DIRECTORATE: FOOD CONTROL

GUIDELINES FOR MONITORING IRRADIATED FOODSTUFFS IN SOUTH AFRICA

October 2004

Contents

1. Introduction
2. Definitions and Descriptions
3. Background/Purpose of Food Irradiation
4. Regulatory Aspects and Principles of Food Irradiation
5. Responsibility of national Department of Health
6. Responsibility of provincial health departments
7. Responsibility of local authorities
8. Other role players
9. Conclusion

1. INTRODUCTION

The purpose of this document is to provide information and guidelines to all those persons that are involved in the administration and enforcement of regulations relating to food irradiation in South Africa.

Food irradiation is a modern technology that offers many benefits. It is however prudent that regulatory control be exercised to ensure that consumer confidence in the safety and wholesomeness of irradiated food products is maintained, as well as to ensure that consumers are able to exercise their right of choice when purchasing foods.

Regulations under the Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act 54 of 1972), stipulate that no foodstuff that has been irradiated may be sold unless the Minister of Health or the Director-General of Health has in writing, approved the sale of such irradiated foodstuff (Government Notice No. R.1600 of 22 July 1983). This authority has been delegated to the Director: Food Control of the Department of Health.

The Minister of Health is responsible for the promulgation of regulations that govern food irradiation. The national Department of Health administers such regulations, while authorized local authorities are responsible for enforcing the regulations in their areas of jurisdiction.

In South Africa there are currently four facilities that irradiate food as well as commodities such as medical devices. These are located in Cape Town, Durban and Kempton Park. In past years there was also such a facility in Tzaneen, but it is no longer in operation. By far, the foodstuffs that are most frequently irradiated in South Africa are spices followed by honey and fresh garlic.

The document provides background information, and also explains the roles of the different sectors of government. Much attention is given to the role of local authorities. A checklist for the purpose of monitoring is included as a guide for Environmental Health Officers and other role players.

The principles on which the irradiation of foodstuffs rest should be noted very carefully, as the measures that are necessary for the control of food irradiation are dependent on the understanding of these principles.

It is trusted that careful adherence to these guidelines by all stakeholders will serve to uphold the current position whereby the South African food irradiation industry operates within a minimum of regulations but within the principles on Good Manufacturing Practice (GMP) and Good Irradiation Practice (GIP).

2. DEFINITIONS AND DESCRIPTIONS

Batch or lot: A quantity of food irradiated under the same conditions for an uninterrupted period.

Codex Alimentarius Volume XV: Codex General Standards for Irradiated Foods and Recommended International Code of Practice for the Operation of Radiation Facilities used for the Treatment of Foods, 1982 (ANNEX A).

Dosimetry system: A system that is used for determining absorbed dose consisting of dosimeters, measurement instruments and their associated reference standards, and procedures for the system’s use.

Good Irradiation Practices (GIP): Practices that specifically apply to food irradiation facilities and irradiated food products, to supplement those provisions of Good Manufacturing Practice (see definition) that would ordinarily apply to the approved activities of the irradiation facility. GIP would include:

• Treatment practices such as International Consultative Group on Food Irradiation Codes of GIP to be used as guidance;
• Product inventory and process parameters;
• Handling practices; and
• Record keeping.

Good Manufacturing Practice (GMP) where applicable: Practices applicable to methods of manufacture or handling or a procedure employed, taking into account the principles of hygiene so that food cannot be contaminated or spoiled during manufacturing or processing, which include:

• Specifications of every aspect of manufacturing, processing, packaging;
• Facilities, equipment, instruments;
• Prevention of contamination;
• Personnel – training, job descriptions;
• Production procedures; and
• Best available technology.

Gray (Gy) is the unit of absorbed dose. One Gray is equal to the absorption of one joule per kg.

International Atomic Energy Agency (IAEA): An international body responsible for all relevant aspects of the peaceful utilization of atomic energy

International Consultative Group on Food Irradiation (ICGFI) is an international group of experts designated by governments to evaluate and advise on global activities in food irradiation.
It was established under the aegis of the Food and Agriculture Organization (FAO), the IAEA and the World Health Organization (WHO)

Manager of the Irradiation Installation or his Delegate: The person officially in charge of or officially authorized to act.

Minimum Effective Absorbed Dose is the minimum absorbed dose to achieve the desired effect.

3. BACKGROUND / PURPOSE OF FOOD IRRADIATION

Food is inter alia irradiated for the same reasons it may be exposed to heat, refrigeration or freezing. Food irradiation should therefore be seen as one of an array of techniques that contribute to the same objectives. It combats food borne disease by attacking one of its main causes, namely harmful microorganisms such as Salmonella, Campylobacter and other pathogens. It also destroys insects and their larvae in food and fulfils a technological need by preventing sprouting, for example of onions, garlic and potatoes. In this way the shelf life of food is extended, the quality of food is improved and dissemination of organisms that are unacceptable to the agricultural sector, is prevented. Irradiation therefore contributes to overcoming quarantine barriers and to extending the marketability of food.

Food irradiation is a physical process by which food is passed through a field of ionising energy. Some energy is absorbed but not enough to warm the food to a significant extent. The most common source of energy used for this purpose – also in South Africa – is Cobalt-60 (a radioactive form of cobalt). The energy applied to irradiate food is extremely low and does not induce radioactivity. Most foodstuffs are irradiated at doses between 0.1 and 10 kGy. An irradiation dose refers to the quantity of irradiation energy absorbed by the foodstuff as it passes through the irradiation field during the process of irradiation. It is measured using a unit called Gray (Gy) whereby 10 kGy is the equivalent of 10 000 Gy. Although it is important to ensure that the minimum irradiation dose is achieved in order to ensure the required quality and safety of the foodstuff being irradiated, a too high irradiation dose would spoil the food, similar to the over cooking of food.

Food safety, nutritional adequacy and microbial risks have been extensively evaluated over many years. According to the World Health Organization.

• An irradiation dose of up to 100 kGy is completely safe;
• Specifying upper dose limits is therefore superfluous;
• No particular nutritional problems are caused;
• There are no special microbiological risks; and
• Unlike chemicals or pesticides, the irradiation process does not leave any potentially harmful residues.

Because Cobalt-60 is a radioactive element, statutory provisions provide for the radiological safety of staff dealing with food irradiation and for the environment of the industrial facilities in which food is irradiated. Control measures to monitor these installations exist and are carried out by the Directorate: Radiation Control of the Department of Health that is located in Bellville.

Based on practical experience and in consideration of the safety aspects following from normal Good Manufacturing Practices, all irradiated foodstuffs have been divided into different classes. (Additional classes, specific for South African needs, were added to the suggested international list) (ANNEX B). This list (as indicated in ANNEX B) relates to the reason for irradiation of foodstuffs. For example, Class 2 refers to fresh fruits and vegetables which are irradiated for the purposes of delaying ripening or extending shelf-life. Applications for the irradiation of foods and the quarterly reports (ANNEX C) of irradiation of foodstuffs must be in accordance with these classes.

ANNEX D to this document also contains a checklist that identifies aspects to be taken into account during monitoring actions. The checklist however only serves as a guide. The concept of the Hazard Analysis and Critical Control Points System (HACCP) is also applicable and should eventually also determine points to control.

Labelling is an important means of identifying foodstuffs processed by irradiation. It provides consumers with the information needed to make a choice on whether or not to select irradiated foodstuffs for specific reasons. Industry also has an opportunity to make food safety or other claims by means of statements on labels.

4. REGULATORY ASPECTS AND PRINCIPLES OF FOOD IRRADIATION

4.1 REGULATORY ASPECTS:

4.1.1 Legislation for regulating the irradiation of foodstuffs

The Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act 54 of 1972), makes provision for the control over the safety and quality aspects of the sale, manufacture and importation of foodstuffs, as well as of aspects such as labelling. Regulation No. R.1600 of 1983 of this Act governs the irradiation of food. The Hazardous Substances Act, 1973 (Act 15 of 1973), requires the licensing of irradiation facilities, training experience and qualification of the operators and prescribes the requirements for radiological safety.

4.1.2 Labelling of irradiated foodstuffs

The labelling of foodstuffs is regulated so as to ensure that consumers are not misled and that they are able to make informed choices. Specific references to the labelling of foodstuffs in terms of the Foodstuffs, Cosmetic and Disinfectants Act, 1972, are found in the Regulations Governing the Labelling and Advertising of Foodstuffs (G.N. No. R.2034 of 29 October 1983).

Regulation 3(28) states that "All containers of irradiated foodstuffs shall be unambiguously labelled with the internationally recognized "Radura" emblem in accordance with the specifications in Annex 5 (see ANNEX E) together with one of the following words: "Irradiated" or "Radurised", "Bestraal" or "Geraduriseerd" directly below the emblem". The Codex General Standard for the Labelling of Prepackaged Food however regards the use of Radura emblem as voluntary. In order to remain compliant with this international standard, the use of the emblem in South Africa should not be enforced in a rigid manner.

In the case of a foodstuff containing an irradiated component(s) in more than 10% of the finished product the words "Irradiated" or "Radurized", "Bestraal" or "Geraduriseerd" shall appear opposite the relevant component(s) in the list of ingredients on the label.

Where:

• bulk containers of irradiated foodstuffs are opened at the point of sale in such a manner that the statement that the foodstuffs has been irradiated is obscured from the consumers view, or
• foodstuffs containing an irradiated component(s) in more than 10% of the mass of the product are presented in such a way that the consumer can no longer see that the foodstuff contains an irradiated component(s).

A notice with the information that is required shall be displayed in immediate proximity to such a foodstuff and in clear view of the purchaser.

The producer of an irradiated foodstuff may also indicate the purpose of irradiation of such a foodstuff, e.g. "Irradiated for purposes of insect control".

In order to identify irradiated food that is being transported, relevant shipping documents are required and the foods must also be correctly labelled. The identification of irradiated food applies to all the various points in the distribution chain.

4.1.3 Licensing of irradiation facilities

Requirements to ensure radiological safety are prerequisites for permission to proceed with the licensing of irradiation facilities, including those involved in the irradiation of food. In South Africa, a register of all irradiation facilities is maintained by the Department of Health’s Directorate: Radiation Control in Bellville. These facilities must be operated and controlled by competent trained personnel. This requirement emphasizes the requirement in respect of the training of radiation personnel in general as laid down by the Hazardous Substances Act, 1973 (Act 15 of 1973). The Directorate: Radiation Control of the national Department of Health is responsible for the licensing and various other safety aspects in terms of the Act.

4.1.4 Regulations governing general hygiene requirements for food premises and the transport of food (No.R. 918 of 30 July 1999) under the Health Act, 1977 (Act No. 63 of 1977

4.1.5 Occupational Health and Safety Act, 1993 (Act No. 85 of 1993)

4.2 PRINCIPLES:

4.2.1 Technological needs and food hygiene purpose

Irradiation is a process that, like other processes such as conventional cooking, microwave cooking, and freezing serves specific purposes in food preparation, for example the lengthening of shelf life. No food preparation method is intended to improve poor quality of food. Irradiation is not a substitute for poor GMP. The irradiation of food is therefore justified only when it fulfils a technological need, or where it serves a food hygiene purpose due to unavoidable circumstances (Codex Section 4.1). Examples of the latter include the microbiological contamination of herbs and spices, as well as the contamination of poultry meat due to modern mass-slaughtering practices.

Compliance with GMP is the responsibility of both the food industry and of managers of food irradiation installations.

4.2.2 Kinds of foodstuffs

Codex Alimentarius (Section 4.1) does not impose any restriction on the kinds of food that may be irradiated. For the sake of convenience the International Consultative Group on Food Irradiation (ICGFI) has divided foodstuffs to be irradiated into different classes based on:

• Similarities in kind and composition;
• The treatment intended (or has the potential) to achieve an identified technological need or food hygiene purpose; and
• Comparability to the radiation dosages which are necessary to achieve the objective and the similarity in sensorial quality after irradiation.

South Africa adapted the ICGFI classification by adding four additional classes, namely for:

• Foodstuffs irradiated at high doses;
• Phyto-sanitary requirements of the National Department of Agriculture;
• Integrated combination processes and;
• Imported foodstuffs not requiring phyto-sanitary clearance

4.2.3 Control

Because of the difficulty in establishing whether a food has been irradiated, and the amount of radiation applied, the process of irradiation rather than the presence of radiolytic products is controlled.

A number of control measures must be in place to ensure that the correct foodstuff is irradiated with the correct dose. The following are required:

• Standard operating procedures and working instructions must be available. These must cover all aspects of the operations;
• An adequate product tracking system should be in place so that consignments can be traced back both to the irradiation facility and the client from whom they were obtained;
• A quality assurance system must be in place, to ensure that the treatment was consistently applied according to current procedures and criteria;
• A suitable and accurate dosimetry system must be in place. This should be calibrated and traceable to a national or international standard or system; and,
• The Department of Health must be informed regularly of specific activities by means of quarterly reports from irradiators and quarterly monitoring reports from local authorities in whose areas of jurisdiction the irradiation facilities are located.

4.2.4 Importation

The regulations do not directly address the importation of irradiated foodstuffs. Irradiated foodstuffs, including imported irradiated foodstuffs, may however not be sold without the approval of the Minister or Director-General of Health. Persons wishing to import irradiated foodstuffs into South Africa are advised to first contact the Directorate: Food Control in this regard.

4.2.5 Packaging

Packaging is an important factor in the maintenance of acceptable standards of hygiene and must be appropriate for irradiation.

5. RESPONSIBILITY OF NATIONAL DEPARTMENT OF HEALTH

5.1 FOOD IRRADIATION FACILITIES

The national Department of Health must receive the assurance that the irradiation facility is in compliance with the Regulations Governing General Hygiene Requirements for Food

Premises and the Transport Food (G.N. No. R.918 of 30 July 1999) and is able to handle food in accordance with GIP.

5.2 PROCESSING OF APPLICATIONS FOR INDIVIDUAL FOOD GROUPS

Application is made per food class according to the list in ANNEX B.

The application is made by the owner of the food (food producer, manufacturer or importer) in consultation with the manager or designated person of the irradiation facility. The application form (ANNEX F) must be completed in conjunction with the manager of the irradiation facility and then submitted to the Directorate: Food Control of the Department of Health. If approved, both the food owner and the manager of the food irradiation installation will receive letters indicating such approval (see ANNEX G) and stipulating the conditions to which such approval may be subject. The conditions could be specific to the situation or case but would include items mentioned in the "Checklist for Monitoring by the National Department of Health" (ANNEX H). The provincial authority in whose area of jurisdiction the food irradiation facility is located will be notified in this respect, i.e. will receive copies of the letters of approval.

5.3 PRE APPROVAL ASSESSMENT OF FOOD MANUFACTURING FACILITIES

Circumstances may require an assessment of the premises or of the manufacturing procedures or of the reasons for irradiation before approval is granted. An example is where irradiated foodstuffs pose specific microbiological hazards. Such an assessment should be done in consultation with the various role players, depending on the specific case. The assessment should preferably be done by an expert with thorough knowledge and sufficient experience, as far as possible, in the application of Good Irradiation and Good Manufacturing Practices.

5.3.1 Special considerations

Matters that may need special consideration during the pre-approval assessment of food to be irradiated include:

• Written methods of preparation of the food products;
• Reasons for the inclusion (or exclusion) of specific additives such as preservatives;
• Previous records of food processing and the results of bacterial counts;
• Reasons for specific steps in the processing;
• Determination of an expiry date where applicable;
• Instructions for refrigeration and maintenance of the cold chain where applicable. For some foodstuffs this is of the utmost importance. Assurance should be given of an acceptable procedure of cold chain maintenance during storage and transportation at any time during manufacture and irradiation. Labelling with an expiry date is advisable.
• Records of the quality of stocks, especially bacterial counts; and
• Storage facilities.

5.3.2 Effectivity studies

The Department of Health may require studies to confirm the effectivity of the irradiation process. These studies should be conducted by a reputable independent organization with experience in food product development, in consultation with the Department.

5.4 MONITORING OF THE IRRADIATION PROCESS

The irradiation of food is a very specialized technology. Both the safety of the personnel and the achievement of the purpose of irradiating food must be addressed in monitoring of the process. Safety of personnel lies within the jurisdiction of the Directorate: Radiation Control of the Department of Health, whose headquarters is located in Bellville.

5.5 IMPORTATION AND IRRADIATION OF FOODSTUFFS

Phyto-sanitary requirements are laid down by the Directorate: Plant Health and Quality of the National Department of Agriculture for specific commodities such as:

• Honey that is to be irradiated to prevent dissemination of Bacillus larvae, and
• Fresh garlic and onions to prevent germination.

The importer must produce a permit signed by the National Department of Agriculture before the national Department of Health may proceed with processing of the application. There may also be other special circumstances where the irradiation of food will only be allowed after consultation between the Department of Health and the national Department of Agriculture.

5.6 QUARTERLY AND ANNUAL REPORT ON FOOD IRRADIATION

The Department of Health compiles an annual report on food irradiation in South Africa, based on the reports received from the three irradiation facilities and forward this report to the International Atomic Energy Agency which can be used to update the ICGFI

5.7 WORKING GROUP ON FOOD IRRADIATION OF THE FOOD LEGISLATION ADVISOY GROUP (FLAG)

This Working Group reports to FLAG, who advises the Director: Food Control on matters concerning food irradiation and especially on irradiation legislation. Meetings are held biannually or when necessary.

6. RESPONSIBILITY OF PROVINCIAL HEALTH DEPARTMENTS

As mentioned previously, there are four food irradiation facilities in South Africa. These are located in four different provinces, namely Gauteng, KwaZulu/Natal, North West and the Western Cape. Based on the White Paper for Health, the role and responsibilities of the provincial health authorities towards these facilities rest within the broad scope of food control responsibilities that have been assigned to the provinces. They inter alia are:

• Support, monitor and evaluate the district (local) level services; and
• Coordinate health services within the province.

Provincial health departments execute food import control on behalf of the national Department. Foodstuffs irradiated outside South Africa may not be sold in South Africa without the written

approval of the Minister or Director-General of Health. Such foodstuffs must be detained until written approval has been received from the provincial Port Health Authorities.

All irradiated foodstuffs must be correctly labelled in terms of the Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act 54 of 1972). Documentary evidence is required for food irradiated elsewhere and to be imported into South Africa. The importer must produce an authentic certificate with the following information:

• Name of the foodstuffs;
• Name and Address of the owner;
• Name of irradiation facility and address in the country of irradiation;
• Date of irradiation;
• Absorbed dose; and
• Verification of a governmental authority of exportation of foodstuffs.

Copies of the approvals to sell irradiated foodstuff are received from the national Department of Health. The provincial administration must send copies of such approvals to the local authorities in whose area of jurisdiction the foodstuffs that are destined for irradiation are sourced. The provincial authorities must liaise closely with the local authorities in whose area of jurisdiction the irradiated plant is located. Officers of provincial authorities should also visit irradiation plants from time to time in order to ensure a satisfactory level of control. They must also liaise with all the local authorities concerned in order to ensure that irradiated foods are labelled as such.

7. RESPONSIBILITY OF LOCAL AUTHORITIES

The local authorities in whose areas of jurisdiction the irradiation facilities are located are responsible for the enforcement of applicable regulations under the Health Act, 1977 (Act No. 63 of 1977)) and the Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act No 54. of 1972) at such facilities. Their responsibility is to monitor within their area of jurisdiction certain activities and precautions that are to be taken by food irradiator managers and the food managers (see ANNEX I for address list).

The Regulations Governing General Hygiene Requirements for Food Premises and the Transport of Food (No. R. 918 of 30 July 1999) in particular are of importance. A certificate of acceptability in terms of these Regulations must accompany each application for irradiation to the national Department. Local authorities must ensure that the irradiation facilities and all food premises from which food destined for irradiation originated, are in possession of a valid certificate of acceptability.

Local authorities of those areas from where foodstuffs are sent for irradiation, where they are irradiated and where they are sold must liaise closely in order to ensure effective control. The correct labelling of such irradiated foodstuff is of particular importance as the label on the foodstuff is the only indication of irradiation. The only way of monitoring is to trace the origin of the irradiation process by means of documentation, called the chain of custody.

It is also prudent for other aspects pertaining specifically to the irradiation of food to be monitored. In broad terms these are-

• Good Manufacturing Practice – before, during and after the process;
• Good Irradiation Practices – handling, treatment, product technology, labelling, physical barriers and record keeping.
• The monitoring of dosimetry must receive special attention.

In summary the purpose of communication with the managers of the food irradiation facilities would be to:

• Ensure Good Hygiene Practices and GMP;
• Ensure compliance with GIP;
• Trace labelling of irradiated food; and
• Ensure compliance with conditions for irradiation.

The following information should be made available by the irradiation facility.

• Name and address of the client;
• Type of foodstuff irradiated;
• Purpose of irradiation;
• Date of irradiation;
• Assurance of physical separation of irradiated from non-irradiated food (fence, visual colour change irradiation indicator);
• Each batch identified by a number;
• Records of at least five years after irradiation;
• Register containing – the type of food/ the date on which the irradiation took place/ the number of containers and identification of each batch / the dose applied versus the dose approved / the signature of the plant supervisor against the details of each batch treated. These records could also be recorded as electronic data such as an electronic signature;
• Storage facilities;
• Cold chain arrangements where necessary; and
• Records of microbial analysis of foodstuffs to be irradiated must be kept

To initiate an investigation into the chain of custody to confirm labelling of irradiated foodstuffs, the following should be made available by the food managers:

• Names and addresses of retail/wholesale outlets;
• Labelling instructions and examples of labels/labelled food;
• Labelling instructions for distribution purposes (to distributors/retail outlets);
• Storage facilities; and
• Cold chain facilities where applicable.

8. OTHER ROLE PLAYERS

8.1 NATIONAL DEPARTMENT OF AGRICULTURE

The role of the Department of Agriculture consists of sanitary and phyto-sanitary requirements at the port of entry. The purpose is to prevent plant and other pests from spreading into non infested areas.

8.1.1 Meat and meat products

Imported meat can be irradiated on request of the national Department of Agriculture.

8.1.2 Foodstuffs other than meat and meat products

A permit for the Importation of Controlled Goods is issued in terms of the provision of section 3 (1) of the Agricultural Pests Act, 1983 (Act 36 of 1983), whereby authorization is granted to import foodstuffs subject to conditions laid down by the authorities. Irradiation in terms of the Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act 54 of 1972) may therefore be a phyto-sanitary condition with respect to the importation of certain commodities.

An irradiation dosage and sometimes the dimensions of the containers are prescribed by the Department of Agriculture and must be adhered to.

8.2 MANAGER OF THE IRRADIATION INSTALLATION

The irradiation facility must comply with:

• The Hazardous Substances Act, 1973 (Act 15 of 1973);
• The Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act 54 of 1972);
• Regulations Governing General Hygiene Requirements for Food Premises and Transport of Food (R 918 of 30 July 2002) under the Health Act, 1977 (Act No. 63 of 1977);
• Codex Alimentarius (Annexure A); and
• These Guidelines.

The manager must dedicate a person to be responsible for compliance with the above requirements. This manager must, apart from applying GMP, also convince the local authority that GIP is being applied. With respect to food irradiation the manager of the food irradiation facility must satisfy the authorities on the following matters.

• Suitability of the facility (use of proper type of source, suitability to handle food, ability to maintain the necessary environment, ability to treat the product within the legal limits, ability to segregate irradiated and non-irradiated products);
• Personnel competency (official qualifications, experience, job descriptions, documented training records, chain of command, responsibilities);
• Process control (operating procedures, product tracing system, quality assurance system, dosimetry system);
• Records (classification of foodstuff, batch number, quantity, name of company ordering and the company receiving the treated foodstuff, date of irradiation, packaging material during treatment, reference to data control). The records must be kept for a period of five years.

The procedures followed to ensure the correct dose are described in detail by Codex Alimentarius (ANNEX A). The accepted practice in South Africa is to ensure a minimum dose, whereas the overall average absorbed dose is recommended by Codex Alimentarius. Exporters must adhere to the requirements of the country of importation. Specific requirements are:

• A record must be kept to illustrate routine dose measurements;
• Facility parameters such as transport speed or time spent in the radiation zone (ANNEX A);
• Validation measurements for each new foodstuff irrespective of classification;
• Traceability to primary sources;
• Interlaboratory calibration.

The irradiation of a foodstuff should be done after consultation between the manager (and his delegate) of the irradiation facility and the owner of the food. It is recommended that a contract to specify the responsibilities of each party, be signed by both parties. Upon completion of irradiation a certificate to confirm irradiation at the correct requested dose, should be issued by the manager of the irradiation facility.

The manager of the irradiation facility be responsible for labelling bulk containers of the irradiated product and must explain the importance of labelling to the food producer.

Quarterly reports stating quantities of food commodities irradiated according to classes must be submitted to the Director: Food Control of the national Department of Health, using the template provided in ANNEX C of the guidelines.

8.3 OWNER OF THE FOODSTUFF

The responsibilities of the owner of the foodstuff are as follows:

• Apply for approval for the irradiation of the foodstuff to the Director: Food Control in consultation with the manager or designated of the proposed food irradiation installation by submitting a completed application form per irradiation class (ANNEX B) and per food irradiator (ANNEX I).
• Where applicable the necessary permit from the Department of Agriculture must be submitted simultaneously with the application to the Department of Health;
• Provide evidence of GMP;
• Provide evidence of GIP;
• Provide evidence of GHP; and
• Ensure compliance with applicable legislation including the provision of the certificate of acceptability.

GIP in the case of the owner of the food would be:

• To keep records in order to ensure traceability of the irradiated foodstuffs as far as possible;
• To describe the foodstuff that is to be irradiated;
• To specify the minimum dose by doing the necessary research and providing documentation to confirm the dose;
• To apply microbiological criteria to determine if the product to be irradiated is in a suitable wholesome state and to record in this regard;
• To prepack the foodstuffs to be irradiated in packaging material appropriate for irradiation, of durable quality to prevent spilling or re contamination (ANNEX J);
• In the case of imported food, to supply proof of no previous irradiation of the foodstuff;
• Ensure correct labelling in terms of the Act.

9. CONCLUSION

The document attempts to address most of the activities when food is irradiated in South Africa. It should be considered as a guideline and should be applied as such. The guideline will need to be updated from time to time, as science and practices of food irradiation are developing continuously worldwide.

Due to better communication, a greater understanding of the valuable technology of food irradiation has developed. The advantages of irradiated food are acknowledged and accordingly irradiated foodstuffs are gaining increased acceptance by consumers. This document should therefore be another tool in increasing trust in the manner in which food irradiation is controlled in this country.

Annexures [PDF]