About
What it is and where it shows up.
Vitamin A (retinol) is a fat-soluble essential nutrient critical for vision, immune function, and the growth and integrity of cells in body tissues. It is added to foods as a fortification ingredient—typically in the ester forms retinyl acetate or retinyl palmitate—to address dietary deficiency.
Safety summary
The regulatory and scientific consensus.
At recommended dietary intake levels, Vitamin A is safe and essential; EFSA sets Population Reference Intakes of 750 μg RE/day for men and 650 μg RE/day for women. Chronic intake of preformed vitamin A above the Tolerable Upper Intake Level of 3,000 μg/day in adults can cause hypervitaminosis A, including hepatotoxicity and reduced bone mineral density. High intake of preformed vitamin A during pregnancy carries a teratogenic risk, making it a critical concern for women of childbearing age.
Regulatory landscape
What food-safety regulators have decided.
| Jurisdiction | Status | Note |
|---|---|---|
| EFSA (European Food Safety Authority) (European Union) | Approved | Tolerable Upper Intake Level (UL) of 3,000 μg/day (3 mg/day) for adults applies to preformed vitamin A (retinol and retinyl esters) from all dietary sources including supplements. A 2024 EFSA scientific opinion reviewed and updated this UL. Vitamin A is authorised as a fortification nutrient under Regulation (EC) No 1925/2006. No E-number assigned; preformed retinol is classified as a nutritive additive, not a food colour or preservative.source |
| FSSAI (Food Safety and Standards Authority of India) (India) | Approved | Approved for mandatory/voluntary fortification in vegetable oil, milk, toned milk, double-toned milk, skimmed milk, and milk powder under FSS (Fortification of Foods) Regulations, 2018. Health supplements are capped at 1 RDA (600 μg/day for adults per ICMR) per FSSAI Nutraceutical Regulations 2016. FSSAI's Advertising & Claims Regulations explicitly permit the claim 'Vitamin A helps against night blindness' for fortified foods.source |
| FDA (Food and Drug Administration) (United States) | Approved | Retinyl acetate (21 CFR 184.1930) and retinyl palmitate (21 CFR 184.1945) are classified as GRAS for use as nutrient supplements in food. The Institute of Medicine (IOM) Tolerable Upper Intake Level for adults is 3,000 μg RAE/day (10,000 IU/day). The adult Recommended Dietary Allowance (RDA) is 700–900 μg RAE/day.source |
Who should approach with care
Whose guidance would steer them away.
Pregnancy — High preformed vitamin A intake during pregnancy is associated with teratogenic risk; EFSA's 2024 opinion upholds the UL of 3,000 μg/day and supplemental use above this level should only occur under medical supervision.
Infants — Infants have significantly lower age-specific Tolerable Upper Intake Levels for preformed vitamin A and are at heightened risk of toxicity from excess intake via fortified formulas or supplements, per EFSA guidance.
Children — Children have lower ULs for preformed vitamin A than adults; cumulative intake from fortified foods and supplements should be monitored to prevent chronic excess, per EFSA dietary reference value assessments.
Liver Disease — Preformed vitamin A is stored in hepatic stellate cells, and excess intake can exacerbate hepatotoxicity in individuals with pre-existing liver conditions, as identified in EFSA's 2024 preparatory systematic review.
Lactation — EFSA sets an elevated PRI of 1,300 μg RE/day for lactating women to compensate for retinol secreted in breast milk, but supplemental preformed vitamin A above the established UL should be avoided as excess passes to the infant.
Research citations
The sources behind this verdict.
- 1EFSA. Scientific opinion on the tolerable upper intake level for preformed vitamin A and β-carotene, 2024. efsa.europa.eu
- 2EFSA. Overview on Tolerable Upper Intake Levels as derived by EFSA (2024 summary report), 2024. efsa.europa.eu
- 3EFSA. Preparatory work for the update of the tolerable upper intake levels for vitamin A, 2024. efsa.europa.eu
- 4FSSAI. Food Safety and Standards (Fortification of Foods) Regulations, 2018 – Compendium (amended September 2021), 2021. fssai.gov.in
- 5EFSA. Scientific Opinion on Dietary Reference Values for vitamin A, 2015. efsa.europa.eu
Independently researched5 citations