Lactobacillus plantarum 299v and an increase of non‐haem iron absorption: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Abstract

Following an application from Probi AB submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Sweden, 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 299v and an increase of non-haem iron absorption. The food that is the subject of the health claim is ‘Lactobacillus plantarum 299v (Lp299v)’. The Panel considers that Lp299v is sufficiently characterised. The claimed effect proposed by the applicant is ‘increase of non-haem iron absorption’. The target population proposed by the applicant is ‘healthy adults who want to increase their iron uptake’. The Panel considers that increasing non-haem iron absorption is a beneficial physiological effect. In weighing the evidence, the Panel took into account that the results of two double-blind, placebo-controlled, cross-over studies are inconsistent, as one study with some methodological limitations showed a positive effect of Lp299v on non-haem absorption, whereas the other did not show an effect. The Panel noted that among four single-blind, placebo-controlled, sequential studies at risk of systematic bias, three studies showed a positive effect of Lp299v on non-haem absorption and one did not show an effect. The Panel also took into account that there is no evidence for a plausible mechanism by which Lp299v could increase non-haem iron absorption in vivo in humans. The Panel concludes that the scientific evidence is insufficient to establish a cause and effect relationship between the consumption of Lp299v and an increase of non-haem iron absorption.