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

28. 3. 89                                 Official Journal of the European Communities                                            No C 76/1
                                                                 II
                                                         (Preparatory Acts)
                                                    COMMISSION
             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
                                                        COM(88) 785 final
                                       (Submitted by the Commission on 11 January 1989)
                                                            (89/C 76/01)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                             whereas there is nevertheless a certain risk of the spread of
                                                                     such disease in the case of trade in e m b r y o s ;
Having regard to the Treaty establishing the European
Economic Community and in particular Article 43 thereof,
                                                                     W h e r e a s , in the context of the C o m m u n i t y policy of
                                                                     h a r m o n i z i n g national animal health provisions governing
Having regard to the proposal from the Commission,                   i n t r a - C o m m u n i t y trade in animals and animal p r o d u c t s , it
                                                                     is n o w necessary to create a h a r m o n i z e d system for intra-
                                                                     C o m m u n i t y trade and i m p o r t s into the C o m m u n i t y of
Having regard to the opinion of the European Parliament,             embryos of bovine a n i m a l s ;
Having regard to the opinion of the Economic and Social              W h e r e a s , in the context of i n t r a - C o m m u n i t y trade in
Committee,                                                           e m b r y o s , the M e m b e r State where the e m b r y o s are
                                                                     collected should be under an obligation to ensure that such
                                                                     e m b r y o s have been collected and processed by a p p r o v e d
Whereas the use of embryos of domestic animals of the
                                                                     and supervised e m b r y o collection t e a m s , have been
bovine species is part of an efficient breeding policy which
                                                                     obtained from animals w h o s e health status is such as to
leads to better productivity and increases margins in this
                                                                     ensure that the risk of spread of animal disease is
sector; whereas, in addition, the free movement of such
                                                                     eliminated, have been collected, processed, stored and
embryos should encourage a rational development by
                                                                      transported in accordance with the rules which preserve
taking into account the use of optimum production factors;
                                                                      their health status and are accompanied during t r a n s p o r t to
                                                                     the country of destination by an animal health certificate in
Whereas the provisions relating to animal health problems             order to ensure that this obligation has been fulfilled;
in intra-Community trade in bovine animals and swine
appear in Council Directive 64/432/EEC ( ! ), as last
amended by Directive 87/489/EEC ( 2 ); whereas, in                    Whereas the difference in the policies pursued within the
addition, Council Directive 72/462/EEC (3), as last                   C o m m u n i t y with regard to vaccination against foot-and-
amended by Directive 87/64/EEC (4), contains provisions               m o u t h disease justifies the m a i n t e n a n c e of derogations,
relating to veterinary inspection problems upon impor-                limited in time, authorizing the r e q u i r e m e n t by the
tation of bovine animals and swine from third countries;              M e m b e r States of additional protection against t h a t
                                                                      disease;
Whereas the abovementioned provisions have ensured,
with regard to intra-Community trade and imports into the             Whereas a list of third countries should be d r a w n u p ,
Community of bovine animals and swine from third                      taking into account animal health criteria, from which
countries, that the country of provenance guarantees that             e m b r y o s may be imported into the C o m m u n i t y ; whereas,
 animal health criteria have been fulfilled, so that the risk of      w i t h o u t prejudice to such a list, the M e m b e r States should
animal disease spreading has been virtually eliminated;               authorize importation of embryos only by embryo
                                                                      collection teams which reach certain standards and which
                                                                      are officially supervised; whereas, in addition, in respect of
 (!) OJ No 121, 29. 7. 1964, p. 1977/64.                              countries on that list, specific animal health conditions
 (2) OJ No L 280, 3. 10. 1987, p. 28.                                 should be laid down according to circumstances; whereas,
 (3) OJ No L 302, 31. 12. 1972, p. 28.                                in order to verify compliance with those standards, on-the-
 (4) OJ No L 34, 5. 2. 1987, p. 52.                                   spot checks may be carried out;
 ---pagebreak--- No C 76/2                               Official Journal of the European Communities                                      28. 3. 89
Whereas, in order to prevent the transmission of certain               thority to carry out the diagnostic tests laid down in this
contagious diseases, import controls should be carried out             Regulation.
when a consignment of embryos arrives on the territory of
the Community, except in the case of external transit;
                                                                                               CHAPTER II
Whereas, in the case of internal transit, the measures to be                      Rules for intra-Community trade
taken by Member States after such control must be defined;
                                                                                                 Article 3
Whereas the Commission should be entrusted with taking
certain measures for implementing this Regulation;                 Only embryos meeting the following conditions shall be
whereas, to that end, procedures should be established for         sent from the territory of a Member State to the territory of
cooperation between the Commission and the Member                  another Member State:
States;
                                                                   (a) They must have been conceived as a result of artificial
                                                                       insemination or in vitro fertilization with semen from a
Whereas this Regulation does not affect trade in embryos
                                                                       donor sire standing at a semen collection centre as
produced before the date on which the Member States must
                                                                       defined in Article 2(b) of Council Directive 88/407/
comply with it,                                                        EEC ( ' ) o r a s a result of natural service by bulls whose
                                                                       health status complies with Annex B to that Directive.
HAS ADOPTED THIS REGULATION:
                                                                   (b) They must have been collected from domestic animals
                                                                       of the bovine species whose health status complies with
                                                                       Annex B.
                          CHAPTER I
                                                                   (c) They must have been collected, processed and stored by
                      General provisions
                                                                       an embryo collection team approved in accordance with
                           Article 1                                   Article 5(1).
                                                                   (d) They must have been collected, processed and stored by
This Regulation defines the animal health conditions
                                                                       the embryo collection team in accordance with
governing intra-Community trade in and importation from
                                                                       Annex A.
third countries of fresh and frozen embryos of domestic
animals of the bovine species.                                     (e) They must be accompanied, during transport to the
                                                                       Member State of destination, by an animal health
                                                                       certificate complying with Article 6(1).
                            Article 2
For the purposes of this Regulation, the definitions                                              Article 4
contained in Article 2 of Directive 64/432/EEC and
                                                                   1. Member States which do not practise vaccination
Article 2 of Directive 72/462/EEC shall apply as necessary.
                                                                   against foot-and-mouth disease may, until 31 Decem-
                                                                   ber 1991:
Moreover:
                                                                   — prohibit the introduction into their territory of fresh
 (a) 'embryo' means the initial stage of development of a              embryos from Member States where vaccination is
     domestic animal of the bovine species while it is capable         practised, and
     of being transferred to a recipient dam;
                                                                   — require in the case of introduction of frozen embryos
 (b) 'embryo collection team' means an officially approved             from Member States where vaccination is practised that
     group of technicians supervised by a team veterinarian            a sample of flushing fluids from each collection
     competent to perform the collection, processing and               intended for trade may be subjected to a virus isolation
     storage of embryos according to the conditions laid               test for foot and mouth in an approved diagnostic
     down in Annex A;                                                  laboratory in the Member State of destination or in an
                                                                       approved diagnostic laboratory specified by that
 (c) 'team veterinarian' means the veterinarian responsible            Member State. If the result is positive, admission of the
     for the supervision of an embryo collection team in               embryos may be refused.
     compliance with the conditions laid down in Annex A;
                                                                   2. Before 1 January 1991 the Council shall review this
 (d) 'consignment of embryos' means a quantity of embryos          Article on the basis of a Commission report accompanied
     from a single donor covered by a single certificate;          by proposals.
 (e) 'country of collection' means the Member State or third                                      Article 5
     country in which embryos are collected and from which
     they are sent to a Member State;                              1. Approval of an embryo collection team as provided for
                                                                   in Article 3(c) shall be granted only where the provisions of
 (f) 'approved diagnostic laboratory' means a laboratory
     situated in the territory of a Member State or third
     country designated by the competent veterinary au-            (!) OJ No L 194, 22. 7. 1988, p. 10.
 ---pagebreak--- 28. 3. 89                              Official Journal of the European Communities                                 No C 76/3
Annex A are observed and where the embryo collection              2.   The certificate must:
team is able to satisfy the other provisions of this
Regulation.                                                       (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
The approval of the team shall be renewed whenever the                a Member State concerned in the movement of the
team veterinarian is replaced or whenever any major                   embryos may require a translation into one of the
changes are made in its organisation or the laboratories or           official languages of that Member State;
equipment at its disposal.
                                                                  (b) be made out to a single consignee;
The official veterinarian shall supervise the observance of       (c) accompany the consignment to its destination in its
the provision outlined above. Approval shall be withdrawn             original form.
where one or more of the provisions is no longer observed.
2. All approved embryo collection teams shall be                                           CHAPTER III
registered by the competent authority of the Member State,                 Rules for importation from third countries
each team being given a veterinary registration number. A
list of embryo collection teams and their veterinary                                         Article 7
registration numbers shall be sent by each Member State to
the other Member States and to the Commission.                    1. Embryos shall be imported only from those third
Withdrawal of approval shall also be notified.                    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
Where a Member State considers that the provisions                with the same procedure.
governing approval are not, or are no longer, observed by
an embryo collection team in another Member State, it             2. In deciding whether a third country or parts thereof
shall inform the competent authority of that State. The           may appear on the list referred to in paragraph 1, particular
latter shall then take all necessary measures and notify the      account shall be taken of:
competent authority of the other Member States of the
decisions taken and the reasons for them.                         (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
If that other Member State fears that the necessary                   environmental health situation in that country, which
measures have not been taken or are inadequate, it shall so           might endanger animal health in the Community;
inform the Commission, which shall seek the opinion of
one or more veterinary experts. In the light of that opinion,     (b) the regularity and rapidity of the information supplied
Member States may be authorized, in accordance with the               by the third country concerning the existence of
procedure laid down in Article 18, to prohibit temporarily            contagious animal diseases in its territory, in particular
the admission of embryos collected by the team in question.           those diseases mentioned in lists A and B of the
                                                                      International Office of Epizootic Diseases;
Such authorization may be withdrawn in accordance with            (c) that country's rules on animal disease prevention and
the procedure laid down in Article 19 in the light of a fresh         control;
opinion delivered by one or more veterinary experts.
                                                                  (d) the structure of the veterinary services in the country
                                                                      and their powers;
The veterinary experts must be nationals of a Member
State other than those involved in the dispute.
                                                                  (e) the organization and implementation of measures to
                                                                      prevent and control contagious animal diseases; and
3. The detailed rules for applying this Article shall be
adopted in accordance with the procedure laid down in             (f) the guarantees which the third country can give with
Article 19.                                                           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
                           Article 6                              European Communities.
1. An animal health certificate drawn up by an official                                      Article 8
veterinarian of the Member State of collection on a form
conforming to the specimen in Annex C shall accompany             1. In accordance with the procedure laid down in
each consignment. A separate certificate shall be issued for      Article 18, a list shall be drawn up of embryo collection
each consignment of embryos.                                      teams which are authorized to collect in third countries
 ---pagebreak--- No C 76/4                                Official Journal of the European Communities                                  28. 3. 89
embryos which are destined for the Community. The list              case basis, to waive those conditions where the third
may be amended or supplemented in accordance with the               country concerned provides similar animal health guaran-
same procedure.                                                     tees.
2. In deciding whether an embryo collection team in a               3.    Article 4 shall apply mutatis  mutandis.
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                                    Article 10
third country, the powers of the veterinary services and the
supervision to which embryo collection teams are subject.            1. Importation of embryos shall take place only on
                                                                    submission of an animal health certificate drawn up and
3. An embryo collection team may appear on the list                 signed by an official veterinarian of the third country of
provided for in paragraph 1 only if:                                collection.
(a) it operates in one of the countries or parts thereof on the     The certificate must:
    list referred to in Article 7(1);
                                                                    (a) be drawn up in one of the official languages of the
(b) it fulfils the requirements of Annex A;                             Community as specified by the Member State of
                                                                        destination and one of those of the Member State where
(c) it has been officially approved for exports to the                  the import control provided for in Article 11 is carried
    Community by the veterinary services of the third                   out;
    country concerned; and
                                                                    (b) be made out to a single consignee;
(d) it is subject to regular inspection by an official
    veterinarian of the third country concerned.                    (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
                            Article 9
                                                                    down in Article 18.
1. Importation of embryos from the territory of a third
country or part thereof on the list drawn up in accordance
                                                                                              Article 11
with Article 7(1) shall take place only if the embryos:
                                                                    1. Each consignment of embryos entering the customs
(a) come from donor animals which, immediately prior to
                                                                    territory of the Community shall be subjected to control
    the collection of their embryos, have remained for at
                                                                    before being put into free circulation or placed under a
    least six months in the territory of the third country
                                                                    customs procedure. The introduction of such embryos into
    concerned; and
                                                                    the Community shall be prohibited if the import control
                                                                    made on arrival reveals that:
(b) comply with the animal health requirements adopted in
    accordance with the procedure laid down in Article 19
                                                                    — the embryos do not come from the territory of a third
    for imports of embryos from that country.
                                                                        country or parts thereof on the list drawn up in
                                                                        accordance with Article 7(1),
In adopting the requirements referred to in the preceding
subparagraph, consideration shall be given to:                      — the embryos were not collected by an embryo collection
                                                                        team on the list provided for in Article 8(1),
(a) the health situation in the area surrounding the place of
    embryo collection, with particular reference to the             — the embryos come from the territory of a third country
    diseases appearing on list A of the International Office            or parts thereof from which imports are prohibited in
    of Epizootic Diseases;                                              accordance with Article 14(2),
(b) the state of health of the herd concerned in the embryo         — the animal health certificate which accompanies the
    collection, including testing requirements;                         embryos is not in conformity with the conditions laid
                                                                        down in Article 10 and fixed pursuant thereto.
(c) the state of health of the donor animal and testing
    requirements;                                                   This paragraph shall not apply to consignments of embryos
                                                                    which arrive in the customs territory of the Community
(d) processing requirements in relation to embryos.                 and are placed under a customs transit procedure for
                                                                    consignment to a destination situated outside the said
2. The reference basis for fixing animal health conditions          territory.
in accordance with paragraph (1) for bovine tuberculosis
and brucellosis shall be the standards laid down in Annex A         However, it shall be applicable where customs transit is
to Directive 64/432/EEC. It may be decided, in accordance           waived during transport through the territory of the
with the procedure laid dqwn in Article 19, on a case-by-           Community.
 ---pagebreak---  28. 3. 89                               Official Journal of the European Communities                                   No C 76/5
 2. Necessary measures may be taken by a Member State               down in Article 20. Resumption of importation from the
 including storage in quarantine, in order to obtain definite       third country concerned shall be authorized in accordance
 proof in cases where embryos are suspected of being                with the same procedure.
 contaminated by pathogenic organisms.
 3. If the importation of embryos has been prohibited on
                                                                                               Article 15
 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                 1. Veterinary experts from the Commission may, in co-
 veterinary authority of the Member State of destination            operation with the competent authorities of the Member
 may order them to be destroyed.                                    States or third countries, make on-the-spot checks insofar
                                                                    as that is indispensable for ensuring uniform application of
                                                                    this Regulation.
                           Article 12
                                                                    The country of collection within whose territory a check is
 Each consignment of embryos authorized for importation             being carried out shall give all necessary assistance to the
 into the Community by a Member State on the basis of the           experts in carrying out their duties. The Commission shall
 control referred to in Article 11(1) must, when sent to the        inform the country of collection concerned of the results of
 territory of another Member State, be accompanied by the           the investigation.
 original certificate or an authenticated copy thereof,
 suitably endorsed, in either case, by the competent                The country of collection concerned shall take any
 authority which was responsible for the examination                measures which may prove necessary to take account of the
 carried out in accordance with Article 11.                         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
                           Article 13                               Committee, have recourse to the provisions of the fourth
                                                                    subparagraph of Article 5(2) or to the provisions of
 If it is decided to take destruction measures pursuant to          Article 7(1) in the case of third countries.
 Article 11(3), any costs incurred shall be chargeable to the
 consignor, the consignee or their agent, without compens-
 ation by the Member States.                                        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
                         CHAPTER IV                                 procedure set out in Article 19.
           Rules on safeguard and control measures
                          Article 14
                                                                                             CHAPTER V
 1. If, in a third country, a contagious animal disease                                    Final provisions
which can be carried by embryos and is liable to endanger
the health of the livestock in a Member State breaks out or                                    Article 16
spreads or if any other reason connected with animal health
so justifies, the Member State of destination concerned
                                                                   Amendments to the Annexes to this Regulation, in
shall prohibit the importation of those embryos whether
                                                                   particular to adapt them to advances in technology, shall be
imported directly or indirectly through another Member
                                                                   decided in accordance with the procedure set out in
State, either from the whole of the third country or from
                                                                   Article 19.
part of its territory.
2. Measures taken by Member States pursuant to
paragraph 1 and the repeal of such measures must be                                           Article 17
communicated immediately to the other Member States
and the Commission together with the reasons for such              The Commission shall be assisted by the Standing
measures.                                                          Veterinary Committee (hereafter called 'the Committee')
                                                                   set up by the Council Decision of 15 October 1968.
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 coordinate them with measures
adopted by other Member States, or that they must be                                          Article 18
repealed.
                                                                   1. Where reference is made to the procedure laid down in
3. If the situation envisaged in paragraph 1 arises and if it      this Article, the following provisions shall apply.
is necessary that other Member States also apply the
measures taken under that paragraph, amended where                 2. The representative of the Commission shall submit to
necessary in accordance with paragraph 2, appropriate              the Committee a draft of the measures to be taken. The
steps shall be taken in accordance with the procedure laid         Committee shajl deliver i,ts opinion on the draft within, a
 ---pagebreak--- No C 76/6                                   Official Journal of the European Communities                                     28. 3. 89
time limit which the chairman may lay down according to                   2. The representative of the Commission shall submit to
the urgency of the matter, if necessary by taking a vote.                 the Committee a draft of the measures to be taken. The
                                                                          Committee shall deliver its opinion on the draft within a
3. The opinion shall be recorded in the minutes; in                       time limit which the chairman may lay down according to
addition, each Member State shall have the right to ask to                the urgency of the matter. The opinion shall be delivered by
have its position recorded in the minutes.                                the majority laid down in Article 148 (2) of the Treaty in the
4. The Commission shall take the utmost account of the                    case of decisions which the Council is required to adopt on
opinion delivered by the Committee. It shall inform the                   a proposal from the Commission. The votes of the
Committee of the manner in which its opinion has been                     representatives of the Member States within the Committee
taken into account.                                                       shall be weighted in the manner set out in that Article. The
                                                                          chairman shall not vote.
                            Article 19                                    3. The Commission shall adopt the measures envisaged if
1. Where reference is made to the procedure laid down in                  they are in accordance with the opinion of the Committee.
this Article, the following provisions shall apply.
                                                                          4. If the measures envisaged are not in accordance with
2. The representative of the Commission shall submit to                   the opinion of the Committee, or if no opinion is delivered,
the Committee a draft of the measures to be taken. The                    the Commission shall, without delay, submit to the Council
Committee shall deliver its opinion on the draft within a                 a proposal relating to the measures to be taken. The
time limit which the chairman may lay down according to                   Council shall act by a qualified majority.
the urgency of the matter. The opinion shall be delivered by
the majority laid down in Article 148(2) of the Treaty in the             If, on expiry of a period of fifteen days from the date on
case of decisions which the Council is required to adopt on               which the matter was referred to it, the Council has not
a proposal from the Commission. The votes of the                          acted, the proposed measures shall be adopted by the
representatives of the Member States within the Committee                 Commission.
shall be weighted in the manner set out in that Article. The
chairman shall not vote.                                                                             Article 21
3. The Commission shall adopt the measures envisaged if                   1. This Regulation shall not apply to embryos collected
they are in accordance with the opinion of the Committee.                 and processed in a Member State before 1 July 1989.
4. If the measures envisaged are not in accordance with                   2. Until the date of entry into force of the decisions
the opinion of the Committee, or if no opinion is delivered,              adopted pursuant to Articles 7, 8 and 9, the Member States
the Commission shall, without delay, submit to the Council                shall not apply to imports of embryos from third countries
a proposal relating to the measures to be taken. The                      more favourable conditions than those resulting from the
Council shall act by a qualified majority.                                application of Chapter II of this Regulation.
If, on expiry of a period of three months from the date on
which the matter was referred to it, the Council has not                                             Article 22
acted, the proposed measures shall be adopted by the
Commission.                                                               This Regulation shall enter into force on the 30th day
                                                                          following its publication in the Official Journal of the
                            Article 20                                    European Communities.
1. Where reference is made to the procedure laid down in                  This Regulation shall be binding in its entirety and directly
this Article, the following provisions shall apply.                       applicable to all Member States.
                                                                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 the 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;
 ---pagebreak--- 28. 3. 89                                Official Journal of the European Communities                                         No C 76/7
          (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 accommodating equipment and materials used in contact with the donor animals,
              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 its 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 its 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 animals.
               (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 10 km radius in which during the previous 30 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.
 ---pagebreak--- No C 7 6 / 8                             Official Journal of the European Communities                                         28. 3. 89
                (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 10 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 its 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.
                (1) 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.
                (m)In accordance with the procedure laid down in Article 19 a protocol shall be drawn up concerning
                    authorized flushing and washing fluids, washing techniques and if necessary, enzymatic treatments
                    together with authorized 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 transit area for 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.
                (d) The storage premises shall be subject to inspection by 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.
                                                                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/
                        infectious 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 10 km radius in which during the previous 30 days
                        there has been no case of foot-and-mouth disease,
                    — in which animals have not been vaccinated against foot-and-mouth disease within 30 days
                        immediately prior to embryo recovery;
                (b) shall show no clinical signs of disease.
 ---pagebreak--- 28. 3. 89                                   Official Journal of the European Communities                                     No C 76/9
                                                                 ANNEX C
                                                        EUROPEAN COMMUNITY
   1. Consignor (name and full address)                                                      ANIMAL HEALTH CERTIFICATE
                                                                                       No                                  ORIGINAL
                                                                                      2. Member State of Collection
   3. Consignee (name and full address)                                               4. Competent authority
                                                                                      5. Competent local authority
 NOTES
  (a) A separate certificate shall be issued for each consignment of embryos.
  (b) The original of this certificate shall accompany the consignment to the         6. Address of premises where embryos have been
      place of destination.                                                              collected
   7. Place of loading
                                                                                      8. Name and address of embryo collection team
   9. Means of transport
  10. Place and Member State of destination                                          11. Registration number of embryo collection team
  12. Number and code-marks of embryo containers
  13. Identification of consignment
  (a) Number of             (b) Date(s) of collection         (c) Identification of donor dam and donor sire    (d) Breed
      embryos
  14. I, the undersigned official veterinarian, certify that:
      (a) the embryos described above where collected, processed and stored under conditions which comply with the standards laid
           down in Regulation ...
      (b) the embryos described above were sent to the place of loading in sealed containers under conditions which comply with
           Regulation ...
      (c) (Additional certification pursuant to Article 4 of Regulation ...)
 Done at:                                                     on:
                                                              Signature:
                                                              Name in block letters:
                                                              Qualification: