(fra kommisjonsforordningen)

(1) Commission Implementing Decision (EU) 2018/945 (2) establishes a list of communicable diseases and related special health issues to be covered by epidemiological surveillance. In addition, it sets out the case definitions for the purposes of submitting data for the epidemiological surveillance of those communicable diseases. That Implementing Decision was adopted on the basis of Decision No 1082/2013/EU of the European Parliament and of the Council (3), which has now been repealed by Regulation (EU) 2022/2371.

(2) The list of communicable diseases and related special health issues established by Implementing Decision (EU) 2018/945 should be updated to reflect changes in disease epidemiology and the public health needs and priorities of the Union and the Member States. The updated list should cover certain communicable diseases and related special health issues in accordance with the criteria for the selection of communicable diseases and related special health issues for epidemiological surveillance set out in Section 1 of Annex I to Regulation (EU) 2022/2371.

(3) In addition, the list of case definitions, currently set out in Implementing Decision (EU) 2018/945, should be updated in the light of new scientific information and evolving laboratory diagnostic criteria and practices.

(4) Antimicrobial resistance is estimated to cost millions of lives globally every year. As the strongest determinant of antimicrobial resistance, antimicrobial consumption has been under voluntary surveillance at Union level for over 20 years and should therefore also be included in Annex I to this Regulation as a special health issue subject to epidemiological surveillance.

(5) Coronavirus disease 2019 (COVID-19) caused a pandemic with very high morbidity and mortality and should therefore be subject to epidemiological surveillance at Union level. The surveillance of COVID-19 should be integrated with the sentinel syndromic and virologic surveillance of influenza and respiratory syncytial virus to ensure standardised surveillance of respiratory viral infections more independently of changing testing and control policies.

(6) Hantavirus infection is a zoonosis causing a few thousand cases in the Union every year. It may present as a viral haemorrhagic fever and should be subject to epidemiological surveillance at Union level to enable early warning, faster diagnosis, and more effective response in neighbouring Member States.

(7) Any zoonotic influenza virus (an animal-hosted type A influenza virus that crosses the species barrier to infect humans) may cause a pandemic in the future, hence any human infection with such a virus should be subject to epidemiological surveillance at Union level. In Annex I to this Regulation, ‘Zoonotic influenza’ should therefore replace the ‘influenza A/H5N1’ as currently listed in Implementing Decision (EU) 2018/945.

(8) Rabies virus and other lyssaviruses can cause central nervous disease in humans. It is therefore appropriate to expand ‘rabies’, as currently listed in Implementing Decision (EU) 2018/945, to ‘rabies and other lyssavirus infections’ in Annex I to this Regulation.

(9) Mpox clade II caused a global epidemic in 2022 predominantly among gay, bisexual and other men who have sex with men (MSM). Mpox clade I is prevalent in sub-Saharan Africa and is spreading in sexual networks affecting both men and women. Cases infected outside Europe have been detected in the Union and the countries in the European Economic Area and resulted in some onward transmission through household transmission or heterosexual contact. In late 2025, clade I started to spread also among MSM in the Union with cases acquired in the country of residence or through travel to other Member States or to the countries in the European Economic Area. Mpox should therefore be subject to event-based surveillance at Union level to detect any upsurge in cases in at-risk populations or the general population.

(10) Respiratory syncytial virus (RSV) infection causes a considerable number of hospitalisations among young children and the elderly and should therefore be subject to epidemiological surveillance at Union level. Like COVID-19, the surveillance of RSV infection should be integrated with the sentinel syndromic and virologic surveillance of influenza. Routine surveillance of RSV infection is also expected to contribute to measuring the impact of RSV vaccines.

(11) According to the criteria for the selection of communicable diseases and related special health issues for epidemiological surveillance as set out in Section 1 of Annex I to Regulation (EU) 2022/2371, the following diseases should no longer be subject to epidemiological surveillance at Union level:

• Cryptosporidiosis is a common but predominantly mild gastrointestinal infection that may cause local water-borne outbreaks but has no cross-border public health dimension that would justify continued surveillance at Union level,
• Like Cryptosporidiosis, Giardiasis tends to cause local outbreaks of self-limited diarrhoea,
• Lyme neuroborreliosis is difficult to diagnose and only accounts for a small fraction of Lyme disease. Routine surveillance of Lyme neuroborreliosis at Union level is therefore not suitable for estimating and monitoring the burden of Lyme disease,
• Severe acute respiratory syndrome (SARS) caused a large outbreak of severe respiratory infection which ended in 2004, but no further cases have been reported since,
• Thanks to decades of routine childhood vaccination in the Union, Tetanus has become exceedingly rare. It is not transmitted from person to person. Discontinuing tetanus surveillance at Union level therefore poses no major public health risks,
• Cases of typhoid and paratyphoid fever are mostly imported from outside the Union and are relatively mild and easily treatable by antibiotics. Their continued surveillance at Union level adds little public health value.

(12) In accordance with Article 9 of Regulation (EC) No 851/2004 of the European Parliament and of the Council (4), the European Centre for Disease Prevention and Control has provided, at the Commission's request, scientific assistance on the establishment of case definitions for antimicrobial consumption, arenavirus infection, Crimean-Congo haemorrhagic fever, filovirus infection, Hantavirus infection, healthcare-associated COVID-19, Lyssavirus infection, mpox, respiratory viral infections (influenza-like illness, acute respiratory infection, severe acute respiratory infection, COVID-19, seasonal influenza, zoonotic influenza, and RSV infection), Rift Valley fever. The assistance also included the revision of the case definitions for botulism, chikungunya virus disease, chlamydial infection including chlamydial lymphogranuloma venerum, cholera, variant Creutzfeldt-Jakob disease, dengue, gonococcal infection, hepatitis B, hepatitis C, Legionnaires’ disease, malaria, measles, plague, Q fever, rubella, Shiga toxin-producing E. coli infection, shigellosis, smallpox, syphilis and congenital syphilis, tick-borne encephalitis, tuberculosis, tularaemia, West Nile virus infection, intestinal yersiniosis, Zika virus disease, antimicrobial resistance and healthcare-associated infections. The respective case definitions should be amended accordingly.

(13) This Regulation replaces Implementing Decision (EU) 2018/945 which should be repealed.

(14) The measures provided for in this Regulation are in accordance with the opinion of the Committee on serious cross-border threats to health established under Article 29 of Regulation (EU) 2022/2371.

(15) The competent authorities of the Member States should be given until 1 July 2028 in order to prepare themselves to apply the rules laid down in this Regulation,