HEALTH & CONSUMERS DIRECTORATE-GENERAL

Transcription

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 CHILE FROM 28 JANUARY TO 05 FEBRUARY 2009 IN ORDER TO EVALUATE CONTROLS OF PESTICIDES IN FOOD OF PLANT ORIGIN INTENDED FOR EXPORT TO THE EUROPEAN UNION

2 Executive Summary The objective of the mission was to evaluate the control system in Chile for pesticides in food of plant origin intended for export to the European Union (EU). It was decided to carry out a mission to Chile in view of the very significant volume of its fruit and vegetable exports to the EU. There were also some notifications of unacceptable levels of pesticide residues in food of plant origin from Chile within the EU Rapid Alert System for Food and Feed (RASFF). Legislation is in place for the authorisation and control of the marketing and use of plant protection products (PPPs), and for voluntary training and certification of operators. A small number of national MRLs were set in There is a system for authorisation of PPPs, but the risk of authorised PPPs for the consumers is not sufficiently evaluated. Several of the active substances, contained in authorized PPPs in Chile, can not be legally marketed and used in the EU. If applied on produce for the export market, they can lead to exceedance of EC MRLs. A list of PPPs authorised for marketing and use is regularly up dated on the web-site of the competent authority, but the details of the authorisations are not fully transparent to users. A system is in place for risk-based and unannounced controls of retailers and users of PPPs. Documented procedures are implemented, including follow-up measures. Sanctions are proportionate. The inspections observed by the mission team were comprehensive and detailed, but the packaging of some PPPs was of a low standard, which requires a high level of protective measures for workers health and safety. Neither special provisions nor control plans exist for pesticide residues in food of plant origin intended for export to the EU. However, a pilot study for a possible monitoring programme is currently planned, and private controls for pesticide residues are operated by the well organised and export-oriented growers, pack-houses and exporters. There was evidence of satisfactory follow-up of recent EU RASFF notifications on pesticide residues in fruit by the CA. The two visited private laboratories for pesticide residues are accredited to ISO They analyse only private samples, and the scope of analyses does not cover all pesticides used by growers. Both laboratories have the potential for a broad official monitoring programme with quality control procedures equivalent to the EU Guidelines. Overall conclusion Compliance of fruit and vegetables imported from Chile with EU pesticide maximum residue levels (MRLs) is mainly ensured by the comprehensive auto-control systems operated by the export-oriented growers, pack-houses and exporters. The competent authorities perform well organised controls for the marketing and use of plant protection products, but national authorisation of these products is not founded on risk assessment, and details are not fully transparent for operators. There is no official control for pesticide residues in exported produce and no designated laboratory with sufficient analytical capabilities to cover EU MRLs and pesticides used by growers. The report contains recommendations to Chile to address identified shortcomings. i

3 TABLE OF CONTENTS 1 INTRODUCTION OBJECTIVES OF THE MISSION LEGAL BASIS FOR THE MISSION BACKGROUND MAIN FINDINGS Legislation Competent authorities Controls of the marketing and use of plant protection products Authorisation of plant protection products Controls of the marketing and use of plant protection products Formulation laboratory Controls of pesticide residues in food of plant origin to be exported Communication of EC MRLs Control of pack-houses Traceability and record-keeping Sampling programmes for pesticide residues Certification of exports Follow-up of notifications in the EU RASFF Laboratories for pesticide residue analysis Additional private controls CONCLUSIONS Legislation Competent authorities Controls of the marketing and use of plant protection products Controls of pesticide residues in food of plant origin to be exported Overall conclusion CLOSING MEETING RECOMMENDATIONS ii

4 ABBREVIATIONS & SPECIAL TERMS USED IN THE REPORT Abbreviation ADI ARfD CA CODEX DAD DG SANCO ECD EU EUROSTAT FVO GAP GC GC-MS/MS HA HPLC IPM ISO LC-MS/MS Explanation Acceptable Daily Intake Acute Reference Dose Competent Authority Codex Alimentarius, FAO/WHO Food Standards Diode Array Detector Directorate-General for Health and Consumers of the European Commission Electron Capture Detector European Union Statistical Office of the European Communities Food and Veterinary Office Good Agricultural Practice Gas Chromatograph Gas Chromatograph - Tandem Mass Spectrometry Hectare High Performance Liquid Chromatography Integrated Pest Management International Organisation for Standardisation Liquid Chromatograph Tandem Mass Spectrometry LD50 Lethal Dose, 50 % LOQ MRL NOAEL NPD PHI PPP Limit of Quantification Maximum Residue Level No Observed Adverse Effect Level Nitrogen Phosphorous Detector Pre-Harvest Interval Plant Protection Product iii

5 Abbreviation RASFF SAG Explanation Rapid Alert System for Food and Feed Agriculture and Livestock Service iv

6 1 INTRODUCTION The mission took place in Chile from 28 January to 5 February The mission team comprised two inspectors from the Food and Veterinary Office (FVO), one Member State expert and was accompanied by one official of the Health and Consumers Directorate General of the European Commission, Directorate E. The mission was undertaken as a part of the FVO's planned mission programme and was the first mission to Chile dealing with pesticide residues in produce of plant origin. The inspection team was accompanied during the whole mission by representatives from the central competent authority, the Agriculture and Livestock Service (SAG). An opening meeting was held on 28 January 2009 with SAG and the Ministry of Health, Department for Food and Nutrition. At this meeting, the objectives of, and itinerary for, the mission were confirmed by the inspection team. 2 OBJECTIVES OF THE MISSION The objective of the mission was to evaluate the control systems for pesticide residues in foodstuffs of plant origin intended for export to the European Union (EU). The facilities and measures in place for the determination of such residues in foodstuffs of plant origin intended for export to the EU were assessed to ensure that the produce is within specified limits laid down in EU legislation. As residue controls are related to the placing on the market and use of plant protection products (PPPs), the control system for the latter functions was also evaluated. The mission formed part of a wider series of missions to Third Countries to evaluate control systems and operational standards in this sector. The mission was carried out in the framework of: Regulation (EC) No 178/2002; Regulation (EC) No 882/2004; Regulation (EC) No 852/2004; Regulation (EC) No 396/2005. In pursuit of these objectives, the following sites were visited: Table 1: Mission visits and meetings 1

7 Visits/meetings Comments Competent Authorities Central Regional Laboratories 2 2 SAG and Ministry of Health, Department for Food and Nutrition; SAG regional offices in Rancagua (region VI) and Talca (region VII); Private laboratories for Pesticide Residues analysis 2 Conduct private pesticide residue analysis; Inspection or site visits Packing houses / Exporters 3 Visit to three pack-houses and exporters of various fruits in regions VI and VII, one of the exporters was involved in three notifications in the EU RASFF systems for pesticide residues in fruit; Growers 4 Observation of inspections of four medium and large scale producers of various fruit in regions VI and VII (producer of apples, cherries and hazelnut on 66 ha; producer of apples, grapes, kiwis and blueberries on 280 ha; producer of cherries, apples, kiwi, plums on 84 ha; and a producer of cherries, pears and table grapes on 30 ha); Retailers of PPPs 2 Observation of inspections of two retailers of PPPs in region VI (family company selling to small and medium size companies) and region VII (part of a national chain). 2

8 3 LEGAL BASIS FOR THE MISSION The mission was carried out under the general provisions of Community legislation, in particular under Article 46 of Regulation (EC) No 882/2004, and in agreement with the competent authorities in Chile. Legal acts quoted in this report refer, where applicable, to the last amended version. Full references to the acts quoted in this report are given in the Annex. 4 BACKGROUND According to data from EUROSTAT for the year 2007, Chile was the third largest exporter of fresh fruits to the EU, amounting to approximately 700,000 tonnes or 9.3 % of the total imports of fresh fruit to the EU. According to information received from SAG, Chile has the largest volumes of exports of table grapes and plums worldwide, is the most important exporting country of apples, peaches, raspberries, blueberries and avocados in the southern hemisphere, and accounts for 50 % of all fruit exports from the southern hemisphere. The SAG informed that 33 % of the Chilean fruit exports are shipped to Europe. There are 518 fruit exporters, and 65 % of the domestic fruit production is exported. In total, table grapes are grown on 53,000 hectares (ha), apples on 32,000 ha, avocados on 30,000 ha, peaches on 15,000 ha, cherries on 14,000 ha and blueberries on 13,000 ha. The fruit production covers a total of 317,000 ha. The mission team visited the most important regions for the production of fruit, the region VI de O'Higgins and region VII del Maule. In region VI, fruit is grown on 78,000 ha, in particular table grapes (17,000 ha), plums (7,300 ha) and red apples (6,800 ha). This region accounts for one third of the fruit exported from Chile. In region VII, fruit is grown on 55,000 ha, in particular red apples (16,000 ha), cherries (5,900 ha), kiwis (5,000 ha) and raspberries (4,500 ha). Raspberries are grown by small producers with less than 1 ha of raspberry production. A total of 18,500 tonnes of raspberries are exported to the EU, mostly frozen. According to SAG, 57,856 tonnes of PPPs were sold in Chile in Of these, 34,172 tonnes are formulated domestically. 5 MAIN FINDINGS 5.1 LEGISLATION Legislation on the marketing and use of PPPs and their control is laid down by Decree Law No of The Resolutions for the implementation of this Law include requirements for the authorisation of PPPs and obligations for retailers of PPPs to declare 3

9 the sales and any stocks of products with expired shelf-life. A small number of national pesticide maximum residue levels (MRLs) were established by Resolution No. 581 of 1999 of the Ministry of Health. The MRLs were based on CODEX limits, and not revised or amended since Article 34 of Decree Law No establishes that SAG can forbid the movement and sale, or can confiscate fruit and vegetables containing pesticide residues above the national legal limits. SAG Resolution No of 2000 implemented a voluntary system for the training and official certification of PPP users. SAG Resolution No of December 2008, based on Decree No. 3 of 1982, describes the general requirements for laboratories to become authorised by SAG for pesticide residue analysis. SAG Resolution No of 2002 is in place regarding the control of export of raspberries, including requirements for traceability. There is no traceability requirement for other fruits and vegetables legally established. There is no requirement for keeping of records of PPP uses legally established. 5.2 COMPETENT AUTHORITIES The competent authority (CA) for authorisation, importation, manufacture, distribution, sale and use of PPPs and controls of their marketing and use is SAG through the Agriculture Protection Division. The Ministry of Health is the CA for authorisation of PPPs for home and garden use, and for the setting of national MRLs. For fruit and vegetables sold on the domestic market, the Ministry of Health is the CA for checking compliance with national MRLs. For primary agricultural products intended for export, SAG is responsible for Phytosanitary Certification and Certification of Fitness for Human Consumption, when required by the importing country. In addition to its central office in Santiago, SAG has 15 regional and 63 local offices. In total, SAG has 1,600 permanent staff. In each region, one regional official co-ordinates the controls, and in each of the local offices, at least 1 agronomist and 1 technician carry out the controls. The inspectors met by the mission team were knowledgeable, experienced and regularly trained. There is some communication regarding pesticide residue control between SAG and the Ministry of Health at central level, and the report of the 2006 SAG monitoring programme for pesticides residues was formally submitted to the Ministry of Heath. Communication between staff of SAG and the Ministry of Health also takes place through the regional pesticide committees. The Ministry of Health and SAG expect that the recently founded Chilean Health Agency will further improve communication between the CAs. SAG implemented a system of internal checks and audits and, as examples, the report of an audit of the local office in Rancagua in December 2008, and the report of an internal check within the region VI was shown to the mission team. The internal check and the audit followed standardised procedures. 4

10 5.3 CONTROLS OF THE MARKETING AND USE OF PLANT PROTECTION PRODUCTS Authorisation of plant protection products All PPPs require authorisation prior placing on the market and use. Eight staff of SAG are involved in the authorisation of PPPs, and a private consultant performs a toxicological evaluation. The contract with the private consultant does not address the risk of a conflict of interest. The consultant demonstrated an example of a toxicological risk assessment for operators on the basis of LD50 values for acute toxicity (oral, dermal, inhalation). No risk analyses on the basis of No Observed Adverse Effect Levels (NOAEL), Acceptable Daily Intake (ADI), Acute Reference Dose (ARfD), and no consumer risk assessment on the basis of residue data from Supervised Field Trials are performed. No MRLs are set at the time of authorisation of a PPP. There are 970 PPPs authorised in Chile, containing 420 active substances. Several of these substances can not be legally marketed and used in the EU, and their use in Chile can lead to residues in excess of EU MRLs, if the treated fruits are exported to the EU. This is the case for azinphos-methyl, methomyl, carbaryl and carbofuran, which were involved in recent EU RASFF notifications regarding fruit from Chile. Also the authorised Good Agricultural Practices (GAPs) differ from the EU, and may lead to o residues in excess of EU MRLs. SAG stated that the official register of authorised PPPs is up-dated every two weeks. It is published and regularly up dated on the SAG website ( However, the information on the website does not contain full information about the authorised Good Agricultural Practice (GAP), i.e. the authorised time and quantity of the application and the pre-harvest interval (PHI). The mission team observed a case where a grower had used a PPP close to harvest, and the SAG inspector could not verify whether the authorised pre-harvest interval was observed Controls of the marketing and use of plant protection products For each region, the SAG central office sets annual targets for numbers of inspections of retailers and growers. The targets are based on statistical data on the number of pesticide retailers and farms in the different regions. Based on these instructions, each region sets up an annual control programme. Inspections of growers are prioritised on small and medium sized farms and growers producing for export. The central SAG office monitors whether the targets for inspection numbers are observed. In the regions VI and VII, which were visited by the mission team, every retailer has to be inspected at least once annually and around 1 % of growers should be inspected. For raspberries, every grower is inspected annually as required by SAG Resolution 3410 of Post-harvest uses of pesticides at pack-houses are not checked by SAG. There were centrally standardised report forms for controls of retailers and growers and for reporting infringements. The forms were used as check-lists by the inspectors. In addition, inspectors used aide memoirs. 5

11 Retailers notify their activity to SAG on a voluntary basis, and SAG has established a national register listing 483 PPP retailers. Retailers also sell fertilisers, and have a legal obligation to notify this activity to SAG. An additional registration of retailers is required from the Ministry of Health, who inspects health and safety of the workplace. The purchase of PPPs is not restricted to persons with any specific qualifications. SAG contract courses for the safe handling and use of PPPs in accordance with SAG Resolution 2147 of Courses comprise 30 hours. Almost 30,000 operators have been trained and certified between 2002 and 2007, including 7,300 operators in region VI and 5,900 operators in region VII. The participation is voluntary, but certified operators receive tax benefits. Trained operators receive a card with photo identification. The mission team observed the inspection of two retailers of PPPs. Inspections were performed by one or two SAG inspectors. They focussed on health and safety aspects of the work place and environmental issues such as layout of the building, conditions of storage, separation of product groups as well as flammable and non-inflammable products. Inspectors also checked whether PPPs contain a SAG authorisation number, a proper label with expiry date and hazard pictograms and colours for the toxicity group in accordance with the authorisation. Retailers take back properly washed and perforated empty containers, which are safely stored, and eventually sent for recycling. The mission team noted the low quality of packaging material for some products, and large packages exceeding the quantity needed for one treatment. This means that operators may have to open and close packages several times. A strong smell of pesticides was noted in many storage rooms for PPPs, and SAG inspectors were equipped with gasmasks. The mission team observed inspections of four different fruit growers. The inspections were carried out by one or two SAG inspectors. They performed a visual check of the correct functioning of any PPP equipment which is in use at the time of inspection, they checked the pesticides store with a similar scope as at the retailer, check protective clothing and may check the invoices to verify the source of the stocks in the pesticide store. Records of uses of PPPs are normally not checked in region VII. Additional regular phytosanitary checks are carried out on the farms by SAG inspectors. Inspections are not announced. The SAG inspectors stated that typically 3-4 inspections are performed on a day. Inspection reports for retail and grower inspections are completed in 3 copies, one for the company representative, one for the inspector and one for the regional SAG office. Reports are copied to the SAG central office. SAG stated that records are kept for 3 years. In total, SAG performed 896 inspections on the marketing of PPPs in 2007, including 116 in region VI and 82 in region VII. SAG performed a total of 3,576 inspections on the use of PPPs, including 157 in region VI and 382 in region VII. In case of infringement, administrative penalties are applied by the regional SAG directors, after consulting a lawyer and a technical expert in the service. In 2008, 36 infringements were recorded by SAG in Chile, including 24 in region VI, and 8 infringements in region VII. Penalties can range from approximately EUR 25 to 1,875, and in the examples observed by the mission team, penalties were applied in a proportionate manner. Products can be seized, and if considered necessary the business can be closed down. The operator has a right to appeal at the central SAG office. The 6

12 mission team observed a case, where a non-compliance of a PPP label was identified for an importer and a retailer, who operate in different regions. At the time of the FVO visit in the region, the grower who used the PPP involved had been fined, but the SAG regional office of the respective regions had not been informed for the possible follow-up of the non-compliance at the importer and retailer Formulation laboratory SAG takes samples of PPPs for formulation analysis. Samples are mostly taken at point of import and at national formulators before release of the products on the market. In addition, samples can be taken at retailers, but this was not done in the visited region VII. SAG stated that they aim to sample 5 % of imported consignments. Formulation analysis is performed by five authorised private laboratories. The SAG central office had filed copies of 58 analyses performed in CONTROLS OF PESTICIDE RESIDUES IN FOOD OF PLANT ORIGIN TO BE EXPORTED Communication of EC MRLs SAG stated that information on new EC MRLs is received by the Permanent Representation of Chile to the EU and forwarded by SAG to the professional organisations. In addition, the Chilean Exporters Association publishes information on MRLs in the importing countries on their website, including a link to the website of the European Commission Control of pack-houses Pack-houses must be authorized by the Ministry of Health, who is responsible for food hygiene inspections. Additionally, pack-houses can apply for operational agreements with SAG in the context of phytosanitary certification. Where a pack-house applied for an operational agreement, which simplifies procedures for phytosanitary certification, SAG performs additional sanitary checks. SAG does not normally perform controls of pesticide residues at pack-houses, but has carried out inspections of pack-houses in the follow-up of EU RASFF notifications Traceability and record-keeping There is a legal requirement for traceability for the export of raspberries as required by SAG Resolution No of 2002, but not for other fruits and vegetables. However, the exporter must demonstrate traceability for phytosanitary certification. Comprehensive traceability systems were implemented in the pack-houses visited in region VI and VII. The systems allowed tracing back to the farmer or even to the plot, respectively. There is no requirement for keeping of records of PPP uses legally established. Nevertheless, the keeping of records is required by the private standards to which growers are certified and by the self-control systems implemented by pack-houses; the 7

13 keeping of such records was verified by the mission team Sampling programmes for pesticide residues In 2006, a pesticide monitoring programme for fruit and vegetables on the domestic market was carried out by SAG. In this study, 374 samples were taken in 49 supermarkets. The results showed a high level of non-authorised uses. This study was not co-ordinated with the Ministry of Health, who is responsible for monitoring MRLs on the domestic market. However, the result of the study was formally sent to the Ministry of Health. The Ministry of Health has performed two separate monitoring studies on the domestic market in 2008 with around 1,000 samples and up to 17 analytes. SAG plan to implement a monitoring programme in food intended for export, with a pilot project to be carried out in region VI with 431 samples. SAG stated that the scope of the study is the compliance of exports for the main markets USA, EU and the Russian Federation. SAG also stated that 75 inspectors have been trained for sampling at the end of January 2009, and that the budget for the pilot study has been agreed. At the time of the mission, the details of the pilot study had not been finalised and the tendering procedure for private laboratories which would carry out the analyses had not yet been initiated Certification of exports Certification of plant produce for pesticide residues intended for export to the EU is not performed Follow-up of notifications in the EU RASFF In 2007, there were seven rapid alert notifications for pesticide residues, mainly in table grapes, and there were another 2 notifications in SAG provided information about the systematic follow-up of the rapid alert notifications. The EC Delegation receives RASFF notifications electronically from the Directorate Health and Consumers of the European Commission (DG SANCO). The Delegation prepares a Note Verbal for the General Directorate of International Economic Affairs at the Ministry of Foreign Affairs along with the RASFF documentation. The Note Verbal is delivered by hand, and a copy is stamped confirming reception. The copy is then scanned and sent to DG SANCO and to SAG's International Affairs Division. The RASFF notifications are received by the SAG Plant Protection Division within two to three weeks. In the cases observed by the mission team, the operators had been informed immediately about the non-compliances by their European customers. The growers and the pack-houses involved were contacted by SAG, and inspections were carried out by central and regional SAG staff on the spot. The inspectors checked the spraying records, invoices for PPPs, the production and product distribution of the grower, and in one case samples were taken for pesticide residue analysis. Where a misuse by a grower was identified, a fine was applied to the grower by the regional SAG office. In other cases, the infringements of EU MRLs resulted from an authorised use of a PPP in Chile, and no sanctions could be applied by SAG. Nevertheless, the exporters discussed and agreed corrective measures with SAG. 8

14 Comprehensive reports of the investigations were drawn up by SAG Laboratories for pesticide residue analysis Organisation SAG Resolution No of December 2008 describes the general requirements for authorisation of laboratories for pesticide residue analysis, but the objectives for authorising pesticide residue laboratories were not clearly stated. The technical criteria in Resolution No regarding equipment, methods, analytes and quality control procedures are not sufficiently detailed to assure the detection of infringements with EU MRLs for pesticides frequently used by Chilean growers, e.g. acetamiprid. No laboratory has been authorised yet to the requirements of the Resolution. SAG has authorised four private laboratories for official pesticide residue analysis under previous requirements, and these authorisations were stated to expire in 6 months. SAG stated that in parallel to the authorisation activities, they recently started to develop an official laboratory for pesticide residue control. Samples taken by the Ministry of health are analysed in the Public Health Institute. The mission team visited one of the authorised private laboratories and another private laboratory, which has applied for authorisation under Resolution No Both laboratories currently do not analyse official samples of produce intended for export Resources and training The authorised laboratory has good facilities in a new purpose-built building. Eight staff, including 5 analysts with third level education, perform pesticide residue analysis. The staff is regularly trained and have good skills. The laboratory is equipped with GC with ECD and NPD detectors and HPLC-DAD. The laboratory recently received GC-MS equipment, which has been used in some cases for confirmation purposes only. Additionally, two LC-MS/MS were recently purchased, but they are not currently used for pesticide residue analysis. The second laboratory also has good facilities in a new purpose-built building. Nine staff, including analysts with third level education, perform pesticide residue analysis. The staff have good skills. The laboratory is equipped with GC-MS/MS detectors and HPLC. Additional equipment is not currently used for pesticide residue analysis Analytical spectrum and methods The authorised laboratory uses the Luke multi-residue method. Approximately 4,500 samples are analysed annually for private customers, often targeted analysis for industry. The second laboratory uses an accredited in-house multi-residue method based on ethyl acetate extraction, and started to implement the QuEChERS method. Around 700 samples are analysed annually for private customers, often targeted analysis for industry. 9

15 Quality assurance systems Quality control procedures in the authorised laboratory were traceable, and included bracketed and matrix matched calibration at 4 points and routine recovery checks for 10 selected pesticides. The laboratory participates in proficiency tests with limited scope, mostly cereals, and good results. Weaknesses were identified in the control of standards and confirmation of positive results. Validation of methods was only performed for apples and some pesticides. Quality control procedures in the second laboratory were also traceable, and included calibration at 6 points and routine recovery checks for 5 selected pesticides, but calibration was not performed with matrix matched standards. The laboratory has participated in proficiency tests with a very limited scope, and has obtained some unsatisfactory results. The current scope of analysis in both laboratories does not cover many pesticides currently used by growers. For several pesticides the limits of quantification (LOQs) achieved are above 0.01 mg/kg, which is the MRL for many pesticides in the EU. For analysis of monitoring samples with a broad multi-residue screen and low LOQs both visited laboratories would need to use LC-MS/MS to allow also the detection of new pesticides used by growers. Both laboratories are accredited to ISO by the National Accreditation Body INN, and have the knowledge and capabilities for a broad monitoring programme with quality control procedures, which are equivalent to the EU Guidelines on Method Validation and Quality Control Procedures for Pesticide Residues Analysis in Food and Feed (SANCO 2007/3131). They stated that any decision on the related investment on equipment and validation of methods would depend on any decision of SAG to designate them for performing the planned monitoring analyses Additional private controls The Chilean Exporters Association has published on their website EU MRLs and unofficial PHI values, which aim to achieve compliance with MRLs of the EU and other markets. The unofficial PHI values are based on degradation curve studies commissioned in Chile. The values are generally used in the spraying plans of growers, pack-houses and exporters, also for those active substances, which were involved in EU RASFF notifications and which cannot be legally marketed and used in the EU. There was no evidence of systems for Integrated Pest Management (IPM) at the growers visited by the mission team. Growers, pack-houses and exporters operate comprehensive self-control systems for pesticide residues. Controls include certification to private standards and private sampling for pesticide residue analysis. Sampling is typically co-ordinated by the pack-houses, and high numbers of samples are analysed. Laboratory reports of these analyses showed that analysis is mainly performed by GC equipment. The mission team noted that farmers are using pesticides which cannot be detected, or not be detected with the required precision, by the equipment and methods generally referred to in the analytical reports seen by the mission team. 10

16 6 CONCLUSIONS 6.1 LEGISLATION 1. Legislation is in place for the authorisation and control of the marketing and use of PPPs, and for voluntary training and certification of operators. A small number of national MRLs were set in There is no legal requirement for traceability except regarding raspberry production for export, and no legal requirement for producers to keep records of PPP uses. 6.2 COMPETENT AUTHORITIES 1. Responsibilities for the two CAs for the authorisation of PPPs and for the control of pesticide residues are clearly defined, and there was evidence for communication between the CAs. SAG has a sufficient number of trained staff for the control of the marketing and use of PPPs, and established a system for internal checks and audits. 6.3 CONTROLS OF THE MARKETING AND USE OF PLANT PROTECTION PRODUCTS 1. There is a system for authorisation of PPP, but the risk of authorised PPPs for the consumers is not sufficiently evaluated, and the risk of a conflict of interest of the private toxicological consultant is not addressed. 2. Several of the active substances, contained in authorized PPPs in Chile, can not be legally marketed and used in the EU. If applied on produce for the export market, they can lead to exceedance of EC MRLs. 3. An official register of authorised PPPs is kept, and a list of PPPs authorised for marketing and use is regularly up dated on the SAG website. However, the details of the authorisations are not fully transparent to users, as the published list does not contact information on the authorised GAP. 4. A system is in place for risk-based and unannounced controls of retailers and users of PPPs. Documented procedures are implemented, including follow-up measures. Sanctions are proportionate. The inspections observed by the mission team were comprehensive and detailed, but the packaging of some PPPs was of a low standard, which requires a high level of protective measures for workers health and safety. In one observed case, follow-up of an infringement in other regions had not taken place. In addition to controls, the CA also arranges training for operators. 5. The quality of PPPs is checked by formulation analyses. 6. Comprehensive traceability systems were implemented in the pack-houses visited 11

17 by the mission team. 7. In compliance with Article 10 of Regulation (EC) No. 852/2004 in connection with Article 4.1 and Annex I, Part A.III of the same Regulation, the producers met by the mission team kept records of uses of PPPs. 6.4 CONTROLS OF PESTICIDE RESIDUES IN FOOD OF PLANT ORIGIN TO BE EXPORTED 1. Pack-houses exporting fresh fruits and vegetables must be authorised, as required by Article 10 of Regulation (EC) No. 852/2004 in connection with Article 6 of the same Regulation. Authorisations are granted by the Ministry of Health, who performs hygiene inspections. Controls of pesticide residues at pack-houses are performed by SAG only in the follow-up of RASFF notifications. 2. Neither special provisions nor control plans exist for pesticide residues in food of plant origin intended for export to the EU. However, a pilot study for a possible monitoring programme is currently planned, and private controls for pesticide residues are operated by the well organised and export-oriented growers, pack-houses and exporters. 3. There was evidence for satisfactory follow-up of recent EU RASFF notifications on pesticide residues in fruit. 4. The two visited private laboratories for pesticide residues are accredited to ISO They analyse only private samples, and the scope of analyses does not cover all pesticides used by growers. Both laboratories have the knowledge and capabilities for a broad monitoring programme with quality control procedures equivalent to the EU Guidelines, but do not currently invest in the required equipment and validation of methods due to uncertainty about their participation in a clearly defined official pesticide residue control programme. 6.5 OVERALL CONCLUSION Compliance of fruit and vegetables imported from Chile with EU pesticide MRLs is mainly ensured by the comprehensive auto-control systems operated by the export-oriented growers, pack-houses and exporters. The competent authorities perform well organised controls for the marketing and use of PPPs, but national authorisation of these products is not founded on risk assessment, and details are not fully transparent for operators. There is no official control for pesticide residues in exported produce, and no designated laboratory with sufficient analytical capabilities to cover EU MRLs and pesticides used by growers. 7 CLOSING MEETING 12

18 A closing meeting was held on 5 February 2009 with SAG. At this meeting, the main findings and conclusions of the mission were presented by the inspection team. The representatives of the CA offered some initial comments and provisionally accepted the preliminary findings. 8 RECOMMENDATIONS No In relation to pesticide residues in food of plant origin intended for export to the European Union, Chile should improve the controls, in order to guarantee that the produce complies with, or is equivalent to, European Union standards in accordance with Article 11 of Regulation (EC) No 178/2002. In particular, Recommendation Chile should consider improving the authorisation procedure for plant protection products by including a consumer risk assessment and by addressing the risk of a conflict of interest for private experts contracted for the evaluation process; Chile should consider improving transparency of the register for authorised plant protection products for growers, pack-houses and exporters; Chile should consider implementing the planned monitoring study for pesticide residues in produce intended for export to the EU, and should consider providing clear criteria for the designation of private laboratories. The competent authorities of Chile have sent an action plan to the European Commission in response to the recommendations. The competent authority's response to the recommendations can be found at: 13

19 ANNEX 1 - LIST OF LEGISLATION REFERENCED IN THE REPORT Reference OJ Ref. Detail Directive 91/414/EEC Regulation (EC) No 178/2002 Regulation (EC) No 852/2004 Regulation (EC) No 882/2004 Regulation (EC) No 396/2005 Regulation (EC) No 2076/2005 OJ L 230, , p OJ L 31, , p OJ L 139, , p. 1, Corrected and re-published in OJ L 226, , p. 3 OJ L 165, , p. 1, Corrected and re-published in OJ L 191, , p. 1 OJ L 70, , p OJ L 338, , p Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market 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 Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs Regulation (EC) No 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 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 Commission Regulation (EC) No 2076/2005 of 5 December 2005 laying down transitional arrangements for the implementation of Regulations (EC) No 853/2004, (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council and amending Regulations (EC) No 853/2004 and (EC) No 854/