The dossier was submitted by Estonia-based Piimandusühistu E-Piim under the Article 13.5 channel of the European Union's Nutrition & Health Claims Regulation. The company produces Harmony, a brand of Edam-style cheese called Südamejuust – or 'Heart Cheese' in English – that contains the probiotic bacteria Lactobacillus plantarum TENSIA.
Piimandusühistu E-Piim applied for the claim: "Regular consumption (at least three weeks) of 50g/day Südamejuust of Harmony brand comprising probiotic Lactobacillus plantarum TENSIA helps to maintain the cardio-vascular system/heart health through reduction of blood pressure."
The company submitted four unpublished studies to back its application. All, however, were considered inadequate by EFSA's Panel on Dietetic Products, Nutrition and Allergies to prove the claim.
In its opinion, EFSA said: "In weighing the evidence, the panel took into account that the only randomized, placebo-controlled human intervention study provided did not show an effect of consumption of L. plantarum TENSIA in Edam-type cheese on blood pressure.
"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."