ARCHIVED - Novel Food Information on: Vegetable Diacylglycerol Oil

Health Canada notified Archer Daniels Midland, of Decatur, Illinois, USA and the Kao Corporation, of Japan, via a letter to their Canadian agent, in September of 2004 that it has no objection to the sale of vegetable diacylglycerol oil (also known as Enova^TM Oil). The Department has conducted a comprehensive assessment of this oil 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 Archer Daniels Midland/Kao Corporation's Canadian agent and the evaluation by Heath Canada and contains no confidential business information.

1. Introduction

Vegetable-based oils and fats naturally contain triglycerides and minor amounts of diglycerides and monoglycerides. By an enzymatic process developed by Kao Corp., the ratio of glycerides found in the oil covered by this notification is shifted from triglycerides to diglycerides. Vegetable diacylglycerol oil contains 80% diglycerides (mixture of 1,3- and 1,2-diglycerides at a ratio of 7:3), =20% triglycerides, =5% monoglycerides, emulsifiers and antioxidants. The main constituent fatty acids of this oil are oleic, linoleic and linolenic acid. The vegetable diacylglycerol oil is to be used as a 1:1 (w/w) replacement for liquid vegetable oils in all applications.

The assessment conducted by Food Directorate evaluators considered: how the vegetable diacylglycerol oil that is the subject of this notification is produced; how its composition and nutritional quality compare to other oils; the nutritional impact and safety of the use of this oil; and the potential for the presence of any toxicants, anti-nutrients, allergens or chemical contaminants which could be found in this oil. Based on the data provided by the petitioner, no safety or nutritional concerns related to the consumption of vegetable diacylglycerol oil have been identified.

Under Division 28 of Part B of the Food and Drug Regulations, the Food Program has responsibility for pre-market assessment of novel foods and novel food ingredients. Vegetable diacylglycerol oil is considered a novel food, as per B.28.001, as it is "a food that has no history of safe use."

2. Description of the Novel Process

Vegetable diacylglycerol oil is manufactured through esterification of fatty acids (derived from food-grade soybean and canola oils) with either monoacylglycerol or glycerol. The fatty acids are obtained by a standard process of heat hydrolysis of the oil. Esterification is catalyzed by a lipase listed in Table V of Division 16 of the Canadian Food and Drugs Act and Regulations. After the esterification, the reaction mixture is refined, washed and deodorized. Then, permitted additives (antioxidants and emulsifiers) are added to the refined oil prior to packaging/storage.

3. Microbiology

The lipase used in the manufacturing process, and its source microorganism, is listed in Table V of Division 16 of the Canadian Food and Drugs Act and Regulations. Thus, the assessment of the production organism is not necessary.

4. Dietary Exposure

The petitioner is proposing the use of vegetable diacylglycerol oil as a 1:1 replacement for liquid vegetable oils incorporated into the following food products: baked goods, pizza, fats and oil (edible oils, margarines, mayonnaise, and salad dressing), health bars, meal replacements, frozen entrees, and soup mixes and gravies.

5. Nutrition

As stated previously, vegetable diacylglycerol oil contains =80% diglycerides (mixture of 1,3- and 1,2-diglycerides at a ratio of 7:3), =20% triglycerides, and =5% monoglycerides. The fatty acid profile of vegetable diacylglycerol oil is comparable with that of other vegetable oils. The primary fatty acids found in this oil are oleic acid (C18:1), linoleic acid (C18:2) and linolenic acid (C18:3) and the levels of these fatty acids are comparable to the levels found in most vegetable oils. Oleic acid is present at levels of 20-65% by weight in vegetable diacylglycerol oil compared to corn oil (20.0 - 42.2%), palm oil (36 - 44%) and olive oil (56 - 83%). Linoleic acid is present at levels of 15 - 65% by weight in vegetable diacylglycerol oil compared to corn oil (39.4 - 62.5%), cottonseed oil (46.7 - 58.2%), sunflower oil (48.3 - 74%), soybean oil (49.8 - 57.1%) and safflower oil (67.8 - 83.2%). Linolenic acid is present at levels of less than or equal to 15% by weight in vegetable diacylglycerol oil. Most vegetable oils contain low amounts of linolenic acid. Overall, the levels of these fatty acids present in vegetable diacylglycerol oil do not pose any nutritional concerns.

To establish the estimated daily intake of vegetable diacylglycerol oil by the Canadian population, the petitioner looked at information on the proposed food-uses of this oil (as a replacement for vegetable-based table and cooking oils and as an ingredient in foods) in Canada and data from the Quebec and Saskatchewan Nutrition Surveys, conducted in 1990 and 1993-1994. Based on the survey data approximately 98% of the Canadian population was identified as consumers of the proposed food-uses of vegetable diacylglycerol oil . This resulted in an estimated mean "all-user intake" of 8.5 and 9.6 g/person/day vegetable diacylglycerol oil by the populations in Quebec and Saskatchewan, and 90th percentile values ranged from 19.9 and 22.1 g/person/day. On an individual basis, male adults had higher vegetable diacylglycerol oil intakes than female adults, with mean and 90th percentile values ranging from 9.4 to 10.7 g/person/day and 24.0 to 24.5 g/person/day, respectively. It may be noted that this calculation is based on select foods in which vegetable diacylglycerol oil will be used. According to our calculations, mean intake of fats and oils in Quebec is 18.5g/day (total fat intake is 77g/day).

The upper intake estimates by the petitioner were less than the dose levels of vegetable diacylglycerol oil used in published/unpublished clinical studies provided by the petitioner. These studies were undertaken to investigate the possible effects of repeated ingestion (1 to 12 months) of vegetable diacylglycerol oil. The intake level varied from 10 to 44 g oil/day. In one study, ad libitum intake for 12 months was studied. The parameters measured in these studies included: blood parameters, serum chemistry, lipid profile and liver function. No treatment related adverse effects were found. In one study, the effect of vegetable diacylglycerol oil in comparison to a conventional oil on the absorption of the fat-soluble vitamins (A, D, and E) was assessed. No significant difference was found between the effect of the conventional oil and vegetable diacylglycerol oil consumption on the absorption of the vitamins.

On the basis of the data provided, the Bureau of Nutritional Science has no objection to the use of vegetable diacylglycerol oil as a replacement for other vegetable oils currently available in the market.

6. Chemistry/Toxicology

The Bureau of Chemical Safety has reviewed the data package submitted, including the manufacturing process, product analysis covering heavy metals, arsenic and lead and toxicological data.

No concerns were raised about heavy metal levels. Lead and arsenic levels were above those listed in Food Chemical Codex standards when compared to the source oils (soybean, canola and corn oils), however there were no health risks associated with these levels based on intake estimates from Canadian nutrition surveys supplied.

The impact of heating of the vegetable diacylglycerol oil on its safety was considered. Based on the thermal properties of this oil, where all the thermal indicators were well above 196ºC, the maximum frying temperature of the frying oil reached in many frying operations, this oil can be considered as a safe frying oil. Furthermore, in a study by Shimizu et al¹, the thermal deterioration of cooking oil during deep-frying with a vegetable diacylglycerol oil was compared with that of a cooking oil composed of a blend of commercial cooking oils with a comparable fatty acid composition and tocopherol content. Analyses of several indices of deterioration indicated no substantial difference in p-anisidine value, iodine value and oxidized fatty acids (these are all indicators of oxidation in oils), and degree of polymerization between the notified oil and the commercial oil. This study concluded that there was no difference in thermal deterioration between these oils during deep-frying.

In various oral/feeding toxicity studies in rats, vegetable diacylglycerol oil had no deleterious effects specific to its intake, other than those that might be expected with the consumption of high fat levels (e.g., short-term diarrhea after gavage). Other diglyceride formulations were found to be non-mutagenic in bacteria and (where conclusions could be drawn) in yeast. In animal experiments and human clinical trials, the effects of vegetable diacylglycerol oil were comparable with those of corresponding amounts of triglycerides with similar fatty acid composition administered to control animals or subjects. There was even a tendency for certain health-related parameters, such as serum triglycerides and cholesterol levels, to be slightly decreased in human subjects consuming vegetable diacylglycerol oil relative to those consuming triglycerides. In these subjects, vegetable diacylglycerol oil appeared to be without effect on parameters of toxicological interest, such as levels of liver enzymes in the serum, glycemic regulation, and clinical chemistry parameters, at intakes of 20 to > 40 g/day in studies lasting up to 12 weeks or of about 10 g/day in studies lasting one year.

There is therefore no reason to believe that the substitution of triglycerides with vegetable diacylglycerol oil oil at a 1:1 ratio by weight in various fats and oils or in baked goods, prepared foods, and mixes containing those oils will be of toxicological concern. Furthermore, since vegetable diacylglycerol oil oil is composed of fatty acids from edible oils, it would appear that any effects resulting from the consumption of vegetable diacylglycerol oil oil would relate to altered metabolism as a consequence of a greater proportion of diglyceride as opposed to triglyceride in dietary fat.

On the basis of the data provided, the Bureau of Chemical Safety does not object to the use of this novel food ingredient for the purposes proposed by the petitioner.

¹ Shimizu et al., 2004, JAOCS, vol. 81, 571-576, Thermal Deterioration of Diacylglycerol and Triacylglycerol Oils During Deep-Frying

7. Labelling

The CFIA's Bureau of Food Safety and Consumer Protection has been consulted in regard to the naming of the novel food ingredient. The common name, based on discussions with CFIA and the petitioner, is to be:
(naming the source oil(s) from which the fatty acids are derived) diacylglycerol oil.

For instance, if canola oil was used as feedstock for fatty acids, then the proper name of the ingredient/food would be canola diacylglycerol oil. If canola and soybean were used, then the name would be canola and soybean diacylglycerol oil.

The oil may also be called by the more general name vegetable diacylglycerol oil, with the exceptions of vegetable diacylglycerol oil derived from the following feedstocks: coconut oil, palm oil, palm kernel oil, peanut oil or cocoa butter (as prescribed in column I of items 14 and 17 of the table following B.01.010). In this case, the source oil must then be clearly identified in the name.

The listing of vegetable diacylglycerol oil in the list of ingredients must provide for the oil used as feedstock in the following manner:
(naming the source oil(s) from which the fatty acids are derived) diacylglycerol oil

For instance, if canola oil was used as feedstock for fatty acids, then the proper listing of the oil would be canola diacylglycerol oil. If canola and soybean were used, then the name would be canola and soybean diacylglycerol oil.

Conclusion:

Health Canada's review of the information presented in support of the vegetable diacylglycerol oil, that is the subject of this notification, concluded that there are no human food safety concerns associated with their sale in Canada.

This opinion is solely with respect to the suitability of vegetable diacylglycerol oil for sale as human food. It is the continuing responsibility of Archer Daniels Midland and the Kao Corporation, to ensure that their products are in compliance with all applicable statutory and regulatory requirements. Any new information obtained in relation to these products which have potential health and safety implications should be forwarded to Health Canada for our consideration in order to ensure the continued safety and integrity of all foods available in the Canadian marketplace. The sale of a food which poses a hazard to the health of consumers would contravene the provisions of the Food and Drugs Act.

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
Tunney's Pasture
Ottawa, Ontario K1A 0L2

Telephone: (613) 941-5535
Facsimile: (613) 952-6400