EU General Court annuls operative provisions of Commission Regulation prohibiting use of natural botanical extracts

13/11/24

Judgment of the General Court (6^th Chamber, Extended Composition) of 13.11.2024 in Aboca SpA & Ors v European Commission, T-302/21, EU:T:2024:808

The EU’s General Court today took the rare step of annulling a decision of the European Commission concerning food regulation, notwithstanding the broad discretion from which the Commission benefits when undertaking scientific assessments in this area.

Regulation (EC) No 2021/468 was adopted by the Commission under Regulation (EC) No 1925/2006, on the addition to foods of substances and ingredients containing them. It purported to regulate botanical species containing hydroxyanthracene derivatives (“HADs”). HADs occur naturally in multiple botanical species, including aloe and rhubarb.

The Commission had asked the European Food Safety Authority (EFSA) to evaluate the safety of HADs in all food sources. EFSA’s evaluation concluded that certain HADs (notably emodin, aloe-emodin and danthron) were genotoxic and carcinogenic and that there was a safety concern for extracts containing them, “although uncertainty persists”. EFSA was unable to provide advice on a daily intake of HADs that did not give rise to concerns about harmful effects to health.

Following EFSA’s conclusions, the Commission adopted the contested Regulation. It purported to ban aloe-emodin, emodin, danthron and “all preparations in which those substances are present”, along with all “preparations” from the leaf of the Aloe species containing HADs.

The Application for Annulment was taken by Aboca and Coswell, both Italian companies specialising in the manufacture of food supplements, and by APARD, a Portuguese trade association representing the interests of the food supplements industry. They contended, inter alia, that the Commission exceeded its legislative competence in adopting the Contested Regulation and breached the principle of legal certainty in so far as it purported to regulate “preparations”, and not simply “substances” and/or “ingredients”. They further contended that the Commission infringed the principle of proportionality and/or of essential procedural requirements in that the relevant provisions were not justified by the conclusions EFSA had reached.

All of these contentions were upheld by the General Court. In upholding the Applicants’ competence and legal certainty pleas, the Court expressly departed from EFSA’s 2009 Guidance, criticising its definition of “preparations” as “circular” ([50]). In upholding the Applicants’ proportionality and procedural pleas, the Court held that it was not good enough for the Commission to prohibit HADs entirely on the basis of an insufficiency of data as to daily amounts that did not give rise to health concerns ([82]).

The Judgment can be found here.