How much propyl gallate is considered safe?

The regulators disagree. EFSA's 2014 re-evaluation set an acceptable daily intake of 0.5 mg per kg of body weight per day, and found that high consumers — including adults and the elderly — can exceed it. The WHO's expert committee (JECFA) set 1.4 mg per kg in its 1996 evaluation — nearly three times EFSA's figure.

Which foods contain propyl gallate?

It is a synthetic antioxidant used to stop fats and oils going rancid: edible oils and fats, chewing gum, fat-based snacks, dehydrated soups and stock cubes, some breakfast cereals and processed meat products. On labels it appears as propyl gallate, E310, INS 310 or under 'antioxidant (310)'. In India it is permitted in edible oils and fats up to 100 ppm.

Does propyl gallate cause cancer or hormone problems?

No regulator has concluded that it does. What EFSA's 2014 re-evaluation actually said is that there were gaps in the data on effects on reproduction and cancer, so it applied an extra safety factor and set a deliberately low daily limit while calling for better studies. That is a data-gap finding, not a cancer finding — we report it as exactly that.

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Is propyl gallate (E310) safe?

Q: Is propyl gallate banned anywhere?

We found no regulator that has banned propyl gallate (E310) itself — it is permitted within limits in the EU, US and India. Its two chemical cousins, octyl gallate (E311) and dodecyl gallate (E312), were removed from the EU's authorised additive list in October 2018 after no safety data was submitted to confirm they were safe.

Q: Is propyl gallate the same as propylparaben?

No — they are different substances that are often confused because of the similar names. California's 2023 Food Safety Act bans propylparaben (along with Red 3, potassium bromate and brominated vegetable oil) from 2027. Propyl gallate is not covered by that law and remains listed as GRAS by the US FDA.

By LabelCop · Last updated 19 August 2026 · Sources: EFSA, FDA, FSSAI, WHO/JECFA

The short answer: it's permitted everywhere — but it's the last of its chemical family left on the EU list, and regulators disagree nearly threefold on the safe daily amount.

EU: permitted within limits — but EFSA set a low daily limit in 2014, found high consumers can exceed it, and noted gaps in the data on reproduction and cancer effects
EU, 2018: its two cousins — octyl gallate (E311) and dodecyl gallate (E312) — were removed from the authorised list after no safety data was submitted
US & India: permitted within limits — FDA lists it as GRAS; FSSAI allows up to 100 ppm in edible oils
LabelCop: flags E310 as a medium-risk additive — you see the reasons and the sources

What is propyl gallate?

A synthetic antioxidant — its one job is to stop fats and oils going rancid
Made industrially from gallic acid; it does not occur naturally in food
Often used alongside other antioxidants like BHA and BHT
Label names: propyl gallate, E310, INS 310, or "antioxidant (310)"

Which foods contain it?

Edible oils, fats and margarines
Chewing gum
Fat-based snacks and fried snack foods
Dehydrated soups, stock cubes and seasonings
Some breakfast cereals and processed meat products

In India: most common in packaged edible oils and vanaspati — FSSAI permits gallates up to 100 ppm in oils and fats. Look for INS 310 or "antioxidant (310)" on the label

What the regulators actually say

Regulator	Status	Reasoning
EFSA / European Union	Permitted within limits; low daily limit set in 2014	EFSA's 2014 re-evaluation set an acceptable daily intake of 0.5 mg/kg body weight — applying an extra-large safety factor because of gaps in the data on effects on reproduction and cancer. It found high consumers, including adults and the elderly, can exceed that limit, but concluded current uses were not a safety concern given how cautiously exposure was estimated.
European Union (sister gallates)	E311 & E312 removed from authorised list (2018)	Octyl gallate (E311) and dodecyl gallate (E312) were removed from the EU's authorised additive list by Commission Regulation (EU) 2018/1481, applying from 25 October 2018 — EFSA could not confirm their safety and no business submitted the requested toxicological data. Propyl gallate is the only gallate still authorised in the EU.
FDA (United States)	Permitted within limits (GRAS)	Listed as GRAS under 21 CFR 184.1660 as an antioxidant. Total antioxidant content must not exceed 0.02% of a food's fat or oil content.
FSSAI (India)	Permitted within limits	Permitted as an antioxidant in edible oils and fats — gallates (propyl, octyl, dodecyl, alone or combined) up to a maximum of 100 ppm under FSSAI's additive regulations.
WHO / JECFA	ADI set (1996) — nearly 3× EFSA's	JECFA's last evaluation (1996) allocated propyl gallate an acceptable daily intake of 0–1.4 mg/kg body weight — and set no ADI for octyl or dodecyl gallate. That is almost three times the daily limit EFSA later set in 2014 from the same kind of evidence.

The real story: the last gallate standing

Three chemical cousins entered EU food law: propyl (E310), octyl (E311) and dodecyl (E312) gallate — once covered by a single shared safe limit
2014: EFSA re-evaluated them, withdrew the shared limit, and said each had to stand on its own evidence
For E311 and E312, nobody supplied the requested safety data — so in 2018 the EU removed them from the authorised list. Not because harm was proven, but because safety could not be confirmed
E310 survived — but with a deliberately low daily limit, an extra safety factor, and EFSA's own note that data on reproduction and cancer effects had gaps
The disagreement that remains: EFSA says 0.5 mg/kg a day; WHO/JECFA's 1996 figure is 1.4 mg/kg — a near-threefold gap with no sign of convergence
We show you that disagreement instead of quietly picking a side

How LabelCop scores it

E310 is a medium-risk flag in LabelCop
Why: EFSA (2014) set a low safe daily limit — high consumers, including adults and the elderly, can exceed it — and noted gaps in the data on effects on reproduction and cancer
The product's score takes a penalty — and you see the flag, the reason and the sources. No black box

Frequently asked questions

Is propyl gallate banned anywhere?

We found no regulator that has banned E310 itself — it is permitted within limits in the EU, US and India. Its cousins E311 and E312 were removed from the EU's authorised list in 2018 after no safety data was submitted. If you've seen "banned" claims about propyl gallate, they usually confuse it with the other gallates — or with propylparaben.

Is propyl gallate the same as propylparaben?

No — different substances, similar names. California's 2023 Food Safety Act bans propylparaben (with Red 3, potassium bromate and BVO) from 2027. Propyl gallate is not covered by that law and remains FDA GRAS.

How much is considered safe?

EFSA (2014): 0.5 mg per kg of body weight per day, with a finding that high consumers can exceed it. WHO/JECFA (1996): 0–1.4 mg/kg — nearly three times higher. The gap reflects how each weighed the same incomplete evidence.

Which label names should I look for?

Propyl gallate, E310, INS 310, or "antioxidant (310)" — most common in edible oils, chewing gum, stock cubes and fat-based snacks.

Does it cause cancer or hormone problems?

No regulator has concluded that. EFSA's 2014 review said the data on reproduction and cancer effects had gaps, applied an extra safety factor, and set a deliberately low daily limit while calling for better studies. A data-gap finding is not a harm finding — we report it as exactly what it is.

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Sources

EFSA (2014): Re-evaluation of propyl gallate (E 310) — EFSA Journal 2014;12(4):3642 (ADI 0.5 mg/kg; JECFA's 1996 ADI of 1.4 mg/kg is documented here) · Commission Regulation (EU) 2018/1481 — removal of octyl gallate (E311) and dodecyl gallate (E312) from the authorised list · FDA: 21 CFR 184.1660 — propyl gallate (GRAS, antioxidant limit) · FSSAI: Food Safety and Standards (Food Products Standards and Food Additives) Regulations — permitted antioxidants · California AB 418 (2023) — the Food Safety Act text (bans propylparaben, not propyl gallate)

Related ingredients: BHA & BHT (E320/E321) · TBHQ (E319) · Palm oil & palmolein

This article explains regulatory status and published scientific assessments in plain English. It is not medical advice.