Novel Food Information: Isomaltulose (Palatinose™)
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- 1.0 Introduction
- 2.0 Product Development/Formulation
- 3.0 Dietary Exposure
- 4.0 Chemical Assessment
- 5.0 Microbiological Assessment
- 6.0 Nutrition
- 7.0 Toxicology
- 8.0 Labelling
Health Canada has notified Beneo-Palatinit GmbH that it has no objection to the sale of isomaltulose (Palatinose™) as a food ingredient to be added to food and beverages in Canada. Isomaltulose is intended to be used as a carbohydrate source, totally or partially replacing sucrose or other highly digestible carbohydrates in a variety of food categories, with the primary applications being beverages, sport nutrition products, dairy products, beer and beer specialties, meal replacements, clinical and enteral nutrition products, chocolate, cereals and bars, baked goods, powder applications and others. Some of the foods in which isomaltulose might be intended to be used (for example, beer, bread, chocolate) have a standard of identity and composition set out in the Food and Drug Regulations (FDR). The standard may not contain a provision for the food to contain isomaltulose. Therefore, it is recommended to consult with the Canadian Food Inspection Agency to confirm whether standardized foods of interest are, in fact, permitted to contain isomaltulose.
The Department has conducted a comprehensive safety assessment of the addition of isomaltulose to the Canadian food supply
The following provides a summary of the notification from Beneo-Palatinit GmbH and the evaluation by Health Canada and contains no confidential business information.
Isomaltulose is a disaccharide which, just like sucrose, has the chemical formula C12H22O11 and is composed of the monosaccharides glucose and fructose. However, the monosaccharides composing isomaltulose are linked differently; instead of an α-1,2-glycosidic bond for sucrose, the monosaccharides composing isomaltulose are linked via an α-1,6-glycosidic bond. The chemical name for isomaltulose is 6-O-α-D-glucopyranosyl-D-fructofuranose.
The Food Directorate has a legislated responsibility for the 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). Isomaltulose is considered to be a novel food under 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;”
2.0 Product Development/Formulation
Crystalline isomaltulose is a white substance similar to crystalline sucrose. It is produced from the isomerisation of food-grade sucrose by the action of the sucrose-6-glucosylmutase enzyme from non-viable cells of Protaminobacter rubrum entrapped in a calcium alginate matrix. First, sucrose is dissolved in deionized water, and then the solution is sterilized and buffered with a sterile, food-grade calcium acetate solution. The sterile aqueous sucrose solution is then passed through a column containing the enzyme preparation which converts the α-1,2-linkage in sucrose to the α-1,6-linkage in isomaltulose. The product of the enzymatic reaction is then purified via ion exchange, evaporated, crystallized, and centrifuged to produce pure isomaltulose crystals. It may be noted that isomaltulose is further processed to produce isomalt, a sweetener permitted to be sold in Canada.
Calcium acetate is permitted as a pH adjusting agent in unstandardized foods at a maximum level consistent with Good Manufacturing Practice (Item C.1, Table X, Division 16 to Part B of the FDR). There are no objections from a food safety perspective regarding its use to buffer the solution of sucrose and deionized water during the manufacture of isomaltulose provided that the calcium acetate used meets the specifications set out for calcium acetate in the most recent edition of the Food Chemicals Codex.
The submission does not characterize the ion exchange resin(s) used in the manufacture of isomaltulose. However, there is no regulatory requirement under the FDR for pre-market clearance of ion exchange resins used to manufacture this type of ingredient. Rather, such use of ion exchange resins, like any substance used in food manufacture, must not result in a violation of Section 4 of the Food and Drugs Act.
3.0 Dietary Exposure
Isomaltulose is a sugar that occurs naturally in small quantities in honey and sugar cane juices. In Canada, these foods are generally consumed in small quantities. The levels at which isomaltulose is present in these foods are very low (for example, less than 1% in honey) in comparison to the proposed amounts to be added to various foods.
Isomaltulose can theoretically be used at the same level as sucrose in a wide variety of foods, however the petitioner estimated that an intake as high as that of sucrose will likely not be reached due to the cost of manufacturing isomaltulose, its limited solubility in water, and its lower sweetness than sucrose. Based on previous market experience, the petitioner estimated that isomaltulose will replace the use of sucrose in the market at levels between 2.5% and 10% with a daily consumption ranging between 1.6 and 9.2 g/person/day, but more realistically ranging between 2 and 4 g/person/day.
Modelling was conducted by Health Canada to calculate the dietary intake of isomaltulose in the Canadian population using data from the Canadian Community Health Survey Cycle 2.2 (CCHS 2004) and the Health Canada’s Canadian Nutrient File (CNF 2001b). The intake of isomaltulose in various age-sex groups (≥ 1 year, 1-3 years, 4-8 years, males 9-13 years, females 9-13 years, males 14-18 years, females 14-18 years, males ≥ 19 years, and females ≥ 19 years) of the Canadian population was estimated by replacing 2.5% and 10% of the total sugar in the target foods . At a replacement level of 2.5% of total sugar, the estimated mean intakes of isomaltulose ranged from 2 to 4 g/day and the 95th percentile intakes from 5 to 9 g/day among the groups. When considering a replacement level of 10% of total sugar, the estimated mean intakes were between 9 and 17 g/day and the estimated 95th percentile ranged from 20 to 36 g/day. Males aged 14-18 years had the highest exposures to isomaltulose among all age-sex groups with mean and 95th percentile intakes of 17 g/day and 36 g/day respectively at a 10% sugar replacement level.
Health Canada also estimated the highest isomaltulose intakes in the age-sex groups by replacing all sugar in every food category proposed by the petitioner with the maximum use-levels of isomaltulose. In this scenario, the mean and 95th percentile intakes were, 27-53 g/day and 60-139 g/day, respectively. Here again, the group with the highest exposures to isomaltulose were males aged 14-18 years with mean and 95th percentile intakes of 53 g/day and 139 g/day respectively.
All scenarios were considered overestimates and unlikely since the calculations were based on total sugar intakes and not on added sugar intakes, which would be more realistic for isomaltulose.
4.0 Chemical Assessment
Data from the chemical product analysis provided for five (5) lots of isomaltulose showed that the product consistently met specifications of the Food Chemicals Codex (8th edition, 2012) with respect to identity and purity of isomaltulose.
The contaminant analysis was compared to average concentrations in white sugar most recently reported by the Canadian Total Diet Study (TDS). Based on these comparisons, the use of isomaltulose as a carbohydrate source in foods is expected to have an insignificant impact on the population’s current average dietary exposure to lead, cadmium, nickel, mercury and arsenic from white sugar.
Overall, considering the information provided by the petitioner, isomaltulose is not expected to pose an unacceptable risk to health from a chemical contaminant perspective.
5.0 Microbiological Assessment
Microbial specification data for isomaltulose were provided by the petitioner. Results of analyses from 2000 to 2003 showed that the following microbial specifications have been established for isomaltulose: absence of E. coli in 10 g, average mesophilic aerobic count of 14 cfu/10 g, average yeast count of 14 cfu/10 g, average mould count of 1 cfu/10 g.
Analysis of isomaltulose samples showed the absence of residual protein or catalytic activity from the biocatalyst P. rubrum. In addition, results of studies in rabbits and mice receiving intravenous administration of viable cells per animal showed that P. rubrum is not pathogenic and has a low order of toxigenicity, providing a high degree of confidence that there would be no safety concerns if P. rubrum or its by-products should unintentionally enter the final product.
The data did not raise microbiological concerns regarding the use of isomaltulose as a food ingredient.
Isomaltulose, like sucrose, provides 4 kcal or 17 kJ of physiological energy per gram. Once ingested, isomaltulose is hydrolyzed into its constituents, glucose and fructose, by the isomaltase subunit of the sucrase-isomaltase complex, located in the small intestine brush border membrane. Results of in vitro and in vivo studies showed that isomaltulose is hydrolyzed more slowly than sucrose and is virtually completely digested and absorbed in the small human intestine. Consequently, glucose and fructose are absorbed completely but more slowly into the systemic circulation than sucrose.
Some studies provided by the petitioner showed that isomaltulose may have non-cariogenic properties as its consumption leads to a lower acid formation by oral plaque bacteria and does not lead to glucan formation, a prerequisite to provide a habitat for cariogenic microorganisms at the tooth surface.
Since the intended use of isomaltulose is to totally or partially replace sucrose or other highly digestible carbohydrates, it is unlikely that it will contribute to an increase in the overall glucose or fructose intake in the diet.
Results of the toxicological studies provided including subchronic toxicity, teratogenicity, and genotoxicity showed no evidence of potential toxicity. No signs of gastrointestinal discomfort were observed in clinical studies carried out in healthy, hyperlipidaemic or diabetic subjects at doses as high as 50 g/day (highest dose tested).
Isomaltulose is considered not to pose an allergenic risk because the product is digested into common dietary sugars (glucose and fructose) and has negligible residual protein from the manufacturing process.
People with disorders affecting the digestion of disaccharides such as Congenital Sucrase-Isomaltase Deficiency (CSID) or Hereditary Fructose Intolerance (HFI) should avoid consuming isomaltulose, including isomaltulose in clinical and enteral nutrition products, as it could lead to similar adverse effects to the consumption of sucrose. Affected people are not able to digest sucrose or isomaltulose completely. Consequently, sucrose and isomaltulose reach the colon and are fermented similar to lactose in lactase-deficient people. The symptoms of this enzyme deficiency include mainly diarrhea, but failure to thrive, an inability to gain weight, vomiting and abdominal distension can also occur. Individuals with this condition are advised to consume diets low in sucrose, dextrins and starch. The ingestion of isomaltulose by these individuals is considered to be self-limiting and would not pose a greater risk to these individuals than other food sources of sucrose.
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.
Beneo-Palatinit GmbH was informed of the labelling requirements when isomaltulose is added to food or beverages. Isomaltulose is a disaccharide and its contribution to the carbohydrate and sugar amount must be included in the amounts reported in the Nutrition Facts table. Also, foods with added isomaltulose must declare isomaltulose on the list of ingredients as well as its components, glucose and fructose.
Health Canada's review of the information presented in support of the use of isomaltulose as a food ingredient concluded that there are no food safety concerns. It is the continuing responsibility of Beneo-Palatinit GmbH 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.
(Également disponible en français)
For further information, please contact:
Novel Foods Section
Health Products and Food Branch
Health Canada, PL2204A1
251 Frederick Banting Driveway
Ottawa, Ontario K1A 0K9
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