Food and Drug Regulations (C.R.C., c. 870)

DIVISION 26Food Irradiation

Interpretation

B.26.001 In this Division, irradiation means treatment with ionizing radiation.

Application

B.26.002 This Division does not apply to foods exposed to ionizing radiation from a measuring instrument used to determine weight, estimate bulk solids, measure the total solids in liquids or perform other inspection procedures.

General

• B.26.003 (1) Subject to subsection (2), no person shall sell a food that has been irradiated.

• (2) A food that is set out in column 1 of the table to this Division that has been irradiated may be sold if both of the following requirements are met:

  • (a) the ionizing radiation is of a type and from a source set out in column 2 for the purpose of irradiation set out in column 3; and

  • (b) the ionizing radiation that is absorbed by the food is either within the range set out in columns 4 and 5 or, if there is no minimum absorbed dose set out in column 4, is not more than the maximum absorbed dose set out in column 5.

Records

• B.26.004 (1) A manufacturer who sells a food that has been irradiated shall keep on their premises, for at least two years after the date of the irradiation, a record that contains all of the following information:

  • (a) the name of the food that was irradiated and the quantity and lot numbers of the food;

  • (b) the purpose of the irradiation;

  • (c) the date of the irradiation;

  • (d) the dose of ionizing radiation that was absorbed by the food;

  • (e) the type and source of the ionizing radiation;

  • (f) a statement that indicates whether the food was previously irradiated and, if it was previously irradiated, the information referred to in paragraphs (a) to (e) in respect of that previous irradiation.

• (2) A person who imports a food for sale in Canada that has been irradiated shall keep on their premises, for at least two years after the date of importation, a record of the information required by subsection (1).

Changes to the Table

B.26.005 A request that a food be added or a change made to the table to this Division shall be accompanied by a submission to the Minister containing the following information:

• (a) the purpose and details of the proposed irradiation — including the type and source of the ionizing radiation — and the proposed number of treatments and the minimum and maximum absorbed doses of the ionizing radiation;

• (b) data indicating that the minimum dose of ionizing radiation proposed to be used accomplishes the intended purpose of the irradiation and the maximum dose of ionizing radiation proposed does not exceed the amount required to accomplish the purpose of the irradiation;

• (c) information on the nature of the dosimeter used, the frequency of the dosimetry on the food and data pertaining to the dosimetry and phantoms used to assure that the dosimetry readings reflect the dose absorbed by the food during irradiation;

• (d) data indicating the effects, if any, on the nutritional quality of the food, raw and ready-to-serve, under the proposed conditions of irradiation and any other processes that are combined with the irradiation;

• (e) data establishing that the irradiated food has not been significantly altered in chemical, physical or microbiological characteristics to render the food unfit for human consumption;

• (f) where the Minister so requests, data establishing that the proposed irradiation is safe under the conditions proposed for the irradiation;

• (g) the recommended conditions of storage and shipment of the irradiated food including the time, temperature and packaging and a comparison of the recommended conditions for the same food that has not been irradiated;

• (h) details of any other processes to be applied to the food prior to or after the proposed irradiation; and

• (i) such other data as the Minister may require to establish that consumers and purchasers of the irradiated food will not be deceived or misled as to the character, value, composition, merit or safety of the irradiated food.