CAC/RCP 19-1979

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CODE OF PRACTICE FOR RADIATION PROCESSING OF FOOD

(CAC/RCP 19-1979)
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 General Standard for Irradiated
Foods (CODEX-STAN 106-1983) 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 General Principles of Food Hygiene (CAC/RCP 1-1969), 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. 1
2.2

Use

The General Principles of Food Hygiene (CAC/RCP 1-1969) 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 General Standard for Irradiated Foods (CODEX STAN 106-1983) and the
General Standard for the Labelling of Pre-Packaged Foods (CODEX STAN 1-1985).
1

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, PO Box 100, A-1400 Vienna, Austria.

Adopted 1979. Revision 2003. Editorial correction 2011.

CAC/RCP 19-1979

2.3

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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 General Standard for
Irradiated Foods (CODEX-STAN 106-1983). 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 General Principles of Food
Hygiene (CAC/RCP 1-1969) 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.
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 General Principles of Food Hygiene (CAC/RCP 1-1969) 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.

CAC/RCP 19-1979

5.

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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 (CAC/RCP 1-1969)
- General Standard for Irradiated Foods (CODEX-STAN 106-1983) and this Code.
5.1

Design and layout

This section is concerned with the areas in which food products are stored and irradiated. Prevention 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 nonirradiated 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)

b)
c)
d)
e)
f)
g)

5.2

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.
Range of doses: The range of doses needed to process a wide variety of products for various
applications.
Throughput: The amount of product to be processed within a defined period of time.
Reliability: The property of providing correct performance as needed.
Safety-systems: The systems intended to protect operating personnel from hazards posed by
radiation.
Compliance: The adherence to good manufacturing practices and relevant government regulations.
Capital and operational costs: The basic economic considerations necessary for sustainable
operation.
Radiation sources

As described in the General Standard for Irradiated Foods (CODEX-STAN 106-1983), the following sources of
ionizing radiation may be used in food irradiation:
a)
b)
c)

Gamma rays from radionuclides 60Co or 137Cs;

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

CAC/RCP 19-1979

5.3

Control of operation

5.3.1

Legislation

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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 General Principles of Food Hygiene
(CAC/RCP 1-1969) for personal hygiene recommendations and to the General Standard for Irradiated Foods for
recommendations regarding the need for an adequate, trained and competent personnel. 2
5.3.3

Requirements for process control

Requirements for process control are included in the General Standard for Irradiated Foods (CODEX-STAN
106-1983). 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 process in accordance with
internationally accepted procedures. 3
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 nonirradiated 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 nonirradiated 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

Training manuals for facility operators and control officials have been produced by ICGFI, available through the International Atomic Energy Agency, PO Box 100, A-1400 Vienna, Austria. ICGFI also, through its FIPCOS, provides such
training.
Such procedures are specified, for example, by the American Society for Testing and Materials (ASTM) in their annual
handbooks.

CAC/RCP 19-1979

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Refer to the General Standard for Irradiated Foods (CODEX-STAN 106-1983).

6.2

Process determination

It is important that all steps in the determination of process procedures are documented to:
a)
b)
c)
d)
e)
f)
6.3

ensure that the application of the process complies with relevant regulatory requirements;
establish a clear statement for the technological objectives of the process;
estimate the dose range to be applied to achieve the technological objective based on appropriate
knowledge of the food product;
demonstrate that irradiation of test samples has been carried out to confirm the estimated dose
range under practical production conditions;
ensure that it is possible to meet the technological requirements, e.g. dose range and effectiveness
of treatment, under practical production conditions; and
establish the process parameters under practical production conditions.
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. 4
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 response 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. 5
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. 6 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

5
6

ISO/ASTM 51204 Standard Practice or Dosimetry in Gamma Irradiation Facilities for Food Processing;
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.
ISO/ASTM 51261 Standard Guide for Selection and Calibration of Dosimetry Systems for Radiation Processing
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

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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). 7
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 General Principles of Food Hygiene (CAC/RCP 1-1969).
The radiation processor should apply HACCP principles, as described in the General Principles of Food Hygiene
(CAC/RCP 1-1969), 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 General Principles of Food Hygiene (CAC/RCP 1-1969) for general storage and handling guidance.
8.

LABELLING

The General Standard for Irradiated Foods (CODEX STAN 106-1983) and the General Standard for the Labelling of Pre-Packaged Foods (CODEX STAN 1-1985) 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 the competent authorities.

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.