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Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law’) (Text with EEA relevance)
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1.A Member State may apply to the Commission for approval of disease–free status for one or more of the listed diseases referred to in points (b) and (c) of Article 9(1), for one or more of the relevant animal species, for its entire territory or for one or more zones thereof, provided that one or more of the following conditions are fulfilled:
(a)none of the listed species for the disease covered by the application for disease–free status is present anywhere in the territory of the Member State concerned or in the relevant zone or zones covered by the application;
(b)the disease agent is known not to be able to survive in the entire territory of the Member State, or in the relevant zone or zones covered by the application, according to the criteria referred to in point (a)(ii) of Article 39;
(c)in the case of listed diseases only transmitted by vectors, none of the vectors are present, or they are known not to be able to survive in the entire territory of the Member State, or in the relevant zone or zones covered by the application, according to the criteria referred to in point (a)(ii) of Article 39;
(d)freedom from the listed disease has been demonstrated by:
an eradication programme complying with the rules laid down in Article 32(1) and rules adopted pursuant to paragraph 2 of that Article; or
historical and surveillance data.
2.Applications by Member States for disease–free status shall include evidence demonstrating that the conditions for disease–free status laid down in paragraph 1 are fulfilled.
3.A Member State may in certain specific cases apply to the Commission for approval of disease–free status for one or more of the listed diseases referred to in point (a) of Article 9(1), and in particular for approval of non–vaccination status for the entire territory, or for one or more zones thereof, provided that the following conditions are fulfilled:
(a)freedom from the listed disease has been demonstrated by:
an eradication programme complying with the rules laid down in Article 32(1) and rules adopted pursuant to paragraph 2 of that Article; or
historical and surveillance data;
(b)it has been demonstrated that vaccination against the disease would lead to costs which would exceed those resulting from maintaining freedom from disease without vaccination.
4.The Commission shall, by means of implementing acts, approve, subject to amendments where necessary, applications by Member States for disease–free status or non-vaccination status when the conditions referred to in paragraphs 1 and 2 and, as relevant, paragraph 3 are fulfilled.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
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