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

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.

Keywords: E 955; food additive; sucralose; sweetener.

FIGURE 1

Chemical structure of E 955.

FIGURE 2

Structure of the sucralose (E 955) degradation product identified under basic conditions.

FIGURE 3

Percentage of change with respect to the control of the mean final body weight in rats or mice after exposure to sucralose doses in the range 62.5–3000 mg/kg bw per day (from 8 references: Soffritti et al., ; Glendinning et al., ; Ren et al., ; Farid et al., ; two generation reproductive toxicity study in rats, 104‐week combined toxicity and carcinogenicity study in rats, a 26‐week study in rats with exposure by gavage and pair fed dietary restriction study in rats; Documentation provided to EFSA No 1). In the studies with more than one time point measurement, only the values at the end of the study were included. Each colour represents data from one reference. Symbols: Triangles: M, Dots: F, Squares: M/F combined. Studies: Red: Soffritti et al.,  (chronic), Yellow: Reproductive toxicity study (Documentation provided to EFSA No 1), Blue: 104‐week combined chronic and carcinogenicity study (Documentation provided to EFSA No 1), Orange: pair fed dietary restriction study‐sub‐chronic (Documentation provided to EFSA No 1), Green: 26 weeks gavage study‐sub‐chronic (Documentation provided to EFSA No 1), Purple: Glendinning et al.,  (sub‐acute), Dark blue: Ren et al.,  (sub‐acute), Grey: Farid et al.,  (sub‐chronic). Black dashes indicate values after exposure to doses in the range 0.043–43.2 mg/kg bw per day.

FIGURE 4

Scheme to consider the adversity of body weight changes, adapted from Flamm et al. (2003).

FIGURE A.1

PRISMA flow chart (adapted from Moher et al., 2009).

FIGURE A.2

Matrix for integration of animal and human body of evidence based on identification of effect and level of evidence.