Abstract
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).
Summary
As part of the re-evaluation programme of all food additives authorised for use in the European Union before January 2009, the European Commission requested the European Food Safety Authority (EFSA) to re-assess the safety of the low/no-calorie sweetener acesulfame K.
Following a comprehensive review of the existing authorisations, evaluations, and all available scientific data, including evidence from in vitro tests, toxicological studies in animals, and interventional and epidemiological studies in humans, EFSA experts reconfirmed the safety of acesulfame K.
As a result of this thorough assessment, EFSA established an acceptable daily intake (ADI) of 15 mg/kg bw per day for the additive, increasing the previous ADI established by the Scientific Committee on Food in 2000.
These conclusions are consistent with a previous evaluation of the sweetener conducted by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1991, and with other assessments carried out by international regulatory authorities worldwide, which have also confirmed the safety of acesulfame K.