CHAPTER IV

A rapid alert system for notifying at Union level alerts in relation to serious cross-border threats to health, an ‘Early Warning and Response System’ (EWRS), is hereby established. The EWRS shall enable the Commission and the competent authorities responsible at national level to be in permanent communication for the purposes of alerting, assessing public health risks and determining the measures that may be required to protect public health. The Commission shall, by means of implementing acts, adopt procedures concerning the information exchange in order to ensure the proper functioning of the EWRS and the uniform implementation of Articles 8 and 9 and to avoid overlap of activities or conflicting actions with existing structures and mechanisms for monitoring, early warning and combating serious cross-border threats to health. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 18(2). National competent authorities or the Commission shall notify an alert in the EWRS where the emergence or development of a serious cross-border threat to health fulfils the following criteria: it is unusual or unexpected for the given place and time, or it causes or may cause significant morbidity or mortality in humans, or it grows rapidly or may grow rapidly in scale, or it exceeds or may exceed national response capacity; and it affects or may affect more than one Member State; and it requires or may require a coordinated response at Union level. Where the national competent authorities notify the WHO of events that may constitute public health emergencies of international concern in accordance with Article 6 of the IHR, they shall at the latest simultaneously notify an alert in the EWRS, provided that the threat concerned falls within those referred to in Article 2(1) of this Decision. When notifying an alert, the national competent authorities and the Commission shall promptly communicate through the EWRS any available relevant information in their possession that may be useful for coordinating the response such as: the type and origin of the agent; the date and place of the incident or outbreak; means of transmission or dissemination; toxicological data; detection and confirmation methods; public health risks; public health measures implemented or intended to be taken at national level; measures other than public health measures; personal data necessary for the purpose of contact tracing in accordance with Article 16; any other information relevant to the serious cross-border threat to health in question. The Commission shall make available to the national competent authorities through the EWRS any information that may be useful for coordinating the response referred to in Article 11, including information related to serious cross-border threats to health and public health measures related to serious cross-border threats to health transmitted through rapid alert and information systems established under other provisions of Union law or the Euratom Treaty. Where an alert is notified pursuant to Article 9, the Commission shall, where necessary for the coordination of the response at Union level and upon request of the HSC referred to in Article 17 or on its own initiative, make promptly available to the national competent authorities and to the HSC, through the EWRS, a risk assessment of the potential severity of the threat to public health, including possible public health measures. That risk assessment shall be carried out by: the ECDC in accordance with Article 7(1) of Regulation (EC) No 851/2004 in the case of a threat referred to in points (i) and (ii) of point (a) of Article 2(1) or point (d) of Article 2(1); and/or the European Food Safety Authority (EFSA) in accordance with Article 23 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety OJ L 31, 1.2.2002, p. 1. in the case of a threat referred to in Article 2 of this Decision where the threat falls under the mandate of the EFSA; and/or other relevant Union agencies. Where the risk assessment needed is totally or partially outside the mandates of the agencies referred to in paragraph 1, and it is considered necessary for the coordination of the response at Union level, the Commission shall, upon request of the HSC or its own initiative, provide an ad hoc risk assessment. The Commission shall make the risk assessment available to the national competent authorities promptly through the EWRS. Where the risk assessment is to be made public, the national competent authorities shall receive it prior to its publication. The risk assessment shall take into account, if available, relevant information provided by other entities, in particular by the WHO in the case of a public health emergency of international concern. The Commission shall ensure that information that may be relevant for the risk assessment is made available to the national competent authorities through the EWRS and to the HSC. Following an alert pursuant to Article 9, on a request from the Commission or a Member State and on the basis of the available information, including the information referred to in Article 9 and the risk assessments referred to in Article 10, Member States shall consult each other within the HSC and in liaison with the Commission with a view to coordinating: national responses to the serious cross-border threat to health, including where a public health emergency of international concern is declared in accordance with the IHR and falls within Article 2 of this Decision; risk and crisis communication, to be adapted to Member State needs and circumstances, aimed at providing consistent and coordinated information in the Union to the public and to healthcare professionals. Where a Member State intends to adopt public health measures to combat a serious cross-border threat to health, it shall, before adopting those measures, inform and consult the other Member States and the Commission on the nature, purpose and scope of the measures, unless the need to protect public health is so urgent that the immediate adoption of the measures is necessary. Where a Member State has to adopt, as a matter of urgency, public health measures in response to the appearance or resurgence of a serious cross-border threat to health, it shall, immediately upon adoption, inform the other Member States and the Commission on the nature, purpose and scope of those measures. In the event of a serious cross-border threat to health overwhelming the national response capacities, an affected Member State may also request assistance from other Member States through the Community Civil Protection Mechanism established by Decision 2007/779/EC, Euratom. The Commission shall, by means of implementing acts, adopt the procedures necessary for the uniform implementation of the information exchange, consultation and coordination provided for in paragraphs 1 to 3. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 18(2).

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.