2007/407/EC: Commission Decision of 12 June 2007 on a harmonised monitoring of antimicrobial resistance in Salmonella in poultry and pigs (notified under document number C(2007) 2421) (Text with EEA relevance)
Date: 2007-06-12
Institutions: European Commission
Subjects: disease prevention, exchange of information, food inspection, infectious disease, poultry, public health, swine, zoonosis

L 153/26

EN

Official Journal of the European Union

14.6.2007

(Acts adopted under the EC Treaty/Euratom Treaty whose publication is not obligatory)

II

DECISIONS

COMMISSION

COMMISSION DECISION

of 12 June 2007
on a harmonised monitoring of antimicrobial resistance in Salmonella in poultry and pigs

(notified under document number C(2007) 2421)

(Text with EEA relevance)

(2007/407/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(2)

Having regard to the Treaty
Community,

establishing the European

the European
Having regard to Directive 2003/99/EC of
Parliament and of the Council of 17 November 2003 on the
monitoring of zoonoses and zoonotic agents, amending Council
Decision
repealing Council Directive
92/117/EEC (1), and in particular Article 7(3) thereof,

90/424/EEC and

is

of

for

there

instance

increased

frequency

in 2003 concluded that

A FAO/OIE/WHO workshop on scientific assessment on
non-human usage of antimicrobials and antimicrobial
resistance
clear
evidence of adverse human health consequences due to
resistant organisms resulting from non-human usage of
infections,
antimicrobials:
increased frequency of treatment failures (in some cases
infections, as docu-
death) and increased severity of
fluoroquinolone-resistant
mented
human Salmonella infections. Evidence shows that
the
amount and pattern of non-human usage of antimi-
crobials affect
the occurrence of resistant bacteria in
animals and food and thereby human exposure to
these resistant bacteria (Joint FAO/OIE/WHO Expert
it should be noted that
Workshop, 2003). However,
most of
the resistance problems in human medicine
are caused by human usage and over usage of antimi-
crobial agents for therapy and prophylaxis (European
Parliament, October 2006).

by

Whereas:

(1)

Pursuant to Directive 2003/99/EC, Member States shall
ensure that monitoring provides comparable data on the
occurrence of antimicrobial resistance in zoonotic agents
and, in so far as they present a threat to public health,
other agents.

(3)

The European Food Safety Authority (EFSA) indicates in
its ‘Community Summary Report on Trends and Sources
of Zoonoses, Zoonotic agents, Antimicrobial Resistance
and Foodborne Outbreaks in the European Union in
2005’ (2) that a relatively high proportion of Campylo-
bacter and Salmonella isolates from animals and food
to antimicrobials commonly used in
were resistant
treatment of human diseases. Food-borne infections
caused by these resistant bacteria pose a particular risk
to humans due to possible treatment failure.

(1) OJ L 325, 12.12.2003, p. 31. Directive amended by Council

Directive 2006/104/EC (OJ L 363, 20.12.2006, p. 352).

(2) The EFSA Journal (2006), 94.

14.6.2007

EN

Official Journal of the European Union

L 153/27

(Gallus
Member States. It shall cover Salmonella spp.
gallus), turkeys, and slaughter pigs without prejudice to addi-
tional antimicrobial resistance monitoring in accordance with
the requirements in Article 7(1) of Directive 2003/99/EC.

in fowl

Article 2

Collection and analyses of isolates

The collection of isolates of Salmonella spp. referred to in Article
1 and the analysis thereof shall be performed by the competent
authority or under
its supervision in accordance with the
technical specifications set out in the Annex.

Article 3

Confidentiality of the data

National aggregated data and results of the analyses shall be
made available publicly in a form that ensures confidentiality.

Article 4

Application

This Decision shall apply from 1 January 2008.

This Decision is addressed to the Member States.

Article 5

Done at Brussels, 12 June 2007.

For the Commission

Markos KYPRIANOU
Member of the Commission

(4)

(5)

(6)

(7)

adopted

an Opinion on ‘Review of

The Scientific Panel on Biological Hazards and of the
Scientific Panel an Animal Health and Welfare of the
EFSA,
the
Community Summary Report on Trends and Sources
and Antimicrobial
of Zoonoses, Zoonotic Agents
Resistance in the European Union in 2004’ (1) during
its meeting on respectively 7 and 8 September 2006.
With regard to antimicrobial
the
Opinion indicates the importance to provide detailed
information on the Salmonella serovar for each isolate
and to harmonise the breakpoints applied for resistance
assessment and reporting.

resistance testing,

scheme of

The Task Force on Zoonoses Data Collection of the EFSA
adopted a ‘Report including a proposal for a harmonised
monitoring
in
Salmonella in fowl (Gallus gallus), turkeys and pigs and
in broilers’ (2) on 20
Campylobacter
February 2007. The report makes recommendations on
a harmonised monitoring scheme and harmonised meth-
odology for susceptibility testing.

jejuni and C.

antimicrobial

resistance

coli

In view of the increasing public health risk posed by
antimicrobial resistance and the evidence that use of anti-
biotics affects this risk, comparable information should
be collected from all Member States on the antimicrobial
resistance occurrence in zoonotic agents in animals by
implementing Article 7 of Directive 2003/99/EC. This
implementation should be based on the proposal of
the EFSA Task Force but is without prejudice to further
implementation rules in the future.

The measures provided for
accordance with
Committee on the Food Chain and Animal Health,

in this Decision are in
Standing
the

opinion

the

of

HAS ADOPTED THIS DECISION:

Article 1

Subject matter and scope

This Decision lays down detailed rules for monitoring antimi-
crobial resistance in accordance with Article 7(3) and Annex
in the
II(B) of Directive 2003/99/EC to be carried out

(1) The EFSA Journal (2006), 403, pp. 1 to 62.
(2) The EFSA Journal (2007) 96, pp. 1 to 46.

L 153/28

EN

Official Journal of the European Union

14.6.2007

ANNEX

TECHNICAL SPECIFICATIONS REFERRED TO IN ARTICLE 2

1. Origin of isolates

Salmonella isolates collected through control and monitoring programmes, set up in accordance with Article 5 of
Regulation (EC) No 2160/2003 of the European Parliament and of the Council (1) and/or Commission Decisions
2006/662/EC (2), 2006/668/EC (3), shall be collected for antimicrobial resistance monitoring in accordance with
Table 1.

Years in which certain zoonotic agents isolated from the indicated animal populations shall be selected for
antimicrobial resistance testing

Table 1:

Year

2007

2008

2009

2010

2011

2012

All Salmonella serovars

Laying hens

Broilers

Turkeys

X (*)

Slaughter pigs

X (**)

X

X

X

X

X

X

X

X

X

X

X

X

X

X

(*) Isolates from samples collected in 2007 and stored in accordance with the provisions in Decision 2006/662/EC.
(**) Isolates from samples collected in 2007 and stored in accordance with the provisions in Decision 2006/668/EC.

Not more than one isolate per Salmonella serovar from the same epidemiological unit per year shall be included in the
monitoring. The epidemiological unit for laying hens, broilers, and turkeys is the flock. For pigs, the epidemiological
unit is the holding.

2. Number of isolates to be tested

The number of Salmonella isolates to be included in the antimicrobial resistance monitoring per Member State per year
shall be 170 for each study population (i.e. laying hens, broilers, turkeys and slaughter pigs).

In those Member States where, in any given year, a lower number of isolates than the target sample size is available
from the monitoring or control programmes, all these isolates shall be included in the antimicrobial resistance
monitoring.

In those Member States where a higher number of isolates is available all isolates, or a representative random selection
equal or larger than the target sample size, shall be included.

3. Antimicrobial susceptibility testing

Member States shall test at least the antimicrobials that are specified in Table 2, using the cut-off values given and an
appropriate concentration range to determine the susceptibility of Salmonella.

(1) OJ L 325, 12.12.2003, p. 1.
(2) OJ L 272, 3.10.2006, p. 22.
(3) OJ L 275, 6.10.2006, p. 51.

14.6.2007

EN

Official Journal of the European Union

L 153/29

Dilution methods shall be performed according to the methods described by the European Committee on Antimi-
crobial Susceptibility Testing (EUCAST) and the Clinical and Laboratory Standards Institute (CLSI), accepted as inter-
national reference method (ISO standard 20776-1:2006). It is recommended that the selected isolates of S. Enteritidis
and S. Typhimurium are phage typed.

4. Collection of the data and reporting

The results of the antimicrobial resistance monitoring shall be assessed and reported, in accordance with Article 9 of
Directive 2003/99/EC, in the yearly report on trends and sources of zoonoses, zoonotic agents and antimicrobial
resistance.

Without prejudice to the provisions of Annex IV of Directive 2003/99/EC the following information shall be reported
for Salmonella in laying hens, broilers, turkeys and pigs:

— Origin of isolates i.e. baseline study, control programme, passive surveillance,

— number of isolates susceptibility tested,

— number of isolates found to be resistant per antimicrobial, and

— number of fully-susceptible isolates and number of isolates resistant to 1, 2, 3, 4 and > 4 antimicrobials listed in

Table 2.

Table 2:
Antimicrobials to be at least included for Salmonella and the cut-off values to be used to determine
susceptibility

Antimicrobial

Cut-off value (mg/L) R >

Salmonella

Cefotaxime

Nalidixic acid

Ciprofloxacin

Ampicillin

Tetracycline

Chloramphenicol

Gentamicin

Streptomycin

Trimethoprim

Sulphonamides

0,5

16

0,06

4

8

16

2

32

2

256