That September 2010 EC move was welcomed at the time by a herbal supplements industry which had campaigned hard against the clinical trial-focused nutrition and health claim regulation (NHCR) it said discriminated against tradition-of-use, claim-backing data.
Now European Union member states are considering what kind of scientific protocols are appropriate to treat the 1500-odd botanical health claim submissions that are set for assessment at some point by the EU’s head science agency.
They have until the end of the month to peruse and comment upon a discussion paper that has been circulated on the contentious subject. The EC is set to meet with member states to debate their conclusions in mid-September.
“It is difficult to predict what will happen,” said Patrick Coppens, secretary general of the European Responsible Nutrition Alliance (ERNA) and the European Botanical Forum (EBF).
“There are two fundamental routes – continue with the current procedures which will almost certainly remove almost all botanical indication claims, or consider other actions to deal with botanicals. We support a rethink and suspect MS will too.”
“If the support is unanimous the changes could come quickly as the EC will have a very strong signal that the current NHCR stipulations are not suitable for botanicals.”
Coppens said different scientific criteria was appropriate for botanicals as nutrients that were potential candidates such as probiotics or soy did not place such importance on tradition-of-use of data to demonstrate their efficacy.
There was also the issue of foods versus botanical medicines, with many herbal supplements registering health indications with tradition-of-use data under the EU Traditional Herbal Medicinal Products Directive (THMPD) that kicked into life last year and saw 751 products registered across the bloc by the end of 2011.
Indeed THMPD-registered products must state they are, “for use in specified indications exclusively based upon long-standing use.”
The discussion document highlights the problem that herbal regulations are not unified in the EU, meaning the same botanical could be classed as a food in one member state and a medicine in another.
Of the reforming option, the document posits that such a stance would, “explore the opportunity of changes to the existing legal framework applying to health claims made on botanicals used in foods in order to give recognition to evidence based ‘traditional use’ as sufficient to substantiating health claims.”
“In this context, there would also be the possibility for the risk managers to start a more comprehensive reflection on the use of botanicals in foods which would extend to issues other than the proof of the efficacy of botanicals and the relevant communication to consumers in the form of health claims.”
Root and branch reform
Rob Verkerk, PhD, the chief and scientific executive officer at the Alliance for Natural Health-International got in touch to say even such a reform as that would not go far enough.
"How can the public be informed or educated properly if a supplier can't say, for example, that broccoli or cherries, or products derived from them, are beneficial to them. But tinkering around the edges won't resolve the problem. Nothing short of root and branch reform is needed - and not just for botanicals. A different evaluation system applied to just one group would make the process both legally disproportionate and scientifically irrational.”