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
(notified under document C(2020) 7894)
(Only the English version is authentic)
(Text with EEA relevance)
Article 1
Subject matter and scope
Article 2
Definitions
Article 3
Sampling framework and analysis
Article 4
Annual AMR reporting and assessment
Article 5
Publication of the data
Article 6
Repeal
Article 7
Application
Article 8
Addressees
ANNEX
PART A
Sampling framework and analysis
1.
Origin of bacterial isolates subject to antimicrobial susceptibility testing
2.
Sampling frequency
3.
Sampling design and sample size
3.1.
At slaughterhouse level
(a) Sampling design:
(b) Sample size:
3.2.
At retail level
(a) Sampling design:
(b) Sample size:
3.3.
At border control posts
(a) Sampling design:
(b) Sample size:
Type of fresh meat |
Recommended annual sampling frequency rates of consignments arrived at the border control posts |
Broiler meat |
3 % |
Turkey meat |
15 % |
Pig meat |
10 % |
Bovine meat |
2 % |
4.
Antimicrobial susceptibility testing
4.1.
Number of isolates to be tested
4.2.
Analytical methods for detection and antimicrobial susceptibility testing
Antimicrobial |
Class of antimicrobial |
Species |
Interpretative thresholds of AMR (mg/L) |
Range of concentrations (mg/L) (No of wells in brackets) |
|
ECOFF |
Clinical breakpoint |
||||
Amikacin |
Aminoglycoside |
Salmonella |
> 4 (*) |
> 16 |
4-128 (6) |
E. coli |
> 8 |
> 16 |
|||
Ampicillin |
Penicillin |
Salmonella |
> 8 |
> 8 |
1-32 (6) |
E. coli |
> 8 |
> 8 |
|||
Azithromycin |
Macrolide |
Salmonella |
NA |
NA |
2-64 (6) |
E. coli |
NA |
NA |
|||
Cefotaxime |
Cephalosporin |
Salmonella |
> 0,5 |
> 2 |
0,25-4 (5) |
E, coli |
> 0,25 |
> 2 |
|||
Ceftazidime |
Cephalosporin |
Salmonella |
> 2 |
> 4 |
0,25-8 (6) |
E, coli |
> 0,5 |
> 4 |
|||
Chloramphenicol |
Phenicol |
Salmonella |
> 16 |
> 8 |
8-64 (4) |
E, coli |
> 16 |
> 8 |
|||
Ciprofloxacin |
Fluoroquinolone |
Salmonella |
> 0,06 |
> 0,06 |
0,015-8 (10) |
E, coli |
> 0,06 |
> 0,5 |
|||
Colistin |
Polymyxin |
Salmonella |
NA |
> 2 |
1-16 (5) |
E, coli |
> 2 |
> 2 |
|||
Gentamicin |
Aminoglycoside |
Salmonella |
> 2 |
> 4 |
0,5-16 (6) |
E, coli |
> 2 |
> 4 |
|||
Meropenem |
Carbapenem |
Salmonella |
> 0,125 |
> 8 |
0,03-16 (10) |
E, coli |
> 0,125 |
> 8 |
|||
Nalidixic acid |
Quinolone |
Salmonella |
> 8 |
NA |
4-64 (5) |
E, coli |
> 8 |
NA |
|||
Sulfamethoxazole |
Folate pathway antagonist |
Salmonella |
NA |
NA |
8-512 (7) |
E, coli |
> 64 |
NA |
|||
Tetracycline |
Tetracycline |
Salmonella |
> 8 |
NA |
2-32 (5) |
E, coli |
> 8 |
NA |
|||
Tigecycline |
Glycylcycline |
Salmonella |
NA |
NA |
0,25-8 (6) |
E, coli |
> 0,5 |
> 0,5 |
|||
Trimethoprim |
Folate pathway antagonist |
Salmonella |
> 2 |
> 4 |
0,25-16 (7) |
E, coli |
> 2 |
> 4 |
|||
NA: not available. |
Antimicrobial |
Class of antimicrobial |
Species |
Interpretative thresholds of AMR (mg/L) |
Range of concentrations (mg/L) (No of wells in brackets) |
|
ECOFF |
Clinical breakpoint |
||||
Chloramphenicol |
Phenicol |
C. jejuni |
> 16 |
NA |
2-64 (6) |
C. coli |
> 16 |
NA |
|||
Ciprofloxacin |
Fluoroquinolone |
C. jejuni |
> 0,5 |
> 0,5 |
0,12-32 (9) |
C. coli |
> 0,5 |
> 0,5 |
|||
Ertapenem |
Carbapenem |
C. jejuni |
NA |
NA |
0,125-4 (6) |
C. coli |
NA |
NA |
|||
Erythromycin |
Macrolide |
C. jejuni |
> 4 |
> 4 |
1-512 (10) |
C. coli |
> 8 |
> 8 |
|||
Gentamicin |
Aminoglycoside |
C. jejuni |
> 2 |
NA |
0,25-16 (7) |
C. coli |
> 2 |
NA |
|||
Tetracycline |
Tetracycline |
C. jejuni |
> 1 |
> 2 |
0,5-64 (8) |
C. coli |
> 2 |
> 2 |
|||
NA: not available |
Antimicrobial |
Class of antimicrobial |
Species |
Interpretative thresholds of AMR (mg/L) |
Range of concentrations (mg/L) (No of wells in brackets) |
|
ECOFF |
Clinical breakpoint |
||||
Ampicillin |
Penicillin |
E. faecalis |
> 4 |
> 8 |
0,5-64 (8) |
E. faecium |
> 4 |
> 8 |
|||
Chloramphenicol |
Phenicol |
E. faecalis |
> 32 |
NA |
4-128 (6) |
E. faecium |
> 32 |
NA |
|||
Ciprofloxacin |
Fluoroquinolone |
E. faecalis |
> 4 |
> 4 |
0,12-16 (8) |
E. faecium |
> 4 |
> 4 |
|||
Daptomycin |
Lipopeptide |
E. faecalis |
> 4 |
NA |
0,25-32 (8) |
E. faecium |
> 8 |
NA |
|||
Erythromycin |
Macrolide |
E. faecalis |
> 4 |
NA |
1-128 (8) |
E. faecium |
> 4 |
NA |
|||
Gentamicin |
Aminoglycoside |
E. faecalis |
> 64 |
NA |
8-1 024 (8) |
E. faecium |
> 32 |
NA |
|||
Linezolid |
Oxazolidinone |
E. faecalis |
> 4 |
> 4 |
0,5-64 (8) |
E. faecium |
> 4 |
> 4 |
|||
Quinupristin/Dalfopristin |
Streptogramin |
E. faecalis |
NA |
NA |
0,5-64 (8) |
E. faecium |
NA |
> 4 |
|||
Teicoplanin |
Glycopeptide |
E. faecalis |
> 2 |
> 2 |
0,5-64 (8) |
E. faecium |
> 2 |
> 2 |
|||
Tetracycline |
Tetracycline |
E. faecalis |
> 4 |
NA |
1-128 (8) |
E. faecium |
> 4 |
NA |
|||
Tigecycline |
Glycylcycline |
E. faecalis |
> 0,25 |
> 0,25 |
0,03-4 (8) |
E. faecium |
> 0,25 |
> 0,25 |
|||
Vancomycin |
Glycopeptide |
E. faecalis |
> 4 |
> 4 |
1-128 (8) |
E. faecium |
> 4 |
> 4 |
|||
NA: not available |
5.
Specific monitoring of ESBL- or AmpC- or CP-producing
E. coli
5.1.
Methods for detection of presumptive ESBL- or AmpC- or CP-producing E. coli
Antimicrobial |
Class of antimicrobial |
Species |
Interpretative thresholds of AMR (mg/L) |
Range of concentrations (mg/L) (No of wells in brackets) |
|
ECOFF |
Clinical breakpoint |
||||
Cefepime |
Cephalosporin |
Salmonella |
NA |
> 4 |
0,06-32 (10) |
E. coli |
> 0,125 |
> 4 |
|||
Cefotaxime |
Cephalosporin |
Salmonella |
> 0,5 |
> 2 |
0,25-64 (9) |
E. coli |
> 0,25 |
> 2 |
|||
Cefotaxime + clavulanic acid |
Cephalosporin/beta-lactamase inhibitor combination |
Salmonella |
NA |
NA |
0,06-64 (11) |
E. coli |
> 0,25 |
NA |
|||
Cefoxitin |
Cephamycin |
Salmonella |
> 8 |
NA |
0,5-64 (8) |
E. coli |
> 8 |
NA |
|||
Ceftazidime |
Cephalosporin |
Salmonella |
> 2 |
> 4 |
0,25-128 (10) |
E. coli |
> 0,5 |
> 4 |
|||
Ceftazidime + clavulanic acid |
Cephalosporin//beta-lactamase inhibitor combination |
Salmonella |
NA |
NA |
0,125-128 (11) |
E. coli |
> 0,5 |
NA |
|||
Ertapenem |
Carbapenem |
Salmonella |
NA |
> 0,5 |
0,015-2 (8) |
E. coli |
NA |
> 0,5 |
|||
Imipenem |
Carbapenem |
Salmonella |
> 1 |
> 4 |
0,12-16 (8) |
E. coli |
> 0,5 |
> 4 |
|||
Meropenem |
Carbapenem |
Salmonella |
> 0,125 |
> 8 |
0,03-16 (10) |
E. coli |
> 0,125 |
> 8 |
|||
Temocillin |
Penicillin |
Salmonella |
> NA |
NA |
0,5-128 (9) |
E. coli |
> 16 |
NA |
|||
NA: not available |