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Health Canada has notified the Canola Council of Canada that it has no objection to the food use of Low Erucic Acid Rapeseed Oil derived from Canola-quality Brassica juncea (L.) Czern. lines PC 97-03, PC98-44 and PC98-45. The Department conducted a comprehensive assessment of the three B. juncea lines according to its Guidelines for the Safety Assessment of Novel Foods. These Guidelines are based upon internationally accepted principles for establishing the safety of foods with novel traits.
The following provides a summary regarding the Canola Council of Canada notification to Health Canada and contains no confidential business information.
Brassica juncea lines PC97-03, PC98-44 and PC98-45 were developed using conventional breeding and selection techniques to meet canola-quality standards of less than 2% erucic acid in oil and less than 30 moles of aliphatic glucosinolates per gram in canola meal.
The three canola-quality B. juncea lines were developed through interspecific crosses between an Indian B. juncea line and low glucosinolate, zero erucic acid B. rapa line. The novel phenotype (canola-quality) has been stably incorporated into the plant by repeated backcrossing with the Indian B. juncea. Breeding history was presented to demonstrate how these three lines were selected. No novel DNA or novel proteins were introduced into the plant to achieve the low erucic acid and low glucosinolate 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.
The novel phenotype is expressed as expected with low glucosinolate levels and less than 1% erucic acid content. The oil derived from these lines meets with specifications for canola oil as listed in the Food Chemicals Codex, 4th Edition.
The human consumption of canola products is limited to the refined oil. The oil derived from lines PC97-03, PC98-44 and PC98-45 is to be used in similar applications as traditional canola oils by the food industry in Canada. Canola oil is used in both salad and cooking oil products, and is also acceptable in hydrogenated products, such as margerine and shortenings. The development of canola-quality B. juncea will not result in any change in the consumption pattern for these products.
The fatty acid profiles of the low erucic acid rapeseed oil from canola-quality B. juncea (L.) Czern. lines PC97-03, PC98-44 and PC98-45 are withing the normal range of other canola and vegetable oils. The consumption of refined oil from PC97-03, PC98-44 and PC98-45 will have no significant impact on the nutritional quality of the Canadian food supply.
Since these three canola-quality B. juncea lines are products of traditional breeding, and there was no novel DNA or novel protein introduced into the plant, there are no additional toxicity or allergenicity concerns with this product. The application of traditional breeding techniques to the development of the three B. juncea (L.) Czern lines do not raise any specific concerns.
Health Canada's review of the information presented in support of the food used of low erucic acid rapeseed oil derived from canola-quality Brassica juncea (L.) Czern. lines PC97-03, PC98-44 and PC98-45 concluded that this canola does not raise concerns related to human food safety. Health Canada is of the opinion that processed oil from these three canola lines is as safe and nutritious as that available from current commercial canola varieties. The department has no objection to oil derived from these lines being labelled as "canola oil".
Health Canada's opinion pertains only to the food use of these lines. Issues related to growing Canola-quality B. juncea in Canada and its use as animal feed are addressed separately through existing regulatory processes in the Canadian Food Inspection Agency.
For further information, please contact:
Novel Foods Section
Health Products and Food Branch
Ottawa, Ontario K1A 0L2
Telephone: (613) 941-5535
Facsimile: (613) 952-6400