EFSA approves saccharin safety threshold increase following comprehensive review

In a newly published scientific opinion, the European Food Safety Authority (EFSA) has concluded that saccharin is safe for human consumption and increased the acceptable daily intake (ADI) from 5 to 9 mg/kg of body weight per day.

The ADI, which reflects the safe amount of a substance that can be consumed daily over a lifetime, covers saccharin and its sodium, calcium and potassium salts (E954).

The previous ADI was set in 1995 based on the increased incidence of bladder tumors observed in rat studies. However, there is now scientific agreement that these tumors are specific to male rats and not relevant to humans. 

DNA damage 

EFSA experts have reviewed all available data and concluded that saccharin does not cause DNA damage and that it is unlikely that its consumption is associated with cancer risk in humans. 

In addition, consumer exposure is below the newly derived ADI, meaning that there is no health risk.  

Salts of saccharin 

Saccharin has been used to sweeten foods and drinks for over 100 years, becoming popular as a sugar replacement in the ’60s and ’70s.  

The salts of saccharin are used because they dissolve better in water. This makes it easier to add them to foods and drinks and can make them sweeter.

As for all food additives, saccharin and its salts must be labeled on products, allowing consumers to make informed choices.

This re-evaluation is part of a broader work to review the safety of all food additives that were permitted for use in foods before January 20, 2009, as required by EU regulations.

Calorie Control Council responds

In response to the report, the Calorie Control Council has issued the following statement:

“This rigorous scientific review from the European Food Safety Authority on saccharin not only reinforces decades of research validating its safety but recommends an increase of the Acceptable Daily Intake, further endorsing its status as a trusted ingredient,” says Carla Saunders, president of Calorie Control Council‎. 

“As one of the most extensively researched substances in the international food supply, saccharin remains a valued tool for consumers to reduce sugar and caloric intake for healthier outcomes.”