The Italian Ministry of Health has revised probiotic characterisation, labelling and claim guidelines that may open claim-making around the idea of microflora balance.
While the European Food Safety Authority (EFSA) has said increasing healthy gut flora is not of itself a health benefit, the Italian ministry missive indicates “supports balance of the internal microflora” is a condition of use and therefore potentially offers more flexibility than EU laws.
“We may gather from this, that according to the Italian Ministry of Health, this indication is not to be considered as a health claim in the sense of the Regulation [the nutrition and health claims regulation],” wrote Barbara Klaus from the legal firm Meyer Meisterernst in Italy, in the European Food and Feed Law Review.
“This interpretation of the law is ‘innovative’ and is, in the opinion of the Italian Ministry of Health, also in the interest of consumers; who need to be informed of the ‘area of application’ of functional foods (enriched foodstuffs or food supplements)."
Klaus noted however that this was just the interpretation of the Italian Ministry, that the EU regulatory situation with regard to probiotics remained unresolved and that any disputes may end up before the Court of Justice of the European Union.
"Hence, it is the food business operator's responsibility to consider whether or not taking the 'risk' of an eventual dispute..." Klaus wrote.
The statement also includes basic definitions of what probiotics are; minimum dosage (10 billion colony forming units per strain per day) and safety (no need for fresh safety data if safety data exists for species).
Pre- and Probiotics 2012 Virtual Conference and Expo
Regulatory developments and cutting edge health conditions for pre- and probiotics will be discussed at the NutraIngredients Pre & Probiotics virtual conference on February 1, 2012. More details here.