Re‐evaluation of saccharin and its sodium, potassium and calcium salts (E 954) as food additives

作者：EFSA Panel on Food Additives and Flavourings (FAF), Laurence Castle, 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, Monika Batke, Ellen Merete Bruzell, James Kevin Chipman, Karlien Cheyns, Riccardo Crebelli, Cristina Fortes, Peter Fürst, Thorhallur Ingi Halldorsson, Jean‐Charles Leblanc, Manuela Mirat, Oliver Lindtner, Alicja Mortensen, Evangelia Ntzani, Romina Shah, Heather M. WALLACE, Matthew Liam Wright, Stefania Barmaz, Consuelo Civitella, Petra Georgelova, Federica Lodi, Elena Mazzoli, Josef Daniel Rasinger, Ana María Rincón, Alexandra Tard, Panagiota Zakidou, Maged Younes · 发表于：EFSA Journal · 年份：2024 · DOI：10.2903/j.efsa.2024.9044 · 被引用次数：17 · 研究领域：Dye analysis and toxicity、Biochemical Analysis and Sensing Techniques、Consumer Attitudes and Food Labeling

This opinion deals with the re-evaluation of saccharin and its sodium, potassium and calcium salts (E 954) as food additives. Saccharin is the chemically manufactured compound 1,2-benzisothiazol-3(2H)-one-1,1-dioxide. Along with its sodium (Na), potassium (K) and calcium (Ca) salts, they are authorised as sweeteners (E 954). E 954 can be produced by two manufacturing methods i.e. Remsen-Fahlberg and Maumee. No analytical data on potential impurities were provided for products manufactured with the Maumee process; therefore, the Panel could only evaluate saccharins (E 954) manufactured with the Remsen-Fahlberg process. The Panel concluded that the newly available studies do not raise a concern for genotoxicity of E 954 and the saccharins impurities associated with the Remsen-Fahlberg manufacturing process. For the potential impurities associated with the Maumee process, a concern for genotoxicity was identified. The data set evaluated consisted of animals and human studies. The Panel considered appropriate to set a numerical acceptable daily intake (ADI) and considered the decrease in body weight in animal studies as the relevant endpoint for the derivation of a reference point. An ADI of 9 mg/kg body weight (bw) per day, expressed as free imide, was derived for saccharins (E 954). This ADI replaces the ADI of 5 mg /kg bw per day (expressed as sodium saccharin, corresponding to 3.8 mg /kg bw per day saccharin as free imide) established by the Scientific Committee on Food. The ...