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 E-piim production Ltd, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Estonia, 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 “Lactobacillus plantarum TENSIA® in the semi-hard Edam-type “heart cheese” of Harmony™” and maintenance of normal blood pressure (BP). The food constituent 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 47 references which did not address the effects of L. plantarum TENSIA® on BP. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim. Two human randomised, double-blind, placebo-controlled, intervention studies investigated the effect on BP of L. plantarum TENSIA® consumed in Edam-type cheese for three and eight weeks. In weighing the evidence, the Panel took into account that only one human intervention study with important methodological limitations showed a BP-lowering effect of L. plantarum TENSIA® consumed in the Edam-type “heart cheese” of Harmony™ when consumed daily for eight weeks, and that no evidence was provided for a mechanism by which L. plantarum TENSIA® in the Edam-type “heart cheese” of Harmony™ could exert the claimed effect. The Panel concludes that a cause and effect relationship has not been established between the consumption of Lactobacillus plantarum TENSIA®in the semi-hard Edam-type “heart cheese” of Harmony™ and maintenance of normal blood pressure.