2.1. Zapobieganie i leczenie raka prostaty (ID 221)

The claimed effect is “prostate health”. The Panel assumes that the target population is adult males.
The Panel notes that the references provided referred to the consumption of boron in relation to prostate cancer prevention and treatment.
The Panel considers that the claim is related to the prevention and treatment of a disease, and does not comply with the criteria laid down in Regulation (EC) No 1924/2006.

2.2. Utrzymanie prawidłowego funkcjonowania tarczycy (ID 222)

The claimed effect is “thyroid health”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings, the Panel assumes that the claimed effect refers to the maintenance of normal thyroid function.
The Panel considers that maintenance of normal thyroid function is a beneficial physiological effect.

2.3. Udział w prawidłowym przebiegu funkcji poznawczych (ID 223)

The claimed effect is “mental health”. The Panel assumes that the target population is the general population.
In the context of the references provided, the Panel assumes that the claimed effect refers to contribution to normal cognitive function. Cognitive function includes memory, attention (concentration), learning, intelligence and problem solving, which are well defined constructs and which can be measured by validated psychometric cognitive tests.
The Panel considers that contribution to normal cognitive function is a beneficial physiological effect.

3.1. Utrzymanie prawidłowego funkcjonowania tarczycy (ID 222)

Among the references provided to substantiate the claim were two narrative reviews that discussed possible biological functions of boron but did not provide original data for the scientific substantiation of the claim. One reference was in Russian and a translation in an EU language was not available to the Panel. One animal study did not address endpoints related to normal thyroid function. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
One animal study addressed the effects of boron supplementation on thyroid hormone concentrations in pigs. The Panel considers that human studies are required for the substantiation of a claim, and that evidence provided in animal studies alone is not sufficient to predict the occurrence of an effect of boron consumption on the maintenance of normal thyroid function in humans.
The Panel concludes that a cause and effect relationship has not been established between the consumption of boron and maintenance of normal thyroid function.

3.2. Udział w prawidłowym przebiegu funkcji poznawczych (ID 223)

Among the references provided was one animal study which did not address endpoints related to normal cognitive function. The Panel considers that no conclusions can be drawn from this reference for the scientific substantiation of the claim. Among the references provided were also several textbooks, reports from authoritative bodies and narrative reviews referring to potential biological functions of boron in humans. Some of these references mentioned a possible role for boron in brain function, and referred to the work of Penland (1994, 1998) described below.
A randomised, double-blind, placebo-controlled, cross-over trial was undertaken in 13 healthy post- menopausal women aged 50 to 78 years not receiving oestrogen-replacement therapy (Penland, 1994, 1998). For 21 days (equilibration period), subjects received a diet supplemented with 200 mg magnesium and 3 mg boron/2000 kcal/day. Each subject was then given all four supplement combinations created by the factorial crossing of 0 (placebo) and 200 mg magnesium with 0 (placebo) and 3 mg boron for 42 days, each in a random order. Supplements were administered using a Latin square design. Two types of measure were collected. One of these measures was brain electrical activity, which was analysed according to frequency bands. The Panel notes that brain electrical frequency patterns are not established measures of cognitive function. The second type of measure was a selection of cognitive and psychomotor tests taken from the Cognition Psychomotor Assessment System battery which was developed by the author, and which was inadequately referenced and does not appear to have been fully validated. These data were collected during the last week of each 42-day period. The Panel notes that the test battery comprised 13 cognitive and psychomotor tests, some of which included several sub-tests, and that no adjustment for multiple testing was made. The Panel considers that no conclusions can be drawn from this reference for the scientific substantiation of the claim.
Two other human studies were undertaken by the same laboratory in 15 healthy adults (five men, five post-menopausal women on oestrogen-replacement therapy, and five post-menopausal women not on oestrogen-replacement therapy) (Penland, 1994, 1998). Studies began with a 14-day equilibration period, followed by a 63-day boron-depletion period, and ended with a 49-day boron-repletion period. The basal diet was supplemented with 3 mg boron/day during the equilibration and boron-repletion periods, and in one study the diets were also supplemented with 0.8 mg copper/day. Various tests of brain electrical activity and cognitive tasks were carried out at the end of these two periods. However, because the boron treatments were not randomised, it is not possible to distinguish between time and treatment effects. The Panel considers that no conclusions can be drawn from these two studies for the substantiation of the claim.
One animal study investigated the effect of boron on measures of behaviour in rats. The Panel considers that evidence provided in animal studies is not sufficient to predict the occurrence of an effect of boron consumption on normal cognitive function in humans.
The Panel concludes that a cause and effect relationship has not been established between the consumption of boron and contribution to normal cognitive function.