COUNCIL DIRECTIVE of 25 September 1989 on animal health conditions governing intra-Community trade in and importation from third countries of embryos of domestic animals of the bovine species (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 is part of an efficient breeding policy which leads to better productivity and increased margins in this sector; whereas, in addition, the free movement of such embryos should encourage a rational development by taking into account the use of optimum production factors;
Whereas the provisions relating to animal health problems in intra-Community trade in bovine animals and swine appear in Directive 64/432/EEC (4), as last amended by Directive 89/360/EEC (5); whereas in addition, Directive 72/462/
EEC (6), as last amended by Directive 89/227/EEC (7)
contains provisions relating to veterinary inspection problems upon importation 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; 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, that they have been obtained from animals whose health status is such as to ensure that the risk of spread of animal disease is eliminated, that they 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, for fresh embryos, 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 must not authorize importation unless the embryos have been collected, processed and stored 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 on-the-spot checks may be carried out in order to verify compliance with those standards;
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 controls must be defined;
Whereas the Commission should be entrusted with taking certain measures for implementing this Directive; whereas to that end procedures should be established for cooperation between the Commission and the Member States;
Whereas this Directive does not affect trade in embryos obtained, 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. This Directive 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.
2. This Directive shall not apply to embryos resulting from in vitro fertilization nor to embryos subjected to sexing, splitting (twinning), cloning or any manipulation which interferes with the integrity of the 'zona pellucida'.
The Commission shall submit to the Council, before 1 January 1992, a report, together with any proposals, on the conditions for bringing such embryos within the scope of this Directive.
The Council shall act on these proposals by a qualified majority.
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 transferred to a recipient dam;
(b)
'embryo collection team' means an officially approved group of technicians or structure supervised by a team veterinarian competent to perform the collection, processing and storage of embryos according to the conditions set out in Annex A;
(c)
'team veterinarian' means the veterinarian responsible for the supervision of an embryo collection team in accordance with the conditions laid 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 certificate;
(e)
'country of collection' means the Member State or third country in which embryos are produced, collected, processed and, where necessary, 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 the competent veterinary authority to carry out the diagnostic tests laid down in this Directive.
CHAPTER II
Rules for intra-Community trade
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 the following conditions:
(a) they must have been conceived as a result of artificial insemination with semen from a donor sire standing at a semen collection centre as defined in Article 2 (b) of Directive 88/407/EEC (8).
In accordance with the procedure laid down in Article 18, the Commission may authorize trade in embryos of certain specific species conceived as a result of natural service by bulls whose health status complies with Annex B to that Directive;
(b)
they must have been collected from domestic animals of the bovine species whose health status complies with Annex B of this Directive;
(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 this Directive;
(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 December 1992:
- prohibit the introduction into their territory of fresh embryos from Member States where vaccination is practised, and
- require, in the case of importation of frozen embryos from Member States where vaccination is practised, in addition that:
i(i) the donor animals come from a holding:
- in which no animal has been vaccinated against foot-and-mouth disease during the 30 days prior to collection,
- which is not subject to prohibition or quarantine measures pursuant to Directive 64/432/EEC.
(ii) the embryos must have been stored under approved conditions during a minimum period of 30 days before consignment.
2. Before 1 January 1992 the Council shall review this Article on the basis of a Commission report accompanied by any proposals.
Article 5
1. Approval of an embryo collection team as provided for in Article 3 (c) shall be granted only where the provisions of Annex A, Chapter I are observed and where the embryo collection team is able to satisfy the other provisions of this Directive.
Any major change in the organization of the team is to be notified to the competent authority.
The approval of the team shall be renewed whenever the team veterinarian is replaced or whenever any major changes
are made in its organization or the laboratories or equipment at its disposal.
The official veterinarian shall supervise observance of the provisions outlined above. Approval shall be withdrawn where one or more of the provisions is no longer observed.
2. All approved embryo collection teams shall be registered by the competent authority of the Member State concerned, 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, which shall also be notified of any amendment made to that list.
Where a Member State considers that the provisions governing approval are not, or are no longer, observed by an embryo collection team in another Member State, it shall inform the competent authority of that State. The latter shall then take all necessary measures and notify the competent authority of the other Member State of the decisions taken and the reasons for them.
If that other Member State fears that the necessary measures have not been taken or are inadequate, it shall so inform the Commission, which will 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 17, to prohibit temporarily the admission into their territory of embryos collected by the team in question.
Such authorization may be withdrawn in accordance with the procedure laid down in Article 17 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 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 the specimen 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
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 Member States;
(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)
the rules of the third country on animal disease prevention and control;
(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 guarantees which the third country can give with regard to compliance with the rules set out in this Directive.
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, process or store in third countries embryos which are destined for the Member States. 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 that 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 carries out its activities 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 inspections at least twice a year 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 in a maximum of two herds complying with at least the requirements set out in paragraph 2;
(b)
comply with the animal health requirements adopted in accordance with the procedure laid down in Article 18 for imports of 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 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)
collecting, processing and storing requirements in relation to embryos.
2. The reference basis for fixing animal health conditions in accordance with paragraph 1 for tuberculosis, bovine brucellosis and enzootic bovine leucosis shall be the standards laid down in Annexes A and G to Directive 64/432/EEC. Under the procedure laid down in Article 18 and on a case-by-case basis, derogations from those provisions may be decided upon where an interested third country provides similar and at least equivalent guarantees with reference to animal health.
3. Article 4 shall apply mutatis mutandis.
Article 10
1. Importation of embryos shall be authorized 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 at least the official language or languages of the Member State of destination and the official language or languages 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 animal health 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 territory of the Community shall be subjected to control before being put into free circulation or placed under a customs procedure.
The admission 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, processed and stored 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.
2. Necessary measures may be taken by a Member State of destination, 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 30 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 animal health certificate or an authenticated copy thereof, suitably endorsed, in either case, by the competent authority which was responsible for the control carried out in accordance with Article 11.
Article 13
Any costs arising from implementation of measures pursuant to Article 11 (2) and (3) shall be chargeable to the consignor, the consignee or their agent, without compensation by the Member States.
CHAPTER IV
Rules on safeguard and control measures
Article 14
1. If a contagious animal disease which can be carried by embryos breaks out or spreads or if any other reason connected with animal health which might endanger the health of the livestock in a Member State so justify and where:
- the territory of a Member State is concerned, the safeguard measures laid down in Article 9 of Directive 64/432/EEC may be applied,
- all or part of the territory of a third country is concerned, the Member State of destination 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 only 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 17 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 17. 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 cooperation with the competent authorities of the Member States or third countries, make on-the-spot checks in so far as that is indispensable for ensuring uniform application of this Directive.
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, authorize Member States to refuse entry into their territory for embryos obtained, processed or stored by the collection team in question or withdraw approval in the case of third countries.
2. The general provisions for implenting 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 18.
CHAPTER V
Final provisions
Article 16
Amendments to the Annexes, in particular to adapt them to advances in technology, shall be decided in accordance with the procedure set out in Article 18.
Article 17
1. Where the procedure laid down in this Article is to 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 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, within 15 days of 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 this Article is to be followed, the chairman shall refer the matter without delay to the committee either 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 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, within three months of the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission.
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 imports of embryos from third countries more favourable conditions than those resulting from the application of Chapter II.
Article 20
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 1 January 1991. They shall forthwith inform the Commission thereof.
Article 21
This Directive is addressed to the Member States.
Done at Brussels, 25 September 1989.