Safety evaluation of curdlan as a food additive

作者：EFSA Panel on Food Additives and Flavourings (FAF), Monica Andreassen, Gabriele Aquilina, Maria de Lourdes Bastos, Polly Boon, Biagio Fallico, Rex FitzGerald, María José Frutos Fernández, Bettina Grasl‐Kraupp, Ursula Gundert‐Remy, Rainer Gürtler, Eric Houdeau, Marcin Kurek, Henriqueta Louro, Patricia Morales, Sabina Passamonti, José Manuel Barat Baviera, Gisela H. Degen, David Michael Gott, Lieve Herman, Jean‐Charles Leblanc, Peter W. Moldeus, Ine D. H. Waalkens-Berendsen, Detlef Wölfle, Consuelo Civitella, Jaime Aguilera Entrena, Agnieszka Mech, Salvatore Multari, Laura Ruggeri, Camilla Smeraldi, Alexandra Tard, Sam Vermeiren, Laurence Castle · 发表于：EFSA Journal · 年份：2024 · DOI：10.2903/j.efsa.2024.8985 · 被引用次数：10 · 研究领域：Agricultural safety and regulations、Aluminum toxicity and tolerance in plants and animals、Plant Micronutrient Interactions and Effects

Abstract The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion on the safety of curdlan as a new food additive used as firming and gelling agent, stabiliser, thickener. Curdlan is a high molecular weight polysaccharide consisting of β‐1,3‐linked glucose units, produced by fermentation from Rhizobium radiobacter biovar 1 strain NTK‐u. The toxicological dataset consisted of sub‐chronic, chronic and carcinogenicity, reproductive and developmental toxicity studies as well as genotoxicity. In vivo data showed that curdlan is not absorbed as such but is extensively metabolised by the gut microbiota into CO2 and other innocuous compounds. Curdlan was not genotoxic and was well‐tolerated with no overt organ‐specific toxicity. Effects observed at very high doses of curdlan, such as decreased growth and increased cecum weight, are common for indigestible bulking compounds and therefore considered physiological responses. In a combined three‐generation reproductive and developmental toxicity study, decreased pup weight was observed during lactation at 7500 mg curdlan/kg body weight (bw) per day, the highest dose tested. The Panel considered the observed effects as treatment‐related and adverse, although likely secondary to nutritional imbalance and identified a conservative no observed adverse effect level (NOAEL) of 2500 mg/kg bw per day. Despite the limitations noted in the dataset, the Panel was able to conclude applying the margin of exposure (MOE) app...