EFSA FAQ’s

Q: What is the European Food Safety Authority (EFSA)?

A: The European Food Safety Authority (EFSA) is an independent agency of the European Union (EU), established in 2002 and based in Parma, Italy, that provides scientific advice and risk assessments regarding food and feed safety. It supports EU institutions and member states in ensuring consumer protection, covering areas like nutrition, animal health/welfare, and plant protection. Generally accepted as the ‘gold standard’ globally for ingredient safety evaluation, EFSA evaluates and re-evaluates food ingredients to ensure consumer safety, providing independent scientific advice that informs European legislation and the authorization of ingredients. Evaluations are conducted for new products, while systematic re-evaluations assess older ingredients against new data, scientific advances, or changes in consumption levels.

Q: Why is EFSA reviewing sucralose?

The European Commission mandated EFSA to re-evaluate all food additives approved for use in the European Union prior to January 2009. This enables any new or relevant data on sucralose since the original assessment to be reviewed and evaluated. EFSA conducted this comprehensive re-evaluation of sucralose as part of that initiative. EFSA’s independent experts carefully reviewed all available scientific evidence, including short- and long-term health effects, the product’s manufacturing process, and the amount consumed through diet. This resulted in the most thorough assessment carried out in the past 20 years.

Q. When was the last time sucralose was evaluated, and what did it conclude?

A. The original assessment of sucralose in the EU was completed by the EU Scientific Committee on Food (the predecessor of EFSA) in 2000 and concluded it was a safe food ingredient.

Q. What did EFSA’s re-evaluation of sucralose find?

A. EFSA reaffirmed the safety of sucralose. The review conducted by the EFSA Panel on Food Additives and Flavorings examined available scientific evidence, including the original safety and technical data that formed the basis of the original approval of sucralose, as well as new data published since that approval, the primary source being published scientific literature. Based on their findings, EFSA concluded that sucralose is safe and that no revision to the current Acceptable Daily Intake (ADI) of 15 mg/kg body weight per day is warranted. ADI is the average daily intake of a food ingredient that can be consumed over a lifetime without appreciable health risk.

Q. What is an ADI and what does an ADI of 15 mg/kg body weight per day mean?
A. ADI, or the Acceptable Daily Intake, is the amount of an ingredient in a food or beverage that can be ingested every day, on average, over the course of a lifetime without posing a health risk, including children and pregnant women.  The ADI for sucralose is 15 milligrams per kilogram of body weight (mg/kg) per day. For a 150-pound person, this would be 1,020 milligrams of sucralose, which is equivalent to more than 85 packets of Splenda or 29 cans of diet soda per day. This is 100 times lower than what has been tested and considered safe. This example illustrates that ADI values are quite conservative.

Q: Is EFSA the only group to affirm sucralose’s safety?

A. No, the safety of sucralose is documented by one of the most extensive and thorough testing programs ever conducted on a new food additive. In addition to assessments conducted by global safety authorities such as the Joint FAO/WHO Expert Committee on Food Additives (JECFA), more than 100 studies conducted and evaluated over a 20-year period clearly demonstrate the safety of sucralose. Studies were conducted across a broad range of areas to assess potential safety risks related to cancer, genetic effects, reproduction and fertility, birth defects, immunology, the central nervous system, and metabolism.

Q: Does the FDA recognize sucralose as safe?

A. Yes, the FDA (U.S. Food and Drug Administration) considers sucralose safe for human consumption, having approved it as a general-purpose sweetener in 1999 after reviewing over 110 studies to identify potential toxic effects, including carcinogenicity and metabolism. Sucralose is deemed safe for the general population, including children, pregnant, and breastfeeding individuals. 

Q. What does this re-evaluation mean for people who enjoy products with sucralose?

A. It is good news for consumers! EFSA once again affirmed the safety of sucralose, following the most comprehensive evaluation of scientific evidence in the past 20 years, which gives consumers continued confidence to enjoy lower-sugar, great-tasting products, including those intended for the management of body weight and diabetes.