Xanthan Gum | whatsinit

About

What it is and where it shows up.

Xanthan gum is a polysaccharide produced by pure-culture fermentation of Xanthomonas campestris bacteria, composed of glucose, glucuronic acid, acetylmannose, and pyruvylated mannose residues. It is widely used in food as a thickener, stabiliser, and emulsifier to improve texture and prevent ingredient separation.

Safety summary

The regulatory and scientific consensus.

EFSA concluded there is no need for a numerical ADI and no safety concern for the general population; no adverse effects were observed in chronic or carcinogenicity studies and there is no genotoxicity concern. At very high doses (up to 214 mg/kg bw/day for ten days), some adults experienced mild abdominal discomfort considered an undesirable but not adverse effect. The standard risk assessment does not cover infants under 12 weeks of age, for whom a separate regulatory framework and dedicated 2023 EFSA opinion applies.

Regulatory landscape

What food-safety regulators have decided.

Jurisdiction	Status	Note
EFSA (European Food Safety Authority) (European Union)	Approved	Authorised under Annex II and Annex III of Regulation (EC) No 1333/2008; purity criteria set in Commission Regulation (EU) No 231/2012. EFSA ANS Panel re-evaluated in 2017 and confirmed no numerical ADI needed and no safety concern for the general population. A follow-up 2023 EFSA FAF Panel opinion (EFSA Journal 2023;21(5):e07951) further confirmed no safety concerns for use in special medical purpose foods for infants below 16 weeks.source
FSSAI (Food Safety and Standards Authority of India) (India)	Approved	Listed as INS 415 (Xanthan Gum) in the FSSAI Infant Foods Regulations Compendium Version II (04.01.2024). Maximum level 5000 mg/kg singly or in combination with other permitted gums (Guar gum INS 412, Gum Arabic INS 414, Pectins INS 440, etc.) in gluten-free cereal-based foods; listed in FSSAI Food Additives Regulations Appendix A.source
FDA (Food and Drug Administration) (United States)	Approved	Permitted as a food additive under 21 CFR 172.695; produced from Xanthomonas campestris by pure-culture fermentation and purified by recovery with isopropyl alcohol. Also listed in FDA Substances Added to Food (formerly EAFUS) database. An ethanol-precipitate variant was separately determined GRAS (GRAS Notice GRN 000121).source

Who should approach with care

Whose guidance would steer them away.

Infants — EFSA explicitly noted the general population risk assessment is not applicable to infants under 12 weeks of age and cautioned against ad-libitum use as a thickener outside authorised food categories; a dedicated 2023 EFSA opinion covers authorised use in special medical purpose formulae for infants below 16 weeks.

Ibs — High-dose intake has been associated with abdominal discomfort in some adults, which may be more pronounced in individuals with irritable bowel syndrome given xanthan gum's fermentation by gut microbiota.

Research citations

The sources behind this verdict.

1FDA. Code of Federal Regulations Title 21 §172.695 – Xanthan Gum. accessdata.fda.gov
2WHO. JECFA Food Additives and Contaminants Database – Xanthan Gum (CAS 11138-66-2, INS 415). apps.who.int
3FSSAI. Food Safety and Standards (Infant Foods) Regulations – Compendium Version II (04.01.2024), 2024. fssai.gov.in
4PubMed. Re-evaluation of xanthan gum (E 415) as a food additive in foods for infants below 16 weeks of age and follow-up of its re-evaluation as a food additive for uses in foods for all population groups, 2023. pubmed.ncbi.nlm.nih.gov
5EFSA. Re-evaluation of xanthan gum (E 415) as a food additive in foods for infants below 16 weeks of age and follow-up of its re-evaluation as a food additive for uses in foods for all population groups, 2023. efsa.europa.eu
6PubMed. , 2017.

Independently researched7 citations