About
Vitamin E is a fat-soluble essential nutrient and antioxidant existing in eight chemical forms (alpha-, beta-, gamma-, and delta-tocopherol and tocotrienols), with alpha-tocopherol being the only form recognized to meet human requirements. It is added to foods as an antioxidant to prevent lipid oxidation and rancidity, and as a nutritional fortification agent.
Safety summary
EFSA found no concern that tocopherols are genotoxic or carcinogenic, though data remain insufficient to fully address reproductive and developmental toxicity at high doses. The critical adverse effect of excess intake is prolonged coagulation time and associated bleeding risk. JECFA established a group ADI of 0.15–2.0 mg/kg body weight/day for alpha-tocopherol, and the EU Scientific Committee on Food set a Tolerable Upper Intake Level of 300 mg/day for adults.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| EFSA (European Food Safety Authority) (European Union) | Approved | EFSA NDA Panel (2024) reviewed and retained the Tolerable Upper Intake Level for vitamin E (as alpha-tocopherol) of 300 mg/day for adults, with impaired coagulation/bleeding identified as the critical adverse effect. ULs also retained for children and adolescents at lower levels.source |
| FDA (Food and Drug Administration) (United States) | Approved | Tocopherols are GRAS under 21 CFR 182.3890 for use as antioxidants in food at GMP levels. No maximum daily intake set by FDA for food-additive use.source |
Who should approach with care
Research citations
- 1WHO. JECFA Food Additives Database: Mixed Tocopherol Concentrate / Vitamin E (INS 306, INS 307b). apps.who.int
- 2FDA. Food Additive Status List — Tocopherols (21 CFR 182.3890). fda.gov
- 3other. Vitamin E — Health Professional Fact Sheet. ods.od.nih.gov
- 4EFSA. Scientific opinion on the tolerable upper intake level for vitamin E, 2024. efsa.europa.eu
- 5PubMed. An Update on Vitamin E, Tocopherol and Tocotrienol — Perspectives, 2018. pmc.ncbi.nlm.nih.gov
- 6EFSA. 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, 2015. efsa.europa.eu
