1992L0065 — EN — 03.09.2008 — 009.003

This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents

Amended by:





Amended by:

A1 C 241 21 29.8.1994 L 001 1 .. ►A2 L 236 33 23.9.2003





Corrected by:









▼B

COUNCIL DIRECTIVE 92/65/EEC

of 13 July 1992

laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A (I) to Directive 90/425/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 proposals 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 live animals and products of animal origin are included in the list of products in Annex II to the Treaty; whereas the placing on the market of such animals and products constitutes a source of income for part of the farming population; Whereas in order to ensure the rational development in this sector and increase productivity, animal health rules for the animals and products should be laid down at Community level; Whereas the Community must adopt the measures intended to establish the internal market progressively over a period expiring on 31 December 1992; Whereas in view of the abovementioned objectives the Council has laid down animals health rules applicable to cattle, swine, sheep and goats, equidae, poultry and hatching eggs, fish and fish products, bivalve molluscs, semen of bulls and boars, ovine embryos, fresh meat, poultrymeat, meat products, game meat and rabbit meat; Whereas animal health rules should be adopted for the placing on the market of animals and products of animal origin which are not yet covered by the abovementioned rules; Whereas provision should be made for applying this Directive without prejudice to Council Regulation (EEC) No 3626/82 of 3 December 1982 on the implementation in the Community of the Convention on International Trade in Endangered Species of Wild Fauna and Flora ( 4 ); Whereas, as regards certain technical aspects, reference must be made to Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine ( 5 ) and Directive 85/511/EEC of 18 November 1985 introducing Community measures for the control of foot-and-mouth disease ( 6 ); Whereas, in respect of the organization of checks and the follow-up thereto, as well as the safeguard measures to be implemented, reference must be made to the general rules laid down in Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market ( 7 ); Whereas, save where otherwise provided, trade in animals and products of animal origin must be liberalized, without prejudice to recourse to possible safeguard measures; Whereas, given the significant risk of the spread of diseases to which animals are exposed, for certain animals and products of animal origin particular requirements should be specified to be imposed when they are placed on the market for the purposes of trade, particularly when intended for regions with a high health status; Whereas the specific situation pertaining in the United Kingdom of Great Britain and Northern Ireland and in Ireland given the insular position of those countries, and the fact that they have been free of rabies for a considerable period of time, warrants particular provisions to ensure that the placing on the market in the United Kingdom and Ireland of dogs and cats which do not originate in those countries does not involve a risk of introducing rabies into those States, without however affecting the abolition of veterinary checks at the frontiers between Member States; Whereas a health certificate is the most appropriate means of guaranteeing and monitoring compliance with these requirements; Whereas, to maintain the health situation in the Community, when the animals and products of animal origin referred to in this Directive are placed on the market, they should be made subject to the minimum requirements laid down for trade and compliance therewith monitored in accordance with the principles and rules laid down in Council Directive 90/675/EEC of 10 December 1990 laying down the principles governing the organization of veterinary checks on products entering the Community from third countries ( 8 ); Whereas provision should be made for a procedure establishing close co-operation between the Member States and the Commission within the Standing Veterinary Committee; Whereas the deadline for transposition into national law, set at 1 January 1994 in Article 29, should not affect the abolition of veterinary checks at frontiers on 1 January 1993, HAS ADOPTED THIS DIRECTIVE:







CHAPTER I

General provisions

Article 1

▼C1

This Directive lays down the animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to the animal health requirements laid down in the specific Community acts referred to in Annex F.

▼B

This Directive shall apply without prejudice to the provisions adopted pursuant to Regulation (EEC) No 3626/82.

This Directive shall not affect the national rules applicable to pet animals, although their retention may not jeopardize the abolition of veterinary checks at the frontiers between Member States.

Article 2

1. For the purposes of this Directive:

(a) ‘trade’trademeans trade as defined by Article 2 (3) of Directive 90/425/EEC;

(b) ‘animals’means specimens of animal species other than those referred to in Directives 64/432/EEC, 90/426/EEC ( 9 ), 90/539/EEC ( 10 ), 91/67/EEC ( 11 ), 91/68/EEC ( 12 ), 91/492/EEC ( 13 ) and 91/493/EEC ( 14 );

(c) ‘approved body, institute or centre’ means any permanent, geographically limited establishment, approved in accordance with Article 13, where one or more species of animal are habitually kept or bred, whether or not for commercial ends, and exclusively for one or more of the following purposes: — display of the animals and education of the public — conservation of the species; — basic or applied scientific research or breeding of animals for the purposes of such research;

(d) ‘notifiable diseases’means the diseases listed in Annex A.

2. In addition, the definitions, other than those of approved centres and bodies, contained in Article 2 of Directives 64/432/EEC, 91/67/EEC and 90/539/EEC shall apply mutatis mutandis.







CHAPTER II

Provisions applicable to trade

Article 3

The Member States shall ensure that the trade referred to in Article 1, first paragraph, is not prohibited or restricted for animal health reasons other than those arising from the application of this Directive or from Community legislation, and in particular any safeguard measures taken.

▼

Pending Community provisions on the matter, Sweden may maintain its national rules as regardssnakes and other reptiles consigned to it.

▼B

Article 4

Member States shall take the necessary measures to ensure that, for the purposes of applying Article 4 (1) (a) of Directive 90/425/EEC, the animals referred to in Articles 5 to 10 of this Directive may without prejudice to Article 13 and to the particular provisions to be adopted in implementation of Article 24, be the subject of trade only if they satisfy the conditions laid down in Articles 5 to 10 and come from the holdings or businesses referred to in Article 12 (1) and (3) of this Directive which are registered by the competent authority and which undertake to:

— have the animals held examined regularly in accordance with Article 3 (3) of Directive 90/425/EEC,

— notify the competent authority, aside from the outbreak of notifiable diseases, of the outbreak of the diseases referred to in Annex B for which the Member State concerned has drawn up a control or monitoring programme,

— comply with the specific national measures to control a disease which is of particular importance to a given Member State and is covered by a programme drawn up in accordance with Article 14 or a decision under Articles 15 (2),

— place on the market for the purposes of trade only animals which show no signs of disease and which come from holdings or areas not subject to any ban on animal health grounds and with respect to animals not accompanied by a health certificate or a commercial document provided for in Articles 5 to 11, only animals accompanied by self-certification by the operator stating that the animals in question do not at the time of dispatch show any obvious signs of disease and that his holding is not subject to any animal-health restrictions,

— comply with the requirements ensuring the welfare of the animals held.

Article 5

1. Member States shall ensure that trade in apes (simiae and prosimiae) is restricted solely to animals consigned from and to a body, institute or centre approved by the competent authorities of the Member States in accordance with Article 13 and that such animals are accompanied by a veterinary certificate corresponding to the specimen in Annex E, the declaration in which must be completed by the official veterinarian of the body, institute or centre of origin to guarantee the animals' health.

2. The competent authority of a Member State may, by way of derogation from paragraph 1, authorize the acquisition by an approved body, institute or centre of apes belonging to an individual.

Article 6

A. Without prejudice to Article 14 and 15, Member States shall ensure that ungulates of species other than those referred to in Directives 64/432/EEC, 90/426/EEC and 91/68/EEC may be the subject of trade only if they meet the following requirements: 1. in general they: (a) must be identified in accordance with Article 3 (1) (c) of Directive 90/425/EEC; (b) must not be intended for slaughter under a programme for the eradication of an infectious disease; (c) must not have been vaccinated against foot-and-mouth disease and must satisfy the relevant requirements of Directive 85/511/EEC and Article 4a of Directive 64/432/EEC; (d) must come from a holding referred to in Article 3 (2) (b) and (c) of Directive 64/432EEC which is not the subject of animal health measures, particularly those taken under Directives 85/511/EEC, 80/217/EEC ( 15 ) and 91/68/EEC and have been kept therein permanently since birth or for the last thirty days before dispatch; ▼M7 (e) must be accompanied by a certificate corresponding to the specimen given in Annex E part 1, bearing the following declaration: ▼M7 ————— ▼B 2. in the case of ruminants: (a) they must come from an officially tuberculosis-free and officially brucellosis-free herd in accordance with Directive 64/432/EEC or Directive 91/68/EEC and satisfy, as regards animal health rules, the relevant requirements laid down for the bovine species in Article 3 (2) (c), (d), (f), (g) and (h) of Directive 64/432/EEC or Article 3 of Directive 91/68/EEC; ▼M7 (b) where they do not come from a herd meeting the conditions laid down in (a), they must come from a holding in which no case of brucellosis or tuberculosis has been recorded in the 42 days preceding loading of the animals and in which the ruminants have in the 30 days prior to dispatch undergone with negative results a test for brucellosis and tuberculosis; ▼ (c) in accordance with the procedure laid down in Article 26, provisions may be adoptedregarding leukosis; ▼B 3. in the case of suidae: (a) they must not have come from an area which is the subject of prohibition measures associated with the presence of African swine fever in accordance with Article 9a of Directive 64/432/EEC; (b) they must come from a holding which is not subject to any of the restrictions laid down in Directive 80/217/EEC as a result of classical swine fever; (c) they must come from a brucellosis-free holding in accordance with Directive 64/432/EEC and satisfy the relevant animal health requirements laid down for swine in Directive 64/432/EEC; (d) where they do not come from a herd meeting the conditions set out in (c), they must, in the 30 days prior to their dispatch, have undergone with negative results a test designed to show the absence of antibodies to brucellosis; ▼M7 ————— ▼M7 4. the testing requirements referred to in this Article and their criteria may be established in accordance with the procedure laid down in Article 26. These decisions shall take into consideration the case of ruminants reared in the arctic regions of the Community. Pending the decisions provided for in the preceding subparagraph, national rules shall continue to apply. ▼B

B. Directive 64/432/EEC is amended as follows: 1. in Article 2 (b) and (c), for ‘bovine animal(s)’ read ‘animal(s) of the bovine species (including Bubalus bubalus)’; 2. the following Article is inserted: ‘Article 10a Under the procedure laid down in Article 12, the health certificates, a specimen of which is reproduced in Annex F, may be amended or supplemented, in particular in order to take account of the requirements of Article 6 of Directive 92/65/EEC.’

Article 7

A. Member States shall ensure that birds other than those referred to in Directive 90/539/EEC may be the subject of trade only if they meet the following requirements: 1. in general they must: (a) come from a holding in which avian influenza has not been diagnosed in the 30 days preceeding the dispatch; (b) come from a holding or an area not subject to restrictions under measures to be applied to combat Newcastle disease. Pending the implementation of the Community measures referred to in Article 19 of Directive 90/539/EEC, national requirements for combating Newcastle disease shall continue to apply, in compliance with the general provisions of the Treaty; (c) have, in accordance with the third indent of Article 10 (1) of Directive 91/496/EEC, been quarantined, if they have been imported from a third country, in the holding to which they were taken after they entered the territory of the Community; 2. in addition, psittacidae must: (a) not come from a holding nor have been in contact with animals from a holding on which psittacosis (Chlamydia psittaci) has been diagnosed. The period of prohibition since the last recorded case and the period of treatment under veterinary supervision recognized under the procedure provided for in Article 26 must be at least two months; (b) be identified in accordance with Article 3 (1) (c) of Directive 90/425/EEC. The methods for identifying psittacidae, and in particular sick psittacidae, shall be established under the procedure provided for in Article 26; (c) be accompanied by a commercial document signed by the official veterinarian or by the veterinarian responsible for the holding or business of origin and empowered for this purpose by the competent authority.

B. In the second subparagraph of Article 2 (2) of Council Directive 91/495/EEC of 27 November 1990 concerning public health and animal health problems affecting the production and placing on the market of rabbit meat and farmed game meat ( 16 ), the words ‘and ratites (Ratitae)’ shall be inserted in the third line after the words ‘Directive 90/539/EEC’. In point 1 of Article 2 (2) of Council Directive 90/539/EEC of 15 October 1990 on animal health conditions governing intra-Community trade in, and imports from, third countries of poultry and hatching eggs ( 17 ), the words ‘and ratites (Ratitae)’ shall be inserted after the words ‘and partridges.’

Article 8

Member States shall ensure that bees (Apis melifera) may be the subject of trade only if they meet the following requirements:

(a) come from an area which is not the subject of a prohibition order associated with an occurrence of American foulbrood. The period of prohibition must continue for at least 30 days following the last recorded case and the date on which all hives within a radius of three kilometres have been checked by the competent authority and all infected hives burned or treated and inspected to the satisfaction of the said competent authority. In accordance with the procedure laid down in Article 26, and after consulting the Scientific Veterinary Committee, the requirements applied to bees (Apis melifera) or equivalent requirements may be applied to bumble bees;

(b) are accompanied by a health certificate corresponding to the specimen in Annex E the declaration in which is completed by the competent authority to certify that the requirements laid down in (a) are met.

Article 9

1. Member States shall ensure that lagomorphs may be the subject of trade only if they meet the following requirements:

(a) they must not come from or have been in contact with animals from a holding on which rabies is present or is suspected of having been present within the last month;

(b) they must come from a holding in which no animal shows clinical signs of myxomatosis.

2. Member States which require a health certificate for movements of lagomorphs in their territory may require animals being sent to them to be accompanied by a health certificate corresponding to the specimen in Annex E, supplemented by the following declaration:

‘I, the undersigned, …, certify that the above consignment satisfies the requirements of Article 9 of Directive 92/65/EEC and that the animals showed no clinical sign of disease on examination.’

This certificate must be issued by the official veterinarian or by the veterinarian responsible for the holding of origin and empowered for this purpose by the competent authority and for industrial breeding, by the official veterinarian. Member States wishing to use this option shall inform the Commission which must ensure that the requirement laid down in the first paragraph has been satisfied.

3. Ireland and the United Kingdom may require the submission of a health certificate guaranteeing that the requirement laid down in paragraph 1 (a) has been satisfied.

Article 10

1. Member States shall ensure that there is a prohibition on trade in ►M5 ————— ◄ mink and foxes which come from or have been in contact with animals from a holding on which rabies is present or is suspected of having been present within the previous six months, inasmuch as no systematic vaccination programme is applied.

▼M5

2. To be the subject of trade, dogs, cats and ferrets must satisfy the requirements set out in Articles 5 and 16 of Regulation (EC) No 998/2003 of the European Parliament and of the Council of 26 May 2003 on the animal health requirements applicable to the non-commercial movement of pet animals and amending Council Directive 92/65/EEC ( 18 ).

The certificate accompanying the animals must also confirm that, 24 hours before dispatch of the animals, a clinical examination was carried out by a veterinarian authorised by the competent authority showing the animals to be in good health and able to withstand carriage to their destination.

3. By way of derogation from paragraph 2, when trade is to Ireland, the United Kingdom or Sweden, dogs, cats and ferrets shall be subject to the conditions set out in Articles 6 and 16 of Regulation (EC) No 998/2003.

The certificate accompanying the animals must also confirm that, 24 hours before dispatch of the animals, a clinical examination was carried out by a veterinarian authorised by the competent authority showing the animals to be in good health and able to withstand carriage to their destination.

▼A2

4. Ireland, Cyprus, Malta, and the United Kingdom may, without prejudice to paragraphs 2 and 3, retain their national regulations on quarantine for all carnivores ►M5 with the exception of the species referred to in paragraphs 2 and 3 ◄ , primates, bats and other animals susceptible to rabies covered by this Directive which cannot be shown to have been born on the holding of origin and kept in captivity since birth, although the retention of those regulations may not jeopardize the abolition of veterinary checks at the frontiers between Member States.

▼B

5. Decision 90/638/EEC is amended as follows:

1. the following indent is added to Article 1: — ‘for programmes to control rabies: the criteria set out in Annex III.’

2. the following Annex is added:



‘ANNEX III Criteria for programmes to control rabies Programmes to control rabies shall contain at least: (a) the criteria referred to in points 1 to 7 of Annex 1; (b) detailed information regarding the region or regions in which the oral immunization of foxes is to take place and its natural limits. This region or these regions must cover at least 6 000 km2 or the total national area of a Member State and may include adjacent areas of a third country; (c) detailed information regarding the vaccines to be used, the distribution system, the density and frequency of bait-laying; (d) where appropriate, all details and the cost and purpose of schemes to conserve or preserve flora and fauna undertaken by voluntary organizations on the territory covered by these projects.’

6. The Council, acting by a qualified majority on a proposal from the Commission, shall designate a specific institute to establish the criteria necessary for the standardization of the serological tests and shall decide on its responsibilities.

7. Member States shall ensure that the costs of applying the serological test are borne by the importers.

▼M5 —————

▼

Article 10a

As regards rabies and in accordance with the procedure laid down in Article 26, following presentation of the appropriate grounds, Articles 9 and 10 shall be amended to take account of the situation in Finland and Sweden in order to apply to them the same provisions as applicable to Member States in an equivalent situation.

▼M9

Article 11

1. The Member States shall ensure that, without prejudice to the decisions to be taken in implementation of Articles 21 and 23, only semen, ova and embryos meeting the conditions laid down in paragraphs 2, 3, 4 and 5 are the subject of trade.

2. Semen of the ovine, caprine and equine species must, without prejudice to any criteria to be complied with for the entry of equids in stud books for certain specific breeds:

— have been collected, processed and stored with a view to artificial insemination in a centre approved from the health point of view in accordance with Annex D(I), or, in the case of ovine and caprine animals by way of derogation from the above, in a holding satisfying the requirements of Directive 91/68/EEC,

— have been collected from animals meeting the conditions laid down in Annex D(II),

— have been collected, processed, preserved, stored and transported in accordance with Annex D(III),

— have been accompanied during transport to another Member State by a health certificate corresponding to a specimen to be determined in accordance with the procedure referred to in Article 26.

3. Ova and embryos of the ovine, caprine, equine and porcine species must:

— have been removed from donor females meeting the conditions laid down in Annex D(IV) by a collection team or have been produced by a production team approved by the competent authority of the Member State and satisfying the conditions to be established in Annex D(I) in accordance with the procedure referred to in Article 26,

— have been collected, processed and preserved in an appropriate laboratory, stored and transported in accordance with Annex D(III),

— be accompanied during transport to another Member State by a health certificate corresponding to a specimen to be determined in accordance with the procedure referred to in Article 26.

Semen used for the insemination of donor females must comply with the provisions of paragraph 2 in the case of sheep, goats and equids and with the provisions of Directive 90/429/EEC for swine.

Any additional guarantees may be determined in accordance with the procedure referred to in Article 26.

4. The approved centres referred to in the first indent of paragraph 2 and the approved teams referred to in the first indent of paragraph 3 shall be registered by the competent authority of the Member State concerned, each centre and team being given a veterinary registration number.

Each Member State shall draw up and keep up to date a list of those approved centres and teams and their veterinary registration numbers and shall make it available to the other Member States and to the public.

Detailed rules for the uniform application of this paragraph may be adopted in accordance with the procedure referred to in Article 26.

5. The animal health requirements and the specimen health certificates applicable to semen, ova and embryos of species not mentioned in paragraphs 2 and 3 shall be established in accordance with the procedure referred to in Article 26.

Pending the establishment of animal health requirements and specimen health certificates for trade in such semen, ova and embryos, national rules shall continue to apply.

▼B

Article 12

1. The rules on checks established by Directive 90/425/EEC shall apply, in particular as regards the organization of and follow-up to the checks to be carried out, to the animals, semen, ova and embryos covered by this Directive which are accompanied by a health certificate. Other animals must come form holdings subject to the principles of that Directive as regards checks on origin and destination.

2. Article 10 of Directive 90/425/EEC shall apply to animals, semen, ova and embryos covered by this Directive.

3. For the purpose of trade, Article 12 of Directive 90/425/EEC shall extend to dealers who keep, on a permanent or occasional basis, animals referred to in Articles 7, 9 and 10.

4. The communication of the place of destination as provided for in Article 4 (2) of Directive 90/425/EEC shall, in respect of animals, semen, ova or embryos accompanied by a health certificate in accordance with this Directive, take place using the Animo system.

5. Without prejudice to the specific provisions of this Directive, the competent authority shall, where it is suspected that this Directive has not been complied with or there is doubt as to the health of the animals or the quality of the semen, ova and embryos referred to in Article 1, carry out any checks it deems appropriate.

6. Member States shall take the appropriate administrative or penal measures to penalize any infringement of this Directive, in particular where it is found that the certificates or documents drawn up do not correspond to the actual state of the animals referred to in Article 1, that the identification of the animals or the marking of the semen, ova and embryos in question does not comply with this Directive or that the animals or products in question have not undergone the checks provided for in this Directive.

Article 13

1. Trade in animals of species susceptible to the diseases listed in Annex A or to the diseases listed in Annex B, where the Member State of destination applies the guarantee provided for in Articles 14 and 15, and trade in semen, ova or embryos of such animals consigned to and from bodies, institutes or centres approved in accordance with Annex C shall be subject to production of a transport document corresponding to the specimen in Annex E. This document, which must be completed by the veterinarian responsible for the body, institute or centre of origin, must specify that the animals, semen, ova or embryos come from a body, institute or centre approved in accordance with Annex C and must accompany them during transport.

2.

(a) To be approved, bodies, institutes or centres shall, as regards notifiable diseases, submit to the competent authority of the Member State all relevant supporting documents relating to the requirements contained in Annex C.

(b) After receiving the file relating to the request for approval or for renewal of approval, the competent authority shall examine it in the light of the information it contains and, where appropriate, of the results of the tests conducted on the spot.

(c) The competent authority shall withdraw approval in accordance with point 3 of Annex C.

▼M9

(d) All approved bodies, institutes and centres shall be registered and issued with an approval number by the competent authority. Each Member State shall draw up and keep up to date a list of approved bodies, institutes and centres and their approval numbers and shall make it available to the other Member States and to the public. Detailed rules for the uniform application of this point may be adopted in accordance with the procedure referred to in Article 26.

▼

(e) Sweden shall have a period of two years from the date of entry into force of the Accession Treaty to implement the measures laid down regarding bodies, institutes and centres.

▼B

Article 14

1. Where a Member State draws up or has drawn up, either directly or through the breeders, a voluntary or compulsory control or monitoring programme for one of the diseases referred to in Annex B, it may present the programme to the Commission outlining in particular:

— the distribution of the disease in its territory,

— whether the disease is notifiable,

— reasons for undertaking the programme, taking account of its cost-effectiveness and the significance of the disease,

— the geographical area in which the programme is to be implemented,

— the status categories to be applied to establishments, the requirements for each species when being introduced into a holding and the test procedures to be used,

— the programme monitoring procedures, including the extent of the breeders' involvement in implementing the control or monitoring programme,

— the action to be taken if, for any reason, a holding loses its status,

— the measures to be taken if the results of the tests carried out under the programme are positive,

— the non-discriminatory nature of trade in the territory of the Member State concerned with respect to intra-Community trade.

2. The Commission shall examine the programmes presented by the Member States. Programmes may be approved under the procedure provided for in Article 26 in compliance with the criteria laid down in paragraph 1. Under the same procedure, the additional guarantees, general or limited, which may be required in trade, shall be defined at the same time or at the latest three months after presentation of the programmes. Such guarantees must not exceed those which the Member State implements nationally.

3. Programmes submitted by Member States may be amended or supplemented under the procedure laid down in Article 26. Under the same procedure, amendments may be made to the guarantees referred to in paragraph 2.

Article 15

1. Where a Member State considers that its territory or part of its territory is free from one of the diseases listed in Annex B to which the animals covered by this Directive are susceptible, it shall present to the Commission appropriate supporting documentation, setting out in particular:

— the nature of the disease and the history of its occurrence in its territory,

— the results of surveillance testing based on serological, microbiological, pathological or epidemiological investigation,

— the period during which this disease was notifiable to the competent authorities,

— the period over which the surveillance was carried out,

— where applicable, the period during which vaccination against the disease has been prohibited and the geographical area concerned by the prohibition,

— the arrangements for verifying the absence of the disease.

2. The Commission shall examine the documentation provided for in paragraph 1 and submit to the Standing Veterinary Committee a decision approving or rejecting the plan submitted by the Member State. If the plan is accepted, the additional guarantees, general or specific, which may be required in trade shall be defined under the procedure laid down in Article 26. They must not exceed those which the Member State implements nationally.

Pending a decision, the Member State concerned may maintain in its trade dealings the relevant requirements needed in order to maintain its status.

3. The Member State concerned shall notify the Commission of any change in the particulars specified in paragraph 1. The guarantees defined as laid down in paragraph 2 may, in the light of such notification, be amended or withdrawn under the procedure laid down in Article 26.







CHAPTER III

Provisions applicable to imports into the Community

Article 16

The conditions applicable to imports of animals, semen, ova and embryos covered by this Directive must be at least equivalent to those laid down in Chapter II.

▼M5

With respect to cats, dogs and ferrets, import conditions must be at least equivalent to those of Chapter III of Regulation (EC) No 998/2003.

The certificate accompanying the animals must also confirm that, 24 hours before dispatch of the animals, a clinical examination was carried out by a veterinarian authorised by the competent authority showing the animals to be in good health and able to withstand carriage to their destination.

▼B

Article 17

1. For the purposes of uniform application of Article 16, the provisions of the following paragraphs shall apply.

▼C2

2. Only animals and semen, ova and embryos referred to in Article 11 which satisfy the following requirements may be imported into the Community:

▼M9

(a) they must come from a third country on a list to be drawn up in accordance with paragraph 3(a);

(b) they must be accompanied by the health certificate corresponding to a specimen to be drawn up in accordance with the procedure referred to in Article 26, signed by the competent authority of the exporting country and certifying that, (i) the animals — meet the additional conditions or offer the equivalent guarantees referred to in paragraph 4, and — come from approved centres, bodies, institutes offering guarantees at least equivalent to those in Annex C; (ii) semen, ova and embryos come from approved collection and storage centres or collection and production teams offering guarantees at least equivalent to those to be established in Annex D(I) in accordance with the procedure referred to in Article 26.

Pending the establishment of lists of third countries, approved establishments listed in point (b), animal health requirements and specimen health certificates as referred to in paragraphs (a) and (b), national rules shall continue to apply provided they are not more favourable than those laid down in Chapter II.

3. The following shall be established:

(a) in accordance with the procedure referred to in Article 26, a list of third countries or parts of third countries able to provide Member States and the Commission with guarantees equivalent to those provided for in Chapter II in relation to animals, semen, ova and embryos;

(b) in accordance with this point, a list of approved centres or teams as referred to in the first indent of paragraph 2 of Article 11 and the first indent of paragraph 3 of that article situated in one of the third countries appearing on the list referred to in point (a) of this paragraph and for which the competent authority is able to give the guarantees provided for in Article 11(2) and (3). The list of approved centres and teams referred to in the first subparagraph and their veterinary registration numbers shall be communicated to the Commission. The approval of centres or teams must be immediately suspended or withdrawn by the competent authority of the third country where it no longer complies with the conditions referred to in Article 11(2) and (3) and the Commission must be immediately informed thereof. The Commission shall provide the Member States with any new and updated lists that it receives from the competent authority of the third country in accordance with the second and third subparagraphs and shall make them available to the public for information purposes. Detailed rules for the uniform application of this point may be adopted in accordance with the procedure referred to in Article 26;

(c) in accordance with the procedure referred to in Article 26, the specific animal health requirements, in particular for the protection of the Community from certain exotic diseases, or guarantees equivalent to those provided for in this Directive. The specific requirements and equivalent guarantees established for third countries may not be more favourable than those provided for in Chapter II.

▼B

4. The list provided for in paragraph 3 may include only third countrys or parts of third countries:

(a) from which imports are not prohibited: — as a result of the existence of one of the diseases referred to in Annex A or of any other disease exotic to the Community, — pursuant to Articles 6, 7 and 14 of Directive 72/462/EEC and Article 17 of Directive 91/495/EEC and of Directive 71/118/EEC ( 19 ) or, in the case of the other animals covered by this Directive, under a decision taken in accordance with the procedure laid down in Article 26 account being taken of their state of health;

(b) which, in view of their legislation and the organization of their veterinary services and inspection services, the powers of such services and the supervision to which they are subject, have been recognized, in accordance with Article 3 (2) of Directive 72/462/EEC, as capable of guaranteeing the implementation of their legislation in force;

(c) the veterinary services of which are able to guarantee that health requirements at least equivalent to those laid down in Chapter II are being complied with.

5. Experts from the Commission and the Member States shall carry out on-the-spot inspections to verify whether the guarantees given by the third country regarding the conditions of production and placing on the market can be considered equivalent to those applied in the Community.

The experts from the Member States responsible for these inspections shall be appointed by the Commission acting on a proposal from the Member States.

These inspections shall be made on behalf of the Community, which shall bear the cost of any expenditure in this connection.

6. Pending the organization of the inspections referred to in paragraph 5, national rules applicable to inspection in third countries shall continue to apply, subject to notification, through the Standing Veterinary Committee, of any failure to comply with the guarantees offered in accordance with paragraph 3, found during these inspections.

Article 18

1. Member States shall ensure that the animals, semen, ova and embryos covered by this Directive are imported into the Community only if they:

— are accompanied by a certificate to be drawn up by the official veterinarian. — The specimen certificate shall, depending on the species, be drawn up under the procedure laid down in Article 26,

— have satisfied the checks required by Directives 90/675/EEC and 91/496/EEC ( 20 ),

— have undergone, prior to shipment to Community territory, a check by an official veterinarian to ensure that the transport conditions specified in Directive 91/628/EEC ( 21 ) have been complied with, in particular as regards watering and feeding,

— have, in the case of the animals referred to in Articles 5 to 10, been quarantined before being placed on the market, in accordance with detailed rules to be established under the procedure laid down in Article 26.

2. Pending the establishment of specific rules for this Article, the national rules applicable to imports from third countries for which such requirements have not been adopted at Community level shall continue to apply, provided they are not more favourable than those laid down in Chapter II.

Article 19

The following shall be decided under the procedure laid down in Article 26:

(a) specific animal health requirements, for imports into the Community, and the nature and content of accompanying documents for animals intended for zoos, circuses, amusement parks or experimental laboratories, according to the species;

(b) additional guarantees to those provided for in respect of the various animal species covered by this Directive, to protect the Community species concerned.

Article 20

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The rules laid down in Directive 97/78/EC shall apply in particular to the organisation of, and follow-up to the checks to be carried out by the Member States and the safeguard measures to be applied in accordance with the procedure referred to in Article 22 of that Directive.

▼B

Pending implementation of the decisions provided for in Article 8 (3) and Article 30 of Directive 91/496/EEC, the relevant national rules for applying Article 8 (1) and (2) of the said Directive shall continue to apply, without prejudice to compliance with the principles and rules referred to in paragraph 1 of this Article.







CHAPTER IV

Common final provisions

Article 21

Any specimens of certificates applicable to trade and the animal health conditions to be met in order for it to be possible to trade in animals, semen, ova and embryos other than those covered by Article 5 to 11 shall, where the need arise, be determined under the procedure laid down in Article 26.

Article 22

The Annexes to this Directive shall, where the need arises, be amended under the procedure laid down in Article 26.

▼

Annex B shall be re-examined before the date of entry into force of the Accession Treaty in order,in particular, to amend the list of diseases to include those to which ruminants and suidae are susceptible and those which are transmissible by ovine semen, ova and embryos.

▼B

Article 23

Under the procedure laid down in Article 26, special requirements may be laid down, if appropriate, by way of derogation ►M7 ————— ◄ from Chapter II, for the movement of circus and fairground animals and for trade in animals, semen, ova and embryos intended for zoos.

Article 24

1. The Member States shall be authorized to subject the entry into their territory of the animals (including cage birds), semen, ova and embryos referred to in this Directive which have passed through the territory of a third country to production of a health certificate certifying compliance with the requirements of this Directive.

2. Member States which have recourse to the possibility laid down in paragraph 1 shall inform the Commission and the other Member States within the Standing Veterinary Committee.

Article 25

The following shall be added to Annex A to Directive 90/425/EEC:

‘Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A (1) to Directive 90/425/EEC (OJ No L 268, 14.9.1992, p. 54).’

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Article 26

1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health instituted by Article 58 of Regulation (EC) No 178/2002 of the European Parliament and of the Council ( 22 ).

2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply.

The period laid down in Article 5(6) of Decision 1999/468/EC ( 23 ) shall be set at three months.

3. The Committee shall adopt its Rules of Procedure.

▼B

Article 27

Member States which implement an alternative control system providing guarantees equivalent to those laid down in this Directive as regards movements within their terrritory of the animals, semen, ova and embryos which it covers, may grant one another derogations from Article 6 (A) (1) (f), Article 8 (b) and Article 11 (1) (d) on a reciprocal basis.

Article 28

Under the procedure laid down in Article 26, transitional measures may be adopted for a period of three years to facilitate the transition to the new arrangements established by this Directive.

Article 29

1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 January 1994. They shall forthwith inform the Commission thereof.

When these measures are adopted by the Member States, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.

2. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field governed by this Directive.

3. The setting of the deadline for transposition into national law at 1 January 1994 shall be without prejudice to the abolition of veterinary checks at frontiers provided for in Directive 89/662/EEC and 90/425/EEC.

Article 30

This Directive is addressed to the Member States.

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ANNEX A







Notifiable diseases in the context of this Directive Disease Order/family/species primarily concerned African horse sickness Equidae African swine fever Suidae and Tayassuidae Avian influenza Aves American foulbrood Apis Anthrax Bovidae, Camelidae, Cervidae, Elephantidae, Equidae and Hippopotamidae Bluetongue Antilocapridae, Bovidae, Cervidae, Giraffidae, and Rhinocerotidae Brucella abortus Antilocapridae, Bovidae, Camelidae, Cervidae, Giraffidae, Hippopotamidae and Tragulidae Brucella melitensis Antilocapridae, Bovidae, Camelidae, Cervidae, Giraffidae, Hippopotamidae and Tragulidae Brucella ovis Camelidae, Tragulidae, Cervidae, Giraffidae, Bovidae and Antilocapridae Brucella suis Cervidae, Leporidae, Ovibos moschatus, Suidae and Tayassuidae Classical swine fever Suidae and Tayassuidae Contagious bovine pleuropneumonia Bovines (including zebu, buffalo, bison and yak) Ebola Non-human primates Foot-and-mouth disease Artiodactyla and Asian elephants Infectious haematopoeitic necrosis Salmonidae Lumpy skin disease Bovidae and Giraffidae Monkey pox Rodentia and non-human primates Mycobacterium bovis Mammalia, in particular Antilocapridae, Bovidae, Camelidae, Cervidae, Giraffidae, and Tragulidae Newcastle disease Aves Peste des petits ruminants Bovidae and Suidae Porcine enterovirus encephalomyelitis Suidae Psitacosis Psittaciformes Rabies Carnivora and Chiroptera Rift valley fever Bovidae, Camelus species and Rhinocerotidae Rinderpest Artiodactyla Small hive beetle (Aethina tumida) Apis and Bombus Sheep and goat pox Bovidae Swine vesicular disease Suidae and Tayassuidae Tropilaelaps mite (Tropilaelaps spp). Apis Vesicular stomatitis Artiodactyla and Equidae TSE Bovidae, Cervidae, Felidae and Mustelidae

▼B









ANNEX B







LIST OF DISEASES FOR WHICH NATIONAL PROGRAMMES MAY BE RECOGNIZED UNDER THIS DIRECTIVE Mink Viral enteritis Aleutian disease Bees European foulbrood varroasis and acariasis Apes and felids Tuberculosis Ruminants Tuberculosis Lagomorphs Myxomatosis Viral haemorrhagic disease Tularaemia

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ANNEX C

CONDITIONS GOVERNING APPROVAL OF BODIES, INSTITUTES OR CENTRES

1. In order to be granted official approval under Article 13(2) of this Directive, a body, institute or centre as defined in Article 2(1)(c) must: (a) be clearly demarcated and separated from its surroundings or the animals confined and located so as not to pose a health risk to agricultural holdings whose health status might be jeopardised; (b) have adequate means for catching, confining and isolating animals and, have available adequate quarantine facilities and approved procedures for animals coming from non-approved sources; (c) be free of the diseases listed in Annex A and the diseases listed in Annex B where the country concerned has a programme pursuant to Article 14. In order that a body, institute or centre is declared free from these diseases, the competent authority shall assess the records on the animal health status kept for at least the previous three years and the results of the clinical and laboratory tests carried out on the animals in the body, institute or centre. However, by way of derogation from this requirement new establishments shall be approved if the animals forming the collection are derived from approved establishments; (d) keep up to date records indicating: (i) the number and identity (age, sex, species and individual identification where practical) of the animals of each species present in the establishment; (ii) the number and identity (age, sex, species and individual identification where practical) of animals arriving in the establishment or leaving it, together with information on their origin or destination, the transport from or to the establishment and the animals health status; (iii) the results of blood tests or any other diagnostic procedures; (iv) cases of disease and, where appropriate, the treatment administered; (v) the results of the post-mortem examinations on animals that have died in the establishment, including still-born animals; (vi) observations made during any isolation or quarantine period; (e) either have an arrangement with a competent laboratory to perform post-mortem examinations, or have one or more appropriate premises where these examinations may be performed by a competent person under the authority of the approved veterinarian; (f) either have suitable arrangements or on-site facilities for the appropriate disposal of the bodies of animals which die of a disease or are euthanised; (g) secure, by contract or legal instrument, the services of a veterinarian approved by and under the control of the competent authority, who: (i) shall comply mutatis mutandis with the requirements referred to in Article 14(3)(B) of Directive 64/432/EEC, (ii) shall ensure that appropriate disease surveillance and control measures in relation to the disease situation of the country concerned are approved by the competent authority and applied in the body, institute or centre. Such measures shall include: — an annual disease surveillance plan including appropriate zoonoses control of the animals, — clinical, laboratory and post-mortem testing of animals suspected to be affected by transmissible diseases, — vaccination of susceptible animals against infectious diseases as appropriate, only in conformity with Community legislation; (iii) shall ensure that any suspect deaths or the presence of any other symptom suggesting that animals have contracted one or more of the diseases referred to in Annexes A and B is notified without delay to the competent authority, if that particular disease is notifiable in the Member State concerned; (iv) shall ensure that incoming animals have been isolated as necessary, and in accordance with the requirements of this Directive and the instructions, if any, given by the competent authority; (v) shall be responsible for the day to day compliance with the animal health requirements of this Directive and of Community legislation on welfare of animals during transport and disposal of animal waste; (h) if it keeps animals intended for laboratories carrying out experiments, in conformity with the provisions of Article 5 of Directive 86/609/EEC.

2. Approval shall be maintained where the following requirements are met: (a) the premises are under the control of an official veterinarian from the competent authority, who: (i) shall visit the premises of the body, institute or centre at least once per year; (ii) shall audit the activity of the approved veterinarian and the implementation of the annual disease surveillance plan; (iii) shall ensure that the provisions of this Directive are met; (b) only animals coming from another approved body, institute or centre, are introduced into the establishment, in accordance with the provisions of this Directive; (c) the official veterinarian verifies that: — the provisions of this Directive are fulfilled, — the results of the clinical, post-mortem and laboratory tests on the animals have revealed no occurrence of the diseases referred to in Annexes A and B; (d) the body, institute or centre keeps the records referred to in point 1(d) after approval, for a period of at least ten years.

3. By way of derogation from Article 5(1) of this Directive and point 2(b) of this Annex, animals including apes (simiae and prosimiae) having an origin other than an approved body, institute or centre may be introduced in an approved body, institute or centre, provided that these animals undergo a quarantine under official control and in accordance with the instructions given by the competent authority before being added to the collection. For apes (simiae and prosimiae) the quarantine requirements laid down in the OIE International Health Code (Chapter 2.10.1 and Appendix 3.5.1) shall be respected. For other animals undergoing quarantine in accordance with point 2(b) of this Annex, the quarantine period must be at least 30 days with respect to the diseases listed in Annex A.

4. Animals held in an approved body, institute or centre, shall only leave this establishment if destined to another approved body, institute or centre, in that Member State or another Member State; however, if not destined to an approved body, institute or centre, shall only leave in accordance with the requirements of the competent authority to ensure no risk of possible spread of disease.

5. Where a Member State benefits from additional guarantees under Community legislation it may request appropriate additional requirements and certification for the susceptible species to be added to the approved body, institute or centre.

6. The procedures for partly or completely suspending, withdrawing or restoring approval are the following: (a) where the competent authority finds that the requirements of point 2 have not been fulfilled or there has been a change of usage which is no longer covered by Article 2 of this Directive the approval shall be suspended or withdrawn; (b) where notification is given of the suspicion of one of the diseases listed in Annex A or B, the competent authority shall suspend approval of the body, institute or centre, until the suspicion has been officially ruled out. Depending on the disease involved and the risk of disease transmission, the suspension may relate to the establishment as a whole or only to certain categories of animals susceptible to the disease in question. The competent authority shall ensure that the measures necessary to confirm or rule out the suspicion and to avoid any spread of disease are taken, in accordance with Community legislation governing measures to be taken against the disease in question and on trade in animals; (c) where the suspected disease is confirmed, the body, institute or centre shall again be approved only when, after eradication of the disease and source of infection in the premises, including suitable cleaning and disinfection, the conditions laid down in point 1 of this Annex, with the exception of point 1(c), are again fulfilled; (d) the competent authority shall inform the Commission of the suspension, withdrawal or restoration of approval of a body, institute or centre.

▼B









ANNEX D

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CHAPTER I

I. Conditions governing the approval of semen collection centres

Semen collection centres must:

1. be placed under the supervision of a ‘centre veterinarian’;

2. have at least (a) lockable animal accommodation and if required for equidae an exercise area which are physically separated from the collection facilities, the processing and storing rooms; (b) isolation facilities which have no direct communication with the normal animal accommodation; (c) semen collection facilities including a separate room for the cleansing and disinfection or sterilization of equipment; (d) a semen processing room separated from the collection facilities which need not necessarily be on the same site; (e) a semen storage room which need not necessarily be on the same site;

3. be so constructed or isolated that contact with outside livestock is prevented;

4. be so constructed that the entire centre except the office rooms and, in the case of equidae, the exercise area can be readily cleaned and disinfected.

II. Conditions for the supervision of semen collection centres

Semen collection centres must:

1. be supervised that they contain only animals of the species whose semen is to be collected; However, other domestic animals may be admitted, provided that they present no risk of infection to those species whose semen is to be collected and they fulfil the conditions laid down by the centre veterinarian. If in the case of equidae the collection centre shares a site with an artificial insemination or service centre, then mares, teaser stallions and stallions for natural service are admitted provided they meet the requirements of Annex D Chapter II paragraph A (1), (2), (3) and (4);

2. be monitored to ensure that records are kept which show: — the species, breed, date of birth and identification of each animal present in the centre, — any movement of animals entering or leaving the centre, — the health history and all diagnostic tests and the results thereof, treatments and vaccinations carried out on animals kept, — the date of collecting and processing semen, — the destination of semen, — the storage of semen;

3. be inspected by an official veterinarian during the breeding season at least once a year in the case of animals with seasonal breeding and twice a year in the case of a nonseasonal reproduction in order to consider and verify all matters relating to the conditions of approval and supervision;

4. be so supervised that the entry of unauthorized persons is prevented. Furthermore, authorized visitors must be required to comply with the conditions laid down by the centre veterinarian;

5. employ competent staff who have received adequate training on disinfection and hygiene techniques to prevent the spread of disease;

6. be monitored to ensure that: — none of the animals kept in the centre is used for natural breeding at least 30 days prior to first semen collection and during the collection period, — the collection, processing and storage of semen is carried out only in premises set aside for these purposes, — all utensils coming into contact with the semen or the donor animal during collection or processing are either properly disinfected or sterilized prior to use or new, disposable and discarded after use, — If, in the case of equidae, the collection centre shares a site with an artificial insemination centre or a service centre, there must be a strict separation between instruments and equipment for artificial insemination or natural service and instruments and equipment coming into contact with donor animals or other animals kept in the collection centre and the semen, — products of animal origin such as diluents, additives or extenders are used in the processing of the semen, which present no animal health risk or which have undergone prior treatment to preclude such risk, — in the case of frozen or chilled semen cryogenic agents are used, which had not been used previously for other products of animal origin, — any receptacle for the storage or transport of semen is either disinfected or sterilized as appropriate prior to use or new, disposable and discarded after use;

7. ensure that each individual dose of semen is indelibly identified in such a way that the Member State of origin, date of collection, the species, the breed, the identity of the donor animal and the name and/or number of the approved centre which collected the semen may be established.

▼B

CHAPTER II

Conditions applicable in collection centres

Requirements as regards the admission of donor males

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A. STALLIONS

Only a stallion which to the satisfaction of the centre veterinarian meets the following requirements may be used for the collection of semen:

1. it must not show any sign of an infectious or contagious disease at the time of admission and on the day the semen is collected;

2. it must come from the territory or, in the case of regionalization, from the part of the territory of a Member State or a third country and from a holding under veterinary supervision each of which satisfy the requirements of Council Directive 90/426/EEC;

3. it must have been kept for 30 days prior to semen collection in holdings where no equine has shown any clinical sign of equine viral arteritis during that period;

4. it must have been kept for 60 days prior to semen collection in holdings where no equine has shown any clinical sign of contagious equine metritis during that period;

5. it must not be used for natural mating during 30 days prior to the first semen collection and during the collection period;

6. it must be subjected to the following tests, carried out and certified in a laboratory recognized by the competent authority according to the programme set up in paragraph 7: (i) an agar-gel immuno-diffusion test (Coggins test) for equine infectious anaemia with negative result; (ii) a serum neutralization test for equine viral arteritis. Unless a negative result at a serum dilution of 1 in 4 is achieved, a virus isolation test for equine viral arteritis shall be carried out with negative result on an aliquot of the entire semen of the donor stallion; (iii) a test for contagious equine metritis carried out on two occassions with an interval of seven days by isolation of Taylorella equigenitalis from pre-ejaculatory fluid or a semen sample and from genital swabs taken at least from the penile sheath, urethra and urethral fossa with negative result in each case;

7. it must have been subjected to one of the following testing programmes: (i) Where semen is collected for trade in fresh or chilled semen: — and the donor stallion is continuously resident on the collection centre for at least 30 days prior to the first semen collection and during the collection period, and no equidae on the collection centre come into direct contact with equidae of lower health status than the donor stallion, the tests required in paragraphs 6 (i), (ii) and (iii) shall be carried out at least 14 days after the start of the above residence period and at least once a year at the beginning of the breeding season. — and the donor stallion is not continuously resident on the collection centre, and/or other equidae on the collection centre come into direct contact with equidae of lower health status, the tests required in paragraphs 6 (i), (ii) and (iii) shall be carried out within the 14 day period before the first semen collection and at least once a year at the beginning of the breeding season. Furthermore, the test required in paragraph 6 (i) shall be repeated at least every 120 days during the period of semen collection. The test required in paragraph 6 (ii) shall be carried out not more than 30 days before each semen collection, unless the non-shedder state of a seropositive stallion for equine viral arteritis is confirmed by virus isolation test which must be carried out annually. (ii) Where semen is collected for trade in frozen semen, the testing programmes as described in paragraph 7 (i) first and second indent shall apply or, alternatively, the tests required in paragraph 6 (i), (ii) and (iii) shall be carried out during the mandatory 30 days storage period of the semen and not less than 14 days after the collection of the semen, irrespective of the residence status of the stallion.

▼B

B. SHEEP AND GOATS

1. Only sheep and goats from centres or holdings which, to the satisfaction of the official veterinarian, meet the following requirements may be used for the collection of semen: (a) they are in good health on the day the semen is collected; (b) they meet the requirements laid down in Articles 4, 5 and 6 of Directive 91/68/EEC on intra-Community trade. In addition, donor animals must undergo, during the thirty days before the collection, with negative results: — a test to detect brucellosis (B. melitensis) in accordance with Annex C to Directive 91/68/EEC, — a test for contagious epididymitis (B. ovis) in accordance with Annex D to Directive 91/68/EEC, — a test for the Border disease virus; c) they have undergone the relevant tests or checks designed to guarantee compliance with the requirements set out in (a) and (b) above.

2. The tests referred to in 1. must be carried out by a laboratory approved by the Member State.

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C. If any of the tests referred to in A or B proves positive, that animal must be isolated and the semen, collected from it since the last negative test shall not be subject of trade. The same applies to semen collected from the other animals susceptible to the disease concerned at the holding or collection centre since the date on which the positive test was carried out. Trade shall not resume until the health status of the centre has been re-established.

CHAPTER III

Requirements applicable to semen, ova and embryos

Semen, ova and embryos must have been collected, processed and preserverd in accordance with the following principles:

(a) The washing of ova and embryos even in the case of equidae must be carried out in accordance with conditions to be laid down in accordance with the procedure laid down in Article 26. Pending the adoption of such condition, international standards are applicable. The zona pellucida of ova and embryos must remain intact before and after washing. Only ova and embryos from the same donor may be washed at the same time. After washing, the zona pellucida of each ovum or embryo must be examined over its entire surface area under a magnification of at least 50 and be certified as being intact and free from any adherent material.

(b) The medium and solutions used for collection, processing (examination, washing and treatment), conservation or freezing of ova and embryos must be sterilized in accordance with approved methods and handled in such a way that they remain sterile. Antibiotics must be added to the collection, washing and conservation mediums for ova and embryos and to the diluents for semen. If necessary detailed rules will be determined under the procedure provided for in Article 26.

(c) All materials used for the collection, processing, conservation or freezing of semen, ova and embryos must be either disinfected or sterilized as appropriate before use or new, disposable and discarded after use.

(d) Additional tests may be established under the procedure provided for in Article 26, in particular as regards the collection of washing liquids, so as to establish that no pathogens are present.

(e) Ova and embryos, which have successfully undergone the examination provided for in (a), and semen shall be placed in sterile containers, which are duly identified, contain only products from one male or female donor and are sealed immediately. The identification to be established under the procedure provided for in Article 26 shall ensure that at least the country of origin, the date of collection, the species, the breed, the identity of the donor animal and the name and/or the number of the collection centre/team may be established.

(f) Frozen semen, ova and embryos must be placed in sterile liquid nitrogen containers which present no risk of contamination to the product.

(g) Frozen semen, ova and embryos must be stored in approved conditions for a minimum period of 30 days prior to dispatch.

(h) Semen, ova and embryos must be transported in containers which either have been cleaned, disinfected or sterilized as appropriate before use or are new, disposable and discarded after use.

CHAPTER IV

Donor females

Females may be used for the collection of embryos or ova only if they and the herds from which they originate meet, to the satisfaction of the official veterinarian, the requirements of the relevant Directives on intra-Community trade in live animals for breeding and production for the species concerned.

The provisions of Council Directive 64/432/EEC apply for swine and the provisions of Council Directive 91/68/EEC apply for ovine and caprine animals.

In addition to the requirements established by Council Directive 90/426/EEC equidae must have been kept prior to the collection of ova or embryos in holdings free from clinical signs of contagious equine meritis for 60 days. They must not be used for natural breeding during the period of 30 days prior to the collection of ova or embryos.

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ANNEX E

Part 1 — Health Certificate for trade in animals from holdings

Part 2 — Health certificate for trade in colonies of bees/queen bees and bumble bees

Part 3 — Health certificate for trade in animals, semen, embryos and ova from approved bodies, institutes or centres

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ANNEX F

Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine

Council Directive 88/407/EEC of 14 June 1988 laying down the animal health requirements applicable to intra-Community trade in and imports of deep-frozen semen of domestic animals of the bovine species

Council Directive 89/556/EEC 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

Council Directive 90/426/EEC of 26 June 1990 on animal health conditions governing the movement and import from third countries of Equidae

Council Directive 90/429/EEC of 26 June 1990 laying down the animal health requirements applicable to intra-Community trade in and imports of semen of domestic animals of the porcine species

Council Directive 90/539/EEC of 15 October 1990 on animal health conditions governing intra-Community trade in, and imports from third countries of, poultry and hatching eggs

Council Directive 91/67/EEC of 28 January 1991 concerning the animal health conditions governing the placing on the market of aquaculture animals and products

Council Directive 91/68/EEC of 28 January 1991 on animal health conditions governing intra-Community trade in ovine and caprine animals

Council Directive 2004/68/EC of 26 April 2004 laying down animal health rules for the importation into and transit through the Community of certain live ungulate animals, amending Directives 90/426/EEC and 92/65/EEC and repealing Directive 72/462/EEC.