EFSA’s comprehensive re-evaluation of sucralose (E 955) confirms the existing acceptable daily intake of 15 mg/kg body weight per day and finds no safety concerns under authorised conditions – but emerging evidence on chlorinated degradation products at elevated temperatures has blocked an application to extend its use into fine bakery wares, with direct implications for formulation and process design.

Re-evaluation confirms the existing safety profile

Sucralose, the organochlorine high-intensity sweetener authorised as E 955 in the European Union, has been in commercial use for more than three decades. Approximately 600 times sweeter than sucrose on a weight-for-weight basis, it is produced by the selective chlorination of three hydroxyl groups on the sucrose molecule – a synthesis route that confers resistance to digestive hydrolysis and, by extension, its effectively zero-calorie profile. Its current EU authorisation covers reduced-energy and sugarfree products including flavoured fermented milk, confectionery, table-top sweeteners, and flavoured beverages.

The reassessment, adopted by the EFSA Panel on Food Additives and Flavourings (FAF) on 10 December 2025 and published on 17 February 2026, draws on animal and human toxicology, genotoxicity data, stability and degradation chemistry, and dietary exposure modelling across multiple EU population groups. Using benchmark dose modelling (BMD) on data from a combined chronic and carcinogenicity study in rats, the Panel derived a benchmark dose lower confidence limit (BMDL) of 55 mg/kg body weight per day based on decreased body weight – the relevant endpoint on a weight-of-evidence basis. A chemical-specific assessment factor was applied in lieu of the conventional default uncertainty factor of 100, yielding a reference point consistent with the existing ADI of 15 mg/kg body weight per day.

Dietary exposure estimates confirmed that population exposure remains below the ADI across all age groups. In the regulatory maximum level scenario, the highest mean exposure was in toddlers at 3.9 mg/kg body weight per day, with a 95th percentile of 13.5 mg/kg body weight per day. Among adults consuming solely from a single food category, table-top sweeteners delivered the highest estimated exposure at up to 18.8 mg/kg body weight per day at the 95th percentile – an extreme but technically notable scenario. On genotoxicity, the Panel found no safety concerns for sucralose or its key degradation products, principally 1,6-dichlorofructofuranose (1,6-DCF) and 4-chlorogalactopyranose (4-CG), and maintained its earlier position that data from the Ramazzini Institute did not support conclusions of carcinogenicity in mice.

Thermal stability: Where the science becomes more complex

The more technically significant part of the opinion concerns sucralose behaviour at elevated temperatures. Thermal gravimetric and differential thermal analysis studies establish that sucralose is stable up to approximately 119°C, with initial thermal degradation – involving water loss and subsequently HCl elimination – commencing at around 130°C. These thresholds are routinely exceeded in commercial baking, which commonly operates between 180°C and 230°C.

A 2024 study by Hellwig investigated degradation products from sucralose under thermal conditions using sucralose in isolation, in the presence of protein, and as a formulated ingredient. No formation of the carbohydrate degradation product 5-hydroxymethylfurfural (HMF) was observed at 80°C or 85°C. At higher temperatures, HMF formation rose in parallel with overall reaction browning. HPLC-TOF-MS analysis identified a further UV-active compound – a chlorinated furanone – though no quantitative data on its formation were reported. A 2.5% conversion of sucralose to HMF was observed in a cookies experiment; HMF formation was absent in muffins and coconut macaroons, attributed to more alkaline dough pH and lower baking temperature.

“Overall, the Panel considered that the study by Hellwig (2024) indicates that sucralose is not stable at raised temperatures, such as some baking temperatures.”

EFSA Panel on Food Additives and Flavourings

A separate investigation, prompted by a 2019 review from the German Federal Institute for Risk Assessment (BfR), examined the potential for sucralose to generate polychlorinated dibenzo-p-dioxins (PCDDs), dibenzofurans (PCDFs), and chloropropanols – including 3-mono-chloropropandiol (3-MCPD) – when heated to approximately 120°C–250°C. Pyrolysis experiments at 400°C generated 31 ng/g of PCDD/PCDF congeners, 25 times the concentration produced at 350°C, underlining the steep temperature-dependence of these reactions. Industry-provided baking trials using biscuits (baked for 12 minutes at 180°C) and wafers found that PCDD/PCDF formation was neither statistically significant nor toxicologically relevant against the EFSA CONTAM Panel’s tolerable weekly intake of 2 pg/kg body weight per week – a conclusion that held when recalculated using updated 2022 WHO toxicity equivalency factors. However, the 3-MCPD study used only four recipes and baking conditions, and the PCDD/PCDF study only two, and the Panel was explicit that it could not determine whether the same results would have been obtained at higher temperatures or with different formulations.

The fine bakery wares application and its regulatory consequences

The occasion for this scrutiny was an application to extend sucralose’s authorised uses to energy-reduced or without-added-sugar fine bakery wares (food category 7.2 of Part E of Annex II to Regulation (EC) No 1333/2008) at a maximum use level of 700 mg/kg. The category encompasses cakes, pastries, biscuits, muffins, waffles, and similar goods prepared across a wide spectrum of process conditions.

The Panel’s conclusion diverges sharply from its overall safety confirmation. While dietary exposure did not increase substantially when the proposed extension was modelled, the uncertainty around chlorinated compound formation across the range of baking processes applicable to FC 7.2 was judged too broad to resolve on available evidence.

“We confirmed that the current uses of sucralose as a food additive are safe. However, we could not reach the same conclusion for the new proposed uses we assessed, as these may involve several industrial processes requiring prolonged high temperatures.”

Laurence Castle, Chair of the EFSA Panel on Food Additives and Flavourings

The existing authorisation already covers sucralose in wafer paper, cones, and wafers for ice cream – formats with comparatively constrained baking parameters. The broader FC 7.2 category introduces high-fat biscuit formulations, laminated pastry, and products exposed to Maillard-reactive matrices at elevated temperatures for extended periods. The Panel’s concern is not primarily with exposure to sucralose itself, but with the suite of chlorinated organic compounds that may be generated and whose toxicological profiles remain inadequately characterised. EFSA also recommended that the European Commission consider the potential formation of chlorinated compounds during domestic cooking with sucralose – a flag that could influence future labelling or consumer guidance, given that home baking and frying introduce temperature and timing variability well beyond that in controlled trials.

Regulatory and industry implications

The opinion issues several technical recommendations on EU specifications. Current limits – 0.5% chlorinated disaccharides and 0.1% chlorinated monosaccharides by TLC method – do not adequately characterise the full range of impurities now analytically detectable. Industry data covering sucralose manufactured between April 2020 and January 2024 identified chlorinated monosaccharides including 4-CG and 1,6-DCF, with the highest reported total chlorinated monosaccharide concentration at 354 mg/kg (0.035%), alongside chlorinated disaccharides including multiple tetrachlorogalactosucrose congeners – all below current limits but detectable by modern methods. The Panel recommended revision of EU specifications to include appropriate HPLC-based limits, replacing the existing TLC method which carries greater analytical uncertainty. It also noted the absence of manufacturing process information in current specifications, relevant given the use of tin-containing catalysts in sucralose synthesis.

For manufacturers operating within currently authorised food categories, the opinion provides reassurance: the ADI is confirmed, current exposure is within safe limits, and the regulatory status of existing applications is unchanged. The signal for product developers is nonetheless clear. Any future application to extend sucralose use into processing contexts involving prolonged elevated temperatures will require substantially more detailed thermal degradation data – spanning a broader range of temperatures, times, food matrices, and fat contents – before a positive safety determination can be made. Whether the bakery wares application is withdrawn, amended with additional data, or proceeds to a further scientific opinion will depend on the industry’s capacity to generate that evidence.

More broadly, the opinion raises a methodological question for food safety science: how should risk assessment frameworks handle additives that are safe at the point of addition but whose downstream processing behaviour remains incompletely characterised? The FAF Panel’s approach – confirming current authorisation while withholding endorsement of extended uses – provides a working answer, and one that is likely to recur as high-intensity sweeteners and other functional additives are deployed across an increasingly diverse range of thermally processed food systems.

Source

EFSA Panel on Food Additives and Flavourings (FAF). 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. EFSA Journal. 2026;24:e9854. doi: https://doi.org/10.2903/j.efsa.2026.9854 .