CELEX: 51991PC0310
Language: en
Date: 1991-09-04
Title: 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

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)
 ---pagebreak---                                         - 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;
 ---pagebreak---                                      - 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".
 ---pagebreak---                                        - 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-,
 ---pagebreak---                                               - 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
                                                                               1
89/397/EEC of 14 June 1989 on the official control of foodstuffs* >;
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.
 ---pagebreak---                                         - 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.
 ---pagebreak---                                        • 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).
 ---pagebreak---                                        - 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.
 ---pagebreak---                                         - 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.
 ---pagebreak---                                       - 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.
 ---pagebreak---                                        - 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;
 ---pagebreak---                                        - 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.
 ---pagebreak---                                     - 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
 ---pagebreak---                                     - 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.
 ---pagebreak---                                         - 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.
 ---pagebreak---                                      - 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;
 ---pagebreak---                                  - 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.
 ---pagebreak---                                - 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.
 ---pagebreak---                                  - 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                               20
                 30 - 39                               25
                 40 - 49                               30
                 50 - 59                               35
                 60 - 89                               40
                 90 - 199                              50
                200 - 499                              55
                500 or more                            60*
     * The maximum number of samples required in one flock.
 ---pagebreak---                                     - 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.
 ---pagebreak---                                   - 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.
 ---pagebreak---                                        - 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.
 ---pagebreak---                                         - 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.
 ---pagebreak---                                          - 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;
 ---pagebreak---                                            - 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.
 ---pagebreak---                                      - 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)
 ---pagebreak---                                     - 27 -
V.  Campylobacter
     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)
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                                                              COM(91) 310 final
                                                      DOCUMENTS
EN                                                                              03
                                Catalogue number : CB-CO-91-342-EN-C
                                                             ISBN 92-77-74805-2
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