The article 13.5 petition from Finnish dairy and ingredients supplier, Valio, was turned down by EFSA on the grounds that causality was not sufficiently demonstrated.
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 last month.
EFSA has also adjudicated on two other article 14 children’s health dossiers, with a xylitol/dental carries claim receiving a positive opinion.
A claim relating animal protein consumption and bone development in children was not supported for want of proof demonstrating animal proteins are lacking in the diets of European children.
Probiotics and gastro-intestinal benefits
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”.
Valio was not able to be contacted by the time of publication.
The Association de la Transformation Laitière Française (ATLA) lodged a claim linking animal protein consumption and healthy bone growth in children between three and 18.
While the NDA supported a causal effect between animal protein consumption and bone health in children, it found no evidence of inadequate consumption among European children, and therefore did not support the claim.
“Provided that the requirements for total nitrogen and indispensable amino acids are fulfilled, there is no particular need for the consumption of animal protein for normal growth and development of bone,” the panel wrote.
A xylitol gum/children’s tooth decay claim submitted by LEAF Int., Leaf Holland and Leaf Suomi Oy, was supported.
The Leaf companies included 31 human intervention studies and 16 other review publications in their dossier.
The NDA said a cause and effect relationship had been established between chewing 100 per cent sweetened xylitol gum and the reduction of risk in tooth decay in children. However a claim for pastilles sweetened with only 56 per cent xylitol was not supported.
Consuming 2-3g of chewing gum sweetened with 100 per cent xylitol, at least three times per day after meals could deliver benefits, NDA found, a quantity that could “easily be consumed as part of a balanced diet.”
But it warned against under-3s consuming chewing gum.
The approved claim stated: “xylitol chewing gum reduces the risk of caries in children”.
It is expected the Commission will deliver decisions on some of EFSA’s opinions by year’s end. EFSA hasa minimum of about 200 article 14 claims and 2500 article 13 claims to be assessed by January 31, 2010.