Dispatches from Vitafoods Europe 2011

EU regulatory experts debate herbs (don’t panic) and health claims (shout louder)

By Shane Starling

- Last updated on GMT

Related tags European union

The European Union Traditional Herbal Medicinal Products Directive (THMPD) is ultimately a force for good, although some “small guys” may disagree, says leading consultancy and contract research organisation, analyze&realize. The nutrition and health claims regulation (NHCR)? Well, that’s another matter.

THMPD: Uniformity is good

“We are a believer in European harmonisation – we think it is a good thing…that one product can go to all the member states and be distributed with the same labels and the same claims,”​ said owner and president Joerg Gruenwald, PhD.

“[But] every legislation change is good for some people and bad for other people... There will be products coming off the shelves – it’s hard for some companies definitely – but I would say the majority of products will stay on the markets and there will be more uniformity of the products all over Europe.”

Gruenwald said building files to gain THMPD botanical registrations typically cost at least €100,000, which inevitably meant, “small guys suffer the most”.

NHCR: Listening is good

“I think some aspects of batch four are interesting because it shows there are chances to get positive opinions like polyphenols, sugar replacers and other starches,”​ commented senior consultant Christiane Alexander, PhD.

“There is a chance to really convince EFSA in a scientific way of the effects that products can have. But there were many opinions that were again disappointing.”

She observed the joint health area was particularly disappointing because the “inflammation aspects cannot be dealt with”.

“There was guidance on joint health but it is not useful because it is just a summary … of the published opinions which we know. We expected something new… that they give us good directions about how we should design the trials and also show a willingness of making this whole thing of the health regulation useful for the industry and for the customers.”

Alexander said she hoped a recently announced restructuring at EFSA would improve the chances of dialogue with the agency, including ongoing stakeholder meetings.

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1 comment

Creative and new ways to work with the THMPD

Posted by Dr John Wilkinson,

For small companies or companies that have many different products to get approved - the THMPD is hard for them and many may have to close down or significantly re formulate their products. Also, some herbal remedies were borderline medicines / foods and can, with reformulation, be resold as a food supplement with or without claims. However these arguments need to be carefully thought out and be scientifically justifiable - we have been successful with this route on many occasions in the past and consequently many of our clients are asking us to do this now the THMPD is in force. Also others are looking for history of use in the EU that up until now they did not possess – i.e., we are finding evidence of history of use that companies were not aware of – lets not forget that the EU is a large place and evidence can often be found! Finally, The regulations are not set in stone, and negotiations are possible. We plan to file dossiers without the 30 year rule (but closely meet it) and also submit high quality “history of use “ data from outside of the EU as dossiers in which we are deliberately challenging the accepted norms. For some companies this is their only option and they would rather try something creative & speculative than simply “lying down and letting their products die”. Such actions will help change the 30 year ruling which I believe was thought to be a good idea at the time, but is not based on good science – evidence of safe history of use should be useable from anywhere in the world and not just based on usage in the EU. We have managed to copnduct such innovations in the novel foods area and believe we can do the same for the THMPD. All of the directives change over time as the boundaries widen and the regulatory authorities begin to relax and get more experience with these new directives. I am still very positive that herbal medicines will remain in the EU as at the end of the day, the consumer wants them! Dr John Wilkinson, Director, Herbal Sciences International Ltd, UK

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