Statement on the validity of the conclusions of a mouse carcinogenicity study on sucralose (E 955) performed by the Ramazzini Institute

Abstract The Panel on Food Additives and Nutrient Sources added to Food (ANS) was requested from the European Commission to provide a statement on the validity of the conclusions of a mouse study on the carcinogenic potential of sucralose (E 955) performed by the Ramazzini Institute (Soffritti et al., ). Sucralose (E 955) is authorised as a food additive in the EU in accordance with Annex II to Regulation (EC) No 1333/2008 on food additives. According to Commission Regulation (EU) No 257/2010, the full re‐evaluation of sucralose shall be completed by December 2020. Taking into consideration the publication from Soffritti et al. (), the technical report and additional information provided by the Ramazzini Institute and other information available for sucralose (E 955), the Panel noted: (i) the design of the bioassay that considers exposure from gestation up to natural death of animals implies an increase in background pathology that results in the possibility of misclassifications and a difficult interpretation of data, especially in the absence of both an appropriate concurrent control group and a recent historical database; (ii) the lack of a dose–response relationship between the exposure to sucralose and incidence of lymphomas and leukaemias (combined); (iii) the lack of a mode of action and failure to meet all the Bradford‐Hill considerations for a cause–effect relationship between intake of sucralose and the development of tumours in male mice only; (iv) a comprehensive database was available for sucralose and no carcinogenic effect was reported in adequate studies in rats and mice. Moreover, there was no reliable evidence of in vivo genotoxicity. Therefore, the Panel concluded that the available data did not support the conclusions of the authors (Soffritti et al., ) that sucralose induced haematopoietic neoplasias in male Swiss mice.