A leading probiotics researcher says the ongoing uncertainty about endpoints and biomarkers in European Food Safety Authority (EFSA) health claim evaluations, means the best chance for probiotic products to make claims is to combine them with nutrients that have won approval.
Professor Ger Rijkers, PhD, from the University Medical Center in Utrecht, in the Netherlands, expressed disappointment at the latest batch of article 13 general function opinions that saw eight individual strains rejected for varying health relationships.
These rejections have added to the 200+ probiotic submissions already refused by EFSA’s Panel on Nutrition Allergies and Dietetic Products (NDA), leaving Professor Rijkers to suggest a last-ditch method to permit a probiotic health claim.
“In the absence of clear-cut criteria, and an EFSA panel which admits they are evaluating the applications on a ‘case-by-case’ scenario, there is little hope for the remainder of the applications which are currently under evaluation,” he said.
“Adding water to the probiotics, in order to maintain normal physical and cognitive functions, for the short term is the only solution.”
His comment refers to positive opinions issued in the same batch of NDA opinions for water’s ability to maintain normal physical and cognitive functions and thermoregulation.
Characterisation, claims clarity
Professor Rijkers wondered why the strain L. plantarum BFE 1685 was deemed sufficiently characterised even though it is not deposited in any official culture collection.
He said the rejection of the dossier for Bifidobacterium animalis ssp. lactis Bb-12 could be attributed to the claim wording.
“This bacterium has been demonstrated to be effective in reducing antibiotic associated diarrhoea, but no data on changes in gut microbiota were provided,” he said.
“The claim ‘maintaining intestinal microbiota . . (while) receiving antibiotic treatment’ therefore was rejected.”
The NDA panel verdict that pathogens were insufficiently characterised in a Lactobacillus rhamnosus LB21 NCIMB 40564 dossier demonstrated the, “the lack of precision of the EFSA guidelines”, he said, and called on EFSA to publish a promised update following the gut and immune health workshop in Amsterdam last December.
Professor Glenn Gibson from the University of Reading said the NDA assessments demonstrated a, “skewed agenda against these harmless and effective interventions”.
This month the NDA found:
- Lactobacillus paracasei LMG P 22043 does not decrease potentially pathogenic gastro-intestinal microorganisms or reduce gastro-intestinal discomfort.
- Lactobacillus johnsonii BFE 6128 . Immunity and skin claims all too general for consideration under the NHCR.
- Lactobacillus fermentum ME-3 not shown to decrease potentially pathogenic gastro-intestinal microorganisms.
- Lactobacillus plantarum BFE 1685. Immunity claim deemed too general for NHCR.
- Bifidobacterium longum BB536 does not improve bowel regularity; does not resist cedar pollen allergens; does not decrease pathogens.
- Bifidobacterium animalis ssp. lactis Bb-12 does not help maintain normal LDL-blood cholesterol; does not decrease pathogens or boost immunity.
- Lactobacillus plantarum 299v does not reduce flatulence and bloating or protect DNA, proteins and lipids from oxidative damage.
- Lactobacillus rhamnosus LB21 NCIMB 40564 does not help maintain individual intestinal microbiota in subjects receiving antibiotic treatment.