Case C-596/25, Sonifer: Request for a preliminary ruling from the Tribunal Superior de Justicia de Madrid (Spain) lodged on 9 September 2025 – Sonifer S. A. v Ministerio de Sanidad
Date: 2025-09-09
Institutions: Court of Justice
Subjects: food contact material, food inspection, food safety, health control, national competent authority, national law, precautionary principle








C_202506495EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2025/6495


15.12.2025






Request for a preliminary ruling from the Tribunal Superior de Justicia de Madrid (Spain) lodged on 9 September 2025 – Sonifer S. A. v Ministerio de Sanidad


(Case C-596/25, Sonifer)

(C/2025/6495)
Language of the case: Spanish

Referring court

Tribunal Superior de Justicia de Madrid

Parties to the main proceedings


Applicant: Sonifer S. A.

Defendant: Ministerio de Sanidad

Questions referred







1.


May the precautionary principle, as already declared to be applicable to the protection of human health inter alia by the Communication from the European Commission of 2 February 2000 on the precautionary principle (1) and recital 6 of Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (2) (without prejudice to the case-law of the Court of Justice of the European Union on that subject), be considered to be directly applicable for the purpose of taking administrative silence as a refusal, when, as a general rule, administrative silence is to be taken as consent under the applicable national legislation, where no domestic provision with the force of law exists which derogates from that general rule in the particular field being examined?










2.


In the event that the precautionary principle laid down in Article 191 TFEU, as developed by the case-law of the CJEU, is considered to be insufficient by itself to counteract a national rule which treats administrative silence as positive or as signifying consent, ‘unless a provision of Community law provides otherwise’, given that Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004, (3) Commission Regulation (EC) No 2023/2006 of 22 December 2006, (4) and Commission Regulation (EU) No 10/2011 of 14 January 2011 (5) make no reference in that regard, is the European Union requirement that competent national authorities must have procedures and/or arrangements in place to ensure the effectiveness of official controls and other official activities, laid down in Article 5(1)(a) of Regulation (EU) 2017/625, (6) in conjunction with Articles 44 and 45 thereof, to be construed as constituting a rule of European Union law which creates an exception to the rule that administrative silence is to be taken as consent, laid down by national law in health control procedures for products intended to come into contact with food?






(1)  COM/2000/0001 final.

(2)  
            OJ 2003 L 268, p. 29.

(3)  Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ 2004 L 338, p. 4).

(4)  Commission Regulation (EC) No 2023/2006 of 22 December 2006 on good manufacturing practice for materials and articles intended to come into contact with food (OJ 2006 L 384, p. 75).

(5)  Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food (OJ 2011 L 12, p. 1).

(6)  Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (OJ 2017 L 95, p. 1).


ELI: http://data.europa.eu/eli/C/2025/6495/oj
ISSN 1977-091X (electronic edition)