European functional-ingredients suppliers are nursing yet another hangover induced by the Nutrition & Health Claims Regulation.
On October 1, the European Food Safety Authority (EFSA) published opinions relating to 523 Article 13.1 claims submitted for inclusion on the 'Community List' of claims that will eventually be available for use by any company across the European Union.
Almost a third of the claims put forward were given positive opinions — mainly well-established claims for essential vitamins and minerals. Worryingly for the industry, however, more than two thirds were rejected, with popular ingredients such as probiotics, glucosamine and chondroitin among the highest-profile victims.
Nearly half of the rejected claims were turned down by the EFSA's NDA panel, which is carrying out the evaluations, because the ingredients in question were not 'characterised' properly. In simple terms, this means an ingredient was not described in enough detail to satisfy EFSA's scientists that the evidence cited to support a claim was relevant for that ingredient.
This was a fate that befell dozens of probiotics because although the name of the species had been submitted, a strain number was not. Several botanicals, too, found themselves on the wrong end of negative opinions on the basis of poor characterisation.
To have a claim rejected for this reason does not necessarily mean the evidence submitted was flawed. In essence it amounts to failing on a technicality. For this reason, the issue of characterisation has become highly controversial. There is a feeling among some that the EFSA could have referred poorly characterised ingredients back to member states for further attention. It has already done this with several claims that were considered too vague for evaluation. Certainly, this is the view of the European Federation of Associations of Health Product Manufacturers (known as EHPM). Its director of regulatory affairs, Lorène Courrège, said, "We are somewhat puzzled that the EFSA has not asked for further clarification on those claims to member states, as it has done for so many other claims. We believe further clarification on this would be of interest to all, industry as well as consumers."
Consultant David Richardson of London-based DPR Nutrition agrees. "Clearly, there are concerns that the EFSA or the commission had plenty of time to ask for further information about the characterisation of the food or constituent," he said. "If the industry had been told claims would be rejected on the basis of a lack of characterisation they probably would have been able to provide the EFSA with more information. But they didn't come back and ask, apparently."
Not everyone holds this view, however. Nino Binns of Ireland-based NB Consulting said it would have been a lot to expect the EFSA to have screened claims out early on the basis of characterisation. "That involves quite a detailed assessment," she said. "The first screen was done largely by the \[EFSA\] secretariat. There would have been information there about the characterisation and it would have looked OK. So they weren't aware then there wasn't sufficient characterisation, until they looked in more detail."
Nigel Baldwin, scientific and regulatory consultant at Cantox Health Sciences International, said that from a scientific perspective, failing to characterise an ingredient correctly is a basic and avoidable error. "It's fundamental," he said. "The first thing that happens in any kind of review for any kind of natural ingredient is that they bombard you with questions about the composition."
Characterisation is particularly important in relation to probiotic cultures, he said. "Take E coli. E coli 0157 can kill you, but your gut's full of E-coli. It's a perfectly normal enteric micro-organism. One strain of E coli can kill you and another forms a perfectly normal part of your gut. Strain is very important in micro-organisms."
The good news is that characterisation need not be a major impediment to successfully gaining a positive opinion from the EFSA at a later date. "It's easily rectifiable," said Baldwin; however, there is no appeals procedure in the Article 13.1 process. This will have to be done through a new Article 13.5 dossier. There remain nearly 4,000 Article 13.1 claims for the EFSA to evaluate, with further batches of opinions expected in February, July and then, lastly, in the summer of 2011.