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U.S. Department of Health and Human Services

Food

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Select Committee on GRAS Substances (SCOGS) Opinion: Propylene glycol monostearate

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.

Propylene glycol monostearate

  • SCOGS-Report Number: 27*
  • Type Of Conclusion: 1
  • ID Code: 57-55-6
  • Year: 1973
  • 21 CFR Section: There is no CFR citation.

SCOGS Opinion:

Propylene glycol is metabolized by animals and can be used as a carbohydrate source. Propylene glycol can be ingested over long periods of time and in substantial quantities (up to 5 percent of the total food intake) without causing frank toxic effects. Propylene glycol monostearate is readily hydrolysed in vivo and the propylene glycol and fatty acid moieties enter their respective metabolic pathways. At lethal or near lethal doses (6 g per kg or more), however, it has been reported to cause kidney damage in several species and toe deformities in chicks. These doses contrast with the few mg per kg per day estimated in Section III of this report to be the human daily dietary intake of propylene glycol. The Select Committee has weighed the available information and concludes that: There is no evidence in the available information on propylene glycol and propylene glycol monostearate that demonstrates, or suggests reason to suspect, a hazard to the public when they are used at levels that are now current or that might reasonably be expected in future.

*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.