Novel food information: Ahiflower Oil

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Health Canada has notified Nature's Crops International that it has no objection to the sale of Ahiflower® oil as an ingredient for use in foods and beverages sold in Canada at a level providing up to 375 mg stearidonic acid per serving of food. The Department conducted a comprehensive assessment of the product 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.

Background:

The following provides a summary of the notification from Nature's Crops International, and the evaluation by Health Canada. It contains no confidential business information.

1. Introduction

Ahiflower® oil is extracted from the seeds of Buglossoides arvensis (L.) I.M.Johnst., commonly called corn gromwell or bastard alkanet, a herbaceous annual plant belonging to the Boraginaceae family that is native to Europe and Asia. B. arvensis is not genetically modified but is produced through traditional breeding techniques.

Ahiflower® oil is a plant seed oil containing triglycerides (90%), diglycerides (2-6%), monoglycerides (2-4%), free fatty acids (<0.3%) and a unsaponifiable fraction (<1.5%) comprised of phytosterols including β-sitosterol, campesterol, stigmasterol, and γ-tocopherol.

Ahiflower® oil contains approximately 20% stearidonic acid (SDA) (% of fatty acids), an omega-3 fatty acid that is an intermediate in the synthesis of eicosapentaenoic acid (EPA) from alpha-linolenic acid (ALA). Ahiflower® oil also contains approximately 45% ALA and 6 % gamma-linolenic acid (GLA). Ahiflower® oil is proposed for use as an ingredient in a wide range of food categories at levels to provide up to 375 mg SDA per serving of food.

The safety assessment performed by the Food Directorate considered the safety of the B. arvensis source plant, the manufacturing process for the oil, the nutritional composition of the oil, and what the potential is for the oil to present a toxic or allergenic concern.

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). The available information on Ahiflower® oil's history of safe use as a food was insufficient to demonstrate that the food has been an ongoing part of the diet for a number of generations in a large genetically diverse human population where it has been used in ways that are similar to those expected or intended in Canada. Therefore, Ahiflower® oil was considered to be a novel food under the following part of the definition of novel foods:

"(a) a substance, including a microorganism, that does not have a history of safe use as a food."

2. Development of the product

Ahiflower® oil is manufactured in accordance with Good Manufacturing Practices using food grade raw materials and processing aids. Ahiflower® oil is obtained via traditional manufacturing processes that are commonly used to produce food oils.

The oil is extracted from the seed of B. arvensis by either expeller pressing or solvent extraction at set temperature ranges. Solvent extraction is done with hexane or isohexane. After extraction, the crude oil is refined by methods commonly used in the edible oil industry, such as degumming, addition of sodium hydroxide to neutralise free fatty acids, bleaching, deodorisation and filtration.

Ahiflower® oil is subject to the standard for vegetable fats and oils (B.09.001 of the Food and Drugs Regulations) and as such may contain emulsifying agents, Class IV preservatives, an antifoaming agent, and β-carotene in a quantity sufficient to replace that lost during processing, if such an addition is declared on the label.

3. Dietary exposure

The Petitioner states that Ahiflower® oil can serve as an alternative source of fat in a wide range of foods including baked goods and baking mixes, breakfast cereals and grains, cheeses, dairy product analogs, fats and oil, fish products, frozen dairy desserts and mixes, grain products and pasta, gravies and sauces, meat products, milk products, nuts and nut products, poultry products, processed fruit juices, processed vegetable products, puddings and fillings, snack foods, soft candy, and soups and soup mixes. The Petitioner notes that Ahiflower® oil is self-limiting by the level of fat that can be added to the proposed foods and that the cost and composition of Ahiflower® oil make it unsuitable for high temperature cooking (e.g., deep-frying). The Petitioner intends to use Ahiflower® oil at a level that will provide up to 375 mg SDA/serving of food.

Using the aforementioned estimated exposure/intakes, the Food Directorate estimated the potential intake of the various fatty acids in Ahiflower® oil.

The projected intakes of ALA, SDA, and GLA from Ahiflower® oil, if it were to be used in all foods proposed at the maximum inclusion rate, is up to 14 g/day, 5.3 g/day, and 2 g/day, respectively. The amount of EPA estimated to be metabolized from SDA in Ahiflower® oil, is up to 2 g/day.

4. Chemistry

There are no specifications for Ahiflower® oil set out in the Food Chemicals Codex (FCC). The Petitioner has established specifications for Ahiflower® oil, including limits on the trace elements of greatest potential concern to human health, that is, arsenic, cadmium, lead and mercury. Results of batch analyses of these trace elements were provided by the Petitioner, demonstrating that Ahiflower® oil consistently meets the limits set out in the Petitioner's specifications. To further assess the safety of arsenic, cadmium, lead and mercury in Ahiflower® oil, dietary exposure to these trace elements from the consumption of the oil was estimated assuming each trace element was present at a concentration equivalent to the Petitioner's specifications and the highest consumption rate on a body weight basis. Potential exposures to each trace element were determined to be very low and therefore are not expected to represent a health concern.

A list of substances used in the Ahiflower® oil manufacturing process was included in the submission. No safety or regulatory concerns were identified with the uses of the substances described by the Petitioner. However, the Petitioner is responsible for ensuring that the presence of trace elements in the product and the use of any substance in the manufacture of Ahiflower® oil is compliant with the Food and Drugs Act. In this regard, the Petitioner noted that all of the substances used in the production of Ahiflower® oil are of food grade and that the food additives hexane, ascorbyl palmitate, and tocopherols are used in accordance with the List of Permitted Food Additives and meet the specifications for these additives set out in the FCC or in the Combined Compendium of Food Additives Specifications prepared by the Joint FAO/WHO Expert Committee of Food Additives (JECFA).

5. Microbiology

Ahiflower® oil is produced using industrial processes standard to the edible oil industry using food-grade raw materials and processing aids. These processes ensure that no microbial contamination is present in the finished product which is demonstrated by microbiological analyses of the oil.

6. Nutrition

Ahiflower® oil is high in polyunsaturated fatty acids. The total amount of omega-3 fatty acids in the oil is approximately 64% (with 45% ALA). The total amount of omega-6 fatty acids in Ahiflower® oil is approximately 18% (with 12% linoleic acid). Other fats are listed below.

Table 1: Fatty acid profile of Ahiflower® oil
Fat (as percent of total fatty acids) Ahiflower® oil
Saturated fat 8.25
Monounsaturated fat (Oleic acid) 10
  • Polyunsaturated fat
  • Linoleic acid
  • Gamma-linolenic acid (GLA)
  • Alpha-linolenic acid (ALA)
  • Stearidonic acid (SDA)
  • 82.25
  • 12
  • 6.25
  • 45
  • 19
Trans fatty acid ≤2

The amounts of each fatty acid found in Ahiflower® oil are in the range of those found in commercially available oils. Ahiflower® oil is intended to replace existing fat in foods; therefore, no change in total fat intake is expected.

The nutritional safety of the Ahiflower® oil fatty acid profile was reviewed with respect to Dietary Reference Intakes including the Acceptable Macronutrient Distribution Range (AMDR) set by the Institute of Medicine (IOM; IOM, 2005), its predicted effect on cardiovascular health, its predicted effect on long chain omega-3 polyunsaturated fatty acid concentrations in tissues, its effect on prostate cancer risk, its potential effect on lipid peroxidation, and any possible adverse events or side effects. No nutritional safety concerns were identified from the intended use of Ahiflower® oil.

High amounts of ALA are present in flax seeds, soybean and canola oils, chia seeds, hemp seeds, mayonnaise, and margarine (soybean) (Canadian Nutrient File, 2015). Flaxseed oil contains 50-60% ALA. The majority of ingested ALA is oxidized to acetyl CoA, which is recycled into de novo synthesis of cholesterol, saturated and monounsaturated fatty acids, or further metabolized to carbon dioxide (Delaney et al., 2000). ALA is also a precursor of the long-chain omega-3 fatty acids EPA and docosahexaenoic acid (DHA), but its conversion to EPA and DHA is limited.

SDA is a metabolic intermediate between ALA and EPA (i.e., ALA→SDA→EPA). The main dietary source of SDA is seafood, although it represents only 0.5-2% of fatty acids present in fish and seafood. An exception is mackerel which contains as much as 7% SDA (Frankel et al., 2002). Most plants do not contain SDA; however, plants from the Boraginaceae, Grossulariaceae, Caryophyllaceae, and Primulaceae are unique because of their higher SDA levels. Echium oil is a commercially available plant source of SDA at levels of 3.5-9% and a SDA soybean oil with 20-29% SDA is also available.

The consumption of SDA by humans results in an increase in EPA levels in plasma, neutrophils, erythrocytes, and plasma phospholipids (Surette et al., 2004; James et al., 2003). 1 g of dietary SDA is approximately equivalent to 300 mg of dietary EPA (James et al., 2003). DHA levels are not similarly effected by SDA supplementation. Further, SDA does not accumulate in tissues, indicating SDA is readily metabolized to EPA (James et al., 2003). Based on the 3:1 conversion rate to EPA, Ahiflower® oil intakes would provide the equivalent of less than 2 g per day of EPA, which is below the Food Directorate internal guidance of 3 g/day and the scientific opinion on the tolerable upper intake level of 5 g/day for EPA and DHA combined (EFSA, 2012).

GLA, an omega-6 fatty acid, is found in trace amounts in oats, barley, human breast milk, meats, fish, green leafy vegetables, and nuts. GLA is typically found in borage oil (18-26%), evening primrose oil (7-10%), and blackcurrant oil (15-20%) (Fan and Chapkin, 1998). GLA is produced in the body from linoleic acid and is converted rapidly to dihomo-gamma-linolenic acid (DGLA), an anti-inflammatory molecule, resulting in a decrease in proinflammatory arachidonic acid. Evidence suggests dietary sources of GLA are non-toxic, and doses up to 2.8 g/day (Zurier et al., 1996) are well tolerated.

7. Toxicology

Standard toxicology studies were not conducted with Ahiflower® oil. These studies were considered not necessary, as the oil is produced by processes conventionally used for edible oil and is similar in composition to other edible oils.

The Petitioner referred to two unpublished short-term studies conducted in mice administered Ahiflower® oil in the diet at levels equivalent to a dose of 3.9 g/kg body weight per day for 3 weeks. No overt signs of toxicity were reported. In addition, two randomized double-blind controlled human clinical studies were reviewed. In the studies, healthy adults received Ahiflower® oil at a dose of 9.1 g per day (equivalent to 130 mg/kg bw per day for a 70 kg individualFootnote 1) for 28 days. No significant health effects were identified. The information submitted by the Petitioner suggests that in short term studies, Ahiflower® oil is well tolerated.

B. arvensis contains pyrrolizidine alkaloids (PA), a group of toxins found naturally in a wide variety of plant species that have genotoxic and carcinogenic properties. PAs are consumed in the diet as a contaminant of a variety of foods, including grains, honey, milk and herbal teas. PAs are water-soluble, thus the bulk of any PAs present in the B. arvensis seed would be expected to be left in the seed meal on extraction, and the level in the oil to be further reduced during refining. The Petitioner reported that unrefined Ahiflower® oil contains 44 ppb of PAs, whereas the refining process reduces this to below 1 ppb, using a sum parameter method for detection. This means that almost all toxic PAs present in the samples can be quantitatively determined, and is considered a conservative approach. The Petitioner has set a specification for PAs at 4 ppb (µg/kg). Analysis of a worst case exposure scenario for PA's from the consumption of Ahiflower® oil is considered to be negligible.

The Petitioner identified that erucic acid is present in Ahiflower® oil with a specification of 1% (as a percent of the fatty acids). In comparison, low-erucic acid rapeseed oil, such as canola oil, has a maximum of 2% erucic acid (as % of total fatty acids). Based on the specifications for erucic acid in Ahiflower® oil set below that of canola, and given that Ahiflower® oil would be used as a replacement in the diet for canola oil (or at a lower level) as a vegetable oil, erucic acid levels are not expected to present a health concern.

No other concerns were identified in regards to undesirable substances in the oil sourced from B. arvensis, based on the available information. In addition, post market data in the U.S. (2014) and Europe (2015) indicate no serious adverse events have been reported with more than 30 million servings of Ahiflower® oil consumed.

A literature review conducted by the Petitioner identified no incidences of allergenic reactions to the source organism of the oil, B. arvensis. Ahiflower® oil, like other refined edible oils, is highly processed and contains negligible quantities of protein. Thus, the Ahiflower® oil does not contain known allergens or biologically active proteins and is not expected to pose an allergenic concern to those that consume it.

Conclusion:

Health Canada's review of the information presented in support of the use of Ahiflower® oil as a food ingredient in Canada within the proposed conditions of use concluded that there are no food safety concerns for the general population. It is the continuing responsibility of the manufacturers, sellers and distributors of Ahiflower® oil to ensure that marketed products are in compliance with all statutory and regulatory requirements, including labelling and advertising.

The 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.

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.

(Également disponible en français)

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

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