To date no probiotic submissions to EFSA’s NDA [dietetic products, nutrition and allergies] panel, which considers health claims, have been successful.
They have either been rejected for insufficient characterisation of the active ingredients and/or lack of evidence of efficacy on a healthy population or withdrawn by the companies submitting them.
But Dr Julian Stowell, scientific affairs director at Danisco, told Food Manufacture that he was now slightly more optimistic about the prospects for getting positive approvals on probiotics following a working group meeting on the immune system and digestive health organised by EFSA in Amsterdam last week.
“We are feeling slightly more positive,” said Stowell.
Draft guidelines for applicants
Following the meeting, draft guidelines are likely to emerge to help companies supply information in the form that the NDA panel finds acceptable, he said.
Stowell was also hopeful that in future biomarkers for disease would be acceptable as a means of proving the efficacy of probiotics in a ‘healthy’ population.
Stowell said Danisco was committed to a strategy predicated on robust science and working to create a more “pragmatic” regulatory environment for health claims in Europe.
However, he warned that Dansico, which spends around £100m a year on research, could concentrate on other areas of its activities, such as enzymes or in regions of the world such as Japan, if the regulatory environment in Europe proved too difficult.
Growing frustration
While participants at the Amsterdam meeting welcomed the opportunity to quiz EFSA over its approach to gut heath and immunity claims, several suppliers of probiotics at the event felt their concerns about biomarker validation, trial design and disease versus disease risk reduction had not been addressed.
Indeed, Frederic Rene, vice president of research and development at Danone Dairy, told our sister publication Nutraingredients.com that he was still none-the-wiser about EFSA’s dossier requirements.
Click here to watch a webcast of the meeting.
Click here to listen to the Nutringredients podcast with Danone.