ARCHIVED - NuSunTM MID-OLEIC SUNFLOWER OIL

Novel Food Information

Health Canada has notified Archer Daniels Midland Company that it has no objection to the food use of NuSun^TM mid-oleic sunflower oil. The Department conducted a comprehensive assessment of NuSun^TM mid-oleic sunflower oil according to its Guidelines for the Safety Assessment of Novel Foods. These Guidelines are based upon internationally accepted principles for establishing the safety of novel foods.

BACKGROUND:

The following provides a summary of Health Canada's assessment of Archer Daniels Midland Company's notification to the Department and contains no confidential business information.

1. Introduction

Archer Daniels Midland Company has developed NuSun^TM sunflower hybrids with a mid-oleic phenotype. Mid-oleic sunflower oils have a number of beneficial properties with respect to a longer shelf life and increased stability during frying. This oil falls outside the standard for sunflower oil in the Food and Drug Regulations with respect to iodine value, refractive index and relative density.

2. Development and Production of the Modified Plant

NuSun^TM hybrids have been produced by breeding a traditional sunflower line that is low in oleic acid with a high-oleic acid sunflower line, resulting in a hybrid cultivar that falls within a mid-oleic range. These hybrids were developed by conventional breeding, therefore no novel DNA has been introduced to achieve the mid-oleic phenotype.

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.

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For further information, please contact:

Novel Foods Section

Food Directorate

Health Products and Food Branch

Health Canada

Tunney's Pasture

Ottawa, Ontario K1A 0L2

Telephone: (613) 941-5535

Facsimile: (613) 952-6400

3. Product Information

NuSun

TM

hybrid sunflower seeds exhibit an oil composition of oleic acid (18:1) in the range of 55-75% and linoleic acid (18:2) in the range of 15-35%. This compares to an oleic content of 13-40% and linoleic acid content of 40-74% in traditional sunflower oils. The high linoleic acid content found in traditional sunflower oils is associated with poor frying stability. In addition, linoleic acid oxidizes more readily than oleic acid which decreases the shelf life of traditional sunflower oils. Thus, a mid-oleic oil with higher than traditional levels of oleic acid and lower than traditional linoleic acid levels is preferable in these regards.

4. Dietary Exposure

NuSun

TM

oil is expected to be used in similar applications as other sunflower and vegetable oils for home use and by the food industry. It may be used to replace partially hydrogenated oils and fats which are sources of trans and saturated fatty acids.

5. Nutrition

As noted above, the levels of oleic acid in the NuSun

TM

are higher than those found in traditional sunflower oil, and the linoleic acid levels are lower in the NuSun

TM

oils. There were also minor changes in some other fatty acids that are present in smaller amounts. These were not considered nutritionally significant. The alpha tocopherol levels in the NuSun

TM

oil fell within ranges found in the literature and in the Canadian Nutrient File for various commercial sunflower oils There are no nutritional concerns associated with the introduction of NuSun

TM

mid-oleic oil in Canada as long as consumers are informed about the change in fatty acid composition compared to traditional sunflower oil.

6. Toxicology

There are no toxicological concerns associated with NuSun

TM

oil based on the fact that both parent plants are commonly used as food and no novel substances have been introduced.

CONCLUSION:

Health Canada's review of the information presented in support of the food use of NuSun^TM mid-oleic sunflower oil, concluded that this oil does not raise any concerns related to human food safety. Health Canada is of the opinion that NuSun^TM mid-oleic sunflower oil is as safe as oils derived from current commercial sunflower varieties, differing only in nutritional quality due to its intentionally modified fatty acid profile. Health Canada's opinion deals solely with respect to the suitability for sale as human food of NuSun^TM mid-oleic sunflower oil.

It should be noted that since the fatty acid profile differs from traditional sunflower oil, the common name used on labels including in ingredient lists should reflect this difference. The issue of mid-oleic sunflower oils not meeting the standard for sunflower oil in the Food and Drug Regulations could be addressed by applying the modified common name. Nutrition labelling will also assist consumers in choosing foods including sunflower oils with varying fatty acid composition.