Food Irradiation Submission Checklist

Submissions for amendment of Division 26, Part B of the Food and Drug Regulations

December 27, 2007

PDF (620 KB)

A Food Irradiation Submission Checklist has been developed to assist petitioners in meeting the information requirements pertaining to the irradiation process intended to be applied to a specified food: purpose for using irradiation; details of the irradiation process; efficacy data pertaining to the dose applied; dosimeters and dosimetry; safety of the irradiated food; effect of the irradiation or combination processes on the nutrient composition of raw and ready-to-consume irradiation-treated produce; chemical/physical/microbiological effects of the irradiation; details of pre- and post-irradiation handling and storage of the food; details of other technological processes applied to food destined for irradiation; and any other information pertaining to the safety of a given irradiated food.

Food Irradiation Submission Checklist

Please, provide all information in black ink. Where appropriate, place checkmarks () in the boxes to indicate the desired response.

We request that the completed and signed checklist accompany the submission package. The package, if less than 20 pages, may be sent electronically, using the words "Food Irradiation Submission" in the subject line of the E-mail: smiu-ugdi@hc-sc.gc.ca. Otherwise, a hardcopy and, if possible, a softcopy (e.g. CD-ROM, DVD) of the submission package must be mailed to the Submission Management and Information Unit, Food Directorate, Health Products and Food Branch, Health Canada, 251 Sir Frederick Banting Driveway, Postal Locator: 2202E, Ottawa, Ontario, Canada, K1A 0K9. For additional information on submission preparation, please refer to A Guide for the Preparation of Submissions on Food Additives.

For use by Health Canada only:

Date of receipt

(DD/MM/YYYY)

CHHAD Mailno

Petitioner Information

Name of Petitioner (manufacturer, company, consultant, importation agent, etc.):

Full postal address (street, city, country, postal code):

E-mail:____________________________________________________

Telephone No.: (     )____________ Fax No.: (     )_________________

Alternative name and address for correspondence:

Description of the Submission

Title

Date of Submission
(DD/MM/YYYY)

Please indicate the technical purpose of this application for the use of irradiation:

• Anti-microbial preservation
• Anti-infestation
• Quarantine
• Sprouting Inhibition

Checklist of enclosed information and data

Cover letter

 Yes

 No

Purpose and details of the proposed irradiation (B.26.005  a)

 Yes

 No

Efficacy data of the proposed irradiation (B.26.005  b)

 Yes

 No

Information pertaining to dosimeters and dosimetry (B.26.005  c)

 Yes

 No

Effects of irradiation on the nutritional quality of irradiated food (B.26.005  d)

 Yes

 No

Data demonstrating safety of applied irradiation (food chemical, physical and microbiological characteristics, B.26.005  e)

 Yes

 No

Data demonstrating toxicological safety of applied irradiation (B.26.005  f)

 Yes

 No

Recommended conditions of storage and shipment of irradiated food (B.26.005  g)

 Yes

 No

Details of other technological processes applied to food (B.26.005  h)

 Yes

 No

Any other relevant data and information (B.26.005 i)

 Yes

 No

If you checkmarked "No" for any items listed above, please provide a rationale for not providing that information.

Summary of information pertaining to the irradiation technique

Please summarize the purpose and details of the applied irradiation; dosimeters and dosimetry; efficacy data pertaining to the dose applied; chemical / physical / microbiological / nutritional effects of the irradiation; details of pre- and post-irradiation; handling and storage of the food; specific toxicological end-points if applicable; status of other national jurisdictions; other important relevant information (e.g. any additional technological process applied).