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Health Canada has notified Pioneer Hi-Bred International, Inc. that it has no objection to the food use of the novel canola lines 45A37 and 46A40, which have been developed to produce oil with high oleic acid content in combination with low linolenic acid content. The Department conducted a comprehensive assessment of 45A37 and 46A40 according to its Guidelines for the Safety Assessment of Novel Foods (September 1994). These guidelines are based upon internationally accepted principles for establishing the safety of foods derived from genetically modified organisms.
The following provides a summary regarding the Pioneer Hi-Bred International Inc. notification to Health Canada and contains no confidential business information.
The 45A37 and 46A40 lines of canola (Brassica napus) were developed through the combination of induced mutagenesis, to achieve the high oleic acid trait, and traditional breeding with the registered canola varieties Stellar and Apollo, to achieve the low linolenic acid trait. The processed oil derived from these novel varieties, designated P6 canola oil, has levels of oleic acid similar to that of peanut and olive oils.
The high oleic acid trait in lines 45A37 and 46A40 was selected following induced mutagenesis by exposing seeds of canola varieties Regent, Topas and Andor to a solution of ethylnitrosourea (8 mM) in dimethylsulfoxide. It is believed that the induced mutation in lines 45A37 and 46A40 is analogous to that in fad2 mutants of Arabidopsis thaliana. The fad2 gene encodes a desaturase enzyme that catalyzes the conversion of C18:1 to C18:2 and C18:3 fatty acids in plant cells. A mutation within the fad2 gene that blocks expression of an active desaturase enzyme results in the accumulation of C18:1 oleic acid. The low linolenic acid trait was introduced by breeding with the registered low linolenic acid canola varieties Stellar and Apollo. The only significant difference between lines 45A37 and 46A40 is that the former was selected for early maturity while 46A40 matures later in the growing season (medium maturity).
Based on the information provided, there are no novel proteins produced and only the refined seed oil will be used as a food. Refined edible canola oil does not contain any detectable protein and consists of purified glycosides. Other than the traits of high oleic acid content and low linolenic acid content in the seed oil, the disease, pest and other agronomic characteristics of the 45A37 and 46A40 canola lines were comparable to other commercially available canola varieties.
The human consumption of canola products is limited to the refined oil. High oleic acid oils are reported to be desirable as cooking oils because of their greater oxidative stability when compared with polyunsaturated oils. The level of oleic acid in P6 canola oil is similar to levels in peanut and olive oils.
A comparison of the oleic, linoleic and linolenic acid levels in P6 canola oil and other dietary oils is shown in Table 1. Canola oil from lines 45A37 and 46A40 (P6 oil) contained 24% higher levels of oleic acid and 40% or 75% lower levels of linoleic and linolenic acid, respectively, when compared with traditional canola oil. The analysis of other fatty acids, unsaponifiable matter, saponification value, iodine value and refractive index did not reveal any significant differences between P6 oil and traditional canola oil. The levels of tocopherols in P6 oil were lower than for regular canola oils, as was the peroxide value, which is consistent with P6 being a less unsaturated oil.
The fatty acid composition of P6 canola oil falls within the normal range observed for other dietary oils and its consumption will have no significant impact on the nutritional quality of the Canadian food supply.
Since only the processed oil from 45A37 and 46A40, or lines derived there from, will be available for human consumption and the processing removes proteinaceous material, there are no additional toxicity or allergenicity concerns with this product.
Health Canada's review of the information presented in support of the food use of high oleic acid, low linolenic acid canola lines 45A37 and 46A40 concluded that these lines do not raise concerns related to human food safety. Health Canada is of the opinion that processed oil from 45A37 and 46A40 canola is as safe and nutritious as that available from current commercial canola varieties.
Health Canada's opinion pertains only to the food use of these high oleic acid, low linolenic acid, lines of canola. Issues related to growing high oleic acid, low linolenic acid, lines of canola in Canada and their use as animal feed are addressed separately through existing regulatory processes in the Canadian Food Inspection Agency.
This Novel Food Information document has been prepared to summarize the opinion regarding the subject product provided by the Food Directorate, Health Protection 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:
Office of Food Biotechnology
Health Protection Branch
Ottawa, Ontario K1A 0L2
Telephone: (613) 941-5535
Facsimile: (613) 952-6400