Proposal for reduced Vit B6 limit deemed “slippery slope for free choice and self-care”

02-Mar-2023 - Last updated on 02-Mar-2023 at 11:29 GMT

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The Alliance for Natural Health (ANH) Europe has critiqued “gross irregularities” in the scientific process used by EFSA to consider halving the safe maximum daily limit of vitamin B6 from supplements.

The European Food Safety Authority (EFSA) recently held a public consultation on its proposal to reduce the Tolerable Upper Level (TUL) for vitamin B6, to 12.5 mg per day, down from 25mg previously set by The Scientific Committee on Food (SCF) in 2000.

The proposal came after the European Commission requested EFSA to review the previous opinions of the Scientific Committee on Food (SCF) or the NDA Panel on the ULs for vitamin A1, folic acid/folate1, vitamin D1, vitamin E1, vitamin B61, iron1, manganese1 and β-carotene1 to take into account recent scientific developments and evidence.

Dr Robert Verkerk, ANH founder and scientific director, says this proposed suggested limit is just one eighth of the amount deemed safe (100 mg/day) by the US equivalent, the National Academy of Medicine and argues the authority's proposal cites “old, discredited or irrelevant science”.

“The remit given to EFSA by the Commission was to review the level based on new science and methodologies. Instead, EFSA ignored new methodologies and used old, discredited, or irrelevant science, including an old study on five beagle dogs conducted over 45 years ago."

Dr Verkerk adds: “Not only that, EFSA wants to apply this new level to all forms of vitamin B6 to protect people from any risk of peripheral neuropathy, despite this only having been linked to one form – pyridoxine – and then only when megadoses of 1000 mg have been taken over extended periods.”

ANH Europe asserts that it would be legally disproportionate if EU member states or the European Commission attempt to lower levels of all forms, especially the bioactive, coenzyme, pyridoxal 5’-phosphate form, based on this reduced TUL.

Director of ANH Europe, Dr Nick van Ruiten, voiced his concern: “This is part of a very slippery slope for free choice and self-care in the EU. On the back of a conclusive body of science showing that higher dose B6, B12, folate and Omega-3 fatty acids lower the risk of cognitive decline and Alzheimer’s, as well as thousands of women relying on B6 to relieve their PMS symptoms, EFSA’s proposal is nonsensical. Especially in view of the huge amount of data on the vitamin’s safety, especially when used in the coenzyme form.”

The alliance members are hopeful that some adjustments will be made to EFSA’s final opinion, arguing that this could soon lead national regulators to further lower their own limits as the Commission has indicated its intention to push ahead with the harmonisation of vitamin and mineral levels across the EU.

EFSA’s Draft scientific opinion on the Tolerable Upper Intake Level 1 for vitamin B6 states: “Systematic reviews of the literature were conducted by a contractor. The relationship 13 between excess vitamin B6 intakes and the development of peripheral neuropathy is well established 14 and is the critical effect on which the UL is based.

“A lowest-observed-effect-level (LOAEL) could not be established based on the available 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 and the representativeness of the study used to identify the RP. This leads to a UL of 12.5 mg/day.

“From a sub-chronic study in Beagle dogs, a LOAEL of 50 mg/kg body weight per day can be identified. Using an UF of 300, and a default body weight 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 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.”

In response to ANH’s comments, a spokesperson for EFSA told NutraIngredients: “We welcome all input received as part of our public consultations on scientific advice. Our scientific Panel on Nutrition, Novel Foods and Food Allergens (NDA) will carefully consider all comments received during the public consultation from interested parties, including those from The Alliance for Natural Health. Our Panel will discuss and possibly adopt its assessment of vitamin B6 during a plenary meeting by the end of March 2023.”