Speaking at a recent congress in Brussels on the subject, Dr Vittorio Silano called on the admittance of tradition-of-use data in any assessment process – an issue that forced botanicals out of the EU health claims process in September 2010. About 1500 claim applications under the 2006 nutrition and health claims regulation remain on-hold.
Silano said: “It would be advisable, in my opinion, that the European Commission and member states, with the collaboration of EFSA and EMA (European Medicines Agency), undertake a new ad hoc collaborative effort to improve and further harmonise the current regulatory framework by developing:
- A practical approach to better identify/characterise botanical species and preparations more suited for use as food supplements or medicinal products.
- A balanced approach to safety and efficacy assessment of both typologies of products, preferably based on traditional use, to be used throughout the European Union in a substantially coherent manner.
Silano, who stated his views were his own and not EFSA's, emphasised the divide that often existed between herbals used as food supplements versus medicines; a divide that partially informed the writing into law of the EU Traditional Herbal Medicinal Products Directive (THMPD) in 2004 and which became active across the EU in 2011.
“Botanical food supplements are intended to complement the normal diet, whereas medicinal products should be mainly intended for treating or preventing specific symptoms of disease.”
On the other hand, “Botanical food supplements could be for lifetime exposure…”
“Indications of use for food supplements and medicinal products should be clearly different; EFSA and EMA should collaborate to help the European Commission clearly establish such differences.”
Silano noted that by the end of 2011 there had been 751 THMPD registrations across the EU with the most at that point in Poland (164), the UK (150), Germany (107) and Austria (92).
The most popular health areas were: cough and cold; gut disorders; and cognitive function.
Germany (€2400m), Italy (€1500m) and France (€1500m) are the EU’s biggest markets in combined food-medicine herbal products.
In an earlier presentation at the same congress, Penny Viner, vice president of the UK Health Food Manufacturers’ Associaiton (HFMA), asserted that whether or not tradition-of-use data was deemed admissible, there would be, “change to the way the botanical food industry currently operates.”
Current EFSA health claims panel chief, professor Ambroise Martin, will discuss some of these issues at the Vitafoods Europe event in Geneva on the first day of the show, May 14. More details here.