A dossier was submitted in June 2005 by UK-based supplements manufacturer, Higher Nature, but EFSA found it lacking in detailed evidence and said it could not conclude either way whether boron-enriched yeast could be safely used in food supplements despite High Nature submitting additional data in January, 2008.
“The Panel notes that it was not possible to assess the bioavailability of boron from boron-enriched yeast since neither data nor suitable supporting references were provided,” said EFSA’sPanel on Food Additives and Nutrient Sources added to Food (ANS).
A positive opinion would have seen the nutrient added to the Annex 2 positive list of the 2002 Food Supplements Directive (FSD), as is the case for the boron form, boric acid, which has been proven safe for use and is employed widely by supplement manufacturers usually in relation to bone health.
The nutrient will cease to be legal from December 31 this year.
Higher Nature product director, Karen Wilson, said she disagreed with the opinion.
“It will be a loss, reducing consumer choice,” she told NutraIngredients.com this morning, noting Higher Nature employed the nutrient in multivitamins and bone health products.
The ANS said there was inconclusive evidence demonstrating the safety of the particular form of boron-enriched yeast referenced by Higher Nature, which the company suggested was similar to boron-enriched yeast produced in the body.
The ANS said Higher Nature’s description of the manufacturing process used to produce boron-enriched yeast was, “insufficient to characterise the product.”
The Panel took issue with the assumption made by Higher Nature that its form of boron-enriched yeast should be considered safe because of the long history of use of boron in the regular diet and Saccharomyces cerevisiaein in fermented foods and beverages.
Boron-enriched yeast is derived from cultures of specified strains of Saccharomyces cerevisiae grown in the presence of boric acid.
“The assumption is that, provided there is no overload of normal metabolic pathways, fermentation within eukaryotic cells will produce organic boron compounds similar to those produced in vivo in other species,” the ANS stated.
Highlighting the principle reasons for rejecting the dossier it added: “…the petitioner has insufficiently characterised the product and therefore has not demonstrated that the organic boron compounds are similar to those present in the diet, that there is no overload of normal metabolic pathways leading to unexpected metabolic products.”
In its dossier, Higher Nature, described boron-enriched yeast as an amorphous hygroscopic cream-coloured powder with slight yeast odour which is water soluble at 20 °C.
In its formulation it noted boron is present at one per cent of the source, with the rest made up of 40 per cent carbohydrate, 35 per cent protein and six per cent lipid. The loss on drying is six per cent; ash content is 10 per cent.
The ANS noted usage levels were not provided by Higher Nature. “The Panel notes that Saccharomyces cerevisiae has a qualified presumption of safety (EFSA, 2008) but considers that this presumption of safety might not be applicable to the specific conditions of culture of the yeast in presence of a high quantity of boron.”
The UK-based arm of multinational supplements manufacturer, Solgar, said it did not include boron-enriched yeast in any of its supplements.
EFSA has until the end of the year to give opinions on all nutrients currently on-market by right of derogation.