Health Canada’s Proposal to Enable the Use of Long-Chain Glycolipids from Dacryopinax spathularia MUCL 53181 as a Preservative in Various Non-Alcoholic Beverages

Notice of Proposal – Lists of Permitted Food Additives

Reference Number: NOP/ADP-0037

September 23, 2021

(PDF version: 717 K, 5 pages)

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 long-chain glycolipids from Dacryopinax spathularia MUCL 53181 as a preservative in certain standardized and unstandardized non-alcoholic beverages. The requested maximum use levels range from 25 parts per million (ppm) to 100 ppm in the finished beverage. The petitioner stated that long-chain glycolipids from D. spathularia MUCL 53181 can be used as an alternative or complement to other preservation techniques such as heat treatment or as a substitute for currently permitted preservatives in beverages.

The Food Directorate concluded that information related to the safety and efficacy of long-chain glycolipids from D. spathularia MUCL 53181 supports its use as an antibacterial agent and an antifungal/antimycotic agent in the beverages of interest. Therefore, Health Canada proposes to enable this use of long-chain glycolipids from D. spathularia MUCL 53181 by adding the entries shown in the tables below to Part 2 and Part 3 of the List of Permitted Preservatives.

Proposed Modifications to Part 2 and Part 3 of the List of Permitted Preservatives

The following information is proposed to be added in Part 2 of the List of Permitted Preservatives:

The following information is proposed to be added in Part 3 of the List of Permitted Preservatives:

Rationale

Health Canada’s Food Directorate completed a premarket safety and efficacy assessment of the requested uses of long-chain glycolipids from D. spathularia MUCL 53181. The Department concluded that information related to allergenicity, chemistry, microbiology, molecular biology, nutrition, and toxicology supports the safety and efficacy of long-chain glycolipids from D. spathularia MUCL 53181 for its requested uses. 

Long-chain glycolipids from D. spathularia MUCL 53181 is a mixture of long chain glycolipids obtained by submerged fed-batch pure culture fermentation of the edible jelly fungus Dacryopinax spathularia (Schwein) G.W. Martin strain MUCL 53181. This mushroom species is also known as “sweet osmanthus ear” and belongs to phylum Basidiomycota.

The production begins with an inoculum of D. spathularia MUCL 53181, which undergoes seed fermentation, followed by main fermentation. The seed fermentation is run under controlled agitation and air supply. The main fermentation is a controlled, fed batch, submerged fermentation process. The main fermentation is carried out at 30°C, and it runs for several days in order to achieve the maximum concentration of glycolipids (not less than 93.0%). Spray or freeze drying leads to the final commercial product, which is a white to off-white/ivory, water soluble powder.

Glycolipids are not identified as food allergens and no reports of allergic reactions to the source organism were located in the literature despite this mushroom having a long history of food use. Long-chain glycolipids from D. spathularia MUCL 53181 is unlikely to be genotoxic and is not mutagenic or clastogenic. Health Canada established an acceptable daily intake (ADI) of 2.5 mg/kg bw. Its use as a preservative as proposed does not pose any chemical, microbiological, nutritional or toxicological safety concerns.

The results of the premarket assessment support the safety and efficacy of long-chain glycolipids from D. spathularia MUCL 53181 for use as a preservative as set out in the tables above. Health Canada is therefore proposing to enable the uses of this new food additive as shown in the above tables.

Other Relevant Information

Australia and New Zealand permit ‘sweet osmanthus ear glycolipids’ in various non-alcoholic beverages at levels ranging from 10 to 100 mg/kg, depending on the beverage.^{Footnote 1} “Sweet osmanthus ear glycolipids” are the same long chain glycolipids obtained from D. spathularia MUCL 53181 that have been requested for use in Canada. In the United States, long-chain glycolipids from D. spathularia MUCL 53181 is a substance Generally Recognized as Safe (GRAS) for use as an antimicrobial preservative in various non-alcoholic beverages at use levels ranging from 2 to 100 mg/kg (or mg/L).^{Footnote 2}

Food additives such as long-chain glycolipids from D. spathularia MUCL 53181 are required to meet food-grade specifications set out in Part B of the Regulations or those set out in 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. The Combined Compendium of Food Additive Specifications, which contains specifications prepared by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), is published by the Food and Agriculture Organization of the United Nations. There are no specifications for long-chain glycolipids from D. spathularia MUCL 53181 in either of those publications. Until such time that a specification is established within the FCC or by JECFA for long-chain glycolipids from D. spathularia MUCL 53181, Health Canada considers the specifications provided by the petitioner to be acceptable.

Implementation and Enforcement

The proposed changes will be effective the day on which they are published in Part 2 and Part 3 of the List of Permitted Preservatives. 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: hc.bcs-bipc.sc@canada.ca

If communicating by e-mail, please use the words “long-chain glycolipids (NOP-0037)” in the subject line of your e-mail.  Health Canada is able to consider information received by December 6, 2021, 75 days from the date of this posting.