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:
(a)
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;
(b)
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;
(c)
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;
(d)
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;
(e)
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;
(f)
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.
2. At the request of the Union agency or body carrying out the risk assessment within its mandate, the Union agencies and bodies referred to in paragraph 1 of this Article shall, without undue delay, provide any relevant information and data at their disposal. Processing of personal data, whenever applicable, shall be carried out in accordance with the data protection requirements as laid down in Article 27.
3. Where the risk assessment needed is totally or partially outside the mandates of the Union agencies and bodies referred to in paragraph 1, and is considered necessary for the coordination of the response at Union level, the Commission shall, at the request of the HSC or on its own initiative, provide an ad hoc risk assessment.
4. The Commission shall make risk assessments available to the national competent authorities promptly through the EWRS and to the HSC, and, if appropriate, through linked alert systems. Where the risk assessment is to be made public, the national competent authorities shall receive it 24 hours prior to its publication, unless the immediate publication of the risk assessment is required on grounds of urgency and necessity.
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.
5. 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.