Consultation on the Proposal to Amend 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


"Notice to reader – this consultation is now closed"

Health Canada's Food Directorate has recently completed a detailed safety assessment of 'citric acid esters of mono- and diglycerides'.

Citric acid esters of mono- and diglycerides is a food additive whose intended use in this proposal is as an emulsifying agent in infant formulae for special medical purposes, specifically those that are based on crystalline amino acids or protein hydrolysates, or both. Citric acid esters of mono- and diglycerides is a group of substances to which monoglyceride citrate belongs. Monoglyceride citrate is already permitted as a class IV (antioxidant) preservative and as a carrier or extraction solvent in certain foods. Therefore, it is also intended that citric acid esters of mono- and diglycerides be permitted in the same foods as monoglyceride citrate, and at the same levels currently permitted in the Food and Drug Regulations for monoglyceride citrate. For unstandardized foods in particular, the possible use of citric acid esters of mono- and diglycerides as either a preservative or as an emulsifier would be recognised in the Food Additive Tables of the Regulations.

Based on the safety assessment, Health Canada's Food Directorate scientists have concluded that there are no health or safety concerns with the use of citric acid esters of mono- and diglycerides in certain food products, as described in the proposal. Therefore, the Department is proposing amendments to Division 16 of the Regulations to enable the uses described in the consultation document. The purpose of this communication is to seek comments on this proposed action.

How to get Involved

This consultation is open for comment starting November 18, 2010 until January 31, 2011 (75 calendar days). Comments on this proposal may be submitted in writing, by regular mail or electronically. If you are submitting your comments electronically, please use the words "Citric acid esters of mono- and diglycerides" in the subject box of your e-mail.

Bureau of Chemical Safety
Chemical Health Hazard Assessment Division
251 Sir Frederick Banting Drive
Health Canada, Tunney's Pasture
Address Locator: 2201C
Ottawa, Ontario K1A 0L2

Phone: 613-957-0973
Fax: 613-954-4674

Consultation Document

Submissions must be received by 12:00 a.m. EDT, January 31, 2011.

Supporting Information

Reporting to Canadians

Health Canada will make the results of this consultation available on this Web site. If you have any questions, contact us at

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