Sucralose E955
artificial — Primarily synthetic.
1,6-Dichloro-1,6-dideoxy-β-D-fructofuranosyl-4-chloro-4-deoxy-α-D-galactopyranoside
CAS: 56038-13-2
Factual Regulatory Reference
This database provides factual regulatory information compiled from official government sources. It does not constitute medical, nutritional, or safety advice. Regulatory status varies by country and is subject to change. Always refer to your local regulatory authority for the most current information.
What Is Sucralose?
Sucralose is a chlorinated derivative of sucrose, approximately 600 times sweeter with essentially no caloric value. Unlike aspartame, it is heat-stable for use in baking and cooking. It was approved in Canada in 1991, the USA in 1998, and EU in 2004. JECFA established an ADI of 15 mg/kg body weight. EFSA reaffirmed this ADI in 2017. Some recent studies have explored potential effects on gut microbiota and glucose metabolism, but EFSA's 2017 assessment concluded that sucralose was safe at the established ADI. Approved in EU, USA, Japan, Canada, and Australia.
? Did You Know?
Beyond food, Sucralose is also used in medicine, household products. Its versatility makes it one of the most multi-purpose chemical compounds in everyday life.
To reach the Acceptable Daily Intake limit, a 60kg adult would need to consume approximately ~18 cans of diet soda (355ml) in a single day. (This is a mathematical illustration, not a safety recommendation.)
Sucralose is fully synthetic — it doesn't exist in nature and is manufactured entirely through chemical processes.
Regulatory Analysis
Sucralose (E955) was long considered among the most thoroughly evaluated high-intensity sweeteners, with approvals granted by the FDA in 1998 and EFSA reaffirming its ADI of 15 mg/kg body weight in 2017. The regulatory picture shifted when 2023 studies identified sucralose-6-acetate — a metabolite formed in the gut — as a genotoxic concern in in vitro assays, prompting EFSA to announce a formal re-evaluation scheduled for completion in 2026. This sequence illustrates a standard challenge in post-approval surveillance: metabolite formation that was not fully characterized during original approval can re-open safety questions even for well-established additives. Whether EFSA's 2026 evaluation will result in ADI revision depends on whether animal and human exposure data confirm in vitro findings — a distinction that has historically separated regulatory responses from laboratory observations.
Detailed Regulatory Assessment
European Union (EFSA)
Under re-evaluation by EFSA (expected 2026)
United States (FDA)
Approved since 1998
Japan (MHLW)
Compliant with Japanese food sanitation law.
Acceptable Daily Intake (ADI)
International Standard (JECFA)
mg/kg body weight per day
European Standard (EFSA)
Everyday Perspective
For a 60kg adult, this limit is roughly equivalent to consuming:
Natural Occurrence
This additive is not known to occur naturally in significant quantities.
Manufacturing
Produced by selective chlorination of sucrose, replacing three hydroxyl groups with chlorine atoms.
Applications Beyond Food
Used in liquid medicines, chewable tablets, and nutritional supplements.
Sold as table-top sweetener (Splenda)