After more than two years of deliberation by the European Food Safety Authority on derogated forms of vitamins and minerals under the EU Food Supplements Directive, the first negative opinion has now been issued leading to imminent bans.
First public notification of EFSA's ban on 6 forms of vanadium, an important trace mineral known to help regulate blood glucose levels (and therefore compete against anti-diabetic drugs), came from the UK Foods Standards Agency (FSA). See letter.
The basis of EFSA's negative opinion is that vanadium is potentially toxic at high doses and is more bioavailable in the 6 forms it considered here, compared with when it is found in foods such as shellfish.
We have brought to the attention of the FSA that such a justification is meaningless unless a dosage threshold is set ie there is no difference between the amount of vanadium consumed when the consumer is exposed to more of a less bioavailable form of vanadium as compared with less of a more bioavailable form.
We have therefore provided them with the following rationale:
EFSA does not apply this negative opinion to all sources of vanadium. Vanadium amino acid chelate is a key source that has yet not been given a negative opinion and we assume can therefore continue to be used.
EFSA does not state that sources of vanadium in the diet are in themselves harmful, but instead considers that the sources about which it has given this opinion may allow for higher levels of absorption compared with vanadium in the diet (e.g. from wholegrains, seafood, meats and dairy products) on account of their increased bioavailability in the supplemental forms.
The risk of vanadium is thus accepted as being primarily a function of the amount of vanadium absorbed (dose-response is obviously a major factor in any toxicological assessment). We would accept that valency is another factor, with pentavalent forms being intrinsically more toxic than lower valency forms.
I had proposed therefore that it may be prudent, as a means of not imposing a disproportionate measure, to have a variable approach to the withdrawal of these vanadium sources from the market, based on the dose of vanadium in food supplements containing this mineral.
There is no evidence that food supplements containing vanadium at low dosages (e.g. < 500 mcg/day) are unsafe. We recognise that some food supplement products, notably certain bodybuilding supplements, that contain dosages in excess of 5 mg/day may pose some risk to health if consumed over long periods.
The EVM has estimated (2003) that maximum dietary intakes of vanadium from all sources may be 500 mcg/day.
We would propose therefore, using a safety factor of 2, that the FSA consider a national derogation allowing continued use of food supplements containing 250 mcg or less of vanadium up to 31 December 2009, the date of expiry of the derogation phase as per Directive 2002/46/EC and the corresponding UK statutory instruments.
We recognise that the EFSA opinion may make it difficult to allow sales of products containing the six sources of vanadium between Member States, so we request that this measure be considered only for application for products selling within the UK market.
We have spoken to a number of key practitioner suppliers and they have indicated that an immediate ban on the previously derogated forms of vanadium would cause very significant costs to be incurred, apart from the loss of product sales.
Our proposal to you whereby the FSA, as the UK competent authority, would allow low dose vanadium products (containing the any of the six forms of vanadium evaluated by EFSA and subsequently given a negative opinion) to be phased out over the remaining period of EU-wide derogation period under Directive 2002/46/EC is considered to be proportionate by the suppliers that we have spoke to today.