EFSA said the workshops will provide extra guidance for health claim applicants.
The gut health and immunity workshop will be followed by:
- February 2011: Post-prandial blood glucose responses/blood glucose control and weight management/energy intake/satiety
- May 2011: Oxidative damage and cardiovascular health
- September 2011: Bone, joint and oral health and cognitive function
- February 2012: Physical performance
EFSA said places at the workshop will be limited to about 100 with a preference for scientific experts in the gut and immune function area.
The Parma, Italy-based agency said the gut health and immunity workshop would feature discussion on two specific issues:
- Which claimed effects are beneficial physiological effects?
- Which studies/outcome measures are appropriate for the substantiation of function claims and disease risk reduction claims?
The seminar would also feature input the agency expects to receive from a public consultation following publication of a draft guidance document on gut and immune function in October.
That document will then be revised after the workshop.
“The overall aim of the consultations will be to provide additional guidance to applicants for the substantiation of health claims in selected areas,” EFSA said.
The gut and immune function workshop will interest prebiotic and probiotic players which to date have not fared well under the new European Union nutrition and health claims regulation.
Not a single probiotic dossier has won a positive opinion from EFSA’s Panel on Dietetic Products, Nutrition and Allergies which has rejected 284 article 13.1 probiotic strain health claim submissions in two batches since October last year.
Most of the dossiers were rejected before their scientific data was analysed however as the strains were deemed not to have been sufficiently characterised to warrant NDA scrutiny.
The probiotics industry has been scrambling to meet the NDA’s requirements ever since and recently held a regulatory workshop at the International Scientific Conference on Probiotics and Prebiotics in Kosice, Slovakia.
Workshop chair Dr Elinor McCartney, director of Pen & Tec Consulting, described the regulatory situation at the time as “a mess”.
“We’re all trying to work our way through it with little or no guidance from EFSA,” she said. “They’re just throwing out claims. We’ve all been surprised by how rigid an approach they’ve taken to probiotics.”
Potential attendees can sign up to the EFSA workshop on the EFSA website from September.