1.7.2005   

EN

Official Journal of the European Union

L 170/12

(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)

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

(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)

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

(5)

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

(6)

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 salmonella 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 appropriate period of time in all Member States in the year 2004.

(7)

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 the Community, it is necessary to organise repeated 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.

(8)

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 to Directive 92/117/EEC. It is 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.

(9)

Due to that period of collection of information, 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.

(10)

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 transitional 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 group with the participation of the European Food Safety Authority (EFSA). Without 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.

(11)

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

(a)

at the hatchery; or

(b)

at the holding.

(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.

(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).

(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:

(b)

Five pairs of boot swabs:

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:

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.

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.

(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.

(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.

(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.

(a)

at the laboratory place each sample (or pooled sample as appropriate) into an equal weight of Buffered Peptone Water and mix gently;

(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.

(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.