EUROPEAN COMMISSIONHEALTH AND CONSUMERS DIRECTORATE-GENERAL

Directorate F - Food and Veterinary Office

FINAL REPORT OF AN AUDIT

CARRIED OUT IN

CHILE

FROM 07 TO 17 JUNE 2011

IN ORDER TO EVALUATE THE MONITORING 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 a footnote.

DG(SANCO) 2011-8916 - MR FINAL

Ares(2011)1149875

Executive SummaryThis report describes the outcome of a Food and Veterinary Office (FVO) audit in Chile, carried out between 7 to 17 June 2011, as part of the published programme of FVO audits on the monitoring of residues in live animals and animal products in European Union (EU) Member States and in third countries. The objective of the audit was to evaluate the implementation of national measures, aimed at the control of residues and contaminants in live animals and animal products, in order to assess whether these systems offer adequate assurance that the products and animals concerned are within the specified residue limits laid down in EU legislation. Since the authorisation, distribution and use of veterinary medicinal products and feed additives have an impact on the monitoring of residues, the national rules governing the control systems in these areas were also part of the audit. The audit 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 EU requirements. It also examined the implementation of corrective actions promised in response to recommendations made in the report of a previous FVO residues mission to Chile (DG (SANCO)/7316/2007 MR Final). It is concluded that the Chilean residue monitoring plan, with some exceptions, provides guarantees with an effect equivalent to that provided for by Council Directive 96/23/EC. The follow-up of non-compliant results is carried out consistently and comprehensively and the performance of the laboratory network is strong and has improved relative to the previous FVO mission. Nevertheless the effectiveness of the plan is compromised by a number of factors, notably its advance publication which is not in line with the requirement laid down in Annex III to Council Directive 96/23/EC. Some of the screening methods used (particularly for antibiotics) are not sufficiently sensitive to detect MRL violations and in relation to honey, whilst the scope of testing has improved relative to previous years, the absence of testing for fumagillin is an important deficiency, particularly considering its use in Chilean apiculture. With regard to implementation of the residue monitoring plan, the competent authorities have systems in place guaranteeing consistent implementation and have a comprehensive overview of the progress being made. However the taking of samples by industry and inadequate or non-existent sealing of samples undermine the effectiveness of residue controls and the advance notification of farmers prior to sampling has the potential to reduce the competent authorities' ability to detect the illegal use of substances on-farm. The additional pre-export testing programmes put in place for fish and honey in principle provide additional assurances on the residues status of those consignments eligible for export to the EU. However discrepancies observed in the results obtained from pre-harvest testing and official testing question the reliability of the pre-harvest testing data in guaranteeing that the EU MRL for oxytetracycline is not exceeded in consignments exported to the EU. With regard to honey, the fact that fumagillin is used in apiculture but is neither included in the pre-export programme (nor in the official SAG programme) means that residues of this substance may be present in consignments exported to the EU. National rules governing the authorisation, distribution and use of veterinary medicinal products are broadly similar to those applicable in the EU, however, the requirement for the maintenance of treatment records (as specified in Article 10 of Council Directive 96/23/EC) has not been met for all commodities currently eligible for export to the EU (i.e. honey – which was also the case in 2007). In relation to the controls on the use of hormonal growth promotants and beta-agonists for growth promotion, the PABCO A programme provides assurances that beef eligible for export to the EU has not been obtained from cattle so treated and is therefore in line with the requirements of Council Directive 96/22/EC. Official controls on the distribution and use of veterinary

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medicinal products, are carried out regularly using well defined procedures and have generally been carried out in accordance with national requirements. However, the reports of the controls on pharmacies and wholesalers were not always complete in respect of the important requirement to check whether hormonal growth promotants had been sold to PABCO A farms. This omission, in an otherwise comprehensive control system, weakens its effectiveness.

The report makes a number of recommendations to the Chilean competent authorities, aimed at rectifying the shortcomings identified and enhancing the implementing and control measures in place.

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Table of Contents 1 INTRODUCTION ........................................................................................................................1 2 OBJECTIVES ............................................................................................................................1 3 LEGAL BASIS ..........................................................................................................................1 4 BACKGROUND ..........................................................................................................................2

4.1 COUNTRY STATUS IN RELATION TO EU-APPROVAL OF RESIDUE MONITORING PLANS ....................................2 4.2 SUMMARY OF PREVIOUS FVO AUDIT REPORTS ....................................................................................2 4.3 RAPID ALERT SYSTEM FOR FOOD AND FEED (RASFF) NOTIFICATION FOR PRODUCTS OF ANIMAL ORIGIN FROM CHILE CONCERNING RESIDUES ........................................................................................................2 4.4 PRODUCTION AND TRADE INFORMATION ............................................................................................2

5 FINDINGS AND CONCLUSIONS ...................................................................................................3 5.1 RESIDUE MONITORING ....................................................................................................................3

5.1.1 COMPETENT AUTHORITIES INVOLVED ...........................................................................................3 5.1.2 PLANNING OF THE RESIDUE MONITORING PLAN ..............................................................................3 5.1.3 IMPLEMENTATION OF THE RESIDUE MONITORING PLAN .....................................................................6 5.1.4 OTHER RESIDUES MONITORING PROGRAMMES ................................................................................8 5.1.5 FOLLOW-UP OF NON-COMPLIANT RESULTS ....................................................................................9

5.2 LABORATORIES ............................................................................................................................12 5.2.1 GENERAL DESCRIPTION ..........................................................................................................12 5.2.2 ON-THE-SPOT VISITS IN THE LABORATORIES ................................................................................12

5.3 VETERINARY MEDICINAL PRODUCTS AND MEDICATED FEEDINGSTUFFS ....................................................16 5.3.1 AUTHORISATION, DISTRIBUTION AND USE OF VETERINARY MEDICINAL PRODUCTS ..................................16 5.3.2 CONTROLS ON THE DISTRIBUTION AND USE OF VETERINARY MEDICINAL PRODUCTS ...............................20

6 OVERALL CONCLUSIONS .........................................................................................................23 7 CLOSING MEETING ................................................................................................................24 8 RECOMMENDATIONS ...............................................................................................................24ANNEX 1 - LEGAL REFERENCES .................................................................................................26

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ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT

Abbreviation ExplanationCCα / Ccβ Decision Limit / Detection Capability DG(SANCO) Health and Consumers Directorate-General EC European Community EU European UnionFVO Food and Veterinary OfficeGroup A, B Categories of substances listed in Annex I to Council Directive 96/23/EC:ISO International Organisation for Standardisation LC-MS/MS Liquid Chromatography-(Tandem) Mass SpectrometryLoD Limit of DetectionML Maximum LevelMRL Maximum Residue LimitMRPL Minimum Required Performance Limit NRL National Reference LaboratoryPABCO Programa de Planteles Animales bajo Certificación Oficial / Program of

animal holdings under official certificationRAMEX Registro de Apicultores de Miel de Exportación / Register of honey

exporting apiariesRASFF Rapid Alert System for Food and FeedSAG Servicio Agrícola y Ganadero de Chile - Agriculture and Livestock ServiceSernapesca Servicio Nacional de Pesca - National Fisheries ServiceSOP Standard Operating Procedure

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1 INTRODUCTION

The audit took place in Chile from 7 to 17 June 2011. The audit team comprised two auditors from the Food and Veterinary Office (FVO) and one expert from a European Union (EU) Member State. The audit was undertaken as part of the FVO's audit programme, evaluating control systems and operational standards in the residues sector. Representatives from the central competent authority responsible for control of residues in animals and animal products accompanied the audit team during the audit. An opening meeting was held on 7 June 2011with the central competent authorities responsible for implementing residue monitoring in live animals and animal products and the authorisation of veterinary medicinal products. At this meeting, the objectives of, and itinerary for, the audit were confirmed and the control systems were described by the authorities.

2 OBJECTIVES

The objective of the audit was to evaluate the implementation of national measures, aimed at the control of residues and contaminants in live animals and animal products, in order to assess whether these systems offer adequate assurance that the products and animals concerned are within the specified residue limits laid down in EU legislation. Since the authorisation, distribution and use of veterinary medicinal products and feed additives have an impact on the monitoring of residues, the national rules governing the control systems in these areas were also part of the audit. The audit focussed on the roles of the competent authorities at central and regional levels, the legal and administrative measures in place to give effect to the relevant EU requirements, controls with regard to residues and veterinary medicinal products and their operation, and the performance of residue laboratories. Attention was paid to examining the implementation of corrective actions promised in response to recommendations made in the report of a previous FVO residues mission to Chile (DG (SANCO)/7316/2007 MR Final) in March 2007.

Meetings/Visits N CommentsCompetent Authorities

Central 3 Opening and closing meetings with the Agriculture and Livestock Service (SAG) and the National Fisheries Service (Sernapesca)

Regional 2 A regional office of SAG and of SernapescaLaboratories 4 A government laboratory and three private laboratoriesFarms 3 A pig farm, an aquaculture farm and an apiaryEstablishments 5 A slaughterhouse for pigs and cattle, a slaughterhouse for sheep and

cattle, two fish processing plants and a honey processing centreOther Sites 4 A feed mill and three distributors of veterinary medicinal products

3 LEGAL BASIS

The audit was carried out under the general provisions of EU legislation, and in particular:• Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and

residues thereof in live animals and animal products, and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC;

• 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

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law, animal health and animal welfare rules. A full list of the legal instruments referred to in this audit report is provided in the Annex and refers, where applicable, to the last amended version.

4 BACKGROUND

4.1 COUNTRY STATUS IN RELATION TO EU-APPROVAL OF RESIDUE MONITORING PLANS

Commission Decision 2011/163/EC indicates that Chile's residue monitoring plan is approved in accordance with Council Directive 96/23/EC for cattle, sheep, poultry, aquaculture, milk, wild game and honey. SAG has expressed an interest in also being listed for goats and a residue monitoring plan for goats has been submitted for 2011.

4.2 SUMMARY OF PREVIOUS FVO AUDIT REPORTS

The residues sector was last inspected by the FVO in 2007. The report of this mission (henceforth referred to as the 2007 FVO report) had been published on the website of the Directorate–General for Health and Consumers here: http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_id=1765The report concluded that many improvements in the residues control system had taken place since the previous residues mission in 2000. In general, the residues control programme was in line with the relevant European legislation and was satisfactorily implemented with good laboratory performance though shortcomings in the follow-up of non-compliant results were noted. The system of authorisation and control on distribution and use of veterinary medicinal products was generally effective though controls in some sectors such as apiculture were weak. 4.3 RAPID ALERT SYSTEM FOR FOOD AND FEED (RASFF) NOTIFICATION FOR PRODUCTS OF ANIMAL ORIGIN FROM CHILE CONCERNING RESIDUES

Since the 2007 mission there was one RASFF notification for residues of veterinary medicinal products: a finding of chloramphenicol in salmon originating from Chile. The actions taken by the Chilean authorities in response to this are detailed in section 5.1.5.3. 4.4 PRODUCTION AND TRADE INFORMATION

Exports of food of animal origin from Chile to the EU in 2010 are listed in the table below.

Commodity Quantity (in tonnes)Poultry meat † 18918Pork † 8547Honey † 8254Lamb † 5483Beef † 2336Trout* 692Salmon* 338Wild game † 71Milk † 4

(* from Eurostat – Statistical Office of the EU'; † from SAG)

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5 FINDINGS AND CONCLUSIONS

5.1 RESIDUE MONITORING

5.1.1 Competent authorities involved

SAG resides under the Ministry of Agriculture. It is the competent authority for residue monitoring in terrestrial animals and products thereof, based on Law No 18.755 of 7 January 1989 on the Organisation of the Agriculture and Livestock Service as amended by Law No 19.283 of 5 January 1994. Sernapesca resides under the Ministry of Economy and Development. It is the competent authority for residue monitoring in aquaculture based on the General Law of Fisheries and Aquaculture, Executive Decree No 430 of 1991, Decree with Force of Law No 5/1983 and Decree No 319/2001. Both SAG and Sernapesca are organised at central, regional and local levels. The Ministry of Health is responsible for setting residue limits/tolerances for pharmacologically active substances (Resolution No 1462 of 25 February 1999), for pesticides (Resolution No 33 of 5 February 2010) and for dioxins and poly-chlorinated biphenyls (PCBs) (Decree No 64 of 17 September 2009) in foodstuffs. However, other residue limits may be applied by SAG and Sernapesca when products are produced for export, depending on the requirements of the export market, and for the purpose of setting withdrawal periods when granting marketing authorisations for veterinary medicinal products by SAG (see 5.3.1).

5.1.2 Planning of the residue monitoring plan

Legal RequirementsThird countries which export live animals or animal products to the European Union are obliged to submit to the European Commission a specific plan setting out the guarantees which it offers as regards the monitoring of the groups of residues and substances referred to in Annex I to Council Directive 96/23/EC on measures to monitor certain substances and residues thereof in live animals and animal products. The residue plan should take account of the results of monitoring from the previous year and should be revised annually and updated at the request of the Commission, particularly when checks carried out by the Commission render it necessary. Article 29 of said Directive states that guarantees must have an effect at least equivalent to those provided for in the Directive and must, in particular, meet the requirements of Article 4 and specify the particulars laid down in Article 7 and meet the requirements of Article 11(2) of Directive 96/22/EC. Articles 3 to 7 of Council Directive 96/23/EC deal with the requirements for residue monitoring plans. The levels and frequencies of sampling for residues are specified in Annex IV to Council Directive 96/23/EC and Commission Decision 97/747/EC. Article 11 of Regulation (EC) No 178/2002, laying down the general principles and requirements of food law, specifies that food and feed imported into the EU for placing on the market within the EU shall comply with the relevant requirements of food law or conditions recognised by the EU to be at least equivalent thereto. In relation to maximum levels of residues and contaminants in food, Regulation (EC) No 470/2009 of the European Parliament and of the Council lays down Maximum Residue Limits (MRLs) for residues of pharmacologically active substances in food

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which are listed in Table 1 of the Annex to Commission Regulation (EU) No 37/2010. Regulation (EC) No 396/2005 lays down maximum residue levels of pesticides in or on food and feed of plant and animal origin. Commission Regulation (EC) No 1881/2006 lays down Maximum Levels (MLs) for contaminants in food. Minimum Required Performance Limits (MRPLs) are defined in Article 4 of Commission Decision 2002/657/EC.In accordance with Article 29 of Council Directive 96/23/EC, Commission approval of every third country’s residue monitoring plan is necessary if that country is to remain on the list of third countries from which EU Member States may import animals and animal products. The list of countries and commodities with approved residue monitoring plans is in the Annex to Commission Decision 2004/432/EC. FindingsThe residue monitoring plan – for which SAG elaborates the plan for terrestrial animals and Sernapesca, the plan for aquaculture - is based on Council Directive 96/23/EC. The preparation of the next year's residue monitoring starts in December and ends in March when the plan is disseminated to the regions. The plan can be amended during the sampling year, for example when new analytical methods become available.Concerning both the SAG and Sernapesca plans the audit team noted that:• the calculation of the sample numbers is based on national production data for

aquaculture, cattle, goats, pigs, poultry, wild game and milk and on export volumes for sheep and honey;

• samples are proportionally spread over the production areas and throughout the year taking into consideration the seasonal production of some commodities;

• some action limits for pesticides are higher than the EU maximum residue levels (MRLs) laid down in Regulation (EC) No 396/2005.

With regard to the SAG plan the audit team noted that: • the SAG laboratory Lo Aguirre has participated in preparatory meetings for the

residue monitoring plan;• SAG takes into consideration information on authorised veterinary medicinal

products. The most recent data used were from 2008;• all substance groups relevant for each of the commodities are included in the plan.

The scope of testing within substance groups has been significantly extended after the 2007 mission and in this respect recommendation 1 of the 2007 FVO report has been partly addressed;

• nevertheless, the plan does not include some of the veterinary medicinal products authorised in Chile for use in food producing animals which contain pharmacologically active substances for which no MRL has been established in the EU. These include inter alia acetylpromazine (pigs), bacitracin (pigs), coumafos (cattle, pigs, sheep, goats), ethopabate (poultry) and norfloxacin (pigs, poultry). It is also noted that the antibiotic fumagillin, which is not actually authorised in Chile but is imported under special license and used in Chilean apiculture (see 5.3.1) is not tested for in honey. This substance is also not included in the industry pre-export testing programme – see 5.1.4.2.;

• there are several other substances for which there are EU MRLs which are

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authorised for use in Chile and are not included in the plan. These include inter alia, carprofen (cattle), closantel (cattle, sheep), dexamethasone (cattle, pigs, sheep, goats), eprinomectin (cattle), narasin (poultry), prednisolone (cattle, pigs, sheep), rafoxinide (cattle, sheep) and trimethoprim (cattle, pigs, poultry);

• with regard to the sensitivity of analytical methods, the limit of detection (LoD) for stilbenes (A1) and beta-agonists (A5) have been lowered as recommended in the 2007 FVO report;

• whilst thyrostats (A2) are now tested for in urine (as suggested in the 2007 FVO report) the LoD is five times greater than the figure recommended by the EU Reference Laboratories (URLs) (50 versus 10 μg/kg);

• the screening test for aminoglycosides, macrolides and tetracyclines is not suitable for detecting MRL violations for all of the individual substances in these antibiotic families as the LoDs are considerably higher than the EU MRLs for some individual substances within each group. For example, the LoD for the aminoglycoside screening test in bovine and porcine muscle is 500 μg/kg whereas the MRL for gentamycin is 50 μg/kg. Similarly the LoD for the tetracycline screening test in poultry, bovine and porcine muscle is 250 μg/kg whereas the MRL for oxytetracyline is 100 μg/kg and the LoD of the macrolide screening test in muscle of the same species is 400 μg/kg whereas the MRL for erythromycin is 200 μg/kg;

• some action limits specified in the plan are high: nicarbazin in muscle 200 μg/kg (EU MRL is 25 μg/kg); salinomycin in muscle 45 μg/kg (EU MRL is 5 μg/kg). In the case of clopidol in muscle, the level of action is 5000 μg/kg. There is no EU MRL for this coccidiostat;

• the residue monitoring plan is published in the context of a public tender for residue testing in cattle and milk, and for the purpose of informing industry which laboratories can be used for testing.

With regard to the Sernapesca plan the audit team noted that: • all relevant substance groups are included in the plan and the pharmacologically

active substances authorised for use in fish are covered.

Conclusions on planning of the residue monitoring planThe planning process takes account of all relevant factors and as a result the plan, with some exceptions, provides guarantees with an effect equivalent to that provided for by Council Directive 96/23/EC. Nevertheless the effectiveness of the plan is compromised by a number of factors. The fact that the plan is published in advance means that food business operators have prior knowledge of the substances tested for (and what is not tested for), which is not in line with the requirement laid down in Annex III to Council Directive 96/23/EC. Some of the screening methods used (particularly for antibiotics) are not sufficiently sensitive to detect MRL violations and in relation to honey, whilst the scope of testing has improved relative to previous years, the absence of testing for fumagillin is an important deficiency, particularly considering its use in Chilean apiculture.

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5.1.3 Implementation of the residue monitoring plan

Legal RequirementsArticle 29 of Council Directive 96/23/EC states that guarantees offered by residue monitoring plans submitted by third countries must have an effect at least equivalent to those provided for in the Directive and must, in particular, meet the requirements of Article 4 and specify the particulars laid down in Article 7. Article 4(2)(b) and (c) of Council Directive 96/23/EC lays down the requirements for central competent authorities in co-ordinating the activities of all bodies involved in residues controls. Articles 5 and 12 of Council Directive 96/23/EC deal with aspects pertaining to the implementation of the residue monitoring plan. Sampling requirements are specified in Annex IV to Council Directive 96/23/EC and Commission Decision 97/747/EC and Commission Decision 98/179/EC lays down the rules for official sampling under the residue monitoring plan. EU methods of sampling for the official control of a wide range of residues in products of animal origin are laid down in several pieces of EU legislation: Commission Directive 2002/63/EC (pesticides); Commission Regulation (EC) No 1883/2006 (dioxins and dioxin-like PCBs); Commission Regulation (EC) No 333/2007 (certain chemical elements); Commission Regulation (EC) No 401/2006 (mycotoxins). FindingsSAG and Sernapesca offices at regional level are responsible for implementation and allocate samples to official staff for sampling at establishments and on farms.The audit team noted that:• the 2011 plan had been received in time by the regional SAG and Sernapesca

offices visited; • in 2010 samples were taken from January to December. A heavy earthquake

damaged laboratory equipment in February 2010. This resulted in delays in testing and overall under-implementation of the residue monitoring plan in the following months. However, the plan had been largely implemented by the end of the year. In 2011 sampling started in January and was generally on schedule;

• both SAG and Sernapesca have comprehensive sampling instructions. Staff interviewed at all levels were well aware of their tasks and responsibilities;

• on-farm sampling is announced a day in advance to ensure that the farmer is present;

• with the exception of seals, sampling materials are provided by the food business operator who is also responsible for the shipment of residue monitoring samples to the laboratory. In addition none of the seals on the sample containers seen in the establishments were tamper proof.

With regard to the SAG plan the audit team noted that: • sampling requests are sent weekly through an online SAG database to SAG staff at

the slaughterhouse and to local SAG offices for sampling of live animals (on-farm). Samples can be tracked in the SAG online database, from the planning of the sample to the test result;

• at the time of the audit sampling had not started in goats as slaughtering is seasonal (October). SAG stated that sampling would start subject to approval of the plan by

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the European Commission;• honey samples are taken at the collection centre and are traceable to individual bee-

keepers. The number of samples taken is directly related to the quantity of honey exported from the collection centre and exceeds the requirements of Council Directive 96/23/EC;

• at the SAG regional office visited three samples which had to be taken on-farm before March 2011 were outstanding. There was evidence of correspondence in which the local office was requested to clarify the matter, however, the samples were still outstanding at the time of the audit. It was explained that for on-farm sampling more time is allowed than for samples taken at establishments, since suitable categories of animals may not always be available for sampling;

• urine samples from live cattle are taken only from those farms taking part in the hormonal growth promotant-free 'split system' (PABCO-A: Programme of animal holdings under official certification), since on other cattle farms the use of growth promoting hormones (forbidden in the EU) is permitted;

• residue monitoring milk samples are not always taken by official staff but can be taken by the driver of the truck collecting the milk from the farm or by the official staff in the dairy plant;

• at the slaughterhouses visited samples had been taken according to the weekly schedule. When planning the weekly samples, care was taken to select animals from farms which had not been sampled earlier in the year. Sampling was spread over different days of the week and was randomised;

• according to the SAG sampling instruction (updated in 2011) animals should be sampled if there is a suspicion of a recent treatment and in case there is a history of residue violations. Since there are no farms with such a recent history and since there had been no suspect animals identified in the slaughterhouse visited, samples were taken randomly.

With regard to the Sernapesca plan the audit team noted that: • at fish processing plants samples are taken each month. At each fish farm, from

hatchery to finishing, samples are taken once a year. Samples are traceable to individual farms and cages;

• in the region visited sampling at sea farms was equally spread over the year, but sampling at lake farms was limited to the last six months of the year, due, according to Sernapesca, to budgetary constraints;

• in the establishment visited a residue monitoring sample was taken from a batch of fish for which a pre-harvest test result (see 5.1.4.1.) accompanying the batch already indicated that the level of oxytetracycline was above the EU and Chilean MRL. The competent authority explained that the fish had been specifically targeted for this reason;

• in contrast to the situation with SAG, the seals available to Sernapesca staff were tamper-proof. These are required to be used according to Sernapesca instructions. However, the regional Sernapesca office visited had stopped using the seals because the seals damaged the polystyrene boxes during transport.

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Conclusions on the implementation of the residue monitoring planThe competent authorities have systems in place guaranteeing consistent implementation of the plan and have a comprehensive overview of the progress being made. Nonetheless there are some factors which undermine the effectiveness of the plan including the taking of samples by industry and inadequate or non-existent sealing of samples. The advance notification of farmers prior to sampling has the potential to reduce the competent authorities' ability to detect the illegal use of substances on-farm.

5.1.4 Other residues monitoring programmes

Legal RequirementsArticle 29 of Council Directive 96/23/EC states that guarantees offered by residue monitoring plans submitted by third countries must have an effect at least equivalent to those provided for in the Directive. Article 11 of Council Directive 96/23/EC gives the option of conducting other residues testing, particularly in relation to detection of illegal treatment of food producing animals. Article 9 of Council Directive 96/23/EC foresees the application of own-checks by food business operators. Findings

5.1.4.1 Pre-harvest testing in fishIn the framework of the Pharmaceutical Products Control Programme (see 5.3.1.3.) and as part of the Hazard Analysis Critical Control Point (HACCP) requirements for processing establishments, fish are sampled and analysed for residues of a defined list of veterinary medicinal products administered in the last six months prior to harvesting. Sampling procedures and analysis requirements are established in detail in Technical Regulations No 1 and No 4, Procedures Guideline No 2 of the Laboratories Programme and Procedures Guideline No 1 of the Residues Control Programme. The veterinarian of the farm has to sign a sworn declaration in the case that there have been no treatments in the six months prior to harvesting. Such fish are not sampled under the pre-harvest testing programme. Sampling is carried out by authorised samplers and analysis is performed by authorised private laboratories.The audit team noted that:• five private laboratories have been authorised for pre-harvest testing. None

of these laboratories test for the residue monitoring plan;• tests have been carried out for oxytetracycline, oxolinic acid, flumequine,

florfenicol, diflubenzuron and emamectin. More than 75,000 samples were analysed in 2010;

• in cases where the pre-harvest testing result exceeded the EU MRL, the consignments were not exported to the EU;

• it was seen in the establishment visited that quite a number of consignments of fish arriving at the establishment had pre-harvest test results for oxytetracycline just below the EU and Chilean MRL. However in some cases when these batches were also tested in the residue

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monitoring plan for oxytetracycline, concentrations exceeding the EU MRL were confirmed.

5.1.4.2 Pre-export testing in honeyThe pre-export testing programme for honey is an industry self-control for forbidden and non-authorised substances, in order to fulfil the export requirements laid down in Resolution 361 of 2006. Honey exporters have to provide compliant test results before a health certificate is signed.The audit team noted that:• at the honey collection centre visited export batches of honey had been

tested by accredited laboratories. No non-compliant results were reported;• the tests reports seen by the audit team did not include fumagillin (see also

5.1.2).

Conclusions on other residue monitoring programmesPre-harvest testing of fish and the pre-export testing programme for honey in principle provide additional assurances on the residues status of those consignments eligible for export to the EU. However discrepancies observed in the results obtained from pre-harvest testing and official testing question the reliability of the pre-harvest testing data in guaranteeing that the EU MRL for oxytetracycline is not exceeded in consignments exported to the EU. With regard to honey, the fact that fumagillin is used in apiculture but is neither included in the pre-export programme (nor in the official SAG programme) means that residues of this substance may be present in consignments exported to the EU.

5.1.5 Follow-up of non-compliant results

Legal RequirementsArticle 29 of Council Directive 96/23/EC states that guarantees offered by residue monitoring plans submitted by third countries must have an effect at least equivalent to those provided for in the Directive. Measures to be taken by competent authorities in response to the finding of non-compliant residues results are described in Articles 13, 16, 17, 18, 19, 23, 24, 27 and 28 of Council Directive 96/23/EC. FindingsSAG and Sernapesca are responsible for the follow-up of non-compliant results within their respective areas of competence. The legal basis for so doing is described in section 5.1.1 of this report. Follow-up in relation to products (to be) placed on the domestic market is under the responsibility of the Ministry of Health. The audit team noted that:• overall the corrective actions promised in response to recommendation 2 of the

2007 FVO report have been implemented.

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5.1.5.1 Non-compliant results in the residue monitoring plan for terrestrial animalsIn addition to the legal framework described in 5.1.1., of relevance to follow-up by SAG are Resolution No 6976 of 2010 laying down the rules of the PABCO programme and Resolution No 3673 of 1998 establishing the residue monitoring programme in livestock products for export. In case of non-compliant findings, five follow-up samples are be tested and all results need to be compliant. In case of a non-compliant result in honey, three consecutive batches are to be sampled.The penalties foreseen under PABCO rules are suspension or elimination from the programme, meaning a temporary or permanent ban on exports. Honey producers will be suspended for three months from the RAMEX programme (register of honey exporting apiaries) following a non-compliant result.The audit team noted that:• laboratories enter the analytical results directly into the SAG database.

Official interpretation of the result is the responsibility of the Industry and Technology Sub-division of the Livestock Protection Division of SAG;

• there have been no non-compliant test results from 2010 to date. In 2009 there was a finding of chloramphenicol (Group A6) in milk and a finding of 17-beta-19-nortestosterone (Group A3) in pigs. In the latter case as this substance occurs naturally in intact boars and cryptorchid male pigs, SAG attributed the result to natural causes;

• SAG carried out a comprehensive well documented investigation into the chloramphenicol case. The investigation was carried out promptly, but because of delays in obtaining the initial result, considerable time had elapsed since the original sample had been taken. The farm of origin was inspected, dairy products were traced and the distribution of veterinary medicinal products to the farm was investigated. SAG informed the dairy plant that milk from the farm could not be used for export (although the milk was in any case not eligible for export since the farm was not part of the PABCO-A programme). There was evidence of communication between central and regional levels of SAG and the Ministry of Health was informed. The cause of the finding could however, not be established.

5.1.5.2 Non-compliant results in the residue monitoring plan for aquacultureSernapesa Procedures Manual PAC/MP1 of March 2011 contains detailed instructions for the follow-up of non-compliant results.The audit team noted that:• in contrast to SAG, Sernapesca has no online database and the laboratory

sends results by email to Sernapasca and to the establishment or farm of origin;

• in 2009 crystal violet was detected in five out of eight samples taken from a batch of salmon imported from another third country for processing in Chile. Duplicate samples were sent for analysis to a laboratory in an EU

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Member State and crystal violet was confirmed in four samples at concentrations up to 7.2 μg/kg. The authorities in the originating third country were informed and the consignment was returned. Sernapesca put in place an intensified monitoring for crystal violet in fish imported from the third country in question but no subsequent findings have been made from that source;

• in 2011 crystal violet was also detected in two samples. Sernapesca was not able to identify the cause and concluded that the source of crystal violet could have been the marker pen used for writing on the sample containers, though this hypothesis was not investigated. An instruction was sent to the regional offices that marker pens should not be used to identify samples. The regional Sernapesca office visited had received the instruction, but the staff interviewed were not aware of this rule;

• from 2009 to date there have been 23 findings of oxytetracyline above the EU MRL. The batches of fish concerned were directed to export markets other than the EU. Sernapesca conducted investigations at the processing establishments and on the farms, finding that too short a withdrawal period was frequently applied and that in some cases there had been off-label use of an injectable oxytetracylcine formulation. Sernapesca informed the Ministry of Health and it was seen that in one case fish had been destroyed by order of the Ministry of Health.

5.1.5.3 Non-compliant results reported under the RASFFOn 25 March 2011 a RASFF notification was reported for chloramphenicol (70 μg/kg) in Chilean salmon. The audit team noted that:• Sernapesca informed the establishment on 28 March 2011 and requested

them to trace the source, to take preventive measures and to provide information on exported and stored products within five days. The establishment did this, identifying two different supplier farms (neither of which it transpired, used chloramphenicol). The establishment gave a commitment that it would start testing feedingstuffs for chloramphenicol;

• Sernapesca took 41 samples of the fishery products in storage in the establishment. Chloramphenicol was found at a level of 0.55 μg/kg in one sample from a container with fish originating from three farms including the two originally implicated farms. Sernapesca also reviewed the reports of the 15 farm visits it carried out on these farms in 2010 and 2011. There was no indication that chloramphenicol had ever been used. The supplying feed mill was requested to provide information on test reports of feed ingredients as it had been testing imported feedingstuffs for chloramphenicol and florfenicol since July 2010. Sernapesca submitted a request to SAG on 29 April 2011 to provide information from the manufacturer of the florfenicol-containing veterinary medicinal product with regard to contamination with chloramphenicol. SAG's response was pending at the time of the FVO audit.

Conclusions on follow-up of non-compliant resultsWritten procedures, generally comprehensive investigations, well documented files, traceability of products and exclusion of non-compliant products from export to the

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EU collectively underpin the effectiveness of the follow-up carried out by the competent authorities.

5.2 LABORATORIES

Legal RequirementsArticle 29 of Council Directive 96/23/EC states that guarantees offered by residue monitoring plans submitted by third countries must have an effect at least equivalent to those provided for in the Directive. Article 15 of Council Directive 96/23/EC requires that official samples are examined in approved laboratories. Requirements for accreditation of laboratories are laid down in Point 1.2. of the Annex to Commission Decision 98/179/EC. The rules for analytical methods to be used in the testing of official samples taken pursuant to Article 15(1) of Council Directive 96/23/EC are laid down in Commission Decision 2002/657/EC – in particular Articles 3, 4, 5 and 6 which cover, inter alia, validation requirements and quality control. More specific requirements for analytical methods for certain substances are laid down in the annexes to Commission Regulation (EC) No 1883/2006 (dioxins and dioxin-like PCBs in foodstuffs), Commission Regulation (EC) No 333/2007 (chemical elements in foodstuffs) and Commission Regulation (EC) No 401/2006 (mycotoxins). Findings

5.2.1 General descriptionSernapesca has designated one private laboratory to carry out all tests for the aquaculture residue monitoring plan. This laboratory is not involved in the pre-harvest testing programme. Industry pays for the costs of testing directly to the laboratory. Sernapesca audits the laboratory four times per year. SAG has accredited seven private laboratories for its residue monitoring plan. Two SAG laboratories are also involved. The SAG laboratory in Punta Arenas is also involved in testing of anthelmintics and heavy metals in sheep, goats and cattle and the SAG laboratory in Santiago (Lo Aguirre) – which has been designated as a national reference laboratory (NRL) - tests for nitrofurans in drinking water whilst no private laboratory is providing this test for the moment. Two foreign laboratories are involved in the testing of antibiotics in honey and the confirmation of certain antibiotics in muscle respectively.SAG conducts tenders for the testing of cattle and milk annually. Different contracts are awarded for the various analyte/matrix combinations. For other commodities industry can choose the accredited laboratory to which it will send samples and pays the costs of analysis directly to the laboratory. The SAG accreditation process is designed to ensure that laboratories apply validated methods which are fit for the purpose of the residue monitoring plan. SAG technical instructions of March 2010 stipulate a maximum sample turnaround time of 20 calendar days (reduced from 25 days in previous years). The performance of the laboratories can be monitored through the SAG database for residue monitoring.

5.2.2 On-the-spot visits in the laboratoriesThe audit team visited the SAG laboratory Lo Aguirre, as well as three SAG-

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accredited private laboratories (B, C and D), one of which is also the laboratory designated by Sernapesca for testing in fish.The audit team noted that:• overall the corrective actions pertaining to laboratory performance which were

proposed by the competent authorities in response to recommendations 3, 4 and 5 of the 2007 FVO report have been implemented;

• the laboratories visited have all been accredited to ISO (International Organisation for Standardisation) Standard 17025, three by the Chilean accreditation body INN (Instituto Nacional de Normalizatión de Chile) and one by DAkkS (Deutsche Akkreditierungsstelle). In all cases written documents (Standard Operating Procedures (SOPs) and work instructions were in place;

• the number of staff in each laboratory visited was commensurate with the tasks to be performed;

• in all cases seen, quality control samples were analysed;• laboratories B, C and D were well-equipped with modern, state of the art,

equipment. Each had been audited and accredited by SAG, with evidence of specific training of SAG staff for carrying out such audits. Laboratory C had also been audited by Sernapesca. Observations made during these audits had been followed-up promptly.

5.2.2.1 Laboratory SAG Lo AguirreSAG Lo Aguirre is responsible for supervising the laboratories involved in the residue monitoring plan for terrestrial animals. In its role as an NRL it audits these laboratories at least once a year. It requires them to participate in internationally organised proficiency tests and it re-analyses 5 to 7% of the compliant samples of the residue monitoring plan. SAG Lo Aguirre does not offer screening or confirmatory tests to industry and does not participate in tenders for the residue monitoring plan. Testing for the plan is only carried out if there is no accredited private provider available. The audit team noted that:• equipment which had been damaged in the earthquake in February 2010

had not been repaired or replaced and the equipment present was not capable of performing all tests of the residues monitoring plan. However, tests that could not be performed at Lo Aguirre had been outsourced to laboratories outside Chile;

• the results of re-analysed compliant residue monitoring samples were consistent with the results of the initial analyses;

• the method for nitrofurans, the only test done directly for the residue monitoring plan, has been validated close to the requirements of Commission Decision 2002/657/EC. The validation data showed that the method is fit for purpose;

• the method for avermectins was also adequately validated and proved to be fit for purpose;

• the method for benzimidazole anthelmintics covers the administered active

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pharmacologically substances only but not the metabolites, which in the EU are included in the marker residue;

5.2.2.2 Laboratory BFindingsLaboratory B is a private laboratory performing tests for various substances, in particular those belonging to Group A, in terrestrial animals.The audit team examined the general operation of the laboratory and two analytical methods, and noted that:• in 2009 and 2010 the turnaround times for samples (receipt to reporting)

were 24 and 41 days respectively. Times were shorter in 2011 with an average of 21 days;

• the laboratory has participated regularly in proficiency tests and in general has obtained satisfactory z-scores. In one proficiency test for ß-agonists, one analyte (zilpaterol) was not detected in pig liver. The cause established by the audit team (retention time shifts) had not been identified by the laboratory when it followed up the proficiency test result;

• the method for analysing ß-agonists was validated close to the requirements of Commission Decision 2002/657/EC. The method was fit for purpose;

• the method for analysing nitroimidazoles had been validated for dimetridazole, ipronidazole, metronidazole and ronidazole. The common hydroxy-metabolite of dimetridazole and ronidazole was included but the hydroxy-metabolites of ipronidazole and metronidazole were missing. These metabolites should be included in the scope of the method.

5.2.2.3 Laboratory CFindingsLaboratory C is a private laboratory performing tests for various substances belonging to Group A and B in terrestrial animals. In addition, Laboratory C is designated by Sernapesca for analysing all aquaculture residue monitoring samples. The audit team examined the general operation of the laboratory and two analytical methods, and noted that:• turnaround times of samples in 2010 and 2011 (January to April) were 15

and 16 days respectively;• in March 2011 crystal violet was detected in salmon - see 5.1.5.2. The

audit team used this case as an example of how samples had been processed in the laboratory. All procedures to process samples were well described and implemented. Every step of processing samples was double checked. Two methods have been established for analysing dyes in salmon. The first method was based on a post-column oxidation of the leuco- forms of the dyes using lead dioxide. This method was practised until the end of March 2011 and the crystal violet in the afore-mentioned salmon case was identified and quantified applying this method. After

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March 2011 an LC-MS/MS (Liquid Chromatography-(Tandem) Mass Spectrometry)-based method established in the laboratory has been used for a second confirmation of dyes. The method was validated according to all of the criteria of Commission Decision 2002/657/EC. With a CCα of 0.1 µg/kg and CCß of 0.2 µg/kg for malachite green (and its leuco- form), crystal violet (and its leuco- form) and brilliant green, the method was fit for purpose;

• the audit team also evaluated the validation data for the antimicrobial growth inhibition test (four plate test). Whilst the data demonstrated that SAG's detection limits of tetracycline, macrolides, ß-lactams and aminoglycosides could be met (as has been stated in section 5.1.2.), the method is not suitable for detecting residues of all of the individual substances within these antibiotic families at their respective EU MRLs.

5.2.2.4 Laboratory DLaboratory D is a private laboratory performing tests for various substances belonging to group A and B in terrestrial animals. The audit team examined the SOP for handling samples and the SOPs for two analytical methods and noted that:• turnaround times of samples in 2010 and 2011 (January to April) were 4

and 3 days respectively;• the SOP for handling samples contained detailed instructions but did not

include instructions on what to do with samples with broken or missing seals;

• it was reported that on occasion the amount of test material received was insufficient for analysis. SAG had been informed;

• the validation data of the LC-MS/MS based method for thyrostats demonstrated that the method was validated according to all of the criteria of Commission Decision 2002/657/EC. With CCα and CCß below 50 µg/kg the method was fit for the requirements of SAG's residue monitoring plan. Chromatograms of spiked samples showed that the method could detect lower concentrations if required;

• the validation data of the LC-MS/MS method for avermectins also fulfilled all of the performance criteria required by Commission Decision 2002/657/EC. The values of CCα and CCß for the avermectins showed that the method was fit for purpose.

Conclusions on laboratoriesThe performance of each of the laboratories visited by the audit team was consistent with that expected of laboratories accredited to ISO 17025. The regular audits by SAG and Sernapesca, the participation and overall satisfactory performance in internationally organised proficiency testing schemes, and the retesting of a proportion of all compliant samples by SAG, collectively help to ensure consistent laboratory performance. Both competent authorities can have confidence in the analytical results generated by these laboratories, which underpins the effectiveness

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of residue monitoring and the guarantees on the residue status of food of animal origin.

5.3 VETERINARY MEDICINAL PRODUCTS AND MEDICATED FEEDINGSTUFFS

5.3.1 Authorisation, distribution and use of veterinary medicinal products

Legal RequirementsArticle 29 of Council Directive 96/23/EC states that guarantees offered by residue monitoring plans submitted by third countries must have an effect at least equivalent to those provided for in the Directive and must, in particular, meet the requirements of Article 4 and specify the particulars laid down in Article 7 thereof and meet the requirements of Article 11(2) of Directive 96/22/EC. Article 7 of Council Directive 96/23/EC provides for legislation on the use of (pharmacologically active) substances listed in Annex I to the Directive and, in particular, provisions on their prohibition or authorisation, distribution and placing on the market and the rules governing their administration. Articles 4, 5 and 7 of Council Directive 96/22/EC establish conditions for the administration of substances, referred to in its Annex II, List B and Annex III, to farm and aquaculture animals.According to Article 11(2) of Council Directive 96/22/EC, Member States may not import live animals or animal products from third countries which authorise the use of stilbenes or thyrostats in food producing animals. Member States are also prohibited from importing products of animal origin for human consumption if the animals from which such products have been derived have been treated at any time with either thyrostatic substances, stilbenes, stilbene derivatives, their salts and esters, oestradiol 17β and its ester-like derivatives, and beta-agonists if administered for the purposes of growth promotion. The relevant provisions in EU law governing the marketing authorisation of veterinary medicinal products are laid down in Articles 5-15, 21-30, 58-62 and 83 of Directive 2001/82/EC and for certain products authorised on an EU-wide basis, in Articles 30-40 of Regulation (EC) No 726/2004. Provisions governing the distribution and use of veterinary medicinal products are laid down in Articles 65-71 of Directive 2001/82/EC. Veterinary medicinal products which are authorised for use in food producing animals may only contain pharmacologically active substances which are listed in Table 1 of the Annex to Commission Regulation (EU) No 37/2010. Article 67(aa) of Directive 2001/82/EC requires that veterinary medicinal products for food producing animals are only dispensed to the public under a veterinary prescription unless exempted under the conditions laid down in Article 2 of Commission Directive 2006/130/EC. In respect of medicated premixes conditions governing their distribution and use are laid down in Articles 2, 8 and 9 of Council Directive 90/167/EEC. Production of medicated feedingstuffs can only take place in establishments which have been authorised for the production of feedingstuffs containing additives in accordance with Articles 9, 10, 11 and 13 of Regulation (EC) No 183/2005 and the production process must satisfy the conditions laid down in Annexes I and II to that Regulation.

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FindingsThe Sub-Department Registration and Control of Veterinary Drugs of the Livestock Protection Division of SAG is responsible for the marketing authorisations of veterinary medicinal products for all animal species including aquaculture. Only veterinary medicinal products registered by SAG are allowed to be distributed or used in Chile (Article 2 of Decree No 25 of 1995). SAG is also responsible for rules on the use on prohibition of natural and synthetic anabolic substances (Law No 19.283 of 1994, amending Article 43 of Law No 18.755).An authorisation for a veterinary medicinal product is valid for five years, which is renewable. With regard to veterinary medicinal products for food producing animals, SAG Procedure P-PP-RM-001 – in force since 01.03.2011 - requires that the applicant provides for a withdrawal period which ensures that the MRL established by Codex Alimentarius or the EU can be met, whichever is the lowest. SAG stated that Resolution No 1462 of the Ministry of Health which contains MRLs for residues of pharmacologically active substances in food producing animals applies to the domestic market only. Some of these MRLs are higher than those applicable in the EU. Labelling requirements follow the requirements of EU legislation and withdrawal periods have to be indicated on the labels of the veterinary medicinal products. Currently off-label use is not provided for in national legislation. However, SAG stated that it is planned to amend national legislation in this respect.Importers and manufacturers may sell veterinary medicinal products to wholesalers, pharmacies, or (mainly on prescription) directly to veterinarians and producers, except for restricted substances, e.g. anabolic substances. Article 6 of Decree No 25 of 1995 lists four different types of distribution: (1) without veterinary prescription, (2) on veterinary prescription, (3) on veterinary prescription and with retention of the prescription at the selling establishment (e.g. veterinary medicinal products containing prostaglandins, SAG Resolution No 3772, dated 11.12.1996) and (4) on veterinary prescription with retention of the prescription and recording of sales data in a register at the selling establishment for which detailed rules are laid down in SAG Resolution No 667, dated 29.1.2010. Examples of the latter category are veterinary medicinal products containing ketamine (SAG Resolution No 1816, dated 31.3.2010) and anabolic substances. SAG Resolution No 3773, dated 11.12.1996 classifies veterinary medicinal products as "prescription only medicines" except veterinary medicinal products for external use (disinfectants and antiparasitics) and minerals and vitamins for oral administration. Article 6 of Decree No 25 of 1995 provides for the required content of a veterinary prescription: name, address and number of the identity card of the veterinarian, product prescribed and its application, type of animal treated, name of the owner and date of prescription. The withdrawal period is not required to be indicated. The audit team noted that:• a list of all registered veterinary medicinal products is publicly available on the

SAG website, including relevant information on inter alia, pharmacologically active substances, species and withdrawal periods. It was noted that information with respect to withdrawal periods and restrictions on use published on the web

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page summary did not always correspond with the information provided in the published product information;

• the production, importation, distribution, possession and use of stilbenes and thyrostats has been prohibited in food producing animals by SAG Resolution No 2973, dated 2.5.2011;

• the use of some substances has been prohibited for food producing animals: chloramphenicol and its salts by SAG Resolution No 3599 dated 29.11.1996, nitrofurans, 5-nitroimidazoles and their metabolites by SAG Resolution No 1500 dated 19.05.1998 and beta agonists (e.g. clenbuterol, ractopamine) by SAG Resolution No 3108, dated 15.10.1997. With regard to beta agonists, one product containing clenbuterol is authorised for bovines and ovines for therapeutic use. SAG stated, that although not clearly written in Resolution No 3108, that it is the use of such substances for growth promotion which is prohibited;1

• products containing carbadox, olaquindox or malachite green, crystal violet, brilliant green and their metabolites are not authorised;

• for honey bees, two substances are authorised, flumethrin and amitraz. No antimicrobials are registered for use in bees, which is in line with the situation in the EU. However, for the last ten years, SAG has allowed on request of bee keepers/honey collection centres the importation and use of a non-authorised veterinary medicinal product containing fumagillin (permit no 000394, dated 05.08.2010). The permit defines specific requirements such as the amount of product that can be purchased and that distribution to the individual bee-keepers has to be recorded and based on a laboratory diagnosis of disease. It was indicated on the product that it should not be used during the honey flow. No withdrawal period was indicated on the label;

• at present there are nine hormonal growth promotants (implants) authorised for bovines containing inter alia, oestradiol, trenbolone, zeranol and testosterone. For therapeutic use, one product containing testosterone is authorised as an injectable for cattle, sheep, goats and pigs.

11.1.1.1 PABCOIn order to comply with the requirements of Article 11 of Council Directive 96/22/EC, a segregated production system called PABCO has been implemented since 2004. The current system is described in Procedure (P-PP-IT-007) - in force since 01.12.2010 by means of Resolution No 6976 SAG, dated 11.11.2010 - and it covers cattle, pigs, poultry, sheep and goats including milk of all relevant species. Six specific Instructions (I-PP-IT-016 to 021) complete the requirements of the PABCO programme, which comprise inter alia, traceability of animals, SAG-accredited veterinary practitioners, recording of medicinal treatments of the animals and regular inspections by SAG officials. These official controls have to be carried out in line with respective check lists F-PP-IT-050 to 055. For bovines, PABCO has two versions, PABCO A and PABCO B, the

1 In their response to the draft audit report, SAG indicated that Resolution 3108 has been repealed and replaced with Resolution 5325 dated 09 August 2011. The new Resolution expressly prohibits the manufacture, import, distribution, sale, possession and use of beta-agonists and anabolics for growth promoting purposes in animals producing food for human consumption.

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former covering cattle and the latter covering sheep, goats, pigs and poultry. In both systems the farmer guarantees that no anabolic substances have been applied to the animals since birth and possession or use of anabolic substances is prohibited for all these farms. Bovine meat and milk exported to the EU must originate from PABCO A farms. The audit team noted that:• the updated Procedure and Instructions, although in force since

December 2010, have to be applied by the latest in August 2011, as the implementing Resolutions provide for a transitional period of eight months. As a consequence, requirements such as recording the relevant withdrawal periods in the treatment records for pigs and to include in this record the use of medicated feed were not obligatory at the time of the audit;

• new movement control documents for pigs and sheep have been developed and will become applicable in August 2011;

• prescriptions for veterinary medicinal products used by a PABCO farm can only be issued by veterinary practitioners who are accredited by SAG. This accreditation is valid for three years and is renewable;

• at the slaughterhouse visited, the veterinarian checked the ear tag numbers of all PABCO A cattle in the national electronic system. In cases where it could not be verified that the cattle had originated from the PABCO A farm specified on the movement control document accompanying the animals, the carcases were retained. The veterinarian contacted the local SAG office responsible for the PABCO A farm in question and the respective animals were only released for export to the EU if the SAG offices confirmed - by updating the electronic system – that the ear tag numbers belonged to PABCO A farms. Evidence was seen, that one animal was excluded from export to the EU, where its origin could not be confirmed;

• so far no goat farms have signed up to PABCO.

11.1.1.2 RAMEXWith respect to the export of honey the RAMEX register was established in February 2006. Bee-keepers who export honey are required to be registered in RAMEX. The Manual of Procedure (RAMEX/MP) requires traceability of the origin of honey and prohibits the use of nitrofurans, nitroimidazoles, chloramphenicol and other substances defined by SAG. Resolution No 361 of SAG dated 20.01.2006, requires that each batch of honey has to be analysed before export and that nitrofurans, chloramphenicol, sulphonamides and streptomycin should not be detected - see 5.1.4.2. The audit team noted that:• SAG stated in their action plan in relation to recommendation 7 of the

2007 FVO report, that they intended to update the Manual of Procedure with the aim to implement an updated registry of therapeutic and preventive treatments carried out in the apiaries. However the keeping of treatment records is still not a requirement in the RAMEX/MP.

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11.1.1.3 Pharmaceutical Products Control ProgrammeWith regard to the export of aquaculture fish, the Fisheries Health Department of Sernapesca has established the Pharmaceutical Products Control Programme, and the respective Manual of Procedures (FAR/MP1) describes the requirements and control measures. The main elements of this programme are a declaration of the owner of a fish farm that he has not treated the animals with prohibited or unauthorised substances, and that in case of treatment of fish with authorised substances, that the MRLs applicable in the country of destination are respected. The Programme requires pre-harvest testing for residues if the fish have been treated within the last six months before harvest. The objective is to confirm that the relevant MRLs have been respected - see 5.1.4.1. At least once a year, an official sampling for prohibited or unauthorised substances is also required. The results of sampling and the assurance declaration must accompany the batch of fish to the processing plant. The veterinarian of the fish farm has to send monthly records of treatments, which include withdrawal periods, to Sernapesca (required by Article 12 of the Sanitary Regulation for Aquaculture, S.D. N° 319/2001).The audit team noted that: • for at least ten years Sernapesca has accepted the off-label use of

authorised injectable veterinary medicinal products containing oxytetracycline and florfenicol in fish even though off-label use is not provided for in national legislation and explicitly not provided for by the Programme;

• Sernapesca has asked SAG for an amendment of the relevant national legislation in order to provide an appropriate legal basis for this practice. Sernapesca stated that in case of off-label use withdrawal periods have to be established by the veterinarian of the farm. Detailed information was available to Sernapesca on the actual withdrawal periods prescribed. There was quite some variation seen but generally the withdrawal periods prescribed were significantly longer than the minimum 500 degree days applicable for 'cascade' use in the EU under Article 11 of Directive 2011/82/EC.

Conclusions on authorisation, distribution and use of veterinary medicinal productsThe authorisation procedure and rules governing the distribution and use of veterinary medicinal products are broadly similar to those applicable in the EU. However, the requirement for the maintenance of treatment records (as specified in Article 10 of Council Directive 96/23/EC) has not been met for all commodities currently eligible for export to the EU (i.e. honey – which was also the case in 2007). In relation to the controls on the use of hormonal growth promotants and beta-agonists for growth promotion, the PABCO A programme provides sufficient assurances that beef eligible for export to the EU has not been obtained from cattle so treated and is therefore in line with the requirements of Council Directive 96/22/EC.

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11.1.2 Controls on the distribution and use of veterinary medicinal products

Legal RequirementsArticle 29 of Council Directive 96/23/EC states that guarantees offered by residue monitoring plans submitted by third countries must have an effect at least equivalent to those provided for in the Directive and must, in particular, meet the requirements of Article 4 and specify the particulars laid down in Article 7 which provides for legislation on the use of (pharmacologically active) substances listed in Annex I to the Directive and, in particular, provisions on their prohibition or authorisation, distribution and placing on the market and the rules governing their administration. Article 10 of Council Directive 96/23/EC lays down the veterinary medicines record keeping requirements for stockowners. The relevant provisions in EU law governing competent authorities' obligations to carry out inspections throughout the distribution chain of veterinary medicinal products in order to verify compliance with the provisions of the EU code relating to veterinary medicinal products (Directive 2001/82/EC) are laid down in Articles 65, 66, 68, 69 of that Directive. With regard to ensuring that the production of medicated feedingstuffs is in accordance with Council Directive 90/167/EEC, the rules governing control functions by the competent authorities are laid down in Articles 4, 9 and 13 of said Directive. FindingsSAG has overall responsibility for the control of: the distribution chain of veterinary medicinal products (including aquaculture); feed mills producing medicated feedingstuffs (including aquaculture) and farms (terrestrial animals) (Articles 41 and 42 of Law No 18.755). Sernapesca is responsible for official controls on aquaculture farms. Since 2009 Sernapesca can also carry out controls on feed mills producing feed for aquaculture species based on a co-operation agreement with SAG. SAG has issued instructions for inspections including target inspection frequencies and check lists for all levels of the distribution chain. SAG and Sernapesca have issued check lists for official controls on farms, which also serve as report templates for the local offices carrying out the controls. The audit team noted that:• the local SAG and Sernapesca offices had carried out official controls on the

distribution chain, on feed mills and on farms at the nationally required frequencies and the centrally-provided check lists had been used and in general filled in to record the results of these controls;

• copies of the reports of official controls were available at the regional offices visited and for detected non-compliances were also available at the central level.

11.1.2.1 Controls at wholesale level, retail level and on veterinary practitioners

Distributors of veterinary medicinal products need to be licensed by the local offices of SAG. The audit team noted that:• in one of the regions visited, official controls carried out at importers,

wholesalers and pharmacies by the local SAG offices in 2010, resulted in six non-compliances. The offenders had been prosecuted and in three cases

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penalties between 800 and 3000 US $ had been imposed; • at the three wholesalers/pharmacies visited, the nationally required

documentation and records (e.g. monthly stock records for anabolic substances purchased and sold and veterinary prescriptions) were available and the reports of the official controls did not reveal any non-compliances;

• the check list for official controls at wholesalers/pharmacies includes a question on whether veterinary prescriptions for anabolic substances which have been issued by a veterinarian accredited for PABCO A farms have been completed only for farms which are not members of the PABCO A programme. (PABCO A farms are prohibited from receiving anabolic substances whereas other farms can do so legally). The response to this question was recorded in one of the four reports examined by the audit team.

11.1.2.2 Controls on feed mills (medicated pre-mixes and medicated feedingstuffs)

At present, there are 74 feed mills registered at SAG which manufacture medicated feedingstuffs, 56 of which produce only for animals owned by the same company that owns the feed mills in question. Feed mills do not need a specific authorisation to produce medicated feedingstuffs, but official controls are to be carried out twice a year instead of the normal once a year frequency, if medicated feedingstuffs are produced. The Chilean Feed Law and Resolutions No 5580 of 2005 and No 5025 of 2009 provide for the national legal requirements, inter alia the requirement to minimise the risk of cross-contamination and to implement a quality assurance programme. National legislation requires a veterinary prescription for the production of medicated feedingstuffs. The audit team noted that:• according to the information provided by Sernapesca, about 10 to 15 % of

the fresh water aquaculture farms produce their own medicated feed on farm. These farms are not included in the list of registered feed mills.

• the general check list for feed mills includes one point related to medicated feedingstuffs, requiring either that medicated feedingstuffs are produced in a separate line or that documented procedures to avoid cross-contamination are in place;

• the feed mill visited by the audit team had implemented several measures to avoid cross-contamination including weekly cleaning of the two production lines, a fixed order of feed production, flushing etc. Verification of the efficacy of these procedures had been carried out by analysing the flushing batch for drug residues;

• although not a national legal requirement, the feed mill had retained all of the veterinary prescriptions for medicated feedingstuffs produced since 2008. All of the veterinary medicinal products prescribed and used had been authorised by SAG;

• medicated feedingstuffs were accompanied by a transport document, that

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indicated the veterinary medicinal products used, even though national legislation does not require the labelling of medicated feedingstuffs.

11.1.2.3 Controls on farms

FindingsThe audit team noted that:• at the PABCO pig farm visited, the updated instructions of the PABCO

system were not yet applied (see 5.3.1). The required records of purchase of veterinary medicinal products and treatment records were available on the farm, but not the veterinary prescription required for veterinary medicinal products used in medicated feed, as the accredited veterinarian of the farm had not issued prescriptions for the four different antibiotics used in the medicated feed on this farm. Inspections by the accredited veterinarian and by SAG were seen to be carried out in accordance with the check list. There were no non-compliances listed in the report of the last official control;

• at the bee keeper visited, a RAMEX registration document, records of treatments (not officially required) and a copy of the last official control of the local SAG office were available;

• since 2010, new check lists have been used for official controls on aquaculture fish farms, which include a more detailed chapter on the use of veterinary medicinal products. Evidence was seen for the fish farm visited that the required veterinary prescriptions and treatment records were kept and that the monthly treatment reports had been provided to Sernapesca.

Conclusions on official controls on the distribution and use of veterinary medicinal products

Official controls on the distribution and use of veterinary medicinal products, are carried out regularly using well defined procedures and have generally been carried out in accordance with national requirements. However, the reports of the controls on pharmacies and wholesalers were not always complete in respect of the important requirement to check whether hormonal growth promotants had been sold to PABCO A farms. This omission, in an otherwise comprehensive control system, weakens its effectiveness.

12 OVERALL CONCLUSIONS

It is concluded that the Chilean residue monitoring plan, with some exceptions, provides guarantees with an effect equivalent to that provided for by Council Directive 96/23/EC. The follow-up of non-compliant results is carried out consistently and comprehensively and the performance of the laboratory network is strong and has improved relative to the previous FVO mission. Nevertheless the effectiveness of the plan is compromised by a number of factors, notably its advance publication which is not in line with the requirement laid down in

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Annex III to Council Directive 96/23/EC. Some of the screening methods used (particularly for antibiotics) are not sufficiently sensitive to detect MRL violations and in relation to honey, whilst the scope of testing has improved relative to previous years, the absence of testing for fumagillin is an important deficiency, particularly considering its use in Chilean apiculture. With regard to implementation of the residue monitoring plan, the competent authorities have systems in place guaranteeing consistent implementation and have a comprehensive overview of the progress being made. However the taking of samples by industry and inadequate or non-existent sealing of samples undermine the effectiveness of residue controls and the advance notification of farmers prior to sampling has the potential to reduce the competent authorities' ability to detect the illegal use of substances on farms.

The additional pre-export testing programmes put in place for fish and honey in principle provide additional assurances on the residues status of those consignments eligible for export to the EU. However discrepancies observed in the results obtained from pre-harvest testing and official testing question the reliability of the pre-harvest testing data in guaranteeing that the EU MRL for oxytetracycline is not exceeded in consignments exported to the EU. With regard to honey, the fact that fumagillin is used in apiculture but is neither included in the pre-export programme (nor in the official SAG programme) means that residues of this substance may be present in consignments exported to the EU.

National rules governing the authorisation, distribution and use of veterinary medicinal products are broadly similar to those applicable in the EU. However, the requirement for the maintenance of treatment records (as specified in Article 10 of Council Directive 96/23/EC) has not been met for all commodities currently eligible for export to the EU (i.e. honey – which was also the case in 2007). In relation to the controls on the use of hormonal growth promotants and beta-agonists for growth promotion, the PABCO A programme provides assurances that beef eligible for export to the EU has not been obtained from cattle so treated and is therefore in line with the requirements of Council Directive 96/22/EC. Official controls on the distribution and use of veterinary medicinal products, are carried out regularly using well defined procedures and have generally been carried out in accordance with national requirements. However, the reports of the controls on pharmacies and wholesalers were not always complete in respect of the important requirement to check whether hormonal growth promotants had been sold to PABCO A farms. This omission, in an otherwise comprehensive control system, weakens its effectiveness.

13 CLOSING MEETING

A closing meeting was held on 17 June 2011 with representatives of SAG and Sernapesca. At this meeting, the audit team presented the main findings and preliminary conclusions of the audit. The authorities did not express disagreement. SAG indicated that measures would be taken to oblige apiaries to keep treatment records from the next honey flow season, starting in September 2011, and to include fumagillin in the residue monitoring plan. SAG indicated that it would start testing goats this year subject to goat farmers subscribing to PABCO and in anticipation of approval of the residue monitoring plan by the Commission services. SAG presented legislative changes in relation to the bovine identification and registration system, requiring movements of PABCO A animals to be recorded within 5 days.

14 RECOMMENDATIONS

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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 twenty five working days of receipt of this audit report.

N°. Recommendation

1. To expand the scope of testing carried out in the national residue monitoring plan for terrestrial animals taking into account the veterinary medicinal products used in each production sector, and to adjust limits of detection and action levels to those laid down in Regulation (EU) No 37/2010 and Regulation (EC) No 396/2005, in order to have an effect at least equivalent to that provided for in Council Directive 96/23/EC.

2. To ensure that samples are taken by official staff and to ensure that sampling is unexpected and that samples are sealed, in line with the requirements laid down in the Annex to Commission Decision 98/179/EC.

3. To ensure that treatment records are kept for bees with an equivalent effect to Article 10 of Council Directive 96/23/EC.

4. To consider strengthening the official controls on sales records of anabolic substances to ensure that these are not used for growth promotion in cattle intended for export to the EU (Article 3 of Directive 96/22/EC).

The competent authority's response to the recommendations can be found at:

http://ec.europa.eu/food/fvo/ap/ap_cl_2011-8916.pdf

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ANNEX 1 - LEGAL REFERENCES

Legal Reference Official Journal Title

Audits by the Commission Services

Reg. 882/2004 OJ L 165, 30.4.2004, p. 1, Corrected and re-published in OJ L 191, 28.5.2004, p. 1

Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules

Food Law

Reg. 178/2002 OJ L 31, 1.2.2002, p. 1-24

Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety

Reg. 852/2004 OJ L 139, 30.4.2004, p. 1, Corrected and re-published in OJ L 226, 25.6.2004, p. 3

Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs

Reg. 853/2004 OJ L 139, 30.4.2004, p. 55, Corrected and re-published in OJ L 226, 25.6.2004, p. 22

Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin

Monitoring and sampling of residues in food of animal origin

Dir. 96/23/EC OJ L 125, 23.5.1996, p. 10-32

Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC

Dec. 97/747/EC OJ L 303, 6.11.1997, p. 12-15

97/747/EC: Commission Decision of 27 October 1997 fixing the levels and frequencies of sampling provided for by Council Directive 96/23/EC for the monitoring of certain substances and residues

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Legal Reference Official Journal Title

thereof in certain animal products

Dec. 98/179/EC OJ L 65, 5.3.1998, p. 31-34

98/179/EC: Commission Decision of 23 February 1998 laying down detailed rules on official sampling for the monitoring of certain substances and residues thereof in live animals and animal products

Approval of residue monitoring plans submitted by third countries

Dec. 2011/163/EU OJ L 70, 17.3.2011, p. 40-46

2011/163/EU: Commission Decision of 16 March 2011 on the approval of plans submitted by third countries in accordance with Article 29 of Council Directive 96/23/EC

Validation of analytical methods for residues and Minimum Required Performance Limits

Dec. 2002/657/EC OJ L 221, 17.8.2002, p. 8-36

2002/657/EC: Commission Decision of 12 August 2002 implementing Council Directive 96/23/EC concerning the performance of analytical methods and the interpretation of results

Bans on the use of hormones and beta-agonists for growth promotion in food producing animals

Dir. 96/22/EC OJ L 125, 23.5.1996, p. 3-9

Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of ß-agonists, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EEC

Maximum Residue Limits for veterinary medicinal products in food of animal origin

Reg. 470/2009 OJ L 152, 16.6.2009, p. 11-22

Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council

27

Legal Reference Official Journal Title

Reg. 37/2010 OJ L 15, 20.1.2010, p. 1-72

Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin

Maximum Residue Levels for pesticide residues in food of animal origin

Reg. 396/2005 OJ L 70, 16.3.2005, p. 1-16

Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC

Maximum Levels for contaminants in food

Reg. 1881/2006 OJ L 364, 20.12.2006, p. 5-24

Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs

Authorisation of veterinary medicinal products

Dir. 2001/82/EC OJ L 311, 28.11.2001, p. 1-66

Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products

Dir. 2006/130/EC OJ L 349, 12.12.2006, p. 15-16

Commission Directive 2006/130/EC of 11 December 2006 implementing Directive 2001/82/EC of the European Parliament and of the Council as regards the establishment of criteria for exempting certain veterinary medicinal products for food-producing animals from the requirement of a veterinary prescription

Reg. 726/2004 OJ L 136, 30.4.2004, p. 1-33

Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency

Medicated feedingstuffs and additives

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Legal Reference Official Journal Title

Dir. 90/167/EEC OJ L 92, 7.4.1990, p. 42-48

Council Directive 90/167/EEC of 26 March 1990 laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Community

Reg. 1831/2003 OJ L 268, 18.10.2003, p. 29-43

Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition

Reg. 183/2005 OJ L 35, 8.2.2005, p. 1-22

Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene

Sampling methods and methods of analysis for contaminants in foodstuffs

Reg. 333/2007 OJ L 88, 29.3.2007, p. 29-38

Commission Regulation (EC) No 333/2007 of 28 March 2007 laying down the methods of sampling and analysis for the official control of the levels of lead, cadmium, mercury, inorganic tin, 3-MCPD and benzo(a)pyrene in foodstuffs

Reg. 401/2006 OJ L 70, 9.3.2006, p. 12-34

Commission Regulation (EC) No 401/2006 of 23 February 2006 laying down the methods of sampling and analysis for the official control of the levels of mycotoxins in foodstuffs

Reg. 1883/2006 OJ L 364, 20.12.2006, p. 32-43

Commission Regulation (EC) No 1883/2006 of 19 December 2006 laying down methods of sampling and analysis for the official control of levels of dioxins and dioxin-like PCBs in certain foodstuffs

Sampling methods for pesticides in foodstuffs

Dir. 2002/63/EC OJ L 187, 16.7.2002, p. 30-43

Commission Directive 2002/63/EC of 11 July 2002 establishing Community methods of sampling for the official control of pesticide residues in and on products of plant and animal origin and repealing Directive 79/700/EEC

Horse identification (passport)

Reg. 504/2008 OJ L 149, 7.6.2008, p. 3-32

Commission Regulation (EC) No 504/2008 of 6 June 2008 implementing Council Directives

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Legal Reference Official Journal Title

90/426/EEC and 90/427/EEC as regards methods for the identification of equidae

Medicines essential for the treatment of equidae

Reg. 1950/2006 OJ L 367, 22.12.2006, p. 33-45

Commission Regulation (EC) No 1950/2006 of 13 December 2006 establishing, in accordance with Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products, a list of substances essential for the treatment of equidae

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