Leading experts on probiotics have called on the European Food Safety Authority (EFSA) to change the way it assesses health claims applications lodged under the EU’s Nutrition & Health Claims Regulation.
The group of 10 researchers, who together form the board of directors of the International Scientific Association for Probiotics & Prebiotics (ISAPP), have also demanded that EFSA allow companies applying for claims approval to hold pre-submission meetings with the agency’s NDA Panel, which is assessing all health claims applications.
Writing an open letter in the British Journal of Nutrition, the group said ISAPP scientists were "concerned that claims supported by solid scientific evidence are being rejected." They continued: "The NDA should adjust its approach on what it requires as the standard of evidence. A requirement of evidence of 'the highest possible standard' may be unrealistic for a functional food that is proposed to maintain health or reduce risk of disease."
With EFSA yet to approve any health claim application for a probiotic ingredient, the scientists said they would like companies to be offered the chance to have a pre-submission meeting with the NDA Panel before handing in a dossier to establish how best to design and carry out studies. "This would enable companies to gain NDA feedback on a research approach before launching expensive and time-consuming studies," the group wrote.
Proposal has broad support
The ISAPP is far from alone in wanting this to happen. Finland-based probiotics supplier Valio waded into the debate recently when it received a negative opinion from EFSA for a claim linking its Lactobacillus GG bacteria with gastrointestinal health benefits.
The company had submitted 86 studies, 45 of which were human clinical studies, in support of its application but was surprised to learn that the NDA Panel was unconvinced by the data it had presented.
In an interview in the July 2011 edition of New Nutrition Business magazine, the company’s development manager for R&D and nutrition, Tuula Tuure, urged EFSA to allow dialogue before, during and after the evaluation of a dossier.
"A dialogue during the evaluation process might have made it possible to formulate the claim in a way that meant the panel could have accepted a majority of the evidence," she said. "In addition, the conclusions one can draw from a given study are always subjective, so it would have been helpful to have discussed the outcomes in detail with the panel, once they had establish their view of them."
EFSA has stated that it does not have the resources to offer one-to-one consultations. But Tuure told NNB such discussions could actually save the agency time because "they would get much better quality applications."
Francisco Guarner et al Probiotic and prebiotic claims in Europe: seeking a clear roadmap. British Journal of Nutrition, Available on CJO 2011 doi:10.1017/S0007114511002248