The European food safety watchdog warned that “some substances” belonging to the group of plant-based ingredients known as hydroxyanthracene derivatives “can damage DNA” and “may cause cancer” when added to food.
The EFSA concluded that certain hydroxyanthracene derivatives are genotoxic and said it is therefore not possible to set a “safe” daily intake. When tested in animal studies, some of these substances have also been shown to cause cancer in the intestine, the EFSA added.
This group of substances naturally occurs in plants such as aloe or senna species.
Health claim stands
An EFSA spokesperson stressed that the safety body warns against the prolonged use, or high levels of consumption, of foods containing hydroxyanthracene derivatives. However, the spokesperson also told FoodNavigator that the EFSA has approved a health claim for hydroxyanthracene derivatives. The EFSA found that hydroxyanthracene derivatives in food can improve bowel function.
“In 2013, EFSA substantiated a health claim related to hydroxyanthracene derivatives in food and improvement of bowel function, but advised against the long-term use and high doses due to potential safety concerns,” the spokesperson explained.
At the time, the EFSA’s Dietetic Products, Nutrition and Allergies (NDA) Panel noted: “stimulant laxatives should not be consumed continually for periods longer than one to two weeks” and “the use of stimulant laxatives for more than two weeks requires medical supervision”.
The European Commission subsequently asked EFSA to assess the safety of these plant ingredients when used in foods, and provide advice on a daily intake not associated with adverse health effects.
The EFSA’s latest assessment that it is impossible to set "safe" limits will now be passed to regulators, the spokesperson added. “In terms of next steps, EFSA’s advice will feed into discussions among the regulators – [the] European Commission and EU Member States.”
Green light for medicinal use
The medicinal use of hydroxyanthracene derivatives for the treatment of constipation remains approved by the European Medicines Agency.
According to EMA recommendations, the dose of hydroxyanthracene derivatives used in herbal medicinal laxative products should not exceed 30 mg per day for a maximum period of two weeks. Use is approved in in adults only and consumption is not recommended for pregnant and lactating women as well as in children.