Propyl Gallate E310
synthetic phenolic antioxidant — Primarily synthetic.
Propyl 3,4,5-trihydroxybenzoate
CAS: 121-79-9
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 Propyl Gallate?
Propyl gallate is an ester of gallic acid used as a lipid antioxidant in fats, oils, and fat-containing products including margarine and chewing gum base. It is often used in combination with BHA (E320) and BHT (E321) for synergistic antioxidant effects. JECFA established an ADI of 0.1 mg/kg body weight (as gallates group). EFSA reviewed gallates in 2014 and confirmed the ADI, noting that exposure was within safe limits for most population groups. It is approved in the EU, USA (GRAS), and many other jurisdictions.
? Did You Know?
Beyond food, Propyl 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 Analysis
Propyl gallate (E310) survived a 2018 EU regulatory review intact while its two structural analogues — octyl gallate (E311) and dodecyl gallate (E312) — were removed under Commission Regulation (EU) 2018/97. The divergence reflects different outcomes from EFSA's 2014 re-evaluation: EFSA established an ADI of 0.5 mg/kg body weight per day specifically for propyl gallate, while concluding that adequate safety data for E311 and E312 to establish individual ADIs were unavailable. This differentiated outcome contrasts with the 1976 SCF approach, which had treated all three gallate esters as a group under a single ADI. JECFA's 1996 evaluation similarly allocated an ADI only to propyl gallate. The FDA treats propyl gallate as GRAS under 21 CFR 184.1660, permitting use at ≤0.02% of fat content. The regulatory divergence between the EU and USA reflects differing requirements for evidentiary sufficiency rather than differing safety conclusions about propyl gallate itself.
Detailed Regulatory Assessment
European Union (EFSA)
E311 (octyl gallate) and E312 (dodecyl gallate) removed from EU list in 2018; E310 remains with restrictions
Official EFSA LinkUnited States (FDA)
FDA allows <0.02% of fat/oil content (individually or combined with octyl/dodecyl gallate, BHT, BHA, ascorbyl palmitate)
Japan (MHLW)
Used particularly in butter and oil products with defined limits
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 (3,4,5-trihydroxybenzoic acid) with propanol (propyl alcohol). The resulting compound is a white to creamy-white crystalline powder. Linear formula: 3,4,5-(HO)₃C₆H₂CO₂CH₂CH₂CH₃, Molecular weight: 212.20.
Applications Beyond Food
Antioxidant preservative in cosmetic formulations
Antioxidant in drug formulations
Lubricants, biodiesel, adhesives