Maltitol | whatsinit

About

What it is and where it shows up.

Maltitol is a sugar alcohol (polyol) produced by the hydrogenation of maltose, with approximately 85–95% the sweetness of sucrose and a caloric value of 2.4 kcal/g — lower than sugar. It is commercially available as crystalline maltitol (E965i) and maltitol syrup (E965ii), and is widely used in confectionery, chocolate, baked goods, and dairy products as a bulk sugar replacer.

Safety summary

The regulatory and scientific consensus.

Both JECFA and the EU Scientific Committee on Food assigned maltitol an ADI of 'not specified' — their safest regulatory category — following extensive acute, subchronic, chronic, and reproductive toxicological testing. The FDA has granted self-affirmed GRAS status with no numerical ADI. The principal known risk is a dose-dependent osmotic laxative/diarrhoeal effect at high intake; EU law mandates a 'excessive consumption may produce laxative effects' warning on foods containing more than 10% added polyols. EFSA issued a formal call in January 2023 for new in vitro micronucleus genotoxicity data as part of its ongoing re-evaluation, representing a current data gap.

Regulatory landscape

What food-safety regulators have decided.

Jurisdiction	Status	Note
EFSA (European Food Safety Authority) (European Union)	Approved	Approved at quantum satis (GMP) under Regulation (EC) No 1333/2008 for bakery goods, confectionery, ice cream, desserts, and fruit preparations. Polyols are generally not permitted in beverages (except erythritol) due to over-consumption laxation risks. Foods containing >10% added polyols must carry a laxative-effects label warning per Annex III. Cannot be used together with sugars in the EU unless a technical purpose other than sweetness or a ≥30% calorie reduction results. EFSA re-evaluation is ongoing; a call for additional in vitro micronucleus genotoxicity data was issued January 2023.source
FSSAI (Food Safety and Standards Authority of India) (India)	Approved	Maltitol is listed as a permitted polyol (caloric) sweetener at GMP levels under Appendix A of the FSS (Food Products Standards and Food Additives) Regulations, 2011, alongside sorbitol, mannitol, xylitol, isomalt, and lactitol.source
FDA (Food and Drug Administration) (United States)	Approved	Self-affirmed GRAS status based on petition filed December 23, 1986 by Towa Chemical Industry Co., Ltd. FDA has not designated a numerical ADI. Permitted as a sugar alcohol/noncariogenic carbohydrate sweetener. No prohibition on using polyols in combination with sugars. Classified as a food additive or GRAS under 21 CFR.source

Who should approach with care

Whose guidance would steer them away.

Ibs — Maltitol is poorly absorbed and fermented in the colon; its osmotic effect can exacerbate IBS symptoms such as bloating, cramping, and diarrhoea, particularly at doses above ~20 g/day.

Ibd — Colonic fermentation and osmotic laxative properties of maltitol may aggravate intestinal inflammation or symptoms in individuals with inflammatory bowel disease.

Diabetes — Although maltitol has a lower glycemic index (~36) and produces a slower insulin response than sucrose, it is not glycemically neutral and large quantities may still meaningfully raise blood glucose in people with diabetes.

Infants — Polyols including maltitol are not recommended for infants due to immature gastrointestinal tracts and high susceptibility to osmotic diarrhoea and electrolyte imbalance.

Children — Children may be more susceptible to the laxative effects of polyols at lower doses; EU Regulation (EC) No 1333/2008 requires laxative-effect labelling on foods containing more than 10% added polyols to alert consumers including parents.

Research citations

The sources behind this verdict.

1FDA. Aspartame and Other Sweeteners in Food. fda.gov
2WHO. JECFA Maltitol Entry — WHO Food Additives and Contaminants Database. apps.who.int
3EFSA. Call for data on genotoxicity data on maltitol (E 965 i), 2023. efsa.europa.eu
4PubMed. Maltitol: Analytical Determination Methods, Applications in the Food Industry, Metabolism and Health Impacts, 2020. pmc.ncbi.nlm.nih.gov
5FDA. NDA 22-581 Pharmacological Review — Maltitol Regulatory Background (FDA Drug Review Document), 2011. accessdata.fda.gov

Independently researched5 citations