Scientific Opinion on the substantiation of a health claim related to glucosamine and maintenance of joints pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Following an application from Béres Pharmaceuticals Ltd., submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Hungary, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim based on newly developed scientific evidence related to glucosamine and maintenance of joints. The food constituent that is the subject of the health claim is glucosamine, which is sufficiently characterised. The claimed effect is "contributes to the protection of joint cartilage exposed to excessive motion or loading and helps to improve the range of motion in joints". The target population proposed by the applicant is healthy individuals exposed to excessive load on the joints. Maintenance of joints is a beneficial physiological effect. The applicant provided two human studies as pertinent to the claim. One study was carried out in patients with acute injury of the knee. The evidence provided does not establish that patients with acute knee injury are representative of the target population with regard to the status of joint tissues, or that results obtained in studies on subjects with acute knee injury can be extrapolated to the proposed target population. The second study was an intervention with endpoints on putative biomarkers of collagen type II metabolism. The study was not adequately controlled and the evidence provided does not establish that changes in the proposed biomarkers over periods of three months can predict net changes in collagen type II in joint cartilage. The Panel concludes that a cause and effect relationship has not been established between the consumption of glucosamine and maintenance of joints.