Novel Food Information: Highly Refined DHA-Enhanced Oil Derived from NS-B50027-4 Canola

Health Canada has notified Nuseed Americas that it has no objection to the food use of highly refined oil derived from NS-B5ØØ27-4 canola. The Department conducted a comprehensive assessment of this canola variety 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.

Background

The following provides a summary of the notification from Nuseed Americas and the evaluation by Heath Canada and contains no confidential business information.

1. Introduction

Nuseed Americas has developed a genetically modified B. napus (canola) variety which produces docosohexaenoic acid (DHA, C22:6 n-3) in the seed.

To achieve this trait, seven different genes encoding either a desaturase or elongase enzyme, were introduced into the canola genome. When expressed together, the seven novel proteins comprise a DHA biosynthesis pathway that converts oleic acid (OA) into DHA. An eighth gene encoding a phosphinothricin acetyltransferase (PAT) was introduced as a marker for the selection of successful transformants in tissue culture.

The safety assessment performed by Food Directorate evaluators was conducted according to Health Canada's Guidelines for the Safety Assessment of Novel Foods. These Guidelines are based on harmonization efforts with other regulatory authorities and reflect international guidance documents in this area (e.g., Codex Alimentarius). The assessment considered: how this canola variety was developed; how the composition and nutritional quality of this variety compared to non-modified canola varieties; and the potential for highly refined oil derived from this canola variety to be toxic or cause allergic reactions. Nuseed Americas has provided data that demonstrate that the highly refined oil derived from NS-B5ØØ27-4 canola is as safe and of the same nutritional quality as highly refined oil derived from traditional canola varieties used as food in Canada.

The Food Directorate has a legislated responsibility for pre-market assessment of novel foods and novel food ingredients as detailed in the Food and Drug Regulations(Division B.28). NS-B5ØØ27-4 is considered a novel food 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:

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

2. Development of the Modified Plant

The petitioner has provided information describing the methods used to develop NS-B5ØØ27-4 canola and the molecular biology data that characterize the genetic change, which results in the production of the fatty acid DHA in the plant's seeds.

NS-B5ØØ27-4 canola was developed through Agrobacterium-mediated transformation of canola cultivar AV Jade with a binary vector (pJP3416_GA7-ModB) containing a construct (T-DNA) of seven microalgae and yeast genes (Micpu-Δ6D, encoding a Δ6-desaturase; Pyrco-Δ5E, encoding a Δ5-elongase; Pavsa-Δ5D, encoding a Δ5-desaturase; Picpa-ω3D, encoding a Δ15-/ω3-desaturase; Pavsa-Δ4D, encoding a Δ4-desaturase; Lackl-Δ12D, encoding a Δ12-desaturase; and Pyrco-Δ6E, encoding a Δ6-elongase) in the DHA biosynthetic pathway, and a selection marker gene (pat). Expression of the seven DHA biosynthesis genes results in the conversion of OA to DHA in NS-B5ØØ27-4 canola.

The genes used for DHA biosynthesis in NS-B5ØØ27-4 canola were chemically synthesized based on the sequences originally identified and characterized from the source organisms. Although the DNA sequence of each gene was modified so that the codon sequence (G:C ratio) resembled the typical G:C ratio found in canola; the amino acid sequence of each protein is unchanged. No component from the source organisms was directly used in the development of NS-B5ØØ27-4 canola.

The petitioner provided information to support the safety and historical use of each source organism (Micromonas pusilla, Micpu-Δ6D; Pyraminonas cordata, Pyrco-Δ5E and Pyrco-Δ6E; Pavlova salina, Pavsa-Δ5D and Pavsa-Δ4D; Pichia pastoris, Picpa-ω3D; Lachancea kluyveri, Lackl-Δ12D; and Streptomyces viridochromogenes, PAT).

The PAT protein derived from S. viridochromogenes has been used frequently as a selectable marker in genetically modified organisms and has been previously assessed in many organisms including a herbicide tolerant and insect resistant corn event MZIR098 (Health Canada, 2016), a herbicide tolerant corn event MZHG0JG (Health Canada, 2016), a herbicide tolerant corn MON 87419 (Health Canada, 2016), a herbicide tolerant cotton DAS-81910-7 (Health Canada, 2015), a herbicide tolerant soybean DAS-44406-6 (Health Canada, 2013), a herbicide tolerant soybean DAS-68416-4 (Health Canada, 2012), and a herbicide tolerant sugar beet Event T120-7 (Health Canada, 2000).

3. Characterization of the Modified Plant

The number of integration sites of the T-DNA insert in NS-B5ØØ27-4 canola was characterized through a vector-targeted, Illumina-based sequencing of two T3 lines and six T4 lines. Based on the results of this whole genome sequencing (WGS) analysis, two T-DNA integration sites were identified: the first in the A02 chromosome and the second in the A05 chromosome of the NS-B5ØØ27-4 canola genome. Sanger sequencing further confirmed the position of both T-DNA inserts. With the vector-targeted sequencing approach, the absence of vector backbone sequence in NS-B5ØØ27-4 canola was confirmed

The integrity and adjacent canola genomic sequences of the A02 and A05 T-DNA inserts were further characterized through WGS analysis of two lines only containing the A05 T-DNA insert, and one line only containing the A02 T-DNA insert. In addition, PCR-amplicon sequencing (PAS) of a T5 line was conducted.

WGS and PAS confirmed that the A02 T-DNA insert had a partial insert of the construct from the transformation vector pJP3416_GA7-ModB, containing the complete expression cassettes of the genes Micpu-Δ6D, Pyrco-Δ5E, Pavsa-Δ5D, and Picpa-ω3D. A 43 bp residual right border sequence was observed upstream of the T-DNA. The sequence of the A02 T-DNA insert perfectly matches the vector reference sequence of pJP3416_GA7-ModB; thus no amino acid (AA) variations were observed in the protein sequences of the four genes compared to their references. Since the four genes in the A02 T-DNA insert still have their own complete expression cassettes, expression of the four genes is not adversely affected.

WGS and PAS confirmed that the A05 T-DNA insert had two sets of the construct from the transformation vector pJP3416_GA7-ModB. The two sets were linked by a 156-bp of palindromic left border sequence and flanked by 40 bp of right border sequence upstream and 42 bp of right border sequence downstream. The two sets formed a palindromic structure with RB-LB:LB-RB orientation.

The sequence of the A05 T-DNA insert perfectly matched the vector reference sequence of pJP3416_GA7-ModB, and thus no AA variations were observed in the protein sequences of the eight genes compared to their references. Since the two sets still had their own complete expression cassettes, the presence of the palindromic structure does not adversely affect the expression of the genes. This is further supported by the consistent percentage of DHA observed in the transgenic lines with different backgrounds and in different environments.

A02 T-DNA insert replaced a 15 bp sequence from the 3′ UTR of a hypothetical putative protein (HPP) gene of unknown function. The HPP gene was located on chrUn-random of the B. napus reference genome and on chromosome A02 of the B. rapa reference genome. The A05 T-DNA insert replaced a 20 bp sequence in the 2^nd exon of the Pto-Interacting (PTI)-like gene. The PTI-like gene and the 20 bp sequence replaced were located on the A05 chromosome of the B. napus reference genome. The PTI protein is a serine-threonine kinase involved in the hypersensitive response (HR)-mediated signaling cascade. The function of the canola PTI-like protein is uncharacterized. Based on the compositional analysis of NS-B5ØØ27-4 canola, neither the insertion of the A02 T-DNA insert nor the A05 T-DNA insert resulted in deleterious effects at a phenotypic level.

Bioinformatics analyses were performed to investigate the potential toxicity and allergenicity of potentially expressed proteins identified as open reading frames (ORFs) at the individual DNA junctions of the A02 and A05 T-DNA inserts. The sequences of potential ORFs were predicted by computer predicted translation of DNA overlapping the junctions at the T-DNA insertion sites between the canola gDNA and the T-DNA inserts for each insertion site, as well as the joined segment of the two palindromic sequences of the insert in the A05 chromosome. Potential ORFs were defined as a sequence length spanning from one stop codon to the next stop codon in regions overlapping the DNA junctions. These potential ORFs were translated and evaluated for sequence identity matches to known toxins and allergens to identify any need for additional safety tests. None of the bioinformatics analyses revealed any basis to suspect that any of the putative proteins are toxigenic or allergenic.

Eight Kompetitive Allele-Specific PCR (KASP) assays, which targeted the four end DNA junctions (two assays/junction) of the two T-DNA inserts, were developed to analyse the genetic stability and inheritance of each insert in NS-B5ØØ27-4 canola over multiple generations. KASP is a proprietary genotyping technology owned by LGC Limited (Headquarters in United Kingdom). KASP is a homogenous, fluorescence (FRET)-based assay that enables accurate bi-allelic discrimination of known single nucleotide polymorphisms (SNPs) and insertions/deletions (InDels). KASP uses three components: test DNA with the SNP (or InDel) of interest; KASP Assay mix containing two different, allele-specific, competing forward primers with unique tail sequences and one reverse primer; and the KASP Master Mix containing FRET cassette plus Taq polymerase in an optimized buffer solution.

The results of the KASP assays indicate the high genetic stability of both T-DNA inserts over multiple generations of NS-B5ØØ27-4 canola.

Six F2 and six BC1F2 populations were used to study the inheritance of the two T-DNA inserts in NS-B5ØØ27-4 canola in different genetic backgrounds (elite lines). All of the 12 F2 populations were segregating for both T-DNA inserts. The populations were genotyped with KASP assays targeting both inserts. Chi-squared (χ²) analysis was used to analyze the segregation data for all 12 F2 populations. The analysis confirmed that the two inserts were stably inherited into different backgrounds and populations according to Mendelian principles.

4. Product Information

NS-B5ØØ27-4 canola differs from its traditional counterparts by the addition of eight genes: Micpu-Δ6D, encoding a Δ6-desaturase; Pyrco-Δ5E, encoding a Δ5-elongase; Pavsa-Δ5D, encoding a Δ5-desaturase; Picpa-ω3D, encoding a Δ15-/ω3-desaturase; Pavsa-Δ4D, encoding a Δ4-desaturase; Lackl-Δ12D, encoding a Δ12-desaturase; and Pyrco-Δ6E, encoding a Δ6-elongase, and a selection marker gene (pat), encoding a phosphinothricin acetyltransferase (PAT) protein. The expression products of the first seven genes compose a DHA biosynthesis pathway whereby OA is converted into DHA. The PAT protein was used to select for successful transformants containing the T-DNA insert in tissue culture.

Protein expression of the seven DHA biosynthesis enzymes was quantified during the life cycle of NS-B5ØØ27-4 canola within different tissues. The quantification was achieved by highly sensitive Liquid Chromatography Multiple Reaction Monitoring Mass Spectrometry (LC-MRM-MS). The sampling times represent specific growth stages of canola allowing for various tissue types, including leaves, roots, pods, and reproductive tissues.

LC-MRM-MS quantification confirmed that none of the novel proteins were detected in 250 µg of total protein extracts from WT canola, including all seven sampling points at five growth stages, from two field trial sites. Moreover, none of the proteins were detected in total protein extracts in the non-seed tissues of NS-B5ØØ27-4 canola, from the seven sampling points at five growth stages, from two field trial sites. However, all seven proteins of the DHA biosynthesis pathway were detected in developing and/or mature seeds of NS-B5ØØ27-4 canola.

The Pyrco-Δ5E protein was below the limit of detection (LOD) in developing seeds, while the Pyrco-Δ6E protein was below the LOD in mature seeds. The Pavsa-Δ4D protein was detected with the highest abundance of the seven proteins, with up to 1,500 femtomoles in mature seeds. Based on the molecular mass of each protein, the level of each transgenic protein was determined (on a per mg protein basis). The lowest protein level was 20 ng of the Pyrco-Δ5E per mg total protein, and the highest protein level was 740 ng of the Pavsa-Δ4D per mg total protein.

Low level expression of the PAT protein was confirmed in NS-B5ØØ27-4 canola using LC-MRM-MS, wherein a trace amount of PAT protein was detected in all tested tissues of the canola. The low expression of PAT in NS-B5ØØ27-4 canola was also supported by Western blot analysis with an anti-PAT antibody. No obvious specific band was detected in wild type (WT) or NS-B5ØØ27-4 canola BBCH15 whole plant, BBCH335 whole plant, and BBCH79 developing seed, suggesting that PAT expression level is below the LOD.

5. Dietary Exposure

NS-B5ØØ27-4 canola will provide an alternate source of DHA for existing markets. According to the petitioner, DHA from NS-B5ØØ27-4 canola will be offered in the form of highly refined oil.

6. Nutrition

Compositional data for NS-B5ØØ27-4 canola, its parental variety AV Jade, and seven commercial canola reference varieties were collected from eight field trials in 2015 in the major canola growing regions of Australia. In each trial, five replicates of each entry were planted in a randomized complete block design. The petitioner states that at each site, planting and cultivation was done according to local agronomic practices.

Seed samples were harvested and analyzed for protein, fat, acid detergent fibre (ADF), neutral detergent fibre (NDF), crude fibre, ash, fatty acids, amino acids, minerals, vitamins, tocopherols/sterols, and anti-nutrients (glucosinolates, phytic acid, and phenolics). These compositional components are in line with recommendations listed in the Organization for Economic Co-operation and Development (OECD) consensus document on the compositional considerations for new varieties of low erucic acid rapeseed (Canola) (OECD, 2011). The analyses for each component were conducted on all samples by a single laboratory using internationally approved and validated analytical methods and following consistent and appropriate sample storage and preparation procedures.

The data collected from the field trials were analyzed using statistically appropriate methodology. The data was summarized and the mean, minimum, maximum and standard deviation was provided. Where a statistically significant difference (P-value <0.05) was identified, further context for interpreting the possible nutritional significance of the difference was gathered through comparisons of the mean with the range of values for each analyte from the commercial varieties.

In NS-B5ØØ27-4 canola, seven fatty acid desaturases and elongases were introduced to convert oleic acid to DHA. As expected, the fatty acid profile was impacted which resulted in the presence of fatty acids not normally found in conventional canola. Low levels of DHA were found in the parental and reference varieties as a result of the side-by-side plot experimental design.

In addition, statistical differences were observed in C18:1 n-9 oleic acid (reduced by 26%), C18:2 n-6 linoleic acid (reduced by 56%), and C18:3 n-3 alpha-linolenic acid (increased by 88%). These differences in the fatty acid profile of NS-B5ØØ27-4 canola compared to the parental control are consistent with shifting the fatty acid synthesis pathway towards DHA production.

Other statistically significant fatty acid changes in NS-B5ØØ27-4 canola compared to control were observed in: C16:0 palmitic acid (increased by 4.5%), C16:1 n-9 palmitoleic (increased by 55%), C17:0 heptadecanoic (margaric) acid (increased by 4.3%), C17:1 heptadecenoic acid (reduced by 25%), C18:1 n-7 cis-vaccenic acid (increased by 7.2%), C20:0 arachidic acid (increased by 24%), C20:1 n-9 gadoleic (eicosenoic) acid (increased by 25%), C20:2 n-6 eicosadienoic acid (increased by 52%), C22:0 behenic acid (increased 34%), C24:1 n-9 nervonic acid (reduced by 39%). In addition to individual fatty acid levels, several fatty acid groups were also statistically different including C16:1 total (increased by 10%), C18:1 total (reduced by 25%, 18:2 total (reduced by 55%) 18:3 total (increased by 97%), and C24:1 total (reduced by 39%). Although statistically different, all mean values were either within the reference ranges or differences were nutritionally not important as they are not associated with intermediates in the DHA pathway. No statistically significant differences were observed in C14:0 myristic acid, C16:1 n-7 palmitoleic acid, C18:0 stearic acid, and lignoceric acid C24:0.

Interestingly, the total fatty acid level of NS-B5ØØ27-4 canola was 9% lower compared to the parental control. This is consistent with the observed reduction in crude fat however the levels were not outside the reference ranges. NS-B5ØØ27-4 canola seeds also had higher total trans fatty acids than the control and the other commercial non-GM canola lines. Although higher, the total transfat content was less than 1%. This was not considered nutritionally important as the total trans fatty acids are present at similar levels in other refined non-GM vegetable oils, including soybean and sunflower.

Statistical differences in the means for several non-fatty acid related analytes were identified; however, the means were within the reference ranges generated from the commercial varieties except for δ-5-avenasterol. A cursory search of the literature did not indicate any obvious nutritional concerns regarding this specific phytosterol. Moreover, the total phytosterol level in NS-B5ØØ27-4 canola was slightly higher however it was within the reference ranges and was not deemed to be nutritionally significant.

The Bureau of Nutritional Sciences (BNS) considered various scenarios in estimating dietary intake of DHA from NS-B5ØØ27-4 canola. Data from the Canadian Community Health Survey – Cycle 2.2. on Nutrition (Health Canada, 2015) ^{Footnote 1} was used to estimate the worst case scenario (eaters only, 95^th percentile) and assuming that NS-B5ØØ27-4 canola replaces all the vegetable oil in the Canadian diet, the estimated dietary intake was less than the reference intake of 3g/day recommended in the FD draft document entitled "Re-evaluation of the FD position on reference intake for addition of oils rich in EPA/DHA to foods as part of the Novel Foods notification process (Division 28)". It is unlikely that the consumption of NS-B5ØØ27-4 canola will pose a nutritional concern.

With respect to health claims, both NS-B5ØØ27-4 canola and the highly refined oil derived from NS-B5ØØ27-4 canola would qualify for claims regarding replacement of saturated fats with mono- and polyunsaturated fats and blood cholesterol lowering.

The Nutrition Pre-Market Assessment Division (NPAD) does not have any safety concerns with NS-B5ØØ27-4 canola from a nutritional perspective.

7. Chemistry/Toxicology

The Pre-Market Toxicology Assessment Section (PTAS) evaluated the safety of NS-B5ØØ27-4 canola by assessing the potential toxicity and allergenicity of the finished product, which is the highly refined seed oil.

Although the petitioner provided some evidence of incidental food exposure to L. kluyveri on the surfaces of some cheeses (e.g. Rokpol) and of P. pastoris use in the preparation of injectable pharmaceuticals in the United States (e.g. killikrein inhibitor used in the treatment of hereditary angioedema), no history of safe food exposure rationale could be supplied for the microalgae donor organisms (M. pusilla, P. salina and P. cordata).

The level of expression for each protein was determined in the seed of NS-B5ØØ27-4 canola using LC-MRM-MS. Levels of protein expression ranged from 20-740 ng/mg total protein in the developing and mature seeds from canola grown at two sites.

Novel expression of the PAT protein derived from S. viridochromogenes has been previously approved by Health Canada in various crop varieties intended for human consumption. The safety of S. viridochromogenes PAT protein is well established and therefore does not require re-evaluation in this submission. The equivalence of this PAT sequence with those of previously approved GM crops was confirmed by the Bureau of Microbial Hazards (BMH).

The predicted amino acid sequence of Lackl-Δ12D, Micpu-Δ6D, Pavsa-Δ4D, Pavsa-Δ5D, Picpa-ω3D, Pyrco-Δ5E and Pyrco-Δ6E were compared to sequences of known toxins retrieved from NCBI Entrez Protein database (search date December 19, 2016; E score cut off ranging from 0.23 to 4e-36). The petitioner reported only the top three E score sequence alignments for each of the eight proteins introduced into canola. The alignments were shown to share 22 to 42% sequence identity over an area that spanned from 41amino acids to the length of the protein. The petitioner stated that none of these matches occurred with proteins that were identified as "toxic" or a "toxin". It was concluded that Lackl-Δ12D, Micpu-Δ6D, Pavsa-Δ4D, Pavsa-Δ5D, Picpa-ω3D, Pyrco-Δ5E and Pyrco-Δ6E do not share sequence similarity with known oral toxins.

The petitioner stated that NS-B5ØØ27-4 canola will only be used for the production of highly refined canola oil for food use. The petitioner provided data showing that the NS-B5ØØ27-4 canola oil (Aquaterra™ and Nutriterra™ DHA oil), much like other highly processed vegetable oils, is devoid of all proteins, including the eight transgenic proteins assessed in this petition.

The PTAS concluded that the Lackl-Δ12D, Micpu-Δ6D, Pavsa-Δ4D, Pavsa-Δ5D, Picpa-ω3D, Pyrco-Δ5E and Pyrco-Δ6E proteins expressed in NS-B5ØØ27-4 canola would not be expected to pose any toxicological concerns to consumers as they will be absent from the final highly refined oil. Should the petitioner request additional food uses for NS-B5ØØ27-4 canola that contains its proteins, further assessment would be required to address the data gaps that exist in the toxicological database for these proteins.

There are no toxicological food safety concerns with the use of highly refined oil derived from NS-B5ØØ27-4 canola, based on the available toxicity data. Therefore, the PTAS has no safety concerns from a toxicological perspective.

The petitioner performed a bioinformatics analysis using the predicted amino acid sequence of the Lackl-Δ12D, Micpu-Δ6D, Pavsa-Δ4D, Pavsa-Δ5D, Picpa-ω3D, Pyrco-Δ5E and Pyrco-Δ6E proteins and compared it with sequences of known allergens retrieved from the AllergenOnline database (version 16; 1956 sequences). The proteins did not share ≥ 35% amino acid identity with any known allergen or contain potential allergen epitopes (an eight exact sequence match over 8 amino acids). Based on the results of the bioinformatics analysis, it was concluded that Lackl-Δ12D, Micpu-Δ6D, Pavsa-Δ4D, Pavsa-Δ5D, Picpa-ω3D, Pyrco-Δ5E and Pyrco-Δ6E did not match known allergens.

The petitioner also performed a protein BLAST alignment of the predicted amino acid sequences with known and putative allergens from the NCBI Entrez Protein database (December 19, 2016) using the keywords "allergen" and "allergy". Proteins sharing 50% or more in sequence identity were considered a positive match. The petitioner stated that there was no significant match between the transgenic proteins and any known or putative allergens.

The petitioner demonstrated that histidine-tagged Lackl-Δ12D, Micpu-Δ6D, Pavsa-Δ4D, Pavsa-Δ5D, Picpa-ω3D, Pyrco-Δ5E and Pyrco-Δ6E proteins, derived from aninsect cell line expression system, were degraded when incubated at temperatures 95 °C for 30 minutes (as determined by Western blot). The authors reported that less than 36% of the Lack1-Δ12D, and less than 15% of all other proteins, remained after heating which demonstrates that all eight transgenic proteins are structurally unstable at high temperatures.

The processing and refining of canola into oil generally involve similarly high temperatures (between 80 to 105 °C for 15 to 20 minutes). It is expected that the denatured and/or degraded proteins will be more susceptible to digestion in the gastrointestinal tract.

The petitioner demonstrated that histidine-tagged Lackl-Δ12D, Micpu-Δ6D, Pavsa-Δ4D, Pavsa-Δ5D, Picpa-ω3D, Pyrco-Δ5E and Pyrco-Δ6E proteins, derived from E. coli or insect cell line expression systems, were digested into small protein fragments (up to 18 amino acids in length) following incubation with simulated gastric fluid (SGF; 75 µg pepsin; pH 1.2; incubated at 37 °C) for 60 minutes, respectively, as determined by LC-MS/MS (Liquid chromatography-tandem mass spectrometry). As such, Lackl-Δ12D, Micpu-Δ6D, Pavsa-Δ4D, Pavsa-Δ5D, Picpa-ω3D, Pyrco-Δ5E and Pyrco-Δ6E proteins are expected to be digested into small fragments under the conditions normally found in the stomach.

The PTAS concluded that the Lackl-Δ12D, Micpu-Δ6D, Pavsa-Δ4D, Pavsa-Δ5D, Picpa-ω3D, Pyrco-Δ5E and Pyrco-Δ6E proteins expressed in NS-B5ØØ27-4 canola would not be expected to pose any allergenic safety concerns to consumers as they will be absent from the final highly refined oil.

Based on the information provided, use of highly refined oil derived from NS-B5ØØ27-4 canola is not expected to pose an additional allergenic concern. Therefore the PTAS has no safety concerns from an allergenic perspective.

Conclusion

Health Canada's review of the information presented in support of the food use of highly refined oil derived from NS-B5ØØ27-4 canola does not raise concerns related to food safety. Health Canada is of the opinion that highly refined oil derived from this canola variety is as safe and nutritious as highly refined oil derived from current commercial canola varieties.

As there is a significant change to the nutritional composition of the highly refined oil derived from NS-B5ØØ27-4 canola, special labelling is required for this product. The petitioner was advised to contact the Canadian Food Inspection Agency (CFIA) for the Agency to review the petitioner's proposed common name and labelling for this product for purposes of sale.

Health Canada's opinion deals only with the food use of NS-B5ØØ27-4 canola. Issues related to its use as animal feed have been addressed separately through existing regulatory processes in the CFIA.

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, PL2204A1
251 Frederick Banting Driveway
Ottawa, Ontario K1A 0K9
hc.bmh-bdm.sc@canada.ca