Understanding the Science: Is xanthan gum banned in other countries?

October 6, 2025 •

3 min read

According to regulatory bodies worldwide, including the Joint FAO/WHO Expert Committee on Food Additives (JECFA), xanthan gum has an 'acceptable daily intake' (ADI) that is 'not specified,' which indicates very low toxicity. Yet, many consumers still wonder: Is xanthan gum banned in other countries? This article will examine the regulatory landscape to put concerns to rest and explain where restrictions do exist.

Quick Summary

Xanthan gum is not banned in major countries but is subject to varying national regulations. This article examines the safety consensus and specific rules in key global markets, addressing common misconceptions and outlining restrictions, particularly concerning infants and allergies.

Key Points

No Major Country Ban: Xanthan gum is not banned in any major country, including the U.S., EU, Canada, or Australia.
Strict Infant Formula Restrictions: Specific warnings and restrictions exist for use in infant formula, particularly for premature infants, due to rare but serious health risks like necrotizing enterocolitis (NEC).
Allergen Sourcing: The fermentation process for xanthan gum can use common allergens (wheat, soy, corn, dairy); people with severe allergies should check the source.
Considered Safe at Normal Levels: Food safety authorities globally, including JECFA and EFSA, consider xanthan gum safe for the general population at typical consumption levels.
Potential Digestive Side Effects: Excessive intake can cause digestive upset like gas or bloating, but these are typically not adverse effects and are difficult to reach through a standard diet.
Regulated by E-Numbers and GRAS: Xanthan gum is identified by the E-number E415 in Europe and Australia, and listed as Generally Recognized as Safe (GRAS) in the U.S..
Serves Multiple Food Functions: It is a valuable additive for its thickening, stabilizing, and emulsifying properties, particularly in gluten-free foods.

A Global Consensus on Safety

No major country or regulatory body has banned xanthan gum for general food use. While there might be confusion due to varying regulations for food additives across regions or specific incidents involving infant feeding, the international consensus is that xanthan gum is safe. Xanthan gum, often identified as E415 in some regions, is approved by several key regulatory bodies:

The U.S. Food and Drug Administration (FDA) considers it "Generally Recognized as Safe" (GRAS).
The European Food Safety Authority (EFSA) confirmed its safety in 2017 at typical usage levels.
Health Canada permits its use as an emulsifying, gelling, stabilizing, or thickening agent.
Food Standards Australia New Zealand (FSANZ) includes it as additive number 415.

Regional Regulatory Frameworks

Specific regulations for xanthan gum usage differ globally, affecting labeling, permitted food types, and maximum levels.

United States (FDA)

Xanthan gum is regulated under 21 CFR § 172.695 and is GRAS, allowed in foods unless prohibited by identity standards.

European Union (EFSA)

The EU allows xanthan gum (E415) in many foods, often at quantum satis levels, but has stricter limits for products targeting infants under 16 weeks. E-number labeling is mandatory.

Canada (Health Canada)

Health Canada permits xanthan gum as a food additive under Good Manufacturing Practice and recently approved its use in certain infant formulas.

Australia and New Zealand (FSANZ)

Xanthan gum (415) is permitted as a thickener and stabilizer in many processed foods according to the Food Standards Code, with some products having maximum concentration limits and mandatory labeling.

Special Cases and Controversies

Concerns regarding xanthan gum primarily relate to specific, sensitive applications, not its general use.

Risks for Premature Infants

A notable incident involved a xanthan gum-based thickener, SimplyThick, linked to necrotizing enterocolitis (NEC) in premature infants, resulting in recalls. This has led to age-based restrictions in the EU and US for preemies, who have underdeveloped digestive systems.

Allergen Contamination

Xanthan gum production may use allergens like corn, soy, or wheat. Individuals with severe allergies should confirm the source if concerned.

Digestive Concerns

As a soluble fiber, excessive consumption can cause digestive issues. However, typical food amounts are usually too low to cause these effects.

Comparison of Xanthan Gum Regulations in Major Markets


Feature	United States (FDA)	European Union (EFSA)	Canada (Health Canada)	Australia/New Zealand (FSANZ)
Approval Status	GRAS (Generally Recognized as Safe) since 1969.	Approved as food additive E415.	Permitted food additive.	Approved as food additive 415.
Designated Code	None for food label; CAS number 11138-66-2.	E415.	None for food label.	415.
General Use Limits	Good Manufacturing Practice (GMP); no set max levels.	Mostly *quantum satis* (as needed).	GMP for most foods.	GMP and specific max levels for certain foods.
Infant Use Restrictions	Caution advised for premature infants due to NEC risk.	Stricter limits for infants under 16 weeks of age.	Special approval required, such as for certain infant formulas.	Guidelines and max permitted concentrations.
Acceptable Daily Intake (ADI)	"Not specified".	"Not specified".	Based on global standards; considered safe.	"Not specified" based on JECFA assessment.

Conclusion: A Global Ingredient, Not a Global Ban

Xanthan gum is not banned internationally but is a globally accepted food additive regulated by major authorities like the FDA, EFSA, Health Canada, and FSANZ, all of whom consider it safe at typical levels. Regulations vary in implementation, such as the EU's E-number system versus the U.S. GRAS designation. Strict restrictions are in place for sensitive groups, particularly premature infants. For most consumers, xanthan gum is a safe and widely used ingredient. Those with specific allergies should verify the source materials.

How Xanthan Gum is Made

Xanthan gum is made by fermenting sugars (which can be from corn, wheat, soy, or dairy) with the Xanthomonas campestris bacteria. The resulting substance is purified and dried into a powder used in food as a thickener, stabilizer, or emulsifier. The use of natural starting materials can lead to confusion about its classification.

The Function of Xanthan Gum in Food

Xanthan gum provides several functions in food products:

Thickening: Increases liquid viscosity for sauces and soups.
Stabilizing: Prevents ingredient separation in dressings and ice cream.
Emulsifying: Blends oil and water for consistent textures.
Gluten-Free Baking: Provides structure similar to gluten.
Suspension: Keeps particles evenly distributed in liquids.

Understanding regulations and past safety incidents helps consumers make informed choices about xanthan gum. Concerns are largely unfounded for the general population, and clear labeling aids those with sensitivities.

Frequently Asked Questions

Xanthan gum is restricted in formula for premature infants because it was linked to an increased risk of necrotizing enterocolitis (NEC), a severe intestinal disease, in this vulnerable population with underdeveloped digestive systems.

Xanthan gum is created through a fermentation process using bacteria and a natural sugar source. While the process is industrial, the starting materials are natural. Therefore, it is often referred to as a natural-sourced additive, but it is not found in nature in its final form.

Yes, people with celiac disease can typically consume xanthan gum. However, they should be aware that the sugar source for its fermentation can sometimes be wheat or corn. While purification removes the allergen, those with severe sensitivities may want to verify the source used by the manufacturer.

Consuming very large amounts of xanthan gum can cause digestive discomfort such as bloating, gas, and softer stools due to its soluble fiber content. However, such high doses are not achievable through normal food consumption.

Yes, E415 is the official E-number designation for xanthan gum in the European Union and other regions, including Australia and New Zealand.

Yes, xanthan gum is vegan. It is a polysaccharide produced by bacterial fermentation and does not use any animal derivatives in its production.

Allergic reactions to xanthan gum itself are rare. However, in some individuals with severe allergies, a reaction could occur if the sugar source used for fermentation was a major allergen like wheat, soy, or corn, and traces remained.