About
Riboflavin (Vitamin B2) is a water-soluble B vitamin naturally present in foods of plant and animal origin, and an essential component of the coenzymes flavin mononucleotide (FMN) and flavin adenine dinucleotide (FAD), which drive energy metabolism, cellular growth, and fat/drug/steroid metabolism. It is added to foods for nutritional fortification and is also used as a yellow-orange food colouring agent.
Safety summary
Riboflavin is designated GRAS by the FDA and was re-evaluated and confirmed safe by the EFSA ANS Panel in 2013; the joint FAO/WHO JECFA expert committee allocated a group ADI of 0–0.5 mg/kg body weight/day for riboflavin and riboflavin-5'-phosphate. Oral toxicity is extremely low (LD50 >40,000 mg/kg in animal studies), and no adverse effects have been reported at normal dietary intake levels. Riboflavin is a known photosensitiser and may elicit skin and eye photoallergic reactions in susceptible individuals, particularly at high supplemental doses.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| EFSA (European Food Safety Authority) (European Union) | Approved | Authorised as food colour E101(i) (riboflavin) and E101(ii) (riboflavin-5'-phosphate sodium) under Regulation (EC) No 1333/2008; also authorised for use in food supplements and foods for particular nutritional use. JECFA group ADI of 0–0.5 mg/kg bw/day referenced in the 2013 EFSA re-evaluation; the SCF noted no ADI was needed for riboflavin as a colour at levels that do not significantly alter average daily intake.source |
| FSSAI (Food Safety and Standards Authority of India) (India) | Approved | Approved as a permitted nutrient source (riboflavin and riboflavin-5'-phosphate sodium, INS 101) for food fortification (e.g., wheat flour, cereal products at 0.11–0.22 mg/100g), infant formula, health supplements, and nutraceuticals under FSS (Health Supplements, Nutraceuticals…) Regulations, 2016 and FSS (Fortification of Foods) Regulations. Health supplements must not exceed one RDA per day. FSSAI advertising guidance confirms permitted claim: 'riboflavin is necessary to release the energy from food.'source |
| FDA (Food and Drug Administration) (United States) | Approved | Designated Generally Recognized as Safe (GRAS); listed in FDA's Inactive Ingredients Guide for oral use; approved as a component of multi-vitamins for intravenous therapeutic use. No upper limit established other than current Good Manufacturing Practice (cGMP) standards.source |
Who should approach with care
Research citations
- 1other. Riboflavin – Health Professional Fact Sheet (NIH Office of Dietary Supplements). ods.od.nih.gov
- 2FDA. Regulatory Status of Color Additives – Riboflavin, 2026. hfpappexternal.fda.gov
- 3FSSAI. Food Safety and Standards (Fortification of Foods) Regulations – Compendium Version III, 2021. fssai.gov.in
- 4EFSA. Dietary Reference Values for riboflavin (Vitamin B2) – EFSA Scientific Opinion, 2017. efsa.europa.eu
- 5EFSA. Scientific Opinion on the re-evaluation of riboflavin (E 101(i)) and riboflavin-5'-phosphate sodium (E 101(ii)) as food additives, 2013. efsa.europa.eu