NHCR botanicals removal provides a longevity loophole?

By Shane Starling

- Last updated on GMT

How significant will the botanicals reprieve turn out to be?
How significant will the botanicals reprieve turn out to be?

Related tags: European union

The European Commission decision to remove around 2000 submissions for botanical extracts from the 2006 nutrition and health claims process will allow substances to remain on-market, and may provide a loophole to help companies thinking about herbal medicinal product registrations, according to a consultant.

Mark J Tallon, PhD, the chief executive officer of UK-based Nutrisciences, warned companies needed to beware of the food/drug borderline.

“This loophole should be utilised with caution given the recent actions of Ireland, Germany and Denmark releasing draft lists and guidance over what they consider medicinal herbs,” ​Tallon said.

“Claims should not be used at all if evidence cannot be provided to support specific nutrition/functional effects, and to take care on what studies are used to substantiate their botanical status.”

Tallon said the fact botanical products will not even be looked at for potential claims under the nutrition and health claims regulation until the end of 2011 would assist those companies that may not yet have registered products under the 2004 Traditional Herbal Medicinal Products Directive (THMPD).

The deadline for such registrations is April 30, next year, but with some products already making non-disease claims in some member states, they could in theory remain, “on the market for an additional 6-8 months, if not longer.”

The UK has been the most active member state by far in terms of THMPD product registrations, with the UK Medicines and Healthcare products Regulatory Agency (MHRA) approving 78 products so far out of 166 applications received. None have as yet been rejected.

The 69 approvals have featured 27 different herbs from valerian to sage, black cohosh, St John’s Wort and Echinacea. Thirty one applications have been lodged so far in 2010. A list of the latest registrations can be found here.

Registrations are known to have occurred in Germany, the Netherlands and Slovenia but at low numbers.

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