Nearly forty years after the safety of sucralose was extensively investigated, allowing its 1st approval for use as a sweetener, it is now approved globally for use in foods and beverages. This history of approvals reflects repeated confirmation, by renowned health and regulatory agencies from around the world, that sucralose is safe for use. This 2017 review, by experts with a long history in the science and safety evaluation of low calorie sweeteners (LCSs), offers an in-depth look at the broad array of studies that demonstrate the safety of sucralose. . To date this paper is the most extensive review of the safety of sucralose. It includes studies on the chemical characterization and stability of sucralose, toxicokinetics in animals and humans, assessment of genotoxicity, and animal and human feeding studies. Studies included evaluated the effects of sucralose on growth, development, reproduction, neurotoxicity, immunotoxicity, carcinogenicity and overall health status, including human studies on the effects of sucralose in people with diabetes. More recent safety studies reviewed focused on carcinogenic potential and the effect of sucralose on the gut microflora including the activation of sweet taste receptors in the gut by sucralose and their potential impact on overall glycemic control. The paper also includes estimated daily intakes of sucralose in a variety population subgroups. It finds that intakes are well below acceptable daily intake (ADI). This review concludes that sucralose is safe for its intended use as a LCS.
Due to the extensive length of the review by Magnuson et al., Heartland Food Products Group developed a “pocket guide” reference which offers a summary of this review.View full article Back to top
Aguilar F, Crebelli R, et al. European Food Safety Authority (EFSA) Panel on Food Additives and Nutrient Sources added to Food. Statement on the validity of the conclusions of a mouse carcinogenicity study on sucralose (E 955) performed by the Ramazzini Institute EFSA Journal. 2017;15(5):4784.
On May 8, 2017, the European Food Safety Authority (EFSA) published a positive scientific opinion on sucralose safety with regard to carcinogenicity. For background, EFSA was set up in 2002 as an independent body of the European Union as an entity to conduct reviews and evaluations for risk assessment and scientific advice on food and ingredients. Within its charter, EFSA has a duty to communicate their scientific findings to the public. Learn more about EFSA here
This review was conducted by EFSA in response to a mouse study published in 2016 by the Ramazzini Institute. That study alleged that sucralose - a sweetening ingredient found in many foods, beverages and table top sweeteners, including original SPLENDA Sweeteners -caused cancer in the animal models used. This finding was inconsistent with the long-held global scientific consensus about the safety of sucralose. Historically, the Ramazzini Institute has been criticized by the regulatory and research community for not complying with recognized research standards in its studies. After a thorough review, EFSA rejected findings from the 2016 Ramazzini Institute study and upheld years of research that shows sucralose is safe and not carcinogenic. The EFSA statement is consistent with the global scientific consensus regarding sucralose safety, which reflects the unanimous renowned regulatory authority conclusions that sucralose is safe and does not cause cancer.View full article Back to top
Berry C, et al. Sucralose non-carcinogenicity: A review of the scientific and regulatory rationale. Nutrition and Cancer: An International Journal.68: published online September 21, 2016.
This publication lays out the thorough process used by experts to assess the carcinogenicity of a new food ingredient, and reviews the research conducted to investigate the potential for sucralose to be carcinogenic. This important review, published in the journal Nutrition and Cancer, was conducted by experts in pathology, genotoxicity and toxicology, at the request of the makers of SPLENDA Sweeteners. The review includes both independently conducted and industry-funded research on sucralose chemistry, pharmacokinetics, metabolism, toxicity, genotoxicity, and long-term safety - including carcinogenicity, identified through a comprehensive search of electronic databases. Based on the framework used by health and regulatory authorities around the world for assessing potential carcinogenicity, the authors verify how research clearly demonstrates that sucralose is not cancer-causing.
The collective data in this newly published review support four key points with regard to sucralose safety:
- There is no evidence of chemical concerns or toxicity;
- There are no metabolites [any breakdown products] found to be carcinogenic;
- There is no evidence of mutagenic potential (ability to change genes, which could indicate cancer-causing potential);
- At doses hundreds of times the maximum expected daily intake in humans, toxicity and long-term carcinogenicity studies “showed no evidence of sucralose having carcinogenic potential.”
The findings in this review are consistent with the reviews by the U.S. Food and Drug Administration (FDA), the European Food Safety Authority (EFSA), Health Canada, and many other health and regulatory agencies worldwide all that have approved sucralose as safe for consumption by the entire population.View full article Back to top
Magnuson BA, et al. Biological Fate of Low Calorie Sweeteners Nutrition Reviews. 2016; 74(11):670–689.
This is an extensive review of the biological fates of today’s most well used low calorie sweeteners (LCSs), including acesulfame potassium, aspartame, saccharin, stevia leaf extract (steviol glycoside), and sucralose. Beyond that these food ingredients all impart a sweet taste with no, or virtually no, calories, they are a diverse group of compounds with important differences including their structure and biological fate. The authors note that an understanding of this point is critically important, because there are have been many instances when investigators have inappropriately characterized findings from a study of one LCS as being applicable to all LCSs. To truly understand the safety profile of any LCS demands a detailed understanding of how LCSs are handled in the body. This paper provides clear information on the toxicokinetics of the most common, approved LCSs. This includes data on the absorption, distribution, metabolism, and excretion derived from studies in both animal models and humans. The authors note that complete knowledge of the biological fate of these ingredients is a prerequisite for their regulatory approval across the globe. This review also includes discussions of the increasingly common use of combinations of LCS in foods and beverages and discussion of some of the more recent questions around potential effects, such as the potential impact on gut microflora. The authors, all with long term involvement in the science and safety of LCS, note they’re hopeful that this review will decrease the hesitancy among some healthcare providers to recommend these LCS to people who may utilize them effectively to manage chronic health issues such as obesity or diabetes.View full article Back to top
Roberts A., The Safety and Regulatory Process for Low Calorie Sweeteners in the United States. Physiology & Behavior, 2016;164, Part B, 439–444.
This article provides an in-depth review of the regulatory processes for low calorie sweeteners (LCS), including the Food Additive Approval process and the Generally Recognized as Safe (GRAS) process used by the U.S. FDA. The same level of scientific evidence is required to support safety and ensure a reasonable certainty of no harm in both review processes. This publication discusses how the regulatory review processes enable scientifically sound safety determinations, and pays attention to some of the most common questions raised about LCS, including topics such as potential carcinogenicity, effects on body weight gain, glycemic control and effects on the gut microbiome.View full article Back to top
Grotz VL, Munro IC. An overview of the safety of sucralose Regul Toxicol Pharmacol 2009;55:1-5.
This paper summarizes the extensive research conducted and submitted to regulatory authorities around the world, to investigate the safety of sucralose. The review focuses on physicochemical properties of sucralose and its pharmacokinetics, which are important in understanding toxicity potential, and key findings from both acute and long-term toxicology research and clinical trials. Also discussed are the properties and safety determinations of ingredients in the granulated retail product, SPLENDA No Calorie Sweetener. The unanimous conclusions by trained safety and health protection experts from global regulatory agencies regarding these ingredients, support that both sucralose and granulated SPLENDA No Calorie Sweetener can be safely used and may be a useful adjunct to the diet in meal plans designed to reduce unwanted calories or carbohydrate from nutritive sweeteners.View full article Back to top