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Locust bean gum safety in neonates and young infants: An integrated review of the toxicological database and clinical evidence

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Author: Meunier, L. · Garthoff, J.A. · Schaafsma, A. · Krul, L. · Schrijver, J. · Goudoever, J.B. van · Speijers, G. · Vandenplas, Y.
Type:article
Date:2014
Source:Regulatory Toxicology and Pharmacology, 1, 70, 155-169
Identifier: 513388
doi: doi:10.1016/j.yrtph.2014.06.023
Keywords: Health · Carob bean gum · Gastro-oesophageal reflux · Infant formula · Infants · Locust bean gum · Regurgitation · Thickener · Food additive · Galactomannan · Locust beam gum · Polysaccharide · Unclassified drug · Acute toxicity · Artificial milk · Carcinogenicity · Chemical structure · Chronic toxicity · Dietary intake · Food composition · Food safety · Genotoxicity · Human · Hypersensitivity · In vitro study · In vivo study · Nonhuman · Nutritional assessment · Priority journal · Reproductive toxicity · Safety · Surface property · Teratogenicity · Thickness · Toxicity testing · Biomedical Innovation · Healthy Living · Life · RAPID - Risk Assessment Products in Development · ELSS - Earth, Life and Social Sciences

Abstract

Locust bean gum (LBG) is a galactomannan polysaccharide used as thickener in infant formulas with the therapeutic aim to treat uncomplicated gastroesophageal reflux (GER). Since its use in young infants below 12. weeks of age is not explicitly covered by the current scientific concept of the derivation of health based guidance values, the present integrated safety review aimed to compile all the relevant preclinical toxicological studies and to combine them with substantial evidence gathered from the clinical paediatric use as part of the weight of evidence supporting the safety in young infants below 12. weeks of age. LBG was demonstrated to have very low toxicity in preclinical studies mainly resulting from its indigestible nature leading to negligible systemic bioavailability and only possibly influencing tolerance. A standard therapeutic level of 0.5. g/100. mL in thickened infant formula is shown to confer a sufficiently protective Margin of Safety. LBG was not associated with any adverse toxic or nutritional effects in healthy term infants, while there are limited case-reports of possible adverse effects in preterms receiving the thickener inappropriately. Altogether, it can be concluded that LBG is safe for its intended therapeutic use in term-born infants to treat uncomplicated regurgitation from birth onwards. © 2014 The Authors. Chemicals/CAS: galactomannan, 11078-30-1