes AGROCALIDAD (Agencia Ecuatoriana de Aseguramiento de la Calidad del Agro) Standard Operating Procedure iv

6 1 INTRODUCTION The mission took place in Ecuador from 15 to 23 October The mission team comprised three inspectors from the Food and Veterinary Office (FVO). The mission was undertaken as part of the FVO's planned mission programme, evaluating control systems and operational standards in this sector. Representatives from the central competent authority (the Instituto Nacional de Pesca - INP) accompanied the inspection team during the whole mission. An opening meeting was held on 15 October At this meeting, the objectives of, and itinerary for, the mission were confirmed by the inspection team and the first discussions with the competent authority officials were held. 2 OBJECTIVES OF THE MISSION The objective of the mission was to evaluate the implementation of national measures, aimed at the control of residues and contaminants in live animals and animal products, including the controls on the distribution and use of veterinary medicinal products and feed additives, the use of which may give rise to residues in such products. The mission was based on the evaluation of the equivalence of Ecuador's standards to Council Directive 96/23/EC[1] and other relevant Community legislation in this field, including legislation on the control and distribution of veterinary medicinal products. The mission focused on the role of the competent authorities, the legal and administrative measures in place to give effect to the relevant requirements with regard to import of food of animal origin into the European Union (EU), controls on residues and veterinary medicinal products and the performance of residue testing laboratories. The table below lists sites visited and meetings held in order to achieve the objectives. [1] EU legal acts quoted in this report and included in the Annex refer, where applicable, to the last amended version. 1

7 Comments Competent Authorities Central 2 Opening and closing meetings 1 Meeting with SESA 1 Interim meeting with INP and SESA Others 1 Meeting with officials in charge of implementation of the NRCP Laboratories 1 Private carrying out all the analysis under the national control plan Other sites 2 1 Laboratory (hatchery) for production of shrimp larvae 1 Primary production sites (integrated shrimp farm) 1 Primary production sites (tilapia farm with hatchery) 1 Primary production site (tilapia and shrimp farm) 1 Feed mill producing feedingstuffs for shrimp and tilapia 2 Wholesaler/importer/retailer of veterinary medicinal products for aquaculture 1 Wholesaler/importer/retailer of veterinary

8 medicinal product for all species 1 Primary processor of shrimps 2 Retailers of veterinary medicinal products for aquaculture 3 LEGAL BASIS FOR THE MISSION The mission was carried out under the general provisions of Community legislation and, in particular: Article 46 of Regulation (EC) No 882/2004 of the European Parliament and of the Council on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules; Commission Decision 98/140/EC of 4 February 1998 laying down certain detailed rules concerning on-the-spot checks carried out in the veterinary field by Commission experts in third countries. A full list of the legal instruments referred to in this report is provided in the Annex. 4 BACKGROUND 4.1 COUNTRY STATUS IN RELATION TO SUBMISSION OF RESIDUES CONTROL PLANS Commission Decision 2004/432/EC, indicates that Ecuador's National Residues Control Plan (hereafter referred to as the national residues plan) is approved in accordance with Council Directive 96/23/EC for aquaculture products. 4.2 INFORMATION ON TRADE AND PRODUCTION Ecuador exports fishery products (including aquaculture products) to the EU this is the only food of animal origin exported to the EU-. The exports include two species, shrimp (Penaeus vannamei) and tilapia (Oreochromis spp.). Total national production and export data for the years 2006 and 2007 were supplied by the competent authority and are reflected in the table below. 3

9 Commodity Production Exports to EU Production Exports to EU Shrimp 120,164 57, ,801 63,145 Tilapia 11, , The type of shrimp production in Ecuador is predominantly extensive farming (98% of the total production), with relatively little intensive and semi-intensive husbandry. Tilapia is mostly farmed semi-intensively. Most of the farms are vertically integrated with feed mills, and exporting companies. Details of the numbers of operators registered and approved by the competent authority in Ecuador are included in the table below. Type of establishment Registered Registered and approved Total Shrimp farms Hatcheries Feed mills for aquaculture Fish mills Primary processors Exporters/processors MAIN FINDINGS 5.1 NATIONAL RESIDUE CONTROL PLAN Prior to April 2007, the controls over the aquaculture sector were the responsibility of the Ministry of External Trade, Industry, Fisheries and Competition (Ministerio de Comercio Exterior, Industrialización, Pesca y Competitividad). After that date it became a responsibility of the Ministry of Agriculture, Animal husbandry, Aquaculture and Fisheries (Ministerio de Agricultura, Ganadería, Acuacultura y Pesca, MAGAP), and for this purpose the Sub-secretary of Aquaculture was created on the 19 of April The National Institute for Fisheries (Instituto Nacional de Pesca, INP) within the MAGAP is responsible for the planning and implementation of the national residue control plan (national residues plan). In June 2008 the management board of the INP changed. From this date, major re-adjustments in the procedures for official controls 4

10 have been implemented. The legal basis for the official controls on residues of veterinary medicinal products and contaminants is established in the law of fisheries and fishery development (Ley de Pesca y Desarrollo Pesquero), implemented in 2002 by Executive Decree 3198 RO/690. This Decree establishes the obligations of the food business operators to keep on-farm records of the use of veterinary medicinal products. The competent authority maintains lists of exporters and other establishments involved in the production chain of aquaculture: hatcheries for the production of shrimp larvae (so called laboratories), farms, feed mills and fish mills. Exporting companies are obliged to source all materials (e.g. feed, larvae) from listed operators. Registration is a pre-requisite for inclusion in the system. Competent authority approval of registered operators is the second step. At the beginning of 2008, some delays were noted in the implementation of visits for approval of establishments. Representatives of the INP explained that additional resources have been allocated to this task so all the establishments are expected to be visited by January A monthly exercise in export establishments for verifying that raw materials have been correctly sourced from registered operators has recently been implemented by the competent authority. By the time of the mission, 130 inspections had taken place. The competent authority stated that this is also applied in the approval procedure for farms where their suppliers (hatcheries, feed mills) also are required to be registered Planning of the national residue control plan The 2008 national residues plan was received by Commission services on the 1st April After assessing the plan additional information was requested from the competent authority in June. An updated national residues plan was received in August 2008 which addressed many of the questions raised in the Commission services' evaluation. The mission team noted that: the national residues plan is designed centrally by managerial staff in the INP; for planning, the activity of the business operator and its exporting activity data were taken into account; the plan covers all the stages of the aquaculture production: hatcheries, laboratories for production of shrimp larvae, farms, primary processors, exporters and feed mills. Each establishment involved at any stage in the export chain was included in the plan; all registered food business operators are obliged to be sampled as part of the competent authority approval process for approval for export to the EU. The subsequent frequency of sampling is defined by the activity of the operator. Exporters are sampled and tested once per month. Other operators (e.g. primary producers and feed mills) are sampled at least once per year. Sampling is spread throughout the year and is thus equivalent to the requirements of Commission Decision 98/179/EC. Additional samples can be taken if the competent authority suspects there is a problem; the total number of samples was based on the quantities exported to the EU during 5

11 the previous year. The number of samples planned goes beyond minimum EU requirements laid down in Annex IV to Council Directive 96/23/EC : 1260 samples for shrimp vs. a minimum of 631, and 23 samples of tilapia instead of 6; in addition to routine samples, further samples are taken from each batch of fish/shrimp intended for export in the exporting establishment. The issuing of an export certificate is contingent upon a satisfactory outcome of the residue tests performed; from August 2008, each sample taken has been tested for all of the substance groups listed in the national residue plan, thus exceeding EU requirements; the national residues plan covers all of the relevant groups of substances for aquaculture as specified in Annex I to Council Directive 96/23/EC, with the exception of Group B2a (anthelmintics), which is not tested for in tilapia. Anthelmintics are available for use in aquaculture in Ecuador. Emamectin which has a Maximum Residue Limit (MRL) for fin fish in the EU has been authorised for use in aquaculture by the INP, and benzimidazoles, whilst not authorised by the INP were nevertheless found on the market for use in aquaculture during the mission. This latter group of anthelmintics do not have an MRL for aquaculture in the EU; the scope of testing within the groups of substances whilst comprehensive for most of the groups did not always take into account the availability of veterinary medicinal products. For example, in group B1 neither doxycycline nor fosfomycin, both of which are authorised by the INP for use in aquaculture are tested for. These two antibiotics do not have a Community MRL for aquaculture; there were some deficiencies in the analytical methods listed in the plan which reduce the possibility of reliably detecting residues of certain substances. For example, there are no confirmatory methods available for Groups A3 (steroids) and B3d (aflatoxins). The analytical method used for nitroimidazoles (Group A6) did not detect the marker residue for dimetridazole, HMMNI (see chapter 5.3, Laboratories); the national residues plan has been disseminated to all of the operators in the aquaculture sector and is available on the INP web site together with the checklists in use by the officials. Thus, the scope of residues testing is known to the industry Implementation of the national residue control plan Business operators are charged directly by the laboratory involved for the cost of residue testing under the national residue plan (see follow-up). Since the 22 August 2008 the competent authority is publishing on its website ( ) the list of the batches sampled under the national residues plan and the establishment where the samples were taken until the results are available (i.e. a pending list). When the results are available and compliant the batch is removed from the list. This tool is intended to prevent the exporters from inadvertently purchasing batches of shrimp/tilapia with an unknown residues status. The mission team noted that: 6

12 controls under the national residues plan (including sampling) in the aquaculture sector are carried out exclusively by official staff; controls are unexpected by the operator and are carried out without previous warning, except in remote areas where the farmer's presence during the visit needs to be ensured. Controls on the same operator are carried out by different official staff on a rotational basis in order to address any possible conflicts of interest; newly recruited INP inspectors 'shadow' experienced inspectors for the first two months. In addition inspection staff (all of which are now headquartered in Guayaquil) are obliged to attend weekly meetings where they discuss aspects of their inspection duties. Comprehensive training on verification of HACCP systems in the aquaculture sector took place in July 2008 and a second one on controls aimed to comply with EU legal requirements took place in October Effectiveness of the training is measured inter alia by means of written examinations which all of the INP inspectors have had to sit; planning of the sampling visits is done by the co-ordinator of the national residues plan. The sampling plan is prepared two or three weeks in advance and provides for the establishments to be visited every day; once at the establishment, the inspector chooses the batch, tank or pool to be sampled. Comprehensive instructions for carrying out sampling of young and adult animals and feedingstuffs were available to staff. Standard sampling forms were in use in all the premises visited. Staff met were well aware of sampling requirements; official samples taken under the national residues plan are in triplicate. If the initial sample is non-compliant, the second (contra-sample) and (if the second sample result is compliant) third (arbitration) sample are also tested for residues of the substance found in the initial sample. Two out of the three samples must test non-compliant for the results to be declared non-compliant; samples are individually identified, sealed and frozen. Representatives of the INP explained that new sampling materials had been purchased in order to improve the standard of packaging, sealing etc; transport of the samples to the laboratory is done by the INP officials. It was seen that in general samples were delivered to the laboratory on the same day of collection or, if collected in remote areas, by the end of the week. Such samples are securely stored in recently purchased freezers which are located in INP offices in the more remote provinces; rules for the custody of official samples have recently been modified. Previously the samples were left under the responsibility of the business operator, who was then in charge of the transport to the laboratory and of keeping the contra-sample and the arbitration sample. The official laboratory is currently custodian of all three sub-samples until the official testing has concluded. Representatives of the competent authority noted that this is a temporary solution until the construction of a walk-in freezer in the facilities of the INP has completed; at the time of the mission all of the samples foreseen in the 2008 residue plan had 7

13 already been taken. The competent authority stated that sampling would continue with the same regularity but that not all of the substance groups would be tested for in every sample. Emphasis would be placed on testing for banned substances such as nitrofurans, malachite green etc; turnaround times have been agreed between the competent authority and the official laboratory. From the 1st September 2008, results of samples from hatcheries and exporters are obliged to be delivered within eight working days and from farms in five working days. Reports reviewed during the mission showed compliance with those turnaround times Supervision of implementation of the national residue control plan The mission team noted that: the leader of the inspection team is also supervising the implementation of the controls. Supervision is carried out by monitoring on a daily or weekly basis the activities carried out by the inspectors. When sampling does not take place (e.g. due to inadequate size/age of the animals on the farm), the supervisor re-schedules the sampling of that farm to another date; in the examples selected at random by the mission team, sample forms were correctly filled and staff at the laboratory informed the mission team that 100 per cent of samples received had been adequately documented, sealed and frozen. None had been rejected as unfit for analysis Follow-up of non-compliant results The INP is the competent authority for all follow-up activities. sanctions is the duty of the Sub-secretary of Aquaculture. The imposition of On the 22nd August 2008, INP's responsibilities were updated by means of the Agreement 138, giving the INP the authority to detain and, when necessary, destroy aquaculture products found to contain residues in excess of maximum residue limits (i.e. non-compliant). Since 2005 there has been only one RASFF notification for residues of a veterinary medicinal product in fishery and aquaculture products from Ecuador. The marker residue (AOZ) for the nitrofuran, furazolidone was found in shrimps in The mission team noted that: follow-up is carried out by the same staff of the INP who carries out sampling and inspections. Instructions for follow up include verification of traceability of the batch back to farm or to the feed mill when relevant. However, the instructions are very general and on-farm investigations are not routinely carried out; until August 2008, the competent authority had 27 non-compliant results for shrimps (initial sample only). There were two confirmed non-compliant results all year (one for malachite green found during the mission and one for lead) in all the other cases the tests carried out on the contra-sample and/or the arbitration sample 8

14 were compliant. There were no non-compliant results for the tilapia samples; several of the files concerning these samples were examined by the mission team. In one case a very high result had been observed in the initial sample for residues of the EU-banned drug dimetridazole. In this case the competent authority had scheduled a follow-up visit to this farm for the end of October (It is also noted that when the raw data for this result was examined in the laboratory, the result was not actually valid); in a non-compliant result for lead, both initial and contra-sample results were higher than the Community Maximum Limit (ML). An on farm investigation had been carried out which suggested fuel contamination as the source and further sampling had been carried out, the results of which had been compliant; during 2007 residues of several steroids were detected in samples of shrimp tested using a range of commercially available enzyme-linked immunosorbent assay (ELISA) kits. The samples were not subject to chemical confirmation and contra-analysis was carried out only for four samples again using ELISA. (It is noted that the ELISA tests used were not fit for purpose as they had not been adequately validated for testing either shrimp or tilapia muscle); during 2007, 17 per cent of the shrimp samples and three out of eleven tilapia samples tested positive for malachite green. All results were under the Community MRPL of 2 µg/kg. The competent authority had identified incorrect agricultural practices and the use of malachite green as a fungicide in feed materials as the possible origin of those residues; in relation to the follow-up carried out for non-compliant results during 2007, INP representatives presented the Commission services with detailed information on those cases. In 2007, a consistent follow-up of the initially non-compliant results was not in place. Not all of the samples were subjected to confirmatory testing and only one shrimp sample was finally confirmed non-compliant for the antibiotic oxytetracycline (group B1 substance). 5.2 OTHER RESIDUES CONTROL PROGRAMMES Pre-export testing The mission team noted that: the competent authority has established a requirement that links the issuing of export certificates for batches intended for export to the receipt of satisfactory (compliant) residue test results for that batch. Each export batch is tested for all of the substance groups listed in the national residues plan. This requirement was documented in the exporter visited. 9

15 5.2.2 Testing for melamine in feed The mission team noted that: since August 2008 a test for melamine in feedingstuffs has been included in the analysis of samples taken within the framework of the national residues plan. Examples of those tests were presented in the feed mill visited Establishments' own-checks The mission team noted that: all primary producers visited had in place own controls that included routine testing of soil, water, feed and own production; in the integrated tilapia farm visited comprehensive testing had been carried out in the framework of the own checks programme. Residues tested for included chloramphenicol, heavy metals and inhibitors. Batches from other holdings sending their tilapia to the processing establishment within this integrated unit were also routinely tested; in relation to the use of 17#-methyl-testosterone (for sex inversion in tilapia fry), documentary evidence was available of a study undertaken by the farm to verify the absence of residues by the time of marketing. (However it was noted that the ELISA method used by the laboratory employed by the farm for this study had not been validated for fish muscle); in the feed mill visited a comprehensive testing programme for aflatoxins in raw materials was included in their own control programme; currently business operators have the legal obligation to notify the competent authority of any non-compliant results obtained in the course of own-control checks. 5.3 LABORATORIES By the time of the mission one private laboratory had been contracted by the INP to provide analytical services for the national residues plan. The INP also has a laboratory which is being set up to carry out residue testing for some analyses; however this laboratory was not being used for the national residues plan. During the visit to the private laboratory, the mission team noted that: the laboratory is accredited to ISO by the American Association for Laboratory Accreditation. The most recent accreditation audit was in 2007 and a re-inspection is scheduled for February Seven analytical methods for residues of pharmacologically active substances and contaminants are within the scope of accreditation and a further five have been submitted for inclusion in the next audit; agreements between the INP and the laboratory were available for inspection. Under the agreement the INP has the right to carry out annual technical audits. The last of these had been in June 2007 where the INP had employed an ISO17025 assessor to carry out this task on their behalf. The outcome of the audit had been 10

16 satisfactory. In addition, a technical assessment had also been performed by another expert on behalf of INP in March 2008 which had resulted in a recommendation to validate analytical methods according to Commission Decision 2002/657/EC; the laboratory carries out testing for a wide range of clients including the INP. Sample traceability was ensured with a sequential laboratory number coding system and the analysts were unaware of the ownership of the samples as the name of the company was removed from the form accompanying the samples to the laboratory. It was noted however that in some cases names of individual persons working for the farm or establishment where the sample was taken remained on the sample worksheet even though the company had been deleted. Laboratory management stated that this would be rectified immediately; some deficiencies were observed in the sample preparation area. The plastic cups in which samples were homogenised were not adequately cleaned and thus accidental cross contamination of samples could not be ruled out. Prevention of such contamination is required in Chapter of Annex I to Commission Decision 2002/657/EC (see Endnote); the laboratory was well equipped with state of the art analytical equipment including two LC-MS/MS, three HPLC with either UV, DAD or FL detectors and GC-MS. There are 14 staff involved in residues testing; the laboratory was generally functioning as expected of an ISO-accredited facility. A quality manual was in place and there were method SOPs available including a validation SOP. It was noted that while the validation files of several methods examined showed that the methods had been comprehensively validated in accordance with the requirements of Commission Decision 2002/657/EC, the validation SOP had not been updated and did not reflect this. Several other discrepancies in documentation were noted with labels on pipettes and solvents indicating that the materials were out of date when in fact it could be seen from the records that re-calibration and preparation of new solutions had been carried out as required; the laboratory regularly participates in internationally recognised proficiency testing schemes as required by the ISO standard. In every case examined by the mission team, performance of the laboratory had been satisfactory; with regard to the LC methods used, multi-point matrix-fortified standard curves are used in every case with positive and negative control samples included in every run with recovery ranges set as an acceptability criterion. Some of the MS/MS methods also use deuterated internal standards (e.g. chloramphenicol); with the exception of the nitroimidazole method, quality control charts (recovery of the positive control) are also plotted for all of the LC methods and also the AA methods for chemical elements. There is an SOP detailing actions to be taken when a method falls out of statistical control. However, the SOP had not been followed when the nitrofurans method had briefly been out of control on two consecutive days in September 2008 for two of the metabolites (AOZ and AHD). With this exception, for all control charts selected at random by the mission team, the methods 11

17 were in statistical control; method and validation data for nitrofurans, malachite green, nitroimidazoles and steroids were examined. The methods for nitrofurans and malachite green had been well validated and CC# and CCß were in both cases less than the respective Community MRPLs for these EU-banned substances, as reflected in Annex II to Commission Decision 2002/657/EC; with regard the nitroimidazoles method (HPLC-DAD), it was noted that: o the method covered three compounds metronidazole, ronidazole and dimetridazole but did not include the major 2-hydroxy metabolite (HMMNI) for the latter compound. As such, the method is not fit for purpose for the detection of dimetridazole residues; o the spiking level for the positive control sample is too high (50 µg/kg) as this is much bigger than the level of interest (< 5 µg/kg). This is not in accordance with chapter of the Guidelines for the Implementation of Decision 2002/657/EC (document SANCO/2004/2726rev2); o CC# estimates for each of the three parent molecules were around 5 µg/kg, which are in excess of the recommended figure of 2 µg/kg proposed by the Community Reference Laboratory; o one very high result for dimetridazole (199 µg/kg) had been found and when repeated the apparent concentration was similar. However, the recovery of the dimetridazole spike exceeded the acceptability criterion thus invalidating the result. It was noted that in the contra-sample analysed some days later, no residues of nitroimidazoles were detected; with regard to screening for steroid residues, this is done by commercially available ELISA kits. It was noted that: o the tests (e.g. for nortestosterone, ethinyl estradiol, trenbolone) had not been validated for fish or shrimp muscle by the manufacturer or by the laboratory. Validation of analytical methods is required under Article 3 (c) of Commission Decision 2002/657/EC; o no performance characteristics had been established by the laboratory as required in point of Annex I to Commission Decision 2002/657/EC; o it was seen that in some cases the ELISA reagents had expired; o neither optical density data nor standard curves for quantification were available for inspection and positive and negative controls were not routinely run in each assay; o in 2007 there had been several screening positive results though none had been subject to confirmation by mass spectrometric methods and, in light of the way in which the methods have been run, those screening results were not reliable (see Endnote). 12

18 5.4 VETERINARY MEDICINAL PRODUCTS AND MEDICATED FEEDINGSTUFFS Authorisation of veterinary medicinal products Executive Decree 3198 RO/690 designates the INP as the competent authority for issuing authorisations to import veterinary medicinal products to be used in aquaculture, as well as for keeping a unified register of all such products. Controls on veterinary medicinal products intended for use for other species are under the responsibility of the Ecuadorian Service of Animal Health (Servicio Ecuatoriano de Sanidad Agropecuaria, SESA). This service maintains on its website ( ) a register of the veterinary medicinal products registered for use in Ecuador. The web page does not include information on the target species for which these products are intended. The mission team noted that: veterinary medicinal products may be imported into Ecuador under the authorisation of three separate competent authorities: INP, SESA and the Ministry of Health. To import veterinary medicinal products for use in aquaculture the operator needs to apply for registration to the INP. The INP authorisations for importers are currently valid for five years; each brand and commercial presentation of an active substance for use in aquaculture is registered individually. The INP gives a unique registration number for the formulation/presentation which is valid for two years; pharmacologically active substances currently included in Annex IV to Council Regulation (EEC) No 2377/90 are not authorised for use in aquaculture production in Ecuador in line with Community rules. of the 296 products in the INP register (most of which are probiotics and diets), there were nine products containing pharmacologically active substances the use of which is also authorised in the EU according to Council Regulation (EEC) No 2377/ oxytetracycline, florfenicol, and emamectin. Three substances are not authorised for use in aquaculture species in the EU - the antibiotics doxycycline and fosfomycin and the synthetic peptide hormone, recombinant bovine somatotropin (rbst) (see Endnote). By the end of the mission, the competent authority had withdrawn the authorisation for rbst and notified the importer accordingly Distribution and use of veterinary medicinal products SESA is the competent authority responsible for registration of manufacturers, importers and distributors of veterinary medicinal products. It is also responsible for inspections on wholesalers and retailers of those products. For the purpose of controls, SESA has an agreement with the police to carry out joint inspections 13

19 By the time of the mission, 443 companies involved in the distribution of veterinary medicinal products (including those for use in the aquaculture sector) had a registration number, of which 383 were in activity. The majority of those companies were registered for more than one activity (e.g., 427 operators were approved as importers and marketers). The competent authority stated that there is an increasing trend towards the use of probiotics in shrimp farming in Ecuador with decreasing use of antibiotics. It is common practice that when a disease is detected harvesting is carried out immediately. This information was also received from the farmers on each of the shrimp and tilapia farms visited. The mission team noted that: all veterinary medicinal products in Ecuador are sold over the counter (i.e. no veterinary prescription is needed); retailers of veterinary medicinal products require a register from the provincial competent authority in order to operate. There is not yet an overview at central level of the number of retailers of veterinary medicinal products. One of the wholesalers visited informed the mission team that his company was marketing products through aproximately 2000 retailers; in relation to the veterinary medicinal products inspected during the mission, the situation differed among the wholesalers and retail outlets visited. o In one wholesaler all of the veterinary medicines were correctly labelled. At the time of the visit no INP-registered veterinary medicinal products were in stock, but copies of each of the INP registration documents were available for inspection. In a second wholesaler seven INP-registered products were in stock and whilst the national labelling requirements were not met, customers were being provided with a Spanish translation of the label in a separate leaflet. In a third wholesaler products containing benzimidazole and enrofloxacine were stored. The manager of the company explained that those products not included in the INP register - had been marketed since 1999 and had been sold as recently as August Whilst very small quantities of both products had been sold in 2008 there were substantial quantities of the benzimidazole (> 1.5 tonnes) remaining. Registration documents for both products were not available and the competent authority was not aware if these products had ever been registered in previous years; o two retailers of veterinary medicinal products were visited. In both premises the mission team found preparations of non-authorised pharmacologically active substances including EU-banned substances such as furazolidone and a nitroimidazole. Labels on those products indicated manufacturing and/or packaging in Ecuador and the companies involved were registered neither by SESA nor by the INP. Other preparations were found which contained pharmacologically active substances which were either not permitted for use in aquaculture in Ecuador (sulphonamides, enrofloxacin, diclazuril, salinomycin, benzimidazoles) or which were permitted (oxytetracycline) but were not registered (see Endnote). 14

20 5.4.3 Controls on the distribution and use of veterinary medicinal products Controls on importers, wholesalers and retailers The mission team noted that: the INP stated that their right to carry out inspections of veterinary medicinal product importers, wholesalers and retailers (selling INP-registered products) has only been recently been granted by Norm 138 which was published in the Official Gazette in September Since then the INP had carried two or three visits to importers of INP registered products (see Endnote); SOPs or checklists for those visits have not yet been developed. None of the wholesalers visited by the mission team had ever received an inspection by the INP. There was no documentary evidence to prove that SESA had inspected any of the wholesalers one of the three wholesalers thought that SESA had carried out an inspection whereas the other two were adamant that they had never been inspected by SESA; with regard to the retailers of veterinary medicinal products visited by the mission team, neither SESA nor the INP had carried out inspections on such premises (see Endnote) Controls in feed mills (medicated pre-mixes and medicated feedingstuffs) INP is also responsible for registration and approval of feed mills producing feedingstuffs for the aquaculture sector. Aquaculture farms registered for export are obliged to obtain feed from a feed mill which is approved by the INP. The feed mills registered are required to source their raw materials from registered premises. The mission team noted that: the feed mill visited during the mission was inspected by the competent authority once per month, and reports of the inspections were kept by the operator; samples had been sent for official testing under the national residues plan. The official testing covered all of the compulsory groups of substances. In recent months, the testing had also included analysis for melamine; the company was certified by several different international bodies for the production of ecological (organic) feed. This mill did not produce medicated feedingstuffs. A comprehensive HACCP system was in place Controls on farms The mission team noted that: 15

21 farms producing shrimps and tilapia for export are required to maintain records of treatments with veterinary medicinal products. On the three farms visited, this requirement had been respected; checks on the use of veterinary medicinal products and record keeping are made by INP during their annual inspections of export-approved farms. A uniform check list is used for this purpose. However, in one of the farms visited by the mission team, the presence of two veterinary medicinal products which were not included in the INP list had not been detected by the inspector in two consecutive visits. 6 CONCLUSIONS 6.1 NATIONAL RESIDUE CONTROL PLAN 1. The national residues control plan for aquaculture exceeds the requirements of Council Directive 96/23/EC in relation to some aspects and it has been implemented satisfactorily. Notwithstanding the absence of testing for some substances which weakens its overall effectiveness, the plan and its implementation can be judged to give guarantees which are for the most part equivalent to those provided for by Article 29 of Council Directive 96/23/EC for aquaculture products exported to the EU. 2. The dissemination of the national residues control plan to all food business operators and its publication on the web could militate against effective residues controls as the precise scope of testing is known to the aquaculture sector. Unscrupulous operators could therefore use antibiotics and other pharmacologically active substances which are not currently included in the plan and thus evade detection. The finding of several illegal veterinary medicinal products on the market for aquaculture farmers highlights the importance of increasing the scope of the plan and ensuring that operators are not aware of the technical capability of the testing system. 3. In comparison with the situation in 2007, where follow-up investigations were not carried out for any of the non-compliant results reported, follow-up of non-compliant results has been carried out in However, detailed follow-up procedures which would guarantee consistency in the case of confirmed non-compliant results have not yet been developed. 4. The compulsory registration and approval of all food business operators eligible to supply aquaculture products for export to EU and the controls on traceability increase confidence in the safety of Ecuadorian products exported to the EU. However, the lack of controls of the availability of veterinary medicinal products allied with the findings of EU-banned substances on the market and the fact that some of these substances are not included in the national residues plan raise some concerns on the residue status of aquaculture products exported the EU. 16

22 6.2 OTHER RESIDUES CONTROL PROGRAMMES The existence of own-check programmes for residues and the obligation of food business operators to inform the competent authority of the non-compliant results found within this monitoring increases confidence in the residue status of Ecuadorian aquaculture products. 6.3 LABORATORIES The accreditation of the private laboratory, the comprehensive validation of analytical methods and the satisfactory laboratory performance in internationally recognised proficiency tests gives the competent authority confidence in the reliability of analytical results. However, this confidence is undermined by the fact that some methods employed are not fit for purpose in particular those methods employed for analysing steroid and nitroimidazole residues. 6.4 VETERINARY MEDICINAL PRODUCTS AND MEDICATED FEEDINGSTUFFS 1. The decision of the competent authority to adopt Community requirements in relation to MRLs and the ban on use of EU-prohibited substances such as chloramphenicol, nitrofurans and dyes means that Ecuador is fully in line with those same requirements included in Council Regulation (EEC) No 2377/90, thereby increasing confidence in the residues status of aquaculture products exported to the EU. 2. The fact that there are relatively few pharmacologically active substances authorised for use in aquaculture and the use of these substances is required to be recorded by the farmer mitigates to some extent the fact that these veterinary medicinal products are available over the counter without veterinary prescription, which is in contrast to the situation in the EU Member States (Article 67 of Directive 2001/82/EC). 3. In spite of the regulatory framework governing the importation and marketing of veterinary medicinal products in Ecuador, the finding on the market of several EU-prohibited substances and other medicines without a national authorisation together with the lack of checks at wholesale and retail distribution level demonstrates that the current control system for veterinary medicinal products is inadequate and can not be considered to offer guarantees with an effect equivalent to those provided for by Article 80 of Directive 2001/82/EC. 4. Whilst the competent authority is carrying out controls on approved farms covering the use of veterinary medicinal products and maintenance of medicinal treatment records, the finding by the mission team of several non-authorised substances on a farm which had recently been inspected by the competent authority raises some questions on the effectiveness of these controls. These findings suggest that the 17

23 current controls do not give guarantees equivalent to those provided for by Article 10 of Council Directive 96/23/EC. 6.5 OVERALL CONCLUSION The Ecuadorian national residues plan goes beyond minimum EU requirements in relation to the number of samples programmed and the testing for non-essential groups of substances. In general its implementation, both in terms of sampling and testing is satisfactory. A procedure for registration, approval, inspection and sampling controls on the food business operators eligible to export products to the EU has been developed. However, the absence of effective controls on the retail distribution of veterinary medicinal products and the presence on the market of several EU-banned substances weakens competent authority guarantees on the residues status of the products exported to EU. It must be stated however that there was no evidence observed of the use of any EU-banned substances in the approved farms visited by the mission team. 7 CLOSING MEETING A closing meeting was held on 23 October 2008 with representatives of the competent authorities. At this meeting, the inspection team presented the main findings and preliminary conclusions of the mission. The competent authority did not express disagreement and committed itself to rectify the shortcomings noted. 8 RECOMMENDATIONS The competent authorities are invited to provide details of the actions taken and planned, including deadlines for their completion ('action plan'), aimed at addressing the recommendations set out below, within one month of receipt of this mission report. No Recommendation Review the scope of the national residues plan and ensure that the range of veterinary medicinal products monitored for in aquaculture products reflects the availability and usage of substances on the market in Ecuador in order to provide guarantees with an effect equivalent to those foreseen by Articles 3, 5 and 7 of Council Directive 96/23/EC. Ensure that procedures for follow-up investigations are developed and that they provide equivalent guarantees to those defined in Articles of Council Directive 96/23/EC. Remove the details on the scope of testing under the national residues control plan from the publicly available information, in order to provide guarantees with an effect equivalent to those foreseen by Article 12 of Council Directive 18

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