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Health Canada has notified BioNeutra Inc. that it has no objection to the use of IMO as a food ingredient. Isomalto-oligosaccharide is a food ingredient added to foods with a relative sweetness level equal to approximately 60% of sucrose. Chemically, IMO is a mixture of glucose oligomers with alpha-(1-6)-linkages.
IMO may be added to a variety of foods including, but not limited to, baked goods and baking mixes, beverages and beverage bases, condiments, salad dressings, frozen dairy deserts and mixes, gravies, sauces, hard and soft candies, jams, meat and nut products, processed fruits and vegetables, sugar substitutes, sweet sauces, and toppings. IMO is not permitted to be added to a food for which a standard exists in the Food and Drug Regulations unless the standard provides for the addition.
The following provides a summary of the notification from BioNeutra Inc. and the evaluation by Health Canada and contains no confidential business information.
Isomalto-oligosaccharide is a food ingredient that is added to various foods as either powder or a syrup. Chemically, IMO is a mixture of glucose oligomers with alpha-(1-6)-linkages such as isomaltose, panose, isomaltotriose, and isomaltopentose. The majority of glucose oligosaccharides found in IMO consist of 3-6 monosaccharide units linked together, however disaccharides as well as longer polysaccharides (up to 9 units) are also present.
Isomalto-oligosaccharide is formed by enzyme-catalyzed hydrolysis of starch from different cereal crops (wheat, barley, corn), pulses (lentils, peas), rice, tapioca (cassava), potato and other starch sources. Enzymes, including alpha-glucosidase, alpha-amylase, and pullulanase, hydrolyse the polysaccharides in starch to produce mono-, di-, tri-, and other smaller oligosaccharides with alpha- 1,4 and alpha-1,6 glycoside linkages. Yeast is added to remove glucose that may be formed as a result of the enzymatic hydrolysis reactions.
The final step in the starch hydrolysis is a saccharification step that yields high maltose syrup. Maltose syrup naturally contains di- and tri- oligosaccharides with alpha- 1,4 glycoside linkages. In order to convert these molecules into functional and low caloric molecules, these alpha-1,4 linkages are enzymatically converted into alpha-1,6 linkages, thus forming IMO. This step is achieved by the addition of an enzyme, transglucosidase (TG). To summarize, the TG enzyme converts malto-oligosaccharides to IMO.
The petitioner provided composition data related to the carbohydrate fractions of IMO. The content of glucose, isomaltose and other oligosaccharides was determined by high performance liquid chromatography (HPLC).
Isomalto-oligosaccharide is composed of 15-20% of smaller saccharides and 70-80% of the larger oligosaccharides. Thus, IMO contains both digestible and non-digestible saccharides. The fractions composed of isomaltose, maltose, and panose would be digested in the small intestine and absorbed as glucose following oral administration. The non-digested oligosaccharides would pass through the small intestine and undergo microbial fermentation in the large intestine. The non-digested oligosaccharides would consist of the larger oligosaccharides.
Isomalto-oligosaccharide is completely devoid of vitamins, minerals, fats, proteins (amino acids, nucleic acids), anti-nutritional factors (phytate, tryspin inhibitors). The energy/caloric value for IMO is 2.4 kcal/g.
Isomalto-oligosaccharides are naturally found in honey, miso, sake, and soy sauce. In Canada these foods are generally consumed in small quantities. The levels at which IMO are present in honey, miso, sake, and soy sauce, are very low in comparison to the proposed amounts to be added to various foods.
Modelling was conducted to determine the potential exposure of the Canadian population to IMO given the different proposed levels of the foods requested for consideration. An intake of IMO higher than 30 g/day may cause possible gastrointestinal problems (flatulence, bloating, soft stool, or diarrhea). Also, according to Oku and Nakamura (Pure Appl. Chem., 2002) the maximum intake of IMO that would not cause diarrhea is 1.5 g/kg body weight. For a 70 kg person, this equals 105g per day. Based on the modelling, Health Canada considers the risk of over-exposure to IMO to be low.
Based on the evidence provided, the toxicological evaluation concluded that there are no toxicological issues with IMO at the proposed maximum intake of 30 g/person/day, for the general population.
Physical and chemical specifications were submitted for both IMO powder and IMO syrup. The HPLC specifications indicated that the preparation (both the syrup and powder) contains less than 5% glucose and more than 90% isomaltose and oligosaccharides. The levels of the heavy metals lead and arsenic are each lower than 0.5 ppm and the petitioner has certified that there is a lack of carry-over of other chemical contaminants.
The manufacturing process shows the use of several enzymes, which are all approved for food use as per Division 16 of the Food and Drug Regulations except the enzyme transglucosidase. Since June 2009 the TG enzyme used in this process is considered an essential reactant, assimilated with a processing aid classification and therefore no regulatory amendment to the Food and Drug Regulations is necessary in order to enable its use in IMO production.
All data provided were adequate to demonstrate that the final product is safe and raises no safety concerns.
Microbiological specifications for IMO were provided. The specifications covered total aerobic plate count (no more than 104 CFU/g), yeast (no more than 102 CFU/g), E.coli (no more than 101 CFU/g), and Salmonella (absent). All three certificates of analysis submitted indicated compliance with these specifications.
Health Canada and the Canadian Food Inspection Agency (CFIA) share responsibilities in regard to labelling requirements for foods. Health Canada is responsible for policy and standard setting under the Food and Drugs Act and Regulations, whereas CFIA is responsible for enforcement. CFIA also administers and enforces those aspects of the Food and Drugs Act and the Consumer Packaging and Labelling Act that ensure labelling is understandable, truthful and not misleading.
Isomalto-oligosaccharide is to be included in the declared carbohydrate amount in the Nutrition Facts table and should be included in the ingredient list. BioNeutra Inc. has been notified to consult with the CFIA to determine common name and labelling requirements for food products containing IMO.
Health Canada's review of the information presented in support of the use of IMO as a food ingredient concluded that there are no food safety concerns. Health Canada is of the opinion that IMO can be added to a variety of foods. It is the continuing responsibility of BioNeutra Inc. to ensure that their products are in compliance with all applicable statutory and regulatory requirements.
This Novel Food Information document has been prepared to summarize the opinion regarding the subject product provided by the Food Directorate, Health Products and Food Branch, Health Canada. This opinion is based upon the comprehensive review of information submitted by the petitioner according to the Guidelines for the Safety Assessment of Novel Foods.
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For further information, please contact:
Office of Food Biotechnology
Health Products and Food Branch
Ottawa, Ontario K1A 0L2