Scientific Opinion on the re-evaluation of propyl gallate (E 310) as a food additive

The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re-evaluating the safety of propyl gallate (E 310). Propyl gallate is an antioxidant authorised as a food additive in the EU. In 1976, the SCF established a group ADI of 0-0.2 mg/kg bw for three gallates (propyl, octyl, dodecyl). JECFA in its last evaluation in 1996 allocated an ADI only to propyl gallate of 0-1.4 mg/kg bw and did not establish ADIs for octyl and dodecyl gallate. The Panel considered that no substantial new toxicological data have emerged since this last evaluation. The Panel concluded that the 90-day toxicity study in rats was the key study for the evaluation of propyl gallate considering the uncertainties and lack of a NOAEL in the carcinogenicity database on propyl gallate. Based on the NOAEL of 135 mg propyl gallate/kg bw/day of this study and taking account of the Opinion of the Scientific Committee of EFSA on Default values, the Panel concluded that an uncertainty factor of 300 should be applied for extrapolation from a subchronic to chronic data and due to the limitations in the reproductive toxicity database and derived an ADI of 0.5 mg/kg bw/day for propyl gallate.The Panel also concluded that there was no longer a basis for the present group ADI and that propyl, octyl and dodecyl gallates should be evaluated separately and the present group ADI should be withdrawn. The high level of exposure exceeded the ADI in adults and the elderly. However, given the conservatism of the exposure assessment, the Panel concluded that the use of propyl gallate as food additive at the current uses and use levels is not of safety concern.