ID 1564 - Glukozamina (też z siarczanem chondroityny)

PL: Glukozamina (też z siarczanem chondroityny)
EN: Glucosamine (Glucosamine HCl or Glucosamine sulphate) and Chondroitin sulphate
Pdf: glucosamine alone or in combination with chondroitin sulphate

Oświadczenie (2)

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claims is glucosamine, either as glucosamine hydrochloride or as glucosamine sulphate, either alone or in various combinations with chondroitin sulphate.
Glucosamine is an amino monosaccharide where a hydroxyl group (-OH) is replaced with an amino group (-NH2) (2-amino-2-deoxy-D-glucose). The raw material is derived from chitin, a biopolymer present in the exoskeleton of marine invertebrate animals (Foot and Mulholland, 2005). Glucosamine is usually formulated as the hydrochloride salt or as glucosamine sulphate. Glucosamine sulphate is most often the glucosamine-6-sulphate. There are large differences between the hydrochloride and the sulphate compounds regarding biological activity (Foot and Mulholland, 2005).
Chondroitins are glycosaminoglycans consisting of an alternating sequence of D-glucuronate and N- acetyl-D-galactosamine-4/6-sulphate 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. Chondroitin is a mixture of different forms. The most common ones are chondroitin-4-sulphate, also known as chondroitin sulphate A, chondroitin-6-sulphate also known as chondroitin sulphate C, and dermatan sulphate, also known as chondroitin sulphate B (Foot and Mulholland, 2005; Šimánek et al., 2005; Lamari and Karamanos, 2006).
The Panel considers that the food constituent, glucosamine, either as glucosamine hydrochloride or as glucosamine sulphate, either alone or in various combinations with chondroitin sulphate, which is the subject of the health claims, is sufficiently characterised.

2.1. Utrzymanie prawidłowego stanu stawów (ID 1561, 1562, 1563, 1564, 1565)

The claimed effect is “joints health”. The Panel assumes that the target population 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.

3.1. Utrzymanie prawidłowego stanu stawów (ID 1561, 1562, 1563, 1564, 1565)

A total of 11 human intervention studies (plus one sub-analysis of one of the interventions and one combination of two of the studies), three meta-analyses including most of the individual studies, 21 reviews and background papers, 2 animal studies, one in vitro study, one short report, and one case report were provided for the substantiation of the claimed effect.
Glycosaminoglycans are the major polymers of the ground substance of connective tissue. Glucosamine is a structural component of several glycosaminoglycans other than chondroitin sulphate which is an important structural component of joint cartilage and in part responsible for its resistance to compression. Both glucosamine and chondroitin sulphate are formed in the body. No dietary requirement for the maintenance of the structure (e.g. of cartilage or other connective tissues) or function (e.g. maintenance of flexibility or mobility of the joints) of the joints in healthy humans has been demonstrated by the evidence provided.
All the human studies presented on the effects of glucosamine (either as glucosamine hydrochloride or as glucosamine sulphate), either alone or in combination with chondroitin sulphate, 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 normal joints in the general population.
The Panel also considers that the evidence provided in the animal and in vitro studies submitted does not predict the occurrence of an effect of glucosamine intake, either alone or in combination with chondroitin, on the maintenance of normal joints in humans.
The Panel concludes that a cause and effect relationship has not been established between the consumption of glucosamine (either as glucosamine hydrochloride or as glucosamine sulphate), either alone or in combination with chondroitin sulphate, and the maintenance of normal joints.

Warunki i możliwe ograniczenia stosowania oświadczenia

Claim to be only used for Foods for sportpeople under the Dir. 89/398/EEC Glucosamine 1000-1500 mg and chondroitin sulphate 800-1200 mg daily for at least 4 - 8 weeks.