Diario Oficial de la Unión Europea del 4/5/2023 - Sección Legislación
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Fuente: Diario Oficial de la Unión Europea - Sección Legislación
EN
4.5.2023
Official Journal of the European Union
L 116/1
II
Non-legislative acts
REGULATIONS
COMMISSION DELEGATED REGULATION EU 2023/905
of 27 February 2023
supplementing Regulation EU 2019/6 of the European Parliament and of the Council as regards the application of the prohibition of use of certain antimicrobial medicinal products in animals or products of animal origin exported from third countries into the Union Text with EEA relevance
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation EU 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC 1, and in particular Article 1182 thereof, Whereas:
1
Antimicrobial resistance is a major threat to public health. When resistance develops to an antimicrobial agent used to treat a specific infection for which there are no alternative treatments and that resistance spreads, it has serious and potentially life-threatening consequences for humans. Human health, animal health and the environment are interlinked. Therefore, one of the objectives of Regulation EU 2019/6 is to contain the spread of antimicrobial resistance with concrete measures to promote the prudent and responsible use of antimicrobial medicinal products in animals.
2
The use of antimicrobial medicinal products to promote growth or to increase yield is neither prudent nor responsible. An extensive body of scientific literature has shown that the use of antimicrobials for such purposes can trigger antimicrobial resistance. Therefore, by Regulation EU 2019/6, the use of antimicrobial medicinal products for the purpose of promoting growth or to increase yield is prohibited, which includes antimicrobials contained in veterinary medicinal products as well as antimicrobials contained in human medicinal products.
3
Moreover, Regulation EU 2019/6 provides for the procedure to designate certain antimicrobials to be reserved for the treatment of infections in humans. Such antimicrobials are not to be used in antimicrobial medicinal products administered to animals. That measure aims to preserve the efficacy of certain antimicrobials used to treat infections in humans, especially those considered treatments of last resort. Criteria for the designation of antimicrobials reserved for the treatment of certain infections in humans are laid down in Commission Delegated Regulation EU 2021/1760 2 and the list of antimicrobials reserved for treatment of certain infections in humans is set out in Commission Implementing Regulation EU 2022/1255 3.
1 OJ L 4, 7.1.2019, p. 43.
2 Commission Delegated Regulation EU 2021/1760 of 26 May 2021 supplementing Regulation EU 2019/6 of the European Parliament and of the Council by establishing the criteria for the designation of antimicrobials to be reserved for the treatment of certain infections in humans OJ L 353, 6.10.2021, p. 1.
3 Commission Implementing Regulation EU 2022/1255 of 19 July 2022 designating antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans, in accordance with Regulation EU 2019/6 of the European Parliament and of the Council OJ L 191, 20.7.2022, p. 58.
