Novel food information: Structured medium- and long-chain triacylglycerol (MLCT oil)

On this page

• Background
• Introduction
• Product development
• Dietary exposure
• Chemical assessment
• Microbiology
• Nutrition
• Toxicological assessment
• Allergen assessment
• Conclusion

Background

Health Canada notified Bunge Oils Inc., Missouri, USA, that it has no objection to the use of medium- and long-chain triacylglycerol (MLCT) oil as a food ingredient. The Department has reviewed the information provided and conducted a comprehensive toxicological, chemical, nutritional, and microbiological safety assessment of the MLCT oil.

The following provides a summary of the notifications from Bunge Oils Inc. and the evaluation by Health Canada, and contains no confidential business information.

Introduction

The MLCT oil is designed to provide a source of medium-chain fatty acids (MCFAs) and long-chain fatty acids (LCFAs) in a range of food categories. These include baked goods and baking mixes, beverages and beverage bases, dairy analogs, fats and oils, grain products and pastas, milk products, snack foods, and baby foods (i.e., nutritional drinks for young children). The MCFAs in MLCT oil are derived from palm kernel oil and/or coconut oil, while the LCFAs are sourced from canola oil or similar alternatives.

The Food and Nutrition Directorate (FND) has conducted the safety assessment 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 FND has a legislated responsibility for the 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 safety of the MLCT oil was assessed as a novel food, because it was best described as "a substance that does not have a history of safe use as a food."

Product development

The MLCT oil is produced through an enzymatic esterification process. Esterification is a well-recognized method in the production of fat products. The esterification process is followed by standard purification steps, including bleaching and deodorization, which are common in the production of edible vegetable oils. The random distribution of triacylglyceride structural variants was predicted by modeling and verified analytically.

Dietary exposure

To estimate potential intake of the MLCT oil, the petitioner used a serving-type approach. The daily intakes were calculated assuming five servings per day. For adults, a conservative daily exposure of 73 g of structured MLCT oil (26.3% total energy) was estimated, with 36.5 g/day of MCFAs (13.1% TE). Assuming 2,500 kcal/day for average adult. For children consuming nutritional beverages (5 servings/day), exposure was estimated at 28 g of structured MLCT oil (25.2% TE), with 14 g/day of MCFAs (12.6% TE). Assuming 1,000 kcal/day for average 1- to 3-year-old. The exposure estimates assume that all food servings contain the maximum level of MLCT oil (17 g/serving) and that all servings consumed in a day include the ingredient. Actual levels of MLCT oil in foods will vary, and market penetration may not be 100%.

Chemical assessment

The MLCT oil is manufactured in accordance with current Good Manufacturing Practices (GMP) and the principles of Hazard Analysis and Critical Control Points. Residues of the lipase are expected to be minimally released from its immobilized granulate and are insoluble in oil. Any residue of the lipase and other processing aids are expected to be removed by the downstream purification steps described by the petitioner. Ascorbyl palmitate and tocopherols are added to stabilize the final product and are permitted for use as preservatives in oils used in infant formula at levels of use consistent with GMP. No safety concerns were identified with respect to potential residual chemical concentrations in the MLCT oil or exposures to chemicals from MLCT oil consumption.

Microbiology

The MLCT oil is a low-moisture product and is not expected to support microbial growth. The petitioner submitted testing data conducted using internationally recognized methods, which confirmed the absence of pathogens and indicator microorganisms.

Nutrition

The MLCT oil is made exclusively from edible vegetable oils, with medium-chain triacylglycerols (MCTs) sourced from plant materials such as palm kernel and coconut, while long-chain triacylglycerols (LCTs) are sourced from canola oil. The oil primarily consists of caprylic acid (C8:0) and capric acid (C10:0) (approximately 50% and not less than 42%) and the LCFAs, oleic acid (C18:1), linoleic acid (C18:2), and α-linolenic acid (C18:3ω3). The structured MLCT oil also contains small amounts of palmitic acid (C16:0) (≤3%) and other MCFAs (lauric acid (C12:0)) and LCFAs (myristic acid (C14:0), palmitoleic acid (C16:1), stearic acid (C18:0), and arachidic acid (C20:0)). Both MCTs and LCTs present in the MLCT oil are normal components of the human diet and are metabolized through standard fatty acid pathways after ingestion. Consequently, neither the novel fatty acid composition nor the individual fatty acids themselves are expected to present any safety concerns.

Toxicological assessment

The MLCT oil is produced from edible oils that have a history of safe food use (i.e., coconut, palm, canola oil). No toxicological concerns were identified.

Allergen assessment

Most food allergens are proteins. The manufacturing of the MLCT oil is consistent with highly refined oils with low protein levels and would not be expected to be of allergenicity concern.

Conclusion

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

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