European authority sets safety levels for boron
the mineral boron, despite the fact that it is not included on the
list of nutrients permitted in food supplements under the new
directive.
However a scientific dossier for the nutrient is being prepared for borate/boric acid, according to UK trade association HFMA, in order to support its addition to the list of approved nutrients. Industry sources have also claimed that the recent opinion, published last week, confirms the safety of boron for supplement and food use, and supports its inlcusion on the primary list of vitamins and minerals allowed under the directive (annex 1).
"It is a very strong message for the Commission, justifying boron's safety," said David Pineda, regulatory affairs director at IADSA. "This opinion...confirms that boron as a mineral is safe and that the Commission can include it in Annex 1."
An EFSA spokesperson was more cautious however and noted that while the panel working on the food supplement directive would consider the new information (from a different group of scientists), it could not yet confirm how this would influence the nutrient's status under the food supplements legislation.
Boron is a trace mineral found in foods like fruits, mushrooms, nuts, as well as wine and beer as borate and boric acid. It has not been established as an essential nutrient in humans but there is some evidence that it may influence the metabolism of other nutrients such as vitamin D, which in turn stimulates the absorption of calcium.
It is therefore widely used in bone health formulations, many of which are selling well in markets such as the UK.
"We have a calcium, magnesium and boron formula that sells really well and there are a lot of formulas like ours out there," confirmed Paul Chamberlain, director of technical affairs at Solgar UK.
He added however that scientific opinion on the use of boron remains divided. Research suggests that boron may be essential in the conversion of vitamin D to its active form and may reduce body calcium loss by increasing the beneficial effects of oestrogen on bone health.
There is also evidence that at levels of greater than 13mg/kg of body weight the mineral can have developmental and reproductive effects in animals. But while there are reports of intoxication in humans causing vomiting and diarrhoea, there is a lack of clinical data forcing EFSA's Scientific Panel on Dietetic Products, Nutrition and Allergies to base upper intake level on animal studies.
They have concluded a tolerable upper intake level of 10 mg/day for adults, which was welcomed by industry associations for being above the average levels currently used in supplements in Europe. The level recommended by the US Food Nutrition Board was 20 mg/day and the UK's expert working group on vitamins and minerals (EVM) recommended 6mg.
However Chamberlain cautioned: "The problem ultimately is that boron is not on annex 1. In the worst case scenario [if a dossier is not completed or not approved] we would have to reformulate which is time-consuming and expensive. People will also see this nutrient has been removed from a formula which may be working well for them."
European authorities have already issued tolerable upper intake levels for more than 20 vitamins and minerals, which will be used to define maximum levels for the 2002 food supplements directive (2002/46/EC) and a proposed regulation on addition of vitamins and minerals to foods.
Much of this work was done by the former Scientific Committee on Food (SCF) but the remainder - vitamin C, chloride, fluoride, iron, phosphorus, potassium - has been taken over by EFSA. The safety panel was also asked by the Parliament, while debating the supplements directive, to allow boron, nickel, silicon, vanadium and tin in food supplements, requiring scientific opinions on these additional nutrients.
