Tereos Syral challenges health claim rejection: Our study was not ‘considered adequately’ by EFSA
The company sent its grievances to the European Commission, which forwarded the comments to EFSA.
In its letter to the Commission dated February, Tereos Syral questioned EFSA’s assertion that “no conclusion” could be drawn from an unpublished study (Benamouzig 2015) involving 150 subjects.
The study was submitted as part of its claim dossier for short-chain fructooligosaccharides (scFOS) from sucrose and the maintenance of “normal intestinal transit regularity by increasing stool frequency”, which was rejected in January.
Dr Frédérique Respondek, scientific and regulatory affairs manager for the company, wrote: “We stress that a number of features of study design and results were not considered adequately during the evaluation: the adequacy of statistical analysis; the attribution of drop outs; the return to baseline values during the follow-up period.”
A spokesperson for EFSA told us:“The company put forward its comments to be taken into account for a future application, not to appeal EFSA’s conclusions.”
The company declined to comment.
Following the rejection, Tereos Syral told us it was prepared to invest €0.5m to fill in evidence gaps with studies concerning a scFOS dose of 5 g per day and resubmit the claim by the end of the year.
“We want to obtain the claim. We have the resources, we have the funds,” Daniel Cochet, marketing and commercial development manager for company, said.
A response to the “request” would be published in no more than four months, EFSA said, but it declined to comment further on the on-going case.
Forwarding the letter onto EFSA, head of the Commission's DG SANTE unit for nutrition, food composition and information, Alexandra Nikolakopoulou, wrote: “Before considering further steps on this matter, and given that the above-mentioned comments relate to scientific matters for which EFSA is responsible, we would like EFSA to examine them, and let us know whether they are likely to modify the conclusions of the relevant opinion.”
However, the precedent suggests EFSA would be unlikely to deviate from its published conclusion.
One rare U-turn came in 2013 when EFSA backtracked on its previous rejection of a claim for prunes and 'normal bowel function'.
The claim application was submitted through Beghin Meiji – Tereos Syral’s joint venture with Japanese company Meiji Co.