Commission Regulation (EC) No 1003/2005 of 30 June 2005 implementing Regulation (EC) No 2160/2003 as regards a Community target for the reduction of the prevalence of certain salmonella serotypes in breeding flocks of Gallus gallus and amending Regulation (EC) No 2160/2003   (Text with EEA relevance)
Date: 2005-06-30
Institutions: European Commission
Subjects: evaluation method, food safety, poultry, veterinary inspection

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COMMISSION REGULATION (EC) No 1003/2005

of 30 June 2005

implementing Regulation (EC) No 2160/2003 as regards a Community target for the reduction of
the prevalence of certain salmonella serotypes in breeding flocks of Gallus gallus and amending
Regulation (EC) No 2160/2003

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(4)

Having regard to the Treaty
Community,

establishing the European

the
Having regard to Regulation (EC) No 2160/2003 of
European Parliament and of
the Council of 17 November
2003 on the control of salmonella and other specified food-
borne zoonotic agents (1) and,
in particular Article 4(1) and
Article 13 thereof,

Whereas:

(1)

(2)

(3)

The purpose of Regulation (EC) No 2160/2003 is to
ensure that proper and effective measures are taken to
detect and control salmonella and other zoonotic agents
at all relevant stages of production, processing and distri-
bution, particularly at the level of primary production, in
order to reduce their prevalence and the risk they pose to
public health.

the

Under that Regulation a Community target is to be estab-
the prevalence of all
lished for
salmonella serotypes with public health significance in
breeding flocks of Gallus gallus at the level of primary
production.

reduction of

that

Regulation (EC) No 2160/2003 provides
the
Community target is to include a numerical expression
the maximum percentage of epidemiological units
of
remaining positive and/or the minimum percentage of
reduction in the number of
epidemiological units
remaining positive,
the maximum time-limit within
which the target must be achieved and the definition
of the testing schemes necessary to verify achievement
of the target. It is also to include a definition, where
relevant, of serotypes with public health significance.

(1) OJ L 325, 12.12.2003, p. 1.

for a transitional
That Regulation also provides that
for
period of
three years,
is to cover the five
breeding flocks of Gallus gallus
most
frequent salmonella serotypes in human salmo-
nellosis, which are to be identified on the basis of data
collected through Community monitoring systems.

the Community target

human

salmonellosis

The information from Community monitoring systems
shows that the five most frequent salmonella serotypes
in
enteritidis,
Salmonella hadar, Salmonella infantis, Salmonella typhi-
murium and Salmonella virchow. The Community target
established by this Regulation should therefore cover
those serotypes.

Salmonella

are

In order to set the Community target, comparable data
on the prevalence of the concerned salmonella serotypes
in breeding flocks of Gallus gallus in Member States
should be available. The minimum requirements for
control of
in accordance with Council
Directive 92/117/EEC (2) have been used as a basis for
collecting the relevant data on prevalence in the Member
States. Such information was collected during an appro-
priate period of time in all Member States in the year
2004.

salmonella

In order to verify achievement of the target and taking
into account the relatively low prevalence of the relevant
salmonella serotypes in breeding flocks of Gallus gallus in
is necessary to organise repeated
the Community,
sampling of a representative number of
flocks of a
sufficient size, which should be 250 birds or more, as
was required under Directive 92/117/EEC.

it

The testing scheme necessary to verify the achievement
of the Community target is significantly different and
likely to be more sensitive than the scheme that was
used to collect comparable data in Member States
pursuant
therefore
necessary to provide for a review of the Community
target after a maximum of one year of implementation
of the corresponding national control programmes.

to Directive 92/117/EEC.

is

It

(5)

(6)

(7)

(8)

(2) OJ L 62, 15.3.1993, p. 38. Directive repealed by Directive
2003/99/EC of the European Parliament and of the Council
(OJ
L 325, 12.12.2003, p. 31).

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(9)

(10)

(11)

collection of

to that period of

information,
Due
comparable data were not available in time before the
establishment of the Community target within the date
laid down in Annex I to Regulation (EC) No 2160/2003
in relation to breeding flocks of Gallus gallus. The date of
establishment of that target should therefore be extended
with six months and Regulation (EC) No 2160/2003
should be amended accordingly.

The measures foreseen in Article 4(5) of Regulation (EC)
No 2160/2003 for the establishment of the Community
target in breeding flocks of Gallus gallus during the tran-
sitional period are based on the methodology for
controlling salmonella already established pursuant
to
Directive 92/117/EEC, and the remaining aspects of the
measures
relate to risk management. The measures
provided for in this Regulation have been prepared in
a working
the
(EFSA). Without
Safety Authority
European Food
prejudice to the requirement to consult EFSA provided
for in Article 15 of Regulation (EC) No 2160/2003 on
any matter that could have a significant impact on public
health, a formal consultation of EFSA is not necessary at
this stage.

group with the participation of

The measures provided for in this Regulation are in
accordance with
Standing
Committee on the Food Chain and Animal Health,

opinion

the

the

of

HAS ADOPTED THIS REGULATION:

Article 1

Community target

1.
The Community target for the reduction of Salmonella
enteritidis, Salmonella hadar, Salmonella infantis, Salmonella typhi-
murium and Salmonella virchow in breeding flocks of Gallus gallus

shall be a reduction of
breeding flocks comprising at
positive to 1 % or less by 31 December 2009.

the maximum percentage of adult
remaining

least 250 birds

for Member States with fewer than 100 breeding
However,
flocks, not more than one adult breeding flock shall remain
positive.

The testing scheme to verify the achievement of

2.
Community target is set out in the Annex.

the

Article 2

Review

The Commission shall review the Community target set out in
Article 1 in the light of the results of the first year of imple-
mentation of
the national control programmes approved in
accordance with Article 6 of Regulation (EC) No 2160/2003.

Article 3

Amendment of Regulation (EC) No 2160/2003

In Annex I to Regulation (EC) No 2160/2003,
column 4 of the first row is replaced by the following:

the text in

‘18 months after the date of entry into force of this Regu-
lation.’

Article 4

Entry into force

This Regulation shall enter into force on the day of its publi-
cation in the Official Journal of the European Union.

It shall apply from 1 July 2005.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 30 June 2005.

For the Commission

Markos KYPRIANOU
Member of the Commission

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Testing scheme necessary to verify the achievement of the Community target for the reduction of Salmonella
enteritidis, Salmonella hadar, Salmonella infantis, Salmonella typhimurium and Salmonella virchow in adult breeding
flocks of Gallus gallus

ANNEX

1.

Sampling frame

The sampling frame shall cover all adult breeding flocks of Gallus gallus comprising at least 250 birds (‘breeding
flocks’).

2.

Monitoring in breeding flocks

2.1.

Location, frequency and status of sampling

For the purpose of this Regulation, breeding flocks shall be sampled at the initiative of the operator and as part
of official controls.

2.1.1.

S a m p l i n g a t

t h e i n i t i a t i v e o f

t h e o p e r a t o r

Sampling shall take place every two weeks at the place designated by the competent authority from the following
two possible options:

(a) at the hatchery; or

(b) at the holding.

The competent authority shall implement one of the above options to the whole testing scheme, and shall set up
a procedure so that the detection of salmonella serotypes referred to in Article 1(1) (‘relevant salmonella’) during
the sampling at the initiative of the operator is notified without delay to the competent authority by the
operator, the sampler or the laboratory performing the analyses.

2.1.2. O f f i c i a l c o n t r o l s a m p l i n g

Without prejudice to Annex II, Part C.2 of Regulation (EC) No 2160/2003, official sampling shall consist in:

2.1.2.1. If sampling at the initiative of the operator takes place at the hatchery:

(a) routine sampling every 16 weeks at the hatchery, which shall on that occasion replace the corresponding

sampling at the initiative of the operator;

(b) routine sampling at the holding on two occasions during the production cycle, the first one being within
four weeks following moving to laying phase or laying unit and the second one being towards the end of the
laying phase, not earlier than eight weeks before the end of the production cycle;

(c) confirmatory sampling at the holding, following detection of relevant salmonella from sampling at the

hatchery.

2.1.2.2. If sampling at the initiative of the operator takes place at the holding, routine sampling shall be carried out on

three occasions during the production cycle:

(a) within four weeks following moving to laying phase or laying unit;

(b) towards the end of the laying phase, not earlier than eight weeks before the end of the production cycle;

(c) during the production, at any time sufficiently distant from the samples referred to in points (a) and (b).

2.2.

Sampling protocol

2.2.1.

S a m p l i n g a t

t h e h a t c h e r y

For each breeding flock, the sample shall consist of a minimum of one composite sample of visibly soiled
hatcher basket liners taken at random from five separate hatcher baskets or locations in the hatcher, to reach a
total of at least 1 m2. If the hatching eggs from a breeding flock occupy more than one incubator, then one such
composite sample shall be taken from each incubator.

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In cases where hatcher basket liners are not used, 10 g broken eggshells shall be taken from 25 separate hatcher
baskets, crushed, mixed and a 25 g sub sample taken.

That procedure shall be followed for sampling at the initiative of the operator as well as for official sampling.

2.2.2.

S a m p l i n g a t

t h e h o l d i n g

2.2.2.1. Routine sampling at the initiative of the operator

Sampling shall primarily consist of faecal samples and shall aim to detect a 1 % within flock prevalence, with
95 % confidence limit. To that effect, the samples shall comprise one of the following:

(a) Pooled faeces made up of separate samples of fresh faeces each weighing not less than 1 g taken at random
from a number of sites in the building in which the birds are kept, or where the birds have free access to
more than one building on a particular holding, from each group of buildings on the holding in which the
birds are kept. Faeces may be pooled for analysis up to a minimum of two pools.

The number of sites from which separate faeces samples are to be taken in order to make a pooled sample
shall be as follows:

Number of birds kept in a building

Number of faeces samples to be taken in the building or
group of buildings on the holding

250-349

350-449

450-799

800-999

1 000 or more

(b) Five pairs of boot swabs:

200

220

250

260

300

Boot swabs used shall be sufficiently absorptive to soak up moisture. Tubegauze ‘socks’ are also acceptable.

The surface of the boot swab shall be moistened using appropriate diluent (such as 0,8 % sodium chloride,
0,1 % peptone in sterile deionised water, or sterile water).

Walking around shall be done in a manner which will sample representatively all parts of the sector,
including littered and slatted areas when slats are safe to walk on. All separate pens within a house shall
be included in the sampling. On completion of sampling in the chosen sector, boot swabs must be removed
carefully so as not to dislodge adherent material.

The boot swabs may be pooled for analysis into a minimum of two pools.

(c)

In cage breeding flocks, sampling may consist of naturally mixed faeces from dropping belts, scrapers or
deep pits, depending on the type of house. Two samples of at least 150 g shall be collected to be tested
individually:

(i)

droppings belts beneath each tier of cages which are run regularly and discharged into an auger or
conveyor system;

(ii) droppings pit system in which deflectors beneath the cages are scraped into a deep pit beneath the

house;

(iii) droppings pit system in a step cage house when cages are offset and faeces fall directly into the pit.

There are normally several stacks of cages within a house. Pooled faeces from each stack shall be represented
in the overall pooled sample. Two pooled samples shall be taken from each flock as described below.

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In systems where there are belts or scrapers, these shall be run on the day of the sampling before sampling is
carried out.

In systems where there are deflectors beneath cages and scrapers, pooled faeces which has lodged on the
scraper after it has been run, shall be collected.

In step-cage systems where there is no belt or scraper system it is necessary to collect pooled faeces from the
deep pit.

Droppings belt systems: pooled faecal material from the discharge ends of the belts shall be collected.

2.2.2.2. Official sampling

(a) Routine sampling shall be as described in point 2.2.2.1.

(b) Confirmatory sampling following detection of relevant salmonella from sampling at the hatchery shall be

carried out as follows.

In addition to the sampling as described in point 2.2.2.1, the sampling may include a sample of birds taken
at random from within each house of birds on the farm, normally up to five birds per house, unless the
authority deems necessary to sample a higher number of birds. The examination shall consist in a test for
research of anti-microbials or of bacterial growth inhibitory effect in samples. A test is considered failed if a
positive is found in any of the birds.

In case the presence of relevant salmonella is not detected but anti-microbials or bacterial growth inhibitory
effect are, sampling of the flock for relevant salmonella and bacterial growth inhibitory effect shall be
repeated until no bacterial growth inhibitory effect is detected, or the breeding flock is destroyed. In the
latter case, the breeding flock shall be accounted for as an infected breeding flock for the purpose of the
Community target.

(c) Suspect cases

In exceptional cases where the competent authority has reasons to suspect false negative results at the first
official sampling at the holding, a secondary official confirmatory sampling may be performed, composed of
faeces or birds (for the detection of salmonella in organs).

In exceptional cases where the competent authority has reasons to suspect false positive sampling performed
at the initiative of the operator at the holding, follow-up official sampling may be performed.

3.

Examination of the samples

3.1.

Preparation of the samples

3.1.1. H a t c h e r b a s k e t

l i n e r s

(a) place in 1 litre Buffered Peptone Water (BPW) which has been been prewarmed at room temperature and

mix gently;

(b) continue culture of the sample by using the detection method in 3.2.

3.1.2.

B o o t s w a b s s a m p l e s

(a) carefully unpack the pair of boot swabs (or ‘socks’) to avoid dislodging adherent faecal material and place in

225 ml BPW which has been prewarmed to room temperature;

(b) where five pairs of boot swabs are pooled into two samples, place five individual samples into a minimum of

225 ml BPW and ensure that all the samples are totally immersed in the BPW;

(c) swirl to fully saturate the sample and continue culture by using the detection method in 3.2.

3.1.3. O t h e r f a e c a l m a t e r i a l s a m p l e s

(a) at the laboratory place each sample (or pooled sample as appropriate) into an equal weight of Buffered

Peptone Water and mix gently;

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(b) allow the sample to soften for 10-15 minutes then mix gently;

(c) immediately after mixing remove 50 g of the mixture and add to 200 ml of Buffered Peptone Water which

has been pre-warmed to room temperature;

(d) continue culture of the sample by using the detection method in 3.2.

3.2.

Detection method

The method recommended by the Community Reference Laboratory for Salmonella in Bilthoven, Netherlands,
shall be used: the method is a modification of ISO 6579 (2002), where a semi solid medium (MSRV) is used as
the single selective enrichment medium. The semi-solid medium should be incubated at 41,5 +/– 1 °C for 2 ×
(24 +/– 3) hours.

As regards the boot swabs samples and other faecal material samples referred to in paragraph 3.1., it is possible
to pool incubated BPW enrichment broth for future culture. To do that, incubate both samples in BPW as
normal. Take 1 ml of incubated broth from each sample and mix thoroughly then take 0,1 ml of the mixture
and inoculate the MSRV plates in the usual way.

3.3.

Serotyping

At least one isolate from each positive sample shall be typed, following the Kaufmann-White scheme.

4.

Results and reporting

A breeding flock shall be considered positive for the purpose of verifying the achievement of the Community
target, when presence of relevant salmonella (other than vaccine strains) was detected in one or more faecal
samples (or if there is a secondary official confirmation in the Member State, in the relevant faecal samples or
birds organ samples), taken at the holding. This shall not apply in exceptional cases of suspect breeding flocks
where salmonella detection at the holding at the initiative of the operator was not confirmed by official
sampling.

The cumulative results from sampling and testing in breeding flocks at holding level shall be accounted for, i.e.
each breeding flock shall be counted only once irrespective of the number of sampling and testing operations.
Positive breeding flocks shall be counted only once,
irrespective of the number of sampling and testing
operations.

Reporting shall include:

(a) detailed description of the options implemented for the sampling scheme and the type of samples taken, as

appropriate;

(b) number of existing breeding flocks and those tested;

(c) results of the testing;

(d) explanations on the results, in particular concerning exceptional cases.