propyl gallate
propyl gallate

Propyl Gallate

Common names: Propyl 3,4,5-trihydroxybenzoate, 3,4,5-Trihydroxybenzoic acid propyl ester, Afoxolaner (brand name), Antioxidant P (brand name), E310 (European food additive code).
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KIDSADVISORY SAFETY RATING
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Caution
Published by Jordana Tobelem, RD, LDN — Last Updated on Apr 16, 2025
Medically reviewed by Dr. William Lin, MD
Propyl gallate is a synthetic antioxidant widely used in the food industry to prevent the oxidation of fats and oils, which extends the shelf life of processed foods. It is particularly effective in stabilizing products like margarine, baked goods, and snack foods.[1] The compound works by neutralizing free radicals, making it a key additive for preserving the quality and flavor of fatty and oily products.[2]
Despite its functionality, propyl gallate has raised concerns about potential health effects, including its association with allergic reactions and endocrine disruption at higher concentrations.[2] Regulatory agencies such as the FDA and EFSA allow its use within strict limits, ensuring its safety in most applications.[1] However, increasing consumer awareness has prompted interest in exploring natural alternatives to synthetic antioxidants.[3]

Safety Overview

Regulatory Bodies

FDA (US)
The U.S. Food and Drug Administration (FDA) lists propyl gallate as “generally recognized as safe” (GRAS) for use as an antioxidant in food products, provided it complies with specific concentration limits.[1] The FDA regulates its use in food packaging to prevent oxidative degradation of fats and oils.[2]
Health Canada
Health Canada permits the use of propyl gallate in food and pharmaceutical products as an antioxidant under strict quality standards.[4] It emphasizes adherence to established safety limits to minimize potential allergenic and toxic effects.[4]
EFSA (Europe)
EFSA has approved propyl gallate as a food additive (E310), setting an acceptable daily intake (ADI) of 0.5 mg/kg body weight.[2] However, EFSA has highlighted potential concerns regarding its endocrine-disrupting properties and allergenic potential at high concentrations.[2]
WHO (World Health Organization)
The WHO, in collaboration with the Joint FAO/WHO Expert Committee on Food Additives (JECFA), has established an ADI of 0.5 mg/kg body weight for propyl gallate, affirming its safety when consumed within regulated limits.[5] The organization notes its primary use as an antioxidant in processed foods and oils.[5]

FDA GRAS

U.S. Food and Drug Administration – Generally Recognized as Safe (GRAS)
Current Status
Classified

EWG Rating

Environmental Working Group
  • EWG Rating: Propyl gallate has an EWG rating of 4-6, indicating moderate to high concern, depending on its use in food or cosmetics.[6]
  • Level of Caution: The Environmental Working Group advises caution due to studies suggesting potential endocrine disruption and allergic reactions.[2]
  • Possible Health Risks: Health risks associated with propyl gallate include skin irritation, hypersensitivity reactions, and potential endocrine-disrupting effects at higher concentrations.[7]
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More about Propyl Gallate

  • Processed Meats: Sausages, hot dogs, and deli meats.
  • Fats and Oils: Cooking oils, salad dressings, and margarine.
  • Packaged Snacks: Chips, crackers, and snack bars.

Historical Use
Propyl gallate was first introduced in the 1940s as a synthetic antioxidant to prevent rancidity in fats and oils.¹ Its use expanded into the food industry due to its efficiency in preserving the flavor and shelf life of processed products.[2]
Current Exposure
Today, consumers are frequently exposed to propyl gallate through processed foods like snack items, baked goods, and cooking oils.[1] It is also found in pharmaceutical products and cosmetics, where it acts as a stabilizer and preservative.[7]

Endocrine Disruption
Research suggests that propyl gallate may interfere with hormone regulation, particularly at high concentrations, raising concerns about its potential as an endocrine disruptor.[2] Animal studies have indicated alterations in thyroid and reproductive hormones linked to its exposure.[5]
Allergic Reactions
Propyl gallate has been associated with allergic reactions, including contact dermatitis and hypersensitivity, particularly in individuals with pre-existing sensitivities.[4] These reactions are rare but may occur in products containing high concentrations of the additive.[4]
Genotoxicity Concerns
Some studies have raised concerns about propyl gallate’s potential to cause DNA damage under specific conditions, although the findings remain inconclusive.[2] This has prompted calls for further research to evaluate its genotoxic risk at typical exposure levels.[6]
Oxidative Stress
While propyl gallate acts as an antioxidant, excessive amounts may paradoxically induce oxidative stress in cells, potentially leading to inflammation and cellular damage.[8] Such effects have primarily been observed in high-dose animal studies.[8]

Toxicological Studies
Toxicological evaluations have shown that propyl gallate is generally safe at approved levels, with an acceptable daily intake (ADI) of 0.5 mg/kg body weight set by the WHO and EFSA.[2] However, high-dose animal studies have reported potential endocrine disruption, genotoxicity, and oxidative stress.[5]
Long-Term Safety
Long-term studies suggest that chronic exposure to high concentrations of propyl gallate may lead to thyroid hormone alterations and other systemic effects.[2] At regulated levels, propyl gallate is considered safe for human consumption, though further research is recommended to fully understand its cumulative impact.[5]

High-Risk Groups
Vulnerable groups include individuals with pre-existing allergies or sensitivities to food additives, as propyl gallate may trigger allergic reactions such as contact dermatitis or hypersensitivity.[7] Pregnant women and children may also be more susceptible to potential endocrine-disrupting effects due to their developing hormonal systems.[2]
Health Impacts
In vulnerable populations, exposure to propyl gallate has been linked to allergic reactions, including skin irritation and gastrointestinal discomfort.[7] Long-term exposure in sensitive individuals may exacerbate potential hormone regulation issues or oxidative stress-related effects.[5]

Recommended Intake
The acceptable daily intake (ADI) for propyl gallate is set at 0.5 mg/kg body weight by both the WHO and EFSA, ensuring its safe use as an antioxidant in food products.[2][5]

General Safety Level
Propyl gallate is approved by regulatory bodies such as the FDA and EFSA as safe for use in food products when used within regulated limits.[1] However, it has been flagged for potential health concerns in high doses based on animal studies.[2]
Sensitive Individuals
Propyl gallate has been associated with rare allergic reactions, such as skin irritation and contact dermatitis, particularly in sensitive individuals.[9] Some studies suggest that it may trigger hypersensitivity reactions in individuals predisposed to allergies.[7]

FAQ

What is propyl gallate in food?

Propyl gallate is a synthetic antioxidant added to processed foods to prevent fats and oils from spoiling.

Is propyl gallate gluten-free?

Yes, propyl gallate is gluten-free as it does not contain wheat, barley, or rye.

References

  1. US Food and Drug Administration FDA n.d. Code of Federal Regulation 21 - Propyl gallate Available at: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-184/subpart-B/section-184.1660 ↩︎
  2. European Food Safety Authority EFSA 2014 Scientific Opinion on the re-evaluation of propyl gallate E 310 as a food additive EFSA Journal 12(4) 3773 Available at: https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2014.3642 ↩︎
  3. Environmental Working Group EWG n.d. Propyl Gallate Available at: https://www.ewg.org/skindeep/ingredients/705311-PROPYL_GALLATE/ ↩︎
  4. Health Canada 2024 List of Permitted Preservatives Lists of Permitted Food Additives Available at: https://www.canada.ca/en/health-canada/services/food-nutrition/food-safety/food-additives/lists-permitted/11-preservatives.html ↩︎
  5. World Health Organization n.d. Propyl gallate Available at: https://apps.who.int/food-additives-contaminants-jecfa-database/Home/Chemical/1272 ↩︎
  6. Environmental Working Group EWG n.d. Propyl Gallate Available at: https://www.ewg.org/skindeep/ingredients/705311-PROPYL_GALLATE/ ↩︎
  7. Witkowski M Grajeta H Gomutka K 2022 Hypersensitivity Reactions to Food Additivesu2014Preservatives Antioxidants Flavor Enhancers International Journal of Environmental Research and Public Health 19(18) 11493 Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC9517530/ ↩︎
  8. PubChem n.d. Propyl Gallate National Center for Biotechnology Information Available at: https://pubchem.ncbi.nlm.nih.gov/compound/propyl_gallate ↩︎
  9. Cosmetic Ingredient Review CIR 2007 Final report on the amended safety assessment of Propyl Gallate International Journal of Toxicology 26(Suppl 3) 89-118 Available at: https://pubmed.ncbi.nlm.nih.gov/18080874/ ↩︎

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