Common Position (EC) No 14/2003 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 regulation of the European Parliament and of the Council on the control of salmonella and other specified food-borne zoonotic agents
Date: 2003-02-20
Institutions: Council of the European Union
Subjects: animal disease, disease prevention, food inspection, food safety, health legislation, research body, veterinary inspection, zoonosis

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COMMON POSITION (EC) No 14/2003

adopted by the Council on 20 February 2003

with a view to adopting Regulation (EC) No . . ./2003 of the European Parliament and of the
Council of . . . on the control of salmonella and other specified food-borne zoonotic agents

(2003/C 90 E/03)

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 European Economic and
Social Committee (2),

After consulting the Committee of the Regions,

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

Whereas:

(1) Live animals and food of animal origin appear on the list
in Annex I
to the Treaty. Livestock farming and the
placing on the market of food of animal origin 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) Zoonoses present at the level of primary production must
be adequately controlled to ensure the achievement of the
in the case of
this Regulation. However,
objectives of

(1) OJ C 304 E, 30.10.2001, p. 260.
(2) OJ C 94, 18.4.2002, p. 18.
(3) Opinion of the European Parliament of 15 May 2002 (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).

it

law.

primary production leading to the direct supply of small
quantities of primary products, by the food business
operator producing them, to the final consumer or to
is appropriate to protect public health
local shops,
through national
In this case there is a close
relationship between the producer and the consumer.
Such
significant
contribution to the average prevalence of zoonoses in
animal populations in the Community as a whole. The
general requirements for sampling and analysis may not
be practical or appropriate for producers with very small
numbers of animals who may be located in regions
suffering from special geographical constraints.

not make

production

should

a

for protection against

(6) 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 (4) provided for
the establishment of monitoring systems
for certain
zoonoses and controls on salmonella in certain poultry
flocks.

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

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

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

(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 L 113, 30.4.1997, p. 9.

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(10) 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 (1) deals with bovine
tuberculosis and bovine brucellosis. Council Directive
91/68/EEC of 28 January 1991 on animal health
conditions governing intra-Community trade in ovine
and caprine animals (2) deals with ovine and caprine
any
brucellosis. This Regulation should not
unnecessary duplication of these existing requirements.

create

cover

(11) Moreover, future Community legislation on food hygiene
should
the
prevention, control and monitoring of zoonoses and
zoonotic agents and include specific requirements for the
microbiological quality of food.

elements necessary

specific

for

(12) 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

(13) 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
in particular due to Salmonella Enteritidis
salmonellosis,
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 do not necessarily
give the full picture of the situation.

(14) 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
Committee
monitoring
arrangements and identified risk management options.

fully comparable. As
recommended

a
improved

consequence,

(15) It is therefore necessary to improve the existing control
systems for specific zoonotic agents. Simultaneously, the

(1) 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).

(2) 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).

rules laid down in 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
Directive
repealing
and
Council
92/117/EEC (3) will
replace the monitoring and data
collection systems established by Directive 92/117/EEC.

(16) In principle, controls should cover the whole food chain,

from farm to table.

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

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

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

(20) The targets

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

feed and food,

(21) To ensure the achievement of the targets in good time,
Member States should set up specific control programmes,
which the Community should approve.

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

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

(3) See p. 9 of this Official Journal.

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(24) 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
for the reduction of the prevalence of specified zoonoses
and zoonotic agents. It should, therefore, be possible to
approve the use of such methods at Community level.

the results of

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

inspection

veterinary

problems

and

(26) The adoption of this Regulation should not affect

95/50/EC (4),

94/968/EC (3),

the
additional guarantees agreed for Finland and Sweden on
their accession to the Community and confirmed by
95/160/EC (5),
Decisions
95/161/EC (6), 95/168/EC (7), 95/409/EC (8), 95/410/EC (9)
and 95/411/EC (10). This Regulation should provide a
procedure for the granting, for a transitional period, of
guarantees to any Member State that has an approved
national control programme exceeding the minimum
Community requirements in relation to salmonella. The
results of tests on live animals and hatching eggs traded
with such a Member State should meet the criteria laid
Future
down in its national
food of
Community legislation on hygiene rules

control programme.
for

animal origin should provide a similar procedure in
respect of meat and table eggs.

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

equivalent measures

the

(28) As regards control of salmonella, available information
tends to show that poultry products are a major source
of human salmonellosis. Control measures
should,
therefore, be applied to production of
those products,
thus extending the measures initiated under Directive
it
92/117/EEC. As regards the production of table eggs,
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
food business operators
to the measures
envisaged, which may be adapted further in particular in
the light of scientific risk assessment.

to adapt

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

(30) To ensure the uniform application of the provisions of this
Regulation, provision should be made for the organisation
of Community audits and inspections in accordance with
other Community legislation in this field.

(1) OJ L 302, 31.12.1972, p. 28. Directive as last amended by
Commission Decision 2002/995/EC (OJ L 353, 30.12.2002, p. 1).
(2) OJ L 303, 31.10.1990, p. 6. Directive as last amended by
Commission Decision 2001/867/EC (OJ L 323, 7.12.2001, p. 29).

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

last amended by

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

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

last amended by

Commission Decision 97/278/EC.

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

Commission Decision 97/278/EC.

(8) OJ L 243, 11.10.1995, p. 21. Decision as last amended by
Commission Decision 98/227/EC (OJ L 87, 21.3.1998, p. 14).
(9) OJ L 243, 11.10.1995, p. 25. Decision as last amended by

Commission Decision 98/227/EC.

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

Commission Decision 98/227/EC.

(31) Appropriate procedures should be laid down for amending
certain provisions of this Regulation to take account of
technical and scientific progress and for the adoption of
implementing and transitional measures.

(32) 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 of the
European Parliament and of the Council of 28 January
2002 laying down the general principles and requirements
food law, establishing the European Food Safety
of
Authority, and laying down procedures in matters of
food safety (11).

(11) OJ L 31, 1.2.2002, p. 1.

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(33) The measures necessary for the implementation of this
Regulation should be
adopted in accordance with
Council Decision 1999/468/EC of 28 June 1999 laying
down the procedures for the exercise of implementing
powers conferred on the Commission (1),

HAVE ADOPTED THIS REGULATION:

CHAPTER I

INTRODUCTORY PROVISIONS

Article 1

Subject-matter and scope

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.

2.

This Regulation shall cover:

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

of specified zoonoses in animal populations:

(i) at the level of primary production, and

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

(b) the approval of specific control programmes established by
Member States and food and feed business operators;

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

methods applied in the reduction of
zoonoses and zoonotic agents;

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

3.

This Regulation shall not apply to primary production:

(a)

for private domestic use; or

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

retail

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

5.
This Regulation shall apply without prejudice to more
specific Community provisions on animal health, animal

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

food hygiene,

communicable human diseases,
nutrition,
health and safety in the workplace, gene technology and trans-
missible spongiform encephalopathies.

Article 2

Definitions

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

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

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

3. the following definitions:

(a)

‘herd’ means an animal or group of animals kept on a
holding as an epidemiological unit; and

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

Article 3

Competent authorities

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

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

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

The

2.
responsible in particular for:

competent

authority or

authorities

shall

be

(a) drawing up the programmes provided for in Article 5(1)
thereto which prove
in particular in the light of data and results

and preparing any amendments
necessary,
obtained;

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

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(c) carrying out regular checks on the premises of food and, if
the purpose of checking
for

needed,
feed businesses
compliance with this Regulation.

benefits. This analysis shall take account, in particular,
of the criteria laid down in paragraph 6(c). Member
States shall, on request, provide the Commission with
all the assistance necessary to enable it to prepare the
analysis.

CHAPTER II

COMMUNITY TARGETS

Article 4

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

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

(a) the experience gained under existing national measures;

and

Food

(b) information forwarded to the Commission or

European
Community requirements,
of information provided for in Directive 2003/. . ./EC,
particular Article 5 thereof.

to the
existing
in particular in the framework
in

Safety Authority

under

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

The targets referred to in paragraph 1 shall consist at

2.
least of:

(a) a numerical expression of:

(i) the maximum percentage of epidemiological units

remaining positive; and/or

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

epidemiological units remaining positive;

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

achieved;

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

subparagraph (a);

(b) Before

each

proposing

the
Commission shall consult Member States within the
Committee referred to in Article 14(1) on the results
of its analysis.

Community

target,

(c) In the light of the results of a favourable cost/benefit
analysis and the consultation of Member States,
the
Commission shall propose Community targets where
appropriate.

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

The Community target established for breeding flocks of Gallus
gallus for this transitional period shall cover the five most
frequent salmonella serotypes in human salmonellosis, which
shall be identified on the basis of data collected through EC
monitoring systems, expressed as a weighted average of the
data for the last three years for which data are available. The
Community targets established for laying hens, broilers and
turkeys for the transitional period shall cover Salmonella Enter-
itidis and Salmonella Typhimurium. However, if necessary, these
targets may be extended to no more than five serotypes on the
basis of the results of a cost/benefit analysis carried out in
accordance with paragraph 4.

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

6. (a) Annex I may be amended,

in accordance with the
procedure laid down in Article 14(2), for the purposes
listed in subparagraph (b), after
in
taking account
particular of the criteria listed in subparagraph (c).

(b) Amendments to Annex I may alter the scope of the
of
restricting or

requirements
regarding
Community targets by supplementing,
modifying:

establishment

the

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

achievement of the target; and

(i) the zoonoses or zoonotic agents;

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

Community targets shall be established for the first time

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

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

(iii) the animal populations concerned.

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

4. (a) When defining each Community target, the Commission
its expected costs and

shall provide an analysis of

(i) its frequency in animal and human populations,

feed and food;

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(ii) the gravity of its effects for humans;

(b) define the respective responsibilities of competent auth-

orities and food and feed business operators;

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

(iv) epidemiological trends in animal and human popu-

lations, feed and food;

(v) scientific advice;

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

(vii) requirements

and trends

concerning breeding

systems and production methods.

Annex III may be

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

amended or

supplemented in

(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)

feed production;

(b) primary production of animals;

The Commission shall review the implementation of
this review when

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

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

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

CHAPTER III

CONTROL PROGRAMMES

Article 5

National control programmes

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

shall have

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;

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.

territory, as part of

for

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

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

control programmes

establishment of

their national

submit

the

Article 6

Approval of the national control programmes

After

submits a national

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

submission of

receiving

such a

the

the

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

zoonoses and zoonotic agents at the stage of the primary
production of animals and other stages in the food chain;

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

of the methods referred to in subparagraph (a);

Amendments

to paragraph 2 may be approved,

3.
pursuant
with the procedure referred to in Article 14(2),
account of
State concerned,
referred to in Article 5(3)(d).

to a programme previously approved
in accordance
to take
the evolution in the situation in the Member
the results

in the light of

in particular

Article 7

Food and feed business operators' control programmes

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

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

The

competent

authority may

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

approve

(c) detailed rules may be

adopted concerning necessary
as minimum
documents
requirements for the methods referred to in subparagraph
(a); and

procedures

as well

and

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

shall not be used as a part of control programmes.

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

CHAPTER V

TRADE

Article 9

Intra-Community trade

1.
As from the dates mentioned in Column 5 of Annex I 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 provided for in Community legislation.

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

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

2.
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 regards salmonella
as those laid down under its approved national programme, in
accordance with Article 5(5),
for consignments despatched
within its territory.

CHAPTER IV

CONTROL METHODS

Article 8

Specific control methods

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

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

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

(a)

it may be decided that specific control methods may or
the reduction of prevalence of
shall be applied for

to Article 5(6),

rules
4. 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

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Article 10

Imports from third countries

for

in Community legislation,

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

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.

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

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

laid down by Community

import certificates,

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,

Admission to or retention on the lists of third countries
6.
provided for
the relevant
category of products, from which Member States are authorised

in Community legislation,

for

to import those products covered by this Regulation shall be
subject to submission to the Commission by the third country
concerned of guarantees equivalent to those provided for by
this Regulation.

CHAPTER VI

LABORATORIES

Article 11

Reference laboratories

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

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

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

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

Article 12

Approval of

laboratories, quality requirements
approved testing methods

and

Laboratories

participating

programmes
1.
pursuant
the purposes of
analysing samples to test for the presence of zoonoses and
zoonotic agents referred to in Column 1 of Annex I:

to Articles 5 and 7 shall,

control
for

in

(a) be designated by the competent authority; and

(b) apply quality assurance systems

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

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

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

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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

Implementing and transitional measures

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

Article 14

Committee procedure

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

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

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

3.

The Committee shall adopt its Rules of Procedure.

Article 15

Consultation of the European Food Safety Authority

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

Article 16

Report on financial arrangements

The Commission shall, within three years of the entry
to the

1.
into force of
European Parliament and to the Council.

submit a report

this Regulation,

2.

The report shall discuss:

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

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

of those measures.

The Commission shall,

3.
report with relevant proposals.

if appropriate, accompany its

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

CHAPTER VIII

GENERAL AND FINAL PROVISIONS

Article 17

Community controls

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

inform the competent authority of

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

Article 18

Entry into force

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

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

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

Done at . . .

For the European Parliament

The President

For the Council

The President

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ANNEX I

SPECIFIED ZOONOSES AND ZOONOTIC AGENTS FOR WHICH COMMUNITY TARGETS FOR THE
REDUCTION OF PREVALENCE ARE TO BE ESTABLISHED PURSUANT TO ARTICLE 4

1

2

3

4

5

Zoonosis or zoonotic agent

Animal population

Stage of food chain

Date by which target
must be established (1)

Date from which testing
must take place

All salmonella serotypes
with public health
significance

Breeding flocks of
Gallus gallus

All salmonella serotypes
with public health
significance

Laying hens

All salmonella serotypes
with public health
significance

Broilers

All salmonella serotypes
with public health
significance

Turkeys

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

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

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

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

18 months after the date
referred to in column 4

18 months after the date
referred to in column 4

18 months after the date
referred to in column 4

18 months after the date
referred to in column 4

All salmonella serotypes
with public health
significance

Herds of slaughter
pigs

Slaughter

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

18 months after the date
referred to in column 4

All salmonella serotypes
with public health
significance

Breeding herds of
pigs

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

18 months after the date
referred to in column 4

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

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CONTROL OF ZOONOSES AND ZOONOTIC AGENTS LISTED IN ANNEX I

ANNEX II

A. GENERAL REQUIREMENTS FOR NATIONAL CONTROL PROGRAMMES

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

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

concerned;

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

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

(d) specify the following points:

1.

General

1.1.

the occurrence of the zoonosis or zoonotic agent concerned in the Member State with specific reference to the
results obtained in the framework of monitoring in accordance with Article 4 of Directive 2003/. . ./EC of the
European Parliament and of the Council;

1.2.

the geographical area or, where appropriate, the epidemiological units,
implemented;

in which the programme will be

1.3.

the structure and organisation of the relevant competent authorities;

1.4.

approved laboratories where samples collected within the programme are analysed;

1.5. methods used in the examination of the zoonosis or zoonotic agent;

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

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

1.8. measures taken by the competent authorities with regard to animals or products in which zoonoses or
in particular to protect public health; and any preventive measures

zoonotic agents have been detected,
taken, such as vaccination;

1.9.

relevant national legislation, including any national provisions concerning the activities referred to in Article
1(3)(b);

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

the national control

programme.

2.

Concerning food and feed businesses covered by the programme

2.1.

the structure of the production of the given species and products thereof;

2.2.

the structure of the production of feed;

2.3.

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

— hygiene management at farms,

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

farms, and

— hygiene in transporting animals to and from farms.

2.4.

routine veterinary supervision of farms;

2.5.

registration of farms;

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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.

B. MINIMUM SAMPLING REQUIREMENTS

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

1

2

3

Zoonosis or zoonotic agent

Animal population

Phases of production which
sampling must cover

salmonella serotypes with

All
public health significance

Breeding flocks of Gallus gallus:

— rearing flocks

— adult breeding flocks

salmonella serotypes with

All
public health significance

Laying hens:

— rearing flocks

— laying flocks

salmonella serotypes with

All
public health significance

Broilers

salmonella serotypes with

All
public health significance

Turkeys

salmonella serotypes with

All
public health significance

Herds of pigs:

— breeding pigs

— slaughter pigs

— day-old chicks
— four week-old birds
— two weeks before moving to laying

phase or laying unit

every second week during the laying
period

— day-old chicks
— pullets two weeks before moving to

laying phase or laying unit

every 15 weeks during the laying
phase

birds leaving for slaughter (1)

birds leaving for slaughter (1)

animals
carcasses at the slaughterhouse

leaving

for

slaughter

animals
carcasses at the slaughterhouse

leaving

for

slaughter

or

or

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

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

concerning antemortem inspection.

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

(a) date and place of sampling; and

(b) identification of the flock/herd.

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

vaccine used does not interfere with the testing method applied.

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C. SPECIFIC REQUIREMENTS CONCERNING BREEDING FLOCKS OF GALLUS GALLUS

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

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

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

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

However, such eggs may be used for human consumption if they are treated in a manner that guarantees the
elimination of Salmonella Enteritidis and Salmonella Typhimurium in accordance with Community legislation on food
hygiene.

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

5. Where eggs for hatching from flocks in which Salmonella Enteritidis or Salmonella Typhimurium is present are still
present in a hatchery, they must be destroyed or treated in accordance with Regulation (EC) No 1774/2002.

D. SPECIFIC REQUIREMENTS CONCERNING FLOCKS OF LAYING HENS

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

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

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

E. SPECIFIC REQUIREMENT CONCERNING FRESH MEAT

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

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

‘Salmonella: absence in 25 grams’.

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

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

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

(1) OJ L 273, 10.10.2002, p. 1.

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SPECIFIC CRITERIA TO DETERMINE SALMONELLA SEROTYPES WITH PUBLIC HEALTH SIGNIFICANCE

ANNEX III

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

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

systems, expressed as a weighted average of the data for the last three years for which data are available;

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

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

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STATEMENT OF THE COUNCIL'S REASONS

I. INTRODUCTION

The Commission proposed a Regulation on the control of zoonoses and zoonotic agents in August
2001.

The European Parliament adopted an opinion on the proposed Regulation 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 Regulation are:

(a) to create a flexible framework permitting the progressive implementation of a pathogen reduction

policy through national control programmes;

(b) to provide for scientific and political scrutiny of specific pathogen reduction targets;

(c)

to provide a procedure through which the use of specific control measures may be made
mandatory, subjected to conditions or prohibited;

(d) to ensure that food business operators know the status of holdings from which they receive live

animals and hatching eggs.

III. ANALYSIS OF THE COMMON POSITION

A. Introduction

The Council, the European Parliament and the Commission agree that the Regulation should
establish certain basic principles.
In particular, the three institutions agree that the Regulation
should:

— provide a flexible framework allowing the progressive extension of control measures to

additional animal populations and pathogens, and

— in principle, cover all stages of the food chain.

As a consequence, the Common Position adopted by the Council encompasses several 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

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. The Common Position is therefore
consistent with the relevant Parliamentary amendments (2).

To ensure consistency with the principle of subsidiarity, the Common Position would leave the
control of zoonoses at the level of primary production to national law when such production takes
place on a very small scale (3). The Council considers that it is not appropriate to establish
Community control rules to regulate food production activities that have only a slight and
localised impact on public health. However, national law would have to achieve the food safety
objectives of the Regulation.

(1) The Committee of the Regions decided not to provide an opinion.
(2) Amendments 11, 15 and 17 to 20; Articles 3(2)(c), 5(3)(b) and 7.
(3) Article 1(3)(b).

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C. Community targets

The Council agrees that:

— the Articles ought to contain more detail regarding the setting of Community targets for the

reduction of the prevalence of zoonoses and zoonotic agents,

— targets ought

to be established in respect of all salmonella serotypes with public health

significance as soon as is reasonably practicable,

— it is appropriate to provide for targets both for breeding and slaughter pigs.

However, the Council does not believe that it is yet appropriate to envisage targets for sheep or
calves, or for other bovine animals.

The Common Position is
amendments (1) and partly consistent with the others (2).

therefore

consistent with one of

the

relevant parliamentary

In addition, the Common Position contains clarification on the scope of Community targets. These
would apply to salmonella serotypes with public health significance. Since there are very many
salmonella serotypes, and their impact on public health varies greatly, it is necessary to clarify how
a list of those salmonella serotypes with public health significance would be drawn up. The
Common Position does this through general criteria contained in the Articles and specific criteria
laid down in the Annexes (3).

As regards the timetable for the implementation of Community targets, the Common Position sets
relative dates, linked to the Regulation's entry into force date (4). This would ensure that, whatever
the final date of adoption of the Regulation, there would always be a proper balance between the
need to avoid undue delay in implementing the targets and the need to allow sufficient time to
make implementation practicable. The Common Position also provides for an additional six months
between the setting of a target and the start of the obligation to carry out testing. This would ensure
that Member States have time to adapt and to implement national control programmes.

The Common Position provides for the Commission to carry out a cost/benefit analysis before
proposing Community targets (5).

To avoid the implementation of the targets from creating undue burdens for primary producers in
the first few years of application of the Regulation, it provides for transitional periods. Each target for
poultry would, for its first three years of application, apply only to the most prevalent salmonella
serotypes (the five most frequent in human salmonellosis as regards breeding hens, and the two
most frequent in human salmonellosis in the case of other poultry) (6). The requirement for the
Commission to carry out a cost/benefit analysis would not apply during these transitional periods.
However, should the Commission carry out such an analysis voluntarily, and if the conclusions
justify it, it would be possible to extend the requirements for poultry other than breeding hens to
the five most frequent serotypes during the transitional period.

(1) Amendments 13 and 31; Article 4(2).
(2) Amendments 29, 32, 34, 36 and 38. Annexes I and II.B.
(3) Article 4(2)(e).
(4) Annex I.
(5) Article 4(4).
(6) Article 4(5).

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D. Specific control requirements

The Council agrees that the specific control measures for laying hens should apply to all salmonella
serotypes with public health significance. However, it does believe that it would not be practicable
to extend the specific control measures for breeding flocks beyond the two most common serotypes
in the short term. Consequently, the Common Position incorporates one of the two relevant
parliamentary amendments (1), but not the other (2).

To be consistent with the approach adopted for Community targets, the Common Position provides
for relative dates for the introduction of specific control measures. It clarifies that detailed rules on
how to check compliance with the objective of salmonella-free poultry meat would be laid down
through comitology, at the latest one year before the requirement applies.

E. 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.

The Common Position is therefore consistent with the objective of the relevant parliamentary
amendments (3).

F.

Intra-Community trade

The Common Position makes clear that the special measures concerning salmonella that currently
apply to live animals dispatched to Finland and Sweden would continue to apply after entry into
force of the Regulation (4).

Moreover, as the Commission proposed, the Regulation would contain a mechanism making it
possible, for a transitional period, to apply additional requirements to trade with other Member
States whose national control programmes go beyond the minimum requirements of the Regu-
lation (5). The same mechanism would allow the requirements concerning Sweden and Finland to be
updated.

The Council agrees that it is superfluous for this mechanism to cover food, since the Regulation
laying down specific hygiene rules for food of animal origin should contain an equivalent
mechanism. The Council cannot accept the application of the mechanism to control measures
taken to combat zoonotic agents other than salmonella. It believes that it would be disproportionate
for failure to have a national control programme approved on time to exclude a Member State from
intra-Community trade. Consequently, while it can accept the Parliamentary amendment on the first
point (6), it cannot accept those on the two others (7).

G. Financial issues

The Council agrees that national control programmes must have regard to the financial implications
for food and feed business operators of control measures. The Common Position therefore incor-
porates the relevant parliamentary amendment (8).

In addition, the Common Position provides for the Commission to report on financial issues and, if
appropriate, to make proposals, within three years of entry into force of the Regulation (9).

(1) Amendment 34; Annex II.D.
(2) Amendment 33.
(3) Amendments 12 and 30; Article 4(6)(c).
(4) Article 9(3).
(5) Article 9(2).
(6) Amendment 23.
(7) Amendments 22 and 24.
(8) Amendment 14; Article 5(1).
(9) Article 16.

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to prejudice the content of

this report, and the outcome of discussions on any
So as not
Commission proposals within the European Parliament and the Council, the Common Position
on the Directive on the monitoring of zoonoses and zoonotic agents includes a consequential
modification to the amendment to Article 29 of 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.

As regards minimum sampling requirements, the Common Position would maintain an obligation for
food business operators to have samples taken and analysed, but would not specify who should
meet the costs of these activities (1). To ensure transparency, Member States would have to include
in their national control programmes details of any financial assistance provided to food and feed
business operators (2).

H. Relationship with other legislation

The Common Position incorporates amendments to ensure consistency with Regulation (EC)
No 178/2002 (3). In particular, Article 2 now imports the definitions of that Regulation rather
than repeating some of them.

The Common Position provides for free-standing definitions of ‘herd’ and ‘flock’, obviating the need
for the reader to consult separate acts to understand their meaning.

I. Consultation of the European Food Safety Authority

The Council agrees that the Commission should consult the European Food Safety Authority (EFSA)
before proposing specific control methods. The Common Position would also require the
Commission to consult EFSA before proposing Community targets.

The Council does not believe, however, that it is appropriate to make consultation compulsory in
all cases. It should be necessary only in cases where the Commission's proposal would have a
significant impact on public health.

The Common Position is therefore consistent with one of the relevant Parliamentary amendments (4)
but only partially consistent with the other (5).

J. Other

The Common Position incorporates Parliamentary amendments:

— ensuring that the recitals are consistent with the Articles (6),

— enabling 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 (7),

(1) Annex II, part B.
(2) Annex II, part A.
(3) Amendments 6 and 8; recital 32; Article 1(3)(a).
(4) Amendment 21; Article 15.
(5) Amendment 27; Article 15.
(6) Amendments 4 and 5; recitals 27 and 30.
(7) Amendment 9; Article 3(1).

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— providing for the Commission's Food and Veterinary Office to monitor third countries' control

programmes (1),

— on Community controls (2).

The Common Position does not incorporate amendments:

— proposing amendments to the recitals that are not consistent with the Articles or the

Annexes (3),

— proposing a political statement rather than a legal obligation (4),

— shortening the deadline for reports (5),

— extending national control programmes to food of plant origin (6).

The Council agrees that laboratories should have to keep pace with any updating of the relevant
EN/ISO standard. It considers that it would be impracticable, however, to require compliance with
the current standard by 1 January 2004. Instead, the Common Position would give laboratories 24
months from entry into force of the Regulation to do so (7).

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

— delete the definition of ‘prevalence’, which was superfluous since the Regulation always uses the

term in a non-technical manner to describe general objectives,

— clarify the procedure for the approval of national control programmes (8) and food and feed
business operators' control programmes (9) and the required content of national control
programmes (10),

— if necessary to compensate for a different epidemiological situation and to secure equivalent
from

guarantees, make it possible to establish requirements for third countries different
Community targets (11),

— provide for the Regulation to apply six months after its entry into force (12) (that is, at the same

time as the repeal of Directive 92/117/EEC), and

— clarify the minimum sampling requirements (13) and specific control requirements for flocks of

breeding hens (14).

IV. CONCLUSION

The Council welcomes the fact that it has been able to incorporate several 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 Regulation.

(1) Amendment 25 (part).
(2) Amendment 28; Article 17.
(3) Amendments 1 to 3.
(4) Amendment 7.
(5) Amendment 10.
(6) Amendment 16.
(7) Amendment 26; Article 12(1)(b).
(8) Article 6.
(9) Article 7.
(10) Annex II, part A.
(11) Article 10(4).
(12) Article 18.
(13) Annex II, part B.
(14) Annex II, part C.