Commission Regulation (EU) No 1086/2011
of 27 October 2011
amending Annex II to Regulation (EC) No 2160/2003 of the European Parliament and of the Council and Annex I to Commission Regulation (EC) No 2073/2005 as regards salmonella in fresh poultry meat
(Text with EEA relevance)

THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
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, and in particular Article 5(6) thereof,
OJ L 325, 12.12.2003, p. 1.
Having regard to Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs, and in particular Article 4(4) thereof,
OJ L 139, 30.4.2004, p. 1.
Whereas:
(1) Regulation (EC) No 2160/2003 aims at ensuring 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 in order to reduce their prevalence and the risk they pose to public health. That Regulation covers, amongst other things, the adoption of targets for the reduction of the prevalence of specified zoonoses in animal populations and the adoption of rules concerning trade within the Union and imports from third countries of certain animals and products thereof.
(2) Commission Regulation (EC) No 646/2007 of 12 June 2007 implementing Regulation (EC) No 2160/2003 of the European Parliament and of the Council as regards a Community target for the reduction of the prevalence of Salmonella enteritidis and Salmonella typhimurium in broilers and repealing Regulation (EC) No 1091/2005 sets a Union target for the reduction of those two serotypes of salmonella in broilers. That Regulation aims for a reduction to be achieved in the number of flocks of broilers remaining positive to Salmonella enteritidis and Salmonella typhimurium to 1 % or less by 31 December 2011.
OJ L 151, 13.6.2007, p. 21.
(3) Commission Regulation (EC) No 584/2008 of 20 June 2008 implementing Regulation (EC) No 2160/2003 of the European Parliament and of the Council as regards a Community target for the reduction of the prevalence of Salmonella enteritidis and Salmonella typhimurium in turkeys sets a Union target for the reduction of those two serotypes of salmonella in turkey flocks. That Regulation aims for a reduction to be achieved in the number of fattening turkey flocks remaining positive to Salmonella enteritidis and Salmonella typhimurium to 1 % or less by 31 December 2012.
OJ L 162, 21.6.2008, p. 3.
(4) Annex II to Regulation (EC) No 2160/2003 sets out specific measures to be taken for the control of the zoonoses and zoonotic agents listed in Annex I thereto. More specifically, point 1 of Part E of Annex II to Regulation (EC) No 2160/2003 provides that, as from 12 December 2010, certain fresh poultry meat from animals listed in Annex I thereto may not be placed on the market for human consumption unless it meets the criterion: ‘Salmonella: absence in 25 grams’. That Regulation also provides for detailed rules for that criterion to be laid down, in particular, rules specifying sampling schemes and analytical methods.
(5) As regards fresh poultry meat, provision should be made to ensure that the detailed rules for the salmonella criterion in poultry meat result in a reasonable assurance that it is free from the relevant salmonella and that a harmonised application results in fair competition and similar conditions for placing on the market.
(6) Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs lays down microbiological criteria for certain micro-organisms and the implementing rules that are to be complied with by food business operators when implementing the general and specific hygiene measures referred to in Article 4 of Regulation (EC) No 852/2004.
OJ L 338, 22.12.2005, p. 1.
(7) In the interests of consistency of Union legislation, it is appropriate to amend the specific requirements concerning fresh poultry meat set out in Part E of Annex II to Regulation (EC) No 2160/2003 and to introduce detailed rules of the salmonella criterion in Annex I to Regulation (EC) No 2073/2005.
(8) In accordance with Commission Decision 2005/636/EC of 1 September 2005 concerning a financial contribution of the Community towards a baseline survey on the prevalence of Salmonella spp. in broiler flocks of Gallus gallus to be carried out in the Member States, Commission Decision 2006/662/EC of 29 September 2006 concerning a financial contribution from the Community towards a baseline survey on the prevalence of salmonella in turkeys to be carried out in the Member States and Commission Decision 2007/516/EC of 19 July 2007 concerning a financial contribution from the Community towards a survey on the prevalence and antimicrobial resistance of Campylobacter spp. in broiler flocks and on the prevalence of Campylobacter spp. and Salmonella spp. in broiler carcases to be carried out in the Member States information was collected on the prevalence of salmonella in broiler flocks, turkey flocks and broiler carcases, respectively. The results of these surveys, as well as preliminary results of the first year of national salmonella control programmes in broilers (2009) in accordance with Article 5 of Regulation (EC) No 2160/2003 show that salmonella prevalence in flocks of broilers and turkeys is still high. In addition, national salmonella control programmes in turkeys in accordance with Regulation (EC) No 2160/2003 only became mandatory from 2010 onwards. The application of the criterion to all salmonella serotypes before a notable reduction of the prevalence of salmonella in flocks of broilers and turkeys has been demonstrated may result in a disproportionate economic impact for the industry. Chapter 1 of Annex I to Regulation (EC) No 2073/2005 should therefore be amended.
OJ L 228, 3.9.2005, p. 14.
OJ L 272, 3.10.2006, p. 22.
OJ L 190, 21.7.2007, p. 25.
www.efsa.europa.eu
(9) According to the Community Summary Report on trends and sources of zoonoses, and zoonotic agents and food-borne outbreaks in the European Union in 2008 by the European Food Safety Authority approximately 80 % of human salmonellosis cases are caused by Salmonella enteritidis and Salmonella typhimurium which is similar to preceding years. Poultry meat remains a major source of human salmonellosis.
EFSA Journal (2010); 8(1): 1496.
(10) Setting a criterion for Salmonella enteritidis and Salmonella typhimurium would provide the best balance between reducing human salmonellosis attributed to the consumption of poultry meat and the economic consequences of the application of that criterion. At the same time, it would encourage food business operators to take measures at previous stages of poultry production that may contribute to the reduction of all serotypes of salmonella with public health significance. Focusing on those two serotypes would also be consistent with the Union targets set for primary production of poultry.
(11) The sampling plans for other salmonella food safety criteria have been provided for in Regulation (EC) No 2073/2005. They have been demonstrated to be practical for use by food business operators and are therefore also appropriate for fresh poultry meat sampling.
(12) The international standard EN/ISO 6579 is the horizontal method for the detection of Salmonella spp. in food and animal feeding stuffs. In addition, Annex I to Regulation (EC) No 2073/2005 provides for that standard to be the reference method for all salmonella criteria. It should, therefore, also be laid down as a reference method for the criterion for fresh poultry meat, without prejudice to provisions on the use of alternative methods laid down in that Regulation. The European Union Reference Laboratory for Salmonella recommends that it is appropriate to use the White-Kaufmann-Le Minor scheme as reference method for serotyping.
(13) Monophasic strains of Salmonella typhimurium have rapidly emerged as one of the most commonly found serotype of salmonella in several species of animals and in clinical isolates from humans. According to the Scientific Opinion on monitoring and assessment of the public health risk of ‘Salmonella typhimurium-like’ strains monophasic Salmonella typhimurium strains with the antigenic formula 1 ,4,[5],12:i:- are considered as variants of Salmonella typhimurium and current evidence has shown that these strains appear to pose a public health risk comparable to that of other Salmonella typhimurium strains. Therefore, it is appropriate to clarify that provisions for Salmonella typhimurium are applicable also to these monophasic strains.
EFSA Journal (2010); 8(10): 1826.
Substituted by Corrigendum to Commission Regulation (EU) No 1086/2011 of 27 October 2011 amending Annex II to Regulation (EC) No 2160/2003 of the European Parliament and of the Council and Annex I to Commission Regulation (EC) No 2073/2005 as regards salmonella in fresh poultry meat (Official Journal of the European Union L 281 of 28 October 2011).
(14) Regulation (EC) No 2073/2005 lays down a process hygiene criterion for salmonella in poultry carcases of broilers and turkeys after chilling in slaughterhouses. The process hygiene criterion aims at controlling faecal contamination of poultry carcases if derived from infected flocks or due to cross-contamination in the slaughterhouse. Under Article 10 of Regulation (EC) No 2073/2005, the criteria and conditions concerning the presence of salmonella in poultry carcases are to be revised in the light of the changes observed in salmonella prevalence. Since the Union targets laid down for flocks of broilers in Regulation (EC) No 646/2007, and for turkeys in Regulation (EC) No 584/2008, must be achieved by the end of 2011 and the end of 2012 respectively, the number of sample units accepted to exceed the set limit should be decreased. Chapter 2 of Annex I to Regulation (EC) No 2073/2005 should therefore be amended accordingly.
(15) Regulations (EC) No 2160/2003 and (EC) No 2073/2005 should therefore be amended accordingly.
(16) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health and neither the European Parliament nor the Council has opposed them,
HAS ADOPTED THIS REGULATION:

Article 1 In Annex II to Regulation (EC) No 2160/2003, point 1 of Part E is replaced by the following:

‘1. From 1 December 2011, fresh poultry meat from animal populations listed in Annex I shall meet the relevant microbiological criterion set out in Row 1.28 of Chapter 1 of Annex I to Commission Regulation (EC) No 2073/2005.
OJ L 338, 22.12.2005, p. 1.’.’.

Article 2 Annex I to Regulation (EC) No 2073/2005 is amended in accordance with the Annex to this Regulation:
Article 3 This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
It shall apply from 1 December 2011.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX Annex I to Regulation (EC) No 2073/2005 is amended as follows:
(1) in Chapter 1, the following Row 1.28 and the corresponding footnotes 20 and 21 are added:

‘1.28 Fresh poultry meat This criterion shall apply to fresh meat from breeding flocks of Gallus gallus, laying hens, broilers and breeding and fattening flocks of turkeys.	Salmonella typhimurium As regards monophasic Salmonella typhimurium only 1 ,4,[5],12:i:- is included.’ Salmonella enteritidis	5	0	Absence in 25 g	EN/ISO 6579 (for detection) White-Kaufmann-Le Minor scheme (for serotyping)	Products placed on the market during their shelf-life

(2) in Chapter 2, Row 2.1.5 is replaced by the following and the corresponding footnote 10 is added:

‘2.1.5 Poultry carcases of broilers and turkeys	Salmonella spp. Where Salmonella spp. is found, the isolates shall be further serotyped for Salmonella typhimurium and Salmonella enteritidis in order to verify compliance with the microbiological criterion set out in Row 1.28 of Chapter 1.’	50 (5)	7 (6) From 1.1.2012 c = 5 for broilers From 1.1.2013 c = 5 for turkeys	Absence in 25 g of a pooled sample of neck skin	EN/ISO 6579 (for detection)	Carcases after chilling	Improvement in slaughter hygiene and review of process controls, origin of animals and biosecurity measures in the farms of origin

(3) in Chapter 3, Section 3.2 is replaced by the following:

‘3.2. Bacteriological sampling in slaughterhouses and at premises producing minced meat, meat preparations, mechanically separated meat and fresh meat

Sampling rules for carcases of cattle, pigs, sheep, goats and horses
The destructive and non-destructive sampling methods, the selection of the sampling sites and the rules for storage and transport of samples to be used are set out in standard ISO 17604.
Five carcases shall be sampled at random during each sampling session. Sample sites must be selected taking into account the slaughter technology used in each plant.
When sampling for analyses of Enterobacteriaceae and aerobic colony counts, four sites of each carcase shall be sampled. Four tissue samples representing a total of 20 cm2 shall be obtained by the destructive method. When using the non-destructive method for this purpose, the sampling area shall cover a minimum of 100 cm2 (50 cm2 for small ruminant carcases) per sampling site.
When sampling for salmonella analyses, an abrasive sponge sampling method shall be used. Areas most likely to be contaminated shall be selected. The total sampling area shall cover a minimum of 400 cm2.
When samples are taken from the different sampling sites on the carcase, they shall be pooled before examination.

Sampling rules for poultry carcases and fresh poultry meat
Slaughterhouses shall sample whole poultry carcases with neck skin for salmonella analyses. Other establishments processing fresh poultry meat shall take samples for salmonella analysis giving priority to whole poultry carcases with neck skin, if available, but ensuring that also chicken portions with skin and/or chicken portions without skin or with only a small amount of skin are covered, and that choice shall be risk-based.
Slaughterhouses shall include in their sampling plans poultry carcases from flocks with an unknown salmonella status or with a status known to be positive for Salmonella enteritidis or Salmonella typhimurium.
When testing against the process hygiene criterion set out in Row 2.1.5 of Chapter 2 for salmonella in poultry carcases in slaughterhouses, neck skins from a minimum of 15 poultry carcases shall be sampled at random after chilling during each sampling session. A piece of approximately 10 g from neck skin shall be obtained from each poultry carcase. On each occasion the neck skin samples from three poultry carcases from the same flock of origin shall be pooled before examination in order to form 5 x 25 g final samples. These samples shall also be used to verify the compliance with the food safety criterion set out in Row 1.28 of Chapter 1.
For the salmonella analyses for fresh poultry meat other than poultry carcases, five samples of at least 25 g of the same batch shall be collected. The sample taken from chicken portions with skin shall contain skin and a thin surface muscle slice in case the amount of skin is not sufficient to form a sample unit. The sample taken from chicken portions without skin or with only a small amount of skin shall contain a thin surface muscle slice or slices added to any skin present to make a sufficient sample unit. The slices of meat shall be taken in a way that includes as much as possible of the surface of the meat.

Guidelines for sampling
More detailed guidelines on the sampling of carcases, in particular concerning the sampling sites, may be included in the guides to good practice referred to in Article 7 of Regulation (EC) No 852/2004.

Sampling frequencies for carcases, minced meat, meat preparations, mechanically separated meat and fresh poultry meat
The food business operators of slaughterhouses or establishments producing minced meat, meat preparations, mechanically separated meat or fresh poultry meat shall take samples for microbiological analysis at least once a week. The day of sampling shall be changed each week to ensure that each day of the week is covered.
As regards the sampling of minced meat and meat preparations for E. coli and aerobic colony count analyses and the sampling of carcases for Enterobacteriaceae and aerobic colony count analyses, the frequency may be reduced to fortnightly testing if satisfactory results are obtained for six consecutive weeks.
In the case of sampling for salmonella analyses of minced meat, meat preparations, carcases and fresh poultry meat, the frequency may be reduced to fortnightly if satisfactory results have been obtained for 30 consecutive weeks. The salmonella sampling frequency may also be reduced if there is a national or regional salmonella control programme in place and if this programme includes testing that replaces the sampling laid down in this paragraph. The sampling frequency may be further reduced if the national or regional salmonella control programme demonstrates that the salmonella prevalence is low in animals purchased by the slaughterhouse.
However, when justified on the basis of a risk analysis and consequently authorised by the competent authority, small slaughterhouses and establishments producing minced meat, meat preparations and fresh poultry meat in small quantities may be exempted from these sampling frequencies.’