'If they are not included, they may be relegated to novel food hell'

And the losers were… BELFRIT’s missing botanicals compiled

22-Jun-2014 - Last updated on 24-Jun-2014 at 15:39 GMT

“Some plants were excluded because it was felt that the industry was not really using them. Evidence to the contrary would be important,” says Italian consultant.

Related tags Novel food Dietary supplement Europe

Firms must fight the case of the botanicals that did not make it on the BELFRIT list, according to a consultant behind a comprehensive index of those excluded from the Belgian, French and Italian agreement.

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.

1 comment

Muira Puama and Tabebuia avellanedae?

Posted by Ken, 27 June 2014 - 21:37 GMT

Under the botanical name of Ptychopetalum alacoides, the wood of muira puama was the subject of a monograph published by the German Commission E on October 15, 1987. Due to a lack of evidence to show its effectiveness, it was listed among "unapproved" herbs. One could argue that muira puama was used in Germany before 1987 or it would not have been included in the Commission E. As for the inclusion of Tabebuia avellanedae -- a species taxonomically known today as Handroanthus impetiginosus -- on a list of plant products requiring safety data, a number of animal studies found no evidence of toxicity from large and repeated doses of the inner bark prepared as water and solvents extracts. The primary concern for the safety of the species appears to be largely based on lapachol, a naphthoquinone reported in the wood of the genus in a wide range of concentrations (e.g, less than 1% to 6%). Reports of higher contents in the wood of various species of Tabebuia and closely related trees date from the early part of the 20th century and can not be considered reliable. For the inner bark, which is the part widely used in commerce and herbal medicine, studies have repeatedly shown that lapachol is either absent or found in minute amounts in diverse members of the genus of either Tabebuia or Handroanthus. It should also be noted that lapachol is known for its poor solubility in water and intestinal absorption. In a pilot clinical study in leukemia patients by the U.S. National Cancer Institute, lapachol at an oral dosage of 2 g/day for 5 days resulted in prolonged prothrombin times. At lower dosages, no effects on blood, including coagulation, were found. Chemical analyses of 12 commercial products of the inner bark by researchers at Health Canada found that only one contained any lapachol. The content in the sample was minor -- 0.003-0.004%. By extrapolation, the daily intake of the inner bark to achieve the equivalent dosage of lapachol found to prolong the prothrombin time would be 50 kg or 100,000 capsules at 500 mg/capsule.