EFSA Confirms Safety of Sucralose, Rejecting Findings of Ramazzini Institute

In April 2017, the European Food Safety Authority’s (EFSA) Scientific Panel on Food Additives and Nutrient Sources Added to Food (ANS) discussed the 2016 publication by Soffritti et al., from the Ramazzini Institute on the carcinogenic potential of sucralose. ANS has now published a statement regarding the study and the authors’ conclusions, dismissing the Ramazzini Institute’s findings due to significant limitations.

In their statement, the ANS Panel noted areas of major concern regarding the Soffritti et al. (2016) study, the technical report and additional information provided by the Ramazzini Institute for the Panel’s consideration. The concerns included:

  • a lack of a dose–response relationship,
  • no mode of action, and
  • failure to meet all the Bradford-Hill considerations for a cause–effect relationship, a study design that increases the difficulty of appropriate data interpretation particularly due to limited control database.

Therefore, the Panel concluded that the available data did not support the conclusions of the authors (Soffritti et al., 2016) that sucralose induced haematopoietic neoplasias in male Swiss mice.

The concerns related to this evaluation of cancer in mice fed sucralose are similar to concerns that EFSA raised in 2011 when they stated, “Regarding the design of the study, EFSA advised that experimental studies carried out over animals’ lifetimes can lead to erroneous conclusions. Older animals for instance are more susceptible to illness and when a carcinogenicity study in mice is extended beyond the recommended 104 weeks, age-related pathological changes (such as spontaneous tumours) can appear which may confound the interpretation of any compound-related effects.”

Importantly, an extensive database of other studies conducted to assess possible carcinogenicity of sucralose does not show any reliable evidence of a cancer risk. Hundreds of publications related to sucralose have been reviewed by regulatory authorities around the world, including the Joint Food and Agricultural Organization/World Health Organization (FAO/WHO) Expert Committee on Food Additives (JECFA), the United States Food and Drug Administration (FDA), and the European Commission’s Scientific Committee for Food (now EFSA). All of these organizations continue to agree that sucralose is safe. Additionally, sucralose has numerous benefits, including those related to oral health, diabetes and blood glucose management, and weight management. These factors are important for health and the benefits of taste and versatility in cooking that make it a simple substitute for sugar and other caloric sweeteners.

Photo: Lucio Rossi for EFSA, Studio Valle Progettazioni, Art & Build, Manens -Tifs, Pool Engineering, Art Ambiente Risorse e Territorio

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