Scientific Opinion of the Panel on food additives, flavourings, processing aids and materials in contact with food

Following a request from the Commission, the Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food was asked to deliver a scientific opinion on vanadium
citrate, bismaltolato oxo vanadium and bisglycinato oxo vanadium added for nutritional purposes to foods for particular nutritional uses and foods (including food supplements) intended for the
general population and onvanadyl sulphate, vanadium pentoxide and ammonium monovanadate added for nutritional purposes to food supplements.

The present opinion deals with the safety of a number of vanadium compounds as sources of vanadium and with the bioavailability of vanadium from these sources added for nutritional purposes to
foods for particular nutritional uses and foods (including food supplements) intended for the general population. The safety evaluation of vanadium itself is outside the remit of this Panel.

The absorption of vanadium from vanadium pentoxide is low and comparable to absorption of vanadium from the normal diet. The data on intestinal absorption of vanadium from vanadyl sulphate and
sodium monovanadate in rats and from vanadyl sulphate in humans show that after oral administration vanadium from these sources is more bioavailable. The same is also reported from an
unpublished study of bisglycinato oxo vanadium in humans. The available data indicate that the bioavailability of vanadium from most of these vanadium sources is higher than has been estimated
for the absorption of vanadium from the normal diet in humans.

The anions sulphate and citrate as well as the ammonium cation have been considered by the Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) as
safe constituents of a large number of authorised food additives. On the basis of these evaluations, the Panel concluded that they are of no safety concern as constituents of vanadyl salts or
vanadates. Considering the existing safety evaluation of maltol and the safe use of maltol and glycine in food, the Panel concluded that the ligands maltol and glycine in the vanadate complexes
bismaltolato and bisglycinato oxo vanadium are also of no safety concern at the levels considered in this opinion, if they are released from the complex compounds both in the gastrointestinal
tract and in the metabolism after absorption.

However the Panel also noted the conclusions and risk characterisation in the opinion of the Scientific Panel on Dietetic Products, Nutrition and Allergies (NDA Panel) on vanadium, based on the
toxicity of the vanadium sources vanadyl sulphate, vanadium pentoxide, ammonium monovanadate and some other vanadium compounds. The NDA Panel concluded that a no-observed-adverse-effect level
(NOAEL) cannot be derived from the available studies, neither from subacute/subchronic studies, in which adverse effects were observed on kidneys, spleen, lungs and blood pressure, nor from
studies, in which developmental toxicity was seen in the offspring of rats. Therefore, a tolerable upper intake level for vanadium could not be derived. The AFC Panel considers that these
conclusions are relevant, not only for vanadium itself, but also for the vanadium sources under consideration in the present opinion.

Although data on use levels and categories of the foods intended for particular nutritional uses have not been provided by the applicant, based on the available information on bioavailability
and the conclusions of the NDA Panel, the AFC Panel concludes that safe use of these sources for vanadium added to foods intended for the general population (including food supplements) and
foods for particular nutritional uses, cannot be established.

The Panel noted the inconsistency and the lack of information on specific elements in the specifications of heavy metals in the different dossiers as well as the high levels of arsenic and lead
in the specifications of some vanadium sources in comparison to other sources.

Opinion (PDF)

[1] For citation purposes: Scientific Opinion of the Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food on a Request from the Commission on Vanadium
Compounds as Sources for Vanadium. The EFSA Journal (2008) 634, 1-15.

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