2006/668/EC: Commission Decision of 29 September 2006 concerning a financial contribution from the Community towards a baseline survey on the prevalence of Salmonella in slaughter pigs to be carried out in the Member States (notified under document number C(2006) 4306)
Date: 2006-09-29
Institutions: European Commission
Subjects: EU financing, agricultural census, data collection, swine, veterinary inspection, zoonosis, zootechnics

6.10.2006

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Official Journal of the European Union

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II

(Acts whose publication is not obligatory)

COMMISSION

COMMISSION DECISION

of 29 September 2006

concerning a financial contribution from the Community towards a baseline survey on the
prevalence of Salmonella in slaughter pigs to be carried out in the Member States

(notified under document number C(2006) 4306)

(2006/668/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

Having regard to Council Decision 90/424/EEC of 26 June
1990 on expenditure in the veterinary field (1), and in particular
Article 20 thereof,

(4)

Whereas:

(1)

(2)

Pursuant to Decision 90/424/EEC the Community is to
undertake or assist the Member States in undertaking the
the
technical and scientific measures necessary for
development of veterinary
the
legislation and for
development of veterinary education or training.

(5)

Under Article 4 of Regulation (EC) No 2160/2003 of the
European Parliament and of the Council of 17 November
2003 on the control of Salmonella and other specified
food-borne zoonotic agents (2), a Community target is to
be established for reducing the prevalence of Salmonella
in populations of herds of slaughter pigs by the end of
2007.

(3)

The Scientific Panel on Biological Hazards of
the
European Food Safety Authority (EFSA) adopted an
opinion on the request from the Commission related to

‘Risk assessment and mitigation options of Salmonella in
pig production’, during its meeting of 16 March 2006.
The opinion proposes
for a
baseline
study on the prevalence of Salmonella in
fattening pigs in the EU.

specifications

technical

in the Member States needs

In order to set the Community target, comparable data
on the prevalence of Salmonella in populations of
to be
slaughter pigs
available. Such information is not at hand and a special
survey should therefore be carried out to monitor the
prevalence of Salmonella
a
suitable period in order to take account of possible
seasonal variations.

in slaughter pigs over

The EFSA opinion recommends slaughterhouse sampling
by taking ileocaecal lymph nodes to reflect the Salmonella
status of the pig sent to slaughter. Such sampling should
therefore be used as a tool to monitor the prevalence of
Salmonella in slaughter pigs. It is opportune to use this
baseline survey also to evaluate the effect of contami-
the pigs during transport and lairage, and
nation of
contamination of
slaughter
process by taking carcase swabs. In addition, serological
methods have been developed to assess the Salmonella
status of a pig and may be used for monitoring
Salmonella in pigs within the frame of national control
programmes to be implemented in accordance with
Article 5 of Regulation (EC) No 2160/2003.

carcase during the

the

(1) OJ L 224, 18.8.1990, p. 19. Decision as last amended by Decision

2006/53/EC (OJ L 29, 2.2.2006, p. 37).

(2) OJ L 325, 12.12.2003, p. 1. Regulation as amended by Commission

Regulation (EC) No 1003/2005 (OJ L 170, 1.7.2005, p. 12).

(6)

A number of Member States volunteered to carry out the
additional analyses by taking carcase swabs or carrying
out serology on meat juice.

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(7)

(8)

(9)

(10)

(11)

The survey is to provide technical information necessary
for the development of Community veterinary legislation.
Given the importance of collecting comparable data on
the prevalence of Salmonella in slaughter pigs in the
Member States, they should be granted a Community
implementing the specific
financial contribution for
requirements of
to
survey.
reimburse 100 % of the costs incurred on the laboratory
to a ceiling. All other costs such as
testing, subject
travel, administration, etc should not be
sampling,
eligible for any Community financial contribution.

appropriate

the

is

It

A financial contribution from the Community should be
in
granted provided that
accordance with the relevant provisions of Community
law and subject
to compliance with certain other
conditions.

the survey is carried out

A financial contribution from the Community should be
granted in so far as the actions provided for are effec-
tively carried out and provided that
the authorities
furnish all
the necessary information within the time
limits provided for.

There is a need to clarify the rate to be used for the
conversion of payment
in
national currencies as defined in Article 1(d) of Council
Regulation (EC) No 2799/98 of 15 December 1998
establishing agrimonetary arrangements for the euro (1).

applications

submitted

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

Objective of the survey and general provisions

1.
A survey shall be carried out to assess the prevalence of
Salmonella spp. across the Community in slaughter pigs sampled
in the slaughter house. The survey shall also be used to collect
at the same time information on contamination of carcases in
slaughterhouses and on the relation between bacteriological and
serological tests.

The results of the survey shall be used to set Community
2.
targets as provided for
in Article 4 of Regulation (EC)
No 2160/2003 and to consider the best approach to evaluate
in the future the achievement of the target.

The survey shall cover a one-year period commencing on

3.
1 October 2006.

For the purposes of this Decision,

‘competent authority’
4.
shall be the authority or authorities of a Member State as
designated under Article 3 of Regulation (EC) No 2160/2003.

Article 2

Technical specifications

The survey in slaughter pigs shall be organised by the Member
States and shall be performed from 1 October 2006 in slaugh-
terhouses. Sampling and analysis shall be performed by the
competent authority or under its supervision.

Sampling and analysis shall be performed in accordance with
the provisions in Annex I.

Article 3

Collection of data, assessment and reporting

The competent authority responsible for preparing the
to Article 9(1) of Directive
of
the
and assess
achieved
this Decision and shall report all

1.
yearly national report pursuant
2003/99/EC of
Council (2)
shall
pursuant
necessary data and its assessment to the Commission.

the
collect
to Article 2 of

Parliament
the

and
results

European

The Commission shall forward the results to the European

2.
Food Safety authority, which shall examine them.

National aggregated data and results

3.
available publicly in a form that ensures confidentiality.

shall be made

Article 4

Scope of the Community financial contribution

The Community shall provide financial contribution for
1.
the costs incurred by the Member States on laboratory testing,
i.e. bacteriological detection of Salmonella spp., serotyping of the
relevant isolates and serology.

2.
The maximum financial
Community shall be EUR 20 per
detection of Salmonella spp., EUR 30 for serotyping of
relevant isolates and EUR 10 for serology on meat juice.

from the
for bacteriological
the

contribution

test

3.
The financial contribution from the Community shall not
exceed the amounts set out in Annex II for the duration of the
survey.

Article 5

Conditions

for

granting

a

Community

financial

contribution

1.
The financial contribution provided for in Article 4 shall
be granted to the Member States provided that the survey is
implemented in accordance with the relevant provisions of
Community law,
including the rules on competition and on
the award of public contracts, and subject to compliance with
the following conditions:

(1) OJ L 349, 24.12.1998, p. 1.

(2) OJ L 325, 12.12.2003, p. 31.

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(a) by 1 October 2006, the laws, regulations and administrative
provisions required to implement the survey shall come into
force;

(b) a progress report covering the first three months of the
survey shall be forwarded by 28 February 2007. The
information requested
progress report should contain all
in Annex III of
the Scientific Panel on
Biological Hazards on the request from the Commission
related to ‘Risk assessment and mitigation options of
Salmonella in pig production’.

the Opinion of

(c) a final report shall be forwarded by 31 October 2007 at the
latest on the technical execution of the survey, together with
supporting evidence for the costs incurred and the results
attained during the period 1 October 2006 to 30
September 2007; the evidence as to costs incurred shall
comprise at least the information set out in Annex III;

Article 6

Conversion rate for applications in national currencies

The conversion rate for applications submitted in national
currencies in month ‘n’ shall be that
for the 10th day of
month ‘n+1’ or the first day before that day for which a rate
is quoted.

Article 7

Application

This Decision shall apply from 1 October 2006.

Article 8

Addressees

(d) the survey shall be implemented effectively.

This Decision is addressed to the Member States.

2.
An advance of 50 % of the total amount referred to in
Annex II may be paid at the request of the Member State
concerned.

3.
Failure to comply with the time limit in paragraph 1(c)
shall entail a progressive reduction of the financial contribution
to be paid, amounting to 25 % of the total amount by 15
November 2007, 50 % by 1 December 2007 and 100 % by
15 December 2007.

Done at Brussels, 29 September 2006.

For the Commission

Markos KYPRIANOU
Member of the Commission

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ANNEX I

1.

Sampling frame

Technical specifications in accordance with Article 2

A minimum number of pigs, kept during at least the preceding three months in the Member State, shall be ad
random sampled in accordance with Table 1.

Table 1

Minimum sample size

Number of pigs present in the population

Minimum sample size (1)

> 20 000 000

10 to 20 000 000

2 to 10 000 000

< 2 000 000

2 400

1 067

600

384

(1) Based on an infinite population (> 100 000 per year), an estimated prevalence of 50 %, a confidence level of 95 % and a accuracy

of 2, 3, 4 and 5 % respectively.

Member States shall take a 10 % extra number of samples, to be analyzed in case some samples would be excluded
from the study for various reasons.

Samplings shall be stratified by month to ensure to cover the different seasons.

Sampling shall be stratified by slaughterhouses that participate and proportional to slaughterhouse capacity. Each
Member State shall rank all slaughterhouses according to their fattening pigs throughput in the previous year. Thus,
each Member State shall identify those plants that accounted for at least 80 % of all slaughtered fattening pigs.

The total number of pigs and carcases to be sampled in each of the slaughterhouses included in the study shall be
estimated by multiplying the sample size (e.g. 2 400) by the proportion of fattening pigs processed in the previous
year. For example, if one slaughterhouse accounted for 25 % of fattening pigs slaughtered in the selected slaughter-
houses (those representing at least 80 % of all fattening pigs slaughtered in the Member State), then (2 400 × 0,25)
600 pigs shall be sampled. These shall be evenly divided so that 50 pigs were sampled in every month, for 12
months. A further example is shown in Table 2.

Naturally, if a slaughterhouse is no longer in production, if a new facility has been opened or there is predicted to be
a significant change in plant throughput during the survey, then the estimated throughput shall be adjusted
accordingly.

Table 2

Weighing of slaughterhouses for the purpose of allocating the number of fattening pigs to be sampled from
each slaughterhouse; calculation of sampled animals per slaughterhouse

Slaughterhouse ID

Number of fattening
pigs processed
previous year

Percent of total
slaughter included in
the study

Number of samples per
slaughterhouse

Samples per month
(/12)

AXD

SVH

TPB

MLG

GHT

88 000

25 000

75 000

100 000

212 000

17,6

5,0

15,0

20,0

42,4

0,176 × 2 400 = 422,4

422,4:12 = 36

Total

500 000 (1)

100,0

(1) This number should represent at least 80 % of slaughtered fattening pigs in a Member State.

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For each slaughterhouse each month, a number between 1 and 31 shall be selected at random. If the randomly
selected number is a slaughtering day, for that month, then that day is selected for sampling. If not, then a new
number is selected randomly. This process is performed once a month and repeated so many times as there are
samples to be collected at the slaughterhouse. For example, in the slaughterhouse AXD the process shall be repeated
at least 36 times to select at least 36 working days randomly. Naturally, it might be more than one carcase to be
sampled on the same day.

As the number of animals slaughtered on a specific day may vary enormously, the random selection of the
individual animal shall take place at the slaughterhouse at the day randomly selected for sampling. The given
day, the total number of animals is known, and the personnel of the slaughterhouse shall then randomly select a
carcase or carcases using the randomisation sheet which has been provided to them and which has been generated
using a maximum that exceeds the highest possible number of fattening pigs slaughtered on any given day in any
slaughterhouse in the Member State.

A randomisation table may then look as shown in Table 3.

Table 3

Randomisation table

Slaughterhouse

Day of the month

Identity of carcase (1)

AXD

19

4

12

12

8

5

2

124

2

59

(1) i.e. the fifth carcase to be processed on the 19th day of that month should be sampled for the survey.

The following animals shall be excluded from the baseline study:

— animals with a live weight of less than 50 kg or more than 170 kg,

— animals that have undergone emergency slaughter,

— any carcase that is totally condemned.

2.

Samples

2.1. Sampling in general

The following samples shall be collected:

— the aggregate of ileocaecal lymph nodes or at least five individual ileocaecal lymph nodes of all selected pigs. If

possible, at least 25 grams of lymph nodes without fat or connective tissues shall be collected,

— a sponge swabbed at four sites in accordance with paragraph 2(3), per carcase, from a total of at least 384 pigs,
randomly selected from the selected pigs. The sponge sampling method shall be used in accordance with the
most recent edition of standard ISO 17604. This sampling shall be carried out in Belgium, the Czech Republic,
Denmark, France, Ireland, Cyprus, Latvia, Lithuania, Austria, Poland, Slovenia, Sweden and the United Kingdom,

— a muscle sample for serology on meat juice or blood (if equivalent to the method on meat juice) from all selected
pigs. Sufficient neck or diaphragm muscle shall be taken to yield enough meat juice to allow a portion to be
frozen and stored for later comparative studies. This sampling shall be carried out in Denmark, Germany, France,
Ireland, Cyprus, Lithuania, the Netherlands, Slovenia, Sweden and the United Kingdom.

Records shall be kept at the slaughterhouse on the muscle which is sampled, time and date of sampling of each
sample and the time and date and name of the courier that takes delivery of the samples.

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2.2. Details on sampling of ileocaecal lymph nodes

The mesenterium between the caecum and the part of the ileum that is closest to the caecum shall be torn and the
ileocaecal lymph nodes are presented at the surface of the torn-open area. Without a knife, but with gloved fingers,
the lymph nodes shall be bluntly ‘harvested’ from such opened mesenterium if individual lymph nodes are collected.
The lymph nodes or the aggregate shall be placed in a plastic bag which is marked with date, time, slaughterhouse
identification and sample identification code.

2.3. Details on carcase sampling by surface swabs-sampling

Sampling of the carcase shall be performed after evisceration and before chilling. A surface of about 100 cm2 per
site shall be swabbed using one single abrasive sponge for all the following sites as indicated and numbered below in
accordance with Annex A of standard ISO 17604:

— hind limb, medial (9),

— abdomen, lateral (belly, 3),

— mid-dorsal region (mid-back, 4),

— jowl (7).

Two sites shall be swabbed with one side of the sponge, which shall then be turned over for the remaining two sites,
and a scrubbing action shall be used. Enough pressure shall be used to push the lower part of the carcase slightly (2
to 5 mm) away from the sampler. The sponge shall be wiped over each sampling site for a total of approximately 10
times in the vertical and 10 times in the horizontal direction. If templates are used, precautions shall be taken to
avoid cross-contamination between carcases.

The sample shall be kept at max. 7 °C during storage and transportation. The plastic bag is marked with the date,
time, slaughterhouse identification and sample identification code.

3.

Transport

Samples shall be sent within 36 hours by fast mail or courier and shall reach the laboratory no later than 72 hours
after sampling. Samples arriving later than within 72 hours after sampling shall be discarded unless analysis is
initiated within 96 hours after sampling and the cold chain was not interrupted.

4. Analysis of samples

Analysis and serotyping shall take place at the National Reference Laboratory (NRL). In case that the NRL does not
have the capacity to perform all analyses or if it is not the laboratory that performs detection routinely, the
competent authorities may decide to designate a limited number of other laboratories involved in official control
of Salmonella to perform the analyses. These laboratories should have proven experience of using the required
detection method and have a quality assurance system complying with ISO standard 17025 and be submitted to
the supervision of the NRL.

At the laboratory, samples shall be kept refrigerated until bacteriological examination, which shall be carried out
within 24 hours after receipt and so that analysis is initiated no later than 96 hours after the sample was collected.

The muscle sample for serology shall be kept frozen until analysis, which shall be carried out immediately after
thawing.

4.1. Sample preparation for bacteriology

Lymph nodes shall be surface de-contaminated before analysis by dipping into absolute alcohol and drying by air.

All lymph nodes shall be pooled and closed in a plastic bag and banged with a hammer or so on the plastic bag
smashing the lymph nodes.

The homogenised lymph nodes shall be weighed and placed in a sterile container with pre-warmed buffered peptone
water (BPW) in dilution 1:10. Containers shall be incubated for a total of (18 ± 2) hours at (37 ± 1) °C.

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Regarding swabs sample, at the laboratory, 100 ml of BPW shall be added for pre-enrichment. The sample shall be
incubated at 37 °C overnight and examined for Salmonella using the modified semi-solid Rappaport-Vassiladis
medium (MRSV) method (draft Annex D of the ISO 6579:2002(E).

4.2. Detection method for bacteriology

The method recommended by the Community Reference Laboratory (CRL) for Salmonella in Bilthoven, the Neth-
erlands, shall be used. This method is described in the current version of draft Annex D of ISO 6579:2002:
‘Detection of Salmonella spp. in animal faeces and in samples of the primary production stage.’ In this method,
MSRV shall be used as the single selective enrichment medium.

4.3. Serotyping

All strains isolated and confirmed as Salmonella spp. shall be serotyped according to the Kaufmann-White scheme.

For quality assurance, 16 typable strains and 16 non-typable isolates shall be sent to the CRL. If less strains have
been isolated, all shall be sent.

4.4. Phage typing

In case isolates of Salmonella serovar typhimurium and Salmonella serovar enteritidis are phage typed (optional), the
methods described by WHO reference centre for phage typing of Salmonella of the Health Protection Agency (HPA),
Colindale, United Kingdom, shall be used.

4.5. Testing of anti-microbial susceptibility

In case of testing for anti-microbial susceptibility (optional), a validated and controlled method for testing shall be
used, such as those recommended by the National Committee for Clinical Laboratory Standards (NCCLS, since
1 January 2005: ‘Clinical and Laboratory Standards Institute’ — CLSI).

Both agar diffusion and broth dilution methods are acceptable. Results shall be reported both as quantitative data
(MIC for dilution methods and inhibition zone diameter for diffusion methods) and as qualitative data (proportion
resistant isolates). Qualitative data shall be based on interpretation according to epidemiological cut-off values
presented by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) at: http://www.eucast.org

The isolates shall be tested for the susceptibility to the antimicrobial substances listed below:

— Ampicillin or Amoxicillin,

— Tetracycline,

— Chloramphenicol,

— Florfenicol,

— Nalidixic acid,

— Ciprofloxacin (preferably) or Enrofloxacin,

— Sulphonamide (preferably Sulfametoxazole),

— Sulphonamide/Trimethoprim or Trimethoprim,

— Gentamicin,

— Streptomycin,

— Kanamycin (preferably) or Neomycin,

— third generation Cephalosporin, (preferably Cefotaxime),

— Colistin (optional).

Before initiation of the study Member States are encouraged to organise training for the involved parties.

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5. Records and sample storage

Records of bacteriology shall be kept on all samples processed in a format like or comparable to the example given
in Table 4.

All strains isolated shall be stored at the NRLs of the different Member States as long as it ensures integrity of the
strains for a minimum of five years.

All samples of meat juice for serology shall be stored frozen for two years.

Table 4

Example of records to be taken on all processed samples

Sample

Receipt

Analysis

)
1
(

e
p
y
t

+
D

I

e
l
p
m
a
S

1 S

2 L

3 L

D

I

e
s
u
o
h
r
e
t
h
g
u
a
l
S

e
m
a
N

e
t
a
D

e
m
T

i

e
m
a
N

e
t
a
D

e
m
T

i

e
v
i
t
a
g
e
N

r
o

e
v
i
t
i
s
o
P

r
a
v
o
r
e
S

e
p
y
t
e
g
a
h
P

m
a
r
g
o
b
i
t
n
A

i

D

I

e
g
a
r
o
t
S

EU012

PW 3-10-06 12:00 AB

3-10

14:00

Neg

EU023

PW

4-10

12:30 AB

4-10

14:00

EU083

PW

8-10

16:30 AB

9-10

9:00

Pos

Pos

Typh

DT104

ASTSu

(IDnr)

Agona

n.a. (2)

ASTE

(IDnr)

(1) Type of sample: L = lymph nodes, S = swab, MJ = meat juice.
(2) n.a. = not applicable (phage typing is only done after Salmonella typhimurium and Salmonella enteritidis isolation).

6. Reporting from Member States

The competent authority responsible for the preparation of the yearly national report on the monitoring of
Salmonella in animals pursuant to Article 9 of Directive 2003/99/EC shall collect and evaluate the results and
report to the Commission.

Reports shall be made including at least the following information:

6.1. Overall description on the implementation of the programme

— description of the population under study stratified according to slaughterhouses capacity,

— description of randomisation procedure, including notification system,

— sample size calculated,

— details of authorities and laboratories involved in sampling/testing/typing,

— overall results of the study (samples analysed by bacteriology and serology, number of positive, serovar, phage

type and antibiotic resistance testing).

6.2. Complete data on each animal sampled and corresponding tests results:

The Member States shall submit the results of the investigation in the form of raw data using a data dictionary and
data collection forms provided by the Commission. This dictionary and forms shall be established by the
Commission:

— reference of the slaughterhouse,

— capacity of the slaughterhouse,

— date and time of sampling,

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— reference of the samples (e.g. number),

— type of samples taken: lymph nodes, carcase swab,

— date of shipment to the laboratory.

The following information shall be collected in Member States for each sample sent to the laboratory:

— ID of the laboratory (in case several laboratories are involved),

— means of transport of samples,

— date of reception by the laboratory,

— when testing lymph nodes, weight of the specimen,

— result for the individual sample tested:

‘negative’ or in case positive for Salmonella spp., also the results of

serotyping ‘Salmonella serovar’ or ‘untypable’,

— results for strains subject to antimicrobial susceptibility testing and/or phagetyping results.

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ANNEX II

Maximum Community financial contribution to the Member States

Member State

Amount

(in EUR)

Belgium — BE

Czech Republic — CZ

Denmark — DK

Germany — DE

Estonia — EE

Greece — EL

Spain — ES

France — FR

Ireland — IE

Italy — IT

Cyprus — CY

Latvia — LV

Lithuania — LT

Luxembourg — LU

Hungary — HU

Malta — MT

Netherlands — NL

Austria — AT

Poland — PL

Portugal — PT

Slovenia — SI

Slovakia — SK

Finland — FI

Sweden — SE

United Kingdom — UK

25 584

25 584

48 396

86 400

9 984

9 984

62 400

48 396

23 808

15 600

23 808

19 968

23 808

9 984

15 600

9 984

38 412

25 584

37 726

15 600

23 808

9 984

9 984

23 808

31 584

Total

675 778

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ANNEX III