Scientific Opinion on the substantiation of a health claim related to “<em>Lactobacillus plantarum</em> TENSIA™ in the semi-hard Edam-type “heart cheese” of Harmony™” and maintenance of normal blood pressure pursuant to Article 13(5) of Regulation (EC) No 1924/2006
Following an application from Piimandusühistu E-Piim, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Estonia, 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 and including a request for the protection of proprietary data, related to Lactobacillus plantarum TENSIA™ and maintenance of normal blood pressure. The food constituent, the strain L. plantarum TENSIA™, which is the subject of the health claim, is sufficiently characterised. The Panel considers that the maintenance of normal blood pressure is a beneficial physiological effect. The applicant provided a total of 38 publications as being pertinent to the claim. The Panel notes that none of these publications addressed the effects of L. plantarum TENSIATM and considers that no conclusions can be drawn from these references for the scientific substantiation of the claim. Four unpublished reports on human intervention studies (identified as proprietary by the applicant) investigating the effects of the L. plantarum TENSIATM strain on blood pressure were provided. In weighing the evidence, the Panel took into account that the only randomised, placebo controlled human intervention study provided did not show an effect of consumption of L. plantarum TENSIATM in Edam-type cheese on blood pressure. The Panel concludes that a cause and effect relationship has not been established between the consumption of L. plantarum TENSIA™ in the semi-hard Edam-type “heart cheese” of Harmony™ and maintenance of normal blood pressure.