Scientific Opinion on the re‐evaluation of octyl gallate (E 311) as a food additive

The EFSA ANS Panel was asked to deliver a scientific opinion re‐evaluating octyl gallate (E 311) as a food additive. The Panel considered that, whilst from theoretical considerations octyl gallate could be metabolised to octyl alcohol and gallic acid, there were insufficient data to demonstrate the rate and extent of octyl gallate metabolism in vivo. Having reviewed the data on the toxicokinetics (rate and extent of metabolism) of propyl, octyl and dodecyl gallate in a previous EFSA evaluation of propyl gallate, the Panel concluded that the available metabolism data on gallates were insufficient to provide a basis for the read‐across of systemic toxicity data on propyl, octyl and dodecyl gallate to be valid. The Panel noted the absence of concern for genotoxicity and the lack of increase in the number of tumours in the long‐term study. However, owing to the lack of detailed reports on carcinogenicity and chronic toxicity studies with octyl gallate and the absence of a basis for read‐across for systemic toxicity from propyl gallate data, the Panel could not reach a definitive conclusion on the presence or absence of a carcinogenic potential of octyl gallate. The Panel identified a no observed adverse effect level of 50 mg/kg body weight per day in a reproductive toxicity study. Overall, the available database was too limited to either establish an acceptable daily intake or serve as a basis for a margin of safety approach to be applied with confidence. The Panel concluded that, although a safety concern was unlikely from the single use (chewing gum) for which usage and analytical data were provided, an adequate assessment of the safety of octyl gallate as a food additive in all its currently permitted uses would require a sufficient toxicological database in line with its current guidance for submission for food additive evaluations.