EN    EN EN 
SANCO/2010/11010  
 
 
 
 
  
EN    EN  EUROPEAN COMMISSION  
 
  
Draft 
COMMISSION REGULATION (EU) No …/.. 
of […] 
amending Annex II to Regulation (EC) No 2160/2003 of the European Parliament and of 
the Council and Annex I to Regulation (EC) No 2073/2005 as regards Salmonella  in 
fresh poultry meat 
 
  
EN 2   EN Draft 
COMMISSION REGULATION (EU) No …/.. 
of […] 
amending Annex II to Regulation (EC) No 2160/2003 of the European Parliament and of 
the Council and Annex I to Regulation (EC) No 2073/2005 as regards Salmonella  in 
fresh poultry meat 
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(
1), and in particular Article 5(6) thereof, 
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(2), and in particular Article 4(4) 
thereof, 
Whereas: 
(1) Regulation (EC) No 2160/2003 ai ms at ensuring that proper and effective measures 
are taken to dete ct and control Salmonella  and other zoonotic ag ents at all relevant 
stages of production, processing and distribution in order to reduce it s prevalence and 
the risk it poses 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 rule s concerning trade within the Union and 
imports from third countries of certa in animals and products thereof.  
(2) Commission Regulation (EC) No 646/2007 of 12 June 2007 implementing 
Regulation (EC) No 2160/2003 of the Europe an Parliament and of the Council as 
regards a Community target for the reduction of the prevalence of Salmonella 
Enteritidis and Salmonella Typhimurium in broilers a nd repealing Regulation (EC) 
No 1091/2005(3) sets a Union target for the re duction of those two serotypes of 
Salmonella  in broilers. That Regul ation aims for a reductio n to be achieved in the 
number of flocks of broi lers remaining positive to Salmonella Enteritidis  and 
Salmonella Typhimurium to 1 % or less by 31 December 2011.  
                                                 
1  OJ L 325, 12.12.2003, p. 1. 
2  OJ L 139, 30.4.2004, p. 1. 
3  OJ L 182, 13.7.2005, p. 3.  
EN 3   EN (3) Commission Regulation (EC) No 584/2008 of 20 June 2008 implementing 
Regulation (EC) No 2160/2003 of the Europe an Parliament and of the Council as 
regards a Community target for the reduction of the prevalence of Salmonella  
Enteritidis and Salmonella  Typhimurium in turkeys(4) 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. 
(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 fr esh 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 a pplication 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(
5) 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.  
(7) In the interests of consistency of Union le gislation, 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 in Regulation (EC) No 2073/2005.  
(8) In accordance with Commission Decision 2005/636/EC of 1 September 2005 
concerning a financial contri bution of the Community towa rds a baseline survey on 
the prevalence of Salmonella  spp. in broiler flocks of Gallus gallus  to be carried out 
in the Member States(
6), 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(7) 
and Commission Decision 2007/516/EC of 19 July 2007 concer ning a financial 
contribution from the Community towa rds 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 carcasses to be 
carried out in the Member States(8) information was collected on the prevalence of 
                                                 
4  OJ L 162, 21.6.2008, p. 3. 
5  OJ L 338, 22.12.2005, p.1. 
6  OJ L 228, 3.9.2005, p. 14. 
7  OJ L 272, 3.10.2006, p. 22. 
8  OJ L 190, 21.7.2007, p. 25.  
EN 4   EN Salmonella  in broiler flocks, turk ey flocks and broiler carcases, respectively. The 
results of these surveys, as well as prelim inary results of the first year of national 
Salmonella  control programmes in broilers (2 009) in accordance with Art. 5 of 
Regulation 2160/2003 show that Salmonella  prevalence in floc ks of broilers and 
turkeys is still high(9). In addition, national Salmonella  control programmes in 
turkeys in accordance with Regulati on 2160/2003 only became ma ndatory 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.  
(9) According to the Community Summary Re port on trends and sources of zoonoses, 
and zoonotic agents and food-borne out breaks in the European Union in 2008(
10) by 
the European Food Safety Authority a pproximately 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. 
(10) Setting a criterion for Salmonella  Enteritidis and Salmonella  Typhimurium would 
provide the best balance be tween 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 poultr y production that ma y contribute to the 
reduction of all serotypes of Salmonella with public health si gnificance. Focusing on 
those two serotypes would also be consiste nt 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 b een demonstrated to be practical for 
use by food business operators and are ther efore also appropriate for fresh poultry 
meat sampling.  
(12) The international standard EN/ISO 6579 is th e horizontal method for the detection of 
Salmonella  spp. in food and animal feeding stuf fs. In addition, Annex I to Regulation 
(EC) 2073/2005 provides for that standard to be the reference method for all Salmonella  criteria. It should, theref ore, 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 is it 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(
11) 
                                                 
9  www.efsa.europa.eu. 
10  The EFSA Journal (2010); 8(1): 1496. 
11  The EFSA Journal (2010); 8(10): 1826.  
EN 5   EN 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 applic able also to these 
monophasic strains.  
(14) Regulation (EC) No 207 3/2005 lays down a proce ss hygiene criterion for Salmonella  
in poultry carcases of broilers and turk eys after chilling in slaughterhouses. The 
process hygiene criterion aims at control ling faecal contamina tion 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 Regulat ion (EC) No 646/2007, and for turkeys in 
Regulation (EC) No 584/2008, must be ach ieved 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) Regulation (EC) Nos 2160/2003 and 2073/2 005 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 se t out in Row 1.28 of Chapter 1 of Annex I to 
Regulation (EC) No 2073/2005.' 
 
Article 2 
Annex I to Regulation (EC) No 2073/2005 is ame nded in accordance with the Annex to this 
Regulation: 
Article 3 
This Regulation shall enter into force on the […] day following that of its publication in the 
Official Journal of the European Union .  
EN 6   EN It shall apply from 1 December 2011. 
This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels, x.x.2011. 
 For the Commission 
 The President  José Manuel BARROSO  
EN 7   EN  
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 foot notes 20 and 21 are 
added: 
 
'1.28 Fresh 
poultry meat (
20) Salmonella 
Typhimurium(21) 
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' 
'(20) This criterion shall apply to fr esh meat from breeding flocks of Gallus gallus, laying 
hens, broilers and breeding and fa ttening flocks of turkeys. 
(21) As regards monophasic Salmonella  Typhimurium only 1 ,4,[5],12:i:- is included.' 
 
(2) In Chapter 2, Row 2.1.5 and the corre sponding footnote 10 are replaced by the 
following: 
 
'2.1.5 
Poultry carcases of broilers and turkeys  Salmonella 
spp.(
10) 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' 
'(10) Where Salmonella  spp. is found, the isolates sh all 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.'  
(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  
  
EN 8   EN Sampling rules for carcases of cattle, pigs, sheep, goats and horses 
The destructive and non-destruc tive sampling methods, the selec tion of the sampling sites and 
the rules for storage and trans port of samples to be used are set out in standard ISO 17604. 
Five carcases shall be sampled at random dur ing each sampling session. Sample sites must be 
selected taking into account the slau ghter technology used in each plant.  
When sampling for analyses of Enterobacteria ceae 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 samp ling area shall cover a 
minimum of 400 cm².  
When samples are taken from the different samp ling 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 car cases with neck skin, if avai lable, 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 sampli ng 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 th e process hygiene criterion set ou t in Row 2.1.5 of Chapter 2 for 
Salmonella  in poultry carcases in sl aughterhouses, 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 othe r than poultry carcases, five samples 
of at least 25 g of the same batch shall be collected. The samp le 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 ta ken 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. 
  
EN 9   EN Guidelines for sampling 
More detailed guidelines on the sampling of car cases, in particular co ncerning the sampling 
sites, may be included in the guides to good pr actice 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 fo r Enterobacteriaceae and aerobic colony count 
analyses, the frequency may be reduced to fo rtnightly 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 re duced 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 re duced 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.'