HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"EN
6.4.2011 Official
Journal
of
the
European
Union L
90/27
DECISIONS
COMMISSION DECISION
of 1 April 2011
amending Annexes II to IV to Council Directive 2009/158/EC on animal health conditions
governing intra-Community trade in, and imports from third countries of, poultry and hatching
eggs
(notified under document C(2011) 2068)
(Text with EEA relevance)
(2011/214/EU)
THE EUROPEAN COMMISSION,
for Animal Health and changes to the nomenclature of
Salmonella according to the Collaborating Centre of the
World Health Organisation for Reference and Research
Having regard to the Treaty on the Functioning of the European
on Salmonella in the White-Kauffmann-Le Minor Scheme
Union,
for Antigenic Formulae of the Salmonella serovars of
2007 and in line with Chapter 2.3.11 of the Manual
of Diagnostic Tests and Vaccines of the World Organi
Having regard to Council Directive 2009/158/EC of
sation for Animal Health.
30 November 2009 on animal health conditions governing
intra-Community trade in, and imports from third countries
of, poultry and hatching eggs ( 1 ), and in particular Article 34
thereof,
(4) Annex
III
to
Directive
2009/158/EC
sets
out
poultry
vaccination conditions. It should be amended in order
to include specific conditions for vaccination against
Whereas:
Salmonella.
(1) Directive
2009/158/EC
lays
down
animal
health
conditions governing intra-Union trade in, and imports
(5) It
is
also
necessary
to
amend
certain
references
in
relation
from third countries of, poultry and hatching eggs.
to vaccination against avian influenza in the model
Annex II thereto sets out the rules for the approval of
veterinary certificates set out in Annex IV to Directive
establishments for the purposes of intra-Union trade in
2009/158/EC.
those commodities. Chapters II, III and IV of that Annex
set out the conditions for facilities and operation of
establishments, disease surveillance programmes and the
criteria for suspending or withdrawing approval of an
(6) Regulation
(EC)
No
2160/2003
of
the
European
establishment, which include testing for certain micro-
Parliament and of the Council of 17 November 2003
organisms, Salmonella and Mycoplasma, that have to be
on the control of salmonella and other specified food-
carried out in establishments approved for trade within
borne zoonotic agents ( 2 ) lays down rules to ensure that
the Union.
proper and effective measures are taken to detect and
control salmonella and other zoonotic agents. It
provides that the flocks and herds of origin of certain
(2) Experience
gained
in
implementing
the
conditions
for
species listed in Annex I to that Regulation are to be
facilities and operation of establishments set out in
tested for certain specified zoonoses and zoonotic
Chapter II of Annex II to Directive 2009/158/EC show
agents prior to any dispatch of live animals or
that it is appropriate to adapt them to current practices
hatching eggs from the food business of origin. The
in the industry, in particular with respect to the laying
date and the results of testing are to be included in the
behaviour of different poultry species.
relevant veterinary certificates provided for in Union
legislation, including Directive 2009/158/EC.
(3) In
addition,
Chapters
III
and
IV
of
Annex
II
to
Directive
2009/158/EC should be amended to take account of
scientific progress made in diagnostic techniques for
(7) Annex
IV
to
Directive
2009/158/EC
sets
out
model
Mycoplasma in line with Chapter 2.3.5 of the Manual of
veterinary certificates for intra-Union trade in poultry
Diagnostic Tests and Vaccines of the World Organisation
and hatching eggs.
( 1 ) OJ L 343, 22.12.2009, p. 74.
( 2 ) OJ L 325, 12.12.2003, p. 1.

---

L 90/28
EN
Official Journal of the European Union
6.4.2011
(8) Commission
Regulation
(EC)
No
584/2008
of
20
June HAS ADOPTED THIS DECISION:
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
Article 1
Salmonella enteritidis and Salmonella typhimurium in
Annexes II, III and IV to Directive 2009/158/EC are amended in
turkeys ( 1 ) lays down that testing requirements also
accordance with the Annex to this Decision.
apply to turkey flocks from 1 January 2010 and the
respective veterinary certificates set out in Annex IV to
Directive 2009/158/EC should therefore be amended
Article 2
accordingly.
This Decision is addressed to the Member States.
(9) Annexes
II,
III
and
IV
to
Directive
2009/158/EC
should
therefore be amended accordingly.
Done at Brussels, 1 April 2011.
For the Commission
(10) The
measures provided for in this Decision are in
accordance with the opinion of the Standing
John DALLI
Committee on the Food Chain and Animal Health,
Member of the Commission
( 1 ) OJ L 162, 21.6.2008, p. 3.

---

EN
6.4.2011 Official
Journal
of
the
European
Union L
90/29
ANNEX
Annexes II, III and IV to Directive 2009/158/EC are amended as follows:
1. Annex II is amended as follows:
(a) Chapter II is amended as follows:
(i) in Section A, point 2(e) is replaced by the following:
‘(e) Eggs must be:
(i) collected at frequent intervals, at least daily and as soon as possible after laying;
(ii) cleaned and disinfected as soon as possible, unless disinfection takes place at a hatchery in the same
Member State;
(iii) placed either in new or in clean and disinfected packaging material.’;
(ii) in Section B, in point 2(e), the first indent is replaced by the following:
‘— eggs, between the time of their arrival at the hatchery and the incubation process or at the time of their
dispatch for trade within the Union or export to a third country, unless they have been previously
disinfected at the breeding establishment of origin,’;
(b) Chapters III and IV are replaced by the following:
‘CHAPTER III
DISEASE SURVEILLANCE PROGRAMME
Without prejudice to health measures and to Articles 16 and 17, disease surveillance programmes must, as a
minimum, comprise surveillance of the infections and species listed in Sections A to D.
A. Salmonella Pullorum ( i ), Salmonella Gallinarum ( ii ) and Salmonella arizonae ( iii ) infections
1. Species concerned
(a) Salmonella Pullorum and Salmonella Gallinarum: fowls, turkeys, guinea fowls, quails, pheasants, partridges
and ducks.
(b) Salmonella arizonae: turkeys.
2. Disease surveillance programme
(a) Serological and/or bacteriological tests must be used to determine whether an infection is present (*).
(b) Samples for testing must be taken, as appropriate, from blood, embryos that fail to hatch (namely
embryos dead-in-shell), second grade chicks, meconium, post mortem tissues, especially liver, spleen,
ovary/oviduct and ileo-caecal junction (**).
(c) Direct enrichment in Selenite-cysteine broth for faecal/meconium and intestinal samples is to be used.
Non-selective pre-enrichment followed by selective enrichment in soya based Rappaport-Vassiliadis
(RVS) broth or Müller-Kauffmann Tetrathionate-novobiocin broth (MKTTn) may be used for samples
(such as embryos dead-in-shell) where competing flora is expected to be minimal (***), (****).
(d) When blood samples are taken from a flock for serological testing for Salmonella Pullorum and
Salmonella Gallinarum or Salmonella arizonae, the prevalence of infection in the Member State
concerned and its past incidence in the establishment must be allowed for in determining the
number of samples to be taken. However, a statistically valid number of samples for serological
and/or bacteriological testing to detect infection must always be taken.

---

L 90/30
EN
Official Journal of the European Union
6.4.2011
(e) Flocks must be inspected during each laying period at the best time for detecting the disease in question.
(f) Samples for bacteriological testing must not be taken from poultry or eggs that have been treated with
antimicrobial medicinal products during the 2 to 3 weeks prior to testing.
(g) Detection techniques must be capable of differentiating serological responses to Salmonella Pullorum and
Salmonella Gallinarum infection from serological responses due to the use of Salmonella Enteritidis
vaccine, where this vaccine is used (*****). Such vaccination must therefore not be used if serological
monitoring is to be used. If vaccination has been used, bacteriological testing must be used, but the
confirmation method used must be capable of differentiating live vaccinal strains from field strains.
___________
(*) Note that serological testing in avian species other than fowls may sometimes result in an
unacceptable proportion of false-positive reactions.
(**) Note that environmental samples are generally not suitable for reliable detection of Salmonella
Pullorum and Salmonella Gallinarum.
(***) Note that direct plating of aseptically collected tissues on to a minimally selective agar, such as
MacConkey agar, is also useful for diagnosis.
(****) Salmonella Pullorum and Salmonella Gallinarum do not readily grow in the modified semi-solid
Rappaport Vassiliadis (MRSV) medium that is used for monitoring of zoonotic Salmonella spp. in
the Union.
(*****) Note that there is currently no test that can differentiate between the response to Salmonella
Pullorum and Salmonella Gallinarum infection and vaccination for this serotype.
B. Mycoplasma gallisepticum and Mycoplasma meleagridis infections
1. Species concerned
(a) Mycoplasma gallisepticum: fowls and turkeys.
(b) Mycoplasma meleagridis: turkeys.
2. Disease surveillance programme
(a) The presence of infection must be tested by validated serological and/or bacteriological and/or molecular
tests. The presence of air sacculitis lesions in day-old chicks and turkey poults suggests that a
Mycoplasma infection is present and must be investigated.
(b) Samples for testing for the presence of Mycoplasma infection must be taken, as appropriate, from blood,
day-old chicks and turkey poults, sperm, or swabs taken from the trachea, the choanae, cloaca or air
sacs and in particular for the detection of Mycoplasma meleagridis samples must be taken from oviduct
and penis of turkeys.
(c) Tests for detecting Mycoplasma gallisepticum or Mycoplasma meleagridis must be performed on a repre
sentative sample in order to allow continuous surveillance of the infection during rearing and laying,
namely just before the start of laying and every 3 months thereafter.
C. Results and measures to be taken
If there are no reactors, the test must be deemed to be negative. Otherwise, the flock must be deemed to be
suspect and the measures set out in Chapter IV must be applied to it.
D. In the case of holdings which consist of two or more separate production units, the competent veterinary
authority may derogate from the measures set out in point 3(b) of Chapter IV required for restoring of
approval as regards healthy production units on a holding where the infection is present provided that the
authorised veterinarian has confirmed that the structure and size of those production units and the operations
carried out there are such that the production units provide completely separate facilities for housing, keeping
and feeding, so that the disease in question cannot spread from one production unit to another.
___________
( i ) Salmonella Pullorum means Salmonella enterica subspecies enterica serovar Gallinarum biochemical variant
(biovar) Pullorum.
( ii ) Salmonella Gallinarum means Salmonella enterica subspecies enterica serovar Gallinarum biochemical variant
(biovar) Gallinarum.
( iii ) Salmonella arizonae means Salmonella enterica subspecies arizonae serogroup K (O18) arizonae.

---

EN
6.4.2011 Official
Journal
of
the
European
Union L
90/31
CHAPTER IV
CRITERIA FOR SUSPENDING OR WITHDRAWING APPROVAL OF AN ESTABLISHMENT
1. Approval granted to an establishment must be suspended:
(a) when the conditions laid down in Chapter II are no longer met;
(b) until an investigation appropriate to the disease has been completed,
if:
— an outbreak of avian influenza or Newcastle disease is suspected at the establishment,
— the establishment has received poultry or hatching eggs from an establishment with a suspected or
confirmed outbreak of avian influenza or Newcastle disease,
— contact liable to transmit the infection has occurred between the establishment and the site of an
outbreak of avian influenza or Newcastle disease;
(c) until such time as new tests are performed, if the results of surveillance carried out in accordance with the
conditions laid down in Chapters II and III for infection by Salmonella Pullorum, Salmonella Gallinarum,
Salmonella arizonae, Mycoplasma gallisepticum or Mycoplasma meleagridis give cause to suspect an outbreak;
(d) until completion of the appropriate measures required by the official veterinarian, if the establishment is
found not to conform with the requirements of point 1(a), (b) and (c) of Chapter I.
2. Approval must be withdrawn if:
(a) an outbreak of avian influenza or Newcastle disease is confirmed on the establishment;
(b) a second test of an appropriate type confirms an outbreak of infection by Salmonella Pullorum, Salmonella
Gallinarum, Salmonella arizonae, Mycoplasma gallisepticum or Mycoplasma meleagridis;
(c) after a second notice served by the official veterinarian on the person responsible for the establishment,
action to bring the establishment into line with the requirements of point 1(a), (b) and (c) of Chapter I, has
not been taken.
3. Conditions for restoring approval if:
(a) approval has been withdrawn because of an outbreak of avian influenza or Newcastle disease, it may be
restored 21 days after cleansing and disinfection if sanitary slaughter has been carried out;
(b) approval has been withdrawn because of an outbreak caused by:
— Salmonella Pullorum and Salmonella Gallinarum, or Salmonella arizonae, it may be restored after negative
results have been recorded in two tests performed with an interval of at least 21 days on the estab
lishment following sanitary slaughter of the infected flock and after disinfection for which the
effectiveness has been verified by suitable tests on dried surfaces,
— Mycoplasma gallisepticum or Mycoplasma meleagridis, it may be restored either after negative results have
been recorded in two tests performed on the entire flock with an interval of at least 60 days or after
negative results have been recorded in two tests performed with an interval of at least 21 days on the
establishment after disinfection following sanitary slaughter of the entire infected flock.’;
2. Annex III is amended as follows:
(a) point 1 is replaced by the following:
‘1. Vaccines used for vaccinating poultry or flocks producing hatching eggs must have a marketing authorisation
issued by the competent authority of any Member State.’;
(b) the following point 3 is added:
‘3. In relation to vaccination against any Salmonella serotype the following conditions shall be met:
(a) Salmonella vaccination programmes must not interfere with serological detection in the context of field
investigation, or result in false-positive tests;

---

L 90/32
EN
Official Journal of the European Union
6.4.2011
(b) live Salmonella vaccines must not be used in the framework of national control programmes:
(i) in breeding or productive poultry during their reproductive or laying stage unless the safety of their use
has been demonstrated and they are authorised for such purpose in accordance with Directive
2001/82/EC of the European Parliament and of the Council (*);
(ii) where the manufacturer does not provide an appropriate method to distinguish bacteriologically wild-
type strains of Salmonella from vaccine strains.
___________
(*) OJ L 311, 28.11.2001, p. 1.’.
3. Annex IV is replaced by the following:

---

EN
6.4.2011 Official
Journal
of
the
European
Union L
90/33
‘ANNEX IV
VETERINARY CERTIFICATES FOR TRADE WITHIN THE UNION
(Models 1 to 6)
MODEL 1

---

L 90/34
EN
Official Journal of the European Union
6.4.2011

---

EN
6.4.2011 Official
Journal
of
the
European
Union L
90/35

---

L 90/36
EN
Official Journal of the European Union
6.4.2011
MODEL 2

---

EN
6.4.2011 Official
Journal
of
the
European
Union L
90/37

---

L 90/38
EN
Official Journal of the European Union
6.4.2011

---

EN
6.4.2011 Official
Journal
of
the
European
Union L
90/39
MODEL 3

---

L 90/40
EN
Official Journal of the European Union
6.4.2011

---

EN
6.4.2011 Official
Journal
of
the
European
Union L
90/41

---

L 90/42
EN
Official Journal of the European Union
6.4.2011
MODEL 4

---

EN
6.4.2011 Official
Journal
of
the
European
Union L
90/43

---

L 90/44
EN
Official Journal of the European Union
6.4.2011

---

EN
6.4.2011 Official
Journal
of
the
European
Union L
90/45
MODEL 5

---

L 90/46
EN
Official Journal of the European Union
6.4.2011

---

EN
6.4.2011 Official
Journal
of
the
European
Union L
90/47

---

L 90/48
EN
Official Journal of the European Union
6.4.2011
MODEL 6

---

EN
6.4.2011 Official
Journal
of
the
European
Union L
90/49

---