Cyclamate E952
artificial — Primarily synthetic.
Sodium cyclohexylsulfamate
CAS: 139-05-9
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 Cyclamate?
Cyclamate (E952) is a synthetic non-caloric sweetener approximately 30 to 50 times sweeter than sucrose, produced by sulfonation of cyclohexylamine followed by neutralization with sodium hydroxide to yield sodium cyclamate; it does not occur in nature. It is used in diet beverages, sugar-free confectionery, and tabletop sweeteners in the EU, Canada, Australia-NZ, and over 50 other countries, but has been banned in the United States since 1969 and is not permitted in Japan. The US ban was triggered by rat studies suggesting a possible bladder cancer risk, a finding that subsequent re-evaluations — including by EFSA (2017) and JECFA (2017), which established an ADI of 7 mg/kg and 11 mg/kg body weight per day respectively — have not reproduced in studies using lower, more human-relevant doses; the FDA denied a formal re-approval petition in 2000, and the ban remains in place despite the scientific re-evaluations.
? Did You Know?
Cyclamate isn't just a food additive — it's also used in medicine.
Regulatory opinions differ: Cyclamate is approved in EU, CANADA but banned in USA, JAPAN. This reflects different risk assessment philosophies between regions.
To reach the Acceptable Daily Intake limit, a 60kg adult would need to consume approximately ~2 cans of diet beverage (355ml, in EU/Canada) in a single day. (This is a mathematical illustration, not a safety recommendation.)
Regulatory Analysis
Cyclamate's half-century US ban is arguably the most durable regulatory decision based on subsequently questioned science in food safety. The 1970 prohibition stemmed from a study administering cyclohexylamine (a cyclamate metabolite) to rats at doses vastly exceeding human exposure, using a protocol that later reviews found methodologically flawed. Despite over 50 countries including the EU maintaining approval, and a formal re-approval petition denied by the FDA in 2000, the ban persists -- illustrating how the political cost of reversing a consumer-protection decision can exceed the scientific justification for maintaining it, and how a single early study can create regulatory path dependence lasting decades.
Detailed Regulatory Assessment
European Union (EFSA)
Maximum levels typically 250-1600 mg/kg
Official EFSA LinkUnited States (FDA)
Banned since 1969 due to bladder cancer concerns in animal studies
Japan (MHLW)
Not approved for use in foods
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 sulfonation of cyclohexylamine followed by neutralization with sodium hydroxide.
Applications Beyond Food
Used in some countries in pharmaceutical preparations.
Safety & Regulatory History
Full Timeline →Cyclamate discovered accidentally by graduate student Michael Sveda at University of Illinois.
FDA approved cyclamate as GRAS (Generally Recognized As Safe) sweetener.
Studies suggested that cyclamate combined with saccharin may cause bladder cancer in laboratory r...
FDA banned cyclamate in the USA under Delaney Clause due to cancer concerns in animal studies.
JECFA established ADI of 0-11 mg/kg bw/day, concluded cyclamate is safe at this level.
Cyclamate approved as E952 in the EU with maximum use levels specified.
Scientific Committee on Food re-evaluated cyclamate, confirmed ADI of 7 mg/kg bw/day (lower than ...
EFSA re-evaluated cyclamate and cyclamic acid (E952), maintained previous safety conclusions and ...
Cyclamate remains banned in USA despite multiple petitions for re-approval and approval in many o...
Cyclamate discovered accidentally by graduate student Michael Sveda at University of Illinois.
FDA approved cyclamate as GRAS (Generally Recognized As Safe) sweetener.
Studies suggested that cyclamate combined with saccharin may cause bladder cancer in laboratory rats.
FDA banned cyclamate in the USA under Delaney Clause due to cancer concerns in animal studies.
JECFA established ADI of 0-11 mg/kg bw/day, concluded cyclamate is safe at this level.
Cyclamate approved as E952 in the EU with maximum use levels specified.
Scientific Committee on Food re-evaluated cyclamate, confirmed ADI of 7 mg/kg bw/day (lower than JECFA).
EFSA re-evaluated cyclamate and cyclamic acid (E952), maintained previous safety conclusions and ADI.
Cyclamate remains banned in USA despite multiple petitions for re-approval and approval in many other countries.