Lesaffre’s just sent €1m+ dossier seeks to link the strain, Saccharomyces cerevisiae boulardii CNCM I-3799, with the, “maintenance of intestinal comfort”.
Lesaffre Human Care commercial and marketing director Benoît Laplaize told NutraIngredients the company had worked on the dossier for more than a year and was confident the article 13.5 emerging and proprietary science submission would succeed.
It had also learnt a great deal from a probiotic yeast submission it withdrew in 2011 after stop-the-clock interaction with EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) highlighted issues it knew it could not overcome at the time. That dossier is being reworked.
“Probiotics will always be difficult for EFSA because it is about putting live organisms into live organisms but we are confident about these studies and the ability to demonstrate mechanisms of action,” Laplaize said.
He said the dossier had also been informed by the 40+ studies on “the 50-year-old” boulardii strain, interaction with French government agencies and other national governments, regulatory consultants, industry players and trade associations.
He opined that winning a claim was more important than the content of the claim itself, as EFSA validation acted as a ‘quality seal’ that was increasingly recognised by consumers across the European Union.
Lesfaffre's withdrawn article 13.5, probiotic yeast claim proposed that strain, CNCM-3856, also from the boulardii family, could, "Noticeably reduce digestive discomfort after four weeks of consumption".