new rules on use in supplements approved

The European Union recently imposed a ban on the use of aloe, rhubarb and other plants in the production of food supplements.

The measure, based on a scientific opinion from the European Food Safety Authority (EFSA), However, it has raised quite a few criticisms by the main Italian associations in the agri-food sector. Coldiretti and Filiera Italia, for example, did not hesitate to define it as a case of “regulatory squint”accusing Europe of an overly rigid approach to natural products.

The reasons for the stop in the EU, because aloe and rhubarb are potentially dangerous

The European Union’s ban on the use of aloe and rhubarb in food supplements is mainly related to presence of hydroxyanthracene derivatives (Had) in the plants themselves. According to the European Food Safety Authority (EFSA), these substances, if taken in concentrated and purified form, can have negative effects on health. In the scientific analyzes conducted, it emerged that Had, at high doses, could result toxic risks for the bodywith possible implications for the gastrointestinal tract and, in some cases, the liver.

According to some experts and trade associations, however, EFSA applied evaluation standards closer to pharmaceutical ones to make this decision, inappropriate for natural productswhere the concentration of the compounds is usually much lower.

The European Union, meanwhile, justified the decision by calling it more a precautionary approachaimed at avoiding health risks, underlining a growing attention to the safety of food supplements, which are consumed by a large segment of the population in Europe.

Coldiretti and Filiera Italia: “Double weights and double measures between natural and synthetic”

According to Coldiretti and Filiera Italia, the EU decision on aloe vera and rhubarb reveals a underlying problemor, as mentioned, the different treatment reserved for natural products compared to synthetic ones.

It means that on the one hand, the associations argue, natural products are required to undergo a complex and expensive authorization processsimilar to that envisaged for drugs, even when there is no certain evidence of their danger. While on the other hand, for synthetic products – often less known in terms of long-term safety – we proceed with less rigor and with much more permissive parameters.

The fear is that “the Commission decides to operate blindfolded, without worrying about the risks that the European agri-food sector could run”, the two associations write in their statement. Underlining that “the interpretation of scientific data remains to be demonstrated” regarding the dangers of aloe and rhubarb in natural supplements.

The Had scientific question on aloe and rhubarb

Had include compounds such as aloe-emodin, emodin and dantrone, present in various plant species, including aloe and rhubarb. These compounds work stimulating intestinal contractionswhich promote intestinal transit and the elimination of feces. They are therefore appreciated as natural remedies for constipation problems, but their effectiveness has always been balanced by the recommendation of limited and sporadic use.

There scientific concern arises from the fact that, in high doses and in purified form, some Had can have harmful effects, such as:

  • Genotoxicityas experimental studies have suggested that aloe-emodin and similar compounds could cause DNA damage in cells, increasing the risk of mutations. However, this evidence comes from in vitro (laboratory) and animal tests, and has not been fully confirmed in humans;
  • Carcinogenicitysince genotoxicity, in the long term, could imply an increased risk of cancer. A study conducted in animal models associated aloe-emodin with an increase in pre-cancerous and cancerous lesions in the gastrointestinal tract. This result led EFSA to consider a theoretical risk of carcinogenicity for humans, even if direct demonstration in humans is lacking;
  • Liver and Gastrointestinal Toxicityas prolonged use of Had can cause damage to the colon and, in some cases, the liver, due to their irritating action. This chronic irritation of the colon has been found in cases of abuse of Had-containing laxatives.

A Furthermore, the recruitment method is also controversial and the concentration of the Had. In supplements, these compounds are often found in natural form, mixed with plant fibers and other substances that reduce their biological impact and effective concentration. Scientific studies that warn of the risks of HAD, however, have often analyzed purified compounds and at high doses, which do not necessarily reflect actual conditions of use.

The economic impact

According to what was reported by Coldiretti and Filiera Italiana, the EU decision currently risks having serious economic consequences. The aloe and rhubarb cropsused by many supplement manufacturers and appreciated by consumers, constitute an important source of income for numerous agricultural companies in Europe, especially in Italy.

This measure, therefore, could undermine the competitiveness of producers.

“The Commission is operating blindfolded,” accuse Coldiretti and Filiera Italia, “ignoring the risks for our agri-food sectorwhich could suffer a very hard blow due to short-sighted political decisions.” More precisely, the fear is that these restrictions indirectly favor synthetic product multinationals, threatening the diversity and sustainability of European agricultural production which, instead, has managed to turn the production of natural supplements into an interesting economic sector.

Public health or market interests?

In fact, it must be said, however, that the controversy surrounding the ban on aloe and rhubarb in supplements raises a broader question: To what extent is it right to limit the use of natural products in the name of safety? Coldiretti and Filiera Italia question the impartiality of the regulation, accusing Europe of bowing to market interests. For consumers, the case represents yet another chapter in the debate on safety and freedom of choice, between trust in natural products and an increasingly complex and controversial regulatory system.

While EFSA, however, has chosen a precautionary approach, in line with the risk reduction principlealthough critics argue that this is a type of excessive scientific evaluation for natural foods.

The hope of the associations is that the European Union reviews the banmanaging to find a balance between protecting public health and valorising natural products, while ensuring that decisions taken are based on clear and objective scientific evidence.