Scientific Opinion on the substantiation of a health claim related to Cynatine^® and maintenance of normal joint mobility pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Following an application from Roxlor Nutra LLC, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Cynatine^® and maintenance of normal joint mobility. The Panel considers that Cynatine^®, which is a keratin powder extracted from sheep wool, is sufficiently characterised. The claimed effect proposed by the applicant refers to “joint flexibility”. The Panel considers that maintenance of normal joint mobility is a beneficial physiological effect. The applicant presented one unpublished human intervention study as being pertinent to the health claim. The Panel notes that the study was specifically designed to identify patients with clinical diagnosis of osteoarthritis, and considers that normal cells and tissues are genetically (gene expression) and functionally different from osteoarthritic cells and tissues, and therefore may respond differently to interventions with exogenous substances. In addition, the mechanisms involved in the onset and/or progression of osteoarthritis are largely unknown. It would have to be established, therefore, that an intervention which has an effect on the progression of the disease (in patients with osteoarthritis) would also have an effect on its onset (subjects without the disease). The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claim. The Panel concludes that a cause and effect relationship has not been established between the consumption of Cynatine^® and maintenance of normal joint mobility.

© European Food Safety Authority, 2012

Following an application from Roxlor Nutra LLC, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Cynatine^® and maintenance of normal joint mobility.

The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence and including a request for the protection of proprietary data.

The food that is the subject of the health claim is Cynatine^®, which is a keratin powder extracted from sheep wool. The Panel considers that Cynatine^® is sufficiently characterised.

The claimed effect proposed by the applicant refers to “joint flexibility”. The target population proposed by the applicant is healthy adults, and in particular healthy individuals with “sensitive joints”. The Panel considers that the health claim refers to the maintenance of joint mobility in subjects without chronic joint diseases, and does not include the treatment of chronic joint diseases. The Panel considers that maintenance of normal joint mobility is a beneficial physiological effect.

The applicant presented one unpublished human intervention study as being pertinent to the health claim.

The study was a randomised, double-blind, placebo-controlled parallel trial in which 50 subjects with clinical diagnosis of osteoarthritis of the knee were randomised to consume daily 500 mg of Cynatine FLX^™ or placebo for 60 days. Inclusion criteria were 25-75 years of age, unilateral or bilateral osteoarthritis of the knee according to the American College of Rheumatology clinical criteria for the classification of idiopathic osteoarthritis of the knee, a total Western Ontario and McMaster Universities (WOMAC) osteoarthritis score of 15-75 (the worst score being 96) in the target knee, and ability to walk unassisted.

The Panel notes that the study was specifically designed to identify patients with clinical diagnosis of osteoarthritis, and considers that normal cells and tissues are genetically (gene expression) and functionally different from osteoarthritic cells and tissues, and therefore may respond differently to interventions with exogenous substances. In addition, the mechanisms involved in the onset and/or progression of osteoarthritis are largely unknown. It would have to be established, therefore, that an intervention which has an effect on the progression of the disease (in patients with osteoarthritis) would also have an effect on its onset (subjects without the disease). The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claim.

The Panel notes that no studies from which conclusions could be drawn for the scientific substantiation of the claim were provided by the applicant.

The Panel concludes that a cause and effect relationship has not been established between the consumption of Cynatine^® and maintenance of normal joint mobility.

Cynatine®, joints, mobility, osteoarthritis, chronic inflammation, health claims