Dodecyl gallate
A synthetic antioxidant formerly added to fats and oils, now banned in UK and EU food since October 2018 because its safety could not be established.
No longer permitted in UK or EU food. EFSA could not rule out carcinogenic potential and found the safety database too limited to set a safe daily intake. Dodecyl gallate is also a known contact allergen and skin sensitiser.
What is it?
Dodecyl gallate is a synthetic ester made by combining gallic acid (a plant-derived phenolic acid) with dodecanol (a 12-carbon alcohol). It belongs to the gallate family of antioxidants, which also includes propyl gallate (E310) and octyl gallate (E311).
What does it do?
It works by donating hydrogen atoms to free radicals, interrupting the chain reactions that cause fats and oils to go rancid. This is called radical scavenging. It was particularly effective in animal fats and vegetable oils where oxygen-driven oxidation degrades flavour and shelf life.
Where you will see it
Formerly used in lard, dripping, suet, vegetable oils, margarine, and fat-containing processed foods such as biscuits, crisps, and pastries. It was also used in chewing gum bases and some packaging materials. Any product containing it after April 2019 is non-compliant with UK and EU food law. On older labels it appears as 'dodecyl gallate' or 'E312'.
What the science says
EFSA could not establish a safe intake level
When EFSA re-evaluated E312 in 2015, it found the available toxicological data insufficient to set an acceptable daily intake (ADI). The panel concluded that the existing database was too limited to support the margin-of-safety approach normally used to confirm that a food additive is not harmful at the levels people consume it.
EFSA's ANS Panel concluded that the available safety database on dodecyl gallate was insufficient to either establish an ADI or apply a margin-of-safety approach with confidence, meaning the Panel could not confirm the absence of risk at current use levels.
Unresolved carcinogenic potential
EFSA identified that available animal genotoxicity and carcinogenicity data were inadequate to draw firm conclusions. The panel could not rule out the possibility that dodecyl gallate has carcinogenic potential, which was a key reason the European Commission ultimately withdrew its authorisation.
The EFSA Panel could not reach a definitive conclusion on the presence or absence of carcinogenic potential for dodecyl gallate due to limitations in the available safety data, including gaps in genotoxicity and long-term animal carcinogenicity studies.
Banned from UK and EU food in 2018
Following the inadequate EFSA safety opinion, the European Commission removed dodecyl gallate (along with octyl gallate, E311) from the list of permitted food additives. The removal took effect on 25 October 2018, with a sell-through period allowing products already lawfully placed on the market to be sold until 25 April 2019. Any food product sold in the UK or EU containing E312 after that date is non-compliant with food law.
EU Commission Regulation 2018/1481 deleted dodecyl gallate (E 312) and octyl gallate (E 311) from the Union list of permitted food additives with effect from 25 October 2018, following EFSA's conclusion that the safety of these additives could not be adequately assessed. Article 3 of the Regulation permitted foods already lawfully placed on the market before that date to continue to be marketed until 25 April 2019.
Contact allergy and skin sensitisation
Dodecyl gallate is classified as a skin sensitiser and has been identified as a cause of allergic contact dermatitis in people exposed to it through food, cosmetics, or occupational settings. The gallate family as a group is recognised for its sensitising potential, and case reports of contact stomatitis (mouth inflammation) have been documented with dodecyl gallate specifically.
Propyl, octyl, and dodecyl gallates are reported as causes of allergic contact dermatitis. Dodecyl gallate in particular is described as a strong sensitiser, and patch-test positive cases have been documented in clinical contact dermatitis studies.
Cases of allergic contact stomatitis attributed to dodecyl gallate in food have been reported, with positive patch test results indicating sensitisation in affected individuals.
Where it stands with the regulators
Who should be careful
Everyone: E312 is not legally permitted in UK or EU food, so no food product should contain it. People with known gallate sensitivity should also avoid products containing propyl gallate (E310), which is still permitted, and check cosmetics and topical products for 'dodecyl gallate', 'lauryl gallate', or 'gallate' on the ingredient list.
The honest read
E312 sits in a small category of additives that were withdrawn not because a harm was definitively proven, but because the evidence submitted for safety review was inadequate and regulators were not prepared to keep it authorised under those conditions. The inability to rule out carcinogenic potential was the decisive factor. This is a case where the precautionary approach led to a ban before a risk was confirmed, not after. The contact allergy evidence is more robust and is the better-established concern at a mechanistic level.
Related additives
Common questions
Is E312 banned in the UK?
Yes. Dodecyl gallate was withdrawn from the EU's list of permitted food additives by Regulation 2018/1481 with effect from 25 October 2018. A short sell-through period allowed products already lawfully placed on the market to be sold until 25 April 2019. This regulation is retained in UK law unchanged, so no food sold in the UK may legally contain E312.
Why was E312 banned?
EFSA re-evaluated it in 2015 and concluded the available safety data were too limited to establish an acceptable daily intake or confirm the absence of carcinogenic risk. The European Commission removed it from the permitted list in 2018 as a result.
What foods contain E312?
Before the 2018 ban it appeared in lard, vegetable oils, margarine, biscuits, crisps, pastry products, and chewing gum. No food legally sold in the UK or EU should contain it today. If you see E312 on a label, the product is non-compliant with current food law.
Is E312 vegan?
The compound itself is synthetic, but it was historically used to preserve animal fats such as lard and dripping, so products containing it were not necessarily vegan. The question is largely academic since it is no longer permitted in food.
Sources
- EFSA ANS Panel: Re-evaluation of dodecyl gallate (E 312) as a food additive, EFSA Journal 2015
- Commission Regulation (EU) 2018/1481 of 4 October 2018 deleting E311 and E312 from the Union list of permitted food additives
- Commission Regulation (EU) 2018/1481 as retained in UK law (legislation.gov.uk)
- Gallate Contact Dermatitis: Systematic Review and Product Update, Dermatitis
- European Commission Food Additives Re-evaluation overview
- UK FSA Approved Additives and E Numbers
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