1989L0556 — EN — 01.03.1994 — 003.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COUNCILDIRECTIVE
of25September1989
on animal health conditions governing intra-Community trade in and importation from third
countriesofembryosofdomesticanimalsofthebovinespecies
(89/556/EEC)
(OJ L 302, 19.10.1989, p. 1)
Amended by:
Official Journal
No page date
►M1Council Directive 90/425/EEC of 26 June 1990 L 224 29 18.8.1990
►M2Council Directive 93/52/EEC of 24 June 1993 L 175 21 19.7.1993
►M3Commission Decision 94/113/EC of 8 February 1994 L 53 23 24.2.1994
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COUNCILDIRECTIVE
of25September1989
on animal health conditions governing intra-Community trade in
and importation from third countries of embryos of domestic
animalsofthebovinespecies
(89/556/EEC)
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
ispart of an efficient breeding policy which leadsto better productivity
and increased margins in this sector; whereas, in addition, the free
movement of such embryos should encourage a rational developmentby taking into account the use of optimum production factors;
Whereasthe provis ionsrelating to animal health problemsin intra-
Community trade in bovine animalsand s wine appear in Directive 64/
432/EEC(
4), aslas t amended by Directive 89/360/EEC(5); whereasin
addition, Directive 72/462/EEC(6), aslas t amended by Directive 89/
227/EEC(7) contains provisions relating to veterinary inspection
problemsupon importation of bovine animalsand s wine from thirdcountries;
Whereas the abovementioned provisions have ensured, with regard to
intra-Community trade and importsinto the Community of bovineanimals and swine from third countries, that the country of provenanceguaranteesthat animal health criteria have been fulfilled, s o that therisk of animal disease spreading has been virtually eliminated; whereasthere is nevertheless a certain risk of the spread of such disease in the
case of trade in embryos;
Whereasin the context of the Community policy of harmonizing
national animal health provisions governing intra-Community trade inanimals and animal products, it is now necessary to create a harmo-
nized system for intra-Community trade and imports into the
Community of embryosof bovine animals ;
Whereasin the context of intra-Community trade in embryos , the
Member State where the embryosare collected s hould be under anobligation to ensure that such embryos have been collected and
processed by approved and supervised embryo collection teams, that
they have been obtained from animals whose health status is such asto ensure that the risk of spread of animal disease is eliminated, thatthey have been collected, processed, stored and transported in accor-dance with the rules which preserve their health status and areaccompanied during transport to the country of destination by an
animal health certificate in order to ensure that this obligation has
been fulfilled;
Whereasthe difference in the policiespurs ued within the Community
with regard to vaccination against foot-and-mouth disease justifies themaintenance, for fresh embryos, of derogations, limited in time, author-1989L0556 — EN — 01.03.1994 — 003.001 — 2
(1) OJ No C 76, 28. 3. 1989, p. 1.
(2) OJ No C 120, 16. 5. 1989, p. 313.
(3) OJ No C 139, 5. 6. 1989, p. 56.
(4) OJ No 121, 29. 7. 1964, p. 1977/64.
(5) OJ No L 153, 6. 6. 1989, p. 29.
(6) OJ No L 302, 31. 12. 1972, p. 28.
(7) OJ No L 93, 6. 4. 1989, p. 25.
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izing the requirement by the Member Statesof additional protection
against that disease;
Whereas a list of third countries should be drawn up, taking into
account animal health criteria, from which embryosmay be imported
into the Community; whereas without prejudice to such a list the
Member States must not authorize importation unless the embryoshave been collected, processed and stored by embryo collection teamswhich 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;
whereason-the-s pot checksmay be carried out in order to verifycompliance with those standards;
Whereas in order to prevent the transmission of certain contagious
diseases, import controls should be carried out when a consignment ofembryosarriveson the territory of the Community, except in the cas eof external transit;
Whereas, in the case of internal transit, the measures to be taken by
Member States after such controls must be defined;
Whereas the Commission should be entrusted with taking certain
measures for implementing this Directive; whereas to that end proce-dures should be established for cooperation between the Commissionand the Member States;
WhereasthisDirective doesnot affect trade in embryosobtained,
treated or stored before the date on which the Member States must
comply with it,
HAS ADOPTED THIS DIRECTIVE:
CHAPTER I
General provisions
Article 1
1. ThisDirective definesthe animal health conditionsgoverning
intra-Community trade in and importation from third countriesof fres hand frozen embryos of domestic animals of the bovine species.
2. This Directive shall not apply to embryos derived by transfer of
nuclei.
Article 2
For the purposes of this Directive, 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 transferredto a recipient dam;
(b) ‘embryo collection team’ meansan officially approved group of
technicians or structure supervised by a team veterinarian compe-
tent to perform the collection, processing and storage of embryosaccording to the conditionss et out in Annex A;
(c) ‘team veterinarian’ means the veterinarian responsible for the
supervision of an embryo collection team in accordance with the
conditionslaid down in Annex A;
(d) ‘consignment of embryos’ means a quantity of embryos removed in
one operation from a single donor and covered by a single certifi-cate;1989L0556 — EN — 01.03.1994 — 003.001 — 3
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(e) ‘country of collection’ meansthe Member State or third country in
which embryos are produced, collected, processed and, wherenecessary, stored, 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 approved by thecompetent veterinary authority to carry out the diagnostic tests
laid down in thisDirective;
(g) ‘embryo production team’ meansan officially approved embryo
collection team for in vitro fertilization in accordance with the
conditionslaid down in the relevant Annex.
CHAPTER II
Rulesforintra-Communitytrade
Article 3
Each Member State shall ensure that embryos shall not be sent from its
territory to that of another Member State unless they meet thefollowing conditions:
(a) they must have been conceived as a result of artificial insemination
orin vitro fertilization with semen from a donor sire standing at a
semen collection centre approved by the competent authority forthe collection, processing and storage of semen or by semen
imported in accordance with Directive 88/407/EEC(
1).
In accordance with the procedure laid down in Article 18, the
Commission may authorize trade in embryos of certain specificspecies conceived as a result of natural service by bulls whosehealth 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 of this Direc-tive;
(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 of thisDirective;
(e) they must be accompanied, during transport to the Member State of
destination, by an animal health certificate complying with Article
6 (1).
Article 5
1. Approval of an embryo collection team asprovided for in Article
3 (c) shall be granted only where the provisions of Annex A, Chapter Iare observed and where the embryo collection team is able to satisfythe other provisions of this Directive.
Any major change in the organization of the team isto be notified to
the competent authority.
The approval of the team shall be renewed whenever the team veteri-
narian isreplaced or whenever any major changesare made in itsorganization or the laboratories or equipment at its disposal.1989L0556 — EN — 01.03.1994 — 003.001 — 4
(1) OJ No L 194, 22. 7. 1988, p. 10. Directive aslas t amended by Directive 90/
425/EEC (OJ No L 224, 18. 8. 1990, p. 29).▼M2
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The official veterinarian shall supervise observance of the provisions
outlined above. Approval shall be withdrawn where one or more ofthe provisions is no longer observed.
2. All approved embryo collection teams shall be registered by the
competent authority of the Member State concerned, each team beinggiven 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,which shall also be notified of any amendment made to that list.
The veterinary expertsmus t be nationalsof a Member State other than
those involved in the dispute.
2a. Approval of an embryo production team for embryosderived by
in vitro fertilization shall be granted only where the provisions of the
relevant Annex to thisDirective are obs erved and where the embryoproduction team is able to satisfy the other relevant provisions of thisDirective and in particular the provisions of paragraphs 1 and 2 of this
Article, which shall apply mutatis mutandis .
3. The detailed rulesfor applying thisArticle s hall be adopted in
accordance with the procedure laid down in Article 18.
Article 6
1. An animal health certificate drawn up by an official veterinarian
of the Member State of collection on a form conforming to thespecimen in Annex C shall accompany each consignment of embryos.A separate certificate shall be issued for each consignment.
2. The animal health certificate must:
(a) consist of a single form and be drawn up in at least the official
language(s) of the Member State of destination;
(b) be made out to a single consignee;
(c) accompany the consignment of embryos to its destination in its
original form.
CHAPTER III
Rulesforimportationfromthirdcountries
Article 7
1. Embryos shall be imported only from those third countries or
partsthereof which appear on a lis t 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 partsthereof 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 MemberStates;
(b) the regularity and rapidity of the information supplied by the third
country concerning the existence of contagious animal diseases inits territory, in particular those diseases mentioned in lists A andB of the International Office of Epizootic Diseases;
(c) the rules of the third country on animal disease prevention and
control;1989L0556 — EN — 01.03.1994 — 003.001 — 5
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(d) the structure of the veterinary services in the third country and their
powers;
(e) the organization and implementation of measures to prevent and
control contagious animal diseases; and
(f) the guaranteeswhich the third country can give with regard to
compliance with the ruless et out in thisDirective.
3. The list referred to in paragraph 1 and all amendments thereto
shall be published in the Official Journal of the European Commu-
nities.
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, process or store in third countries embryos which are destinedfor the Member States. The list may be amended or supplemented inaccordance with the same procedure.
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 that country, the powers of the veterinary services and thesupervision 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 carriesout itsactivitiesin one of the countriesor partsthereof on
the list referred to in Article 7 (1);
(b) it fulfilsthe requirementsof Annex A;
(c) it hasbeen officially approved for exportsto the Community by the
veterinary services of the third country concerned; and
(d) it is subject to inspections at least twice a year by an official veter-
inarian of the third country concerned.
Article 9
1. Importation of embryosfrom the territory of a third country or
part thereof on the list drawn up in accordance with Article 7 (1) shalltake place only if the embryos:
(a) come from donor animalswhich, immediately prior to the collec-
tion of their embryos, have remained for at least six months in theterritory of the third country concerned, and in a maximum of two
herds complying with at least the requirements set out in paragraph
2;
(b) comply with the animal health requirementsadopted in accordance
with the procedure laid down in Article 18 for importsof embryos
from that country.
In adopting the requirements referred to in the first 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 onlist 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) collecting, processing and storing requirements in relation to
embryos.
2. The reference basis for fixing animal health conditions in accor-
dance with paragraph 1 for tuberculosis, bovine brucèllosis andenzootic bovine leucosis shall be the standards laid down in AnnexesA and G to Directive 64/432/EEC. Under the procedure laid down inArticle 18 and on a case-by-case basis, derogations from those provi-sions may be decided upon where an interested third country provides1989L0556 — EN — 01.03.1994 — 003.001 — 6
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similar and at least equivalent guarantees with reference to animal
health.
3. In laying down animal health provisions concerning foot-and-
mouth disease in accordance with paragraph 1, it must be taken into
account that:
— only frozen embryosmay be imported from third countrieswhere
vaccination against foot-and-mouth disease is practised. Theembryos must be stored under approved conditions for a minimumof 30 daysbefore cons ignment,
— donor animalsmus t come from a holding in which no animal has
been vaccinated against foot-and-mouth disease during the 30 daysprior to collection, and which isnot s ubject to any prohibition or
quarantine measures.
Article 10
1. Importation of embryos shall be authorized only on submission of
an animal health certificate drawn up and signed by an official veteri-narian of the third country of collection.
The certificate must:
(a) be drawn up in at least the official language or languages of the
Member State of destination and the official language or languagesof the Member State where the import control provided for inArticle 11 iscarried out;
(b) be made out to a single consignee;
(c) accompany the embryosin the original.
2. The animal health certificate must be on a form conforming to a
specimen drawn up in accordance with the procedure laid down inArticle 18.
Article 11
The principlesand ruleslaid down by Directive 90/675/EEC(
1) shall
apply, in particular asregardsthe organization of the checksto be
carried out by Member Statesand the follow-up to thos e checksaswell as the safeguard measures to be implemented.
CHAPTER IV
Rulesonsafeguardandcontrolmeasures
Article 14
The ruleslaid down in Council Directive 90/425/EEC of 26 June 1990
concerning veterinary and zootechnical checksin intra-Community
trade in certain live animalsand productswith a view to the comple-
tion of the internal market(2), shall apply in particular to checks at
origin, to the organization of, and follow-up to, the checksto be carriedout by the country of destination, and to the safeguard measures to beimplemented.1989L0556 — EN — 01.03.1994 — 003.001 — 7
(1) OJ No L 373, 31. 12. 1990, p. 1. Directive aslas t amended by Regulation
(EEC) No 1601/92 (OJ No L 173, 27. 6. 1992, p. 13).
(2) OJ No L 224, 18. 8. 1990, p. 29.▼M2
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Article 15
1. Veterinary experts from the Commission may, in cooperation
with the competent authoritiesof the Member Statesor third countries ,make on-the-spot checks in so far as that is indispensable for ensuringuniform application of thisDirective.
The 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 shall inform the country of collectionconcerned 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 Commis-sion may, after the situation has been examined by the StandingVeterinary Committee, authorize Member Statesto refus e entry intotheir territory for embryos obtained, processed or stored by the collec-tion team in question or withdraw approval in the case of third
countries.
2. The general provisions for implenting this Article, especially as
regardsthe frequency and method of carrying out the checksreferredto in the first subparagraph of paragraph 1, shall be laid down in accor-
dance with the procedure set out in Article 18.
CHAPTER V
Finalprovisions
Article 16
Amendmentsto the Annexes , in particular to adapt them to advancesin
technology, shall be decided in accordance with the procedure set out
in Article 18.
Article 17
1. Where the procedure laid down in thisArticle isto be followed,
the chairman shall refer the matter forthwith to the committee either on
his initiative or at the request of the representative of a Member State.
2. The representative of the Commission shall submit to the
committee a draft of the measures to be taken. The committee shalldeliver itsopinion on the draft within a time limit which the chairmanmay 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 adopton a proposal from the Commission. The votes of the representatives ofthe Member Stateswithin the committee s hall be weighted in themanner 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 themeasures to be taken. The Council shall act by a qualified majority.
If, within 15 daysof the date of referral to the Council, the Council has
not acted, the proposed measures shall be adopted by the Commission.
Article 18
1. Where the procedure laid down in thisArticle isto be followed,
the chairman shall refer the matter without delay to the committeeeither on his own initiative or at the request of the representative of a
Member State.
2. The representative of the Commission shall submit to the
committee a draft of the measures to be taken. The committee shalldeliver itsopinion on the draft within a time limit which the chairman1989L0556 — EN — 01.03.1994 — 003.001 — 8
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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 theTreaty 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 Stateswithin the committee s hall be weighted in themanner 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, within three monthsof the date of referral to the Council, the
Council has not acted, the proposed measures shall be adopted by theCommission.
Article 19
1. This Directive shall not apply to embryos collected, processed
and stored in a Member State before 1 January 1991.
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
importsof embryosfrom third countriesmore favourable conditions
than those resulting from the application of Chapter II.
Article 20
Member States shall bring into force the laws, regulations and admin-
istrative provisions necessary to comply with this Directive no laterthan 1 January 1991. They shall forthwith inform the Commissionthereof.
Article 21
This Directive is addressed to the Member States.1989L0556 — EN — 01.03.1994 — 003.001 — 9
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ANNEX A
CHAPTER I
Conditions for the approval of embryo collection and embryo production
teams
In order to be given approval each embryo collection team must fulfil the
following requirements:
(a) the collection, processing and storage of embryos must be carried out either
by a team veterinarian or under his responsibility by one or more techni-
cianswho are competent and trained by the team veterinarian in methods
and techniquesof hygiene;
(b) it must be placed under the general supervision and authority of the official
veterinarian;
(c) it must 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;
(d) in the case of a permanently sited laboratory, it must have at its disposal:
— a room where embryoscan be manipulated which isadjacent to but
physically separate from the area used to handle the donor animals
during collection,
— a room or area equipped for cleansing and sterilizing instruments and
equipment used in embryo collection and manipulation,
— where micromanipulation of the embryo which involvespenetration of
thezona pellucida is to be carried out, this shall be done in suitable
laminar-flow facilities which shall be properly cleaned and disinfected
between batches;
(e) it must 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 embryoswhich s hall be a
clean section, and
— the other for accommodating equipment and materialsus ed in contact
with the donor animals.
A mobile laboratory shall always have contact with a permanently sited
laboratory to ensure the sterilization of its equipment and the provision of
fluids and other products necessary for the collection and manipulation of
embryos.
Furthermore, to be approved as a team for the production and processing of
embryosderived by in vitro fertilization and/or in vitro culture, an embryo
production team must fulfil the following additional requirements:
(f) the personnel must be trained in appropriate disease control and laboratory
techniques, particularly in procedures for working in sterile conditions;
(g) it must have at its disposal a permanently-sited processing laboratory which
must:
— have adequate equipment and facilities, including a separate room for
recovering oocytes from ovaries, and separate rooms or areas for proces-
sing oocytes and embryos, and storing embryos,
— have laminar-flow facilities under which all oocytes, semen and embryos
must be processed; however, the centrifugation of semen may be carried
out outs ide the laminar-flow facility, aslong asfull hygienic precautions
are taken;
(h) where oocytes and other tissues are to be collected in an abattoir, it must
have at its disposal suitable equipment for the collection and transport of
the ovaries and other tissues to the processing laboratory in a hygienic and
safe manner.1989L0556 — EN — 01.03.1994 — 003.001 — 10
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CHAPTER II
Conditions relating to the collection, processing, storage and transport of
embryosbytheapprovedembryocollection ►M3 orproduction ◄team
1.Collection and processing
(a) Embryos shall be collected and processed by an approved collection
team, without coming into contact with any other consignment of
embryosnot meeting the requirementsof thisDirective.
(b) Embryos shall be collected in a place which is isolated from other parts
of the premises or holding and which must be in good repair and easy to
cleanse and disinfect.
(c) Embryos shall be processed (examined, washed, treated and placed in
identified and sterile containers) in either a permanent laboratory facility
or a mobile laboratory facility, which is not situated in a zone subject to
prohibition or quarantine measures.
(d) All implementswhich come into contact with the embryosor the donor
animal during collection and processing shall be disposable or shall be
properly disinfected or sterilized prior to use.
(e) Productsof animal origin us ed during collection of the embryosand in
the transport medium shall be obtained from sources which present no
animal health risk or are to be so treated prior to use so that such risk
isprevented. ►M3All media and solutions shall be sterilized by
approved methodsaccording to the recommendationsof the manual of
the International Embryo Transfer Society (IETS). Antibiotics may be
added to the media in accordance with the IETS manual. ◄
(f) Storage flasks and transport flasks shall be properly disinfected or steri-
lized before the commencement of each filling operation.
(g) The cryogenic agent used shall not have been previously used for other
productsof animal origin.
(h) Each embryo container and the containersin which they are s tored and
transported shall be clearly code-marked in such a way that the date of
collection of the embryosand the breed and identification of the donor
s ire and donor dam, aswell asthe regis tration 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 18.
(i) Each embryo shall be washed at least 10 times in a special fluid for
embryos which shall be changed each time and which, unless decided
otherwise under point (m), shall contain trypsin, in accordance with
internationally recognized procedures. Each wash shall be a 100-fold
dilution of the previous wash and a sterile micropipette shall be used to
transfer the embryo on each occasion.
(j) After the last wash each embryo shall be subjected to microscopic
examination ►M3at a magnification of at least × 50 ◄over itsentire
surface to determine that the ‘zona pellucida’ isintact and isfree from
any adherent material. ►M3Any micromanipulation which involves
penetration of the zona pellucida must be carried out in the facilities
approved for the purpose, and after the last wash and examination.
Such micromanipulation may only be carried out on an embryo having
an intactzona pellucida .◄
(k) Each consignment of embryos that has successfully undergone the
examination provided for in (j) shall be placed in a sterile container
marked in accordance with (h) and which shall be sealed immediately.
(l) Each embryo shall, where appropriate, be frozen as soon as possible and
stored in a place which is under the control of the team veterinarian and
which is subject to regular inspection by an official veterinarian.
(m) In accordance with the procedure laid down in Article 18 a protocol
shall be drawn up before the date provided for in Article 20 concerning
authorized flushing and washing fluids, washing techniques and, where
necessary, enzymatic treatments together with authorized transportation
media.
Pending the adoption of a protocol on enzymatic treatments, the national
rules on the use of trypsin shall continue to apply, in compliance with
the general provisions of the Treaty.
(n) Each collection team must submit routine samples of flushing fluids,
washing fluids, disintegrated embryos, non-fertilized ova etc., resulting
from itsactivitiesfor official examination for bacterial and viral contam-
ination. 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 18. If1989L0556 — EN — 01.03.1994 — 003.001 — 11
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the standards laid down are not achieved the competent authority which
granted the official approval to the team shall withdraw that approval.
(o) Each collection team must keep a record of its activities in respect of
embryo collection during the 12 monthsbefore and 12 monthsafter
storage including:
— the breed, age and identification of the donor animalsconcerned,
— the place of collection, processing and storage of embryos collected
by the team,
— the identification of the embryostogether with detailsof their des ti-
nation if known,
— detailsof micromanipulation techniqueswhich involve penetration of
thezona pellucida or other techniquess uch as in vitro fertilization
and/orin vitro culture which have been performed on the embryos.
In the case of embryos derived by in vitro fertilization, the identifi-
cation may be done on the basis of a batch, but must contain details
of the date and place of collection of ovaries and/or oocytes. It must
also be possible to identify the herd of origin of the donor animals.
The conditions laid down in subparagraphs (a) to (o) shall apply as appro-
priate to the collection, processing, storage and transport of ovaries, oocytes
and other tissues for use in in vitro fertilization and/or in vitro culture.
Furthermore, the following additional conditionss hall apply:
(p) when ovaries and other tissues are to be collected at an abattoir, the abat-
toir should be officially approved and under the control of an official
veterinarian whose responsibility it is to carry out ante-and post-mortem
inspection of donors;
(q) materialsand equipment coming into direct contact with ovariesand
other tissues shall be sterilized before use and after sterilization, used
exclusively for those purposes. Separate equipment shall be used to
handle oocytesand embryosfrom different batchesof donor animals ;
(r) ovaries and other tissues shall not be be allowed to enter the processing
laboratory until completion of the post-mortem inspection of the batch. If
relevant disease is found in the batch of donors, or in any animals
slaughtered in that abattoir on that day, all tissues from that batch must
be traced and discarded;
(s) the washing and examination procedure laid down in subparagraphs (i)
and (j) shall be carried out after the culture procedure has been
completed;
(t) any micromanipulation which involvespenetration of the zona pellucida
shall be carried out in accordance with the provisions of subparagraph
(j), after the procedures laid down in subpargraph (s) have been
completed;
(u) only embryos from the same batch of donors should be stored in the
same ampoule/straw.
2.Storage
Each embryo collection ►M3or production ◄team shall ensure that the
embryos are stored at suitable temperatures in premises approved for the
purpose by the competent authority.
In order to be approved these premises must:
(i) comprise at least one lockable room intended exclusively for embryo
storage;
(ii) be easy to cleanse and disinfect;
(iii) have permanent recordsof all incoming and outgoing movementsof
embryos. The final destination of the embryos in particular shall be
specified in such records;
(iv) be subject to inspection by the official veterinarian.
The competent authority may authorize the storage of semen that fulfils the
requirements of Directive 88/407/EEC in the approved storage premises.
3.Transport
Embryos for trade must be transported in satisfactory hygienic conditions in
sealed containers from the approved storage premises until their arrival at
their destination.
The containers must be marked in such a way that the number coincides with
the number on the animal health certificate.1989L0556 — EN — 01.03.1994 — 003.001 — 12
▼M3
▼B
▼M3
ANNEX B
Conditionsapplyingtodonoranimals
1. For the purposes of embryo collection, donor animals must meet the
following requirements:
(a) they must have spent at least the previous six months within Community
territory or in the third country of collection;
(b) they must have been present in the herd of origin for at least 30 days
prior to collection;
(c) they must come from herds which are:
— officially tuberculosis free,
— officially brucellosis free or brucellosis free,— enzootic bovine leucosis free
in derogation from the third indent, they may come from a herd (or
herds) which is/are not leucosis-free but for which certification has been
obtained that there hasnot been any clinical cas e of enzootic bovine
leucosis during the past three years;
(d) during the previous year, they must not have been present in a herd (or
herds) which have shown any clinical sign of infectious bovine rhinotra-
cheitis/infectious pustular vulvovaginitis.
2. On the day of embryo collection the donor cow:
(a) shall be kept in a holding which is not subject to veterinary prohibition
or quarantine measures;
(b) shall show no clinical signs of disease.
3. Furthermore, the above conditionss hall apply to live animalsintended as
donorsof oocytesby ovum pickup or ovariectomy.
4. In the case of donors of ovaries and other tissues to be collected after
slaughter in an abattoir, they should not have been designated for slaughter
as part of a national disease eradication programme, nor should they have
come from a holding subject to restrictions because of animal disease.
5. The abattoir where the ovaries and other tissues are collected must not be
situated in a zone subject to prohibition or quarantine measures.1989L0556 — EN — 01.03.1994 — 003.001 — 13
▼B
ANNEX C
►(1) (2) (3)M31989L0556 — EN — 01.03.1994 — 003.001 — 14