Prebiotic and probiotic players have had a tough time of convincing the experts that sit on the European Food Safety Authority’s health claims panel (NDA Panel) that there is solid scientific evidence to back up an authorised health claim for their product.
Many have tried; all have failed. And while some may have learned valuable lessons from previous dossier submissions, there are also some who seem more concerned with complaining about regulations than building their own evidence, warned NDA Panel member Professor Hans Verhagen while speaking at a conference session at the Hi Europe show in Amsterdam.
“Please put your energy in science, do not put every effort in marketing, and certainly not in complaining,” warned Verhagen.
Indeed, when questioned on the prospect of business flouting EFSA rules by continuing to make claims, or by attempting to find ways around regulations, the Dutch scientist reiterated that good scientific evidence for any product should be the primary concern for any product.
“There are claims on the market that are not authorised and not on hold either,” commented Verhagen - noting that some suppliers and exhibitors at the Hi Europe show floor were breaching health claims laws.
“The enforcement is not down to EFSA, it is down to the individual national authorities,” he added.
Generic descriptor debate?
While some may be happy to simply ignore the EU-wide health claims regulation, and risk the consequences of national enforcement agencies, others have put effort in fighting the rules or to finding ‘loopholes’ around the regulation.
For example, Italian authorities have permitted the use of probiotic and prebiotic claims as a ‘generic descriptor’. But according to Verhagen, such a move does not fit with the guidelines for items that can be placed on the generic descriptors list.
“With respect to the generic descriptors, I do not know what will happen,” he told delegated. “There is a regulation, but I think it would not be good to place pro- and prebiotics on that particular list because they are generally understood by consumers to have a connotation to health, and the generic descriptor list is there for non-health associated generic descriptors.”
“As far as I know, Italy is part of the European Union, and we have the regulation that means the rules are mandatory for all countries for all countries in the EU, including Italy,” said the NDA Panel member.
However, Verhagen added that he can only evaluate the science, and would leave any battles over the interpretations of regulations, or the breaking of regulations, to the lawyers.
“Basically, I would think that if there is no evidence that it works, then the claim cannot be authorised and it should not be allowed,” he said. “My gut feeling is that the [EU generic descriptors] list will not have them.”
Call to action
The EFSA scientist challenged the prebiotic and probiotic industry to submit new dossiers that provide a robust scientific argument to substantiate their dossier, warning that many have failed in basic areas of science and clinical trial design.
“I invite experts … to come up with good scientific evidence for probiotics or prebiotics or synbiotics, and I think everybody would love to see at least one approved health claim in these areas at some point in time,” said Verhagen.
The scientist also reminded applicants that the wording EFSA uses does not mean that all hope is lost if a claim is rejected.
“Bear in mind that saying there is ‘no evidence’ does not mean that it is not true,” said Verhagen. “It means that there is currently no evidence that the claim is true, and that is a tiny bit different.”
New dossier caution
The Hi Europe session also saw Leon Knippels of Danone Nutricea Research speaking about the potential of prebiotics and probiotics. During a final Q&A session after all of the presentations Verhagen questioned Knippels on whether the pre- and probiotic industries will be able to deliver dossiers that will enable health claim approvals.
Knippels replied: ‘I think so’.
“I think we are still working on the dossiers,” he added. “We have learned from the previous ones, but it’s not easy.”
“We are re-thinking how to submit, and when to submit, and what is needed,” said the Danone Nutricea expert – noting that “big companies are much more careful about submitting dossiers.”