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U.S. Department of Health and Human Services


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Select Committee on GRAS Substances (SCOGS) Opinion: Mannitol


  • SCOGS-Report Number: 10*
  • Type Of Conclusion: 1
  • ID Code: 69-65-8
  • Year: 1972
  • 21 CFR Section: 180.25

SCOGS Opinion:

The available evidence reveals no short-term toxicological consequences in mice, rats, hamsters, or man when mannitol is fed in amounts exceeding those currently consumed in man's daily diet. There is no evidence that consumption of mannitol in the United States since 1950, when it was first used, has had adverse effects. It is recognized that mannitol exerts a laxative effect at levels that are from 5 to 10 times the estimated average adult intake level and about 2 to 3 times the maximum adult intake level. Children in the age groups 6-11 months and 12­23 months are now estimated to be consuming mannitol in amounts close to or in excess of those capable of exerting a laxative effect. Recognizing this and also that the reported average and maximum intake levels are generous over estimates, it is the opinion of the Select Committee that the use of mannitol in food in the present or reasonably foreseeable amounts poses no problem in this regard. The lack of experimentla data on long-term studies, carcinogenicity, mutagenicity, or effects on reproduction mertis special attention. This is pertinent because ofthe repidly increasing use of mannitol in food products. The Select Committee has weighed the foregoing and concludes that: There is no evidence in the available literature to show that mannitol constitues a hazard to the public when 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.