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 related to Lactobacillus plantarum TENSIA™ and maintenance of normal blood pressure.
The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence and including a request for the protection of proprietary data.
The food constituent that is the subject of the health claim is L. plantarum TENSIA™ in the semi hard Edam-type “heart cheese” of Harmony™. The strain L. plantarum TENSIA™ (DSM 21380) has been specified using phenotypic and genotypic methods. Data on the conditions of use, specifications, manufacturing process, bioavailability as well as information on stability of the strain were provided. The Panel considers that L. plantarum TENSIA™, which is the subject of the health claim, is sufficiently characterised.
The claimed effect is “helps to maintain the cardio-vascular system/heart health through reduction of blood pressure”. The target population as proposed by the applicant is the general population. The Panel notes that the claimed effect relates to the maintenance of normal blood pressure. 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Four unpublished reports on human intervention studies (identified as proprietary by the applicant) investigating the effects of the strain L. plantarum TENSIATM on blood pressure were provided.
Two of the studies were pilot, non-randomised and sequential interventions. The Panel notes that these studies were uncontrolled and considers that no conclusions can be drawn from these pilot studies for the scientific substantiation of the claim.
The third study was an open label human intervention which investigated the acute effects of a single dose of Edam-type cheese comprising L. plantarum TENSIATM on blood pressure (primary outcome) and arterial stiffness. The Panel considers that no conclusions can be drawn from this acute and uncontrolled study for the scientific substantiation of the claim.
The fourth study was a randomised, double-blind, placebo-controlled, cross-over human intervention which investigated the effects of consuming 50 g/day of Edam-type cheese containing L. plantarum TENSIATM compared to the same amount of cheese without L. plantarum TENSIATM on blood pressure in healthy volunteers aged 18 to 65 years. The test and control cheeses were consumed daily for three weeks each with a washout period of two weeks in between. A total of 90 subjects were randomised and 83 participants completed the trial. Changes in systolic and diastolic blood pressure were the primary outcomes of the study. No significant differences in systolic or diastolic blood pressure changes were observed between the intervention and control groups during the study. The Panel notes that this study does not show an effect of L. plantarum TENSIATM on blood pressure. Post-hoc analyses were carried out by dividing the study population according to systolic blood pressure values at baseline. The Panel notes that these post-hoc analyses were not pre-planned and considers that no conclusions can be drawn from these analyses for the scientific substantiation of the claim.
Information on the functional properties (in vitro production of nitric oxide, polyamines, and angiotensin converting enzyme inhibitory peptides) of the strain L. plantarum TENSIATM were provided by the applicant. The Panel considers that this information does not predict an effect of L. plantarum TENSIATM on blood pressure in vivo in humans.
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 Lactobacillus plantarum TENSIA™ in the semi-hard Edam-type “heart cheese” of Harmony™ and maintenance of normal blood pressure.