IngredientsHydrogenated starch hydrolysates (HSHs), also known as polyglycitol syrup (INS 964), are mixtures of several sugar alcohols (a type of sugar substitute). The substance carries the CAS registry number 68425-17-2 and is listed in the United States Pharmacopeia and National Formulary (USP–NF) under the monograph title Hydrogenated Starch Hydrolysate.
By USP definition, Hydrogenated Starch Hydrolysate is a mixture that contains not less than 50% of hydrogenated polysaccharides containing more than 3 d-glucopyranosyl units terminated with a d-glucityl unit, calculated on the anhydrous basis, and may also include sorbitol, maltitol, and other sugar polyols.
JECFA recognises polyglycitol syrup as a synonym for hydrogenated starch hydrolysate, defining it as a mixture consisting mainly of maltitol and sorbitol and lesser amounts of hydrogenated oligo- and polysaccharides and maltotriitol, manufactured by the catalytic hydrogenation of a mixture consisting of glucose, maltose, and higher glucose polymers; it is typically supplied as a syrup but may also be dried and supplied as a solid product.
The term "hydrogenated starch hydrolysate" can correctly be applied to any polyol produced by the hydrogenation of the saccharide products of starch hydrolysis; however, certain polyols such as sorbitol, mannitol, and maltitol are referred to by their common chemical names, and "hydrogenated starch hydrolysate" is more commonly used to describe the broad group of polyols that contain substantial quantities of hydrogenated oligo- and polysaccharides in addition to any monomeric or dimeric polyols.
Because in HSHs the starch is not completely hydrolyzed, a mixture of sorbitol, maltitol, and longer chain hydrogenated saccharides (such as maltotriitol) is produced. When no single polyol is dominant in the mix, the generic name hydrogenated starch hydrolysates is used; however, if 50% or more of the polyols in the mixture are of one type, it can be labeled as "sorbitol syrup," or "maltitol syrup," etc.
By JECFA description, polyglycitol syrup is a colourless and odourless, clear viscous liquid or white crystalline mass, with functional uses as sweetener, humectant, texturizer, stabilizer, and bulking agent.
Hydrogenated starch hydrolysates are produced by the partial hydrolysis of starch — most often corn starch, but also potato starch or wheat starch — which creates dextrins (glucose and short glucose chains); the hydrolyzed starch (dextrin) then undergoes hydrogenation to convert the dextrins to sugar alcohols.
The manufacturing process is a two-step procedure. First, the starch undergoes partial hydrolysis, typically via enzymatic methods using amylases, although acid or heat-assisted hydrolysis may also be used, to break down the starch polymer into a mixture of dextrins, glucose, maltose, and higher oligosaccharides (short glucose chains); the degree of hydrolysis is controlled to achieve the desired composition. The hydrogenated glucose syrups or hydrogenated starch hydrolysates may be produced by catalytic hydrogenation of standard glucose syrups (acid and/or enzyme converted) to the point where all the glucose end groups of the saccharides are reduced to alcohols — that is, dextrose to sorbitol.
The end product is an ingredient composed of sorbitol, maltitol, and higher hydrogenated saccharides (maltotriitol and others); by varying the conditions and extent of hydrolysis, the relative occurrence of various mono-, di-, oligo-, and polymeric hydrogenated saccharides in the resulting product can be obtained.
Hydrogenated starch hydrolysates are similar to sorbitol: if the starch is completely hydrolyzed so that only single glucose molecules remain, then after hydrogenation the result is sorbitol.
The exact polyol profile of an HSH product depends heavily on the degree of polymerization (DP) of the starch hydrolysate before hydrogenation. HSH consists primarily of sugar alcohols (polyhydric alcohols or polyols), including sorbitol, maltitol, and higher-order polyols or polysaccharides.
One commercially significant HSH composition, described in patent literature under the tradename LYCASIN 80/55, has the following profile: the preferred hydrogenated starch hydrolysates contain 4–14% of sorbitol, 45–60% by weight of hydrogenated disaccharides, no more than 3% by weight of hydrogenated polysaccharides having a degree of polymerization of at least 20, and the balance constituting a mixture of hydrogenated polysaccharides having a degree of polymerization of 3 to 20; the most preferred form comprises 6–8% by weight of D-sorbitol, 50–55% by weight of hydrogenated disaccharides, 20–25% by weight of hydrogenated tri- to hexasaccharides, and from 15–20% by weight of hydrogenated polysaccharides having a degree of polymerization greater than hexasaccharides.
Another compositional range described in patent literature encompasses a mixture with approximately 2.6 to 7.7 wt-% of hydrogenated monosaccharides (DP=1); 21.4 to 40.1 wt-% of hydrogenated disaccharides (DP=2); 8.9 to 13.6 wt-% of hydrogenated trisaccharides (DP=3); 16.0 to 29.3 wt-% of hydrogenated oligosaccharides (DP=4 to 10); and 22.5 to 37.1 wt-% of hydrogenated polysaccharides of greater than hydrogenated decasaccharides (DP≥11).
HSH demonstrate excellent stability, resisting Maillard browning reactions due to the absence of reducing groups, and remaining stable under acidic conditions across a pH range of 3 to 7; this chemical inertness allows their use in heat-processed foods without discoloration or degradation.
In syrup form, HSH achieve concentrations up to 80% solids at room temperature, facilitating their incorporation into aqueous formulations; in syrup form, HSH provide a viscosity range typically between 100 and 500 cP, depending on molecular weight and concentration, contributing to body and mouthfeel without the crystallization seen in pure sugar alcohols like sorbitol or mannitol.
Hydrogenated starch hydrolysates were developed by the Swedish company Lyckeby Starch in the 1960s. HSH were developed by a Swedish company in the 1960s and have been used by the food industry for many years, especially in confectionery products.
Since its development in the mid-20th century, HSH has gained widespread use as a bulk sweetener in various nutritional products, including sugar-free candies, chewing gums, meal replacements, and protein bars.
HSH as a food ingredient has no pre-modern or traditional ethnobotanical history. It is an entirely manufactured ingredient whose origins are industrial. Its adoption grew out of the food industry's demand for sugar alternatives suitable for diabetics and for non-cariogenic confectionery. The non-cariogenic character of hydrogenated hydrolysates under the trade name LYCASIN 80/55 was commercially documented from 1978.
Hydrogenated starch hydrolysates are recognized as Generally Recognized as Safe (GRAS) by the U.S. Food and Drug Administration (FDA) for use as direct food ingredients in a variety of applications, including as sweeteners, humectants, and stabilizers; this status allows for self-affirmation by industry, with a notable GRAS notice (GRN No. 59) submitted in 2001 for general use in foods, following earlier petitions dating back to the 1980s that supported its safety profile.
In the European Union, HSH is approved as a food additive under the designation E 964 (polyglycitol syrup) pursuant to Regulation (EC) No 1333/2008, and is permitted in numerous food categories such as confectionery, beverages, and baked goods, at levels up to quantum satis.
The HSH family of polyols is an approved food ingredient in Canada, Japan, and Australia.
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 the European Community's Scientific Committee for Food.
On the basis of information reviewed at both the 1998 and 1999 meetings, JECFA allocated a group acceptable daily intake (ADI) of "not specified" to materials conforming to the specifications for polyglycitol syrup and maltitol syrup, meaning that polyglycitol syrups do not, in the opinion of JECFA, represent a hazard to health and the establishment of a specific numerical limit on average daily intake is not needed.
In 1984, the Scientific Committee for Food of the European Union evaluated maltitol syrups and concluded it was not necessary to set an ADI for maltitol syrups.
HSH is not a single chemical entity but a complex mixture. Its primary constituents and their individual contributions are:
HSH are more slowly absorbed in the digestive tract; a portion of HSH may be enzymatically hydrolyzed in the body to sorbitol, maltitol, and glucose, however this process is slow; therefore, HSH have a reduced glycemic potential relative to glucose for individuals with and without diabetes.
The greater digestibility of hydrogenated starch hydrolysates with the highest content of highly polymerized saccharides was considered to be the consequence of a greater activity or affinity of digestive enzymes for glucose-glucose than for glucose-sorbitol bonds. Data indicated that the higher-order polyols would be completely hydrolyzed to glucose and maltitol or sorbitol, with a considerable portion undergoing fermentation by the gut flora; bacterial fermentation was demonstrated by the detection of an increased amount of Hâ‚‚ in the breath of human subjects.
Since HSH are more slowly absorbed, a portion of HSH in a food reaches the lower digestive tract where it is metabolized by naturally occurring colonic bacteria, resulting in a reduction in available calories and permitting its use as a reduced-calorie alternative to sugar.
Hydrogenated starch hydrolysates are non-cariogenic because they are only slightly (or not at all) fermented by cariogenic oral microorganisms and inhibit sucrose utilization by Streptococcus mutans (especially strain GS-5).
Very high molecular weight products (DP higher than 20) that are present in hydrogenated syrups are essentially responsible for any acidification produced by bacteria of the mouth that causes attack on dental enamel; therefore, such hydrogenated hydrolysates used in confectionery must not contain polyols with a DP higher than 20, or at the most an amount less than 3%, to preserve the non-cariogenic character.
The caloric value of HSH is approximately 2.4 kcal/g in the EU and 3 kcal/g in the US, lower than that of sucrose at 4 kcal/g.
The area with the strongest human clinical evidence for HSH is its effect on postprandial blood glucose and insulin responses. Multiple controlled human studies have examined this.
Wheeler et al. (1990), Diabetes Care: The objective was to determine whether HSHs, used as bulking/sweetening agents in hard candies, produce a diminished postmeal glycemic response relative to glucose in individuals with and without diabetes; the study followed a randomized double-blind crossover design and was performed in 12 individuals with diabetes (6 non-insulin dependent, 6 insulin dependent) and 6 nondiabetic individuals. After an overnight fast, each subject was challenged with 50 g of glucose, HSH 5875 (7% sorbitol/60% maltitol), and HSH 6075 (14% sorbitol/78% hydrogenated maltooligosaccharides)/1.73 m² of body surface area in random order on 3 successive days. For all groups, the order of plasma glucose responses over 5 hours post-challenge was glucose > HSH 6075 > HSH 5875 (P < 0.001 glucose vs. HSH); pooled data confirmed that HSH 6075 resulted in greater glycemia than HSH 5875 (P < 0.05). HSH ingestion as a single carbohydrate ingredient results in decreased glycemia relative to glucose in individuals with and without diabetes; decreased glycemia results from altered small intestinal carbohydrate absorption.
Livesey et al. (2002), European Journal of Clinical Nutrition (Lycasin HBC study): Six healthy and six type 2 diabetic men participated in the study; each subject absorbed, after an overnight fast, a challenge of either 50 g of glucose or 50 g of Lycasin HBC using a randomised double-blind crossover design, with blood samples collected during a 3-hour period. The calculated glycaemic index of Lycasin HBC was 47 ± 10% in healthy subjects and 25 ± 6% in patients with type 2 diabetes mellitus; the insulinaemic index was 23 ± 4% and 39 ± 14%, respectively.
Due to their slow digestion and absorption, HSH exhibit a low glycemic index, typically ranging from 25 to 50, making them suitable for individuals managing diabetes as they cause a lower rise in blood glucose.
The evidence for attenuated glycemic and insulinemic responses with HSH versus glucose, in both diabetic and healthy populations, is consistent across the published human studies and is considered well established. These studies are generally small (6–18 subjects), limiting statistical power, but their conclusions are convergent and mechanistically supported by absorption kinetics data (e.g., breath hydrogen measurements). They are also corroborated by regulatory evaluations from JECFA and EFSA.
Unlike sugars, HSH are not readily fermented by oral bacteria, and are used to formulate sugarless products that do not promote dental caries; polyols, including HSH, are resistant to metabolism by oral bacteria that break down sugars and starches to release acids that may lead to cavities or erode tooth enamel, and are therefore non-cariogenic and safe for teeth.
The non-cariogenic character of HSH has been established both mechanistically and through in vitro studies. The use of hydrogenated starch hydrolysate in combination with natural sugars in foods, confections, and chewing gum provides a tool in the fight against dental caries; the hydrogenated starch hydrolysate in combination with sucrose has been found to inhibit growth of Streptococcus mutans strains, a prime contributor to formation of dental plaque and tooth decay; in fact, HSH inhibits sucrose utilization by Streptococcus mutans GS-5.
The non-cariogenicity of HSH has been evaluated using an in vitro B-test based on the determination of acidification of a given amount of HSH after inoculation with saliva, measuring the drop in pH over time compared with a control broth; it should be emphasized that this test is not sufficient to characterize in an absolute manner the non-cariogenicity of a product as its results can vary with the quality of the saliva used, but it permits valid comparisons between different products.
The usefulness of polyols as alternatives to sugars and as part of a comprehensive program including proper dental hygiene has been recognized by the American Dental Association. The primary evidence base here is mechanistic and in vitro; long-term randomized clinical trials in humans specifically evaluating HSH-sweetened products and caries incidence are limited. HSH is considered less potent as an active anti-caries agent than xylitol, which has additional anti-cariogenic properties beyond simple non-fermentability.
HSH are more slowly absorbed in the digestive tract; a portion of HSH may be enzymatically hydrolyzed in the body to sorbitol, maltitol, and glucose, however this process is slow; therefore, HSH have a reduced glycemic potential relative to glucose; since HSH are more slowly absorbed, a portion of HSH in a food reaches the lower digestive tract where it is metabolized by naturally occurring colonic bacteria, resulting in a reduction in the available calories and permitting its use as a reduced-calorie alternative to sugar.
Dedicated long-term randomized controlled trials examining HSH's independent effect on body weight in human subjects have not been identified in the peer-reviewed literature. The reduced caloric contribution relative to sucrose is extrapolated from the known metabolic fate (partial colonic fermentation) rather than from weight-outcome trials. Evidence for direct weight management benefits is therefore indirect and preliminary.
Data indicates that higher-order polyols in HSH would be completely hydrolyzed to glucose and maltitol or sorbitol, with a considerable portion undergoing fermentation by gut flora; bacterial fermentation was demonstrated by the detection of an increased amount of Hâ‚‚ in the breath of human subjects.
The fermentation of unabsorbed HSH fractions by colonic bacteria produces short-chain fatty acids (SCFAs) and gases. This property is confirmed in the human clinical studies referenced above, where elevated breath hydrogen was directly measured. However, the broader functional significance of this fermentation (e.g., effects on gut microbiota composition, systemic SCFA signalling) has not been characterized in dedicated clinical trials specifically examining HSH. Breath hydrogen data from the Wheeler et al. (1990) study, for instance, confirmed that breath Hâ‚‚ after glucose was low, whereas HSH 5875 > HSH 6075 (P = 0.003), confirming differential colonic fermentation by HSH composition.
Based on available evidence, HSH is associated with the following body systems and health areas:
HSH is not used as a standalone dietary supplement in defined therapeutic doses. It appears as a food ingredient across multiple product categories. The following dosage forms and amounts are cited in the scientific literature:
HSH is used in food products to add bulk, body, texture, and viscosity to mixtures, and can protect against damage from freezing and drying; HSH products are generally blended with other sweeteners, both caloric and artificial.
In humans, the main reported adverse effect specifically associated with polyglycitol syrup exposure was gastric disturbance. HSH, like sorbitol and other sugar alcohols, is slightly sweet and poorly absorbed by the body; as with most sugar alcohols, eating significant amounts of HSH may cause intestinal gas and diarrhea. Gastric distress was noticed with all products in the Wheeler et al. metabolic study.
The EFSA scientific opinion concluded that gastric disturbances are the main adverse effect, particularly in children, at exposure levels close to those observed in human trials, and highlighted that typical dietary exposure could approach these levels, necessitating caution in its use.
Doses of polyglycitol syrup equal to 13 g/kg bw per day in the diets of rats for 13 weeks were not associated with adverse effects; the only effects observed — increased weight of the empty caecum and increased urinary calcium excretion in the absence of elevated serum calcium — were considered to be the consequence of the accumulation of poorly absorbed material in the caecum and to be of no toxicological significance.
In an acute oral toxicity study using a test substance described as a hydrogenated starch hydrolyzate, the lethal dose (LDâ‚…â‚€) was greater than 2,500 mg/kg (Toxicity Category III).
There is no evidence about a cancer-promoting effect (carcinogenicity) of maltitol syrup (polyglycitol).
The caecal enlargement noted in rodent studies is a well-known, non-adverse physiological response to poorly absorbed carbohydrates. Increased weight of the empty caecum and increased urinary calcium excretion were considered to be the consequence of the accumulation of poorly absorbed material in the caecum and to be of no toxicological significance.
The FDA issued guidance (May 2023) requiring testing of hydrogenated starch hydrolysate, sorbitol solution, maltitol solution, glycerin, and propylene glycol for diethylene glycol (DEG) and ethylene glycol (EG) as part of compliance with identity standards in USP–NF monographs, reflecting the risk of contamination by these adulterants in polyol-based pharmaceutical excipients.
When no single polyol is dominant in the mix, the generic name hydrogenated starch hydrolysates is used; however, if 50% or more of the polyols in the mixture are of one type, it can be labeled as "sorbitol syrup" or "maltitol syrup." This has practical significance for individuals monitoring specific polyol intake: a product labelled "maltitol syrup" and another labelled "HSH" may have significantly different polyol profiles and different glycemic impacts, as demonstrated by the differential responses to HSH 5875 and HSH 6075 in the Wheeler et al. study.
HSH, although less sweet than sucrose, blends well with other sweeteners and flavors and can mask unpleasant off-flavors such as bitter notes; HSH products are synergistic with low-calorie sweeteners; applications for HSH include confectioneries, baked goods, icings, and frozen desserts.
The evidence for HSH's attenuated glycemic and insulinemic responses is well characterized in small controlled human crossover trials, consistently demonstrating GI values of approximately 25–47 compared to a glucose reference of 100. These findings are mechanistically coherent and have been reviewed favorably by JECFA, EFSA, and the U.S. FDA. They are limited in statistical power (sample sizes of 6–18 subjects) but are consistent and regulatory-grade in their design.
The evidence for non-cariogenicity is established by in vitro microbiological data and mechanistic studies, with regulatory acceptance by bodies including the American Dental Association. Dedicated long-term clinical caries-prevention trials specifically on HSH are not prominently represented in the peer-reviewed literature.
Evidence regarding body weight management, gut microbiota modulation, and prebiotic effects is indirect and at most preliminary; no dedicated randomized controlled trials have isolated HSH's contribution to these outcomes in human subjects.
Health conditions that Hydrogenated starch hydrolysate may help support.
Body systems that Hydrogenated starch hydrolysate may help support.
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