While many claims have been rejected because they are scientifically weak, others stand a chance of approval if resubmitted with a closer eye on the guidelines EFSA has issued, according to professor of medicine and nutrition and EFSA panel member, Jean-Louis Bresson.
Article 13.5 claims involve new science and/or proprietary claims while article 14 relates to disease reduction and children’s health and development claims.
Naive
Bresson said some dossiers were strong scientifically but had fallen down on ‘technicalities’ because substances were insufficiently characterised or claims had not matched the science presented.
“Many of the claims submitted so far demonstrate a naivety about the requirements of the process,” he told NutraIngredients.com after taking part in a forum hosted by regulation specialist, Pharmanager Group at its booth at Vitafoods.
“With a little more attention to detail and more careful wording of claims, it is possible the science is there for some of these claims to be approved.”
But he added many claims were weak scientifically and stood little chance of gaining a positive opinion from EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA), if re-submitted.
He wasn’t explicit about which of the 60-or-so rejected claims to date possessed the best chance of a positive verdict, but “several stood a good chance” if tweaked.
Additional guidance due to be issued by the Parma-based assessor this month, as well as a stakeholder meeting in Brussels on June 15, would provide industry with detailed information about exactly what EFSA requires for a claim submission to be approved, Bresson said.
Better understanding
Danone is one company that has decided to wait for such clarification. The French dairy company pulled three proprietary article 13.5 claims relating probiotic consumption and digestive health and immunity last month and stated it was “better to know the rules before playing the game”.
“There has been a lot of misunderstanding and misinterpretation of the regulation,” Bresson added. “Which is why additional guidance is being issued and some of those problem areas will be clarified to make the process more transparent.”
Article 13.1
He added, without going into detail, that assessment of claims in the article 13.1 list was underway, with the NDA reaching “many positive opinions”.
NDA opinions on the first 1024 of a list of about 4000 article 13.1 claims, which are non-proprietary, are due by the end of July. The whole process is due to be wrapped up by the end of January, next year.
EFSA’s statement on its plans to issue further guidance can be viewed here.