Latest EFSA opinions on gastrointestinal health

EFSA recently published three opinions under Article 13.5 of Regulation (EC) 1924/2006 relating to gastrointestinal health. Sugar beet fiber wins a positive opinion on the increase faecal bulk, mainly substantiated by two clinical studies showing significant results. Indeed, the three criteria required by the Panel, the characterization of the ingredient, the health relationship and the scientific justification, are achieved permitting a positive outcome. However, EFSA also rejected a request on the sugar beet fiber and its effect on intestinal transit due to insufficient scientific justification. The quality of studies and methodology are in fact challenged.

An application on the scientific substantiation of a health claim related to a mixture of β-galactooligosaccharides and reducing gastro-intestinal discomfort was also evaluated negatively by EFSA. It seems that although a link between the ingredient and the increase in bifidobacteria in gut is admitted, as the link between health and maintenance of gastrointestinal function, it lacks the connecter between increasing bifidobacteria and the proper gastrointestinal function.

According to EFSA’s opinions on gastrointestinal health, it seems that getting a claim relating to the maintenance function is achievable, but to this day, none of them deals with the concept of intestinal comfort or improvement in function.

For any requirement regarding the “gastrointestinal health application”, do not hesitate to contact our experts.

Data Solution

The most efficient DATA Solution to create your products in the 28 European Member States


The artificial intelligence solution for regulatory review & labelling. Enter your formula and start the analysis!