The European Food Safety Authority (EFSA) has rejected three article 13.5 probiotic and prebiotic health claims and one article 14 claim linking prebiotics with a range of benefits from immunity to diarrhoea for failing to demonstrate causality.

EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) rejected one emerging science, article 13.5 claim from Sunstar Suisse linking p Lactobacilllus reuteri-fortified, probiotic chewing gum and tablets and oral health.

Italy-based Sunstar Suisse proposed the claim: “Gum Periobalance, combined with a correct oral hygiene, helps re-balancing the oral microflora and improving oral health.”

But the NDA said while decreasing the levels of mutans streptococci in the oral cavity and reducing the amount of dental plaque may be beneficial to health, the dossier did not demonstrate how the product in question, Gum Periobalance, helped this to be so.

The dossier contained two published human intervention studies and one unpublished in vitro study, all of which were found wanting for lack of relevance to the claimed effect or lack of demonstrated causality.

Probiotic supplements

Three prebiotic submissions from UK-based Clasado Limited also drew negative opinions from the scientific assessor for similar reasons.

Clasado submitted three claims for a prebiotic supplement, Bimuno, that contained a β-galacto-oligosaccharide mixture.

Two article 13.5 claims proposed gut health and immunity benefits, while an article 14 disease reduction claim linked the supplement with traveller’s diarrhoea.

Gut health

For the gut health claim, the NDA dismissed three human intervention trials and 11 non-human trials submitted by Clasado it hoped would back its claim that the supplement could improve “gastrointestinal function”. Reasons included lack of power, use of old formulations, non-matching formulations (between trial and product in question).

Clasado proposed the claim: “Bimuno (BGOS) Prebiotic selectively stimulates and increases the number of bifidobacteria in the gut of regular consumers. Bifidobacteria are recognised as health promoting bacteria that support the general well-being of the host.”

While some bifidogenic effects were detected at doses between 2.75g/d and 5.5 g/d, the NDA said this did not translate into a health benefit.

“The results do not show that the changes in the number of bifidobacteria are beneficial for the gut function,” it concluded.

Immunity

For the article 13.5 immunity claim, Clasado proposed the following health relationship: “Bimuno (BGOS) Prebiotic supports the immune system by helping to increase the natural killer cell and phagocyte activity in regular consumers. Natural killer cell activity and leukocyte phagocyte activity both play a key role in the function of the immune system.”

Its simplified claim read: “Supports your natural defences” and was intended for elderly people who consumed 5.5g of Bimuno Prebiotic per day for at least 10 weeks.

The NDA considered that only one clinical trial involving 44 elderly people, was relevant but found it wanting as it dod not, “provide any evidence that the observed changes in counts of faecal bifidobacteria, NK cell activity, production of inflammatory cytokines and phagocytosis activity constitute beneficial changes in the immune system”.

Traveller’s diarrhoea

Clasado’s article 14 disease-reduction claim stated: “Regular consumption of Bimuno (BGOS) Prebiotic helps to protect against the bad bacteria that can cause travellers’ diarrhoea.”

But again the NDA said the claim at a level of 5.5g per day was not substantiated by an unpublished, human clinical trial, an unpublished animal study, three in vitro studies and one review.

The three in vitro and review were deemed irrelevant because were not specifically testing or referring to Bimuno.

The clinical trial was deemed insufficient because of a number of flaws including a high drop-out rate, insufficiently characterised population, lack of data risk factors and insufficient description of statistical analyses.

More than 4000 claims are due to be processe under the 2006 nutrition and health claims regulation by the end of January, 2010, although the European Commission has admitted it is unlikely this deadline will be met.

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