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U.S. Department of Health and Human Services

Food

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Select Committee on GRAS Substances (SCOGS) Opinion: Enzymatically hydrolyzed protein

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.

Enzymatically hydrolyzed protein

  • SCOGS-Report Number: 37b*
  • Type Of Conclusion: 1
  • ID Code: There is no ID Code
  • Year: 1980
  • 21 CFR Section: There is no CFR citation.

SCOGS Opinion:

The average level of consumption of protein hydrolyzates for flavoring purposes is less than 3 mg per kg per day. Protein hydrolyzates are not used for flavoring purposes in commercially processed baby foods wich formerly may have contained about 2 percent by weight. The Select Committee was unable to locate reports of experimentally demostrable adverse effects of high concentrations of glutamate in dietary mixtures.

In light of the above, and assuming that appropriate product specifications are adopted, the Select Committee concludes that: There is no evidence in the available information on acid hydrolyzed proteins, enzymatically hydrolyzed protein, yeast autolysates, and soy sauces, that demonstrates, or suggests reasonable grounds to suspect, a hazard to the public when they are used as flavoring agents at levels that are now current or that might reasonably be expected in the future.

The situation is different regarding the use of enzymatic casein hydrolyzates as nutrients. These hydrolyzates are consumed or administered in much higher doses, frequently as the sole source of dietary protein in products that are used as special dietary foods.

Decades of clinical experience have revealed no reports of untoward effects when casein hydrolyzates are administered orally in combination with other nutrients such as glucose. Adverse effects of the dicarboxylic amino acid components have been reported only in rodents under unusual conditions of administration (e.g., gavage or subcutaneous injection) and are not considered relevant to the use of casein hydrolyzates by humans.

The Select Committee therefore concludes that: There is no evidence in the available information on enzymatically hydrolyzed casein that demostrates, or suggests reasonable grounds to suspect, a hazard to the public when it is used as a nutrient in special dietary foods 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.