Novel Food Information - Biscuits Leclerc Praeventia Cookies with Red Wine Extract

Health Canada has notified Biscuits Leclerc Ltée that it has no objection to the sale of dark chocolate chip 70% cocoa cookies containing added red wine extract (herein referred to as Praeventia cookies with red wine extract). The red wine extract is produced by Cyvex Nutrition of Irvine, California from grape seeds and grape skins after fermentation and contains resveratrol and other polyphenols. One biscuit packet (30 g) contains 113.1 mg of total polyphenols, 0.204 mg resveratrol and 2.19 g inulin. The cookies are to be marketed for an adult population and used as a dessert or snack.

The Department has conducted a comprehensive safety assessment, including how the red wine extract was developed; the composition and nutritional quality of the cookies compared with other cookies in Canada and the potential for the presence of any toxicants, anti-nutrients, or allergens.

Background:

The following provides a summary of the notification from Biscuits Leclerc Ltée and the evaluation by Health Canada and contains no confidential business information.

"Praeventia" refers to Biscuits Leclerc Ltée's line marketed as "wellness" cookies comprising dark chocolate chips (70% cocoa) with added ingredients such as antioxidants, green tea extract, whole grains, inulin and red wine extract. The red wine extract is from grapes, Vitis vinifera L.

1. Introduction

Praeventia cookies with red wine extract are considered novel under the definition of novel foods in that it is "a substance that does not have a history of safe use as a food". Red wine has a history of safe use that can be measured in millennia whereas red wine extract does not. The negative effects of red wine are primarily due to the alcohol content, which would not occur with the red wine extract (alcohol content of 0.08% in the extract versus 12 to 14% in red wine).

2. Description of the Novel Food

Red wine extract contains concentrated carbohydrate and polyphenols (including resveratrol) and is prepared from fermented grape seeds and grape skins used in the production of red wine. Inulin in the cookies is obtained from chicory root. One package of Praeventia Cookies with red wine extract contains 113.1 mg total polyphenols (compared to 108.3 mg in 125 mL red wine and 212.8 mg in grape juice). The resveratrol level is less than in grape juice but more than in red wine (although wine varieties of different origins have a wide range of resveratrol amounts).

3. Product Development/Composition of product

Grapes are fermented and then the grape seeds and skins are collected, purified and concentrated. They undergo a water extraction and are then purified on adsorbent resin. The extract is washed with 60% ethanol, and then distilled to concentrate the grape polyphenols and remove the ethanol. The concentrated material is then spray dried into a powder.

4. Dietary Exposure

One serving of cookies is one packet (30 g). Red wine extract is added at a level of 0.062% such that one packet contains 113.1 mg total polyphenols, 0.204 mg resveratrol and 2.19 g of inulin with an ethanol content of 0.08%. One serving of Praeventia cookies with red wine extract (30 g) contains less total polyphenols, resveratrol and alcohol than a serving (125 mL) of red wine or grape juice. Specifically, red wine contains 0.48 to 0.91 mg resveratrol per 125 mL, and 12 to 14% ethanol. The inulin content of the cookies is comparable to that found in garlic, pears, and onions.

5. Chemical Assessment

These cookies are targeted for an adult population. From a chemical perspective, no concerns were raised. Specifications with regard to heavy metals are considered acceptable and there are no added food colours. The chemicals of concern resulting from the addition of red wine extract are the alcohol residues from the extraction process and sulphites.

The alcohol residue in the extract was measured as 785.6 ppm and the extract is present at a level of 0.062% in cookies. Assuming no alcohol is lost due to evaporation, the maximum possible level of 0.487 ppm ethanol is not considered a concern.

6. Microbiological Assessment

Microbiological safety data was submitted by Biscuits Leclerc Ltée as well as certificates of analysis which included microbial specifications (total plate counts, yeast and mould levels and total coliforms (E. coli and Salmonella spp.) for several batches of the red wine extract. Based on the information provided by Cyrex Nutrition, the addition of red wine extract to Praeventia cookies would not increase the exposure to microbial pathogens.

7. Nutrition

The nutritional analysis of the cookies indicated the addition of red wine extract does not affect the proximate composition (ash, moisture, carbohydrates, fat and protein) and that the nutrient composition of Praeventia cookies with red wine extract is comparable to conventional, commercial cookies. The cookies have increased polyphenols, resveratrol and inulin. These levels are comparable to other foods as described above.

The amount of fibre (inulin) present per serving meets the conditions that would permit a "source of fibre" nutrient content claim.

8. Toxicology

The toxicological assessment concluded there are no toxicological concerns with the marketing of Praeventia cookies with red wine extract in Canada.

The novelty of the cookies results from the addition of red wine extract which provides resveratrol and other polyphenols at levels comparable to those found in commonly consumed products such as grape juice and wine. The grapes used to make the red wine extract are not a source of antinutrients or toxins. There is no added food colour other than the colour imparted through the red wine extract.

The very low levels of ethanol (0.08%), a residue of the extraction process, and endogenously formed sulphites in the red wine extract are present in parts per billion and are not of toxicological concern. The presence of inulin contributes to fibre content and is also not a concern.

There is a small amount of protein from the grapes but it is not a source of any major allergens.

Red wine extract contains sulphites at a level of up to 300 ppm and when it is added at a level of 0.062%, results in a negligible amount (5.6 micrograms per 30 g package) or 0.186 ppm. There is no added food colour other than the colour imparted through the wine extract.

The group acceptable daily intake (ADI) for sulphites set by both Health Canada and JECFA (Joint FAO/WHO Expert Committee on Food Additives) is 0 to 0.7 mg/kg body weight. A 60-kg adult could safely consume 42 mg of sulphites per day and a 10-kg child could consume 7 mg per day. The intake of sulphites from one packet of cookies is 125 times below the ADI on a kg body weight basis and 1,250 times below the acceptable intake for a 10-kg child.

Although there are sulphites present, the low level is not a concern from an allergenicity or intolerance perspective. No additional labelling for sulphites is required other than to be included in the list of ingredients on the label.

Conclusion:

Health Canada does not object to the sale of Praeventia cookies with red wine extract as food in Canada.

This Novel Food Information document has been prepared to summarize the opinion regarding the subject product provided by the Food Directorate, Health Products and Food Branch, Health Canada. This opinion is based upon the comprehensive review of information submitted by the petitioner according to the Guidelines for the Safety Assessment of Novel Foods.

For further information, please contact:

Novel Foods Section
Food Directorate
Health Products and Food Branch
Health Canada, PL2204A1
251 Frederick Banting Driveway
Ottawa, Ontario K1A 0K9
novelfoods-alimentsnouveaux@hc-sc.gc.ca

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