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Re‐evaluation of sucralose (E 955) as a food additive and evaluation of a new application on extension of use of sucralose (E 955) in fine bakery wares.

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Title: Re‐evaluation of sucralose (E 955) as a food additive and evaluation of a new application on extension of use of sucralose (E 955) in fine bakery wares.
Authors: Castle, Laurence (AUTHOR), Andreassen, Monica (AUTHOR), Aquilina, Gabriele (AUTHOR), Bastos, Maria Lourdes (AUTHOR), Boon, Polly (AUTHOR), Fallico, Biagio (AUTHOR), FitzGerald, Reginald (AUTHOR), Fernandez, Maria Jose Frutos (AUTHOR), Grasl‐Kraupp, Bettina (AUTHOR), Gundert‐Remy, Ursula (AUTHOR), Gürtler, Rainer (AUTHOR), Houdeau, Eric (AUTHOR), Kurek, Marcin (AUTHOR), Louro, Henriqueta (AUTHOR), Morales, Patricia (AUTHOR), Passamonti, Sabina (AUTHOR), Batke, Monika (AUTHOR), Dourus, Antonios (AUTHOR), Chipman, James (AUTHOR), Crebelli, Riccardo (AUTHOR)
Source: EFSA Journal. Feb2026, Vol. 24 Issue 2, p1-125. 125p.
Subject Terms: *Food additives, *Genetic toxicology, *Chlorine compounds, Sucralose, Baked products, Dose-effect relationship in pharmacology, Safety
Abstract: 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. [ABSTRACT FROM AUTHOR]
Copyright of EFSA Journal is the property of European Food Safety Authority and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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  Data: Re‐evaluation of sucralose (E 955) as a food additive and evaluation of a new application on extension of use of sucralose (E 955) in fine bakery wares.
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  Data: 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. [ABSTRACT FROM AUTHOR]
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  Data: <i>Copyright of EFSA Journal is the property of European Food Safety Authority and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
PLink https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=8gh&AN=192088537
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        Value: 10.2903/j.efsa.2026.9854
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        Text: English
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