100s of UK herbals face ban as registration deadline looms

By Shane Starling

- Last updated on GMT

Related tags: European union

Hundreds of botanical products face removal from the UK market if
their manufacturers do not submit applications to have them
registered under the European Union Traditional Herbal Medicinal
Products Directive (THMPD) directive.

The British Herbal Medicines Association (BHMA) has urged companies to begin the registration process or allow products to face market extinction come the April 2011 deadline. At that point all herbal products not deemed foodstuffs such as 'spice rack' herbs like garlic or rosemary or, at the other end of spectrum, those that are deemed medicines, must be registered under the THMPD. In the UK, this process is being conducted by the Medicines and Healthcare products Regulatory Agency (MHRA) which has approved 14 applications since 2005 and has another 21 applications in lieu. Pre-flood? ​ Yet the UK is the most advanced member state in this area - along with Germany and Ireland - which account for the bulk of registrations since the THMPD was enacted in 2005. BHMA said 100 registration applications had been lodged by October 2007, the most recent figures it could gather. Some member states have registered no products so far, with others still to transpose the THMPD into their national legislatures. A BHMA spokesperson told NutraIngredients.com 35 applications "was a remarkably small number"​ despite the MHRA being as "helpful as it possibly could". ​He said he did not know of any registrations that had been granted in other member states which he described as "an extraordinary situation". "What the enforcement situation will be in 2011 remains to be seen," he said. "It could be rather hard on some companies. We hope there will be a flood of applications but we have no further statistics at the moment." Deadline pressure ​MHRA senior press officer Stephen Hallworth said MHRA was working closely with industry to ensure transparency in regard to the status of the Directive and to assist companies going through the registration process. "We have gone out to talk to industry and let them know what the Directive is asking of them,"​ he said. "We look forward to seeing more and more applications as the deadline draws closer." ​Hallworth said companies should note that registration in one member state does not apply across the bloc and that registrations must be sought in each member state in which a company sought to market its products with THMPD registrations. The 14 approvals have been granted to four manufacturers with seven being handed to German pharma group-owned MedicHerb. The last registration approved by the MHRA was for a St John's wort product manufactured by Bioforce. Further approvals include two other St John's wort products, two devil's claw products, two valerian products, an arnica product, a black cohosh product, a horse chestnut product and a saw palmetto product.

Related topics: Botanicals, Suppliers, Supplements

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