EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to ♀EFAX™ and reduction of menstrual discomfort pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Following an application from Nutrilinks Sarl submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Cyprus, 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 ♀EFAX™ and reduction of menstrual discomfort. The food, ♀EFAX™, which is standardised pure krill oil and is the subject of the health claim, is sufficiently characterised. The claimed effect, reduction of menstrual discomfort, is a beneficial physiological effect. No human intervention studies from which conclusions could be drawn for the scientific substantiation of the claim were provided by the applicant. A cause and effect relationship has not been established between the consumption of ♀EFAX™ and reduction of menstrual discomfort

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2013 . S tatement on the safety of ' Cetyl Myristoleate Complex ' as an ingredient in food supplements

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to update its opinion on the safety of ‘Cetyl Myristoleate Complex’ (CMC) as a novel food ingredient in the light of a new repeated dose 90-day oral toxicity study in mice. In its previous opinion of 2010, the Panel concluded that based on the available data, the safety of CMC as an ingredient in food supplements has not been established. This conclusion was based on the considerations that in the absence of appropriate data on absorption, distribution, metabolism and excretion, the provided toxicological data were insufficient. Whereas the applicant considers that the NOAEL of CMC in this new 90-day study was 1000 mg/kg body weight (bw), the highest dose tested, the Panel considers that this study and study report has many shortcomings to be a reliable source of information supporting the absence of adverse effects of the parent material CMC. The Panel concludes that the safety of 'Cetyl Myristoleate Complex' has not been established

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to E<em>ff</em>_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 EffEXT™ and maintenance of normal joint mobility. The Panel considers that EffEXT™, 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 EffEXT™ and maintenance of normal joint mobility

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to Slendesta® Potato Extract and reduction of body weight pursuant to Article 13(5) of Regulation (EC) No 19 24/2006

Following an application from Kemin Foods LC, submitted for authorisation of a health claim 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 Slendesta® Potato Extract and reduction of body weight. The food constituent, Slendesta® Potato Extract, that is the subject of the health claim is sufficiently characterised. The claimed effect, a reduction of body weight, is a beneficial physiological effect for overweight individuals. In weighing the evidence, the Panel took into account that all four human intervention studies from which conclusions could be drawn for the scientific substantiation of the claim did not show an effect of Slendesta® Potato Extract on the reduction of body weight. The Panel concludes that a cause and effect relationship has not been established between the consumption of Slendesta® Potato Extract and reduction of body weight