Update to the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents to Enable the Use of Propylene Glycol Mono Fatty Acid Esters as an Emulsifier and Stabilizer in Ice Milk Mix

Notice of Modification - Lists of Permitted Food Additives
Reference Number: NOM/ADM-0005

February 13, 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 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 has received a food additive submission seeking approval for the use of propylene glycol mono fatty acid esters as an emulsifier and stabilizer at a maximum level of 0.35% in ice milk made from ice milk mix. There are standards of composition for ice milk and ice milk mix set out in section B.08.072 and section B.08.071, respectively, of Division 8 of the Food and Drug Regulations (Part B). However, there is no provision in the Lists of Permitted Food Additives for the use of propylene glycol mono fatty acid esters in either of these standardized foods.

Propylene glycol mono fatty acid esters is already permitted for use in Canada as an emulsifier and stabilizer in unstandardized foods at a level consistent with Good Manufacturing Practice (GMP) as well as in ice cream mix at a maximum level of use of 0.35% of the ice cream made from the mix. 

The results of Health Canada's evaluation of available data support the safety and efficacy of propylene glycol mono fatty acid esters when used as requested by the petitioner.  Therefore, Health Canada has modified the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents to extend the use of this food additive by adding the following entry to the list.

Rationale

Health Canada's Food Directorate has completed a pre-market safety assessment of propylene glycol mono fatty acid esters.  The assessment considered the toxicological, chemical and technical aspects of propylene glycol mono fatty acid esters when used as requested in the food additive submission.   

Propylene glycol mono fatty acid esters used in foods sold in Canada meet the food-grade specifications for this additive set out in the most recent edition of the Food Chemicals Codex. Propylene glycol esters of fatty acids, which includes propylene glycol mono fatty acid esters, is listed in Table 1 of the Codex Alimentarius General Standard for Food Additives (GSFA). The GSFA provides for its use in a variety of foods including food category 01.7 dairy based desserts (for example, pudding, fruit or flavoured yogurt), a category that includes ice cream and ice milk, at a maximum level of use of 5,000 mg/kg (i.e., 0.5% or 5,000 p.p.m.).

Since the petitioner requested the extension of use of propylene glycol mono fatty acid esters to a standardized food, Health Canada consulted with the Canadian Food Inspection Agency (CFIA) and the appropriate food industry associations.  Responses were received from the CFIA and one of the industry associations.  No objections, regarding the proposed use of this additive in the standardized product, were received.

Based on the results of the safety assessment, Health Canada's Food Directorate considers that the data support the safety of propylene glycol mono fatty acid esters when used in ice milk mix at levels that result in no more that 0.35% of the additive in the ice milk made from the mix.  The Department has therefore enabled the use of propylene glycol mono fatty acid esters as described in the table above.

Implementation and Enforcement

The above modification came into force the day it was published in the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents.

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

Health Canada's Food Directorate is committed to reviewing any new scientific information on the safety in use of any food additive, including propylene glycol mono fatty acid esters. Anyone wishing to submit new scientific information on the use of this additive 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 "propylene glycol mono fatty acid esters" 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