CELEX: 51996GC0540
Language: en
Date: 2008-11-04
Title: Draft Commission Decision of […] on animal health requirements and veterinary certification for imports into the Community of ova and embryos of the equine species (…/…/EC) (Codified version)

EN
|[pic]                     |COMMISSION OF THE EUROPEAN COMMUNITIES                                                                           |

                                        Brussels,
                                        C

                                                                      Draft

                                                               COMMISSION DECISION

                                                                      of […]

        on animal health requirements and veterinary certification for imports into the Community of ova and embryos of the equine species

                                                                     (…/…/EC)

                                                                (Codified version)

                                            ê 96/540/EC (adapted)

                                                                      Draft

                                                               COMMISSION DECISION

                                                                      of […]

        on animal health requirements and veterinary certification for imports into the Community of ova and embryos of the equine species

                                                            (Text with EEA relevance)

                                                                     (…/…/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing  trade  in  and  imports  into  the
Community of animals, semen, ova and embryos not subject to animal health requirements laid down in  specific  Community  rules  referred  to  in
Annex A(I) to Directive 90/425/EEC[1], and in particular Articles 17 and 18 thereof,

Whereas :

                                            ê 

   1) Commission Decision 96/540/EC of 4 September 1996 on animal health requirements and veterinary certification for imports into the Community
      of ova and embryos of the equine species[2] has been substantially amended[3]. In  the  interests  of  clarity  and  rationality  the  said
      Decision should be codified.

                                            ê 96/540/EC Recital 1 (adapted)

   2) Ö By Decision 2004/211/EC[4] the Commission established a list of third countries from  which  Member  States  authorise  imports  of  live
      equidae and semen, ova and embryos of the equine species. Õ

                                            ê 96/540/EC Recital 2 (adapted)

   3) In Annex D Ö to Õ Directive 92/65/EEC the Council laid down sanitary conditions for the collection, processing Ö , Õ storage and  transport
      of ova and embryos and health conditions Ö applicable Õ to the donor mares. However, for imports into the Community of ova and  embryos  of
      the equine species it is necessary to require additional guarantees in  particular  as  regards  the  official  veterinary  supervision  of
      collection teams.

                                            ê 96/540/EC Recital 3 (adapted)

   4) The animal health requirements for imports of ova and embryos of the equine species Ö should Õ take into account the  different  conditions
      under which ova and embryos have been collected, processed and stored or embryos have been produced.

                                            ê 96/540/EC Recital 4 (adapted)

   5) Certain infectious diseases of equidae are transmissible via ova and embryos. Therefore  specific  animal  health  tests  are  required  to
      identify such diseases. Ö Those tests Õ must be carried out prior to the collection of ova and embryos.

                                            ê 96/540/EC Recital 5 (adapted)

   6) 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 96/540/EC

HAS ADOPTED THIS DECISION:

                                            ê 96/540/EC (adapted)

                                                                    Article 1

Member States shall authorise imports of ova and embryos of the equine species complying with  the  requirements  set  Ö out Õ  in  the  specimen
animal health certificate in Annex Ö I Õ and accompanied by such a certificate duly completed.

                                            ê 

                                                                    Article 2

Decision 96/540/EC 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 III.

                                            ê 96/540/EC (adapted)

                                                                    Article 3

The Decision is addressed to Ö the Õ Member States.

Done at Brussels, […]

      For the Commission
      […]
      Member of the Commission

                                            ê 96/540/EC (adapted)
                                            è1 2000/284/EC Art. 2
                                            Corrigendum, OJ L 212, 23.8.2000, p. 11

                                                                   ANNEX Ö I Õ

                                                                      [pic]

       13.  I, the undersigned official veterinarian of .............................. (insert name  of  exporting  country)  have  read  and  am
       familiar with Council Directive 92/65/EEC as amended and certify that:

13.1.1.     Ö the Õ ova/embryos (1) described above were collected, processed and stored by a  team  approved  by  the  competent  authority  for
       collecting, processing and storing of equine ova or embryos and placed under  the  general  supervision  and  authority  of  the  official
       veterinarian who inspects the team, including associated laboratory facilities, at least once a year to consider and to verify all matters
       relating to the approval and supervision;

13.1.2.     the collection, processing, and storage of these ova/embryos (1) was carried out, either by a team  veterinarian  (1)  or  under  his
       direction by one or more technicians (1) who are competently trained by the team veterinarian in the methods and techniques of hygiene;

13.1.3.     Ö the Õ ova/embryos (1) were collected at a place separated from other parts of the premises or holding which is in good  repair  and
       was cleaned and disinfected prior to the collection;

13.1.4.     Ö the Õ ova/embryos (1) have been examined, processed and packed in laboratory facilities which are not situated in  a  zone  subject
       to prohibition or quarantine measures as set out in 13.2., in a section which is separated from the  section  for  storing  equipment  and
       materials used in contact with donor animals and from the area where the donor animals are handled;

13.1.5.     all records relating to the activities of the team in respect of these ova/embryos (1)  will  be  kept  for  12  months  after  their
       dispatch;

13.2. Ö the Õ ova/embryos (1) were collected from donor mares which:

13.2.1.     have been continuously resident for three months (or since entry if they were directly imported from a Member State of  the  European
       Ö Community Õ during the three months period) on the territory or in the case of regionalization in a part of the  territory  (1)  of  the
       country of export which was during that period free of:

         – African horse sickness, in accordance with Community legislation,

         – Venezuelan equine encephalomyelitis for two years,

         – glanders for six months,

         – dourine for six months;

13.2.2.     either originated from a country of export which was on the day of collection free of vesicular stomatitis for six months (1)

      or

      were tested by a virus neutralisation test for vesicular stomatitis on a blood sample taken on  ..............................  (2)  within
       30 days prior to collection, with negative result at a serum dilution of 1 in 12 (1);

13.2.3.     during the past 30 days prior to collection have been located in holdings under veterinary supervision  which  were  on  the  day  of
       collection of ova/embryos (1) until the date of their despatch (1),

      or

      in the case of frozen ova/embryos (1), until the period of 30 days mandatory  storage  at  approved  premises  elapsed  not  subject  to  a
       prohibition order for animal health reasons which laid down one of the following conditions:

13.2.3.1.   Ö if Õ not all the animals of species susceptible to the disease located on the holding  were  slaughtered,  the  prohibition  lasted
       for:

         – six months, beginning on the day on which the equidae suffering from  the  disease  Ö were Õ  slaughtered,  in  the  case  of  equine
           encephalomyelitis,

         – a period required to carry out with negative result two Coggins tests three months apart on the animals remaining after the  infected
           animals Ö were Õ slaughtered, in the case of infectious equine anaemia,

         – six months, in the case of vesicular stomatitis,

         – one month from the last recorded case, in the case of rabies,

         – 15 days from the last recorded case, in the case of anthraxÖ ; Õ

13.2.3.2.   Ö if Õ all the animals of species susceptible to the  disease  located  on  the  holding  have  been  slaughtered  and  the  premises
       disinfected, the prohibition lasted for 30 days, or 15 days in the  case  of  anthrax,  beginning  on  the  day  on  which  following  the
       destruction of the animals the disinfection of the premises was satisfactorily completed Ö ; Õ

13.2.4.     have been kept prior to the collection in holdings free from clinical signs of contagious equine metritis for 60 days Ö ; Õ

13.2.5.     have been subjected to the following health tests:

13.2.5.1.   an agargel- immunodiffusion test (Coggins test) for equine infectious anaemia carried out with negative  result  on  a  blood  sample
       taken on .............................. (2) during the past 30 days prior to collection è1(5)ç;

13.2.5.2.   a test for contagious equine metritis carried out by isolation of Taylorella equigenitalis on  two  occasions  with  an  interval  of
       seven days from genital swabs taken at least from the clitorial fossa and the clitorial sinuses on .............................  (2)  and
       on .............................. (2) and on at least one occasion  from  swabs  taken  from  the  endometrium  during  early  oestrus  on
       .............................. (2) during 30 days prior to collection of ova/embryos (1);

13.2.6.     have not been used for natural breeding during the period of 30 days prior to the collection;

13.2.7.     to the best of my knowledge and as far as I could ascertain, have not been in contact with equidae suffering from  an  infectious  or
       contagious disease during the 15 days immediately preceding the collection;

13.2.8.     have on the day of collection not shown clinical signs of an infectious or contagious disease;

13.3. the semen used for the artificial insemination of the donor mares complies the requirements of Directive 92/65/EEC (3);

13.4. the ova used for the in vivo production of embryos comply the requirements of Directive 92/65/EEC and in particular  the  requirements  set
       Ö out Õ in 13.1. and 13.2. of this certificate (1);

13.5. ova/embryos (1) were collected, processed and stored according to the requirements of Annex D Ö to Õ Directive 92/65/EEC and:

13.5.1.     they did not come into contact with other ova or embryos which do not meet the requirements of Directive 92/65/EEC Ö ; Õ

13.5.2.     products of animal origin used during their collection and processing and in the transport medium were obtained  from  sources  which
       present no risk to spread contagious or infectious diseases to equidae or other species, or they were treated prior to use  so  that  such
       risk of spread is prevented Ö ; Õ

13.5.3.     the zona pellucida was examined after washing over its entire surface area under a magnification of at least  50  and  proved  to  be
       intact and free from adherent material Ö ; Õ

13.5.4.     ova/embryos (1) were frozen in alcohol (1) or fresh liquid nitrogen (1) without delay Ö ; Õ (1)

13.6. ova/embryos (1) have been stored at a suitable temperature in approved premises  by  use  of  cryogenic  agent  which  had  not  been  used
       previously for other products of animal origin Ö ; Õ

13.7. ova/embryos (1) will be dispatched in containers according to Annex D of Directive 92/65/EEC Ö . Õ

Done at ..............................., on ...............................

                                                                                                         (Signature of the official veterinarian)

Stamp (4)

                                                                                                        (Name and qualification in block letters)

_______________

(1)   Delete as appropriate.

(2)   Insert date.

(3)   Does not apply to ova.

(4)   The signature and the stamp must be different in colour to that of the printing.

è1 (5)      The agargel-immunodiffusion test (Coggins test) for equine infectious anaemia is not required for donor equidae  which  have  resided
       in Iceland from birth and it is certified that Iceland is officially free of equine infectious anaemia. ç

                                                                  _____________

                                            é

                                                                     ANNEX II

                                                       Repealed Decision and its amendment

|Commission Decision 96/540/EC                                      |                                                                   |
|(OJ L 230, 11.9.1996, p. 28)                                       |                                                                   |
|Commission Decision 2000/284/EC                                          |Only as regards, on the one hand, Article 2(2) and, on|
|(OJ L 94, 14.4.2000, p. 35)                                              |the other hand, the reference made in Article 2(3) to |
|                                                                         |Article 2(2)                                          |

                                                                  _____________

                                                                    ANNEX III

                                                                Correlation Table

|Decision 96/540/EC                                                 |This Decision                                                      |
|Article 1                                                          |Article 1                                                          |
|Article 2                                                          |________                                                           |
|________                                                           |Article 2                                                          |
|Article 3                                                          |Article 3                                                          |
|Annex                                                              |Annex I                                                            |
|________                                                           |Annex II                                                           |
|________                                                           |Annex III                                                          |

                                                                  _____________

                                                             -----------------------
[1]   OJ L 268, 14.9.1992, p. 54. Ö Directive as last amended by Directive 2004/68/EC (OJ L 139, 30.4.2004, p. 320). Õ
[2]   OJ L 230, 11.9.1996, p. 28. Decision as amended by Decision 2000/284/EC (OJ L 94, 14.4.2000, p. 35).
[3]   See Annex II.
[4]   OJ L 73, 11.3.2004, p. 1.