PROPOSAL FOR A COUNCIL REGULATION ( EEC ) CONCERNING MEASURES FOR THE PREVENTION OF SPECIFIED ZOONOSES AND OF SPECIFIED ZOONOTIC AGENTS IN ANIMALS AND PRODUCTS OF ANIMAL ORIGIN IN ORDER TO PREVENT OUTBREAKS OF FOOD-BORNE INFECTIONS AND INTOXICATIONS
Date: 1991-09-04
Institutions: European Commission
Subjects: animal disease, exchange of information, food inspection, health legislation, research body, veterinary legislation

COMMISSION OF THE EUROPEAN  COMMUNITIES 

< ',>»• T^dfS 

COM(91) 310 final 

Brussels, 4 September 1991 

'•fSS* *faci?s'Xfc^ 

Proposal  for a 

COUNCIL REGULATION (EEC) 

concerning measures for the prevention of specified  zoonoses 

and of specified  zoonotic agents  in animals and products 

of  animal  origin  in order  to prevent  outbreaks 

of  food-borne  Infections and intoxications 

(presented by the Commission) 

-  2 -

EXPLANATORY  MEMORANDUM 

The  zoonoses  are  those  diseases  and  infections  naturally  transmitted  between 

vertebrate animals and man. 

They  represent, on  top of  the health  hazards  to man,  a negative affect  on  the 

agricultural  economy,  due  to  losses  of  productivity  and  commercial 

restrictions. 

Furthermore,  different  policies  in relation  to  zoonoses  causes  distortions of 

competition  between  agricultural  producers  and  poses  problems  to  Intra-

Community  trade of  living animals and  products of  animal  origin. 

The  prevention  of  zoonoses  is based  on  different  strategies  which  may  depend 

on  the  nature  of  the  disease,  the  pathogen  involved  and  its  way  of 

transmission. 

Strategies are based  principally on a reduction of  contamination  possibilities 

and,  where  possible,  the  eradication  of  the  disease,  in  the  livestock  or 

wildlife.  Specific  actions  have already  been undertaken  at Community  level  to 

control  some  zoonotic  diseases  in  livestock  or  wildlife,  in  particular,  for 

bovine  tuberculosis,  bovine  brucellosis,  brucellosis  in  sheep  and  goats  and 

rabies. 

Furthermore,  measures  intended  to  reduce  the  contamination  of  feeding  stuffs 

and  specific  feed  of  animal  origin  by  zoonotic  agents  have  been  already 

adopted or  proposed  at Community  level. 

The present  proposal  consists of  : 

-  an obligation  for  the Member  States  to collect  information on  the  incidence 

of  zoonotic  agents  in man  and  animals,  and  to  report  this  information  to 

the  Commission; 

-  an  obligation  to  take  measures  for  the  detection  of  zoonotic  agents  in 

animals,  feedingstuffs  and  products of  animal  origin; 

-  3 -

-  special  actions  for  specific  zoonotic  agents.  In  a  first  instance,  such 

measures  will  focus  on  a  programme  related  to  Salmonellae  in  poultry 

production  and  Listeria  monocytogenes  in  soft  cheese  and  cooked  ready  to 

eat  products; 

-  the  appointment  of  reference  laboratories  providing  the  technical 

assistance necessary  for correct  implementation of  the  system. 

"The Commission  underlines  that  this  proposed  regulation, which  covers  at  the 

same  time  not  only  foodstuffs  but  also  animals  and  feedlngstuffs,  does  not 

affect  the  existing  Council  Directive  89/397  of  14 June  1989  on  the  special 

control  of  foodstuffs whose  rules and procedures will  continue  to apply". 

- 4 -

Proposal  for a 

COUNCIL  REGULATION  (EEC) 

concerning  measures  for  the prevention of  specified  zoonoses 

and of  specified  zoonotic agents  in animals  and  products 

of  animal  origin  in order  to prevent  outbreaks 

of  food-borne  infections and  intoxications 

THE COUNCIL  OF  THE  EUROPEAN  COMMUNITIES, 

Having  regard  to  the Treaty  establishing  the  European  Economic  Community,  and 

in particular  Article  43  thereof, 

Having  regard  to  the proposal  from  the  Commission, 

Having  regard  to  the opinion  of  the  European  Parliament, 

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

Whereas  live  animals  and  products  of  animal  origin  appear  on  the  list  In 

Annex  II  to  the  Treaty;  whereas  livestock  farming  and  the  placing  on  the 

market  of  products of  animal  origin  constitutes a source  of  income  for  a  large 

part  of  the agricultural  population; 

Whereas  the  rational  development  of  this  sector,  and  an  improvement  In  its 

productivity,  may  be  achieved  by  the  initiation  of  veterinary  measures  aimed 

at  protecting  and  raising  the  level  of  public  and  animal  health  in  the 

Community; 

Whereas  It  is  necessary  to  prevent  and  reduce,  by  appropriate  measures,  the 

appearance  of  zoonoses  which  pose  a  threat  to  human  health,  in  particular, 

through  food of  animal  origin-, 

-  5 -

Whereas  the  Community  has  already  undertaken  action  for  the  eradication  of 

certain  zoonotic  diseases  and  in  particular  bovine  tuberculosis,  bovine 

brucellosis,  brucellosis  in  sheep  and  goats  and  rabies;  whereas  it  is 

advisable  to collect  epidemiological  information  on  those  diseases; 

Whereas,  in  order  to  control  some  food-borne  diseases,  it  is  necessary  to 

establish  combined  actions  requiring  specific  interventions  at  the  level  of 

production  of  feedlngstuffs, at  the  level  of  breeding  animals, at  the  level  of 

poultry  flocks  and  at  the  level  of  transformation  of  products  of  animal 

origin; 

Whereas  those  rules  should  apply  without  prejudice  to  Council  Directive 
89/397/EEC of  14 June  1989 on  the official  control  of  foodstuffs*1>; 

Whereas  it  is  necessary  to  collect  information  in  the  Member  States  on  the 

incidence  of  zoonotic  diseases  in  the  human  population,  in  domesticated 

animals,  in  animal  feedlngstuffs  and  wildlife  in  order  to  assess  the 

priorities for  the preventive actions; 

Whereas  it  is  opportune  that  the  Commission  follows  the  development  of  the 

epidemiological  situation and  takes  the appropriate measures; 

Whereas  the  harmonization of  essential  requirements  concerning  the  protection 

of  public  health  presupposes  the  designation  of  Community  liaison  and 

reference  laboratories  and  the  undertaking  of  technical  and  scientific 

actions; 

Whereas  detailed  rules  governing  the  Community's  financial  contribution 

towards  some  actions  laid  down  in  this  Regulation  have  been  laid  down  by 

Council  Decision  90/424/EEC  of  26 June  1990  on  expenditure  in  the  veterinary 
field*2), as amended  by Decision  91/133/EEC<3>; 

Whereas  it  is appropriate  to confer  upon  the Commission  the  task of  taking  the 

necessary  measures of  application, 

HAS ADOPTED THIS REGULATION : 

(1)  0J  NO L  186, 30.6.1989, p. 23. 

(2)  OJ  No L 224, 18.8.1990, p. 19. 

(3)  OJ  No L  66, 13.3.1991, p. 18. 

-  6 -

Article 1 

1. This  Regulation  lays  down  the  rules  for  the  collection  of  information  on 

zoonoses  and  zoonotic  agents  and  the measures  to be  taken  for  zoonoses  and 

of  zoonotic  agents  in the Member  States and  at Community  level. 

2. This Regulation  shall  apply without  prejudice  to Directive  89/397/EEC. 

Article  2 

For  the purpose of  this Regulation : 

1. "zoonoses"  means  those  diseases  and  infections  naturally  transmitted 

between vertebrate animals and man; 

2.  "zoonotic  agent"  means  any  bacterium,  virus  or  parasite  which  can  cause  a 

zoonos18 ; 

3.  "fowl  breeding  flock" means  any  group  of  more  than  25  fowl  (Gal lus gal lus) 

reared  for  production  of  hatching  eggs,  continuously  housed  in  one  house 

or,  in the case of  free  range  fowls, any group of more  than 25 fowls having 

common  access  to one or more houses; 

4.  "fowl  commercial  flock"  means  any  group  of  more  than  100  fowl  (Gal lus 

gal lus) reared  for production of  poultry meat  and/or  the production of  eggs 

for  consumption,  continuously  housed  in one  house  or,  in  the  case  of  free 

range  fowls, any  group  of  more  than  100  fowls  having  common  access  to one 

or more houses; 

5. "approved  laboratory"  means  a  laboratory  approved  by  the  competent 

authority  of  a Member  State  to  carry  out  examinations  of  samples  in order 

to detect  a zoonotic agent; 

6.  "sample"  means  a  sample  taken  on  behalf  of  the  owner  or  manager  of  the 

establishment  or  of  the  animals, for  the examination  of  the  zoonotic  agent 

concerned; 

7.  "official  sample"  means  a  sample  taken  by  the  competent  authority  for  the 

examination  of  the  zoonotic  agent  concerned.  The  official  sample  bears  a 

reference  to the species, the type, the amount  and  the method of  collection 

and  the  Identification of  the origin of  the animal  or  the product  of  animal 

origin;  this sample  is to be taken without  prior  warning. 

• 7 -

Artw a 

t. Each Member State shall ensure that the activities undertaken  In accordance 

with  this  Regulation  by  the  public  health  authorities,  veterinary 

authorities and other  relevant authorities in its territory are coordinated 

at  national  and  local  level,  in  particular  in  relation  to  the 

epidemiological  enquiries. 

2. Each  Member  State  shall  designate the competent  authority  responsible for 
the submission of the data collected  in accordance with Articles 4 and 8 at 
the national  level. 

3. The competent  authorities  at  local  level  shall  be assisted  by approved 

laboratories. 

4. Each  Member  State  shall  designate  reference  laboratories  for zoonoses and 
zoonotic agents.  Where necessary the final  identification or confirmation 
of  a  zoonotic  agent  shaM  be carried  out in the appropriate  reference 
laboratories. 

Article 4 

1. For the zoonoses  listed  In Annex  1, point  I, the following  rules  shall 

apply. 

2. The diagnosis of a clinical case shall  rest with the appropriate members of 
the medical and veterinary profession.  The isolation and identification of 
a  zoonotic  agent or any other  evidence of their  presence  rests  with  the 
person  in charge of the laboratory  or, where  the Identification  is made 
elsewhere  than at a  laboratory  by serological  or other  examination,  with 
the person responsible for the examination. 

3. The diagnosis  and  identification  of  a  zoonotic  agent  referred  to in 

paragraph 2  shall  be  reported  to  the  appropriate  public  health  or 

veterinary  authority.  This  authority  shall  report  to  the  competent 

authority  referred to in Article 3(2). 

- 8 -

4. The  Commission,  in accordance  with  the procedure  laid  down  in Article 14, 

may  extend  the provisions of  this Article  to  zoonoses  and  zoonotic  agents 

referred  to  in Annex  1, point  II. 

Article § 

1. The  national  authority  referred  to  in  Article  3(2)  shall  evaluate  the 

information  collected  in  accordance  with  Article  4(3).  They  shall 

communicate  to  the  Commission,  every  twelve  months,  the  trends  of  the 

infections and the sources of the  infections. 

2. Paragraph  1 shall  not exclude more frequent communications by Member  States 

to  the  Commission,  or  requests  from  the  Commission  for  additional 

information, where the circumstances warrant  it. 

3. The Commission shall, by 1 January  1995, present a report  to the Council  on 

the  collection  of  data  with  proposals  in order  to  improve  the  reporting 

system. 

4.  if  necessary  the  implementing  measures  necessary  to  ensure  the  uniform 

application  of  this  Article  shall  be  laid  down  in  accordance  with  the 

procedure  laid down  in Article 14. 

Article 6 

The  systems of  tracing  the  movement  of  farm  animals  laid  down  in Commission 
Decision  89/153/EEC(4>  shall  be  enforced  in  relation  to  the  measures  for 

zoonoses and zoonotic agents  laid down  in this Regulation. 

(4)  OJ NO L 59, 2.3.1989, p. 33. 

- 9 -

Article 7 

1. Member  States,  taking  into  account  the  general  principles  of  Directive 
89/397/EEC,  shall  submit  to  the  Commission  by  1 April  1992  national 
measures  to be  taken  to achieve  the stated objective of  this Regulation  in 
respect of zoonoses  in accordance with Annexes 2, 3 and 4.  However, Member 
States may  include  zoonoses or  zoonotic  agents other  than  those  Indicated 
In Annexes 2 and 3. 

2. The measures must  take  into account  the  specific  situation  of  each  Member 

State and specify  inter alia, 

(a)  the  structure  and  distribution  of  the  domestic  animal  population  in 

the national  territory; 

(b)  the number  and distribution of establishments producing  final  compound 

feedlngstuffs; 

(c)  the number  and distribution of establishments producing  food of animal 

origin; 

(d)  the  infrastructure  of  the  services  (in  particular  giving  details  of 
the  authorities  associated  with  the  implementation  of  the  plans  and 
the type and size of  the bodies  involved  In such  implementation); 
(e)  the  number  of  approved  laboratories  at  which  the  examination  and 
identification  will  take  place  and  the  approval  procedures  for  such 
laboratories. 

3. The measures must  Indicate,  In relation to monitoring  : 

(a)  the monitoring  of  the zoonotic  agents  referred  to  in Annex  2, point I 

at  the  level of  the herds or  flocks; 

(b)  the monitoring  of  zoonotic  agents referred  to  in Annex  2, point  II at 

the  level of  final production of compound  feedlngstuffs; 

(c)  the  monitoring  of  the  zoonotic  agents  referred  to  In Annex  2,  point 

III at  the  level of production of  food of animal  origin; 

(d)  eventually  the  monitoring  of  zoonoses  or  zoonotic  agents  included  by 

the concerned Member  State. 

- 10 -

4. The measures must  comply with  the minimum  level  of  sampling  referred  to in 

Annex  3,  points  III,  IV  and  V.  However  derogations  can  be  granted  to 

specific  Member  States,  in  accordance  with  the  procedure  laid  down  in 

Article 14  for  categories  of  animals  or  products  where  they  represent  a 

minimal  part of  the production of  that Member State. 

5. The measures must  indicate  the actions to be taken  in relation to controls 

in accordance with Annex 4. 

6. The  Commission  shall  examine  the measures  communicated  in accordance  with 

paragraph  1,  in order  to determine  whether  they  conform  to  the  provisions 

laid down  in this Regulation. 

7.  In accordance  with  the  procedure  laid  down  in Article  14, the  Commission 

shall, by 1 July 1992, approve the measures referred  to  in paragraph  1.  In 

accordance  with  the  same  procedure  the  Commission  may  decide  that  the 

Member  States  concerned  must  amend  or  supplement  the  measures  which  they 

have submitted. 

8. At  the  request of  the Member  States concerned  and  in order  to take account 

of  the developments of  the situation  in that Member  State or  in one of  its 

regions,  the  Commission  may  decide,  in  accordance  with  the  procedure 

provided  for  in  Article  14,  to  approve  any  amendment  or  addition  to 

measures previously  approved pursuant  to paragraph 7. 

9.  In accordance  with  the  procedure  laid  down  in Article  14, the  Commission 

may decide that a Member State must amend or supplement measures previously 

approved  pursuant  to  paragraph  7  in  order  to  take  account  of  the 

development  in the situation  in that  State or  of  the  findings established 

under Articles 5 and 8. 

Article  8 

Every year  the Member States shall  present  to the Commission, within the frame 

of  the  committee  referred  to  In  Article  14,  the  results  of  the  measures 

referred  to  in Article 7. 

-  11 -

Article 9 

Veterinary  experts  from  the  Commission  may,  in  collaboration  with  the 

authorities of the Member  State concerned,  In so far as  la necessary  to ensure 

uniform  application  of  this  Regulation,  make  on-the-spot  checks;  the 

Commission  shall  inform the Member  States of the results of  the  Investigation. 

A Member  State  in whose  territory  a check  is being carried out  shall  give all 
the necessary assistance to the experts  in carrying out  their  duties. 

The  general  provisions  for  implementing  this Article  shall  be  determined  In 
accordance with the procedure  laid down  in Article 14. 

ArtlClff 10 

The  reference  laboratories  referred  to  in Article 3(4) shall  liaise with  the 
Community  reference  laboratories referred  to in Annex  5. The powers and duties 
of  the Community  reference  laboratories shall  be  laid down,  in so far as they 
are  not  already  covered  by  Article 28 of  Decision  90/424/EEC,  in  accordance 
with  the procedure  laid down  in Article 14. 

ATtlClt 11 

The  Commission  shall  follow  the  development  of  the  situation  in  relation  to 

zoonotic  diseases  in  the  Community,  particularly  on  the  basis  of  the 

information collected pursuant  to Articles 5 and 8 and may  : 

a)  institute specific  studies,  in particular  in relation  to the evaluation of 
the  risks  from  zoonotic  agents,  diagnostic  procedures  and  measures  in 
collaboration  with  the  appropriate  reference  laboratories  referred  to  in 
Article  3(4)  and  the  Community  reference  laboratories  referred  to  in 
Article  10 and  the Scientific Veterinary  Committee; 

- 12 -

b)  in  accordance  with  the  procedure  laid  down  in  Article  14, establish  the 

standard  operating  procedures  for  approved  laboratories  referred  to  In 

Article 3(3); 

c) establish guidelines for the measures concerning zoonoses. 

Article 12 

Detailed  rules  governing  the  Community's  financial  contribution  towards  the 

actions arising  from this Regulation are  laid down  in Decision 90/424/EEC. 

Article 13 

The  Annexes  to  this  Regulation  may  be  amended  by  the  Commission,  in 

accordance  with  the procedure  laid down  in Article  14,  in order  to  take  Into 

account  the development of  the situation  in relation to zoonotic diseases. 

Article  14 

Where  the procedure  laid down  in this Article  is to be  followed, the chairman 

shall, without  delay,  refer  the matter  to  the  Standing  Veterinary  Committee, 

hereinafter  referred  to as "the Committee", either on his own  initiative or at 

the request of a Member State. 

The representative of  the Commission  shall  submit  to the Committee a draft of 

the  measures  to  be  taken.  The  Committee  shall  deliver  its  opinion  on  the 

draft  within  a  time-limit  which  the  chairman  may  lay  down  according  to  the 

urgency of  the matter,  if necessary by taking a vote. 

The opinion  shall  be  recorded  in the minutes;  in addition, each Member  State 

shall have the right  to ask  to have  its position recorded  in the minutes. 

The Commission  shall  take  the utmost  account  of  the opinion  delivered  by  the 

Committee.  It shall  Inform  the Committee of  the manner  in which  its opinion 

has been taken  into account. 

-  13 -

Article  15 

This Regulation  shall  enter  into force on  1 January  1992. 

This  Regulation  shall  be  binding  in  its  entirety  and  directly  applicable  in 

a 11 Member  States. 

Done at Brussels, 

For  the Council 

The President 

-  14 -

ANNEX 1 

I.  -  Tuberculosis due to Mycobacterium Bovis 

-  Brucellosis and  the agents  thereof 

-  Salmonellosis and the agents  thereof 

-  Rabies 

-  Trichinosis and the agents thereof. 

II.  -  Campylobacteriosis 

-  Listeriosis 

-  ToxopIasmos i s 

-  Yersiniosis 

and the agents thereof. 

-  15 -

ANNEX  2 

I. 

-  Salmonella 

II.  -  Salmonella 

III. A. The  choice  of  the  specific  zoonotic  agent  to  be  monitored  is made  by 

the  individual  Member  States  taking  into  account 

a) the  specific  food of  animal  origin  involved; 

b) the  specific  establishment  to be  monitored; 

c) the  evidence  of  the  direct  hazard  of  the  specific  food  to  human 

health; 

d) the effect  of  processing  on  the microbiological  status of  the  food; 

e)  the  level  of  microbiological  monitoring  systems  (HACCP)  which  are 

carried  out  in  that  establishment  in  the  control  of  hygiene  and 

good  manufacturing  practices. 

B. The  choice  is made  from  the  following  specified  zoonotic  agents  : 

-  Listeria  monocytogenes 

-  Campylobacter  jejuni  and  Campylobacter  coll 

-  Salmonella 

-  Yers i nI a enterocoIi 11ca. 

However,  soft  cheese  and  cooked  ready  to  eat  products  must  be  examined 

for  Listeria  monocytogenes. 

- 16 -

ANNEX 3 

I.  The measures must indicate 

-  the number and type of samples to be taken 

-  the number and type of official samples to be taken 

-  the methods of sampling 

-  the methods of  examination of  the samples and  identification of the 

zoonotic organisms. 

II.  The  measures  must  take  into  account  the  following  criteria  for 

establishing the sampling procedures: 

A. Variable criteria at level of herds or flocks or  individual animals. 

a) factors  liable  to  encourage  the  spread  of  one  or  more  zoonotic 

diseases; 

b) previous history of  this zoonotic disease  in a given country, or 

part thereof, in domestic animals or wildlife-, 

c) the animal population concerned as regards 

- total size of population 

- homogenity of population groups 

- age of animals 

- animal production; 

d) the environment of the farms as regards 

- regional differences 

- the concentration of animals 

- the relation to urban areas 

- the relation to areas populated by wildlife; 

e) farm production systems including 

-  intensive farming units 

- extensive farming units 

-husbandry  systems,  in  particular  feeding  regimes  and  animal 

health care measures; 

f) problems  liable  to  arise,  in  the  light  of  known  precedents  and 

other information; 

-  17 -

g) the  required  degree  of  protection,  according  to  the  nature  and 

gravity of  the disease  in question. 

B. Variable  criteria  at  level  of  establishments  of  final  production  of 

compound  feedlngstuffs 

a) Types  of  materials  produced  and  the  animals  to  which  they  are 

intended  to be  fed; 

b) methods of  production; 

c) total  production of each  type of material; 

d) frequency of  production; 

e) the  level  of  bacteriological  monitoring  carried  out  in  accordance 

with  Council  Regulation  (EEC)  No  .../...  [laying  down  the 

veterinary  rules  for  the  disposal  and  processing  of  animal  waste, 

for  its  placing  on  the market  and  for  the  prevention  of  pathogens 

in feedstuffa]; 

f) previous  history  of  transmission  to  animals  of  zoonotic  diseases 

through  the given  product. 

C. Variable  criteria  at  level  of  establishments producing  food of  animal 

origin or: 

a) previous  history  of  animals  from  which  products  of  animal  origin 

originate; 

b) previous  history  of  transmission  to  human  beings  of  a  zoonotic 

disease  through  a given  product; 

c) the production  concerned  as regards : 

-  the  total  production 

-  the homogeneity of  the production 

-  the treatment  to which  the products have undergone; 

d) problems  liable  to  arise,  in  the  light  of  known  precedents  and 

other  information; 

e) the  required  degree  of  protection,  according  to  the  nature  and 

gravity of  the disease  in question. 

-  18 -

A. The measures must  comply  with  the  following  minimum  level  of  sampling 

for  the zoonotic agents referred  to  In Annex  2.1 : 

1. Breeding  flocks 

(a) Rearing  flocks 

All  fowl  flocks  being  reared  for  breeding  purposes must  be  sampled 

at  least  at a day old, 4 weeks of  age and  2 weeks prior  to entering 

the  laying phase. 

(b) Breeding  laving  flocks 

All  fowl  flocks maintained  for  the production of  hatching  eggs must 

be sampled  at  least  every  two weeks during  the  laying period. 

2. Commercial  egg  laving flocks, from  1 July  1994 at  the  latest 

(a) Rearing  flocks 

All  fowl  flocks  being  reared  for  the  production  of  eggs  for  human 

consumption  should  be sampled  at  least  at  a day old, 4 weeks of  age 

and  2 weeks prior  to entering  the  laying  phase. 

(b) Laying  flocks 

All  fowl  flocks maintained  for  the production  and  sale of  eggs  for 

human  consumption  should  be  sampled  at  least  every  12 weeks  during 

the  laying period. 

3. Commercial  fowl  meat  production  flocks,  from  1  July  1995  at  the 

latest 

All  fowl  flocks  maintained  for  the  production  of  fowl  for  human 

consumption  should  be  sampled  at  least  a day  old  and  3 weeks prior 

to slaughter. 

-  19 -

4. Hatcheries 

Hatcheries  with  an  incubator  capacity  greater  than  1,000  eggs 

should  carry  out  environmental  sampling  at  least  once  per  week 

whlle  in operation. 

B. All  flocks  and  hatcheries  referred  to  in point A  must  be  sampled  and 

examined  according  to the following rules: 

1. Samples  to be taken 

Sampling  may  be  carried  out  either  on  the  farm  or  in the  hatchery 

servicing  those  flocks  where  appropriate  (i.e.  for  the  monitoring 

requirements  for  day old  chicks or  for  the monitoring  requirements 

of breeding  flocks when  in the  laying  period). 

When  sampling  is carried  out  on  the  farm  the  sample  shall  consist 

of  pooled  faecal  samples.  When  the sampling  is carried  out  in the 

hatchey  the sample  shall  consist  of  dead  in shells, culled  day old 

chicks and meconium obtained  at  the point of hatch. 

2. Number  of samples to be taken 

The  number  of  samples  to  be  taken  in  respect  of  any  one  flock  is 

determined on a statistical  basis of a 95% probability of  detecting 

one  positive  sample  given  that  the  level  of  infection  in  the 

population being sampled  is 5%  i.e.: 

Number of birds  in a flock 

Number of samples to be taken 
randomly at the farm or  hatchery 

25 -  29 
30 -  39 
40 -  49 
50 -  59 
60 -  89 
90 - 199 
200 - 499 
500 or more 

20 
25 
30 
35 
40 
50 
55 
60* 

* The maximum number  of samples required  in one flock. 

-  20 -

3. Bacteriological  technique 

The  total  number  of  samples  taken  from  any one  flock at  the farm or 

the hatchery may  be pooled  for  bacteriological  Investigation, using 

either  an  ISO  method  for  salmonella  or  a  comparable  alternative 

method  specified by  the Member  State. 

C. All  flocks  and  hatcheries  referred  to  in  point  A  must  be  officially 

sampled  and examined  at  least once very  year. 

IV.  A. The  measures must  comply  with  the  following  minimum  level  of  sampling 

for  the zoonotic  agents  referred  to  in Annex  2.11. 

Every month  each  type of compound  feedingstuff  intended  for  the flocks 

referred  to  in  111.A, produced  in the establishment  should  be  sampled. 

B. Feedlngstuffs  referred  to  in  point  A  must  be  sampled  and  examined 

according  to the  following  rules.  The samples  taken  for  analysis must 

comprise  five  units  weighing  100 grams  each  from  the  final  product. 

The  frequency  of  this monitoring  is  increased where  the  final  compound 

feedingstuff  is not  subjected  to  heat  or  other  alternative methods of 

treatment  adequate  to eliminate  the  risk of  zoonotic  agents  and  where 

a  risk of  transmission  of  a zoonotic  agent  has  been  established.  The 

samples  may  be  pooled  for  bacteriological  investigation, using  either 

an  ISO  method  for  salmonella  or  a  comparable  alternative  method 

specified by  the Member  State. 

C. Each  type  of  compound  feedingstuff  referred  to  In  point  A  must  be 

officially  sampled  and examined  at  least once every  year. 

-  21 -

V.  A. The measures must  comply with  the  following  minimum  level  of  sampling 

for Listeria monocytogenes referred  to  in Annex 2.1 N . B. 

Every  month  each  type  of  product  produced  in  the  establishments 

producing  soft  cheese  and  cooked  ready  to  eat  products  should  be 

samp Ied. 

B. The  sampling  technique  and  the  bacteriological  methods  will  be 

established according to the procedure referred  to  in Article 14. 

C. Each  type of product  referred  to  in point A must be officially sampled 

and examined at  least once every year. 

-  22 -

ANNEX  4 

I. 

The  measures  must  comply  with  the  following  minimum  action  levels  for 

zoonotic agents  referred  to  in Annex  2.1. 

A. Breeding  flocks 

1. Rearing  flocks 

Where  as  a  result  of  the monitoring  carried  out  in accordance  with 

Annex  3.111.A  and  C,  the  presence  of  Salmonella  enter itidis  or 

S.  typhimurlum  is  detected  in  a  rearing  flock,  the  flock  is 

officially  sampled  according  to  point  III,  B,  2  of  Annex  3,  in 

order  to  confirm  the  initial  findings.  Liver,  ovary  and  bone 

marrow  of  each  bird  are  separately  examined  for  presence  of 

Salmonella,  using  either  an  ISO  method  for  Salmonella  or  a 

comparable  alternative method  specified  by  the Member  State. 

Where  infection  with  S. enter itidis or  S.  typhimurlum  is confirmed 

in a rearing  flock  no movements of  live fowl  (other  than by  licence 

issued  by  the veterinary  authority  direct  to slaughter) or  eggs may 

be  made  from  that  flock  until  it  can  be  established  to  the 

satisfaction of  the verterinary  authority  that  infection with  these 

serotypes  Is no  longer  present. 

2. Breeder  laying  flocks 

Where,  as a result  of  the monitoring  carried  out  in accordance  with 

3.111.A  and  C,  the  presence  of  Salmonella  enteritis  or  typhimurlum 

is  detected  in  a  breeder  laying  flock,  the  flock  is  officially 

sampled  according  to  point  III,  B,  2  of  Annex  3,  in  order  to 

confirm  the  initial  findings.  Liver, ovary  and  bone marrow of  each 

bird  are  separately  examined  for  presence  of  Salmonella,  using 

either  an  ISO  method  for  Salmonella  or  a  comparable  alternative 

method  specified  by  the Member  State. 

-  23 -

Where  infection  with  Salmonella  enteritidis  or  typhimurlum  is 

confirmed  in  a  breeder  laying  flock,  no  movements  of  live  fowl 

other  than  by  licence  issued  by  the  local  veterinary  authority 

direct  to slaughter  or  eggs other  than direct  for  production of  egg 
products  in  accordance  with  Directive  89/437/EEC(1)  may  be  made 

from  that  flock, until  it can  be established  to the satisfaction of 

the verterinary  authority  that  infection with  those  serotypes  is no 

longer  present. 

Where  hatching  eggs  from  flocks  in  which  the  presence  of 

S. enteridis or  S.  typhimurlum  has been  confirmed  are  still  present 

in a hatchery,  those eggs must  be  destroyed. 

3. According  to the procedure  referred  to  in Article  14 specific  rules 

intended  to save  valuable genetic material  may  be  decided. 

B. Commercial  egg  laying  flocks,  from  1 July  1994 at  the  latest 

1. Rearing  flocks 

The same  rules  referred  to  in A.1  shall  apply. 

2. laying  flocks 

The same  rules  referred  to  in A.2 shall  apply. 

C. Commercial  fowl  meat  production  flocks,  from  1 July  1995 at  the  latest 

Where,  as  a  result  of  the  monitoring  carried  out  in  accordance  with 

Annex  3.111.A  and  C,  the  presence  of  Salmonella  enteritidis  or 

typhimurlum  is detected  in a  fowl  meat  production  flock,  the  flock  is 

officially  sampled  according  to  point  III, B,  2  of  Annex  3,  in order 

to confirm  the  initial  findings.  Liver, ovary  and  bone marrow of  each 

bird  are  separately  examined  for  presence  of  Salmonella,  using  either 

an  ISO  method  for  Salmonella  or  a  comparable  alternative  method 

specified  by  the Member  State. 

(1)  OJ  No L 212, 22.7.1989, p. 87. 

-  24 -

Where 

infection  with  Salmonella  enteritidis  or  typhimurlum 

is 

confirmed  in  a  fowl  meat  production  flock,  no  movements  of  live  fowl 

other  than  by  licence  issued  by  the  local  veterinary  authority  direct 

to slaughter  may  be made  from  that  flock. 

D. All  flocks 

Where  Salmonella enteritidis or  typhimurlum  is confirmed  in any of  the 

flocks  referred  to  in A,  B  and  C,  the  following  supplementary  actions 

must  also be  taken: 

1. Where  birds  are  sent  direct  to  slaughter  for  human  consumption  the 

local  veterinary  authority  must  give  notice  of  the movement  to  the 

slaughterhouse.  These  birds  must  be  slaughtered  at  the  end  of  the 

slaughter  day  and  must  undergo  heat  treatment,  or  other  suitable 

method  of  treatment,  allowing  the  destruction  of  Salmonella. 

2.  Following  depopulation  of  premises  occupied  by  flocks  infected  with 

Salmonella  enteritidis  or  typhimurlum,  then  effective  cleansing  and 

disinfection  procedures,  including  the  safe  disposal  of  manure  or 

litter  is set  out  by  the  local  veterinary  authority. 

E. Hatcher ies 

Where,  as  a  result  of  environmental  or  other  monitoring  activities 

carried  out  in  accordance  with  Annex  3.111.A  and  C,  the  presence  of 

any  Salmonella  serotype 

is  detected,  effective  cleansing  and 

disinfection  procedures  including  the  safe  disposal  of  hatcheries 

wastes  are  set  out  by  the  local  veterinary  authority. 

II.  The  measures  must  comply  with  the  following  minimum  action  levels  for 

zoonotic  agents  referred  to  in Annex  2,ll. 

Where  as a  result  of  the monitoring  in accordance  with  Annex  3.IV.A  and  C 

a  sample  is positive  for  Salmonella,  an  investigation  is carried  out  by 

the  local  veterinary  authority  in order  to: 

1.  identify  the  source  of  contamination  in  particular  by  means  of 

official  samples  taken  at  different  steps of  the  production; 

-  25 -

2. examine  the  application of  rules and  controls  concerning  the  disposal 

and  processing  of  animal  waste  and  in  particular  those  laid  down  in 

Council  Directive  90/667/EEC  of  27 November  1990  laying  down  the 

veterinary  rules  for  the disposal  and  processing  of  animal  waste,  for 

its  placing  on  the  market  and  for  the  prevention  of  pathogens  in 

feedstuffs  of  animal  or  fish  origin  and  amending  Directive 
90/425/EEC<2>; 

3. establish  procedures  for  good  manufacturing  practices  and  ensure 

compliance  with  the established  procedures. 

III. The  measures  must  comply  with  the  following  minimum  action  levels 

referred  to  in Annex  2.III  : 

A. Establishments producing  soft  cheese  and  cooked  ready  to eat  products. 

Where  as  a  result  of  monitoring  carried  out  in  accordance  with 

Annex  3.V.A  and  C,  the  presence  of  Listeria  monocytogenes  is detected 

the  product  of  the  contaminated  batch  should  be  withdrawn  from  the 

market  and  a  radical  disinfection  of  the  premises  should  be  carried 

out. 

B. All  establishments 

Where  as  a  result  of  the  monitoring  a  sample  is  positive  for  the 

zoonotic  agent  or  agents  designated  in  the  plan,  an  investigation  is 

carried  out  by  the Veterinary  authority  in order  to: 

1.  identify  the  source  of  contamination  in  particular  by  means  of 

official  samples  taken at  different  steps of  the production; 

2. examine  the current  procedures of  control  in the establishment; 

3. establish  procedures  for  good  manufacturing  practices  and  ensure 

compliance  with  the established  procedures. 

IV.  The  measures  must  indicate  the  actions  of  information  of  food  handlers 

and  consumers  intended  to avoid mishandling  of  food of  animal  origin. 

(2)  OJ  No L 363, 27.12.1990, p. 51. 

-  26 -

ANNEX  5 

List  of  communitory  reference  laboratories for  zoonoses 

I. 

Epidemiology of  zoonoses 

Institute of Veterinary  Medicine 

(Robert  von Ostertag  Institute) 

Postfach 33 00  13 

Thielallee  88/92 

D-100 Berlin  (Federal  Republic of  Germany) 

I.  Salmonellae 

RiJksinstituut  voor  de Volksgezondheid 

P.O. Box 1 

NL-3720 BA  Bilthoven  (The Netherlands) 

III. Yersinia 

Institut  Pasteur 

27,  rue du Docteur  Roux 

F-75724  Paris Cedex  15  (France) 

IV.  Listeria 

Institute of  Hygiene  and  Microbiology 

The Royal  Veterinary  and Agricultural  University 

13 BUIowsvej 

DK-1870 Copenhagen  (Denmark) 

V. 

Campylobacter 

-  27 -

Institut  National  de Recherche  Vétérinaire 

Groeselenberg  99 

B-1180 Bruxelles  18  (Belgium) 

VI.  Parasites 

Istituto Super lore di  Sanité 

Via  Regina  Elena  299 

1-00161  Rome  (Italy) 

ISSN 0254-1475 

COM(91) 310 final 

DOCUMENTS 

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Catalogue number : CB-CO-91-342-EN-C 

ISBN 92-77-74805-2 

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