The European Food Safety Authority (EFSA) Panel on Dietetic Products, Nutrition and Allergies (NDA) said the mechanism of action data in three fresh clinical trials was weak for the low-calorie bulking agent.
Tate & Lyle proposed that because polydextrose arrived at the colon undigested, its partial fermentation there would increase bacterial mass and stool bulk.
The NDA was unimpressed and noted similarly weak data and “poor methodological quality of the human intervention studies“ for a previous article 13.1 general function submission under the EU nutrition and health claims regulation (NHCR).
Of the three new studies, one showed the effect of 20 g/day for 10 days but polydextrose doses of 21 and 18 g/day for 3-4 weeks did not show an effect in normal defecation.
The NDA concluded: “On the basis of data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of polydextrose and maintenance of normal defecation.”
Tate & Lyle specialises in sugar-based food ingredients and produces a polydextrose called STA-LITE.
The low-calorie bulking agent can be used in bakery, cereals, dairy deserts, fruit fillings, flavoured water, ice-cream, juice drinks, ketchups, snacks and sauces to help replace sugar at one kcal per gram.
The firm promotes polydextrose as a low glycaemic response soluble fibre with prebiotic properties.
Tate & Lyle proposed the claim: "Polydextrose contributes to an improved bowel function by increasing stool bulk."
The NDA opinion is here.