EU herbal directive will close health food stores, say owners
Related topics: Botanicals, Regulation, Phytochemicals, plant extracts
Health food store owners are warning they will be forced to close down after April 30 this year, when the European Union Traditional Herbal Medicinal Products Directive (THMPD) kicks in.
Companies have had a seven year-grace period since the THMPD entered EU law books in 2004, but EU-wide registrations under the regulation have been chronically low, meaning unless thousands of products register in the coming months, they will be stripped from health store and other retail shelves.
Selwyn Soe of the London-based The Herbal Factory told the BBC: “Unfortunately it looks as if we will have to close down because of this legislation.”
“The problem for us is that although we would have to pay many thousands of pounds for a licence to keep making each product, unlike a drug company we would not have a licence to make that product exclusively. It just will not be worth paying out the money.”
The regulation requires all herbal products making health claims to be registered. As of December 31, 2010, there had been 187 registrations for individual products in the UK. Eighty four products have been approved and none rejected.
The 100 per cent success has been attracting the interest of food supplement manufacturers and herbal ingredient suppliers who have struggled to have their science accepted under the 2006 nutrition and health claims regulation (NHCR).
But herbal sector observers and associations have been surprised by the lack of THMPD registration applications – with the UK leading the way, followed by Germany, but many member states recording no applications at all. The relative high cost of registrations has deemed as partly to blame for the situation.
The fact that there is a clear discrepancy between the way science is treated under the THMPD and the NHCR has caused some confusion, and was partially responsible for the European Commission recently removing botanicals from the NHCR process to reconsider how science in the sector should be treated.
That issue is unlikely to be revisited until the end of 2012.