The European Food Safety Authority (EFSA) has concluded that saccharin — once thought to cause cancer — is safe for human consumption and has increased the acceptable daily intake.
The previous acceptable daily intake (5 mg per kg of body weight) was set in 1995 based on the increased incidence of bladder tumors observed in rat studies. Now, citing scientific agreement that these tumors are specific to male rats and not relevant to humans, EFSA has increased the acceptable daily intake to 9 mg per kg of body weight.
An EFSA Panel on Food Additives and Flavorings re-evaluated the 1995 opinion on saccharin — a chemically manufactured compound — and its sodium, potassium and calcium salts as food additives. The biological and toxicological data set available to the panel for the re-evaluation of saccharins comprised evidence from animal toxicological studies and human data, both published and unpublished, made available to EFSA in response to calls for data and related clarification requests and/or also identified from the published literature.
Currently, saccharins are authorized food additives in the EU in 34 food categories (corresponding to 46 authorized uses) with maximum reported use levels ranging from 50 to 3000 mg/kg.
Saccharin has about 200–700 times the sweetening power of granulated sugar. While mostly used in food products, it can be used to sweeten nutraceutical and pharmaceutical products. In the U.S., the National Toxicology Program of the National Institutes of Health concluded in 2000 that saccharin should be removed from the list of potential carcinogens. Products containing saccharin no longer have to carry the warning label.