Health Canada’s Proposal to Enable the Use of alpha-Cyclodextrin as an Emulsifying, Stabilizing or Thickening Agent in Various Foods

Notice of Proposal – Lists of Permitted Food Additives
Reference Number: NOP/ADP-0039
October 6, 2022
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Summary

Food additives are regulated in Canada under Marketing Authorizations (MAs) issued by the Minister of Health and the Food and Drug Regulations (Regulations). Approved food additives and their permitted conditions of use are set out in the Lists of Permitted Food Additives that are incorporated by reference in the MAs and published on the Canada.ca website. A petitioner can request that Health Canada approve a new additive or a new condition of use for an already approved food additive by filing a food additive submission with the Department's Food Directorate. Health Canada uses this premarket approval process to determine whether the scientific data support the safety of food additives when used under specified conditions in foods sold in Canada.

Health Canada’s Food Directorate received a food additive submission seeking approval for the use of alpha-cyclodextrin in numerous foods at maximum levels of use ranging from 1% to 5%, depending on the food. The petitioner indicated that alpha-cyclodextrin functions primarily as an emulsifier, stabilizer and thickener.

The Food Directorate concluded that information related to the safety and efficacy of alpha-cyclodextrin supports its use for one or more of these functions in the following foods: unstandardized bakery products, beverage whiteners, unstandardized emulsified sauces, unstandardized dips, icings and yogurt. Therefore, Health Canada proposes to enable the use of alpha-cyclodextrin by adding the entries shown in the table below to the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agent.

Rationale

Health Canada’s Food Directorate completed a premarket safety and efficacy assessment of various requested uses of alpha-cyclodextrin. The assessment concluded that information related to allergenicity, chemistry, microbiology, molecular biology, nutrition, and toxicology supports the safety of alpha-cyclodextrin for use as proposed in this Notice, and technical information indicates this food additive is effective for use as an emulsifying, stabilizing or thickening agent.

Alpha-Cyclodextrin (CAS 10016-20-3), also known as alfadex and cyclohexaamylose, is a cyclic oligosaccharide, consisting of six alpha-(1,4)-linked glucose units. It is manufactured from liquefied cornstarch in a multistep process that uses several substances. The liquefied cornstarch is treated with the enzyme cyclodextrin glycosyltransferase (CGTase; EC 2.4.1.19; CAS 9030-09-5), which converts the linear starch molecules into cyclic, crown-shaped molecules. The final alpha-cyclodextrin product is a white, odourless powder that is purified to 98% or more alpha-cyclodextrin.

Efficacy data and other technical information support the use of alpha-cyclodextrin as a food additive in certain types of oil and water emulsion-based foods (e.g., coffee whiteners, cooking sauces, dips, dressings, icings), yogurt, and certain bakery products.

Most of the alpha-cyclodextrin that is consumed as a food ingredient will be digested by bacteria in the lower intestine to regular dietary components, such as short chain fatty acids. At high consumption amounts (e.g. more than 7 grams per day in the case of alpha cyclodextrin), consumers may experience mild gastrointestinal effects such as abdominal pain, bloating, nausea and diarrhea. This is not unusual with high consumption of isolated fibre sources, and these effects are expected to resolve within hours of stopping intake of alpha-cyclodextrin, without the need for additional treatment.

No further nutritional concerns and no allergenic, chemical, microbiological, molecular biological or toxicological safety concerns were identified with the proposed uses of alpha-cyclodextrin. The results of the premarket assessment support the safety and efficacy of alpha-cyclodextrin for use as set out in the table above. Health Canada is therefore proposing to enable the use of this food additive as shown in the table.

Other Relevant Information

Alpha-Cyclodextrin is a permitted novel food in Australia, New Zealand and the European Union. In the United States, the Food and Drug Administration had no further questions about the notifier’s conclusion that alpha-cyclodextrin is ‘Generally Recognized as Safe’ (GRAS) for use in “selected foods for fiber supplementation, as a carrier or stabilizer for flavors (flavor adjuvant), colors, vitamins and fatty acids, and to improve mouth-feel in beverages”, as detailed in their response letter^{Footnote 1}. In the international Codex General Standard for Food Additives (GSFA), alpha-cyclodextrin (INS 457) is a Table Three additive assigned the functional classes of stabilizer and thickener. As such, it is acceptable in foods in general at quantum satis levels, except foods that are in the annex to Table Three.

The petitioner has determined that alpha-cyclodextrin meets the definition of dietary fibre for labelling purposes. This determination should not be interpreted as Health Canada recognizing alpha-cyclodextrin as a fibre source. Fibre declarations and content claims are subject to regulatory oversight, as described in Health Canada’s Policy for Labelling and Advertising of Dietary Fibre-Containing Food Products. Manufacturers can voluntarily request that Health Canada recognize a fibre source by submitting the request and accompanying data to the Food Directorate’s Bureau of Nutritional Sciences for consideration.

Food additives such as alpha-cyclodextrin are required to meet food-grade specifications set out in Part B of the Regulations, where such specifications exist, or those set out in the most recent edition of the Food Chemicals Codex or the Combined Compendium of Food Additive Specifications. The Food Chemicals Codex is a compendium of standards for purity and identity for food ingredients, including food additives, published by the United States Pharmacopeial Convention. Specifications in the Combined Compendium of Food Additive Specifications are prepared by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and published by the Food and Agriculture Organization of the United Nations.

Implementation and Enforcement

The proposed change will be effective the day on which it is published in the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents. This will be announced via a Notice of Modification that will be published on the Government of Canada’s website.

The Canadian Food Inspection Agency is responsible for the enforcement of the Food and Drugs Act and its associated regulations with respect to foods. 

Contact Information

For additional information or to submit comments related to this proposal, please contact: 

Bureau of Chemical Safety, Food Directorate
251 Sir Frederick Banting Driveway
Tunney’s Pasture, PL: 2202C
Ottawa, Ontario K1A 0K9
E-mail: bcs-bipc@hc-sc.gc.ca

If communicating by e-mail, please use the words “alpha-cyclodextrin (NOP-0039)” in the subject line of your e-mail. Health Canada is able to consider information received by December 19, 2022, 75 days from the date of this posting.