# L_2006211EN.01000401.xml

| 1.8.2006 | EN | Official Journal of the European Union | L 211/4 |
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1.8.2006

EN

Official Journal of the European Union

L 211/4

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COMMISSION REGULATION (EC) No 1168/2006

of 31 July 2006

implementing Regulation (EC) No 2160/2003 as regards a Community target for the reduction of the prevalence of certain salmonella serotypes in laying hens of Gallus gallus and amending Regulation (EC) No 1003/2005

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to 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 (1) and, in particular Article 4(1) and Article 13 thereof,

Whereas:

| (1) | 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 distribution, particularly at the level of primary production, in order to reduce their prevalence and the risk they pose to public health. |
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(1)

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 distribution, particularly at the level of primary production, in order to reduce their prevalence and the risk they pose to public health.

| (2) | Regulation (EC) No 2160/2003 provides for a Community target is to be established for the reduction of the prevalence of all salmonella serotypes with public health significance in laying hens of Gallus gallus at the level of primary production. Such reduction is important in view of the strict measures which are to apply to infected flocks in accordance with that Regulation (EC) No 2160/2003 from December 2009 on. In particular, eggs originating from flocks with unknown salmonella status, that are suspected of being infected or from infected flocks may be used for human consumption only if treated in a manner that guarantees the elimination of salmonella serotypes with public health significance in accordance with Community legislation on food hygiene. |
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(2)

Regulation (EC) No 2160/2003 provides for a Community target is to be established for the reduction of the prevalence of all salmonella serotypes with public health significance in laying hens of Gallus gallus at the level of primary production. Such reduction is important in view of the strict measures which are to apply to infected flocks in accordance with that Regulation (EC) No 2160/2003 from December 2009 on. In particular, eggs originating from flocks with unknown salmonella status, that are suspected of being infected or from infected flocks may be used for human consumption only if treated in a manner that guarantees the elimination of salmonella serotypes with public health significance in accordance with Community legislation on food hygiene.

| (3) | Regulation (EC) No 2160/2003 provides that the Community target is to include a numerical expression of the maximum percentage of epidemiological units 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. |
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(3)

Regulation (EC) No 2160/2003 provides that the Community target is to include a numerical expression of the maximum percentage of epidemiological units 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.

| (4) | In order to set the Community target, comparable data on the prevalence of the concerned salmonella serotypes in laying hens of Gallus gallus in Member States have been collected in accordance with Commission Decision 2004/665/EC of 22 September 2004 concerning a baseline study on the prevalence of salmonella in laying flocks of Gallus gallus (2). |
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(4)

In order to set the Community target, comparable data on the prevalence of the concerned salmonella serotypes in laying hens of Gallus gallus in Member States have been collected in accordance with Commission Decision 2004/665/EC of 22 September 2004 concerning a baseline study on the prevalence of salmonella in laying flocks of Gallus gallus (2).

| (5) | Regulation (EC) No 2160/2003 provides that for a transitional period of three years, the Community target for laying hens of Gallus gallus is to cover Salmonella enteritidis and Salmonella typhimurium. |
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(5)

Regulation (EC) No 2160/2003 provides that for a transitional period of three years, the Community target for laying hens of Gallus gallus is to cover Salmonella enteritidis and Salmonella typhimurium.

| (6) | In order to verify achievement of the Community target, it is necessary to organise repeated sampling of flocks. |
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(6)

In order to verify achievement of the Community target, it is necessary to organise repeated sampling of flocks.

| (7) | In accordance with Article 15 of Regulation (EC) No 2160/2003, the European Food Safety Authority (EFSA) was consulted on the setting of the Community target for laying hens of Gallus gallus. |
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(7)

In accordance with Article 15 of Regulation (EC) No 2160/2003, the European Food Safety Authority (EFSA) was consulted on the setting of the Community target for laying hens of Gallus gallus.

| (8) | Since the adoption of 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, alternative analysis methods have been developed and validated. In addition salmonella strains detected in breeding flocks should be stored for future phagetyping and anti-microbial susceptibility testing. Therefore Regulation (EC) No 1003/2005 should be amended accordingly. |
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(8)

Since the adoption of 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, alternative analysis methods have been developed and validated. In addition salmonella strains detected in breeding flocks should be stored for future phagetyping and anti-microbial susceptibility testing. Therefore Regulation (EC) No 1003/2005 should be amended accordingly.

| (9) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
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(9)

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

HAS ADOPTED THIS REGULATION:

Article 1

Community target

1.   The Community target referred to in Article 4(1) of Regulation (EC) No 2160/2003 for the reduction of Salmonella enteritidis and Salmonella typhimurium in adult laying hens of Gallus gallus (Community target) shall be as follows:

| (a) | An annual minimum percentage of reduction of positive flocks of adult laying hens equal to at least:






  (i) | 10 % if the prevalence in the preceding year was less than 10 %; |
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(a)

An annual minimum percentage of reduction of positive flocks of adult laying hens equal to at least:

(i)

10 % if the prevalence in the preceding year was less than 10 %;

| (ii) | 20 % if the prevalence in the preceding year was between 10 and 19 %; |
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(ii)

20 % if the prevalence in the preceding year was between 10 and 19 %;

| (iii) | 30 % if the prevalence in the preceding year was between 20 and 39 %; |
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(iii)

30 % if the prevalence in the preceding year was between 20 and 39 %;

| (iv) | 40 % if the prevalence in the preceding year was 40 % or more; |
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(iv)

40 % if the prevalence in the preceding year was 40 % or more;

or;

| (b) | a reduction of the maximum percentage to 2 % or less; however, for Member States with less than 50 flocks of adult laying hens, not more than one adult flock may remain positive. |
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(b)

a reduction of the maximum percentage to 2 % or less; however, for Member States with less than 50 flocks of adult laying hens, not more than one adult flock may remain positive.

The first target should be achieved in 2008 based on the monitoring starting in the beginning of that year. With regard to the target in 2008, the results of the baseline study as carried out pursuant to Article 1(1) of Decision 2004/665/EC shall be used as reference referred to in this Article.

2.   The testing scheme to verify the progress on the achievement of the Community target is set out in the Annex.

The achievement shall be evaluated taking into account the results of three consecutive years.

When not described in the Annex, the technical specifications referred to in Article 5 of Commission Decision 2004/665/EC shall be considered as recommendations for the implementation of this point in the national control programmes.

3.   The Commission shall consider a review of the testing scheme in the Annex based on the experience gained during the first year of the control programme as referred to in Article 5(1) of Regulation (EC) No 2160/2003 (the national control programme).

Article 2

Amendment to Regulation (EC) No 1003/2005

In the Annex to Regulation (EC) No 1003/2005, the following points 3.4 and 3.5 are inserted:

‘3.4.   Alternative methods

With regard to samples taken at the initiative of the operator, the methods of analysis provided for in Article 11 of Regulation (EC) No 882/2004 (*1), may be used instead of the methods for the preparation of samples, detection methods and serotyping provided for in point 3 of this Annex, if validated in accordance with EN/ISO 16140/2003.

3.5.   Storage of strains

At least the strains isolated as part of the official controls, shall be stored for future phagetyping or anti-microbial susceptibility testing, using the normal methods for culture collection, which must ensure the integrity of the strains for a minimum period of two years.

Article 3

Entry into force

This Regulation shall enter into force on the third day following its publication in the Official Journal of the European Union.

Official Journal of the European Union

It shall apply from 1 August 2006.

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

Done at Brussels, 31 July 2006.

For the Commission

Markos KYPRIANOU

Member of the Commission

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(1)  
  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).

1

(2)  
  OJ L 303, 30.9.2004, p. 30.

2

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ANNEX

Testing scheme necessary to verify the achievement of the Community 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) referred to in Article 1 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 (operator) and by the competent authority.

Sampling at the initiative of the operator shall take place at least every fifteen weeks. The first sampling shall take place at the 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; |
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(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 salmonella was detected in the preceding flock; |
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(b)

at the age of 24 ± 2 weeks in laying flocks housed in buildings where salmonella was detected in the preceding flock;

| (c) | in any case of suspicion of Salmonella enteritidis or Salmonella typhimurium infection, as a result of the epidemiological investigation of food-borne outbreaks in accordance with Article 8 of Directive 2003/99/EC of the European Parliament and of the Council (1); |
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(c)

in any case of suspicion of Salmonella enteritidis or Salmonella typhimurium infection, as a result of the epidemiological investigation of food-borne outbreaks in accordance with Article 8 of Directive 2003/99/EC of the European Parliament and of the Council (1);

| (d) | in all other laying flocks on the holding in case Salmonella enteritidis or Salmonella typhimurium are detected in one laying flock on the holding; |
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(d)

in all other laying flocks on the holding in case Salmonella enteritidis or Salmonella typhimurium are detected in one laying flock on the holding;

| (e) | in cases where the competent authority considers it appropriate. |
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(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 operator.

2.2.   Sampling protocol

In order to maximise sensitivity of sampling, both faecal material and the environment shall be sampled at least as provided for in (a) and (b):

| (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. |
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(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 be taken, without changing overboots between boot swabs. |
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(b)

In barn or free-range houses, two pairs of boot swabs or socks be taken, without changing overboots between boot swabs.

In the case of sampling by the competent authority, 250 ml containing at least 100 gram of dust shall be collected from prolific sources of dust throughout the house. If there is not sufficient dust, an additional sample of 150 grams naturally pooled faeces or an additional pair of boot swabs or socks shall be taken.

In the case of sampling referred to in point 2.1(b), (c) and (d), the competent authority shall satisfy itself by conduction further tests as appropriate 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 effect are it shall be accounted for as an infected laying flock for the purpose of the Community target referred to in Article 1(2).

3.   EXAMINATION OF THE SAMPLES

3.1.   Transport and preparation of the samples

Samples shall be sent by express mail or courier to the laboratories referred to in Article 11 of Regulation (EC) No 2160/2003, on the day of collection. At the laboratory, samples shall be kept refrigerated until examination, which shall be carried out within 48 hours following receipt.

3.1.1.   Boot swab samples

| (a) | The two pairs of boot swabs (‘or socks’) shall be carefully unpacked to avoid dislodging adherent faecal material, pooled and placed in 225 ml Buffered Peptone Water (BPW) which has been pre-warmed to room temperature; |
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(a)

The two pairs of boot swabs (‘or socks’) shall be carefully unpacked to avoid dislodging adherent faecal material, pooled and placed in 225 ml Buffered Peptone Water (BPW) which has been pre-warmed to room temperature;

| (b) | The sample shall be swirled to fully saturate it and culture shall be continued by using the detection method in 3.2. |
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(b)

The sample shall be swirled to fully saturate it and culture shall be continued by using the detection method in 3.2.

3.1.2.   Other faecal material and dust samples

| (a) | The faeces samples shall be pooled and thoroughly mixed and a 25 gram sub-sample shall be collected for culture. |
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(a)

The faeces samples shall be pooled and thoroughly mixed and a 25 gram sub-sample shall be collected for culture.

| (b) | The 25 gram sub-sample shall be added to 225 ml of BPW which has been pre-warmed to room temperature. |
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(b)

The 25 gram sub-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 in 3.2. |
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(c)

Culture of the sample shall be continued by using the detection method in 3.2.

If ISO standards on the preparation of faeces for the detection of salmonella are agreed on, they shall be applied and replace the above provisions on sampling preparation.

3.2.   Detection method

The method recommended by the Community Reference Laboratory (CRL) for Salmonella in Bilthoven, the Netherlands, for detection 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, a semi-solid medium (modified semi-solid Rappaport-Vassiladis medium, MSRV) is used as the single selective enrichment medium.

3.3.   Serotyping

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

3.4.   Alternative methods

With regard to samples taken at the initiative of the operator, the methods of analysis provided for in Article 11 of Regulation (EC) No 882/2004 (2), may be used instead of the methods for the preparation of samples, detection methods and serotyping provided for in point 3 of this Annex, if validated in accordance with EN/ISO 16140/2003.

3.5.   Storage of strains

At least the strains isolated from samples collected by the competent authority, shall be stored for future phagetyping or anti-microbial susceptibility testing, using the normal methods for culture collection, which must ensure integrity of the strains for a minimum of two years.

4.   RESULTS AND REPORTING

A laying flock shall be considered positive for the purpose of verifying the achievement of the Community target, where the presence of Salmonella enteritidis and Salmonella typhimurium (other than vaccine strains) was detected in one or more samples in the laying flock. Positive laying flocks shall be counted only once, irrespective of the number of sampling and testing operations and only be reported in the first year of detection.

Reporting shall include:

| (a) | the total number of flocks of laying hens tested and the number of laying flocks tested for each status of sampling referred to in point 2.1; |
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(a)

the total number of flocks of laying hens tested and the number of laying flocks tested for each status of sampling referred to in point 2.1;

| (b) | the total number of infected flocks and the results of the testing for each status of sampling referred to in point 2.1; |
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(b)

the total number of infected flocks and the results of the testing for each status of sampling referred to in point 2.1;

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

explanations on the results, in particular concerning exceptional cases.

The results referred to in this point 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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(1)  
  OJ L 325, 12.12.2003, p. 31.

(2)  
  OJ L 191, 28.5.2004, p. 1.

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