The company told NutraIngredients it had in fact tried to contact the companies involved in the general function, article 13 submission to urge them against proceeding with it via their relevant member states: Slovakia, France and Finland.
“We knew the dossier was not strong from what we had seen so we tried to contact the two or three companies – smaller players – to advise against it because we were certain it would not succeed, but they went ahead with it anyway and were rejected as we expected,” a company spokesperson said. “It had nothing to do with us.”
Ingredia has a proprietary hydrolysate version called Lactium but has not yet submitted a health claim for it as it continues to build scientific data for it, but has a submission in the wings.
In a statement the company said it, “keeps running new clinical trials.”
“One ongoing study on a shorter period of use actually showed very promising results. Ingredia Nutritional could consider collaborating with the EFSA (European Food Safety Authority) to make the most of all these clinical evidences.”
Rejected claim
Ingredia bemoaned the rejected claim which it said was seriously flawed, aside from the fact the general function, article 13 list may not have been appropriate for it.
“Unfortunately, incomplete data and inaccurate wording of these early requests - at a time when submission guidelines were not yet fully clarified - resulted in the negative opinion of the EFSA,” it said.
“Besides, those dossiers were submitted under article 13.1, which is inappropriate. If a request was to be made for a health claim for Lactium, it would have to be under article 13.5, as Lactium is a patented ingredient and its scientific and clinical data are proprietary.”
The EFSA opinion can be found here.