Other names for the additive (synonyms)
General Information
The food additive E310 is a synthetic antioxidant known as propyl gallate, which is used in the food industry to prevent the oxidation of fats and oils.
Propyl gallate is not a naturally occurring compound and is not found in plants, minerals, or other natural objects in its ready form. In nature, gallic acid is widely distributed; propyl gallate is produced industrially by esterification of gallic acid.
Gallates began to be used in the 20th century as effective fat stabilizers, particularly in fat-containing foods and animal feeds. The chemical formula of propyl gallate is C₁₀H₁₂O₅. From a physical standpoint, the additive E310 is a white or cream-colored crystalline powder, slightly soluble in water and readily soluble in alcohols and fats. The antioxidant E310 is stable under normal conditions but may oxidize during prolonged exposure to air and light. The additive exhibits pronounced reducing properties, thereby inhibiting the formation of peroxides in lipid systems.
For food industry use, propyl gallate is obtained by esterification of gallic acid with propanol, followed by purification and impurity control in accordance with the specifications of Regulation (EU) No 231/2012.
Effects on the Body
Benefits of Additive E310
Propyl gallate is not a physiologically essential substance for the human body and does not perform a nutritional function. Its benefit is purely technological: it prevents fat rancidity, preserves the organoleptic properties of foods, and extends their shelf life.
In its scientific opinion on the re-evaluation of propyl gallate, EFSA stated that, provided the established ADI is respected, the use of additive E310 does not pose a risk to consumers.
Harm of Additive E310
In toxicological studies in animals, gallates, including propyl gallate, showed signs of toxicity at very high doses (above approximately 10,000 mg/kg of feed), such as growth retardation, anemia, changes in the liver and kidneys, and hyperplasia of the gastric mucosa. At levels around 5,000 mg/kg, induction of hepatic enzymes was observed. At 1,000 mg/kg of feed, no adverse effects were detected, which was defined as the no-effect level for the group of gallates in 1976.
A review published in 2024 indicated that some synthetic antioxidants, including propyl gallate, may exhibit cytotoxic and genotoxic effects in laboratory models; however, this does not constitute direct clinical harm to humans at typical dietary exposure levels.
Some assessments have shown that propyl gallate has the potential to act as a contact sensitizer. It may cause contact dermatitis upon topical exposure in experimental models, and the frequency of positive patch test results in humans has increased over time, suggesting the possibility of allergic reactions in sensitive individuals.
In its evaluation of additive E310, EFSA identified a key 90-day study in rats in which a NOAEL of 135 mg/kg body weight per day was established. Applying an uncertainty factor of 300 (due to limitations in chronic and reproductive toxicity data), EFSA established an ADI of 0.5 mg/kg body weight per day.
Previously, the SCF had established a group ADI for gallates; however, EFSA concluded that propyl, octyl, and dodecyl gallates should be assessed separately.
In 1996, JECFA established an ADI for propyl gallate of 0–1.4 mg/kg body weight.
Exceeding the ADI could theoretically lead to increased burden on the liver or endocrine system; however, at current levels of intake, EFSA does not identify a risk to public health.
Uses
Additive E310 is used as an antioxidant in fats and oils, as well as a stabilizer in margarines and cooking fats. It is also used as a protective component in meat products and may be applied as an ingredient in chewing gum and certain confectionery products.
The additive is often used in combination with other antioxidants (for example, BHA or BHT) to achieve a synergistic effect.
In the food industry, propyl gallate is used at very low concentrations sufficient to prevent oxidation without affecting the taste of the product.
Legal Status
In the European Union, propyl gallate (additive E310) is authorised in accordance with Regulation (EC) No 1333/2008, with maximum permitted levels established depending on the food category.
The ADI for antioxidant E310 is set at 0.5 mg/kg body weight per day (EFSA, 2014).
In Ukraine, the use of additive E310 is permitted under legislation harmonised with EU requirements. In the United States, propyl gallate is authorised by the FDA as a food antioxidant with specified concentration limits.
In Canada and Japan, the use of propyl gallate is permitted in defined food categories, and its application is strictly regulated in compliance with established ADI levels.