The Global Alliance for Probiotics (GAP) that includes Chr Hansen, DuPont-Danisco, Yakult, Valio and Danone, is working with academics and experts with a view to producing systematic reviews of “clusters of probiotics” in its ongoing effort to win the European Union’s first probiotic health claim.
Newly elected GAP chairman, Valio VP in R&D, Ross Crittenden, told us the work was not expected to be completed, “for about another six months” at which point the ‘related strain’ data could be added to any prospective dossier for European Food Safety Authority (EFSA) perusal.
“While it is known that individual probiotic strains can have strain specific properties, it is also evident that there are common effects from functionally related organisms,” Crittenden said.
“GAP is working with world leading experts in host-microbe interactions and systematic reviews to explore where strong evidence for physiological benefits falls within related clusters of probiotics.”
“But it is too early in our process to tell which groups of organisms can be rationally clustered based on their composition, function and host response.”
GAP’s action follows a recent re-rejection of about 74 dossiers that had been looked at a second time by EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) after many of them failed on strain characterisation grounds the first time around.
Included in those digestive and immune health rejections were:
- Lactobacillus casei DG CNCM I-1572
- Saccharomyces boulardii
- Propionibacterium freudenreichii SI 41
- Propionibacterium freudenreichii SI 26
- Lactobacillus helveticus CNCM I-1722
- Lactobacillus fermentum 57A
- Lactobacillus plantarum 57B
- Lactobacillus gasseri 57C
- Lactobacillus gasseri PA 16/8
- Bifidobacterium bifidum M 20/5
- Bifidobacterium longum SP 07/3
- Saccharomyces cerevisiae var. boulardii CNCM I-107
About 200 of these kinds of health associations are now rejected in EU law under article 13 of the nutrition and health claims regulation (NHCR) – including about 125 for the Lactobacillus genus alone.
This means local inspectors can begin removing products making any such claims from December 14 this year – when the six month transition period expires.
Call for dialogue
One of GAP’s stated goals is to improve dialogue between the probiotics sector and EFSA and the European Commission, but Crittenden said there had been no dialogue as yet with EFSA. There had been some preliminary discussions with the EC.
GAP and others in the probiotic community have become increasingly frustrated and annoyed about how it is that more than 7500 individual pieces of probiotic research have translated into so many health claim rejections and not a single approval from EFSA.
On behalf of GAP – which also includes Canadian firm Institut Rosell Lallemand and Swedish supplier Probi – Crittenden previously stated, “There is clearly a discord between the amount and quality of clinical science literature to support the benefits of probiotics and the absence of successful claim applications”.
“GAP supports the NHCR and its objectives and is fully committed to working within its framework. GAP seeks recognition of the benefits of selected microorganisms based on generally accepted scientific evidence.”
An example of a recent NDA probiotic rejection can be found here.