Octyl gallate
A synthetic antioxidant once used to stop fats going rancid. Removed from the UK and EU approved list in 2018 because manufacturers could not supply the required safety data.
No longer permitted in UK or EU food. If you see it on a label, the product should not be on sale. Manufacturers were unable to provide regulators with the toxicological evidence needed to confirm it posed no risk.
What is it?
Octyl gallate is a synthetic ester made by combining gallic acid (a plant-derived phenolic acid) with octanol (an eight-carbon alcohol). It belongs to the gallate family of antioxidants, which also includes propyl gallate (E310) and dodecyl gallate (E312). It is an oily or waxy solid, poorly soluble in water but soluble in fats and oils.
What does it do?
Octyl gallate works by donating hydrogen atoms to free radicals produced during fat oxidation, interrupting the chain reaction that turns fats rancid. It was used to extend the shelf life of oils, fats and fat-containing foods by preventing the development of off-flavours and odours associated with oxidative spoilage.
Where you will see it
Prior to its removal from the approved list, octyl gallate appeared mainly in edible fats and oils, chewing gum, and some processed foods with a high fat content. It would appear on ingredients lists as 'octyl gallate' or 'E311'. Since October 2018 it should not appear on any UK or EU food product currently in legal sale.
What the science says
Removed from the approved list: missing safety data
The European Commission removed E311 (and the related E312 dodecyl gallate) from the EU authorised food additives list in October 2018. The reason given was the absence of appropriate toxicological data. Manufacturers had not submitted the evidence needed under the re-evaluation programme that was reviewing all pre-2009 food additive approvals. Without that data the regulator could not confirm the additive's safety to a modern standard, so authorisation was withdrawn.
Octyl gallate (E311) and dodecyl gallate (E312) were deleted from the Union list of authorised food additives due to the absence of appropriate toxicological data submitted by interested parties.
Allergic and sensitivity reactions
The gallate family of antioxidants, including propyl gallate (E310), octyl gallate (E311) and dodecyl gallate (E312), have been associated in case reports with contact dermatitis and allergic reactions, particularly in people who are sensitive to other gallate esters or to gallic acid derivatives. People with known sensitivity to propyl gallate are generally advised to avoid all gallates. The cross-reactive potential within this chemical family is recognised in dermatological literature.
Gallate esters are recognised contact allergens. Cross-reactivity within the gallate group (propyl, octyl, dodecyl) has been documented in contact dermatitis cases.
Animal studies and historical toxicology concerns
Earlier animal studies on gallate esters, including octyl gallate, raised questions about effects on red blood cells (methaemoglobin formation) at high doses in certain animal species. These findings contributed to the call for updated toxicological data. However, the critical issue at the point of removal was not a confirmed harm at dietary exposure, but the failure of the data package to meet modern regulatory standards, leaving the question unanswered.
Gallic acid esters including octyl gallate showed methaemoglobin-forming potential in animal studies, raising questions about haematological effects that were not resolved by the available data package.
Where it stands with the regulators
Who should be careful
Everyone, because the additive is no longer legally permitted in UK or EU food. Anyone who sees 'octyl gallate' or 'E311' on a product currently on sale should treat it as a labelling irregularity and can report it to the Food Standards Agency. People with known sensitivity to gallate antioxidants (look for 'propyl gallate', 'octyl gallate', 'dodecyl gallate', 'E310', 'E311', 'E312' on labels of any product) should be aware that cross-reactive contact reactions within the gallate family are documented.
The honest read
The removal of E311 from the approved list is a regulatory data gap, not a confirmed proof of harm at typical food levels. The honest position is that regulators required modern toxicological evidence, manufacturers did not provide it, and authorisation was withdrawn as a result. That is the appropriate outcome of a precautionary system: when the evidence package is incomplete, the additive does not remain on the list. Whether octyl gallate at the concentrations previously used in food posed a meaningful risk to human health is a question the available science does not fully answer, because the required studies were never submitted. Propyl gallate (E310), the closely related and still-authorised gallate, has continued under EFSA scrutiny. The picture for the gallate family as a whole remains active, not closed.
Related additives
Common questions
Is E311 banned in the UK?
Yes. Octyl gallate (E311) was removed from the EU authorised food additives list in October 2018 by Commission Regulation (EU) 2018/1481, and this is assimilated into UK law. It is not on the UK FSA's approved additives list. It should not appear in any UK food product currently on sale.
Why was E311 removed from the approved list?
Manufacturers failed to submit the updated toxicological data required under the EU's re-evaluation programme for pre-2009 food additives. Without that data, the regulator could not confirm the additive met modern safety standards, so authorisation was withdrawn. It was not removed because a specific harm was proven, but because the evidence package was incomplete.
What foods contain E311?
E311 should not be in any food currently on sale in the UK or EU. Before its removal in 2018 it was used mainly in edible fats and oils and some fat-containing processed foods. If you see it on a label today, that product should not be on sale and can be reported to the FSA.
Is E311 vegan?
Octyl gallate is a synthetic compound derived from gallic acid (found in plant matter) and a fatty alcohol. It does not contain animal-derived ingredients. However, as it is not an authorised food additive in the UK or EU, the question of its dietary suitability is moot for current food products.
Sources
- Commission Regulation (EU) 2018/1481 of 4 October 2018 amending Annexes II and III to Regulation (EC) No 1333/2008 as regards octyl gallate (E311) and dodecyl gallate (E312)
- Commission Regulation (EU) 2018/1481 full text, EUR-Lex
- Approved additives and E numbers, UK Food Standards Agency
- JECFA monograph: Gallates (WHO Food Additives Series 32) — group ADI and individual ADI history for propyl, octyl and dodecyl gallate
- EFSA ANS Panel scientific opinion on the re-evaluation of propyl gallate (E310) as a food additive, EFSA Journal 2014
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