Novel Food Information - Sucromalt (Xtend™) as a food ingredient

Health Canada has notified Cargill Inc. that it has no objection to the sale of sucromalt as a food ingredient that can be used as a partial or complete substitute for sweetening agents available in the Canadian market, e.g. sucrose, corn syrup, high fructose corn syrup (HFCS), brown rice syrup and malt syrup.

The Department has reviewed the information provided by Cargill Inc. in support of the acceptability and safety of sucromalt as a food ingredient. The safety assessment included the evaluation of chemical, microbiological, nutritional and toxicological data. A comparison with other sweetening agents was also made with respect to how it is digested and absorbed in the body and the potential for allergenicity.

Background

The following provides a summary of the notification from Cargill Inc. and the evaluation by Health Canada and contains no confidential business information.

"Sucromalt" is the proposed common name for the saccharide product of sucrose and maltose. Sucromalt is a slow release carbohydrate that is fully digestible with a caloric content of 4.0 kcal/gram and has a glycemic index of 53 relative to glucose's 100. The trade name of the product is Xtend™.

1. Introduction

Sucromalt is a concentrated aqueous solution of saccharides with varying chain lengths obtained by an enzymatic reaction between sucrose and maltose. The final product contains fructose (35-45%), leucrose (7-15%), other mono and disaccharides (< 5%) and 40 to 60% higher oligosaccharides (containing up to 12 degrees of polymerization).

Sucromalt is considered to be a novel food ingredient because it does not have a history of safe use as a food in Canada.

2. Description of the Novel Food

Sucromalt is intended to be a partial or complete substitute for sweetening agents available in the market. It will be consumed as a sweetening agent that can be used as a food ingredient in a wide variety of foods in accordance with current good manufacturing practices (CGMP) and in accordance with Schedule M to the Food and Drug Regulations. This includes: bakery products (2 to 50%), beverages (5 to 15%), cereal and other grain products (5 to 30%), dairy products and substitutes (3 to 15%), desserts (8 to 35%), dessert toppings and fillings (12 to 40%), fats and oils (8 to 20%), foods for special dietary use (15%), fruit and fruit juices (5 to 45%), jams, jellies and marmalades (25 to 60%), miscellaneous (15%), sauces, dips, gravies and condiments (3 to 25%), snacks (10%), sugars and sweets (5 to 85%).

Sucromalt does not fulfill the compositional standard [B.18.001] for "sugar" and currently may not be used in foods that have a prescribed composition standard which permits sugar as an ingredient.

3. Product Development/Formulation

Sucromalt is manufactured from the raw materials, sucrose and maltose (or high-maltose corn syrup), mixed in a ratio of 8:1 to 11:1 at a total aqueous concentration of 40 to 50%, before adding the enzyme alternansucrase. The enzyme is produced from a strain of Leuconostoc citreum or a recombinant strain of Bacillus licheniformis. The enzyme cleaves the alpha-1,2-bond of sucrose, creating free glucose and fructose in the reaction medium. The enzyme then catalyses the re-linking of free glucose and a portion of free fructose via an alpha-1,5 linkage to create leucrose. The enzyme also functions to sequentially transfer free glucose to the non-reducing terminal of maltose via alternating alpha-1,6 and alpha-1,3 linkages. The chain length and distribution of saccharides in sucromalt depend on the ratio of sucrose and maltose in the starting materials.

4. Dietary Exposure

Sucromalt will be consumed in a wide variety of foods since it will be a partial or complete replacement for sweetening agents. Approximately 98.5% of the total Canadian population is identified as potential consumers of sucromalt from the proposed foods. Estimates of sucromalt intake were compiled from the proposed food uses in conjunction with food consumption data from the Canadian Community Health Survey (CCHS 2.2). Mean intakes were calculated to be 28.6 g/person/day (0.5 g/kg body weight/ day) among all users. The 90^th percentile value is 58.7 g/person/day (1.0 g/kg bw/day). The greatest mean intakes are among male teenagers 40.7 g/person/day (0.6 g/kg bw/day) with a 90^th percentile value of 77 g/person/day for this group.

The caloric content of sucromalt is the same as sucrose, 4.0 kcal/g and this will be counted toward total energy content on the Nutrition Facts table (NFt). The amount of sucromalt will also be included in the amount of sugars and carbohydrates in the NFt. Excess sugar intake is a concern because it can lead to obesity, a risk factor for chronic disease. Health Canada is considering changes to the way sugars are labelled as part of its proposed updates to nutrition labelling.

5. Chemical Assessment

Sucromalt is manufactured using an enzymatic process. The enzyme used in the process, alternansucrase (EC 2.4.1.1.140, CAS 100630-46-4), is a glucosyltransferase enzyme derived from Leuconostoc citreum or Bacillus licheniformis, which meets the specifications for food enzyme preparations established by the latest edition of the Food Chemicals Codex (FCC) and by the Joint FAO/WHO Expert Committee on Food Additives (JECFA).

The enzyme is considered a processing aid. It is inactivated and removed during the manufacturing process and is not expected to be present in the final product. The amount of residual alternansucrase protein in sucromalt is estimated not to exceed 6 ppm and does not pose a health risk.

Sucromalt may contain sulphite preservatives at a maximum sulphur dioxide level of 5 ppm. Heavy consumers of sucromalt can be exposed to 5 µg sulphur dioxide/ kg bw /day however it is unlikely that sensitive persons will experience any adverse effects at this maximum level.

6. Microbiological Assessment

The enzyme alternansucrase is derived from non-toxigenic, non-pathogenic strains of Leuconostoc citreum and Bacillus licheniformis. The enzyme used in Cargill's process is derived from L. citreum strain NRRL B-30894, a glucose-constitutive over-producer of the alternansucrase enzyme.

L. citreum is found ubiquitously in nature, e.g., on green vegetation and plant roots. It is frequently isolated from foods including fresh fruits and vegetables and fermented foods (e.g. sauerkraut). Leuconostoc species have been in commercial use for more than 50 years in food manufacturing, including dairy, bread dough, meat, wine, and pickle and sauerkraut fermentations.

B. licheniformis is commonly found in soil and bird feathers and is part of the subtilis group of Bacillus subtilis and Bacillus pumilus. Although these bacteria are known to cause food poisoning and food spoilage, industrial strains of B. licheniformis have a long history of safe use.

Based on the information provided, there are no microbiological concerns regarding the enzyme donor organisms, the specifications for assuring microbiological safety or the food use of sucromalt as a food ingredient.

7. Nutrition

In vitro and in vivo animal and human studies on the nutritional safety of sucromalt were evaluated. The study data demonstrated that no hazards are associated with its digestion for humans. The digestibility of sucromalt was determined in children and adults by measuring hydrogen in exhaled breath. The lack of change in breath hydrogen excretion following consumption of sucromalt demonstrates it is well digested by both children and adults. Effects of sucromalt in sport drinks compared to effects of sucrose in drinks were also studied and no differences were found in gastrointestinal discomfort, aftertaste, sweetness, sourness and bitterness.

After digestion, sucromalt is broken down to its fundamental constituents, glucose and fructose in a manner that is comparable with other sugars available in the market. No nutritional concerns related to its consumption have been identified.

8. Toxicology

Sucromalt is digested into common dietary sugars, glucose and fructose which are normal constituents of food. A short-term (28-day) toxicity study showed no adverse effects in rats when they were fed sucromalt at a dietary concentration of 200,000 ppm. This concentration was equivalent to 20 and 19 g/kg bw/day in female and male rats, respectively. In addition, standard bacterial reverse mutation assays demonstrated that sucromalt was not a mutagen, under the conditions of the assay. Several studies in human volunteers ingesting 30 to 100 g/day of sucromalt indicated the substance is well tolerated with no overt adverse effects. At the proposed level of use, sucromalt is not expected to pose a health concern.

Leucrose, a minor component of sucromalt (present at 7 to 15%) was assessed for safety and for tolerability in humans. It is digested into common sugars, fructose and glucose, and absorbed and metabolized as are other sugars. The safety of leucrose was supported by several short-term oral toxicity studies in rats, dogs and rabbits, which showed that it had no potential for teratogenicity, genotoxicity or mutagenicity. In addition, studies in human volunteers showed leucrose was well-tolerated at doses up to 265 g/day for 7 days. At the proposed level of use, leucrose would not be expected to pose a health concern.

The sucromalt product does not contain a protein component in its mixture, and as such it would not be expected to pose an allergenic risk.

Conclusion

Health Canada does not object to the sale of sucromalt for human food use in Canada. Food products containing sucromalt may be imported into Canada from the United States provided the labelling complies with Canadian Food and Drug Regulations.

No health claims for this product were requested or considered as part of the evaluation.

Sucromalt does not fulfill the compositional standard for "sugar" and may not be used in foods that have a prescribed composition standard which permits sugar as an ingredient.

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:

Novel Foods Section
Food Directorate
Health Products and Food Branch
Health Canada, PL2204A1
251 Frederick Banting Driveway
Ottawa, Ontario K1A 0K9
novelfoods-alimentsnouveaux@hc-sc.gc.ca