Amended proposal for a Directive of the European Parliament and of the Council on the monitoring of zoonoses and zoonotic agents, amending Council Decision 90/424/EEC and repealing Council Directive 92/117/EEC (presented by the Commission pursuant to Article 250(2) of the EC-Treaty)
Date: 2002-11-27
Institutions: European Commission
Subjects: epidemiology, food inspection, health policy, public health, statistical method

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 27.11.2002
COM(2002) 684 final

2001/0176 (COD)
2001/0177 (COD)

Amended proposal for a

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on the monitoring of zoonoses and zoonotic agents, amending Council Decision
90/424/EEC and repealing Council Directive 92/117/EEC

Amended proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on the control of salmonella and other specified food-borne zoonotic agents

(presented by the Commission pursuant to Article 250(2) of the EC-Treaty)

EXPLANATORY MEMORANDUM

A.

Procedure

In August 2001 the Commission submitted proposals for a Directive of the European
Parliament  and  the  Council  on  the  monitoring  of  zoonoses  and  zoonotic  agents,
amending  Council  Decision  90/424/EEC  and 
repealing  Council  Directive
92/117/EEC and for a Regulation of the European Parliament and 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  (COM(2001)  452  final  –
2001/0176(COD)-2001/0177(COD)) for  adoption  by  the  co-decision  procedure  laid
down in Article 251 of the Treaty establishing European Community.

On  15  May  2002  the  European  Parliament  took  position  in  the  first  reading.  The
Parliament adopted 66 Amendments (respectively 30 on the proposed Directive and
36 on the proposed Regulation), of which 54 (respectively 28 and 26) were accepted
by the Commission in the entirety or in part or on conditions or after reformulation.

In  the  light  of  these  developments,  the  Commission  has  drafted  these  amended
proposals.  The  amendments  are  in  ‘bold’  and  ‘underlined’,  where  adding  or
modifying,  and  in  “bold”  and  “strikeout’,  where  deleting  text.  Only  extensive
linguistic changes will be mentioned below. Editorial changes made pursuant to B III
below are not marked in the text.

B.

Explanations of the amendments

I.

Proposed Directive on monitoring of zoonoses and zoonotic agents

1.

Scope to cover products of plant origin (and mixtures)

The  European  Parliament’s  amendments  1,  6  and  12  wholly  or  partly
require  zoonotic  agents  to  be  monitored  not  only  in  animals,  feed  and
food of animal origin as foreseen in the Commission proposals, but also
in  food  of  plant  origin  and  food  of  mixed  origin.  The  Commission  has
accepted  these  amendments. Monitoring  of products  of  plant origin is  a
useful addition, as vegetables and fruits are increasingly found to harbour
zoonotic  agents  and  to  form  a  source  of  human  infections.  The  new
wording  in  these  revised  proposals  is  not  the  same  as  the  European
Parliament’s amendments, but is consistent with them: it refers to “food”,
which  according  to  Regulation  (EC)  No  178/2002  of  28 January  2002
laying  down  the  general  principles  and  requirements  of  food  law,
establishing  the  European  Food  Safety  Authority  and  laying  down
procedures  in  matters  of  food  safety,  means  any  substance  or  product
intended to be, or reasonably expected to be ingested by humans.

2

2.

Collection of comparable data

The European Parliament’s amendments 5, 12, 14, 28 and 31 wholly or
partly  aiming  to  strengthen  the  collection  of  comparable  and  uniform
data on zoonoses from the Member States, have been taken into account
by  amending  the  relevant  articles.  These  amendments  follow  the
objective of the proposal and are largely along the lines followed by the
Council working group.

3.

Co-operation between national authorities

The  European  Parliament’s  amendments  9  and  10  ask  for  a  non-
exhaustive  list  of  authorities  (including  competent  authorities  for
legislation  on  animal  feed)  and  organisations  to  be  included  in  the  co-
operation required in the collecting of zoonoses data at the national level.
The  Commission  has  introduced  these  amendments  in  the  relevant
article.  The  amendments  improve  the  proposal  from  a  technical  and
editorial  point  of  view  and  they  are  globally  in  line  with  the
developments in the Council working group.

4.

Reporting and publication of reports

The European Parliament’s amendments 4, 8 and part of amendment 20
requesting  that  the  national  reports  on  zoonoses  should  be  published
without delay, are incorporated in the relevant articles. The other part of
the amendment  20  seeking  to  shorten  the  time  allowed  for  the  Member
States  to  submit  their  reports  to  the  Commission  is  not  accepted.
Although the tightening of the reporting schedule would be desirable as
such,  it  is  unrealistic  in  the  light  of  the  experience  with  the  existing
Directive. However amendment 29 and 32, which would shorten the time
for  the  European  Food  Safety  Authority  to  compile  the  Community
report, seems  to be  realistic and this amendment  is included  in  the  new
proposal. Finally, the revised proposal lays down that the Member States
will send their national reports to the Commission only, which will then
send  them  to  the  European  Food  Safety  Authority.  The  latter  will
produce the general report.

5.

Responsibilities  of  food  business  operators  to  keep  samples  and  testing
results

The  European  Parliament’s  amendments  17  and  19  tightening  the
responsibilities of food businesses to keep relevant food samples in case
of  food-borne  outbreaks  and  the  testing  results  on  zoonotic  agents  are
included  in  the  proposed  text.  The  amendments  are  largely  along  the
lines followed by the Council working group.

6.

Broadening the scope of monitoring of anti-microbial resistance

The  European  Parliament’s  amendments  28-33  wholly  or  partly
broadening  the  scope  of  the  monitoring  of  antimicrobial  resistance  to
agents other than zoonotic ones are included in the proposed text, subject
to editorial change in the light of the development in the Council.

3

7.

Comitology procedure

The  European  Parliament’s  amendment  23  requests  that  the  Committee
on the Communicable Diseases Network should also be consulted where
appropriate,  in  addition  to  the  Standing  Committee  on  the  Food  Chain
and  Animal  Health.  Although  it  would  create  stronger  linkage  between
the veterinary matters and public health, it would not be consonant with
the principles and rules laid down in Council Decision 1999/468/EC, as
required by Article 202, third indent, of the Treaty. Only one committee
may assist the Commission in the exercise of the powers that the Council
has delegated to it. Therefore, the wording of the relevant article has been
revised,  so  that  the  Commission  shall  be  assisted  by  the  Standing
Committee on the Food Chain and Animal Health, or where appropriate,
by the other Committee.

8.

Criteria for zoonoses and other agents to be included in monitoring

The  European  Parliament’s  amendments  13,  25,  26,  28  and 31
transferring certain criteria from annexes to articles have been taken into
account  in  the  proposal.  The  amendments  would  enable  the  European
Parliament and the Council to be involved if further amendments would
be  proposed  to  the  criteria.  These  criteria  concern  the  addition  and
deletion  of  zoonoses  subject  to  monitoring  or  to  the  need  for  the
monitoring of anti-microbial resistance to complement the monitoring of
human isolates.

9.

Consultation of European Food Safety Authority

The European Parliament’s amendment 16 making the consultation of the
European  Food  Safety  Authority  compulsory  when  establishing  co-
ordinated  monitoring  programmes  is  incorporated  in  the  proposal.  This
type  of  scientific  input  would  always  be  useful.  However,  the
amendment 22 seeking for systematic prior consultation before amending
the  annexes  or  taking  transitional  measures  is  rejected.  This  is  because
scientific advice is not necessary when establishing purely administrative
measures.

10. Various topics

The European Parliament’s amendment 18 is rejected as it would require
systematic microbiological studies (instead of “as far as possible”) during
investigation of food-borne outbreaks. This may not always be possible if
the suspected food is not available any longer.

European  Parliament’s  amendments  2,  3,  6,  7,  11,  24,  27  improve  the
proposal  from  a  technical  and  editorial  point  of  view.  They  have  been
taken into account in the revised proposal.

4

II.

Proposed  Regulation  on  the  control  of  salmonella  and  other  food-borne
zoonotic agents

11. Overall objective of Regulation

The European Parliament’s amendment 7 adding an overriding long-term
objective to avoid completely the presence of zoonotic agents in the feed
and  food  chain,  is  rejected.  This  kind  of  objective  is  unrealistic;  it  is
impossible  to  achieve  total  absence  of  zoonotic  agents  in  the  food  and
feed chain irrespective the control measures taken.

12.

Involvement of the feed business operators in controls

The  European  Parliament’s  amendments  11,  15,  17,  18,  19  and 20
involving  feed  industry  together  with  the  food  industry  in  the  control
measures to combat zoonoses, are taken into account in the proposal. The
amendments  clarify  and  strengthen  the  Regulation  and  are  in  line  with
the developments in the Council working groups.

13. Exclusion of production for own use from the scope

The  European  Parliament’s  amendment  8  exempting  the  production  for
domestic  use  from  the  scope  of  the  Regulation  is  introduced  in  the
proposal. This is in line with Article 1.3 of Regulation (EC) No 178/2002
of 28 January 2002.

14.

Inclusion of products (food) of plant origin in the scope

The European Parliament’s amendments 1 and 16 seeking to add controls
of  food  and  other  products  of  plant  origin  in  the  scope  of  controls,  is
rejected.  Feed of plant origin is already covered by the Regulation. The
control measures similar to those  in animal  populations  foreseen  in  this
Regulation are not possible in plant production. The controls of food of
plant  origin  is  tackled  in  the  recast  of  food  hygiene  legislation
(COM(2000) 438).

15. National  control  programmes 

to 

take 

into  account  economic

repercussions

The  European  Parliament’s  amendment  14  requiring  Member  States,
when drawing up their national control programmes, to take into account
the cost and benefits in order to achieve appropriate distribution of costs,
is introduced in the relevant article.

5

16. Prohibition on use of antibiotics

The European Parliament’s amendment 3 adding an objective to prohibit
the use of any antibiotics for preventive purposes or to promote growth in
animals is rejected. The Commission already announced the total phasing
out  of  antimicrobials  used  for  growth  promoting  purposes  in  a  separate
proposal.  The  use  of  antibiotics  as  veterinary  medicines  for  preventive
purposes  does  not  fall  into  the  scope  of  this  Regulation.  However,  the
Commission  intends  to  ask  for  a  scientific  opinion  on  the  risks  and
benefits  of  the  use  of  antimicrobials  to  control  salmonella  in  animal
populations.

17. Additional guarantees in intra-Community trade

The  European  Parliament’s  amendments  2  and  22  aiming  to  grant
transitional  additional  guarantees  for  regions  with  lower  prevalence  of
zoonotic  agents  were  rejected.  These  additional  guarantees  would  have
applied  to  all  zoonotic  agents  in  live  animals,  hatching  eggs  and
foodstuffs. The proposal already includes the possibility to set additional
guarantees  for  salmonella  as  regards  the  trade  of  live  animals  and
hatching  eggs.  However,  extending  this  option  to  cover  also  other
zoonotic agents may create  barriers  to  trade and would be  premature as
no pathogen reduction targets and  control programmes are proposed for
them  in  the  current  proposal.  Additional  guarantees  for  food  fall  under
the recast of food hygiene legislation (COM(2000) 438) currently subject
to  first  reading  in  co-decision  procedure.  However,  amendment 23  is
taken  into  account  as  it  has  no  impact  on  the  implementation  of  the
Regulation.

18. Sanctions in intra-Community trade

The  European  Parliament’s  amendment  24  requiring  Member  States
without  an  approved  control  programme  to  be  excluded  from  intra-
Community  trade  in  the  relevant  animals  or  products  is  rejected.
Sanctions  will  be  dealt  with  in  a  separate  proposal  for  a  Regulation  on
official feed and food control.

19.

Importation from third countries

The European Parliament’s amendment 25 requiring the European Food
Safety  Authority  (EFSA)  and the  Food and Veterinary  Office  (FVO)  to
be  closely  involved  in  monitoring  that  equivalent  control  programmes
exist  in  third  countries,  is  taken  into  account  only  as  regards  the  FVO.
This is because such a task would not fall within the remit of EFSA.

6

20. Salmonella  reduction  targets,  sampling  schemes  and  timetable  to

implement them

The  European  Parliament’s  amendments  29,  32,  36  and  38  aiming  to
tighten and add salmonella reduction targets are partly taken into account
in  the  proposal.  The  target  for  laying  hens  is  extended  to  cover  all
salmonella serotypes with public health significance and a new target for
slaughter pigs is added. The possibility  to  adopt  a  progressive  approach
for  pigs  is  foreseen.  These  changes  are  in  accordance  with  the
developments in the Council. The European Parliament’s proposal to add
new  targets  for  calves,  other  cattle,  sheep  is  dismissed.  Before  setting
such  targets  scientific  advice  is  needed.  Especially  as  cattle  and  sheep
seem to be minor contributors  to human  salmonellosis. The amendment
seeking to change the minimum sampling frequency for laying hens from
every  9  weeks  to  every  15  weeks  is  introduced.  The  new  frequency
would still ensure an adequate level of control and is in line with a past
opinion of the EC Scientific Veterinary Committee. As regards slaughter
pigs,  the  sampling  scheme  needs  further  work  on  the  issue  and  it  is
proposed  to  decide  on  it  when  the  salmonella  reduction  target  is
established.  Finally,  the  column  titled  “data”  in  Annex  II.B.1  of  the
proposal is deleted from the original text as it did not establish substantial
requirements and discussions in the  Council showed that  it may lead  to
confusion.

21. Specific measures in infected poultry flocks

The European Parliament’s amendment 34 broadening certain predefined
control  measures  for  salmonella  positive  flocks  of  laying  hens  is  taken
into  account  in  the  proposal.  The  corresponding  amendment  33  as
regards breeding flocks is rejected.

22. Reporting and publication of reports

The  European  Parliament’s  amendment  10  seeking  to  shorten  the  time
allowed for the Member States to submit their reports to the Commission
is not accepted.

The experience of the existing data collection system has shown that the
Member States have difficulties to meet the current deadline, which is the
same as the one in the proposal.

23. Laboratories

European  Parliament’s  amendment  26  shortening  the  deadline  for
laboratories  to  apply  international  standards  for  quality  assurance
the  deadline  seems  unrealistic,
schemes 
considering  the  time  needed  to  prepare  and  reach  accreditation  and
because laboratories have not been warned adequately in advance.

is  rejected.  Shortening 

7

24. Criteria for zoonoses and other agents to be included in monitoring

The  European  Parliament’s  amendments  12,  13,  30  and  31  transferring
certain criteria from annexes to articles have been taken into  account in
the  proposal.  The  amendments  would  enable  the  European  Parliament
and the Council to be involved if further amendments would be proposed
to  the  criteria.  These  criteria  concern  the  addition  and  deletion  of
pathogen reduction targets for zoonotic agents.

25. Consultation of the European Food Safety Authority

The European Parliament’s amendment 21 making the consultation of the
European  Food  Safety  Authority  compulsory  before  adopting  decisions
concerning  specific  control  measures  has  been  introduced  in  the
proposal.  Scientific  advice  is  necessary  for  the  preparation  of  such
decisions.  However,  amendment  27  seeking  systematic  consultation
before amending the annexes or taking transitional measures is rejected.
This is  because  scientific  advice  is  not  necessary  when  adopting  purely
administrative measures.

26. Editorial amendments

The European Parliament’s amendments 4, 5, 6, 9, 17 and 28 improve the
proposal from the technical and editorial point of view. They include also
the  re-wording  of  the  provisions  for  on-the-spot  checks  by  the
Commission. They have been taken into account in the revised proposal.

III. Other changes

Certain technical changes have been made to the text to ensure its conformity
with  the  Interinstitutional  Agreement  of  22  December  1998  on  common
guidelines  for  the  quality  of  drafting  of  Community  legislation  (OJ  C  73,
17.3.1999, p. 1), drawn up pursuant to Declaration No 39 annexed to the Final
Act of Amsterdam on the quality of the drafting of Community legislation. In
accordance with points (b) and (g) of that Agreement, the text has been revised
to take account of the common guidelines and the Joint Practical Guide drawn
up under point (a) thereof.

8

2001/0176 (COD)

Amended proposal for a

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on the monitoring of zoonoses and zoonotic agents, amending Council Decision
90/424/EEC and repealing Council Directive 92/117/EEC

(Text with EEA relevance)

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 Commission1,

Having regard to the opinion of the Economic and Social Committee2,

Having regard to the opinion of the Committee of the Regions3,

Acting in accordance with the procedure laid down in Article 251 of the Treaty4,

Whereas:

(1) 

(2) 

(3) 

(4) 

1

2

3

4

5

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

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

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

Council  Directive  92/117/EEC  of  17  December  1992  concerning  measures  for
protection  against  specified  zoonoses  and  specified  zoonotic  agents  in  animals  and
products of animal origin in order to prevent outbreaks  of  food-borne  infections  and
intoxications5  provided  for  the  establishment  of  a  monitoring  system  for  certain
zoonoses both at the level of Member States and at Community level.

OJ C ...
OJ C ...
OJ C ...
OJ C ...
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

                                                
(5) 

The  results  of  the  monitoring  are  collected  yearly  from  the  Member  States  and
compiled  by  the  Commission,  with  the  assistance  of  the  Community  Reference
Laboratory for the epidemiology of zoonoses. The results have been published yearly
since  1995  and  they  provide  a  basis  for  the  evaluation  of  the  current  situation
concerning  zoonoses  and  zoonotic  agents.  However,  the  data  collection  systems  are
not harmonised and therefore do not permit comparisons between Member States.

(6)  Monitoring and control  of  certain zoonoses in animal populations has been  provided
for  by  other  Community  legislation,  in  particular  Council  Directive  64/432/EEC  of
26 June  1964  on  animal  health  problems  affecting  intra-Community  trade  in  bovine
animals  and  swine6,  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 animals7, as regards ovine and
caprine brucellosis.

(7)  Moreover, Regulation (EC) No…./… of the European Parliament and of the Council
of  ….  [on  the  hygiene  of  foodstuffs]8  covers  specific  elements  necessary  for
prevention,  control  and  monitoring  of  zoonoses  and  zoonotic  agents,  and  includes
specific requirements for the microbiological quality of food.

(8) 

Directive  92/117/EEC  provides  for  collection  of  data  on  human  cases  of  zoonoses.
Decision  No  2119/98/EC  of  the  European  Parliament  and  of  the  Council  of
24 September  1998  setting  up  a  network  for  the  epidemiological  surveillance  and
control  of  communicable  diseases  in  the  Community9  was  adopted  in  order  to
reinforce the collection of such data and to contribute to improving the prevention and
control, in the Community, of communicable diseases.

(9) 

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

(10)  The Scientific Committee on Veterinary Measures relating to Public Health has, in its
Opinion on zoonoses adopted on 12 April 2000, considered that the current measures
to control food-borne zoonotic infections are insufficient and that the epidemiological
data as currently collected by Member States are incomplete and not fully comparable.
On  that  basis,  the  Committee  recommended  improved  monitoring  arrangements  and
identified risk management options. In particular, the Committee identified Salmonella
(VTEC),  Listeria
spp.,  Campylobacter  spp.,  verotoxigenic  Escherichia  coli 
monocytogenes, Cryptosporidium spp., Echinococcus granulosus / multilocularis and
Trichinella spiralis as public health priorities.

6

7

8

9

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

10

                                                
(11) 

It  is,  therefore,  necessary  to  improve  the  existing  monitoring  and  data  collection
systems  established  by  Directive  92/117/EEC.  Simultaneously,  the  specific  control
measures established by Directive 92/117/EEC will be replaced by the rules laid down
in Regulation (EC) No…/… of the European Parliament and of the Council of …..[on
the control of salmonella and other specified food-borne zoonotic agents]10. Directive
92/117/EEC should therefore be repealed.

(12)  The  new  framework  for  scientific  advice  and  scientific  support  in  matters  of  food
safety set up by Regulation (EC) No 178/2002 of the European Parliament and of the
Council of 28 January 2002 laying down the general principles and requirements of
food  law,  establishing  the  European  Food  Safety  Authority,  and  laying  down
procedures  in  matters  of  food  safety11should  be  used  to  collect  and  analyse  the
relevant data.

(13)  Where  necessary,  procedures should be created  which provide  data  on  a  harmonised
basis,  making  it  possible  to  evaluate  trends  and  sources  of  zoonoses  and  zoonotic
agents  within  the  Community.  The  data  collected,  together  with  data  from  other
sources, should form the basis for risk assessment of zoonotic agents.

(14)  Priority  should  be  given  to  those  zoonoses  posing  the  greatest  risk  to  human  health.
However,  the  monitoring  systems  should  also  facilitate  the  detection  of  emerging  or
newly emerging zoonoses and zoonotic agents.

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

(16) 

In accordance with the principle of proportionality, it is necessary and appropriate for the
achievement  of  the  basic  objective  of  monitoring  zoonoses  and  zoonotic  agents  of
importance  at  Community  level,  to  lay  down  rules  on  the  provision  of  data  in  a
harmonised way and monitoring measures. This Directive does not go beyond what is
necessary  in  order  to  achieve  the  objectives  pursued  in  accordance  with  the  third
paragraph of Article 5 of the Treaty.

(17) 

In  addition  to  general  monitoring,  specific  needs  may  be  recognised  which  may
necessitate  the  establishment  of  co-ordinated  monitoring  programmes.  Attention
should be paid in particular to zoonoses listed in Annex I to Regulation (EC) No…./…
[on the control of salmonella and other specified food-borne zoonotic agents].

(18)  Food-borne outbreaks of zoonoses, if thoroughly investigated, provide the opportunity
to  identify  the  pathogen,  the  food  vehicle  involved  and  the  factors  in  the  food
preparation and handling that contributed to the outbreak. It is, therefore, appropriate
to  make  provision  for  such  investigations  and  for  a  close  co-operation  between  the
various authorities.

10

11

OJ L ...
OJ L 31, 1.2.2002, p. 1.

11

                                                
(19)  Transmissible  spongiform  encephalopathies  are  subject  to  Regulation  (EC)  No
999/2001 of the European Parliament and of the Council of 22 May 2001 laying down
rules  for  the  prevention,  control  and  eradication  of  certain  transmissible  spongiform
encephalopathies12.  Therefore  they  should  be  excluded  from  the  scope  of  this
Directive.

(20) 

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

(21)  The reports should be submitted on an annual basis. However, additional reports may

be appropriate, when warranted by circumstances.

(22) 

It  may  be  appropriate  to  designate  National  and  Community  Reference  Laboratories
for giving guidance and assistance for analysis and testing in relation to zoonoses and
zoonotic agents falling within the scope of this Directive.

(23)  Council  Decision  90/424/EEC  of  26  June  1990  on  expenditure  in  the  veterinary
field13,  should  be  amended  as  regards  the  detailed  rules  governing  the  Community's
financial contribution towards certain actions relating to the monitoring and control of
zoonoses and zoonotic agents.

(24)  Appropriate  procedures  should  be  laid  down  for  amending  certain  provisions  of  this

Directive and for the adoption of implementing and transitional measures.

(25)  The  EFSA  should  be  consulted  as  appropriate,  and  particular  on  matters  having

significant impact on public health.

(26)  The measures necessary for the implementation of this Directive should be adopted in
accordance  with  Council  Decision  1999/468/EC  of  28  June  1999  laying  down  the
procedures for the exercise of implementing powers conferred on the Commission14.

12

13

14

OJ  L  147,  31.5.2001,  p.  1.  Regulation  as  last  amended  by  Commission  Regulation  (EC)
No 1494/2002 (OJ L 225, 22.8.2002, p. 3).
OJ L 224, 18.8.1990, p. 19. Decision as last amended by Decision 2001/572/EC (OJ L 203, 28.7.2001,
p. 16).
OJ L 184, 17.7.1999, p. 23.

12

                                                
HAVE ADOPTED THIS DIRECTIVE:

Chapter I
Introductory provisions

Article 1
Subject-matter and scope

1.

The  purpose  of  this  Directive  is  to  ensure  that  zoonoses  and,  zoonotic  agents,
foodborne  outbreaks  and  antimicrobial  resistance  of  zoonotic  agents  are
properly  monitored  so  that  the  necessary  information  may  be  collected  in  the
Community to evaluate their trends and sources of zoonoses and zoonotic agents.
Those  evaluations  shall  provide  a  basis  for  effective  risk  assessment  and  for  the
action to be taken to prevent and control zoonoses and zoonotic agents relevant to the
Community.

2.

This Directive covers:

(a)

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

(b)     the monitoring of antimicrobial resistance;

(c)

the epidemiological investigation of foodborne outbreaks;

(d)

the exchange of information related to zoonoses and zoonotic agents.

3.

This Directive shall not apply to transmissible spongiform encephalopathies.

Article 2
Definitions

For  the  purposes  of  this  Directive,  the  definitions  set  out  in  Article  2  and  Article  3  of
Regulation (EC) No 178/2002 shall apply.

The following definitions shall also apply:

(a)

(b)

“zoonosis”  means  any  disease  and/or  infection  which  is  naturally  transmissible
directly or indirectly from animals to humans;

“zoonotic  agent”  means  any  virus,  bacterium,  fungus,  parasite  or  other  biological
entity which is likely to cause a zoonosis;

13

(c)

(d)

(e)

(f)

1.

2.

3.

“antimicrobial resistance”  means the  ability of micro-organisms of certain species
to  survive  or  even  to  grow  in  the  presence  of  a  given  concentration  of  an
antimicrobial agent, that is usually sufficient to inhibit or kill micro-organisms of the
same species;

“communicable  diseases”  means  diseases  caused  by  zoonotic  agents  occurring  in
humans which are covered by Decision No 2119/98/EC;

“foodborne  outbreak”  means  the  observation  under  given  circumstances  of  an
incidence of two or  more human  cases of  the  same  disease  and/or  infection,  or  the
situation  when  the  observed  number  of  cases  exceeds  the  expected  number  and
where the cases are linked, or are probably linked, to the same food source;

“monitoring” means a system of collecting, analysing and disseminating data on the
occurrence of zoonoses, zoonotic agents and antimicrobial resistance related thereto;

Article 3
General obligations

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

Each Member  State  shall  designate  its  competent  authority  for  the  purposes  of  this
Directive  (hereinafter  referred  to  as  “the  competent  authority”)  and  notify  the
Commission thereof.

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

(a)     the  competent  authorities  designated  for  the  purpose  of  Community

legislation on feed;

(b)

(c)

(d)

the  competent  authorities  designated  for  the  purposes  of  the  Community
legislation on animal health;

the  competent  authorities  designated  for  the  purposes  of  the  Community
legislation on food hygiene;

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

(e)      other authorities and organisations concerned.

4.

Each Member State shall ensure that the relevant officials of the competent authority
designated for the purposes of this Directive are suitably qualified to undertake their
duties  and,  where  necessary,  are  trained  in  microbiology  and  epidemiology  and
receive  regular  up-to-date  training  which  reflects  scientific  progress  in  those
areas.

14

Chapter II
Monitoring of zoonoses and zoonotic agents

Article 4
General rules on monitoring of zoonoses and zoonotic agents

1.

The  Member  States  shall  collect  data  that  is  relevant  and  comparable  in  order  to
identify and characterise hazards, to assess exposures and to characterise risks related
to  zoonoses  and  zoonotic  agents.  The  monitoring  shall  take  place  in  animal
populations, especially at the stage of primary production but also, where necessary,
at  the  other  stages  in  the  food  chain  including  the  production  of  feedingstuffs  and
further preparation and production of foodproducts of animal origin.

2.

The monitoring shall cover zoonoses and zoonotic agents listed in Annex I, Part 1.A.

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

3.

The  monitoring  shall  be  based  on  the  systems  in  place  in  Member  States.  Where
necessary to make the data easier to compile and compare, detailed rules for the
monitoring of zoonoses and zoonotic agents listed  in  Annex I may be laid down in
accordance  with  the  procedure  referred  to  in  Article 12(2)  and  taking  into
consideration other Community rules laid down in the fields of animal health, food
hygiene and communicable diseases. Those detailed rules shall specify in particular:

(a)

the  animal  populations  or  sub-populations  or  stages  in  the  food  chain  to  be
covered by monitoring;

(b)

the nature and type of data to be collected;

(c)

case definitions;

(d)

sampling methods to be used;

(e)

laboratory methods to be used in testing;

(f)

the  frequency  of  reporting,  including  guidelines  for  reporting  between  local,
regional and central authorities.

Article 5
Monitoring of antimicrobial resistance

1.

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

Monitoring  shall  be  coordinated  with  the  surveillance  of  antimicrobial
resistance conducted in accordance with Decision No 2119/98/EC.

15

2.

1.

2.

3.

4.

1.

2.

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

Article 6
Co-ordinated monitoring programmes

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

Where  a  co-ordinated  monitoring  programme  is  established,  special  reference  shall
be  made  to  zoonoses  and  zoonotic  agents  in  animal  populations  referred  to  in
Annex I  to  Regulation  (EC)  No  …/…  [on  the  control  of  salmonella  and  other
specified food-borne zoonotic agents].

The  minimum  rules  concerning  the  establishment  of  co-ordinated  monitoring
programmes shall be those set out in Annex III.

The  results  of  the  co-ordinated  monitoring  programmes  shall  be  provided  to  the
European Food Safety Authority.

Chapter III
Food-borne outbreaks

Article 7
Epidemiological investigation of food-borne outbreaks

Member  States  shall  ensure  that  when  a food business  operator  becomes  aware,  or
has reason to believe, that a foodstuff produced or processed by him has caused, or
is  likely  to  cause,  a  foodborne  outbreak,  he  shall  inform  the  competent  authority
without  delay.  The  foodstuff,  or  an  appropriate  sample  a  relevant  number  of
samples thereof, shall be preserved in a way which neither impedes its investigation
in a laboratory, nor a further epidemiological investigation of the suspected outbreak.

When  a  competent  authority  receives  information  pursuant  to  paragraph 1  or  is
otherwise informed of a food-borne outbreak, it shall investigate the outbreak in co-
operation with the authorities referred to in Article 1 of Decision No 2119/98/EC.

The epidemiological investigation shall provide data on the epidemiological profile,
the  foodstuffs  potentially  implicated  and  the  potential  causes  of  the  food-borne
outbreak.  The  epidemiological  investigation  shall  include,  as  far  as  possible,
adequate epidemiological and microbiological studies.

16

The competent authority shall transmit to the Commission and to the European Food
Safety  Authority  a  summary  report  on  the  results  of  the  epidemiological
investigations carried out, containing the information referred to in Annex IV, Part E,
to this Directive.

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

3.

Paragraphs 1  and  2  shall  apply  without  prejudice  to  more  specific  Community
provisions on product safety, early warning and response systems for the prevention
and control of communicable diseases and food hygiene.

Chapter IV
Exchange of information

Article 8
Examinations for zoonotic agents at the level of food business operators

Where food business operators carry out examinations for the presence of the zoonoses
and  zoonotic  agents  pursuant  to  Annex  I,  Member  States  shall  ensure  that  food  business
operators keep, for a period to be specified by the competent authority, and communicate to
the competent authority at its request, the results of such examinations for the presence of the
zoonoses and zoonotic agents listed in Annex I, part 1.A.

Article 9
Assessment of trends and sources of zoonoses, zoonotic agents, food-borne outbreaks and
antimicrobial resistance

1.

Member  States  shall  assess  trends  and  sources  of  zoonoses,  zoonotic  agents,  food-
borne outbreaks and antimicrobial resistance related thereto in their territory.

Each Member State shall transmit to the Commission every year by the end of May a
report on trends and sources of zoonoses, zoonotic agents, food-borne outbreaks and
antimicrobial  resistance  related  thereto,  covering  the  data  collected  pursuant  to
Articles  4  to  7  during  the  previous  year.  The  reports,  or  and  summaries  of  them,
shall be made publicly available without delay.

The  reports  shall  also  contain  the  information  referred  to  in  Article 3(2)(b)  of
Regulation (EC)  No …./… [on  the  control  of  salmonella  and  other  specified  food-
borne zoonotic agents].

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

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

17

2.

The  Commission  shall  send  the  reports  referred  to  in  paragraph  1  to  the  European
Food Safety Authority.

Within  six  months  of  receipt  of  those  reports,  the  European  Food  Safety
Authority  shall  each  year  and  within  nine  months  after  receiving  them  shall
publish  a  summary  report  on  the  trends  and  sources  of  zoonoses,  zoonotic  agents,
food-borne outbreaks and antimicrobial resistance in the Community.

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

– 

– 

– 

– 

Article 8 of Directive 64/432/EEC;

Article 14(2) of Council Directive 89/397/EEC15;

Article 24 of Decision 90/424/EEC;

Article 4 of Decision 2119/98/EC.

Chapter V
Laboratories

1.

2.

3.

4.

15

Article 10
Community and National Reference Laboratories

One  or  more  Community  Reference  Laboratories  for  the  analysis  and  testing  of
zoonoses  and  zoonotic  agents  and  antimicrobial  resistance  related  thereto  may  be
designated in accordance with the procedure referred to in Article 12(2).

The  responsibilities  and  tasks  of  the  Community  Reference  Laboratories,  in
particular  with  regard  to  co-ordination  of  their  activities  and  those  of  the  National
Reference Laboratories, shall be laid down in accordance with the procedure referred
to in Article 12(2).

Member States shall designate National Reference Laboratories for each field where
a  Community  Reference  Laboratory  has  been  established  and 
the
Commission thereof.

inform 

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

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

18

                                                
Chapter VI
Implementation

Article 11
Amendments to the Annexes and transitional and implementing measures

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

The Commission shall consult the European Food Safety Authority on any matter that
could have a significant impact on public health.

Amendments to Annex I shall take into account in particular the following:

(a)          the occurrence of the relevant zoonosis or zoonotic agent in animal and human

populations, feed and food;

(b)          its gravity in humans;

(c)          its economic consequences for health care and feed and food businesses;

(d)          epidemiological trends in animal and human populations, feed and food.

Article 12
Committee

1.

2.

1.

The Commission shall be assisted by the Standing Committee on the Food Chain
and Animal Health instituted by Article 58 of Regulation  (EC) No 178/2002 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 safety] or, where appropriate, by the
Committee instituted by Article 7 of Decision No 2119/98/EC.

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 three months.

Article 13
Transposition

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

They shall apply those provisions from 1 January 2003.

19

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

2.

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

Chapter VII
Final and Transitional provisions

Article 14
Repeal and transitional provisions

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

However,  measures  which  Member  States  have  adopted  pursuant  to  Article 8(1)  of  that
Directive  and  implemented  in  accordance  with  Article  10(1)  thereof  and  plans  approved  in
accordance  with  Article  8(3)  thereof  shall  remain  in  force  until  corresponding  control
programmes have been approved in accordance with Article 6 of Regulation (EC)…./…. [on
the control of salmonella and other specified food-borne zoonotic agents].

Article 15
Amendment of Decision 90/424/EEC

Decision 90/424/EEC is amended as follows:

1.

Article 29 is replaced by the following

“Article 29

1.

2.

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

As regards control of zoonoses, the Community financial contribution shall be
introduced as part of a national plan referred to in Article 6 of Regulation (EC)
No  …./…  of  the  European  Parliament  and  of  the  Council  [on  the  control  of
salmonella and other specified food-borne zoonotic agents] [*].

20

The  level  of  Community  financial  participation  for  measures  provided  for  in
Annex II, point C, to Regulation (EC) No …./… [on the control of salmonella
and other specified food-borne zoonotic agents] shall be fixed at a maximum of
50%  of  the  cost  incurred  in  the  Member  State  by  way  of  compensation  for
owners for the slaughter and destruction measures of breeding flocks of Gallus
gallus because of the infection concerned.

- - -

*

OJ L ….”.

2.

The following Article 29a is inserted:

“Article 29a

Member States may seek from the Community the financial contribution referred to
in  Article  29(2)  for  a  national  plan  which  was  approved  on  the  basis  of  Directive
92/117/EEC, until the date  on  which  corresponding  control  programmes  have  been
approved in accordance with Article 6 of Regulation (EC) No …./… [Regulation of
the European Parliament and of the Council on the control of salmonella and other
specified food-borne zoonotic agents].”

3.

In the Annex, the following indents are added to the list under Group 2:”

– 

– 

– 

– 

– 

– 

Campylobacteriosis

Cryptosporidiosis

Listeriosis

Salmonellosis (zoonotic salmonella)

Trichinellosis

Verotoxigenic Escherichia coli.”

Article 16
Entry into force

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

21

Article 17
Addressees

This Directive is addressed to the Member States.

Done at Brussels,

For the European Parliament
The President

For the Council
The President

22

ANNEX I

Zoonoses and zoonotic agents to be monitored pursuant to Article 4

A.

Zoonoses and zoonotic agents to be included in monitoring

Brucellosis and agents thereof

Campylobacteriosis and agents thereof

Cryptosporidiosis and agents thereof

Echinococcosis and agents thereof

Listeriosis and agents thereof

Salmonellosis and agents thereof

Trichinellosis and agents thereof

Tuberculosis due to Mycobacterium bovis

Verotoxigenic Escherichia coli

B.

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

1.

Viral zoonoses

Calicivirus

Hepatitis A virus

Influenza virus

Rabies

Tick borne Viruses spread by arthropods

2.

Bacterial zoonoses

Borreliosis and agents thereof

Botulism and agents thereof

Leptospirosis and agents thereof

Psittacosis and agents thereof

Tuberculosis other than in Point A

Vibriosis and agents thereof

Yersiniosis and agents thereof

23

3.

Parasitic zoonoses

Anisakiasis and agents thereof

Cysticercosis and agents thereof

Toxoplasmosis and agents thereof

4.

Other zoonoses and zoonotic agents

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

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

– 

– 

– 

– 

their occurrence in animal and human populations, feed and food

their gravity in humans,

their economic consequences for health care and food businesses,

epidemiological trends in animal and human populations, feed and food.

24

ANNEX II

Requirements for monitoring of antimicrobial resistance pursuant to Article 5

A.

General requirements

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

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

The  Member  States  shall  ensure  that  the  monitoring  system  for  antimicrobial
resistance provided for in Article 5 provides at least following information:

1.

2.

3.

4.

5.

6.

7.

animal species included in monitoring

bacterial species and/or strains included in monitoring

sampling strategy used in monitoring

antimicrobials included in monitoring

laboratory methodology used for the detection of resistance

laboratory methodology used for the identification of microbial isolates

methods used for the collection of the data

8.       the production system from which data was collected

B.

Specific requirements

Member States shall ensure that the monitoring as set out in Part A provides relevant
information at least with regard to:

– 

Antibiograms  for  a  representative  number  of  isolates  of  Salmonella  spp.,
Campylobacter jejuni and Campylobacter coli from cattle, pigs and poultry.

25

ANNEX III

Co-ordinated monitoring programmes as provided for in Article 6

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

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

its purpose

its time period

its geographical area or region

the zoonoses and / or zoonotic agents concerned

the type of samples and other data units requested

minimum sampling schemes

the type of laboratory testing methods

the responsibility of competent authorities

the resources to be allocated

the estimation of its costs and how they will be covered

the method and time of reporting the results to the Commission and to other Member
States.

26

ANNEX IV

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

The report as provided for in Article 9(1) shall provide at least for the following information:

A.

Initially  the  following  shall  be  described  for  each  zoonosis  and  zoonotic  agent
(subsequently only changes are required to be reported):

(a) Monitoring  systems  (sampling  strategies,  frequency  of  sampling,  kind  of

specimen, case definition, diagnostic methods used);

(b) Vaccination policy and other preventive actions;

(c) Control programmes;

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

(e) Notification systems in place;

(f) History of the disease and/or infection in the Member State.

B.

Each year the report shall include the following:

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

– 

– 

Number of herds or flocks

Total number of animals

(b) Laboratories and institutions involved in reporting.

C.

Each  year  the  following  details  on  each  zoonotic  agent  and  data  category
concerned shall be described with their consequences:

(a) Changes in the systems already described;

(b) Changes in previously described methods;

(c) Results  of  the  investigations  and  of  further  typing  or  other  methods  of
characterization used in laboratories (for each category reported on separately);

(d) National  evaluation  of  the  recent  situation,  the  trend  and  the  sources  of

infection;

(e) Relevance as zoonotic disease;

(f)

Relevance  of  findings  in  animals  and  foodstuff  to  human  cases,  source  of
human infection;

(g) Control  strategies  recognized  that  could  be  used  to  prevent  or  minimize

transmission of the zoonotic agent to humans;

27

(h) Need of any specific action in the Member State or at Communitylevel on the

basis of the recent situation.

D.

Reporting of results of examinations

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

E.

For food-borne outbreak data:

(a)

Total number of outbreaks during the year;

(b) Number of ill and dead persons in these outbreaks;

(c)

The  causative  agents  of  the  outbreaks,  including,  where  possible,  serotype  or
other  definitive  description  of  the  agent.  Where  the  identification  of  the
causative agent is not possible, the  reason  for  why  it  is  impossible  should  be
stated;

(d)

Foodstuffs implicated in the outbreak and other potential vehicles;

(e)

Identification  of  the  type  of  place  where  the  foodstuff  incriminated  was
produced / purchased / acquired/ consumed;

(f)

Contributory factors, for example, deficiencies in food processing hygiene.

28

2001/0177 (COD)

Amended proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on the control of salmonella and other specified food-borne zoonotic agents

(Text with EEA relevance)

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 Commission1,

Having regard to the opinion of the Economic and Social Committee2,

Having regard to the opinion of the Committee of the Regions3,

Acting in accordance with the procedure laid down in Article 251 of the Treaty4,

Whereas:

(1)

(2)

(3)

(4)

1

2

3

4

5

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

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

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

Council  Directive  92/117/EEC  of  17  December  1992  concerning  measures  for
protection  against  specified  zoonoses  and  specified  zoonotic  agents  in  animals  and
products of animal origin in order to prevent outbreaks  of  food-borne  infections  and
intoxications5  was  adopted  in  order  to  establish  monitoring  systems  for  certain
zoonoses and to establish controls on salmonella in poultry flocks.

OJ C ...
OJ C ...
OJ C ...
OJ C ...
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).

29

                                                
(5)

(6)

(7)

(8)

(9)

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/EC6
amending  Directive  92/117/EEC,  pending  the  review  provided  for  in  Article 15a  of
Directive 92/117/EEC.

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  introduction  of  salmonella
onto a farm.

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.

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 swine7 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  animals8  as  regards  ovine  and  caprine
brucellosis.

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

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

(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 unreported and therefore the data collected does not
necessarily give the full picture of the situation.

6

7

8

9

OJ L 113, 30.4.1997, p. 9.
OJ  L  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) .
OJ L 46, 19.2.1991 p. 19. Directive as last amended by CommissionDecision 2002/261/EC (OJ L 91,
6.4.2002, p. 31).
OJ L ...

30

                                                
(12)

(13)

(14)

(15)

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.

It is, therefore, necessary to improve the existing control systems for specific zoonotic
agents,  starting  with  salmonella.  Simultaneously,  the  monitoring  and  data  collection
systems established by Directive 92/117/EEC will be replaced by the rules laid down
in  Directive  …/…  of  the  European  Parliament  and  of  the  Council  of  …..  [on  the
monitoring of zoonoses and zoonotic agents, amending Council Decision 90/424/EEC
and repealing Council Directive 92/117/EEC]10.

The  principle  should  be  established  of  controls  covering  the  whole  food  chain  from
farm to table.

The  rules  governing  such  controls  should  generally  be  those  laid  down  under
Community legislation on feedingstuffs, animal health and food hygiene.

(16) However,  for  certain  food-borne  zoonoses  and  zoonotic  agents  it  is  necessary  to  lay

down specific requirements for controls.

(17)

(18)

(19)

(20)

Those specific requirements should be based on Community targets for the reduction
of the prevalence of food-borne zoonoses and zoonotic agents.

The  Community  targets  should  be  established  for  food-borne  zoonoses  and  zoonotic
agents  in  animal  populations  taking  into  account  in  particular  their  incidence  and
epidemiological  trends  in  animal  and  human  populations,  their  gravity  for  humans,
their potential economical  consequences for health care  and  for  food  businesses, and
the existence of appropriate  measures  to reduce their prevalence. Community  targets
may also be established in respect of other parts of the food chain, where necessary.

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

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

(21) Within  their  control  programmes  Member  States  or  businesses  may  wish  to  use
specific  control  methods.  However,  certain  methods  may  not  be  acceptable,  in
particular  if  they  hamper  the  achievement  of  the  Community  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
Commission  to  decide  that  certain  control  methods  should  not  be  used  as  part  of
control programmes.

10

OJ L

31

                                                
(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 for the reduction of prevalences of specified food-borne zoonoses and zoonotic
agents.  The  Commission  should,  therefore,  have  the  authority  to  approve  the  use  of
such methods at Community level.

(23)

It is 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  legislation  on  intra-Community  trade  and
imports from third countries, in particular as regards consignments of live animals and
hatching eggs. Directive 64/432/EEC, Council Directive 72/462/EEC of 12 December
1972 on health and veterinary inspection problems upon importation of bovine, ovine,
caprine  animals  and  swine,  fresh  meat  or  meat  products  from  third  countries11  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 eggs12 should be amended accordingly.

(24) 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  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  control  programmes  for  the  control  of  zoonoses  should  also  be
implemented in third countries exporting to the Community at the same time as
measures  are  applied  in  the  Community  guarantees  should  be  required  from
third countries, in due course.

(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.

11

12

OJ L 302, 31.12.1972, p. 28. Directive as last amended by Regulation (EC) No 1452/2001 (OJ L 198,
21.7.2001, p. 11).
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).

32

                                                
(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  Community  legislation  in  this  field.  Commission  Decision
98/139/EC of 4 February 1998 laying down certain detailed rules concerning on-
the-spot checks carried out in the veterinary field by Commission experts in the
Member  States  and  Commission  Decision  98/140/EC  of  4  February  1998  laying
down  certain  detailed  rules  concerning  on-the-spot  checks  carried  out  in  the
veterinary field by Commission experts in third countries.

(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  the
adoption of implementing and transitional measures.

(28)

In accordance with the principle of proportionality, it is necessary and appropriate for
the achievement of the basic objective of ensuring public health, to lay down rules on
the  control  of  salmonella  and  other  food-borne  zoonoses  and  zoonotic  agents  of
importance  at  Community  level.  This  Regulation  does  not  go  beyond  what  is
necessary  in  order  to  achieve  the  objectives  pursued  in  accordance  with  the  third
paragraph of Article 5 of the Treaty.

(29)

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 Commission13.

HAVE ADOPTED THIS REGULATION:

Chapter I
Introductory provisions

Article 1
Subject-matter and scope

1.

2.

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

This Regulation covers:

(a)

the adoption of targets for the reduction of prevalences of specified food-borne
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, but excluding the primary production for private domestic use;

(b)

the approval of specific control programmes established by Member States and
food business operators;

13

OJ L 184, 17.7.1999, p. 23.

33

                                                
(c)

(d)

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

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 definitions in Article 2 and Articles 3 of Regulation
(EC)  No  178/2002  and  in  Article  2  (a)  and  (b)  of  Directive  …/…  [on  the  monitoring  of
zoonoses  and  zoonotic  agents,  amending  Council  Decision  90/424/EEC  and  repealing
Council Directive 92/117/EEC] shall apply.

The following definitions shall also apply:

(a)

(b)

(c)

1.

“prevalence” 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;

“herd”  means  an  animal  or  group  of  animals  as  defined  in  Article 2(2)(a)  of
Directive 64/432/EEC;

“flock”  means  an  animal  or  group  of  animals  as  defined  in  Article 2(2)(7)  of
Directive 90/539/EEC.

Article 3
Competent authorities

Each  Member  State  shall  designate  its  competent  authority  or  authorities  for  the
purpose  of  this  Regulation  and  notify  the  Commission  thereof.  Each  Member
State shall designate one  of  those  authorities  to  be  responsible  for  liasing with
the Commission.

2.

The competent authority shall be responsible in particular for:

(a)

(b)

drawing  up  the  programmes  provided  for  in  Article  5(1)  and  preparing  any
amendments  thereto  which  prove  necessary,  in  particular  in  the  light  of  data
and results obtained;

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  and  to  the  European  Food  Safety
Authority  by  31 May  of  the  following  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  feed  and  food  business
operators for the purpose of checking compliance with this Regulation.

34

Chapter II
Community targets

Article 4
Community targets for the reduction of prevalences of food-borne zoonoses and zoonotic
agents

1.

Community  targets  shall  be  established  for  the  reduction  of  prevalences  of  food-
borne  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:

(a)

the experience gained under existing national measures;

(b)

information  forwarded  to  the  Commission  or  to  the  European  Food  Safety
Authority  under  existing  Community  requirements,  in  particular  in  the
framework of reports provided for in 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)

the following criteria: laid down in Annex I, Part B.

(i)      their occurrence in animal and human populations, feed and food,

(ii)     their gravity in humans,

(iii)    the economic consequences for health care and food businesses,

(iv)    epidemiological  trends  in  animal  and  human  populations,  feed  and

food,

(v)     management  options 
Community target, and

foreseen  at 

the  relevant  stage  of 

the

(vi)    breeding systems and production methods.

Community  targets  may  be  established  for  other  stages  in  the  food-chain  in
accordance with the procedure laid down in Article 14(2).

2.

Community targets shall at least include the following details: set out in Annex I,
Part C.

(a)     a numerical expression of either:

(i)      the  maximum  percentage  of  epidemiological  units  remaining

positive, and / or

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

epidemiological units,

(b)     the  maximum  time  limit  within  which  the  Community  target  shall  be

achieved,

35

3.

4.

1.

2.

3.

(c)      a definition of epidemiological units referred to in point (a) (i), and

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

the Community target.

Community targets shall be established for the first time before the respective dates
indicated in Annex I, Part A, column 4.

The  Community  targets,  as  well  as  any  amendments  to  them,  shall  be  adopted  in
accordance with the procedure referred to in Article 14(2), and after consultation of
the European Food Safety Authority.

Without  prejudice  to  Community  rules  on  animal  nutrition,  animal  health,  or  food
hygiene,  the  reduction  of  prevalences  of  food-borne  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

Member States shall, in particular in the light of the Community targets provided for
in  Article 4,  and  the  geographical  distribution  of  food-borne  zoonoses  in  their
territory, and  the economic repercussions  for primary producers, and  feed  and
food  business  operators,  which  ensue  from  effective  control,  establish  national
control  programmes  for  each  food-borne  zoonosis  and  zoonotic  agent  listed  in
Annex I.

National control programmes shall be continuous and cover a period of at least three
consecutive years.

National control programmes shall:

(a)

(b)

(c)

(d)

provide  for  the  detection  of  food-borne  zoonoses  and  zoonotic  agents  in
accordance  with  the  requirements  and  minimum  sampling  rules  laid  down  in
Annex II, Part B;

define  the  responsibilities  of  the  competent  authorities  and  feed  and  food
business operators concerned, especially in terms of their control programmes
as provided for in Article 7;

specify the control measures to be taken following the detection of food-borne
zoonoses and zoonotic agents, in particular to protect public health, including
at least the implementation of the specific requirements laid down in Annex II;

allow  for  the  progress  under  their  provisions  to  be  evaluated  and  for  those
programmes to be reviewed, in particular in the light of results obtained from
the detection of food-borne zoonoses and zoonotic agents.

36

4.

5.

6.

1.

2.

3.

1.

National  control  programmes  shall  cover  at  least  the  following  stages  of  the  food
chain:

(a)

feedingstuff production;

(b)

primary production of animals;

(c)

processing and preparation of foodstuffs of animal origin.

National control programmes shall contain, where relevant, the provisions laid down
in relation to testing methods and criteria against which the results of these tests shall
be  assessed,  for  testing  animals  and  hatching  eggs  to  be  dispatched  within  the
national  territory,  as  part  of  the  official  controls  provided  for  in  Annex  II,  Part A,
point 1.6.

Within  6  months  of  the  establishment  of  the  Community  targets  provided  for  in
Article 4,  Member  States  shall  submit  their  national  control  programmes  to  the
Commission and set out the measures to be implemented.

Article 6
Approval of the national control programmes

The  Commission  shall,  within  six  months  of  submission  of  a  national  control
programme,  establish  whether  it  complies  with  the  relevant  rules  including  in
particular  this  Regulation.  The  Commission  may  ask  Member  States  to  modify  or
supplement their national control programmes so that they conform with Community
law.  When  the  Commission  has  established  the  conformity  of  the  national  control
programmes, they shall be approved in accordance with the procedure referred to in
Article 14(2).

Amendments  to  a  national  control  programme  previously  approved  pursuant  to
paragraph 1, in order to take account of 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).

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  that
information is provided.

Article 7
Control programmes of feed and food business operators

Member  States  shall  encourage  feed  and  food  business  operators  or  organisations
representing such  operators, which  have  full  responsibility  for  the  production  of
certain  animals  or  products  of  animal  origin  to  establish  one  or  more  control
programmes, which shall incorporate as far as possible all stages of production,
processing and distribution.

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

37

2.

3.

4.

5.

1.

Feed and food business operators or their representative organisations shall  submit
their  control  programmes  and  any  amendments  thereto  for  the  approval  of  the
competent  authority  of  the  Member  State  in  which  they  are  located.  If  the  primary
production  of  animals  takes  place  in  different  Member  States,  these  programmes
shall be approved individually for each Member State.

The competent authority may approve the control programmes submitted pursuant to
paragraph 2  only  if  it  is  satisfied,  after  an  inspection  visit,  that  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.

Member  States  shall  maintain  up-to-date  lists  of  approved  control  programmes  of
feed and food business operators or their representative organisations.

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

Feed  and  food  business  operators  or  their  representative  organisations  shall
communicate  regularly  the  results  of  their  control  programmes  to  the  competent
authorities.

Chapter IV
Control methods

Article 8
Specific control methods

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

(a)

(b)

(c)

(d)

decisions  that  specific  control  methods  may  or  shall  be  applied  to  reduce  the
prevalence  of  food-borne  zoonoses  and  zoonotic  agents  at  the  stage  of  the
primary production of animals and other stages in the food chain;

rules concerning the conditions for the  use of the  control methods referred to
in point (a);

detailed  rules  concerning  the  necessary  documents  and  procedures  as  well  as
minimum requirements for the control methods referred to in point (a);

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  control
methods using substances or techniques covered by other Community legislation on
animal nutrition, food additives or veterinary medicinal products.

38

Chapter V
Trade

Article 9
Intra-Community trade

1.

2.

3.

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  food-borne
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.

A 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 relevant health
certificates  for  consignments of animals and  hatching  eggs  subject  to  testing  in  the
Member  State  of  dispatch,  fulfil  the  same  criteria  relating  to  results  of  testing  as
those laid down under its approved national control programme for consignments of
animals and hatching eggs to be dispatched within its territory.

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

Specific rules concerning the setting by Member States of the criteria referred to in
Article 5(5) and in paragraph 2, may be laid down in accordance with the procedure
referred to in Article 14(2).

4.            The provisions of paragraphs 1 and 2 shall not apply to dispatching of eggs for

packaging or processing.

Article 10
Imports from third countries

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  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 an official control
programme  equivalent  to  those  provided  for  under  Article  5.  The  programme  shall
give details of the guarantees offered by the third country as regards inspections and
controls for food-borne 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  monitor  the
equivalence of control programmes in such third countries.

39

2.

3.

4.

5.

6.

1.

2.

The programmes submitted under paragraph 1 shall be approved in accordance with
the  procedure  referred  to  in  Article  14(2),  provided  that  the  equivalence  of  the
guarantees  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 established, the provisions of
Article 5(7) and Article 6(1) and (3) concerning time periods for the submission and
approval of national control programmes shall apply. For third countries establishing
or resuming a trade flow, the time periods provided for in Article 6 shall apply.

Flocks  and  herds  of  origin  of  species  listed  in  Annex  I,  Part  A,  column 2  shall  be
tested for the food-borne zoonoses and zoonotic agents listed in Annex 1, 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,  for  which  the  models  laid  down  by  Community  legislation  shall  be
amended accordingly.

A Member State of final destination may, in accordance with the procedure referred
to in Article 14(2), be authorised for a transitional period to require that the relevant
health certificates for consignments of animals and hatching eggs subject to testing in
the third country of dispatch, fulfil the same criteria relating to results of testing  as
those laid down under its approved national control programme, for consignments of
animals and hatching eggs to be dispatched within its territory.

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

Admission to or retention from the lists of third countries provided for in Community
legislation,  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.

Chapter VI
Laboratories

Article 11
Reference laboratories

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

The  responsibilities  and  tasks  of  the  Community  Reference  Laboratories,  in
particular  with  regard  to  co-ordination  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).

40

3.

4.

1.

2.

3.

Member  States  shall  designate  National  Reference  Laboratories  for  zoonoses  and
food-borne  zoonotic  agents  referred  to  in  Annex  I,  column  1.  The  names  and
addresses of such laboratories shall be communicated to the Commission.

Certain  responsibilities  and  tasks  of  the  National  Reference  Laboratories,  in
particular  with  regard  to  co-ordination  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 and approved testing methods

Laboratories participating in control programmes pursuant to Articles 5 and 7 where
samples  are  analysed  for  the  testing  of  the  presence  of  food-borne  zoonoses  and
zoonotic agents referred to in Annex I, column 1 shall be approved by the competent
authority.

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

The  laboratories  shall  regularly  participate  in  collaborative  testing  organised  or  co-
ordinated by the National Reference Laboratory.

Testing for  the  presence of  zoonoses  and  food-borne  zoonotic  agents  referred  to  in
Annex I,  column  1  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 referred to in the first subparagraph.

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

The  Annexes  may  be  amended  or  appropriate  transitional  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).

The Commission shall consult the European Food Safety Authority on any matter that
could have a significant impact on public health.

41

1.

2.

1.

2.

Article 14
Committee

The Commission shall be assisted by the Standing Committee on the Food Chain and
Animal Health instituted by Article 58 of Regulation (EC) No 178/2002.

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 three months.

Chapter VIII
General and final provisions

Article 15
Community controls

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

Such checks shall be carried out in co-operation with the competent authorities
of  the  Member  State  concerned  and  the  Member  State  shall  provide  all
necessary  assistance  to  the  Commission  experts  to  enable  them  to  carry  out
their tasks.

The  Commission  shall  inform  the  competent  authority  of  the  Member  State
concerned of the results of the checks carried out.

Detailed rules for the implementation of this Article, in particular as regards the
co-operation with the competent authorities of the Member States, shall be laid
down in accordance with the procedure referred to in Article 14(2).

42

Article 16
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.

Done at Brussels,

For the European Parliament
The President

For the Council
The President

43

Specified food-borne zoonoses and zoonotic agents for which Community targets for the
reduction of prevalence shall be established pursuant to Article 4

ANNEX I

 1. Food-borne
Zoonosis /
zoonotic agent

 All salmonella
serotypes with
public health
significancea

 Salmonella
Enteritidis
and
Salmonella
Typhimurium

 All salmonella
serotypes with
public health
significancea

 All salmonella
serotypes with
public health
significancea

 All salmonella
serotypes with
public health
significancea

 All salmonella
serotypes with
public health
significance(a)

 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

 Breeding
flocks of
Gallus gallus

 Primary
production

 31.12.2003

 1.1.2005

 Laying hens

 Primary
production

 31.12.2004

 1.1.2006

 Broilers

 Primary
production

 31.12.2005

 1.1.2007

 Turkeys

 Primary
production

 31.12.2006

 1.1.2008

 Slaughter pigs
and breeding
herds of pigs

 Primary
production

 31.12.2006(b)

 1.1.2008

(a)

(b)

Serotypes shall be defined when the Community target is established.

This date shall apply to one or both categories of animal populations. Following consultation of
the European Food Safety Authority, a progressive approach may be decided.

44

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

– 

– 

– 

– 

– 

their occurrence in animal and human populations, feed and food,

their gravity in humans,

their economic consequences for health care and food businesses,

epidemiological trends in animal and human populations, feed and food, and

management options foreseen at the relevant stage of the target.

C.         Details of targets

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

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.

45

ANNEX II

Control of food-borne zoonoses and zoonotic agents listed in Annex I, column 1

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 the following

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

1.5

1.6

1.7

1.8

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

the  methods  used  in  the  examination  of  the  food-borne  zoonotic
agents,

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

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

the type  of  measures laid  down  by  the  competent  authorities  with
regard  to  animals  or  products  in  which  food-borne  zoonoses  and
zoonotic agents  have been detected,  in particular to  protect public
health,

1.9

relevant national legislation;

46

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

– 

– 

hygiene management at farms,

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

– 

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)

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.

47

B.

MINIMUM REQUIREMENTS OF SAMPLING

1.

After  the  respective  national  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 food-borne zoonosis or zoonotic
agents listed in Annex I, with the minimum scope of sampling indicated below
being respected.

 Animal species

 Data

 Sampling shall cover at least
these phases of production

 1. Breeding flocks
of Gallus gallus

 1.1 Rearing flocks

 1.2. Adult breeding
flocks

 2. Commercial
layers

 2.1 Rearing flocks

 a)feedingstuffs

 i) Day-old chicks

 b) live animals

 ii) 4 week old birds

 a) feedingstuffs

 b) live animals

 iii) 2 weeks before moving to
laying phase or laying unit

 i) every second week during
the laying period

 a) feedingstuffs

 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

 b) live animals

 i) every 9 15 weeks during the
laying phase

 3. Broilers

 a) feedingstuffs

 i) Birds leaving for slaughter

 b) live animals

 c) Ante mortem
inspection

 a) Ante mortem
inspection

 a) Ante mortem
inspection

 4. Turkeys

 5. Breeding pigs

 6. Slaughter pigs

 i) Birds leaving for slaughter

 i) Animals leaving for
slaughter

 Shall be defined when the
target is established

 Food-borne
Zoonosis /
zoonotic agent

 All salmonella
serotypes with
public health
significancea

 Salmonella
Enteritidis and
Salmonella
Typhimurium

 All
salmonella
serotypes
with public
health
significancea

 All salmonella
serotypes with
public health
significancea

 All salmonella
serotypes with
public health
significancea

 All
salmonella
serotypes
with public
health
significance(a)

(a)

Serotypes shall be defined when the Community target is established.

48

 
 
 
 
 
 
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.

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, 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, all the 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  [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]14,  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]15.

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]16.

14

15

16

OJ L ...
OJ L ...
OJ L ...

49

                                                
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 the Table of Part B and subsequently found non
contaminated.

The  eggs  originating  from  flocks  with  unknown  status,  suspected  of  being
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  all  salmonella  serotypes
with public health significance, in accordance with Regulation (EC) No …/… [on
the hygiene of foodstuffs]:.

Without prejudice to the requirements under Part E, all the birds in the flock must be
slaughtered  or  destroyed  so  as  to  reduce  as  much  as  possible  the  risk  of  spreading
salmonella  zoonoses.  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]:

“Salmonella: absence in 25 grammes”

50

LEGISLATIVE FINANCIAL STATEMENT

Policy area(s):Health and Consumer Protection

Activity(ies): veterinary public health

TITLE OF ACTION:

1.

2.

Proposal  for  a  Directive  of  the  European  Parliament  and  of  the  Council  on  the
monitoring  of  zoonoses  and  zoonotic  agents,  amending  Council  Decision
90/424/EEC and repealing Council Directive 92/117/EEC

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

1.

BUDGET LINE(S) + HEADINGS

B1-330  Animal  disease  eradication  and  monitoring  programmes  and  monitoring  of
the physical conditions  of  animals that could pose  a  public-health  risk  linked  to  an
external factor.

This  Chapter  will  cover  co-ordinated  monitoring  programmes  as  referred  to  in
Article  6  of  the  above  proposal  for  a  Directive  and  certain  actions  under  national
control  programmes  to  be  implemented  in  Member  States,  pursuant  to  the  above
proposal  for  a  Regulation.  The  financial  provisions  are  established  in  the  new
Chapter  on  zoonoses  of  Council  Decision  90/424/EEC  on  expenditure  in  the
veterinary field1, as revised pursuant to the above proposal for a Directive.

B1-331 Other measures in the veterinary, animal welfare and public health field.

This  Chapter  will  cover  financing  of 
Laboratories.

the  relevant  Community  Reference

2.

2.1

2.2

OVERALL FIGURES

Total allocation for action (Part B): 2.4 € millions in EC

Period of application: 2003-

The  existing  Zoonosis  Directive  (92/117/EEC)  is  reviewed.  The  aim  is  to  enhance
the monitoring and control of zoonoses in the Community in order to protect public
health. Expenses are due to

– 

– 

– 

activities of Community Reference Laboratories

co-financing of Community co-ordinated monitoring programmes

co-financing of certain specified control measures.

1

OJ  L  224,  18.8.1990.  Decision  as  last  amended  by  Council  Decision  2001/12/EC,  OJ  L  3,  6.1.2001,
p. 27.

51

                                                
As  regards  financing  of  specified  control  measures,  Community  financing  will  be
continued on the basis of the existing rules in Directive 92/117/EEC. See also 5.1.2
below.

Only  co-financing  of  co-ordinated  monitoring  programmes  is  a  technical  measure
additional  to  the  measures  already  established  under  existing  Council  Directive
92/117/EEC and financed under Council Decision 90/424/EEC. For this measure, it
is foreseen to  allocate  yearly  0.4 Mio€. That is why  financing of this new  measure
only is included in the estimate for the proposals.

2.3

Overall multiannual estimate on expenditure :

a)

Schedule  of  commitment  appropriations/payment  appropriations  (financial
intervention) (see point 6.1.1)

Year n

n + 1

n + 2

€ million (to 3rd decimal place)
Total
n + 3

n + 4

n + 5
and
subs.
years
0.4

0.4

2.4

2.4

Commitments

Payments

0.4

0.4

0.4

0.4

0.4

0.4

0.4

0.4

0.4

0.4

Technical  and  administrative  assistance  and  support  expenditure  (see  point
6.1.2)

b)

NO

Commitments/
payments

Subtotal a+b

Commitments

Payments

c)

Overall  financial  impact  of  human  resources  and  other  administrative
expenditure
(see points 7.2 and 7.3)

Commitment/
payments

0.432

0.432

0.432

0.432

0.432

0.432

2.592

TOTAL a+b+c

0.432

0.432

0.432

0.432

0.432

0.432

2.592

Commitments

Payments

52

These resources in the Commission services will be used for the overall management
of  the  implementation  of  the  proposals.  It  will  consist  in  particular  in  technical
management of the programmes to be submitted by Member States and non-Member
Countries and to be approved by the Commission, and in supervision/management of
the (co-)financing of actions in Member States.

2.4

Compatibility with the financial programming and the financial perspective

X

Proposal compatible with the existing financial programming

(cid:1) This  proposal  will  entail  reprogramming  of  the  relevant  heading  in  the

financial perspective

(cid:1) This  may  entail  application  of  the  provisions  of  the  Interinstitutional

Agreement.

2.5

Financial impact on revenue

No

(cid:1) No financial implications (involves technical aspects regarding implementation

of a measure)

OR

(cid:1) Financial impact – the effect on revenue is as follows:

Note:  All  details  and  observations  pertaining  to  the  method  of  calculating  the
effect on revenue should be included in a separate annex.

Budget line Revenue

€ million (to 1 decimal place)

Situation following action

Year n

n+1

n+2

n+3

n+4

n+5

Prior to
action
(Year n-
1)

a) Revenue in absolute terms

b) Change in Revenue

 (cid:1)

(Please state each budget line involved, adding the appropriate number of rows to
the table if there is an effect on more than one budget line)

3.

BUDGET CHARACTERISTICS

Type of expenditure

New

EFTA
participation

Participation
applicant
countries

Heading
Financial
Perspective

Comp

Non-diff

YES*

NO

NO

N° 1 A

*:

only co-ordinated monitoring programmes

53

4.

LEGAL BASIS

Legal basis for the proposals: Article 152 of Treaty.

Financial instrument: Council Decision 90/424/EEC of 26 June 1990 on expenditure
in the veterinary field.

5.

5.1

DESCRIPTION AND GROUNDS

Need for Community intervention 2

5.1.1

Objectives pursued

Preliminary:  a  revision  of  the  current  legislation  on  the  prevention  of  zoonoses
(Directive 92/117/EEC) was foreseen pursuant to article 15a of the Directive and in
that framework, expansion of controls to laying hens was foreseen. The proposals are
part of the  programme  foreseen  in  the  White  paper  on  Food  Safety  adopted  by  the
Commission on 12 January  2000.  It is  essential  that  the  proposals  respect  the  main
principles of the White paper on Food Safety, in particular: assuring a high standard
of food safety; creating an integrated policy from 'farm to table'; being based on risk
analysis, including possibilities to take into account the precautionary principle  and
other legitimate factors.

The essential aim is to increase protection of public health, essentially by decreasing
seriously  the  number  of  human  cases  of  salmonellosis,  due  to  food  consumption.
This  will  be  achieved  by  decreasing  prevalence  of  salmonella  in  the  main  animal
populations source of salmonella (breeding flocks of Gallus gallus, then commercial
flocks, then turkeys and breeding herds of pigs). Decreasing the prevalence in animal
populations will decrease the concentration in primary products and further down the
food chain.

The  cost  of  food-borne  salmonellosis  (impact  of  human  disease)  is  estimated  to
yearly 560-2840Mio€. Given the very high economic costs occasioned by zoonoses,
not  only  to  operators  but  also  to  society  at  large,  public  financing  of  measures  to
reduce  or  eliminate  the  diseases/infections  is  justified.  The  need  for  a  Community
dimension  to  financial  support  is  also  clear.  Community  financial  participation
provides  a  means  for  ensuring  that  all  Member  States  affected  by  a  given
disease/infection make co-ordinated efforts which, taken together, will be much more
effective at reducing or eliminating that threat throughout the Community,  while  at
the same time permitting States to continue to address problems that are particularly
important  on  their  territory.  In  the  absence  of  Community  participation,  they  will
naturally tend to prefer to address only their own priorities. As regards financing of
certain  specified  control  measures,  Community  financing  will  be  continued  on  the
basis of the existing rules in Directive 92/117/EEC, as established in the proposals.

2

For further information see a separate guidance paper .

54

                                                
The only new measure for Community co-financing in the proposals is relating to co-
ordinated  monitoring  programmes,  which  are  an  important  element  to  enhance
monitoring  and  define  baseline  values  of  pathogens  (salmonella).  It  will  be  a
preliminary step for setting or reviewing pathogen reduction targets as required under
the proposals.

5.1.2 Measures taken in connection with ex ante evaluation

As  indicated  above,  public  financing  of  measures  to  reduce  or  eliminate  the
diseases/infections is justified. The effectiveness of programmes in a Member State
can be limited or undermined where in others higher levels of infection persist either
directly  through  contamination  across  borders  or  indirectly  due  to  economic
pressures  resulting  from  unequal  financial  efforts  of  authorities  and  operators  in
different States. Moreover, for geographical and historical reasons, national priorities
are not the same. Even if progress in reducing or eliminating diseases/infections has
been  uneven  and  too  limited,  measures  taken  have  proved  to  be  effective  in  many
cases  and  show  that,  where  these  are  properly  managed,  substantial  improvements
are feasible.

Only  co-financing  of  co-ordinated  monitoring  programmes  is  a  technical  measure
additional  to  the  measures  already  established  under  existing  Council  Directive
92/117/EEC  and  financed  under  Council  Decision  90/424/EEC.  For  this  new
measure, it is foreseen to allocate yearly 0.4 € millions.

As  regards  financing  of  certain  specified  control  measures,  Community  financing
will  be  continued  on  the  basis  of  the  existing  rules  in  Directive  92/117/EEC.  It  is
likely that more and more Member States will present a request for co-financing of
their plans. Financing of the plans will be handled in the framework of the budgetary
procedures and the yearly programming. A maximum limit of 50% for co-financing
of  certain  measures  has  been  included  in  the  proposed  revision  of  the  Chapter  on
zoonoses of the financial instrument (Council Decision 90/424/EEC).

5.1.3 Measures taken following ex post evaluation

5.2

Actions envisaged and arrangements for budget intervention

Three areas:

– 

– 

Community Reference Laboratories (CRL): 100% Community financing of the
CRL,  as  already  established  under  Council  Decision  90/424/EEC.  The  yearly
technical  work-programmes  and  estimated  costs  to  be  discussed,  before  a
Commission  Decision  is  adopted  each  year.  Payment  to  the  competent
authorities in the relevant Member States.

Co-ordinated  monitoring  programmes:  Community  co-financing  (50%),
pursuant  to  Council  Decision  90/424/EEC.  Programmes  to  be  established  in
Commission Decisions.

55

– 

Certain  specified  control  measures:  the  beneficiaries  are  the  farmers,  when
their  flocks  or  products  thereof  have  to  be  slaughtered  or  disposed  of  under
specified  conditions,  to  prevent  risks  for  public  health.  Financing  of
programmes is  subject to the procedures  in Council Decision 90/424/EEC: in
particular, programmes for financing have  to  be  submitted  by  Member  States
on  a  yearly  basis;  a  technical  and  financial  evaluation  is  carried  out  by  the
Commission  services  before  adoption  by  Commission  Decision.  Payment  to
the competent authorities in the Member States. Maximum limit of 50% for co-
financing.

5.3

Methods of implementation

Direct management of technical and financial approval of the actions by Commission
staff. Payment of actions subject to the procedures in Council Decision 90/424/EEC.
Reimbursement  of  expenses  in  Member  States  by  payment  to  the  Competent
authorities. See also 5.2 above.

6.

6.1

FINANCIAL IMPACT

Total financial impact on Part B - (over the entire programming period)

(The  method  of  calculating  the  total  amounts  set  out  in  the  table  below  must  be
explained by the breakdown in Table 6.2.)

6.1.1

Financial intervention in € million (to the 3rd decimal place)

Only  financing  of  new  measures  in  the  proposals,  i.e.  co-ordinated  monitoring
programmes is included.

Breakdown

Year n

n + 1

 n + 2

n + 3

n+ 4

0.400

0.400

0.400

0.400

0.400

n + 5 and
subs.
years
0.400

Total

2.400

Action 1

Action 2

Etc.

TOTAL

0.400

0.400

0.400

0.400

0.400

0.400

2.400

56

6.1.2 Technical and administrative assistance, support expenditure and IT expenditure
n + 5 and
subs.
years

Year n

 n + 2

n + 4

n + 3

n + 1

Total

1) 
administrative assistance

Technical 

and

Technical 

a) 
offices

assistance

b)  Other 
administrative assistance:

technical 

and

- intra muros :

- extra muros :

of  which  for  construction
and 
of
maintenance 
computerised  management
systems

Subtotal 1

2) Support expenditure

a) Studies

b) Meetings of experts

c) Information and
publications

Subtotal 2

TOTAL

57

6.2.

Calculation  of  costs  by  measure  envisaged  in  Part  B  (over  the  entire
programming period)3

Only  financing  of  new  measures  in  the  proposals,  i.e.  co-ordinated  monitoring
programmes is included. See calculation example in Annex

Commitments in € million (to the 3rd decimal place)

Breakdown

Type
of outputs
(projects, files )

1

(total for years
1…n)
2

Number of
outputs

Average unit
cost

Total cost

(total for years
1…n)

3

4=(2X3)

Action 1
- Measure 1
- Measure 2
Action 2
- Measure 1
- Measure 2
- Measure 3

Etc.

TOTAL COST

See calculation in the annex

tests

6x35.000

50 % of 24 €

2.400 (6x0,400)

2.400

7.

IMPACT ON STAFF AND ADMINISTRATIVE EXPENDITURE

7.1.

Impact on human resources

Staff to be assigned to management of the
action using existing and/or additional
resources

Number of
permanent posts
2

Number of
temporary posts
1
1

Description of tasks deriving from the
action

Total

If necessary, a fuller description of the
tasks may be annexed.

Types of post

or

A
Permanent
B
officials 
C
Temporary staff
Other human resources
Total

3

For further information see a separate guidance paper.

58

                                                
7.2

Overall financial impact of human resources

Type of human resources

Amount €

Method of calculation *

Officials
Temporary staff

Other human resources

0.216
0.216

0.432

(give budget line)
Total

The amounts are total expenditure for twelve months.

7.3

Other administrative expenditure deriving from the action

2*0.108
2*0.108

Amount €

Method of calculation

Budget line
(number and heading)

Overall allocation (Title A7)
A0701 – Missions
A07030 – Meetings
A07031 – Compulsory committees (1)
A07032 – Non-compulsory committees (1)
A07040 – Conferences
A0705 – Studies and consultations
… Other expenditure (state which)

Information systems (A-5001/A-4300)

Other expenditure - Part A (state which)

The amounts are total expenditure for twelve months.

Total

(1)

I.

II.

III.

8.

8.1

Specify the type of committee and the group to which it belongs.

Annual total (7.2 + 7.3)

Duration of action

Total cost of action (I x II)

€

Years

€

FOLLOW-UP AND EVALUATION

Follow-up arrangements

– 

– 

Financing of Community Reference Laboratories (CRL): The  yearly technical
work-programmes and estimated costs are evaluated between the Commission
services  and  the  relevant  CRL;  they  are  revised  if  necessary,  before  a
Commission Decision is adopted each year.

Co-ordinated monitoring programmes: the programme,  as  established  through
Commission Decisions will be performed whenever possible during one  year.
It is very likely that the authorities in the Member States will have to perform
sampling and examinations themselves. The industry may be involved.

59

– 

Co-financing  of  certain  specified  control  measures:  the  financial  contribution
will be introduced as part of a national plan submitted to and approved by the
Commission. Financing of the control measures is subject to the procedures in
Council  Decision  90/424/EEC:  in  particular,  the  national  plans  containing
measures  for  financing  have  to  be  submitted  by  Member  States  on  a  yearly
basis;  a  technical  and  financial  evaluation  is  carried  out  by  the  Commission
services  before  adoption  by  Commission  Decision.  Rules  are  foreseen  at
Article  5.3.(d)  of  the  proposed  Regulation  to  allow  progress  with  the  control
plans to be evaluated. When the pathogen reduction targets are established, the
Commission  decides  on  the  timeframe  within  which  the  target  shall  be
achieved.

To verify the implementation of the relevant national plans, Article 16 lays down that
the Commission shall carry out on-the-spot checks.

8.2

Arrangements and schedule for the planned evaluation

For Community Reference Laboratories as well as for control plans implemented by
Member States, a documentary evaluation is performed on a yearly basis (see above).
In  addition,  the  EU  Food  and  Veterinary  Office  performs  on-the-spot  missions  to
assess  implementation  of  Community  legislation,  including  the  national  plans.  The
frequency  of  the  missions  will  depend  on  the  priority  set  for  the  relevant  issue.  So
far,  missions  for  major  animal  diseases  control  programmes  have  been  carried  out
regularly, up to once per year. In addition, financial audit missions are carried out by
the  relevant  service  in  Directorate  General  for  Health  and  Consumer  Protection.  A
prioritisation system is in place. Corrections are made in case of deficiencies.

9.

ANTI-FRAUD MEASURES

See 8.1 and 8.2 above.

Also,  OLAF  may  intervene  on  its  own  initiative  or  following  information  from
different sources, in particular those mentioned under 8.2 above.

60

ANNEX TO FINANCIAL STATEMENT

Method of calculation of the estimated costs:

1.

CO-ORDINATED MONITORING PROGRAMMES

Article 6 of the proposal for  a  Directive  on  the  monitoring  of  zoonoses  creates  the
possibility for establishing co-ordinated monitoring programmes. These programmes
will serve to create sets of harmonised data which will be used as a reference when
pathogen reduction targets are established according to the proposal for a Regulation
on  control  of  salmonella  and  other  food-borne  zoonotic  agents.  Since  the
Commission  would  need  to  request  the  Member  States  to  carry  out  specified
sampling  and  testing  schemes,  which  possibly  differ  from  the  procedures  of  the
national  monitoring  system,  it  is  deemed  necessary  that  the  Community  could
finance such co-ordinated programmes.

For  example,  a  single  study  on  the  exact  prevalence  of  salmonella  in  the  poultry
population  in  the  different  member  States  would  need  testing  of  a  representative
number of samples. On the basis of around 35,000 samples within the EU and taking
into  account  the  estimated  cost  of  a  salmonella  bacteriological  test:  EUR 24,  it  is
estimated that the financing of such a study would be yearly EUR 800 000, of which
the  Community  would  co-finance  50%.  It  is  foreseen  that  such  studies  would  be
needed  yearly,  in  conjunction  with  the  establishment  of  pathogen  reduction  targets
for specified combinations of pathogen/commodities.

61