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26.5.2011 Official
Journal
of
the
European
Union L
138/45
COMMISSION REGULATION (EU) No 517/2011
of 25 May 2011
implementing Regulation (EC) No 2160/2003 of the European Parliament and of the Council as
regards a Union target for the reduction of the prevalence of certain Salmonella serotypes in laying
hens of Gallus gallus and amending Regulation (EC) No 2160/2003 and Commission Regulation (EU)
No 200/2010
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
spread Salmonella infection via their eggs to the
consumer. Therefore, a reduction in the prevalence of
Salmonella in laying flocks contributes to the control of
that zoonotic agent in eggs, which is an important public
Having regard to the Treaty on the Functioning of the European
health risk.
Union,
(4) Commission
Regulation
(EC)
No
1168/2006
of
31
July
Having regard to Regulation (EC) No 2160/2003 of the
2006 implementing Regulation (EC) No 2160/2003 as
European Parliament and of the Council of 17 November
regards a Community target for the reduction of the
2003 on the control of Salmonella and other specified food-
prevalence of certain Salmonella serotypes in laying
borne zoonotic agents
( 1 ), and in particular the second
hens of Gallus gallus and amending Regulation (EC)
subparagraph of Article 4(1), and Article 13(1), thereof,
No 1003/2005 ( 2 ) provides for a Union target for the
reduction of the prevalence of Salmonella Enteritidis and
Salmonella Typhimurium in adult laying hens of Gallus
gallus. The Union target for each Member State is an
Whereas:
annual minimum percentage of reduction of positive
flocks of adult laying hens by 10 to 40 % depending
on the prevalence in the preceding year. Alternatively, a
reduction of the maximum percentage to 2 % or less.
(1) The
purpose
of
Regulation
(EC)
No
2160/2003
is
to
ensure that measures are taken to detect and control
Salmonella and other zoonotic agents at all relevant
stages of production, processing and distribution,
(5) Regulation
(EC)
No
2160/2003
provides
that
experience
particularly at the level of primary production, in order
gained under existing national measures and information
to reduce their prevalence and the risk they pose to
forwarded to the Commission or to the European Food
public health.
Safety Authority (‘EFSA’) under existing Union
requirements, in particular in the framework of
information provided for in Directive 2003/99/EC of
the European Parliament and of the Council of
(2) Regulation
(EC)
No
2160/2003
provides
for
Union
17 November 2003 on the monitoring of zoonoses
targets to be established for the reduction of the
and zoonotic agents, amending Council Decision
prevalence of the zoonoses and zoonotic agents listed
90/424/EEC and repealing Council Directive
in Annex I thereto in the animal populations listed
92/117/EEC ( 3 ), and in particular Article 5 thereof, is to
therein. It also lays down certain requirements for
be taken into account when setting the Union target.
those targets. Such reduction is important in view of
the strict measures which have to be applied to
infected flocks in accordance with Regulation (EC) No
2160/2003. In particular, eggs originating from flocks
with unknown Salmonella status, that are suspected of
(6) The
Community
Summary
Report
on
Trends
and
being infected or from infected flocks, may be used for
Sources of Zoonoses, Zoonotic Agents and Food-borne
human consumption only if treated in a manner that
Outbreaks in the European Union in 2008 ( 4 ) showed
guarantees the elimination of Salmonella serotypes with
that Salmonella Enteritidis and Salmonella Typhimurium
public health significance in accordance with Union legis
are the serovars most frequently associated with human
lation on food hygiene.
illness. Human cases caused by S. Enteritidis decreased
markedly in 2008, while an increase in S. Typhimurium
cases was observed. In accordance with the requirements
of Regulation (EC) No 2160/2003, the EFSA has been
consulted on the setting of a permanent Union target for
(3) Annex
I
to
Regulation
(EC)
No
2160/2003
refers
to
all
laying flocks of Gallus gallus.
Salmonella serotypes with public health significance in
laying flocks of Gallus gallus. Those laying flocks may
( 2 ) OJ L 211, 1.8.2006, p. 4.
( 3 ) OJ L 325, 12.12.2003, p. 31.
( 1 ) OJ L 325, 12.12.2003, p. 1.
( 4 ) The EFSA Journal 2010; 8(1):1496.

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L 138/46
EN
Official Journal of the European Union
26.5.2011
(7) On
10
March
2010,
the
Panel
on
Biological
Hazards
of
in accordance with Council Decision 2009/470/EC of
EFSA adopted on a request from the Commission a
25 May 2009 on expenditure in the veterinary field ( 4 ).
Scientific Opinion on a quantitative estimation of the
Those programmes were based on Regulation (EC)
public health impact of setting a new target for the
No 1168/2006 and approved in accordance with
reduction of Salmonella in laying hens ( 1 ). It concludes
Commission Decision 2010/712/EU of 23 November
that Salmonella Enteritidis is the most successful vertically
2010 approving annual and multiannual programmes
transmitted zoonotic Salmonella serotype in poultry. It
and the financial contribution from the Union for the
also concludes that Union control measures in laying
eradication, control and monitoring of certain animal
hens have successfully contributed to the control of
diseases and zoonoses presented by the Member States
Salmonella infections in production stock and to the
for 2011 and following years ( 5 ).
reduction of human health risks from poultry.
(14) Regulation
(EC)
No
1168/2006
should
be
repealed
and
(8) Monophasic
strains
of Salmonella Typhimurium have
replaced by this Regulation. The technical provisions in
rapidly become one of the most commonly found
the Annex to Regulation (EC) No 1168/2006 achieve the
Salmonella serotypes in several species of animals and
same results as the Annex to this Regulation. Therefore,
in clinical isolates of humans. According to the Scientific
Member States would be able to apply the latter
Opinion on monitoring and assessment of the public
immediately without the need of a transitional period.
health risk of ‘Salmonella Typhimurium-like strains’ ( 2 ),
adopted by the Panel on Biological Hazards of EFSA
on 22 September 2010, monophasic Salmonella Typhi
(15) The
measures
provided
for
in
this
Regulation
are
in
murium strains with the antigenic formula 1,4,[5],12:i:-
accordance with the opinion of the Standing
are considered as variants of Salmonella Typhimurium and
Committee on the Food Chain and Animal Health and
pose a public health risk comparable to that of other
neither the European Parliament nor the Council has
Salmonella Typhimurium strains.
opposed them,
(9) Accordingly, for the purposes of clarity of Union
HAS ADOPTED THIS REGULATION:
legislation, it is appropriate to amend Regulation (EC)
No 2160/2003 and Commission Regulation (EU)
No 200/2010 of 10 March 2010 implementing Regu
Article 1
lation (EC) No 2160/2003 of the European Parliament
Target
and of the Council as regards a Union target for the
reduction of the prevalence of Salmonella serotypes in
1. The
Union
target
referred
to
in
Article
4(1)
of
Regulation
adult breeding flocks of Gallus gallus (
(EC) No 2160/2003 for the reduction of the prevalence of

3 ) in order to
provide that Salmonella Typhimurium include monophasic
Salmonella Enteritidis and Salmonella Typhimurium in adult
strains with the antigenic formula 1,4,[5],12:i:-.
laying hens of Gallus gallus (‘Union target’) shall be as follows:
(10) Taking into account the Scientific Opinion of
(a) an annual minimum percentage of reduction of positive
22 September 2010 and considering that more time is
flocks of adult laying hens equal to at least:
needed to assess the trend of Salmonella in flocks after
the introduction of national control programmes, it is
(i) 10 % where the prevalence in the preceding year was
appropriate to provide for a Union target for the
less than 10 %;
reduction of Salmonella in adult laying flocks of Gallus
gallus similar to the Union target provided for in Regu
lation (EC) No 1168/2006.
(ii) 20 % where the prevalence in the preceding year was
more than or equal to 10 % and less than 20 %;
(11) In
order
to
ascertain
progress
in
the
achievement
of
the
Union target, it is necessary to provide for repeated
(iii) 30 % where the prevalence in the preceding year was
sampling of flocks of adult laying hens of Gallus gallus.
more than or equal to 20 % and less than 40 %;
(12) The
technical
amendments
introduced
in
the
Annex
to
(iv) 40 % where the prevalence in the preceding year was
this Regulation are directly applicable and harmonised in
more than or equal to 40 %;
Member States, therefore possible adaptations of national
control programmes in accordance with this Regulation
do not require reapproval by the Commission.
or
(13) National
control
programmes
for
the
achievement
of
the
(b) a reduction of the maximum percentage equal to 2 % or less
Union target for 2011 for flocks of adult laying hens of
of positive flocks of adult laying hens; however, for Member
Gallus gallus have been submitted for Union co-financing
States with less than 50 flocks of adult laying hens, not
more than one adult flock may remain positive.
( 1 ) The EFSA Journal 2010; 8(4):1546.
( 2 ) The EFSA Journal 2010; 8(10):1826.
( 4 ) OJ L 155, 18.6.2009, p. 30.
( 3 ) OJ L 61, 11.3.2010, p. 1.
( 5 ) OJ L 309, 25.11.2010, p. 18.

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EN
26.5.2011 Official
Journal
of
the
European
Union L
138/47
The Union target shall be achieved every year based on the
Article 4
monitoring of the previous year. As regards the target to be
achieved in 2011, the results of the year 2010 based on the
Amendment to Regulation (EU) No 200/2010
monitoring carried out in accordance with Article 1 of Regu
In Article 1(1), the first subparagraph is replaced by the
lation (EC) No 1168/2006 shall be used as reference.
following:
As regards monophasic Salmonella Typhimurium, serotypes with
‘1. From
1
January
2010,
the
Union
target,
as
referred
to
the antigenic formula 1,4,[5],12:i:- shall be included in the
in Article 4(1) of Regulation (EC) No 2160/2003, for the
Union target.
reduction of Salmonella spp. in breeding flocks of Gallus
gallus (“the Union target”) shall be a reduction to 1 % or
2. The
testing
scheme
necessary
to
verify
progress
on
the
less of the maximum percentage of adult breeding flocks of
achievement of the Union target is set out in the Annex
Gallus gallus remaining positive for Salmonella Enteritidis,
(‘testing scheme’).
Salmonella Infantis, Salmonella Hadar, Salmonella Typhimurium,
including monophasic Salmonella Typhimurium with the
Article 2
antigenic formula 1,4,[5],12:i:-, and Salmonella Virchow (the
Review of the Union target
relevant Salmonella serotypes).’.
The Union target shall be reviewed by the Commission taking
Article 5
into account the information collected in accordance with the
testing scheme and the criteria laid down in Article 4(6)(c) of
Repeal of Regulation (EC) No 1168/2006
Regulation (EC) No 2160/2003.
Regulation (EC) No 1168/2006 is repealed.
Article 3
References to Regulation (EC) No 1168/2006 shall be construed
Amendment to Regulation (EC) No 2160/2003
as references to this Regulation.
In Annex II to Regulation (EC) No 2160/2003, in Part C, the
following subparagraph is inserted:
Article 6
Entry into force and applicability
‘6. All references in this section to ‘Salmonella Typhimurium’
shall also include monophasic Salmonella Typhimurium
This Regulation shall enter into force on the third day following
with the antigenic formula 1,4,[5],12:i:-,’.
its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 25 May 2011.
For the Commission
The President
José Manuel BARROSO

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L 138/48
EN
Official Journal of the European Union
26.5.2011
ANNEX
Testing scheme necessary to verify the achievement of the Union target for the reduction of Salmonella
Enteritidis and Salmonella Typhimurium in adult laying hens of Gallus gallus, as referred to in Article 1(2)
1. SAMPLING
FRAME
The sampling frame shall cover all flocks of adult laying hens of Gallus gallus (‘laying flocks’) within the framework
of the national control programmes provided for in Article 5 of Regulation (EC) No 2160/2003.
2. MONITORING
IN
LAYING
FLOCKS
2.1. Frequency
and
status
of
sampling
Laying flocks shall be sampled at the initiative of the food business operator and by the competent authority.
Sampling at the initiative of the food business operator shall take place at least every 15 weeks. The first sampling
shall take place at the flock-age of 24 +/– 2 weeks.
Sampling by the competent authority shall take place at least:
(a) in one flock per year per holding comprising at least 1 000 birds;
(b) at the age of 24 +/– 2 weeks in laying flocks housed in buildings where the relevant Salmonella was detected in
the preceding flock;
(c) in any case of suspicion of Salmonella infection when investigating food-borne outbreaks in accordance with
Article 8 of Directive 2003/99/EC or any cases where the competent authority considers it appropriate, using
the sampling protocol laid down in point 4(b) of Part D to Annex II to Regulation (EC) No 2160/2003;
(d) in all other laying flocks on the holding in case Salmonella Enteritidis or Salmonella Typhimurium is detected in
one laying flock on the holding;
(e) in cases where the competent authority considers it appropriate.
A sampling carried out by the competent authority may replace one sampling at the initiative of the food business
operator.
2.2. Sampling
protocol
In order to maximise the sensitivity of the sampling, and to ensure the correct application of the sampling
protocol, the competent authority or the food business operator shall ensure that samples are taken by trained
persons.
2.2.1. Sampling by the food business operator
(a) In cage flocks, 2 × 150 grams of naturally pooled faeces shall be taken from all belts or scrapers in the house
after running the manure removal system; however, in the case of step cage houses without scrapers or belts
2 × 150 grams of mixed fresh faeces must be collected from 60 different places beneath the cages in the
dropping pits.
(b) In barn or free-range houses, two pairs of boot swabs or socks shall be taken.
Boot swabs used must be sufficiently absorptive to soak up moisture. The surface of the boot swab must be
moistened using appropriate diluents.
The samples must be taken while walking through the house using a route that produces representative
samples for all parts of the house or the respective sector. This shall include littered and slatted areas
provided that slats are safe to walk on. All separate pens within a house must be included in the sampling.
On completion of the sampling in the chosen sector, boot swabs must be removed carefully so as not to
dislodge adherent material.

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EN
26.5.2011 Official
Journal
of
the
European
Union L
138/49
2.2.2. Sampling by the competent authority
At least one sample must be collected using the sampling protocol in addition to samples referred to under point
2.2.1. Further samples shall be taken in order to ensure representative sampling if required by the distribution or
the size of the flock.
In the case of sampling referred to in point 2.1(b), (c), (d) and (e), the competent authority shall satisfy itself by
conducting further checks, namely by laboratory tests and/or documentary checks as appropriate to ensure that the
results of examinations for Salmonella in birds are not affected by the use of antimicrobials in the flocks.
Where the presence of Salmonella Enteritidis and Salmonella Typhimurium is not detected but antimicrobials or
bacterial growth inhibitory effects are detected it shall be considered and accounted for as an infected laying
flock for the purpose of the Union target.
The competent authority may decide to allow replacement of one faecal sample or one pair of boot swabs by a
dust sample of 100 grams collected from multiple places throughout the house from surfaces with a visible
presence of dust. As an alternative one or several moistened fabric swab(s) of at least 900 cm 2 surface area in total
may be used instead to gather dust from multiple surfaces throughout the house, ensuring that each swab is well
coated with dust on both sides.
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, namely the biosecurity conditions, the
distribution or size of the flock or other relevant conditions.
3. EXAMINATION
OF
THE
SAMPLES
3.1. Transport
and
preparation
of
the
samples
Samples shall preferably be sent by express mail or courier to the laboratories referred to in Articles 11 and 12 of
Regulation (EC) No 2160/2003, within 24 hours after collection. If they are not sent within 24 hours, they shall
be stored refrigerated. The samples may be transported at ambient temperature provided that excessive heat
(namely over 25 °C) or exposure to sunlight is avoided. At the laboratory the samples shall be kept refrigerated
until examination, which must be started within 48 hours following receipt and within 4 days after sampling.
Separate preparations shall be made of the boot swabs and dust or the fabric dust swab in the case of samples by
the competent authority, but as regards samples by food business operators the different sample types may be
combined in one test.
3.1.1. Boot and fabric swab samples
(a) The two pairs of boot swabs (or ‘socks’) or dust swabs shall be carefully unpacked to avoid dislodging adherent
faecal material, pooled and placed in 225 ml of Buffered Peptone Water (BPW) which has been pre-warmed to
room temperature, or the 225 ml of diluent must be added directly to the two pairs of boot swabs in their
container as received in the laboratory. The boot/socks or fabric swab 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.
(b) The sample shall be swirled to fully saturate it and culture shall be continued by using the detection method
set out in point 3.2.
3.1.2. Other faecal and dust material
(a) The faeces samples shall be pooled and thoroughly mixed and a 25-gram sub-sample shall be collected for the
culture.
(b) The 25-gram sub-sample (or 50 ml of suspension containing 25 grams of the initial sample) shall be added to
225 ml of BPW which has been pre-warmed to room temperature.
(c) Culture of the sample shall be continued by using the detection method set out in point 3.2.
If ISO standards on the preparation of relevant samples for the detection of Salmonella are agreed on, they shall be
applied and replace those set out in points 3.1.1 and 3.1.2.

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L 138/50
EN
Official Journal of the European Union
26.5.2011
3.2. Detection
method
The detection of Salmonella shall be carried out according to Amendment 1 of EN/ISO 6579-2002/Amd1:2007
‘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.
After incubation the samples in BPW shall not be shaken, swirled or otherwise agitated.
3.3. Serotyping
At least one isolate from each positive sample taken by the competent authority shall be serotyped, following the
Kaufmann-White-LeMinor scheme. In isolates taken by the food business operators, at least the serotyping for
Salmonella Enteritidis and Salmonella Typhimurium must be carried out.
3.4. Alternative
methods
With regard to samples taken on the initiative of the food business operator, alternative methods may be used
instead of the methods for the preparation of samples, detection methods and serotyping set out in points 3.1, 3.2
and 3.3 of this Annex, if validated in accordance with the most recent version of EN/ISO 16140.
3.5. Testing
for
antimicrobial
resistance
The isolates shall be tested for antimicrobial resistance in accordance with Article 2 of Commission Decision
2007/407/EC ( 1 ).
3.6. Storage
of
strains
The competent authority shall ensure that at least one isolated strain of the relevant Salmonella serotypes from
sampling as part of official controls per house and per year is stored for possible future phagetyping or anti
microbial susceptibility testing, using the normal methods for culture collection, which must ensure integrity of the
strains for a minimum period of 2 years.
If the competent authority so decides, isolates from sampling by food business operators shall also be stored for
these purposes.
4. RESULTS
AND
REPORTING
4.1. A laying flock shall be considered positive for the purpose of ascertaining the achievement of the Union
target where:
(a) the presence of the relevant Salmonella serotypes (other than vaccine strains) has been detected in one or more
samples taken in the flock, even if the relevant Salmonella serotype is only detected in the dust sample or dust
swab; or
(b) antimicrobials or bacterial growth inhibitors have been detected in the flock.
This rule shall not apply in exceptional cases described in Annex II D point 4 of Regulation (EC) No 2160/2003,
where the initial Salmonella positive result has not been confirmed by that respective sampling protocol.
4.2. A
positive
laying
flock
shall
only
be
counted
once
regardless
of:
(a) how often the relevant Salmonella serotype has been detected in this flock during the production period;
or
(b) whether the sampling was carried out at the initiative of the food business operator or by the competent
authority.
However, if sampling during the production period is spread over 2 calendar years, the result of each year shall be
reported separately.
( 1 ) OJ L 153, 14.6.2007, p. 26.

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EN
26.5.2011 Official
Journal
of
the
European
Union L
138/51
4.3. Reporting
shall
include:
(a) the total number of adult laying flocks which were tested at least once during the year of reporting;
(b) the results of the testing including:
(i) the total number of laying flocks positive with any Salmonella serotype in the Member State;
(ii) the number of laying flocks positive at least once with Salmonella Enteritidis and Salmonella Typhimurium;
(iii) the number of positive laying flocks for each Salmonella serotype or for Salmonella unspecified (isolates that
are untypable or not serotyped);
(c) explanations of the results, in particular concerning exceptional cases or any substantial changes in number of
flocks tested and/or found positive.
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.

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