Italians take pragmatic health claims approach

An Italian delegation from the Italian Ministry of Health told the European Health Claims Alliance conference in Brussels last week of reservations it holds transposing the 2006 nutrition and health claims regulation (NHCR) into the Italian legislature.

Bruno Scarpa and Stefania Dalfra explained how the NHCR may come into conflict with existing Italian law – especially the decree that transposed the 2002 EU Food Supplements Directive into Italian law in May, 2004.

That decree stated that nutritional or physiological effects had to be noted on-product to advise consumers about the intended uses of products, but this law may be challenged if and when European Food safety Authority (EFSA) opinions such as those dealing with herbal supplements become law in the EU.

Member states are then expected to follow the EU law although the European Commission has indicated, at least in regard to herbal products, that it may reconsider whether they should be judged in the same way as other substances under the NHCR.

But speculating on a situation where the NHCR and Italy’s FSD decree may come into conflict, Scarpa asked: “Why would we remove the need of the label effects of food supplements?”

Scarpa emphasised that all products on the Italian market – the largest for herbal food supplements in the European Union – had to be, “safe and bear adequate and appropriate labelling”.

Suggested dosage was also mandatory.

Backing for claims was determined by, “all the available evidence and traditional use” and there was no expectation that cause and effect be demonstrated in any kind of pre-determined clinical manner.

As long as the efficacy was, “plausible on the basis of long-standing use and experience” the claim was permissible on-product.

“We still need information that is relevant to the average consumer,” he said.