Council Directive 92/65/EECDangos y teitl llawn

[F1 ANNEX A U.K.

Textual Amendments

F1 Substituted by Commission Regulation (EC) No 1398/2003 of 5 August 2003 amending Annex A to Council Directive 92/65/EEC to include the small hive beetle (Aethina tumida), the Tropilaelaps mite (Tropilaelaps spp.), Ebola and monkey pox (Text with EEA relevance).

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]

ANNEX B U.K.

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

[F2 ANNEX C U.K. CONDITIONS GOVERNING APPROVAL OF BODIES, INSTITUTES OR CENTRES

Textual Amendments

F2 Substituted by Commission Regulation (EC) No 1282/2002 of 15 July 2002 amending Annexes to Council Directive 92/65/EEC 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 (Text with EEA relevance).

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.]

ANNEX D U.K.

[F3 CHAPTER I U.K.

I. Conditions governing the approval of semen collection centres U.K.

Semen collection centres must:

1.

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

2.

have at least

(a)

lockable animal accommodation and if required for equidae an exercise area which are physically separated from the collection facilities, the processing and storing rooms;

(b)

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

(c)

semen collection facilities including a separate room for the cleansing and disinfection or sterilization of equipment;

(d)

a semen processing room separated from the collection facilities which need not necessarily be on the same site;

(e)

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

3.

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

4.

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

II. Conditions for the supervision of semen collection centres U.K.

Semen collection centres must:

1.

be supervised that they contain only animals of the species whose semen is to be collected;

However, other domestic animals may be admitted, provided that they present no risk of infection to those species whose semen is to be collected and they fulfil the conditions laid down by the centre veterinarian.

If in the case of equidae the collection centre shares a site with an artificial insemination or service centre, then mares, teaser stallions and stallions for natural service are admitted provided they meet the requirements of Annex D Chapter II paragraph A (1), (2), (3) and (4);

2.

be monitored to ensure that records are kept which show:

• the species, breed, date of birth and identification of each animal present in the centre,

• any movement of animals entering or leaving the centre,

• the health history and all diagnostic tests and the results thereof, treatments and vaccinations carried out on animals kept,

• the date of collecting and processing semen,

• the destination of semen,

• the storage of semen;

3.

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

4.

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

5.

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

6.

be monitored to ensure that:

• none of the animals kept in the centre is used for natural breeding at least 30 days prior to first semen collection and during the collection period,

• the collection, processing and storage of semen is carried out only in premises set aside for these purposes,

• all utensils coming into contact with the semen or the donor animal during collection or processing are either properly disinfected or sterilized prior to use or new, disposable and discarded after use,

  If, in the case of equidae, the collection centre shares a site with an artificial insemination centre or a service centre, there must be a strict separation between instruments and equipment for artificial insemination or natural service and instruments and equipment coming into contact with donor animals or other animals kept in the collection centre and the semen,

• products of animal origin such as diluents, additives or extenders are used in the processing of the semen, which present no animal health risk or which have undergone prior treatment to preclude such risk,

• in the case of frozen or chilled semen cryogenic agents are used, which had not been used previously for other products of animal origin,

• any receptacle for the storage or transport of semen is either disinfected or sterilized as appropriate prior to use or new, disposable and discarded after use;

7.

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

Textual Amendments

F3 Substituted by Commission Decision of 6 April 1995 amending Annexes C and D of Council Directive 92/65/EEC 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 (95/176/EC).

CHAPTER II U.K. Conditions applicable in collection centres

Requirements as regards the admission of donor males U.K.

[F3 A. STALLIONS U.K.

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

1.

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

2.

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

3.

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

4.

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

5.

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

6.

it must be subjected to the following tests, carried out and certified in a laboratory recognized by the competent authority according to the programme set up in paragraph 7:

(i)

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

(ii)

a serum neutralization test for equine viral arteritis. Unless a negative result at a serum dilution of 1 in 4 is achieved, a virus isolation test for equine viral arteritis shall be carried out with negative result on an aliquot of the entire semen of the donor stallion;

(iii)

a test for contagious equine metritis carried out on two occassions with an interval of seven days by isolation of Taylorella equigenitalis from pre-ejaculatory fluid or a semen sample and from genital swabs taken at least from the penile sheath, urethra and urethral fossa with negative result in each case;

7.

it must have been subjected to one of the following testing programmes:

(i)

Where semen is collected for trade in fresh or chilled semen:

• and the donor stallion is continuously resident on the collection centre for at least 30 days prior to the first semen collection and during the collection period, and no equidae on the collection centre come into direct contact with equidae of lower health status than the donor stallion, the tests required in paragraphs 6 (i), (ii) and (iii) shall be carried out at least 14 days after the start of the above residence period and at least once a year at the beginning of the breeding season.

• and the donor stallion is not continuously resident on the collection centre, and/or other equidae on the collection centre come into direct contact with equidae of lower health status, the tests required in paragraphs 6 (i), (ii) and (iii) shall be carried out within the 14 day period before the first semen collection and at least once a year at the beginning of the breeding season. Furthermore, the test required in paragraph 6 (i) shall be repeated at least every 120 days during the period of semen collection. The test required in paragraph 6 (ii) shall be carried out not more than 30 days before each semen collection, unless the non-shedder state of a seropositive stallion for equine viral arteritis is confirmed by virus isolation test which must be carried out annually.

(ii)

Where semen is collected for trade in frozen semen, the testing programmes as described in paragraph 7 (i) first and second indent shall apply or, alternatively, the tests required in paragraph 6 (i), (ii) and (iii) shall be carried out during the mandatory 30 days storage period of the semen and not less than 14 days after the collection of the semen, irrespective of the residence status of the stallion.]

B. SHEEP AND GOATS U.K.

1.

Only sheep and goats from centres or holdings which, to the satisfaction of the official veterinarian, meet the following requirements may be used for the collection of semen:

(a)

they are in good health on the day the semen is collected;

(b)

they meet the requirements laid down in Articles 4, 5 and 6 of Directive 91/68/EEC on intra-Community trade.

In addition, donor animals must undergo, during the thirty days before the collection, with negative results:

• a test to detect brucellosis (B. melitensis) in accordance with Annex C to Directive 91/68/EEC,

• a test for contagious epididymitis (B. ovis) in accordance with Annex D to Directive 91/68/EEC,

• a test for the Border disease virus;

(c)

they have undergone the relevant tests or checks designed to guarantee compliance with the requirements set out in (a) and (b) above.

2.

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

[F3 C. If any of the tests referred to in A or B proves positive, that animal must be isolated and the semen, collected from it since the last negative test shall not be subject of trade. The same applies to semen collected from the other animals susceptible to the disease concerned at the holding or collection centre since the date on which the positive test was carried out. Trade shall not resume until the health status of the centre has been re-established.] U.K.

[F3 CHAPTER III U.K. Requirements applicable to semen, ova and embryos

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

(a)

The washing of ova and embryos even in the case of equidae must be carried out in accordance with conditions to be laid down in accordance with the procedure laid down in Article 26. Pending the adoption of such condition, international standards are applicable.

The zona pellucida of ova and embryos must remain intact before and after washing.

Only ova and embryos from the same donor may be washed at the same time.

After washing, the zona pellucida of each ovum or embryo must be examined over its entire surface area under a magnification of at least 50 and be certified as being intact and free from any adherent material.

(b)

The medium and solutions used for collection, processing (examination, washing and treatment), conservation or freezing of ova and embryos must be sterilized in accordance with approved methods and handled in such a way that they remain sterile.

Antibiotics must be added to the collection, washing and conservation mediums for ova and embryos and to the diluents for semen. If necessary detailed rules will be determined under the procedure provided for in Article 26.

(c)

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

(d)

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

(e)

Ova and embryos, which have successfully undergone the examination provided for in (a), and semen shall be placed in sterile containers, which are duly identified, contain only products from one male or female donor and are sealed immediately.

The identification to be established under the procedure provided for in Article 26 shall ensure that at least the country of origin, the date of collection, the species, the breed, the identity of the donor animal and the name and/or the number of the collection centre/team may be established.

(f)

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

(g)

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

(h)

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

[F3 CHAPTER IV U.K. Donor females

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

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

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

[F2 ANNEX E U.K.

Part 1 U.K.

Part 2 U.K.

Part 3 U.K.

]

[F4 ANNEX F U.K.

Textual Amendments

F4 Inserted by 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 (Text with EEA relevance).

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.]