All five article 14 claims were submitted by the Institute of Biotechnology, Sera and Vaccines Biomed SA, a Krakow, a Poland-based biotechnology company, and each were denied by EFSA for failing to demonstrate causality between a proprietary probiotic supplement and a range of proposed effect.
EFSA is yet to deliver a positive opinion on a probiotic health claim, but one industry analyst said the probiotic dossiers assessed so far were weak and clearly below EFSA’s scientific requirements.
The latest verdicts bring the total number of EFSA opinions to 27 of which five have been positive. The Parma-based group has about 3000 claims to process before January, 2010.
Article 14 claims deal with children’s health and disease reduction claims while article 13.1 and 13.5 claims, which number something like 2700, are more generic claims.
Lactoral data lack
The claims related to children’s health and sought to make claims for a Biomed proprietary probiotic called Lactoral:
- maintenance of natural intestinal microflora during travel
- building of the natural intestinal barrier
- living probiotic bacteria
- normal functioning of the alimentary tract
- improvement of the general immunity
EFSA said the claims were not supported by the submitted science, which often did not relate to the strains from which Lactoral, a freeze-dried powder, was composed. These were Lactobacillus plantarum, Lactobacillus rhamnosus, and Bifidobacterium longum.
“The published studies provided to substantiate the health claim relate to a number of different probiotic strains but not to the bacterial strains in Lactoral,” the NDA said.
“As probiotic effects are strainspecific and dose-dependent these publications cannot be used to substantiate the health claim for Lactoral.”
The product in question came in the form of a sachet Biomed said contained 10bn colony forming units (CFUs).
EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) said Biomed’s phenotypic testing were “not sufficient for a proper identification of the bacterial strains…Thus the identification of the bacteria remains doubtful.”
The NDA also questioned the quality of the bacterial powder provided and said the Lactoral sachet had not been sufficiently characterized.
For the claim, “natural intestinal microflora during travel”, the NDA said “natural intestinal microflora” had not benn sufficiently characterised.
In relation to this claim, the NDA observed a weakness that applied across the board when it stated: “No intestinal microbiota analysis studies have been performed during or after the administration of Lactoral in any conditions.”
Of the other four claims,EFSA stated the presence of in vitro trials were“not sufficient to predict in vivo efficacy in humans.”
Biomed qualified person, Marek Cwiertnia, said the company had not yet formulated a response to EFSA’s opinions.