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Document 01992L0065-20171122

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

ELI: http://data.europa.eu/eli/dir/1992/65/2017-11-22

01992L0065 — EN — 22.11.2017 — 015.002


This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document

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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

(OJ L 268 14.9.1992, p. 54)

Amended by:

 

 

Official Journal

  No

page

date

 M1

COMMISSION DECISION 95/176/EC of 6 April 1995

  L 117

23

24.5.1995

 M2

COMMISSION DECISION 2001/298/EC of 30 March 2001

  L 102

63

12.4.2001

►M3

COMMISSION REGULATION (EC) No 1282/2002 of 15 July 2002

  L 187

3

16.7.2002

 M4

Amended by: COMMISSION REGULATION (EC) No 1802/2002 of 10 October 2002

  L 274

21

11.10.2002

►M5

REGULATION (EC) No 998/2003 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 26 May 2003

  L 146

1

13.6.2003

►M6

COMMISSION REGULATION (EC) No 1398/2003 of 5 August 2003

  L 198

3

6.8.2003

►M7

COUNCIL DIRECTIVE 2004/68/EC Text with EEA relevance of 26 April 2004

  L 139

320

30.4.2004

►M8

COMMISSION DECISION 2007/265/EC of 26 April 2007

  L 114

17

1.5.2007

►M9

COUNCIL DIRECTIVE 2008/73/EC Text with EEA relevance of 15 July 2008

  L 219

40

14.8.2008

►M10

COMMISSION REGULATION (EU) No 176/2010 of 2 March 2010

  L 52

14

3.3.2010

►M11

COMMISSION DECISION 2010/270/EU of 6 May 2010

  L 118

56

12.5.2010

 M12

COMMISSION DECISION 2010/684/EU of 10 November 2010

  L 293

62

11.11.2010

►M13

COMMISSION IMPLEMENTING DECISION 2012/112/EU of 17 February 2012

  L 50

51

23.2.2012

►M14

DIRECTIVE 2013/31/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL Text with EEA relevance of 12 June 2013

  L 178

107

28.6.2013

►M15

COMMISSION IMPLEMENTING DECISION 2013/518/EU of 21 October 2013

  L 281

14

23.10.2013

►M16

COMMISSION IMPLEMENTING REGULATION (EU) No 846/2014 of 4 August 2014

  L 232

5

5.8.2014

►M17

COMMISSION IMPLEMENTING DECISION (EU) 2017/2174 Text with EEA relevance of 20 November 2017

  L 306

28

22.11.2017


Amended by:

 A1

ACT concerning the conditions of accession of the Kingdom of Norway, the Republic of Austria, the Republic of Finland and the Kingdom of Sweden and the adjustments to the Treaties on which the European Union is founded (94/C 241/08)

  C 241

21

29.8.1994

 

  L 001

1

..

►A2

ACT concerning the conditions of accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic and the adjustments to the Treaties on which the European Union is founded

  L 236

33

23.9.2003


Corrected by:

►C1

Corrigendum, OJ L 226, 25.6.2004, p.  128 (2004/68/EC)

►C2

Corrigendum, OJ L 049, 20.2.2009, p.  48  (1992/65)

►C3

Corrigendum, OJ L 084, 23.3.2013, p.  29  (1992/65)

►C4

Corrigendum, OJ L 102, 23.4.2018, p.  100 (2010/270/EU)




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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



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 ( 1 ), 90/539/EEC ( 2 ), 91/67/EEC ( 3 ), 91/68/EEC ( 4 ), 91/492/EEC ( 5 ) and 91/493/EEC ( 6 );

(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 regards snakes 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 ( 7 ) 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:

image

▼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 adopted regarding 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 ( 8 ), 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 ( 9 ), 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.

▼M14

2.  To be the subject of trade, dogs, cats and ferrets shall:

(a) satisfy the conditions set out in Article 6 and, where applicable, in Article 7 of Regulation (EU) No 576/2013 of the European Parliament and of the Council of 12 June 2013 on the non-commercial movement of pet animals ( 10 );

(b) undergo a clinical examination carried out within 48 hours prior to the time of dispatch of the animals by a veterinarian authorised by the competent authority; and

(c) be accompanied during transport to the place of destination by a health certificate which:

(i) corresponds to the specimen in Part 1 of Annex E; and

(ii) is signed by an official veterinarian who shall attest that the veterinarian authorised by the competent authority has documented in the relevant section of the identification document in the format provided for in Article 21(1) of Regulation (EU) No 576/2013 the clinical examination carried out in accordance with point (b) showing, at the time of the clinical examination, that the animals are fit to be transported for the intended journey in accordance with Council Regulation (EC) No 1/2005 of 22 December 2004 on the protection of animals during transport and related operations ( 11 ).

▼M14 —————

▼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.

▼M14

With respect to cats, dogs and ferrets, import conditions must be at least equivalent to those provided for in points (a) to (d) of Article 10(1) and point (a) of Article 12 of Regulation (EU) No 576/2013.

In addition to the conditions referred to in the second subparagraph, dogs, cats and ferrets shall, during transport to the place of destination, be accompanied by a health certificate, which is completed and signed by an official veterinarian who shall attest that a clinical examination was carried out within 48 hours prior to the time of dispatch of the animals by a veterinarian authorised by the competent authority who has verified that at the time of the clinical examination, the animals were fit to be transported for the intended journey.

▼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:

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(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.

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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 ( 12 ) 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 ( 13 ),

 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 ( 14 ) 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

►C3  Pending implementation of the decisions provided for in Article 8, point B 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 ( 15 ).

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 ( 16 ) 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.

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ANNEX D

CHAPTER I

Conditions applicable to semen collection centres, semen storage centres, embryo collection teams and embryo production teams

I.    Conditions for the approval of semen collection and storage centres

1.

In order to be given approval and the veterinary registration number referred to in Article 11(4) each semen collection centre shall:

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1.1. be placed under the supervision of a centre veterinarian authorised by the competent authority;

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1.2. have at least:

(a) lockable animal accommodation and if required for equidae an exercise area which is physically separated from the collection facilities, the processing and storage rooms;

(b) isolation facilities which have no direct communication with the normal animal accommodation;

(c) semen collection facilities, that may be open air protected from adverse weather effects, with slip-proof flooring which protects from dramatic injury in case of fall, at and around the place of semen collection, without prejudice to the requirements in point 1.4;

(d) a separate room for the cleansing and disinfection or sterilisation of equipment;

(e) a semen processing room separated from the collection facilities and the room for cleansing equipment referred to in point (d) which need not necessarily be on the same site;

(f) a semen storage room which need not necessarily be on the same site;

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

1.4. be so constructed that the entire semen collection centre except the office rooms and, in the case of equidae the exercise area, can be readily cleansed and disinfected.

2.

In order to be given approval each semen storage centre shall:

(a) in the case the storage is not limited to semen of a single species collected at semen collection centres approved in accordance with this Directive, or embryos are stored at the centre in compliance with this Directive, be given distinct veterinary registration numbers referred to in Article 11(4) for each of the species the semen of which is stored at the centre;

(b) be placed under the permanent supervision of a centre veterinarian authorised by the competent authority;

(c) have a semen storage room furnished with the necessary installation to store the semen and/or the embryos, which is so constructed that it protects those products and the installation from adverse weather and environment effects;

(d) be so constructed that contact with outside livestock or other animals is prevented;

(e) be so constructed that the entire centre except the office rooms and, in the case of equidae the exercise area, can be readily cleansed and disinfected;

(f) be so constructed that unauthorised access of people is effectively prevented.

II.    Conditions for the supervision of semen collection and storage centres

1.

Semen collection centres shall:

1.1. be supervised to ensure that:

(a) they contain only animals of the species whose semen is to be collected;

Other domestic animals may none the less also be admitted, provided that they present no risk of infection to those species whose semen is to be collected, and that they comply with the conditions laid down by the centre veterinarian.

If in the case of equidae the semen collection centre shares a site with an artificial insemination or service centre, then female equidae (mares) and uncastrated male equidae (stallions) for teasing or natural service shall be admitted provided that they meet the requirements of points 1.1, 1.2, 1.3 and 1.4 of Section I of Chapter II;

(b) the entry of unauthorised persons is prevented and that authorised visitors are required to comply with the conditions laid down by the centre veterinarian;

(c) only competent staff is employed who have received adequate training on disinfection and hygiene techniques to prevent the spread of disease;

1.2. be monitored to ensure that:

(a) records are kept which show:

(i) the species, breed, date of birth and identification of each animal present in the centre;

(ii) any movement of animals entering or leaving the centre;

(iii) the health history and all diagnostic tests and the results thereof, treatments and vaccinations carried out on animals kept;

(iv) the date of collecting and processing semen;

(v) the destination of semen;

(vi) the storage of semen;

(b) none of the animals kept in the centre is used for natural breeding at least 30 days prior to the date of the first semen collection and during the collection period;

(c) the collection, processing and storage of semen is carried out only in premises set aside for these purposes;

(d) all instruments which come into contact with the semen or the donor animal during collection and processing are properly disinfected or sterilised prior to use, except for instruments which are new, disposable and discarded after use (single-use instruments);

Where, in the case of equidae, the collection centre shares a site with an artificial insemination centre or a service centre, there shall be a strict separation between the semen and 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;

(e) products of animal origin used in the processing of semen, including diluents, additives or extenders, are obtained from sources which present no animal health risk or are so treated prior to use that such risk is prevented;

(f) cryogenic agents used for the preservation or storage of semen have not been previously used for other products of animal origin;

(g) storage containers and transport containers are either properly disinfected or sterilised before the commencement of each filling operation, except for containers which are new, disposable and discarded after use (single-use containers);

(h) each individual dose of semen or each ejaculate of fresh semen intended for further processing is clearly marked in such a way that the date of collection of the semen, the species, the breed and identification of the donor animal and the approval number of the semen collection centre can be readily established;

1.3. be inspected by an official veterinarian during the breeding season at least once every calendar year in the case of animals with seasonal breeding and twice every calendar year in the case of a non-seasonal reproduction in order to consider and verify, where necessary on the base of records, standard operating procedures and internal audits, all matters relating to the conditions of approval, supervision and monitoring.

2.

Semen storage centres shall:

2.1. be supervised to ensure that:

(a) the status of the donor animals whose semen is stored at the centre complies with the requirements of this Directive;

(b) the requirements laid down in points 1.1(b) and (c) are complied with;

(c) records are kept of all movement of semen entering and leaving the storage centre;

2.2. be monitored that:

(a) only semen collected in and coming from approved semen collection or storage centres and transported in conditions offering every possible health guarantee, having had no contact with semen not complying with this Directive, is brought into an approved semen storage centre;

(b) storage of semen takes place only on the premises set aside for the purpose and under strict conditions of hygiene;

(c) all instruments which come into contact with the semen are properly disinfected or sterilised prior to use, except for single-use instruments;

(d) storage containers and transport containers are either properly disinfected or sterilised before the commencement of each filling operation, except for single-use containers;

(e) cryogenic agents used for preservation or storage of semen have not been previously used for other products of animal origin;

(f) each individual dose of semen is clearly marked in such a way that the date of collection of the semen, the species, the breed and identification of the donor animal, the approval number of the semen collection centre can be readily established; each Member State shall communicate to the Commission and other Member States the characteristics and form of the marking used in its territory;

2.3. by way of derogation from point 2.2(a), the storage of embryos in the approved semen storage centre is authorised provided they meet the requirements of this Directive and are stored in separate storage containers;

2.4. be inspected by an official veterinarian at least twice every calendar year in order to consider and verify, where necessary based on records, standard operating procedures and internal audits, all matters relating to the conditions of approval, supervision and monitoring.

III.    Conditions for the approval and the supervision of embryo collection teams and embryo production teams

1.

In order to be given approval each embryo collection team shall comply with the following requirements:

1.1. the collection, processing and storage of embryos shall be carried out either by a team veterinarian or under his responsibility by one or more technicians who are competent and trained by the team veterinarian in methods and techniques of hygiene and in techniques and principles of disease control;

1.2. the team veterinarian shall be responsible for all team operations, including amongst others:

(a) verification of the identity and health status of the donor animal;

(b) sanitary handling and surgery of donor animals;

(c) disinfection and hygienic procedures;

(d) keeping records which shows:

(i) the species, breed, date of birth and identification of each donor animal;

(ii) the health history and all diagnostic tests and the results thereof, treatments and vaccinations carried out on donor animals;

(iii) the place and date of collecting, processing and storing of oocytes, ova and embryos;

(iv) the identification of embryos and details of their destination if known;

1.3. the team shall be placed under the general supervision of the official veterinarian, who shall inspect it at least once every calendar year to ensure, where necessary based on records, standard operating procedures and internal audits, compliance with the sanitary conditions regarding collection, processing and storage of embryos and to verify all matters relating to the conditions of approval and supervision;

1.4. the team shall have at its disposal a permanently sited laboratory or a mobile laboratory where embryos can be examined, processed and packed, consisting of at least a work surface, an optical or stereo microscope and cryogenic equipment where necessary;

1.5. in the case of a permanently sited laboratory, it shall have:

(a) a room where embryos can be processed which is physically separate from the area used to handle the donor animals during collection;

(b) a room or area for cleansing and sterilising instruments, except when using only single-use equipment;

(c) a room for storing embryos;

1.6. in the case of a mobile laboratory, it shall:

(a) have a specially equipped part of the vehicle consisting of two separate sections:

(i) one for the examination and processing of embryos which shall be a clean section; and

(ii) the other for accommodating equipment and materials used in contact with the donor animals;

(b) use only single-use equipment, unless the sterilisation of its equipment and the provision of fluids and other products necessary for the collection and processing of embryos can be ensured by the contact with a permanently sited laboratory;

1.7. the design and layout of buildings and laboratories shall be laid out and team operations carried out so as to ensure that cross-contaminations of embryos are prevented;

1.8. the team shall have at its disposal storage premises which shall:

(a) comprise at least one lockable room for the storage of ova and embryos;

(b) be easy to cleanse and disinfect;

(c) have permanent records of all incoming and outgoing ova or embryos;

(d) have storage containers for ova and embryos which are stored in a place which is under the control of the team veterinarian and which is subject to regular inspections by an official veterinarian;

1.9. the competent authority may authorise storage of semen in storage premises referred to in point 1.8 provided that the semen:

(a) meets the requirements of this Directive for either ovine and caprine species or equine species, or of 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 ( 17 ) for porcine species;

(b) is stored for the operation of the team in separate storage containers in the premises for storing approved embryos.

2.

In order to be given approval each embryo production team shall also comply with the following additional requirements:

2.1. the team members have received adequate training on disease control and laboratory techniques, particularly in procedures for working in sterile conditions;

2.2. the team shall have at its disposal a permanently sited laboratory which shall:

(a) have adequate equipment and facilities, including separate rooms for:

 recovering oocytes from ovaries,

 processing oocytes, ova and embryos,

 storing embryos;

(b) have a laminar-flow or other suitable facilities where all technical operations associated with specific sterile conditions (processing of ova, embryos and semen) are conducted.

However, the centrifugation of semen may be carried out outside the laminar-flow facility or other facility, as long as full hygienic precautions are taken;

2.3. where ova and other tissues are to be collected in a slaughterhouse, it shall have at its disposal suitable equipment for the collection and transport of the ovaries and other tissues to the processing laboratory in a hygienic and safe manner.

CHAPTER II

Conditions applicable to donor animals

I.    Conditions applicable to donor stallions

1.

In order to be used for the collection of semen, the donor stallion shall, to the satisfaction of the centre veterinarian, meet the following requirements:

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

1.2. it shall come from the territory or, in the case of regionalisation, 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 Directive 90/426/EEC;

1.3. it shall be kept for 30 days prior to the date of semen collection in holdings where no equine has shown any clinical sign of equine viral arteritis or contagious equine metritis during that period;

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

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1.5. it shall be subjected to the following tests, carried out and certified in a laboratory which is recognised by the competent authority and has the tests referred to hereinafter included in its accreditation in accordance with Article 12 of Regulation (EC) No 882/2004 of the European Parliament and of the Council ( 18 ), according to the programme provided for in point 1.6:

(a) an agar-gel immuno-diffusion test (Coggins test) or an ELISA for equine infectious anaemia with negative result;

(b) a test for the isolation of the equine arteritis virus or the detection of its genome by polymerase chain reaction (PCR) or real-time PCR carried out with negative result on an aliquot of the entire semen of the donor stallion, unless the donor stallion has reacted with negative result at a serum dilution of one in four in a serum neutralisation test for equine viral arteritis;

(c) an agent identification test for contagious equine metritis, carried out with negative result in each case on three specimens (swabs) taken from the donor stallion on two occasions with an interval of not less than seven days, and in no case earlier than seven days (systemic treatment) or 21 days (local treatment) after possible antimicrobial treatment of the donor stallion, from at least the following sites:

 the penile sheath (prepuce),

 the urethra,

 the fossa glandis.

The specimens shall be placed in transport medium with activated charcoal, such as Amies medium, before dispatch to the laboratory.

The specimens shall be subjected to at least one of the following tests:

(i) culture under microaerophilic conditions for at least 7 days for the isolation of Taylorella equigenitalis, set up within 24 hours after taking the specimens from the donor animal, or 48 hours where the specimens are kept cool during transport; or

(ii) polymerase chain reaction (PCR) or real-time PCR for the detection of genome of Taylorella equigenitalis, carried out within 48 hours after taking the specimens from the donor animal.

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1.6. it shall be subjected to one of the following testing programmes:

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(a) if the donor stallion is continuously resident on the semen collection centre for at least 30 days prior to the date of the first semen collection and during the collection period, and no equidae on the semen collection centre come into direct contact with equidae of lower health status than the donor stallion, the tests required in point 1.5 shall be carried out on samples taken from the donor stallion at least once a year at the beginning of the breeding season or prior to the first collection of semen intended for trade in fresh, chilled or frozen semen and not less than 14 days following the date of the commencement of the residence period of at least 30 days prior to the date of first semen collection;

(b) if the donor stallion is resident on the semen collection centre for at least 30 days prior to the date of the first semen collection and during the collection period, but may leave the centre occasionally under the responsibility of the centre veterinarian for a continuous period of less than 14 days, and/or other equidae on the collection centre come into direct contact with equidae of lower health status, the tests required in point 1.5 shall be carried out as follows:

(i) at least once a year on samples taken from the donor stallion at the beginning of the breeding season or prior to the first collection of semen intended for trade in fresh, chilled or frozen semen and not less than 14 days following the date of the commencement of the residence period of at least 30 days prior to the date of first semen collection; and

(ii) during the period of collection of semen intended for trade in fresh, chilled or frozen semen as follows:

 the test required in point 1.5(a) on samples taken not more than 90 days prior to the collection of semen for trade,

 the test required in point 1.5(b) on samples taken not more than 30 days prior to the collection of semen for trade, unless the non-shedder state of a donor stallion is confirmed by virus isolation test, PCR or real-time PCR carried out on samples of an aliquot of the entire semen taken not more than 6 months prior to the collection of semen for trade and the donor stallion has reacted with positive result at a serum dilution of at least one in four in a serum neutralisation test for equine viral arteritis,

 the test required in point 1.5(c) on samples taken not more than 60 days prior to the collection of semen for trade, which in the case of PCR or real-time PCR may be carried out on three specimens (swabs) taken on a single occasion;

(c) if the donor stallion does not meet the conditions in points (a) and (b) and the semen is collected for trade in frozen semen, the tests required in point 1.5 shall be carried out on samples collected from the donor stallion as follows:

(i) at least once a year at the beginning of the breeding season;

(ii) during the storage period provided for in point 1.3(b) of Section I of Chapter III and before the semen is removed from the centre or used, on samples taken not earlier than 14 days and not later than 90 days following the date of collection of the semen.

By way of derogation from point (ii) of the first subparagraph, post-collection sampling and testing for equine viral arteritis as described in 1.5(b) is not required in case the non-shedder state of a seropositive donor stallion is confirmed by virus isolation test, PCR or real-time PCR carried out with negative result on samples of an aliquot of the entire semen of the donor stallion taken twice a year at an interval of at least four months and the donor stallion has reacted with positive result at a serum dilution of at least one in four in a serum neutralisation test for equine viral arteritis.

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1.7. if any of the tests provided for in point 1.5 is positive, the donor stallion shall be isolated, and the semen collected from it since the date of the last negative test shall not be subject for trade with the exception, for equine viral arteritis, of semen from every ejaculate which has undergone the equine arteritis virus isolation test with negative result.

Semen collected from all other stallions at the semen collection centre since the date when the last sample was collected that gave a negative result in one of the tests provided for in point 1.5. shall be kept in separate storage and shall not be subject for trade until the health status of the semen collection centre has been restored and the semen stored has undergone the appropriate official investigations to rule out the presence in the semen of pathogens causing diseases mentioned in point 1.5;

1.8. semen collected from stallions at a semen collection centre subject to a prohibition order in accordance with Article 4 or 5 of Directive 90/426/EEC shall be kept in separate storage and shall not be subject for trade until the health status of the semen collection centre has been restored by the official veterinarian in accordance with Directive 90/426/EEC and the semen stored has undergone the appropriate official investigations to rule out the presence in the semen of pathogens causing diseases listed in Annex A to Directive 90/426/EEC.

II.    Conditions applicable to male ovine and caprine donor animals

1.

For all ovine and caprine animals admitted to a semen collection centre the following requirements shall apply:

1.1. they have been kept in quarantine for a period of at least 28 days in accommodation specifically approved for the purpose by the competent authority, and where only animals having at least the same health status are present (quarantine accommodation);

1.2. prior to their stay in the quarantine accommodation, they have belonged to an officially brucellosis-free ovine or caprine holding pursuant to Article 2 of Directive 91/68/EEC and they shall not be previously kept in a holding of a lower health status as regards brucellosis;

1.3. they come from a holding where during the 60 days prior to their stay in the quarantine accommodation they have undergone a serological test for contagious epidydimitis (B. ovis) carried out in accordance with Annex D to Directive 91/68/EEC or any other test with an equivalent documented sensitivity and specificity;

1.4. they have undergone the following tests carried out on a blood sample collected within the 28 days preceding the commencement of the period of quarantine specified in point 1.1, with negative results in each case, except for the test for Border disease referred to in point (c)(ii):

(a) for brucellosis (B. melitensis), a serological test carried out in accordance with Annex C to Directive 91/68/EEC;

(b) for contagious epidydimitis (B. ovis), a serological test carried out in accordance with Annex D to Directive 91/68/EEC, or any other test with an equivalent documented sensitivity and specificity;

(c) for Border disease:

(i) a virus isolation test or a test for virus antigen; and

(ii) a serological test to determine the presence or absence of antibodies (antibody test).

The competent authority may authorise that the tests referred to in this point are carried out on samples collected in the quarantine accommodation. If such authorisation is granted, the period of quarantine referred to in point 1.1 shall not commence before the date of sampling. However, if any of the tests referred to in this point prove positive, the animal concerned shall be immediately removed from the quarantine accommodation. In the event of group isolation, the quarantine period referred to in point 1.1 shall not commence for the remaining animals until the animal which tested positive has been removed;

1.5. they have undergone the following tests carried out on samples taken during the period of quarantine specified in point 1.1, and at least 21 days after being admitted to the quarantine accommodation, with negative results:

(a) for brucellosis (B. melitensis), a serological test carried out in accordance with Annex C to Directive 91/68/EEC;

(b) for contagious epidydimitis (B. ovis), a serological test carried out in accordance with Annex D to Directive 91/68/EEC, or any other test with an equivalent documented sensitivity and specificity;

1.6. they have undergone the tests for Border disease referred in points 1.4(c)(i) and (ii) carried out on the blood samples taken during the period of quarantine specified in point 1.1, and at least 21 days after being admitted to the quarantine accommodation.

Any animal (seronegative or seropositive) shall only be allowed entry to the semen collection centre if no sero-conversion occurs in animals which tested seronegative before the day of entry into the quarantine accommodation.

If sero-conversion occurs, all animals that remain seronegative shall be kept in quarantine over a prolonged time, until there is no more sero-conversion in the group for a period of three weeks from the day the sero-conversion occurred.

Serologically positive animals shall be allowed entry into the semen collection centre subject to a negative result in a test referred in point 1.4(c)(i).

2.

Animals shall only be admitted to the semen collection centre with the express permission of the centre veterinarian. All movements into and out of the semen collection centre shall be recorded.

3.

No animals admitted to the semen collection centre shall show any clinical sign of disease on the date of admission.

All animals shall, without prejudice to point 4, have come from quarantine accommodation, which on the day of dispatch of the animals to the semen collection centre complies with the following conditions:

(a) it is situated in an area in which there has been no outbreak of foot-and-mouth disease for the past 30 days within a 10 kilometre radius;

(b) it has for the past three months been free from foot-and-mouth disease and brucellosis;

(c) it has for the past 30 days been free from compulsory notifiable diseases as defined in Article 2(b)(6) of Directive 91/68/EEC.

4.

Provided, that the conditions set out in point 3 are complied with and the routine tests referred to in point 5 have been carried out during 12 months prior to the movement of the animals, animals may be moved from one approved semen collection centre to another of equal health status, without isolation or testing if the transfer is direct. The animal in question must not come into direct or indirect contact with cloven-hoofed animals of a lower health status and the means of transport used shall be disinfected before use. If an animal is moved from one semen collection centre to a semen collection centre in another Member State that movement shall be carried out in accordance with Directive 91/68/EEC.

5.

All ovine and caprine animals kept at an approved semen collection centre shall be subjected at least once every calendar year to the following tests, with negative results:

(a) for brucellosis (B. melitensis), a serological test carried out in accordance with Annex C to Directive 91/68/EEC;

(b) for contagious epidydimitis (B. ovis) a serological test carried out in accordance with Annex D to Directive 91/68/EEC, or any other test with an equivalent documented sensitivity and specificity;

(c) for Border disease, the antibody test referred to in point 1.4(c)(ii) which is applied only to seronegative animals.

6.

All tests referred to in this section shall be carried out by an approved laboratory.

7.

If any of the tests described in point 5 is positive, the animal shall be isolated and the semen collected from it since the date of the last negative test shall not be subject for trade.

The animal referred to in the first paragraph shall be removed from the centre, except in the case of Border disease, in which case the animal shall be subjected with negative result to a test referred in point 1.4(c)(i).

Semen collected from all other animals at the semen collection centre since the date when the last sample was collected that gave a negative result in one of the tests described in point 5 shall be kept in separate storage and shall not be subject for trade until the health status of the semen collection centre has been restored and the semen stored has undergone the appropriate official investigations to rule out the presence in the semen of pathogens causing diseases mentioned in point 5.

8.

Semen shall be obtained from animals which:

(a) show no clinical signs of disease on the date the semen was collected;

(b) during the 12 months prior to the date of the collection of the semen:

(i) either have not been vaccinated against foot-and-mouth disease; or

(ii) have been vaccinated against foot-and-mouth disease at least 30 days prior to the collection, in which case 5 % (with a minimum of five straws) of each semen collection shall be submitted to a virus isolation test for foot-and-mouth disease with negative results;

(c) have been kept at an approved semen collection centre for a continuous period of at least 30 days prior to the date of collection of the semen, in the case of collection of fresh semen;

(d) meet the requirements laid down in Articles 4, 5 and 6 of Directive 91/68/EEC;

(e) if kept on holdings referred to in the first indent of Article 11(2), had undergone with negative results during the 30 days prior to the date of collection of the semen:

(i) a serological test for brucellosis (B. melitensis) carried out in accordance with Annex C to Directive 91/68/EEC;

(ii) a serological test for contagious epididymitis (B. ovis) carried out in accordance with Annex D to Directive 91/68/EEC, or any other test with an equivalent documented sensitivity and specificity;

(iii) a test for the Border disease virus;

(f) shall not be used for natural breeding during at least 30 days prior to the date of first semen collection and between the date of the first sample referred to in points 1.5 and 1.6 or in point (e) and until the end of the collection period.

9.

Semen collected from male ovine and caprine donor animals at a semen collection centre or holding referred to in first indent of Article 11(2) subject to a prohibition on animal health grounds in accordance with Article 4 of Directive 91/68/EEC shall be kept in separate storage and shall not be subject for trade until the health status of the semen collection centre or the holding has been restored by the official veterinarian in accordance with Directive 91/68/EEC and the semen stored has undergone the appropriate official investigations to rule out the presence in the semen of pathogens causing diseases listed in Annex B(I) to Directive 91/68/EEC.

CHAPTER III

Requirements applicable to semen, ova and embryos

I.    Conditions for the collection, processing, preservation, storage and transport of semen

1.1. Where, without prejudice to Directive 2001/82/EC of the European Parliament and of the Council ( 19 ), antibiotics or a mixture of antibiotics are added with a bactericidal activity at least equivalent to that of the following mixtures in each ml of semen: gentamicin (250 μg), tylosin (50 μg), lincomycin-spectinomycin (150/300 μg); penicillin (500 IU), streptomycin (500 μg), lincomycin-spectinomycin (150/300 μg); or amikacin (75 μg), divekacin (25 μg), the names of the antibiotics added and their concentration shall be stated in the health certificate referred to in the fourth indent of Article 11(2).

1.2. All instruments used for the collection, processing, preservation or freezing of semen shall be either disinfected or sterilised as appropriate before use, except for single-use instruments.

1.3. Frozen semen shall:

(a) be placed and stored in storage containers:

(i) which have been cleansed and disinfected or sterilised before use, or are single-use containers;

(ii) with a cryogenic agent; which shall not be previously used for other products of animal origin;

(b) prior to dispatch or use, be stored in approved conditions for a minimum period of 30 days from the date of collection.

1.4. Semen to be subject for trade shall:

(a) be transported to the Member State of destination in transport containers which have been cleansed and disinfected or sterilised before use, or are single-use containers, and which have been sealed and numbered prior to dispatch from the approved semen collection or storage centres;

(b) be marked in such a way that the number on the straws or other packages coincides with the number on the health certificate referred to in the fourth indent of Article 11(2) and with the container in which they are stored and transported.

II.    Conditions for ova and embryos

1.   Collection and processing of in vivo derived embryos

In vivo derived embryos shall be conceived as a result of artificial insemination with semen meeting the requirements of this Directive and shall be collected, processed and preserved in accordance with the following:

1.1. Embryos shall be collected and processed by an approved embryo collection team, without coming into contact with any other batch of embryos not complying with the requirements of this Directive.

1.2. Embryos shall be collected in a place, which is separated from other parts of the premises or holding where the embryo is collected and which shall be in good repair and constructed with materials which permit its effective and easy cleansing and disinfection.

1.3. Embryos shall be processed (examined, washed, treated and placed in identified and sterile straws, ampoules or other packages) in either a permanently sited laboratory or a mobile laboratory, which, as regards susceptible species, is situated in an area in which there has been no outbreak of foot-and-mouth disease for the past 30 days within a 10 kilometre radius.

1.4. All equipment used to collect, handle, wash, freeze and store embryos shall either be sterilised or properly cleansed and disinfected prior to use according to the IETS Manual ( 20 ), or be single-use equipment.

1.5. Any biological product of animal origin used in the media and solutions for collection, processing, washing or storage of embryos shall be free of pathogenic micro-organisms. Media and solutions used in the collection, freezing and storage of embryos shall be sterilised by approved methods according to the IETS Manual and handled in such a manner as to ensure that sterility is maintained. Antibiotics might be added, when appropriate, to collection, processing, washing and storage media according to the IETS Manual.

1.6. The cryogenic agents used for preservation or storage of embryos shall not be previously used for other products of animal origin.

1.7. Each embryo straw, ampoule or other package shall be clearly identified by labels according to the standardised system according to the IETS Manual.

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1.8. The embryos shall be washed and have an intact zona pellucida, or the embryonic capsule in case of equine embryos, before and immediately after washing. In accordance with the IETS Manual, the standard washing procedure shall be modified to include additional washes with the enzyme trypsin where recommended for the inactivation or removal of certain pathogens.

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1.9. Embryos from different donor animals shall not be washed together.

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1.10. The zona pellucida of each embryo, or the embryonic capsule in case of equine embryos, shall be examined over its entire surface area at not less than 50 × magnification and certified to be intact and free of adherent material.

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1.11. Embryos of a batch that has successfully undergone the examination set out in point 1.10 shall be placed in a sterile straw, ampoule or other package marked in accordance with point 1.7 which shall be sealed immediately.

1.12. Each embryo shall, where appropriate, be frozen as soon as possible and stored in a place which is under the control of the team veterinarian.

1.13. Each embryo collection team shall submit for official examination for bacterial and viral contamination routine samples of non-viable embryos or ova, flushing fluids or washing fluids resulting from its activities according to the IETS Manual.

1.14. Each embryo collection team shall keep a record of its activities in respect of embryo collection for a period of two years after the embryos have been the subject of trade or import, including:

(a) the breed, age and individual identification of the donor animals concerned;

(b) the place of collection, processing and storage of embryos collected by the team;

(c) the identification of the embryos together with details of the consignee of the shipment.

2.   Collection and processing of ova, ovaries and other tissues, with the aim of producing in vitro derived embryos

The conditions set out in points 1.1 to 1.14 shall apply mutatis mutandis to the collection and processing of ova, ovaries and other tissues for use in in vitro fertilisation and/or in vitro culture. In addition, the following shall apply:

2.1. The competent authority shall have knowledge of, and authority over, the holding(s) of origin of the donor animals.

2.2. When ovaries and other tissues are collected at a slaughterhouse, either from individual animals or from batches of donors (batch collection), the slaughterhouse shall be officially approved in accordance with Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption ( 21 ) and under the supervision of a veterinarian whose responsibility it is to ensure that ante-mortem and post-mortem inspections of potential donor animals are carried out and to certify them to be free of signs of the relevant contagious diseases transmissible to animals. The slaughterhouse shall, as regards susceptible species, be situated in an area in which there has been no outbreak of foot-and-mouth disease for the past 30 days within a 10 kilometre radius.

2.3. Batches of ovaries shall not be brought into the processing laboratory until post-mortem inspection of donor animals is completed.

2.4. Equipment for removal and transport of ovaries and other tissues shall be cleansed and disinfected or sterilised before use and exclusively used for these purposes.

3.   Processing of in vitro derived embryos

The conditions laid down in points 1.1 to 1.14 shall apply mutatis mutandis to the processing of in vitro derived embryos. In addition, the following shall apply:

3.1.  In vitro derived embryos shall be conceived as a result of in vitro fertilisation with semen meeting the requirements of this Directive.

3.2. After the in vitro culture period is completed but prior to freezing, storage and transport of the embryos, they shall be washed and undergo the treatments referred to in points 1.8, 1.10 and 1.11.

3.3. Embryos from different donor animals, in the case of individual animal recovery, or from different batch collections shall not be washed together.

3.4. Embryos from different donor animals, in the case of individual animal recovery, or from different batch collections shall not be stored in the same straw, ampoule or other package.

4.   Processing of micromanipulated embryos

Prior to any micromanipulation which compromises the integrity of the zona pellucida, all embryos or ova shall be collected and processed according to the sanitary conditions set out in points 1, 2 and 3. In addition, the following conditions shall apply:

4.1. Where micromanipulation of the embryo which involves penetration of the zona pellucida is carried out, this shall be done in suitable laboratory facilities under supervision of an approved team veterinarian.

4.2. Each embryo collection team shall keep records of its activities according to point 1.14, including details of micromanipulation techniques which involve penetration of the zona pellucida and which have been performed on the embryos. In the case of embryos derived by in vitro fertilisation, the identification of the embryos may be done on the basis of a batch, but shall contain details of the date and place of collection of ovaries and/or ova. It shall also be possible to identify the holding of origin of the donor animals.

5.   Storage of embryos

5.1. Each embryo collection and production teams shall ensure that the embryos are stored at suitable temperatures in storage premises referred to in point 1.8 of Section III of Chapter I.

5.2. Frozen embryos shall, prior to dispatch, be stored in approved conditions for a minimum period of 30 days from the date of their collection or production.

6.   Transport of embryos

6.1. Embryos to be subject for trade shall be transported to the Member State of destination in containers which have been cleansed and disinfected or sterilised before use, or are single-use containers, and which have been sealed and numbered prior to dispatch from the approved storage premises.

6.2. The straws, ampoules or other packages shall be marked in such a way that the number on the straws, ampoules or other packages coincides with the number on the health certificate referred to in the third indent of Article 11(3) and with the container in which they are stored and transported.

CHAPTER IV

Requirements applicable to donor females

1.

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

2.

In addition to the requirements laid down in Directive 64/432/EEC, donor females of porcine species shall, except in vivo derived embryos subject to a trypsin treatment, comply with the requirements for Aujeszky’s disease laid down in accordance with Article 9 or 10 of that Directive.

3.

The provisions of Directive 91/68/EEC shall apply to donor females of ovine and caprine species.

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4.

In addition to the requirements laid down in Directive 90/426/EEC, donor mares shall:

4.1. not be used for natural breeding during at least 30 days prior to the date of collection of ova or embryos and between the date of the first sample referred to in points 4.2 and 4.3 and the date of the collection of ova and embryos;

4.2. be subjected with negative result to an agar-gel immuno-diffusion test (Coggins test) or an ELISA for equine infectious anaemia carried out on a blood sample taken not less than 14 days following the date of the commencement of the period of at least 30 days referred to in point 4.1 and not more than 90 days prior to the collection of ova or embryos for trade;

4.3. be subjected to an agent identification test for contagious equine metritis, carried out with negative result in each case in a laboratory referred to in point 1.5 of Chapter (II)(I) on at least two specimens (swabs) taken from the donor mare in no case earlier than seven days (systemic treatment) or 21 days (local treatment) after possible antimicrobial treatment of the donor mare, from at least the following sites:

 the mucosal surfaces of the clitoral fossa,

 the clitoral sinuses.

The specimens shall be taken during the period referred to in point 4.1 on two occasions with an interval of not less than seven days in the case of the test referred to in point (i), or on one occasion in the case of the test referred to in point (ii).

The specimens shall be placed in transport medium with activated charcoal, such as Amies medium, before dispatch to the laboratory.

The specimens shall be subjected to at least one of the following tests:

(i) culture under microaerophilic conditions for at least seven days for the isolation of Taylorella equigenitalis, set up within 24 hours after taking the specimens from the donor animal, or 48 hours where the specimens are kept cool during transport; or

(ii) polymerase chain reaction (PCR) or real-time PCR for the detection of genome of Taylorella equigenitalis, carried out within 48 hours after taking the specimens from the donor animal.

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ANNEX E

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Part 1 —   Health Certificate for trade in animals from holdings (ungulates, birds vaccinated against avian influenza, lagomorphs, dogs, cats and ferrets) 92/65 EI

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Part 2 —   Health certificate for trade in bees and bumble bees

92/65 EII

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►(3) M17  

►(3) M17  

►(3) C4  

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►(1) M17  

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Part 3 —   Health certificate for trade in animals, semen, ova and embryos from approved bodies, institutes or centres 92/65 EIII

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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.



( 1 ) Council Directive 90/426/EEC of 26 June 1990 on animal health conditions governing the movement and import from third countries of equidae (OJ No L 224, 18.8.1990, p. 42). Amended by Directive 91/496/EEC (OJ No L 268, 24.9.1991, p. 56).

( 2 ) 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 (OJ No L 303, 31.10.1990, p. 6). Last amended by Directive 91/496/EEC (OJ No L 268, 24.9.1991, p. 56).

( 3 ) 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 (OJ No L 46, 19.2.1991, p. 1).

( 4 ) Council Directive 91/68/EEC of 28 January 1991 on animal health conditions governing intra-Community trade in ovine and caprine animals (OJ No L 46, 19.2.1991, p. 1).

( 5 ) Council Directive 91/492/EEC of 15 July 1991 laying down the health conditions for the production and the placing on the market of live bivalve moluscs (OJ No L 268, 24.9.1991, p. 1).

( 6 ) Council Directive 91/493/EEC of 22 July 1991 laying down the health conditions for the production and the placing on the market of fishery products (OJ No L 268, 24.9.1991, p. 15).

( 7 ) Council Directive 80/217/EEC of 22 January 1980 introducing Community measures for the control of classical swine fever (OJ No L 47, 21.2.1980, p. 11). Last amended by Directive 87/486/EEC (OJ No L 280, 3.10.1987, p. 21).

( 8 ) OJ No L 268, 24.9.1991, p. 41.

( 9 ) OJ No L 303, 31.10.1990, p. 6.

( 10 ) OJ L 178, 28.6.2013, p. 1.

( 11 ) OJ L 3, 5.1.2005, p. 1.

( 12 ) Council Directive 71/118/EEC of 15 February 1971 on health problems affecting trade in fresh poultrymeat (OJ No L 55, 8.3.1971, p. 23). Last amended by Directive 90/654/EEC (OJ No L 353, 17.12.1990, p. 48).

( 13 ) Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organization of veterinary checks on animals entering the Community from third countries and amending Directive 89/662/EEC, 90/425/EEC and 90/675/EEC (OJ No L 268, 24.9.1991, p. 56).

( 14 ) Council Directive 91/628/EEC of 19 November 1991 on the protection of animals during transport and amending Directives 90/425/EEC and 91/496/EEC (OJ No L 340, 11.12.1991, p. 17).

( 15 ) OJ L 31, 1.2.2002, p. 1

( 16 ) OJ L 184, 17.7.1999, p. 23.

( 17 ) OJ L 224, 18.8.1990, p. 62.

( 18 ) Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (OJ L 165, 30.4.2004, p. 1).

( 19 ) OJ L 311, 28.11.2001, p. 1.

( 20 ) Manual of the International Embryo Transfer Society — A procedural guide and general information for the use of embryo transfer technology emphasising sanitary procedures, published by the International Embryo Transfer Society, 1111 North Dunlap Avenue, Savoy, Illinois 61874 USA (http://www.iets.org/).

( 21 ) OJ L 139, 30.4.2004, p. 206.

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