Octyl Gallate E311
synthetic phenolic antioxidant — Primarily synthetic.
Octyl 3,4,5-trihydroxybenzoate
CAS: 1034-01-1
Factual Regulatory Reference
This database provides factual regulatory information compiled from official government sources. It does not constitute medical, nutritional, or safety advice. Regulatory status varies by country and is subject to change. Always refer to your local regulatory authority for the most current information.
What Is Octyl Gallate?
Octyl gallate is an octyl ester of gallic acid used as an antioxidant in fats and oils, sharing the same mechanism as propyl gallate (E310) — donating hydrogen atoms to free radicals in lipid phases. It belongs to the gallate group evaluated by EFSA in 2014, with a group ADI of 0.1 mg/kg body weight (as gallates). Approved in the EU under Regulation EC 1333/2008, primarily for use in fats and oils. It is less widely used than propyl gallate due to its lower solubility in aqueous systems.
? Did You Know?
Beyond food, Octyl Gallate is also used in cosmetics, medicine, industrial applications. Its versatility makes it one of the most multi-purpose chemical compounds in everyday life.
Regulatory opinions differ: Octyl Gallate is approved in USA, JAPAN, CANADA but banned in EU. This reflects different risk assessment philosophies between regions.
Regulatory Analysis
The 2018 removal of octyl gallate (E311) from the EU approved additives list illustrates how JECFA's 1996 decision not to establish an individual ADI — citing insufficient data — functioned as an early regulatory signal. EFSA's subsequent re-evaluation could not complete a positive safety determination, and under EU positive-list regulation, the absence of confirmed safety data is itself grounds for removal under Regulation (EC) No 1333/2008. The same mechanism eliminated E312 (dodecyl gallate) simultaneously. The FDA maintains approval under 21 CFR 172.615 for octyl gallate in the USA, applying the GRAS historical-use framework rather than a prospective evidence requirement. Japan and Australia also retain authorization. This divergence demonstrates that regulatory architecture — what standard of proof is required to maintain approval — produces different outcomes from the same body of evidence.
Detailed Regulatory Assessment
European Union (EFSA)
REMOVED from EU approved additives list in 2018 due to persistent safety concerns
United States (FDA)
Previously approved with limits; current use declining after EU removal
Japan (MHLW)
Status maintained despite EU removal
Acceptable Daily Intake (ADI)
International Standard (JECFA)
mg/kg body weight per day
European Standard (EFSA)
Everyday Perspective
For a 60kg adult, this limit is roughly equivalent to consuming:
Natural Occurrence
This additive is not known to occur naturally in significant quantities.
Manufacturing
Produced by esterifying gallic acid with octanol (octyl alcohol). Greater fat solubility than propyl gallate due to longer carbon chain (8 carbons). Linear formula: 3,4,5-(HO)₃C₆H₂CO₂(CH₂)₇CH₃, Molecular weight: 282.33.
Applications Beyond Food
Historical use in cosmetics (now largely discontinued)
Historical use (discontinued)
Limited to research/analytical standards