Held in Kosice as part of a the week-long International Scientific Conference on Probiotics and Prebiotics, the workshop aimed to explore the reasons for probiotic health claim rejections in order to carve a strategy for the industry moving forward.
The probiotic sector has been hard hit by the new health claim regulations in Europe, without a single claim approval coming through to date. In March this year, the European Food Safety Authority (EFSA) issued negative opinions for 94 article 13.1 probiotic strain health claim submissions, which followed on from 191 article 13.1 rejections in October last year.
It’s a mess
“It’s a mess and we’re all trying to work our way through it with little or no guidance from EFSA. They’re just throwing out claims. We’ve all been surprised by how rigid an approach they’ve taken to probiotics,” said chair of the regulatory workshop Dr Elinor McCartney, who is the director of Pen & Tec Consulting.
Attendees at last week’s workshop examined the health claim dossier structures in light of the string of probiotic claim rejections, and aimed to set out possible strategies for success, including ways to overcome certain “obvious and overseen barriers”.
“There’s only two ways around EFSA in this situation: you either do the work or you change the law. In the short term, industry will have to reduce their claims to deal with simple things like improved fecal consistency, but obviously those claims won’t be amenable to creative marketing,” said McCartney.
Other speakers included Caroline Herody, from the European Food and Feed Cultures Association; Danisco’s Arthur Ouwehand; and EFSA NDA Panel expert Yolanda Sanz.
Old concerns
An article appearing last week in the Canadian Medical Association Journal (CMAJ) re-iterated industry’s long-standing frustrations with EFSA’s health claims approach, going as far as stating that the regulations may push the European probiotic food industry out of the consumer market. The article can be viewed here.
In March this year, the leading trade group for the sector – International Probiotics Association (IPA) – broke its diplomatic silence to vent its frustration to NutraIngredients.com.
IPA director general Ioannis Misopoulos said EFSA’s approach was fundamentally “flawed”.
He said the NDA Panel’s (Panel on Dietetic Products, Nutrition and Allergies) preference for human intervention studies on healthy populations was flawed, and that these preferences had been defined too late.
“It can take three years to get these kinds of human studies together but in the meantime the claims are going to be wiped away,” he said. “The regulation is killing this industry and the job losses are already being felt. We’ve had enough of EFSA’s process as it stands and so are considering our options.”