ID 223 -
Bor
PL: Bor
EN: Boron
Pdf: boron
1. Charakterystyka żywności / składnika
The food constituent that is the subject of the health claims is boron.
It has not been established that boron is an essential nutrient for humans. Boron occurs in foods as borate and boric acid, and can be measured by established methods. Daily intakes of boron from food and water vary from 1 to 7 mg/day, depending on geographical region and dietary patterns (Richold, 1998). Main dietary sources are plant foods. Fruits, legumes, leafy vegetables, nuts, wine, cider and beer are particularly rich sources (Naghii et al., 1996). Drinking water typically contains <1 mg boron/L, albeit the range is large. The mean intake from water ranges from 0.2-0.6 mg/day (EFSA, 2004).
Boron is authorised for addition to foods (Annex I of Regulation (EC) No 1925/20066 and Annex I of Directive 2002/46/EC7). This evaluation applies to boron naturally present in foods and added to foods.
The Panel considers that the food constituent, boron, which is the subject of the health claims, is sufficiently characterised.
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.
3.2. 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.
Warunki i możliwe ograniczenia stosowania oświadczenia
0.8 – 1,5 mg of boric acid
Must meet minimum requirements for use of the claim "source of [name of vitamin/s] and/or [name of mineral/s]" as per Annex to Regulation 1924/2006
