Dr Luca Bucchini, managing director of the Italian firm Hylobates Consulting, said the botanicals not included in the BELFRIT consensus - a 1000-strong list of authorised botanicals agreed by the three countries in April – would have to prove that they were safe, of interest to the supplement industry and have been used traditionally if they wanted to avoid being relegated to "novel food hell".
In Italy, food firms have been invited by the Ministry of Health to submit additional data regarding safety and consumption patterns of excluded substances by 30 September 2014, with an updated BELFRIT list expected in spring next year.
Number crunching
Bucchini said his firm had crunched the numbers of information released by the Italian Ministry of Health this month to compile a list of botanicals that did not make it on to the approved BELFRIT register because of a lack of evidence of safety and/or traditional use. According to EU law, food and supplement ingredients could be legally used if they were in demonstrable use in Europe before 1997. Otherwise they would be classified as ‘novel’ – in which case novel approval must be sought to establish safety. The Italian consultant said this procedure was “too expensive for most companies”.
There are 174 names of the list of botanicals requiring more consumption data and 42 on the list for safety.
He said the list of those rejected was significant because "companies may learn whether some plants they care about [...] could be included if data was provided or excluded from the plants permitted in the three major EU markets and, in the future, in most EU countries”.
Currently the list only applies to the three countries behind it – but advocates hope it will be adopted by more member states and lead to greater harmonisation at EU level.
Of those not included, for which industry needs to submit more data, Maqui (also referred to as Aristotelia chilensis or chilean Wineberry) and Muira puama (Ptychopetalum) were “more relevant and popular”. He said it would be “a pity” if they didn’t make it on the updated list.
“If they are not included, they may relegated to ‘novel food hell’,” he said.
“The botanicals which won't make it to the BELFRIT will end up in limbo. There will be grounds for defending them in Italy for some more time, but eventually, with no backing in Italy or elsewhere in Europe, it will be difficult to use them legally,” he said.
The greatest challenges
He said there were two regulatory barriers in using botanicals in food supplements. “The first is that they are considered unauthorised novel foods. Inclusion in the Belfrit list could be regarded by most - if not all - countries in Europe as proof that they are not unauthorised novel foods. The second is medicinal law. Inclusion in Belfrit would help support the case for food supplement use in most member states.”
Even if a botanical excluded from the BELFRIT list was not officially recognised as an unauthorised novel food, its status would be “uncertain”.
“It is very difficult to prove that the botanical is not a novel food, and therefore that it is legally on the market. Novel food hell or limbo.”
He said that there should be “no question” as to the novel food status of those that were on the list. “You can just point to the Belfrit list. It will also be hard to prove that a BELFRIT botanical is unsafe, in order to ban it.”
”Countries like the UK may argue that some BELFRIT botanicals are medicinal - but, if the product does not make medicinal claims, they should be the exception rather than the rule.”
On the list
He said companies wanting to get their botanical on the updated list should keep in mind that: “Some plants were excluded because it was felt that the industry was not really using them. Evidence to the contrary would be important.”
A period of transition was agreed for those not included in the first April list running up to the end of March 2015.