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

Following an application from Nutrilinks Sarl, 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 Eff_EXT™ and maintenance of normal joint mobility. The Panel considers that Eff_EXT™, which is standardised pure krill oil, is sufficiently characterised. The claimed effect proposed by the applicant is “contributes to support joint flexibility”. The Panel considers that maintenance of normal joint mobility is a beneficial physiological effect. The applicant identified one human intervention study as being pertinent to the health claim. The Panel notes that chronic inflammation was an inclusion criterion of the study, that a significant number of the patients recruited were reported to have confirmed diagnosis of osteoarthritis, rheumatoid arthritis, or of both cardiovascular disease and osteoarthritis, and that the WOMAC osteoarthritis questionnaire was administered only to patients with arthritic disease (osteoarthritis or rheumatoid arthritis). The Panel also notes that no evidence which could justify the extrapolation of the results, obtained in patients with joint diseases characterised by chronic inflammation, to the target population, subjects without chronic joint diseases, was provided by the applicant. 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 Eff_EXT™ and maintenance of normal joint mobility.

© European Food Safety Authority, 2012

Following an application from Nutrilinks Sarl, 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 Eff_EXT™ 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.

The food that is the subject of the health claim is Eff_EXT™, which is standardised pure krill oil. The Panel considers that Eff_EXT™ is sufficiently characterised.

The claimed effect proposed by the applicant is “contributes to support joint flexibility”. The target population proposed by the applicant is adults 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 identified one human intervention study as being pertinent to the health claim.

The study was a randomised, double-blind, placebo-controlled 30-day trial in 90 patients who had confirmed diagnosis of at least one chronic inflammatory disease (i.e. cardiovascular disease, rheumatoid arthritis (RA), osteoarthritis (OA)) and steadily (i.e. for three consecutive weeks) increased plasma concentrations of C-reactive protein (CRP ≥ 10.0 mg/l). Patients were randomised to consume daily 300 mg Neptune Krill Oil™ (n=45) or a placebo (n=45). The primary outcome of the study was blood concentration of CRP. As a secondary outcome, patients with arthritic disease (having either RA or OA) were asked to complete the Western Ontario and McMaster Universities (WOMAC) osteoarthritis questionnaire.

The Panel notes that chronic inflammation was an inclusion criterion of the study, that a significant number of the patients recruited were reported to have confirmed diagnosis of OA, RA, or of both cardiovascular disease and OA, and that the WOMAC osteoarthritis questionnaire was administered only to patients with arthritic disease (OA or RA). In addition, the Panel considers that although the criteria used for the diagnosis of OA or RA were not specified in the publication, a chronic inflammatory disease of the joints is likely in patients with chronically elevated CRP concentrations of ≥ 10 mg/l and mean WOMAC scores for pain, stiffness and functional impairment ranging from 2.85 to 3.45 (the worst score being 4) at baseline. The Panel also notes that no evidence which could justify the extrapolation of the results, obtained in patients with joint diseases characterised by chronic inflammation, to the target population, subjects without chronic joint diseases, was provided by the applicant. 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 Eff_EXT™ and maintenance of normal joint mobility.

EffEXT™, krill oil, joints, osteoarthritis, chronic inflammation, health claims