ARCHIVED - Amendment to the Food and Drug Regulations to permit the use of Citric Acid Esters of Mono- and Diglycerides as a Food Additive in Infant Formulae For Medical Purposes and in those Foods that Contain Monoglyceride Citrate

Health Canada's Food Directorate recently completed a consultation on its proposal to amend the Food and Drug regulations to permit the use of citric acid esters of mono- and diglycerides (1) as a food additive in infant formulae for special medical purposes; and (2) in those foods that are currently permitted to contain monoglyceride citrate. This consultation was open to both domestic and international stakeholders for a 75 day period between November 18, 2010 and January 31, 2011.

There were no comments received on this proposal; however, one request from a domestic industry contact was received, seeking further clarity on the proposal. This request was addressed through direct correspondence with the company. In addition, the Canadian Food Inspection Agency (CFIA) was consulted during the development of this regulatory project and no objection was expressed with regard to the use of this food additive both as an emulsifying agent in infant formulae for special medical purposes, or as a class IV (antioxidant) preservative and as a carrier or extraction solvent (i.e.: in those same foods that monoglyceride citrate is currently permitted).

As a result of this process, the proposal to permit the use of citric acid esters of mono- and diglycerides (1) as a food additive in infant formulae for special medical purposes; and (2) in those foods that are currently permitted to contain monoglyceride citrate, was  published in the Canada Gazette Part II on Wednesday November 9, 2011. The proposed uses of this food additive in Canada as described are now enabled.

For more information on this initiative, please contact the Bureau of Chemical Safety's Chemical Health Hazard Assessment Division at bcs-bipc@hc-sc.gc.ca.