Danone has formed the Global Alliance for Probiotics (GAP) with other sector giants like Yakult, DuPont-Danisco and Chr Hansen as the frustrated industry seeks to win a first European Union health claim.
GAP wants meetings with the European Commission and the European Food Safety Authority (EFSA) to gain a “three years plus” moratorium on the assessment of probiotic science, with the removal of botanicals from the EU health claims process an example of how this can be done, an industry source said.
“The botanicals industry lobbied very well and won exemption from the process so this is a good example of what can be achieved,” the source said of the 1500 botanical dossiers EU authorities acknowledged needed to be treated differently to other nutrients.
“The probiotics lobbying effort has been a bit disappointing so far and so there has been growing momentum to make the lawmakers understand that there needs to be a moratorium for probiotics too.”
“EFSA needs to be given the chance to say that it is not ready to assess probiotic dossiers under the current regime.”
But GAP, which began as an adhoc initiative as Danone sought greater EFSA-EC dialogue after it withdrew its own probiotic claims from the system, may run into the same wall of frustrations as other probiotic groups, with initial efforts for meetings falling on deaf EU ears.
The group, whose other members include Canadian firm Institut Rosell Lallemand, Swedish supplier Probi, and Finnish dairy group Valio, is keen for discussions about the state of probiotic science, and the wellness promoting nature of probiotics, and the mismatch they see with the medicalised approach adopted by EFSA.
It is set to meet internally in March to further advance its cause in this area, whilst simultaneously developing ideas about better dossier submission under the EU nutrition and health claims regulation (NHCR).
More sophisticated multi-strain dossiers is one proposal being looked at, an indication GAP does not hold out much hope for the 70 or so recently resubmitted probiotic dossiers that failed at the point of first submission in 2007-08 due to strain characterisation issues.
The group has remained under the radar until publicised by DuPont-Danisco head of regulatory affairs, Dr Paul Tenning, at a probiotics summit in Brussels on February 7.
There Dr Tenning emphasised that GAP’s main objective is to, “promote understanding and awareness of probiotics.”
“GAP members want to define and promote the initiatives required to create a favourable framework for the approval of the health benefits of probiotics and the communication of meaningful and understandable claims on them,” he said of the €12bn+ global category.
In his presentation Dr Tenning noted that Danone had been fined in Denmark for making unauthorised links between probiotic immunity benefits and its Actimel drinking yoghurt.