Case T-690/25: Action brought on 7 October 2025 – Avicenn and Gillet v Commission
Date: 2025-10-07
Institutions: General Court
Subjects: administrative transparency, artificial food colouring, disclosure of information, health risk, infringement of EU law, market approval, medicinal product, oxide, precautionary principle, scientific report








C_202506211EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2025/6211


8.12.2025






Action brought on 7 October 2025 – Avicenn and Gillet v Commission


(Case T-690/25)

(C/2025/6211)
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:






—


declare that, by failing to adopt, within the period laid down in Article 3 of Regulation (EU) 2022/63, (1) an act reviewing the need to maintain or withdraw titanium dioxide (E171) in medicinal products, the European Commission has failed to fulfil its obligations under Article 265 TFEU;










—


declare that that failure constitutes a manifest breach of the precautionary principle and Articles 168 and 191 TFEU;










—


declare that Staff Working Document SWD(2025) 244 final has no legal value, in that it does not constitute a formal act setting out reasons enabling the Commission to fulfil the obligation laid down in Article 3 of Regulation (EU) 2022/63;










—


order the European Commission to decide within a reasonable period of time on the necessity of maintaining or withdrawing titanium dioxide (E171) from medicines, in accordance with the requirements of EU law;










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order the Commission to disclose to the public the scientific assessment on which its position is based, in accordance with Article 41 of the Charter of Fundamental Rights and the principle of administrative transparency;










—


order the European Commission to pay the costs.





Pleas in law and main arguments

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






1.


First plea in law, alleging infringement of Article 3 of Regulation 2022/63. The applicants argue that the European Commission failed to comply with its legal obligation under Article 3 of Regulation (EU) 2022/63, which requires a review, within three years, of the need to maintain titanium dioxide (E171) in medicinal products. No formal decision was adopted or published before the deadline of 7 February 2025. Furthermore, the document entitled ‘Staff Working Document’ SWD(2025) 244 final, published on 5 August 2025, does not constitute a decision within the meaning of EU law and does not satisfy the requirements of the Regulation.










2.


Second plea in law, alleging infringement of the precautionary principle and the right to health protection (Articles 168 and 191 TFEU and Article 35 of the Charter of Fundamental Rights of the European Union) (the ‘Charter’). The applicants argue that the Commission has de facto maintained the authorisation of titanium dioxide in medicinal products without carrying out the planned review, despite scientific uncertainties regarding the risks of genotoxicity and immunotoxic effects. According to the applicants, that unjustified maintenance is contrary to the precautionary principle, the right to a high level of health protection and the Charter. The applicants criticise the Commission’s position, which they consider to be based on insufficient justifications relating to the technical feasibility of substitution, industrial competitiveness and the risks of shortages, without conclusive evidence or a timetable for phasing out.






(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 (E 171) (OJ 2022 L 11, p. 1).


ELI: http://data.europa.eu/eli/C/2025/6211/oj
ISSN 1977-091X (electronic edition)