The European Food Safety Authority (EFSA) has issued new draft guidance on submitting gut and immune system-related claims under the European Union's Nutrition & Health Claims Regulation.
The consultation document is a prelude to EFSA's first claims-specific technical seminar, which will take place on 2 December in Amsterdam and which will also address gut and immune function claims.
The guidance is designed to give the nutrition industry a clearer idea of what scientific evidence EFSA's Panel on Dietetic Products, Nutrition & Allergies (NDA panel), which is assessing dossiers submitted under the regulation, will require to approve a claim.
It will prove of particular interest to companies operating in the probiotics sector, which has suffered particularly hard at the hands of an NDA panel that has yet to approve a single claim for a probiotic ingredient.
In the guidance document, the NDA panel addresses which claimed effects it will consider beneficial and what kinds of studies and outcomes will be considered sufficient to substantiate claims.
The panel makes it clear that simply showing increased levels of beneficial bacteria in the intestinal tract will not be considered sufficient to validate a claim. Instead, its scientists would like to see evidence of significant reductions in pathogens or toxic microorganisms.
The guidance states: "For claims related to maintaining normal defence against pathogens in the gastrointestinal tract, appropriate outcome measures could include reduction of numbers of pathogenic microorganisms or their toxins in suitable samples as well as clinical outcomes demonstrated in human intervention studies."
The document also says that reducing "gastro-intestinal discomfort" is considered a positive effect, and that IBS sufferers are a valid group on which to test the effect of an ingredient on this condition.
EFSA is holding a public consultation on the draft guidance until 22 October. Comments can be submitted here: http://www3.efsa.europa.eu/cf/consultation.cfm?doc=60.