EFSA Reaffirms Sucralose Safety, Dismisses Previous Study on Mice

09 May 2017 --- The European Food Safety Authority (EFSA) has published a scientific opinion dismissing the findings of a study on sucralose by the Ramazzini Institute. The study, conducted by Soffritti et al, concluded that sucralose induced hematopoietic neoplasias in male Swiss mice. Sucralose (E 955) is authorized as a food additive in the EU in accordance with Annex II to Regulation (EC) No 1333/2008 on food additives.

According to the scientific opinion, “the Panel on Food Additives and Nutrient Sources added to Food (ANS) was requested by 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., 2016).” 

The EFSA opinion states that the panel concluded that the available data did not support the conclusions of the authors and that there were flaws in the methodology used by the authors, including a lack of a dose–response relationship and lack of a cause–effect relationship between intake of sucralose and the development of tumors.

In a statement on its website, the International Sweeteners Association (ISA) welcomed the publication of the scientific opinion.

“This scientific opinion from EFSA is entirely consistent with the global scientific and regulatory consensus that sucralose is safe,” ISA Chairman Robert Peterson says.

In a statement, ISA added that safety evaluations conducted by the Joint Food and Agricultural Organization/World Health Organization (FAO/WHO) Expert Committee on Food Additives (JECFA), the United States Food & Drug Administration and regulatory authorities around the world, including the European Commission’s Scientific Committee for Food (now EFSA), all agree that sucralose is safe.