EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL

Directorate F - and Veterinary Office

DG (SANCO)/7075/2004 – MR final

FINAL REPORT OF A MISSION

CARRIED OUT IN INDIA

FROM 16th TO 27th FEBRUARY 2004

IN ORDER TO

ASSESS THE CONTROL SYSTEMS IN PLACE TO CONTROL SUDAN I-IV CONTAMINATION IN PARTICULAR RELATED TO CHILLI AND CHILLI PRODUCTS

AND

TO ASSESS THE CONTROL SYSTEMS IN PLACE TO PREVENT CONTAMINATION IN SPICES INTENDED FOR EXPORT INTO THE EUROPEAN UNION

Please note that factual errors have been corrected in bold italic type. Clarifications provided by the Indian Authorities are given as footnotes in bold, italic type to the relevant part of the report.

19/07/04 - 35808

TABLE OF CONTENTS

1. INTRODUCTION...... 5

2. OBJECTIVES OF THE MISSION ...... 5

3. BASIS AND LEGAL FRAMEWORK FOR THE MISSION...... 6

4. BACKGROUND...... 7 4.1. Overview of previous missions regarding aflatoxin contamination in foodstuffs...... 7 4.2. Background to present mission ...... 7 4.3. Public health information ...... 8 5. MAIN OBSERVATIONS...... 9 5.1. Relevant Indian legislation...... 9 5.2. Structure and official control activities of the Competent Authorities...... 10 5.3. Sampling and export procedures for consignments intended for export into the EU...... 11 5.4. Training programmes and research activities...... 12 5.5. Visited laboratory services ...... 13 5.6. Private companies auto-controls...... 14 5.7. Good Agricultural Practices ...... 15 6. CONCLUSIONS...... 15 6.1. Relevant legislation...... 15 6.2. Structure and official control activities of the Competent Authorities...... 15 6.3. Training programmes and research activities...... 16 6.4. Sampling and export procedures for consignments intended for export into the EU...... 16 6.5. Visited laboratory services ...... 17 6.6. Private companies auto-controls...... 17 6.7. Good Agricultural Practices...... 18 6.8. General overview conclusions...... 18 7. CLOSING MEETING...... 18

8. RECOMMENDATIONS ...... 18 8.1. To the Competent Authorities of India...... 18 9. ADDENDUM...... 19

2 EXECUTIVE SUMMARY

The discovery of the presence of Sudan I in chilli and chilli products originating from India led to Commission Decision 2003/460/EC on emergency measures regarding hot chilli and hot chilli products. Confirmation of the adulteration by finding also Sudan II, III and IV in various products containing chilli as an ingredient led subsequently to the extension of original measures to curry powder and to additional controls on Sudan II, III and IV by Commission Decision 2004/92/EC. Measures taken by the Indian authorities were notified to the European Commission on 3rd December 2003.

From 2001 onwards, seventeen messages on the Rapid Alert System concerned exceedance of levels in Indian Spices. This issue was included therefore in the scope of the mission.

The Spices Board is the statutory body (under the Ministry of Commerce and Industry) in charge of controls of spices intended for export. The Spices Board circular issued on 23rd October 2003 provides for sampling and analysis for the controls of Sudan I in spices containing chilli for export. Another circular on 17th November 2003 extended the controls on each consignment for aflatoxin checks.

The mission identified the following main problems:

• The instructions in the circular do not correspond to the requirements set down in Commission Decision 2004/92/EC that repealed Commission Decision 2003/460/EC. Investigation of Sudan II, Sudan III and Sudan IV is not foreseen. • The sampling instructions differ from requirements of Commission Directive 98/53/EC, laying down the sampling methods and the methods of analysis for the official control of aflatoxin contamination in foodstuff. • Supervision of the sampling procedure has only been recently and partially implemented in some of the main ports of export. The appointed supervisors had no training or technical background, particularly with regard to aflatoxin sampling. • There is no evidence of official food hygiene inspections being performed in the companies visited. • There are no domestic monitoring activities for spices regarding aflatoxin contamination and activities focusing on prevention are negligible. • Controls of non-compliant lots at export point are not effective due to delays in delivering analytical results and lack of communication between different competent authorities. Current implementation of established procedures does not guarantee that consignments of ground chilli, chilli products and curry powder are free from Sudan I, II, III and IV contamination.

Current implementation of the proposed measures at points of export together with the absence of domestic controls and activities, does not ensure that consignments of spices exported to the EU comply with the levels of aflatoxins laid down in Commission Regulation (EC) No. 466/2001.

A number of recommendations in relation with the identified deficiencies were made to the Competent Authority.

3 ABBREVIATIONS & SPECIAL TERMS USED IN THE REPORT

CCA Central Competent Authority

CRM Certified Reference Material

FAPAS Food Analysis Performance Assessment Scheme, UK

FVO Food and Veterinary Office

ISO International Standards Organisation

HACCP Hazard Analysis and Critical Control Points

HPLC High Pressure Liquid Chromatography

LOD Limit of detection

LOQ Limit of quantification

QEL Quality Evaluation Laboratory

MoH Ministry of Health

MS Member States

NGOs Non-Governmental Organisations

RASFF Rapid Alert System for Food and Feed

4 1. INTRODUCTION

The mission took place in India from 16th to 27th February 2004. The mission team comprised 3 inspectors from the Food and Veterinary Office (FVO) and one national expert.

The mission was undertaken as part of the FVO's planned mission programme, and in agreement with the Indian Spices Board which is part of the Indian Ministry of Commerce and Industry.

The mission team was accompanied during the whole mission by representatives from the central competent authority.

An opening meeting was held on 16th February 2004 at the premises of the Agricultural and Processed Food Products Export Development Authority (APEDA), the central competent authority for mission SANCO/7076/2004, which was carried out in parallel. During this meeting, the objectives of, and itinerary for the mission were finalised and confirmed by the mission team.

2. OBJECTIVES OF THE MISSION

The objectives of the mission were

• To verify that adequate controls are in place to prevent the presence of Sudan I, II, III and IV in foodstuffs, in particular in chilli and chilli products and to ensure that facilities and official controls are adequate to guarantee that products exported to the EU do not contain these colorants, in accordance with Commission Decision 2004/92/EC.

• To verify that adequate controls are in place with regard to aflatoxin contamination in spices, and to ensure that facilities and official controls are adequate to guarantee that products exported to the EU can be produced within specified European Union contaminant limits and in accordance with Commission Regulation (EC) No. 466/2001/EC.

In pursuit of these objectives, the visits were carried out in accordance with the itinerary agreed between the Spices Board and the FVO of the European Commission and were as follows:

COMPETENT AUTHORITY VISITS Comments Competent authority Central 4 Spices Board central offices (Cochin) Ministry of Health and Family Welfare Ministry of Agriculture Ministry of Commerce and Industry Regional 5 Andhra Pradesh State Health Department Andhra Pradesh State Agriculture Department Maharashtra State Health Department Maharashtra State Agriculture Department Spices Board Regional Offices (Mumbai) LABORATORY VISITS Public laboratories 3 Quality Evaluation Laboratory of the Spices Board (Cochin) State Health laboratory (Andhra Pradesh) National Nutrition Research Centre (Andhra Pradesh)

5 Private laboratories 3 One private laboratory (Andhra Pradesh) Two in-house laboratories in the processing companies (Mumbai and Cochin) FARMERS 1 A farmers’ village in Andhra Pradesh PROCESSING ESTABLISHMENTS Andhra Pradesh 2 One processor of spices for the Indian domestic market One warehouse for spices. Mumbai 2 One processor and exporter of spices One processor and exporter of spices (only to observe the sampling procedure) Cochin 2 One processor and exporter of spices One processor and exporter of spices (only to observe the sampling procedure) PORTS Mumbai 1 Customs Authorities 1 Port Management Private Company Cochin 1 Customs Authorities 1 Public Port Authorities

3. BASIS AND LEGAL FRAMEWORK FOR THE MISSION

The mission was carried out in agreement with the Spices Board and under the general provisions of Community legislation, in particular:

– Council Regulation (EEC) No 315/931 of 8 February 1993 laying down Community procedures for contaminants in food,

– Council Directive 85/591/EEC2 of 20 December 1985 concerning the introduction of Community methods of sampling and analysis for the monitoring of foodstuffs intended for human consumption,

– Council Directive 89/397/EEC3 of 14 June 1989 on the official control of foodstuffs,

– Council Directive 93/99/EEC4 of 29 October 1993 on additional measures concerning the official control of foodstuffs,

– Commission Directive 98/53/EC5 of 16 July 1998 laying down sampling methods and the methods of analysis for the official control of the levels for certain contaminants in foodstuffs,

– Commission Regulation (EC) No. 466/20016 of 8 March 2001 setting maximum levels for certain contaminants in food,

– Commission Decision 2004/92/EC7 of 21 January 2004 on emergency measures regarding chilli and chilli products, repealing Commission Decision 2003/460/EC8.

1 OJ L 37 of 13 February 1993, p. 1. 2 OJ L 372 of 31 December 1985, p. 50. 3 OJ L 186 of 30 June 1989, p. 23. 4 OJ L 290 of 24 November 1993, p. 14. 5 OJ L 201 of 17 July 1998, p. 93. 6 OJ L 77 of 16 March 2001, p. 1. 6 4. BACKGROUND

4.1. Overview of previous missions regarding aflatoxin contamination in foodstuffs

The European Commission has carried out missions to third countries to assess the official control systems for aflatoxins in foodstuffs originating in Egypt, Iran, Turkey, China and Brazil. In addition, missions to most of the Member States with the objective of assessing controls on imported products of plant origin were carried out. The reports of these missions are available on the DG Health and Consumer Protection Internet site, at

http://europa.eu.int/comm/food/fs/inspections/fnaoi/reports/contaminants/index_en.h tml

4.2. Background to present mission

Council Directive 89/397/EEC lays down a general obligation for Member States to undertake random analysis of foodstuffs. There are also specific conditions imposed in Commission Decisions over products from certain third countries where the risk of contamination is considered greater. These specific conditions relate to contamination in certain commodities originating in some third countries and to Sudan dyes contamination in chilli and chilli products originating from India and intended for import into the EU.

The main growing areas of chillies in India are the States of Andhra Pradesh and Karnataka whereas the most important ports of export to EU are Mumbai, Cochin and Chennai. According to the Agricultural Census more than 90% of the farms are extremely small, the average size being 0.95 ha. It is estimated that there are close to a million farmers of this type producing chillies in India.

According to Eurostat data from 2000 to 2003, India exported the amounts of goods as in the table below (in tonnes); the main importing MS are indicated in brackets.

2000 2001 2002 2003

Spices (general) 25786 28245 31787 28703 (UK, NL and I) (UK, I and NL) (UK, I and NL) (UK, I and FR) of which 3442 3543 3991 3179 Chilli and chilli (UK, I and NL) (UK, NL and I) (UK, I and NL) (UK, I and FR) powder of which 2685 2490 3176 3016 Curry powder (UK) (UK) (UK) (UK)

7 OJ L 27 of 30 January 2004, p. 52.

8 OJ L 154 of 21 June 2003, p. 114.

7

The Rapid Alert System for Food and Feed (RASFF) received 119 notifications related to presence of Sudan I in 2003. Thirty-four of these messages, from 8 different MS, indicated presence of the non authorised colorant Sudan I in chilli, chilli products, mixtures of spices, sauces and snacks originating in India (test performed mainly at import points). Sudan I, Sudan II, Sudan III and Scarlet Red (Sudan IV) were also in chilli and chilli products from other third countries. Additionally there has been a large number of messages related to different EU originating products, allegedly prepared using contaminated imported chilli or chilli products.

In 2001, one RASFF notification reported aflatoxin exceeding specified limits in chilli powder of Indian origin. In 2002, 5 MS sent five notifications for Indian spices, while in 2003 there were eleven notifications concerning aflatoxin exceedance in spices of Indian origin sent by 4 MS.

In view of the number of notifications, as well as information provided in a letter (issued on the 25th of November 2003) by the Indian authorities regarding activities implemented in response to the letter sent by the DG SANCO, the FVO decided to conduct a mission with the objectives mentioned above.

4.3. Public health information

Sudan I

Sudan I is an industrial dye that is used for colouring , oils, , petrol, and shoe and floor polishes. It is prohibited as a food ingredient in the EU.

The discovery of the presence of Sudan I in chilli and chilli products originating from India was considered as a serious health threat, thus leading to Commission Decision 2003/460/EC on emergency measures regarding hot chilli and hot chilli products which was adopted in June 2003. In implementation of that Decision, all consignments of such products had to be accompanied by an analytical certificate confirming the absence of Sudan I and MS had to detain and analyse all consignments arriving to the import point without this analytical certificate. As required by the protective EU measures taken on chilli and chilli products, Member States have carried out checks for the presence of the substance concerned and related substances in chilli and chilli products on their own market.

Adulteration was confirmed by findings in various products originating in several countries and containing chilli as an ingredient. Taking into consideration the findings, original measures foreseen in Commission Decision 2003/460/EC were extended to curry powder and to additional controls on Sudan II, III and IV by Commission Decision 2004/92/EC.

Sudan I, II, III and Scarlet Red (Sudan IV) have been classified as category 3 by the International Agency for Research on Cancer.

Aflatoxins

Aflatoxins are produced by certain species of Aspergillus, which develop at high temperatures and humidity levels and may be present in a large 8 number of . The aflatoxins group includes a number of compounds of varying toxicity and frequency in food. is the most toxic compound. For safety reasons, it is advisable to limit both the total aflatoxin content (compounds B1, B2, G1 and G2) of food and the aflatoxin B1 content. In accordance with the Annex to Commission Regulation (EC) No. 466/2001, the maximum admissible aflatoxin levels in various spices and products thereof intended for human consumption are as follows:

—Capsicum spp. (dried fruits thereof, whole or • 5 µg/kg aflatoxin B1 content ground, including chillies, chilli powder, cayenne and paprika).

—Piper spp. (fruits thereof, including white and • 10 µg/kg total aflatoxin black pepper) content —Myristica fragrans (nutmeg) —Zingiber officinale (ginger) —Curcuma longa (turmeric)

In addition, sampling plays a crucial part in determining aflatoxin levels, which are very heterogeneously distributed in a consignment. Therefore, in Commission Directive 98/53/EC a sampling procedure and general criteria were set down to ensure that laboratories in charge of the analysis use methods of analysis with comparable levels of performance.

5. MAIN OBSERVATIONS

5.1. Relevant Indian legislation

Official control activities regarding food hygiene at domestic market are covered by the Prevention of Food Adulteration Act (PFA) and Rules made thereunder. This legislation regulates inspection of food operators and quality standards for foodstuffs.

Rules 27 and 28 relate to permitted and banned colorants in foods; Rule 57 establishes a level of 30 ppb total aflatoxin content in all foods and Appendix B to rule 5, sets down quality standards for spices. According to the Indian national standards, no added colorant is allowed in chilli and chilli products.

Export of food products is regulated under the Export Inspection and Quality Control Act, implemented by the Export Inspection Council. In the case of spices, except for black pepper exported to USA, powers have been delegated by the Indian Ministry of Commerce and Industry to the Spices Board to execute these controls on spices according to Spices Board Act and Rules.

The Spices Board circular issued on 23rd October 2003 provides for sampling and analysis for the controls of Sudan I in each spice consignment containing chilli for export. It does not include provisions regarding Sudan II, III and IV. Details on sampling are provided in chapter 5.3.

9 Another circular on 17th November 2003 extended the controls on each consignment to aflatoxin checks. Written instructions sent to the interested parties describe the sampling procedure.

5.2. Structure and official control activities of the Competent Authorities

Domestic market controls

In India, there are 25 states, six union territories and the National Capital Territory (Delhi), each with a State Health Department and a State Agriculture Department.

The Ministry of Health and Family Welfare is the authority responsible for implementation of PFA Act and Rules. The Food Authorities belonging to the State Health Departments are responsible for the practical enforcement of the PFA Act and rules. Seventy-two Public Health laboratories assist the authorities by analysing food samples taken at domestic market level.

According to the PFA Act, food operators shall undergo official inspections at least once a year, and also in the event of consumer complaints or suspicion. Inspections are also carried out for the purpose of taking samples. In each State, food controllers employed by the State Departments of Health in co-operation with the municipalities or other local authorities, as appropriate, are responsible for carrying out the supervision of food operators and for the control of products at these points. None of the companies visited, (warehouses, processors for domestic market and for export or exporters) have ever had food hygiene inspections performed.

The Public Health laboratories of the visited States are not currently performing analyses for aflatoxins in spices. In the Public Health laboratory visited samples have been analysed for presence of banned colorants for more than 25 years. Data showed that over the years the presence of non-authorised dyes was detected. Compiled data of the results from the different state laboratories is sent monthly to the Ministry of Health and Family Welfare.

The State Departments of Agriculture are responsible for controls and advisory activities at farmer level. In the States visited, there is very little or no activity with regard of the prevention of aflatoxin contamination in spices by these authorities.

Export controls

Regarding export controls, the Spices Board is the Competent Authority. The Spices Board is a body created in 1987 by the Indian Ministry of Commerce and Industry, to develop and promote export of spices. Its structure, functions and powers are described in the Spices Board Act and Rules. All exporters of spices must be registered with the Spices Board to operate. This compulsory registration does not include any requirements. Since October 2003, the Spices Board is in charge of the compulsory controls on exported spices set down by the Indian Authorities.

As a result of Commission Decision 2003/460/EC and to facilitate trade in spices, the Spices Board issued a circular in October 2003. According to it, all consignments containing chilli or chilli products must undergo a supervised compulsory sampling and analysis for Sudan I prior to export. In November 2003,

10 Spices Board sent out a circular informing to the interested parties that obligatory controls were expanded to aflatoxin tests.

Controls are effected in a manner that does not hinder trade and the consignments are not retained pending the results.

The Quality Evaluation Laboratory (QEL) belonging to the Spices Board is currently the only laboratory empowered to perform analyses for the presence of Sudan I and aflatoxin analysis in spices intended for export.

5.3. Sampling and export procedures for consignments intended for export into the EU

The Spices Board established the sampling procedure in a circular sent to its regional offices and to the sampling agencies. According to these instructions all spices consignments containing chilli intended for export shall be sampled and sealed in the presence of officials of the Spices Board before the containers are loaded. Exporters should notify the nearest regional Spices Board's office using an official form not later than 48 hours before shipment. The regional offices inform the actual samplers who belong to private operators. The Spices Board has appointed two private companies as designated agencies for drawing samples. A Spices Board representative shall supervise the sampling process and completes and signs a report9.

Data indicated, however, that the supervision of the sampling procedure has been implemented in Mumbai since November, while it just started in Chennai from late January and in Cochin from early February. No evidence of supervision was provided for Kolkata.

The team met several of the supervisors appointed by the Spices Board who were working both at Mumbai and Cochin. All of them were administrative staff with no technical background related to foodstuffs and had been temporarily assigned to inspection tasks. There was a complete lack of training on sampling procedures, food hygiene or contaminants in foodstuffs for the Spices Board supervisors.

According to the instructions, the samples are drawn at random by applying the square root of the number of bags in the export consignment or alternatively drawn from 10% of the packs. Samples thus drawn are mixed thoroughly to make four aggregate samples, each weighing around 200 grams. Samples packed, labelled and sealed in a polythene bag are distributed as follows: Two sealed samples are sent to

9 The Indian Competent authorities stated that since they had no previous experience of the work of the designated agencies, they deployed employees of the Spices Board to accompany those engaged by the agencies to ensure timely sampling and dispatch of samples to Spices Board and to act as a double check to confirm that the samples drawn by the designated agencies actually represent material exported/meant to be exported. They were to also verify that containers are stuffed with material from which samples were drawn and are sealed in their presence. As such, their knowledge or otherwise of sampling procedures was irrelevant to the task assigned to them. Consequently, training of representatives of Spices Board in sampling is required only if they are dispensing with the services of the external agencies and conduct sampling through their own employees, a course of action not contemplated as of now.

11 the Spices Board Laboratory, one is retained by the sampling agency and the last sample is handed over to the exporter. The instructions require four samples of 100 grams in the case of whole chillies.

The mission team observed two sampling procedures at the exporter’s premises in Mumbai and Cochin. The samplers, whilst experienced in sampling of various products, had not received any training on sampling procedures for mycotoxin analysis.

The exporter can immediately export the consignment or wait for the receipt of analytical report from the QEL of the Spices Board prior to effecting shipment. According to the circular, in the case of detection of Sudan I, the non-compliant consignment must be returned to the exporter.

Customs officials have no official function in the controls of contaminants in spices. Neither the exporter nor the customs authorities receive any written evidence that sampling of the container has taken place.

The customs authorities in the two main ports stated that spices consignments for export are not detained unless the regional offices of Spices Boards confirm that the lots are non-compliant. The regional offices do not receive information on the results of the tests. Only results regarding non-compliant samples are sent from the QEL to the central offices. In addition, delays of up to 40 days between sampling and delivery of analysis results were noted in some cases. In the five non-compliant cases detected, no information has been sent to the customs authorities.

In case of a non-compliant sample, the Spices board is empowered to temporarily suspend the export licence. Permanent de-registration of companies has been carried out by the Ministry of Commerce and Industry following proposal by the Spices Board for five companies involved in some of the RASFF messages. At internal market level, evidence was presented of infringement procedures being recommended when chilli powder was found to contain an added colorant.

5.4. Training programmes and research activities

At the initiative of the Spices Board and with the participation of other concerned public and private organisations, a pilot programme has very recently been introduced to improve the quality of the chilli production at farmer’s level. These activities are at a very early stage, their implementation is still minimal and their influence negligible in the context of total Indian production of chillies.

Training activities for the private sector included production and dissemination of brochures and advice on the prevention of diseases at growing, harvesting and drying. Prevention of aflatoxin contamination forms only a minor part of the activities since their main emphasis is to promote organic farming practices. Prevention of aflatoxin contamination at processing, storage, transport and packaging of these food commodities has not been covered.

Regarding the research activities, some studies have been carried out in the National Nutrition Research Centre but no practical outcome on prevention of aflatoxin contamination has been reported.

12 5.5. Visited laboratory services

Public laboratories

All samples taken for aflatoxin and Sudan I analysis are sent to the Quality Evaluation Laboratory of the Spices Board, which is currently the only laboratory empowered by the Indian Authorities to analyse spice samples for purposes of export. Before October 2003 it only conducted private analysis for exporting companies.

It is certified to ISO 9002 standard but not yet accredited to ISO 17025. It has not taken part in any internationally recognised proficiency test regarding aflatoxin determination.

The laboratory is only testing for Sudan I and not for Sudan II, III and IV. Test results are sent directly to the exporter. The central offices of the Spices Board receive a copy of the report only in the case of non-compliant results.

The laboratory is equipped with HPLC with simple UV detector thus their limit of detection (LOD) for Sudan I is 3 ppm and their limit of quantification (LOQ) is 5 ppm. The method has been validated. Positive results are reconfirmed by spiking the samples.

Regarding aflatoxin analysis, the method and equipment used allows a limit of detection of around 0.5 ppb for each substance. Validation of the method is completed.

The staff is adequately educated, trained and qualified to perform the routine tasks assigned. The layout and physical conditions of the laboratory visited are satisfactory for the correct performance of the tests.

The Public Health laboratory visited in Andhra Pradesh analyses samples of chilli powders taken from the Indian market according to the criteria set down in PFA act.

It employs 34 technical staff, performing chemical and microbiological tests in foodstuffs. The laboratory is not accredited to ISO 17025. The laboratory has been analysing for Sudan I since its creation in 1959 and since January 2004 also analyses for Sudan II, III, and IV. The laboratory uses a thin layer chromatography method with an unknown limit of detection. Despite the lack of sensitivity of the method, evidence was seen of Sudan dyes contamination being found over many years. Detections of Sudan I increased since 2002.

The Public Health laboratory of the Maharashtra State Department of Health was not visited but last years figures for Sudan analyses were provided to the team. Data showed that positive samples for banned colorants were also found in the Public Health laboratories of this State.

Private laboratory

The private laboratory in Maharashtra performs only private analysis on spices to be exported, usually at request of the exporters. It is not authorised by the Spices Board to carry out official analysis of spices to be exported, as required by the instructions issued by the Spices Board in the relevant circular.

13 The equipment, staff training and layout seemed adequate to carry out aflatoxin analysis. The laboratory was accredited to ISO 17025 and the aflatoxin determination method is included in the scope of accreditation.

5.6. Private companies auto-controls

None of the companies had been subjected to any documented official inspection regarding food hygiene or aimed at preventing risks to public health.

The farms visited formed part of a pilot project, starting this season, whereby 250 farmers have received polythene sheets to dry their harvest. Normally the farmers dry chillies in their own open farmyards for 8 to 10 days with no protection from birds, insects or dust. Usually dried chillies are sold in the Agricultural Markets Yards to wholesalers, processors or exporters through commission agents although increasingly exporters buy green chillies grown, dried and stored under their direct supervision.

The farmers visited had received advice on integrated pest management and were aware of the mould infection potentially leading to aflatoxin contamination but their concern was mostly related to the commercial quality of the produce and, ultimately, to the price obtained in the market.

The producer visited is a co-operative founded in May 2001 with the support of the Non-Governmental Organisation working in co-operation with the Spices Board. It employs 8 staff and produces four different products, all containing spices distributed and sold on the local market. They buy the chillies directly from the local farmers, grind them and pack them in retail packets. Their production is around 11 tons per year. The local health authorities have never inspected the company and there was no system in place related to food safety issues.

The warehouse visited is a company owning a cold storage centre for chillies (80% of the total produce stored), turmeric (10%), tamarind (5%) and others. Around 45% of the storage capacity is dedicated to products to be exported. It buys produce from the markets for storage and off-season sales to wholesalers, processors or exporters. It also stores spices owned by third parties. It has storage facilities for up to 4500 tonnes. There have been no inspections from the local health authorities since its creation in 1985. The company had no system in place related to food safety issues.

The visited exporters were amongst the biggest suppliers to EU countries. In all the companies the team was informed that no visits regarding hygiene of foodstuffs had taken place by any official health authority.

In two companies the inspection team was present at the sampling procedure and gathered information but no full inspection of the company was carried out. Details on the sampling procedures are given in section 5.3.

The other two companies visited had systems based on HACCP requirements and their own laboratories for auto-control purposes. In one of the companies aflatoxins were not identified as a hazard and despite the existence of a laboratory no evidence was provided to prove that regular aflatoxin analysis of the lots was carried out. In the other company, examples of effective measures put in place to control the contaminated batches and to trace back to the source of contamination were seen. 14 The laboratory of this company was well equipped and performed analysis for aflatoxins and for Sudan I in raw materials and in produced batches.

5.7. Good Agricultural Practices

In the States visited, the competent authority has produced and distributed some pamphlets on Good Agricultural Practices for different commodities but aflatoxin contamination is only briefly mentioned. Advisory activities at farmers’ level with regard of the prevention of mould infection and aflatoxin development were insignificant.

The Spices Board has started introducing a training programme for farmers in co- operation with State Agricultural Departments and Non-Governmental Organisations (NGOs) to improve post-harvest handling methods and Good Agricultural Practices. As part of this programme, the Spices Board has supplied polythene sheets at a subsidised price and funded the construction of drying yards. Nevertheless, the implementation of these activities has barely started and its impact on the production is as yet negligible.

In addition, both organic farming and Integrated Pest Management is encouraged and supported among groups of farmers organised through NGOs. In Andhra Pradesh, 41 villages are involved in this initiative and exporters are encouraged to choose their suppliers from these groups.

6. CONCLUSIONS

6.1. Relevant legislation

The body of the relevant national legislation and legal instruments provides powers for the official bodies to carry out official controls.

The instructions laid down in the circular from the Spices Board do not correspond to the requirements set down in Commission Decision 2004/92/EC repealing Commission Decision 2003/460/EC. Investigation of Sudan II, Sudan III and Sudan IV is not foreseen.

The sampling instructions as laid down in the Spices Board letter differ from requirements of Commission Directive 98/53/EC, laying down the sampling methods and the methods of analysis for the official control of aflatoxin contamination in foodstuff, in particular regarding the number of aggregate samples.

6.2. Structure and official control activities of the Competent Authorities

The Food Authorities belonging to the State Health Departments are responsible for the practical enforcement of PFA Act in India. No evidence was provided of official food inspections being performed in the companies visited.

The Public Health laboratories belonging to the State Health Departments analyse samples taken at domestic market level. There are no domestic monitoring activities 15 for spices regarding aflatoxin contamination but the laboratories have been analysing and detecting the presence of banned colorants for years.

The State Departments of Agriculture are responsible for controls and advisory actions at farmer level but activities with regard of the prevention of aflatoxin contamination in spices were negligible.

The Spices Board under the Ministry of Commerce and Industry is the single Competent Authority with the overall responsibility for performing official aflatoxin and Sudan I controls in spices originating in India and intended for export to MS.

The Spices Board issued a circular in October 2003 requiring supervised compulsory sampling and analysis for Sudan I prior to export for all consignments containing chilli or chilli products. In November 2003, Spices Board included aflatoxin tests in the obligatory controls.

The Quality Evaluation Laboratory of the Spices Board is the laboratory performing analyses for the presence of Sudan I and aflatoxin analysis in spices intended for export.

6.3. Training programmes and research activities

While instructions on sampling have been issued by the Spices Board no detail or specific training, particularly in the case of aflatoxin sampling, has been provided.

Research activities carried out have not resulted in any applicable outcome for the purposes of controlling aflatoxin contamination in spice production.

6.4. Sampling and export procedures for consignments intended for export into the EU

The Spices Board has established the sampling procedure, according to which all spices consignments containing chilli intended for export shall be sampled by an appointed private company and sealed in the presence of officials of the Spices Board. Data indicated, however, that the supervision of the sampling procedure has been only implemented in Mumbai since November, while it just started in the rest of the ports of export.

The supervisors appointed by the Spices Board were administrative staff with no technical background related to foodstuffs and had been temporarily assigned to inspection tasks. They have received no training on sampling procedures, food hygiene or contaminants in foodstuffs.

Delays on the delivery of analytical results and lack of communication between the different authorities involved in the export procedures on spices jeopardise the performance of adequate controls.

Evidence was presented of permanent de-registration of exporting companies in case of a non-compliant sample. At domestic market level, infringement procedures were recommended when chilli powder was found to contain an added colorant.

16 The customs authorities have not detained contaminated consignments since they have not received the relevant information. Thus, controls of non-compliant lots at export point are not effective.

6.5. Visited laboratory services

The Quality Evaluation Laboratory of the Spices Board is currently the only laboratory empowered to analyse spice samples for export purposes. It is certified to ISO 9002 standard but not yet accredited to ISO 17025 and has not taken part in any internationally recognised proficiency test regarding aflatoxin determination.

The laboratory is only testing for Sudan I using a validated method but does not carry out analyses for Sudan II, III and IV. Test results are sent directly to the exporter and the Spices Board central offices are notified only in the case of non- compliant results.

The laboratory empowered for official analyses does not generate results for Sudan examination with complete reliability, since its limit of detection for Sudan I is 3 ppm which is not sufficiently low and, furthermore, as Sudan II, III and IV are not in their analytical scope10.

Regarding aflatoxin analysis, the method is validated and limits of detection and quantification are within the range of legal limits laid down in the European legislation.

The Public Health laboratory visited in Andhra Pradesh analyses samples of chilli powders from the domestic market. The laboratory is not accredited to ISO 17025. The laboratory has been analysing for Sudan I for decades and since January 2004 also analyses for Sudan II, III, and IV. Despite the lack of sensitivity of the method used, evidence was seen of Sudan contamination being found over many years.

Data provided by the Maharashtra State Department of Health indicated that positive samples for Sudan were also found in the Public Health laboratories of this State.

6.6. Private companies auto-controls

While auto-controls for aflatoxin contamination in spices were acceptable in one of the exporting companies, the system was not adequate in another one and the remaining four of the six visited companies did not have any system at all.

Some of the companies have set up internal laboratories for auto-control purposes.

10 The Indian Competent Authorities stated that arrangements have being made to acquire more sensitive and sophisticated equipments with lower LOD. They have since been acquired at a cost of more than Rs.16 million. These equipments have detection limits at 5 ppb or less. The newly acquired equipments are being installed and test procedures are being validated. It was expected to commence analysis of samples using these equipments in about 15 days.

17 6.7. Good Agricultural Practices.

The competent authorities have just started some activities focused on prevention of aflatoxin contamination but these are negligible in the context of the whole production of Indian chillies and are only extended to a small number of farmers.

6.8. General overview conclusions

As result of Commission Decision 2003/460/EC, the Spices Board has introduced certain procedures for the control of Sudan I in spices for export. These do not cover Sudan II, III and IV. The current implementation of such procedures does not guarantee that consignments of ground chilli, chilli products and curry powder are free from Sudan I, II, III and IV contamination.

Additional measures have been taken by the Spice Board regarding aflatoxin tests in spices for export. Current implementation of these measures at points of export together with the absence of domestic activities and controls, does not enable guarantees that consignments of spices exported to the EU comply with the levels of aflatoxins laid down in Commission Regulation (EC) No. 466/2001.

7. CLOSING MEETING

A closing meeting was held on 27th February 2004 with representatives of the Competent Authority, the Spices Board. At this meeting, the main observations and initial conclusions were presented by the mission team. The representatives of the Competent Authority accepted the observations and initial conclusions presented during that meeting with some general comments.

8. RECOMMENDATIONS

8.1. To the Competent Authorities of India

The Competent Authorities should address the shortcomings and deficiencies set out in the conclusions to this report and in particular:

– Modify the instructions laid down in the circular from the Spices Board to ensure controls are in line with the requirements set down in Commission Decision 2004/92/EC repealing Commission Decision 2003/460/EC, regarding the investigation of Sudan II, Sudan III and Sudan IV.

– Ensure that the Spices Board representatives and staff involved in the sampling procedure are suitably qualified and experienced staff, in particular in areas related to food hygiene and technology so that the controls and sampling procedure can be carried out adequately.

– Improve communication between the competent authorities involved on the controls at points of export and reinforce controls at export point to ensure that consignments of spices intended for export to EU are adequately monitored.

18 – Reinforce controls at all possible stages of the food chain to reduce aflatoxin contamination in spices intended for export to EU11.

– The Quality Evaluation Laboratory of the Spices Board should be in line with the general criteria for the operation of testing laboratories laid down in ISO Standard 17025 and should also participate in international inter-laboratory comparison programmes to generate reliable analysis results, in accordance with Art 3 of Council Directive 93/99/EEC.

A programme in response to these recommendations should be produced by the Competent Authority, which should provide detailed information on the actions that will be taken and propose deadlines by which these actions will be completed within 2 months of receipt of the final report.

9. ADDENDUM

The Indian Competent Authorities stated in their response that the QEL of the Spices Board is on the verge of getting accreditation under ISO 17025 and final audit towards this end is expected to take place during the last week of this month between 27 and 29 May, 2004. The QEL is expected to be accredited under 17025 shortly thereafter.

11 The Indian Competent Authorities stated that given the enormous number of farmers involved in chilli growing and the extent of area where it is grown, it will be impossible for Spices Board to reinforce controls at all “stages of the food chain” covering production, post harvest operations, packaging, transport, processing, storage and shipment. However, they provide incentives for cleaner production, proper and hygienic post harvest handling, integrated pest management and organic production and encourage exporters to establish backward linkages to quality producers, enter into contract farming and to take charge of post harvest operations and processing to ensure quality of the raw material. These efforts are continuing and are being stepped up. Eventually the only effective way the Spices Board can ensure that spices exported to the EU do not contain aflatoxins beyond permissible limits is to sample consignments readied for export to the EU. and analyse them to determine the quality before it is delivered to European buyers as is being done now.

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