Safety assessment of hydrogenated starch hydrolysates

Regul Toxicol Pharmacol. 1993 Aug;18(1):80-114. doi: 10.1006/rtph.1993.1047.


Hydrogenated starch hydrolysates (HSH) are mixtures of polyhydric alcohols such as sorbitol, maltitol, and higher-order sugar alcohols. They are important food ingredients because of their sweetness, low cariogenic potential, and useful functional properties. These traits permit HSH products to be used as viscosity or bodying agents, humectants, crystallization modifiers, and rehydration aids. A substantial body of safety information is available for HSH products and their individual chemical components. Based on this information, the substances have received favorable evaluations from international expert safety organizations such as the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and European Community's Scientific Committee for Food. This same information has been submitted to the United States Food and Drug Administration (FDA) as part of the petitioning process to affirm the generally recognized as safe (GRAS) status of these substances. Some of the animal feeding studies important to a full safety assessment for HSH substances, while long available to international safety expert organizations and governmental organizations, have never been published in the literature. Three of these studies, i.e., a chronic (24-month) feeding study, a multigeneration reproduction study, and a teratology study, are reported on this article, together with metabolic information. The results of this evaluation establish HSH substances as safe food ingredients.

MeSH terms

  • Animals
  • Behavior, Animal / drug effects
  • Blood Chemical Analysis
  • Body Weight / drug effects
  • Bone Development / drug effects
  • Bone and Bones / drug effects
  • Diarrhea / chemically induced
  • Eating / drug effects
  • Female
  • Fetus / pathology
  • Male
  • Organ Size / drug effects
  • Pregnancy
  • Rats
  • Rats, Sprague-Dawley
  • Reproduction / drug effects
  • Starch / chemistry
  • Starch / toxicity*
  • Sugar Alcohols / toxicity*
  • Teratogens / toxicity


  • Sugar Alcohols
  • Teratogens
  • Starch