Article 10

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.

← art_9__para_4__text_1 · All articles · 1. →

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