It is for this reason 171 of 181 article 13.1 probiotic dossiers were rejected by EFSA at the beginning of October.
Submitted by German firm, Töpfer GmbH, the article 14 children’s and disease reduction health claim proposed a relation between the consumption of a four-strain probiotic formulation and a decrease in “potentially pathogenic intestinal microorganisms” in children up to the age of 36 months.
EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) said it could not be established that the four strains in question – Bifidobacterium bifidum, Bifidobacterium breve, Bifidobacterium infantis, Bifidobacterium longum – are the same in the studies as in the claim.
The NDA therefore concluded a cause and effect relationship had not been established.
The Panel said that further characterization information had been requested of Töpfer, but none had been forthcoming.
“No data on species identification and characterisation of the strains Bifidobacterium bifidum NIZO3804, Bifidobacterium breve NIZO3676, Bifidobacterium infantis Reuter ATCC15697, and Bifidobacterium longum NIZO3694 are included in the application or in the references provided, even after having requested supplementary information to the applicant,” the NDA wrote.
Töpfer proposed the claim: “Probiotic bifidobacteria lead to a healthy intestinal flora comparable to the composition of the intestinal flora of breast-fed infants intestine.”
Regardless of the lack of characterization, the Panel noted that intestinal tract science was emerging. “The gastrointestinal tract is populated with a large number of microorganisms and it normally acts as an effective barrier against generalised systemic infections. It is not possible to provide the exact number of bacterial groups that would constitute a beneficial microbiota.”
Töpfer made no comment on the opinion that can be found here by the time of publication.
The NDA is yet to approve any probiotic-based health claim.
EFSA also recently reconfigured its scientific output into the EFSA Journal to make the information more accessible and present it in a more academic journal looking way.