Hydroxyanthracene derivative is a chemical substance that is naturally present in the middle layer (between the external green peel and the inner gel) of aloe vera. This substance is widely used in food supplements to improve bowel’s function.

But in June 2016, the European Commission (EC) asked the European Food Safety Authority (EFSA) to evaluate its safety from all food sources, and to recommend a daily intake that does not give rise to concerns about possible harmful effects.

This request was based on Article 8 of Regulation (CE) No 1925/2006 (1) on the addition of vitamins and minerals and of certain other substances to food, which allows the EC to restrict or prohibit ingredients that represent a potential risk to health (after a safety assessment by EFSA).

Such mechanism is typical of the respective division between the EC and EFSA in terms of food safety: EFSA is responsible for risk assessment, while the Commission is responsible for risk management.

In 2017, EFSA (2) concluded that all three substances have shown to be genotoxic in vitro,at least partially due to the HADs present in the extract. However, the EFSA Panel was unable to provide advice on a daily intake of HADs.

Based on this scientific opinion, the Commission surprisingly considered that such substances should not be restricted but prohibited, and, therefore, decided to include them in Annex III, Part A of Regulation (EC) No 1925/2006, through the adoption of Commission Regulation (EU) 2021/468 (3).

Several companies and trade associations in the food supplements sector, considering that the EC had exceeded its legislative powers in adopting this Regulation, brought the case before the ECJ (4).

Their main arguments were based on the interpretation of Article 8 which allows the EC to regulate or ban ‘substances’ or ‘ingredients but does not mention ‘preparations’. In addition, they claimed that the EC had breached the principle of proportionality and essential procedural requirements since the provisions were not sufficiently supported by EFSA's conclusions.

The ECJ upheld the 2 legal grounds.
First of all, Article 8 only mentions ‘substance’ and ‘ingredients’ and therefore it does not allow to restrict preparations contrary to what the EC did. 
Secondly and most importantly, the ECJ evaluated whether the EC accurately balanced all scientific information when doing its risk management. 
Accordingly with Article 8, two conditions must be met to ban a substance or ingredients: 

• The ingestion of greater amounts of [the substance] should represent a potential risk to consumers (rather than the quantity that can reasonably be expected to be ingested under normal conditions of consumption of a balanced and varied diet) and,
• A ‘harmful effect’ on health must have been identified. 

However, in this case, only one of the conditions was fulfilled.
Actually, if EFSA did not provide any advice on a daily intake of HADs derivatives, it means that no data on concentration levels of HADs in parts of the plants typically consumed as part of the normal diet, were available. 
The EC could have simply added the substances to the list of Substances under Community scrutiny (Annex III, part C) and asked EFSA to prepare a second opinion. 
Consequently, on the 13th of November 2024 (5), the ECJ rightly considered, that the EC had exceeded its powers by going beyond the scientific opinion provided by EFSA, and annulled the ban on: 

• ‘aloe-emodin and all preparations in which this substance is present’;
• ‘emodin and all preparations in which this substance is present’;

And,

• ‘preparations from the leaf of Aloe species containing hydroxyanthracene derivatives’;
  
  Therefore, Regulation no 1925/2006 should be updated soon.  This case represents a symbolic defeat for the EC which received a strong reminder about the limit of its risk management.