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
Date: 2003-11-17
Institutions: Council of the European Union, European Parliament
Subjects: animal disease, disease prevention, food inspection, food poisoning, health legislation, infectious disease, veterinary inspection, zoonosis

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I

(Acts whose publication is obligatory)

REGULATION (EC) No 2160/2003 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on the control of salmonella and other specified food-borne zoonotic agents

of 17 November 2003

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

Having regard to the Treaty establishing the European Com-
munity, and in particular Article 152(4)(b) thereof,

Having regard to the proposal from the Commission (1),

Having regard to the opinion of the European Economic and
Social Committee (2),

After consulting the Committee of the Regions,

Acting in accordance with the procedure laid down in Article
251 of the Treaty (3),

Whereas:

(1)

(2)

(3)

Live animals and food of animal origin appear on the list
in Annex I to the Treaty. Livestock farming and the
placing on the market of food of animal origin consti-
tute an important source of income for farmers. The
implementation of veterinary measures aimed at raising
the level of public and animal health in the Community
assists the rational development of the farming sector.

The protection of human health against diseases and
infections transmissible directly or indirectly between
animals and humans (zoonoses) is of paramount impor-
tance.

Zoonoses transmissible through food may cause human
suffering, as well as economic losses to food production
and the food industry.

(1) OJ C 304 E, 30.10.2001, p. 260.
(2) OJ C 94, 18.4.2002, p. 18.
(3) Opinion of the European Parliament of 15 May 2002 (OJ C 180 E,
31.7.2003, p. 160), Council Common Position of 20 February
2003 (OJ C 90 E, 15.4.2003, p. 25) and Position of the European
Parliament of 19 June 2003 (not yet published in the Official
Journal). Council Decision of 29 September 2003.

(4)

(5)

(6)

(7)

Zoonoses transmitted through sources other than food,
especially from wild animal and pet animal populations,
are also a matter of concern.

Zoonoses present at the level of primary production
must be adequately controlled to ensure that the objec-
tives of this Regulation are achieved. However,
in the
case of primary production leading to the direct supply
of small quantities of primary products, by the food
business operator producing them, to the final consumer
or to local shops,
it is appropriate to protect public
health through national law. In this case there is a close
relationship between the producer and the consumer.
Such production should not make a significant contribu-
tion to the average prevalence of zoonoses in animal
populations in the Community as a whole. The general
requirements for sampling and analysis may not be prac-
tical or appropriate for producers with very small
numbers of animals who may be located in regions
suffering from special geographical constraints.

Council Directive 92/117/EEC of 17 December 1992
concerning measures for protection against specified
zoonoses and specified zoonotic agents in animals and
products of animal origin in order to prevent outbreaks
of food-borne infections and intoxications (4) provided
for the establishment of monitoring systems for certain
zoonoses and controls on salmonella in certain poultry
flocks.

That Directive required Member States to submit to the
Commission the national measures that they had taken
to achieve the objectives of the Directive and to draw up
plans for monitoring salmonella in poultry. However,
Council Directive 97/22/EC (5) amending Directive 92/
117/EEC suspended the requirement pending the review
provided for in Article 15a of Directive 92/117/EEC.

(4) OJ L 62, 15.3.1993, p. 38. Directive as last amended by Council

Regulation (EC) No 806/2003 (OJ L 122, 16.5.2003, p. 1).

(5) OJ L 113, 30.4.1997, p. 9.

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(8)

(9)

Several Member States have already submitted their
plans for
the monitoring of salmonella, which the
Commission has approved. Moreover, all Member States
were required, with effect from 1 January 1998, to fulfil
the minimum measures laid down for salmonella in
Annex III, Section I, to Directive 92/117/EEC, and to
establish rules specifying the measures to be taken to
avoid the introduction of salmonella on to a farm.

Those minimum measures focused on monitoring and
controlling salmonella in breeding flocks of the species
Gallus gallus. When serotypes Salmonella enteritidis or
Salmonella typhimurium were detected and confirmed in
samples taken, Directive 92/117/EEC laid down specific
measures to control the infection.

(10) Other Community legislation provides for the moni-
toring and control of certain zoonoses in animal popula-
tions. In particular Council Directive 64/432/EEC of 26
June 1964 on animal health problems affecting intra-
Community trade in bovine animals and swine (1) deals
with bovine tuberculosis and bovine brucellosis. Council
Directive 91/68/EEC of 28 January 1991 on animal
health conditions governing intra-Community trade in
ovine and caprine animals (2) deals with ovine and
caprine brucellosis. This Regulation should not create
any unnecessary duplication of these existing require-
ments.

to Salmonella enteritidis and Salmonella typhimurium, thus
reflecting the success of related control measures taken
in the Community. Nevertheless, it is assumed that many
cases remain unreported and therefore the data collected
do not necessarily give the full picture of the situation.

(14)

(15)

In its opinion on zoonoses adopted on 12 April 2000,
the Scientific Committee on Veterinary Measures relating
to Public Health considered that the measures in place at
that time to control food-borne zoonotic infections were
insufficient. It further considered that the epidemiolo-
gical data that Member States were collecting were
incomplete and not fully comparable. As a consequence,
the Committee recommended improved monitoring
arrangements and identified risk management options.

It is therefore necessary to improve the existing control
systems for specific zoonotic agents. Simultaneously, the
rules laid down in Directive 2003/99/EC of the Euro-
pean Parliament and of the Council of 17 November
2003 on the monitoring of zoonoses and zoonotic
agents, amending Council Decision 90/424/EEC and
repealing Council Directive 92/117/EEC (3) will replace
the monitoring and data collection systems established
by Directive 92/117/EEC.

(16)

In principle, controls should cover the whole food chain,
from farm to table.

(11) Moreover, future Community legislation on food hygiene
should cover specific elements necessary for the preven-
tion, control and monitoring of zoonoses and zoonotic
agents and include specific requirements for the micro-
biological quality of food.

(17)

The rules governing such controls should generally be
those laid down under Community legislation on
feedingstuffs, animal health and food hygiene.

(12) Directive 92/117/EEC provided for the collection of data
on the occurrence of zoonoses and zoonotic agents in
feedingstuffs, animals,
food and humans. That data
collection system, although not harmonised and there-
fore not allowing comparison between Member States,
does provide a basis for evaluating the current situation
concerning zoonoses and zoonotic agents in the Com-
munity.

(18) However, for certain zoonoses and zoonotic agents it is
necessary to lay down specific requirements for controls.

(19)

Those specific requirements should be based on targets
for the reduction of the prevalence of zoonoses and
zoonotic agents.

(13)

The results of
the data collection system show that
certain zoonotic agents, namely Salmonella spp. and
spp., cause the majority of cases of
Campylobacter
zoonoses in humans. There seems to be a decreasing
trend of human cases of salmonellosis, in particular due

(1) OJ 121, 29.7.1964, p. 1977/64. Directive as last amended by
Commission Regulation (EC) No 1226/2002 (OJ L 179, 9.7.2002,
p. 13).

(2) OJ L 46, 19.2.1991, p. 19. Directive as last amended by Regulation

(EC) No 806/2003.

(20)

The targets should be established for zoonoses and
zoonotic agents in animal populations taking account, in
particular, of their frequency and epidemiological trends
in animal and human populations, feed and food, their
gravity for humans,
their potential economic conse-
quences, scientific advice and the existence of appro-
priate measures to reduce their prevalence. Targets may
be established in respect of other parts of the food chain,
where necessary.

(3) See page 31 of this Official Journal.

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(21)

To ensure the achievement of the targets in good time,
Member
control
programmes, which the Community should approve.

specific

should

States

set

up

(22)

The main responsibility for the safety of food should lie
with food and feed business operators. Member States
should, therefore, encourage the creation of business-
wide control programmes.

(23) Within their control programmes, Member States and
food and feed business operators may wish to use
specific control methods. However, certain methods may
not be acceptable,
they hamper the
in particular if
achievement of the target in general, interfere specifically
with necessary testing systems or give rise to potential
threats to public health. Appropriate procedures should
therefore be laid down enabling the Community to
decide that certain control methods should not be used
as part of control programmes.

(24)

(25)

Control methods may also exist or be developed which,
as such, do not fall under any specific Community legis-
lation on product approval but would help to achieve
the targets for the reduction of the prevalence of speci-
fied zoonoses and zoonotic agents. It should, therefore,
be possible to approve the use of such methods at Com-
munity level.

the results of

It will be essential to ensure that restocking of animals
takes place from flocks or herds that have been subject
to controls in accordance with the requirements of this
Regulation. When a specific control programme is in
force,
testing should be forwarded to
purchasers of animals. To that end, specific requirements
should be added to the corresponding Community legis-
lation on intra-Community trade and imports from third
countries, in particular as regards consignments of live
animals
and hatching eggs. Directive 64/432/EEC,
Council Directive 72/462/EEC of 12 December 1972 on
health and veterinary inspection problems upon impor-
tation of bovine animals and swine and fresh meat from
third countries (1) and Council Directive 90/539/EEC of
15 October 1990 on animal health conditions governing
intra-Community trade in, and imports from third coun-
tries of, poultry and hatching eggs (2) should be amended
accordingly.

(1) OJ L 302, 31.12.1972, p. 28. Directive as last amended by Commis-
sion Regulation (EC) No 807/2003 (OJ L 122, 16.5.2003, p. 36).
(2) OJ L 303, 31.10.1990, p. 6. Directive as last amended by Regu-

lation (EC) No 806/2003.

(26)

The adoption of this Regulation should not affect the
additional guarantees agreed for Finland and Sweden on
their accession to the Community and confirmed by
Commission Decisions 94/968/EC (3), 95/50/EC (4), 95/
160/EC (5), 95/161/EC (6), 95/168/EC (7) and by Council
Decisions 95/409/EC (8), 95/410/EC (9) and 95/411/
EC (10). This Regulation should provide a procedure for
the granting, for a transitional period, of guarantees to
any Member State that has an approved national control
programme
the minimum Community
requirements in relation to salmonella. The results of
tests on live animals and hatching eggs traded with such
a Member State should meet the criteria laid down in its
national control programme. Future Community legisla-
tion on hygiene rules for food of animal origin should
provide a similar procedure in respect of meat and table
eggs.

exceeding

(27)

Third countries exporting to the Community must
implement equivalent measures
the control of
zoonoses at the same time as measures are applied in
the Community.

for

(28) As regards control of salmonella, available information
tends to show that poultry products are a major source
of human salmonellosis. Control measures should, there-
fore, be applied to production of those products, thus
extending the measures initiated under Directive 92/
117/EEC. As regards the production of table eggs, it is
important to establish specific measures concerning the
placing on the market of products originating from
flocks that have not been tested free of relevant salmo-
nella. As regards poultry meat, the aim is to place on the
market poultry meat with reasonable assurance that it is
free from relevant salmonella. A transitional period is
necessary for food business operators to adapt to the
measures envisaged, which may be adapted further in
particular in the light of scientific risk assessment.

(29)

It is appropriate to designate national and Community
reference laboratories to give guidance and assistance on
matters falling within the scope of this Regulation.

(30)

To ensure the uniform application of this Regulation,
provision should be made for the organisation of Com-
munity audits and inspections in accordance with other
Community legislation in this field.

(3) OJ L 371, 31.12.1994, p. 36.
(4) OJ L 53, 9.3.1995, p. 31.
(5) OJ L 105 9.5.1995, p. 40. Decision as last amended by Decision

97/278/EC (OJ L 110, 26.4.1997, p. 77).

(6) OJ L 105, 9.5.1995, p. 44. Decision as last amended by Decision

97/278/EC.

(7) OJ L 109, 16.5.1995, p. 44. Decision as last amended by Decision

97/278/EC.

(8) OJ L 243, 11.10.1995, p. 21. Decision as last amended by Decision

98/227/EC (OJ L 87, 21.3.1998, p. 14).

(9) OJ L 243, 11.10.1995, p. 25. Decision as last amended by Decision

98/227/EC.

(10) OJ L 243, 11.10.1995, p. 29. Decision as last amended by Decision

98/227/EC.

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(31) Appropriate procedures

laid down for
amending certain provisions of this Regulation to take
account of technical and scientific progress and for the
adoption of implementing and transitional measures.

should be

(32)

technical and scientific progress,
To take account of
close and effective cooperation should be ensured
between the Commission and the Member States within
the Standing Committee set up by Regulation (EC) No
the
178/2002 of
Council of 28 January 2002 laying down the general
principles and requirements of food law, establishing the
European Food Safety Authority, and laying down proce-
dures in matters of food safety (1).

the European Parliament and of

(33)

The measures necessary for the implementation of this
Regulation should be adopted in accordance with
Council Decision 1999/468/EC of 28 June 1999 laying
down the procedures for the exercise of implementing
powers conferred on the Commission (2),

(b) leading to the direct supply, by the producer, of small
quantities of primary products to the final consumer or to
local retail establishments directly supplying the primary
products to the final consumer.

4. Member States shall establish, under national law, rules
governing the activities referred to in paragraph 3(b). Such
national rules shall ensure that the objectives of this Regulation
are achieved.

5.
This Regulation shall apply without prejudice to more
specific Community provisions on animal health, animal nutri-
tion, food hygiene, communicable human diseases, health and
safety in the workplace, gene technology and transmissible
spongiform encephalopathies.

Article 2

Definitions

HAVE ADOPTED THIS REGULATION:

CHAPTER I

INTRODUCTORY PROVISIONS

For the purposes of this Regulation the following definitions
shall apply:

1. the definitions laid down in Regulation (EC) No 178/2002;

2. the definitions laid down in Directive 2003/99/EC; and

Article 1

3. the following definitions:

Subject matter and scope

1.
The purpose of this Regulation is to ensure that proper
and effective measures are taken to detect and to control salmo-
nella and other zoonotic agents at all relevant stages of produc-
tion, processing and distribution, particularly at the level of
primary production, including in feed, in order to reduce their
prevalence and the risk they pose to public health.

2.

This Regulation shall cover:

(a) the adoption of targets for the reduction of the prevalence

of specified zoonoses in animal populations:

(i) at the level of primary production; and
(ii) where appropriate for the zoonosis or zoonotic agent
concerned, at other stages of the food chain, including
in food and feed;

(b) the approval of specific control programmes established by

Member States and food and feed business operators;

(c) the adoption of specific rules concerning certain control
the prevalence of

methods applied in the reduction of
zoonoses and zoonotic agents;

(d) the adoption of rules concerning intra-Community trade
and imports from third countries of certain animals and
products thereof.

3.

This Regulation shall not apply to primary production:

(a) for private domestic use; or

(1) OJ L 31, 1.2.2002, p. 1.
(2) OJ L 184, 17.7.1999, p. 23.

(a) ‘herd’ means an animal or group of animals kept on a

holding as an epidemiological unit; and

(b) ‘flock’ means all poultry of the same health status kept
on the same premises or in the same enclosure and
constituting a single epidemiological unit; in the case of
housed poultry, this includes all birds sharing the same
airspace.

Article 3

Competent authorities

1.
Each Member State shall designate a competent authority
or competent authorities for the purpose of this Regulation and
notify the Commission thereof. If a Member State designates
more than one competent authority, it shall:

(a) notify the Commission of the competent authority that will
act as a contact point for contacts with the Commission;
and

(b) ensure that the competent authorities cooperate so as to
guarantee the proper implementation of the requirements
of this Regulation.

The competent authority or authorities shall be respon-

2.
sible in particular for:

(a) drawing up the programmes provided for in Article 5(1)
and preparing any amendments thereto which prove neces-
sary, in particular in the light of data and results obtained;

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(b) collecting the data needed to evaluate the means used and
the results obtained in carrying out the national control
programmes provided for in Article 5 and for submitting
those data and results yearly, including the results of any
surveys undertaken, to the Commission, having regard to
the rules laid down pursuant to Article 9(1) of Directive
2003/99/EC;

(c) carrying out regular checks on the premises of food and, if
needed, feed businesses for the purpose of checking compli-
ance with this Regulation.

CHAPTER II

COMMUNITY TARGETS

Article 4

Community targets shall be established for the first time

3.
before the relevant dates indicated in Annex I, Column 4.

4.

(a) When defining each Community target, the Commission
shall provide an analysis of its expected costs and bene-
fits. This analysis shall take account, in particular, of the
criteria laid down in paragraph 6(c). Member States
shall, on request, provide the Commission with all the
assistance necessary to enable it to prepare the analysis.

(b) Before proposing each Community target, the Commis-
sion shall consult Member States within the committee
referred to in Article 14(1) on the results of its analysis.

(c) In the light of the results of that analysis and the consul-
tation of Member States, the Commission shall propose
Community targets where appropriate.

Community targets for the reduction of the prevalence of
zoonoses and zoonotic agents

5.
However, by way of derogation from paragraphs 2(e) and
4, the following rules shall apply to poultry for a transitional
period.

1.
Community targets shall be established for the reduction
of the prevalence of zoonoses and zoonotic agents listed in
Annex I, column 1, in the animal populations listed in Annex
I, column 2, taking account, in particular, of:

(a) the experience gained under existing national measures;

and

(b) information forwarded to the Commission or to the Euro-
pean Food Safety Authority under existing Community
requirements, in particular in the framework of information
provided for in Directive 2003/99/EC, in particular Article
5 thereof.

The targets, and any amendments to them, shall be established
in accordance with the procedure referred to in Article 14(2).

The targets referred to in paragraph 1 shall consist at least

2.
of:

(a) a numerical expression of:

(i) the maximum percentage of epidemiological units

remaining positive; and/or

(ii) the minimum percentage of reduction in the number of

epidemiological units remaining positive;

(b) the maximum time limit within which the target must be

achieved;

The Community target established for breeding flocks of Gallus
gallus for this transitional period shall cover the five most
frequent salmonella serotypes in human salmonellosis, which
shall be identified on the basis of data collected through EC
monitoring systems. The Community targets established for
laying hens, broilers and turkeys for the transitional period
shall cover Salmonella enteritidis and Salmonella typhimurium.
However, if necessary, these targets may be extended to other
serotypes on the basis of the results of an analysis carried out
in accordance with paragraph 4.

The transitional period shall apply to each Community target
for the reduction of the prevalence of salmonella in poultry. It
shall
last for three years in each case, starting on the date
mentioned in column 5 of Annex I.

6.

(a) Annex I may be amended, in accordance with the proce-
dure laid down in Article 14(2), for the purposes listed
in subparagraph (b), after taking account in particular of
the criteria listed in subparagraph (c).

(b) Amendments to Annex I may alter the scope of the
requirements regarding the establishment of Community
targets by supplementing, restricting or modifying:

(i) the zoonoses or zoonotic agents;

(ii) the stages of the food chain; and/or

(c) the definition of the epidemiological units referred to in (a);

(iii) the animal populations concerned.

(d) the definition of the testing schemes necessary to verify the

achievement of the target; and

(e) the definition, where relevant, of serotypes with public
health significance or of other subtypes of zoonoses or
zoonotic agents listed in Annex I, column 1, having regard
to the general criteria listed in paragraph 6(c) and any
specific criteria laid down in Annex III.

(c) The criteria to be considered before amending Annex I
include, with respect to the zoonosis or zoonotic agent
concerned:

(i) its frequency in animal and human populations,

feed and food;

(ii) the gravity of its effects for humans;

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(iii) its economic consequences for animal and human
health care and for feed and food businesses;

National control programmes shall cover at

4.
following stages of the food chain:

least

the

(iv) epidemiological trends in animal and human popu-

lations, feed and food;

(v) scientific advice;

(vi) technological developments, particularly relating to
the practicality of the available control options; and

(vii) requirements

and trends

concerning breeding

systems and production methods.

Annex III may be amended or supplemented in accord-

7.
ance with the procedure referred to in Article 14(2).

The Commission shall review the implementation of
this review when

8.
Community targets and take account of
proposing further targets.

(a) feed production;

(b) primary production of animals;

(c) processing and preparation of food of animal origin.

5.
National control programmes shall contain, where rele-
vant, the provisions laid down in relation to testing methods
and criteria against which the results of these tests shall be
for testing animals and hatching eggs despatched
assessed,
within the national territory, as part of the official controls
provided for in Annex II, part A.

9. Measures taken to reduce the prevalence of zoonoses and
zoonotic agents listed in Annex I shall be implemented in
accordance with the rules laid down in this Regulation and any
rules adopted pursuant thereto.

The requirements and minimum sampling rules laid down
6.
in Annex II may be amended, adapted or supplemented,
in
accordance with the procedure referred to in Article 14(2), after
taking account in particular of the criteria listed in point (c) of
Article 4(6).

CHAPTER III

CONTROL PROGRAMMES

Article 5

National control programmes

To achieve the Community targets provided for in Article
1.
4, Member States shall establish national control programmes
for each zoonosis and zoonotic agent
listed in Annex I.
National control programmes shall have regard to the geogra-
phical distribution of zoonoses within each Member State and
to the financial
implications for primary producers and feed
and food business operators of establishing effective controls.

National control programmes shall be continuous and

2.
cover a period of at least three consecutive years.

3.

National control programmes shall:

(a) provide for the detection of zoonoses and zoonotic agents
and minimum

requirements

in accordance with the
sampling rules laid down in Annex II;

(b) define the respective responsibilities of competent authori-

ties and food and feed business operators;

(c) specify the control measures to be taken following the
detection of zoonoses and zoonotic agents, in particular to
the
protect public health,
specific measures laid down in Annex II;

including implementation of

(d) allow for the progress under their provisions to be evalu-
ated and for those programmes to be reviewed, in particu-
lar in the light of results obtained from the detection of
zoonoses and zoonotic agents.

7. Within six months of the establishment of the Com-
munity targets provided for in Article 4, Member States shall
submit their national control programmes to the Commission
and set out the measures to be implemented.

Article 6

Approval of the national control programmes

After

a Member State

submits a national

1.
control
programme in accordance with Article 5, the Commission shall
have two months within which to request any further relevant
and necessary information from that Member State. The
Member State shall provide such further information within
two months of receiving such a request. The Commission shall,
within two months of receiving such further information or, if
it did not request further information, within six months of the
submission of the control programme, establish whether it
complies with relevant rules, including this Regulation in par-
ticular.

2. When the Commission has established the conformity of
a national control programme, or at the request of the Member
State that submitted it, the programme shall be considered
without undue delay with a view to approval in accordance
with the procedure referred to in Article 14(2).

Amendments

3.
to a programme previously approved
pursuant to paragraph 2 may be approved, in accordance with
the procedure referred to in Article 14(2), to take account of
the evolution in the situation in the Member State concerned,
in particular in the light of the results referred to in Article
5(3)(d).

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Article 7

Food and feed business operators' control programmes

1.
Food and feed business operators, or organisations repre-
senting such operators, may establish control programmes,
covering, as far as possible, all stages of production, processing
and distribution.

2.
If they wish their control programmes to form part of a
national control programme, food and feed business operators,
or their representative organisations, shall submit their control
programmes, and any amendments thereto, to the competent
authority of the Member State in which they are located for
approval. If the operations concerned take place in different
Member States, the programmes shall be approved separately
for each Member State.

The

competent

authority may

3.
control
programmes submitted pursuant to paragraph 2 only if it is
satisfied that the control programmes comply with the relevant
requirements set out in Annex II and with the objectives of the
relevant national control programme.

approve

4. Member States shall maintain up-to-date lists of approved
control programmes of food and feed business operators or
their representative organisations. The lists shall be made avail-
able to the Commission upon request.

5.
Food and feed business operators or their representative
organisations shall communicate regularly the results of their
control programmes to the competent authorities.

CHAPTER IV

CONTROL METHODS

Article 8

Specific control methods

At the initiative of the Commission or at the request of a
1.
Member State and in accordance with the procedure referred to
in Article 14(2):

(a) it may be decided that specific control methods may or
shall 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;

(b) rules may be adopted concerning the conditions for the use

of the methods referred to in subparagraph (a);

(c) detailed rules may be adopted concerning necessary docu-
ments and procedures as well as minimum requirements
for the methods referred to in subparagraph (a); and

(d) it may be decided that certain specific control methods

shall not be used as a part of control programmes.

2.
The provisions referred to in paragraph 1(a), (b) and (c)
shall not apply to methods using substances or techniques
covered by Community legislation on animal nutrition, food
additives or veterinary medicinal products.

CHAPTER V

TRADE

Article 9

Intra-Community trade

As from the dates mentioned in Annex I, column 5, at
1.
the latest, flocks and herds of origin of the species listed in
column 2 shall be tested for the zoonoses and zoonotic agents
listed in column 1 prior to any dispatching of the live animals,
or hatching eggs, from the food business of origin. The date
and the result of testing shall be included in the relevant health
certificates provided for in Community legislation.

The Member State of destination may, in accordance with
2.
the procedure referred to in Article 14(2), be authorised for a
transitional period to require that the results of the tests to be
referred to in the relevant health certificates for consignments
of animals and hatching eggs subject to testing in the Member
State of dispatch fulfil the same criteria as regards salmonella as
those laid down under its approved national programme,
in
accordance with Article 5(5),
for consignments despatched
within its territory.

The authorisation may be withdrawn in accordance with the
same procedure.

3.
The special measures concerning salmonella that applied
to live animals dispatched to Finland and Sweden prior to the
entry into force of this Regulation shall continue to apply as if
they had been authorised in accordance with paragraph 2.

4. Without prejudice
rules
concerning the setting by Member States of the criteria referred
to in Article 5(5) and in paragraph 2 above, may be laid down
in accordance with the procedure referred to in Article 14(2).

to Article 5(6),

specific

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Article 10

Imports from third countries

1.
As from the dates mentioned in Annex I, column 5,
third countries
retention on the lists of
admission to or
provided for in Community legislation, for the relevant species
or category,
from which Member States are authorised to
import those animals or hatching eggs covered by this Regu-
lation shall be subject to submission to the Commission by the
third country concerned of a programme equivalent to those
provided for under Article 5 and its approval
in accordance
with this Article. The programme shall give details of the guar-
antees offered by that country as regards inspections and
controls for zoonoses and zoonotic agents. Those guarantees
must be at least equivalent to the guarantees provided for by
this Regulation. The Food and Veterinary Office of
the
Commission shall be closely involved in monitoring to verify
whether equivalent control programmes exist in third coun-
tries.

These programmes shall be approved in accordance with
2.
the procedure referred to in Article 14(2), provided that the
equivalence of the measures described under the programme,
with the relevant requirements applicable under Community
rules,
is objectively demonstrated. Alternative guarantees to
those provided for in this Regulation may be allowed in accord-
ance with that procedure, provided that they are not more
favourable than those applicable to intra-Community trade.

For third countries with which a regular trade flow is
3.
established,
the provisions of Article 5(7) and Article 6(1)
concerning time periods for the submission and approval of
programmes shall apply. For third countries establishing or
resuming a trade flow, the time periods provided for in Article
6 shall apply.

4.
Flocks and herds of origin of species listed in Annex I,
column 2, shall be tested prior to any dispatching of the live
animals or hatching eggs from the food business of origin.
Flocks and herds shall be tested for the zoonoses and zoonotic
agents listed in Annex I, column 1, or, if necessary to achieve
the objective of equivalent guarantees laid down in paragraph
1, such zoonoses and zoonotic agents as may be specified in
accordance with the procedure referred to in Article 14(2). The
date and the result of testing shall be included in the relevant
import certificates, for which the models laid down by Com-
munity legislation shall be amended accordingly.

5.
The Member State of final destination may be authorised,
in accordance with the procedure referred to in Article 14(2),
to require for a transitional period that the results of the testing
referred to in paragraph 4 fulfil the same criteria as those laid
down under its national programme, in accordance with Article

5(5). The authorisation may be withdrawn and, without preju-
dice to Article 5(6), specific rules concerning such criteria may
be laid down, in accordance with the procedure referred to in
Article 14(2).

6.
Admission to or retention on the lists of third countries
provided for in Community legislation, for the relevant cate-
gory of products, from which Member States are authorised to
import those products covered by this Regulation shall be
subject to submission to the Commission by the third country
concerned of guarantees equivalent to those provided for by
this Regulation.

CHAPTER VI

LABORATORIES

Article 11

Reference laboratories

Community reference laboratories for the analysis and
1.
testing of zoonoses and zoonotic agents listed in Annex I,
column 1, shall be designated in accordance with the procedure
referred to in Article 14(2).

2.
The responsibilities and tasks of the Community reference
laboratories, in particular with regard to coordination of their
activities and those of the national reference laboratories, shall
be laid down in accordance with the procedure referred to in
Article 14(2).

3. Member States shall designate national reference labora-
tories for the analysis and testing of zoonoses and zoonotic
agents listed in Annex I, column 1. The names and addresses of
laboratories shall be communicated to the Commission.

Certain responsibilities and tasks of the national reference
4.
laboratories, in particular with regard to coordination of their
activities and those of the relevant laboratories in the Member
States designated under Article 12(1)(a), may be laid down in
accordance with the procedure referred to in Article 14(2).

Article 12

Approval of

laboratories, quality requirements
approved testing methods

and

Laboratories

participating

programmes
1.
pursuant to Articles 5 and 7 shall, for the purposes of analysing
samples to test for the presence of zoonoses and zoonotic
agents referred to in Annex I, column 1:

control

in

(a) be designated by the competent authority; and

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(b) apply quality assurance systems

that conform to the
requirements of the current EN/ISO standard at the latest
within 24 months of entry into force of this Regulation or
within 24 months of the addition of new zoonoses or
zoonotic agents to Annex I, column 1.

2.
Laboratories shall regularly participate in collaborative
testing organised or coordinated by the national reference
laboratory.

3.
Testing for the presence of zoonoses and zoonotic agents
referred to in Annex I, column 1, shall be carried out using the
methods and protocols recommended by international standar-
disation bodies, as reference methods.

Alternative methods may be used if they have been validated in
accordance with internationally recognised rules and offer
equivalent results to those obtained by the relevant reference
method.

Article 15

Consultation of the European Food Safety Authority

the European Food Safety
The Commission shall consult
Authority on any matter within the scope of this Regulation
that could have a significant impact on public health and, in
particular, before proposing Community targets in accordance
with Article 4 or specific control methods in accordance with
Article 8.

Article 16

Report on financial arrangements

The Commission shall, within three years of the entry
1.
into force of this Regulation, submit a report to the European
Parliament and to the Council.

Where necessary, other methods for testing may be approved
in accordance with the procedure referred to in Article 14(2).

2.

The report shall discuss:

CHAPTER VII

IMPLEMENTATION

Article 13

Implementing and transitional measures

Appropriate transitional or implementing measures, including
the necessary amendments to the relevant health certificates,
may be adopted in accordance with the procedure referred to
in Article 14(2).

Article 14

Committee procedure

(a) the arrangements in place, at Community and national
level, to finance measures taken to control zoonoses and
zoonotic agents; and

(b) the effect that such arrangements have on the effectiveness

of those measures.

The Commission shall,
3.
report with relevant proposals.

if appropriate, accompany its

4. Member States shall, on request, provide the Commission
with all the assistance necessary to enable it to prepare its
report.

CHAPTER VIII

GENERAL AND FINAL PROVISIONS

Article 17

Community controls

1.
The Commission shall be assisted by the Standing
Committee on the Food Chain and Animal Health instituted by
Regulation (EC) No 178/2002 (hereinafter referred to as ‘the
Committee’).

2. Where reference is made to this paragraph, Articles 5 and
7 of Decision 1999/468/EC shall apply, having regard to the
provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC
shall be set at three months.

3.

The Committee shall adopt its rules of procedure.

Experts from the Commission shall carry out on-the-spot
1.
checks,
in cooperation with the competent authorities of
Member States, in order to ensure that the provisions of this
Regulation, rules adopted pursuant thereto and any safeguard
measures are applied uniformly. A Member State on whose
territory checks are made shall provide the experts with all the
assistance necessary for carrying out their duties. The Commis-
sion shall inform the competent authority of the results of the
checks made.

2.
Rules for the implementation of this Article, in particular
those governing the procedure for cooperation with national
competent authorities, shall be laid down under the procedure
referred to in Article 14(2).

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Article 18

Entry into force

This Regulation shall enter into force on the day of its publication in the Official Journal of the European
Union.

It shall apply as from six months following its entry into force.

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

Done at Brussels, 17 November 2003.

For the European Parliament

The President

P. COX

For the Council

The President

G. ALEMANNO

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ANNEX I

Specified zoonoses and zoonotic agents for which Community targets for the reduction of prevalence are to
be established pursuant to Article 4

1. Zoonosis or zoonotic

agent

2. Animal population

3. Stage of food chain

4. Date by which target

must be estab-
lished (*)

5. Date from which
testing must take
place

All salmonella sero-
types with public
health significance

All salmonella sero-
types with public
health significance

All salmonella sero-
types with public
health significance

All salmonella sero-
types with public
health significance

All salmonella sero-
types with public
health significance

All salmonella sero-
types with public
health significance

Breeding flocks of
Gallus gallus

Primary production

Laying hens

Primary production

Broilers

Primary production

Turkeys

Primary production

Herds of slaughter
pigs

Slaughter

Breeding herds of
pigs

Primary production

12 months after the
date of entry into
force of this Regu-
lation.

24 months after the
date of entry into
force of this Regu-
lation.

36 months after the
date of entry into
force of this Regu-
lation.

48 months after the
date of entry into
force of this Regu-
lation.

48 months after the
date of entry into
force of this Regu-
lation.

60 months after the
date of entry into
force of this Regu-
lation.

18 months after the
date referred to in
column 4

18 months after the
date referred to in
column 4

18 months after the
date referred to in
column 4

18 months after the
date referred to in
column 4

18 months after the
date referred to in
column 4

18 months after the
date referred to in
column 4

(*) These dates are based on the assumption that comparable data on prevalence will be available at least six months before the establish-
ment of the target. If such data were not available, the date for the establishment of the target would be postponed accordingly.

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ANNEX II

CONTROL OF ZOONOSES AND ZOONOTIC AGENTS LISTED IN ANNEX I

A. General requirements for national control programmes

The programme must take into account the nature of the zoonosis and/or zoonotic agent concerned and the specific
situation in the Member State. It must:

(a) state the aim of the programme taking into consideration the importance of the zoonosis or zoonotic agent

concerned;

(b) comply with the minimum sampling requirements laid down in part B;

(c) where relevant, comply with the specific requirements laid down in parts C to E; and

(d) specify the following points:

1.

General

1.1. The occurrence of the zoonosis or zoonotic agent concerned in the Member State with specific reference to

the results obtained in the framework of monitoring in accordance with Article 4 of Directive 2003/99/EC.

1.2. The geographical area or, where appropriate, the epidemiological units, in which the programme will be

implemented.

1.3. The structure and organisation of the relevant competent authorities.

1.4. Approved laboratories where samples collected within the programme are analysed.

1.5. Methods used in the examination of the zoonosis or zoonotic agent.

1.6. Official controls (including sampling schemes) at feed, flock and/or herd level.

1.7. Official controls (including sampling schemes) at other stages of the food chain.

1.8. Measures taken by the competent authorities with regard to animals or products in which zoonoses or
zoonotic agents have been detected, in particular to protect public health; and any preventive measures taken,
such as vaccination.

1.9. Relevant national legislation, including any national provisions concerning the activities referred to in Article

1(3)(b).

1.10. Any financial assistance provided to food and feed businesses in the context of

the national control

programme;

2.

Concerning food and feed businesses covered by the programme

2.1. The structure of the production of the given species and products thereof.

2.2. The structure of the production of feed.

2.3. Relevant guides for good animal husbandry practices or other guidelines (mandatory or voluntary) defining at

least:

— hygiene management at farms,

— measures to prevent incoming infections carried by animals, feed, drinking water, people working at farms,

and

— hygiene in transporting animals to and from farms.

2.4. Routine veterinary supervision of farms.

2.5. Registration of farms.

2.6. Record-keeping at farms.

2.7. Documents to accompany animals when dispatched.

2.8. Other relevant measures to ensure the traceability of animals.

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B. Minimum sampling requirements

1. After the relevant control programme referred to in Article 5 has been approved, food business operators must have
samples taken and analysed to test for the zoonoses and zoonotic agents listed in Annex I, column 1, respecting the
minimum sampling requirements set out in the following table.

1. Zoonosis or zoonotic agent

2. Animal population

3. Phases of production which sampling

must cover

All salmonella serotypes with public
health significance

Breeding flocks of Gallus gallus:

— rearing flocks

— day-old chicks

— four-week-old birds

— two weeks before moving to

laying phase or laying unit

— adult breeding flocks

— every second week during the

laying period

All salmonella serotypes with public
health significance

Laying hens:

— rearing flocks

— day-old chicks

— pullets two weeks before moving
to laying phase or laying unit

— laying flocks

— every 15 weeks during the laying

phase

All salmonella serotypes with public
health significance

Broilers

— birds leaving for slaughter (*)

All salmonella serotypes with public
health significance

Turkeys

— birds leaving for slaughter (*)

All salmonella serotypes with public
health significance

Herds of pigs:

— breeding pigs

— slaughter pigs

— animals leaving for slaughter or
carcases at the slaughterhouse

— animals leaving for slaughter or
carcases at the slaughterhouse

(*) The results of the analysis on the samples must be known before the animals leave for the slaughterhouse.

2. The requirements laid down in point 1 are without prejudice to the requirements of Community legislation

concerning ante mortem inspection.

3. The results of the analysis must be recorded, together with the following information:

(a) date and place of sampling; and

(b) identification of the flock/herd.

4. Immunological testing may not be used if the animals have been vaccinated, unless it has been proven that the

vaccine used does not interfere with the testing method applied.

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C. Specific requirements concerning breeding flocks of Gallus gallus

1. The measures laid down in points 3 to 5 must be taken whenever the analysis of samples carried out in accordance
with part B indicates the presence of Salmonella enteritidis or Salmonella typhimurium in a breeding flock of Gallus gallus
in the circumstances set out in point 2.

2.

(a) If the competent authority has approved the method of analysis used for samples taken in accordance with part
B, it may require that the measures laid down in points 3 to 5 be taken when such analysis detects the presence
of Salmonella enteritidis or Salmonella typhimurium.

(b) Otherwise, the measures laid down in points 3 to 5 must be taken whenever the competent authority confirms a
suspicion of the presence of Salmonella enteritidis or Salmonella typhimurium arising from the analysis of samples
carried out in accordance with part B.

3. Non-incubated eggs from the flock must be destroyed.

However, such eggs may be used for human consumption if they are treated in a manner that guarantees the elimina-
tion of Salmonella enteritidis and Salmonella typhimurium in accordance with Community legislation on food hygiene.

4. All birds, including day-old chicks, in the flock must be slaughtered or destroyed so as to reduce as much as possible
the risk of spreading salmonella. Slaughtering must be carried out in accordance with Community legislation on food
hygiene. Products derived from such birds may be placed on the market for human consumption in accordance with
Community legislation on food hygiene and, once applicable, part E. If not destined for human consumption, such
products must be used or disposed of in accordance with Regulation (EC) No 1774/2002 of the European Parliament
and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for
human consumption (1).

5. Where eggs for hatching from flocks in which Salmonella enteritidis or Salmonella typhimurium is present are still

present in a hatchery, they must be destroyed or treated in accordance with Regulation (EC) No 1774/2002.

D. Specific requirements concerning flocks of laying hens

1. With effect from 72 months after entry into force of this Regulation, eggs must not be used for direct human
consumption (as table eggs) unless they originate from a commercial flock of laying hens subject to a national
programme established under Article 5 and not under official restriction.

2. Eggs originating from flocks with unknown health status, that are suspected of being infected or from infected flocks
may be used for human consumption only if treated in a manner that guarantees the elimination of all salmonella
serotypes with public health significance in accordance with Community legislation on food hygiene.

3. When birds from infected flocks are slaughtered or destroyed, steps must be taken to reduce the risk of spreading
zoonoses as far as possible. Slaughtering must be carried out in accordance with Community legislation on food
hygiene. Products derived from such birds may be placed on the market for human consumption in accordance with
Community legislation on food hygiene and, once applicable, part E. If not destined for human consumption, such
products must be used or disposed of in accordance with Regulation (EC) No 1774/2002.

E. Specific requirement concerning fresh meat

1. With effect from 84 months after entry into force of this Regulation, fresh poultry meat from animals listed in Annex

I may not be placed on the market for human consumption unless it meets the following criterion:

‘Salmonella: absence in 25 grams’

2. Within 72 months of entry into force of this Regulation, detailed rules for this criterion will be laid down in accord-
ance with the procedure referred to in Article 14(2). These will specify, in particular, sampling schemes and analytical
methods.

3. The criterion laid down in paragraph 1 does not apply to fresh poultry meat destined for industrial heat treatment or

another treatment to eliminate salmonella in accordance with Community legislation on food hygiene.

(1) OJ L 273, 10.10.2002, p. 1. Regulation as last amended by Commission Regulation (EC) No 808/2003 (OJ L 117, 13.5.2003, p. 1).

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ANNEX III

Specific criteria to determine salmonella serotypes with public health significance

When determining which are the salmonella serotypes with public health significance to which Community targets will
apply, account must be taken of the following criteria:

1. the most frequent salmonella serotypes in human salmonellosis on the basis of data collected through EC monitoring

systems;

2. the route of infection (that is, the presence of the serotype in relevant animal populations and feed);

3. whether any serotype shows a rapid and recent ability to spread and to cause disease in humans and animals;

4. whether any serotypes show increased virulence, for instance as regards invasiveness, or resistance to relevant

therapies for human infections.