The General Court of the European Union has annulled Regulation 468/2021 which provided for the marketing ban imposed by the European Commission on “preparations based on leaves of Aloe species containing hydroxyanthracene derivatives (HAD)” as well as restrictions on the sale of other plants containing anthraquinones: Senna, Rhubarb, Frangula and Cascara. The ruling, issued on November 13, 2024, accepts the appeal presented by several European companies in the herbal and food supplement sector supported by industry associations, including Assoerbe and Federazione Erboristi Italiani, and with the support of several scientific studies. The Commission introduced the ban in 2021, based on a 2017 scientific opinion from the European Food Safety Authority (EFSA) that highlighted potential health risks linked to the genotoxicity of some hydroxyanthracenes. However, the Court ruled that the Commission, in prohibiting all Aloe preparations containing hydroxyanthracenes regardless of the quantity, has infringed Article 8 of Regulation (EC) n. 1925/2006.
The crux of the ruling is the lack of a defined risk threshold. EFSA had not been able to indicate a safe daily dose of hydroxyanthracenes for human health due to the lack of sufficient data. The Commission interpreted this lack as an inability to establish a safe level of use, and therefore proceeded with a total ban.
The Court instead stressed that Article 8 of the Regulation provides for a ban only when the ingestion of a substance “largely” exceeds normal levels of consumption and when “harmful effects on health” have been identified. The lack of a risk threshold does not therefore justify a general ban. The ruling does not address the safety of hydroxyanthracenes, but focuses on the correct application of the legislation.
Therefore, the Regulation was annulled and the Commission was ordered to pay court costs.
Sources:
https://eur-lex.europa.eu/legal-content/IT/TXT/HTML/?uri=CELEX:62021TJ0189&qid=1731598193568
https://eur-lex.europa.eu/legal-content/IT/TXT/HTML/?uri=CELEX:62021TJ0302&qid=1731598193568
