Proposal for a Regulation of the European Parliament and of the Council 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
Date: 2001-08-01
Institutions: European Commission
Subjects: animal disease, food inspection, health legislation, health policy, infectious disease, veterinary legislation, zoonosis

C 304 E/260

EN

Official Journal of the European Communities

30.10.2001

Proposal for a Regulation of the European Parliament and of the Council 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

(2001/C 304 E/19)

(Text with EEA relevance)

COM(2001) 452 final (cid:151) 2001/0177(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:

(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.

(5) Directive 92/117/EEC required the Member States

to
submit
to the Commission the national measures that
they are taking to achieve the objectives of the Directive.
Member States were also required to draw up plans for
monitoring salmonella in poultry. That requirement was,
however, suspended by Council Directive 97/22/EC (2)
amending Directive 92/117/EEC, pending the review
provided for in Article 15a of Directive 92/117/EEC.

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

(7) Those minimum measures focused on monitoring and
control of salmonella in breeding flocks of the species
Gallus gallus. When serotypes Salmonella Enteritidis or
Salmonella Typhimurium were detected and confirmed in
samples taken, specific measures to control the infection
were required by Directive 92/117/EEC.

(8) 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 (3) 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 (4) as regards ovine
and caprine brucellosis.

for protection against

(4) Council Directive 92/117/EEC of 17 December 1992
concerning measures
specified
zoonoses and specified zoonotic agents in animals and
products of animal origin in order to prevent outbreaks
of food-borne infections and intoxications (1) was adopted
in order
for certain
to establish monitoring systems
zoonoses and to establish controls on Salmonella in
poultry flocks.

(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).

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

(2) OJ L 113, 30.4.1997, p. 9.
(3) OJ 121, 29.7.1964, p. 1977. Directive as last amended by Directive

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

(4) 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).

30.10.2001

EN

Official Journal of the European Communities

C 304 E/261

(10) Directive 92/117/EEC provided for the collection of data
on the occurrence of zoonoses and zoonotic agents in
food, and humans. That data
feedingstuffs, animals,
collection
and
therefore not allowing comparison between Member
States, does provide a basis for evaluating the current
situation concerning zoonoses and zoonotic agents in
the Community.

harmonised

although

system,

not

(11) The results of the data collection system show that certain
zoonotic agents, namely Salmonella spp. and Campylobacter
spp., cause the majority of cases of zoonoses in humans.
There seems to be a decreasing trend of human cases of
salmonellosis,
in particular due to Salmonella Enteritidis
and Salmonella Typhimurium, thus reflecting the success
of related control measures taken in the Community.
Nevertheless, it is assumed that many cases remain unre-
ported and therefore the data collected does not neces-
sarily give the full picture of the situation.

(12) 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.

(13) It is, therefore, necessary to improve the existing control
systems for specific zoonotic agents. Simultaneously, the
monitoring and data collection systems established by
Directive 92/117/EEC will be replaced by the rules laid
the European Parliament
down in Directive . . ./. . . of
[on the monitoring of
. . .
and of
zoonoses
amending Council
agents,
Decision 90/424/EEC and repealing Council Directive
92/117/EEC].

the Council of
zoonotic

and

(14) The principle should be established of controls covering

the whole food chain from farm to table.

(15) The rules governing such controls should generally be
those laid down under Community legislation on feed-
ingstuffs, animal health and food hygiene.

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

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

agents

should be established for zoonoses and
(18) The targets
zoonotic
into
in animal population taking
account in particular their incidence and epidemiological
trend in animal and human populations, their gravity for
for
humans,
health care and for food businesses, and the existence of
appropriate measures to reduce their prevalence. Targets
may also be established in respect of other parts of the
food chain, where necessary.

their potential economical consequences

(19) To ensure the achievement of the targets in good time, the
Member States should set up specific control programmes,
which should be approved by the Community.

(20) The main responsibility for the safety of food should lie
with food businesses. Member States should, therefore,
encourage
control
programmes.

business-wide

creation

the

of

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

threats

(22) Control methods may also exist or be developed which as
such do not fall under any specific Community legislation
on product approval, but would help to achieve the
targets
specified
zoonoses and zoonotic agents. The Commission should,
therefore, have the authority to approve the use of such
methods at Community level.

the reduction of prevalences of

for

C 304 E/262

EN

Official Journal of the European Communities

30.10.2001

in particular as regards consignments of

(23) It will be essential to ensure that restocking of animals
takes place from flocks or herds that have been subject to
controls in accordance with the requirements of
this
Regulation. When a specific control programme is in
force, the results of testing should be forwarded to the
purchaser of animals. To that end, specific requirements
should be added to the corresponding Community legis-
lation on intra-Community trade and imports from third
countries,
live
animals and hatching eggs. Council Directive 64/432/EEC
of 26 June 1964 on animal health problems affecting
intra-Community trade in bovine animals and swine,
Council Directive 72/462/EEC of 12 December 1972 on
upon
health
and
animals
importation of bovine, ovine,
swine,
from third
countries (1)
and Council Directive 90/539/EEC of
15 October 1990 on animal health conditions governing
from third
intra-Community trade
countries of, poultry and hatching eggs (2) should be
amended accordingly.

caprine
fresh meat or meat products

and imports

inspection

veterinary

problems

and

in,

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

4 February 1998 laying down certain detailed rules
in the
concerning on-the-spot
veterinary
third
countries (4).

carried out
experts

by Commission

checks

field

in

(27) Appropriate procedures should be laid down for the
amendment of certain provisions of
this Regulation
taking into account technical and scientific progress, and
for
implementing and transitional
measures.

adoption of

the

for

the exercise of

(28) 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 (5),
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 of . . . [laying
down the general principles and requirements of
food
law, establishing the European Food Authority, and
laying down procedures in matters of food],

they

HAVE ADOPTED THIS REGULATION:

CHAPTER I

INTRODUCTORY PROVISIONS

Article 1

Subject-matter and scope

(25) It is appropriate to designate National and Community
Reference Laboratories for giving guidance and assistance
on matters falling within the scope of this Regulation.

1.
The purpose of this Regulation is to ensure that proper
and effective measures are taken to control salmonella and
other zoonotic agents in order to reduce their prevalence
and the risk they pose to public health.

(26) In order

to ensure the uniform application of

the
provisions of this Regulation, provision should be made
for the organisation of Community audits and inspections
in accordance with Commission Decision 98/139/EC of
4 February 1998 laying down certain detailed rules
concerning on-the-spot
in the
checks
veterinary field by Commission experts in the Member
States (3)
and Commission Decision 98/140/EC of

carried out

2.

This Regulation covers:

(a) the adoption of targets for the reduction of prevalences of
specified zoonoses, in animal populations, in particular at
the stage of primary production of animals, but also, where
necessary, at other stages in the food chain;

(1) OJ L 302, 31.12.1972, p. 28. Directive as last amended by Directive

97/79/EC (OJ L 24, 30.1.1998, p. 31).

(2) OJ L 303, 31.10.1990, p. 6. Directive as

last amended by

Commission Decision 2000/505/EC (OJ L 201, 9.8.2000, p. 8).

(3) OJ L 38, 12.2.1998, p. 10.

(b) the approval of specific control programmes established by

Member States and food business operators;

(4) OJ L 38, 12.2.1998, p. 14.
(5) OJ L 184, 17.7.1999, p. 23.

30.10.2001

EN

Official Journal of the European Communities

C 304 E/263

(c)

the adoption of specific rules concerning certain control
methods applied in the reduction of prevalences of
zoonoses and zoonotic agents;

necessary,
obtained;

in particular in the light of data and results

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

Article 2

Definitions

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

1.

2.

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

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

3.

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

(b) collecting the data needed to evaluate the means used and
the results obtained in carrying out the national control
programmes provided for in Article 5 and for submitting
those data and results yearly, including the results of any
to the Commission and to the
surveys undertaken,
the following
European Food Authority by 31 May of
year, having regard to the rules laid down pursuant to
Article 9(1) of Directive . . ./. . ./EC [on the monitoring of
zoonoses and zoonotic agents, amending Council Decision
90/424/EEC and repealing Council Directive 92/117/EEC];

(c) carrying out

regular checks on the premises of

food
business operators for the purpose of checking compliance
with this Regulation.

CHAPTER II

COMMUNITY TARGETS

Article 4

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

4.

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

1.
Community targets shall be established for the reduction
of prevalences of zoonoses and zoonotic agents listed in Annex
I, Part A, Column 1 in the animal populations listed in Annex
I, Part A, Column 2, taking into account:

5.

(cid:145)prevalence(cid:146) means the number of cases of epidemiological
units tested positive for a given zoonosis or zoonotic agent
in a given population over a clearly defined period of time;

6.

(cid:145)herd(cid:146) means an animal or group of animals as defined in
Article 2(2)(a) of Directive 64/432/EEC;

7.

(cid:145)flock(cid:146) means an animal or group of animals as defined in
Article 2(2)(7) of Directive 90/539/EEC;

8.

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

Article 3

Competent authorities

Each Member

competent
1.
authority for the purpose of this Regulation and notify the
Commission thereof.

shall designate

State

its

(a) the experience gained under existing national measures;

(b) information forwarded to the Commission or

to the
existing Community
European Food Authority under
requirements,
in particular in the framework of reports
provided for in Article 9(1) of Directive . . ./. . ./EC [on
the monitoring of
agents,
amending Council Decision 90/424/EEC and repealing
Council Directive 92/117/EEC];

zoonoses

zoonotic

and

(c)

the criteria laid down in Annex I, Part B.

When necessary, in accordance with the procedure laid down
in Article 14(2), Annex I may be amended and it may be
decided that Community targets shall be established for other
stages in the food-chain.

Community targets shall at least include the details set

2.
out in Annex I, Part C.

The competent authority shall be responsible in particular

2.
for:

(a) drawing up the programmes provided for in Article 5(1)
thereto which prove

and preparing any amendments

Community targets shall be established for the first time
3.
before the respective dates indicated in Annex I, Part A,
Column 4. The targets, as well as any amendments to them,
shall be established in accordance with the procedure referred
to in Article 14(2), and after consultation of the European Food
Authority.

C 304 E/264

EN

Official Journal of the European Communities

30.10.2001

to Community rules on animal
4. Without prejudice
nutrition, animal health, or food hygiene, the reduction of
prevalences of zoonoses and zoonotic agents listed in Annex
I shall be conducted in accordance with the rules laid down in
this Regulation and any other rules adopted pursuant to it.

CHAPTER III

CONTROL PROGRAMMES

Article 5

National control programmes

in particular in the light of

the
1. Member States shall,
in Article 4 and the
Community targets provided for
geographical distribution of zoonoses
territory,
establish national control programmes for each zoonosis and
zoonotic agent listed in Annex I.

in their

National control programmes shall be continuous and

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

3.

National control programmes shall:

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

requirements

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

(b) define the responsibilities of

food business operators
concerned, especially in terms of their control programmes
as provided for in Article 7;

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

(d) allow for

the progress under

evaluated and for those programmes to be reviewed,
particular
detection of zoonoses and zoonotic agents.

in the light of

their provisions

to be
in
results obtained from the

National control programmes shall cover at

4.
following stages of the food chain:

least

the

(a)

feedingstuff production;

(b) primary production of animals;

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

shall

National

the provisions

control programmes

contain, where
5.
relevant,
laid down in relation to testing
methods and criteria against which the results of these tests
testing animals and hatching eggs
shall be assessed,
despatched within the national
the
official controls provided for in Annex II, Part A, point 1.6.

territory, as part of

for

6.
laid
The requirements and minimum sampling rules
down in Annex II may be amended in accordance with the
procedure referred to in Article 14(2).

the
7. Within 6 months
Community targets provided for in Article 4, Member States
shall
to the
Commission and set out the measures to be implemented.

control programmes

establishment of

their national

submit

after

the

Article 6

Approval of the national control programmes

a national

six months

shall, within

The Commission

control programme,

after
1.
submission of
establish
whether it complies with the relevant rules including this Regu-
lation in particular. The Commission may ask Member States to
to bring them into
modify or
conformity. When the Commission has
established the
conformity of
they shall be approved in
accordance with the procedure referred to in Article 14(2).

supplement programmes

the programmes,

Amendments

to paragraph 1,

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

in order to take account of

3. Where the Commission has requested further information
from a Member State, the six month time-limit referred to in
paragraph 1 shall be suspended until
information is
provided.

that

Article 7

Control programmes of food business operators

1. Member States shall encourage food business operators or
organisations representing such operators, which have full
certain animals or
responsibility for
products of animal origin to establish one or more control
programmes.

the production of

Those control programmes shall cover at
production and primary production of animals.

least

feedingstuff

submit
thereto for

Food business operators or their representative organi-
2.
their control programmes and any
sations
shall
amendments
the competent
authority of the Member State in which they are located. If
the primary production of animals takes place in different
these programmes shall be approved indi-
Member States,
vidually for each Member State.

the approval of

The competent authority shall approve the control
3.
programmes submitted pursuant to paragraph 2 only if they
are satisfied, after an inspection visit,
the control
programmes comply with the minimum requirements set out
in Annex II whenever these requirements are relevant, and with
the objectives of the relevant national control programme.

that

30.10.2001

EN

Official Journal of the European Communities

C 304 E/265

4. Member States shall maintain up-to-date lists of approved
control programmes of
their
representative organisations.

food business operators or

Those lists shall be made available to the Commission upon
request.

Food business operators or their representative organi-
their

5.
sations
control programmes to the competent authorities.

shall communicate regularly the results of

CHAPTER IV

CONTROL METHODS

Article 8

Specific control methods

1.
At the initiative of the Commission or at the request of a
Member State and, where necessary, after consultation of the
European Food Authority, the following may be adopted in
accordance with the procedure referred to in Article 14(2):

(a) decisions that specific control methods may or shall be
applied for the reduction of prevalence of zoonoses and
zoonotic agents at the stage of the primary production of
animals and other stages in the food chain;

to

the

specific

prejudice

requirements
2. Without
concerning the control of salmonella in certain flocks, as laid
down in Annex II, the Member State of destination may, in
accordance with the procedure referred to in Article 14(2), be
authorised for a transitional period to require that the results of
the tests to be referred to in the relevant health certificates for
consignments of animals and hatching eggs subject to testing
in the Member State of dispatch, fulfil the same criteria as
those laid down under its national programme, in accordance
for consignments despatched within its
with Article 5(5),
territory.

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

to Article 5(6),

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

specific

The provisions of paragraphs 1 and 2 shall not apply to

4.
dispatching of eggs for packaging or processing.

(b) rules concerning the conditions for the use of the methods

Imports from third countries

Article 10

referred to in (a);

(c) detailed

rules

concerning necessary

procedures as well as minimum requirements
methods referred to in (a);

documents
for

and
the

(d) decisions that certain specific control methods shall not be

used as a part of control programmes.

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

CHAPTER V

TRADE

Article 9

Intra-Community trade

1.
As from the dates mentioned in Annex I, Part A, Column
5 at the latest, flocks and herds of origin of the species listed in
Column 2 shall be tested for the zoonoses and zoonotic agents
listed in Column 1 prior to any dispatching of the live animals,
or hatching eggs, from the food business of origin. The date
and the result of testing shall be included in the relevant health
certificates, as laid down in Directive 64/432/EEC or Directive
90/539/EEC.

1.
As from the dates mentioned in Annex I, Part A, Column
5, admission to or retention from the lists of third countries
provided for in Community legislation, for the relevant species
from which Member States are authorised to
or category,
import those animals or hatching eggs covered by this Regu-
lation shall be subject to submission to the Commission by the
third country concerned of a programme equivalent to those
provided for under Article 5. The programme shall give details
of the guarantees offered by that country as regards inspections
and controls for zoonoses and zoonotic agents. Those guar-
antees must be at least equivalent to the guarantees provided
for by this Regulation.

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

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

C 304 E/266

EN

Official Journal of the European Communities

30.10.2001

Flocks and herds of origin of species listed in Annex I,
4.
Part A, Column 2 shall be tested for the zoonoses and zoonotic
agents listed in Column 1, prior to any dispatching of the live
animals or hatching eggs from the food business of origin. The
date and the result of testing shall be included in the relevant
import certificates,
laid down by
Community legislation shall be amended accordingly.

for which the models

5.
The Member State of final destination may be authorised,
in accordance with the procedure referred to in Article 14(2),
to require for a transitional period that the results of the testing
referred to in Paragraph 4 fulfil the same criteria as those laid
down under
in accordance with
Article 5(5). The authorisation may be withdrawn and,
without prejudice to Article 5(6), specific rules concerning
such criteria may be laid down,
in accordance with the
procedure referred to in Article 14(2).

its national programme,

retention from the lists of
in Community legislation,

third
Admission to or
6.
countries provided for
the
relevant category of products, from which Member States are
authorised to import those products covered by this Regulation
shall be subject to submission to the Commission by the third
country concerned of guarantees equivalent to those provided
for by this Regulation.

for

CHAPTER VI

LABORATORIES

Article 11

Reference laboratories

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

The

responsibilities

and tasks of

the Community
2.
in particular with regard to co-ordi-
Reference Laboratories,
nation of their activities and those of the National Reference
Laboratories,
shall be laid down in accordance with the
procedure referred to in Article 14(2).

3. Member States shall designate national reference labora-
tories for zoonoses and zoonotic agents referred to in Annex I.
The
be
of
and
communicated to the Commission.

laboratories

addresses

names

shall

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 14(2).

Article 12

Approval of

laboratories, quality requirements
approved testing methods

and

Laboratories

1.
programmes
pursuant to Articles 5 and 7 at which samples are analysed

participating

control

in

for the testing of the presence of zoonoses and zoonotic agents
referred to in Annex I shall be approved by the competent
authority.

2.
At the latest from 1 January 2005, each Member State
shall ensure that laboratories referred to in paragraph 1 apply
quality assurance systems which conform to the requirements
of Standard EN/ISO 17025.

Laboratories shall regularly participate in collaborative testing
organised or co-ordinated by the national reference laboratory.

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

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

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

CHAPTER VII

IMPLEMENTATION

Article 13

Amendments to Annexes, implementing and transitional
measures

Where appropriate after consultation of the European Food
Authority, the Annexes may be amended or appropriate tran-
sitional or implementing measures,
including the necessary
amendments
to the relevant health certificates, may be
adopted in accordance with the procedures referred to in
Article 14(2).

Article 14

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 Council Decision
1999/468/EC shall apply,
in compliance with Article 7 and
Article 8 thereof.

30.10.2001

EN

Official Journal of the European Communities

C 304 E/267

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

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

Article 18

Amendment of Directive 90/539/EEC

CHAPTER VIII

Directive 90/539/EEC is amended as follows:

GENERAL AND FINAL PROVISIONS

Article 15

Community controls

carry out on-the-spot

The Commission shall
in
accordance with Decisions 98/139/EC and 98/140/EC in the
Member States and in third countries in order to ensure that
rules adopted pursuant
this Regulation,
the provisions of
thereto and any safeguard measures are applied uniformly.

checks

1. In Article 6(1), the following point (d) is added:

(cid:145)(d) they have been subject to controls in accordance with
the
the requirements of Regulation (EC)
European Parliament and of the Council (*) [this Regu-
lation]

. . ./. . . of

___________
(*) OJ L . . .(cid:146).

Article 16

Amendment of Directive 64/432/EEC

2. In Article 10, the following point (e) is added:

In Article 3(2) of Directive 64/432/EEC, the following point (f)
is added:
(cid:145)(f) they have been subject, where relevant,

to controls in
accordance with the requirements of Regulation (EC)
No . . ./. . . of
the
Council (*) [this Regulation],
___________
(*) OJ L . . .(cid:146).

the European Parliament

and of

(cid:145)(e) which has been subject to controls in accordance with
the
the Council [this Regu-

the requirements of Regulation (EC)
European Parliament and of
lation].(cid:146)

. . ./. . . of

3. In Article 21(2), the following point (h) is added:

(cid:145)(h) compliance with Community rules on the control of

zoonoses and zoonotic agents(cid:146).

Article 17

Amendment of Directive 72/462/EEC

In Article 6 of Directive 72/462/EEC, the following paragraph
7 is added:
Live animals must originate from third countries with
(cid:145)7.
rules equivalent
to the requirements on the control of
zoonoses and zoonotic agents set out in Regulation (EC)
No . . ./. . . of
the
Council (*) [this Regulation]
___________
(*) OJ L . . .(cid:146).

the European Parliament and of

Article 19

Entry into force

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

It shall apply as from 1 January 2003.

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

C 304 E/268

EN

Official Journal of the European Communities

30.10.2001

ANNEX I

A. Specified zoonoses and zoonotic agents for which Community targets for the reduction of prevalence shall

be established pursuant to Article 4

1. Zoonosis/zoonotic agent

2. Animal population

3. Stage of food-chain

4. Target to be
established by (date)

5. Mandatory testing
and certification for
trade shall apply as
from

All salmonella serotypes with public
health significance (a)

Breeding flocks of
Gallus gallus

Primary production

31.12.2003

1.1.2005

Salmonella Enteritidis and Salmonella
Typhimurium

Laying hens

Primary production

31.12.2004

1.1.2006

All salmonella serotypes with public
health significance (a)

Broilers

All salmonella serotypes with public
health significance (a)

Turkeys

Primary production

31.12.2005

1.1.2007

Primary production

31.12.2006

1.1.2008

All salmonella serotypes with public
health significance (a)

Breeding herds of
pigs

Primary production

31.12.2006

1.1.2008

(a) Serotypes shall be defined when the target is established.

B. Criteria for laying down the list of zoonoses and stages in the food chain in Part A above

When necessary, zoonoses or zoonotic agents may be added in or deleted, or different stages in the food chain may be
specified, 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, and

(cid:151) management options foreseen at the relevant stage of the target.

The Community targets referred to in Article 4(1) shall consist at least of:

C. Details of targets

1. A numerical expression of either

(a) the maximum percentage of epidemiological units remaining positive, and/or

(b) the minimum percentage of reduction in a number of positive epidemiological units,

2. The maximum time limit within which the target shall be achieved,

3. Definition of epidemiological units referred to in point 1, and

4. Definition of the testing schemes necessary to verify the achievement of the target.

30.10.2001

EN

Official Journal of the European Communities

C 304 E/269

CONTROL OF ZOONOSES AND ZOONOTIC AGENTS LISTED IN ANNEX I

ANNEX II

A. General requirements for national control programmes

The programme shall take into account the nature of the zoonosis and/or agent thereof concerned and the specific
situation in the Member State and it shall:

(a) state the aim of the programme taking into consideration the importance of the zoonosis concerned;

(b) specify

1. General

1.1. The occurrence of the zoonosis concerned in the Member State with specific reference to the results
obtained in the framework of monitoring according to Article 4 of Directive . . ./. . ./EC [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],

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

implemented,

1.3. the infrastructure of the relevant competent authorities,

1.4. a list of approved laboratories, where samples collected within the programme are analysed,

1.5. the methods used in the examination of the zoonotic agents,

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

1.7. official controls (including sampling schemes) at other stages of the food chain, and at feedingstuffs level,

1.8. the type of measures laid down by the competent authorities with regard to animals or products in which

zoonoses and zoonotic agents have been detected, in particular to protect public health,

1.9. relevant national legislation;

2. Concerning food businesses covered by the programme

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

2.2. the structure of the production of feedingstuffs,

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

least

(cid:151) hygiene management at farms,

(cid:151) measures to prevent incoming infections carried by animals, feed material, drinking water, people

working at farm,

(cid:151) hygiene in transporting animals to and from farms,

2.4. routine veterinary supervision of farms,

2.5. registration of farms,

2.6. record keeping at farms,

2.7. documents to accompany animals when dispatched,

2.8. other relevant measures to ensure the traceability of animals;

C 304 E/270

EN

Official Journal of the European Communities

30.10.2001

(c) comply with the minimum sampling rules and levels laid down in Part B;

(d) where relevant, comply with the specific requirements laid down in Parts C to E.

B. Minimum requirements of sampling

1. After the respective control programme referred to in Article 5 has been approved, the food business operator
must, at his own expense, have samples taken for analysis for the detection of zoonosis or zoonotic agents listed
in Annex I, with the minimum scope of sampling indicated below being respected.

Zoonosis/zoonotic agent

Animal species

Data

Sampling shall cover at least these
phases of production

All salmonella serotypes with
public health significance (a)

1. Breeding flocks of

Gallus gallus

1.1. Rearing flocks

(a) feedingstuffs

(b) live animals

(i) Day-old chicks
(ii) 4 week old
(iii) 2 weeks before moving
or

phase

laying
to
laying unit

1.2. Adult breeding flocks

(a) feedingstuffs

(b) live animals

(i) every

week
second
during the laying period

Salmonella
Enteritidis
Salmonella Typhimurium

and

2. Commercial layers

(a) feedingstuffs

2.1. Rearing flocks

(b) live animals

(i) Day-old chicks
(ii) pullets 2 weeks before
moving to laying phase
or laying unit

2.2. Laying flocks

(a) feedingstuffs

All salmonella serotypes with
public health significance (a)

3. Broilers

All salmonella serotypes with
public health significance (a)

4. Turkeys

5. Pigs

(a) Serotypes shall be defined when the target is established.

(b) live animals

(i) every 9 weeks during the

laying phase

(a) feedingstuffs

(b) live animals

(i) Birds leaving for

slaughter

(c) Ante mortem
inspection

Ante mortem
inspection

Ante mortem
inspection

(i) Birds leaving for

slaughter

(i) Animals leaving for

slaughter

2. The data collected shall be accompanied with the following information:

(a) Date and place of sampling;

(b) Identification of the flock/herd.

3. Immunological testing may not be used if the animals have been vaccinated unless it has been proved the vaccine

used does not interfere with the testing method applied.

30.10.2001

EN

Official Journal of the European Communities

C 304 E/271

C. Specific requirements concerning breeding flocks of Gallus gallus

Where, as a result of an investigation carried out in accordance with Point 1 of the Table in Part B.1, the presence of
Salmonella Enteritidis or Salmonella Typhimurium is confirmed in the birds in a breeding flock of Gallus gallus, the
following measures must be taken:

Non-incubated eggs from the flock must be destroyed or be intended for the manufacture of egg products or subject
to an equivalent treatment to guarantee the elimination of Salmonella Enteritidis and Salmonella Typhimurium,
in
accordance with Regulation (EC) No . . ./. . . [on the hygiene of foodstuffs];

Without prejudice to the requirements under Part E below, all the birds (cid:151) including day-old chicks (cid:151) in the flock
must be slaughtered or destroyed so as to reduce as much as possible the risk of spreading salmonella. Slaughtering
must be carried out in accordance with [Annex II, Section II, Chapter IV, point 11] (the relevant provisions) of
Regulation (EC) No . . ./. . . of the European Parliament and of the Council of . . . [laying down specific hygiene rules
for food of animal origin], and with [Annex II, Chapter III, Section I, point 5] (the relevant provisions) of Regulation
(EC) No . . ./. . . of the European Parliament and of the Council [laying down detailed rules for the organisation of
official controls on products of animal origin intended for human consumption].

Where eggs for hatching from flocks in which the presence of Salmonella Enteritidis or Salmonella Typhimurium has
been confirmed are still present in a hatchery, they must be destroyed or treated as category 3 material in accordance
with Regulation (EC) No . . ./. . . of the European Parliament and of the Council of . . . [laying down the health rules
concerning animal by-products not intended for human consumption].

D. Specific requirements concerning flocks of laying hens

As from 1 January 2008, eggs shall not be used for direct human consumption (table eggs) unless they originate
from a commercial flock of laying hens subject to the testing scheme in accordance with Point 2 in the Table of Part
B.1 and subsequently found non-contaminated.

The eggs originating from flocks with unknown status, suspected to be contaminated or from contaminated flocks
must be intended for the manufacture of egg products or subject to an equivalent treatment to guarantee the
elimination of Salmonella Enteritidis and Salmonella Typhimurium, in accordance with Regulation (EC) No . . ./. . . [on
the hygiene of foodstuffs]:.

Without prejudice to the requirements under Part E below, all the birds in the flock must be slaughtered or destroyed
so as to reduce as much as possible the risk of spreading salmonella. Slaughtering must be carried out in accordance
with [Annex II, Section II, Chapter IV, point 11] (the relevant provisions) of Regulation (EC) No . . ./. . . of the
European Parliament and of the Council of . . . [laying down specific hygiene rules for food of animal origin] and
with [Annex II, Chapter III, Section I, Point 5] (the relevant provisions) of Regulation (EC) No . . ./. . . of the European
Parliament and of the Council [laying down detailed rules for the organisation of official controls on products of
animal origin intended for human consumption].

E. Specific requirements concerning flocks of broilers

As from 1 January 2009, the following criterion will apply for placing on the market of fresh poultry meat, unless it
is destined for an industrial heat treatment or another treatment able to eliminate salmonella, in accordance with
Regulation (EC) No . . ./. . . [on the hygiene of foodstuffs]:

(cid:145)Salmonella: absence in 25 grammes(cid:146)

These requirements may be revised in accordance with the procedure referred to in Article 14(2) and after consulting
the appropriate Scientific Committee.