Irradiated foods Page 1 of 10

REVISED CODEX GENERAL STANDARD FOR IRRADIATED FOODS

CODEX STAN 106-1983, REV.1-2003

1. SCOPE

This standard applies to foods processed by ionizing radiation that is used in conjunction with
applicable hygienic codes, food standards and transportation codes. It does not apply to foods exposed
to doses imparted by measuring instruments used for inspection purposes.

2. GENERAL REQUIREMENTS FOR THE PROCESS

2.1 Radiation Sources

The following types of ionizing radiation may be used:

a) Gamma rays from the radionuclides 60Co or 137Cs;

b) X-rays generated from machine sources operated at or below an energy level of 5 MeV;

c) Electrons generated from machine sources operated at or below an energy level of 10 MeV.

2.2 Absorbed Dose

For the irradiation of any food, the minimum absorbed dose should be sufficient to achieve the
technological purpose and the maximum absorbed dose should be less than that which would
compromise consumer safety, wholesomeness or would adversely affect structural integrity, functional
properties, or sensory attributes. The maximum absorbed dose delivered to a food should not exceed
10kGy, except when necessary to achieve a legitimate technological purpose.1

2.3 Facilities and Control of the Process

2.3.1 Radiation treatment of foods should be carried out in facilities licensed and registered for this
purpose by the competent authority.

2.3.2 The facilities shall be designed to meet the requirements of safety, efficacy and good hygienic
practices of food processing.

2.3.3 The facilities should be staffed by adequate, trained and competent personnel.

2.3.4 Control of the process within the facility should include the keeping of adequate records
including quantitative dosimetry.

2.3.5 Facilities and records should be open to inspection by appropriate authorities.

2.3.6 Control should be carried out in accordance with the Recommended International Code of
Practice for Radiation Processing of Foods (CAC/RCP 19-1979, Rev.1-2003).

3. HYGIENE OF IRRADIATED FOODS

3.1 The irradiated food should be prepared, processed, and transported hygienically in accordance
with the provisions of the Recommended International Code of Practice – General Principles of Food
Hygiene (CAC/RCP 1-1969, Rev. 3-1997), including the application of the seven principles of Hazard

1
High Dose Irradiation: Wholesomeness of Food Irradiated with Doses above 10kGy, Report of a Joint
FAO/IAEA/WHO Study Group, Technical Report Series 890 WHO. Geneva, 1999; Safety and Nutritional Adequacy
of Irradiated Foods, WHO, Geneva, 1994; and Wholesomeness of Irradiated Food, Report of Joint FAO/IAEA WHO
Expert Committee, Technical Report Series 659, WHO, Geneva, 1981.
Irradiated foods Page 2 of 10

Analysis and Critical Control Point (HACCP) system where applicable for food safety purposes.
Where appropriate, the technical requirements for the raw materials and end product should comply
with applicable hygienic codes, food standards, and transportation codes.

3.2 Any relevant national public health requirement affecting microbiological safety and nutritional
adequacy applicable in the country in which the food is sold should be observed.

4. TECHNOLOGICAL REQUIREMENTS

4.1 General Requirement

The irradiation of food is justified only when it fulfils a technological requirement and/or is
beneficial for the protection of consumer health. It should not be used as a substitute for good hygienic
and good manufacturing practices or good agricultural practices.

4.2 Food Quality and Packaging Requirements

The doses applied shall be commensurate with the technological and public health purposes to
be achieved and shall be in accordance with good radiation processing practice. Foods to be irradiated
and their packaging materials shall be of suitable quality, acceptable hygienic condition and
appropriate for this purpose and shall be handled, before and after irradiation, according to good
manufacturing practices taking into account the particular requirements of the technology of the
process.

5. RE-IRRADIATION

5.1 Except for foods with low moisture content (cereals, pulses, dehydrated foods and other such
commodities) irradiated for the purpose of controlling insect reinfestation, foods irradiated in
accordance with Sections 2 and 4 of this standard should not be re-irradiated.

5.2 For the purpose of this standard, food is not considered as having been re-irradiated when: (a)
the irradiated food is prepared from materials which have been irradiated at low dose levels for
purposes other than food safety, e.g. quarantine control, prevention of sprouting of roots and tubers;
(b) the food, containing less than 5% of irradiated ingredient, is irradiated; or when (c) the full dose of
ionizing radiation required to achieve the desired effect is applied to the food in more than one
increment as part of processing for a specific technological purpose.

5.3 The cumulative maximum absorbed dose delivered to a food should not exceed 10 kGy as a
result of re-irradiation except when it is necessary to achieve a legitimate technological purpose, and
should not compromise consumer safety or wholesomeness of the food.
6. POST IRRADIATION VERIFICATION

6.1 When required and where applicable, analytical methods for the detection of irradiated foods
may be used to enforce authorization and labeling requirements. The analytical methods used should
be those adopted by the Codex Commission.
7. LABELLING

7.1 Inventory Control

For irradiated foods, whether prepackaged or not, the relevant shipping documents shall give
appropriate information to identify the registered facility which has irradiated the food, the date(s) of
treatment, irradiation dose and lot identification.

7.2 Prepackaged Foods Intended for Direct Consumption

The labelling of prepackaged irradiated foods should indicate the treatment and in all aspects
Irradiated foods Page 3 of 10

should be in accordance with the relevant provisions of the Codex General Standard for the Labelling
of Prepackaged Foods (CODEX STAN 1-1985, Rev.2-1999).

7.3 Foods in Bulk Containers

The declaration of the fact of irradiation should be made clear on the relevant shipping
documents. In the case of products sold in bulk to the ultimate consumer, the international logo and
the words “irradiated” or “treated with ionizing radiation” should appear together with the name of the
product on the container in which products are placed.
Irradiated foods Page 4 of 10

RECOMMENDED INTERNATIONAL CODE

OF PRACTICE FOR RADIATION PROCESSING OF FOOD
(CAC/RCP 19-1979, Rev.1-2003)

INTRODUCTION

Food irradiation is the processing of food products by ionizing radiation in order to, among other
things, control foodborne pathogens, reduce microbial load and insect infestation, inhibit the germination
of root crops, and extend the durable life of perishable produce. Many countries are using industrial
irradiators for processing of food products for commercial purposes.

The regulatory control of food irradiation should take into consideration the Codex General
Standard for Irradiated Foods (CX-STAN 106-1983, Rev.1-2003) and this Code.

The purpose of regulatory control of irradiated food products should be:

a) to ensure that radiation processing of food products is implemented safely and correctly, in
accordance with all relevant Codex standards and codes of hygienic practice;

b) to establish a system of documentation to accompany irradiated food products, so that the fact of
irradiation can be taken into account during subsequent handling, storage and marketing; and

c) to ensure that irradiated food products that enter into international trade conform to acceptable
standards of radiation processing and are correctly labelled.

The purpose of this Code is to provide principles for the processing of food products with
ionizing radiation that are consistent with relevant Codex Standards and codes of hygienic practice. Food
irradiation may be incorporated as part of a HACCP-plan where applicable; but a HACCP-plan is not
required for the use of radiation processing of food processed for purposes other than for food safety. The
provisions of this Code will provide guidance to the radiation processor to apply the Hazard Analysis and
Critical Control Point (HACCP) system, as recommended in the Recommended International Code of
Practice General Principles of Food Hygiene (CAC/RCP 1-1969, Rev 3-1997, Amd. 1-1999), where
applicable for food safety purposes, to foods processed by ionizing radiation.

1. OBJECTIVES

This Codex Code of Practice for Radiation Processing of Food identifies the essential practices to
be implemented to achieve effective radiation processing of food products in a manner that maintains
quality and yields food products that are safe and suitable for consumption.

2. SCOPE, USE and DEFINITIONS

2.1 Scope

This Code is concerned with food products processed by gamma rays, X-rays or accelerated
electrons for the purpose of, among other things, control of foodborne pathogens, reduction of microbial
load and insect infestation, inhibition of the germination of root crops, and extension of durable life for
perishable foods.

This Code covers the requirements of the irradiation process in a facility; it also considers other
aspects of the process as primary production and/or harvesting, post-harvest treatment, storage and
shipment, packaging, irradiation, labelling, post-irradiation storage and handling, and training.2

2
Codes of good irradiation practice, compilations of technical data for the authorization and control of the irradiation of
several food classes and also training manuals for facility operators and control officials have been produced by the
International Consultative Group on Food Irradiation (ICGFI), available through the International Atomic Energy Agency,
Irradiated foods Page 5 of 10

2.2 Use

The Recommended International Code of Practice - General Principles of Food Hygiene

(CAC/RCP 1-1969, Rev 3-1997, Amd. 1-1999) and its annex on application of the HACCP system, as
well as other relevant Codex Standards and codes of hygienic practice should be used with this document.
Of particular relevance are the Codex General Standard for Irradiated Foods (CX-STAN 106-1983,
Rev.1-2003) and the General Standard for the Labelling of Pre-Packaged Foods (CX-STAN 1-1985,
Rev 1 - 1991).

2.3 Definitions

For purposes of this Code, the terms below are defined as follows:

Food Irradiation: Processing of food products by ionizing radiation, specifically gamma rays, X-rays or
accelerated electrons as specified in the Codex General Standard for Irradiated Foods.

Irradiated Food: Food products processed by ionizing radiation in accordance with the Codex General
Standard for Irradiated Foods. Such food is subject to all relevant standards, codes and regulations
applicable to the non-irradiated counterpart.

Dosimetry: The measurement of the absorbed dose of radiation at a particular point in a given absorbing
medium.

Dose (absorbed): The absorbed dose, sometimes referred to simply as 'dose', is the amount of energy
absorbed per unit mass of irradiated food product.

Dose Uniformity Ratio: The ratio of maximum to minimum absorbed dose in the production lot.

Dose Distribution: The spatial variation in absorbed dose throughout the production lot with extreme
values being the maximum absorbed dose and the minimum absorbed dose.

Dose Limit: The minimum or maximum radiation dose absorbed by a food product prescribed in
regulations as required for technological reasons. Such dose limits are expressed as ranges or as single
lower or upper values (i.e., no part of the food product shall absorb less than or more than a specified
amount).

3. PRE-IRRADIATION TREATMENT

3.1 Primary production and/or harvesting

Primary food products intended for radiation processing should comply with the Codex General
Principles of Food Hygiene with reference to the hygienic requirements as well as other relevant Codex
standards and codes of practice for primary production and/or harvesting, which ensure that food is safe
and suitable for human consumption.

3.2 Handling, storage and transport

The intent to process food products by irradiation poses no unique requirements regarding
handling, storage and transport of the food products prior to and subsequent to irradiation. All stages
of the processing, i.e., pre-irradiation, irradiation and post-irradiation, should be in accordance with
good manufacturing practices to maximize quality, to minimize contamination, and, if packaged, to
maintain package integrity.

PO Box 100, A-1400 Vienna, Austria.

Irradiated foods Page 6 of 10

Radiation is applied to food products in forms in which they are normally prepared for
processing, commercially traded or otherwise used. Food intended for radiation processing should
conform to handling, storage and transport requirements of the Codex General Principles of Food
Hygiene as well as relevant Codex standards and codes of practice for specific food products.

4. PACKAGING

In general, in order to avoid contamination or infestation after irradiation, food products should be
packaged in materials that provide an effective barrier to re-contamination and re-infestation. Packaging
must also meet the requirements of the importing country.

The size and shape of containers that may be used for irradiation are determined, in part, by the
operating characteristics of the irradiation facility. These characteristics include the product transport
systems and the irradiation source, as they affect the dose distribution within the container.

5. ESTABLISHMENT: DESIGN, FACILITIES and CONTROL

Authorization of a facility to irradiate food is granting approval to a facility licensed for radiation
processing in general to irradiate food products. Authorization may be general in nature or issued for
specific classes or groups of food products.

Facilities which carry out irradiation of food products should meet appropriate standards of
occupational safety and good hygiene conditions, including:

- Regulations regarding design, construction and operation of radiation facilities

- General Principles of Food Hygiene
- General Standard for Irradiated Foods and this Code.

5.1 Design and layout

This section is concerned with the areas in which food products are stored and irradiated. Preven-
tion of contamination requires that all measures be taken to avoid direct or indirect contact of the food
product with sources of potential contamination and to minimize growth of microorganisms.

Irradiation establishments are laid out to provide storage for irradiated and non-irradiated food
products (under ambient, refrigerated and/or freezing temperature conditions), an irradiator, and the
normal accommodation and infrastructure for staff and plant services including record maintenance. In
order to achieve inventory control there should be provision in both the design and operation of the
establishment to keep irradiated and non-irradiated food products separate. This separation can be
accomplished by controlled single-direction movement of the food products through the plant and by
separated storage areas for irradiated and non-irradiated food products.

Radiation facilities must be designed to provide an absorbed dose in the food product within
minimum and maximum limits in accordance with process specifications and government regulatory
requirements. For economic and technical reasons (e.g. maintaining product quality), various techniques
are used to minimize the ratio, which is termed the dose uniformity ratio.

The following factors largely govern the selection of irradiator design:

a) Means of transporting food products: The mechanical design of the irradiation and transport
systems, including the source-to-product geometry in a given process, as required by the form
of the product, e.g. bulk or packaged, and its properties.
b) Range of doses: The range of doses needed to process a wide variety of products for various
applications.
c) Throughput: The amount of product to be processed within a defined period of time.
Irradiated foods Page 7 of 10

d) Reliability: The property of providing correct performance as needed.

e) Safety-systems: The systems intended to protect operating personnel from hazards posed by
radiation.
f) Compliance: The adherence to good manufacturing practices and relevant government
regulations.
g) Capital and operational costs: The basic economic considerations necessary for sustainable
operation.

5.2 Radiation sources

As described in the Codex General Standard for Irradiated Foods, the following sources of
ionizing radiation may be used in food irradiation:

a) Gamma rays from radionuclides 60Co or 137Cs;

b) X-rays generated from machine sources operated at or below an energy level of 5 MeV; and
c) Electrons generated from machine sources operated at or below an energy level of 10 MeV.

5.3 Control of operation

5.3.1 Legislation

Food processing establishments are constructed and operated in accordance with regulatory
requirements in order to ensure safety of the processed foods for consumption and occupational safety of
the plant personnel and the environment. A food irradiation facility, like any other food processing plant,
is also subject to such regulation and should be designed, constructed and operated in compliance with
relevant regulations.

5.3.2 Requirements for staff

The staff at an irradiation facility is subject to relevant sections of the Recommended

International Code of Practice General Principles of Food Hygiene (CAC/RCP 1-1969, Rev 3-1997,
Amd. 1-1999) for personal hygiene recommendations and to the General Standard for Irradiated Foods
for recommendations regarding the need for an adequate, trained and competent personnel.3

5.3.3 Requirements for process control

Requirements for process control are included in the General Standard for Irradiated Foods.
Measuring the dose and monitoring of the physical parameters of the process are essential for process
control. The need for adequate record keeping, including records of quantitative dosimetry, is emphasized
in the General Standard. As for other physical methods of food processing, records are essential means
for the regulatory control of processing by ionizing radiation. Evidence for correct processing, including
adherence to any legal or technological dose limits, depends on the maintenance of full and accurate
records by the irradiation facility. The facility's records link all the information from several sources to
the irradiated food products. Such records enable verification of the irradiation process and should be
kept.

5.3.4 Control of applied dose

The effectiveness of the irradiation process depends on proper application of the dose and its
measurement. Dose distribution measurements should be carried out to characterize the process for each
food product; and thereafter dosimeters should be used routinely to monitor correct execution of the

3
Training manuals for facility operators and control officials have been produced by ICGFI, available through the Inter-
national Atomic Energy Agency, PO Box 100, A-1400 Vienna, Austria. ICGFI also, through its FIPCOS, provides such
training.
Irradiated foods Page 8 of 10

process in accordance with internationally accepted procedures.4

For certain public health or quarantine applications, there may be specific requirements to
regulate the minimum absorbed dose in order to ensure that the desired technological effect is achieved.

5.3.5 Product and inventory control

An adequate system should be in place so that specific consignments of food products can be
traced back both to the irradiation facility and the source from which they were received for
processing.

Plant design and administrative procedures should ensure that it is impossible to mix irradiated
and non-irradiated food products. Incoming products should be logged and given a code number to
identify the packages at each step in its path through the irradiation plant. All relevant parameters such as
date, time, source strength, minimum and maximum dose, temperature, etc. should be logged against the
code number of the product.

It is not possible to distinguish irradiated from non-irradiated product by visual inspection.

Therefore, it is essential that appropriate means, such as physical barriers, be employed for keeping the
irradiated and non-irradiated product separate. Affixing colour change indicator label on each package,
where applicable, provides another means of distinguishing irradiated and non-irradiated product.

6. IRRADIATION

6.1 General

Refer to the Codex General Standard for Irradiated Foods (CX-STAN 106-1983, Rev.1-2003).

6.2 Process determination

It is important that all steps in the determination of process procedures are documented to:

a) ensure that the application of the process complies with relevant regulatory requirements;
b) establish a clear statement for the technological objectives of the process;
c) estimate the dose range to be applied to achieve the technological objective based on
appropriate knowledge of the food product;
d) demonstrate that irradiation of test samples has been carried out to confirm the estimated dose
range under practical production conditions;
e) ensure that it is possible to meet the technological requirements, e.g. dose range and
effectiveness of treatment, under practical production conditions; and
f) establish the process parameters under practical production conditions.

6.3 Dosimetry

Successful radiation processing practice depends on the ability of the processor to measure the
absorbed dose delivered to each point in the food product and in the production lot.

Various techniques for dosimetry pertinent to radionuclide and machine sources are available for
measuring absorbed dose in a quantitative manner. Relevant ISO/ASTM Standard Practices and Guides
for dosimety in food irradiation facilities have been developed and should be consulted.5

4
Such procedures are specified, for example, by the American Society for Testing and Materials (ASTM) in their annual
handbooks.
5
ISO/ASTM 51204 – Standard Practice or Dosimetry in Gamma Irradiation Facilities for Food Processing;
Irradiated foods Page 9 of 10

In order to implement these irradiation practices, facilities should be adequately staffed by

competent personnel trained in dosimetry and its application in radiation processing.

The calibration of the dosimetry system used in radiation processing should be traceable (i.e.,
calibrated) to national and international standards.

6.4 Dosimetry systems

Dosimeters are devices that are capable of providing a quantitative and reproducible
measurement of dose through a change in one or more of the physical properties of the dosimeters in re-
sponse to the exposure to ionizing radiation energy. A dosimetry system consists of dosimeters,
measurement instruments and their associated reference standards, and procedures for the system's use.
Selection of appropriate dosimetry system for radiation processing of food will depend on a variety of
factors, including the dose range needed to achieve a particular technological objective, cost, availability,
and ease of use. A variety of dosimetry systems are available.6

6.5 Dosimetry and process control

In food irradiation, the key quantity that governs the process is the absorbed dose. It is influenced
by various parameters, such as: radiation source type, strength and geometry; conveyor speed or dwell
time; food product density and loading configuration; and carrier size and shape.7 Their overall influence
on dose distribution must be taken into account to ensure that the intended technological objective is
achieved throughout the production lot.

The application of radiation processing is mainly governed by the minimum absorbed dose
achieved in the dose distribution within a given product. If the required minimum is not applied, the
intended technical effect may not be achieved (e.g. sprout inhibition, pathogen reduction). There are also
situations where the application of too high a dose would impair the quality of the treated food (e.g. off
flavours or odours). 8

6.6 Records of irradiation

Radiation processors should maintain adequate records showing the food processed,
identifying marks if packaged or, if not, the shipping details, the bulk density of the food, the
dosimetry results, including the type of dosimeters used and details of their calibration, the date of
irradiation and the type of radiation source. All documentation should be available to authorized
personnel and accessible for a period of time established by food control authorities.

6.7 Control of hazards

Controls of microbiological hazards are described in the International Code of Practice - General
Principles of Food Hygiene (RCP 01-1969, Rev 3-1997, Amd 1-1999).

The radiation processor should apply HACCP principles, as described in the Codex Hazard

ISO/ASTM 51431 – Standard Practice for Dosimetry in Electron and Bremsstrahlung Irradiation
Facilities for Food Processing; ISO/ASTM 51261 – Standard Guide for Selection and Calibration of
Dosimetry Systems for Radiation Processing.
6
ISO/ASTM 51261 – Standard Guide for Selection and Calibration of Dosimetry Systems for Radiation Processing
7
ISO/ASTM 51204 – Standard Practice or Dosimetry in Gamma Irradiation Facilities for Food Processing
and ISO/ASTM 51431 – Standard Practice for Dosimetry in Electron and Bremsstrahlung Irradiation
Facilities for Food Processing
8
Codes of good irradiation practice and compilations of technical data for the authorization and control of the irradiation of
several food classes have been produced by ICGFI, available through the International Atomic Energy Agency, PO Box
100, A-1400 Vienna, Austria.
Irradiated foods Page 10 of 10

Analysis Critical Control Point System and Guidelines for Its Application (1999), as appropriate. In the
overall HACCP context, irradiation is a means of reducing hazards associated with infectious parasites
and microbial contamination of foods and may be used as a method of control.

7. POST-IRRADIATION STORAGE AND HANDLING

Refer to the International Code of Practice - General Principles of Food Hygiene (RCP 01-1969,
Rev 3-1997, Amd 1-1999) for general storage and handling guidance.

8. LABELLING

The Codex General Standard for Irradiated Foods (CX-STAN 106-1983, Rev.1-2003) and the
Codex General Standard for the Labelling of Pre-Packaged Foods (CX-STAN-001, Rev 2, 1999) contain
provisions for labelling of irradiated foods, including the internationally recognized symbol (logo) and the
inclusion of information in shipping documents, and for the labelling of prepackaged irradiated foods,
respectively. All food labelling must meet any additional requirements established by competent
authorities.