Re‐evaluation of oxidised starch (E 1404), monostarch phosphate (E 1410), distarch phosphate (E 1412), phosphated distarch phosphate (E 1413), acetylated distarch phosphate (E 1414), acetylated starch (E 1420), acetylated distarch adipate (E 1422), hydroxypropyl starch (E 1440), hydroxypropyl distarch phosphate (E 1442), starch sodium octenyl succinate (E 1450), acetylated oxidised starch (E 1451) and starch aluminium octenyl succinate (E 1452) as food additives

Abstract

Following a request from the European Commission, the EFSA Panel on Food Additives and Nutrient sources added to Food (ANS) was asked to deliver a scientific opinion on the re-evaluation of 12 modified starches (E 1404, E 1410, E 1412, E 1413, E 1414, E 1420, E 1422, E 1440, E 1442, E 1450, E 1451 and E 1452) authorised as food additives in the EU in accordance with Regulation (EC) No 1333/2008 and previously evaluated by JECFA and the SCF. Both committees allocated an acceptable daily intake (ADI) 'not specified'. In humans, modified starches are not absorbed intact but significantly hydrolysed by intestinal enzymes and then fermented by the intestinal microbiota. Using the read-across approach, the Panel considered that adequate data on short-and long-term toxicity and carcinogenicity, and reproductive toxicity are available. Based on in silico analyses, modified starches are considered not to be of genotoxic concern. No treatment-related effects relevant for human risk assessment were observed in rats fed very high levels of modified starches (up to 31,000 mg/kg body weight (bw) per day). Modified starches (e.g. E 1450) were well tolerated in humans up to a single dose of 25,000 mg/person. Following the conceptual framework for the risk assessment of certain food additives, the Panel concluded that there is no safety concern for the use of modified starches as food additives at the reported uses and use levels for the general population and that there is no need for a numerical ADI. The combined exposure to E 1404-E 1451 at the 95th percentile of the refined (brand-loyal) exposure assessment scenario for the general population was up to 3,053 mg/kg bw per day. Exposure to E 1452 for food supplement consumers only at the 95th percentile was up to 22.1 mg/kg bw per day.

Exposure to food additive mixtures in 106,000 French adults from the NutriNet-Santé cohort

“…Overall, when comparing exposure estimates with EFSA's, intakes of the NutriNet-Santé population were relatively lower. For instance, for modified starches, we estimated a mean intake of 24.33 mg/kg bodyweight per day (95th percentile: 66.4 mg/kg), versus 112.0 mg/kg bodyweight/day (95th percentile: 235.5 mg/kg) in EFSA's non-brand-loyal scenario (French population group) 76 . Similarly for lecithins: 0.83 mg/kg bodyweight per day (95th percentile: 2.6 mg/kg), versus 6.0 mg/kg bodyweight/day (95th percentile: 13.0 mg/kg) 77 .…”

Effect of Thermal Processing on Flow Properties and Stability of Thickened Fluid Matrices Formulated by Tapioca Starch, Hydroxyl Distarch Phosphate (E-1442), and Xanthan Gum Associating Dysphagia-Friendly Potential

“…TS is documented to possess 58 mol% unbranched amylose with an average degree of polymerization by weight of 6680 [ 17 ]. HDP is a thickener approved for use in the European Union (listed as E1442) with hydroxypropyl groups less than 7.00 g/100 g [ 14 , 18 ]. XG is a long-chain polysaccharide (circa 2000 kDa) with d-glucose, d-mannose, and d-glucuronic acid as building blocks (back bone) in a molecular ratio of 3:3:2 with a high number of trisaccharide side chains associated with cations of sodium, potassium, and calcium [ 19 , 20 ].…”

“…However, some other thickeners, such as hydroxypropyl distarch phosphate (HDP, approved by the European Union and listed as E-1442), a modified resistant prepared from tapioca starch, or xanthan gum (XG), would also be even more preferable in terms of resistance to thermally-induced consistency alterations [ 11 , 12 , 13 , 14 ]. Moreover, both HDP and XG could possibly be better associated with fluid bases other than plain water due to their cross-linkages and contained ionic affinity natures [ 11 , 14 ], especially for those fluid bases with low pH and/or relatively high ion contents [ 15 , 16 ]. To date, investigations into the aforementioned flow consistency correlations amongst thickener, thermal processing level, and fluid base variations are lacking.…”

Eudraguard® Natural and Protect: New “Food Grade” Matrices for the Delivery of an Extract from Sorbus domestica L. Leaves Active on the α-Glucosidase Enzyme

“…The FDA estimated an acceptable daily intake (ADI) for BMC as a food additive of up to 11.7 mg/kg bw in adults and 13.3 mg/kg bw in children. For EN, long-term carcinogenicity studies showed no significant effects in terms of histo-pathological changes in rats or humans after 60 g (860 mg/kg bw) of acetylated starch was consumed over four successive days [ 32 ].…”