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Diss Factsheets

Toxicological information

Additional toxicological data

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Administrative data

additional toxicological information
Type of information:
other: GRAS notification
Adequacy of study:
supporting study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: FDA - Generally recognized as safe (GRAS) notification on Medium- and long-chain triacylglycerol (MLCT)-oil as a food ingredient

Data source

Reference Type:
Bibliographic source:
Report date:

Materials and methods

Type of study / information:
Notification on the generally recognized as safe status of medium- and long-chain triglycerides.
Principles of method if other than guideline:
Basis of GRAS Determination
Pursuant to 21 CFR § 170.3, medium- and long-chain triacylglycerol (MLCT)-Oil has been determined GRAS by scientific procedures for its intended conditions of use. The safety of MLCT-Oil is supported by preclinical and clinical studies, and the fact that medium-chain triacylglycerols have been administered to patients with malabsorption syndromes, added to infant formulations, and consumed in the diet from natural sources, while long-chain triacylglycerols contained in vegetable oils have been commonly consumed in the human diet. This determination is based on the views of experts who are qualified by scientific training and experience to evaluate the safety of substances used as ingredients in food.

Test material

Constituent 1
Reference substance name:
Automatically generated during migration to IUCLID 6, no data available
Automatically generated during migration to IUCLID 6, no data available
Details on test material:
Medium- and long-chain triacylglycerol (MLCT)-Oil is an edible vegetable oil manufactured from common edible vegetable oils containing long-chain fatty acids, such as those found in rapeseed, soybean, cottonseed, sunflower seed, peanut, olive, corn, safflower, rice bran, and sesame seed oils, while medium-chain triacylglycerol (MCT) is produced from coconut and palm kernel oils. Specific ratios of edible vegetable oil and MCT produced from edible oils are combined with a food grade lipase utilized to promote a randomized ester exchange, such that the MLCT-Oil produced is composed of both medium- and long-chain triacylglycerols (MLCT). The medium-chain fatty acids (MCFA) of MLCT-Oil consist of only capric and caprylic fatty acids, each containing eight and ten carbons in length, respectively.
For details see tables below

Results and discussion

Any other information on results incl. tables

Regulatory Status

MLCT-Oil (containing approximately 12% MCFA) manufactured via transesterification from LCT (from vegetable oils such as rapeseed oil) and MCT (from coconut and/or palm kernel oil) to produce a novel food product, was granted “Food for Specified Health Use” (FOSHU) status by the Ministry of Health, Labor, and Welfare inon December 6, 2002. FOSHU is defined as a food that has beneficial, effective ingredients added to help in the maintenance of a healthy body condition. The standards for such foods include criteria stating that the food should be expected to improve one’s diet, as well as the maintenance and or enhancement of health. In addition, the food (or its constituents) should be safe to eat, with no significant loss in its nutritive constituents, in comparison with those normally contained in similar foods or food ingredients. MLCT-Oil is sold in as a cooking oil, with the total sales since it was launched in 2003 at approximately $300 million dollars.


Estimated Daily Intake

Key to any food safety risk assessment process is an understanding of the anticipated consumption of the food ingredient(s) in question as an index of consumer exposure at the proposed use level(s) for the ingredient(s). MLCT-Oil is an edible vegetable oil that is equivalent in quality, physical properties, flavor, and taste, to common vegetable oils. As such, MLCT-Oil is intended for use as a substitute of edible vegetable oils consumed in thepopulation, and not to increase the overall consumption of edible vegetable oils. MLCT-Oil will be added to the foods, and the weighted mean and 90thpercentile consumption of MLCT-Oil is calculated at 11.4 and 30.9 g/day, respectively (approximately equivalent to 183.4 and 459.9 mg/kg/day, respectively, based on the weights of the sample population queried for this consumption analysis). The fatty acid composition of edible cooking oils consumed in thepopulation is equivalent to that found in MLCT-Oil; therefore, the dietary fatty acid consumption does not change with ingestion of MLCT-Oil.

Applicant's summary and conclusion