✓ Safety Confirmed – Exceptional Level: The EFSA’s 2018 re-evaluation concluded there is NO NEED FOR A NUMERICAL ADI for E418. This is extremely rare and indicates exceptional safety. No safety concern exists at approved food use levels. The compound is neither absorbed nor fermented in the human digestive system.

The EFSA’s 2018 Comprehensive Safety Re-evaluation

The European Food Safety Authority’s 2018 re-evaluation examined extensive data and concluded gellan gum is exceptionally safe.

Key findings:

– No numerical ADI needed – Indicating exceptional safety margin
– No safety concern at reported uses and use levels
– Unlikely to be absorbed intact – Passes through digestive system unchanged
– Would not be fermented by human intestinal microbiota
– No carcinogenicity concern – Not cancer-causing
– No genotoxicity concern – Does not damage genes
– Chronic toxicity: No adverse effects in mice at 3,627 mg/kg bw/day or in rats at 1,460 mg/kg bw/day (highest doses tested)
– Human study: Intake of 200 mg/kg bw/day for 3 weeks produced no adverse effects
– No allergenic reactions – No indication of allergic reactions
– Maximum estimated exposure: 72.4 mg/kg bw per day in toddlers (95th percentile)

Potential Side Effects

At approved food use levels, no adverse effects are documented.

E418 is well-tolerated at food consumption levels. Human studies show that people consumed 30 times typical food levels of gellan gum for 3 weeks without experiencing adverse effects.

At very high concentrations (far exceeding typical use): E418 might cause flatulence and bloating due to fermentation by intestinal bacteria (similar to consuming excessive dietary fiber). It has mild laxative properties like other dietary fibers.

Important note: One animal study linked chronic intake of very high doses to abnormalities in gut lining, but other studies found no harmful effects. This isolated finding has not been confirmed.

How E418 Is Made

E418 is produced through a biological fermentation process, not chemical synthesis.

Manufacturing process:

1. Bacterial growth: The bacterium Sphingomonas elodea is cultured in fermentation vessels
2. Substrate addition: Starch or sugars are provided as nutrient source
3. Fermentation: The bacterium metabolizes the starch/sugars and produces gellan gum polymer
4. Purification: Gellan gum is separated from the fermentation broth
5. Processing: The purified product is concentrated and dried into powder or liquid form
6. Result: Plant-based polysaccharide suitable for food use

E418 is a naturally produced compound—created through biological processes, not chemical synthesis—making it fundamentally different from purely synthetic additives.

Types of Gellan Gum

E418 comes in different forms with varying properties:

High acyl gellan gum: Higher acyl content (>50%), high molecular weight (1-2 × 10⁶), high viscosity, requires heating (70-80°C) to form thick, elastic gels. Used when strong gel texture is desired.

Low acyl gellan gum: Lower acyl content (≤50%), lower molecular weight (2-3 × 10⁵), lower viscosity, forms firm, brittle gels at lower temperatures (10-60°C). Used for applications requiring cold setting.

Deacylated form: Minimal acyl content, specialized properties for specific applications.

The choice between forms depends on the desired gel texture and the manufacturing process requirements.

Vegan and Dietary Status

E418 is exceptionally suitable for plant-based diets:

– Vegan-friendly ✓ – Produced by bacterial fermentation, not animal-derived
– Gelatin alternative ✓ – Specifically used in vegan gum candies to replace animal-derived gelatin
– Vegetarian ✓
– Plant-based ✓
– Organic-approved ✓ – High-acyl form approved by USDA National Organic Program (2010)
– Kosher – Potentially, depending on certification
– Halal ✓ – Halal certification available
– Gluten-free ✓
– Natural ✓ – Produced through biological fermentation, not chemical synthesis

E418 is particularly valued in vegan and vegetarian products because it’s a plant-based alternative to gelatin (which is derived from animal collagen).

Dietary Fiber Properties

E418 functions as a soluble dietary fiber:

E418 is unlikely to be absorbed intact in the digestive system and would not be fermented by human intestinal microbiota. It passes through largely unchanged, providing dietary fiber benefits without digestive side effects typical of other polysaccharides.

At very high concentrations (far exceeding typical food use), it might cause mild flatulence or bloating—the same response to excessive dietary fiber consumption.

Comparison with Other Gelling Agents

E418 is one of several gelling agents available to food manufacturers:

– Agar (E406): Traditional gelling agent; requires higher use levels
– Gelatin: Animal-derived (from collagen); not vegan/vegetarian
– Xanthan gum: Similar stabilizing/thickening properties
– Locust bean gum: Similar texture control functions

E418 is distinguished by its lower effective use level, plant-based origin, fermentation production method, and vegan credentials.

Approved Use Levels

E418 is approved for use in numerous food categories:

– 4 specific food categories: Defined maximum permitted levels set by regulation
– 67 food categories: Quantum satis basis (“as much as needed”) without numerical limits

Examples of specific approvals: jam, jellies, marmalades, fruit spreads, table-top sweeteners, and as a carrier in food enzyme preparations.

Regulatory Approval Across Regions

E418 is approved by virtually all major regulatory authorities:

– United States (FDA): Approved
– European Union (EFSA): Authorized per Regulation (EC) No 1333/2008
– International (JECFA/FAO/WHO): Approved
– Japan: First approval (1988)
– Canada: Approved
– Korea: Approved
– China: Approved
– Australia/New Zealand: Approved (code 418)
– USDA Organic: High-acyl form approved for organic foods (2010)

This near-universal approval reflects confidence in its safety across different regulatory systems.

Historical Information

E418 has a long history of safe regulatory approval:

– Discovery: Initially identified as a substitute for agar in bacterial culture media
– First approval: Japan (1988)
– Global rollout: FDA, Canada, EU, Korea, China followed
– Organic approval: High-acyl form added to USDA National List (2010)
– Established use: Over 35 years of regulatory safety approval

Notable Uses

E418 has appeared in some well-known food products:

– Orbitz soft drink: The now-discontinued beverage was famous for its unusual floating gel spheres created with gellan gum
– Non-dairy milk alternatives: A key ingredient in soy milk, almond milk, and coconut milk to keep plant proteins suspended
– Vegan candies: Used instead of gelatin to create gel textures in plant-based gum candies

The Bottom Line

E418 (gellan gum) is a naturally produced polysaccharide created through bacterial fermentation, used as a thickener, gelling agent, and stabilizer in food and beverages.

It’s produced by fermenting starch or sugars using the bacterium Sphingomonas elodea—making it a biologically created, plant-based compound.

Regulatory authorities worldwide classify E418 as exceptionally safe. The EFSA’s 2018 re-evaluation concluded there is NO NEED FOR A NUMERICAL ADI—an extremely rare designation indicating exceptional safety.

E418 is neither absorbed nor fermented in the human digestive system, passing through largely unchanged like dietary fiber.

Animal studies found no adverse effects even at very high doses (3,627 mg/kg bw/day in mice, 1,460 mg/kg bw/day in rats). Human studies showed no effects at 200 mg/kg bw/day for 3 weeks, and even at 30 times typical food levels.

E418 is vegan-friendly, making it an ideal gelatin alternative for plant-based products. The high-acyl form is USDA Organic-approved.

Most people eating jam, consuming non-dairy beverages, or eating vegan candies regularly consume E418 without any documented health concerns.

As always, food labels must declare E418 when used, enabling informed consumer choice.