Scientific opinion on the tolerable upper intake level for vitamin B6

Dominique Turck; Torsten Bohn; Jacqueline Castenmiller; Stefaan de Henauw; Karen-Ildico Hirsch-Ernst; Helle Katrine Knutsen; Alexandre Maciuk; Inge Mangelsdorf; Harry J McArdle; Carmen Pelaez; Kristina Pentieva; Alfonso Siani; Frank Thies; Sophia Tsabouri; Marco Vinceti; Susan Fairweather-Tait; Misha Vrolijk; Lucia Fabiani; Ariane Titz; Androniki Naska; EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)

doi:10.2903/j.efsa.2023.8006

Scientific opinion on the tolerable upper intake level for vitamin B6

Dominique Turck, Torsten Bohn, Jacqueline Castenmiller, Stefaan de Henauw, Karen-Ildico Hirsch-Ernst, Helle Katrine Knutsen, Alexandre Maciuk, Inge Mangelsdorf, Harry J McArdle, Carmen Pelaez, Kristina Pentieva, Alfonso Siani, Frank Thies, Sophia Tsabouri, Marco Vinceti, Susan Fairweather-Tait, Misha Vrolijk, Lucia Fabiani, Ariane Titz, Androniki NaskaEFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)

The Rowett Institute of Nutrition and Health

Research output: Contribution to journal › Article › peer-review

Abstract

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food 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 relationship between excess vitamin B6 intakes and the development of peripheral neuropathy is well established and is the critical effect on which the UL is based. A lowest-observed-effect-level (LOAEL) could not be established based on human data. A reference point (RP) of 50 mg/day is identified by the Panel from a 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 onset of symptoms and the limited data available. The latter covers uncertainties as to the level of intake that would represent a LOAEL. This leads to a UL of 12.5 mg/day. From a subchronic study in Beagle dogs, a LOAEL of 50 mg/kg body weight (bw) per day can be identified. Using an UF of 300, and a default bw of 70 kg, a UL of 11.7 mg/day can be calculated. From the midpoint of the range of these two 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 UL for 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 exceed ULs, except for regular users of food supplements containing high doses of vitamin B6.

Original language	English
Article number	e08006
Number of pages	110
Journal	EFSA Journal
Volume	21
Issue number	5
DOIs	https://doi.org/10.2903/j.efsa.2023.8006
Publication status	Published - 17 May 2023

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© 2023 European Food Safety Authority. EFSA Journal published by Wiley-VCH GmbH on behalf of European Food Safety Authority. This is an open access article under the terms of the Creative Commons Attribution-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made.
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Turck, D., Bohn, T., Castenmiller, J., de Henauw, S., Hirsch-Ernst, K.-I., Knutsen, H. K., Maciuk, A., Mangelsdorf, I., McArdle, H. J., Pelaez, C., Pentieva, K., Siani, A., Thies, F., Tsabouri, S., Vinceti, M., Fairweather-Tait, S., Vrolijk, M., Fabiani, L., Titz, A., ... EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) (2023). Scientific opinion on the tolerable upper intake level for vitamin B6. EFSA Journal, 21(5), Article e08006. https://doi.org/10.2903/j.efsa.2023.8006

Turck, D, Bohn, T, Castenmiller, J, de Henauw, S, Hirsch-Ernst, K-I, Knutsen, HK, Maciuk, A, Mangelsdorf, I, McArdle, HJ, Pelaez, C, Pentieva, K, Siani, A, Thies, F, Tsabouri, S, Vinceti, M, Fairweather-Tait, S, Vrolijk, M, Fabiani, L, Titz, A, Naska, A & EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) 2023, 'Scientific opinion on the tolerable upper intake level for vitamin B6', EFSA Journal, vol. 21, no. 5, e08006. https://doi.org/10.2903/j.efsa.2023.8006

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title = "Scientific opinion on the tolerable upper intake level for vitamin B6",

abstract = "Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food 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 relationship between excess vitamin B6 intakes and the development of peripheral neuropathy is well established and is the critical effect on which the UL is based. A lowest-observed-effect-level (LOAEL) could not be established based on human data. A reference point (RP) of 50 mg/day is identified by the Panel from a 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 onset of symptoms and the limited data available. The latter covers uncertainties as to the level of intake that would represent a LOAEL. This leads to a UL of 12.5 mg/day. From a subchronic study in Beagle dogs, a LOAEL of 50 mg/kg body weight (bw) per day can be identified. Using an UF of 300, and a default bw of 70 kg, a UL of 11.7 mg/day can be calculated. From the midpoint of the range of these two 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 UL for 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 exceed ULs, except for regular users of food supplements containing high doses of vitamin B6.",

author = "Dominique Turck and Torsten Bohn and Jacqueline Castenmiller and {de Henauw}, Stefaan and Karen-Ildico Hirsch-Ernst and Knutsen, {Helle Katrine} and Alexandre Maciuk and Inge Mangelsdorf and McArdle, {Harry J} and Carmen Pelaez and Kristina Pentieva and Alfonso Siani and Frank Thies and Sophia Tsabouri and Marco Vinceti and Susan Fairweather-Tait and Misha Vrolijk and Lucia Fabiani and Ariane Titz and Androniki Naska and {EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)}",

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AU - Turck, Dominique

AU - Bohn, Torsten

AU - Castenmiller, Jacqueline

AU - de Henauw, Stefaan

AU - Hirsch-Ernst, Karen-Ildico

AU - Knutsen, Helle Katrine

AU - Maciuk, Alexandre

AU - Mangelsdorf, Inge

AU - McArdle, Harry J

AU - Pelaez, Carmen

AU - Pentieva, Kristina

AU - Siani, Alfonso

AU - Thies, Frank

AU - Tsabouri, Sophia

AU - Vinceti, Marco

AU - Fairweather-Tait, Susan

AU - Vrolijk, Misha

AU - Fabiani, Lucia

AU - Titz, Ariane

AU - Naska, Androniki

AU - EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)

PY - 2023/5/17

Y1 - 2023/5/17

N2 - Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food 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 relationship between excess vitamin B6 intakes and the development of peripheral neuropathy is well established and is the critical effect on which the UL is based. A lowest-observed-effect-level (LOAEL) could not be established based on human data. A reference point (RP) of 50 mg/day is identified by the Panel from a 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 onset of symptoms and the limited data available. The latter covers uncertainties as to the level of intake that would represent a LOAEL. This leads to a UL of 12.5 mg/day. From a subchronic study in Beagle dogs, a LOAEL of 50 mg/kg body weight (bw) per day can be identified. Using an UF of 300, and a default bw of 70 kg, a UL of 11.7 mg/day can be calculated. From the midpoint of the range of these two 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 UL for 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 exceed ULs, except for regular users of food supplements containing high doses of vitamin B6.

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Scientific opinion on the tolerable upper intake level for vitamin B6

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