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Sucralose Safety Backgrounder The safety of sucralose is documented by one of the most extensive and thorough safety testing programs ever conducted on a new food additive. More than 100 studies conducted and evaluated over a 20-year period clearly demonstrate the safety of sucralose. Studies were conducted in a broad range of areas, at amounts many times higher than actual consumption levels, to assess whether there were any safety risks regarding cancer, genetic effects, reproduction and fertility, birth defects, immunology, the central nervous system, and metabolism. These studies all concluded that sucralose is safe for human consumption. Sucralose is produced from sugar through a multistep manufacturing process. During this process a small amount of chlorine is added which changes the structure of the sugar molecule. This change produces a sweetener that has no calories, but is 600 times sweeter than sugar. Today sucralose is permitted for use as a sweetener in more than 100 countries. An overwhelming body of science supports the fact that sucralose has an excellent safety profile. It can be used by all populations, including pregnant women, nursing mothers, and children of all ages. Sucralose is also beneficial for individuals with diabetes because research demonstrates that sucralose has no effect on carbohydrate metabolism, short- or long-term blood glucose control, or insulin secretion. General Safety All food ingredients have to undergo extensive testing prior to approval. Sucralose is no exception. Sucralose is made by a multi-step process that results in a stable sweetener that tastes like sugar, but is calorie-free. After being discovered, sucralose was put through a conclusive safety testing program over a 20-year period. A panel of 16 independent, well recognized, non-governmental scientific experts reviewed the sucralose safety database and concluded it to be safe. This panel represented significant expertise across a wide range of health and safety disciplines, including areas such as general toxicity, reproductive toxicity, mutagenicity, carcinogenicity, pharmacokinetics, immunotoxicity and neurotoxicity. Studies show that sucralose is a safe and essentially inert ingredient. Conclusions from the studies include the following: No known side effects Not toxic: No adverse effects seen in test animals, even in amounts equivalent in sweetness to 40+ pounds of sugar per day for life No effect on carbohydrate metabolism No effect on short- or long-term blood glucose control or on serum insulin levels: Sucralose is suitable for people with diabetes No calories or carbohydrates: Sucralose is not recognized by the body as a carbohydrate and is not metabolized or otherwise broken down for energy 1 Regulatory Scrutiny The safety of sucralose has been considered by leading medical, scientific and regulatory authorities around the world including: The US Food and Drug Administration (FDA) The European Food Safety Authority (EFSA) Health Canada Food Standards Australia/New Zealand Japanese Food Sanitation Council The Joint (Food and Agriculture Organization/World Health Organization) Expert Committee on Food Additives (JECFA) All have found sucralose to be safe for use as a food ingredient by the general population, including children and women who are pregnant or breast-feeding. It is also suitable for people with diabetes. Metabolism Sucralose is not utilized for energy in the body because it is not broken down like sucrose (sugar). It passes rapidly through the body virtually unchanged. Sucralose has been extensively tested and found to be a safe and remarkably inert ingredient. The chemical structure of sucralose has features which are key to its safety: Sucralose is a small, relatively inert molecule Is largely unabsorbed Is not broken down for energy Is eliminated quickly The vast majority (85%) of sucralose is not absorbed and is excreted in the feces unchanged. The small portion (2%) of sucralose that is absorbed, passively crosses to the bloodstream and is then excreted in the urine. Studies show that sucralose is not actively transported into breast milk, across the placenta into the fetus or across the blood-brain barrier into the nervous system. Carcinogenicity Sucralose has been found to be non-carcinogenic. Studies utilizing doses more than a thousand times the level that people would consume on a daily basis showed that sucralose is non-carcinogenic. No acute toxicity was found at large doses including a 175 pound adult consuming the equivalent sweetness of 1000 pounds of sugar. Further, no chronic toxicity was found in in which high doses of sucralose (doses hundreds of times greater than maximum estimated daily intakes and 800-1300 times greater than the Estimated Daily Intake [EDI]) over a lifetime.) Studies evaluated all phases of life, from pre-conception through aging adulthood, and included multi-generational research. In total, over 30 studies have been completed to provide better understanding regarding the possibility that sucralose could lead to cancer. These studies demonstrate that sucralose is safe and not related to cancer. 2 Safe for People with Diabetes The FDA (U.S. Food and Drug Administration) concluded that the overall data on sucralose supports its safety for the general population, including people with diabetes. Numerous studies show that sucralose is not recognized by the body as a carbohydrate and thus, has no effect on blood glucose control or insulin response. Acceptable Daily Intake (ADI) Although regulators may use slightly different strategies in how they calculate ADI, they always set it significantly below levels found to be safe. Thus, ADI is not a toxicity threshold. Rather, it is a level shown to be safe by a wide margin, and, in all cases, represents a 100-fold safety factor for sucralose. For sucralose, regulatory officials around the world have set the ADI from 5 (U.S.) to 15 (EU, Australia) mg/kg bodyweight per day. Importantly, ADIs are also based on chronic consumption. For example, a child weighing between 50 and 100 pounds would need to consume about 3 to 8, eight-ounce glasses of diet drink daily and between 6 and 16, eight-ounce glasses of diet drink daily to reach the 5 to 15 mg/kg/day ADIs set by regulators around the world. And, this level of sucralose consumption would not exceed the levels found to be safe both in animals and people. Intake studies indicate that actual intakes are well below the ADI. Occasional daily intakes in excess of usual intakes or in excess of ADI levels are not considered to be a safety concern. Conclusion Sucralose can be safely used and may be helpful in reducing unwanted calories or carbohydrates. Based upon the wealth of scientific literature, consumers can feel confident in the safety of sucralose. 3