EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

Transcription

1 Ref. Ares(2016) /12/2016 EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Health and food audits and analysis DG(SANTE) MR FINAL REPORT OF AN AUDIT CARRIED OUT IN SRI LANKA FROM 14 SEPTEMBER 2016 TO 22 SEPTEMBER 2016 IN ORDER TO EVALUATE CONTROLS OF PESTICIDES IN FOOD OF PLANT ORIGIN INTENDED FOR EXPORT TO THE EUROPEAN UNION 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.

2 Executive Summary This report describes the outcome of an audit in Sri Lanka carried out from 14 to 22 September 2016, as part of the published DG Health and Food Safety audit programme. The objective of the audit was to assess controls on pesticide residues in tea, fruits, vegetables and tropical herbs intended for export to the European Union (EU). The relatively small numbers of authorised plant protection products, and systematic controls of their importation, facilitate the control of these products on the market. Nevertheless, their correct use by growers is compromised by the lack of a complete and updated register of authorised products, and by contradictory information on recommended uses issued by different authorities. The authorities are taking several measures to control pesticides in fruits, vegetables and herbs intended for export to the EU, but these are at a very early stage of implementation. A small number of growers was registered and in the process of certification for Good Agricultural Practices. In addition, the authorities started a monitoring programme for pesticide residues, but few results were available at the time of the audit. The effectiveness of these controls was compromised by the small analytical scope and the lack of robust quality control systems at the laboratories. Furthermore, there was no system for the communication and follow-up of notifications in the EU Rapid Alert System for Food and Feed, which impedes the taking of adequate measures at the source of the non-compliances. Consequently, these controls cannot provide assurances that produce destined for the EU market complies with EU maximum residue levels for pesticide residues. For tea, however, an official control system was implemented many years ago. It comprises traceability, quality and quantity aspects, and some aspects of pesticide control. These limited official controls for pesticides are supplemented by private controls of processors and exporters of tea, which together provide measures towards compliance of exported tea with EU maximum residue levels. The report contains recommendations to the competent authorities to address the shortcomings identified. I

3 Table of Contents 1 Introduction Objectives and scope Legal Basis and Standards Legal Basis Standards Background Findings and Conclusions Relevant National Legislation Competent Authorities Official Controls of the Marketing and Use of Plant Protection Products Authorisation of Plant Protection Products Controls of Retailers of Plant Protection Products Control of users of Plant Protection Products Formulation Analysis Official Controls of Pesticides Residues in Food of Plant Origin Control at Pack-houses, Processors, Exporters Laboratories for Pesticide Residue Analysis Response to RASFF Notifications Private Controls on Vegetables, Herbs and Tea Exported to the EU Overall Conclusions Closing Meeting Recommendations...15 II

4 ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT Abbreviation CA(s) CAB CAC/GL CDA CODEX DOA EU FBO(s) GAP GMP(s) GC-MS ha HPLC-UV ISO ITI LC-MS/MS(s) MRL(s) MS(s) NPQS PHI(s) PPP(s) RASFF RoP SL-GAP SLTB TRI Explanation Competent Authority(ies) Counselling of Agribusiness Codex Alimentarius Commission/Guideline Coconut Development Authority Codex Alimentarius Commission of the Food and Agriculture Organization of the United Nations and World Health Organization Department of Agriculture European Union Food Business Operator(s) Good Agriculture Practice(s) Good Manufacturing Practices Gas chromatograph coupled to mass spectrometer hectare(s) High Performance Liquid Chromatography with Ultra Violet Detector International Organisation for Standardisation Industrial Technology Institute Liquid Chromatograph coupled to tandem mass spectrometers Maximum Residue Level(s) Member State(s) National Plant Quarantine Service Pre-Harvest Interval(s) Plant Protection Product(s) Rapid Alert System for Food and Feed Registrar of Pesticides Sri Lankan Good Agricultural Practices Sri Lanka Tea Board Tea Research Institute III

5 1 INTRODUCTION This audit took place in Sri Lanka from 14 to 22 September 2016 as part of the Directorate General for Health and Food Safety s planned audit programme. The European Commission team consisted of two auditors from the Directorate General for Health and Food Safety and one expert from a European Union (EU) Member State (MS). It was accompanied throughout the audit by representatives of the Registrar of Pesticides Office, subordinated to the Department of Agriculture (DOA) of the Sri Lankan Ministry of Agriculture. An opening meeting was held on 14 September 2016 at the National Plant Quarantine Service (NPQS) headquarters in Katunayake, during which the objectives and itinerary for the audit were confirmed and additional information necessary for the conduct of the audit was requested. 2 OBJECTIVES AND SCOPE The objectives of the audit were to verify whether there are control systems in place for the control of pesticide residues in tea, fruits, vegetables and tropical herbs including pennywort (Centella asiatica) intended for export to the EU, and assess whether these systems offer adequate assurances that the produce concerned is within the specified residue limits as laid down in EU legislation. In terms of scope, the audit reviewed the controls in place on production and export, including a review of national legislation, Competent Authority (CA) organisation, their controls and enforcement capability, facilities (laboratory capability) and measures in place for the determination of pesticide residues. As the residue controls are directly related to the national rules governing the authorisation, placing on the market and use of Plant Protection Products (PPPs), the control systems in this area were also part of the audit. In pursuit of these objectives, the following sites were visited: Competent Authority/ies No of Meetings Comments Competent Authorities 4 Department of Agriculture, Office of the Registrar of Pesticides, Tea Research Institute, Sri Lanka Tea Board Laboratories Public laboratories 3 Industrial Technology Institute, Office of Registrar of Pesticides and Sri Lanka Tea Board laboratories. 1

6 Producers Growers 4 Two tea growers and two pennywort growers Industry representative groups 1 Tea Exporters Association Exporters/Pack-Houses Exporter of fruits and vegetables 1 Exporter of fruits to the European Union 3 LEGAL BASIS AND STANDARDS 3.1 LEGAL BASIS The audit was carried out under the general provisions of EU legislation, in particular, Article 46 of Regulation (EC) No 882/2004 of the European Parliament and of the Council which stipulates that EU controls in non-eu countries may verify compliance or equivalence of non-eu countries legislation and systems with EU feed and food law and EU animal health legislation. These controls shall have particular regard to the assurances which the non-eu country can give regarding compliance with, or equivalence to, EU requirements. EU legal acts quoted in this report refer, where applicable, to the last amended version. Full references to the EU acts quoted in this report are given in Annex STANDARDS Additionally, Guidelines and Codes of Practice of the Codex Alimentarius Commission of the Food and Agriculture Organization of the United Nations and World Health Organisation (CODEX) were also taken into account in this audit. A full list of applicable standards referred to in this report is provided in Annex 2. Reference to specific provisions of these texts is provided at the beginning of each section. 4 BACKGROUND DG Health and Food Safety has carried out missions in a number of exporting countries to assess official controls for pesticide residues in food of plant origin originating from these countries. The reports on these missions are available on the internet site at An overview report summarising findings and conclusions of these missions has also been published at this site: 2

7 Based on figures from the Statistical Office of the European Union, for the years 2013, 2014 and 2015, Sri Lanka exported agricultural products to the volume of 230, 260 and 308 million Euros to the EU. Sri Lanka is the fourth largest tea producer and the second largest exporter. In 2015, 330 million kg accounting for approximately 8.5% of global tea production, of which around 24 million kg is exported to the EU. In 2015, a total of 122 tonnes of pennywort were exported to the EU. A total of 16 notifications in the EU Rapid Alert System for Food and Feed (RASFF) relating to pesticide residues were made in the period from 2014 to Of these notifications, five related to pennywort, and three to tea. Further notifications related to papaya, peppers, bitter gourd, spinach, passion fruit, long beans and the herb Alternanthera sessilis. 5 FINDINGS AND CONCLUSIONS 5.1 RELEVANT NATIONAL LEGISLATION Legal requirements Article 46(1)(a) of Regulation (EC) No 882/2004 stipulates that EU controls shall have, inter alia, particular regard to the legislation of the non-eu countries. Findings 1. The Control of Pesticides Act No 33 of 1980 provides the legal framework for import and authorisation of PPPs, and for the control of marketing and use of these products. It designates the Office of Registrar of Pesticides (RoP) as the CA and established the Pesticide Technical and Advisory Committee. 2. Control of Pesticides Act No. 33 of 1980 provides provisions to establish national Maximum Residue Levels (MRLs). Pre-harvest intervals (PHIs) and MRLs for 13 insecticides were established in Government extraordinary gazette No 433/9 of A new Draft Government Notification is in the process of being adopted and includes 221 MRLs for 39 crop/food categories for 65 active pesticide substances. Food Act No. 26 of 1980 provides the authority for the implementation of national MRLs on domestic and imported foods. 3. Provisions to control the quality of tea from Sri Lanka are specified in Tea Control Act No 51 of 1957 and Tea (Tax and control of Exports) Act No 16 of The Acts provide for registration and control of tea growers and processors throughout the chain. Conclusions 4. National legislation provides the basis for the control of pesticides. 3

8 5.2 COMPETENT AUTHORITIES Legal requirements Articles 46(1)(b) and (c) of Regulation (EC) No 882/2004 stipulate that EU controls shall have, inter alia, particular regard to the organisation of non-eu countries CAs, their powers and independence, the authority they have to enforce the applicable legislation effectively and the training of staff in the performance of official controls. Findings 5. The Office of Registrar of Pesticides of the DOA, under the aegis of the Ministry of Agriculture, is responsible for the authorisation of PPPs. The Office of the Registrar is also responsible for controlling the marketing of PPPs through registration and inspection of retailers, import controls and formulation analysis. 6. Different authorities are responsible for controlling the use of PPPs and their residues in produce for export: a. DOA: fresh fruits and vegetables b. Department of Export Agriculture: spices c. Sri Lanka Tea Board (SLTB), the Tea Research Institute (TRI) and the Tea Small Holding Development Authority under the Ministry of Plantation Industries: tea d. Coconut Development Authority (CDA): coconut 7. The Ministry of Health is the CA for domestic and imported foods. 8. The NPQS of the DOA is responsible for phytosanitary pre-export controls of plant products. 9. The Sri Lankan Standards Institution under the Ministry of Industry and Commerce is the National Standards Body of Sri Lanka, and issued the Sri Lanka Good Agricultural Practices (GAP) and Good Manufacturing Practices (GMP) standards for growers and processors of food. 10. The Ministry of Industry and Commerce is the EU contact point for RASFF. This competence was not known to the other authorities in the scope of the audit (See section on RASFF 5.4.3). Conclusions 11. CAs are clearly designated and communicated, which is the basis for an effective control system. There was not awareness among other CAs that the Ministry of Industry and Commerce had been designated as EU contact point for the RASFF system. 4

9 5.3 OFFICIAL CONTROLS OF THE MARKETING AND USE OF PLANT PROTECTION PRODUCTS Legal requirements Articles 46(1)(e) and (b) of Regulation (EC) No 882/2004 stipulate that EU controls shall have, inter alia, particular regard to the existence and operation of documented control procedures and control systems based on priorities, and the CA's capability to enforce applicable legislation; Article 10 of Regulation (EC) No 852/2004, in conjunction with Article 4.1 and Annex I, Part A.III of the same Regulation, requires that Food Business Operators producing or harvesting plant products are, in particular, to keep records on any use of PPPs. Findings Authorisation of Plant Protection Products 12. PPPs can only be marketed and used following authorisation at National level. The CA informed the audit team that as of September 2016, 459 commercially available PPPs were authorised, containing 107 active substances. Out of these 107 active substances, 27% are not approved for use in the EU (14 insecticides, 5 fungicides and 10 herbicides). Authorisation of PPPs is granted for a three year period. Contrary to the situation in the EU, the authorisation does not prescribe the precise conditions of use. 13. The website of the DOA ( is publicly available and contains different documents with information on PPPs. The official list of authorised PPPs was last updated on 28 August 2002, and products from that list have since been revoked, and other new products have been authorised. Therefore the list does not reflect the actual state of authorisation of PPPs. The register of authorised pesticides includes the unique registration number, trade name and active substance and its concentration. The register did not include information about the recommended or authorised conditions of use of the products, such as the crops on which the product can be used, the concentrations of the product or the pre-harvest interval. 14. In cases of revocation of PPPs, RoP stated that placing on the market is prohibited from the date the decision is taken. Growers with product stocked are allowed to use this for an undetermined period of time The DOA irregularly releases a "Pest Management Recommendation" including information about the crop, the pest, dosage, PHI (when available) and other remarks. However, the audit team observed that in such documents, the recommendations include reference to the use of active substances which are not formally authorised in Sri Lanka, for example for azadirachtin, dinotefuran, spinetoram, or fenpyroximate. The recommendations issued by the DOA are used by the Extension Services throughout the country in close contact with growers. 1 In their response to the draft report the Competent Authority noted that there is a mechanism for controlling shelf-life of products and market observance, through regular checks by authorised field staff. 5

10 16. The RoP also provided the audit team with a list of pesticides banned in Sri Lanka from 1970 to 2015, including 35 active substances. 17. The TRI is responsible for conducting efficacy trials for products destined for use on tea. These trials are only conducted for PPPs where the authorisation holders agree to pay for this service. The TRI issues circulars with their recommendations, and growers are advised to use only the chemicals listed. The most recent list was released in February In the case of tea, the SLTB also issues circulars with statements on the list of pesticides that can be used. However, neither circulars from TRI nor from SLTB are updated in line with the authorisation of pesticides by the RoP, and, in some cases contain active substances that have been banned, or PPPs for which authorisation have been revoked Controls of Retailers of Plant Protection Products 18. All PPP retailers must be registered under Section 21 of the Control of Pesticides Act 33 of In 2016 there were 1,177 registered retailers. The CA estimated that there are another 800 dealers selling PPPs who are not registered. The CA stated that many of these dealers only operate seasonally. Registered retailers are inspected annually. For registration purposes, it is required that staff are trained by the Office of Registrar of Pesticides. Currently the training consists of a one day training course with an exam. The training requirement is currently under revision, and it is proposed that a minimum qualification will be required or to fulfil a specific six month training and an exam. 19. Controls are conducted in Sri Lanka by 523 Officers under the DOA. Controls to PPP retailers focus on three aspects: the availability of the registration, storage of PPPs away from food, and packaging in appropriate leak proof containers Control of users of Plant Protection Products 20. According to an Official Communication from the DOA of July 2016, operators exporting products of plant origin to the EU must be registered by 15 September Exporters are required to include, within the registration form, the names of pack-houses and growers supplying to the exporter operator. 21. The DOA stated that growers registered as exporting to the EU are required to implement Sri Lankan Good Agricultural Practices (SL-GAP). The SL-GAP Scheme is crop specific and at the time of the audit, there were guidelines available for eleven different crops. It is not possible for producers growing crops other than these eleven to be registered in the system. The SL-GAP guidelines were developed by the DOA in cooperation with the Sri Lanka Standards Institution. 22. On 1 January 2015 the Division for Counselling of Agribusiness (CAB) was established and currently there are 100 counsellors providing advice to growers for the implementation of the requirements of the SL-GAP. They are provided with tablet 2 In their response to the draft report the Competent Authority noted that there are two categories of officers under DOA and Mahaweli Authority of Sri Lanka. "Enforcement" Officers carry out the inspection described in finding No. 19, and "Authorised" Officers inspect label checks and appropriate management of revoked PPPs and other broader controls. 6

11 computers and internet access to facilitate their work. Although counsellors were aware of specific EU MRLs, there were no clear guidelines or measures to take regarding how to use PPPs in a way that their residues would comply with EU MRLs. 23. Certification to SL-GAP is conducted by an independent body within the DOA. The SL- GAP scheme requires growers to keep records of PPP use. At the time of the audit, 285 farms were registered with the scheme and 25 farms had already been certified. The CA acknowledged that some years will be required for all or some growers to reach certification level. The SL-GAP initiative is funded by the DOA and there is no cost to growers in the scheme. 24. In addition to this SL-GAP scheme, growers exporting to the EU are controlled by the NPQS of the DOA. Inspectors of the NPQS are responsible for granting permission for harvesting crops destined for the EU. NPQS inspectors directly control product harvested on farms. The information gathered on farms is provided to NPQS inspectors at the pack-houses, enabling the cross checking of the volumes declared. 25. The SL-GAP standard for pennywort was released in June At the time of the audit, only three growers of pennywort had been registered for the GAP scheme and no grower was certified. The total registered area is less than one hectare (ha). During visits to growers producing pennywort for export, the growers informed the audit team that part of their production had recently been exported to the EU. However, neither NPQS inspectors nor CAB counsellors were aware of this. The DOA stated that the system described in paragraph 24 had not yet been activated for this crop, therefore, no control was conducted during harvesting. 26. There were no PPPs authorised or recommended for use on pennywort, and no effective alternative control measures against insects or mites were available to growers. The SL- GAP advisors had recommended growers of pennywort to protect the perimeter of the plot with a net to control mites. However, due to the large mesh size of the shading net used for this purpose by the growers visited, its low height and its use only in the perimeter, this measure is not suitable to prevent the ingress of pests. 27. There are seven tea producing areas in Sri Lanka. There are more than 300,000 small growers (farms of less than 10 acres) producing 60% of the total production of tea leaves. The remaining 40% is produced by 23 large companies. 28. The audit team visited two large tea producing estates. Estates visited had implemented Integrated Pest Management measures to control pests and diseases as per the recommendations issued by the TRI. The audit team reviewed application records and identified the use of an authorised PPP containing chlorfluazuron in one of the estates visited. Nevertheless, in the circulars issued by the TRI in February 2015 (see paragraph 17), this is not listed as a recommended pesticide for the control of tea tortrix and had been withdrawn at the last revision of the pesticide list. In the case of a fungal disease control (blister blight) at the second estate visited, the records showed the use of another authorised commercial product of an authorised PPP containing the hexaconazole active substance which was not recommended by the TRI. 7

12 5.3.4 Formulation Analysis 29. Formulation analysis of PPPs is performed mostly within the process of import controls. Every imported consignment of PPPs, or technical material for formulating PPPs, must be declared to the RoP before arrival. The RoP issues a "market clearance" approval which is required by customs for authorising the entrance into Sri Lanka. The RoP conducts documentary checks of formulation integrity for each consignment. In addition, random checks including laboratory analysis may take place. The RoP stated that in 2015 the number of imported consignments reached 1,500. The RoP analysed about 800 samples of 400 formulated products, with one non-compliance detected. Examples of refusal of import permits were reviewed and verified during the audit. 30. RoP s laboratory is the official laboratory of this service and of the DOA. The laboratory conducts physical-chemical analyses of PPPs, like checks for wettability, and also identification of active substances. The laboratory is not yet accredited, but has applied for accreditation of formulation analysis for two substances (diazinon and fipronil). Methods are available for another 15 substances, which represent only 16% of the total number of active substances authorised in the country. 31. The available High Performance Liquid Chromatography Ultra Violet (HPLC-UV) and Gas chromatograph coupled to mass spectrometer (GC-MS) are suitable equipment for the formulation control of active substances. An upgrade of the HPLC-system is planned to achieve better specificity for formulation quality control. Conclusions 32. The system of authorisation of PPP and controls of the retailers and imports into Sri Lanka and the relatively small number of active substances and PPPs authorised for use in Sri Lanka provides the basis for efficient control. However, the system in place is not effective to control that only authorised PPPs are marketed due to deficiencies in the availability of updated and consistent information on PPPs. 33. The correct use of authorised PPPs by growers is compromised by the lack of a unique definitive and updated register of authorised products, including the conditions of use such as dosage, crops, pre-harvest interval. It is also compromised by contradictory information released by different CAs. 34. Actions have been taken to introduce a control system for growers of fresh fruits, vegetables and herbs to the EU, however this system was still in the initial stages of implementation and did not provide assurances that products destined for the EU market comply with the relevant MRLs for all type of crops. 35. For pennywort, the lack of authorised PPPs, and effective alternative measures to control pests and diseases, compromises the capability of the grower to produce in line with EU MRLs. It also increases the risk that the growers use unauthorised PPPs to protect their produce from pest attacks. 36. The small scope of the formulation laboratory reduces the effectiveness of the system to identify irregularities of PPPs intended to be placed on the market. 8

13 5.4 OFFICIAL CONTROLS OF PESTICIDES RESIDUES IN FOOD OF PLANT ORIGIN Legal requirements Articles 46(1)(b), (c), (d), (e) and (h) of Regulation (EC) No 882/2004 stipulate that EU controls shall have, inter alia, particular regard to: the existence and operation of documented control procedures and control systems based on priorities, the CA's capability to enforce applicable legislation, the resources including diagnostic facilities available to CAs, the training of staff in the performance of official controls and the assurances which the non-eu country can give regarding compliance with, or equivalence to, EU requirements. Article 11 of Regulation (EC) No 178/2002 stipulates 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. Article 18 of Regulation (EC) No 396/2005 requires that products covered by Annex I of the same Regulation shall not contain, from the time they are placed on the EU market as food or feed, any pesticide residue exceeding EU MRLs, or 0.01 mg/kg for those products for which no specific MRL is set. The CODEX has also established MRLs for pesticides, which are considered for the establishment of EU MRLs (CAC/MRL ). Commission Directive 2002/63/EC establishing EU methods of sampling for the official control of pesticides residues in and on products of plant and animal origin or equivalent international standards (e.g. CODEX Alimentarius Commission/Guidelines (CAC/GL) ). Point 41 of Guidelines of CODEX CAC/GL on the Design, Operation, Assessment and Accreditation of Food Import and Export Inspection and Certification Systems lays down that inspection services should utilize laboratories that are evaluated and/or accredited under officially recognized programmes to ensure that adequate quality controls are in place to provide for the reliability of test results. In accordance with Guidelines of CODEX CAC/GL , point 3, the laboratories should comply with ISO/IEC Guide from the International Organisation for Standardisation. Point 6 of the CODEX Guidelines CAC/GL specifies that upon information about a rejection of a food consignment presented for import, the food control authorities in the exporting country should undertake the necessary investigation to determine the cause of any problem that has led to the rejection of the consignment. Findings Control at Pack-houses, Processors, Exporters 37. According to an Official Communication from the DOA of July 2016, operators exporting products of plant origin to the EU must be registered by 15 September

14 (see paragraph 20). The DOA stated that six exporters were registered by the deadline, but estimated that around 60 companies were exporting to the EU. 38. Sri Lanka has recently approved the implementation of a monitoring programme for pesticides residues in fresh fruits and vegetables, and at the time of the audit, 28 analyses results were available. In 27% of the cases the results showed that EU MRLs were exceeded. The CA stated that the monitoring programme will be extended to 2017 with a budget for around 500 analyses. 39. The tea sector has been regulated since 1957 by the Tea Control Act. All tea operators including growers, transport, factories, brokers and exporters must be registered. The SLTB stated that there were 765 tea processing factories registered, and 373 tea exporters operating in the only authorised tea auction in Colombo through eight selling brokers. The SLTB is responsible for monitoring and approving every batch of tea. Quality control includes organoleptic assessment for each batch, and a monitoring system is in place including physical and chemical properties, and microbiological analyses for at least 10% of batches. Controls on imported tea for blending also include the requirement to provide pesticide residue analyses and, in addition, random samples were analysed at the SLTB laboratory for verification. The laboratory of the Sri Lankan Tea Board analyses every year about 500 to 800 samples of tea for import into Sri Lanka. The SLTB has launched a GMP scheme and at the time of the audit 28 premises were certified. Pesticide residue analysis was required to complete the certification. The SLTB stated that 36 samples of Sri Lankan tea were analysed for the GMP certification of pack-houses. These were the only official Sri Lankan tea samples analysed at the time of the audit. 40. The regulation of the tea production and processing comprises a sound traceability system allowing tracing upstream to the growers, and the SLTB has access to the information, thus facilitating the investigation and implementation of actions in cases of complaints or non-conforming product. The SLTB conduct quality controls to exporters, factories and large farms, and the Tea Small Holders' Development Authority is responsible for conducting quality and quantity controls to small growers. However, the controls in place are related to verification of quantities and quality aspects, and do not include relevant aspects for the use of pesticides. Conclusions 41. The official control system for tea comprises traceability, quality and quantity aspects, and includes a few elements of pesticide control, largely of imported tea, thus contributing to the compliance of tea imported for blending. 42. First steps have been taken to introduce controls on pesticide residues for exports of fresh fruits and vegetables to the EU. This system was still in the initial stages of implementation and did not provide assurances that product destined for the EU market comply with the relevant MRLs for all type of crops. 10

15 5.4.2 Laboratories for Pesticide Residue Analysis 43. The mission team visited three laboratories conducting official pesticide residue analyses: a. The Industrial Technology Institute of the Ministry of Technology b. The laboratory of the Office of Registrar of Pesticides c. The Sri Lankan Tea Board laboratory The Industrial Technology Institute 44. The Industrial Technology Institute (ITI) is an official institution under the Ministry of Technology and Research. The laboratory has 350 staff and provides services in a wide range of technology. 45. The pesticide residues laboratory is well stocked with chemicals and consumables, and equipped with Liquid Chromatograph coupled to tandem mass spectrometers (LC- MS/MSs), GC with Electron Capture Detector and GC-MS. For pesticide residue analysis nine staff members were available, two at scientific level and five for technical assistance. The staff were very competent in the use and basic maintenance of the equipment. The laboratory has received 93 pesticide residue samples from the RoP, of which 53 have been analysed, but reports had been released for only 28 samples (see paragraph 38). 46. The scope of the methods for fruits and vegetables comprised 31 compounds on LC- MS/MS and 28 compounds on GC-MS. Nearly all pesticides in the LC-MS/MS method are or were until recently authorised in Sri Lanka. Detection levels are typically mg/kg in fruits and vegetables. 47. The laboratory applied for accreditation by the Sri Lanka Accreditation Body. The application includes 31 active substances analysed with LC-MS/MS. The validation data for pesticide residue analysis was completed for the LC-MS/MS method and high water content matrix, which are steps needed for accreditation. 48. Weaknesses were identified regarding the absence of correction for matrix effects and the absence of external reference, as the laboratory had not obtained performance information of the first proficiency test they took part in. The scope of analysis in the laboratory did not cover many pesticides used by growers. However, the laboratory has already standards for 120 active substances in stock and was in the process of including them into the method, which would allow enlarging the accreditation scope in the future. The laboratory of the RoP 49. The laboratory of the RoP is the official laboratory of this service and the DOA. Their main task is the control of formulations (see section 5.3.4). Additionally, they analyse pesticide residues in crops and water, and heavy metals in pesticide formulations and food samples. 50. In 2015, pesticide residue analysis was performed in 260 samples with low sensitivity. The methodology used is not suitable for an effective pesticide residue control programme, and samples were outsourced to the ITI, in order to get more reliable results. 11

16 The laboratory of the Sri Lankan Tea Board 51. The laboratory of the SLTB is an integrated part of this board. The laboratory has about 20 staff including qualified and trained technical personnel on the use of analytical equipment. Equipment in use for pesticide residue analysis is a single quadrupole type GC-MS. An LC-MS/MS has been acquired and the laboratory has started preliminary tests. 52. The laboratory is accredited to ISO for pesticide residue analyses, and the scope comprises three active substances. The routine scope covered about 10 analytes, but did not include relevant pesticides recommended for use in tea by the authorities and detected by EU laboratories. The sensitivity is not sufficient to detect analytes with low MRLs, and the GC-instrumentation available at the time of the audit was not suitable to obtain sufficient sensitivity to meet EU MRLs. From January to September 2016, the laboratory had received 451 tea samples for pesticide residue analysis, of which 338 analyses had been finalised at the time of the audit. 53. The quality control procedures for pesticide residue analysis showed weaknesses. In particular, system performances are not checked in each batch. The laboratory took part in proficiency tests with variable results. The last proficiency test report showed an outlier for one pesticide and corrective action had been taken. Conclusions 54. The very small scope of analysis, in particular at RoP and SLTB, has a negative impact on the effectiveness of controls. 55. The three laboratories were either in the process of achieving accreditation to ISO or extending the accreditation scope, which, once achieved, could demonstrate the reliability of their results. The ITI and the formulation laboratory of RoP have minor weaknesses with respect to quality issues, but shortcomings with quality control compromise the capability of the SLTB laboratory to ensure that controls are effective Response to RASFF Notifications 56. The contact point in Sri Lanka for the EU RASFF is the Ministry of Industry and Commerce. The Registrar of Pesticides and the Tea Board stated that they had not been informed about the RASFF notifications received in 2015 and 2016, and for this reason could not investigate and follow up on these notifications. The notifications were received in the communication related to this audit, and an investigation has commenced. The outcome of investigations was not communicated to the Ministry of Industry and Commerce, as this authority was not known by the ROP and the SLTB as official EU contact point of the RASFF system. Consequently, no response was given to the EU. The CODEX Guidelines CAC/GL recommends that, upon receipt of such a communication, the food control authorities in the exporting country should undertake the necessary investigation to determine the cause of any problem that has led to the rejection of the consignment. The food control authority in the exporting country, 12

17 if requested, should provide the authorities in the importing country with information on the outcome of the necessary investigation, if available. Conclusions 57. There is no system in place for the communication and follow-up of RASFF notifications. This hinders the CAs in taking adequate measures at the source of the noncompliances, and sending a response to the EU. 5.5 PRIVATE CONTROLS ON VEGETABLES, HERBS AND TEA EXPORTED TO THE EU Legal requirements Article 10 of Regulation (EC) No 852/2004, in conjunction with Article 3 of the same Regulation, requires FBOs to ensure that all stages of production, processing and distribution of food under their control satisfy the relevant hygiene requirements. Findings 58. The tea producer associations informed the audit team that large companies exporting tea to the EU have implemented GMP and good hygiene practices, which were, in several cases, certified for private schemes. Commonly, importers in the EU require additional certificates of analyses for pesticide residues. The SLTB estimates that 50% of tea processors are certified for private schemes. 59. The SLTB and several tea grower and exporter associations met during the audit stated that estates of large tea companies have implemented private GAP schemes at farm level, as was the case for the two tea estates visited by the audit team. 60. For other crops, the DOA stated that organic production is growing in Sri Lanka although no figures were available for this type of production. There were other private GAP schemes being implemented for fruits and vegetables, but covered only a small number of growers. Conclusions 61. The private controls are more developed in the tea sector, providing additional assurances of compliance of tea with EU MRL requirements. 62. For growers of fresh fruits and vegetables for export to the EU, any private GAP schemes were at an early stage of implementation. They cannot provide assurance that fruits and vegetables exported to the EU comply with EU MRLs. 13

18 6 OVERALL CONCLUSIONS The relatively small number of authorised plant protection products, and systematic controls of their importation, facilitate the control of these products on the market. Nevertheless, their correct use by growers is compromised by the lack of a complete and updated register of authorised products, and by contradictory information on recommended uses issued by different authorities. The authorities are taking several measures to control pesticides in fruits, vegetables and herbs intended for export to the EU, but these were at a very early stage of implementation. A small number of growers was registered and in the process of certification for Good Agricultural Practices. In addition, the authorities started a monitoring programme for pesticide residues, but few results were available at the time of the audit. The effectiveness of these controls was compromised by the small analytical scope and the lack of robust quality control systems at the laboratories. Furthermore, there was no system for the communication and follow-up of notifications in the EU Rapid Alert System for Food and Feed, which impedes the taking of adequate measures at the source of the non-compliances. Consequently, these controls cannot provide assurances that produce destined for the EU market complies with EU MRLs for pesticide residues. For tea, however, an official control system has been implemented since many years. It comprises traceability, quality and quantity aspects, and some aspects of pesticide control. These limited official controls for pesticides are supplemented by private controls of processors and exporters of tea, which together provide measures towards compliance of exported tea with EU MRLs. 7 CLOSING MEETING A closing meeting was held on 22 September 2016 with representative of the CAs. At this meeting, the audit team presented the main findings and preliminary conclusions of the audit. DOA staff offered constructive comments on the findings and conclusions presented. 14

19 8 RECOMMENDATIONS No. Recommendation 1. Ensure the reliability of the authorisation system to provide a guarantee that produce intended for export to the EU meets the requirements laid down in Article 11 of Regulation (EC) 178/2002 and Article 18 of Regulation (EC) No 396/2005. For example, but not exclusively, by further developing a single, accurate, reliable, regularly updated and publicly available source of all relevant data pertaining to pesticide use, so that all information critical for safe PPP use is freely and easily available. Conclusions upon which this recommendation is based: 32, 33 Associated findings upon which this recommendation is based: 13, 15, 17, Ensure that the levels of pesticide residues in foodstuffs exported to the EU comply with EU MRLs as laid down in Article 18 of Regulation (EC) No 396/2005. This could be achieved by providing growers with effective plant protection measures (authorisation of plant protection products and alternative control measures), and implementation of the system of certification to Good Agricultural Practices. Conclusions upon which this recommendation is based: 33, 34, 35 Associated findings upon which this recommendation is based: 12, 13, 22, Ensure that the scope of pesticide residue analyses is broadened in order to provide a guarantee that the exported produce meets the requirements laid down in Article 11 of Regulation (EC) No 178/2002 and Article 18 of Regulation (EC) No 396/2005. The analytical scope should include at least the pesticides marketed in growing areas and those identified in EU RASFF notifications. Conclusion upon which this recommendation is based: 54 Associated findings upon which this recommendation is based: 48, Ensure that laboratories for pesticide residue analysis are evaluated and/or accredited under officially recognised quality management and assurance programmes so as to guarantee reliability of analytical results provided as set out in Point 41 of CODEX CAC/GL 26/1997 on the Design, Operation, Assessment and Accreditation of Food Import and Export Inspection and Certification Systems. Conclusion upon which this recommendation is based: 55 Associated findings upon which this recommendation is based: 47, 50, Ensure that an effective system for investigation of RASFF notifications is implemented, so that these notifications are investigated in a timely manner and the outcome is reported to the EU in all cases as recommended by Codex 15

20 No. Recommendation standard CAC/GL Conclusions upon which this recommendation is based: 57 Associated findings upon which this recommendation is based: 56 The competent authority's response to the recommendations can be found at: 16

21 ANNEX 1 LEGAL REFERENCES Legal Reference Official Journal Title Reg. 178/2002 OJ L 31, , p 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, , p. 1, Corrected and re-published in OJ L 226, , p. 3 Reg. 882/2004 OJ L 165, , p. 1, Corrected and re-published in OJ L 191, , p. 1 Reg. 396/2005 OJ L 70, , p Dir. 2002/63/EC OJ L 187, , p 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 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

22 ANNEX 2 Standard Quoted in the report Reference number Full title Publication details CODEX Guidelines CAC/GL CODEX Guidelines CAC/GL CODEX Guidelines CAC/GL CODEX Guidelines CAC/GL CAC/MRL 1/2009 Guidance for the Exchange of Information between countries on rejections of imported food Guidelines for the design, operation, assessment and accreditation of food import and export inspection and certification systems Guidelines for the Assessment of the Competence of Testing Laboratories Involved in the Import and Export Control of Food Recommended Methods of Sampling for the Determination of Pesticide Residues for Compliance with MRLs Maximum Residue Limits (MRLs) for Pesticides ad/standards/353/cxg_02 5e.pdf ad/standards/354/cxg_02 6e.pdf ad/standards/355/cxg_02 7e.pdf q_editor/cxg_033e.pdf ds/pestres/pesticides/en/