PMID 41710869 Re-evaluation of sucralose (E 955) as a food additive and evaluation of a new application on extension of use in food category 7.2 Agency re-evaluation opinion · EFSA Journal, 2026 Intake limit of 15 mg/kg kept, no genotoxicity concern, exposure below the limit at current uses. But no conclusion on extension into bakery wares, owing to possible chlorinated compounds from baking.
Key summary
An opinion covering the re-evaluation of sucralose (E 955) as a food additive and the safety of a proposed extension of use in food category 7.2, fine bakery wares. Based on the available data, no safety concerns arose for the genotoxicity of sucralose or its impurities and degradation products. Weighing the evidence, the panel took the decrease in body weight observed in rats as the relevant endpoint for a reference point and performed a benchmark dose analysis on the longest study, a combined chronic and carcinogenicity study, with a modified dose-response model to account for the poor palatability of sucralose. The resulting reference point was a benchmark dose lower confidence limit of 55 mg/kg. Considering it appropriate to derive a chemical-specific assessment factor, the panel concluded there was no need to revise the existing intake limit of 15 mg/kg set by the Scientific Committee on Food. Exposure estimates at currently authorised uses did not exceed the limit and overall exposure did not increase substantially under the proposed extension, but because of uncertainties about the potential formation of chlorinated compounds across the wide range of baking processes, the panel could not conclude on the safety of the extension. It issued recommendations focused on revising the EU specifications.
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The present opinion deals with the re-evaluation of sucralose (E 955) as food additive and with the safety of a proposed extension of use in food category (FC) 7.2 'Fine bakery wares'. Based on the available data, no safety concerns arose for genotoxicity of sucralose (E 955) and its impurities and degradation products. Based on the weight of evidence (WoE), the Panel considered the decrease in body weight observed in rats as the relevant endpoint for the derivation of a reference point (RP). The Panel performed a benchmark dose (BMD) analysis on the data from the longest study (combined chronic and carcinogenicity study) with a modified benchmark dose response to account for the poor palatability of sucralose. The resulting RP was 55 mg/kg bw per day (benchmark dose lower confidence limit; BMDL). The Panel considered it appropriate to derive chemical-specific assessment factor for sucralose and concluded that there is no need to revise the current ADI of 15 mg/kg bw per day of sucralose (E 955) previously established by the Scientific Committee on Food. The exposure estimates considering the currently authorised uses did not exceed the ADI. Therefore, the Panel concluded that there is no safety concern at the reported uses and use levels of sucralose (E 955). The overall exposure did not increase substantially when considering the proposed extension of use. However, based on the available data and the identified uncertainties regarding the potential formation of chlorinated compounds under the wide range of baking processes that may be applicable for FC 7.2, the Panel could not conclude on the safety of the proposed extension of use of E 955 in this FC. The Panel issued recommendations to the European Commission, primarily to consider a revision of the EU specifications for sucralose. ※ The abstract text as collected and stored via the API by the pipeline. The key summary is written based solely on this text.
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