Will EFSA take on-board the concerns of ANH-Intl and others with its proposal for dietary reference values?
In Parma, Italy, the seat of Europe’s most powerful on authority on food, the doors closed on receipt of further external views on the dietary reference values for vitamin D. The European Food Safety Authority (EFSA) has invited comments through its consultation process on its own opinion on DRVs for the multi-faceted vitamin, one that is increasingly seen as a low-cost preventative to a wide range of diseases and disorders. Even EFSA’s myopic approach to approving claims couldn’t deny the sunshine vitamin which only accepts health claims based on evidence of a proven-beyond-doubt, cause-and-effect relationship between the consumption of a food or ingredient 11 approved health claims (Table 1).
The problem is that if EFSA sticks to its current version, ignoring input from ourselves and other groups and individuals that have responded to the consultation, there is a grave risk that a miniscule 20 mcg/day (800 IU/day) of vitamin D will be regarded as all that’s needed for an adult European.
Table 1. European Commission authorised, EFSA approved EU health claims
for vitamin D
EU authorised health claims
Article 13.1 ‘general function’ health claims
Vitamin D has a role in the process of cell division
Vitamin D contributes to the normal function of the immune system
Vitamin D contributes to the maintenance of normal teeth
Vitamin D contributes to the maintenance of normal muscle function
Vitamin D contributes to the maintenance of normal bones
Vitamin D contributes to normal blood calcium levels
Vitamin D contributes to normal absorption/utilisation of calcium and phosphorus
Article 14.1a ‘disease risk reduction’ health claims
Calcium and vitamin D help to reduce the loss of bone mineral in post-menopausal women. Low bone mineral density is a risk factor for osteoporotic bone fractures
Vitamin D helps to reduce the risk of falling associated with postural instability and muscle weakness. Falling is a risk factor for bone fractures among men and women 60 years of age and older.
Article 14.1b ‘childrens’ health’ claims
Calcium and vitamin D are needed for normal growth and development of bone in children
Vitamin D is needed for normal growth and development of bone in children.
What’s wrong with EFSA’s draft opinion on dietary reference values for vitamin D?
In our consultation response, we’ve highlighted many deficiencies in EFSA’s opinion. Among the most important are:
Bone and calcium metabolism is the only health function considered. EFSA has based its DRV on published scientific studies that principally affect only one of the key functions of vitamin D, namely those relating to bone and calcium metabolism. There are numerous other health benefits, some of these acknowledged by EFSA (Table 1), yet the amounts required for optimal function in relation to such processes as immunity, risk reduction of diabetes, certain cancers, multiple sclerosis and other diseases, have not been taken into account.
Dose ranges far too narrow. In developing the models to determine DRVs (this work was conducted by an external contractor), the maximum dose considered was 50 mcg/day (2,000 IU/day), this reflecting EFSA’s Upper Level, itself based on excessive uncertainty and safety factors.
EFSA, like the US Institute of Medicine, misrepresents the intakes required to achieve the target blood level among a significant sector of the population. EFSA has set the target blood level at 50 nmol/L which it believes is all that’s needed for the vast majority of the population to maintain bone health in the presence of calcium. Plenty of clinicians would disagree this can be achieved with just 15 mcg (600 IU) of vitamin D per day. The real question should be: how many would not achieve the target level, and is this target level optimal and sufficient for nearly everyone to derive all the benefits that go beyond musculo-skeletal health? We think not. The methodology used also appears to duplicate a statistical error made in calculation that was exposed by statisticians at the School of Public Health, University of Alberta (Veugelers PJ, Ekwaru JP. A statistical error in the estimation of the recommended dietary allowance for vitamin D. 2014, 20; 6(10): 4472-5).
EFSA has failed to validate the model it has used with clinicians expert in using vitamin D to elevate serum levels. EFSA’s approach is typical of desk-based research using selective data without any validation against what happens in the real world. We have provided EFSA with the full list of experts assembled under the ‘Call for D*Action’ orchestrated by GrassrootsHealth.
EFSA has discounted the relevance of those with genetic variations affecting vitamin D metabolism. In its brief review of genetic polymorphisms affecting vitamin D status, EFSA has ignored numerous polymorphisms about which there is abundant recent research and simply discounts all of them by saying the data are “insufficient” to be taken into account.
EFSA will have to take into account all comments submitted. History tells us that EFSA is good at trying to ignore or dismiss comments it doesn’t like. It’s unlikely that EFSA will go back to square 1 on its drawing board. But we have to hope that many experts who we and others have made aware of the consultation have submitted constructive criticisms that might give rise to a significant shift to the current conclusions.
If the current proposed level of 20 mcg (800 IU) per day is accepted for adults, there is an increasing risk that regulatory authorities will be given reason to regard levels of 30-50 mcg (1200-2000 IU) per day and above as medicinal.
In actual fact, daily vitamin D supplementation, in the absence of exposure to the sun, in the range 50 – 250 mcg (2000-10,000 IU) is low cost disease prevention that EU member state authorities should be embracing with open arms.
We’ll keep you informed of progress with EFSA’s opinion.
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