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.

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.