art_20__para_1

1. Where an alert is notified pursuant to Article 19, the Commission shall, where necessary for the coordination of the response at Union level referred to in Article 21 or at the request of the HSC 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 one or more of the following Union agencies or bodies: the ECDC, in accordance with Article 8a of Regulation (EC) No 851/2004, in the case of a serious cross-border threat to health referred to in Article 2(1), points (a)(i) and (a)(ii), including where it relates to substances of human origin that can potentially be impacted by communicable diseases, or in Article 2(1), point (d), of this Regulation; the European Medicines Agency (EMA), in accordance with Article 1 of Regulation (EU) 2022/123 of the European Parliament and of the Council (37), where the serious cross-border threat to health is linked to medicinal products and medical devices; 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 (38), in the case of a serious cross-border threat to health referred to in Article 2 of this Regulation where that threat falls under the mandate of EFSA; the European Chemicals Agency (ECHA), in accordance with Regulation (EC) No 1907/2006 of the European Parliament and of the Council (39), in the case of a serious cross-border threat to health referred to in Article 2(1), point (b) or (c), of this Regulation where that threat falls under the mandate of the ECHA; the European Environment Agency (EEA), in accordance with Regulation (EC) No 401/2009 of the European Parliament and of the Council (40), in the case of a serious cross-border threat to health referred to in Article 2(1), point (c), of this Regulation, where that threat falls under the mandate of the EEA; the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA), in accordance with Regulation (EC) No 1920/2006 of the European Parliament and of the Council (41), in the case of a serious cross-border threat to health referred to in Article 2(1), point (b), of this Regulation, where that threat falls under the mandate of the EMCDDA. The risk assessment shall be carried out in the case of a threat referred to in Article 2(1) of this Regulation in cooperation with the European Union Agency for Law Enforcement Cooperation (Europol) where the serious cross-border threat to health emanates from terrorist or criminal activity referred to in Article 3 of Regulation (EU) 2016/794 of the European Parliament and of the Council (42); and in cooperation with EMA, where the serious cross-border threat to health is linked to medicinal products.

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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.