ARCHIVED - Novel Food Information: Clearfield Sunflower (Helianthus annuus) Line X81359

January 2006

Novel Food Information

Health Canada has notified BASF Canada that it has no objection to the confectionary use of seeds derived from Clearfield™ sunflower variety X81359, which is tolerant to imidazolinone herbicides.Confectionary usage of sunflower is primarily in baking, raw shelled seed consumption and direst whole seed snack consumption. Confectionary usage of Sunflower X81359 is an extension of a previous decision to allow food use of oil from sunflower line X81359. This extension will permit all food products derived from this line to be used in Canada. The Department conducted a comprehensive assessment of sunflower X81359 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.


The following provides a summary regarding BASF Canada's notification to Health Canada and contains no confidential business information.

1. Introduction

BASF Canada developed Clearfield™ sunflower variety X81359 that is tolerant to imidazolinone herbicides by traditional plant breeding techniques. The basis for the herbicide tolerance is the expression in the sunflower plant of a mutant acetohydroxyacid synthase (AHAS). Health Canada has previously indicated no objection to the sale of ClearfieldTM imidazolinone tolerant wheat (Teal 11A, AP205CL and AP602CL), Lentil (RH44), Rice (PWC16, CL121, CL141 and CFX51) and oil usage of Sunflower (X81359) for human food applications in Canada

The safety assessment performed by Food Directorate evaluators was conducted according to Health Canada's Guidelines for the Safety Assessment of Novel Foods. The assessment considered: how Clearfield™ sunflower variety X81359 was developed; how the composition and nutritional quality of sunflower seed derived from Clearfield™ sunflower variety X81359 compare to the sunflower seed of current commercial sunflower varieties; and what the potential is for sunflower seed from Clearfield™ sunflower variety X81359 be toxic or cause allergic reactions.

The Food Directorate has a legislated responsibility for pre-market assessment of novel foods and novel food ingredients as detailed in Division 28 of Part B of the Food and Drug Regulations (Novel Foods). Foods derived from Clearfield™ sunflower variety X81359 are considered novel foods under the following part of the definition of novel foods: "c) a food that is derived from a plant, animal or microorganism that has been genetically modified such that

  1. the plant, animal or microorganism exhibits characteristics that were not previously observed in that plant, animal or microorganism"

2. Development and Production of the Modified Plant

Sunflower variety X81359 is a result of a cross between two imidazolinone tolerant parents and extensive backcrossing with commercial confectionary sunflower varieties. The herbicide tolerance trait is a natural mutation that was originally isolated from the wild sunflower populations by the United States Department of Agriculture. The target of the imidazolinone class of herbicides is the enzyme acetohydroxyacid synthase (AHAS) which is responsible for the first step in the biosynthesis of essential branched chain amino acids.

The imidazolinone tolerance trait in Clearfield™ sunflower X81359 is due to a point mutation of a single nucleotide in the AHAS gene. Previously authorized imidazolinone tolerant rice, corn, canola, lentil and wheat lines were the result of single nucleotide substitutions in the AHAS gene. This single amino acid change alters the binding site for the herbicide on the AHAS enzyme expressed by AHAS gene while having no effect on the normal functioning of the enzyme.

3. Product Information

A mutation in the AHAS enzyme in sunflower could affect the biosynthesis of the essential amino acids isoleucine, leucine, and valine. The amino acid composition of Clearfield™ sunflower was compared to commercial cultivars, confirming that the AHAS activity of the imidazolinone-tolerant sunflower was not affected by the mutation.

4. Dietary Exposure

Confectionary uses for Clearfield™ sunflower X83159l are expected to be primarily in baking, raw shelled seed consumption and direct whole seed snack consumption.

5. Nutrition

The nutrient data pertaining to Clearfield™ sunflower comprised the analyses of antinutrients (phytic acid and trypsin inhibitor), proximates (crude fat, crude fibre, and protein), fatty acids, amino acids and vitamins. Results showed no significant differences in antinutrients and proximates when comparing the X81359 sunflower grain and grain from the control variety 8377NS. The results of the compositional analysis data suggest that the variety X83159 was comparable to the control variety and other conventional sunflower varieties.

6. Toxicology

The impact of single point mutations that confer tolerance of various plant AHAS to imidazolinone herbicides, on the toxic and allergenic potential of the protein have been considered in previous novel food notifications reviewed by Health Canada. No toxicological or allergenic concern was introduced at the level of exposure to AHAS in those products. In the case of Clearfield™ X81359 sunflower derived seeds to be used for confectionary purposes, the AHAS from this product is identical to the wild type sunflower, with respect to heat and digestive degradation. Therefore exposure to an active enzyme is negligible since it would be denatured during preparation or digested in the gastrointestinal tract. There are no additional toxicity or allergenicity concerns with this product.


Health Canada's review of the information presented in support of the confectionary use of sunflower seeds derived from Clearfield™ sunflower variety X81359 concluded this use does not raise any concerns related to human food safety. Health Canada is of the opinion that sunflower seeds derived from Clearfield™ sunflower X81359 are as safe and nutritious as that available from current commercial sunflower varieties.

Health Canada's opinion deals solely with respect to the suitability for sale as confectionary, sunflower seeds derived from Clearfield™ sunflower line X81359.

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