EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

Transcription

1 Ref. Ares(2017) /09/2017 EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Health and food audits and analysis DG(SANTE) FINAL REPORT OF AN AUDIT CARRIED OUT IN INDIA FROM 07 MARCH 2017 TO 16 MARCH 2017 IN ORDER TO ASSESS THE CONTROL SYSTEM IN PLACE TO CONTROL AFLATOXIN CONTAMINATION IN SPICES 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 carried out by the Directorate-General for Health and Food Safety in India from 7 to 16 of March The audit took place due to the increasing number of notifications related to aflatoxin contaminations in spices imported from India. The objectives of the audit were: to evaluate whether official control systems in place to control aflatoxin contamination in spices intended for export to the EU comply with, or are in line with article 10 of Regulation (EC) No 852/2004 of the European Parliament and of the Council, and are adequate to ensure that the produce concerned are within the specified contaminant limits laid down in Commission Regulation (EC) No 1881/2006; to follow-up the recommendations made in the report of the previous audit to India on the same subject (Ref: DG (SANCO) ). While some significant improvements had been put in place regarding traceability and Good Agricultural Practices, the implementation and control of Good Agricultural Practices, Good Manufacturing Practices and Hazard Analysis Critical Control Point principles is not mandatory for all the Food Business Operators involved in the supply chain of the spices exported to EU. Although official controls and analyses are performed on the main spices, not all the official laboratories are subject to ISO/IEC accreditations and analytical reports are not totally in line with Regulation 401/2006. The sampling equipment and procedure audited presented serious gaps with the requirement of Regulation 401/2006 and could not guarantee representative sampling and analytical results. The above failings call into question the reliability of the export certification. The issues raised during the audit could have been avoided if the action plan provided by the authorities in response to the recommendations of the previous audit had been fully implemented. The report contains recommendations to the competent authority of India 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 Standard Legal Basis Standards Background Findings and conclusions Competent Authorities Relevant National Legislation Implementation of Official Controls Procedure for Exporting to the EU Method of Sampling Consignments Laboratory Services Response to RASFF Notifications Follow-up Overall Conclusions Closing Meeting Recommendations...18 Annex 1 EU Legal References Annex 2 CODEX Standards Quoted in the Report II

4 ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT Abbreviation CA CAC/RCP CAC/GL CN CODEX CRES DGFT DG Health & Food Safety EU EIC ESS FBOs FSSAI GAP GMP HACCP HPLC ISO/IEC LOD LOQ MCI MS MoU NABL PT QELs RASFF SHC SPS Explanation Competent Authority Codex Alimentarius Commission/Recommended Code of Practice Codex Alimentarius Commission/Guideline Combined Nomenclature Codex Alimentarius Commission of the Food and Agriculture Organisation of the United Nations and World Health Organisation Certificate of Registration as Exporter of Spices Directorate General of Foreign Trade Directorate-General for Health and Food Safety of the European Commission European Union Export Inspection Council of India Export Support System (software used by the Spices Board and its QELs) Food Business Operators Food Safety and Standards Authority of India Good Agricultural Practices Good Manufacturing Practice Hazard Analysis and Critical Control Points High Performance Liquid Chromatography International Organisation for Standardization/International Electro technical Commission Limit of Detection Limit of Quantification Ministry of Commerce and Industry Member State/s Measurement of Uncertainty National Accreditation Board for Testing Laboratories of India Proficiency Test Quality Evaluation Laboratories Rapid Alert System for Food and Feed Spice House Certification Spice Producers' Society III

5 1 INTRODUCTION The audit took place in India from 7 to 16 March 2017 as part of DG Health and Food Safety's annual audit programme in the context of a series of audits in non-eu countries to evaluate the control systems on contaminants and the operational standards in this sector. The audit team comprised two auditors from DG Health and Food Safety and one national expert from a Member State (MS). The team was accompanied during the audit by representatives of the central Competent Authority (CA), the Spices Board (part of the Ministry of Commerce and Industry, Government of India). The opening meeting was held on 7 March 2017 with the central CA in Cochin. At this meeting the audit team confirmed the objectives of, and itinerary for the audit, and additional information required for the satisfactory completion of the audit was requested. 2 OBJECTIVES AND SCOPE The objectives of the audit were: To evaluate whether official control systems in place to control aflatoxin contamination in spices intended for export to the EU comply with, or are in line with article 10 of Regulation (EC) No 852/2004 of the European Parliament and of the Council and are adequate to ensure that the produce concerned are within the specified contaminant limits laid down Commission Regulation (EC) No 1881/2006. To follow up the recommendations made in the report of the previous audit to India on the same subject (Ref: DG (SANCO) ). It also includes the review of the related national legislation in place and the organisation of the Competent Authorities (CAs) involved in controls on the primary production, processing and export of spices to EU and their enforcement capability. In pursuit of these objectives, the following sites were visited: Table 1: Audit visits and meetings Sites visited Number Comments Competent Authorities Central 1 Spices Board, Cochin Regional/Local 2 Local CA Cochin and Mumbai Laboratories Official 2 Spices Board laboratories in Cochin and Mumbai Private 4 Spices manufacturer's laboratories in Cochin and Mumbai 1

6 Sites visited Number Comments Producers Farmers 3 Nutmeg Producers, Kerala Collectors/Processors/Exporters Processors, exporters 5 In Cochin and Mumbai Point of export 2 Customs in Cochin and Navyar (Mumbai) 3 LEGAL BASIS AND STANDARD 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. Full legal references are provided in Annex 1. Legal acts quoted in this report refer, where applicable, to the last amended version. 3.2 STANDARDS Additionally, Guidelines and recommended Codes of Practice of the Codex Alimentarius Commission of the Food and Agriculture Organization of the United Nations and World Health Organization (CODEX) were taken into account in the frame of the audit. A full list of the applicable CODEX documents referred to in this report is provided in Annex 2. 4 BACKGROUND Commission Regulation (EC) No 1881/2006 set mycotoxins limits (Aflatoxins and Ochratoxin A) for certain spices. According to Article 15(1) of Regulation (EC) No 882/2004, foodstuffs imported into the EU are checked by the CAs of the MS. When risks to public health are detected during these checks, the consignments may be subject to rejections. Following repeated detections of aflatoxin contaminations in imported spices from India, Regulation (EU) No 884/2014 of 13 August 2014 imposed special conditions governing the import of certain spices from India. These spices may be imported into the EU only in accordance with the procedures laid down in this Regulation, including mandatory analyses and issuance of a Health Certificate. 2

7 Currently, Regulation (EU) No 884/2014 applies to: Capsicum annum, whole (CN ), crushed or ground (CN ); Dried fruit of the genus Capsicum, whole, other than sweet peppers (CN ); Nutmeg (Myristica fragrans, CN and CN ). A previous audit in India concerning aflatoxin in spices took place in The report contained nine recommendations to the CAs of the country. The CAs provided an action plan which, if implemented, would have addressed the recommendations made in the report. Despite the commitments given, the number of detection and rejections of consignments of spices from India rose in 2015 and 2016, mainly due to aflatoxin contamination, as shown in the following tables. Table 2: Total rejections during import controls on spices from India CN Codes 1 Spices Pepper of the genus Piper, neither crushed nor ground 2017 Q Pepper of the genus Piper, crushed or ground Dried Sweet Peppers (excl. crushed or ground) Dried fruit of genus Capsicum or Pimenta, neither crushed nor ground (excl. Sweet peppers) Fruits of the genus Capsicum or the genus Pimenta, crushed or ground Nutmeg, neither crusher nor ground Nutmeg, crusher or ground Ginger, Saffron, Turmeric, Thyme, Bay Leaves, Curry and other spices (excl. Pepper of the genus Piper, fruits of the genus Capsicum or Pimenta, Vanilla, Cinnamon, Cinnamontree flowers, cloves (whole fruit), cloves stems, Nutmeg, Mace) Source: TRACES (TRAde Control and Expert System) The information is also disseminated as an alert or notifications through the Rapid Alert System for Food and Feed (RASFF) to all MS and to the exporting country. 1 Combined Nomenclature (CN), Commission implementing Regulation (EU) 2015/1754 3

8 Table 3: RASFF notifications related to mycotoxins controls and related administrative requirements for "Herbs and spices", origin INDIA Causes of notification Mycotoxins Aflatoxins 10 18* 32* 6 Ochratoxin A 2 2* 3* 1 Absence of health certificate(s) and/or certified analytical report Source: RASFF Window, Border Rejections, Food. *: 1 case with Ochratoxin A and Aflatoxins detected Following this increase in RASFF notifications, DG Health and Food Safety decided to carry out an audit in the exporting country to evaluate the official control systems in place for preventing aflatoxin contamination in spices. DG Health and Food Safety has also carried out audits to other exporting non-eu countries to evaluate official control systems in place for preventing aflatoxin contamination in foodstuffs. The reports on these audits are available on the EU Commission's website at: 5 FINDINGS AND CONCLUSIONS 5.1 COMPETENT AUTHORITIES Legal requirements Articles 46(1)(b) and (c) of Regulation (EC) No 882/2004. Articles 3 to 6 and 10 of Regulation (EC) No 852/2004 and Article 11 of Regulation (EC) No 178/2002. Findings 1. The competent authority in the context of this audit is the Spices Board, a board of the Ministry of Commerce and Industry. Constituted in 1987 under the Spices Board Act, it promotes and regulates the export of 52 Spices. 2. The Spices Board includes seven Quality Evaluation Laboratories (QELs) undertaking the mandatory testing of spices before export to the EU. These laboratories also undertake analyses for the Food Business Operators (FBO) on different quality and food safety parameters. 3. The Spices Board is responsible for the issuance of the mandatory Certificate of Registration as an Exporter of Spices (CRES) for spices exporters and manufacturerexporters. The registration process requires exporters to have a valid Importer Exporter Code (IEC) (issued by the India Directorate General of Foreign Trade, DGFT), to pass an initial visit of production premises and to pay the related fees. The CRES is 4

9 renewable every three years. No intermediate surveillance is required except in case of follow up of repeated RASFF notifications. 4. The Agricultural Extension Officers under the Ministry of Agriculture are responsible for promoting and supervising implementation of good agricultural practice (GAP) at farm level. The Spices Board established ten Spice Development Agencies to coordinate the programs related to GAP and Good Manufacturing Practices (GMP). These agencies comprise representatives of farmers, producers and exporters together with officials of the Ministry of Agriculture, Commerce and State Agricultural Universities. 5. The Food Safety and Standards Authority of India (FSSAI) established under the Food Safety and Standards Act of 23 rd August 2006, under the supervision of the Ministry of Health and Family Welfare, is responsible for official controls on the production, storage, distribution, commercialisation and import of spices intended for the domestic market. This includes, among other things, legislation, validation of food, sanitary and phytosanitary standards, registration and inspection of FBOs and monitoring of the products imported (or returned) on the domestic market. 6. The FSSAI licences FBOs in India, including spices manufacturers. However, if the activities of an FBO relate only to export, the inspection is limited to the licensing visit and to checks that there are no domestic related activities. If an establishments is only handling product destined for export but is not itself registered by the Spices Board (i.e. warehouse contracted to store products 100% destined to export) it will not be subject to official controls by CA (i.e. on GMP, HACCP principles, see also paragraph 19). 7. Although the Spices Board has the power to remove the CRES of spices exporters, or to refuse the "clearance" (official endorsement) of a result of analyses it is only the FSSAI who has the powers to destroy contaminated food or to prosecute FBOs. However, there is no evidence of these powers being used in the context of spices production intended for export in the context of this audit. 8. The mandatory sampling of spices for export and the supervision of loading ("stuffing") of containers is delegated under contract to five private agencies. A region may send an "intimation order" (sampling mission order) to different agencies. The contract between the agencies and the Spices Board requires that agencies have sufficient qualified, personnel and adequate sampling and inspection equipment. The actual tender doesn't include requirements related to impartiality of the agencies. The pending new tender will require these agencies to be ISO/IEC or ISO 9001 certificated. Supervision of the performance of the sampling and stuffing practices by the designated agencies is regularly organised by the spices board. 9. The Health Certificate is issued by the Export Inspection Council (EIC) of India of the Ministry of Commerce and Industry for feed and food as designated in Article 5.2.g of Regulation (EU) No 884/

10 10. The customs are also involved in the control of the spices intended to be exported to the EU through checks and clearance before export. It includes documentary and physical checks at the point of exit and sealing of containers (usually done under customs control at the exporting company premises). Customs may also check containers at the point of export or on return from the exporting country. 11. The Spices Board sends regular reports to the Ministry of Commerce and Industry (MCI) on its activities, including details of registrations, quarterly data on exports and the follow up of the RASFF notifications. As a part of the MCI, the Spice Board is subject to annual supervision visits covering financial control and general assessment. 12. Adequate resources and expertise are available and the training of staff in the performance of official controls is regularly organized. Training programmes under the Indo-EU Capacity-building Initiatives for Trade Development (CITD) on sampling procedures for mycotoxins were organized in 2015 and Spices Board s officials designated agencies' sampling agents and technical personnel from FBOs participated in these trainings. 13. Communication between the Spices Board and its regional offices usually takes the form of letters, circulars and instructions. There are also regular exchanges with the Ministry of Commerce and Industry. 14. Communication channels are established between the Spices Board, the CAs and the industries' representatives such as the "All India Spices Exporter Forum" representing around 80% of the exporters. Regular meetings and trainings are organised. The Spices Board also communicate via the web site on the actuality, research, circulars. Conclusions on Competent Authorities 15. The CAs, responsible for the control of aflatoxin contamination of spices intended for export to the EU are clearly designated, independent and have the powers to implement the relevant legislation. Communication between and within CAs is effective and resources are adequate and properly trained. 16. However, not all categories of FBO involved in the supply chain of spices exported to EU are subject to official controls to ensure the respect of requirements laid down in Articles 3 to 6 of Regulation 852/ RELEVANT NATIONAL LEGISLATION Legal requirements Article 46(1)(a) of Regulation (EC) No 882/2004. Regulation (EC) No 1881/2006. Regulation (EC) No 401/

11 Regulation (EU) No 884/2014 of 13 August Articles 3 to 6 and 10 of Regulation (EC) No 852/2004 and Article 11 of Regulation (EC) No 178/2002. Findings 17. The Spices Board Act 1986 establishes the Spices Board and its responsibilities, including the development of export of spices and support to the cardamom supply chain. 18. The mandatory CRES is granted following the requirements of Chapter IV of the Spices Board Act 1986 and of the related 1989 Notification and its amendments in 2004 and Each FBO is also subject to licensing by the FSSAI as required by Article 31 of the Food Safety and Standards Act Although every FBO is subject to licensing and inspections by FSSAI, only the FBOs acting on the local market are subject to regular assessments of the GMP, Good Hygiene Practices (GHP) and implementation of the HACCP principles as required by the Food Safety and Standard Act (FSSAct). Establishments dealing exclusively with exports are only visited by FSSAI to confirm that they are fully dedicated to export. There is no legal requirement for such FBOs, active in the export sector only, to apply HACCP principles. Only the manufacturer-exporters are subject to official controls on GMP during the initial issuance and renewal of the CRES, operators handling only products destined for export but not registered as exporters (i.e. externalised warehouses) are not subject to official controls on the application of the GMP and HACCP principles. The new version of the Spice House Certification standard, waiting approval by the Ministry of Commerce and Industry since 2012, will include requirements related to the implementation of HACCP principles by manufacturers. The participation in this certification program is on a voluntary base. 20. A national maximum limit for aflatoxin in spices on the Indian market is set by the FSSAI (30 µg/kg for the sum of aflatoxins in all foodstuffs). 21. The Spices Board has the authority to define mandatory sampling and analysis requirements before export. The mandatory tests, published in circulars, are listed by country or region of export, spices and spices products and include the parameters and limits. 7

12 For EU, the current requirements are: Spices & Spice Products Parameter Maximum Limit Chilli Whole Turmeric Whole Ginger Whole & Ginger Products Nutmeg Whole & Nutmeg Products Mace Whole & Mace Products Chilli Powder & Chilli Products Turmeric Powder & Products Curry Powder & Curry Masalas Aflatoxin Aflatoxin Aflatoxin B1-5 ppb Aflatoxin Total - 10 ppb Aflatoxin B1-5 ppb Aflatoxin Total - 10 ppb These requirements cover the spices included in Regulation (EU) No 884/2014 (Capsicum and Nutmeg) and other spices subjects to recurring notifications (Ginger and Turmeric). 22. Actually, the Spices Board's risk assessment doesn't request the monitoring of aflatoxin contaminations for other spices (such as Piper spp., also subject to limits in Regulation (EC) No 1881/2006). Conclusions on Relevant National Legislation 23. Registration of spice processors and spice exporters to the EU is required, in line with Article 6 of Regulation (EC) No 852/2004 in conjunction with Article 10 of the same Regulation. 24. There is no legal requirement for FBOs dedicated exclusively to exporting, to implement procedures based on HACCP principles. This does not ensure equivalence with the requirements of Article 5 of Regulation (EC) No 852/2004 in conjunction with Article 10 of the same Regulation. 25. Not all categories of FBOs involved in the supply chain of the spices exported to EU are subject to official controls to ensure the respect of requirements laid down in Articles 3 to 6 of Regulation 852/ IMPLEMENTATION OF OFFICIAL CONTROLS Legal Requirements Articles 46(1)(e) and (b) of Regulation (EC) No 882/2004. Article 10 of Regulation (EC) No 852/2004. Regulation (EC) No 401/2006. The CODEX Code of hygiene practice for spices and dried aromatic plants (CAC/RCP ) contains recommended practices based on GAP, GMP and HACCP. 8

13 Findings Implementation of legislation, organisation and performance of Official Controls Primary production 26. The farmers visited during the audit were participating in initiatives or certification programs related to Integrated Pest Management (IPM) initiatives or Organic certification. Logs allowing the registration of the operations related to the cultivation (purchases of inputs, treatments, fertilization and harvesting) and controls were available. In cases where recommendations intended to reduce mycotoxins' contamination are included in these GAP standards, the records related to the inspections or visits by the supervisors doesn't include conclusions on the respect of these prescriptions and no certificate of conformity to these GAPs is issued. 27. The Spices Board presented a number of promotional and training events aimed at disseminating GAP including recommended practices intended to reduce the products' contamination by mycotoxin producing fungi during cultivation and post-harvest operations. These included training events in the main producing regions and the production of specific GAP guidelines. 28. The Spices Board also provides financial assistance to farmers to mechanise the harvesting and to improve the drying process. The audit team was informed that 124 turmeric boilers, 154 turmeric polishers and 164 nutmeg dryers were installed with such assistance programmes between 2011 and An example of the operation of such small scale nutmeg dryers was observed by the audit team during visits to nutmeg growers. 29. The Spices Board has established 8 "Spice Parks" around the country in major spice producing regions. These provide common processing and storage facilities which allow small farmers to access equipment for post-harvest treatment and controlled storage they wouldn t otherwise be able to afford or access. 30. The Spice Board has established a programme (The e-spice Bazaar) on which there are currently famers and 81 buyers registered. The system is operational for Chilli and Turmeric. After registration in the programme, the farmers are visited by Spices Board's co-ordinators who collect basic descriptive information on the farm and production. They offer advice on GAPs and cultivation technics and allow access to testing of the harvested spices. The farmers can then advertise their products on the e- Spice Bazaar's website, allowing buyers to have a direct access to farmers (with a high degree of traceability) and access information related to the control over the production. 31. The Spices Board also promotes the formation of "Spice Producers' Society" (SPS) to facilitate the marketing and improvement of the quality of spices. Currently 47 SPS are recognised. 9

14 Processing and storage 32. All the processors visited had also recently developed backward integration programmes to support the implementation and supervision of GAPs by small farmers (1-2 ha/farm). This involves supporting groups of small farmers with training, technical support, provision of treated seeds, recommendations for sorting at harvest, etc. They also put in place traceability systems from the farms to reception in combination with controls on the raw materials for physical and chemical parameters (including sorting, visual checks and analyses for aflatoxin). Although these programs have started recently, they are spreading rapidly. 33. During the registration process of the manufacturer-exporters visited, the Spices Board's inspector had described, in the inspection report, the premises of the processing plant, volume of activities, the existence of other certification and license systems and gave a global evaluation of the "Overall hygiene of the unit". 34. At the time of the audit there are 5765 exporters registered by the Spices Board (including 652 manufacturers). Within the 205 exporters to EU, 108 are manufacturers and 42 have a "validated" HACCP plan (validation by third parties as part of private schemes' certification). The list of registered exporters is publically available on the website of the Spices Board: The implementation and validation of HACCP is not required by the Spices Board. During the visits to FBOs and exchanges with the Spices Board representatives, it was also confirmed that if the establishment is only processing or storing commodities dedicated to export, the FSSAI does not perform detailed inspections of the premises or verify whether GMP are implemented or carry out any assessment of the Food Safety Management System (HACCP). 36. The HACCP plans seen by the audit team had no consistent approach to the control of aflatoxin contamination. Indeed in some cases, the development mycotoxin producing fungi was not considered in the list of hazards analysed and thus control programmes and parameters were not considered or assessed. The descriptions of the process in the HACCP study also often stop at the stuffing of the containers and don't include the transportation to the customer (conditions during export). 37. Even though all the companies visited had well-defined control plans for the detection of contamination on raw materials, intermediate or finished products, neither product specifications (such as moisture content or water activity of the spices) nor environmental conditions of storage (T, Hr) had not been validated by the HACCP teams as means of control of aflatoxin contaminations. If the Spice House Certification standard project includes requirements related to GMP and to the implementation of HACCP principles, it doesn t include guidelines on the limits to be respected for these parameters (i.e. maximal moisture of spices, room's temperature during storage). 10

15 38. The premises visited during the audit had adequate infrastructure; equipment and organisation. However, during the establishment visits, the audit team observed very high temperature storage conditions as well as technical specifications of spices with high humidity levels. 39. The personnel met were experienced and qualified and most of the companies had internal laboratories, often ISO17025 accredited by National Accreditation Board for Testing Laboratories of India (NABL), performing own-checks. Some analyses are also contracted out to accredited laboratories. Conclusions on Official Controls on Production and Processing 40. Although many initiatives have been put in place to accelerate the implementation of GAP at farm level, there is currently no obligation for exporters of spices to the EU to use farms that have demonstrated, during official controls, the implementation of GAP dedicated to the prevention of aflatoxin contamination. 41. The correct implementation of HACCP principles is not subject to systematic official controls for FBOs involved in export to EU and numerous non-compliances were detected by the audit team. 5.4 PROCEDURE FOR EXPORTING TO THE EU Legal requirements Article 46(1)(h) of Regulation (EC) No 882/2004. Regulation (EU) No 884/2014 of 13 August Guidelines on the design, operation, assessment and accreditation of food import and export inspection and certification systems (CAC/GL ). Guidelines for the Assessment of the competence of testing laboratories involved in the import and export control of food (CAC/GL ). Findings 42. Exporters of Spice products must be registered as commercial entities to export with the DGFT who issue the Importer Exporter Code. They must also have a valid CRES issued by the Spices Board. 43. In the case of Nutmeg, Mace, Chilli, Ginger, Turmeric or mixes containing these products, the Spices Board also request the performance of additional mandatory official controls (analyses and supervision of the containers) before being cleared for export. 44. When the load is assembled for export, the FBO submits a request for sampling online via the spice board computer system, the Export Support System (ESS). The system provides 24 hours notice to the Spice Board who allocates the sampling to one of the approved sampling agencies. The sampling and stuffing usually takes place in the premises of the exporters. 11

16 45. The three laboratory samples taken by the sampling agency (one left at the FBO and two delivered to the allocated QEL) and the consignment is sealed pending the results to avoid any tampering. Once analysed (normally in 2-3 working days), the results and interpretation by the Spices Board are communicated to the exporter via the ESS. For consignments presenting aflatoxin B1 content between 3 and 5 ppb, the Spices Board advise the exporter not to export them to EU, however, the final decision rests with the exporter. 46. The exporter then submits on the same computer system the details of export date and means of transport to allow for the Spice Board to request the designated agency's representative to attend and supervise the loading (stuffing) of the container, which is subsequently sealed by Customs officials. This usually takes place at the exporting company but can also take place at the exporting terminal. 47. For dried fruit of the genus Capsicum other than sweet peppers (whole), sweet peppers (whole, crushed or ground) and Nutmeg (whole, crushed or ground), the exporter must apply to the EIC for the issuance of the Health Certificate. Application must be accompanied by the cleared analytical results and exporter's CRES number. The issuance of the Health Certificate usually takes a further two days. The Health Certificate issued respects the model of Annex II of Regulation (EU) No 884/ At the customs visited, the customs officials explained the routine documentary checks performed before the authorisation for export. This includes the verification that the exporter is correctly registered by DGFT and verification of the transport and commercial documents. 49. The customs officials also explained that they had received the copies of the letters and circulars from the Spices Board related to the specific conditions applicable to some spices and in these cases, they also verify the presence in the accompanying documents of the copies of the cleared analytical results and CRES. The verification of the availability of the Health Certificate is not required for the commodities subject to Regulation (EU) No 884/ In the customs ports visited, where such controls were demonstrated, the audit team noted that there was no live computer system to flag the required checks, nor any written customs' procedure or SOP describing the specific procedure applicable to some spices. The lists of spices subject to mandatory controls and analyses produced by the Spices Board do not specify the CN codes used by the customs to identify unambiguously the commodities presented before export. 51. Customs may also take random samples or checks at the point of export but there was no evidence that this ever includes analysis for aflatoxins. If customs officials have to access a sealed container they resealed it with another seal. The new seal number is not reported on the accompanying documents or any other document to allow the traceability with the initial seal number referred to on the Health Certificate. 12

17 Conclusion on Procedure for Exporting to the EU 52. There is a clear procedure for the controls of exports of Nutmeg, Mace, Chilli, Ginger, Turmeric or mixes containing these products. 53. There is no official control to verify that Health Certificates are either requested by exporters or accompany the export of spices as required by Regulation (EU) 884/ METHOD OF SAMPLING CONSIGNMENTS Legal requirements Regulation (EC) No 401/2006. Codex Alimentarius Commission/Guideline (CAC/GL) on Sampling contains recommended procedures for the acceptance or refusal of the lot after inspection. Findings 54. The sampling is conducted by the designated sampling agencies contracted by the Spice Board. They receive the "intimation order", including the necessary information for the sampling, though the online computer system ESS. 55. The agencies provide the bags and labels for sampling and sealing. Although the contract requires them to provide adequate sampling equipment, in practice, the sampling equipment is often provided by the operators. The sampling equipment used or presented during the audit was not always adequate to allow the sampling throughout the whole lot (i.e. inadequate length or design). 56. Although the Spices Board still made references to the ISO norm sampling protocol, the sampling procedure presented and followed during the audit is the circular issued the 10 August 2005, "sampling procedures conforming to EU norms". This sampling procedure is not in line with the last version of the Regulation (EC) No 401/2006 (i.e. no reference to the specific sampling methodology for spices with a relatively large particle size (whole nutmeg or whole Chilli), to sampling of lots in retail packs nor preservation from daylight). 57. Although the sampling procedure of the Spices Board requires that the aggregate samples are "thoroughly ground and mixed to make it homogeneous" to prepare the laboratory samples, there is no description on the method to be use for grinding and homogenisation (and validation of its efficiency). During the audit, the aggregate sample was divided into four heaps on a plastic sheet placed on the ground before being remixed prior to collection of the three laboratory samples. No adequate equipment for grinding large aggregate sample or protocol where available in FBOs or QELs visited. 58. After the homogenisation of the aggregate sample, three laboratory samples of 200 gr are prepared in (transparent) sealed bags and labelled. The information required by the 13

18 label template was not always correctly completed on the samples seen by the audit team (missing lot or seal numbers). 59. The records related to the sampling process are generally limited to the information in the ESS (including the identification of the consignment to be sampled: lot number, quantities, destination) and to the labels. No records are kept on the sampling protocol followed on the spot (weight and number of incremental samples, name of the inspector, eventual comments on the presentation of the consignment and storage conditions). 60. The sampling instruction does not describe the specific practices related to the sampling of vacuum packed spices or refrigerated products (transport and storage of the samples). The laboratory samples are sent to the QEL by the designated agencies. Conclusions on Method of Sampling of Consignments 61. The equipment and sampling methodology used during the official controls are not at least equivalent to those laid down by Regulation (EC) No 401/ LABORATORY SERVICES Legal requirements Articles 46(1)(d) and (c) of Regulation (EC) No 882/2004. Article 2 of Regulation (EC) No 401/2006. Points 41 and 42 of Codex Alimentarius Guidelines CAC/GL and point 3 of Codex Alimentarius Guidelines CAC/GL Findings 62. During the audit the audit team visited five private laboratories in producing establishments and two official QELs, one in Cochin and one in Mumbai. Private laboratories 63. All are using the same method of analysis (American Spice Trade Association analytical method 24.2) and with one exception are using a single point calibration for the quantification of aflatoxins on a routine basis. Three of the five laboratories visited are accredited to ISO 17025:2005 for the analysis for Aflatoxins in spices and successfully participated in recognised proficiency schemes. The personnel met were knowledgeable and experienced. 14

19 Official Laboratories 64. The seven QELs are established near the main ports of export. (Kochi, Mumbai, Chennai, Guntur, Tuticorin, Narela and since 2017 Kandla). At the time of the audit Tuticorin and Kandla were not yet accredited and Mumbai was awaiting the renewal of its accreditation due to the moving to new premises. All QEL laboratories take part in proficiency test for spices and the results of the two visited were acceptable. 65. The laboratory at Kochi is acting as the lead laboratory for the other seven laboratories of the Spices Board. Both the official laboratories visited (Cochin and Mumbai) process a large number of samples daily (70-80 capacity at those visited), with a turnaround time of two working days. The information relating to the name of the company and place of collection is replaced by a unique reference in the computer system before transmission to the laboratory; Counter samples are kept in cabinets protected from light at room temperature for 3 months. 66. Both laboratories used 5-point calibration curves during the validation studies but the aflatoxins are routinely quantified using a single point calibration on a routine basis. The LOQ was determined to be 0.5 µg/kg at the Kochi laboratory and 1.0 µg/kg at the Mumbai laboratory. 67. The frequency of quality control checks carried out on a daily basis is insufficient to give reassurance about the results although the Mumbai laboratory had recently introduced some quality control checks for routine analysis. Little use has been made of Schewart charts as a tool to monitor ongoing laboratory performance in the routine analysis of aflatoxins. In general the quality control checks are insufficient to fulfil entirely the NABL s own guidelines for routine quality control (Section 5.9 of the NABL Guidelines). 68. In Cochin, Measurement of Uncertainty (MoU) for the method had been calculated using a bottom-up approach but the MoU had not been calculated for the total aflatoxins. In Mumbai, MoU was calculated for all four Aflatoxins and total using a bottom up approach. In the examples presented related to RASFF notifications, MoU was stated to be ±0.5 µg/kg at the 95% confidence interval. After discussions it was evident that the calculated measurement uncertainty is being applied incorrectly to the analytical results obtained. This also applies to the MoU for the Sudan dyes. 69. The Cleared analytical reports sent to the exporters (valid 45 days) give the recovery factors for the four Aflatoxins but do not state if the recoveries had been applied to the analytical results. This is not in line with the requirements of Regulation (EC) 401/ The Spices Board also introduced a recommendation to exporters not to export consignments found with a contamination of aflatoxin B1 between 3 and 5 µg/kg. This is repeated on the cleared analytical report when the results exceed 3 µg/kg. 15

20 Conclusions on Laboratory Services 71. Not all the active QELs used to perform the official analyses before the issuance of the Health Certificates are accredited to ISO 17025: The accredited laboratories visited are able to produce analytical results that are reliable based on the samples received, but there are some improvements in quality control procedures that would give greater assurance of the validity of results. 73. The results provided to the exporters do not comply with the requirements of Regulation (EC) 401/2006 regarding the information on the correction or not for recovery and the calculation and expression of the Measurement of Uncertainty. 5.7 RESPONSE TO RASFF NOTIFICATIONS Legal requirements Point 6 of CODEX Guidelines CAC/GL requires exchanges of information between countries on rejections of imported food. Findings 74. Although there is no direct link between the Spices Board and the Indian contact point receiving the RASFF notifications, the follow up of RASFF notifications in the context of this audit is undertaken in a satisfactory manner. The Spice Office connects monthly to the RASFF portal to collect information on notifications related to exported spices. The follow up of RASFF notifications is based on a procedure notified to all exporters and valid from August The procedure requires the exporter to provide an explanation and root cause analysis following the first notification, a visit by a Spice Board representative if two notifications occurs in a period of three month and a restriction of export to EU in case of three or more notifications in a three month period. The audit team reviewed a number of files and considered the follow up to be satisfactory. 75. The returned consignments are subject to official controls on import. The audit team was informed that the legislation in India allows the mixing contaminated batches with other batches to reduce the contamination of the final batch. This may also be applied to returned consignments. Conclusion on Response to RASFF Notifications 76. A clear procedure has been developed to follow the RASFF notifications and investigate the root causes. That procedure is correctly implemented. 16

21 6 FOLLOW-UP OF RECOMMENDATION OF AUDIT DG (SANCO) The action plan provided by the CAs in response to the nine recommendations of previous audit would, if implemented, have addressed the issues raised. However the findings of the present audit conclude that only two of the nine recommendations from 2011 had been adequately addressed (inclusion of all the spices subject to the Regulation (EU) No 884/2014 in the mandatory official controls before export and implementation of a procedure to react to RASFF notifications). It is critical that the corrective action plans transmitted by the competent authorities are effectively implemented and their effectiveness verified in order to ensure the improvement of the situation and that the imported products meet the legal requirements. 7 OVERALL CONCLUSIONS The official controls dedicated to ensure that spices exported to EU have been produced, handled, and transported in line with good hygiene practices and to certify that they comply at least with contaminant limits laid down in Regulation (EC) No 1881/2006 present various weaknesses. While some significant improvements have been put in place regarding traceability and GAP, the implementation and control of GAP, GMP and HACCP principles is not mandatory for all the FBOs involved in the supply chain of the spices exported to EU. Although official controls and analyses are performed on the main spices, not all the official laboratories are subject to ISO/IEC accreditations and analytical reports are not totally in line with Regulation 401/2006. The sampling equipment and procedure audited presented serious gaps with the requirement of Regulation 401/2006 and could not guarantee representatives sampling and analytical results. The above failings call into question the reliability of the export certification. The issues raised during the audit could have been avoided if the action plan provided by the CAs in response to the recommendations of previous audit had been implemented in line with the action plan provided at the time. 8 CLOSING MEETING A closing meeting was held on 16 March 2017 with representatives of the CAs concerned. At this meeting the audit team presented the preliminary findings of the audit. The CAs provided additional information/clarifications and outlined further steps to be taken to make the system of official controls in the scope of this audit more efficient. 17

22 9 RECOMMENDATIONS No Recommendation Ensure that all establishments where spices for export to the EU are processed and stored are under official food safety control as require by Article 6 of Regulation (EC) No 852/2004 in conjunction with Article 10 of the same Regulation. Recommendation is based on conclusion No 16 & 25 Associated finding: No 6, 19 Ensure that food business operators exporting spices to the EU implement standards at least equivalent to those required by Article 5 of Regulation (EC) No 852/2004 on food safety procedures based on HACCP principles in conjunction with Article 10 of the same Regulation. Recommendation is based on conclusion No 16, 24 & 41 Associated finding: No 6, 19, 35 and 36 Ensure that GAP principles are implemented in all farms which produce spices for export to the EU as require by Article 4 of Regulation (EC) No 852/2004 in conjunction with Article 10 of the same Regulation. Recommendation is based on conclusion No 40 Associated finding: No 26 To ensure that each consignment of food and feed subject to the special import condition defined by the Commission implementing Regulation (EU) No 884/2014 is also accompanied by a health certificate in accordance with the model set out in Annex II. Recommendation is based on conclusion No 53 Associated finding: No 49 Ensure that sampling procedures for aflatoxin analysis in spices intended for export to the EU meet requirements at least equivalent to those laid down by Regulation (EC) No 401/2006. Recommendation is based on conclusion No 61 Associated finding: No 55, 56, 57, 58 and 60 18

23 No Recommendation Ensure that all laboratories performing official controls are accredited under official recognised programmes (ISO 17025) to make sure that adequate quality controls are in place to confirm the reliability of test results (point 41 of CAC/GL and point 3 of CAC/GL ). Recommendation is based on conclusion No 71 Associated finding: No 64 Ensure that analytical reports issued on aflatoxin analysis in spices for export to the EU meet requirements at least equivalent to those laid down by Regulation (EC) No 401/2006. Recommendation is based on conclusion No 73 Associated finding: No 68 and 69 The competent authority's response to the recommendations can be found at: 19

24 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. 882/2004 OJ L 165, , p. 1, Corrected and re-published in OJ L 191, , p. 1 Reg. 852/2004 OJ L 139, , p. 1, Corrected and re-published in OJ L 226, , p. 3 Reg. 401/2006 OJ L 70, , p Reg. 1881/2006 OJ L 364, , p Reg. 1152/2009 OJ L 313, , p Reg. 884/2014 OJ L 242, , p 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 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs Commission Regulation (EC) No 401/2006 of 23 February 2006 laying down the methods of sampling and analysis for the official control of the levels of mycotoxins in foodstuffs Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs Commission Regulation (EC) No 1152/2009 of 27 November 2009 imposing special conditions governing the import of certain foodstuffs from certain third countries due to contamination risk by aflatoxins and repealing Decision 2006/504/EC Commission Implementing Regulation (EU) No 884/2014 of 13 August 2014 imposing special conditions governing the import of certain feed and food from certain third countries due to contamination risk by aflatoxins and repealing Regulation (EC) No 1152/2009

25 Reg. 2016/24 OJ L 8, , p. 1 5 Commission Implementing Regulation (EU) 2016/24 of 8 January 2016 imposing special conditions governing the import of groundnuts from Brazil, Capsicum annuum and nutmeg from India and nutmeg from Indonesia and amending Regulations (EC) No 669/2009 and (EU) No 884/2014

26 Annex 2 - Standards Quoted in the Report Reference number Full title Publication details CAC/RCP Code of hygiene practice for spices and dried aromatic plants (CAC/RCP ) web/standard list.jsp CAC/GL CAC/GL Guidelines for the exchange of information between countries on rejections of imported food (CAC/GL ). Guidelines on the design, operation, assessment and accreditation of food import and export inspection and certification systems (CAC/GL ). web/standard list.jsp web/standard list.jsp CAC/GL Guidelines for the Assessment of the competence of testing laboratories involved in the import and export control of food (CAC/GL ). web/standard list.jsp CAC/GL General Guidelines on Sampling (CAC/GL ) web/standard list.jsp