What is E311?

Complete guide to understanding E311 (Octyl Gallate) — a banned synthetic antioxidant with critical data gaps

The Quick Answer

E311 (Octyl Gallate) is a synthetic antioxidant that was used to prevent fats and oils from becoming rancid.

However, in 2018, the European Union banned E311 after the EFSA determined that insufficient toxicological data existed to confirm its safety. The additive remains approved in the United States and most other countries, but is no longer permitted in EU foods.

It was not banned because it was proven harmful, but because regulators could not prove it was safe to modern standards — a crucial distinction.

What Exactly Is It?

E311 is octyl gallate, a white crystalline powder — 100% synthetic, created by chemically combining gallic acid with octanol (an 8-carbon alcohol).

Chemical formula: C₁₅H₂₂O₅ — an ester compound that does not occur in nature.

Key properties:

– Highly effective antioxidant in lipid (fat) systems
– Does NOT occur naturally; 100% synthetic
– White powder with characteristic odor; slightly bitter taste
– Darkens in presence of iron salts
– Can cause skin sensitization and allergic reactions
– Often used in combination with other antioxidants (BHA, BHT)
– Synergistic antioxidant effects with other gallate esters

EU Ban: What Happened

Timeline of the Ban

2009: New EU regulation requires all pre-2009 food additives to be re-evaluated to modern safety standards.

2015: EFSA publishes comprehensive re-evaluation of E311 (Octyl Gallate).

2017: European Commission calls on industry to submit additional toxicological data on E311, E310 (propyl gallate), and E312 (dodecyl gallate).

2018: EFSA confirms no manufacturers submitted adequate toxicological data. Commission formally removes E311 and E312 from approved additives list (October 4, 2018).

2018-present: E311 no longer legal in EU foods; non-compliant products removed from market.

Why Was E311 Banned?

EFSA’s 2015 Re-evaluation Findings:

– Insufficient toxicological database: Available data were “too limited” to adequately assess safety
– Cannot confirm carcinogenicity status: “The Panel could not reach a definitive conclusion on the presence or absence of a carcinogenic potential of octyl gallate”
– Insufficient chronic toxicity data: Detailed reports lacking on long-term studies
– Cannot use propyl gallate data as proxy: Each gallate ester requires separate evaluation; insufficient metabolism data for read-across
– Reproductive toxicity concerns: NOAEL identified at 50 mg/kg, but insufficient data for safe-use assessment
– Overall conclusion: “The available database was too limited to either establish an acceptable daily intake or serve as a basis for a margin of safety approach”

Industry Response:

When the EU Commission called for additional data in 2017, the industry response was: NO manufacturers provided the requested toxicological data. EFSA confirmed: “Without it the Authority cannot complete the re-evaluation… it cannot be determined whether those substances still fulfil the conditions for inclusion in the Union list.”

Regulatory Decision:

Rather than continue allowing an additive it couldn’t confirm as safe, the EU removed E311 from the approved list. This is a precautionary regulatory approach: if you can’t prove it’s safe to modern standards, don’t allow it.

Critical Distinction: Data Gap ≠ Proven Unsafe

What EFSA did NOT find:

– No documented public health emergency from E311
– No definitive proof of carcinogenicity
– No proven reproductive or developmental toxicity
– No widespread adverse health effects

What EFSA DID find:

– Insufficient data to rule out carcinogenicity
– Incomplete chronic toxicity database
– Inadequate data for confidence in safety assessment
– Data gaps that would be unacceptable by modern standards

The regulatory principle: EU regulation requires proof of safety. E311 couldn’t meet this burden with the available database. Rather than wait for data that never came, the additive was removed.

Where It Was Found (Pre-Ban)

E311 was used in foods before the 2018 EU ban:

Current status in EU (2025): E311 should not appear on any EU food labels; any foods still containing it are technically in violation of regulations.

E311 Outside the EU

United States

Status: Still FDA-approved and permitted in food products

Approval: FDA approves E311 use in oils, fats, and various processed foods

Difference from EU: US regulatory approach is less stringent; FDA has not conducted equivalent rigorous re-evaluation as EFSA

Implication: American consumers may still encounter E311 in food products, particularly oils, fats, and processed foods

Other Countries

Canada: Approved
Australia/New Zealand: Generally approved
Japan: Approved
Most other countries: Still approved

Key point: The EU ban is unique; most countries still permit E311 due to less stringent re-evaluation standards.

Safety Assessment

Toxicity Profile

The Core Problem: Data Gaps

EFSA explicitly stated the issue: “Owing to the lack of detailed reports on carcinogenicity and chronic toxicity studies with octyl gallate and the absence of a basis for read-across for systemic toxicity from propyl gallate data, the Panel could not reach a definitive conclusion on the presence or absence of a carcinogenic potential of octyl gallate.”

Translation: We don’t have enough information to tell you this is safe. Under EU law, that means it cannot be approved.

Related Gallate Additives: Divergent Fates

Key insight: E310 (propyl gallate) remains approved in the EU because there is MORE toxicological data available (NOAEL at 135 mg/kg vs. 50 mg/kg for E311). E311 and E312 were removed because the data were even more limited.

The Bottom Line

E311 (Octyl Gallate) is a synthetic antioxidant that was banned in the EU in 2018 due to insufficient safety data, but remains approved in the US and most other countries.

What you should know:

• It’s banned in the EU: No longer legal in European food products as of October 2018
• It’s still approved outside the EU: FDA still permits it; commonly used in the US
• It wasn’t banned because it was proven harmful: Rather, safety couldn’t be confirmed to modern standards
• Data gaps were the problem: EFSA couldn’t rule out carcinogenicity due to insufficient studies
• Industry didn’t provide data: When asked for additional safety studies, manufacturers declined
• No documented public health emergency: No widespread adverse effects; precautionary ban based on uncertainty
• It’s purely synthetic: 100% chemically engineered; doesn’t occur in nature
• US consumers may encounter it: Still approved and used in American food products