In a precedent decision, on 13 November 2024, the EU General Court annulled significant parts of a Commission Regulation, which sought to restrict or place under scrutiny the addition of certain botanicals containing hydroxyanthracene derivatives (“HADs”) to foods.  The Court held that the Commission had exceeded its powers by seeking to regulate botanical “preparations.”  Moreover, the Commission, in relying on the scientific opinion of the European Food Safety Authority (“EFSA”), had failed to demonstrate that the relevant substances would be ingested in amounts greatly exceeding those consumed from a normal diet or otherwise represented a potential risk to consumers. 

1. Background

Regulation (EC) 1925/2006 governs the addition of vitamins and minerals and of certain other substances to food (the “Fortification Regulation”).  Article 8 permits the Commission on its own initiative, or on the basis of information provided by Member States, to prohibit, restrict or place under scrutiny “substances” and “ingredients containing a substance”, which are “added to foods or used in the manufacture of foods under conditions that would result in the ingestion of amounts of this substance greatly exceeding those reasonably expected to be ingested under normal conditions of consumption of a balanced and varied diet and/or would otherwise represent a potential risk to consumers.”

In 2016, the Commission, relying on Article 8, requested EFSA to provide a scientific opinion on the safety of HADs and preparations containing HADs.  In November 2017, EFSA adopted its scientific opinion “Safety of hydroxyanthracene derivatives for use in foods” (“the EFSA Opinion”) in which it concluded as follows:

“… the hydroxyanthracenes, emodin, aloe-emodin and the structurally related substance danthron, have been shown to be genotoxic in vitro.

Aloe extracts have also been shown to be genotoxic in vitro and the Panel concluded this was most likely due – at least in part – to [HADs] present in the extract. However, the Panel further noted that Aloe extracts depleted of hydroxyanthracenes, contained an additional genotoxic component(s).

Furthermore, aloe-emodin was shown to be genotoxic in mice, the whole leaf aloe extract was carcinogenic to rats and there was evidence of carcinogenicity of the structural analogue danthron in both rodent species. Given that aloe-emodin and emodin may be present in the extracts, the Panel concluded that [HADs] should be regarded as genotoxic and carcinogenic unless there are specific data to the contrary, such as for rhein, and that there is a safety concern for extracts containing [HADs] although uncertainty persists.

The Panel was unable to provide advice on a daily intake of [HADs] that does not give rise to concerns about harmful effects to health, for the general population, and as appropriate, for vulnerable subgroups of the population.”

Based on the EFSA Opinion, the Commission adopted Commission Regulation (EU) 2021/468 amending the Fortification Regulation by:

• Prohibiting:
  • aloe-emodin and all preparations in which this substance is present;
  • emodin and all preparations in which this substance is present;
  • preparations from the leaf of Aloe species containing hydroxyanthracene derivatives; and
  • danthron and all preparations in which this substance is present.

• Placing under scrutiny:
  • preparations from the root or rhizome of Rheum palmatum L., Rheum officinale Baillon and their hybrids containing hydroxyanthracene derivatives;
  • preparations from the leaf or fruit of Cassia senna L. containing hydroxyanthracene derivatives; and
  • preparations from the bark of Rhamnus frangula L., Rhamnus purshiana DC. containing hydroxyanthracene derivatives.

2. The Judgments

Four cases were filed in the EU General Court seeking to annul Commission Regulation (EU) 2021/468 (T-189/21 Aloe Vera of Europe v Commission, T-271/21 Ortis v Commission, T-274/21 Syndiet and Others v Commission and T-302/21 Aboca and Others v Commission).  Covington attorneys represented the applicants before the General Court in two (T-189/21 and T-302/21) of the four cases as detailed below.

The combined effect of all four judgments is that the Court annulled the Commission Regulation with respect to all substances that were prohibited or placed under scrutiny other than danthron.  The Court makes two key points:

a. The Commission cannot regulate ‘preparations’ under the Fortification Regulation

First, the Court held that Article 8 of the Fortification Regulation only permitted the Commission to regulate ‘substances’ and ‘ingredients containing a substance’ but not ‘preparations.’  The Court noted that the term ‘preparations’ constituted a broader concept, and, as accepted by the Commission at the hearing, could also include finished products.  The Court did not consider it necessary to define these three terms individually.  It was sufficient to note that since Article 8 did not permit the regulation of ‘preparations’, those aspects of the Commission Regulation were unlawful and had to be annulled.

b. The Commission has not met the conditions to prohibit ‘substances’ or ‘ingredients containing a substance’

Second, the Court reiterated the scope of its judicial review.  In principle, the Commission was afforded broad discretion on complex scientific issues.  However, the Court has full competence to assess legal matters.  On technical scientific questions, the Court would confine itself to assess whether the Commission has complied with procedural requirements and whether there has been a manifest error of assessment.  In assessing whether an institution has committed a manifest error of assessment, the Court will consider whether, based on the evidence submitted by the applicant, the relevant act is implausible.  The Court will also consider whether the evidence the institution relied upon is “factually accurate, reliable and consistent, whether that evidence contains all the information which must be taken into account in order to assess a complex situation, and whether it is capable of substantiating the conclusions drawn from it” (Aloe Vera of Europe, para. 42; Aboca, para. 68).  Moreover, the Court will also assess whether the institution has considered “all relevant factors and circumstances of the situation the act was intended to regulate” (Aloe Vera of Europe, para. 43; Aboca, para. 69).

Turning to the requirements of Article 8 of the Fortification Regulation, the Court held that in order to prohibit the addition or use in the manufacture of certain substances or ingredients containing substances, the Commission would need to meet two conditions: “first, it results in the ‘ingestion of amounts of [the substance in question] greatly exceeding those reasonably expected to be ingested under normal conditions of consumption of a balanced and varied diet and/or would otherwise represent a potential risk to consumers’ and, second, a ‘harmful effect on health has been identified’” (Aloe Vera of Europe, para. 50; Aboca, para. 75).

In both judgments, the Court concluded that the Commission failed to meet the requirements of the first condition.  The EFSA Opinion noted that it had not received any data on concentration levels of HADs in parts of the plants typically consumed as part of the normal diet.  In its conclusions, EFSA stated that it “was unable to provide advice on a daily intake of hydroxyanthracene derivatives that does not give rise to concerns about harmful effects to health.”  According to the Court, the Commission appears to have erroneously concluded that the insufficiency of data was sufficient to prohibit HADs entirely.  However, Article 8 expressly requires that it has been established that harmful effects on health have been identified for ingestion that greatly exceed levels reasonably expected to be ingested under normal conditions.  This had not been established here, given the lack of normal consumption data.

In addition, the Court also noted:

“Moreover, it is not apparent from the 2017 scientific opinion or from any material in the case file that the provisions of the contested regulation were adopted because the substances and preparations in question otherwise represented a potential risk to consumers” (Aloe Vera of Europe, para. 60; Aboca, para. 84).

Thus, overall, it was not possible for the Commission to adopt a general prohibition of substances or ingredients containing substances “irrespective of the amounts of those substances present” (Aboca, para. 86).

The judgments provide important clarifications on the scope of the Commission’s powers under the Article 8 procedure, which will have significant implications for additional botanicals being assessed by EFSA and the Commission under this procedure going forward.

Brian Kelly and Katharina Ewert represented the applicants in Case T-302/21 Aboca and Others v Commission.

Bart Van Vooren and Peter Bogaert represented the applicants in Case T-189/21 Aloe Vera of Europe v Commission.