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Document 32023D1017
Commission Implementing Decision (EU) 2023/1017 of 23 May 2023 amending Implementing Decision (EU) 2020/1729 as regards the monitoring of methicillin-resistant Staphylococcus aureus (MRSA) in fattening pigs (notified under document C(2023)3251) (Text with EEA relevance)
Commission Implementing Decision (EU) 2023/1017 of 23 May 2023 amending Implementing Decision (EU) 2020/1729 as regards the monitoring of methicillin-resistant Staphylococcus aureus (MRSA) in fattening pigs (notified under document C(2023)3251) (Text with EEA relevance)
Commission Implementing Decision (EU) 2023/1017 of 23 May 2023 amending Implementing Decision (EU) 2020/1729 as regards the monitoring of methicillin-resistant Staphylococcus aureus (MRSA) in fattening pigs (notified under document C(2023)3251) (Text with EEA relevance)
C/2023/3251
OJ L 136, 24.5.2023, p. 78–82
(BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
In force
24.5.2023 |
EN |
Official Journal of the European Union |
L 136/78 |
COMMISSION IMPLEMENTING DECISION (EU) 2023/1017
of 23 May 2023
amending Implementing Decision (EU) 2020/1729 as regards the monitoring of methicillin-resistant Staphylococcus aureus (MRSA) in fattening pigs
(notified under document C(2023)3251)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive 2003/99/EC of the European Parliament and of the Council of 17 November 2003 on the monitoring of zoonoses and zoonotic agents, amending Council Decision 90/424/EEC and repealing Council Directive 92/117/EEC (1), and in particular Articles 4(5), 7(3) and Article 9(1), fourth subparagraph, thereof,
Whereas:
(1) |
Directive 2003/99/EC requires the Member States to ensure that monitoring provides comparable data on the occurrence of antimicrobial resistance (AMR) in zoonotic agents and, in so far as they present a threat to public health, other agents. |
(2) |
Directive 2003/99/EC also provides that Member States are to assess the trends and sources of AMR in their territory and transmit to the Commission a report every year covering data collected in accordance with that Directive. |
(3) |
Commission Implementing Decision (EU) 2020/1729 (2) lays down detailed rules for the harmonised monitoring and reporting of AMR in zoonotic and commensal bacteria. The rules laid down in that Implementing Decision cover the period 2021 to 2027 and provide for a yearly rotational sampling system of animal species. In accordance with that rotational system, fattening pigs have to be sampled in 2025. |
(4) |
Methicillin-resistant Staphylococcus aureus (MRSA) is a pathogen that causes many healthcare- and community-associated infections that are difficult to treat in humans as they are resistant to multiple antibiotics. In recent decades, the emergence and increasing prevalence of livestock-associated MRSA (LA-MRSA), particularly sequence type 398 belonging to clonal complex 398, in pigs have become a global concern as its spread can compromise the effective treatment of infectious diseases in humans. Rearing and slaughtering pigs infected with LA-MRSA are also potential risk factors for infection in certain human populations such as farmers and slaughterhouse workers. Monitoring the prevalence of LA-MRSA in fattening pigs would therefore be very valuable for obtaining comprehensive, comparable and reliable information on the development and spread of MRSA at Union level in view to develop, if deemed necessary, appropriate interventions to prevent and control MRSA infections. |
(5) |
On 17 October 2022, the European Food Safety Authority (EFSA) published a scientific report on “Technical specifications for a baseline survey on the prevalence of methicillin resistant Staphylococcus aureus (MRSA) in pigs” (3) (the EFSA technical specifications). This report highlights the appropriateness to conduct a one-year EU-wide survey in batches of fattening pigs at slaughter to estimate the MRSA prevalence in the European population of fattening pigs, and defines a protocol for this survey including the target population, sample requirements, analytical methods and data reporting requirements. |
(6) |
The EFSA technical specifications should be considered when laying down rules for harmonised monitoring and reporting of MRSA in fattening pigs in the Union. |
(7) |
In order to take advantage of the sampling of fattening pigs scheduled in 2025 for other bacteria in accordance with the yearly rotational system already in place, the requirements for MRSA monitoring in fattening pigs should be laid down in Implementing Decision (EU) 2020/1729 and apply from 1 January 2025. |
(8) |
Implementing Decision (EU) 2020/1729 should therefore be amended accordingly. |
(9) |
The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
HAS ADOPTED THIS DECISION:
Article 1
Amendments to Implementing Decision (EU) 2020/1729
Implementing Decision (EU) 2020/1729 is amended as follows:
(1) |
in Article 1(2), the following point (f) is added:
|
(2) |
in Article 3, paragraph 2 is replaced by the following: ‘(2) National reference laboratories for AMR, or other laboratories designated by the competent authority in accordance with Article 37 of Regulation (EU) 2017/625, shall be responsible for carrying out:
|
(3) |
The Annex is amended in accordance with the Annex to this Decision. |
Article 2
Application
This Decision shall apply from 1 January 2025.
Article 3
Addressees
This Decision is addressed to the Member States.
Done at Brussels, 23 May 2023.
For the Commission
Stella KYRIAKIDES
Member of the Commission
(1) OJ L 325, 12.12.2003, p. 31.
(2) Commission Implementing Decision (EU) 2020/1729 of 17 November 2020 on the monitoring and reporting of antimicrobial resistance in zoonotic and commensal bacteria and repealing Implementing Decision 2013/652/EU (OJ L 387, 19.11.2020, p. 8)
(3) https://www.efsa.europa.eu/en/efsajournal/pub/7620
ANNEX
In the Annex to Commission Implementing Decision (EU) 2020/1729, Part A is amended as follows:
1. |
in point 1, the following paragraph (f) is added:
|
2. |
in point 2, paragraph (a) is replaced by the following:
|
3. |
point 3.1 is replaced by the following:
|
4. |
in point 4.1, the following paragraph is added: ‘For MRSA:
|
5. |
point 4.2 is amended as follows:
|
6. |
the following point 5a is inserted after point 5:
In order to detect MRSA in nasal samples collected in accordance with point 1(f), the laboratories referred to in Article 3(2) shall use isolation and PCR-based (4) confirmatory methods as referred to in EFSA technical specifications for a baseline survey on the prevalence of methicillin resistant Staphylococcus aureus (MRSA) in pigs (5) and detailed in the protocols of the EURL for AMR (6). For confirming presumptive MRSA isolates, the laboratories may decide to replace the PCR-based confirmatory method by a WGS method implemented in accordance with the protocols of the EURL for AMR (7). All confirmed MRSA isolates, with a maximum of 208 isolates, identified through the PCR-based or WGS methods shall be tested with the panel of antimicrobial substances in accordance with Table 4a. No more than one isolate per epidemiological unit shall be tested. MRSA isolates which have been confirmed by the PCR-based method and do not belong to the clonal complex 398 shall be tested by the WGS method implemented in accordance with the protocols of the EURL for AMR (8). Twenty percent of MRSA isolates confirmed by the PCR-based method and belonging to the clonal complex 398 shall be tested by the WGS method, with a maximum of twenty isolates tested.’ |
(1) https://www.efsa.europa.eu/en/efsajournal/pub/6364
(2) https://www.efsa.europa.eu/en/efsajournal/pub/7620
(3) https://www.efsa.europa.eu/en/efsajournal/pub/7620
(4) Method based on Polymerase Chain Reaction (PCR) assays
(5) https://www.efsa.europa.eu/en/efsajournal/pub/7620
(6) https://www.eurl-ar.eu/protocols.aspx
(7) https://www.eurl-ar.eu/protocols.aspx
(8) https://www.eurl-ar.eu/protocols.aspx