摘要：Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to carry out the additional assessment for ‘phosphated distarch phosphate’ Novelose® 480HA, as a food ingredient in the context of Regulation (EC) No 258/97. The novel ingredient is a chemically modified starch manufactured from high-amylose maize. Starch chains are cross-linked and esterified with phosphate groups to create a digestion-resistant starch (Resistant Starch Type 4). The novel ingredient is proposed for use in low-moisture food products (e.g. bread and bakery products, breakfast cereals, pastas and snacks) at a maximum level of 15 %. The maximum daily intake based on a conservative estimate, was calculated to occur in male teenagers with a mean of 9.0 g/person and 25.3 g/person for the 97.5th percentile. On a body weight basis, the highest estimated intake is in small children (mean 0.38 and high level 1.09 g/kg bw per day). The toxicological tests described by the applicant to demonstrate the safety of the novel ingredient were carried out using various phosphated starches including varieties of phosphated distarch phosphate that are currently used in Europe as food additive (E1413). They have a similar content of phosphorus but are manufactured from “conventional” maize having starch grains with less than 30 % amylose and 70 % amylopectin. The toxicological tests did not provide reasons for concern. The conservative estimated maximum intake of phosphorus at the 97.5th percentile of 101 mg/day for male teenagers is low compared with European intakes ranging up to about 2600 mg per day and was considered not of concern. The product specification allows up to 0.8 % protein, assumed to be derived from maize, which is not a common allergenic food. The Panel concludes that the novel ingredient, a phosphated distarch phosphate, is safe at the proposed conditions of use and intake levels.
