Update to the List of Permitted Sweeteners to Increase the Permitted Maximum Levels of Use for Acesulfame Potassium and Sucralose in Chewing Gum and Breath Freshener Products Regulated as Food

Notice of Modification - Lists of Permitted Food Additives
Reference Number: NOM/ADM-0006

March 6, 2013

Summary

Food additives are regulated in Canada under the Food and Drug Regulations and Marketing Authorizations (MAs) issued by the Minister of Health.  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. A petitioner can request that Health Canada approve a new food 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 received a food additive submission seeking approval for an increase in the permitted maximum level of use for acesulfame potassium and sucralose as sweeteners in chewing gum from the current levels of 0.35% and 0.15%, respectively, to 0.5% each. The Department also received a second submission requesting an increase in the permitted maximum level of use for sucralose as a sweetener in certain breath freshener products that are regulated as food (intensely flavoured breath freshening micro sweets, intensely flavoured breath freshening chewing gum, and intensely flavoured breath freshening strips) from the current level of 0.15% to 2.5%. For products described under the latter submission, Health Canada's safety assessment was conservatively based on the assumption that all breath freshener products, not just intensely flavoured breath freshening products, including chewing gum contained sucralose at a level of 2.5%.

Acesulfame potassium was first approved for use in Canada as a sweetener in 1994 and sucralose in 1991. The results of Health Canada's evaluation of available scientific data support the safety of acesulfame potassium and sucralose when used at the increased levels in chewing gum and breath freshener products as described above. Therefore, Health Canada has modified the List of Permitted Sweeteners to extend the use of acesulfame potassium and sucralose by adding the entries shown below to the list.

Modification to the List of Permitted Sweeteners
Item No. Column 1
Additive
Column 2
Permitted in or upon
Column 3
Maximum Level of Use and Other Conditions
A.01 Acesulfame potassium (11)
Chewing gum
(11)
0.5%
S.2 Sucralose (5)
Breath freshener products; Chewing gum
(5)
2.5%

In addition, the following modification is required to the List of Permitted Sweeteners as a result of increasing the permitted maximum level of use of acesulfame potassium to 0.5% in chewing gum, but not in other breath freshener products, where the maximum level of use will remain at 0.35%.

Additional Modifications to the List of Permitted Sweeteners
Item No. Column 1
Additive
Column 2
Permitted in or upon
Column 3
Maximum Level of Use and Other Conditions
A.01 Acesulfame potassium (5)
Breath freshener products (except chewing gum)
(5)
0.35%

Rationale

Health Canada's Food Directorate has completed a pre-market safety assessment of the proposed increases in the permitted maximum use levels of: (1) acesulfame potassium in chewing gum and (2) sucralose in chewing gum and breath freshener products regulated as food. The assessment considered the toxicological, chemical, microbiological and nutritional aspects of the use of acesulfame potassium and sucralose as described in the table above.

Acesulfame potassium and sucralose are currently permitted for use as food additives in chewing gum and breath freshener products up to levels of 0.35% and 0.15%, respectively. Both of these sweeteners are permitted for use in a variety of food categories including table-top sweeteners, unstandardized beverages, unstandardized desserts, unstandardized fruit spreads, unstandardized confectionery and unstandardized bakery products. In table-top sweeteners the maximum level of use is identified as good manufacturing practice, while in other foods the levels of use range from 0.007% to 0.35% for acesulfame potassium and 0.015% to 0.15% for sucralose.

Health Canada's assessment has concluded that increasing the permitted maximum level of use of acesulfame potassium in chewing gum and sucralose in chewing gum and breath freshener products, as described in the above table, does not represent a safety concern.

Other Relevant Information

  • Acesulfame potassium and sucralose used in foods sold in Canada must meet the food-grade specifications for these additives set out in the most recent edition of the Food Chemicals Codex, a compendium of standards for the purity and identity of food ingredients, including food additives, which is published by the United States Pharmacopeial Convention.
  • The Codex General Standard for Food Additives (GSFA) has provisions for the use of acesulfame potassium and sucralose in chewing gum at a maximum use level of 5000 mg/kg (specifically, 0.5%). Also, the GSFA provides for the use of sucralose for use in microsweets and breath freshening mints at 30,000 mg/kg (specifically, 3%).

Based on the results of the safety assessment, Health Canada's Food Directorate considers that the available scientific data support the safety of acesulfame potassium and sucralose when used under the conditions of use set out in the table above. The Department has therefore enabled the use of acesulfame potassium and sucralose as described in the above table.

Implementation and Enforcement

The above modifications came into force the day they were published in the List of Permitted Sweeteners.

The Canadian Food Inspection Agency is responsible for the enforcement of the food-related aspects of the Food and Drugs Act and its associated regulations.

Contact Information

Health Canada's Food Directorate is committed to reviewing any new scientific information on the safety in use of any food additive, including acesulfame potassium and sucralose. Anyone wishing to submit new scientific information on the use of acesulfame potassium and sucralose, or to submit any inquiries, may do so in writing, by regular mail or electronically. If you wish to contact the Food Directorate electronically, please use the words "acesulfame potassium" or "sucralose" in the subject line of your e-mail.

Bureau of Chemical Safety
251 Sir Frederick Banting Driveway
Tunney's Pasture, PL: 2202C
Ottawa, Ontario K1A 0L2
E-mail: bcs-bipc@hc-sc.gc.ca

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