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.
2015Regulatory reviewEFSA ANS Panel, Re-evaluation of dodecyl gallate (E 312) as a food additive, EFSA Journal
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.
2015Regulatory reviewEFSA ANS Panel, Re-evaluation of dodecyl gallate (E 312) as a food additive, EFSA Journal
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.
2018RegulatoryCommission Regulation (EU) 2018/1481 of 4 October 2018, Official Journal of the EU; confirmed retained in UK law via legislation.gov.uk
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.
2017ObservationalGallate Contact Dermatitis: Systematic Review and Product Update, Dermatitis (Liebertpub)
Cases of allergic contact stomatitis attributed to dodecyl gallate in food have been reported, with positive patch test results indicating sensitisation in affected individuals.
2001ObservationalWorm et al., Allergic contact stomatitis to dodecyl gallate, Contact Dermatitis