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U.S. Department of Health and Human Services

Food

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Select Committee on GRAS Substances (SCOGS) Opinion: Propyl Gallate

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.

Propyl Gallate

  • SCOGS-Report Number: 11*
  • Type Of Conclusion: 1
  • ID Code: 121-79-9
  • Year: 1973
  • 21 CFR Section: 184.1660

SCOGS Opinion:

Although interpretation of some reports is difficult, particularly where propyl gallate has been studied in mextures with other antioxidants, it is evident that the no effect level of propyl gallate for the rat exceeds 100 mg per kg per day, and no effect levels of this order have also been reported for mice, guinea pigs and dogs. The Select Committee regards as reasonable the estimate of the FAO/WHO Expert committee on Food Additives of 100 mg per kg per day as the level of propyl gallate that causes no significant toxicological effect when fed to the rat. Using this estimate and the consumer exposure data in Section III, the highest no effect level of orally administered propyl gallate is more than 1,500 fold that usually present in an adult's daily diet and more than 400 fold that which would obtain if his diet were to consist only of those foods containing the maximum amount of propyl gallate. Moreover, the highest no effect level is some 200 fold the maximum reported levels of consumption of the children who, according to the data in Section III, consume propyl gallate at the highest rates. In light of the foregoing the Select Committee concludes that: There is no evidence in the available information on propyl gallate that demonstrates it to be a hazard to the public when used at levels that are now current or that might reasonably be expected in the 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.