information document on health canadas 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 document provides information on health canadas proposal to amend the food and drug regulations regulations to permit the use of citric acid esters of mono- and di-glycerides synonymous names citric and fatty acid esters of glycerol caem citrem as a food additive in the following foods including in infant formulae for special medical purposes. the proposed amendments would permit the use of citric acid esters of mono- and di-glycerides as an emulsifying agent in infant formula based on crystalline amino acids or protein hydrolysates or both and in unstandardized foods. the proposed amendments would also permit the use of citric acid esters of mono- and di-glycerides as a class iv preservative in fats and oils lard monoglycerides and diglycerides shortening in unstandardized foods except unstandardized preparations of a meat and meat by-product divisions 14 and 21 b fish and c poultry meat and poultry meat by-product and in margarine. citric acid esters of mono- and di-glycerides would also be used as a carrier or solvent agent in natural extractives spice extracts and in unstandardized flavouring preparations. health canada received a submission requesting that the regulations be amended to permit the addition of citric acid esters of mono- and di-glycerides in infant formulae for special medical purposes. specialized formulas are required for infants with impaired metabolism e.g. infants suffering from certain food allergies and intolerances where whole protein cannot be tolerated inborn error of metabolism - when the offending amino acid must be excluded e.g. phenylketonuria or conditions where the absorptive surface of the gut is damaged or impaired. specialized infant formulas composed of mixtures of amino acids or hydrolyzed proteins fat carbohydrates and other nutritional elements are manufactured for infants with these types of conditions. health canadas food directorate has completed a safety assessment of citric acid esters of mono- and di-glycerides when used as described in the submission through which it has determined that there are no health or safety concerns with its addition to infant formulae that are based on protein hydrolysates or crystalline amino acids or both. such specialized formulas are required for infants with impaired metabolism. therefore the department is proposing amendments to the regulations to allow citric acid esters of mono- and di-glycerides to be added to infant formulae based on crystalline amino acids or protein hydrolysates or both. in addition citric acid esters of mono- and di-glycerides would also be added to the tables in the regulations where monoglyceride citrate is currently permitted. monoglyceride citrate is a class iv preservative synergist antioxidant used in a variety of food products including margarine shortening lard and some unstandardized foods also it is permitted as a carrier or extraction solvent in spice extracts natural extractives and unstandardized flavouring preparations. since a compositional standard for margarine is outlined in the regulations it would be amended accordingly by inclusion of citric acid esters of mono- and di-glycerides