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Appendix VII: Proposed Draft Revised Codex General Standard for Irradiated Foods (At Step 5 of the Procedure)

1. SCOPE

This standard applies to foods processed by irradiation. 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 radionuclide 60Co.

(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

[The overall average dose absorbed by a food subjected to radiation processing should not exceed 10 kGy. 1, 2]

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 wholesomeness or would adversely affect structural integrity, functional properties, or sensory attributes.[92]

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 should 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 Premises 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 Food (CAC/RCP 19-1979, under revision).

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 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 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 need and is a benefit to consumers or where it serves a food hygiene purpose and should not be used as a substitute for good manufacturing practices.

4.2 Food Quality and Packaging Requirements

The doses applied should be commensurate with the technological and public health purposes to be achieved and should be in accordance with good radiation processing practice. Foods to be irradiated and their packaging materials should be of suitable quality, acceptable hygienic condition and appropriate for this purpose and should 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 Section 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 overall average dose absorbed should not exceed 10 kGy as a result of re-irradiation.]

6. LABELLING

6.1 Inventory Control

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

6.2 Prepackaged Foods Intended for Direct Consumption

The labelling of prepackaged irradiated foods should indicate the treatment and in all aspects 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).

6.3 Foods in Bulk Containers

The declaration of the fact of irradiation should be made clear on the relevant shipping documents.

7. METHODS OF ANALYSIS AND SAMPLING

To be developed.


[92] High Dose Irradiation: Wholesomeness of Food Irradiated with Doses above 10 kGy, 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

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