Castle Laurence, Andreassen Monica, Aquilina Gabriele, Bastos Maria Lourdes, Boon Polly, Fallico Biagio, FitzGerald Reginald, Frutos Fernandez Maria Jose, Grasl-Kraupp Bettina, Gundert-Remy Ursula, Gürtler Rainer, Houdeau Eric, Kurek Marcin, Louro Henriqueta, Morales Patricia, Passamonti Sabina, Batke Monika, Bruzell Ellen, Chipman James, Cheyns Karlien, Crebelli Riccardo, Fortes Cristina, Fürst Peter, Halldorsson Thorhallur, Leblanc Jean-Charles, Mirat Manuela, Lindtner Oliver, Mortensen Alicja, Wright Matthew, Barmaz Stefania, Civitella Consuelo, Le Gall Pauline, Mazzoli Elena, Rasinger Josef Daniel, Rincon Ana, Tard Alexandra, Lodi Federica
EFSA J. 2025 Apr 30;23(4):e9317. doi: 10.2903/j.efsa.2025.9317. eCollection 2025 Apr.
The present opinion deals with the re-evaluation of acesulfame K (E 950) as a food additive. Acesulfame K (E 950) is the chemically manufactured compound 6-methyl-1,2,3-oxathiazin-4(3H)-one-2,2-dioxide potassium salt. It is authorised for use in the European Union (EU) in accordance with Regulation (EC) No 1333/2008. The assessment involved a comprehensive review of existing authorisations, evaluations and new scientific data. Acesulfame K (E 950) was found to be stable under various conditions; at pH lower than 3 with increasing temperatures, it is degraded to a certain amount. Based on the available data, no safety concerns arise for genotoxicity of acesulfame K (E 950) and its degradation products. For the potential impurities, based on in silico data, a concern for genotoxicity was identified for 5-chloro-acesulfame; a maximum limit of 0.1 mg/kg, or alternatively, a request for appropriate genotoxicity data was recommended. Based on the synthesis of systematically appraised evidence of human and animal studies, the Panel concluded that there are no new studies suitable for identification of a reference point (RP) on adverse effects. Consequently, the Panel established an acceptable daily intake (ADI) of 15 mg/kg body weight (bw) per day based on the highest dose tested without adverse effects in a chronic toxicity and carcinogenicity study in rats; a study considered of moderate risk of bias and one of two key studies from the previous evaluations by the Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA). This revised ADI replaces the ADI of 9 mg/kg bw per day established by the SCF. The Panel noted that the highest estimate of exposure to acesulfame K (E 950) was generally below the ADI in all population groups. The Panel recommended the European Commission to consider the revision of the EU specifications of acesulfame K (E 950).
本意见涉及对乙酰磺胺酸钾（E 950）作为食品添加剂的重新评估。乙酰磺胺酸钾（E 950）是化学合成的化合物6 - 甲基 - 1,2,3 - 氧杂噻嗪 - 4(3H)- 酮 - 2,2 - 二氧化物钾盐。根据欧盟法规（EC）No 1333/2008，其被批准在欧盟使用。此次评估对现有授权、评价及新的科学数据进行了全面审查。结果发现乙酰磺胺酸钾（E 950）在各种条件下均稳定；在pH低于3且温度升高时，会有一定程度的降解。基于现有数据，乙酰磺胺酸钾（E 950）及其降解产物的遗传毒性不存在安全问题。对于潜在杂质，基于计算机模拟数据，确定5 - 氯 - 乙酰磺胺酸钾存在遗传毒性问题；建议其最大限量为0.1 mg/kg，或者要求提供适当的遗传毒性数据。基于对人和动物研究的系统评估证据的综合分析，专家小组得出结论，没有适合确定不良反应参考点（RP）的新研究。因此，专家小组根据大鼠慢性毒性和致癌性研究中未产生不良反应的最高测试剂量，确定每日可接受摄入量（ADI）为15 mg/kg体重（bw）；该研究被认为存在中等偏倚风险，是食品科学委员会（SCF）和粮农组织/世界卫生组织食品添加剂联合专家委员会（JECFA）先前评估中的两项关键研究之一。这一修订后的ADI取代了SCF确定的每日9 mg/kg bw的ADI。专家小组指出，在所有人群组中，乙酰磺胺酸钾（E 950）的最高暴露估计值通常低于ADI。专家小组建议欧盟委员会考虑修订乙酰磺胺酸钾（E 950）的欧盟规格。
