Tocopherol | whatsinit

About

What it is and where it shows up.

Tocopherols are a group of fat-soluble compounds constituting vitamin E; as food additives they function primarily as antioxidants, preventing oxidative rancidity in fats and oils. They occur naturally in vegetable oils, nuts, and seeds, and are also used as nutrients in food fortification.

Safety summary

The regulatory and scientific consensus.

Tocopherols are widely regarded as safe at food additive use levels, with EFSA confirming their safety upon re-evaluation in 2015 and the FDA granting GRAS status under 21 CFR 182.3890 and 21 CFR 182.8890. High supplemental doses (far exceeding food additive levels) have been associated with increased bleeding risk and potential interaction with anticoagulant medications. No numerical ADI has been established for tocopherols used as food additives, as dietary exposure from this source remains well within safe ranges.

Regulatory landscape

What food-safety regulators have decided.

Jurisdiction	Status	Note
EFSA (European Food Safety Authority) (European Union)	Approved	Approved as E306 (tocopherol-rich extract of natural origin), E307 (alpha-tocopherol, synthetic), E308 (gamma-tocopherol), and E309 (delta-tocopherol). EFSA 2015 re-evaluation under Regulation (EU) No 257/2010 concluded safety at current permitted use levels; no numerical ADI established for additive use. EFSA separately set a Tolerable Upper Intake Level (UL) of 300 mg/day for supplemental alpha-tocopherol as a nutrient.source
FSSAI (Food Safety and Standards Authority of India) (India)	Approved	Approved as INS 307a (alpha-tocopherol), INS 307b (mixed tocopherol concentrate), and INS 307c. Under FSS (Infant Nutrition) Regulations Version II (2024): max 3 mg per 100 ml for mixed tocopherol concentrate (307b) in follow-up formula, and max 1 mg per 100 ml in all types of infant formula, singly or in combination. GMP-level use permitted in broader food categories.source
FDA (Food and Drug Administration) (United States)	Approved	GRAS under 21 CFR 182.3890 as antioxidant and 21 CFR 182.8890 as nutrient; use levels are limited only by current good manufacturing practices (CGMPs) with no numeric upper limit specified.source

Who should approach with care

Whose guidance would steer them away.

Heart Disease — High supplemental doses of alpha-tocopherol have been associated with increased risk of hemorrhagic stroke and cardiovascular events in some clinical studies, though food-additive-level exposure does not carry this risk.

Other — Individuals on anticoagulant medications such as warfarin should be aware that high-dose vitamin E supplementation can potentiate anticoagulant effects and increase bleeding risk; levels from food additives alone are generally not a clinical concern.

Research citations

The sources behind this verdict.

1FDA. 21 CFR 182.3890 – Tocopherols (GRAS as Antioxidant) and 21 CFR 182.8890 (GRAS as Nutrient). accessdata.fda.gov
2PubMed. Scientific opinion on the tolerable upper intake level for vitamin E (EFSA NDA Panel), 2024. pmc.ncbi.nlm.nih.gov
3FSSAI. Food Safety and Standards (Infant Nutrition) Regulations – Compendium Version II (January 2024), 2024. fssai.gov.in
4EFSA. 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
5WHO. JECFA Evaluation: Vitamin E Concentrate / Mixed Tocopherols (INS 307b) – TRS 751-JECFA 30/18, 1986. apps.who.int

Independently researched5 citations