In a statement to NutraIngredients, the company made it clear that the article 13.5, emerging and proprietary science submission was backed by solid science but sought a non-core claim area.
“The health claim submitted by Yakult to EFSA is a specific health claim within a limited area, namely keeping the upper respiratory tract healthy,” Yakult said.
“This is one part of the research and proof which we have been working on. The claim was supported by well-designed double-blind placebo-controlled human studies.”
The firm reiterated its earlier calls for more dialogue with EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA).
“Yakult would like to discuss the evaluation process, scientific criteria and the outcome with EFSA. Yakult is confident in submitting new health claim dossiers, once there is clarity on the specific requirements. The company anticipates a positive EFSA opinion in due course.”
“Yakult will continue to conduct human studies, exploring and confirming the health benefits of its probiotic products.”
“The market remains stable”
A spokesperson added that the submission was intended to test the functioning of the regulation and so focused on URTIs, which did not feature in its existing broader immunity messaging.
“Nothing changes,” a spokesperson said. “It was a dossier submitted at the beginning of the process but it was one we wanted to put forward. The market remains stable.”
He said Yakult, like many others in the probiotics sector, was waiting for the European Commission to give an indication of how many probiotic dossiers are to be treated that sit on a ‘grey list’. More than 200 of these article 13.1 general function claims were initially rejected by the European Food Safety Authority (EFSA) health claims panel.
Yakult’s rejected emerging science, article 13.5 dossier sought to link consumption of its Lactobacillus casei Shirota (LcS) strain and maintenance of defenses against URTIs via a boosted immune system. It contained 15 studies, 12 of which were peer-reviewed, and ten of which were human intervention trials.
The EFSA health claims panel opinion can be found here.