Updated opinion on a request from the European Commission related to the 2nd ERF carcinogenicity study on aspartame, taking into consideration study data submitted by the Ramazzini Foundation in February 2009

The Panel’s assessment of the ERF carcinogenicity study with prenatal exposure on aspartame as reported by Soffritti et al. was directed towards establishing the relevance of the reported findings to human health. In carrying out its assessment the main information available to the Panel was the published paper, in which the presentation of pathological findings was restricted to the incidence of malignant tumours, total number of malignant tumours per group, incidence of lymphomas/leukaemias, and incidence of mammary carcinomas. Further data from this study were requested by EFSA in April 2007, January 2008 and July 2008 in order to aid the interpretation of the study. On 19 February 2009, the Ramazzini Institute submitted to EFSA some of the requested data. Overall, the Panel concluded, on the basis of all the evidence currently available including the last published ERF study that there is no indication of any genotoxic or carcinogenic potential of aspartame and that there is no reason to revise the previously established ADI for aspartame of 40 mg/kg bw/day