Danone withdrew from the process three article 13.5 emerging and proprietary science gut health and immunity claims in April, stating at the time it sought further guidance from EFSA at its stakeholder’s meeting in June.
With that advice pocketed, Danone is refining its submissions which it said would be ready for re-submission in “the coming weeks and months in support of all three claims”.
A Danone spokesperson highlighted three areas that had been clarified at the Brussels stakeholder’s meeting and which were informing Danone’s dossier-tweaking.
These were:
- Stop the clock. Allows more time for dialogue between applicant and EFSA. “For Danone, this will help to clarify some elements in the application and to allow applicants to bring further clarification to the Panel,” the spokesperson said.
- Observational studies. Although EFSA never said they weren’t permissible, it reaffirmed their role as supporting evidence to clinical trials in Brussels.
- Claim wording. EFSA had spelled out the importance of claim wording very tightly matching the available science.
Learnings
But no new science would be presented in the resubmissions, the spokesperson said.
“We can't be specific at this time as to when exactly we'll be re-submitting, but we are planning to resubmit various dossiers over the coming weeks and months,” the spokesperson told NutraIngredients.com.
“We will take learnings from the June 15 meeting and take recent EFSA opinions into account in our re-submissions. However, the science backing for our claims remains the same and is based on numerous clinical studies and more than 20 publications.”
In response to the weekend’s UK Guardian article which questioned the science backing probiotics and highlighted some of the negative EFSA opinions that had already come in, Danone pointed to the demonstrated benefits of those clinical trials.
Not only Danone, but the whole probiotic and wider functional foods industry will be hoping EFSA views the strength of that science and the associated claims, equally strongly.
The withdrawn claims
The three withdrawn article 13.5 claims are:
· Improves digestive comfort (Activia)
· Improves slow transit (Activia)
· Helps to strengthen the body’s natural defences (Actimel)
There have been 24 peer-reviewed studies published about Activia and 16 about Actimel.
At the time of its withdrawal, Groupe Danone corporate communications director in health, nature and external communication, Agnès Berthet-d'Anthonay told NutraIngredients.com:
“We will not change the studies that are in the dossiers but it may be that the way the information is presented needs to be changed and the wording may have to be modified. It is a difficult thing to find the correct wording and that has contributed to the fact no article 13.5 claims have as yet been accepted by EFSA. But we are very confident about the strength of our science.”
Since then one article 13.5 claim has won a positive opinion from EFSA – linking tomato extract consumption and blood platelet aggregation. But this claim was heavily modified by EFSA from that submitted by the UK-based applicant, Provexis Natural Products Limited.