Health Canada has notified Hayashibara International Inc. and Cargill, Inc. that it has no objection to the use of trehalose for human food applications. The Department conducted a comprehensive assessment of this disaccharide according to its Guidelines for the Safety Assessment of Novel Foods. These Guidelines are based upon internationally accepted principles for establishing the safety of novel food products.
The following provides a summary of the notification from Hayashibara International Inc., Cargill, Inc. and the evaluation by Heath Canada and contains no confidential business information.
Hayashibara International Inc. has developed a multi-step enzymatic process to commercially produce trehalose from liquefied starch. The company intends to market trehalose as a nutritive sweetener in various food products. It will be used in food applications as a partial or complete substitute for other sugars or sweeteners.
The Food Directorate has a legislated responsibility for pre-market assessment of novel foods and novel food ingredients as detailed in Division 28 of Part B of the Food and Drug Regulations (Novel Foods). While it is present in small amounts in various food products sold in Canada, it does not have a history of significant consumption as a food ingredient. Since trehalose does not have a history of safe use at levels anticipated in various food applications as proposed by the petitioner, it required a pre-market notification under B.28.002 of the Food and Drug Regulations. Trehalose is considered a novel food ingredient based on the following part of the definition of novel foods: "(a) a substance, including a microorganism, that does not have a history of safe use as a food."
2. Product Information
Trehalose (α-D-glucopyranosyl-α-D-glucopyranoside) is a non-reducing disaccharide that consists of two glucose units linked by a 1,1-α-glycosidic bond. Trehalose exhibits the same technological properties as sucrose with a relative sweetness of 40-45% of that of sucrose. Trehalose is hydrolysed by the enzyme trehalase in the small intestine into two glucose molecules which are absorbed and metabolized. The ingestion, hydrolysis, absorption and metabolism of trehalose is identical to that of all other disaccharides.
Trehalose is found naturally in plants, invertebrates, fungi and microorganism and is therefore present at low levels in a variety of foods available on the marketplace (bread, beer and wine, honey, mushrooms, etc.). However, enzymatically produced trehalose was considered a novel food because the levels of use in various food products is expected to be far greater than previously consumed from natural sources. For commercial production, Hayashibara International Inc. uses a multi-enzymatic process for producing trehalose directly from food-grade starch.
3. Dietary Exposure
Trehalose will provide an additional choice of nutritive sweetener to food manufacturers seeking to optimize or select for various product characteristics. It will be added to the current set of nutritive sweetener candidates such as sucrose, maltose, lactose, high-fructose corn syrup, honey, glucose, etc., or choices of various high, mid, and low gluten flour sources or types.
Hayashibara International Inc. and Cargill, Inc. intend to market trehalose for use in a wide variety of food products ranging from confectionary products to beverages, noodles, fruit purees, and processed meat and seafood. It is to be expected that consumption will reach significantly higher levels compared to the relatively small quantities of trehalose derived from most natural foods today.
This disaccharide is enzymatically hydrolysed by the enzyme trehalase in the small intestine into two glucose subunits which are subsequently absorbed and metabolized in a manner similar to maltose. Common disaccharides such as sucrose and lactose are digested through the same physiological process. The sugar provides approximately 4 kcal of food energy per gram as do other digestible sugars and starches. It is therefore important that diabetics understand that it is a sugar and for everyone to understand that it contributes Calories.
The enzyme trehalase is found in human intestinal system and kidneys although its activity varies and it may be missing in some people. In those cases, malabsorption similar to that found with consumption of lactose in lactose intolerant individuals, or sugar alcohols in most people, may be observed. Fewer persons are thought to be trehalase deficient than are lactase deficient.
Hayashibara International Inc. provided three genotoxicity studies; four acute toxicity studies with mice, rats and dogs; two 14-day studies with mice and dogs; a 13-week feeding study with mice; two oral developmental toxicity studies with rats and rabbits; and an oral 2-generation study of reproductive toxicity with rats in support of the safety of trehalose. The results of toxicology studies, as well as those on the absorption, metabolism and tolerability of trehalose in humans, indicate that the consumption of trehalose at levels that might be expected from its use as a food ingredient are not of toxicological concern. It is also noted that the studies on trehalose have been evaluated by the Joint Food and Agriculture Organisation/World Health Organisation Expert Committee on Food Additives (JECFA, 2001) and allocated an acceptable daily intake (ADI) of "not specified."
The safety assessment conducted by Food Directorate determined that there are no safety or nutritional concerns associated with trehalose. Trehalose is a disaccharide of glucose that is fully available to the body as glucose and it meets the definition of "sugars" in the Food and Drug Regulations. Therefore, its content in a food must be included in total carbohydrates and as part of the "sugars" value in the Nutrition Facts table. This declaration on the Nutrition Facts table will help inform those consumers who need to know their carbohydrate and/or sugar intake.
Health Canada recommends that Hayashibara International Inc. and Cargill, Inc. develop a voluntary education/communication plan to provide information to diabetics, diabetes educators and other health care professionals who may be consulted by diabetics about the nature of trehalose. Hayashibara International Inc. and Cargill, Inc. should discuss the education/communication plan with Health Canada and keep the Department informed on the progress made by both companies when the plan is implemented.
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.