EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the substantiation of a health claim related to Padina pavonica-extract in Dictyolone® and an increase in bone mineral density pursuant to Article 13(5) of Regulation (EC) No 1924/2006.

摘要

Following an application from ICP Ltd, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Malta, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Padina pavonica-extract in Dictyolone® and an increase in bone mineral density. The Panel considers that the Padina pavonica-extract in Dictyolone® is sufficiently characterised. An increase (or reduced loss) in bone mineral density is a beneficial physiological effect. The applicant presented four human intervention studies, four animal studies and two in vitro studies as pertinent to the health claim. No conclusions could be drawn from two of the four human studies as they were carried out with a food that did not comply with the specifications of the food which is the subject of the health claim. The two other human studies did not show an effect of the Padina pavonica-extract in Dictyolone® on bone mineral density. The Panel concludes that a cause and effect relationship has not been established between the consumption of Padina pavonica-extract in Dictyolone® and an increase (or reduced loss) in bone mineral density.