Companies have 30 days to respond to EFSA’s opinions under the terms of the European Union nutrition and health claims regulation. Valio will send additional data it says addresses aspects of its dossier EFSA highlighted as problematic in its opinion.
Valio would not reveal the detail of its additional submission but said it addressed several points in EFSA’s ruling it believed were incorrect.
Valio researcher, Eveliina Myllyluoma, said the company had been in possession of this data before it submitted its dossier, but was unsure whether it was necessary to include it.
“It will be interesting to see what happens now,” she told NutraIngredients.com. “We are confident these are well-designed studies and confident about this area. We want to correct the mistakes in this opinion.”
Valio is yet to make any on-product health claims in the gastro-intestinal area, but had built a body of science and more was on the way.
Myllyluoma expressed disappointment EFSA had not asked Valio to provide further data before the opinion was made public last month.
“It’s a pity,” she said. “The point is that EFSA took issue with minor points. In particular, we disagree with the rejection of the study published in 2008 on the basis that there were no differences in individual symptom scores . Also, we don’t understand why EFSA can’t call for more information before going public with these opinions. Now we wait and see what happens with the additional information.”
It is the second negative opinion EFSA has delivered to Valio, after an article 14 peptide-based arterial stiffening claim was also rejected by the assessor in October.
Valio is not challenging this opinion, which had caught the attention of mainstream Finnish press and TV media. This attention led to Valio altering a television commercial for the product (Evolus) making claims in the area.
The EFSA opinion
The latest article 13.5 petition was turned down by EFSA on the grounds that causality was not sufficiently demonstrated.
Valio’s claim revolved around 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.
EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) found Bifidobacterium breve 99 was not sufficiently characterised as a health benefit-delivering nutrient.
For the characterised mixture, a randomised, placebo-controlled, double-blind, 5-month intervention trial found participants with irritable bowel syndrome (IBS) had improved IBS symptoms, as well as distension and bowel symptoms compared to control groups.
But there were no differences for abdominal pain, flatulence, rumbling, bowel habits or markers of inflammation.
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.
Similar reasoning was used to discount a clinical trial involving the non-characterised mixture.
Other human and in vitro studies submitted by Valio were deemed to be of limited value.
The NDA concluded that “the evidence provided is insufficient to establish a cause and effect relationship between consumption of LGG MAX (Mixture A as well as Mixture B) and the reduction of abdominal discomfort”.
So far EFSA has ruled on 22 claims, with positive opinions issued on five. Dossiers from the likes of Unilever, Bio Serae Laboratoires and Martek have been rejected.