CELEX: 51988PC0785
Language: en
Date: 1989-02-07
Title: Proposal for a COUNCIL REGULATION (EEC) on animal health conditions governing intra-Community trade in and importation from third countries of embryos of domestic animals of the bovine species (presented by the Commission)

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COLLECTION RELIEE DES
DOCUMENTS "COM"
COM (88) 785
Vol. 1988/0255
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Conformément au règlement (CEE, Euratom) n° 354/83 du Conseil du 1er février 1983 concernant
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In accordance with Council Regulation (EEC, Euratom) No 354/83 of 1 February 1983 concerning
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1983 über die Freigabe der historischen Archive der Europäischen Wirtschaftsgemeinschaft und
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 ---pagebreak--- COMMISSION OF THE EUROPEAN COMMUNITIES
                                                     COM(88 ) 785   final
                                                     Brussels , 7 February 1989
 REVISED VERSION
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                              Proposal for a
                       COUNCIL REGULATION ( EEC )
                on animal health conditions governing
  intra-Community trade in and importation from third countries of
         embryos of domestic animals of the bovine species
                        ( presented by the Commission )
 ---pagebreak---                                       jet 3 -
                                     EXPLANTORY NOTE
Rules relative to problems of animal health concerning intra-Community trade
in bovine animals and swine are already in force through Council Directive
64 / 432 / EEC as amended and Directive 72 / 462 / EEC applies in relation to problems
of animal health when bovine animals and swine are imported from third
countries into the Community .      By means of these Directives it has been
possible to ensure that , in trading bovine animals and swine between Member
States and into Member States from third countries , animal health criteria
have been certified by the exporting country so that the risk of spreading
animal disease is virtually eliminated .
When semen and embryos are traded a somewhat lesser risk of spreading animal
disease is involved .      Proposals concerning trade in semen of bovine animals
have recently been adopted by the Council .
The risks of spreading animal disease by way of embryos are well recognised .
However , the embryo should be considered as an entity and when the zona
pellucida is wholly intact and certain washing procedures and enzymatic
treatments are applied the danger of residual contamination is greatly
lessened .
Member States currently apply national rules when embryos are traded and these
vary considerably from one to the other .          In the context therefore of animal
trading rules and to promote stability in the Community in respect of animal
disease it is considered necessary to continue the Community policy of
harmonisation of Member States' national rules .
The basic element of the Commission proposal is that the Member State in which
embryos are collected should be under an obligation to see that the embryos
have been collected and processed by approved and supervised embryo collection
teams and have been obtained from animals whose health status is such as to
ensure that the risk of spread of animal disease is eliminated .          Furthermore ,
the embryos should have been collected , processed , stored and transported in
accordance with rules which preserve their health status and are accompanied
during transport to the country of destination by an animal health
certificate . The proposal also contains certain derogatory provisions in
respect of foot- and-mouth disease which are limited in time and subject to
review .
 ---pagebreak---                                          4
For trade from third countries it is proposed that a list of suitable
countries should be adopted and that specific decisions should follow on a
case - by- case basis .
Because of the facility by which stocks of embryos may be stored for long
periods a phasing-in system is proposed to enable a smooth transition to
Community measures .
The Commission in line with it 's fundamental viewpoint has retained the
consultative committee procedure with a view to , establishing the list of third
countries , the embryo collection teams of those countries which are authorised
to export to the Community and also the model of the certificate which should
be presented by the authorities of those countries .
However , in order not to disturb existing rules in safeguard matters on
temporary prohibitions in trade and the laying down of import conditions the
Commission has for these tasks chosen the regulatory committee procedure .
This choice is without prejudice to the Commission 's preference for the
consultative committee formula .
 ---pagebreak---                                                 5
                                   Proposal for a
                             COUNCIL REGULATION ( EEC )
                          on animal health conditions governing
          intra-Community trade in and importation from third countries of
                  embryos of domestic animals       of the bovine species
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 ( 1 ),
Having regard to the Opinion of the European Parliament ( 2 ),
Having regard to the Opinion of the Economic and Social
Committee ( 3 ),
Whereas the use of embryos of domestic animals of the bovine species is part
of an efficient breeding policy which leads to better productivity and
increased margins in this sector ; whereas, in addition, the free movement of
such embryos should encourage a rational development by taking into account
the use of optimum production factors ;
Whereas the provisions relating to animal health problems in intra-Community
trade in bovine animals and swine appear in Council Directive 64/432/EEC (4), as Last
amended by Directive 87 / 489 / EEC ( 5 ) ; whereas in addition , Council Directive 72/462/EEC
( 6 ), as last amended by Directive 87 / 64 / EEC(7 ) contains provisions relating to
veterinary inspection problems upon importation of bovine animals and swine
from third countries ;
(1)
(2)
(3)
( 4 ) OJ No    121 , 29.07.1964 , P· 1977 / 64
( 5 ) OJ No L  280 , 03.10.1987 , P· 28
( 6 ) OJ No L  302 , 31.12.1972 , P. 28 .
( 7 ) OJ No L    34 , 05.02.1987 , P. 52 .
 ---pagebreak---                                                   6
Whereas the above-mentioned provisions have ensured , with regard to
 intra-Community trade and imports into the Community of bovine animals and
 swine from third countries , that the country of provenance guarantees that
animal health criteria have been fulfilled , so that the risk of animal disease
spreading has been virtually eliminated ; whereas there is nevertheless a
certain risk of the spread of such disease in the case of trade in embryos ;
Whereas in the context of the Community policy of harmonizing national animal
health provisions governing intra-Community trade in animals and animal
products , it is now necessary to create a harmonized system for
 intra-Community trade and imports into the Community of embryos of bovine
animals ;
Whereas in the context of intra-Community trade in embryos the Member State
where the embryos are collected should be under an obligation to ensure that
such embryos have been collected and processed by approved and supervised
embryo collection teams , have been obtained from animals whose health status
 is such as to ensure that the risk of spread of animal disease is eliminated ,
have been collected , processed , stored and transported in accordance with the
rules which preserve their health status and are accompanied during transport
to the country of destination by an animal health certificate in order to
ensure that this obligation has been fulfilled ;
Whereas the difference in the policies pursued within the Community with
regard to vaccination against foot - and -mouth disease justifies the maintenance
of derogations , limited in time , authorizing the requirement by the Member
States of additional protection against that disease ;
Whereas a List of third countries should be drawn up, taking into account animal health criteria, from wrpc
embryos may be imported into the Community; whereas without prejudice to such a list the Member States
should authorize importation of embryos only by embryo collection teams which reach
certain standards and which are officially supervised ; whereas , in addition ,
in respect of countries on that list , specific animal health conditions should
be laid down according to circumstances ; whereas , in order to verify
compliance with those standards , on - the - spot checks may be carried out ;
 ---pagebreak---                                             7
Whereas in order to prevent the transmission of certain contagious diseases ,
import controls should be carried out when a consignment of embryos arrives on
the territory of the Community , except in the case of external transit ;
Whereas /- in the case of internal transit , the measures to be taken by Member
States after such control must be defined ;
Whereas the Commission should be entrusted with taking certain measures for
implementing this Regulation ; whereas to that end procedures should be
established for co-operation between the Commission and the Member States ;
Whereas this Regulation does not affect trade in embryos produced before the
date on which the Member States must comply with it ,
HAS ADOPTED THIS REGULATION :
                                        CHAPTER I
                                   GENERAL PROVISIONS
                                        Article 1
This Regulation defines the animal health conditions governing intra-Community
trade in and importation from third countries of fresh and frozen embryos of
domestic animals of the bovine species .
                                        Article 2
For the purposes of this Regulation , the definitions contained in Article 2 of
Directive 64 / 432 / EEC and Article 2 of Directive 72 / 462 / EEC shall apply as
necessary .
Moreover :
( a) " embryo” means the initial stage of development of a domestic animal of
     the bovine species while it is capable of being transferred to a
     recipient dam,
 ---pagebreak---                                               8
  ( b ) " embryo collection team" means an officially apprpoved group of
        technicians supervised by a team veterinarian competent to perform the
        collection , processing and storage of embryos according to the conditions
        laid down in Annex A;
 ( c ) " team veterinarian " means the veterinarian responsible for the supervision
        of an embryo collection team in compliance with the conditions laid down
        in Annex A ;
 ( d ) " consignment of embryos " means a quantity of embryos from a single donor
        covered by a single certificate ;
 ( e ) " country of collection " means the Member State or third country in which
        embryos are collected and from which they are sent to a Member State ;
 ( f ) " approved diagnostic laboratory" means a laboratory situated in the
        territory of a Member State or third country designated by the competent
        veterinary authority to carry out the diagnostic tests laid down in this
        Regulation .
                                         CHAPTER II
                               RULES FOR INTRA-COMMUNITY TRADE
                                          Article 3
Only embryos meeting the following conditions shall be sent from the territory
of a Member State to the territory of another Member State :
 ( a ) They must have been conceived as a result of artificial insemination or in
        vitro fertilisation with semen from a donor sire standing at a semen
        collection centre as defined in Article 2(b ) of Council Directive 88/407 / EEC or as
        a result of natural service by bulls whose health status complies with
        Annex B to   that Directive .
 ( b ) They must have been collected from domestic animals of the bovine species
        whose health status complies with Annex B.
 ( c ) They must have been collected , processed and stored by an embryo
        collection team approved in accordance with Article 5(1 ).
 ( d ) They must have been collected , processed and stored by the embryo
        collection team in accordance with Annex A.
 ( e ) They must be accompanied , during transport to the Member State of
        destination , by an animal health certificate complying with Article 6 ( 1 ).
80J No L 194, 22.7.1988 , p.10 .
 ---pagebreak---                                          9
                                     Artide 4
1. Member States which do not practice vaccination against foot and mouth
   disease may , until 31 December 1991 :
      prohibit the introduction into their territory of fresh embryos from
      Member States where vaccination is practised , and
      require in the case of introduction of frozen embryos from Member
      States where vaccination is practised that a sample of flushing fluids
      from each collection intended for trade may be subjected to a virus
      isolation test for foot and mouth in an approved diagnostic laboratory
      in the Member State of destination or in an approved diagnostic
      laboratory specified by that Member State . If the result is positive ,
      admission of the embryos may be refused .
2. Before 1 January    1991 the Council shall review this Article on the basis
   of a Commission report accompanied by proposals .
                                     Article 5
1. Approval of an embryo collection team as provided for in Article 3(c )
   shall be granted only where the provisions of Annex A are observed and
   where the embryo collection team is able to satisfy the other provisions
   of this Regulation .
   The approval of the team shall be renewed whenever the team veterinarian
   is replaced or whenever any major changes are made in its organisation or
   the laboratories or equipment at its disposal .
   The official veterinarian shall supervise the observance of the provisions
   outlined above .   Approval shall be withdrawn where one or more of the
   provisions is no longer observed .
2. All approved embryo collection teams shall be registered by the competent
   authority of the Member State , each team being given a veterinary
   registration number .   A list of embryo collection teams and their
   veterinary registration numbers shall be sent by each Member State to the
   other Member States and to the Commission .   Withdrawal of approval shall
   also be notified .
 ---pagebreak---                                          10
    Where a Member State considers that the provisions governing approval are
   not , or are no longer , observed by an embryo collection team in another
   Member State , it shall inform the competent authority of that State .    The
   latter shall then take all necessary measures and notify the competent
   authority of the other Member State of the decisions taken and the reasons
   for them .
   If that other Member State fears that the necessary measures have not been
   taken or are inadequate , it shall so inform the Commission , which shall
   seek the opinion of one or more veterinary experts .    In the light of that
   opinion , Member States may be authorized , in accordance with the procedure
   laid down in Article 18 , to prohibit temporarily the admission of embryos
   collected by the team in question .
   Such authorization may be withdrawn in accordance with the procedure laid
   down in Article 19 in the light of a fresh opinion delivered by one or more
   veterinary experts .
   The veterinary experts must be nationals of a Member State other than
   those involved in the dispute .
3. The detailed rules for applying this Article shall be adopted in
   accordance with the procedure laid down in Article 19 .
                                     Article 6
1. An animal health certificate drawn up by an official veterinarian of the
   Member State of collection on a form conforming to the specimen in Annex C
   shall accompany each consignment .   A separate certificate shall be issued
   for each consignment of embryos .
2. The    certificate must :
   ( a ) be drawn up in one of the official languages of the Community as
         specified by the Member State of collection. Where necessary, the
         competent authority of a Member State concerned in the movement of the
         embryos may require a translation into one of the official languages
         of that Member State ;
   ( b ) be made out to a single consignée ;
   ( c ) accompany the consignment to its destination in its original form .
 ---pagebreak---                                           11
                                     CHAPTER III
                     RULES FOR IMPORTATION . FROM THIRD COUNTRIES
                                      Article 7
1. Embryos shall be imported only from those third countries or parts thereof
   which appear on a list drawn up in accordance with the procedure laid down
   in Article 18 . That list may be supplemented or amended in accordance with
   the same procedure .           -
2. In deciding whether a third country or parts thereof may appear on the
   list referred to in paragraph 1 , particular account shall be taken of :
   ( a ) the state of health of the livestock , other domestic animals and
         wildlife in the third country , with particular reference to exotic
         animal diseases , and of the environmental health situation in that
         country , which might endanger animal health in the Community ;
   ( b ) the regularity and rapidity of the information supplied by the third
         country concerning the existence of contagious animal diseases in its
         territory , in particular those diseases mentioned in lists A and B of
         the International Office of Epizootic Diseases ;
   ( c ) that country 's rules on animal disease prevention and control ;
   ( d ) the structure of the veterinary services in the country and their
         powers ;
   ( e ) the organisation and implementation of measures to prevent and control
         contagious animal diseases ; and
   ( f ) the guarantees which the third country can give with regard to
         compliance with the rules set out in this Regulation .
3. The list referred to in paragraph 1 and all amendments thereto shall be
   published in the Official Journal of the European Communities .
                                      Article 8
1. In accordance with the procedure laid down in Article 18 , a list shall be
   drawn up of embryo collection teams which are authorized to collect
   in third countries embryos which are destined' for the Community . The list
   may be amended or supplemented in accordance with the same procedure .
 ---pagebreak---                                            12
2.  In deciding whether an embryo collection team in a third country may
    appear on the list referred to in paragraph 1 , particular account shall be
    taken of the veterinary supervision of embryo collection systems in the
    third country , the powers of the veterinary services and the supervision
    to which embryo collection teams are subject .
3.  An embryo collection team may appear on the list provided for in
    paragraph 1 only if :
    ( a ) it operates in one of the countries or parts thereof on the list
          referred to in Article 7(1 );
    ( b ) it fulfils the requirements of Annex A ;
    ( c ) it has been officially approved for exports to the Community by the
          veterinary services of the third country concerned ; and
    ( d ) it is subject to regular inspection by an official veterinarian of the
          third country concerned .
                                       Article 9
1.   Importation       of embryos from the territory of a third country or part
    thereof on the list drawn up in accordance with Article 7(1 ) shall take
    place only if the embryos :
   (a ) come from donor animals which, immediately prior to the collection of
         their embryos , have remained for at least six months in the territory
         of the third country concerned , and
   (b ) comply with the animal health requirements adopted in accordance with
         the procedure laid down in Article 19 for imports of embryos from that
         country .
    In adopting the requirements referred to in the preceding      subparagraph ,
    consideration shall be given to :
    ( a ) the health situation in the area surrounding the place of embryo
          collection , with particular reference to the diseases appearing on
          list A of the International Office of Epizootic Diseases ;
    ( b ) the state of health of the herd concerned in the embryo collection ,
          including testing requirements ;
    ( c ) the state of health of the donor animal and testing requirements ;
    ( d ) processing requirements in relation to embryos .
 ---pagebreak---                                           13
2. The reference basis for fixing animal health conditions in accordance with
   paragraph ( 1 ) for bovine tuberculosis and brucellosis shall be the
   standards laid down in Annex A to Directive 64 / 432 / EEC . It may be decided ,
   in accordance with the procedure laid down in Article 19 , on a
   case - by- case basis , to waive those conditions where the third country
   concerned provides similar animal health guarantees .
3. Article 4 shall apply mutatis mutandis .
                                      Artide 10
1. Importation of embryos shall take place only on submission of an animal
   health certificate drawn up and signed by an official veterinarian of the
   third country of collection .
   The    certificate must :
   ( a ) be drawn up in one of the official languages of the Community as
         specified by the Member State of destination and one of those of the
         Member State where the import control provided for in Article 11 is
         carried out ;
   ( b ) be made out to a single consignée ;
   ( c ) accompany the embryos in the original .
2. The certificate must be on a form conforming to a specimen drawn up in
   accordance with the procedure laid down in Article 18 .
                                      Article 11
1. Each consignment of embryos entering the customs territory of the
   Community shall be subjected to control before being put into free
   circulation or placed under a customs procedure .     The introduction of such
   embryos into the Community shall be prohibited if the import control made
   on arrival reveals that :
        the embryos do not come from the territory of a third country or parts
        thereof on the list drawn up in accordance with Article 7(1 );
        the embryos were not collected by an embryo collection team on the list
        provided for in Article 8(1 );
 ---pagebreak---                                         14
        the embryos come from the territory of a third country or parts thereof
        from which imports are prohibited in accordance with Article 14(2 );
        the animal health certificate which accompanies the embryos is not in
        conformity with the conditions laid down in Article 10 and fixed
        pursuant thereto .
    This paragraph shall not apply to consignments of embryos which arrive in
    the customs territory of the Community and are placed under a customs
    transit procedure for consignment to a destination situated outside the
    said territory .
    However , it shall be applicable where customs transit is waived during
    transport through the territory of the Community .
2.  Necessary measures may be taken by a Member State including storage in
    quarantine , in order to obtain definite proof in cases where embryos are
    suspected of being contaminated by pathogenic organisms .
3.  If the importation of embryos has been prohibited on any of the grounds
    set out in paragraphs 1 and 2 and the exporting third country does not
    within thirty days authorize the return of the embryos the competent
    veterinary authority of the Member State of destination may order them to
    be destroyed .
                                    Article 12
Each consignment of embryos authorized for importation into the Community by a
Member State on the basis of the control referred to in Article 11(1 ) must ,
when sent to the territory of another Member State , be accompanied by the
original certificate or an authenticated copy thereof , suitably endorsed , in
either case , by the competent authority which was responsible for the
examination carried out in accordance with Article 11 .
                                    Article 13
If it is decided to take destruction measures pursuant to Article 11(3 ), any
costs incurred shall be chargeable to the consignor , the consignee or their
agent , without compensation by the Member States .
 ---pagebreak---                                          15
                                     CHAPTER IV
                       RULES ON SAFEGUARD AND CONTROL MEASURES
                                     Article 14
1. If , in a third country , a contagious animal disease which can be carried by
   embryos and is liable to endanger the health of the livestock in a Member
   State breaks out or spreads or if any other reason connected with animal
   health so justifies , the Member State of destination concerned shall
   prohibit the importation of those embryos whether imported directly or
   indirectly through another Member State , either from the whole of the third
   country or from part of its territory
2. Measures taken by       Member States pursuant to paragraph 1 and the
   repeal of such measures must be communicated immediately to the other Member
   States and the Commission together with the reasons for such measures .
   In accordance with the procedure laid down in Article 20 it may be decided
   that those measures must be amended , in particular in order to co-ordinate
   them with measures adopted by       other Member States , or that they must be
   repealed .
3. If the situation envisaged in paragraph 1 arises and if it is necessary that
   other Member States also apply the measures taken under that     paragraph,
   amended where necessary in accordance with paragraph 2 , appropriate steps
   shall be taken in accordance with the procedure laid down in Article 20 .
   Resumption of importation from the third country concerned shall be
   authorised in accordance with the same procedure .
                                     Article 15
1. Veterinary experts from the Commission may , in co-operation with the
   competent authorities of the Member States or third countries , make
   on-the - spot checks insofar as that is indispensable for ensuring uniform
   application of this Regulation .
 ---pagebreak---                                            16
     Tae country of collection within whose territory a check is being carried
     out shall give all necessary assistance to the experts in carrying out
     their duties . The Commission shell inform the country of collection
     concerned of the results of the investigation .
     The country of collection concerned shall take any measures which may
     prove necessary to take account of the results of the investigation . If
     the country of collection does not take those measures , the Commission
     may , after the situation has been examined by the Standing Veterinary
     Committee , have recourse to the provisions of the fourth subparagraph of
     Article 5(2 ) or to the provisions of Article 7(1 ) in the case of third
     countries .
2.   The general provisions for implementing this Article , especially as
     regards the frequency and method of carrying out the checks referred to in
     the first subparagraph of paragraph 1 , shall be laid down in accordance
     with the procedure set out in Article 19 .
                                       CHAPTER V
                                   FINAL PROVISIONS
                                      Article 16
Amendments to the Annexes to this Regulation , in particular to adapt them to
advances in technology , shall be decided in accordance with the procedure set
out in Article 19 .
                                      Article 17
The Commission shall be assisted by the Standing Veterinary Committee
( hereafter called " the Committee ") set up by the Council Decision of 15
October 1968 .
 ---pagebreak---                                       - 17 -
                                    Article 18
1. Where reference is made to the procedure laid down in this Article , the
   following provisions shall apply .
2. 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 .
3. 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 .
4. 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 .
                                    Article 19
1. Where reference is made to the procedure laid down in this Article , the
   following provisions shall apply .
2. 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 .   The opinion shall be delivered by the majority
   laid down in Article 148(2 ) of the Treaty in the case of decisions which
   the  Council is required to adopt on a proposal from the Commission .    The
   votes of the representatives of the Member States within the Committee
   shall be weighted in the manner set out in that Article .   The Chairman
   shall not vote .
3. The Commission shall adopt the measures envisaged if they are in
   accordance with the opinion of the Committee .
 ---pagebreak---                                         18
4. If the measures envisaged are not in accordance with the opinion of the
   Committee , or if no opinion is delivered , the Commission shall , without
   delay , submit to the Council a proposal relating to the   measures to be
   taken .  The Council shall act by a qualified majority .
   If , on expiry of a period of three months from the date on which the
   matter was referred to it , the Council has not acted , the proposed
   measures shall be adopted by the Commission .
                                    Article 20
1. Where reference is made to the procedure laid down in this Article , the
   following provisions shall apply .
2. 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 .   The opinion shall be delivered by the majority
   laid down in Article 148(2 ) of the Treaty in the case of decisions which
   the   Council is required to adopt on a proposal from the Commission .   The
   votes of the representatives of the Member States within the Committee
   shall be weighted in the manner set out in that Article .   The Chairman
   shall not vote .
3. The Commission shall adopt the measures envisaged if they are in
   accordance with the opinion of the Committee .
4. If the measures envisaged are not in accordance with the opinion of the
   Committee , or if no opinion is delivered , the Commission shall , without
   delay , submit to the Council a proposal relating to the   measures to be
   taken .  The Council shall act by a qualified majority .
   If , on expiry of a period of fifteen days from the date on which the
   matter was referred to it , the Council has not acted , the proposed
   measures shall be adopted by the Commission .
 ---pagebreak---                                        - 19 -
                                     Article 21
1.  This Regulation shall    not   apply     to   embryos collected and processed
    in a Member State before 1 July 1989 .
2.  Until the date of entry into force of the decisions adopted pursuant to
    Articles 7 , 8 and 9 , the Member States shall not apply to imports of
    embryos from third countries more favourable conditions than those
    resulting from the application of Chapter II of this Regulation .
                                     Article 22
This Regulation shall enter into force on the thirtieth day following its
publication in the Official Journal of the Community .
This Regulation shall be binding in its     entirety and directly applicable to
all Member States .
Done at Brussels ,
                                                    For the Council
 ---pagebreak---                                         20
                                                             ANNEX A
                                     CHAPTER I
            CONDITIONS FOR THE APPROVAL OF AN EMBRYO COLLECTION TEAM
Each embryo collection team shall :
a)  be comprised of technicians competent to perform the collection ,
    processing and storage of embryos and be suitably trained in hygienic
    procedures relevant to the control of spread of animal disease ;
b)  be placed under the direct supervision of the team veterinarian and shall
    operate under the general supervision and approval of the official
    veterinarian . The team veterinarian shall be responsible for the team 's
    training in hygienic procedures ;
c)  have at its disposal permanent or mobile laboratory facilities where
    embryos can be examined , processed and packed , consisting of at least a
    work surface , a microscope and cryogenic equipment . The equipment and
    surface materials comprising such facilities shall be easy to clean and
    disinfect ;
d)  have at its disposal in the case of a permanently sited laboratory :
       a room where embryos can be manipulated which is adjacent to but
       physically separate from the area used to handle the donor animals
       during collection ,
       a room or area equipped for cleansing and sterilising instruments and
       glassware used in embryo collection and manipulation ;
e)  have at its disposal in the case of a mobile laboratory a specially
    equipped part of the vehicle consisting of two separate sections ,
       one for the examination and manipulation of embryos which shall be a
       clean section and
       the other for accomodating equipment and materials used in contact with
       the donor animals ;
 ---pagebreak---                                        - 21
   A mobile laboratory shall always have contact with a permanently sited
    laboratory to ensure the sterilisation of its equipment and the provision
   of fluids and other products necessary for the collection and manipulation
   of embryos ;
f) keep a record of it’s activities in respect of embryo collection during
   the previous 12 months including :
   - the breed , age and identification of the donor animals concerned ,
   -    the place of collection , processing and storage of embryos collected by
        the team ,
   -    the identification of the embryos together with details of their
        destination if known ;
g) submit routine samples of flushing fluids , washing fluids , disintegrated
   embryos , non- fertilized ova etc ., resulting from it 's activities for
   official examination for bacterial and viral contamination . The procedure
   for collecting of samples , conducting such examinations , together with the
   standards to be achieved shall be decided in accordance with the procedure
   laid down in Article 19 .   If the standards laid down are not achieved the
   official approval of the team shall be withdrawn by the official
   veterinarian .
                                     CHAPTER II
            CONDITIONS RELATING TO THE COLLECTION , PROCESSING , STORAGE
         AND TRANSPORT OF EMBRYOS BY THE APPROVED EMBRYO COLLECTION TEAM
1. Collection and Processing :
   ( a)    embryos shall be collected and processed by such a team , without
           coming into contact with any other consignment of embryos not
           meeting the requirements of this Regulation ;
   (b)     embryos shall be collected in a place which is isolated from other
           parts of the premises or holding and which
           - is in good repair and easy to cleanse and disinfect , and
           - has been cleansed and disinfected before admission of the donor
             animais ;
 ---pagebreak---                                       22
( c ) embryos shall be processed ( identified , examined , washed , treated and
      placed in sterile containers ) in either a permanent laboratory
      facility or a mobile laboratory facility which at the time of
      processing is situated in the centre of an area of 10km radius in
      which during the previous thirty days there has been no case of foot
      and mouth disease ;
( d ) all implements which come into contact with the embryos or the donor
      animal during collection and processing shall be disposable or shall
      be properly disinfected or sterilized prior to use ;
( e ) products of animal origin used during collection of the embryos and in
      the transport medium shall be obtained from sources which present no
      animal health risk or shall be so treated prior to use that such risk
      is prevented ;
( f ) storage flasks and transport flasks shall be properly disinfected or
      sterilized before the commencement of each filling operation ;
( g ) the cryogenic agent used shall not have been previously used for other
      products of animal origin ;
( h ) each embryo container shall be clearly code-marked in such a way that
      the date of collection of the embryos and the breed and identification
      of the donor sire and donor dam , as well as the registration number of
      the team can be readily established ; the characteristics and form of
      this code-marking shall be established in accordance with the
      procedure laid down in Article 19 ;
( i ) each embryo shall , before freezing if appropriate , be washed by
      transfer through ten changes of embryo washing fluid .    Each wash shall
      be a 100 fold dilution of the previous wash and a sterile
      micro-pipette shall be used to transfer the embryo on each occasion ;
( j ) each embryo shall after washing be examined over it’s entire surface
      at 50 times magnification to determine that the zona pellucida is
      intact and is free from any adherent material ;
( k ) each embryo shall be placed in sterile containers which shall be
      sealed immediately ;
( l ) each embryo shall , where appropriate , be immediately frozen and stored
      in a place which is under the control of the team veterinarian and
      which is subject to inspection by the official veterinarian ;
 ---pagebreak---                                          23
   ( m ) In accordance with the procedure laid down in Article 19 a protocol
         shall be drawn up concerning authorised flushing and washing fluids ,
         washing techniques and if necessary , enzymatic treatments together
         with authorised transportation media .
2. Storage
   a ) Each embryo collection team shall ensure that the storage of embryos
        takes place in a premises approved for the purpose by the official
        veterinarian comprising at least one lockable room intended exclusively
        for embryo storage which has no direct communication with any shall bea
        of transit of persons or animals ;
   b ) The storage premises must be easy to cleanse and disinfect and must
        contain the necessary cryogenic equipment ;
   c ) The storage premises must include an office where permanent records of
        all incoming and outgoing movements of embryos shall be kept .  The
        final destination of the embryos in particular shall be specified in
        such records ;                                       m
   d ) The storage premises shall be subject to inspection      the official
        veterinarian .
3. Transport
   Embryos for intra-Community trade must be transported in sealed containers
   from the approved storage premises in such a manner as to ensure the full
   viability of the embryos on arrival at their destination .
 ---pagebreak---                                           24
                                                                   ANNEX B
                      CONDITIONS APPLYING TO DONOR ANIMALS
1. For the purposes of embryo collection donor animals shall meet the
   following requirements :
   a ) they must have spent the previous six months , at least , in a herd
       - which is officially tuberculosis free , and
       - which is officially brucellosis free or brucellosis free ;
       -  which during the previous three years has shown no evidence of
          enzootic bovine leukosis
       -  which during the previous year has shown no evidence of infectious
          bovine rhinotracheitis / inf ectious pustular vulvo-vaginitis ;
   b ) during the six months preceding embryo collection , donor cows may have
       spent succesive periods in a maximum of two different herds meeting the
       conditions set out above .
2. On the day of embryo collection the donor cow
   a ) shall be resident in a holding :
       - which has been free from foot and mouth disease for at least three
         months prior to collection of the embryos and is situated in the
         centre of an area of 10km radius in which during the previous thirty
         days there has been no case of foot and mouth disease ;
       - in which animals have not been vaccinated against foot - and -mouth
         disease within thirty days immediately prior to embryo recovery ;
   b ) shall show no clinical signs of disease .
 ---pagebreak---                                                            25                                      ANNEX     C
  EUROPEAN COMMUN I TY
I 1 . Consignor ( name and fult address )                                              ANIMAL     HEALTH   CERTIFICATE
                                                                                                                   ORIGINAL
                                                                             2 .  Member    State   of   Collection
  3 . Consignee ( name and full address )                                    4 .  COMPETENT      AUTHORITY
                                                                             5 .  COMPETENT      LOCAL   AUTHORITY
  NOTES
  o ) A separate certificate shall be i ssued for each                  I
       consignment of embryos .                                              6 . Address of premises where embryos hove
  b ) The original of this certificate shall accompany                  I         been    collected
       the consignment to the place of destination .                    I
  7 .  P I ace of  I oad ί ng
                                                                           8.    Name and address of embryo collection
  9.   Means of    transport                                                     team
  10 .   Place and Member       State of    destination                   11 . Registration number of embryo collection
  12 .   Number and code-marks of embryo containers
  13 .   Identification of consignment
  a ) number of               b ) Date(s ) of           c) Identification of donor dam                               d ) Breed
       emb ryos                   col I ect i on           and donor   sire
         I , the undersigned official veterinarian , certify that :
         a ) the embryos described above where collected , processed and stored under conditions which comply
              the standards laid down in Regulation 89 /          / EEC ;
         b ) the embryos described above were sent to the place of loading in sealed containers under
              conditions which comply with Regulation 89 /           / EEC ;
         c ) ( Additional certification pursuant to Article 4 of Regulation 89 /                     / EEC )
  Done     at :
                                                                        Signature :
                                                                        Name     in  block     letters :
                                                                        Qua I 1 1 I cat i on :