Directive 2003/99/EC of the European 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
Date: 2003-11-17
Institutions: Council of the European Union, European Parliament
Subjects: animal disease, disease prevention, food inspection, health legislation, infectious disease, veterinary inspection, zoonosis

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DIRECTIVE 2003/99/EC OF THE EUROPEAN 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

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EURO-
PEAN 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),

(6) With the assistance of the Community reference labora-
tory for the epidemiology of zoonoses, the Commission
collects the results of monitoring yearly from Member
States and compiles them. Publication of the results has
taken place yearly since 1995. They provide a basis for
the evaluation of
situation concerning
the current
zoonoses and zoonotic agents. However, the data collec-
tion systems are not harmonised and therefore do not
permit comparisons between Member States.

After consulting the Committee of the Regions,

(7)

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

Whereas:

(1)

(2)

(3)

(4)

(5)

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.

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

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 a monitoring system for certain
zoonoses both at the level of Member States and at
Community level.

(1) OJ C 304 E, 30.10.2001, p. 250.
(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. 161), Council common position of 20 February 2003
(OJ C 90 E, 15.4.2003, p. 9) and position of the European Parlia-
ment of 19 June 2003 (not yet published in the Official Journal).
(4) OJ L 62, 15.3.1993, p. 38. Directive as last amended by Regulation

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

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 (5) 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 (6) deals with ovine and
caprine brucellosis. This Directive should not create any
unnecessary duplication of those existing requirements.

Moreover, a future regulation of the European Parlia-
ment and of the Council on the hygiene of foodstuffs
should cover specific elements necessary for prevention,
control and monitoring of zoonoses and zoonotic agents
and include specific requirements for the microbiological
quality of food.

the European Parliament and of

Directive 92/117/EEC provides for collection of data on
human cases of zoonoses. The aim of Decision No
the
2119/98/EC of
Council of 24 September 1998 setting up a network for
the epidemiological surveillance and control of commu-
nicable diseases in the Community (7) is to reinforce the
collection of such data and to contribute to improving
the prevention and control,
in the Community, of
communicable diseases.

(8)

(9)

(10)

The collection of data on the occurrence of zoonoses
and zoonotic agents in animals, food, feed and humans
is necessary to determine the trends and sources of
zoonoses.

(5) OJ 121, 29.7.1964, p. 1977. Directive as last amended by Commis-
sion Regulation (EC) No 1226/2002 (OJ L 179, 9.7.2002, p. 13).
(6) OJ L 46, 19.2.1991, p. 19. Directive as last amended by Commis-

sion Decision 2003/708/EC (OJ L 258, 10.10.2003, p. 11).

(7) OJ L 268, 3.10.1998, p. 1.

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(11)

(12)

(13)

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.
In particular, the Committee identified Salmonella spp.,
Campylobacter spp., verotoxigenic Escherichia coli (VTEC),
Listeria monocytogenes, Cryptosporidium spp., Echinococcus
granulosus/multilocularis and Trichinella spiralis as public
health priorities.

It is therefore necessary to improve the existing moni-
toring and data collection systems established by Direc-
tive 92/117/EEC. Simultaneously, Regulation (EC) No
2160/2003 of
the
Council of 17 November 2003 on the control of salmo-
nella and other specified food-borne zoonotic agents (1)
will replace the specific control measures established by
Directive 92/117/EEC. Directive 92/117/EEC should
therefore be repealed.

the European Parliament and of

The new framework for scientific advice and scientific
support in matters of food safety set up by Regulation
(EC) No 178/2002 of the European Parliament and of
the 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 (2) should be used to
collect and analyse the relevant data.

(14) Where necessary to make data easier to compile and
compare, monitoring should take place on a harmonised
basis. This would make it possible to evaluate trends and
sources of zoonoses and zoonotic agents within the
Community. The data collected, together with data from
other sources, should form the basis for risk assessment
of zoonotic organisms.

(15)

Priority should be given to those zoonoses posing the
greatest risk to human health. However, the monitoring
systems should also facilitate the detection of emerging
or newly emerging zoonotic diseases and new strains of
zoonotic organisms.

(16)

The alarming emergence of resistance to antimicrobial
agents (such as antimicrobial medicinal products and
antimicrobial
is a characteristic that
should be monitored. Provision should be made for such

feed additives)

(1) See page 1 of this Official Journal.
(2) OJ L 31, 1.2.2002, p. 1.

monitoring to cover not only zoonotic agents but also,
in so far as they present a threat to public health, other
agents. In particular, the monitoring of indicator organ-
isms might be appropriate. Such organisms constitute a
reservoir of resistance genes, which they can transfer to
pathogenic bacteria.

In addition to general monitoring, specific needs may be
recognised which may necessitate the establishment of
coordinated monitoring programmes. Attention should
be paid in particular to zoonoses listed in Annex I to
Regulation (EC) No 2160/2003.

thoroughly investigated,

food-borne outbreaks of
If
zoonoses provide
the opportunity to identify the
pathogen, the food vehicle involved and the factors in
the food preparation and handling that contributed to
the outbreak. It is therefore appropriate to make provi-
sion for such investigations and for close cooperation
between the various authorities.

Transmissible spongiform encephalopathies are covered
by Regulation (EC) No 999/2001 of the European Parlia-
ment and of the Council of 22 May 2001 laying down
rules for the prevention, control and eradication of
certain transmissible spongiform encephalopathies (3).

To ensure that information collected on zoonoses and
zoonotic agents can be used effectively, appropriate rules
should be laid down concerning the exchange of all rele-
vant information. That information should be collected
in Member States and transmitted to the Commission in
the form of reports, which should be forwarded to the
European Food Safety Authority and made available to
the public in an appropriate way without delay.

(17)

(18)

(19)

(20)

(21)

The reports should be submitted on an annual basis.
However, additional reports may be appropriate, when
warranted by circumstances.

(22)

(23)

It may be appropriate to designate national and Com-
munity reference laboratories for giving guidance and
assistance for analysis and testing in relation to zoonoses
and zoonotic agents falling within the scope of this
Directive.

Council Decision 90/424/EEC of 26 June 1990 on
expenditure in the veterinary field (4) should be amended
in so far as concerns the detailed rules governing the
Community's
certain
relating to the monitoring and control of
actions
zoonoses and zoonotic agents.

contribution towards

financial

(3) OJ L 147, 31.5.2001, p. 1. Regulation as last amended by Commis-
sion Regulation (EC) No 1494/2002 (OJ L 225, 22.8.2002, p. 3).
(4) OJ L 224, 18.8.1990, p. 19. Decision as last amended by Decision

2001/572/EC (OJ L 203, 28.7.2001, p. 16).

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(24) Appropriate procedures

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

should be

(25)

To take account of
technical and scientific progress,
close and effective cooperation should be ensured
between the Commission and the Member States within
the Standing Committee set up by Regulation (EC) No
178/2002.

(26) Member States cannot, acting alone, collect comparable
data to provide a basis for risk assessment of zoonotic
significance at Community level. The
organisms of
collection of such data can better be achieved at Com-
munity level. The Community may therefore adopt
measures,
in accordance with the principle of subsi-
diarity as set out in Article 5 of the Treaty. In accord-
ance with the principle of proportionality, as set out in
that Article, this Directive does not go beyond what is
necessary in order to achieve those objectives. The
responsibility for establishing and maintaining moni-
toring systems should lie with Member States.

(27)

The measures necessary for the implementation of this
Directive 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 (1),

HAVE ADOPTED THIS DIRECTIVE:

CHAPTER I

INTRODUCTORY PROVISIONS

Article 1

Subject matter and scope

1.
The purpose of this Directive is to ensure that zoonoses,
zoonotic agents and related antimicrobial resistance are prop-
erly monitored, and that food-borne outbreaks receive proper
epidemiological
investigation, to enable the collection in the
Community of the information necessary to evaluate relevant
trends and sources.

2.

This Directive covers:

(a) the monitoring of zoonoses and zoonotic agents;

(b) the monitoring of related antimicrobial resistance;

(c) the epidemiological investigation of food-borne outbreaks;

and

(d) the exchange of
zoonotic agents.

information related to zoonoses and

(1) OJ L 184, 17.7.1999, p. 23.

This Directive shall apply without prejudice to more
3.
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

For the purposes of this Directive, the following definitions
shall apply:

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

and

2. the following definitions:

(a) ‘zoonosis’ means any disease and/or infection which is
naturally transmissible directly or indirectly between
animals and humans;

(b) ‘zoonotic agent’ means any virus, bacterium,

fungus,
parasite or other biological entity which is likely to
cause a zoonosis;

(c) ‘antimicrobial resistance’ means the ability of micro-
organisms of certain species to survive or even to grow
in the presence of a given concentration of an antimi-
crobial agent, that is usually sufficient to inhibit or kill
micro-organisms of the same species;

(d) ‘food-borne outbreak’ means an incidence, observed
under given circumstances, of two or more human cases
of the same disease and/or infection, or a situation in
which the observed number of cases exceeds
the
expected number and where the cases are linked, or are
probably linked, to the same food source;

(e) ‘monitoring’ means a system of collecting, analysing and
disseminating data on the occurrence of zoonoses,
zoonotic agents and antimicrobial
resistance related
thereto.

Article 3

General obligations

1. Member States shall ensure that data on the occurrence of
zoonoses and zoonotic agents and antimicrobial resistance
related thereto are collected, analysed and published without
delay in accordance with the requirements of this Directive and
of any provisions adopted pursuant to it.

Each Member State shall designate a competent authority
2.
or competent authorities for the purposes of this Directive 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 Directive.

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Each Member State shall ensure that effective and contin-
3.
uous cooperation based on free exchange of general informa-
tion and, where necessary, of specific data,
is established
between the competent authority or authorities designated for
the purposes of this Directive and:

(a) the competent authorities for the purposes of Community

legislation on animal health;

(b) the competent authorities for the purposes of Community

legislation on feed;

(c) the competent authorities for the purposes of Community

legislation on food hygiene;

(d) the structures and/or authorities referred to in Article 1 of

Decision No 2119/98/EC;

(e) other authorities and organisations concerned.

4.
Each Member State shall ensure that the relevant officials
of the competent authority or competent authorities referred to
in paragraph 2 undertake suitable initial and ongoing training
in veterinary science, microbiology or epidemiology, as neces-
sary.

(b) the gravity of their effects for humans;

(c) their economic consequences for animal and human health

care and for feed and food businesses;

(d) epidemiological trends in animal and human populations,

feed and food.

5. Monitoring shall be based on the systems in place in
Member States. However, where necessary to make data easier
to compile and compare, detailed rules for the monitoring of
zoonoses and zoonotic agents listed in Annex I may be laid
down in accordance with the procedure referred to in Article
12(2) and taking into consideration other Community rules laid
down in the fields of animal health, food hygiene and commu-
nicable human diseases.

Such detailed rules shall lay down minimum requirements for
the monitoring of certain zoonoses or zoonotic agents. They
may, in particular, specify:

(a) the animal population or subpopulations or stages in the

food chain to be covered by monitoring;

(b) the nature and type of data to be collected;

CHAPTER II

(c) case definitions;

MONITORING OF ZOONOSES AND ZOONOTIC AGENTS

(d) sampling schemes to be used;

Article 4

General rules on monitoring of zoonoses and zoonotic
agents

1. Member States shall collect relevant and comparable data
in order to identify and characterise hazards, to assess expo-
sures and to characterise risks related to zoonoses and zoonotic
agents.

2. Monitoring shall take place at the stage or stages of the
food chain most appropriate to the zoonosis or zoonotic agent
concerned, that is:

(e) laboratory methods to be used in testing; and

(f) the

frequency of

reporting,

including guidelines

for

reporting between local, regional and central authorities.

6. When considering whether to propose detailed rules in
accordance with paragraph 5 to harmonise the routine moni-
toring of zoonoses and zoonotic agents, the Commission shall
give priority to zoonoses and zoonotic agents listed in Part A
of Annex I.

Article 5

(a) at the level of primary production; and/or

Coordinated monitoring programmes

(b) at other stages of the food chain,

including in food and

feed.

3. Monitoring shall cover zoonoses and zoonotic agents
listed in Annex I, Part A. Where the epidemiological situation
in a Member State so warrants, zoonoses and zoonotic agents
listed in Annex I, Part B shall also be monitored.

Annex I may be amended in accordance with the proce-
4.
dure referred to in Article 12(2) to add zoonoses or zoonotic
agents to, or delete them from, the lists therein, taking account
in particular of the following criteria:

(a) their occurrence in animal and human populations, feed

and food;

concerning one or more

1.
If data collected through routine monitoring in accord-
ance with Article 4 are not sufficient, coordinated monitoring
programmes
and/or
zoonotic agents may be established in accordance with the
procedure referred to in Article 12(2). Coordinated monitoring
programmes may be established, especially when specific needs
are identified, to assess risks or to establish base-line values
related to zoonoses or zoonotic agents at the level of Member
States or at Community level.

zoonoses

special

2. Where a coordinated monitoring programme is estab-
lished,
reference shall be made to zoonoses and
zoonotic agents in animal populations referred to in Annex I to
Regulation (EC) No 2160/2003.

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3. Minimum rules concerning the establishment of coordi-
nated monitoring programmes are laid down in Annex III.

Article 6

Food business operators' duties

1. Member States shall ensure that, when food business
operators carry out examinations for the presence of zoonoses
and zoonotic agents subject to monitoring under Article 4(2),
they:

(a) keep the results and arrange for the preservation of any
relevant isolate for a period to be specified by the compe-
tent authority; and

(b) communicate results or provide isolates to the competent

authority on request.

Detailed rules for the implementation of this Article may
2.
be laid down in accordance with the procedure referred to in
Article 12(2).

CHAPTER III

ANTIMICROBIAL RESISTANCE

Article 7

Monitoring of antimicrobial resistance

1. Member States shall ensure,
in accordance with the
requirements set out in Annex II, that monitoring provides
comparable data on the occurrence of antimicrobial resistance
in zoonotic agents and, in so far as they present a threat to
public health, other agents.

Such monitoring shall supplement

the monitoring of
2.
human isolates conducted in accordance with Decision No
2119/98/EC.

3.
Detailed rules for the implementation of this Article shall
be laid down in accordance with the procedure referred to in
Article 12(2).

CHAPTER IV

FOOD-BORNE OUTBREAKS

Article 8

Epidemiological investigation of food-borne outbreaks

1. Member States shall ensure that, when a food business
operator provides information to the competent authority
pursuant to Article 19(3) of Regulation (EC) No 178/2002, the
foodstuff involved, or an appropriate sample of it, is preserved
in order not to impede its investigation in a laboratory or the
investigation of any food-borne outbreak.

The competent authority shall

2.
investigate food-borne
outbreaks in cooperation with the authorities referred to in
Article 1 of Decision No 2119/98/EC. The investigation shall
provide data on the epidemiological profile,
the foodstuffs
potentially implicated and the potential causes of the outbreak.
include, as far as possible, adequate
The investigation shall

epidemiological and microbiological studies. The competent
authority shall transmit to the Commission (which shall send it
to the European Food Safety Authority) a summary report of
the results of the investigations carried out, containing the
information referred to in Part E of Annex IV.

3.
Detailed rules concerning the investigation of food-borne
outbreaks may be laid down in accordance with the procedure
referred to in Article 12(2).

Paragraphs 1 and 2 shall apply without prejudice to Com-
4.
munity provisions on product
safety, early warning and
response systems for the prevention and control of communic-
able human diseases, food hygiene and the general require-
ments of food law, in particular those concerning emergency
measures and procedures for withdrawing food and feed from
the market.

CHAPTER V

EXCHANGE OF INFORMATION

Article 9

Assessment of trends and sources of zoonoses, zoonotic
agents and antimicrobial resistance

1. Member States
and sources of
zoonoses, zoonotic agents and antimicrobial resistance in their
territory.

shall assess

trends

Each Member State shall transmit to the Commission every
year by the end of May a report on trends and sources of
resistance,
zoonoses,
covering the data collected pursuant to Articles 4, 7 and 8
during the previous year. Reports, and any summaries of them,
shall be made publicly available.

and antimicrobial

zoonotic

agents

Reports shall also contain the information referred to in Article
3(2)(b) of Regulation (EC) No 2160/2003.

Minimum requirements concerning the reports are laid down
in Annex IV. Detailed rules concerning the assessment of those
reports, including the formats and the minimum information
that they must include, may be laid down in accordance with
the procedure referred to in Article 12(2).

the Commission may
Where the circumstances warrant
request specific additional information and the Member States
shall submit reports to the Commission upon such request, or
on their own initiative.

it,

The Commission shall send the reports referred to in
2.
paragraph 1 to the European Food Safety Authority, which
shall examine them and publish by the end of November a
summary report on the trends and sources of zoonoses,
zoonotic agents and antimicrobial
resistance in the Com-
munity.

When preparing the summary report, the European Food Safety
Authority may take into consideration other data provided for
in the framework of Community legislation, such as:

— Article 8 of Directive 64/432/EEC,

— Article 14(2) of Directive 89/397/EEC (1),

(1) Council Directive 89/397/EEC of 14 June 1989 on the official

control of foodstuffs (OJ L 186, 30.6.1989, p. 23).

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— Article 24 of Decision 90/424/EEC,

— Article 4 of Decision No 2119/98/EC.

3. Member States shall provide the Commission with the
results of coordinated monitoring programmes established in
accordance with Article 5. The Commission shall send the
results to the European Food Safety Authority. The results, and
any summaries of them, shall be made publicly available.

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.

CHAPTER VI

LABORATORIES

Article 10

Community and national reference laboratories

1.
One or more Community reference laboratories for the
analysis and testing of zoonoses and zoonotic agents and anti-
microbial
resistance related thereto may be designated in
accordance with the procedure referred to in Article 12(2).

2. Without prejudice to the relevant provisions of Decision
90/424/EEC, the responsibilities and tasks of the Community
reference laboratories, in particular with regard to coordination
of their activities and those of the national reference labora-
tories, shall be laid down in accordance with the procedure
referred to in Article 12(2).

3. Member States shall designate national reference labora-
tories for each field where a Community reference laboratory
has been established and inform the Commission thereof.

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

CHAPTER VII

IMPLEMENTATION

Article 11

Amendments to the Annexes and transitional or imple-
menting measures

Annexes II, III and IV may be amended and any appropriate
transitional or implementing measures adopted in accordance
with the procedure referred to in Article 12(2).

Article 12

Committee procedure

1.
The Commission shall be assisted by the Committee on
the Food Chain and Animal Health instituted by Regulation
(EC) No 178/2002 or, where appropriate, by the Committee
set up under Decision No 2119/98/EC.

Article 13

Consultation of the European Food Safety Authority

The Commission shall consult
the European Food Safety
Authority on any matter within the scope of this Directive that
could have a significant impact on public health, in particular
before proposing any amendment to Annexes I or II or before
establishing any coordinated monitoring programme in accord-
ance with Article 5.

Article 14

Transposition

1. Member States shall adopt and publish the laws, regula-
tions and administrative provisions necessary to comply with
this Directive by 12 April 2004. They shall forthwith inform
the Commission thereof.

They shall apply those measures by 12 June 2004.

When Member States adopt those measures, they shall contain
a reference to this Directive or be accompanied by such a refer-
ence on the occasion of their official publication. Member
States shall determine how such reference is to be made.

2. Member States shall communicate to the Commission the
text of the provisions of national law that they adopt in the
field covered by this Directive.

CHAPTER VIII

FINAL PROVISIONS

Article 15

Repeal

Directive 92/117/EEC shall be repealed with effect from 12
June 2004.

adopted
However, measures which Member States have
pursuant to Article 8(1) of Directive 92/117/EEC and those
implemented in accordance with Article 10(1)
thereof and
plans approved in accordance with Article 8(3) thereof shall
remain in force until corresponding control programmes have
been approved in accordance with Article 5 of Regulation (EC)
No 2160/2003.

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Article 16

3. In the Annex, the following indents shall be added to the list

Amendment of Decision 90/424/EEC

Decision 90/424/EEC is hereby amended as follows:

1. Article 29 is replaced by the following:

‘Article 29

1. Member States may seek a Community financial
contribution for the monitoring and control of the zoonoses
specified in the Annex, Group 2, in the framework of the
provisions referred to in Article 24(2) to (11).

2.
As regards control of zoonoses, the Community finan-
cial contribution shall be introduced as part of a national
control programme referred to in Article 5 of 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 (*). The level
of Community financial participation shall be fixed at a
maximum of 50 % of costs incurred for the implementation
of mandatory control measures.

(*) OJ L 325, 12.12.2003, p. 1.’

2. the following Article is inserted:

‘Article 29a

Member States may seek from the Community the financial
contribution referred to in Article 29(2) for a national plan
which was approved on the basis of Directive 92/117/EEC,
until the date on which corresponding control programmes
have been approved in accordance with Article 6 of Regu-
lation (EC) No 2160/2003.’

under Group 2:
‘— Campylobacteriosis and agents thereof

— Listeriosis and agents thereof

— Salmonellosis (zoonotic salmonella) and agents thereof

— Trichinellosis and agents thereof

— Verotoxigenic Escherichia coli.’

Article 17

Entry into force

This Directive shall enter into force on the day of its publica-
tion in the Official Journal of the European Union.

Article 18

Addressees

This Directive is addressed to the 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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A. Zoonoses and zoonotic agents to be included in monitoring

ANNEX I

— brucellosis and agents thereof

— campylobacteriosis and agents thereof

— echinococcosis and agents thereof

— listeriosis and agents thereof

— salmonellosis and agents thereof

— trichinellosis and agents thereof

— tuberculosis due to Mycobacterium bovis

— verotoxigenic Escherichia coli

B. List of zoonoses and zoonotic agents to be monitored according to the epidemiological situation

1. Viral zoonoses

— calicivirus

— hepatitis A virus

— influenza virus

— rabies

— viruses transmitted by arthropods

2. Bacterial zoonoses

— borreliosis and agents thereof

— botulism and agents thereof

— leptospirosis and agents thereof

— psittacosis and agents thereof

— tuberculosis other than in point A

— vibriosis and agents thereof

— yersiniosis and agents thereof

3. Parasitic zoonoses

— anisakiasis and agents thereof

— cryptosporidiosis and agents thereof

— cysticercosis and agents thereof

— toxoplasmosis and agents thereof

4. Other zoonoses and zoonotic agents

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Official Journal of the European Union

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ANNEX II

Requirements for monitoring of antimicrobial resistance pursuant to Article 7

A. General requirements

Member States must ensure that the monitoring system for antimicrobial resistance provided for in Article 7 provides
at least the following information:

1. animal species included in monitoring;

2. bacterial species and/or strains included in monitoring;

3. sampling strategy used in monitoring;

4. antimicrobials included in monitoring;

5.

6.

laboratory methodology used for the detection of resistance;

laboratory methodology used for the identification of microbial isolates;

7. methods used for the collection of the data.

B. Specific requirements

Member States must ensure that the monitoring system provides relevant information at least with regard to a repre-
sentative number of isolates of Salmonella spp., Campylobacter jejuni and Campylobacter coli from cattle, pigs and
poultry and food of animal origin derived from those species.

ANNEX III

Coordinated monitoring programmes as referred to in Article 5

When a coordinated monitoring programme is established, at least the following characteristics of the programme must
be defined:

— its purpose;

— its duration;

— its geographical area or region;

— the zoonoses and/or zoonotic agents concerned;

— the type of samples and other data units requested;

— minimum sampling schemes;

— the type of laboratory testing methods;

— the tasks of competent authorities;

— the resources to be allocated;

— the estimation of its costs and how they will be covered; and

— the method and time of reporting the results.

L 325/40

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Official Journal of the European Union

12.12.2003

ANNEX IV

Requirements for the reports to be submitted pursuant to Article 9(1)

The report referred to in Article 9(1) must provide at least the following information. Parts A to D apply to reports on
monitoring carried out in accordance with Article 4 or 7. Part E applies to reports on monitoring carried out in accord-
ance with Article 8.

A. Initially the following must be described for each zoonosis and zoonotic agent (later only changes have to be

reported):

(a) monitoring systems (sampling strategies, frequency of sampling, kind of specimen, case definition, diagnostic

methods used);

(b) vaccination policy and other preventive actions;

(c) control mechanism and, where relevant, programmes;

(d) measures in case of positive findings or single cases;

(e) notification systems in place;

(f) history of the disease and/or infection in the country.

B. Each year the following must be described:

(a) relevant susceptible animal population (together with the date the figures relate to):

— number of herds or flocks,
— total number of animals, and
— where relevant, methods of production involved;

(b) number and general description of the laboratories and institutions involved in monitoring.

C. Each year the following details on each zoonotic agent and data category concerned must be described with their

consequences:

(a) changes in the systems already described;

(b) changes in previously described methods;

(c) results of the investigations and of further typing or other method of characterisation in laboratories (for each

category reported on separately);

(d) national evaluation of the recent situation, the trend and the sources of infection;

(e) relevance as zoonotic disease;

(f) relevance to human cases, as a source of human infection, of findings in animals and food;

(g) control strategies recognised that could be used to prevent or minimise transmission of the zoonotic agent to

humans;

(h) if necessary, any specific action decided in the Member State or suggested for the Community as a whole on the

basis of the recent situation.

D. Reporting of results of examinations

Results shall be given by stating the number of epidemiological units investigated (flocks, herds, samples, batches)
and the number of positive samples according to the case definition. The results shall, when necessary, be presented
in a way which shows the geographical distribution of the zoonosis or the zoonotic agent.

E. For food-borne outbreak data:

(a) total number of outbreaks over a year;

(b) number of human deaths and illnesses in these outbreaks;

(c) the causative agents of the outbreaks, including, where possible, serotype or other definitive description of the
agents. Where the identification of the causative agent is not possible, the reason for such unidentifiability should
be stated;

(d) foodstuffs implicated in the outbreak and other potential vehicles;

(e) identification of the type of place where the foodstuff incriminated was produced/purchased/acquired/consumed;

(f) contributory factors, for example, deficiencies in food processing hygiene.