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, 
Having regard to the Treaty establishing the European 
Economic Community and in particular Article 43 thereof, 
Having regard to the proposal from the Commission, 
Having regard to the opinion of the European Parliament, 
Having regard to the opinion of the Economic and Social 
Committee, 
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 increases 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 (!), as last 
amended by Directive 87/489/EEC (2); whereas, in 
addition, Council Directive 72/462/EEC (3), as last 
amended by Directive 87/64/EEC (4), contains provisions 
relating to veterinary inspection problems upon impor­
tation of bovine animals and swine from third countries; 
Whereas the abovementioned 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; 
(!) OJ No 121, 29. 7. 1964, p. 1977/64. 
(2) OJ No L 280, 3. 10. 1987, p. 28. 
(3) OJ No L 302, 31. 12. 1972, p. 28. 
(4) OJ No L 34, 5. 2. 1987, p. 52. 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 which 
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; 
No C 76/2 Official Journal of the European Communities 28. 3. 89 
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 
cooperation 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; 
(b) 'embryo collection team' means an officially approved 
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 fertilization with semen from a 
donor sire standing at a semen collection centre as 
defined in Article 2(b) of Council Directive 88/407/ 
EEC (')orasa 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). 
Article 4 
1. Member States which do not practise vaccination 
against foot-and-mouth disease may, until 31 Decem­
ber 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 
(!) OJ No L 194, 22. 7. 1988, p. 10. 
28. 3. 89 Official Journal of the European Communities No C 76/3 
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 provision 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. 
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 States 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 consignee; 
(c) accompany the consignment to its destination in its 
original form. 
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 organization 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 
No C 76/4 Official Journal of the European Communities 28. 3. 89 
embryos which are destined for the Community. The list 
may be amended or supplemented in accordance 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 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. 
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 dqwn in Article 19, on a case-by-case basis, to waive those conditions where the third 
country concerned provides similar animal health guaran­
tees. 
3. Article 4 shall apply mutatis mutandis. 
Article 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 consignee; 
(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), 
— 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. 
28. 3. 89 Official Journal of the European Communities No C 76/5 
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 compens­
ation by the Member States. 
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 coordinate 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 authorized 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. 
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 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. 
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 shajl deliver i,ts opinion on the draft within, a 
No C 76/6 Official Journal of the European Communities 28. 3. 89 
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. 
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. 
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 30th day 
following its publication in the Official Journal of the 
European Communities. 
This Regulation shall be binding in its entirety and directly 
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; 
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. 
No C76/8 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. 
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 
place of destination. 6. Address of premises where embryos have been 
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 
embryos (b) Date(s) of collection (c) Identification of donor dam and donor sire (d) Breed 
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: