Commission Regulation (EC) No 1177/2006 of  1 August 2006  implementing Regulation (EC) No 2160/2003 of the European Parliament and of the Council as regards requirements for the use of specific control methods in the framework of the national programmes for the control of salmonella in poultry   (Text with EEA relevance)
Date: 2006-08-01
Institutions: European Commission
Subjects: European Food Safety Authority, disease prevention, health control, poultry, vaccine, veterinary drug, zoonosis

2.8.2006

EN

Official Journal of the European Union

L 212/3

COMMISSION REGULATION (EC) No 1177/2006

of 1 August 2006

implementing Regulation (EC) No 2160/2003 of the European Parliament and of the Council as
regards requirements for the use of specific control methods in the framework of the national
programmes for the control of salmonella in poultry

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

the
Having regard to Regulation (EC) No 2160/2003 of
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 8(1) thereof,

Whereas:

(1)

(2)

(3)

(4)

Regulation (EC) No 2160/2003 lays down rules for the
detection and control of salmonella in poultry. Pursuant
to Article 8(1)(d) of Regulation (EC) No 2160/2003, it
may be decided that specific control methods are not to
be used as part of national control programmes esta-
blished by Member States to achieve the Community
targets set up in accordance with that Regulation.

Pursuant to Article 8(1)(a) and (b) of Regulation (EC) No
2160/2003 it may be decided that
specific control
methods are or may be applied for the reduction of
prevalence of zoonoses and zoonotic agents at
the
stage of the primary production of animals and other
stages in the food chain, and rules may be adopted
concerning the conditions for the use of such methods.

Pursuant
2160/2003,
European
proposing rules on specific control methods.

to Article 15 of Regulation (EC) No
the
before

Safety Authority

the Commission

consult

(EFSA)

Food

to

is

The Commission consulted the EFSA on the use of anti-
microbials and vaccines for the control of salmonella in
poultry. Following that consultation, the EFSA issued two
separate opinions on those issues on 21 October 2004.

use of antimicrobials should be discouraged due to public
health risks associated with development, selection and
spread of resistance. The use of antimicrobials should be
subject to formally defined conditions that would ensure
protection of public health, and must be fully justified in
advance and recorded by the competent authority.

Therefore, on the basis of the opinion of the EFSA, it is
appropriate to provide that antimicrobials should not be
used as part of national control programmes to be
adopted pursuant to Article 6 of Regulation (EC) No
2160/2003, other than in the exceptional circumstances
referred to by the EFSA in its opinion.

In any circumstances, only veterinary medicinal products
authorised in accordance with Directive 2001/82/EC of
the European Parliament and of
the Council of 6
November 2001 on the Community code relating to
veterinary medicinal products (2), or Regulation (EC) No
726/2004 of the European Parliament and of the Council
of 31 March 2004 laying down Community procedures
for
the authorisation and supervision of medicinal
products for human and veterinary use and establishing
a European Medicines Agency (3), should be used.

Antimicrobial veterinary medicinal products are referred
to as antimicrobials in this Regulation. Products which
are authorised as feed additives in accordance with Regu-
lation (EC) No 1831/2003 of the European Parliament
and of the Council of 22 September 2003 on additives
also
for use
considered as antimicrobials. They should be excluded
from the scope of this Regulation because the use of
these additives may be a tool
salmonella
infection by the feed while they are not associated with
the development, selection and spread of resistance.

in animal nutrition (4)

are however

to limit

The EFSA concluded in its opinion on the use of vaccines
for the control of salmonella in poultry, that vaccination
of poultry is regarded as an additional measure to
increase
salmonella
resistance of birds
exposure and decrease the shedding.

against

the

(6)

(7)

(8)

(9)

(5)

In its opinion on the use of antimicrobials for the control
of salmonella in poultry, the EFSA recommended that the

(1) OJ L 325, 12.12.2003, p. 1. Regulation as amended by Commission

Regulation (EC) No 1003/2005 (OJ L 170, 1.7.2005, p. 12).

(2) OJ L 311, 28.11.2001, p. 1. Directive as last amended by Directive

2004/28/EC (OJ L 136, 30.4.2004, p. 58).

(3) OJ L 136, 30.4.2004, p. 1.
(4) OJ L 268, 18.10.2003, p. 29. Regulation as

amended by
Commission Regulation (EC) No 378/2005 (OJ L 59, 5.3.2005,
p. 8).

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Official Journal of the European Union

2.8.2006

(10)

(11)

(12)

The EFSA in its opinion also stated in particular that
provided that the detection methods are able to diffe-
rentiate the vaccine strains
from wild strains, both
currently available inactivated and live vaccines can be
safely used throughout the life of the birds, except during
the withdrawal period before slaughter and, with regard
to live vaccines, in laying hens during production. Vacci-
nation of layers is considered useful as a measure to
reduce shedding and egg contamination, when the
purpose is to reduce high prevalences. Salmonella enter-
itidis is the most important cause of outbreaks in humans
by the consumption of eggs.

Therefore, on the basis of the opinion of the EFSA, it is
appropriate to provide that currently available live
vaccines should not be used as part of national control
to Article 6 of
programmes to be adopted pursuant
in laying hens during
Regulation (EC) No 2160/2003,
production. Live vaccines should not be used if
the
manufacturer does not provide an appropriate method
to distinguish bacteriologically wild-type
strains of
salmonella from vaccine strains.

Based on the current scientific evidence, the use of live or
inactivated vaccines against Salmonella enteritidis should
be mandatory in Member States with a high prevalence
in order
to improve public health protection. The
prevalence of Salmonella enteritidis demonstrated during
in accordance with Commission
a baseline
Decision 2004/665/EC (1) and in the frame of
the
testing schemes in accordance with Article 4(2)(d) of
Regulation (EC) No 2160/2003, should be used as a
threshold for mandatory vaccination.

study

the European Parliament and of

(13) As regards breeding flocks, Commission Regulation (EC)
No 1091/2005 implementing Regulation (EC) No
2160/2003 of
the
Council as regards requirements for the use of specific
the national
control methods
lays
for
programmes
down provisions on the use of antimicrobials and
vaccines as part of national control programmes for
salmonella in breeding flocks of Gallus gallus.

in the framework of
control of
the

salmonella (2),

(14)

For the sake of clarity,
it is appropriate to repeal and
replace Regulation (EC) No 1091/2005 by this Regu-
lation.

(15)

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

opinion

the

the

of

HAS ADOPTED THIS REGULATION:

Article 1

This Regulation lays down certain rules for the use of antimi-
crobials and vaccines in the framework of the national control
programmes adopted pursuant to Article 6 of Regulation (EC)
No 2160/2003 (national control programmes).

Article 2

Use of antimicrobials

Antimicrobials shall not be used as a specific method to

1.
control salmonella in poultry.

By way of derogation from paragraph 1, and subject to
2.
(b) and (c), and in
the conditions specified in points (a),
this Article, antimicrobials authorised in
paragraph 3 of
accordance with Article 5 of Directive 2001/82/EC or Article
3 of Regulation 726/2004/EC may be used in the following
exceptional circumstances:

(a) poultry presenting salmonella infection with clinical signs in
a way likely to cause undue suffering to the animals; the
infected flocks treated with antimicrobials shall still be
considered infected with salmonella; appropriate measures
shall be taken in breeding flocks to reduce as much as
possible the risk of spreading salmonella through the rest
of the breeding pyramid;

(b) salvaging of valuable genetic material in breeding flocks in
order to establish new salmonella-free flocks, including ‘elite
flocks’, flocks from endangered breeds, and flocks kept for
research purposes; chicks born from hatching eggs collected
from poultry treated with antimicrobials shall be subject to
fortnightly sampling during the rearing phase, with a
scheme aiming to detect 1 % prevalence of
relevant
salmonella with a 95 % confidence limit;

salmonella infection,

(c) authorisation given by the competent authority on a case-
by-case basis for purposes other than salmonella control in
a flock suspect of
in particular
investigation of a food-
following the epidemiological
borne outbreak or
the
the detection of
hatchery or at the holding; however, Member States may
decide to allow treatment without prior authorisation in
emergency situations, subject
to taking samples by an
approved veterinarian as defined in point (g) of Article 2
of Regulation (EC) No 854/2004 (3) and reporting the
the
treatment
flocks shall be considered as infected with salmonella if
sampling did not
take place in accordance with the
provisions in this paragraph.

immediately to the competent authority;

salmonella at

(1) OJ L 303, 30.9.2004, p. 30.
(2) OJ L 182, 13.7.2005, p. 3.

(3) OJ L 226, 25.6.2004, p. 83.

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The use of antimicrobials shall be subject to supervision of
3.
and reporting to the competent authority. This use shall be
based wherever possible on the results of bacteriological
sampling and of susceptibility testing.

4.
The provisions referred to in this Article shall not apply to
substances, micro-organisms or preparations authorised for use
as feed additives in accordance with Article 3 of Regulation (EC)
No 1831/2003.

Article 3

Use of vaccines

Live

salmonella vaccines

shall not be used in the
1.
framework of national control programmes where the manu-
facturer does not provide an appropriate method to distinguish
bacteriologically wild-type strains of salmonella from vaccine
strains.

Live

salmonella vaccines

2.
shall not be used in the
framework of national control programmes in laying hens
during production unless the safety of the use has been demon-
strated and they are authorised for such purpose in accordance
with Directive 2001/82/EC.

Vaccination programmes

3.
enteritidis
reducing the shedding and contamination of eggs, shall be
applied at least during rearing to all laying hens at the latest
from 1 January 2008 on in Member States as long as they did

against Salmonella

the baseline

not demonstrated a prevalence below 10 % based on the results
of
study in accordance with Article 1 of
Commission Decision 2004/665/EC or based on the moni-
toring to follow up the Community target, set in accordance
with Article 4(1) of Regulation (EC) No 2160/2003.

The competent authority may provide derogation from this
provision to a holding if

— it is satisfied with the preventive measures taken on the
holding of rearing and on the holding of egg production,
and

— the absence of Salmonella enteritidis was demonstrated on the
holding of rearing and production during the 12 months
preceding the arrival of the animals.

Article 4

Entry into force

This Regulation shall enter into force on the 20th day following
that of
the European
Union.

its publication in the Official

Journal of

It shall apply to for each poultry population on the respective
dates referred to in Column 5 of Annex I to Regulation (EC) No
2160/2003.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 1 August 2006.

For the Commission

Markos KYPRIANOU
Member of the Commission