The company said it had refined its approach in the wake of meetings with EFSA and the experience of others in the process and come up with a submission it is “fully confident” of.
“We have redrafted the whole dossier, including rewording of the scientific claim, to take aboard elements coming from the June 15 stakeholder meeting [with EFSA],” Danone vice president of external affairs and head of EU regulatory affairs, Patrick O’Quin, told NutraIngredients this morning.
The reworked dossier has been bolstered by a study published in the British Journal of Nutrition (Vol 102, pp1654-1662) this month that demonstrated use of Activia could provide digestive health benefits in a normal population of women.
To view NutraIngredients ahead-of-publication coverage of that study click here.
“It is one of the first clinical studies that shows the impact of a fermented milk to improve the digest comfort within the global population,” O’Quin said.
The dossier contains 11 clinical studies, “selected for their direct relevance to the specific claim that is the subject of the application.”
O’Quin added: “We are fully confident in the quality of the science backing Activia as the effects are among the most carefully studied and best documented for any probiotic product in the world, with related research going back more than 20 years. The efficacy of Activia has been demonstrated in a large number of studies published in internationally recognised scientific journals.”
Back in the game
Danone in April withdrew two article 13.5 digestive health claims for Activia (spoonable yoghurt) and one article 13.5 immunity claim for Actimel (drinking yoghurt) in April this year, as it sought further guidance from EFSA about scientific requirements.
In August, it resubmitted a substantially altered article 14 disease reduction claim for Actimel centred on diarrhoea, but has not yet resubmitted an immunity claim for the product.
Functional claims for Actimel were under review, O’Quin said.
At the time of submitting the Actimel claim for diarrhoea, O’Quin said the dairy giant had learned much form the positive article 13.5 opinion won by UK company, Provexis, for a blood circulation claim for a tomato extract.
“When we withdraw our claims in April, there was much more uncertainty about what was required in the dossiers,” O’Quin said.
“But we closely studied the positive tomato extract opinion that came in at the end of May and it has been very instructive for our ongoing dossier preparations.”
Danone will discuss its response to the health claims process along with Provexis and others at the NutraIngredients Health Claims 2010 conference to be held in Brussels on Thursday, 10th December. Others include Unilever, analyse&realise, Cantox, academics, industry groups, lawyers and market experts. For more information and to register, please click here .