The European Food Safety Authority (EFSA) may have rejected 100% of the probiotic health claim applications that have in recent years appeared in its inbox, leading some to suggest the end of claim-making in the sector, but member state actions are demonstrating otherwise.
In Italy at least, lawmakers are using EFSA’s probiotic stance to date to back its interpretation that claims about boosting healthy gut microflora should be permitted as nutrition claims if not health claims under the nutrition and health claims regulation (NHCR).
The Italian Ministry of Health has said there is no reason probiotic products – especially supplements – should not be able to carry product information about their ability to contribute to a healthy gut microflora.
It said such statements were authorised under the 2002 EU Food Supplements Directive (FSD) and were permitted even if EU lawmakers are suggesting that the name ‘probiotic’ may itself be enough to imply a health claim especially around gut and immunity benefits.
Around 150 article 13.1 probiotic health claim rejections have just been written into EU law giving companies in the sector six months to get their claim-making in order with most of the rejections centering around gut health and immunity.
But Italy’s approach is offering fresh avenues to frustrated probiotic players even if the claims are restricted to the idea that boosting probiotic flora is a good thing for health.
“The principle holds very clearly and is, in my view, sound,” EU food law expert, Luca Bucchini, PhD, the managing director of Rome-based Hylobates Consulting, told New Nutrition Business.
“Under a plethora of EU norms, the Italian authorities are still fully empowered to ensure, also on a case-by-case basis, that the claimed effect does not mislead consumers, and that it is based on sound data.”
But Bucchini warned: “One can still argue that, based on EFSA’s assessment, consumers will interpret the statements as an implied health claim. However, this decision rests with the enforcement authorities, and the courts, and it would be wrong to allocate the decision with a scientific body.”
“EFSA, whose health claims panel is not composed of consumer science experts, has just looked at whether there was an effect scientifically linked to a health outcome; they could not look at what consumers would think.”
Italy’s probiotic food supplements market is the biggest in the EU and valued at about €300 million, according to Euromonitor, with probiotic yoghurts worth another €400m per year.