Commission Regulation (EC) No 1091/2005 of 12 July 2005 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 Text with EEA relevance
Date: 2005-07-12
Institutions: European Commission
Subjects: animal disease, health legislation, infectious disease, livestock, microorganism, poultry, veterinary legislation, zoonosis

13.7.2005

EN

Official Journal of the European Union

L 182/3

COMMISSION REGULATION (EC) No 1091/2005

of 12 July 2005

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

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

be fully justified in advance and recorded by the
competent authority.

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)

(5)

Under Regulation (EC) No 2160/2003, it may be decided
that specific control methods are not to be used as part
of national control programmes established by Member
States to achieve the Community targets set up in
accordance with that Regulation.

Also, under Regulation (EC) No 2160/2003 it may be
decided that specific control methods may or shall be
applied for the reduction of prevalence of zoonoses
the primary
and zoonotic agents at
production of animals and other stages in the food
chain,
adopted concerning the
conditions for the use of such methods.

and rules may be

the stage of

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 EFSA on the use of antimi-
crobials and on the use of vaccines for the control of
request, EFSA
salmonella in poultry. Following that
issued two separate opinions on those
issues on
21 October 2004.

In its opinion on the use of antimicrobials for the control
of salmonella in poultry, EFSA recommended that the
use of antimicrobials should be discouraged due to
development,
public
selection and spread of resistance. The use of antimi-
crobials should be subject to formally defined conditions
that would ensure protection of public health, and must

associated with

health

risks

(1) OJ L 325, 12.12.2003, p. 1.

(6)

(7)

(8)

(9)

(10)

regards

breeding

flocks, while

opinion
the
As
acknowledged the potential
risk of dissemination of
residual Salmonella spp., including dissemination of any
selected resistant strains through the production pyramid,
it
recognised that valuable genetic material may be
salvaged from infected breeding flocks through the use
of antimicrobials. The opinion concluded also that most
generally and for all
types of poultry, on the rare
occasions when Salmonella spp. causes clinical infections,
antimicrobials may be useful in reducing morbidity and
mortality.

it is
Therefore, on the basis of the opinion of EFSA,
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 EFSA in its opinion.

the European Parliament and of

In any circumstances, only veterinary medicinal products
authorised in accordance with Directive 2001/82/EC
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. Anti-
microbial veterinary medicinal products are referred to as
anti-microbials in this Regulation.

It is generally recognised that the basis for successful
control of salmonlla infections in poultry farms are
good farming and hygienic practices as well as testing
and removal of positive flocks from production.

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

(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.

L 182/4

EN

Official Journal of the European Union

13.7.2005

(11)

(12)

(13)

In its conclusions, EFSA also states in particular that
provided that the detection methods are able to differ-
entiate the vaccine strains from wild strains, both inac-
tivated and live vaccines can be safely used throughout
the life of the birds except during the withdrawal period
before slaughter.

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

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

opinion

the

the

of

(b) salvaging of valuable genetic material, including ‘elite flocks’,
flocks from endangered breeds, and flocks kept for research
purposes, in order to establish new salmonella-free flocks;
chicks born from hatching eggs collected from treated
animals 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;

(c) authorisation given by the competent authority on a case by
case basis for purposes other than salmonella control in a
flock suspect of salmonella infection, in particular following
detection of salmonella at the hatchery or at the holding;
however, Member States may decide to allow treatment
without prior
situations,
subject
immediately to the
competent authority.

authorisation in emergency

to reporting the treatment

HAS ADOPTED THIS REGULATION:

Article 1

Use of antimicrobials

1.
Antimicrobials shall not be used as a specific method to
control salmonella in breeding flocks of Gallus gallus in the
framework of national control programmes adopted pursuant
to Article 6 of Regulation (EC) No 2160/2003, except in the
circumstances established in paragraph 2.

2.
By way of derogation from paragraph 1, and subject to
(b) and (c) and in
the conditions specified in points (a),
paragraph 3, antimicrobials authorised in accordance with
Directive 2001/82/EC or Regulation (EC) No 726/2004 may
be used in the following exceptional circumstances:

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

spreading salmonella through the rest of

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

Article 2

Use of vaccines

Live salmonella vaccines for which the manufacturer does not
provide an appropriate method to distinguish bacteriologically
wild-type strains of salmonella from vaccine strains shall not be
used in the framework of national control programmes adopted
pursuant to Article 6 of Regulation (EC) No 2160/2003.

Article 3

Entry into force

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 January 2007.

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

Done at Brussels, 12 July 2005.

For the Commission

Markos KYPRIANOU
Member of the Commission