The company’s nutraceutical project manager, Alexis Lesebvre, said the stop-the-clock dialogue clarified the agency’s position on post-prandial glycaemia responses.
It therefore changed the claim from, “Helps maintain normal activity of post-prandial glycaemic regulation mechanism” to, “Helps reduce post-prandial glycaemic responses”
It withdrew the claim: “Helps improve insulin sensitivity”
Lesebvre said the company was confident because EFSA’s health claims panel had not raised any issues about the contents of the dossiers central clinical tria.
A verdict on the article 13.5 dossier is expected in May this year.