information document on health canadas proposal to amend the food and drug regulations to permit the use of a microbiological preparation of carnobacterium maltaromaticum strain cb1 in certain ready-to-eat meat and poultry products this document provides information on health canadas proposal to amend the food and drug regulations regulations to permit the use of a microbiological preparation of carnobacterium maltaromaticum cb1 strain in certain ready-to-eat meat and poultry products namely sausage wieners hotdogs sliced roast beef sliced cooked ham and sliced cooked turkey. all affected products would be packaged under vacuum and would require mandatory ingredient labelling for bacterial culture. the preparation contains both viable as well as non-viable pasteurized lyophilized cells. it also contains carnobacterium maltaromaticum metabolites of which carnobacteriocins exhibit antibacterial activity. the purpose for adding carnobacterium maltaromaticum cb1 strain to food is that it can be used as an intervention tool against human pathogenic microorganisms such as listeria monocytogenes. the carnobacterium maltaromaticum cb1 strain is a gram-positive non spore-forming lactic acid bacteria. the c. maltaromaticum cb1 preparation would be applied with a liquid applicator or sprayed on the surface of the meat poultry product. the bacterium remains active throughout the shelf life of the ready-to-eat food product. in canada microbiological organisms used in food applications may be considered food additives depending on their conditions of use. permitted food additives that are classified as preservatives are listed in the food additives tables in division 16 table xi of the regulations. before a new food additive is allowed to be used in canada a submission must be filed with health canada so the department can conduct a safety evaluation of the proposed uses of the additive. food manufacturers are not permitted to use the additive until the safety assessment has been completed by health canada and the regulations are amended to formally enable its use. through their evaluation of the submission health canadas food directorate scientists conducted a detailed and rigorous evaluation of both submissions that focussed on safety and efficacy. their evaluation considered both microbiological and toxicological aspects of the proposed use of c. maltaromaticum cb1 as a food additive. it was also noted that the application of c. maltaromaticum cb1 affects neither the nutritional nor the organoleptic quality of the treated food products. based on this assessment health canada scientists had no objections from a safety perspective to the proposed use of c. maltaromaticum cb1. health canada will propose amendments to the food and drug regulations to permit the use of c. maltaromaticum cb1 in these food products at a maximum level of use consistent with good manufacturing practice. the food and drug regulations specify that the amount of the food additive added to a food when the maximum level of use is stated to be good manufacturing practice shall not exceed the amount required to accomplish the purpose for which that additive is permitted to be added to that food. given that c. maltaromaticum cb1 has antilisterial properties that may be of benefit to the health of canadians health canada has assigned a high priority to enabling the use of c. maltaromaticum cb1 in certain ready-to-eat meat and poultry products. c. maltaromaticum cb1 is permitted for use in the united states therefore the approval of the use of c. maltaromaticum cb1 in canada will allow for further harmonization of approved antimicrobial intervention methods in ready-to-eat meat and poultry industry in the united states and in canada