CELEX: 51993GC0342
Language: en
Date: 2006-12-11
Title: Draft Commission Decision of […] laying down the criteria for classifying third countries with regard to avian influenza and Newcastle disease in relation to imports of live poultry and hatching eggs (…/…/EC) (Codified version)

EN

|[pic]                     |COMMISSION OF THE EUROPEAN COMMUNITIES                                                                           |

                                        Brussels,
                                        C(2003)

                                                                      Draft

                                                               COMMISSION DECISION

                                                                      of […]

   laying down the criteria for classifying third countries with regard to avian influenza and Newcastle disease in relation to imports of live
                                                            poultry and hatching eggs

                                                                     (…/…/EC)

                                                                (Codified version)

                                            ê 93/342/EEC (adapted)
                                            è1 94/438/EC Art. 6 pt. 1

                                                                      Draft

                                                               COMMISSION DECISION

                                                                      of […]

 è1 laying down the criteria for classifying third countries with regard to avian influenza and Newcastle disease in relation to imports of live
                                                           poultry and hatching eggs ç

                                                                   (.../../EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 90/539/EEC of 15 October 1990 on animal health conditions governing intra-Community trade in and imports  from
third countries of poultry and hatching eggs[1], as last amended by Ö Regulation (EC) No 806/2003 Õ[2], and in  particular  Article  22(2)  Ö and
(3) Õ thereof,

Whereas:

                                            ê 

   1) Commission Decision 93/342/EEC of 12 May 1993 laying down the criteria for classifying third countries with regard to avian  influenza  and
      Newcastle disease in relation to imports of live poultry and hatching eggs[3] has  been  substantially  amended[4].  In  the  interests  of
      clarity and rationality the said Decision should be codified.

                                            ê 93/342/EEC Recital 1 (adapted)

   2) Poultry Ö and Õ hatching eggs coming from third countries must be free from avian influenza and  Newcastle  disease.  It  is  necessary  to
      establish the criteria for classifying third countries accordingly.

                                            ê 93/342/EEC Recital 2 (adapted)

   3) The criteria for third countries have to be established taking into account the provisions regarding Member States as laid down in  Council
      Directives 92/40/EEC Ö of 19 May 1992 introducing Community measures for the control of avian influenza Õ[5] and  92/66/EEC  Ö of  14  July
      1992 introducing Community measures for the control of Newcastle disease Õ[6] Ö , both as last amended by Regulation (EC) No 806/2003 Õ .

                                            ê 93/342/EEC Recital 3 (adapted)

   4) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee Ö on  the  Food  Chain  and  Animal
      Health Õ ,

                                            ê 93/342/EEC

HAS ADOPTED THIS DECISION:

                                                                    Article 1

For the purpose of this Decision:

                                            ê 93/342/EEC (adapted)

(a)   “Avian influenza” means infection as defined in Chapter I of Annex Ö I Õ ;

(b)   “Newcastle disease” means infection as defined in Chapter II of Annex Ö I Õ ;

(c)   “Ö recognised Õ vaccine” means any vaccine against Newcastle disease complying with the criteria laid down in Annex Ö II Õ ;

                                            ê 93/342/EEC (adapted)

(d)   “Ö emergency Õ vaccination” means vaccination used as a means of controlling the disease following one or more outbreaks and carried out:

       (i)  against avian influenza using any vaccine;

       (ii) against Newcastle disease using non-recognised vaccines;

                                            ê 93/342/EEC (adapted)

(e)   “Ö sanitary Õ slaughter policy” means the application, in the event of outbreaks of avian influenza or Newcastle disease, of  the  measures
       provided for in Annex Ö III Õ ;

                                            ê 94/438/EC Art. 6 pt. 2 (adapted)

(f)   “Ö part Õ of the territory” means a part of a third country of sufficient size, which is well defined geographically  or  administratively,
       taking into account the epizootiological situation.

                                            ê 93/342/EEC

                                                                    Article 2

A third country is classified as free from avian influenza and Newcastle disease if it fulfils the following general criteria:

(a)   it must have a general animal health structure allowing adequate monitoring of poultry flocks;

(b)   it must have legislation which makes avian influenza and Newcastle disease notifiable diseases for all  species  of  poultry  and  for  all
       birds kept in captivity;

(c)   it must undertake to examine closely any suspicion of those diseases;

                                            ê 93/342/EEC (adapted)

(d)   if there is suspicion, it must submit samples of each avian influenza virus or  paramyxovirus  found  to  specific  laboratory  testing  in
       accordance with the procedure set out in Annex Ö I Õ ;

                                            ê 93/342/EEC

(e)   it must have at its disposal laboratory capacity in its own official laboratories or have arrangements  with  other  national  laboratories
       for rapid testing;

                                            ê 94/438/EC Art. 6 pt. 3 (adapted)

(f)   it must send a list of these laboratories, as well as a description of the methods used for diagnosis and pathotyping  of  avian  influenza
       and Newcastle disease to the Commission and allow checking of them by experts from the Community;

(g)   for each primary outbreak it must send virusisolates to the EC reference laboratory in Weybridge (Addlestone, United Kingdom);

(h)   it must notify the Commission, within 24 hours after confirmation, of initial outbreaks in each previously free part of its territory;

(i)   it must send to the Commission, at least monthly in the event of subsequent outbreaks in the same part of the territory, a  report  on  the
       disease situation;

                                            ê 93/342/EEC (adapted)

(j)   in cases where vaccination against avian influenza and/or Newcastle disease is not forbidden, it must officially  control  the  production,
       testing and distribution Ö of Õ the vaccines;

(k)   it must communicate to the Commission the characteristics of each strain used for the production of vaccines  against  avian  influenza  or
       Newcastle disease.

                                                                    Article 3

1.    Without prejudice to the general criteria laid down in Article 2, a third country is classified as free from avian influenza if:

       (a)  no outbreaks of that disease have occurred in poultry on its territory for at least 36 months; and

       (b)  no vaccinations against avian influenza viruses of the same sub-types as those for which highly pathogenic viruses are known to exist
           (currently H5 and H7 sub-types) have been carried out for at least 12 months.

2.    Where a sanitary slaughter policy is practised to control the disease and without prejudice to the provision of paragraph 1(b)  the  period
       of 36 months referred to in paragraph 1(a) is reduced to:

       (a)  6 months if no emergency vaccination has been carried out;

       (b)  12 months if emergency vaccination has been carried out, provided that a further 12-month  period  has  elapsed  after  the  official
           termination of such emergency vaccination.

                                                                    Article 4

1.    Without prejudice to the general criteria laid down in Article 2, a third country is classified as free  from  Newcastle  disease  for  the
       first time if:

       (a)  no outbreaks of that disease have occurred in poultry on its territory for at least 36 months; and

       (b)  no vaccinations against Newcastle disease using non-recognized vaccines have been carried out for at least 12 months.

2.    Where a sanitary slaughter policy is practised to control the disease and without prejudice to the provision of paragraph 1(b)  the  period
       of 36 months referred to in paragraph 1(a) is reduced to:

       (a)  6 months if no emergency vaccination has been carried out;

       (b)  12 months if emergency vaccination has been carried out, provided that a further 12-month  period  has  elapsed  after  the  official
           termination for such emergency vaccination.

                                            ê 93/342/EEC (adapted)

Ö 3. Õ      By way of derogation from paragraphs 1(b) and 2(b) a third country is classified as free from Newcastle disease if it allows the  use
       of vaccines against the disease, which, although complying with the general criteria set out in Annex Ö II Õ  for  the  vaccines,  do  not
       fulfil the specific criteria thereof.

       In such cases the third country concerned Ö shall Õ be authorized to send  live  poultry  and  hatching  eggs  to  the  Community  if  the
       additional guarantees laid down in Annex Ö IV Õ to this Decision are included in the accompanying animal health certificate.

                                            ê 94/438/EC Art. 6 pt. 6

                                                                    Article 5

The provisions of Article 22(1) of Directive 90/539/EEC and of Articles 3 and 4  of  this  Decision  apply  mutatis  mutandis  to  parts  of  the
territory which comply with the requirements laid down therein, provided that satisfactory guarantees have been given as to:

    1. movement restrictions vis-à-vis other parts of the territory which are not free from avian influenza and/or Newcastle disease,

    2. serological screening when necessary,

    3. other possible measures.

                                            ê 

                                                                    Article 6

Decision 93/342/EEC is repealed.

References to the repealed Decision shall be construed as references to this Decision and shall be read in accordance with the correlation  table
in Annex VI.

                                            ê 93/342/EEC Art. 6

                                                                    Article 7

This Decision is addressed to the Member States.

Done at Brussels, […]

      For the Commission
      […]
      Member of the Commission

                                            ê 93/342/EEC Annex A (adapted)

                                                                     ANNEX I

                                             DEFINITIONS OF “AVIAN INFLUENZA” AND “NEWCASTLE DISEASE”

                                                                    CHAPTER I

                                                                 Avian influenza

“Avian influenza” means an infection of poultry caused by any influenza A virus which has an intravenous pathogenicity index (IVPI) in  six-week-
old chickens greater than 1,2 or any infection with influenza A virus of H5 or H7 sub-type for which nucleotide sequencing has  demonstrated  the
presence of multiple basic amino acids at the cleavage site of the haemagglutinin.

The IVPI has to be determined according to the following method:

                                                      Intravenous pathogenicity index (IVPI)

1.    Infective allantoic fluid from the lowest passage level available, preferably from the initial isolation without any selection, is  diluted
       Ö 1:10 Õ in sterile isotonic saline.

2.    0,1 ml diluted virus is injected intravenously into each of 10 six-week-old chickens (specific pathogen free birds should be used).

3.    Birds are examined at 24 hour intervals for 10 days.

4.    At each observation each bird is recorded normal (0), sick (1), severely sick (2) or dead (3).

5.    Record results and calculate index as shown in this example:

|Clinical Signs       |Days after inoculation                                                                |Total        |Score        |
|                     |(number of birds)                                                                     |             |             |
|                                                                                                                                        |
|Index = mean score per bird per observation = 246/100 = 2,46                                                                            |
|(*) This has to be a subjective clinical judgement but normally this would involve birds showing more than one of the following signs:  |
|respiratory involvement, depression, diarrhoea, cyanosis of exposed skin or wattles, oedema of face and/or head, nervous signs.         |

                                                                    CHAPTER II

                                                                Newcastle disease

“Newcastle disease” means an infection of poultry caused by any avian strain of the paramyxovirus 1 with  an  intracerebral  pathogenicity  index
(ICPI) in one-day-old chicks greater than 0,7.

The ICPI has to be determined according to the following method:

                                                  Intracerebral pathogenicity index text (ICPI)

1.    Infective freshly harvested allantoic fluid (HA titre must be greater than 24) is diluted 1:10  in  sterile  isotonic  saline  (antibiotics
       must not be used).

2.    0,05 ml of the diluted virus is injected intracerebrally into each 10 one-day-old chicks (i.e. 24 - 40 hours after  hatching).  The  chicks
       should be hatched from eggs obtained from a specific pathogen-free flock.

3.    The birds are examined at intervals of 24 hours for eight days.

4.    At each observation each bird is scored: 0 = normal; 1 = sick; 2 = dead.

5.    The index is calculated as shown in the following example:

|Clinical signs               |Days after inoculation                                                   |Total           |Score           |
|                             |(number of birds)                                                        |                |                |
|                             |1       |2       |3       |4       |5       |6       |7       |8       |                |                |
|Normal                       |10      |4       |0       |0       |0       |0       |0       |0       |14 × 0          |= 0             |
|Sick                         |0       |6       |10      |4       |0       |0       |0       |0       |20 × 1          |= 20            |
|Dead                         |0       |0       |0       |6       |10      |10      |10      |10      |46 × 2          |= 92            |
|Total = 112                                                                                                                             |
|Index = is a mean score per bird of observation = 112/80 = 1,4                                                                          |

                                                                   ____________

                                            ê 93/342/EEC Annex B

                                                                     ANNEX II

                                                         CRITERIA FOR RECOGNISED VACCINES

1.    General criteria

       A.   Vaccines have to be registered by the competent authorities of the third country concerned before being allowed to be distributed and
           used. For this registration the competent authorities have to rely on a complete file containing data about efficacy  and  innocuity;
           for imported vaccines the competent authorities can rely on data checked by the  competent  authorities  of  the  country  where  the
           vaccine is produced, as far as these checks have been carried out in conformity with internationally accepted standards.

       B.   Furthermore importation or production and distribution of the vaccines have to be controlled by  the  competent  authorities  of  the
           third country concerned.

       C.   Before distribution is allowed, each batch of vaccines has to  be  tested  on  innocuity,  in  particular  regarding  attenuation  or
           inactivation and absence of undesired contaminating agents, and on efficacy on behalf of the competent authorities.

2.    Specific criteria

       A.   Live attenuated Newcastle disease vaccines shall be prepared from a Newcastle disease virus strain for which the master seed has been
           tested and shown to have an intracerebral pathogenicity index (ICPI) of:

            either

           (i)   less than 0,4 if not less than 107 EID50 are administered to each bird in the ICPI test;

            or

           (ii)  less than 0,5 if not less than 108 EID50 are administered to each bird in the ICPI test.

       B.   Inactivated Newcastle disease vaccines shall be prepared from a Newcastle disease virus strain with  an  intracerebral  pathogenicity
           index (ICPI) in one-day-old chicks of less than 0,7 if not less than 108 EID50 are administered to each bird in the ICPI test.

                                                                   ____________

                                            ê 93/342/EEC Annex C (adapted)

                                                                    ANNEX III

         MINIMAL MEASURES TO BE TAKEN WHEN SANITARY SLAUGHTER IS PRACTISED TO ELIMINATE OUTBREAKS OF AVIAN INFLUENZA OR NEWCASTLE DISEASE

1.    In case of suspicion the holding concerned shall be placed under official supervision. This shall in particular mean that:

       (a)  all necessary samples shall be taken without delay and sent to a laboratory approved by the competent authorities for diagnosis;

       (b)  a record shall be made of all categories of poultry kept on the holding showing number of dead  and  diseased  animals;  this  record
           shall be kept up-to-date and should be checked at each official visit;

       (c)  all poultry shall be kept isolated and, whenever possible, in their living quarters;

       (d)  no poultry is allowed to enter or to leave the holding;

       (e)  all movements of persons, vehicles, materials etc. onto and from the holding shall be subject to official authorization;

       (f)  table eggs can leave the holding after adequate disinfection or can be sent  directly  to  an  installation  where  they  receive  an
           adequate heat treatment;

       (g)  appropriate means of disinfection have to be used at the entrances of buildings housing poultry and of the holding itself;

       (h)  an epizootiological inquiry has to be carried out to discover the source of infection and its possible spread;

       (i)  possibly infected contact premises, i. e. these known from the inquiry meant in point (Ö h Õ) have to  be  put  also  under  official
           surveillance.

2.    As soon as the presence of the disease is officially confirmed on a holding, the following measures  shall  be  taken  in  addition  Ö to Õ
       those mentioned under point 1:

       (a)  all poultry on the holding shall be killed on the spot without any  delay;  their  carcasses  and  eggs  shall  be  destroyed;  these
           operations have to be carried out in a way which minimizes the risk of spreading disease;

       (b)  any substance or waste liable to be contaminated shall be destroyed or treated in a way to ensure destruction of any virus present;

       (c)  the meat of poultry slaughtered during the presumed incubation period should be traced and destroyed;

       (d)  hatching eggs laid during the presumed incubation period should be traced and destroyed; poultry which hatched from such  eggs  shall
           be placed under official surveillance;

       (e)  after carrying out killing and destruction operations the premises shall be thoroughly cleansed and disinfected;

       (f)  no poultry shall be reintroduced onto the holding until at least 21 days after the end of the disinfection operations.

3.    The operations mentioned in point 2 may be restricted to parts of holdings which form an epizootiological unit  as  far  as  the  necessary
       guarantees exist to avoid spread of the disease to the non-infected units of the holding.

4.    Around confirmed outbreaks of disease a protection zone with a minimum radius of 3 km and a surveillance zone with a minimum radius  of  10
       km shall be implemented. In these zones stand-still measures and controlled movements of poultry shall be in force until at least 21  days
       after the end of the disinfection operations on the infected holding. Before lifting the measures in these  zones  the  authorities  shall
       carry out the necessary inquiries and sampling of the poultry holdings to confirm  that  disease  is  no  longer  present  in  the  region
       concerned.

5.    The operations mentioned in this Annex have to be carried out by or under the supervision of the official veterinary authorities.

                                                                   ____________

                                            ê 94/438/EC Art.6 pt. 8 (adapted) Corrigendum OJ L

                                                                     ANNEX IV

 ADDITIONAL GUARANTEES TO BE INCLUDED IN THE ANIMAL HEALTH CERTIFICATE FOR IMPORT OF LIVE POULTRY OR HATCHING EGGS INTO THE COMMUNITY FROM THIRD
                                         COUNTRIES WHERE ARTICLE 4( Ö 3 Õ ) OF Ö THIS Õ DECISION APPLIES

Although the use of vaccines against Newcastle disease which do not fulfil the specific  criteria  of  Annex  Ö II Õ  ,  heading  2  of  Decision
Ö [../…/..] Õ is not prohibited in …[7], it is certified that in relation to the:

    4. live poultry[8],

    5. breeding poultry from which the hatching eggs[9]/day-old chicks[10] are derived,

the following guarantees apply:

(a)   they have not been vaccinated for at least 12 months with such vaccines;

(b)   they originate from a flock which has undergone, no earlier than 14 days preceding consignment or  collecting  of  hatching  eggs,  on  the
       basis of a random sample of cloacal swabs of at least 60 birds of each flock concerned, a virus  isolation  test  for  Newcastle  disease,
       carried out in an official laboratory, in which no avian paramyxoviruses with an Intracerebral Pathogenicity Index (ICPI) of more than 0,4
       have been found;

(c)   they have not been in contact during the last 60 days before consignment or collecting of hatching eggs, with poultry which do  not  fulfil
       the guarantees mentioned respectively under (a) and (b); and

(d)   they have been isolated under official surveillance on the holding of origin during the 14-day period mentioned in (b); and

(e)   when it concerns export of day-old chicks, the hatching eggs from which they hatched have not been in contact in  the  hatchery  or  during
       transport with eggs or poultry which do not fulfil the guarantees under (a) to (d).

                                                                   ____________

                                            é

                                                                     ANNEX V

                                                       Repealed Decision with its amendment

|Commission Decision 93/342/EEC                                                   |(OJ L 137, 8.6.1993, p. 24)                             |
|Commission Decision 94/438/EEC, Article 6 only                                        |(OJ L 181, 15.7.1994, p. 35)                 |

                                                                   ____________

                                                                     ANNEX VI

                                                                Correlation Table

|Decision 93/342/EEC                                                 |This Decision                                                       |
|Articles 1, 2 and 3                                                 |Articles 1, 2 and 3                                                 |
|Article 4(1) and (2)                                                |Article 4(1) and (2)                                                |
|Article 4(4)                                                        |Article 4(3)                                                        |
|Article 4a                                                          |Article 5                                                           |
|Article 5                                                           |–                                                                   |
|–                                                                   |Article 6                                                           |
|Article 6                                                           |Article 7                                                           |
|Annex A                                                             |Annex I                                                             |
|Annex B                                                             |Annex II                                                            |
|Annex C                                                             |Annex III                                                           |
|Annex E                                                             |Annex IV                                                            |
|–                                                                   |Annex V                                                             |
|–                                                                   |Annex VI                                                            |

                                                                   ____________

                                                             -----------------------
[1]   OJ L 303, 31.10.1990, p. 6.
[2]   OJ L Ö 122, 16.5.2003, p. 1 Õ .
[3]   OJ L 137, 8.6.1993, p. 24.
[4]   See Annex V.
[5]   OJ L 167, 22.6.1992, p. 1.
[6]   OJ L 260, 5.9.1992, p. 1.
[7]   Name of the country of origin.
[8]   Delete where not applicable.
[9]   Delete where not applicable.
[10]  Delete where not applicable.