Notice of Modification to the List of Permitted Preservatives to Enable the Use of Dimethyl Dicarbonate as a Preservative in Wine and in Unstandardized Water-Based Non-Alcoholic Beverages

Notice of Modification - Lists of Permitted Food Additives
Document Reference Number: [NOM/ADM-0009]

May 22, 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 received a food additive submission seeking approval for the use of dimethyl dicarbonate (DMDC) as a preservative at a maximum level of use of 250 parts per million (p.p.m.) in various unstandardized water-based non-alcoholic beverages and at a maximum level of use of 200 p.p.m. in wine. Unstandardized water-based non-alcoholic beverages includes such products as ready-to-drink teas, fruit-flavoured sport drinks, energy drinks and carbonated flavoured soft drinks.

The results of Health Canada's evaluation of the available scientific data support the safety and efficacy of DMDC when used as requested. Since this is a food additive that was not previously permitted for use in Canada, Health Canada published an Information and Notification Document on Health Canada's Proposal to Enable the Use of Dimethyl Dicarbonate as a Preservative in Wine and in Unstandardized Water-based Non-alcoholic Beverages, on October 25, 2012, seeking comments on the use of DMDC as described above.  No new scientific information was submitted to the Department as a result of this publication. Since the conclusions of the evaluation remain as described in the publication, Health Canada has modified the List of Permitted Preservatives as indicated below.

Modification to the List of Permitted Preservatives

The following information has been added to Part 3 of the List of Permitted Preservatives:
Item No. Column 1
Additive
Column 2
Permitted in or upon
Column 3
Maximum Level of Use and Other Conditions
D.1 Dimethyl dicarbonate (1) Unstandardized water-based non-alcoholic beverages (1) 250 p.p.m.
(2) Wine (2) 200 p.p.m.

Rationale

Health Canada's Food Directorate completed a pre-market safety and efficacy assessment of DMDC. The assessment considered microbiological, toxicological and technical aspects of DMDC when used as requested in the food additive submission

Health Canada's Food Directorate also reviewed the potential exposure to an impurity in DMDC and possible reaction products that could form when DMDC is used in beverages. No toxicological concern was identified for the very low levels of these substances that might be present in beverages from the use of DMDC as a preservative.

Based on the results of the safety assessment, Health Canada's Food Directorate scientists consider that the data demonstrate the safety of DMDC under the requested conditions of use, that is, 250 p.p.m. in unstandardized water-based non-alcoholic beverages and 200 p.p.m. in wine.

Other Relevant Information

Given that one of the areas of use is wine, for which there is a compositional standard (section B.02.100 [S], Division 2 of the Food and Drug Regulations), Health Canada consulted with a national association representing the wine industry. There was no objection to the use of DMDC in wine among the association's membership.

The use of DMDC is consistent with the international Codex General Standard for Food Additives, which includes entries for the use of DMDC in "water-based flavoured drinks, including "sport", "energy" or "electrolyte" drinks and particulated drinks" to a maximum of 250 mg/kg (p.p.m.); and in "grape wines" to a maximum level of 200 mg/kg (p.p.m.).

Notification - Summary of Comments

In response to Health Canada's Information and Notification Document on Health Canada's Proposal to Enable the Use of Dimethyl Dicarbonate as a Preservative in Wine and in Unstandardized Water-based Non-alcoholic Beverages, Health Canada received several comments, all of which supported the use of DMDC as described.

No new scientific information relevant to this proposal was provided to the Department. Questions were raised regarding whether DMDC, used as described, had been appropriately classified as a food additive as is set out under section B.01.001 of the Food and Drug Regulations or whether it should be considered a food processing aid. The Food Directorate has, however, determined that DMDC meets the regulatory definition of a food additive in the applications set out in the table above.

One of the respondents also indicated that the additive should be allowed in a broader range of non-alcoholic beverages than outlined in the proposal. However, the requested foods are outside of the scope of the submission that was evaluated. Health Canada would consider a request to extend the use of DMDC to these or other foods through the filing of a food additive submission in accordance with section B.16.002 of the Food and Drug Regulations.

Since the conclusions of the safety and efficacy evaluation remain unchanged, the Department has enabled the use of DMDC as described in the above table.

Implementation and Enforcement

The above modification came into force on May 22, 2013, the day it was published in the List of Permitted Preservatives.

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 dimethyl dicarbonate. 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 "dimethyl dicarbonate" 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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