The Global Alliance for Probiotics (GAP) is conducting much work in the area of probiotic clusters and said an independent review of strains in the Lactobacillus family with immune benefits had led to the reviewers remarking they had, “never seen such strong data.”
“EFSA [European Food Safety Authority] has not contemplated the cluster method,” GAP chairman and Valio R&D VP Ross Crittenden told the Probiotech and Microbiota 2013 conference in Brussels last week. “That is why we need increased dialogue with EFSA to discuss this. We don’t want to waste EFSA’s time or our time.”
“We call for a dialogue with EFSA in cases where the current guidance doesn’t allow us to submit high-quality dossiers.”
He said GAP, which includes Danone, Yakult, DuPont and Chr Hansen as members, was still debating the best way to submit any dossier into the EU nutrition and health claims regulation (NHCR) if and when a folder of data may be ready.
“We've been debating that internally, the best way to do it and we still have a lot of questions around that,” he said with most delegates at the conference of the opinion that article 13.5’s proprietary and emerging science avenue was the most likely.
Mechanism of action
The GAP chair said probiotic research had not yet identified the mechanism of action that delivered probiotic health benefits to the gut and immune system that have been documented in many peer-reviewed probiotic studies and even systematic reviews performed by the well-respected Cochrane Collaboration.
“We can come up with a plausible mechanism but can’t come up with a known mechanism at the moment,” Crittenden said.
“If EFSA asks us to nail the mechanism then we are in big trouble because we don’t know exactly how they work.”
Crittenden said the group was looking at other avenues like economic impact studies that show benefits of taking certain probiotic products
“We are finding the economic benefit is really quite large but we need regulatory certainty,” he said.
Last year professor Ambroise Martin, the chief of EFSA’s NDA health claims panel, said genomic advances would see probiotics win an EU health claim in “1-2 years.”