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U.S. Department of Health and Human Services

Food

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Select Committee on GRAS Substances (SCOGS) Opinion: Glycerin and Glycerides

The GRAS Substances (SCOGS) Database allows access to opinions and conclusions from 115 SCOGS reports published between 1972-1980 on the safety of over 370 Generally Recognized As Safe (GRAS) food substances. The GRAS ingredient reviews were conducted by the Select Committee in response to a 1969 White House directive by President Richard M. Nixon.

Glycerin and Glycerides

  • SCOGS-Report Number: 30*
  • Type Of Conclusion: 1
  • ID Code: 56-81-5
  • Year: 1975
  • 21 CFR Section: There is no CFR citation.

SCOGS Opinion:

  1. Mono- and diglycerides of edible fat-forming fatty acids  

    Although mono- and diglycerides of edible fat-forming fatty acids are found naturally, those that are used as food additives are usually prepared synthetically. Mono-, di- and triglycerides are metabolized by the same mechanisms. The biological effects of glycerides are either those of the entire molecule or of the metabolic products, fatty acids and glycerin. Triglyceride fats are a major source of calories in the diet of many people. Mono- and diglycerides are minor components of natural fats. They are intermediate metabolic products of ingested triglycerides. There is no evidence that the mono- and diglycerides of edible fatforming fatty acids behave differently from triglycerides upon ingestion.

    There is evidence that ingestion of excesses of saturated fats and cholesterol promotes arteriosclerosis and cardiovascular disease. Continuation of research in this area may refine relationships of the various fatty acids to the point where harmfulness may become an impelling consideration. However, because a reasonable estimate of the consumption of all added mono- and diglycerides is of the order of 1 to 10 g per person per day, only a fraction of which contains saturated fatty acids, it can hardly be concluded that they make a sufficient contribution to any hazard associated with normal ingestion of saturated fatty acids in fatty foods to justify limitation of the level of their current use.

    In light of the scientific information available, the Select Committee concludes that:

    There is no evidence in the available information on mono- and diglycerides of fatformaing fatty acids that demonstrates or suggests reasonable grounds to suspect a hazard to the public when they are used at levels that are now current or that might reasonably be expected in the future.

  2. Diacetyl tartaric acid esters of mono- and diglycerides

    The diacetyl tartaric acid esters of mixed mono- and diglycerides have been found to be without toxic effects in long-term feeding experiments with rats and dogs at levels that were orders of magnitude greater than those to which consumers are exposed. In light of these data, the Select Committee concludes that:

    There is no evidence in the available information on the diacetyl tartaric acid esters of mono- and diglycerdies that demonstrates or suggests reasonable grounds to suspect a hazard to the public when they are used at levels that are now current or that might reasonably be expected in the future.

  3. Triacetin, acettooleins, acetostearins

    Triacetin and two types of acetooleins have been found to be without toxic effects in long-term feeding tests in rats at levels that were several orders of magnitude greater than those to which consumers are exposed. Three types of acetostearins have been found to be without toxic effects in long-term feeding tests in rats at levels up to 5 g per kg per day. This contrasts with an estimated human consumption of a fraction of a milligram per kg per day. It is recognized that at an even higher feeding level (10 g per kg per day) male rats developed testicular atrophy and female rats, uterine discoloration. However, such a level which would amount to 50 g or more for an infant and 600 g for an adult per day, is vastly higher than would be possible in the consumption of foods to which acetostearins are added for functional purposes.

    In light of the available scientific information the Select Committee concludes that:

    There is no evidence in the available information on triacetin, acetooleins, and acetostearins that demonstrates or suggests reasonable grounds to suspect a hazard to the public when they are used at levels that are now current or that might reasonably be expected in the future.

  4. Glyceryl lactopalmitate, glyceryl lactooleate

    Glyceryl lactopalmitate, glyceryl lactooleate have been found to be without toxic effects in long-term feeding tests with rats at levels that were orders of magnitude greater than those to which consumers are exposed.

    In light of the available scientific information the Select Committee concludes that:

    There is no evidence in the available information on glyceryl lactopalmitate and glyceryl lactooleate that demonstrates or suggests reasonable grounds to suspect a hazard to the pulbic when they are used at levels that are now current or that might reasonably be expected in the future.

  5. Oxystearins

    In the only chronic study of the oxystearins available to the Select Committee, levels as high as 7.5 g per kg per day for two years elicited no chronic toxic effects. However, Leydig cell adenomas of the testes were observed. It is recognized that the investigators noted that it was only remotely possible that appearance of these adenomas was related to the oxystearins in the diet and that the dietary level at which they appeared was several orders of magnitude greater than could occur practically. Nevertheless, until this effect has been adequately explained it is inappropriate to conclude that unrestricted use of oxystearins in food would be without hazard. The Select Committee also recognizes the need for establishing the identity of the substances now referred to as the "oxystearins" since the oxidative processes by which they now are prepared would be expected to produce a number of products, such as peroxides, of varying nature and amount.

    In light of the scientific information available, the Select Committee concludes that:

    While no evidence in the available information on oxystearins demonstrates a hazard to the public when they are used at levels that are now current and in the manner now practiced, uncertainties exist requiring that additional studies should be conducted.

  6. Other glycerides

    Opinions and conclusions concerning the sulfoacetate derivatives of mono- and diglycerides, the monosodium phosphate derivatives of mono- and diglycerides and monoglyceride citrate cannot be provided due to the absence or inadequacy of biological data. While chronic feeding studies of a product called succistearin revealed no evidence of toxic effects at levels that were orders of magnitude greater than those to which consumers are exposed, the product fed was a mixture whose primary constituent (stearoyl propylene glycol hydrogen succinate) is not a glyceride. Therefore, a conclusion with respect to succistearin is not included in this report.

*Complete reports containing details of the safety studies that formed the basis of the opinions and conclusions and are available from the National Technical Information Service (NTIS), 5285 Port Royal Road, Springfield, VA 22161 (703) 605-6000.