Safety of inulin-propionate ester as a novel food pursuant to Regulation (EU) 2015/2283.

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the safety of inulin-propionate ester as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF, which is the subject of the application, is a compound constituted by a natural polymer composed mainly of fructose moieties, polysaccharide inulin (65%-95% w/w), esterified with a short-chain fatty acid (SCFA) moiety, propionic acid (5%-35% w/w). The NF is synthesised by the chemical reaction of inulin with propionic anhydride, under alkaline conditions and controlled temperature. The target population for the NF is the general population and it is intended to be used as an ingredient in cereal bars and fruit smoothie type beverages. Based on the provided studies investigating the metabolic fate of the NF, the Panel considers that the NF is not absorbed intact, but it is metabolised mainly in the large intestine to inulin and propionate which then exhibit normal metabolic fate of non-digestible dietary fibre and SCFA, respectively. Taking into account physico-chemical properties of the NF, the production process and metabolic fate of the NF, which do not raise safety concerns, and given that propionic acid and its salts were previously assessed by EFSA ANS Panel (2014), as well as that a large body of safety data were available on inulin, the Panel considers that no genotoxicity and subchronic toxicological studies are required on the NF. Despite the limitations of the provided human studies (primarily designed to investigate efficacy endpoints), the Panel notes that the NF, at doses up to 20 g/day for durations up to 12 months, appears to be generally well-tolerated. The Panel concludes that the NF, inulin-propionate ester, is safe for the general population under the proposed conditions of use.