MIL-OSI Europe: Answer to a written question – Definition and declaration of an international health emergency – E-001491/2025(ASW)

1. A ‘health emergency’ definition is not included in EU legislation. However, Article 3(1) of Regulation (EU) 2022/2371[1] defines a serious cross-border threat to health. Internationally, a public health emergency of international concern is set in the International Health Regulations[2].

2. The EU can recognise a public health emergency on its own. The procedure for the recognition is set in Article 23 of Regulation (EU) 2022/2371[3], which foresees a consultation with relevant agencies and bodies[4]. The recognition has a form of an implementing act, requiring a favourable opinion of the Member States. The Commission does not have to consult the World Health Organisation (WHO) before the recognition, but should nonetheless inform the WHO about its intention to adopt such decision.

3. The substantial conditions for the recognition stem from Articles 2(1) and 3(1) of Regulation (EU) 2022/2371. In particular, the cross-border nature of a health threat and the need for EU-level coordination must be identified.

• [1] Article 3(1) of Regulation (EU) 2022/2371: ‘serious cross-border threat to health’ means a life-threatening or otherwise serious hazard to health of biological, chemical, environmental or unknown origin, as referred to in Article 2(1), which spreads or entails a significant risk of spreading across the national borders of Member States, and which may necessitate coordination at Union level in order to ensure a high level of human health protection (https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L:2022:314:FULL&from=EN).
• [2] https://iris.who.int/bitstream/handle/10665/246107/9789241580496-eng.pdf (Article 6 and Annex II of the International Health Regulations).
• [3] https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32022R2371&qid=1673887469777.
• [4] The European Centre for Disease Prevention and Control, or the Advisory Committee on public health emergencies (referred to in Article 24 of Regulation (EU) 2022/2371) or any other relevant Union agency or body.