Novel food information: Simplot Innate® potato event BG25

Background

Health Canada has notified J.R. Simplot Company (Simplot) that it has no objection to the food use of potato event BG25.

The safety of potato event BG25 for food use was assessed as part of the Health Canada-Food Standards Australia New Zealand (FSANZ) shared assessment process. For this product, FSANZ was the primary assessor and conducted the safety assessment of this potato line. Health Canada acted as the secondary assessor, peer-reviewing FSANZ's initial assessment report for potato event BG25, providing feedback regarding the report, and using the finalized report to inform the Department's own regulatory decision regarding this product.

FSANZ conducted a comprehensive assessment of this potato variety according to FSANZ's Application Handbook, specifically its guidelines for applications for new foods produced using gene technology. These guidelines are based on internationally established scientific principles and guidelines developed through work in international fora (e.g., Codex Alimentarius) and align with Health Canada's Guidelines for the Safety Assessment of Novel Foods.

The following provides a summary of the notification from Simplot and the evaluation conducted by FSANZ and peer-reviewed by Health Canada. This document contains no confidential business information.

Introduction

Simplot has developed a novel potato (Solanum tuberosum (L.)) variety, BG25 which exhibits disease resistance against Phytophthora infestans and Potato Virus Y (PVY), lower reducing sugars, and reduced browning. To achieve these traits, 6 expression cassettes were introduced to the potato genome by Agrobacterium-mediated transformation.

Potato event BG25 is resistant to disease caused by Phytophthora infestans, the fungus that causes late blight, as well as potato virus Y (PVY). Potato event BG25 expresses three resistance proteins (R-proteins) which were derived from wild Solanum species: VNT1, AMR3, and BLB2. These R-proteins allow the potato plant to initiate its native immune response to resist infection by P. infestans. Potato event BG25 expresses an inverted repeat cassette that targets the PVY coat protein (PVY-CP) through the RNA interference (RNAi) pathway to provide protection against PVY infection.

Potato event BG25 exhibits lowered levels of reducing sugars (glucose and fructose) in tubers which is intended to improve processing quality and storage. Potato event BG25 also exhibits reduced expression of polyphenol oxidase (Ppo) enzymes which is intended to result in a decreased incidence of black spot bruising in tubers. These two novel traits are achieved through the expression of an inverted repeat cassette containing small fragments of DNA from two native genes, VInv and Ppo5, which results in the reduced level of mRNA transcripts, and subsequently expressed proteins, for those same genes through the RNAi pathway.

Finally, potato event BG25 is also resistant to acetolactate synthase (ALS) inhibiting herbicides. This trait is the result of the expression of a modified S. tuberosum ALS protein. Simplot has indicated that this trait is included solely as a selection marker during product development.

Potato event BG25 is a 'Generation 3' (Gen3) event of Simplot potatoes and exhibits many of the same traits as the first generation of Simplot Innate potato varieties (Simplot Innate Events Gen1-E12, F10, J3, J55, and V11) and the second generation of Simplot Innate potato varieties (Simplot Innate Event Gen2-W8, X17, Y9, and Z6). The resistance to P. infestans, lower reducing sugars, and reduced browning traits are achieved in the Gen3 potato event BG25 through the expression of some of the same expression cassettes (VNT1, VInv, and Ppo5, respectively) as the Gen1 and Gen2 potato events which were previously assessed by Health Canada.

Potato event BG25 was assessed under the Health Canada and Food Standards Australia New Zealand (FSANZ) Safety Assessment Sharing Initiative. For this assessment, FSANZ was the primary assessor and the safety assessment was conducted according to FSANZ's Application Handbook. These guidelines are based on internationally established scientific principles and guidelines developed through work in international fora (e.g., Codex Alimentarius) and align with Health Canada's Guidelines for the Safety Assessment of Novel Foods. Health Canada evaluators peer reviewed the assessment conducted by FSANZ and used the finalized assessment to inform the recommendations presented herein. The assessment considered: how potato event BG25 was developed, how the composition and nutritional safety of this variety compared to its conventional comparator, and what the potential is for this variety to present a toxic or allergenic concern. Simplot has provided data to support that this variety is safe for use as food in Canada.

The Food and Nutrition 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 potato event BG25 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. i. the plant, animal or microorganism exhibits characteristics that were not previously observed in that plant, animal or microorganism."

Development of the modified plant

Potato event BG25 was created through Agrobacterium-mediated transformation of Russet Burbank potato internode sections with the plasmid pSIM4363. The T-DNA region of the plasmid was integrated into the potato genome and contained 6 gene expression cassettes which together confer to potato event BG25:

disease resistance to P. infestans and PVY
lower reducing sugars
reduced browning, and
tolerance to ALS-inhibiting herbicides as a selectable marker.

The T-DNA insert in potato event BG25 contains the gene expression cassettes for three resistance proteins (R-proteins):

The VNT1 gene and its respective regulatory elements are derived from the wild potato species Solanum venturii;
The AMR3 gene and its respective regulatory elements are derived from the wild potato species Solanum americanum; and
The BLB2 gene and its respective regulatory elements are derived from the wild potato species Solanum bulbocastanum.

The R-proteins confer foliar and tuber resistance to P. infestans, the fungus that causes late blight disease in potatoes. R-proteins are an important part of the plant immune system and are maintained in the cell in an inactive state at low concentrations. Upon recognition of their targetedpathogen-secreted effector proteins, the R-proteins initiate the plant's native immune response to infection which destroys infected plant tissue through programmed cell death, restricting growth and spread of the pathogen.

The T-DNA insert in potato event BG25 contains an expression cassette composed of an inverted repeat sequence that targets the Potato Virus Y coat protein (PVY-CP) transcript. The PVY-CP inverted repeat functions through the RNAi pathway to silence the expression of the PVY-CP gene and confers protection against infection by PVY in potato event BG25.

The T-DNA insert in potato event BG25 contains an expression cassette composed of 2 inverted repeat sequences containing small fragments of DNA from 2 different genes: vacuolar invertase (VInv) and polyphenol oxidase 5 (Ppo5). The target genes were chosen based upon their biochemical roles in accumulation of reducing sugars and black spot bruising, respectively. Due to the nature of the inverted repeat sequences, their transcripts form double-stranded RNA (dsRNA) molecules through complementary binding which acts as guides for the plant's own RNA interference (RNAi) post-transcriptional regulatory pathway. Through RNAi, the VInv and Ppo5 dsRNA guides target messenger RNA (mRNA) that have identical sequence to the guides, resulting in the destruction of the mRNA and down regulation of the target gene. The resulting decrease in VInv activity reduces accumulation of reducing sugars compared to the non-GM Russet Burbank control which intends to lower reducing sugars and improve processing and storage of potato event BG25. The reduction of Ppo5 activity is intended to limit the colouration of oxidized tissues and reduce black spot bruising in potato event BG25.

The T-DNA insert in potato event BG25 contains a stmALS selectable marker gene which encodes the S. tuberosum modified acetolactate synthase (StmALS) protein. The expression of the StmALS protein confers tolerance to ALS-inhibiting herbicides, and allowed for selection of successful transformants with imazamox. The StmALS protein expressed in potato event BG25 has only 2 amino acid substitutions and is 99.7% identical to the native ALS protein present in S. tuberosum. Modified ALS proteins have been previously assessed in many crops including soybean event DP-356043, soybean event CV127, and soybean event DP-305423.

The petitioner provided information to support the safety and historical use of each source organism: S. tuberosum, S. venturii, S. Americanum, S. bulbocastanum, and PVY. Based on the information provided, it was demonstrated that none of the source organisms are pathogenic to humans.

Characterization of the modified plant

The molecular characterization of potato event BG25 was conducted through a combination of Next Generation Sequencing (NGS) with targeted sequence capture, Sanger sequencing, polymerase chain reaction (PCR) and droplet-digital PCR (ddPCR). For the NGS analyses, a set of probes covering the entire pSIM4363 plasmid, including the backbone, were hybridised to genomic DNA extracted from the leaves of potato event BG25 and non-GM Russet Burbank control plants, and the captured samples were sequenced using NGS. Plasmid DNA from pSIM4363 was used as the positive control. The sequencing reads obtained by NGS were compared to the intended insertion sequence, the pSIM4363 plasmid sequence, and to the endogenous potato genome to identify unique junctions attributable to inserted DNA. The NGS results were used to determine the insert copy number, the organization of the inserted DNA, and to confirm the absence of any unintended plasmid sequences. ddPCR was used to determine insert copy number in potato event BG25.

The results from the NGS analysis, Sanger sequencing, and ddPCR indicated that a single copy of the intended insertion, with the intended organization, was integrated into the genome of potato event BG25 with the exception of small deletions in the left and right border regions. Compared to the intended insertion, 34 bp from the right border and 330 bp from the left border are not present in potato event BG25. Such changes during T-DNA insertions are common during Agrobacterium-mediated plant transformation due to DNA repair mechanisms. Given that these sequences are not part of the expression cassettes, it is considered unlikely to affect the function of the inserted genetic elements.

The alignment of the NGS reads from potato event BG25 or the non-GM Russet Burbank control to the pSIM4363 sequence as well as PCR analysis confirmed that there was no integration of the plasmid backbone sequence into potato event BG25, including any antibiotic resistance genes. The analysis revealed a small number of reads aligning between the plasmid to the sequences from potato event BG25 or the non-GM Russet Burbank control due to the presence of endogenous potato sequences in the plasmid backbone.

To determine the location of the T-DNA insertion in the potato event BG25 genome, the identified potato sequences flanking the insertion site were subjected to homology search against the reference genome of the non-GM Russet Burbank control. These searches located the single T-DNA insert on chromosome 12. A 55 bp deletion of the potato genome at the T-DNA integration site was identified which corresponds to an intergenic region. The potato event BG25 T-DNA insertion did not disrupt any endogenous genes or any other known annotated feature in the potato genome.

Bioinformatics analyses were performed to assess the potential toxicity, allergenicity, or biological activity of the putative peptides encoded in both the inserted DNA and junctions between the insert and genomic DNA. All potential open reading frames (ORFs) of ≥ 30 amino acids in length spanning the 5′ and 3′ insert-flank junctions of potato event BG25, or contained within the insert itself, were translated in silico from start codon to stop codon in all six reading frames. A total of 125 theoretical ORFs ≥ 30 aa were identified and queried against allergen and toxin databases.

To assess potential toxicity, similarity searches against the UniProtKB database filtered with the keyword "toxin" were performed using the Basic Local Alignment Search Tool (BLAST; January 2023; https://blast.ncbi.nlm.nih.gov/Blast.cgi). E-value cutoff of 10-2 was used as a criterion for similarity. E-values are a measure of statistical significance in bioinformatic analysis. The smaller the E-value, the less likely that the alignment occurred by random chance and the more stringent the search is considered to be.

From the 125 theoretical ORFs, the BLASTP search identified 9 potential toxins in the UniProtKB database with alignment to putative peptides associated with VNT1, AMR3, BLB2, StmALS proteins and with the PVY-CP and VInv inverted repeats. None of the 9 proteins identified by BLASTP searches are actual toxins but rather are proteins that contain the keyword "toxin" in their accession records. A literature review confirmed that none of these identified proteins are actual toxins; therefore, there are no safety concerns associated with the 9 putative peptides that aligned with the "toxin" proteins in the UniProtKB database. There were no other putative peptides identified with similarity to any known human toxins.

To assess potential allergenicity, similarity searches against the Comprehensive Protein Allergen Resource (COMPARE) (January 2023;) were performed. A full-length sequence search using a FASTA (Fast Alignment Search Tool – All) alignment was performed comparing each predicted ORF sequence to the database entries. Significant homology was determined when there was (i) greater than 50% homology between query protein and database entry and (ii) the E-value was less than 10^-4. In addition, a 80-mer sliding window FASTA search was performed comparing 80 contiguous amino acids within the ORFs to the database entries. Matches were identified if there was greater than 35% homology (E-value of 10). A 8-mer exact match FASTA search was performed comparing 8 contiguous amino acids within the ORF to the database entries. Matches were identified if there was 100% homology.

The potential allergenicity analysis performed on the 125 theoretical ORFs revealed two putative peptides coinciding with the VInv inverted repeat DNA sequences in pSIM4363 T-DNA matched a minor allergenic vacuolar invertase protein from tomato. The vacuolar invertase proteins from tomato and potato share 95% sequence homology but have different glycosylation patterns that can impact allergenicity potential. In potato, the native protein has not been identified as allergenic. Additionally, translation of these two putative peptides is unlikely because the transcripts form an inverted repeat. This match therefore does not raise any allergenicity concerns. There were no other putative peptides identified with similarity to any known allergens.

Potato is a vegetatively propagated crop and its reproduction does not involve meiosis. Therefore, the DNA insertions within potato event BG25 are expected to be stable. Nevertheless, the stability of the DNA insert was assessed by ddPCR and PCR analyses across 3 clonal generations. The ddPCR measured the absolute copy number of six target small amplicons across the T-DNA insert in potato event BG25 and the PCR analysis assessed the left and right flanking regions of the T-DNA insert. The analysis was done on leaf-derived genomic DNA from 3 generations of potato event BG25 (G0, G1, and G2) and compared to the non-GM Russet Burbank control. The results confirmed that the inserted DNA was stably maintained over 3 successive clonal generations in potato event BG25.

Product information

Potato event BG25 differs from its conventional counterpart by the expression of the 3 R-proteins (VNT1, AMR3, BLB2), modified ALS protein (StmALS), and the inverted repeat sequences targeting VInv, Ppo5, and PVY-CP.

Expression of the 3 R-proteins, VNT1, AMR3, and BLB2, in potato event BG25 was analyzed in leaf and tuber samples. Immunoblotting was used to examine the expression of VNT1, AMR3 and BLB2 proteins in BG25 tuber tissue. Polyclonal antibodies were generated for detecting VNT1, AMR3, and BLB2. The immunoblotting analysis showed that the VNT1, AMR3 and BLB2 proteins were not detected and are therefore expressed below the limit of quantification (LOQ) in potato event BG25 tubers. The LOQ for VNT1 and AMR3 were established to be 500 ng/g FW while the LOQ for BLB2 was 100 ng/g FW. These results are in line with the assessment of the VNT1 protein in Gen2 Simplot potatoes and with the published literature as R-proteins are known to be expressed at low levels.

The mRNA transcript levels of VNT1, AMR3, and BLB2 were measured in leaf and tuber samples of potato event BG25 using reverse transcription quantitative real-time PCR(RT-qPCR). The mRNA transcripts of VNT1, AMR3 and BLB2 were detected in potato event BG25 in the leaf and tuber tissue indicating that the VNT1, AMR3 and BLB2 genes are expressed in potato event BG25.

The VInv and Ppo5 inverted repeat sequences introduced into potato event BG25 do not result in the expression of novel proteins, but rather act by reducing the levels of mRNA transcripts and subsequently the expression of the native VInv and Ppo5 proteins. Therefore, mRNA transcript levels of the target genes were evaluated to assess the expression of the inverted repeat sequences in potato event BG25. RT-qPCR analysis was used to determine mRNA transcript levels of VInv and Ppo genes in potato event BG25 and in the non-GM Russet Burbank control. In comparison to the control, potato event BG25 VInv transcript levels are reduced in both tuber and leaf tissue, with a greater reduction in tuber tissue. Potato event BG25 showed reduction of Ppo transcripts in tuber tissue but not in leaf tissue. The expression of the inverted repeat VInv and Ppo DNA sequences are controlled by two promoters which are highly active in tuber cells and should therefore result in high dsRNA expression in the tuber, resulting in the observed tissue-specific silencing of the target genes.

The PVY-CP inverted repeat cassette is intended to function through the RNAi pathway to confer resistance to infection by PVY. Expression of this cassette cannot be directly measured. Instead, the petitioner submitted a study which examined trait efficacy through potato disease resistance to PVY. Based on the results of the study, it was confirmed that the PVY-CP RNAi cassette is expressed and functional in potato event BG25.

The expression of the StmALS protein in potato event BG25 was analyzed in leaf and tuber samples. Protein concentrations were quantified in potato event BG25 and the non-GM Russet Burbank control using immunoblot analysis. A polyclonal antibody that is specific for StmALS with minimal cross-reactivity to the unmodified S. tuberosum ALS (StALS) protein was used. A recombinant form of StmALS protein, derived from E. coli, was used as positive control. StmALS expression was detected in potato event BG25 tuber tissue, with a mean of 420 ng/g FW (range 200 to 570 ng/g FW). StmALS was expressed at a higher level in BG25 leaf tissue, with a mean of 1830 ng/g FW (range 780 – 6010 ng/g FW).

The StmALS protein expressed in potato event BG25 has only 2 amino acid substitutions and is 99.7% identical to the native ALS present in S. tuberosum. The petitioner provided studies comparing the molecular weight and immunoreactivity of the potato event BG25-derived StmALS protein to the E. coli-derived StmALS protein which was used in safety studies. Based on the information provided, the two proteins were determined to be equivalent.

Purification of the 3 R-proteins, VNT1, AMR3, and BLB2, was not possible as E. coli expressed R-proteins are insoluble and could only be recovered from bacterial inclusion bodies. As a result, generating standard protein safety data for R-proteins is impractical considering their intractability and the difficulty of acquiring biologically active R-proteins from the host plant and E. coli.

Based on the available data provided, Health Canada has no safety concerns regarding Simplot potato event BG25 from a molecular perspective.

Dietary exposure

The intended purpose of potato event BG25 is to provide a potato with lower reducing sugars, reduced blackspot bruising, and resistance to late blight and PVY. It is not expected by the petitioner that the introduction of potato event BG25 into the marketplace will result in a significant change in the food use of potatoes.

Nutrition

The petitioner provided compositional data for the potato event BG25 and the non-GM Russet Burbank control from six field trials conducted in the United States during the 2021 growing season. In each trial, four replicates of the novel and control cultivar were planted in a randomized complete block design (n=24 per cultivar). Typical commercial agriculture production practices were used for the field trials.

Potato tubers were harvested at typical harvest maturity and analyzed using acceptable methods for proximates and fibres, starch, vitamins, and minerals as suggested by the Organisation for Economic Co-Operation and Development (OECD) Revised Consensus Document on Compositional Considerations for New Varieties of Potato (Solanum tuberosum): Key Food and Feed Nutrients, Toxicants, Allergens, Antinutrients and Other Plant Metabolites (PDF format) (2020). An intended effect of the genetic modification was to reduce the breakdown of sucrose into its constituent reducing sugars (fructose + glucose) through inhibition of an enzymatic process that is enhanced by cold storage. These sugars were therefore analyzed in recently harvested tubers and in tubers which had been stored for six months under cold-temperature conditions typical of long-term potato storage.

If statistically significant differences between the non-GM Russet Burbank control and potato event BG25 were noted (P-value < 0.05), the nutritional relevance of these differences was further examined by comparing results to the expected range for recently harvested conventional potato based on the OECD consensus document and other publicly available data sources including the Agriculture and Food Systems Institute Crop Composition Database.

As intended, statistically significant differences between potato event BG25 and the non-GM Russet Burbank control were observed for sucrose in stored tubers (higher in potato event BG25), and for reducing sugars in recently harvested and stored tubers (lower in potato event BG25). However, the potato event BG25 values for sucrose and reducing sugars were within the literature range for recently harvested, conventional potatoes, in all cases. These results indicate that levels of sucrose and reducing sugars in potato event BG25 are no different from levels found in some recently harvested, conventional potatoes which are considered to have a history of safe use as food. It is also noted that sucrose is broken down into its constituent reducing sugars (glucose and fructose) during digestion, and these reducing sugars have been shown to be similarly absorbed whether they are consumed as sucrose or an equivalent mixture of individual sugars. Thus, changes in the ratio of sucrose to its constituent reducing sugars in potato event BG25 are not expected to have a significant effect on the utilization of these nutrients by the body. There were no other statistically significant differences in nutrient composition.

Therefore, Health Canada has not identified any nutritional concerns with the food use of potato event BG25.

Chemistry

The petitioner provided analytical data for the total glycoalkaloid (GA) content, defined as the sum of α-solanine and α-chaconine, measured within 24 samples each (4 replicates from 3 different fields grown in 2 consecutive years) of the BG25 and non-GM Burbank Russet control potato tubers.

A statistical comparison of the mean results from the modified and non-GM Burbank Russet control tubers indicated that the BG25 tubers had a somewhat higher propensity for GA formation. Nevertheless, both mean GA concentrations (from the BG25 and control) were comparable to other potato tubers sold in Canada and lower than Health Canada's maximum level (ML) of 200 mg/kg for total GA in potato tubers. A few individual BG25 and non-GM Burbank Russet control samples exceeded the ML, but at a level comparable to other potatoes previously sold in Canada. As with any food or food ingredient sold in Canada, the seller is responsible for ensuring that the product does not result in a violation of Section 4 of the Food and Drugs Act, including maintaining compliance with any applicable ML's. Health Canada encourages the petitioner to remind their potato producers of the existence of the ML as well as the importance of following proper growing and storage practices to minimize the formation of GAs.

Overall, considering the above information, Health Canada is of the opinion that the potato event BG25 is not expected to pose a health concern from a chemical contaminants perspective relative to conventional varieties of potato.

Toxicology

The petitioner provided evidence to support the safety of the four introduced proteins (VNT1, AMR3, BLB2, and StmALS) and the three inverted DNA repeats producing dsRNA (VInv, Ppo5, PVY-CP) expressed in potato event BG25.

The evidence included a history of safe food use, bioinformatics, expression levels, and dietary exposure. No toxicological safety studies were submitted.

The genetic elements for the four proteins (VNT1, AMR3, BLB2, and StmALS) and two of the inverted DNA repeats (VInv, Ppo5) are derived from potatoes with a history of safe food use. The third inverted DNA repeat (PVY-CP) source is potato virus Y, a common pathogen of potatoes with a history of human exposure through the consumption of potatoes.

The petitioner provided bioinformatics analyses finding no relevant matches between the 4 proteins (VNT1, AMR3, BLB2, and StmALS) and known toxins.

The three R-proteins (VNT1, AMR3, and BLB2) have a non-toxic mode of action. All three proteins initiate the same conserved immune pathway that is already active in plants causing plant cell death at the site of infection to prevent the spread of a pathogen. The VNT1 protein was evaluated by Health Canada in previously approved GM potato events (Simplot Innate Event Gen2-W8, X17, Y9, and Z6). No toxicological safety concerns were identified in the risk assessment of the VNT1 protein.

The three R-proteins (VNT1, AMR3, and BLB2) were not detected in the potato event BG25 tubers (Limit of Quantification < 500 ng/g FW). Given the lack of detection, dietary exposure is expected to be negligible.

The marker protein (StmALS) only differs from the native potato ALS protein by two amino acids. It is similar to other modified ALS proteins which were evaluated in previously approved Novel Foods (soybean event 356043 and soybean event CV127). The protein has a non-toxic mode of action which is the synthesis of branched-chain amino acids.

The mean level of StmALS in the potato event BG25 tubers was measured to be 420 ppb. The petitioner estimated a conservative maximum exposure of 0.0034 mg/kg bw/day (children 1-2 years old).

An E. coli-produced StmALS protein, determined to be equivalent to the plant produced StmALS protein, was demonstrated to be heat-labile (loss of activity occurred when heated above 56°C for 20 minutes) and quickly degraded by in vitro digestion (within 30 sec in pepsin or pancreatin).

Dietary exposure to the novel StmALS protein is expected to be negligible because of the low levels present in the tubers and the degradation that occurs from heat exposure and digestion.

A bioinformatic assessment found no human transcripts from NCBI's RNA database with perfect complementarity to any of the potential dsRNA from the inverted DNA repeat sequences in potato event BG25, suggesting that no interaction would occur with human RNA. The VInv and Ppo5 dsRNAs were evaluated by Health Canada in previously approved GM potato events (Simplot Innate Event Gen2-W8, X17, Y9, and Z6).

Dietary exposure to the introduced dsRNA is expected to be negligible. Biological barriers inhibit uptake of RNA from the gut and RNA is readily degraded by heat and digestion. The petitioner estimated a dietary exposure of 29 ng total siRNA/kg bw per day, which is less than the level estimated for the previously approved use of dsRNA VInv and Ppo5 by Health Canada in the second generation of Simplot Innate potato varieties (Simplot Innate Event Gen2-W8, X17, Y9, and Z6).

Based on the available data provided, Health Canada has no safety concerns regarding the potato event BG25 from a toxicological perspective.

Allergenicity

The petitioner provided bioinformatics analyses finding no matches of concern between the 4 proteins and known allergens.

Dietary exposure to the three R-proteins (VNT1, AMR3, BLB2) is expected to be negligible, as these proteins were not detected in the tubers.

For the fourth protein (StmALS), modified ALS proteins have been previously assessed in other Novel Food evaluations by Health Canada and were not found to be an allergenic concern. Additionally, dietary exposure is expected to be negligible due to degradation that occurs from heat exposure and digestion.

Based on the available data provided, Health Canada has no safety concerns regarding the potato event BG25 from an allergenicity perspective.

Conclusion

Health Canada's review of the information presented in support of the use of potato event BG25 does not raise concerns related to food safety.

Health Canada's opinion refers only to the food use of potato event BG25. Issues related to its use as animal feed have been 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 and Nutrition 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.

For further information, please contact:

Novel Foods Section
Food and Nutrition Directorate
Health Products and Food Branch
Health Canada, PL2204A1
251 Frederick Banting Driveway
Ottawa, Ontario K1A 0K9
bmh-bdm@hc-sc.gc.ca

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2026-03-31