What you need to know about EFSA opinion on Ramazzini Institute sucralose study
It comes as no surprise that the European Food Safety Authority (EFSA) rejects the findings of another questionable study performed by the Ramazzini Institute and, as expected, reaffirms sucralose safety. In a scientific opinion1 published on 8th May, following the assessment of the validity of the conclusions of Soffritti et al. mouse study on sucralose2, EFSA concludes that “the available data did not support the conclusions of the authors (Soffritti et al., 2016)”.
The scientific opinion from EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) is entirely consistent with the global scientific and regulatory consensus that sucralose is safe. Following rigorous risk assessment, sucralose has been approved and permitted for use by prominent regulatory authorities around the world—including, among others, the Joint Food and Agricultural Organization/ World Health Organization (FAO/WHO) Expert Committee on Food Additives, the US Food and Drug Administration (FDA) and the Scientific Committee on Food in Europe (now EFSA).
Conclusions in Soffritti et al. study are not supported by the comprehensive safety database on sucralose
The use of unconventional study design leading to inconclusive and unreliable results and the flawed conclusions of the study are just a couple of the serious issues identified by EFSA in their evaluation of the study by Soffritti et al.
EFSA’s experts criticised the significant shortcomings in the methodology used by Ramazzini Institute in the Soffritti et al. publication and highlighted that:
- there was no dose–response relationship between the exposure to sucralose and alleged “effects” reported in the study;
- there is no known mode of action by which sucralose could cause carcinogenic effects and the study fails to meet the standard criteria (Bradford-Hill) for a cause–effect relationship between intake of sucralose and the development of tumours;
- the design of the study included a treatment duration that was up to the natural death of animals, in other words mice were dosed until they died, which compromises reliable data interpretation, as tumor incidences can increase with age;
- A comprehensive database is available and shows no carcinogenic effect for sucralose, reported in adequate studies in rats and mice.
On this basis, therefore, the EFSA ANS 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, contrary to what the Soffritti et al. publication claims, and that a body of evidence show sucralose is safe and does not cause cancer.
The EFSA ANS Panel also noted the long delay in publication of the study (January 2016) given that the study started more than 10 years ago, with the findings already reported during a scientific conference in April 2012.
This is not the first time that food safety authorities dismiss findings and are highly critical of the study design and data interpretation by the Ramazzini Institute. Both EFSA and the US Food and Drud Administration (FDA) have rejected their research techniques and drew attention to a series of significant flaws and shortcomings in the design, conduct, reporting and interpretation in Dr Soffritti’s work in previous assessments3, 4, 5.
Key take away messages
- EFSA concludes that “the available data did not support the conclusions of the authors (Soffritti et al., 2016)”. The EFSA opinion is consistent with the global scientific and regulatory consensus that sucralose is safe.
- The Ramazzini Institute has a history of conducting unreliable studies that use unconventional research techniques in order to draw its flawd conclusions.
- Sucralose is safe and there is no indication of any carcinogenic potential.
- Sucralose is among the most thoroughly tested ingredients in the world with more than 110 studies over a 20-year period confirming its safety.
- Sucralose safety has been shown recently in a comprehensive systematic review by Berry et al.6, published in Nutrition and Cancer in 2016.
With the rates of obesity reaching epidemic proportions in Europe and worldwide, the use of all safe and approved low calorie sweeteners in foods, beverages and table-top sweeteners can be of great importance in the effort to limit overall sugar intake. Low calorie sweeteners can provide a variety of sweet-tasting food products with fewer or no calories, helping us to reduce overall energy intake and therefore in weight loss, when used in place of sugar and as part of a weigth control diet. They also offer a safe way for people with diabetes to decrease their carbohydrate intake.