The European Food Safety Authority (EFSA) published a report concluding that saccharin is safe for human consumption and has increased the Acceptable Daily Intake (ADI) from 5 to 9 milligrams per kilogram of body weight per day, replacing the guidelines established in 1995. The decision comes after experts from the EFSA reviewed all available data regarding saccharin and its sodium, potassium, and calcium salts as food additives. They concluded that saccharin does not cause damage to DNA and that there is no evidence that saccharin causes cancer in humans.
Previously, the acceptable daily intake was based on an increased incidence of bladder tumors observed in studies with rats. However, there is now a scientific consensus that these tumors are specific to male rats and are not extrapolable to humans. The EFSA notes that current consumption of saccharin is below the newly updated recommended daily amount, meaning there are "no safety issues."
Saccharin is a sweetener and food additive that has been used for over 100 years, becoming popular as a sugar substitute in the 1960s and 1970s. It was associated with bladder cancer in rats, although in humans it was found to be metabolized differently. Saccharin was also promoted as a method for weight loss.
Dietitian and nutritionist Juan Revenga explained that the EFSA's guidelines are made considering the general consumption pattern. "No one is going to put in a tablet an amount that by itself exceeds the ADI," Revenga stated, according to EL Pais. He emphasizes that European authorities work from "a principle of precaution", so the EFSA establishes safety guidelines, but when legislating, even more restrictive criteria are set below those maximum thresholds to ensure no one exceeds the ADI.
Revenga also explains the technical complexity behind a saccharin tablet or a sachet of table sweetener: not all the tablet is saccharin. "Artificial sweeteners have a tremendous sweetening capacity, much higher than sucrose [table sugar], and it's very rare to find an individual non-caloric sweetener: most of these artificial sweeteners are combined to generate sensory experiences that resemble sucrose as much as possible," he said. "Also, since they are so sweet, with one milligram, you already sweeten a lot. So, to be able to handle that tiny amount of sweetener, bulking agents are used. In a tablet, there is more bulking agent than saccharin."
Although the EFSA assures that saccharin is a "safe" sweetener for human consumption, this does not mean that its intake is harmless. The scientific community continues to investigate the potential effects of saccharin on the body. In a study published in 2022 in the journal Cell, researchers suggest that saccharin and other non-nutritive sweeteners, like sucralose, may alter the microbiome—the balance of gastrointestinal microorganisms—and affect glucose tolerance.
Last year, the World Health Organization (WHO) discouraged the use of sweeteners like saccharin or stevia for weight control. The WHO stated that these sweeteners can have undesirable effects, such as increasing the risk of type 2 diabetes, if used for a long time without changing lifestyle habits. In the EFSA's opinion, the authors consider "the association between exposure to saccharin and increased body weight has not been convincingly demonstrated by the available studies", as reported by EL PAÍS.
Artificial sweeteners remain under scrutiny. Last year, the International Agency for Research on Cancer (IARC), the WHO body responsible for identifying the carcinogenic potential of substances, concluded that the sweetener aspartame may have the capacity to cause cancer in the population. The IARC classified aspartame within level 2B, which means the evidence is very limited and, while safety is not concerning at the doses commonly used, potential harmful effects have been described. Regarding saccharin, the IARC placed this sweetener in 1998 in group 3, as "not classifiable as to its carcinogenicity in humans".
This reevaluation of saccharin is part of a broader effort by the EFSA to review the safety of all food additives whose use in food was permitted before January 20, 2009, as required by EU Regulation.
This article was written in collaboration with generative AI company Alchemiq