The Court of Justice of the European Union has annulled the regulation that banned aloe and other laxative plants
In its ruling of November 13, the Court of Justice of the European Union decided to fully annul Regulation (EU) 2021/468, which prohibited the marketing of aloe and preparations containing hydroxyanthracene derivatives (HAD), and also imposed restrictions on the use of traditionally employed plants such as Senna, Rhubarb, Frangula, and Cascara.
The decision follows a hearing held in June 2023, after which the Court accepted the appeal filed by several companies in the sector. These companies contested the ban imposed by the European Commission, arguing that it was not sufficiently supported by scientific evidence and was damaging to the food supplements market.
Reasons for the ruling
The contested regulation amended Annex III of Regulation (EC) No. 1925/2006, listing preparations made from aloe leaves containing HAD among the prohibited substances in food, based on 2017 assessments by EFSA (European Food Safety Authority). EFSA had identified potential genotoxic and carcinogenic risks associated with HAD, stating that it was not possible to define a safe daily intake level.
However, the appealing companies argued that such risks were not demonstrable in preparations derived solely from the inner gel of aloe leaves, which does not directly contain HAD in harmful form. The ban, they claimed, was excessive and disproportionate, failing to distinguish between different parts of the plant and the actual concentrations present in commercial products.
Position of the Italian Federation of Herbalists
Angelo Di Muzio, president of the Italian Federation of Herbalists (FEI), welcomed the ruling, emphasizing that it represents essential protection for the natural supplements industry. Di Muzio noted that the plants involved – including Aloe, Senna, Cascara, Rhubarb, and Frangula – have long been used in phytotherapy to support normal intestinal functions and that banning these ingredients would have had serious consequences for companies in the sector.
According to the FEI, the scientific data cited by the Commission was partial and insufficient to justify a complete ban. New evidence presented by trade associations further disproves the hypothesis of in vivo genotoxicity, highlighting the absence of harmful effects at the dosages actually contained in plant-based preparations.
Legal costs and industry impact
The Court also ordered the European Commission to pay legal costs, acknowledging that no actual danger had been demonstrated from HAD at the concentrations found in herbal preparations. Substances such as aloin, emodin, and aloe-emodin are naturally present in various plant species and have long been used in phytotherapy products without evidence of harm to public health.
A symbolic and practical victory
According to Di Muzio, the ruling carries significant symbolic as well as practical weight. It reassures consumers, protects Italy’s herbal tradition, and strengthens the position of those who have long advocated for the responsible use of medicinal plants. The Federation thanked the companies that supported the legal challenge and the Italian Ministry of Health, the only Member State to oppose the ban at the European level.
Following the ruling, the meeting scheduled for November 18 by the Commission—where a new regulation aimed at definitively banning the four laxative plants was to be discussed—was also cancelled.
