Proposal for 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: 2001-08-01
Institutions: European Commission
Subjects: animal disease, food inspection, health legislation, health policy, infectious disease, veterinary legislation, zoonosis

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Official Journal of the European Communities

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Proposal for 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

(2001/C 304 E/18)

(Text with EEA relevance)

COM(2001) 452 final (cid:151) 2001/0176(COD)

(Submitted by the Commission on 1 August 2001)

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,

Having regard to the opinion of
Committee,

the Economic and Social

Having regard to the opinion of the Committee of the Regions,

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

Whereas:

the assistance of the Community Reference Laboratory for
the epidemiology of zoonoses. The results have been
published yearly since 1995 and they provide a basis for
situation concerning
the
zoonoses
the data
collection systems are not harmonised and therefore do
not permit comparisons between Member States.

current
agents. However,

the
and zoonotic

evaluation of

(6) Monitoring and control of certain zoonoses in animal
populations has been provided for by other Community
legislation, in particular Council Directive 64/432/EEC of
26 June 1964 on animal health problems affecting intra-
Community trade in bovine animals and swine (2), as
regards bovine tuberculosis and bovine brucellosis and
Council Directive 91/68/EEC of 28 January 1991 on
animal health conditions governing intra-Community
trade in ovine and caprine animals (3), as regards ovine
and caprine brucellosis.

(1) The protection of human health against diseases and
infections
from
animals to man (zoonoses) is of paramount importance.

transmissible

directly or

indirectly

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

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

for protection against

(4) 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
of food-borne infections and intoxications (1) provided for
the establishment of a monitoring system for certain
the level of Member States and at
zoonoses both at
Community level.

(5) The results of the monitoring are collected yearly from
the Member States and compiled by the Commission, with

(1) 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).

(7) Moreover, Regulation (EC) No . . ./. . . of the European
Parliament and of the Council of . . . [on the hygiene of
for
foodstuffs]
prevention, control and monitoring of zoonoses and
zoonotic agents, and includes specific requirements for
the microbiological quality of food.

necessary

elements

specific

covers

(8) Directive 92/117/EEC provides for collection of data on
human cases of zoonoses. Decision No 2119/98/EC of the
European Parliament and of the Council of 24 September
the epidemiological
1998 setting up a network for
surveillance and control of communicable diseases in
the Community (4) was adopted in order to reinforce the
collection of such data and to contribute to improving the
of
prevention
communicable diseases.

the Community,

control,

and

in

(9) The collection of data on the occurrence of zoonoses and
zoonotic agents
in feedingstuffs, animal populations,
products of animal origin and in humans is necessary
to determine the trends and sources of zoonoses.

(2) OJ 121, 29.7.1964, p. 1977. Directive as last amended by Directive

2000/20/EC (OJ L 163, 4.7.2000, p. 35).

(3) OJ L 46, 19.2.1991, p. 19. Directive as last amended by Commission

Decision 94/953/EC (OJ L 371, 31.12.1994, p. 14).

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

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(10) The Scientific Committee on Veterinary Measures relating
to Public Health has, in its Opinion on zoonoses adopted
on 12 April 2000, considered that the current measures
to control food-borne zoonotic infections are insufficient
and that the epidemiological data as currently collected by
Member States are incomplete and not fully comparable.
On that basis, 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.

(11) It is, therefore, necessary to improve the existing moni-
toring and data collection systems established by Directive
92/117/EEC. Simultaneously, the specific control measures
established by Directive 92/117/EEC will be replaced by
the rules laid down in Regulation (EC) No . . ./. . . of the
European Parliament and of the Council of . . . [on the
control of salmonella and other
food-borne zoonotic
agents and amending Council Directives 64/432/EEC,
72/462/EEC and 90/539/EEC]. Directive 92/117/EEC
should therefore be repealed.

(12) The new framework for scientific advice and scientific
support in matters of food safety set up by Regulation
(EC) No . . ./. . . of the European Parliament and of the
Council of . . . [laying down the general principles and
requirements of
food law, establishing the European
Food Authority, and laying down procedures in matters
of food] should be used to collect and analyse the relevant
data.

(13) Where necessary, procedures should be created which
provide data on a harmonised basis, making 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.

(14) 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.

(15) Alongside emerging new zoonoses and zoonotic agents,
known zoonotic organisms may be converted into new
strains. The emergence of
resistance to antimicrobial
agents is a characteristic that should be monitored.

(16) Since providing data in a harmonised way, to form the
risk assessment of zoonotic organisms of

basis

for

importance at Community level cannot be sufficiently
achieved by the Member States and can therefore, be
better achieved at Community level,
the Community
may 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 moni-
toring systems should lie with Member States.

(17) In addition to general monitoring, specific needs may be
recognised which may necessitate the establishment of
co-ordinated monitoring programmes. Attention should
be paid in particular to zoonoses listed in Annex I, part
A of Regulation (EC) No . . ./. . .
[on the control of
salmonella and other food-borne zoonotic agents and
amending Council Directives 64/432/EEC, 72/462/EEC
and 90/539/EEC].

the

provide

(18) Food-borne outbreaks of zoonoses,
opportunity

if thoroughly inves-
tigated,
the
identify
pathogen, the food vehicle involved and the factors in
the food preparation and handling that contributed to
therefore, appropriate to make
the outbreak.
provision for
close
co-operation between the various authorities.

It
such investigations

and for

is,

to

a

(19) Transmissible spongiform encephalopathies are subject to
Regulation (EC) No . . ./. . . of the European Parliament
. . . [laying down rules for the
and of
prevention, control and eradication of certain trans-
missible spongiform encephalopathies].

the Council of

(20) In order 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 and to the European Food Authority in the
form of reports, which should also be made available to
the public in an appropriate way.

information. That

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.

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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
relating to the monitoring and control of
actions
zoonoses and zoonotic agents.

contribution towards

the detailed rules

governing

concerns

financial

(24) Appropriate procedures

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

should be

for

the exercise of

(25) Since the said measures are measures of general scope
within the meaning of Article 2 of Council Decision
1999/468/EC of 28 June 1999 laying down the
implementing powers
procedures
conferred on the Commission (2),
should be
adopted by use of the regulatory procedure provided for
in Article 5 of that Decision. The Commission should be
assisted by the Committee on Food Safety and Animal
Health set up by Regulation (EC) No . . ./. . . of
the
European Parliament and of the Council [laying down
the general principles and requirements of food law, estab-
lishing the European Food Authority, and laying down
procedures in matters of food],

they

HAVE ADOPTED THIS DIRECTIVE:

CHAPTER I

INTRODUCTORY PROVISIONS

Article 1

Subject-matter and scope

The purpose of this Directive is to ensure that zoonoses
1.
and zoonotic agents are properly monitored so that
the
necessary information may be collected in the Community to
evaluate trends and sources of zoonoses and zoonotic agents.
That evaluation shall provide a basis for the action to be taken
to prevent and control zoonoses and zoonotic agents relevant
to the Community.

2.

This Directive covers:

specific

(a) the monitoring of zoonoses and zoonotic agents, taking
into account
antimicrobial
features
resistance related to zoonotic agents, in animal populations
at the stage of primary production of animals, and, where
including the
necessary, at other stages of
food chain,
production of
feedingstuffs and further preparation and
production of products of animal origin;

such as

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

(1) OJ L 224, 18.8.1990, p. 19. Decision as last amended by Council

Decision 2001/12/EC (OJ L 3, 6.1.2001, p. 27).

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

(c)

the exchange of
zoonotic agents;

information related to zoonoses and

(d) the adoption of specific rules on monitoring.

3.
This Directive shall apply without prejudice to more
specific Community provisions on animal health, animal
nutrition,
food hygiene, communicable diseases, health and
safety at workplace and gene technology.

This Directive shall not apply to transmissible spongiform

4.
encephalopathies.

Article 2

Definitions

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

1.

(cid:145)zoonosis(cid:146) means any disease and/or
infection which is
naturally transmissible directly or indirectly from animals
to humans;

2.

(cid:145)zoonotic agent(cid:146) means any virus, bacterium,
fungus,
parasite or other biological entity which is likely to cause
a zoonosis;

3.

resistance(cid:146) means

ability of micro-
(cid:145)antimicrobial
organisms of certain species to survive or even to grow in
the presence of a given concentration of an antimicrobial
agent,
to inhibit or kill micro-
organisms of the same species;

is usually sufficient

that

the

4.

(cid:145)communicable diseases(cid:146) means diseases caused by zoonotic
agents occurring in humans which are covered by Decision
No 2119/98/EC;

5.

(cid:145)food business(cid:146) means a business as defined in Article 2 of
Regulation (EC) No . . ./. . . [on the hygiene of foodstuffs];

6.

7.

the person or persons
(cid:145)food business operator(cid:146) means
responsible for ensuring that
this
Directive are met within the food business under his/her
or their supervision;

the requirements of

(cid:145)food-borne outbreak(cid:146) means the observation under given
circumstances of an incidence of
two or more human
cases of the same disease and/or infection, or the situation
when the observed number of cases exceeds the expected
number and where the cases are linked, or are probably
linked, to the same food source;

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8.

(cid:145)monitoring(cid:146) means a system of collecting, analysing and
disseminating
zoonoses,
zoonotic agents and antimicrobial resistance related thereto;

data on the occurrence of

9.

(cid:145)primary production(cid:146) means production as defined in Article
2 of Regulation (EC) No . . ./. . .
[on the hygiene of
foodstuffs].

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 disseminated in
accordance with the requirements of
this Directive and of
any provision adopted pursuant to it.

Each Member

2.
competent
authority for the purposes of this Directive and notify the
Commission thereof.

shall designate

State

its

3.
Each Member State shall ensure that effective and
continuous co-operation based on a free exchange of general
information and, where necessary, of specific data, shall be
established between its competent authority designated for
the purposes of this Directive and:

and to characterise risks related to zoonoses and zoonotic
agents. The monitoring shall take place in animal populations,
especially at the stage of primary production but also, where
necessary, at the other stages in the food chain including the
and further preparation and
production of
production of products of animal origin.

feedingstuffs

The monitoring shall cover zoonoses and zoonotic agents

2.
listed in Annex I, part 1.A.

Where the epidemiological situation in a Member State so
warrants, zoonoses and zoonotic agents listed in Annex I,
part 1.B shall also be monitored.

3.
The monitoring shall be based on the systems in place in
Member States. Where necessary, detailed rules for the moni-
toring 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
communicable diseases. Those detailed rules shall specify in
particular:

(a) the animal population or sub-populations or stages in the

food chain to be covered by monitoring;

(a) the

competent

authorities

for

the purposes of

the

Community legislation on animal health,

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

(b) the

competent

authorities

for

the purposes of

the

Community legislation on food hygiene,

(c)

the structures and/or authorities referred to in Article 1 of
Decision No 2119/98/EC.

(c) case definitions;

(d) sampling methods to be used;

(e)

laboratory methods to be used in testing;

4.
Each Member State shall ensure that the relevant officials
of the competent authority for the purposes of this Directive
are suitably qualified to undertake their duties and, where
necessary, are trained in microbiology and epidemiology.

(f)

frequency of

the
reporting between local, regional and central authorities.

including guidelines

reporting,

for

CHAPTER II

Monitoring of antimicrobial resistance

Article 5

MONITORING OF ZOONOSES AND ZOONOTIC AGENTS

Article 4

General rules on monitoring of zoonoses and zoonotic
agents

1.
The Member States shall collect data that is relevant in
order to identify and characterise hazards, to assess exposures

1. Member States shall ensure that the monitoring provides
data on the occurrence of antimicrobial resistance in zoonotic
agents in accordance with the requirements set out in Annex II.

2.
Detailed rules for the implementation of paragraph 1
shall be laid down in accordance with the procedure referred
to in Article 12(2).

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Article 6

Co-ordinated monitoring programmes

1.
Co-ordinated monitoring programmes concerning one or
more zoonoses and/or zoonotic agents may be established in
accordance with the procedure referred to in Article 12(2),
where appropriate after consultation of
the European Food
Authority. Co-ordinated monitoring programmes may be estab-
lished especially when specific needs are identified to assess
to establish base-line values related to
risks, or
zoonoses and/or zoonotic agents at
the level of Member
States and/or at Community level.

in order

special

2. Where a co-ordinated monitoring programme is estab-
lished,
reference shall be made to zoonoses and
zoonotic agents in animal populations referred to in Annex I,
[on the control of
part A, of Regulation (EC) No . . ./. . .
salmonella
and
agents
food-borne
amending Council Directives 64/432/EEC, 72/462/EEC and
90/539/EEC].

and other

zoonotic

3. Minimum rules
co-ordinated monitoring programmes
Annex III.

concerning

the

establishment

of
laid down in

are

The results of the co-ordinated monitoring programmes

4.
shall be provided to the European Food Authority.

CHAPTER III

FOOD-BORNE OUTBREAKS

Article 7

Epidemiological investigation of food-borne outbreaks

shall transmit to the Commission and to the European Food
Authority a summary report on the results of the investigations
carried out, containing the information referred to in Annex IV,
Part E, to this Directive. Detailed rules concerning the investi-
laid down in
food-borne outbreaks may be
gation of
accordance with the procedure referred to in Article 12(2).

Paragraphs 1 and 2 shall apply without prejudice to
3.
Community provisions on product safety, early warning and
response
of
communicable diseases and food hygiene.

the prevention and

systems

control

for

4. Measures concerning the suspected foods and their
production environment shall be laid down in accordance
with Article 12 of Regulation (EC) No . . ./. . .
[on the
hygiene of foodstuffs].

CHAPTER IV

EXCHANGE OF INFORMATION

Article 8

Examinations for zoonoses at the level of food business
operators

Member States shall ensure that food business operators keep,
for a period to be specified by the competent authority, and
communicate to the latter at its request, the results of exam-
inations for the presence of the zoonoses and zoonotic agents
listed in Annex I, part 1.A.

Article 9

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

a

aware

1. Member States shall ensure that when a food business
operator becomes
foodstuff produced or
that
processed by him has caused, or is likely to cause, a food-borne
outbreak, he shall
inform the competent authority without
delay. The foodstuff, or an appropriate sample thereof, shall
be preserved in a way which neither impede its investigation
in a laboratory, nor a further investigation of the suspected
outbreak.

it

receives

authority

competent

to paragraph 1 or
shall

information
2. When a
is otherwise informed of a
pursuant
food-borne outbreak,
investigate the outbreak in
co-operation 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. The inves-
tigation shall
include, as far as possible, adequate epidemi-
ological and microbiological studies. The competent authority

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

trends

assess

shall

Each Member State shall transmit to the Commission and to
the European Food Authority every year by the end of May a
report on trends and sources of zoonoses, zoonotic agents and
resistance related thereto, covering the data
antimicrobial
to Articles 4 to 7 during the previous
collected pursuant
year. The reports, or summaries of
them, shall be made
publicly available.

The reports shall also contain the information referred to in
Article 3(2)(b) of Regulation (EC) No . . ./. . . [on the control of
salmonella
and
food-borne
amending Council Directives 64/432/EEC, 72/462/EEC and
90/539/EEC].

and other

zoonotic

agents

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

those reports,

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,

The European Food Authority shall each year examine
2.
the reports
referred to in paragraph 1 and within nine
months after receiving them shall publish a summary report
on the trends and sources of zoonoses, zoonotic agents and
antimicrobial resistance related thereto in the Community.

the European Food
When preparing the summary report,
Authority may
into consideration other data on
take
zoonoses, zoonotic agents and antimicrobial resistance related
thereto such as those provided for in the framework of the
Community legislation on animal health, food control, food
hygiene and communicable diseases, and in particular:

(cid:151) Article 8 of Directive 64/432/EEC,

(cid:151) Article 14(2) of Council Directive 89/397/EEC (1),

(cid:151) Article 24 of Decision 90/424/EEC,

(cid:151) Article 4 of Decision 2119/98/EC.

CHAPTER V

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-
resistance related thereto may be designated in
microbial
accordance with the procedure referred to in Article 12(2).

2. Without prejudice to the relevant provisions in Decision
90/424/EEC, the responsibilities and tasks of the Community
Reference Laboratories,
in particular with regard to co-ordi-
nation of their activities and those of the National Reference
Laboratories,
shall be laid down in accordance with the
procedure referred to in Article 12(2).

3. Member States shall designate National Reference Labo-
ratories
a Community Reference
Laboratory has been established and inform the Commission
thereof.

each field where

for

and tasks of

Certain responsibilities

the National
4.
Reference Laboratories,
in particular with regard to co-ordi-
nation of their activities and those of the relevant laboratories
in the Member States, may be laid down in accordance with
the procedure referred to in Article 12(2).

CHAPTER VI

IMPLEMENTATION

Article 11

Amendments to the annexes and transitional measures

Where appropriate after consultation of the European Food
Authority, the annexes may be amended or any appropriate
transitional measures may be adopted in accordance with the
procedure referred to in Article 12(2).

Article 12

Committee

1.
The Commission shall be assisted by the Committee on
Food Safety and Animal Health instituted by Regulation (EC)
No . . ./. . . of the European Parliament and of the Council
[laying down the general principles and requirements of food
law, establishing the European Food Authority, and laying
down procedures in matters of food].

2. Where reference is made to this paragraph, the regulatory
procedure laid down in Article 5 of Decision 1999/468/EC
shall apply, in compliance with Article 7 and Article 8 thereof.

The period provided for in Article 5(6) of Decision

3.
1999/468/EC shall be three months.

Article 13

Transposition

1. Member States shall adopt and publish before 1 November
2002 the laws,
regulations and administrative provisions
necessary to comply with this Directive. They shall forthwith
inform the Commission thereof.

They shall apply those provisions from 1 January 2003.

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

(1) OJ L 186, 30.6.1989, p. 23 (to be replaced in due course by a
Regulation on official food and feed safety controls; referred to as
Action No 4 in the White Paper on food safety (COM(1999) 719
final)).

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.

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CHAPTER VII

FINAL PROVISIONS

Article 14

Repeal

slaughter and destruction measures of breeding flocks of
Gallus gallus because of the infection concerned.
___________
(*) OJ L . . .(cid:146).

2. The following Article 29a is inserted:

Directive 92/117/EEC is repealed with effect from 1 January
2003.

(cid:145)Article 29a

However, measures which Member States have
adopted
pursuant to Article 8(1) of that Directive and 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 6 of Regulation (EC) . . ./. . . [on the
control of salmonella and other food-borne zoonotic agents
and amending Council Directives 64/432/EEC, 72/462/EEC
and 90/539/EEC].

Article 15

Amendment of Decision 90/424/EEC

Decision 90/424/EEC is amended as follows:

1. Article 29 is replaced by the following:

(cid:145)1.
A Community financial contribution may be requested
by Member States for the monitoring and control of the
zoonoses
in the
specified in the Annex, Group 2,
framework of the provisions referred to in Article 24(2) to
(11).

As

regards control of zoonoses,

2.
the Community
financial contribution shall be introduced as part of a
national plan referred to in Article 6 of Regulation (EC)
No . . ./. . . of the European Parliament and of the Council
food-borne
[on the
zoonotic
Council Directives
and
64/432/EEC, 72/462/EEC and 90/539/EEC] (*).

control of
agents

salmonella and other

amending

The level of Community financial participation for measures
provided for in Annex II, point C,
to Regulation (EC)
No . . ./. . .
salmonella and other
amending Council
food-borne
Directives 64/432/EEC, 72/462/EEC and 90/539/EEC] shall
be fixed at a maximum of 50 % of the cost incurred in the
Member State by way of compensation for owners for the

[on the control of
zoonotic

agents

and

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 . . ./. . .
the European
Parliament and of the Council on the control of salmonella
food-borne zoonotic agents and amending
and other
Council
and
90/539/EEC].(cid:146)

[Regulation of

64/432/EEC,

72/462/EEC

Directives

3. In the Annex, the following indents are added to the list

under Group 2:

(cid:145) (cid:151) Campylobacteriosis

(cid:151) Cryptosporidiosis

(cid:151) Listeriosis

(cid:151) Salmonellosis (zoonotic salmonella)

(cid:151) Trichinellosis

(cid:151) Verotoxigenic Escherichia coli.(cid:146)

Article 16

Entry into force

This Directive shall enter into force on the twentieth day
following that of its publication in the Official Journal of the
European Communities.

Article 17

Addressees

This Directive is addressed to the Member States.

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Part 1. Zoonoses and zoonotic agents to be monitored pursuant to Article 4

ANNEX I

A. Zoonoses and zoonotic agents to be included in monitoring

Brucellosis and agents thereof

Campylobacteriosis and agents thereof

Cryptosporidiosis 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

Influenzavirus

Rabies

Tick borne viruses

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

Cysticercosis and agents thereof

Toxoplasmosis and agents thereof

4. Other zoonoses and zoonotic agents

Part 2. Criteria for addition or deletion of zoonoses in the list in Part 1

When necessary, zoonoses or zoonotic agents may be added or deleted as regards the list in Part 1 taking into account
especially

(cid:151) their occurrence in animal and human populations, feed and food

(cid:151) their gravity in humans,

(cid:151) their economic consequences for health care and food businesses,

(cid:151) epidemiological trends in animal and human populations, feed and food.

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Requirements for monitoring of antimicrobial resistance pursuant to Article 5

ANNEX II

A. General requirements

Monitoring of antimicrobial resistance should provide relevant information to detect the emergence of and to identify
the trends in antimicrobial resistance in zoonotic agents.

Monitoring should be complementary to the monitoring of human isolates conducted according to Council Decision
2119/98/EC.

The Member States shall ensure that the monitoring system for antimicrobial resistance provided for in Article 5
provides at least 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 shall ensure that the above monitoring provides relevant information at least with regard to:

(cid:151) Antibiograms for a representative number of isolates of Salmonella spp., Campylobacter jejuni and Campylobacter

coli from cattle, pigs and poultry.

ANNEX III

Co-ordinated monitoring programmes as referred to in Article 6

When a co-ordinated monitoring programme is established, at least the following characteristics of the programme shall
be defined:

(cid:151) its purpose

(cid:151) its time period

(cid:151) its geographical area or region

(cid:151) the zoonoses and/or zoonotic agents concerned

(cid:151) the type of samples and other data units requested

(cid:151) minimum sampling schemes

(cid:151) the type of laboratory testing methods

(cid:151) the responsibility of competent authorities

(cid:151) the resources to be allocated

(cid:151) the estimation of its costs and how they will be covered

(cid:151) the method and time of reporting the results to the Commission and to other Member States.

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Requirements for the reports to be submitted pursuant to Article 9

ANNEX IV

The report referred to in Article 9(1) must provide at least for the following information:

A. Initially the following shall 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 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 shall be reported:

(a) Relevant susceptible animal population (and date the figures are related to)

(cid:151) Number of herds or flocks

(cid:151) Total number of animals

(b) Laboratories and institutions involved in reporting

C. Each year the following details on each zoonotic agent and data category concerned shall 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 of findings in animals and foodstuff to human cases, source of human infection

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

humans

(h) Need of any specific action in the Member State or at EU level on the basis of the recent situation

D. Reporting of results of examinations

Results shall be given by stating the number of investigated epidemiological units (flocks, herds, samples, batches)
and the number of positive samples according to the case definition. The results shall be, when necessary, 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 ill and dead persons in these outbreaks

(c) The causative agents of the outbreaks, including, where possible, serotype or other definitive description of the
agent. Where the identification of the causative agent is not possible, the reason for that 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