Consultation Document on Health Canada's Proposal to Enable the Use of a New Food Additive, Monk Fruit Extract (Luo Han Guo Extract), as a Sweetener in Table-Top Sweeteners

March 14, 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 monk fruit extract, also known as luo han guo extract, as a sweetener at a maximum level of use of 0.8% in table-top sweeteners.

The results of Health Canada's evaluation of available scientific data support the safety and efficacy of monk fruit extract when used as proposed. Therefore, it is the intention of Health Canada to modify the List of Permitted Sweeteners by adding the following entry to the list.

Rationale

Health Canada's Food Directorate has completed its pre-market safety and efficacy assessment of monk fruit extract when used as described in the table above. The assessment considered toxicological, chemical, microbiological, nutritional and technical aspects of the proposal.

Monk fruit is the fruit of the plant Siraitia grosvenorii (formerly Momordica grosvenorii Swingle). The plant is a perennial vine belonging to the Cucurbitaceae (cucumber or melon) family which produces a round green fruit. The chemical structures of the sweetening components naturally found in the fruit belong to the triterpenoid group of chemicals and are named mogrosides. The monk fruit extract is obtained from the fruit through a process involving water extraction, filtration and selective concentration of the sweetening components. The finished extract contains no less than 30% mogroside V. The primary sweetening component of monk fruit extract, mogroside V, is 300 to 400 times as sweet as sucrose.

Studies were assessed on the stability of monk fruit extract itself and as a component of a table-top sweetener under various storage temperatures, heat treatment temperatures and a range of pH levels. These studies confirm the stability of the sweetening components of the extract.

No microbiological or nutritional safety concerns have been identified for monk fruit extract when used as proposed and there are no reports indicating a potential association between the ingestion of monk fruit extract and allergies despite a long history of use in other countries, particularly in dietary supplements.

The safety of monk fruit extract was demonstrated in studies that were designed to specifically examine whether monk fruit extract had the ability to cause harmful effects. These studies investigated how monk fruit extract is handled by the body once ingested (metabolism studies); how the consumption of monk fruit extract could adversely affect the health of laboratory animals (acute and short-term oral toxicity studies); and the potential for monk fruit extract to cause mutations (genetic toxicity studies). Other studies examined the effect of monk fruit extract on diabetic and non-diabetic laboratory animals, as well as in diabetic and non-diabetic human volunteers. The results of the assessment of these studies were considered in relation to an evaluation of total dietary exposure to monk fruit extract if present in table-top sweeteners.

Based on the results of the safety assessment, Health Canada's Food Directorate considers that the data support the safety of monk fruit extract under the conditions of use set out in the table above. The Department is therefore proposing to enable the use of monk fruit extract as described in the table.

Other Relevant Information

• Monk fruit extract used in table top sweeteners sold in Canada would be required to meet the food-grade specifications set out in the most recent edition of the Food Chemicals Codex (FCC), a compendium of standards for the purity and identity of food ingredients, including food additives, which is published by United States Pharmacopeial Convention. A key specification of the FCC monograph is that the monk fruit extract contain not less than 30% mogroside V.
• In the United States, two Generally Recognized as Safe (GRAS) notices (GRN 000359 and 000301) for monk fruit extract with a mogroside V content of (25%, 45% or 55%) and >30%, respectively, have been submitted to the Food and Drug Administration (FDA) for review since July 2009. The US FDA has raised no objections regarding the petitioners' determination of GRAS (i.e., self-affirmed GRAS) status of the monk fruit extracts for use as a sweetener and flavour enhancer in foods, excluding meat and poultry products, at levels of use consistent with good manufacturing practice.
• Australia and New Zealand, and the European Union do not permit monk fruit extract as a food additive.
• Monk fruit extract is not listed in the Codex General Standard for Food Additives (GSFA).
• According to published literature, monk fruit extract has been sold as a dietary supplement in Japan, the United States of America, New Zealand and Australia for a number of years.

Implementation and enforcement

The proposed change will be effective the day on which it is published in the List of Permitted Sweeteners. 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 the:

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

"monk fruit extract"

in the subject line of your e-mail. Health Canada is able to consider information received by May 27, 2013, 75 days from date of this posting.