EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

Transcription

1 Ref. Ares(2016) /10/2016 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 INDONESIA FROM 07 MARCH 2016 TO 17 MARCH 2016 IN ORDER TO ASSESS THE CONTROLS OF AFLATOXIN CONTAMINATION IN NUTMEG 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 Indonesia, which took place from 07 March to 17 March 2016 as part of the published DG Health & Food Safety audit programme under the provisions of Regulation (EC) No 882/2004 of the European Parliament and the Council of 29 April The objectives of the audit were to verify whether there are control systems in place to control aflatoxin contamination in nutmeg intended for export to the EU and to assess whether they are adequate to ensure that the produce concerned is within the specified contaminant limits laid down in EU legislation, in particular complying with or being at least equivalent to Regulation (EC) No 1881/2006. The audit team also followed-up the nine recommendations made in the report of the previous audit (2012) on the same subject. There have been some significant improvements made since the 2012 audit. Of the nine recommendations in the previous audit report, five have been fully addressed, three were partly addressed and one was not addressed. New legislation is in place since April 2015 which regulates export controls. Several official guidelines have been drafted and disseminated to reduce the risk of aflatoxin contamination of nutmeg. The process of registration and inspection of farmer groups is at a preliminary stage. Since February 2016 Regulation (EU) 2016/24 imposing special conditions governing the import of nutmeg from Indonesia is in force. As a consequence the competent authorities of Indonesia have adapted the control system for nutmeg intended to be exported to the EU. Since February 2016 all exporters are subject to official hygiene controls and they must apply for export certification for each consignment of nutmeg intended for EU export. Of four laboratories visited only one private laboratory was in compliance with the legal requirements for testing of nutmeg for aflatoxins. At the three official laboratories visited significant deficiencies were noted. However, at the time of the audit official samples were only analysed by the private laboratory. The audit team observed that the control system relied on aflatoxin sampling and laboratory analysis prior to the export of nutmeg to the EU. However, as these controls are not carried out in line with EU requirements on sampling and samples taken were not sufficiently traceable, the aflatoxin controls cannot fully guarantee that all nutmeg exported to the EU complies with the aflatoxin limits specified in Regulation (EC) No 1881/2006. The report makes recommendations to the competent authorities aimed at rectifying the shortcomings identified and enhancing the implementation of control measures. 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 ON PRODUCTION AND PROCESSING PROCEDURE FOR EXPORTING TO THE EU METHOD OF SAMPLING CONSIGNMENTS LABORATORY SERVICES RESPONSE TO RASFF NOTIFICATIONS FOLLOW UP Overall Conclusions Closing Meeting Recommendations...19 Annex 1 - European Union Acts Quoted in the Report Annex 2 - Standards Quoted in the Report II

4 ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT Abbreviation CA CAC/RCP CAC/GL CCA CODEX DGEC DG Health & Food Safety ELISA EU FBO GAP GMP HACCP HPLC ISO KAN MOA MS NADFC PT RASFF RCA RQO Explanation Competent Authority Codex Alimentarius Commission/Recommended Code of Practice CAC/GL Codex Alimentarius Commission/Guideline Central Competent Authority Codex Alimentarius Commission of the Food and Agriculture Organization of the United Nations and World Health Organization Directorate General of Estate Crops Directorate-General Health and Food Safety of the European Commission Enzyme Linked Immunosorbent Assay European Union Food Business Operator Good Agricultural Practices Good Manufacturing Practice Hazard Analysis Critical Control Points High Performance Liquid Chromatography International Organisation for Standardization National Accreditation Committee Komite Akreditasi Nasional Ministry of Agriculture Member State/s National Agency for Drug and Food Control Proficiency Test Rapid Alert System for Food and Feed Regional Competent Authority Regional Quarantine Office III

5 1 INTRODUCTION The audit took place in Indonesia from 7 to 17 March 2016 in order to assess the control of aflatoxin contamination in nutmeg, intended for export to the European Union (EU). The audit team comprised two auditors from Directorate-General for Health and Food Safety (DG Health & Food Safety) and one national expert from a Member State (MS). The audit was undertaken as part of DG Health & Food Safety's annual audit programme in the context of a series of audits in non-eu countries to evaluate the control systems and the operational standards in this sector. The team was accompanied during the audit by a representative of the Central Competent Authority (CCA) - the Ministry of Agriculture (MOA). An opening meeting was held on 7 March with the CCA - the MOA. At this meeting, the objectives of and itinerary for the audit were confirmed. 2 OBJECTIVES AND SCOPE The objectives of the audit were to verify whether there are control systems in place to control aflatoxin contamination in nutmeg intended for export to the EU and to assess whether they are adequate to ensure that the produce concerned is within the specified contaminant limits laid down in EU legislation, in particular complying with or being at least equivalent to Regulation (EC) No 1881/2006. Another objective was to follow-up the nine recommendations made in the report of a previous audit on the same subject (Ref: DG(SANCO) ). In terms of scope, the audit reviewed the controls on the production, processing and export of nutmeg, including the national legislation in place, the organisation of the competent Authorities (CAs) involved, their controls and enforcement capability. Table 1: Sites visited Sites visited Number Comments Competent Authorities Central 1 The MOA Regional 3 3 regional offices in East Java, Maluku and South Sulawesi Laboratories 1

6 Private approved laboratory 1 East Java Official laboratories 3 Jakarta (Laboratory for Quality Testing of Goods, Directorate for Standards and Quality Control, Directorate General of Consumer Protection and Trade Order), Maluku (Regional office of Drug and Food Control) and North Sulawesi (Regional office of Drug and Food Control) Producers Farmers 2 1 small scale farmer in the Maluku region 2 small scale farmer group (farmers co-operative) in the Northern Sulawesi region Collectors/Processors/Exporters Collectors 2 1 collection point owned by a farmer group and, 1 collection point owned by a private company in the Northern Sulawesi region Processors, exporters 3 1 small processor/exporter to the EU in Maluku 2 large processors/exporters to the EU in East Java and Northern Sulawesi region 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 non-eu countries can give regarding compliance with, or equivalence to, EU requirements. A full list of the legal instruments referred to in this report is provided in Annex 1. EU legal acts quoted in this report refer, where applicable, to the most recently amended version. 3.2 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 Organization 2

7 (CODEX) were taken into account in the frame of the audit. A full list of the applicable standards referred to in this report is provided in Annex 2. Reference to the specific provisions of these texts is provided at the beginning of each section. 4 BACKGROUND DG Health & Food Safety has carried out audits to the main exporting countries to evaluate official control systems for preventing aflatoxin contamination in foodstuffs. The reports on these audits are available on the EU Commission's website at: According to Article 15(1) of Regulation (EC) No 882/2004 foodstuffs imported into the EU are checked by the CAs of the MS. Information on foodstuffs found to have public health implications are disseminated as alert notifications through the Rapid Alert System for Food and Feed (RASFF) to all MS and to the exporting country. In the case of nutmeg the notifications relate to the mycotoxin content of goods exceeding EU limits of 5 μg/kg for aflatoxin B1 and 10 μg/kg for total aflatoxins. Since the last audit (2012) to the time of this audit 27 notifications relating to aflatoxin contamination in nutmeg from Indonesia were notified through the RASFF. The breakdown of these notifications as well as the volume of exports to the EU is presented in table 2. Table 2: Statistical Data for Nutmeg Indonesia Nutmeg Indonesia* Exports to EU (tonnes) Number of RASFF notifications Exporters to the EU** Sources: * = Center for Data and Information, MOA ** =Agricultural Quarantine Agency In view of the number of notifications and the volume of exports to the EU, DG Health & Food Safety decided to undertake this audit. 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 non-eu countries. 3

8 Regulation (EC) No 1881/2006 lays down the specific standards for the admissible levels of aflatoxins and sets maximum levels for certain contaminants (including mycotoxins) in foodstuffs. Findings Since the last audit additional legislation in the context of this audit has entered into force in Indonesia: 1. Minister of Agriculture Regulation Number 04/2015 on Food Safety Control of Agrifood Produce of Plant Origin at the exit and entry points; 2. Minister of Agriculture Regulation Number 53/2012 on Guidelines for Post-Harvest Handling of Nutmeg; 3. Minister of Agriculture Regulation Number 320/2015 on Guidelines for Production, Certification, Distribution and Control of Nutmeg Seeds for replanting; Indonesian National Standard 0006:2015 Nutmeg; 4. Minister of Agriculture Regulation No. 20/2010 establishing the requirements for the implementation of good hygiene practice, good manufacturing practice (GMP), good agricultural practice (GAP) and for procedures based on the hazard analysis critical control points (HACCP) principles and the traceability of foodstuffs was at the time of the audit a voluntary code which was awaiting formal amendment to make its requirements mandatory. The CCA informed the audit team that Regulation No. 20/2010 and Regulation No. 51/2008 on Fresh Produce Registration will be merged to a single law for official control and sampling of all agricultural commodities. The publication is expected for May/June At the time of the audit there was still no legal requirement in place for collectors and exporters of fresh produce of plant origin to be registered by the CAs. However, all exporters to the EU are listed and inspected after applying for an export certificate and the registration of farmer groups is progressing. Conclusions on Relevant National Legislation 6. Some elements of the legal framework for the control of exports of nutmeg to the EU have been up-graded since the previous audit, others at the time of the audit were still in the process of revision. Several official guidelines to reduce the risk of aflatoxin contamination of nutmeg have been drafted and disseminated. 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 the non-eu country CAs, their powers 4

9 and independence, the authority they have to enforce the applicable legislation effectively, and the training of staff in the performance of official controls. Findings 7. The CCA in the scope of this audit is still the MOA. The structure of the CCA has changed with the creation by the MOA of the Agency for Food Security which, since January 2016, has taken over the CA functions previously under the responsibility of the Directorate General for Processing and Marketing of Agricultural Product. 8. There are still two Directorates General and the CCA responsible for the activities in the context of this audit : 9. The Directorate General of Estate Crops (DGEC) develops the policy and legislation covering production and drafts the quality standards for fresh produce of plant origin. 10. The Food Security Agency is responsible for the development of policy regarding agrifood safety control systems (standards, technical requirements and regulations). 11. The control and monitoring function is carried out by the CCA which was established in The main task of the CCA is to verify the establishment of, and the work carried out by, the regional level CA. Should a regional level be unable to perform its allotted tasks properly, the CCA takes over. 12. There is a regional CA (RCA) office in each region. Before the regional office starts official controls the establishments in the region must receive CCA approval. The RCA is responsible for official controls of the food chain including the production of fresh produce of plant origin including nutmeg intended for export to the EU. Currently the regional offices are established and fully operational in 29 out of 34 regions. In two of three main nutmeg producing regions they are in the process of being established and are not yet operational. 13. The CCA plans to have all regional offices established and fully operational by the end of Each RCA must report the results of official controls on a quarterly basis to the CCA. Reports are based on the requirements of the guidelines of the CCA. 14. Only one private accredited laboratory in the East Java region was used at the time of the audit for the purpose of official controls in the context of this audit. The laboratory was chosen by the RCA on the basis of its accreditation. 15. There is a total of 27 staff working in the CCA, all with education in agriculture or natural sciences. Training is organised annually for staff members and includes, since 2013, aspects on reduction of aflatoxin contamination in nutmeg. 16. In the East Java region visited by the audit team, six RCA inspectors are involved in the controls within the context of this audit. A training course is provided annually on different topics including general sampling requirements. In 2013 a specific training was organised on sampling for aflatoxin contamination of nutmeg (see also chapter 5.5). The audit team was informed that an in-house training took place in 2015 at RCA and a 5

10 training session was also organised in June 2015 in the North Sulawesi region by the CCA, the EU delegation and the RCA for farmers, collectors, processors and exporters, in order to raise awareness of the problem of aflatoxin in nutmeg and to propose ways to reduce the risk of contamination. 17. In the context of this audit the customs authorities under the Ministry of Finance are responsible for customs clearance of the consignments for export to the EU. The Directorate General for Customs develops the legislation and procedures for customs controls. The audit team was informed by the customs authorities that currently there is no specific procedure in place for nutmeg intended for export to the EU. Conclusions on Competent Authorities 18. The CAs are clearly designated in the context of this audit as basis for a reliable system of official controls. 5.3 OFFICIAL CONTROLS ON PRODUCTION AND PROCESSING 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; EU aflatoxin levels are specified in the Annex to Regulation (EC) No 1881/2006. The CODEX Code of Hygienic Practice for Spices and Dried Aromatic Plants (CODEX Alimentarius Commission/Recommended Code of Practice (CAC/RCP )) contains recommended practices based on GAP, GMP and HACCP. Findings 19. Since February 2016 Regulation (EU) 2016/24 imposing special conditions governing the import of nutmeg from Indonesia is in force. As a consequence the CAs of Indonesia have adapted the control system for nutmeg intended for EU export. Since February 2016 all exporting facilities have been inspected after applying for an export certificate. The CCA informed the audit team that export certificates are only issued for nutmeg after an inspection of the exporter regarding general hygiene requirements, tailored to aflatoxin avoidance. It was reported that in Surabaya region one out of six FBOs that applied for an export certificate did not qualify for the certificate based on poor hygiene conditions of the facilities. 20. In both of the growing regions visited the audit team was informed that currently no official controls are carried out on farmers and collectors. Cultivation 6

11 21. According to Indonesian crop statistics, nutmeg is cultivated mainly in three regions North Maluku, Maluku and North Sulawesi. Nutmeg was produced in Indonesia in 2015 on ha with a production of over 33,000 tonnes of which 17,000 tonnes were exported. In 2015, nutmeg exports to the EU amounted to just over 3,700 tonnes. 22. Dissemination of GAP is done by the central government i.e. DG for Estate Crops and DG for Processing and Marketing of Agricultural Products until 2015 and since then by the Food Security Agency and Estate Crops Offices in relevant provinces and districts. 23. Dissemination is conducted through training of trainers courses, other training courses, workshops and seminars. The CCA has developed guidelines to reduce mycotoxin contamination during production and processing of nutmeg as follows:- - Guideline for nutmeg cultivation. - Guideline on post harvest operations for nutmeg. - Three guidelines on best practices to ensure food safety of nutmeg, i.e. farmers and village traders; provincial traders; c) exporters - Guideline on best practices for nutmeg handling at shipping export level 24. All newly drafted official guidelines on GAP and GHP contain information on avoidance of aflatoxin contamination of nutmeg. Official controls of producers, processors and exporters of nutmeg 25. In Indonesia nutmeg farmers generally work together in groups, so called farmer groups. A farmer group consists of between 20 and 25 farmers and there are roughly 10,000 such groups producing nutmeg. Registration of farmer groups was started in In 2014 the first 100 groups were registered and inspected; in 2015 approximately 300 groups were registered and inspected. The CCA informed the audit team that they have planned to register and inspect a further 600 groups in However, the CCA informed the audit team that establishments, where nutmeg for export to the EU is produced and processed, are not registered and therefore new emerging exporters are not subject to official controls before starting export activities. Currently this lack of official controls is mitigated by the fact that export certification and inspection of exports are carried out (see findings No 19 and 27). 27. The audit team was informed by the CCA that since February 2016 all exporters intending to export nutmeg to the EU had been inspected on general hygiene prior to export. The Regional Competent Authority for Food Safety Central Java presented reports to the audit team as evidence of those inspections in Central Java. Since 2013 exporters must have a register of suppliers. As it had been recently introduced, the audit team could not see evidence of the impact of this upgraded system on ensuring that EU requirements would be met and as shown in table 2, there was still in 2015 a number of RASFF notifications concerning nutmeg exported to the EU. 28. The audit team visited three typical nutmeg farmers with about one hectare of nutmeg in the Maluku and the North Sulawesi regions. In the Maluku region the farmer visited collected the nutmeg directly from the tree with a special collection stick. They are then 7

12 dried naturally on the farm and after drying, they are delivered to the collection point owned by the local farmer group. 29. In the Northern Sulawesi region the first farmer visited knocked the nutmeg off the tree by a hook on a long stick and then collected from the ground. Drying takes place naturally (outdoors) for 5 days and the nutmeg are then stored in the open air for approximately one month. 30. The second farmer visited in Northern Sulawesi had implemented artificial drying measures after receiving training provided by the previous Directorate General for Processing and Marketing of Agricultural Product. 31. The audit team visited a farmer group of 18 farmers in Siau (North Sulawesi). The group leaders twice received a training of trainers course on aflatoxin avoidance organised by the EU-Indonesia Trade Support Programme. The knowledge was passed on via training courses to the members of this group. The farmers reported that all recommended changes addressed in the training had been implemented and they reported increased quality and higher yields of nutmeg. The farmers group invested in a roofed drying facility with artificial heating for nutmeg to reduce the drying period. The farmers reported that they intend to maintain the changes into the future. 32. The audit team visited one collector in the North Sulawesi region, who receives unshelled nutmeg from the local farmers. After arrival the nutmeg is sorted according to the quality parameters set by the collector. If the nutmeg is not dry enough (based on practical experience), they are placed on an artificial dryer using hot air. In this collector's storage area the nutmeg are stored in piles or bags for approximately one month in a clean storage room. 33. The buildings used by the collector visited were designed to prevent the entry of pests. Temperature and moisture levels can be controlled in these buildings. Processing and storage 34. The audit team visited one processor in East Java for a first sampling exercise (see paragraph 53). The FBO concerned has exported nutmeg to the EU since 2001 with an export volume of roughly 500 tons per year. This exporter was inspected by the CA using a comprehensive checklist and the FBO was considered by the CA as a compliant FBO regarding hygiene conditions. The FBO managers informed the audit team that they never had a consignment intended for EU export which was found non-compliant and rejected. The audit team noted no deficiencies at this FBO's premises. 35. Another exporter was visited in the Maluku region. The FBO has, since 2006, exported nutmeg to the EU with an export volume of roughly 60 tons per year. The audit team was informed that the FBO had been inspected three times, in 2015, by the local CA and no non-compliances had been detected. The audit team noted no deficiencies at the FBO premises. The FBO stated that traceability of the product back to each farmer group is possible for about 40% of his exports prior to sorting. About 60% of produce is sourced from collectors outside the region without the possibility of trace back to farmer groups or individual farmers. After the sorting process has taken place all nutmeg are mixed together and traceability is no longer possible. 8

13 36. A third exporter visited was located in the North Sulawesi region. The FBO exports since 2004 nutmeg to the EU with an export volume of roughly 400 tons per year. This exporter was inspected by the CA using the same comprehensive checklist as used in the other regions and the FBO was considered by the CA as compliant regarding hygiene conditions. This FBO has an internal quality assurance system in place that was checked by RCA inspectors. The building is designed to prevent the entry of pests as required by the CAC/RCP Code. This processor has written requirements in place on the quality of raw materials, and these were provided to each individual farmer or the farmer groups. This processor receives shelled nutmeg from the farmers/ groups and had provided training to the farmers on the prevention of contamination with aflatoxins. 37. The nutmeg can also be received unshelled and shelling is the first step in the production process, followed by sorting and packing in jute bags. The traceability of the product back to each farmer group is possible before sorting. The FBO presented a newly developed system to trace the produce after the sorting process has taken place. 38. In all the processing facilities visited the risk of aflatoxin contamination is reduced by strict visual sorting, such sorting is repeated two or three times or more. 39. All the exporters visited had implemented the CODEX Alimentarius Code of Hygienic Practice CAC/RCP for Spices and Dried Aromatic Plants. They have the possibility to control the relative humidity and temperature in their storage areas in order to minimise the risk of mould growth. 40. All exporters visited had procedures in place based on HACCP principles. Non-compliant products 41. There are no procedures in place to deal with consignments considered non-compliant after sampling for export certification and for consignments rejected at the EU border and re-exported back to Indonesia. However, the exporter visited in the Northern Sulawesi region informed the audit team that rejected consignments were returned to Indonesia and sold in another market with higher aflatoxin limits. Conclusions on Official Controls on Production and Processing 42. Considerable progress has been made to ensure that GAP/GMP/HACCP principles are implemented by all farmers and processors that produce nutmeg for export to the EU. 43. The CCA introduced an up-graded control system in February It will take time before the effectiveness of this new control system can be assessed and even if actions have been taken following the entry into force of Regulation (EU) 2016/24 to ensure a certain level of control at exporters of nutmeg, the competent authority still has an incomplete oversight over the production and processing chain and this affects the ability of the competent authority to verify that nutmeg exported to the EU meet the requirements of Regulation (EC) No 1881/2006 regarding aflatoxin contamination. 9

14 5.4 PROCEDURE FOR EXPORTING TO THE EU Legal requirements Article 46(1)(h) of Regulation (EC) No 882/2004 stipulates that EU controls shall have, inter alia, particular regard to the assurances which the non-eu countries can give regarding compliance with, or equivalent to, EU legislation. The CODEX General Guidelines on sampling (CAC/GL ) contains recommended procedures for the acceptance or refusal of the lot after inspection. Findings 44. Since February 2016 all exporting facilities were inspected after applying for an export certificate. 45. The CCA informed the audit team that export certificates are only issued after an inspection of the exporting FBO regarding general hygiene requirements, tailored to aflatoxin avoidance and analysis of official samples. 46. The national export procedure for nutmeg that includes the mandatory aflatoxin inspection requirements is set out in Regulation No 04/2015 of the MOA. This requires exporters to apply to the relevant RCA for sampling and aflatoxin analysis of every consignment intended for export to the EU. These results together with a food safety certificate, issued by the RCA, are delivered by the exporter to the Regional Quarantine Office (RQO). 47. The RQO issues the phytosanitary certificate on the basis of a favourable food safety certificate. In the Manado region, the audit team was informed by the exporter visited, that in the case of non-compliant results, nutmeg is sorted and resampled. In the Northern Sulawesi region, clearance for the export of nutmeg to the EU is done directly. The RQO issue a phytosanitary certificate when the product meets the export requirements (hygiene sanitation inspection, aflatoxin analysis, pest analysis). The audit team was informed that the customs service does not have any special procedure in place to clear nutmeg. Nutmeg is cleared on the basis of the phytosanitary certificate. Conclusion on Procedure for Exporting to the EU 48. There is a comprehensive export procedure for nutmeg exported to the EU in place that could support the reduction of exporting contaminated nutmeg to Europe. 5.5 METHOD OF SAMPLING CONSIGNMENTS Legal requirements 10

15 Regulation (EC) No 401/2006 lays down the methods of sampling and analysis for the official control of the levels of mycotoxins in foodstuffs. Article 1 of Regulation (EC) No 401/2006 requires that sampling for the official control of mycotoxin levels in foodstuffs be carried out in accordance with the methods set out in its Annex I. Concerning nuts (e.g. nutmeg), the method of sampling is laid down in Annex I. part E. The CODEX General Guidelines on Sampling (CAC/GL ) contains requirements for the identification of the sample. Findings 49. The audit team observed one sampling exercise conducted by the RCA inspectors in East Java Region. 50. The sampling exercise in East Java Region was conducted on a typical consignment of 6 tonnes of nutmeg (120 x 50 kg bags). For the sampling exercise the bags were opened, standing side by side on the ground without traceability information on the bags. From the 120 bags a total of 80 incremental samples, each weighing approximately 100 grams, were taken from bags by hand from the top of the bag. This was not in line with Annex I, A.3.4. of Regulation (EC) No 401/2006 which requires that the incremental samples shall be taken at various places. The aggregate sample of about 8 kg was formed and mixed in a big pan. Finally the sample was packed in a black plastic bag and closed only with an adhesive tape but not sealed and labelled. The RCA inspectors send the official aggregate samples with a weight between 500 grams and 8 kilograms to the laboratory for analysing. 51. No sampling report was drafted on the day of sampling. This is not in compliance with Annex I, A.3.8. of Regulation (EC) No 401/2006 and Section of CODEX General Guidelines on Sampling (CAC/GL ). 52. The audit team checked two sampling reports of official samples taken in February The reports contained all information required by CODEX CAC/GL The procedure was in compliance with sampling of spices as powder (Regulation (EC) No 401/2006 part E), but not for nutmeg kernels. Aflatoxins are very heterogeneously distributed in a lot, in particular in a lot of food products with a large particle size such as nutmeg. In order to obtain sufficient representativeness of the sample, for whole nutmeg the sampling method described in Annex I, D.2. of Regulation (EC) No 401/2006 should be applied. 54. In May 2014 Regulation (EC) No 401/2006 was amended by Regulation (EU) No 519/2014 of 16 May 2014 to take into account the particle size. The CAs were not aware of this amendment. Therefore official sampling for nutmeg was done in Indonesia as foreseen for spices in accordance with Annex I, E of Regulation (EC) No 401/2006. The CA confirmed that all official samples were taken in Indonesia applying Annex I, E. 11

16 Conclusions on Method of Sampling of Consignments 55. The sampling procedure in Indonesia did not follow requirements at least equivalent to those laid down by Regulation (EC) No 401/2006 regarding the weight of the incremental sample, weight of the aggregate sample and representativeness of the laboratory sample. This could result in analytical results that are not comparable with results generated in the EU. 5.6 LABORATORY SERVICES Legal requirements Articles 46(1)(d) and (c) of Regulation (EC) No 882/2004 stipulate that EU controls shall have, inter alia, particular regard to the resources including diagnostic facilities available to CAs, and the training of staff in the performance of official controls. Article 2 of Regulation (EC) No 401/2006 requires that sample preparation and methods of analysis used for the official control of mycotoxin levels in foodstuffs comply with the criteria set out in its Annex II. Points 41 and 42 of CODEX Guidelines CODEX Alimentarius Commission/Guideline (CAC/GL) on the Design, Operation, Assessment and Accreditation of Food Import and Export Inspection and Certification Systems which lays down that inspection services should utilise laboratories that are evaluated and/or accredited under officially recognised 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 International Organisation for Standardization (ISO)/International Electro technical Commission Guide Findings 56. At the time of the audit one private laboratory had been approved by the MOA for aflatoxins analysis in nutmeg intended for export to the EU. 57. The MOA plans to approve an additional five official laboratories for this product. The audit team visited the private approved laboratory and three official laboratories which are not yet approved for aflatoxins analysis in nutmeg. 58. In the East Java region the audit team visited the approved private laboratory which provides analytical test services for veterinary drug, pesticides, mycotoxins, heavy metal residue, ingredient and nutrition value, micro and molecular biology. 59. The laboratory is accredited to EN ISO/IEC 17025:2005 by the National Accreditation Body (KAN) since May In October 2015 it was reaccredited. The method of analysis for aflatoxins in nutmeg is included in the scope of the accreditation. 60. The accredited laboratory is an approved laboratory of the MOA in aflatoxins analysis for nutmeg intended for export to the EU. Since the last audit in 2012 the laboratory has 12

17 participated in 30 different Proficiency Tests (PTs) on mycotoxins organised by an internationally recognised service provider. In 2013 the laboratory participated with satisfactory results in a PT for aflatoxins in nutmeg. The PT results of aflatoxins in maize (2014) were unsatisfactory. Additionally in 2015 the PT results of aflatoxins in peanuts were unsatisfactory. However, evidence about corrective actions was provided. 61. The laboratory receives official samples with a weight between 500 grams and 8 kilograms in plastic bags. The samples are registered in the laboratory system and weighed. 62. The aggregate sample is ground in a large mill, reground in a smaller mill, and for a third time in a blender, after which it is passed through a sieve (No. 80, particle size <180 µm), mixed again in a stir machine and finally 1 kilogram (if available) is stored in a freezer upon analysis. A 2 gram analytical sample is processed in the sample preparation for analysis using Liquid Chromatography - Mass Spectrometry/Mass Spectrometry. Results above 1.5 µg/kg aflatoxin B1 and 6.0 µg/kg total aflatoxins quantitative are reported. The laboratory staff does not make any judgments on the compliance of the results; this is the responsibility of the RCA office. 63. In 2015 the laboratory analysed 153 official samples for aflatoxins. Nine results (6%) were non-compliant, 16 samples (10%) gave results within the EU maximum limits (aflatoxin B1: 5 µg/kg, total aflatoxin: 10 mg/kg)while the in remainder (128 samples 84%) no detection was made which means that aflatoxin B1 in these samples was less than 1.5 µg/kg and the total were levels lower than 6 µg/kg. 64. In Jakarta the audit team visited the Testing Laboratory of Directorate for Quality Development of Goods which is attached to the Ministry of Trade. This directorate is the authority for overseeing the mandatory Indonesian National Standard goods registration and supervises the quality of potential export products. It is the national standards body for testing, calibration and certification services and plans to give technical assistance to regional laboratories. 65. The Testing Laboratory is accredited to EN ISO/IEC 17025:2005 by KAN for the method of analysis for aflatoxins in nutmeg since October The MOA plans to approve the accredited laboratory for aflatoxins analysis in nutmeg intended for export to the EU. The laboratory intends to collect the official samples itself. The laboratory has participated in one PT of an international recognised service provider and in the ASEAN programme for two different PTs on aflatoxins. In 2015 the laboratory had satisfactory results in the PT for aflatoxins in nutmeg organised by ASEAN. The PT results of aflatoxins in chilli powder (2014, ASEAN) were unsatisfactory. The PT results of the internationally recognised service provider regarding aflatoxins in mixed spices were satisfactory. Evidence about corrective actions following the chilli PT was not provided. 67. Up to the time of the audit no official samples of nutmeg for export had been analysed for aflatoxins in this laboratory. Only 9 samples in 2014, 32 samples in 2015 and 9 samples in 2016 taken from collectors and exporters were analysed for monitoring purposes. The samples arriving at the laboratory were registered in the laboratory system. The sample weights and the sampling method were not recorded. In the laboratory the whole sample is ground in a mill (sieve: 3 mm). In Annex II, 2. of 13

18 Regulation (EC) No 401/2006 there is a requirement that each laboratory sample shall be finely ground and mixed thoroughly using a process that has been demonstrated to achieve complete homogeneity. The laboratory did not perform testing of the homogeneity of the method of milling. 68. The ground sample is divided in two parts and finally stored one portion from each part of about 100 gram. A 25 gram analytical sample is taken and processed in the sample preparation with affinity column containing monoclonal antibody specific for aflatoxin B1, B2, G1, G2. The extract is analysed by High Performance Liquid Chromatography (HPLC) with fluorescence detection and post column derivatisation (Cobra cell). 69. In the validation report the linearity and the precision was satisfactory but the recovery was in some cases not according to the requirements of Regulation (EC) No 401/2006. The concentrations of the spike samples were in Level 1: 5 µg/kg aflatoxins B1,G1 and : 1,5 µg/kg aflatoxins B2,G2 and in Level 2: 8 µg/kg aflatoxins B1,G1 and : 2,4 µg/kg aflatoxins B2,G2. For this concentration range the recommended value for the recovery for each of the four aflatoxins is 70% to 110%. 70. The recovery for aflatoxin B1 was between 64% and 71%, for aflatoxin B2 it was between 59% and 66%, for aflatoxin G1 it was between 77% and 81% and for aflatoxin G2 it was between 62% and 76%. Low recovery is a sign for inefficient extraction. The limit of detection was between 0.2 μg/kg and 0.6 μg/kg. The limit of quantification was between 0.3 μg/kg and 0,9 μg/kg. These limits are low enough to comply with the limits of the current legislation of 5 µg/kg aflatoxin B1 and 10 µg/kg total aflatoxins. 71. In the Maluku region the audit team visited the National Agency for Drug and Food Control (NADFC) office. The office includes laboratory facilities for general food analysis. In 2016 the laboratory applied to KAN to get accreditation for mycotoxin analysis. The laboratory personnel received training on mycotoxin analysis in 2012 and 2014 by trainers from AINIA 1. In 2013 it was visited by an expert from AINIA to assess the capability of the laboratory for mycotoxin analysis. The laboratory is scheduled to participate in the ASEAN programme for a PT on aflatoxins in nutmeg. Up to now no official samples have been analysed in this laboratory. However six samples in 2015 and one sample in 2016 were analysed for monitoring purposes. 72. The MOA plans to approve the laboratory for aflatoxins analysis on nutmeg intended for export to the EU after accreditation. 73. The laboratory receives usually samples of 600 grams nutmeg kernels (3 packages at 200 gram) in plastic bags. The samples are registered in the laboratory system. The sample weight and the sampling procedure are not recorded. In the laboratory only one third of the nutmeg kernels of each package are tipped in a small blender and ground. The laboratory sample accounts to about 200 grams. Annex II, 1.1. of Regulation (EC) No 401/2006 requires that the complete sample received shall be homogenised, additionally Annex II, 2. of the Regulation requires that each sample shall be finely ground and mixed thoroughly using a process that has been demonstrated to achieve complete homogenisation. The laboratory did not mill the complete sample and did not perform testing of the homogeneity of the sample. 1 A Spanish technology centre with the legal status of a private non-profit association, formed by more than 900 companies mainly from the food sector 14

19 74. The available milling equipment was unsuitable in terms of size for official samples between 1 to 10 kg. 75. For the analytical sample 5 gram of the ground sample was weighed for analysis. This analytical sample is processed in the sample preparation and applied to affinity column containing monoclonal antibody specific for aflatoxin B1, B2, G1, G The extract is analysed by ELISA or HPLC with fluorescence detection and post column derivatisation (UVE system). ELISA is only used for screening. In the validation report of the HPLC method the linearity and the precision was satisfactory but the recovery was in some cases not according to the requirements of Regulation (EC) No 401/2006. The concentration of the spike sample was about 5 µg/kg aflatoxins B1,G1 and about 1,5 µg/kg aflatoxins B2 and G2. For this concentration range the recommended value for the recovery for each of the 4 aflatoxins is 70% to 110%. The recovery of aflatoxin B1 was between 49% and 52%, of aflatoxin B2 was between 61% and 62%, of aflatoxin G1 was between 61% and 63% and of aflatoxin G2 was between 40% and 47%. Low recovery is a sign of inefficient extraction. 77. In the North Sulawesi region the audit team visited the NADFC office. The office includes laboratory facilities for general food analysis. At the time of the previous audit the laboratory equipment was used for general purposes but not for aflatoxin analysis. The laboratory personnel received training on mycotoxin analysis in 2014 which included a method for analysing aflatoxin in nutmeg. The laboratory participated in the ASEAN programme for a PT on aflatoxins in nutmeg in The laboratory had intended to gain accreditation for aflatoxin analysis in nutmeg, but the PT result was unsatisfactory. The PT sample nutmeg powder contained µg/kg aflatoxin B1 for which z-score of -3.9 was obtained. Scores of over 3 should be considered an action value, i.e. a revision of the result is necessary. At present the MOA is planning to gain accreditation of the laboratory for aflatoxins analysis on nutmeg intended for export to the EU. 78. Up to now no official samples of nutmeg were analysed in this laboratory. 79. The available milling equipment is unsuitable for official samples between 1 until 10 kilogram. 80. For the analytical sample 25 gram of the ground sample was weighed for analysis. This analytical sample was processed in the sample preparation with applied to affinity column containing monoclonal antibody specific for aflatoxin B1, B2, G1, G The extract was analysed by HPLC with fluorescence detection and post column derivatisation (PHERD system). 82. In the validation report of the HPLC method the linearity and the precision was satisfactory but the recovery was not according to the requirements of Regulation (EC) No 401/2006. The concentrations of the spike sample were about 4 µg/kg aflatoxins B1, G1 and about 1 µg/kg aflatoxins B2, G2. For this concentration range the recommended value for the recovery for each of the 4 aflatoxins is 70%-110 %. The recovery of aflatoxin B1 was between 20% and 46 %, of aflatoxin B2 was between 22% and 49 %, of aflatoxin G1 was between 15% and 46 % and of aflatoxin G2 was between 17% and 40%. Low recovery is a sign of ineffective extraction. 15

20 Conclusions on Laboratory Services 83. The authorised private laboratory visited is accredited to ISO/IEC 17025:2005. The laboratory performs well in terms of participation in PTs, in terms of the use of reference materials and has quality control measures in place. At the time of the audit official samples were only analysed by this private laboratory. 84. One of the three official laboratories visited was accredited to ISO/IEC 17025:2005. This laboratory had deficiencies regarding grinding which was not performed in line with Annex II, 2. to Regulation (EC) No 401/2006. At the time of the audit the other two official laboratories visited were not accredited to ISO/IEC 17025:2005 for aflatoxin analysis in nutmeg. Both have no suitable milling equipment for official samples between 1 to 10 kg. 5.7 RESPONSE TO RASFF NOTIFICATIONS Legal requirements Point 6 of CODEX Guidelines CAC/GL requires exchange of information between countries on rejections of imported food. In particular 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 a consignment. The food control authority in the exporting country, if requested, should provide the authorities in the importing country with information on the outcome of the necessary investigation, if available. Bilateral discussions should take place as necessary. Findings 85. The audit team checked the follow-up activities regarding all RASFF notifications issued in From the eight notifications, three notifications did not provide sufficient information for trace back to the exporter. All three exporters involved in the remaining five notifications were requested by the CCA to provide full information on the rejected consignments. Following receipt of the information, the CCA inspected all three exporters and reported that all exporters had introduced corrective actions. 86. The audit team was informed by the CA that they have no possibility to trace noncompliant lots as there is no national legislation in place regarding the handling and traceability of non-compliant and re-imported non-compliant consignments. This is not in line with CODEX Guidelines CAC/GL Conclusion on Response to RASFF Notifications 87. Comprehensive RASFF follow-up is in place. However, the handling and traceability of non-compliant and re-imported non-compliant consignments was not assured as required by the CODEX Guidelines CAC/GL This could lead to export of nutmeg consignments that are not compliant with EU aflatoxin limits. 16

21 5.8 FOLLOW UP Table 3: Follow-up to the recommendations made in report DG(SANCO) No Previous recommendation Assessment 1 Ensure that the FBOs exporting nutmegs to the EU should implement standards at least equivalent to those required by Article 5 of Regulation (EC) No 852/2004 on food safety procedures based on the HACCP principles in conjunction with Article 10 of the same Regulation. 2 Ensure that all establishments, where nutmegs for export to the EU are produced and processed, are registered in order to meet requirements equivalent to those in Article 6 of Regulation (EC) No 852/2004 in conjunction with Article 10 of the same Regulation. 3 Ensure that all establishments where nutmegs for export to the EU are produced, processed and stored are under the official food safety controls, to ensure that produce exported to the EU meet the requirements of the CODEX Code of hygiene practice for spices and dried aromatic plants (CAC/RCP ). 4 Ensure that the official information on GAP principles take into account information concerning aflatoxin contamination given in CODEX Code of hygiene practice for spices and dried aromatic plants (CAC/RCP ). 5 Ensure that the storage conditions and the prevention of pests entering nutmeg processing and storage facilities comply with the requirements set out in the CODEX Code of hygiene practice for Spices and Dried Aromatic Plants (CAC/RCP ). 6 Ensure that nutmegs exported to the EU meet the requirements of Regulation (EC) No 1881/2006 regarding aflatoxin contamination. The CA has adopted adequate measures to address the recommendation (see finding No 40). The CA has adopted adequate measures to address the recommendation partly (see findings No 25 and 26). See recommendation No. 1 of the current audit report. The CA has adopted adequate measures to address the recommendation (see findings No 19, 27, 34, 35, 36 and 39). The CA has adopted adequate measures to address the recommendation (see finding No 24). The CA has adopted adequate measures to address the recommendation (see findings No 33, 34, 35, 36 and 39). Recommendation considered as partly addressed (see finding 27). See recommendation No. 1 of the 17