Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods andFood Allergens (NDA) was asked to deliver a scientific opinion on the tolerable upper intake level (UL)for vitamin B6. Systematic reviews of the literature were conducted by a contractor. The relationshipbetween excess vitamin B6 intakes and the development of peripheral neuropathy is well establishedand is the critical effect on which the UL is based. A lowest-observed-effect-level (LOAEL) could not beestablished based on human data. A reference point (RP) of 50 mg/day is identified by the Panel froma case–control study, supported by data from case reports and vigilance data. An uncertainty factor(UF) of 4 is applied to the RP to account for the inverse relationship between dose and time to onsetof symptoms and the limited data available. The latter covers uncertainties as to the level of intakethat would represent a LOAEL. This leads to a UL of 12.5 mg/day. From a subchronic study in Beagledogs, a LOAEL of 50 mg/kg body weight (bw) per day can be identified. Using an UF of 300, and adefault bw of 70 kg, a UL of 11.7 mg/day can be calculated. From the midpoint of the range of thesetwo ULs and rounding down, a UL of 12 mg/day is established by the Panel for vitamin B6 for adults(including pregnant and lactating women). ULs for infants and children are derived from the ULfor adults using allometric scaling: 2.2–2.5 mg/day (4–11 months), 3.2–4.5 mg/day (1–6 years),6.1–10.7 mg/day (7–17 years). Based on available intake data, EU populations are unlikely to exceedULs, except for regular users of food supplements containing high doses of vitamin B6
© 2023 European Food Safety Authority. EFSA Journal published by Wiley-VCH GmbH on behalf of European Food Safety Authority.
- tolerable upper intake level
- vitamin B6
- dietary reference valu
- dietary reference value