EWG evaluation of food chemicals: Propyl gallate

EWG evaluation of food chemicals: Propyl gallate rcoleman June 29, 2026 Dayna de Montagnac, MPH Sydney Evans, MPH Tasha Stoiber, Ph.D. Jump to: What is propyl gallate and why is it added to food? Food propyl gallate is found in What is the regulatory status of propyl gallate? Is food containing propyl gallate always classified as ultra-processed? Is propyl gallate allowed in organic foods? What are the potential health harms associated with propyl gallate? Uncertainties and the need for more research Additional details Other product use categories References June 30, 2026 EWG’s recommendation Propyl gallate is an ingredient of concern, and EWG recommends limiting consumption of food containing this ingredient. Propyl gallate’s toxicity is linked to its breakdown in the body, which produces reactive oxygen species, or ROS. It also causes oxidative stress, a process connected to numerous chronic diseases. When broken down into pyrogallol, a highly reactive oxidizing agent, it can lead to pro-oxidant systemic toxicity, glutathione depletion, and potentially cause damage to the liver (hepatotoxicity) and kidneys (nephrotoxicity). Studies in animals and cells have also shown propyl gallate is associated with reproductive health harms, including inducing male infertility and testicular toxicity in mice, anti-estrogenic effects affecting female reproductive health, and impaired early embryonic development. Science analysis What is propyl gallate and why is it added to food? Propyl gallate is a preservative that prevents oxidation, extending the shelf life of fats and oils in processed foods. Food propyl gallate is found in Propyl gallate is typically added to meat products, frozen food and candy. Propyl gallate is used in 275 of the 172,081 food items added to EWG’s Food Scores between 2023 and 2025. Top 15 food and drink categories organized by supermarket shelf Image Source: EWG’s Food Scores. Label created between 1/1/23 and 10/22/25. What is the regulatory status of propyl gallate? The Food and Drug Administration classified propyl gallate as “generally recognized as safe,” or GRAS , and approved it for use in food in 1948. Propyl gallate is commonly added to food as an antioxidant, but the total antioxidant content cannot exceed 0.02% of the total fat or oil content of the food. Like other synthetic antioxidants, propyl gallate is also approved in the U.S. as a food contact substance – materials and articles intended to come into contact with food. In the European Union, an acceptable daily intake, or ADI, of 0.5 mg/kg was established for three gallates – propyl, octyl and dodecyl – in 1987 by the Scientific Committee on Food. WHO/JECFA established a higher ADI of 1.4 mg/kg of body weight in 1996 for propyl gallate. In 2014, a European Food Safety Authority, or EFSA, panel derived an ADI of 0.5 mg/kg for propyl gallate only. The panel concluded there was no longer a basis for the group ADI. Is food containing propyl gallate always classified as ultra-processed? Yes, propyl gallate and other synthetic preservatives are common ingredients in ultra-processed food, or UPF. As an industrially synthesized ingredient, the NOVA framework classifies it as a UPF ingredient ( Monteiro et al., 2019 ). Because it serves as a flavoring agent and adjuvant , the presence of propyl gallate is enough to qualify a food or beverage as ultra-processed, according to a recent California law defining UPF ( Real Food, Healthy Kids Act, 2025 ). Is propyl gallate allowed in organic foods? No. Under Department of Agriculture organic standards , synthetic substances are prohibited in certified organic foods. What are the potential health harms associated with propyl gallate? Like other synthetic antioxidants, the toxicity of propyl gallate is related to its breakdown in the body and production of ROS, which creates oxidative stress. Oxidative stress damages cells and causes programmed cell death (apoptosis), a process associated with numerous chronic diseases. Propyl gallate rapidly metabolizes into gallic acid in the body. At higher levels, a portion can then be decarboxylated by gut bacteria into pyrogallol, a highly reactive oxidizing agent. The formation of pyrogallol may contribute to pro-oxidant toxicity, resulting in glutathione depletion, which leads to hepatotoxicity and nephrotoxicity ( Park, 2025 ). While gallic acid is less reactive at low dietary exposure levels, it may become pro-oxidative and hepatotoxic at the elevated concentrations typically found in concentrated herbal supplements ( Galati et al., 2006 ). The accumulation of these reactive metabolites and generation of ROS have been associated with cellular DNA breaks ( Javaheri-Ghezeldizaj et al., 2023 ). Evidence of cell damage induced by propyl gallate extends across multiple studies. One found that propyl gallate induces male infertility and testicular toxicity in mice by disrupting calcium homeostasis, causing mitochondrial and endoplasmic reticulum stress, and suppressing cell viability and steroidogenesis in Leydig and Sertoli cells ( Ham et al., 2019 ). Another study found propyl gallate interferes with the production of estrogen ( Amadasi et al., 2009 ), which can affect female reproductive health. In another rodent study, propyl gallate exposure impaired early embryonic development by inducing oxidative stress, DNA damage and autophagy while also disrupting mitochondrial and lysosomal function and altering epigenetic modifications ( Yang et al., 2024 ). Studies investigating the anti-cancer properties of propyl gallate provide further evidence of its pro-oxidant activity. In lung cancer cell models, propyl gallate increased ROS and depleted glutathione, leading to mitochondrial dysfunction and apoptosis ( Park, 2021 ). These mechanisms overlap with the compound’s toxic effects in non-cancer cells, suggesting that oxidative stress may play a central role in both its therapeutic and adverse biological effects. A 1982 carcinogenesis bioassay by the National Toxicology Program concluded that propyl gallate was not carcinogenic in rats or mice. However, the study noted evidence of tumorigenesis in low-dose male rats specifically. They exhibited more, mostly benign pancreatic, adrenal and preputial gland tumors that did not occur in the high-dose treatment groups. Rare tumors were noted in two of the low-dose female rats ( National Toxicology Program, 1982) . In refined exposure assessments conducted by the EFSA in 2014, propyl gallate was estimated to exceed the ADI for the elderly and adults. Higher estimates in adults and the elderly compared to other groups were due to its presence in food supplements ( EFSA ANS Panel, 2014 ). The assessment also found exposure to propyl gallate from food contact materials alone likely exceeded the ADI for most children ( EFSA ANS Panel, 2014 ). But because their exposure models were intentionally conservative, the EFSA concluded current real world use of propyl gallate was not a safety concern . Uncertainties and the need for more research The presence of propyl gallate in food contact materials and cosmetics, as well as octyl gallate and dodecyl gallate, should be considered when determining total exposure risk. Concurrent exposure to propyl gallate and related synthetic antioxidants may contribute to overall exposure and should be considered when evaluating potential health risks ( Wang et al., 2021 ). To refine future exposure assessments, the EFSA panel noted that additional data are needed on the use of propyl gallate in breakfast cereal, soup, processed nuts and food supplements. More research is needed to understand both the cytotoxic and cytoprotective properties of propyl gallate in humans. Additional details Research shows propyl gallate’s anti-cancer activity appears to involve pro-oxidant and apoptotic pathways that overlap with mechanisms implicated in its toxicity. In cancer cell models, propyl gallate induces severe oxidative stress, cell cycle arrest and programmed cell death ( Wei et al., 2019 ; Park, 2020 ). Other product use categories Propyl gallate is also added to cosmetic products as a preservative. It scores 4 in EWG’s Skin Deep® database and is not allowed in EWG Verified® products. References Global health and regulatory agencies EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS). (2014). Scientific opinion on the re‐evaluation of propyl gallate (E 310) as a food additive. EFSA Journal, 12(4), Article 3642. Comprehensive reviews and frameworks Monteiro, C.A., Cannon, G., Levy, R.B., Moubarac, J., Louzada, M.L., Rauber, F., Khandpur, N., Cediel, G., Neri, D., Martinez-Steele, E., Baraldi, L.G., & Jaime, P.C. (2019). Ultra-processed foods: what they are and how to identify them. Public Health Nutrition, 22(5), 936–941. . National Toxicology Program. (1982). Carcinogenesis bioassay of propyl gallate (CAS No. 121-79-9) in F344/N rats and B6C3F1 mice (Feed study) (Technical Report Series No. 240; NIH Publication No. 83-1796). Department of Health and Human Services, National Institutes of Health. Park, W.H. (2021). Enhanced cell death effects of MAP kinase inhibitors in propyl gallate–treated lung cancer cells are related to increased ROS levels and GSH depletion. Toxicology in Vitro, 75, Article 105176. Wang, W., Xiong, P., Zhang, H., Zhu, Q., Liao, C., & Jiang, G. (2021). Analysis, occurrence, toxicity and environmental health risks of synthetic phenolic antioxidants: A review. Environmental Research, 201, 111531. Monteiro, C.A., Cannon, G., Levy, R.B., Moubarac, J., Louzada, M.L., Rauber, F., Khandpur, N., Cediel, G., Neri, D., Martinez-Steele, E., Baraldi, L.G., & Jaime, P.C. (2019). Ultra-processed foods: what they are and how to identify them. Public Health Nutrition, 22(5), 936–941. . Legislation Real Food, Healthy Kids Act, A.B. 1264, Chapter 467, Cal. Stat. (2025). 21 CFR 184.1660 – Propyl gallate. (n.d.). Specific health impact studies Park, W.H. (2025). A comprehensive review of pyrogallol: from fundamental chemistry to advanced applications and toxicological insights. Biotechnology and Bioengineering, 123(3), 527–543. Galati, G., Lin, A., Sultan, A.M., & O'Brien, P.J. (2006). Cellular and in vivo hepatotoxicity caused by green tea phenolic acids and catechins. Free Radical Biology and Medicine, 40(4), 570–580. Javaheri-Ghezeldizaj, F., Mirza Alizadeh, A., Dehghan, P., & Ezzati Nazhad Dolatabadi, J. (2023). Pharmacokinetic and toxicological overview of propyl gallate food additive. Food Chemistry , 423 , Article 135219. Ham, J., Lim, W., Park, S., Bae, H., You, S., & Song, G. (2019). Synthetic phenolic antioxidant propyl gallate induces male infertility through disruption of calcium homeostasis and mitochondrial function. Environmental Pollution, 248, 845–856. Amadasi, A., Mozzarelli, A., Meda, C., Adriana, M., & Cozzini, P. (2009). Identification of xenoestrogens in food additives by an integrated in silico and in vitro approach. Chemical Research in Toxicology, 22(1), 52–63. Yang, S., Yang, F., Zou, Y., Wang, Y., Ding, Z., Zhang, L., Zhou, X., Liu, M., Duan, Z., & Huo, L. (2024). Propyl gallate exposure affects the mouse 2-cell stage embryonic development through inducing oxidative stress and autophagy. Food and Chemical Toxicology, 185, 114488. Wei, P., Huang, C., & Chang, Y. (2019). Propyl gallate inhibits hepatocellular carcinoma cell growth through the induction of ROS and the activation of autophagy. PLoS ONE, 14(1), e0210513. Park, W. (2020). Propyl gallate reduces the growth of lung cancer cells through caspase‑dependent apoptosis and G1 phase arrest of the cell cycle. Oncology Reports, 44(6), 2783–2791.