The functional foods industry will finally get the chance on June 15 to come face to face with health claims assessors reviewing applications under the EU's Nutrition & Health Claims Regulation.
Up to 100 representatives of food and beverage businesses will be in attendance at the Brussels meeting. The European Food Safety Authority (EFSA) promises an exchange between industry/applicants and the assessors panel (NDA).
The conference comes amid growing anxiety about the stringent criteria the NDA Panel is applying when evaluating the dossiers. Of the 59 (at time of writing) Article 13.5 and 14 claims assessed so far, 49 received negative opinions. An 83 per cent failure rate has many spooked.
Food companies are hungry for much-needed guidance. Danone has withdrawn its health-claims dossiers until after the event. David Richardson, of London-based DPR Nutrition, said he believed the meeting was being held too late, but "better late than never… The meeting will be the first opportunity that applicants and those who are writing the dossiers will have to question the process that is being utilised by the EFSA panel… People are very frustrated with the way the whole claims-substantiation process has been handled."
Despite the lack of guidance, EFSA's assessors are placing a major emphasis on so-called 'gold standard' randomised controlled trials involving healthy human subjects. Without these, other evidence sources — in vitro, animal and epidemiological studies — count for little, it appears. It raises the question: will the meeting change this? Unlikely, according to Nino Binns of Ireland-based NB Consulting. "EFSA has said it is simply doing what is required of it in the Regulation," she explained. "It is following the remit it has been given — or its interpretation of that." At the very least, Richardson said companies need to know how much research needs to be done and the cost and time implications of that.