The EFSA has recently – on the 29th of March 2023- completed its opinion on the maximum tolerable level (TUL) of vitamin B6. In its opinion the EFSA sets a dramatically low level of 12.5 mg per day.
The risk is that the EU authorities will accept this low TUL value but will then subtract from it the intake of vitamin B6 through normal diet.
This would then amount to a maximum permitted level (MPL) of less than 10 mg per day!
The draft-opinion has passed the NDA panel (Panel on dietetic products, nutrition and allergies), which had to ultimately assess it, without significant resistance. Regardless of the fact that there a was a lot of criticism, given the comments of the stakeholders in the open consultation procedure.
In November 2021, the EFSA revised its methodology for establishing TUL’ s.
It remains based on a toxicological model developed originally for chemicals in food that have functional but not nutritional value.
The methodology aims to completely rule out any risk of micronutrients in any population, even the possible risks to the most vulnerable and sensitive ones.
This makes this kind of methodology completely unsuitable.
Because we just have to accept that some foods pose some risks to people. Such risks are accepted in conventional foods (gluten-containing grains, dairy, sugars, oxalates, lectins, and so on), but apparently not in dietary supplements.
In the meanwhile, the EFSA completely ignores the overwhelming evidence of the benefits of supplementing high-dose vitamin B6.
There has, for example, been a long standing recognition of the role of higher vitamin B6 intakes in relieving symptoms of premenstrual syndrome.
More recently, substantial evidence has emerged on the role of high dose vitamin B6, in combination with folate, vitamin B12 and omega-3 fatty acids, in slowing age-related cognitive decline and brain shrinkage and in reducing the risk of dementia, most notably Alzheimer’s disease in almost half of those who supplement.
A recent double-blind study also sorted out that high-dose vitamin B6 supplementation (100 mg per day) reduces anxiety within 1 month.
In its opinion EFSA makes a very big slip: It doesn’t take into account that there are obvious different forms of vitamin B6 –totally 6- with quite different safety profiles.
The only form that could possibly be harmful and has been correlated to side-effects is pyridoxin (PN). There is a report that indicates a causal relationship between ‘high’ and long-term PN-intake and peripheral neuropathy.
Most experienced clinicians who have had long-term experience prescribing high dose vitamin B6 are well aware that peripheral neuropathy never occurs when the bioactive form PLP (pyridoxal 5’-phosphate) is used.
The methodology has entirely ignored what appears to be a clear vitamin B6 paradox: The mechanism of which was explained through invitro experimentation by Vrolijk et al (2017), in which high doses of PN mediate symptoms of peripheral neuropathy equivalent to those caused by vitamin B6 deficiency.
This putative mechanism appears to be associated with PN-mediated competitive inhibition of the bioactive, form of vitamin B6: the PLP.
The final opinion will be published shortly.
If The European Commission will adopt the opinion of the EFSA which results in a much lower maximum permitted level beneath the 10mg, this will have a catastrophic impact on the ability of individuals in the EU to self care.
It will for example have a negative effect on the preventing of cognitive decline and dementia. This disease remains nowadays among the greatest burdens on health and care systems.
Also patients who suffer from anxiety or other mental disorders will be deprived of the ability to take high dose vitamin B6 supplements and will become more dependent on psychotropic drugs.