The European Botanical Forum (EBF) will meet representatives from the European Commission (EC) and the European Food Safety Authority (EFSA) tomorrow (Tuesday Dec 11) to thrash out the contentious issue of scientific substantiation for health claims on botanicals.
Crucially, Dr Pilar Rodriguez Iglesias, scientific coordinator of the EFSA panel that will be assessing health claims under the controversial new EU Nutrition and Health Claims Regulation, will also be at the meeting, said EBF secretary Patrick Coppens.
The big worry for manufacturers using botanical extracts in food, drinks or dietary supplements is that claims about many of them are not supported by human intervention studies - the ‘gold standard’ of evidence legal experts believe will be required for claims to gain approval under the new Regulation.
If observational data and traditions of use evidence are not given equal weighting, botanicals and botanical-containing products could be left out in the cold under the Regulation, warned Coppens.
Indeed, large swathes of the dietary supplements market could be killed off, he said. "We are not saying that suppliers shouldn't have to prove that their ingredients work, simply that they should get fair treatment. In the field of traditional herbal medicinal products the value of observational evidence and experience is given substantial weight when assessing efficacy of medicinal effects under medicinal law."
It would be "totally disproportionate" if requirements for proving the efficacy of a health claim were more demanding than they were for proving a medicinal therapeutic effect, he claimed.
A huge number of grey areas within the Regulation still needed to be addressed, according to legal experts speaking at a conference on health claims at Leatherhead Food International (LFI) last week. The lack of any reference to energy or high energy products in the annex of nutrition claims permitted under the Regulation was of particular concern, said LFI business manager, regulatory and technical consultancy services, Kath Veal. “There are references to ‘reduced energy’ and ‘energy free’ on the annex, but what about standard energy drinks? What will they be allowed to say?”
There was also some confusion about whether the frequently-used phrase ‘reduces/lowers cholesterol’ - a known risk factor for cardiovascular disease - would be considered under article 13 or 14 of the Regulation, said Veal. This was not just a technical point, she stressed. If it were considered to be an article 14 claim (a disease risk reduction claim), companies wishing to use it would be required to submit costly scientific dossiers for EFSA to scrutinise, she said. If it were approved under article 13, it would sit on an EU-wide ‘positive list’ of claims that anyone could use in association with approved cholesterol-busting ingredients.
Manufacturers also needed to be aware that vague claims such as ‘guilt-free’ or ‘for vitality’, ‘superfood’ or even ‘nutritionally balanced’ could in future be banned unless they were accompanied by an approved health claim, she said. They also needed to be careful with ‘contains’ statements, she added. The phrase ‘contains lycopene’ was simply a nutrition claim seen as stating a fact, she said. However, the phrases ‘contains prebiotics’ or ‘contains antioxidants’ would have to be accompanied by approved health claims about the prebiotics or antioxidants in question as they implied a health benefit.