The article 13.5 proprietary and emerging science dossier proposes the claim: "Lactobacillus GG improves the body's resistance". It adds to the existing article 13.1 Lactobacillus GG submission already in the system but yet to be assessed by EFSA’s health claims panel.
Valio development manager Tuula Tuure said the Finnish firm was confident it would gain a positive opinion from EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) as it refined on the article 13.1 claim.
She said the initial claim had been limited to ten references by national authorities, whereas the new dossier contained “dozens of clinical studies” including intervention trials and in addition, dozens of animal and in vitro studies.
“Of course it is a very complicated area and there remains some doubts about the requirements but we feel we have a better chance if we can explain the dossier which is possible in article 13.5 rather than article 13.1,” she said.
“Probiotics definitely have a better chance in this article.”
Others on the article 13.5 list hoping the NDA will deliver its first positive probiotics opinion include Yakult which has had dialogue with the panel about its its Lactobacillus casei strain, Shirota-based immunity submission.
But global probiotics leader Danone has withdrawn submissions for its probiotic drinking and spoonable yoghurts, Actimel and Activia, citing a desire to see further clarification on dossier requirements that may come at an EFSA-hosted gut health and immunity workshop scheduled for Amsterdam on December 2.
Tuure said the company had chosen the wording, "Lactobacillus GG improves the body's resistance" because it was more comprehensible to the consumer than some other immunity claims.
“The terminology is very difficult and it is possible that EFSA may change the wording, as they have done with some other claims, but we felt this claim best reflected the science while being something consumers can understand.”
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Valio had a probiotic article 13.5 claim rejected by the NDA in 2008 but it contained a different blend (LGG Max) to the current submission.
That claim related to two probiotic blends – with each containing the same three strains - Lactobacillus rhamnosus, L. rhamnosus and Propionibacterium freudenreichii subspecies shermanii JS – plus a variable strain being either Bifidobacterium animalis subsp. lactis or Bifidobacterium breve 99.
In that study the NDA dismissed a randomised, placebo-controlled, double-blind, 5-month intervention trial that found participants with irritable bowel syndrome (IBS) had improved IBS symptoms, as well as distension and bowel symptoms compared to control groups.
But the NDA found the study did not accurately measure the “symptoms with a high variability” and that the study was not sufficiently controlled post-randomisation for “confounders that could potentially have affected the outcome” such as background diet and medications other than antimicrobials.
It also noted the trial demonstrated no differences for abdominal pain, flatulence, rumbling, bowel habits or markers of inflammation.