Who has problems with constipation and uses supplements based on aloe to improve intestinal transit will have to change habit. All preparations based on this plant and gods hydroxyanthracene derivatives, such as aloe-emodin and emodin, which are also contained in rhubarb, for example, can no longer be sold in Europe. The ban, which entered into force on 8 April 2021, was formalized in a new regulation signed by the European Commission after the European Food Safety Authority expressed in 2018, while admitting great uncertainty and the possibility of evaluating other data, a negative opinion on these substances. EFSA has defined them genotossiche, that is, capable of damaging DNA and possibly causing cancer, but considering that they are naturally present in different plants such as aloe, rhubarb, cassia, and are used all over the world, and for some time now, the restriction has caused surprises in the formulation of anti-constipation products.
“Consumers have been buying and using these products for several years without ever encountering any problems,” he says Antonino Santoro, member of Federsalus and president of the European Federation of Associations of Health Product Manufacturers. Like all food supplements, they were placed on the market with a notification to the Ministry of Health and, even if they did not have to undergo the testing phases necessary for a drug, “they have a very long tradition of use” Santoro specifies. “Toxicology studies, even recent ones, show that they are safe. In many cases these are products developed and manufactured in Italy, which in Europe represents the first market for plant-based food supplements ”.
The decision to ban the preparations has amazed a large part of the international scientific community. “EFSA’s opinion has sparked grievances around the world. But despite this, unusually, the European Commission has not re-evaluated the case and has continued towards the ban – he explains Corrado Galli, president of the Italian Society of Toxicology (Sitox) – in its own text, however, EFSA repeatedly refers to the concept of “scientific uncertainty”. So we ask ourselves why it has come to prohibition and not to a simple monitoring, as is the case for other natural substances and components of supplements ”.
Among the complaints sent to the Commission, also that of Sitox itself, which reproduced the study on aloe-emodin reported by Efsa and considered decisive for the judgment on genotoxicity. The experiment showed that both aloe-modin and the aloe preparation containing it are safe. “In our results we did not detect any genotoxic effect – confirms the expert – not even in vivo on mice with the highest doses”. Instead, according to the regulation published in the Official Journal, EFSA was not able to provide information on a daily dose of hydroxyanthracene derivatives that did not cause concern for human health. And this despite the fact that the same substances can be used in Europe in medicines.
“I wonder why, if these substances are considered dangerous, they are allowed in anti-constipation drugs regularly approved by the European Medicines Agency and the World Health Organization – continues the president Sitox – their only recommendation is not to take them for many weeks or months, because chronic administration can cause irritation of the colon which can lead to harmful consequences “. According to Santoro, there is the doubt that the Commission, “in addition to having followed the precautionary principle, may have been pushed by some Northern European countries, where there is little tradition of using these herbal preparations as where health authorities are more inclined to classify them as herbal medicines. It would have been more sensible – concludes the expert Federsalus – to scrutinize these substances for a certain period, giving companies and the scientific community the opportunity to make and present further studies to Efsa, and then proceed with a further risk assessment ” .
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