Consultation on a Proposal to Enable the Use of Glycerol Ester of Gum Rosin and Glycerol Ester of Tall Oil Rosin as Density Adjusting Agents in Beverages Containing Citrus or Spruce Oils

Notice of proposal - Lists of Permitted Food Additives

May 2, 2013

Summary

Food additives are regulated in Canada under Marketing Authorizations (MAs) issued by the Minister of Health and the Food and Drug 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. 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 two separate food additive submissions seeking approval for the use of glycerol ester of gum rosin and glycerol ester of tall oil rosin, respectively, as density adjusting agents at a maximum level of use of 100 parts per million (p.p.m.) in beverages containing citrus oils. Although neither of these food additives is currently permitted, glycerol ester of wood rosin, a similar food additive, is permitted for use in beverages containing citrus or spruce oils for the same purpose and at the same level of use.

The results of Health Canada's evaluation of available data support the safety of glycerol ester of gum rosin and glycerol ester of tall oil rosin when used in beverages containing citrus or spruce oils as is currently permitted for glycerol ester of wood rosin. Further, the safety in use and the technical function of glycerol ester of wood rosin, glycerol ester of gum rosin and of glycerol ester of tall oil rosin support their use in a manner that provides the choice of using only one or a combination of any of the three, provided the total level of use does not exceed 100 p.p.m. Therefore, it is the intention of Health Canada to modify the List of Permitted Food Additives with Other Generally Accepted Uses by adding the following entries to the list.

These proposed modifications set out a maximum level of use for glycerol ester of gum rosin and glycerol ester of tall oil rosin, when used singly or in combination with one another or with glycerol ester of wood rosin, in beverages containing citrus or spruce oils. Since these proposed modifications would allow for the use of combinations of glycerol ester of gum rosin, glycerol ester of tall oil rosin and glycerol ester of wood rosin, the existing conditions of use for glycerol ester of wood rosin also need to be modified. Therefore, it is also proposed that the entry in Column 4 of Item G.4 of the List of Permitted Food Additives with Other Generally Accepted Uses, which sets out the maximum level of use for glycerol ester of wood rosin in these beverages, be modified, as indicated in the table below.

In addition, it is proposed that the name of the additive for item G.4 in the Liste des additifs alimentarires autorisés ayant d'autres utilisations généralement acceptées be changed from "Ester glycérique de la colophane" to "Esters glycériques de résine de bois" to align with the name used in the International Numbering System for Food Additives CAC/GL-36-1989. It should be noted that this change would not prevent the use of the term "ester glycérique de la colophane" in the list of ingredients on food labels as it would considered an acceptable synonym for "esters glycérique de résine de bois".

Rationale

Health Canada's Food Directorate has completed two separate pre-market safety assessments, one of glycerol ester of gum rosin and the other of glycerol ester of tall oil rosin, when used as density adjusting agents in beverages containing citrus or spruce oils. Citrus-flavoured and spruce-flavoured beverages are examples of oil-in-water emulsions. The effect of glycerol ester of gum rosin and glycerol ester of tall oil rosin, as with glycerol ester of wood rosin, is to reduce the tendency of the oil to separate from the water, thereby stabilising the beverage emulsion. In the absence of a density adjusting agent, citrus oils or spruce oils used as flavouring agents in soft drinks tend to coalesce and rise to the surface, leading to the oxidation of the flavouring oils.

The safety assessments of the two additives considered the toxicological and chemical aspects of the proposals.

Health Canada has established a group acceptable daily intake (ADI) of 12.5 milligrams per kilogram body weight per day (mg/kg bw/day) for glycerol ester of gum rosin, glycerol ester of tall oil rosin, and glycerol ester of wood rosin. This group ADI means that the acceptable total intake of any one or any combination of these additives from food is 12.5 mg/kg bw/day.

Potential intakes of glycerol ester of gum rosin and glycerol ester of tall oil rosin, estimated using consumption data for soft drinks from the 2004 Canadian Community Health Survey - Cycle 2.2 on Nutrition (CCHS 2.2) are below this ADI by an order of magnitude. The intakes were estimated assuming each additive is used singly in soft drinks at the proposed maximum level of use of 100 p.p.m. If the additives were to be used together and/or with glycerol ester of wood rosin, combinations of which would be permitted by the proposed maximum level of use, the estimated total intake would be the same (i.e. an order of magnitude lower than the group ADI) since the proposed maximum level of use is 100 p.p.m. whether the additives are used singly or in combination.

Based on the results of the safety assessments, Health Canada's Food Directorate considers that the data support the safety of glycerol ester of gum rosin and glycerol ester of tall oil rosin when used under the conditions set out in the table above. The Department is therefore proposing to enable the use of these food additives as described in that table.

Other Relevant Information

Glycerol ester of gum rosin and glycerol ester of tall oil rosin used in beverages containing citrus or spruce oils sold in Canada would be required to 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.

Implementation and enforcement

The proposed change will be effective the day on which it is published in the List of Permitted Food Additives with Other Generally Accepted Uses. This will be announced via a Notice of Modification which will be published on Health 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
251 Sir Frederick Banting Driveway
Tunney's Pasture, PL: 2202C
Ottawa, Ontario K1A 0L2
E-mail: bcs-bipc@hc-sc.gc.ca

If communicating by e-mail, please use the words "glycerol ester of gum rosin and/or glycerol ester of tall oil rosin" in the subject line of your e-mail. Health Canada is able to consider information received by July 15, 2013, 75 days from date of this posting.