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
tocopherol-rich extract (E 306), α-tocopherol (E 307), γ-tocopherol (E 308), δ-tocopherol (E 309), food antioxidant, vitamin E
First published in the EFSA Journal:
30 September 2015
9 September 2015
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.
Panel members at the time of adoption:
The Panel wishes to thank the members of the former Working Group ‘B’ Food Additives and Nutrient Sources (2011–2014) and the members of the Standing Working Group on the re-evaluation of food colours: Fernando Aguilar, Riccardo Crebelli, Alessandro Di Domenico, Maria Jose Frutos, Pierre Galtier, David Gott, Claude Lambré, Jean-Charles Leblanc, Agneta Oskarsson, Jeanne Stadler, Paul Tobback, Ine Waalkens-Berendsen and Rudolf Antonius Woutersen, for the preparatory work on this scientific opinion and EFSA staff members Petra Gergelova, Ana Maria Rincon and Stavroula Tasiopoulou for the support provided to this scientific opinion. The ANS Panel wishes to acknowledge all European competent institutions, Member State bodies and other organisations that provided data for this scientific output.
Panel on Food Additives and Nutrient Sources Added to Food
fip [at] efsa.europa.eu
EFSA Journal 2015;13(9):4247
On request from:
© European Food Safety Authority, 2015