1261.pdf

Oryginał 
Scientific Opinion on the substantiation of health claims related to boron and maintenance of bone (ID 218, 219) and maintenance of joints (ID 219, 220) pursuant to Article 13(1) of Regulation (EC) No 1924/2006[sup]1[/sup] EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)2 European Food Safety Authority (EFSA), Parma, Italy
Słowa kluczowe: Boron   bone   health claims   joints  
ID:    219      220      218  
Produkty: Bor  

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claims is boron, which occurs in foods as borate and boric acid and is measurable by established methods.
The Panel considers that the food constituent, boron, which is the subject of the health claims is sufficiently characterised.

2. Znaczenie oświadczenia dla zdrowia człowieka


2.1. Utrzymanie prawidłowego stanu kości (ID 218, 219)

The claimed effects are “bone health” and “bone metabolism” “involved in bone metabolism”. The Panel assumes that the target group is the general population.
In the context of the proposed wordings, the Panel notes that these claimed effects relate to the maintenance of normal bone.
The Panel considers that the maintenance of normal bone is beneficial to human health.

2.2. Utrzymanie prawidłowego stanu stawów (ID 219, 220)

The claimed effect is “joint health”. The Panel assumes that the target group is the general population.
In the context of the proposed wordings, the Panel notes that these claimed effects relate to the maintenance of normal joints.
The Panel considers that the maintenance of normal joints is beneficial to human health.

3. Naukowe uzasadnienia wpływu na zdrowie człowieka

Boron has not been established to be an essential nutrient for humans and a dietary requirement for boron in humans has not been determined. Boron can act as an inhibitor of activity for a wide variety of enzymes in vitro; however, no boron-dependent enzyme has been identified. There is evidence that dietary boron may influence the metabolism of steroid hormones and some nutrients, including calcium, magnesium, and vitamin D, but the mechanisms for these effects are unknown. No specific physiological function for boron has been identified in higher animals or humans (EFSA, 2004; IoM, 2001; SCF, 1993; EVM, 2003; Devirian and Volpe, 2003).

3.1. Utrzymanie prawidłowego stanu kości (ID 218, 219)

Studies of dietary deprivation of boron in animals (rats, pigs, chickens) have reported adverse effects on calcium balance, bone calcification and bone strength that can be corrected by increasing boron intake. The effects of low boron intakes appear to be more marked when accompanied by low status for other nutrients (e.g. vitamin D, magnesium) (Hegsted et al., 1991; Nielsen, 1990; Nielsen and Shuler, 1992; Armstrong and Spears, 2001; Armstrong et al., 2002; Hunt, 1989; Hunt et al., 1994; Kurtoglu et al., 2001; Naghii et al., 2006; Rico et al., 2002; Sheng et al., 2001; Wilson and Ruszler, 1998).
There is some evidence that, in humans, boron intake within the usual dietary range may influence the metabolism and utilisation of calcium. Increasing boron intake from 0.33 to 3.33 mg/d in healthy
postmenopausal women over a 3-week period resulted in elevated urinary calcium excretion and apparent positive calcium balance. There was no effect on plasma sex steroid levels or urinary excretion of pyridinium crosslink markers of bone turnover (Beattie and Peace, 1993). Supplementation of a low boron (0.36 mg/d), low magnesium (109 mg/d) diet with 3 mg boron in healthy postmenopausal women over a 24-day period resulted in reduced urinary calcium excretion. When dietary intake of magnesium was increased over a further 24-day period to 300 mg/d, urinary calcium excretion was increased (Hunt et al., 1997). However, boron supplementation (3 mg/d) of the usual diet over one year had no effect on urinary calcium excretion or bone mineral density in female college students (Volpe et al., 1993; Meacham et al., 1994, Meacham et al., 1995). The Panel considers that these studies do not establish a role for boron in the normal structure or function of bone in humans.
In weighing the evidence, the Panel took into account that, although some animal studies report adverse effects of dietary deprivation of boron on calcium balance, bone calcification and bone strength that can be corrected by increasing boron intake, no consistent effect of boron intake on meaningful markers of bone health have been observed in humans.
The Panel concludes that a cause and effect relationship has not been established between the consumption of boron and the maintenance of normal bone.

3.2. Utrzymanie prawidłowego stanu stawów (ID 219, 220)

Most of the references provided for the substantiation of this claim were related to osteoporosis and not directly pertinent to the claimed effect.
The only human study presented was on the effects of boron in patients with severe osteoarthritis (OA) (Travers et al., 1990). OA is the most common joint disease worldwide (Issa and Sharma, 2006; Corti and Rigon, 2003; Arden and Nevitt, 2006) and a major cause of disability (Hunter et al., 2008; Pollard and Johnston, 2006; Sarzi-Puttini et al., 2005; Ethgen et al., 2004).
The Panel considers that the evidence provided does not establish that patients with OA are representative of the general population with regard to the status of joint tissues, or that results obtained in studies on subjects with OA relating to the treatment of symptoms of this disease (e.g. erosion of articular cartilage, reduced mobility of joints) can be extrapolated to the maintenance of the normal structure or function of joints in the general population. Therefore, no conclusions can be drawn form the study presented in relation to the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the consumption of boron and the maintenance of normal joints.

Wnioski

On the basis of the data presented, the Panel concludes that:
The food constituent, boron, which is the subject of the health claims is sufficiently characterised.
Maintenance of bone (ID 218, 219)
The claimed effects are “important for the normal structure of bone”, “maintain bone health”, “involved in bone metabolism”. The target group is the general population. Maintenance of normal bone is beneficial to human health.
A cause and effect relationship has not been established between the consumption of boron and the maintenance of normal bone.
Maintenance of joints (ID 219, 220)
The claimed effects are “build and maintain healthy joints”, “maintain the flexibility and mobility of the joints”. The target group is the general population. Maintenance of normal joints is beneficial to human health.
A cause and effect relationship has not been established between the consumption of boron and the maintenance of normal joints.