What is E312?
Complete guide to understanding E312 (Dodecyl Gallate) — a banned synthetic antioxidant with critical data gaps
The Quick Answer
E312 (Dodecyl Gallate) is a synthetic antioxidant that was used to prevent fats and oils from becoming rancid.
However, in 2018, the European Union banned E312 after the EFSA determined that toxicological data were so limited that not even a basic safety benchmark could be established. The additive remains approved in the United States and most other countries, but is no longer permitted in EU foods.
E312 had even worse data than its similar compound E311 (octyl gallate), making it the most under-tested of the three gallate antioxidants.
📌 Quick Facts
- Chemical Name: Dodecyl Gallate (also called Lauryl Gallate)
- Type: Synthetic antioxidant; 100% chemically engineered
- EU Status: BANNED (October 4, 2018) — Removed from approved additives list
- US Status: Still approved; FDA permits use in margarine, oils, fats, processed foods
- Reason for EU ban: Severely insufficient toxicological data; NOAEL could not be identified
- EFSA Finding (2015): “Lack of detailed reports on carcinogenicity and chronic toxicity”; “Panel unable to identify any NOAEL”
- Why removed: Industry did not provide requested additional safety data when given opportunity
- Data severity: Even worse data than E311; no identifiable basic toxicological benchmark
What Exactly Is It?
E312 is dodecyl gallate (also called lauryl gallate), a white powder — 100% synthetic, created by chemically combining gallic acid with dodecanol (a 12-carbon alcohol).
Chemical formula: C₁₉H₃₀O₅ — 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 to cream-colored powder; odorless; slightly bitter taste
– Excellent fat solubility due to long 12-carbon alkyl chain
– Can cause skin sensitization and allergic reactions
– Often used in combination with other antioxidants (BHA, BHT)
– Synergistic antioxidant effects with other additives
Unique feature: The longest alkyl chain of the three gallate antioxidants (propyl has 3 carbons, octyl has 8, dodecyl has 12), which provides excellent fat solubility but correlates with the poorest toxicological database.
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 re-evaluation of E312 (Dodecyl Gallate) and concludes data are too limited to assess safety.
2017: European Commission calls on industry to submit additional toxicological data on E310, E311, and E312 (all gallates).
2018: EFSA confirms no manufacturers submitted adequate toxicological data. Commission formally removes E312 (and E311) from approved additives list (October 4, 2018). E310 (propyl gallate) retained with restrictions.
2018-present: E312 no longer legal in EU foods; non-compliant products removed from market.
Why Was E312 Banned?
EFSA’s 2015 Re-evaluation Findings (Most Critical):
– No identifiable NOAEL: “Owing to the limitations of these studies, the Panel was unable to identify any NOAEL” — This is the most severe finding. NOAEL (No Observed Adverse Effect Level) is the most basic toxicological benchmark; if it can’t be identified, safety assessment is essentially impossible
– Cannot confirm carcinogenicity status: “The Panel could not reach a definitive conclusion on the presence or absence of a carcinogenic potential of dodecyl gallate”
– Insufficient chronic toxicity data: Lack of detailed reports on long-term studies
– Cannot use propyl gallate data: Each gallate ester requires separate evaluation; insufficient metabolism data for read-across
– Severely limited database: “The available database was too limited to either establish an ADI or serve as a basis for a margin of safety approach to be applied with confidence”
– Overall conclusion: Cannot confirm safety to modern regulatory standards
Why This Ban Was Stricter Than E311:
While both E311 and E312 were banned on the same date (October 4, 2018), E312 had significantly worse data:
– E311 (octyl): NOAEL identified at 50 mg/kg
– E312 (dodecyl): NOAEL could NOT be identified at all
– Result: E312 considered even more inadequate than E311
Industry Response:
When the EU Commission called for additional data in 2017, manufacturers did not provide the requested studies. EFSA confirmed: “Without it the Authority cannot complete the re-evaluation.”
Regulatory Decision:
Rather than continue allowing an additive it couldn’t adequately assess, the EU removed E312 from the approved list. This is the most precautionary regulatory approach: if you can’t establish basic safety benchmarks, the additive cannot be approved.
Critical Distinction: Data Gap ≠ Proven Unsafe
What EFSA did NOT find:
– No documented public health emergency from E312
– No definitive proof of carcinogenicity
– No proven reproductive or developmental toxicity
– No widespread adverse health effects
What EFSA DID find:
– No identifiable NOAEL (basic toxicological benchmark)
– Cannot rule out carcinogenicity due to insufficient data
– Incomplete chronic toxicity database
– Data gaps so severe that adequate safety assessment was impossible
– Even worse data than similar compound E311
The regulatory principle: EU regulation requires establishment of adequate safety benchmarks. E312 couldn’t meet this threshold because basic benchmarks couldn’t be established. The precautionary approach: if you can’t prove it’s safe at the benchmark level, don’t allow it.
Where It Was Found (Pre-Ban)
E312 was used in many foods before the 2018 EU ban:
| Category | Specific Examples | Pre-Ban Use Level |
|---|---|---|
| Oils & Fats | Vegetable oils, animal fats, frying oils | 200 mg/kg (on fat basis) |
| Margarine & Spreads | Margarine, butter alternatives, spreads | 200 mg/kg |
| Processed Meats | Dehydrated meat products | 200 mg/kg |
| Snacks | Nuts, chips, cereal-based snacks | 200 mg/kg |
| Baked Goods | Cake mixes, instant mixes, pastries | 200 mg/kg |
| Chewing Gum | Chewing gum products | 400 mg/kg (highest reported use) |
| Breakfast Cereals | Cereals with oil content | 200 mg/kg |
| Soups & Broths | Instant soups, powdered broths | 200 mg/kg (on fat basis) |
| Food Supplements | Solid and liquid supplements | 400 mg/kg |
| Condiments | Sauces and seasonings | 200 mg/kg (on fat basis) |
Current status in EU (2025): E312 should not appear on any EU food labels; any foods still containing it are in violation of regulations.
E312 Outside the EU
United States
Status: Still FDA-approved and permitted in food products
Approval: FDA approves E312 use in margarine, oils, fats, and other processed foods
Difference from EU: US regulatory approach is far less stringent; FDA has NOT conducted equivalent rigorous re-evaluation as EFSA and did not remove it
Implication: American consumers may encounter E312 in many food products
Other Countries
Canada: Still approved
Australia/New Zealand: Generally approved
Japan: Still approved
Most other countries: Still approved
Key point: The EU ban of E312 is unique; almost all countries outside EU still permit it due to less stringent re-evaluation standards.
Safety Assessment
Toxicity Profile
| Safety Criterion | Finding | Assessment |
|---|---|---|
| Acute Toxicity | Harmful if swallowed (H302) | Concern at high doses |
| NOAEL Identification | CANNOT BE IDENTIFIED | MOST CRITICAL: Basic toxicological benchmark cannot be established |
| Chronic Toxicity | Data severely limited; NOAEL unidentifiable | Cannot assess adequately |
| Carcinogenicity | Cannot rule out due to insufficient data | No definitive risk but cannot confirm safety |
| Genotoxicity | No indication of concern; negative tests | Safe regarding DNA damage |
| Reproductive Toxicity | Insufficient data; cannot assess | Cannot evaluate |
| Skin Sensitization | May cause allergic skin reaction | Concern for sensitive individuals |
| Overall Assessment | EFSA: Safety cannot be confirmed; NOAEL unidentifiable | Most severe data inadequacy of all three gallates |
The Core Problem: No Identifiable NOAEL
EFSA explicitly stated: “Owing to the limitations of these studies, the Panel was unable to identify any NOAEL.”
This is the most severe finding. NOAEL (No Observed Adverse Effect Level) is the foundation of toxicological assessment. If it cannot be identified, no safety margin can be calculated, and safety assessment is fundamentally impossible.
Compare to E311: E311 at least had an identifiable NOAEL (50 mg/kg). E312 did not even have this basic benchmark.
The Three Gallates: Comparing Data Adequacy
| Gallate | E-Number | Alkyl Chain | EU Status | NOAEL | Regulatory Finding |
|---|---|---|---|---|---|
| Propyl | E310 | 3 carbons | Still approved | 135 mg/kg | More data; ADI established at 0.5 mg/kg |
| Octyl | E311 | 8 carbons | BANNED | 50 mg/kg | Insufficient data; cannot confirm safety |
| Dodecyl | E312 | 12 carbons | BANNED | UNIDENTIFIABLE | Severely insufficient data; no basic benchmark |
Key insight: As alkyl chain lengthens (propyl → octyl → dodecyl), data adequacy progressively worsens. E312, despite being chemically optimized for fat solubility, was the least studied — and therefore the first removed (along with E311).
The Bottom Line
E312 (Dodecyl Gallate) is a synthetic antioxidant that was banned in the EU in 2018 due to severely 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
- Data inadequacy was severe: EFSA couldn’t even identify basic toxicological benchmark (NOAEL)
- It wasn’t proven harmful: Rather, safety couldn’t be confirmed due to data gaps
- 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
- Worst data of the three gallates: Even worse than E311; couldn’t establish basic safety benchmark