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Scientific Opinion on the re-evaluation of tocopherol-rich extract (E 306), α-tocopherol (E 307), γ-tocopherol (E 308) and δ-tocopherol (E 309) as food additives

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The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion re-evaluating the safety of tocopherol-rich extract of natural origin (E 306), synthetic α-tocopherol (all-rac-α-tocopherol; dl-α-tocopherol; E 307), synthetic γ-tocopherol (dl-γ-tocopherol; E 308) and synthetic δ-tocopherol (E 309). The European Union’s Scientific Committee on Food did not set an Acceptable Daily Intake (ADI), but derived a Tolerable Upper Intake Level (UL) for vitamin E of 300 mg/day for adults. The Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an ADI of 0.15–2 mg/kg body weight (bw)/day for dl-α-tocopherol. The acute oral toxicity of tocopherols is low. In both a 13-week and a chronic (16-month) oral toxicity study, the No Observed Adverse Effect Level (NOAEL) was 125 mg/kg bw/day. The critical adverse effect is prolonged coagulation time. There is no concern that tocopherols are genotoxic or carcinogenic. There are insufficient data to address the reproduction and developmental toxicity. The Panel concluded that the available data are too limited to establish an ADI for the tocopherols. However, taking into account that vitamin E is widely consumed via human food, it is an essential nutrient and that the ULs are not exceeded in any population group, except in children in one survey from only one country, α-tocopherol, for the reported uses and use levels as a food additive, is not considered to be of safety concern. The Panel considered that the dataset on tocopherol-rich extract, and γ- and δ-tocopherol was too limited to beincluded in the safety assessment of tocopherols. Moreover, the Panel is aware that much lower concentration levels and fewer uses for γ- and δ-tocopherol are reported in food than for α-tocopherol. Therefore, the Panel concluded that tocopherols (E 306–E 309) are not of safety concern at the levels used in food.