On the 13th of November, the General Court of the EU annulled the European Commission decision prohibiting preparations with hydroxyanthracene derivatives (HADs), which are naturally found in various plants such as aloe and rhubarb. [1]
Regulation 2021/468 aimed to control botanical species that contain HADs through the article 8 procedure under Regulation 1925/2006 concerning the addition of substances and ingredients to food. [2,3]
The European Food Safety Authority (EFSA) was tasked by the Commission to assess the safety of HADs across all food sources. EFSA’s assessment determined that certain HADs, particularly emodin, aloe-emodin, and danthron, were both genotoxic and carcinogenic. EFSA raised safety concerns for extracts that include them, although some uncertainty remained, and it could not provide guidance on a safe daily intake of HADs that would not pose health risks.
Subsequently, the EC implemented the contested Regulation, which sought to prohibit aloe-emodin, emodin, danthron, and any preparations containing these substances, as well as all preparations derived from Aloe species that include HADs.
Four similar annulment applications were filed by several firms and trade association in the food supplements sector (T-189/21, T-271/21, T-274/21, and T-302/21). In the latter, they argued that the Commission overstepped its legislative authority in enacting the Regulation and violated the principle of legal certainty by attempting to regulate “preparations” rather than just “substances” or “ingredients.” Additionally, they claimed that the Commission breached the principle of proportionality and essential procedural requirements since the provisions were not adequately supported by EFSA’s conclusions.
The General Court upheld all these arguments. It supported the applicants’ claims regarding competence and legal certainty by explicitly rejecting EFSA’s 2009 Guidance, criticizing its definition of “preparations” as “circular”. Furthermore, in affirming the applicants’ claims about proportionality and procedural fairness, the Court stated that it was insufficient for the Commission to entirely ban HADs based solely on a lack of data regarding daily amounts that would not lead to health concerns.
The court decided to annul the first, second and third entries in Article 1(1), and Article 1(2), of Commission Regulation (EU) 2021/468. This means in brief that Aloe preparations, and preparations containing aloe-emodin or emodin are authorized again; and that preparations of Rhamnus, Cassia, and Rheum will not be under Community scrutiny anymore.
[1] Judgment of the General Court (6th Chamber, Extended Composition) of 13.11.2024 in Aboca SpA & Ors v European Commission, T-302/21, EU:T:2024:808, https://tinyurl.com/Case-T-302-21
[2] Commission Regulation (EU) 2021/468 of 18 March 2021 amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards botanical species containing hydroxyanthracene derivatives, https://eur-lex.europa.eu/eli/reg/2021/468/oj
[3] Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02006R1925-20240717
[4] EFSA, Safety of hydroxyanthracene derivatives for use in food, Published: 23 January 2018, https://www.efsa.europa.eu/en/efsajournal/pub/5090
Comments are closed, but trackbacks and pingbacks are open.