The Canadian Food Inspection Agency (CFIA) and Health Canada (HC) position on the use of modified milk ingredients as ingredients in food products is described below.
It is Health Canada's position that modified milk ingredients containing more than 5% calcium on a dry matter basis are mineral nutrients for the purposes of the Food and Drug Regulations (FDR). As such, their use in foods must comply with the provisions of the FDR respecting the addition of calcium to foods. These modified milk ingredients containing greater than 5% calcium on a dry matter basis cannot be added to a food unless the food is listed in column I of the table to FDR D.03.002 and calcium is listed in Column II opposite that food.
On September 30, 2006, an Interim Marketing Authorization (IMA) was published in the Canada Gazette, Part I, to permit the addition of calcium, with or without vitamin D, to orange juice, or orange juice and tangerine juice sold as such, in fluid, concentrated, or reconstituted forms.
Health Canada and the CFIA would like to bring to your attention an upcoming initiative that will clarify the above and may impact upon this position. Health Canada will be proposing amendments to the FDR that will prohibit the addition of ingredients that contain more than 5% calcium by weight to a food unless the food is required or is allowed to contain added calcium. In addition, it will also be proposed to specifically prohibit the addition of modified milk ingredients as a source of calcium to orange juices and orange and tangerine juices that are the subject of the above mentioned IMA, as these products are specially designed for people who do not drink milk. Industry comments will be welcomed at the time of pre-publication in Canada Gazette, Part I.
Modified milk ingredients are defined in item 7.1, subsection B.01.010 (3) of the FDR, as "any of the following in liquid, concentrated, dry, frozen or reconstituted form, namely, calcium reduced skim milk (obtained by the ion-exchange process), casein, caseinates, cultured milk products, milk serum proteins, ultrafiltered milk, whey, whey butter, whey cream and any other component of milk the chemical state of which has been altered from that in which it is found in milk".
Section D.02.001 of the FDR defines a mineral nutrient as "any of the following chemical elements, whether alone or in a compound with one or more other chemical elements.......(c) calcium.....".
The table to section D.03.002 of the FDR indicates foods to which calcium and other nutrients may be added.
Originally issued June 11, 2007 (Information Letter To Industry)
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