Case T-685/25: Action brought on 4 October 2025 – Avicenn and Gillet v Commission
Date: 2025-10-04
Institutions: General Court
Subjects: artificial food colouring, infringement of EU law, market approval, medicinal product, oxide, precautionary principle, public health








C_202506139EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2025/6139


8.12.2025






Action brought on 4 October 2025 – Avicenn and Gillet v Commission


(Case T-685/25)

(C/2025/6139)
Language of the case: French

Parties


Applicants: Association de veille et d’information civique sur les enjeux des nanosciences et nanotechnologies (Avicenn) (Paris, France), Sylvie Gillet (Clermont Ferrand, France) (represented by: T. Berger, lawyer)

Defendant: European Commission

Form of order sought

The applicants claim that the Court should:






—


primarily






—


annul the act entitled ‘Commission Staff Working Document on the use of titanium dioxide in medicinal products’ SWD(2025) 244 final, of 4 August 2025, in so far as it constitutes a decision to maintain the authorisation of titanium dioxide (E171) in medicinal products;










—


hold that, by adopting this document, the European Commission has failed to fulfil its obligations under Regulation (EU) 2022/63 (1) of 14 January 2022 and the precautionary principle and the requirements of public health protection (Articles 191(2) and 168 TFEU);










—


note that, in accordance with Article 266 TFEU, the Commission is required to take the necessary measures to comply with the judgment to be delivered, in particular by adopting a review decision that complies with the requirements of EU law;














—


in the alternative






—


hold, in the event of doubt as to the classification of the contested act, that the Commission has failed to comply with its obligation to review under Article 3 of Regulation (EU) 2022/63 and rule that it must do so within a reasonable time;














—


order the European Commission to pay the costs.





Pleas in law and main arguments

In support of the action, the applicant relies on three pleas in law.






1.


First plea in law, alleging infringement of Article 3 of Regulation 2022/63, on the grounds that the regulation required the Commission to review, within three years, the need to maintain E171 in medicinal products. No reasoned decision was adopted within the prescribed period and the Staff Working Document does not constitute a valid response to that obligation. It was not published in the Official Journal, does not set out reasons in accordance with the requirements of transparency and is not binding.










2.


Second plea in law, alleging failure to state reasons and infringement of Article 296 TFEU, on the grounds that document SWD(2025) 244 final does not contain detailed reasons or a precise scientific basis. It refers to an unpublished opinion of the European Medicines Agency (EMA), which remains partially inaccessible despite a formal request by Avicenn. Such a lack of transparency prevents any effective review of the legality of the act.










3.


Third plea in law, alleging infringement of the precautionary principle and the right to health protection (Articles 168 and 191 TFEU). The applicants argue that in 2021 the European Food Safety Authority (EFSA) identified signs of genotoxicity, neurotoxicity and immunotoxicity in E171, leading to its ban in food. They add that there is no new scientific evidence to justify its continued use in medicines, particularly in vulnerable patients. The Commission rejects the EFSA’s opinion without justification and on the basis of limited data, which is recognised as being incomplete. Furthermore, it does not take into account existing alternatives or concrete examples of substitution. Finally, the applicants consider that the asymmetry between the food and pharmaceutical sectors violates the normative consistency of the Union and that, in the absence of proof of safety, the continued use of E171 disregards the precautionary principle.






(1)  Commission Regulation (EU) 2022/63 of 14 January 2022 amending Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the food additive titanium dioxide (E171) (OJ 2022 L 11, p. 1).


ELI: http://data.europa.eu/eli/C/2025/6139/oj
ISSN 1977-091X (electronic edition)