Foodlaw-Reading
Dr David Jukes, The University of Reading, UK
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Commission consultation, 6 December 2022
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Commission consultation: Draft COMMISSION DELEGATED REGULATION (EU) 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. A copy of the draft is avaialble on this site (click on image). |
The consultation is open until 3 January 2023. For more details and to give feedback, see: Fight against antimicrobial resistance consultation. The following is the opening section of the draft:
CONTEXT OF THE DELEGATED ACT
Regulation (EU) 2019/6, replaces the legal framework for veterinary medicinal products established by Directive 2001/82/EC and Regulation (EC) No 726/2004. One of the main objectives of the Regulation is to mitigate the risk of development of antimicrobial resistance, including by strengthening the prudent use of antimicrobial medicinal products. Among others, the Regulation prohibits the use of antimicrobial medicinal products for growth promotion and yield increase, and it forbids the use in animals of medicinal products containing antimicrobials that are reserved for treatment of infections in humans.
The criteria for the designation of antimicrobials reserved for treatment of certain infections in humans are laid down in Commission Delegated Regulation (EU) 2021/1760. The specific list of antimicrobials reserved for human use is contained in Commission Implementing Regulation (EU) 2022/1255.
Article 118(1) of the Regulation (EU) 2019/6 requires third country operators exporting animals or products of animal origin to the Union to respect the prohibition on the use of antimicrobial medicinal products for the purpose of promoting growth or to increase yield, and on the use of antimicrobials that have been reserved for the treatment of certain infections in humans. Article 118(2) of the Regulation (EU) 2019/6 empowers the Commission to adopt delegated acts providing detailed rules on the application of the above-referred prohibitions.
The application of the prohibition of use of certain antimicrobial medicinal products in animals or products of animal origin that are exported from third countries into the Union requires the setting up of an effective enforcement system. As a system permitting controls of animals or products of animal origin imported into the Union does not exist under the Regulation (EU) 2019/6, resort has been made to the Union framework on official controls.
Specifically, the Regulation (EU) 2017/625 was amended in 2021 to include the verification of compliance with the prohibition in Article 118(1) of the Regulation (EU) 2019/6 within the scope of the Union framework on official controls.
The purpose of this Delegated Regulation is to supplement Regulation (EU) 2019/6 by establishing detailed rules necessary for the application of the prohibition foreseen in Article 118(1) thereof, including the setting of the conditions to be respected by animals or products of animal origin that are exported from third countries into the Union.
