Opinion of the SCF on food additive E 955

The Committee is satisfied that the range of studies now available is sufficient for a full safety evaluation of sucralose.

The studies on glucose homeostasis in both normal subjects and subjects with insulindependent and non-insulin-dependent diabetes have been considered in depth. The Committee considers that the possibility of a small effect on glucose homeostasis in diabetic persons cannot be definitively ruled out. However, there is no consistent evidence of any such effect from the various studies. The Committee has concluded that if any such effect occurred, it would be so small as to be clinically insignificant.

There is adequate evidence, both for sucralose and its hydrolysis products, that there are no concerns about mutagenicity, carcinogenicity, developmental or reproductive toxicity. Effects have been observed in some experimental animal studies on immune parameters, the gastrointestinal tract and body weight gain. Consideration of the critical studies on these aspects have identified reduced body weight gain, where it is attributable to direct sucralose toxicity rather than secondary to reduced food intake because of impalatability of the diet, as the pivotal effect for establishing an ADI. The overall NOEL for such reductions in body weight gain was 1500mg/kg bw/day.

The Committee concludes that sucralose is acceptable as a sweetener for general food use and that a full ADI of 0-15mg/kg bw can be established, based on application of a 100-fold safety factor to the overall NOEL of 1500mg/kg bw/day.