COMMISSION REGULATION (EU) No 209/2013  
of 11 March 2013  
amending Regulation (EC) No 2073/2005 as regards microbiological criteria for sprouts and the 
sampling rules for poultry carcases and 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 852/2004 of the European 
Parliament and of the Council of 29 April 2004 on the hygiene 
of foodstuffs (  1 ), and in particular Article 4(4) thereof,  
Whereas:  
(1) Regulation (EC) No 852/2004 lays down general rules 
for food business operators on the hygiene of foodstuffs, 
taking particular account of procedures based on the 
application of hazard analysis and critical control point 
(HACCP) principles. Article 4 of that Regulation provides 
that food business operators are to adopt specific hygiene 
measures concerning, inter alia, compliance with 
microbiological criteria for foodstuffs and sampling and 
analysis requirements.  
(2) Commission Regulation (EC) No 2073/2005 of 
15 November 2005 on microbiological criteria for food ­
stuffs (  2 ) lays down microbiological criteria for certain 
micro-organisms and the implementing rules to be 
complied with by food business operators when imple ­
menting the general and specific hygiene measures 
referred to in Article 4 of Regulation (EC) No 852/2004.  
(3) Chapter 1 of Annex I to Regulation (EC) No 2073/2005 
sets out the food safety criteria to be complied with by 
certain food categories, including sampling plans, 
analytical reference methods and limits for micro- 
organisms or their toxins and metabolites. That Chapter 
lists the food safety criteria for sprouted seeds, as regards 
Salmonella.  
(4) Following the outbreak of Shiga toxin-producing  E. coli  
(STEC) in May 2011 in the Union, consumption of 
sprouts was identified as the most likely origin of the 
outbreaks.  (5) On 20 October 2011 the European Food Safety 
Authority (‘EFSA’) adopted a Scientific Opinion on the 
risk posed by Shiga toxin-producing  Escherichia coli  and 
other pathogenic bacteria in seeds and sprouted seeds (  3 ). 
In its Opinion, EFSA concludes that the contamination of 
dry seeds with bacterial pathogens is the most likely 
initial source of the sprout-associated outbreaks. In 
addition, the Opinion states that, due to the high 
humidity and the favourable temperature during 
sprouting, bacterial pathogens present on dry seeds can 
multiply during sprouting and result in a public health 
risk.  
(6) In its Opinion, EFSA recommends, inter alia, that 
microbiological criteria should be strengthened as one 
of the components of a food safety management 
system for the sprouted seeds production chain. That 
recommendation concerns the existing microbiological 
criteria on  Salmonella  for sprouted seeds and the 
consideration of microbiological criteria on other 
pathogens. EFSA also states that available data indicates 
a higher risk for sprouts in comparison with other 
sprouted seeds.  
(7) In its Opinion, EFSA considers different options for 
microbiological criteria for pathogenic  E. coli  for seeds: 
before the start of the production process, during 
sprouting and in the final product. In that context, 
EFSA states that the detection and mitigation of a 
contamination problem earlier in the sprouted seed 
production chain may have advantages as it avoids 
contamination being amplified during the full sprouting 
process. It also acknowledges that testing seeds alone 
does not allow for the detection of contamination 
which may come at a later stage in the production 
process. EFSA therefore concludes that microbiological 
criteria could be useful during the sprouting process 
and/or for the final product. When considering a 
microbiological criterion for the final sprouted seeds, 
EFSA notes that the time required for the detection 
methods for pathogenic bacteria combined with the 
short shelf-life may not allow withdrawing the product 
in the event of non-compliance. In its opinion EFSA 
considers that it is currently not possible to evaluate 
the extent of public health protection provided by 
specific microbiological criteria for seeds and sprouted 
seeds. This highlights the need for data collection to 
conduct quantitative risk assessment. Therefore this 
criterion should be reviewed taking into account 
progress in science, technology and methodology, 
emerging pathogenic micro-organisms in foodstuffs and 
information from risk assessment.EN 12.3.2013 Official Journal of the European Union L 68/19  
( 1 ) OJ L 139, 30.4.2004, p. 1.  
( 2 ) OJ L 338, 22.12.2005, p. 1.  (  3 ) EFSA Journal 2011 ; 9(11):2424.(8) In order to ensure the protection of public health in the 
Union and in view of that EFSA Opinion, Commission 
Regulation (EU) No 211/2013 of 11 March 2013 on 
certification requirements for imports into the Union of 
sprouts and seeds intended for the production of 
sprouts (  1 ) and Commission Implementing Regulation 
(EU) No 208/2013 of 11 March 2013 on traceability 
requirements for sprouts and seeds intended for the 
production of sprouts (  2 ) were adopted.  
(9) In addition to the measures laid down in those acts and 
considering the potential major health risk posed by the 
possible presence of pathogens in sprouts, provisions on 
additional microbiological criteria should be laid down 
following the EFSA recommendations, in particular on 
STEC serogroups which are considered of most 
important public health concern.  
(10) Microbiological criteria are one of several control options 
in food safety and should be used by food business 
operators as a means to verify implementation of an 
effective food safety management system. However, due 
to the low prevalence and the heterogeneous distribution 
of some pathogens in seeds and sprouted seeds, the stat ­
istical limitations of sampling plans, and the lack of 
information about the application of good agricultural 
practices in the production of seeds, it is necessary to 
test all batches of seeds for the presence of the pathogens 
in cases where food business operators have not put in 
place food safety management systems including steps 
that reduce the microbiological risk. If food management 
systems are in place and if their effectiveness is 
confirmed by historical data, a reduction of sampling 
frequency may be considered. Such frequency should, 
however, never be less than once per month.  
(11) When laying down microbiological criteria for sprouts, 
flexibility should be provided with regard to the stages of 
sampling and the type of samples which are to be taken, 
in order to take into account the diversity of production 
systems, while maintaining equivalent food safety stan ­
dards. In particular, it is appropriate to provide for alter ­
natives to the sampling of sprouts in cases where the 
sampling is technically difficult. The testing of spent irri ­
gation water for pathogenic bacteria has been proposed 
as an alternative strategy, as it seems to be a good 
indicator of the types of micro-organisms in the 
sprouts themselves. Due to the uncertainties regarding 
the sensitivity of this strategy, it is needed that food 
businesses operators using this alternative establish a 
sampling plan, including sampling procedures and 
sampling points of the spent irrigation water.  
(12) Certain STEC serogroups (namely O157, O26, O103, 
O111, O145 and O104:H4) are recognised to be those causing the most of the Haemolytic Uremic Syndrome 
(HUS) cases occurring in the EU. Furthermore serotype 
O104:H4 caused the outbreak in May 2011 in the 
Union. Therefore microbiological criteria should be 
considered for these six serogroups. It cannot be 
excluded that other STEC serogroups may be pathogenic 
to humans as well. In fact, such STEC may cause less 
severe forms of disease such as diarrhoea and or bloody 
diarrhoea or may also cause HUS and therefore represent 
a hazard for the consumer’s health.  
(13) Sprouts should be considered to be ready-to-eat food, as 
they can be consumed without the need for cooking or 
other processing, which would otherwise be effective in 
eliminating or reducing to an acceptable level pathogenic 
micro-organisms. Food business operators producing 
sprouts should therefore comply with the food safety 
criteria for ready-to-eat food laid down in Union legis ­
lation, including the sampling of processing areas and 
equipment as part of their sampling scheme.  
(14) 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 (  3 ) 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.  
(15) Regulation (EC) No 2160/2003, as amended by 
Commission Regulation (EU) No 1086/2011 (  4 ), lays 
down detailed rules on a  Salmonella  food safety 
criterion for fresh poultry meat. As a consequence of 
the amendments made to Regulation (EC) No 
2160/2003, Regulation (EC) No 2073/2005 was also 
amended by Regulation (EU) No 1086/2011. However, 
by that amendment, certain terminological ambiguities 
were introduced in the text of Regulation (EC) No 
2073/2005. Those ambiguities should, in the interest 
of clarity and consistency of Union legislation, be 
clarified.  
(16) Regulation (EC) No 2073/2005 should therefore be 
amended accordingly.  
(17) The measures provided for in this Regulation are in 
accordance with the opinion of the of the Standing 
Committee on the Food Chain and Animal Health and 
neither the European Parliament nor the Council has 
opposed them,EN L 68/20 Official Journal of the European Union 12.3.2013  
( 1 ) See page 26 of this Official Journal.  
( 2 ) See page 16 of this Official Journal.  ( 3 ) OJ L 325, 12.12.2003, p. 1.  
( 4 ) OJ L 281, 28.10.2011, p. 7.HAS ADOPTED THIS REGULATION:  
Article 1  
Regulation (EC) No 2073/2005 is amended as follows:  
(1) In Article 2, the following point (m) is added:  
‘(m) the definition of “sprouts” in Article 2(a) of Commission Implementing Regulation (EU) 
No 208/2013 of 11 March 2013 on traceability requirements for sprouts and seeds intended 
for the production of sprouts (*);  
___________  
(*) See page 16 of this Official Journal.’;  
(2) Annex I is amended in accordance with the Annex to this Regulation.  
Article 2  
This Regulation shall enter into force on the twentieth day following that of its publication in the  Official 
Journal of the European Union . 
It shall apply from 1 July 2013.  
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels, 11 March 2013.  
For the Commission  
The President  
José Manuel BARROSOEN 12.3.2013 Official Journal of the European Union L 68/21ANNEX  
Annex I to Regulation (EC) No 2073/2005 is amended as follows:  
(1) Chapter 1 is amended as follows:  
(a) footnote 12 is deleted;  
(b) in row 1.18 the reference to footnote 12 is replaced by the reference to footnote 23;  
(c) the following row 1.29 and the corresponding footnotes 22 and 23 are added: 
‘1.29 Sprouts (  23 ) Shiga toxin producing  E. coli  
(STEC) O157, O26, O111, 
O103, O145 and O104:H4  5 0  Absence in 
25 grams  CEN/ISO TS 
13136 (  22 ) Products placed on 
the market during 
their shelf-life  
( 22 ) Taking into account the most recent adaptation by the European Union reference laboratory for  Escherichia coli , including 
Verotoxigenic  E. coli  (VTEC), for the detection of STEC O104:H4. 
( 23 ) Excluding sprouts that have received a treatment effective to eliminate  Salmonella  spp. and STEC.’;  
(2) Chapter 3 is amended as follows:  
(a) in Section 3.2, the part concerning ‘Sampling rules for poultry carcases and fresh poultry meat’ is amended as 
follows:  
(i) the first paragraph is replaced by the following:  
‘Slaughterhouses shall sample whole poultry carcases with neck skin for  Salmonella  analyses. Cutting and 
processing establishments other than those adjacent to a slaughterhouse cutting and processing meat received 
only from this slaughterhouse, shall also take samples for  Salmonella  analysis. When doing so, they shall give 
priority to whole poultry carcases with neck skin, if available, but ensuring that also poultry portions with 
skin and/or poultry portions without skin or with only a small amount of skin are covered, and that choice 
shall be risk-based.’;  
(ii) the fourth paragraph is replaced by the following:  
‘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 poultry 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 poultry 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.’;  
(b) the following Section 3.3 is added:  
‘3.3.  Sampling rules for sprouts  
For the purposes of this Section, the definition of batch in Article 2(b) of Implementing Regulation (EU) 
No 208/2013 will apply.  
A. G e n e r a l r u l e s f o r s a m p l i n g a n d t e s t i n g  
1. Preliminary testing of the batch of seeds  
Food business operators producing sprouts shall carry out a preliminary testing of a representative sample of 
all batches of seeds. A representative sample shall include at least 0,5 % of the weight of the batch of seeds in 
sub samples of 50 g or be selected based on a structured statistically equivalent sampling strategy verified by 
the competent authority.  
For the purposes of performing the preliminary testing, the food business operator must sprout the seeds in 
the representative sample under the same conditions as the rest of the batch of seeds to be sprouted.  
2. Sampling and testing of the sprouts and the spent irrigation water  
Food business operators producing sprouts shall take samples for microbiological testing at the stage where the 
probability of finding Shiga toxin producing  E. coli  (STEC) and  Salmonella  spp. is the highest, in any case not 
before 48 hours after the start of the sprouting process.  
Samples of sprouts shall be analysed according to the requirements in rows 1.18 and 1.29 of Chapter 1.EN L 68/22 Official Journal of the European Union 12.3.2013However, if a food business operator producing sprouts has a sampling plan, including sampling procedures 
and sampling points of the spent irrigation water, they may replace the sampling requirement under the 
sampling plans set out in rows 1.18 and 1.29 of Chapter 1 with the analysis of 5 samples of 200 ml of the 
water that was used for the irrigation of the sprouts.  
In that case requirements set out in rows 1.18 and 1.29 of Chapter 1 shall apply to the analysis of the water 
that was used for the irrigation of the sprouts, with the limit of absence in 200 ml.  
When testing a batch of seeds for the first time, food business operators may only place sprouts on the market 
if the results of the microbiological analysis comply with rows 1.18 and 1.29 of Chapter 1, or the limit of 
absence in 200 ml if they analyse spent irrigation water.  
3. Sampling frequency  
Food business operators producing sprouts shall take samples for microbiological analysis at least once a 
month at the stage where the probability of finding Shiga toxin producing  E. coli  (STEC) and  Salmonella  spp. is 
the highest, in any case not before 48 hours after the start of the sprouting process.  
B. D e r o g a t i o n f r o m t h e p r e l i m i n a r y t e s t i n g o f a l l b a t c h e s o f s e e d s s e t o u t i n 
p o i n t A . 1 o f t h i s S e c t i o n  
When justified on the basis of the following conditions and authorised by the competent authority, food business 
operators producing sprouts may be exempted from the sampling set out in point A.1 of this Section:  
(a) the competent authority is satisfied that the food business operator implements a food safety management 
system in that establishment, which may include steps in the production process, which reduces the microbi ­
ological risk; and,  
(b) historical data confirms that during at least 6 consecutive months prior to granting the authorisation, all 
batches of the different types of sprouts produced in the establishment comply with the food safety criteria set 
out in rows 1.18 and 1.29 of Chapter 1.’EN 12.3.2013 Official Journal of the European Union L 68/23