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9.3.2012 Official
Journal
of
the
European
Union L
71/31
COMMISSION REGULATION (EU) No 200/2012
of 8 March 2012
concerning a Union target for the reduction of Salmonella enteritidis and Salmonella typhimurium in
flocks of broilers, as provided for in Regulation (EC) No 2160/2003 of the European Parliament and
of the Council
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(4) Regulation
(EC)
No
2160/2003
provides
that
experience
gained under existing national measures and information
forwarded to the Commission or to the European Food
Safety Authority ('EFSA') under existing Union require
Having regard to the Treaty on the Functioning of the European
ments, in particular in the framework of information
Union,
provided for in 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
Having regard to Regulation (EC) No 2160/2003 of the
Council Directive 92/117/EEC ( 3 ), and in particular
European Parliament and of the Council of 17 November
Article 5 thereof, is to be taken into account when
2003 on the control of salmonella and other specified food-
setting the Union target.
borne zoonotic agents
( 1 ) and, in particular the second
subparagraph of Article 4(1), the second subparagraph of
Article 8(1) and the second paragraph of Article 13 thereof;
(5)
Article 1 paragraph 1 of Commission Regulation (EC) No
646/2007 of 12 June 2007 implementing Regulation
Whereas:
(EC) No 2160/2003 of the European Parliament and of
the Council as regards a Community target for the
reduction of the prevalence of Salmonella enteritidis and
Salmonella typhimurium in broilers and repealing Regu
(1) Regulation
(EC)
No
2160/2003
aims
to
ensure
that
lation (EC) No 1091/2005 ( 4 ) sets the target for the
appropriate and effective measures are taken to detect
reduction of the maximum percentage of flocks of
and control, amongst others, salmonella at all relevant
broilers remaining positive for those two Salmonella
stages and in particular at the level of primary
serotypes to 1 % or less by 31 December 2011.
production, i.e. in flocks, in order to reduce the
prevalence of food-borne zoonotic pathogens and thus
the risk they pose to public health.
(6) The
European
Union
Summary
Report
on
Trends
and
Sources of Zoonoses, Zoonotic Agents and Food-borne
Outbreaks in 2009 (
(2) Article
4
(5)
of
Regulation
(EC)
No
2160/2003
provides

5 ) showed that Salmonella enteritidis
for Union targets to be established for the reduction of
and Salmonella typhimurium are the serovars most
the prevalence of all Salmonella serotypes with public
frequently associated with human illness. Human cases
health significance in broilers. That reduction is key to
caused by Salmonella enteritidis decreased markedly in
ensuring that the criteria for salmonella in fresh meat of
2009, while an increase in Salmonella typhimurium cases
broilers set out in Part E of Annex II to that Regulation
was observed.
and in Chapter 1 of Annex I to Regulation (EC) No
2073/2005 of 15 November 2005 on microbiological
criteria for foodstuffs ( 2 ) can be met.
(7) In
July
2011,
the
EFSA
adopted
a
Scientific
Opinion
on
a
quantitative estimation of the public health impact of
setting a new target for the reduction of Salmonella in
(3) Regulation
(EC)
No
2160/2003
provides
that
the
Union
broilers ( 6 ). It concluded that Salmonella enteritidis is the
target is to include a numerical expression of the
most successfully transmitted zoonotic Salmonella
maximum percentage of epidemiological units
serotype from parent to offspring in poultry. EFSA also
remaining positive and/or the minimum percentage of
observed that Union control measures in broilers have
reduction in the number of epidemiological units
contributed to a considerable reduction in the number of
remaining positive, the maximum time limit within
broiler-associated human salmonellosis cases compared
which the target must be achieved and the definition
to the situation in 2006. The target should therefore
of the testing schemes necessary to verify achievement
be confirmed.
of the target. It is also to include a definition, where
relevant, of serotypes with public health significance.
( 3 ) OJ L 325, 12.12.2003, p. 31.
( 4 ) OJ L 151, 13.6.2007, p. 21.
( 1 ) OJ L 325, 12.12.2003, p. 1.
( 5 ) EFSA Journal 2011; 9(3):2090.
( 2 ) OJ L 338, 22.12.2005, p. 1.
( 6 ) EFSA Journal 2011; 9(7):2106.

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L 71/32
EN
Official Journal of the European Union
9.3.2012
(8) Monophasic
strains
of Salmonella typhimurium have
HAS ADOPTED THIS REGULATION:
developed to be among the most frequently detected
Salmonella serotypes in several species of animals and
Article 1
in clinical isolates from humans in recent years. EFSA's
2010 Scientific Opinion on monitoring and assessment
Union target
of the public health risk of "Salmonella typhimurium-like
1. The
Union
target,
as
referred
to
in
Article
4(1)
of
Regu
strains" adopted on 22 September 2010 ( 1 ) also stated
lation (EC) No 2160/2003, for the reduction of the prevalence
that monophasic Salmonella typhimurium strains with the
of Salmonella enteritidis and Salmonella typhimurium in broilers
antigenic formula 1,4,[5],12:i:-, which includes strains
(‘Union target’) shall be a reduction of the maximum annual
with and without the O5 antigen, have to be considered
percentage of flocks of broilers remaining positive for Salmonella
to be variants of Salmonella typhimurium and to pose a
enteritidis and Salmonella typhimurium equal to 1% or less.
public health risk comparable to that of other Salmonella
typhimurium strains. Salmonella typhimurium strains with
the antigenic formula 1,4,[5],12:i:- should therefore be
As regards monophasic Salmonella typhimurium, serotypes with
included in the target.
the antigenic formula 1,4,[5],12:i:- shall be included in the
Union target.
2. The
testing
scheme
necessary
to
verify
progress
in
the
(9) To
verify
whether
the
Union
target
has
been
met,
it
is achievement of the Union target is set out in the Annex
necessary to sample flocks of broilers repeatedly. To
('testing scheme').
evaluate and compare the results, it is necessary to
describe a common testing scheme to verify whether
Article 2
the Union target has been met.
Review of the Union target
The Union target shall be reviewed by the Commission taking
into account the information collected in accordance with the
(10) National
control
programmes
for
the
achievement
of
the
testing scheme and the criteria laid down in Article 4(6)(c) of
Union target for 2012 for flocks of broilers of Gallus
Regulation (EC) No 2160/2003.
gallus have been submitted for Union co-financing in
accordance with Council Decision 2009/470/EC of
Article 3
25 May 2009 on expenditure in the veterinary field ( 2 ).
The technical amendments introduced in the Annex to
Repeal of Regulation (EC) No 646/2007
this Regulation are directly applicable. As a result the
Commission does not need to re-approve national
Regulation (EC) No 646/2007 is repealed.
control programmes implementing this Regulation. A
transitional period is therefore not needed.
References to the repealed Regulation shall be construed as
references to this Regulation.
Article 4
(11) The
measures
provided
for
in
this
Regulation
are
in
Entry into force
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health and
This Regulation shall enter into force on the third day following
neither the European Parliament nor the Council has
that of its publication in the Official Journal of the European
opposed them,
Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 8 March 2012.
For the Commission
The President
José Manuel BARROSO
( 1 ) EFSA Journal 2010; 8(10):1826.
( 2 ) OJ L 155, 18.6.2009, p. 30.

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EN
9.3.2012 Official
Journal
of
the
European
Union L
71/33
ANNEX
Testing scheme necessary to verify the achievement of the Union target as referred to in Article 1(2)
1. SAMPLING
FRAME
The sampling frame shall comprise all flocks of broilers of Gallus gallus (‘broilers’) within the framework of the
national control programmes provided for in Article 5 of Regulation (EC) No 2160/2003.
2. MONITORING
IN
BROILERS
2.1. Frequency
of
sampling
(a) Food business operators shall sample all flocks of broilers within three weeks before slaughter.
By way of derogation from the sampling obligation set out in the first subparagraph, the competent authority
may provide that food business operators shall sample at least one flock of broilers per round on holdings
with more than one flock where:
(i) an all in / all out system is used in all flocks of the holding;
(ii) the same management applies to all flocks;
(iii) feed and water supply is common to all flocks;
(iv) during at least the last six rounds, tests for Salmonella spp. according to the sampling scheme set out in the
first subparagraph in all flocks on the holding and samples of all flocks of at least one round were carried
out by the competent authority;
(v) all results from the testing according to the first subparagraph and point (b) for Salmonella enteritidis or
Salmonella typhimurium were negative.
By way of derogation from the sampling obligations set out in this point the competent authority may
authorise sampling in the last six weeks prior to the date of slaughter in case the broilers are either kept
more than 81 days or fall under organic broiler production according to Commission Regulation (EC) No
889/2008 ( 1 ).
(b) The competent authority shall each year sample at least one flock of broilers on 10 % of the holdings with
more than 5 000 birds. That sampling may be done on a risk basis and each time the competent authority
considers it necessary.
A sampling carried out by the competent authority may replace the sampling by the food business operator as
required by point (a).
2.2. Sampling
protocol
2.2.1. General instructions for sampling
The competent authority or the food business operator shall ensure that samples are taken by persons trained for
that purpose.
At least two pairs of boot swabs shall be taken for sampling. Boot swabs are put on the boots and the sample is
taken by walking around in the poultry house. Swabs from one flock of broilers may be pooled into one sample.
Before putting on the boot swabs, their surface shall be moistened by:
(a) the application of maximum recovery diluents (MRD: 0,8 % sodium chloride, 0,1 % peptone in sterile deionised
water);
(b) the application of sterile water;
(c) the application of any other diluents approved by the national reference laboratory referred to in Article 11 (3)
of Regulation (EC) No 2160/2003; or
(d) being autoclaved in a container together with diluents.
The way to moisten boot swabs shall be to pour the liquid inside before putting them on or to shake them in a
container of diluent.
( 1 ) OJ L 250, 18.9.2008, p. 1.

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L 71/34
EN
Official Journal of the European Union
9.3.2012
It shall be ensured that all sections in a house are represented in the sampling in a proportionate way. Each pair of
boot swabs must cover about 50 % of the area of the house.
On completion of sampling, the swabs shall be carefully removed from the boots so as not to dislodge adherent
material. Boot swabs may be inverted to retain material. They shall be placed in a bag or pot and labelled.
The competent authority may decide to increase the minimum number of samples in order to ensure represen
tative sampling on a case-by-case evaluation of epidemiological parameters, such as biosecurity conditions, the
distribution or size of the flock.
If the competent authority approves one pair of boot swabs may be replaced by a dust sample of 100g collected
from multiple places throughout the house from surfaces with visible presence of dust. As an alternative, one or
several moistened fabric swab(s) of a combined surface of at least 900 cm 2 may be used to gather dust from
multiple surfaces throughout the house. Each swab shall be well coated with dust on both sides.
2.2.2. Specific instructions for certain types of holdings
(a) For free range flocks of broilers, samples shall only be collected inside the house.
(b) Where access to the houses is not possible due to limited space in flocks with less than 100 broilers, and it is
therefore not possible to use boot swabs when walking around, they may be replaced by the same kind of
hand fabric swabs that are used for dust, where the swabs are rubbed over surfaces contaminated with fresh
faeces, or if this is not feasible, by other sampling techniques for faeces fit for the intended purpose.
2.2.3. Sampling by the competent authority
The competent authority shall satisfy itself by conducting further tests and/or documentary checks as appropriate
to verify that results are not altered through the presence of antimicrobials or other substances inhibiting the
growth of bacteria.
Where the presence of Salmonella enteritidis and Salmonella typhimurium is not detected but antimicrobials or
bacterial growth inhibitory effect are detected, the flock shall be considered to be an infected flock of broilers
for the purpose of the Union target referred to in Article 1(2).
2.2.4. Transport
Samples shall be sent without undue delay either by via express mail or courier, to the laboratories referred to in
Articles 11 and 12 of Regulation (EC) No 2160/2003. During transport they shall be protected from heat over
25°C and exposure to sunlight.
Where it is not possible to send the samples within 24 hours from the time of sampling they shall be stored
refrigerated.
3. LABORATORY
ANALYSIS
3.1. Preparation
of
the
samples
At the laboratory samples shall be kept refrigerated until examination. Examination shall start within 48 hours
following the time of receipt of the samples and within four days from the date of sampling.
Dust samples shall be analysed separately. However, the competent authority may decide to pool them with the
pair of boot swabs for analysis.
The sample shall be swirled to fully saturate it and culturing shall be continued by using the detection method set
out in point 3.2.
The two pairs of boot swabs shall be carefully unpacked to avoid dislodging adherent faecal material, pooled and
placed in 225 ml of buffered peptone water (BPW) pre-warmed to room temperature, or 225 ml of diluent is
added directly to the two pairs of boot swabs in their container as received in the laboratory.
The boot swabs shall be fully submersed in BPW to provide sufficient free liquid around the sample for migration
of Salmonella away from the sample and therefore more BPW may be added if necessary.
If EN/ISO standards on the preparation of faeces for the detection of Salmonella are agreed on, they shall replace
the provisions on the preparation of samples set out in this point as appropriate.

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EN
9.3.2012 Official
Journal
of
the
European
Union L
71/35
3.2. Detection
method
The detection of Salmonella spp. shall be carried out according to Amendment 1 of EN/ISO 6579 “Microbiology of
food and animal feeding stuffs – Horizontal method for the detection of Salmonella spp. – Amendment 1: Annex
D: Detection of Salmonella spp. in animal faeces and in environmental samples from the primary production stage”
of the International Organization for Standardization.
3.3. Serotyping
At least one isolate from each positive sample taken by the competent authority shall be serotyped, following the
current White-Kauffmann-Le Minor scheme.
Food business operators shall ensure that for all isolates, it is at least excluded that they do not belong to the
serotypes Salmonella enteritidis and Salmonella typhimurium.
3.4. Alternative
methods
With regard to samples taken on the initiative of the food business operator, the methods of analysis provided for
in Article 11 of Regulation (EC) No 882/2004 of the European Parliament and of the Council ( 1 ), may be used
instead of the methods for the preparation of samples, detection methods and serotyping provided for in points
3.1, 3.2 and 3.3 of this Annex, if validated in accordance with EN/ISO 16140.
3.5. Storage
of
strains
The competent authority shall ensure that at least one isolated strain of Salmonella serotypes from sampling as part
of official controls per house and per year is stored for future phagetyping or antimicrobial susceptibility testing,
using established methods for culture collection, which must ensure integrity of the strains for a minimum period
of two years from the date of the analysis.
The competent authority may decide that isolates from sampling by food business operators shall also be stored
for future phagetyping or antimicrobial susceptibility testing to provide for isolates to be tested in accordance with
Article 2 of Commission Decision 2007/407/EC ( 2 ).
4. RESULTS
AND
REPORTING
4.1. Calculation of prevalence for the verification of the Union target
A flock of broilers shall be considered positive for the purpose of verifying the achievement of the Union target,
where the presence of Salmonella enteritidis and/or Salmonella typhimurium (other than vaccine strains) was detected
in the flock.
Positive flocks of broilers shall be counted only once per round, irrespective of the number of sampling and testing
operations and only be reported in the year of the first positive sampling.
4.2. Reporting
Reporting shall include:
(a) the total number of flocks of broilers which were tested at least once during the year of reporting;
(b) the total number flocks positive with any Salmonella serotype in the Member State;
(c) the number of broiler flocks positive at least once for Salmonella enteritidis and Salmonella typhimurium including
monophasic strains with the antigenic formula 1,4,[5],12:i:-;
(d) the number of positive broiler flocks for each Salmonella serotype or for Salmonella unspecified (isolates that are
untypable or not serotyped).
The information shall be provided separately for the sampling within the overall national Salmonella control
programme as provided for in point 2.1. (a) and (b), the food business operators sampling as provided for in point
2.1. (a) and the competent authorities sampling as provided for in point 2.1. (b).
The results of the tests shall be considered relevant food chain information as provided for in Section III of Annex
II to Regulation 853/2004 of the European Parliament and of the Council ( 3 ).
( 1 ) OJ L 165, 30.4.2004, p. 1.
( 2 ) OJ L 153, 14.6.2007, p. 26.
( 3 ) OJ L 226, 25.6.2004, p. 22.

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L 71/36
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Official Journal of the European Union
9.3.2012
At least the following information shall be made available to the competent authority from each flock of broilers
tested:
(a) holding reference, remaining unique in time;
(b) house reference, remaining unique in time;
(c) month of sampling.
The results and any additional relevant information shall be reported as part of the report on trends and sources
provided for in Article 9(1) of Directive 2003/99/EC ( 1 ).
The food business operator shall notify the competent authority of the confirmed detection of Salmonella enteritidis
and Salmonella typhimurium without undue delay. The food business operator shall instruct the analysing laboratory
to act accordingly.
( 1 ) OJ L 325, 12.12.2003, p. 31.

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