1266.pdf

Oryginał 
Scientific Opinion on the substantiation of health claims related to hyaluronic acid and maintenance of joints (ID 1572, 1731, 1932, 3132) 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: Hyaluronic acid   health claims   joints   sodium hyaluronate  
ID:    1731      3132      1572      1932  
Produkty: Kwas hialuronowy  

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claim is hyaluronic acid. Hyaluronic acid is a high molecular weight polysaccharide (glycosaminoglycan) produced mainly by fibroblasts and other specialized connective tissue cells and is chemically well defined. Hyaluronic acid consists of an
alternating sequence of D-glucuronate and N-acetyl-D-glucosamine residues linked through alternating bonds. The disaccharide units are joined to one another by a β1-4 linkage. The residues are joined by a β1-3 linkage.
The Panel considers that the food constituent, hyaluronic acid, which is the subject of the health claims, is sufficiently characterised.

2. Znaczenie oświadczenia dla zdrowia człowieka

The claimed effects are “joint health” and “helps keep mobility of joints”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings, the Panel notes the claimed effect relates to the maintenance of normal joints.
The Panel considers that maintenance of normal joints is beneficial to human health.

3. Naukowe uzasadnienia wpływu na zdrowie człowieka - Utrzymanie prawidłowego stanu stawów

Seven systematic reviews/meta-analyses have been provided to substantiate the claimed effect (Wang et al., 2004; Arrich et al., 2005; Modawal et al., 2005; Bellamy et al., 2006; Medina et al., 2006; Reichenbach et al., 2007).
Hyaluronic acid is formed in the body and has structural and functional roles in joints. However, no dietary requirement for maintenance of joint structure (e.g. of cartilage and other connective tissues) or function (e.g. maintenance of flexibility or mobility of the joints) in healthy humans has been demonstrated by the evidence provided.
All the human studies presented on the effects of hyaluronic acid on joint health (e.g. joint pain, joint structure/function) have been conducted in patients with clinical diagnosis of (primarily knee) osteoarthritis (OA). 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 function of the joints in the general population. Therefore, no conclusions can be drawn form these studies in relation to the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the consumption of hyaluronic acid and the maintenance of normal joints.

Wnioski

On the basis of the data presented, the Panel concludes that:
The food constituent, hyaluronic acid, which is the subject of the health claims, is sufficiently characterised.
The claimed effects are “joint health” and “helps keep mobility of joints”. The target population is assumed to be 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 hyaluronic acid and the maintenance of normal joints.