05/10/05 - 45158

EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL Directorate F - Food and Veterinary Office F4 - Food of plant origin, plant health; processing and distribution

DG (SANCO)/7672/2005 – MR final

FINAL REPORT OF A MISSION

CARRIED OUT IN GHANA

FROM 24 MAY TO 1 JUNE 2005

IN ORDER TO

ASSESS THE CONTROL SYSTEMS IN PLACE FOR SUDAN DYES ADULTERATION IN PALM OIL

Please note that factual errors in the draft report have been corrected in the text of this final report. Clarifications provided by the Ghanaian Authorities are given as footnotes, in italic type, to the relevant part of the report.

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TABLE OF CONTENTS

1. INTRODUCTION.......................................................................................................5

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

3. BASIS AND LEGAL FRAMEWORK FOR THE MISSION....................................5

4. BACKGROUND.........................................................................................................6

4.1. Background to present mission .........................................................................6

4.2. Public health information ..................................................................................8

5. MAIN OBSERVATIONS...........................................................................................8

5.1. Relevant Ghanaian legislation...........................................................................8

5.2. Structure and official control activities of the competent authorities................9

5.2.1 The Food and Drugs Board.....................................................................9

5.2.2 The Ghana Standards Board .................................................................10

5.2.3 The Ministry of Local Government and Rural Development...............10

5.2.4 Other Organisations ..............................................................................11

5.3. Process Control in Palm oil .............................................................................12

5.4. Sampling and export procedures for consignments intended for export into the EU.......................................................................................................14

5.5. Visited laboratory services ..............................................................................15

5.6. Visited premises ..............................................................................................17

6. CONCLUSIONS .......................................................................................................17

6.1. Relevant legislation .........................................................................................17

6.2. Structure and official control activities of the competent authorities..............18

6.3. Process Control in Palm oil .............................................................................19

6.4. Sampling and export procedures for consignments intended for export into the EU.......................................................................................................19

6.5. Visited laboratory services ..............................................................................19

6.6. Visited premises ..............................................................................................20

6.7. General overview conclusions.........................................................................20

7. CLOSING MEETING...............................................................................................20

8. RECOMMENDATIONS ..........................................................................................20

To the competent authorities of Ghana .....................................................................20

9. ADDENDUM............................................................................................................21

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EXECUTIVE SUMMARY

The increasing number of rapid alert notifications of Sudan dyes in palm oil from Ghana led to the FVO (Food and Veterinary Office) to undertake a mission in that country. During the mission, Commission Decision 2005/402/EC on emergency measures regarding hot chilli, hot chilli products, curcuma and palm oil was published which repeals Commission Decision 2004/92/EC. Measures taken by the Ghanaian authorities in response to the alerts were notified to the Commission Services and then, through the RASFF (Rapid Alert System for Food and Feed) to the Member States (MS).

Since October 2004, the principal competent authority within the scope of this mission is the Food and Drugs Board (FDB) of the Ministry of Health while the Ministry of Local Government and Rural Development (MLGRD), and the Ghana Standard Board (GSB) of the Ministry of Trade and Industry (MTI) have a lesser role. During the mission the mission team was informed that the GSB would have an enhanced role in the future and would be able to take samples of palm oil and issue export certificates. A date for commencing these activities has not yet been given. The Ghanaian legislation does not provide a clear delineation or allocation of responsibilities for official control of foodstuffs or licensing/registration of food premises.

Since the Sudan dyes adulteration of palm oil arose, the Ghanaian competent authorities have not identified any evidence of where adulteration of the palm oil is occurring and thus, they could not take any legal actions against individual names or companies. A number of samples of palm oil have been taken nationwide. However, no analysis of samples taken on the domestic market has yet been done because of the lack of resources.

According to the export procedures of palm oil, Customs is responsible for releasing the consignments following receipt of the export permit from the FDB. However, this procedure is not always complied with. It was also noted that the majority of exports to EU of palm oil destined for human consumption were not exported with the correct Combined Nomenclature (CN) Code 15111090.

There is one designated official control laboratory the FDB, which is responsible for analysis of consignments for export to the EU. This laboratory is not accredited to ISO 170251 and is currently only testing for Sudan IV with the result that analytical report cannot currently comply with the provisions of Article 2 of Commission Decision 2005/402/EC regarding other dyes.

The official control systems in place have not allowed for the identification of the source of Sudan dye adulteration in palm oil. In addition, the designated official laboratories with responsibility for testing consignments for export do not have the analytical capabilities to test for all Sudan dyes, and it is therefore currently not possible for the competent authorities to certify consignments as per the requirements of Commission Decision 2005/402/EC.

A number of recommendations in relation with the identified deficiencies were made to the competent authorities.

1 In their response to the draft report the Ghanaian Authorities noted that efforts are in line to get this accreditation.

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ABBREVIATIONS & SPECIAL TERMS USED IN THE REPORT

CCA Central Competent Authority

CEPS Customs Excise and Preventive Service

CN-Code Combined Nomenclature Code

GCNET Customs Computer System

EHOs Environmental Health Officers

EU European Union

FDB Food and Drugs Board

FDL Food and Drugs Law

FFB Fresh Fruit Bunches

FRI Food Research Institute

FVO Food and Veterinary Office

GSB Ghana Standards Board

GEPC Ghana Export Promotion Council

HACCP Hazard Analysis and Critical Control Points

HPLC High Pressure Liquid Chromatography

ISO International Standards Organisation

LOD Limit of detection

LOQ Limit of quantification

MLGRD Ministry of Local Government and Rural Development

MTI Ministry of Trade and Industry

MS Member States

PORI Palm Oil Research Institute

RASFF Rapid Alert System for Food and Feed

UV Ultraviolet

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1. INTRODUCTION

The mission took place in Ghana from 24 May to 1 June 2005. The mission team comprised 2 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 Ministry of Trade and Industry.

The mission team was accompanied during the whole mission by representatives from the central competent authority (CCA), the Food and Drugs Board (FDB).

An opening meeting was held on 24th May 2005 at the premises of the FDB. Representatives of the Ministry of Trade and Industry (MTI), the Ghana Standard Board (GSB), the Ghana Export Promotion Council (GEPC), the Food Research Institute (FRI) and the EU Delegation in Ghana were also present. 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 dyes as well as other unauthorised colourants in foodstuffs, in particular in palm oil and to ensure that facilities and official controls are adequate to guarantee that products exported to the EU do not contain these colorants.

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

COMPETENT AUTHORITY VISITS Comments Central 2 FDB and GSB Competent authority Local 2 District assemblies under the responsibility of the Ministry

of Local Government and Rural Development: West Akim District and Kwabibirem District

LABORATORY VISITS 1 FDB laboratory

1 GSB laboratory

PROCESSING ESTABLISHMENTS Large-scale processor 1 Kwabibirem District Small-scale processors 3 West Akim District and Kwabibirem District

Packing houses/exporters 3 Accra District PORTS Tema 1

1 Customs Authorities Port

3. BASIS AND LEGAL FRAMEWORK FOR THE MISSION

The mission was carried out in agreement with the MTI and under the general provisions of Community legislation.

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The relevant legal framework for this mission is as follows:

– Council Directive 89/397/EEC2 of 14 June 1989 on the official control of foodstuffs;

– Council Directive 93/99/EEC3 of 29 October 1993 on the subject of additional measures concerning the official control of foodstuffs;

– Regulation (EC) No 178/20024 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;

– European Parliament and Council Directive 94/36/EC5 of 30 June 1994 on colours for use in foodstuffs;

– Commission Decision 2005/402/EC6 of 23 May 2005 on emergency measures regarding chilli, chilli products, curcuma and palm oil repealing Commission Decision 2004/92/EC7.

4. BACKGROUND

4.1. Background to present mission

According to Council Directive 89/397/EEC Member States (MS) are obliged to carry out routine sampling and analysis of foodstuffs originated from third countries. There are also specific conditions imposed in Commission Decision 2005/402/EC over products originating from third countries and intended for import into the EU, where the risk of adulteration constitutes a serious health risk. These specific conditions, among other things, relate to Sudan dyes adulteration in palm oil.

From July 2004 to the time of the mission 83 notifications relating to Sudan IV adulteration in palm oil from Ghana have been notified through the Rapid Alert System for Food and Feed (RASFF) which are broken down as follows: 53 alerts in 2004 (38 at the market control and 15 at the point of entry) and 30 alerts until May 2005 (28 at the market control and 2 at the point of entry). Additional notifications were received prior to the mission, which included other unauthorized colourants (Bixin and Norbixin) in palm oil. All of them were notified by eight MSs.

In response to the increasing rapid alert notifications, the Ghanaian authorities put the following measures in place in October 2004 which were notified to the Commission Services and then, through the RASFF to the MS:

2 OJ L 186 of 30 June 1989, p. 0023-0026. 3 OJ L 290 of 24 November 1993, p. 0014-0017 4 OJ L 31 of 01 February 2002, p. 0001-0024 5 OJ L 237 of 10 September 1994, p. 0013-0029 6 OJ L 135 of 28 May 2005, p. 0034-0036. 7 OJ L 27 of 30 January 2004, p. 0052-0054

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• The FDB was mandated by the MTI to screen all palm oil consignments destined for EU. In addition, the FDB is responsible for issuing an export permit based on the analytical results (free only of Sudan IV) provided by its laboratory. The FDB has performed traceability pattern of all palm oil consignments meant for export and developed and published guidelines on the Export of palm oil.

• The FDB has carried out a national survey of palm oil to establish the extent of the adulteration of palm oil.

• Meeting with all the relevant competent authorities, including large processors and exporters were held in 2004. Meetings with small-scale processors took place in April or May 2005.

• The FDB is registering all exporters to ensure effective monitoring of non-adulteration of the product.

In view of the increasing number of notifications, the FVO, in consultation with relevant EC services decided to undertake a mission with the abovementioned objectives.

During the mission, Commission Decision 2005/402/EC on emergency measures regarding hot chilli and hot chilli products, curcuma and palm oil was published which repeals Commission Decision 2004/92/EC. In implementation of that Decision, all consignments of such products have to be accompanied by an analytical report confirming the absence of Sudan dyes (I, II, III and IV). In the absence of such analytical report, MS shall detain the consignment under official supervision pending availability of the analytical report.

The EU imported 2.5 millions tonnes of palm oil in 2003 and 2.9 million tonnes in 2004. Indonesia and Malaysia account for around 80% of this total. One of the main African exporting countries of palm oil to the EU is Ghana. However, this only accounts for 0.20% total exports to the EU. The amount of palm oil imported from Ghana in 2003 and 2004 is shown in the table below (in tonnes); the main importing MS are indicated in brackets.

Source: Eurostat, Comext database

The figures provided by the Ghanaian authorities differ significantly from the above figures and no explanation on this issue was provided to the mission team (see also chapter 5.4).

The main growing areas of palm oil in Ghana are the Easter region, the Volta region and the Western region. The route of export to EU is mainly the Tema harbour while

2003 2004 Jan-Mar 2005

Palm oil

CN code 15111090

(according to Commission Decision 2005/402/EC)

1,669

(NL, UK)

5,147

(DE, BE, UK, NL)

332

(NL, UK, FR)

Palm oil

CN code 151190

543

(UK, BE, IT)

714

(UK, NL, BE)

200

(UK, FR, BE)

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the Kotoka international airport plays a limited role. Based on the figures provided by the Ghanaian authorities more than 95% of the palm oil processors are categorised as small-scale processors which are close to 850 in the 3 regions.

4.2. Public health information

Sudan Dyes

Sudan dyes (I, II, III and IV) are industrial dyes that are used for colouring solvents, oils, waxes, petrol, and shoe and floor polishes. They are unauthorised food colourants 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/EC8 on emergency measures regarding hot chilli and hot chilli products which was adopted in June 2003. The detection of other Sudan dyes such as Sudan II, III and IV in various products from several third countries led to extend the measures foreseen in the abovementioned Commission Decision to curry powder and to additional controls on Sudan II, III and IV by another Commission Decision 2004/92/EC which was adopted in January 2004 and repealed the first one.

Adulteration was also confirmed by findings in various products originating in several countries, in particular palm oil from Ghana. Taking into consideration the findings, original measures foreseen in Commission Decision 2004/92/EC were extended to curcuma and palm oil by Commission Decision 2005/402/EC which repeals the last one.

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

5. MAIN OBSERVATIONS

5.1. Relevant Ghanaian legislation

The relevant national legislation within the scope of this mission is the Food and Drugs Law (FDL) of the FDB, 1992 as amended. It states that adulterants, which include Sudan dyes, are not permitted in foodstuffs. This law provides also general official control powers for FDB inspectors such as right of access.

Currently, the FDL of the FDB and the Ghana Standards Decree, 1973 of the GSB do not provide a clear delineation or allocation of responsibilities for official control of foodstuffs or licensing/registration of food premises. There are currently draft bills which propose clearer responsibilities and are expected to be enacted later this year 2005. (e.g the FDB will be responsible for official control activities regarding food hygiene).

The Ghana Standards (Certification Mark) Rules of the GSB, 1970 as amended establish that all industrial products including foodstuffs can use the GSB

8 OJ L 154 of 21 June 2003, p. 0114-0115

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certification mark before they are exhibited for sale, distributed and prepared for export.

Since October 2004 the procedure for export of palm oil, which includes sampling and the issue of export permits, has been given to the FDB by the MTI.

5.2. Structure and official control activities of the Competent Authorities

Since October 2004, the principal competent authority within the scope of this mission is the FDB of the Ministry of Health while the Ministry of Local Government and Rural Development (MLGRD), and the GSB of the MTI have a lesser role.

5.2.1. Food and Drugs Board (FDB)

The FDB was established by the FDL (Provision National Defence Council 305B) 1992 as amended. Although this law was issued in 1992, it was not until August 1997 that the FDB became operational. During those 5 years that the FDB took to establish, the GSB continued providing services or performing functions of the FDB. However, the continued performance by the GSB of these functions has become to overlap the functions of the two institutions. To avoid this overlapping and to provide a clear delineation of responsibilities between them, a Memorandum of Understanding was signed in 2001 by both parts. However, this document was not recognised by the representatives of the GSB who were present in the meeting with the mission team, and its status was questioned.

The FDB is under the control and supervision of the Ministry of Health. At the top of the FDB is the Chief Executive Office who has direct control of the technical and administrative divisions. The FDB has 3 technical divisions of which 2 the food division and the laboratory division come under the scope of this mission. The laboratory services will be described under the heading “5.5 visited laboratory services”.

The food division, which has the responsibility for controlling the manufacture, importation, exportation, distribution, use and advertisements of foodstuffs, employs 40 staff. It consists of 3 departments, namely inspectorate department, food safety department and industrial support service department. The inspectorate department, which has 4 units (veterinary unit, premises inspection unit, port activities unit and post-market surveillance unit), has the responsibility for the inspection of food premises. The food safety departments, which has 3 units (product evaluation and registration unit, food safety and management unit, and food standards unit) is responsible for checking the labelling of foodstuffs, nutritional issues as well as the registration of food products. However, the latter is not seen as clear legal requirement because this requirement is not explicitly mentioned in its legislation. The industrial support service department was created in December 2004, among other things, to support industry to put in place appropriate management quality systems as well as to address the problem of Sudan dyes adulteration in palm oil. This department employs 4 staff including the head of the department and additional 5 staff have been recruited very recently. In relation to the Sudan dyes adulteration in palm oil this department is responsible for producing guidelines for export as well traceability for the suppliers. It also responsible for the incoming notifications from the European Commission regarding RASFF.

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Since October 2004, the FDB is responsible for providing certification for export to EU of palm oil.

In Ghana there are 10 regions and within these regions there are 138 districts. The FDB has begun to decentralise its activities throughout 5 zonal offices which cover the 10 regions. Each zonal office has the responsibility, among other things, for checking foodstuffs on the market regarding labelling issues as well as performing inspections on food safety in processing establishments. The mission team was informed that due to the limited resources, inspections on food safety at retail level are undertaken by the EHOs who perform their works under the umbrella of the Ministry of Local Government and Rural Development at district level. In relation to the Sudan dyes adulteration in palm oil, the mission team was informed that inspections of the small-scale and medium-scale processors of palm oil are undertaken by the EHOs while the large-scale processor are carried out by the inspectors of the FDB at zonal office.

5.2.2. Ghana Standards Board (GSB)

The GSB was established by the National Redemption Council Decree 173 which was promulgated in 1973. The core business of the GSB includes Metrology, Standards, Testing and Quality Assurance.

The Board has 5 main technical divisions of which 2 the standards and certification division, and the chemical science division come under the scope of this mission. The first division, which employ 25 staff, is responsible for providing standards, certification against these standards as well as export certification for different commodities including foodstuffs. Apart from its headquarters in Accra, the GSB has 6 offices throughout the country which cover the 10 regions.

Concerning palm oil the GSB has developed 3 standards which lay down the essential requirements to which this product must conform. These specifications are for “edible palm stearin”, “edible palm oil” and “edible palm olein”. The chemical science division, which provides testing services, will be described under the heading of “5.5 visited laboratory services”.

The mission team was informed that the GSB is now able to take samples of palm oil and issue the export certificate. However, a date for commencing these activities or clear or written undertakings has not been given yet.

5.2.3. Ministry of Local Government and Rural Development (MLGRD)

The mission team visited two district assemblies which have a number of processors of palm oil within the Eastern region. Both districts are under the responsibility of the MLGRD. Both districts were aware of the problem of Sudan dyes adulteration in palm oil because of the press coverage.

The first district was the West Akim district assembly which covers a population of 154,000. This district has a number of small-scale processors as well as retailers of palm oil. There are 16 EHOs in this district who are responsible for the inspections of these premises as well as other food premises. The district had the first meeting with the FDB concerning the problem of adulteration in palm oil in April 2005. As a result of that meeting a team of 7 people (4 EHOs and 3 FDB) was formed with the

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objective of providing information on adulteration of palm oil to the small-scale processors as well as retailers.

The Kwabibirem district was the second district visited which covers a population of 180,000. This district has a number of palm oil processor including small, medium and large processors. There are 20 EHOs in this district who are responsible for the inspections of these premises as well as other food premises. The district had the first meeting with the FDB concerning the problem of adulteration in palm oil in May 2005. As a result of that meeting a team of people between EHOs and the FDB was formed with the objective of providing information on adulteration of palm oil to all the relevant processors of palm oil.

5.2.4. Other Organisations

5.2.4.1. Ghana Export Promotion Council (GEPC)

The GEPC, which was established in 1969 by law, is an Agency who reports to the MTI. They have the role of providing help to exporters to meet the market requirements. The Council has 9 members, 6 of whom come from the private sector including the president. The GEPC has 4 divisions of which the general promotion division comes under the scope of this mission. This division employs 11 staff at central level and has 4 offices at regional level which employ 16 staff.

In relation to Sudan dyes adulteration in palm oil, the GEPC has held meetings in August and September 2004 to address this problem with other competent authorities (GSB, FDB, FRI), the main large scale processors as well some exporters. The findings of these meetings included a lack of awareness by exporters concerning Sudan dye adulteration, the fact that most of the palm oil on the domestic market was adulterated, inadequate storage facilities as well as inadequacies in the production processes of small millers which are reflected in the final product were impurities such as fibre and water are found to be beyond the levels established by the GSB specifications for palm oil.

The GEPC has organised a training programme targeted at the small-scale palm oil producers which has not yet been implemented.

During the meeting with the GEPC, the mission team was informed that all exporters of non-traditional export commodities, in particular palm oil must be registered with the GEPC. However, in 2003 the second biggest export volume was non-registered exporters and some companies exporting in late 2004 were found to be not registered.

In the response of the pre-mission questionnaire and during the mission, the GEPC was seeking an alternative use of food colourants other than Sudan IV such as annatto seeds which produce Bixin and Norbixin which are also unauthorised additives according to European Parliament and Council Directive 94/36/EC on colours for use in oils. The GSB specifications for palm oil do not allow adding any colourant in palm oil either.

5.2.4.2. Customs Excise and Prevention Service (CEPS)

The CEPS is responsible to the Ministry of Finance. It is structured with a central Commissioner and 6 deputy Commissioners. There are an additional 6 Assistant

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Commissioners, with each assistant commissioner responsible for, and based at, a port of entry/exit from the country.

The mission team visited the port of Tema, the largest port in Ghana situated some 40 Km East of Ghana. The CEPS staff here operate 6 days a week from 8 am to 8 pm. There are 430 customs officers situated at the port. Most of these are dealing with imports, and with processing customs data and payment on both imports and exports. Two offices within the CEPS come under the scope of this mission, the Compliance office and the Export office. The first one checks the information logged in by the Forwarded agents to the Customs computer system (GCNET) while the second one has the responsibility to check, among other things, the presence of certification relating to food safety.

Data for import and export is captured by the GCNET.

5.2.4.3. Council for Scientific and Industrial Research (CSIR)

Within the CSIR there are two institutes which come under the scope of this mission, namely the Food Research Institute (FRI) and the Palm Oil Research Institute (PORI).

The FRI started in 1965 with assistance from the United Nations Development Programme (UNDP) while the Food and Agriculture Organisation (FAO) acted as the executing agency. The FRI, which employs 180 staff, has the role in providing scientific and technological support to the growth of the food and agricultural sectors of the national economy. It has 4 scientific divisions of which the food chemistry division has shown any interest in undertaking analysis for the presence of Sudan dyes in palm oil. However, no method has been developed yet.

The PORI is one of the 13 affiliate institutes and centres of the Council for Scientific and Industrial Research (CSIR) in Ghana. This institute has initiated a study on efficiency of the small-scale processors of palm oil. On the 12 January 2005 the GEPC sent out a letter to this institute requesting them to submit a proposal on a training programme targeted at small-scale producers in 11 localities. However, the representative who met the mission team was not aware of this letter.

5.3. Process control in palm oil

It is generally agreed that the oil of the palm tree (Elaeis guineensis) originated in the tropical rain forest region of West Africa. Processing palm oil fruits for edible oil has been practiced in Africa for thousands of years.

Palm oil is rich in carotenoids, from which it derives its deep red colour, and the major component of its glycerides is the saturated fatty acid palmitic; thus it is a viscous semi-solid, even at tropical ambient, and a solid fat in temperate climates.

Because of its economic importance as a source of edible oil, the palm oil is now grown as a plantation crop in areas with high rainfall (≥ 1,200 mm per annum) in tropical climates. The palm bears its fruit in bunches varying in weight from 10 to 40 kg. The individual fruit, ranging from 6 to 20 gm, are made up of an outer skin (the exocarp), a pulp (mesocarp) containing the palm oil; a central nut consisting of a shell (endocarp); and the kernel, which itself contains oil, quite different to palm oil. In a well run palm oil mill, it is expected that each 100 tonnes of fresh fruit bunches (FFBs) processed yields 20 to 24 of crude palm oil. The palm oil tree

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harvest is distributed over the entire year with mainly two peak harvesting periods (April-May and September-October).

In Ghana, palm oil has become one major non-traditional export commodity in the last number of years. Two main variants are exported from this country, the natural which is called “virgin” or “crude palm oil” and “zomi” which is salted and flavoured. The virgin palm oil has an orange-red colour while the zomi variant may present a darker colour resulting from the added flavourings, salt and cooking. The main producing regions of palm oil are the Eastern region and the Central region while the Volta region mainly produces zomi.

The processing of palm oil fruit bunches into edible oil may be grouped into three categories according to their throughput and degree of complexity. These are the small-scale processors, medium-scale mills and large industrial mills. Generally, processing units handling up to 2 tonnes of FFB per hour are considered to be small-scale. Installations that process between 3 and 8 tonnes FFB per hour are termed medium-scale, whereas large-scale refers to mills that process more than 10 tonnes per hour.

In general, the palm oil process involves the following stages: the harvesting of FFB from the plantations, reception at the mill, sterilizing and threshing of the bunches to free the palm oil, mashing the fruit and pressing out the crude palm oil. The crude palm oil might receive a further treatment to purify and dry for storage and export. Harvesting involves the cutting of the bunch from the tree and allowing it to fall to the ground. Bunches can be transported to the processing area either in baskets carried on the head which is the case of small-scale processors or in lorries in the case of large-scale processors. Threshing (removal of the fruit from the bunches) can be achieved by cutting the fruit-laden spikelets from the bunch stem with an axe or machete and then separating the fruit from the spikelets by hand which is the case of small-scale processors. Large-scale processors use a mechanised system which detaches the fruit from the bunch, leaving the spikelets on the stem. Sterilization (120 oC-90 minutes) takes place in large-scale processors before the threshing stage while cooking, which can vary between 90 minutes to 2 days depending on the small-scale processors, is carried out after the threshing stage. The purpose of the sterilization/cooking process is mainly to weaken the pulp structure, softening it and making it easier to detach the fibrous material as well as stopping enzymatic activities. The object of the extraction stage is to remove the oil of a mixture of oil, moisture, fibre and nuts by applying mechanical pressure on the digested mash. In the large-scale processors, the stage of clarification takes place with the purpose of separating the oil from its impurities. Following this the oil is purified by using a centrifuge. In small-scale processors the oil is obtained by using a spindle press and then is heated for approximately 50 minutes to reduce the water content. The residue from the press consists of a mixture of fibre and palm nuts. The nuts are separated from the fibre by hand and the fibre is then pressed in spindle presses to recover a second grade oil that is used normally in soap-making. The process is much more variable in the small scale processors.

The processing in the 3 small-scale processors visited differs significantly from the processing at large-scale level. There also differences such as the time of cooking (90 minutes in the first one, 2 days in the second one and one day for the third one), the heat source (one company used rubber tyres) between the processing procedures within the 3 small-scale processors visited which might produce variations regarding composition and impurities of palm oil.

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Concerning the zomi variant, the mission team did not receive any information on the nature of the added flavourings.

478 samples of palm oil from the domestic market were taken nationwide by the FDB inspectors at zonal office between December 2004 and January 2005. However, no analysis has yet been undertaken because of the lack of resources.

The mission team was informed that since Sudan dyes adulteration of palm oil arose, the Ghanaian competent authorities have not identified any evidence of where adulteration of the palm oil is occurring and thus, they could not take any legal actions against individual names or companies.

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

The export procedure at the visited port of Tema commences when the Forwarding Agent enters data on the consignment into the GCNET. Forwarding agents have access to enable such data input from their offices. The data is then printed on a customs declaration form and presented with the invoice for the consignment at the Compliance office of CEPS. The staff here check that the information on the declaration is compatible with the invoice and the data on GCNET. The documentation is signed and returned to the Forwarding agent. At this stage no check is made on accompanying certification such as phytosanitary certificates from the Plant Protection and Regulatory Service Division of the Ministry of Food and Agriculture or the Sudan certificate for palm oil from the FDB.

The documentation is then presented to the Export office of the CEPS. The staff which were met here were aware of the issue of Sudan dye in palm oil following meetings between them and the FDB in October 2004, and have regular contact with the FDB staff situated at the port. There was however no written evidence of this communication or written instruction in the office regarding required certification. The main check here is on the detail of the declaration and the presence of the FDB analytical report for Sudan IV. Checks are not made at this stage on the company or whether it is registered, this is done at the point of sampling. If there is no analytical report presented, the exporter is informed he needs it and the consignment is held. However, some consignments were released from Customs without the FDB analytical report. If acceptable the container is issued with a customs seal.

Files examined by the mission team showed that certification had been provided since October 2004. In the first month some consignments were held and failed the analysis. These were not exported. Since then the exporters were seeking certification in advance so as to avoid paying port fees/ container fees on a consignment that is not suitable.

It was also noted that many of the consignments being exported were containers with a range of small quantities of various food items, including palm oil. Files examined by the mission team from Customs and GEPC showed that only 219 tonnes of crude palm oil intended for human consumption were shipped abroad within CN Code 15111090 while 3,894 tonnes of crude palm oil were dispatched to EU with different CN Codes which are used for refined palm oil (2,320 tonnes under the CN Code 1511901000 and 1,574 tonnes under the CN Code 1511909000).

No returned non-conforming consignments had arrived at the port.

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An accompanying document is then hand written clearing the consignment and the documentation is forwarded to the Ghana Port and Harbour Authority. They deal with the logistics of the export and movement in the port area, and issue documentation for the forwarding agent on when and where the consignment is exported.

In January 2005 the FDB established a Standard Operating Procedure (SOP) for the sampling of palm oil intended for export into the EU. However, the procedure is imprecise as the sampling frequency is left to the discretion of the inspector. The sampling procedure was described to the mission team as follows: the FDB inspectors determine the lot size based on the information provided by the company and then the samples are drawn at random by applying the square root of the number of drums/ bottles, bearing in mind that the sample can not exceed 1litre per batch. Samples are placed into plastic bottles which are labelled and sealed. This sample is submitted to the FDB laboratory for testing Sudan IV. An additional sample is taken and kept by the inspector. This second sample is submitted to the FDB laboratory in the case of a dispute although this had never happened. Additional information such as company details, source of palm oil, date supplied, quantity supplied and batch number are written down in a specific form with the purpose of traceability.

5.5. Visited laboratory services

The mission team visited the designated official control laboratory for the analysis of Sudan IV in palm oil, FDB laboratory. In addition, the GSB laboratory was visited as they have performed some private analysis on palm oil and stated they intended to provide certification for export in the future.

Currently, none of the two laboratories visited are checking other unauthorised colourants in palm oil such as bixin, norbixin and parared.

FDB laboratory

The laboratory is one of the technical divisions of the FDB. The laboratory, which employs 22 staff (5 analysts, 12 technicians and 5 clerical staff), has 3 units of which the physico-chemical unit comes under the scope of this mission.

The laboratory is not accredited to ISO 17025. There is no finalised quality assurance policy or procedures; a draft Quality Control manual was however shown to the mission team. The laboratory participated in a proficiency test organised by the World Health Organisation in 2002 regarding basic analysis. However, it is not taking part in any relevant inter-laboratory test regarding Sudan dyes determination.

The physico-chemical unit employs 11 staff, 3 of whom have a university degree. Staff had received training in general analytical techniques but not specifically on analysis for Sudan dyes. This unit performs analysis for Customs, the Pharmacy Council, the Police, the FDB as well as private companies. The latter represents only less than 3%. In 2004, 3696 samples were analysed of which 1648 (44%) were foodstuffs. Analysis for Sudan IV commenced in October 2004, since then 202 samples of palm oil had been analysed for export purposes only, with a failure rate of 21%.

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The laboratory uses a UV spectrophotometer screening method, which is able to detect Sudan IV with a limit of detection (LOD) presumed to be 1 mg/kg. However, because of the poor traceability and inconsistent information given to the mission team the LOD could not be verified. After dilution in methanol, the sample extract is scanned for the range 200-600 nm and the spectrum is compared against that for a single negative palm oil reference sample (taken from a large scale processor). Comparison with spiked samples shows absorbance between 500 and 600 nm which is absent in the negative sample. There is however no confirmatory analysis conducted, or cross analysis with other methods or laboratories.

The fact that only one negative sample from a large scale processor is used as a reference material and the lack of confirmatory analysis gives a possibility of false positives on screening analysis. The process of production at a small scale level is significantly different from large scale and impurities like fibres, gums and combustion compounds may interfere with the reading.

The laboratory has standards of Sudan I, II, III and IV, but the method has only been developed for Sudan IV using the method provided by a private company. Therefore, the analytical report issued by the FDB, which accompanies consignments of palm oil to EU, only covers Sudan IV. The use of the method for other Sudan dyes or other possible unauthorised food contaminants has not been demonstrated and is questionable as the spectrum range for the other Sudan dyes lies within the natural range of the oil.

The laboratory has HPLC (High Pressure Liquid Chromatography) equipment which is dedicated to other analytical programmes.

The GSB laboratory

The Chemical Science Division which provides laboratory services is not fully capable of providing Sudan dyes analysis at this stage. It stated that it intended providing analytical capacity in the future.

The laboratory is not accredited to ISO 17025 and is considered at the early stages of developing quality procedures. At present only one staff member performs private analysis for Sudan dyes. There is no specific training in this method and no inter-laboratory or inter-method comparison has been conducted. Deficiencies were noted in basic traceability in that some plates were not dated or labelled.

Two companies have applied for export on a voluntary basis. Samples were taken by the GSB and 12 samples analysed to date, all which were found to be clear.

The method utilised is a TLC (Thin Layer Chromatography) method with visual assessment. This is used to detect Sudan I, II III and IV. The stated LOD is 10 mg/kg for Sudan I and II, and 5 mg/kg for Sudan III and IV. These limits are significantly higher than those agreed on 10 May 2005 by the MSs (0,5-1 mg/kg) at the Standing Committee on the Food Chain and Animal Health.

Data for only one spiked palm oil sample was presented, and as spots were only visible for two of the Sudan dyes (II and IV) the method cannot be considered fully internally validated.

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5.6. Visited premises

The mission team visited 4 processors (1 large-scale and 3 small-scale) of palm oil in two districts within the Eastern region and three packing houses in the Accra region.

The large-scale processor of palm oil visited has its own palm oil plantations as well as outgrower and smallholder farms (all together 19,500 hectares). It has a processing facility of 60 tonnes of FFB per hour. The company produces crude palm oil as well as crude palm kernel oil. In 2004, the company processed 119,000 tonnes of FFB or around 24,000 tonnes of crude palm oil. The company was privatised in 1995 and employs 270 staff. The company was aware of the Sudan dyes adulteration in palm oil through the local press. The FDB contacted the company in November 2004 in order to allocate some production of its palm oil to some exporters. In addition, the FDB requested samples of palm oil from this company to use as a reference sample in the FDB laboratory. However, no inspections were carried out concerning food safety issues. The company has not any food safety procedures in place based on HACCP system.

The 3 small-scale processors of palm oil visited had received inspections from the EHOs. However, none of them had been subjected to any documented official inspection regarding food hygiene. In addition, no samples have been taken in the 3 facilities visited. None of them had food hygiene prerequisites in place or food safety procedures based on HACCP principles. One of the three companies visited was aware of the problem of Sudan adulteration from the press coverage while the other two had only been made aware recently at the visit of the FDB.. All of them source from small plantations of palm oil tree.

Three packing houses of palm oil were visited of which two were notified by the RASFF. All of them had received inspections from the EHOs. However, none of them had been subjected to any documented official inspection regarding food hygiene. The first company evaluated was also a processor of palm oil. In October 2004, the company received the visit of the FDB relating to Sudan dyes adulteration in palm oil. The company started to implement food safety procedure based on HACCP system in 2001. However, the potential hazards of Sudan dyes were not included in its “HACCP plan”. The second and the third company, which were involved in the Sudan dyes adulteration in palm oil, have not food safety procedures based on HACCP principles. Products of palm oil exported to Europe in both premises were labelled as “Products of West Africa”. The mission team was informed that the labelling is not in compliance with the requirements of the GSB or the FDB. Before the issue of Sudan dyes arose, both packing houses mainly sourced from the small-scale processors. After the issue 2 of the 3 premises visited were unable to trace back from adulterated lots to a supplier. The company, who was able to do it, did not inform the competent authorities.

6. CONCLUSIONS

6.1. Relevant legislation

The relevant Ghanaian legislation states that adulterants, which include Sudan dyes, are not permitted in foodstuffs.

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The Ghanaian legislation does not provide a clear delineation or allocation of responsibilities for official control of foodstuff or licensing/registration of food premises. However, there are currently draft bills which should address this issue.

Since October 2004, the Food and Drugs Board (FDB) has been given the mandate to control the procedure for export of palm oil by the Ministry of Trade and Industry (MTI).

6.2. Structure and official control activities of the Competent Authorities

The principal competent authority is the FDB of the Ministry of Health. Responsibility for inspections of food premises is shared with the Environmental Health Officers (EHOs) under the umbrella of the Ministry of Local Government and Rural Development.

The communication between the FDB and the GSB is seen as inadequate. The GSB will have a role in exports palm oil in the future. However, there is no date yet as to when these responsibilities will commence.

The competent authorities have acknowledged the problem of Sudan dye adulteration in meetings held between the processors, exporters and responsible authorities.

Training targeted at the small-scale processors has not yet been implemented.

At the time of the mission, the GEPC was looking at an alternative food colourants for use in palm oil none of which are allowed according to European Parliament and Council Directive 94/36/EC on colours for use in oils.

In the last two years, significant number of consignments of palm oil destined for EU came from non-registered exporters.

Information on Sudan dyes adulteration in palm oil in the two districts assemblies visited was only provided prior to the mission.

6.3. Process control in palm oil

Two main variants of palm oil (crude/virgin and zomi) are exported from Ghana. However, no information concerning the nature of the ingredients of the zomi variant has been provided.

The processing at small-scale levels differs significantly from the processing at large-scale level. There are also differences between the processing procedures within the small-scale processors which might produce variations regarding composition and impurities of the palm oil.

A survey of domestic palm oil is ongoing although no analysis has yet been done because of the lack of resources.

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Since the Sudan dyes adulteration of palm oil arose, the Ghanaian competent authorities have not been able to identify any evidence of where adulteration of the palm oil is occurring.

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

Since October 2004 the Customs authorities have had regular contacts with the FDB concerning the export procedures of palm oil. However, no written instructions were shown to the mission team in this regard.

According to the export procedures of palm oil Customs is responsible for releasing the consignments of palm oils following the receipt of an export permit from the FDB. However, this is not always complied with.

Before Commission Decision 2005/402/EC was issued, the majority of exports of palm oil destined for human consumption to the EU were not exported with the correct CN Code 15111090.

The sampling procedure for export purposes is imprecise and the interpretation regarding sampling frequency is left to the discretion of the sampling officer.

6.5. Visited laboratory services

The FDB laboratory is currently the designated official control laboratory to analyse Sudan IV in palm oil for export purposes. However, The GSB laboratory, which has performed some private analysis in palm oil, has stated they intend to provide certification for export in the future.

Neither the FDB laboratory nor the GSB laboratory are accredited to ISO 17025 and have not taking part in any relevant inter-laboratory test regarding Sudan dyes determination. In addition, none of them are testing other unauthorised colourants in palm oil such as bixin, norbixin and parared.

The analytical report of the FDB is not in compliance with Article 2 of Commission Decision 2005/402/EC as it only covers Sudan IV.

The method is not fully validated and due to the poor traceability and inconsistent information given the limit of detection (LOD), which is presumed to be 1 mg/kg, could not be verified.

The use of one reference sample from a large-scale processor and the lack of confirmatory analysis might give a possibility of false positives on screening analysis.

The method used by the GSB laboratory is not fully validated and the LOD (5-10 mg/kg) differs significantly from the MS.

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6.6. Visited premises

None of the processors of palm oil have food hygiene prerequisites or food safety procedures based on HACCP principles. In addition, no samples have been taken in any premises.

The large-scale processor visited did not receive any inspection concerning food safety while the small-scale processors visited received inspections concerning food safety by EHOs. However, none of them had been subjected to any documented official inspection in this regard.

1 of the 3 packing houses visited had food safety procedures in place based on HACCP principles. However, the hazard of Sudan dyes was not included in the “HACCP plan”.

Although all of the packing houses evaluated received inspection on food safety, none of them had been subjected to any documented official inspection in this regard.

In 2 of the packing houses evaluated, palm oil exported to Europe was labelled “Product of West Africa” which does not make it clear that the products are from Ghana.

6.7. Overall conclusions

The official control systems in place have not allowed for the identification of the source of sudan dye adulteration in palm oil. In addition, the designated official laboratories with responsibility for testing consignments for export do not have the analytical capabilities to test for all sudan dyes, and it is therefore currently not possible for the competent authorities to certify consignments as per the requirements of Commission Decision 2005/402/EC.

7. CLOSING MEETING

A closing meeting was held on 1st June 2005 at the premises of the MTI with representatives of the CCA, the FDB as well as representatives of the MTI, the GSB, the GEPC, the FRI and the EU Delegation in Ghana. At this meeting, the main observations and initial conclusions were presented by the mission team. The representatives of the Competent Authority provisionally accepted the observations and initial conclusions presented during that meeting with some general comments.

8. RECOMMENDATIONS

To the competent authorities of Ghana

(1) Improve communications between the competent authorities involved to ensure that consignments of palm oil intended for export to EU are adequately monitored.

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(2) Reinforce controls at all stages of the food chain to prevent Sudan dyes adulteration in palm oil, and ensure that food businesses exporting to the EU implement standards at least equivalent to Art. 3 of Council Directive 93/43/EEC9 on food hygiene and food safety procedures based on HACCP principles.

(3) Include Sudan I, II, and III in the scope of the analytical report as required by Commission Decision 2005/402 /EC.

(4) Consider expanding analysis to include other colourants not permitted in European Parliament and Council Directive 94/36/EC on colours for use in foodstuffs.

(5) Ensure that analyses for export are carried out using adequately validated method and the laboratories performing this conform with the general criteria for the operation of testing laboratories laid down in ISO standard 17025.

(6) Ensure that all exports of palm oil intended for human consumption to EU are exported with the CN Code 15111090 as required by Article 1 of Commission Decision 2005/402/EC.

(7) Ensure that consignments of palm oil exported to EU from Ghana clearly mention the origin of the product (Article 2 of Directive 2000/13/EC10).

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.

9. ADDENDUM

The Ghanaian competent authorities responded to the draft report making factual corrections and additional comments. The action plan was also received during the preparation of the final report which provides actions to each individual recommendation as follows:

Recommendation (1): The competent authorities involved will hold meetings on a monthly basis to review the RASFF reports, the monitoring scheme of palm oil, the education of palm oil processors as well as their analytical resources.

Recommendation (2): The implementation of food safety procedures based on HACCP principles will be undertaken at large-scale level while GMP and food safety training will be carried out at small-scale level.

9 OJ L 175 of 19 July 1993, p 0001-0011

10 OJ L 109 of 6 May 2000, p 0029-0042

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Recommendation (3): The designated official control laboratory has acquired the reference samples of Sudan I, II and III. In addition, this laboratory has begun to use the HPLC method provided by the French authorities.

Recommendation (4): The analysis of other colourants will be undertaken at the end of 2006.

Recommendation (5): The accreditation of the laboratory will take place in June 2006 while the validation of the method as well as the participation in proficiency testing schemes regarding Sudan dyes will be finished in December 2005.

Recommendation (6): The Customs authorities have already trained their staff regarding the correct use of the CN Code for palm oil.

Recommendation (7): The relevant competent authorities have already put measures in place to enforce labelling requirements.