(Utkast) Kommisjonens gjennomføringsbeslutning om overvåking og rapportering av antimikrobiell resistens hos zoonotiske og kommensale bakterier og oppheving av Kommisjonens gjennomføringsbeslutning 2013/652/EU
(Draft) Commission Implementing Decision on the monitoring and reporting of antimicrobial resistance in zoonotic and commensal bacteria and repealing Commission Implementing Decision 2013/652/EU
Utkast til kommisjonsbeslutning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 17.10.2020
BAKGRUNN (fra kommisjonsbeslutningen, engelsk utgave)
(1) Directive 2003/99/EC requires Member States to ensure that monitoring provides comparable data on the occurrence of antimicrobial resistance (‘AMR’) in zoonotic agents and, in so far they present a threat to public health, other agents.
(2) Directive 2003/99/EC also requires Member States to assess the trends and sources of AMR in their territory and to transmit a report every year covering data collected in accordance with that Directive to the Commission.
(3) Commission Implementing Decision 2013/652/EU lays down detailed rules for the harmonised monitoring and reporting of AMR in zoonotic and commensal bacteria. These rules are applicable until 31 December 2020.
(4) In its Communication of 29 June 2017 to the Council and the European Parliament ‘A European One Health Action Plan against Antimicrobial Resistance’ , the Commission committed to review Union implementing legislation, namely Implementing Decision 2013/652/EU, concerned with the monitoring of AMR in zoonotic and commensal bacteria in farm animals and food to take into account new scientific developments and data collection needs.
(5) From 2015 to 2018, the Commission carried out a series of audits in Member States for the purposes of evaluating the implementation of Implementing Decision 2013/652/EU by competent authorities. A final overview report summarising this series of audits highlighted certain implementation challenges faced by Member States that should be taken into account by the Commission when revising Implementing Decision 2013/652/EU.
(6) On 5 June 2019, the European Food Safety Authority (‘EFSA’) published a scientific report entitled “Technical specifications on harmonised monitoring of antimicrobial resistance in zoonotic and indicator bacteria from food‐producing animals and food” . This report recommends specific adaptations to the current AMR monitoring and reporting system as laid down in Implementing Decision 2013/652/EU in order to respond effectively to the constantly evolving threat of AMR and to ensure continuity in assessing future trends in AMR from 2021. These recommended adaptations primarily concern adaptations as to the food-producing animal populations or food categories to be sampled, the sampling design to be followed, the bacterial species to be tested for AMR and the analytical methods to be used by laboratories in charge of testing for AMR.
(7) In order to continue to obtain comparable and reliable data on AMR, it is important to take recommendations of the EFSA scientific report of 5 June 2019 into account when defining the most relevant combinations of bacterial species, food producing animal species and food products to be included in the harmonised monitoring and reporting of AMR from 2021. It is also appropriate to minimise the burden on competent authorities of Member States to the extent possible, notably by addressing known implementation challenges and by focussing AMR monitoring on biological samples or bacterial isolates collected within the framework of existing national control programmes.
(8) Whole genome sequencing (‘WGS’) is a promising technique to replace conventional phenotypical testing in microbiology and is increasingly used worldwide. However, only a limited number of Member States are currently able to use WGS for AMR monitoring on a routine basis. It is therefore appropriate to authorise the use of WGS as an alternative to the conventional phenotypical techniques on a voluntary basis only, but to impose technical conditions on the WGS technique to ensure data comparability.
(9) AMR is a global threat that can easily spread across borders. Therefore, in order to improve coordination and gain a deeper understanding of how to help reduce the impact of AMR impact globally, it is essential that food products imported into the Union are also subjected to AMR monitoring requirements.
(10) In order to ensure continuity of the harmonised AMR monitoring and reporting by Member States after the period covered by Implementing Decision 2013/652/EU, this Decision should apply from 1 January 2021.
(11) For the sake of legal clarity, Implementing Decision 2013/652/EU should be repealed.
(12) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed
Helse- og omsorgsdepartementet
Landbruks- og matdepartementet