About
Vitamin B6 is the generic descriptor for all 3-hydroxy-2-methylpyridine derivatives (pyridoxine, pyridoxal, pyridoxamine, and their phosphate esters) exhibiting biological pyridoxine activity, with pyridoxal 5'-phosphate (PLP) as the principal active coenzyme form. It is essential for amino acid metabolism, neurotransmitter synthesis, and immune function, and is added to fortified staple foods, infant formula, and dietary supplements to prevent deficiency.
Safety summary
At normal dietary intake levels, Vitamin B6 is safe and well-tolerated with no known adverse effects from food sources alone. The critical adverse effect of excess supplemental intake is peripheral sensory neuropathy, which is well-established at intakes substantially above food-level amounts; EFSA (2023) set a Tolerable Upper Intake Level of 12 mg/day for all adults based on a reference point of 50 mg/day and an uncertainty factor of 4. The US Food and Nutrition Board (FNB) set a more conservative UL of 100 mg/day, and long-term high-dose supplement use can also cause dermatological lesions, photosensitivity, and gastrointestinal symptoms.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| EFSA (European Food Safety Authority) (European Union) | Approved | EFSA NDA Panel (2023) revised Tolerable Upper Intake Level to 12 mg/day for all adults, including pregnant and lactating women; lower age-specific ULs of 2.2–10.7 mg/day apply to infants and children. Authorised supplemental forms for addition to foods include pyridoxine-HCl (PN-HCl), pyridoxine-5'-phosphate (PNP), and pyridoxine dipalmitate under Regulation (EC) No 1925/2006 and Directive 2002/46/EC.source |
| Food Standards Agency (FSA) / Food Standards Scotland (FSS) (United Kingdom) | Approved | UK COT proposed a Tolerable Upper Intake Level of 12.5 mg/day for adults derived from a reference point of 50 mg/day with uncertainty factors accounting for the inverse dose–time relationship for peripheral neuropathy onset and limited long-term data.source |
| FSSAI (Food Safety and Standards Authority of India) (India) | Approved | Approved as pyridoxine hydrochloride and pyridoxal 5'-phosphate for use in fortified staple foods (atta, maida, rice, infant formula) under FSS (Fortification of Foods) Regulations, 2018 (as amended 2021); also listed in the FSS (Health Supplements, Nutraceuticals) Regulations. Health supplements must not exceed 1 RDA per serving as per ICMR standards.source |
| FDA (Food and Drug Administration) (United States) | Approved |
Who should approach with care
Research citations
- 1other. Vitamin B6 – Health Professional Fact Sheet (NIH Office of Dietary Supplements), 2026. ods.od.nih.gov
- 2EFSA. Scientific opinion on the tolerable upper intake level for vitamin B6, 2023. efsa.europa.eu
- 3PubMed. Scientific opinion on the tolerable upper intake level for vitamin B6 (PubMed abstract), 2023. pubmed.ncbi.nlm.nih.gov
- 4FSSAI. Food Safety and Standards (Fortification of Foods) Regulations, 2018 — Compendium Version III (30.09.2021), 2021. fssai.gov.in
- 5FSSAI. Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations — Compendium (29.09.2021), 2021. fssai.gov.in
