Following the ban imposed in 2021, the European Court of Justice overturns restrictions on aloe supplements, paving the way for all products to be reintroduced to the market. A victory for companies in the sector
Do you remember what happened a few years ago with the aloe-based supplements? After a period of great popularity, these products came into the spotlight when the European Food Safety Authority (EFSA) detected possible risks linked to hydroxyanthracene derivatives present in the leaves of aloe and other plants.
These substances, known for their laxative effect, have been considered potentially genotoxic and carcinogenic, leading the European Commission to introduce severe restrictions. In practice, aloe supplements that contained hydroxyanthracene were banned.
Now, however, there is something new in this regard: the European Court of Justice annulled EU regulation 2021/468which imposed a ban on the marketing of preparations based on Aloe leaves containing hydroxyanthracene derivatives (HAD). The ruling, announced on November 13, represents an important victory for companies in the sector, who contested the provision, calling it “arbitrary and disproportionate”.
Regulation (EU) 2021/468 had amended Annex III of Regulation (EC) 1925/2006, classifying HADs as potentially genotoxic and carcinogenic. The decision was supported by the opinion of the European Food Safety Authority (EFSA), which concluded in 2017 that it could not establish a safe daily dose for these substances, due to the potential risk to public health.
However, companies in the sector immediately rebelled, claiming that the ban was unjustified for products obtained from the internal gel of Aloe leaves, which do not contain HADs, underlining that there was a lack of specific evidence of the gel’s dangers. They therefore appealed, contesting the general ban introduced by the European Commission without distinctions on the different types of products and preparations.
The ruling now establishes that the total ban on all preparations based on Aloe leaves is excessive, making it possible to reintroduce these products onto the market. The European Commission is now called to review the regulationpossibly evaluating concentration limits or specific warnings to protect consumer health without compromising the availability of all Aloe-based products.
Angelo Di Muzio, President of the Federation of Italian Herbalists (FEI), commented that the sentence represents “a historic achievement” for the supplements sector and for the health of consumers, who risked being unfairly alarmed. Di Muzio underlined how the studies presented in defense of the safety of HADs have demonstrated the absence of harmfulness of the active components of the plant in the doses actually used. Furthermore, the scientific analyzes following the EFSA decision would have refuted the initial findings, highlighting the incompleteness of the scientific literature on which the ban was based.
The Italian Ministry of Health supported the companies’ cause, supporting a more balanced and scientifically based regulation. This support was fundamental in countering the line of many member states, which had instead approved the ban in full.
The Commission meeting, scheduled for November 18 to discuss further restrictions on other medicinal plants, was cancelled, a sign of how the ruling has influenced the debate at European level.
