Common Position (EC) No 13/2003 of 20 February 2003 adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to adopting a directive of the European Parliament and of the Council on the monitoring of zoonoses and zoonotic agents, amending Council Decision 90/424/EEC and repealing Council Directive 92/117/EEC
Date: 2003-02-20
Institutions: Council of the European Union
Subjects: animal disease, exchange of information, food inspection, health legislation, health policy, infectious disease, veterinary legislation, zoonosis

15.4.2003

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Official Journal of the European Union

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COMMON POSITION (EC) No 13/2003

adopted by the Council on 20 February 2003

with a view to adopting Directive 2003/. . ./EC of the European Parliament and of the Council of
. . . on the monitoring of zoonoses and zoonotic agents, amending Council Decision 90/424/EEC
and repealing Council Directive 92/117/EEC

(2003/C 90 E/02)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

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

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

Having regard to the opinion of the 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) Live animals and food of animal origin appear on the list
to the Treaty. Livestock farming and the
in Annex I
placing on the market of food of animal origin constitute
an important
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.

source of

income

for

(2) The protection of human health against diseases and
indirectly between
is of paramount

transmissible directly or
(zoonoses)

and humans

infections
animals
importance.

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

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

(5) Council Directive 92/117/EEC of 17 December 1992
specified
concerning measures
zoonoses and specified zoonotic agents in animals and
products of animal origin in order to prevent outbreaks

for protection against

(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 (not yet
published in the Official
Journal), Council Common Position of
20 February 2003 and Decision of the European Parliament of
. . . (not yet published in the Official Journal).

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.

zoonoses,

epidemiology of

assistance of
the
for

the Community Reference
(6) With the
Laboratory
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
current
provide
situation concerning zoonoses
agents.
However, the data collection systems are not harmonised
comparisons between
and therefore do not permit
Member States.

the
and zoonotic

evaluation of

a basis

the

for

(7) Other Community legislation provides for the monitoring
and control of certain zoonoses in animal populations. 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
any
unnecessary duplication of these existing requirements.

should not

create

(8) Moreover, a future regulation of the European Parliament
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
the microbiological
specific
quality of food.

requirements

for

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

in the Community (7)

control
is

epidemiological

surveillance

and

(4) OJ L 62, 15.3.1993, p. 38; Directive as last amended by Directive
1999/72/EC of the European Parliament and of the Council (OJ
L 210, 10.8.1999, p. 12).

(5) OJ 121, 29.7.1964, p. 1977; Directive as

last amended by
Commission 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

Commission Decision 2002/261/EC (OJ L 91, 6.4.2002, p. 31).

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

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

food,

(11) 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 epidemiological
data that Member States were collecting were incomplete
and not
the
monitoring
Committee
arrangements and identified risk management options. In
spp.,
particular,
Campylobacter spp., verotoxigenic Escherichia coli
(VTEC),
Listeria monocytogenes, Cryptosporidium spp., Echinococcus
granulosus/multilocularis and Trichinella spiralis as public
health priorities.

fully comparable. As
recommended

identified Salmonella

a
improved

the Committee

consequence,

(16) The alarming emergence of resistance to antimicrobial
agents (such as antimicrobial medicinal products and anti-
microbial feed additives) is a characteristic that should be
monitored. Provision should be made for such 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 organisms might
be appropriate. Such organisms constitute a reservoir of
resistance genes, which they can transfer to pathogenic
bacteria.

(17) 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 . . ./2003.

and

data

collection systems

(12) It is necessary therefore to improve the existing moni-
toring
established by
Directive 92/117/EEC. Simultaneously, Regulation (EC)
No . . ./2003 of
the
Council of . . . on the control of salmonella and other
specified food-borne zoonotic agents (1) will replace the
specific
by Directive
92/117/EEC. Directive 92/117/EEC should therefore be
repealed.

the European Parliament and of

control measures

established

(13) 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
procedures 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.

(18) If

investigated,

food-borne outbreaks of
thoroughly
zoonoses provide
the
the opportunity
pathogen, the food vehicle involved and the factors in
the food preparation and handling that contributed to
the outbreak.
to make
therefore
provision for such investigations and for close cooperation
between the various authorities.

to identify

appropriate

is

It

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

information. That

(20) 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
be
relevant
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.

information

should

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

(22) It may be

appropriate

to designate national

and
Community 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.

(1) See p. 25 of this Official Journal.
(2) OJ L 31, 1.2.2002, p. 1.

(3) OJ L 147, 31.5.2001, p. 1; Regulation as last amended by
Commission Regulation (EC) No 1494/2002 (OJ L 225, 22.8.2002,
p. 3).

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(23) Council Decision 90/424/EEC of 26 June 1990 on expen-
diture in the veterinary field (1) should be amended in so
the
far
as
Community's
certain
contribution
relating to the monitoring and control of
actions
zoonoses and zoonotic agents.

the detailed rules

governing

concerns

financial

towards

(24) Appropriate procedures should be 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.

(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
at Community level. The
significance
organisms of
collection of
achieved at
such data can better be
Community level. The Community may therefore adopt
measures, in accordance with the principle of subsidiarity
as set out in Article 5 of the Treaty. In accordance 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 monitoring 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
implementing powers
the exercise of
conferred on the Commission (2),

for

HAVE ADOPTED THIS DIRECTIVE:

CHAPTER I

INTRODUCTORY PROVISIONS

Article 1

Subject matter and scope

and related antimicrobial

The purpose of this Directive is to ensure that zoonoses,
1.
are
zoonotic agents
properly 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.

resistance

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

(1) 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).

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

(d) the exchange of
zoonotic agents.

information related to zoonoses and

3.
This Directive shall apply without prejudice to more
specific Community provisions on animal health, animal
nutrition,
communicable human diseases,
health and safety in the workplace, gene technology and trans-
missible spongiform encephalopathies.

food hygiene,

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
antimicrobial agent, that is usually sufficient to inhibit
or kill micro-organisms of the same species;

the same disease and/or

(d) ‘food-borne outbreak’ means an incidence, observed
two or more human
under given circumstances, of
cases of
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;
and

(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.

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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) at other stages of the food chain,

including in food and

feed.

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

the

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

4.
Annex I may be amended in accordance with the
procedure 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:

3.
Each Member State shall ensure that effective and
continuous cooperation based on free exchange of general
information and, where necessary, of specific data,
is estab-
lished between the
authorities
authority or
designated for the purposes of this Directive and:

competent

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

and food;

(b) the gravity of their effects for humans;

(a) the competent authorities for the purposes of Community

legislation on animal health;

(c)

their economic consequences for animal and human health
care and for feed and food businesses;

(b) the competent authorities for the purposes of Community

legislation on feed;

(d) epidemiological trends in animal and human populations,

feed and food.

(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
as
in veterinary science, microbiology or
necessary.

epidemiology,

CHAPTER II

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
food hygiene and
down in the fields of animal health,
communicable 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;

MONITORING OF ZOONOSES AND ZOONOTIC AGENTS

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

Article 4

(c) case definitions;

General rules on monitoring of zoonoses and zoonotic
agents

(d) sampling schemes to be used;

1. Member States shall collect relevant and comparable data
to assess
to identify and characterise hazards,
in order
exposures 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:

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

(e)

laboratory methods to be used in testing; and

(f)

frequency of

the
reporting between local, regional and central authorities.

including guidelines

reporting,

for

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.

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Article 5

CHAPTER IV

Coordinated monitoring programmes

FOOD-BORNE OUTBREAKS

If

data

collected

routine monitoring

1.
in
through
accordance with Article 4 are not sufficient, coordinated moni-
toring programmes concerning one or more zoonoses 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 baseline values
related to zoonoses or zoonotic agents at
the level of
Member States or at Community level.

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 . . ./2003

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

Article 6

Food business operators' duties

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

carry out

for

(a) keep the results and arrange for the preservation of any
isolate for a period to be specified by the

relevant
competent authority; and

(b) communicate results or provide isolates to the competent

authority on request.

2.
Detailed rules for the implementation of this Article may
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
conducted in accordance with Decision

2.
human isolates
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).

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
is
preserved in order not
investigation in a
laboratory or the investigation of any food-borne outbreak.

involved, or an appropriate sample of
to impede its

it,

implicated and the potential

The competent authority shall

2.
investigate food-borne
outbreaks in cooperation with the authorities referred to in
Article 1 of Decision 2119/98/EC. The investigation shall
the foodstuffs
provide data on the epidemiological profile,
potentially
the
include, as far as possible,
outbreak. The investigation shall
adequate epidemiological and microbiological
studies. The
competent authority shall transmit to the Commission (which
shall
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.

causes of

send it

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).

systems

4.
Paragraphs 1 and 2 shall apply without prejudice to
Community provisions on product safety, early warning and
response
control of
communicable human diseases, food hygiene and the general
requirements of
those concerning
emergency measures and procedures for withdrawing food
and feed from the market.

the prevention and

in particular

food law,

for

CHAPTER V

EXCHANGE OF INFORMATION

Article 9

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

1. Member States
zoonoses, zoonotic agents and antimicrobial
their territory.

shall assess

trends

and sources of
resistance in

Each Member State shall transmit to the Commission, every
year by the end of May, a report on trends and sources of
zoonoses,
resistance,
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

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

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).

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).

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

it,

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).

2.
The Commission shall send the reports referred to in
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
the
Community.

antimicrobial

resistance

agents

and

in

the European Food
When preparing the summary report,
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),

— 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.

CHAPTER VI

LABORATORIES

Article 10

CHAPTER VII

IMPLEMENTATION

Article 11

Amendments

to the

and
annexes
implementing measures

transitional or

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

The Commission shall be assisted by the Committee on
1.
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.

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.

Community and national reference laboratories

3.

The Committee shall adopt its Rules of Procedure.

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

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

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

Article 13

Consultation of the European Food Safety Authority

the European Food Safety
The Commission shall consult
Authority on any matter within the scope of this Directive
that could have a significant
in
particular before proposing any amendment to Annex I or II
or before establishing any coordinated monitoring programme
in accordance with Article 5.

impact on public health,

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Article 14

Transposition

1. Member States shall adopt and publish the laws, regu-
lations and administrative provisions necessary to comply
with this Directive by . . . (*).

They shall forthwith inform the Commission thereof.

They shall apply those measures by . . . (**).

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

However, measures which Member States have
adopted
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 . . ./2003.

As

regards control of zoonoses,

the Community
2.
financial contribution shall be introduced as part of a
national control programme referred to in Article 5 of
Regulation (EC) No . . ./. . . on the control of salmonella
food-borne zoonotic agents (*). The level of
and other
Community financial participation shall be fixed at a
maximum of 50 % of costs incurred for the implementation
of mandatory control measures.
___________
(*) OJ L . . .’;

2. the following Article shall be 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 . . ./2003.’;

3.

in the Annex, the following indents shall be added to the
list 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

Article 16

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

Amendment of Decision 90/424/EEC

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

1. Article 29 shall be replaced by the following:

‘Article 29

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

the monitoring and control of

Article 18

Addressees

This Directive is addressed to the Member States.

Done at . . .

For the European Parliament

The President

For the Council

The President

(*) Four months after the date of entry into force of this Directive.
(**) Six months after the date of entry into force of this Directive.

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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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REQUIREMENTS FOR MONITORING OF ANTIMICROBIAL RESISTANCE PURSUANT TO ARTICLE 7

ANNEX II

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.

laboratory methodology used for the detection of resistance;

6.

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
representative 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.

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COORDINATED MONITORING PROGRAMMES AS REFERRED TO IN ARTICLE 5

ANNEX III

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.

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REQUIREMENTS FOR THE REPORTS TO BE SUBMITTED PURSUANT TO ARTICLE 9(1)

ANNEX IV

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
accordance 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.

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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.

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STATEMENT OF THE COUNCIL'S REASONS

I. INTRODUCTION

The Commission proposed a Directive on the monitoring of zoonoses and zoonotic agents in August
2001.

The European Parliament adopted an opinion on the proposed Directive in May 2002.

The Economic and Social Committee adopted an opinion in February 2002 (1).

After considering these opinions, the Council adopted a Common Position on 20 February 2003.

II. OBJECTIVE OF THE PROPOSAL

The key aims of the proposed Directive are:

(a) to improve the monitoring of zoonoses and zoonotic agents;

(b) to provide for the monitoring of related antimicrobial resistance;

(c)

to enhance the epidemiological investigation of food-borne outbreaks; and

(d) to promote the exchange of information related to zoonoses and zoonotic agents.

III. ANALYSIS OF THE COMMON POSITION

A. Introduction

There is no difference of opinion between the Council,
the European Parliament and the
Commission regarding the basic principles that the Directive should establish. In particular, the
three institutions agree that:

— data need to be comparable,

— monitoring should in principle cover all stages of the food chain,

— the scope of the monitoring of antimicrobial resistance needs to be flexible.

As a consequence, the Common Position adopted by the Council encompasses the bulk of the
amendments that Parliament adopted at first reading. The Commission accepts these amendments
and the other modifications made to its initial proposal.

B. Scope and aim of monitoring for zoonoses and zoonotic agents

The Council agrees that the monitoring of zoonoses and zoonotic agents ought, in principle, to
cover all stages of the food chain, including food and feed. It also agrees that the aim of monitoring
must be to collect comparable data. The Common Position is therefore consistent with the relevant
Parliamentary amendments (2).

The Common Position clarifies the provisions concerning the harmonisation of Member States'
monitoring systems (3). The aim of such harmonisation would be to lay down minimum
requirements. It would concern as a priority those zoonoses and zoonotic agents in respect of
which monitoring would be mandatory in all Member States.

(1) The Committee of the Regions decided not to provide an opinion.
(2) Amendments 1, 6, 9, 10, 12 and 14; recital 10; Article 3(3); Article 4(1), (2) and (5).
(3) Article 4(5) and (6).

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The Common Position also clarifies that coordinated monitoring programmes would be established
only if data collected through routine monitoring were not sufficient (1).

C. Monitoring of antimicrobial resistance

The Council agrees that the emergence of antimicrobial resistance is alarming, that its monitoring
should be a priority, and that there should be flexibility to extend the scope of such monitoring.
The Common Position is therefore consistent with the relevant Parliamentary amendments (2).

However, rather than providing for the monitoring of zoonotic agents and other bacteriological
agents, it would permit the monitoring of zoonotic agents and, in so far as they present a threat to
public health, other agents. This would provide greater flexibility, while ensuring that monitoring
would target those agents that present a health risk.

In addition, the Common Position would extend the scope of the specific requirements that would
apply initially to the monitoring of antimicrobial resistance to cover certain products of animal
origin.

D. Timetable for reports

The Council believes that the collection and analysis of data should take place as rapidly as is
practicable. The Common Position therefore incorporates those Parliamentary amendments that are
consistent with this aim (3), but not those that would have imposed unrealistic deadlines (4).

E. Food business operators' duties

The Common Position is consistent with the Parliamentary amendment seeking to clarify that food
business operators may, in principle, carry out examinations for the presence of any zoonosis or
zoonotic agent subject to monitoring (5). In addition, to facilitate the investigation of outbreaks of
food-borne diseases, it would require food business operators to preserve relevant isolates and to
provide them to the competent authority on request. It would also provide for the laying down of
detailed rules concerning these duties (6).

F. Comitology

The Council agrees that, while it should be possible to amend technical provisions contained in the
Annexes through comitology, criteria governing such amendments ought to appear in the Articles.

It also agrees that the Commission should, as appropriate, consult either the Committee on the
Food Chain and Animal Health or the Committee set up under Decision No 2119/98/EC. For legal
reasons, however, the Commission cannot consult both Committees on the same proposal.

The Common Position is therefore consistent with the objective of the relevant Parliamentary
amendments (7).

(1) Article 5(1).
(2) Amendments 3, 26, 28, 30, 31 and 33; recital 16; Article 7; Annex II.
(3) Amendments 4, 8, 29 and 32; recital 21.
(4) Amendment 20.
(5) Amendment 19; Article 6(1).
(6) Article 6(2).
(7) Amendments 13, 23 and 25; Article 4(4); Article 12(1).

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G. Consultation of the European Food Safety Authority

The Common Position would require the Commission to consult
Authority before proposing:

the European Food Safety

— amendments to the lists of zoonoses and zoonotic agents subject to monitoring contained in

Annex I,

— amendments to the detailed rules on the monitoring of antimicrobial resistance set out in Annex

II, or

— the establishment of coordinated monitoring programmes (1).

The Council does not agree, however, that such consultation ought to be automatic. In other cases,
the Commission should have some discretion, to ensure that the Authority can concentrate on
those issues that are the most significant for public health.

The Common Position is therefore not consistent with the relevant Parliamentary amendment (2).

H. Community co-financing

The Common Position on the regulation on the control of zoonoses provides for the Commission
to report on financial issues and, if appropriate, to make proposals, within three years of its entry
into force.

to prejudice the content of

So as not
this report, and the outcome of discussions on any
Commission proposals within the European Parliament and the Council, the Common Position
to Article 29 of
on the directive includes a consequential modification to the amendment
Decision 90/424/EEC.

The modified amendment would provide for Community co-financing of up to 50 % to be available,
in principle,
for any costs incurred implementing mandatory control measures, enabling the
decision on the level of resources to be allocated to Community co-financing to be taken in the
light of the Commission's report.

I. Zoonoses and zoonotic agents subject to monitoring

The Council agrees that the directive ought to make explicit that the list of zoonoses and zoonotic
agents to be monitored according to the epidemiological situation includes all viruses transmitted by
arthropods (and not just by ticks). The Common Position therefore incorporates the relevant
Parliamentary amendment (3).

The Council believes that it is premature to make the monitoring of cryptosporidiosis mandatory in
all Member States. Its monitoring should depend on the epidemiological situation. In the Common
Position this zoonosis therefore appears in the list in part B of Annex I. The Council accepts,
however, that it should be possible to amend these lists through comitology, in particular to take
account of epidemiological trends.

(1) Article 13.
(2) Amendment 22.
(3) Amendment 24; Annex I, part B.

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J. Relationship with other legislation

The Common Position incorporates amendments to ensure consistency with Regulation (EC)
No 178/2002 (1). In particular, Article 2 now imports the definitions of that Regulation rather
than repeating some of them.

K. Other

The Common Position also incorporates Parliamentary amendments:

— clarifying the scope of the Directive (2),

— requiring Member States' officials to undergo ongoing training (3),

— providing for reports to describe methods of production, where relevant (4).

The Common Position does not incorporate one amendment because the Council considers it
inappropriate to require epidemiological and microbiological studies in respect of all food-borne
outbreaks. It should be possible to tailor the response to the size and gravity of the outbreak (5).

Finally, compared to the Commission's initial proposal, the Common Position would:

— delete the definition of ‘communicable diseases’, which was superfluous and created confusion,

— to be consistent with the Regulation, enable Member States to designate more than one
competent authority for the purposes of the Directive, provided that there is cooperation
between the authorities and a single contact point for the Commission (6),

— set relative dates for the transposition of

the Directive and for the repeal of Directive
92/117/EEC (six months after entry into force of the Directive), to ensure that this takes
place as soon as is reasonably practicable, whatever the date of adoption of the Directive (7).

IV. CONCLUSION

The Council welcomes the fact
it has been able to incorporate the bulk of the European
Parliament's amendments in its Common Position and that the Commission accepts these and the
other changes to its initial proposal. It hopes that this will permit rapid adoption of the directive.

that

(1) Amendments 2, 16 and 17; recital 13; Article 8(1); Article 13.
(2) Amendment 5; Article 1(1).
(3) Amendment 11; Article 3(4).
(4) Amendment 27; Annex IV.
(5) Amendment 18.
(6) Article 3(2).
(7) Articles 14 and 15.