1992L0065 — EN — 01.01.1995 — 001.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COUNCILDIRECTIVE92/65/EEC
of13July1992
laying down animal health requirements governing trade in and imports into the Community of
animals,semen,ovaandembryosnotsubjecttoanimalhealthrequirementslaiddowninspecific
Communityrulesreferred toinAnnexA(I)toDirective 90/425/EEC
(OJ L 268, 14.9.1992, p. 54)
Amended by:
Official Journal
No page date
►A1Act of Accession of Austria, Sweden and Finland C241 21 29.8.1994
(adapted by Council Decision 95/1/EC, Euratom, ECSC) L 1 1 1.1.1995
▼B
COUNCILDIRECTIVE92/65/EEC
of13July1992
laying down animal health requirements governing trade in and
imports into the Community of animals, semen, ova and embryosnot subject to animal health requirements laid down in specificCommunity rules referred to in Annex A (I) to Directive 90/425/
EEC
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European EconomicCommunity, and in particular Article 43 thereof,
Having regard to the proposals from the Commission(
1),
Having regard to the opinion of the European Parliament(2),
Having regard to the opinion of the Economic and Social
Committee(3),
Whereas live animals and products of animal origin are included in the
list of products in Annex II to the Treaty; whereas the placing on themarket of such animals and products constitutes a source of income forpart of the farming population;
Whereas in order to ensure the rational development in this sector and
increase productivity, animal health rules for the animals and productsshould be laid down at Community level;
Whereas the Community must adopt the measures intended to establish
the internal market progressively over a period expiring on 31
December 1992;
Whereas in view of the abovementioned objectives the Council has laid
down animals health rules applicable to cattle, swine, sheep and goats,
equidae, poultry and hatching eggs, fish and fish products, bivalve
molluscs, semen of bulls and boars, ovine embryos, fresh meat, poul-trymeat, meat products, game meat and rabbit meat;
Whereas animal health rules should be adopted for the placing on the
market of animals and products of animal origin which are not yetcovered by the abovementioned rules;
Whereas provision should be made for applying this Directive without
prejudice to Council Regulation (EEC) No 3626/82 of 3 December1982 on the implementation in the Community of the Convention onInternational Trade in Endangered Species of Wild Fauna and Flora(
4);
Whereas, as regards certain technical aspects, reference must be made
to Council Directive 64/432/EEC of 26 June 1964 on animal healthproblems affecting intra-Community trade in bovine animals and
swine(
5) and Directive 85/511/EEC of 18 November 1985 introducing
Community measures for the control of foot-and-mouth disease(6);
Whereas, in respect of the organization of checks and the follow-up
thereto, as well as the safeguard measures to be implemented, referencemust be made to the general rules laid down in Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnicalchecks applicable in intra-Community trade in certain live animalsand products with a view to the completion of the internal market(
7);1992L0065 — EN — 01.01.1995 — 001.001 — 2
(1) OJ No C 327, 30. 12. 1989, p. 57 and OJ No C 84, 2. 4. 1990, p. 102.
(2) OJ No C 38, 19. 2. 1990, p. 134 and OJ No C 149, 18. 6. 1990, p. 263.
(3) OJ No C 62, 12. 3. 1990, p. 47 and OJ No C 182, 23. 7. 1990, p. 25.
(4) OJ No L 384, 31. 12. 1982, p. 1. Last amended by Regulation (EEC) No
197/90 (OJ No L 29, 31. 1. 1990, p. 1).
(5) OJ No 121, 29. 7. 1964, p. 1977/64. Last amended by Directive 91/499/EEC
(OJ No L 268, 24. 9. 1991, p. 107).
(6) OJ No L 315, 26. 11. 1985, p. 11. Amended by Directive 90/423/EEC (OJ
No L 224, 18. 8. 1990, p. 13.).
(7) OJ No L 224, 18. 8. 1990, p. 29. Last amended by Directive 91/496/EEC
(OJ No L 268, 24. 9. 1991, p. 56).
▼B
Whereas, save where otherwise provided, trade in animals and products
of animal origin must be liberalized, without prejudice to recourse topossible safeguard measures;
Whereas, given the significant risk of the spread of diseases to which
animals are exposed, for certain animals and products of animal originparticular requirements should be specified to be imposed when they
are placed on the market for the purposes of trade, particularly when
intended for regions with a high health status;
Whereas the specific situation pertaining in the United Kingdom of
Great Britain and Northern Ireland and in Ireland given the insular
position of those countries, and the fact that they have been free of
rabies for a considerable period of time, warrants particular provisionsto ensure that the placing on the market in the United Kingdom andIreland of dogs and cats which do not originate in those countriesdoes not involve a risk of introducing rabies into those States, without
however affecting the abolition of veterinary checks at the frontiers
between Member States;
Whereas a health certificate is the most appropriate means of guaran-
teeing and monitoring compliance with these requirements;
Whereas, to maintain the health situation in the Community, when the
animals and products of animal origin referred to in this Directive areplaced on the market, they should be made subject to the minimumrequirements laid down for trade and compliance therewith monitored
in accordance with the principles and rules laid down in Council Direc-
tive 90/675/EEC of 10 December 1990 laying down the principlesgoverning the organization of veterinary checks on products enteringthe Community from third countries(
1);
Whereas provision should be made for a procedure establishing close
co-operation between the Member States and the Commission withinthe Standing Veterinary Committee;
Whereas the deadline for transposition into national law, set at 1
January 1994 in Article 29, should not affect the abolition of veterinarychecks at frontiers on 1 January 1993,
HAS ADOPTED THIS DIRECTIVE:
CHAPTER I
General provisions
Article 1
This Directive lays down the animal health requirements governing
trade in and imports into the Community of animals, semen, ova andembryos not subject to animal health requirements laid down inspecific Community rules referred to in Annex A(I) to Directive 90/425/EEC.
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 ofveterinary checks at the frontiers between Member States.1992L0065 — EN — 01.01.1995 — 001.001 — 3
(1) OJ No L 373, 31. 12. 1990, p. 1. Amended by Directive 91/496/EEC (OJ No
L 268, 24. 9. 1991, p. 56).
▼B
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, geogra-
phically 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 exclusivelyfor 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
Provisionsapplicabletotrade
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 fromCommunity legislation, and in particular any safeguard measures taken.
Pending Community provisions on the matter, Sweden may maintain
its national rules as regardssnakes and other reptiles consigned to it.
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, theanimals 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 theysatisfy the conditions laid down in Articles 5 to 10 and come from1992L0065 — EN — 01.01.1995 — 001.001 — 4
(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 condi-
tions 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 condi-
tions 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).▼A1
▼B
▼B
the holdings or businesses referred to in Article 12 (1) and (3) of this
Directive which are registered by the competent authority and whichundertake 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 forwhich the Member State concerned has drawn upa control or moni-toring programme,
— comply with the specific national measures to control a disease
which is of particular importance to a given Member State and iscovered by a programme drawn up in accordance with Article 14or 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 areasnot subject to any ban on animal health grounds and with respectto animals not accompanied by a health certificate or a commercial
document provided for in Articles 5 to 11, only animals accompa-
nied by self-certification by the operator stating that the animals inquestion do not at the time of dispatch show any obvious signs ofdisease and that his holding is not subject to any animal-healthrestrictions,
— comply with the requirements ensuring the welfare of the animals
held.
Article 5
1. Member States shall ensure that trade in apes (simiae and prosi-
miae) is restricted solely to animals consigned from and to a body,institute or centre approved by the competent authorities of theMember States in accordance with Article 13 and that such animalsare accompanied by a veterinary certificate corresponding to thespecimen 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 dero-
gation from paragraph 1, authorize the acquisition by an approvedbody, 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 oftrade 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 Direc-
tive 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 ofanimal health measures, particularly those taken under Direc-
tives 85/511/EEC, 80/217/EEC(
1) and 91/68/EEC and have
been kept therein permanently since birth or for the lastthirty days before dispatch;1992L0065 — EN — 01.01.1995 — 001.001 — 5
(1) 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).
▼B
(e) if imported:
— must come from a third country included in a column
entitled ‘other ungulates’ to be inserted in the list drawn
upin accordance with Article 3 of Directive 72/462EEC(
1),
— must meet specific animal health conditions, to be laid
down under the procedure provided for in Article 26,which are at least equivalent to the requirements of thisArticle;
(f) must be accompanied by a certificate corresponding to the
specimen given in Annex E bearing the following declara-tion:
‘DeclarationI, the undersigned (official veterinarian) certify that the rumi-
nant/suida (*) other than that covered by Directive 64/432/EEC:
(a) belongs to the … species;
(b) at the time of examination, does not show any clinical
sign of any disease to which it is susceptible;
(c) comes from an officially tuberculosis-free/officially
brucellosis-free or brucellosis-free herd/a holding notsubject to swine-fever restrictions (**) or from a holdingwhere it was subjected with negative results to the tests
laid down in Article 6 (2) (a) (ii) of Directive 92/65/
EEC.
(*) Delete as appropriate.’;
2. in the case of ruminants:
(a) they must come from an officially tuberculosis-free and offi-
cially brucellosis-free herd in accordance with Directive 64/432/EEC or Directive 91/68/EEC and satisfy, as regardsanimal health rules, the relevant requirements laid down forthe 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;
(b) where they do not come from a herd meeting the conditions
laid down in (a), they must come from a holding in which nocase of brucellosis or tubercolosis has been recorded in the
42 days preceding loading of the animals and in which the
ruminants have, in the 30 days prior to their dispatch, under-gone with negative results:
— a tuberculosis reaction test, and
— a test designed to show the absence of antibodies to
brucellosis.
The requirements as regards these tests and the definition of
the tuberculosis and brucellosis status of these holdings shall
be established in accordance with the procedure laid down inArticle 26 of this Directive.
Pending the decisions provided for in the preceding subpara-
graph, national rules shall continue to apply, particularly as
regards tuberculosis. ►
A1These decisions shall take into
consideration the case of ruminants reared in the Arcticregions of the Community; ◄1992L0065 — EN — 01.01.1995 — 001.001 — 6
(1) Council Directive 72/462/EEC of 12 December 1972 on health and veter-
inary inspection problems upon importation of bovine animals and swine
and fresh meat from third countries (OJ No L 302, 31. 12. 1972, p. 28).
Last amended by Directive 91/497/EEC (OJ No L 268, 24. 9. 1991, p. 69).
▼A1
(c) in accordance with the procedure laid down in Article 26,
provisions may be adoptedregarding leukosis;
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 ofAfrican swine fever in accordance with Article 9a of Direc-tive 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 accor-
dance with Directive 64/432/EEC and satisfy the relevantanimal health requirements laid down for swine in Directive64/432/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 theirdispatch, have undergone with negative results a testdesigned to show the absence of antibodies to brucellosis;
(e) as regards swine vesicular disease and during a transitional
period of three years from thedate of entry into force of theAccession Treaty, a serological test with a negative result
must be carried out on suidae for consignments for Finland,
from a region as defined in Article 2 (o) of Directive 64/432/EEC in which an outbreak of swine vesicular disease hasoccurred. This test will be required for a period of twelvemonths after the occurrence of the last outbreak in that
region;
(f) as regards classical swine fever and during a transitional
period of three years from thedate of entry into force of theAccession Treaty, a serological test with a negative resultmust be carried out on suidae for consignments for Finlandand Sweden, from a region as defined in Article 2 (o) of
Directive 64/432/EEC in which an outbreak of classical
swine fever has occurred. This test will be required for aperiod of twelve months after the occurrence of the lastoutbreak in that region. If necessary, detailed rules forapplying this point may be adopted in accordance with theprocedure laid down in Article 26;
(g) as regards porcine reproductive and respiratory syndrome
and during a transitionalperiod of three years from the dateof entry into force of the Accession Treaty, a serologicaltest with a negative result must be carried out on suidae forconsignments for Sweden, from a region as defined inArticle 2 (o) of Directive 64/432/EEC in which an outbreak
of porcine reproductive and respiratory syndrome has
occurred. This test will be required for a period of twelvemonths after the occurrence of the last outbreak in thatregion. Detailed rules for applying this point shall be adoptedin accordance with the procedure laid down in Article 26.
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 certifi-
cates, a specimen of which is reproduced in Annex F, may beamended or supplemented, in particular in order to take accountof the requirements of Article 6 of Directive 92/65/EEC.’1992L0065 — EN — 01.01.1995 — 001.001 — 7
▼B
▼A1
▼B
▼B
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 meetthe 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, nationalrequirements for combating Newcastle disease shall continueto 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 beenimported from a third country, in the holding to which theywere 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 recognizedunder 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 procedureprovided 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 andanimal health problems affecting the production and placing on themarket of rabbit meat and farmed game meat(
1), 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-Commu-nity trade in, and imports from, third countries of poultry andhatching eggs(
2), 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 hiveswithin a radius of three kilometres have been checked by the1992L0065 — EN — 01.01.1995 — 001.001 — 8
(1) OJ No L 268, 24. 9. 1991, p. 41.
(2) OJ No L 303, 31. 10. 1990, p. 6.
▼B
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 requirementsapplied 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 thecompetent 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 thespecimen 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 theanimals 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, bythe official veterinarian. Member States wishing to use this option shallinform the Commission which must ensure that the requirement laiddown 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 para-
graph 1 (a) has been satisfied.
Article 10
1. Member States shall ensure that there is a prohibition on trade in
ferrets, mink and foxes which come from or have been in contact withanimals from a holding on which rabies is present or is suspected ofhaving been present within the previous six months, inasmuch as nosystematic vaccination programme is applied.
2. To be the subject of trade, with the exception of trade between
the Member States referred to in paragraph 3, dogs and cats must
satisfy the following requirements:
(a) animals more than three months old must:
— show no sign of disease, and particularly of contagious diseases
of the species, on the day they are dispatched from the holding,
— be tattooed or have a micro-chipidentification system
implanted in accordance with detailed rules to be laid downunder the procedure provided for in Article 26,
— have after the age of three months, been vaccinated against
rabies with an annual booster injection or, at intervals author-
ized by the Member States of dispatch for that vaccine, by
injection of an inactivated vaccine of at least one internationalantigenic unit (WHO standard) measured in accordance withthe activity test by the method described by the European Phar-macopoeia and recognized under the procedure laid down inArticle 26.1992L0065 — EN — 01.01.1995 — 001.001 — 9
▼B
The vaccination must be certified by an official veterinarian or
by the veterinarian responsible for the holding of origin andempowered for this purpose by the competent authority. The
vaccination certificate must bear the name of the vaccine and
its batch number (self-adhesive label if possible):
— dogs must have been vaccinated against canine distemper,
— be accompanied by an individual passport allowing the animal
to be clearly identified and showing the dates of vaccinationand/or a certificate corresponding to the specimen shown in
Annex E supplemented by the following declaration completed
by an official veterinarian or by the veterinarian responsible forthe holding of origin and empowered for this purpose by thecompetent authority:
‘I, the undersigned … certify that the cats/dogs covered by this
certificate satisfy the requirements of Article 10 (2) (a) and (b)and (3) (b) of Directive 92/65/EEC (*) and come from a holdingin which no case of rabies has been recorded in the last six
months.
(*) Delete as applicable.’;
b) animals less than three months old must:
— satisfy the requirements of the first and fifth indents of (a),
— not come from a holding which is the subject of restrictions on
the movement of animals on animal health grounds,
— have been born on the holding of origin and have been main-
tained in captivity since birth.
3. As from 1 July 1994, by way of derogation from paragraph 2, the
placing on the market in the United Kingdom and Ireland of cats anddogs not originating in those countries shall be subject to the following
conditions:
(a) in general, cats and dogs must
(i) come from a registered holding, registration of which must be
suspended by the competent authority where the conditionsprovided for in Article 4 are no longer met;
(ii) on the day they are dipatched from the holding in question,
show no sign of contagious disease;
(iii) have been provided with a system of identification in accor-
dance with detailed rules to be established under the
procedure laid down in Article 26;
(iv) have been born on the holding and have been maintained in
captivity there since birth with no contact with wild animalssusceptible to rabies;
(v) in the case of dogs, have been vaccinated against canine
distemper;
(vi) be transported in a means of transport recognized for these
purposes by the competent authority of the Member States ofdispatch;
(vii) be accompanied by an individual vaccination record allowing
the animal and its origin to be clearly identified and showingthe dates of vaccination, and by a certificate corresponding toa specimen to be drawn up under the procedure laid down inArticle 26 and completed by an official veterinarian or by the
veterinarian responsible for the holding of origin and empow-
ered for this purpose by the competent authority;
b) in addition, they must:
(i) either have been vaccinated against rabies after the age of three
months and at least six months before dispatch by injection of
an inactivated vaccine of at least 1 international antigenic unit
(WHO standard) measured in accordance with the activity testby the method described by the European pharmacopoeia andrecognized under the procedure laid down in Article 26, withannual booster injection, or at intervals authorized by theMember State of dispatch for that vaccine.1992L0065 — EN — 01.01.1995 — 001.001 — 10
▼B
The vaccination must be certified by an official veterinarian or
by the veterinarian responsible for the holding of origin andempowered for this purpose by the competent authority. The
vaccination certificate must bear the name of the vaccine and
its batch number (self-adhesive label if possible).
Moreover, have undergone, following a vaccination, a serolo-
gical test showing a protective antibody titre of at least 0,5international units, which serological test should be carried outin accordance with WHO specifications. If the test is carriedout after the first vaccination it must be carried out between
the first and third month after the vaccination.
(ii) or, where the conditions provided for in (i) are not met, be sent
under supervision to a quarantine station approved by theMember State of destination to undergo a six-month period ofquarantine.
Until 1 July 1994, national regulations applicable with respect to
rabies shall remain in force, although such retention may not affectthe abolition of veterinary checks at the frontiers between MemberStates.
4. Ireland and the United Kingdom may without prejudice to para-
graphs 2 and 3, retain their national regulations on quarantine for all
carnivores, primates, bats and other animals susceptible to rabiescovered by this Directive which cannot be shown to have been bornon the holding of origin and kept in captivity since birth, although theretention of those regulations may not jeopardize the abolition of veter-inary checks at the frontiers between Member States.
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 forprogrammestocontrolrabies
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 km
2or 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 byvoluntary 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 thecriteria necessary for the standardization of the serological tests andshall decide on its responsibilities.
7. Member States shall ensure that the costs of applying the serolo-
gical test are borne by the importers.
8. This Article, and in particular the application of the serological
test provided for in paragraph 3 (b), will be reviewed before 1 January1997 in the light of developments in the rabies situation in the MemberStates.1992L0065 — EN — 01.01.1995 — 001.001 — 11
▼A1
Article 10a
As regards rabies and in accordance with the procedure laid down in
Article 26, following presentation of the appropriate grounds, Articles9 and 10 shall be amended to take account of the situation in Finlandand Sweden in order to apply to them the same provisions as applic-able to Member States in an equivalent situation.
Article 11
1. The Member States shall ensure that, without prejudice to the
decisions to be taken in implementation of Articles 21 and 23, onlysemen, ova and embryos meeting the conditions laid down in para-graphs 2, 3 and 4 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 and processed with a view to artificial insemi-
nation in a centre approved from the health point of view inaccordance with Annex D (I), or, in the case of ovine and caprineanimals by way of derogation from the above, in a holding satis-fying the requirements of Directive 91/68/EEC,
— have been collected from animals meeting the conditions laid down
in Annex D (II) (admission and routine checks on animals),
— have been collected, processed and preserved 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 deter-
mined under the procedure provided for in Article 26.
3. Ova and embryos of the ovine/caprine and equine species and of
swine must:
— have been removed by a collection team approved by the competent
authority of the Member State and processed in an appropriatelaboratory from donor females meeting the conditions laid down in
Annex D (IV),
— have been treated and stored in accordance with Annex D (III),— be accompanied during transport to another Member State by a
health certificate corresponding to a specimen to be defined underthe procedure laid down 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 equidsand with the provisions of Directive 90/429/EEC for swine. Any addi-tional guarantees may be determined under the procedure laid down in
Article 26.
4. Before 31 December 1997 the Commission shall submit a report
together with any appropriate proposals on the implementation of thisArticle in the light in particular of scientific and technological develop-ments.
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 certifi-cate. Other animals must come form holdings subject to the principlesof 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 10.1992L0065 — EN — 01.01.1995 — 001.001 — 12
▼B
▼B
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 accor-
dance 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 hasnot been complied with or there is doubt as to the health of the animalsor 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 updo notcorrespond to the actual state of the animals referred to in Article 1,that the identification of the animals or the marking of the semen, ovaand embryos in question does not comply with this Directive or thatthe 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 andfrom bodies, institutes or centres approved in accordance with Annex Cshall 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 abody, institute or centre approved in accordance with Annex C andmust 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.
(d) Each Member State shall send the Commission a list of
approved bodies, institutes and centres, together with anychanges to the list. The Commission shall forward this informa-tion to the other Member States.
(e) Sweden shall have a period of two years from the date of entry
into force of the Accession Treaty to implement the measureslaid down regarding bodies, institutes and centres.
Article 14
1. Where a Member State draws upor has drawn up , either directly
or through the breeders, a voluntary or compulsory control or moni-toring programme for one of the diseases referred to in Annex B, itmay 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 imple-
mented,1992L0065 — EN — 01.01.1995 — 001.001 — 13
▼A1
▼B
▼B
— the status categories to be applied to establishments, the require-
ments for each species when being introduced into a holding andthe 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 procedureprovided for in Article 26 in compliance with the criteria laid down inparagraph 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 theMember State implements nationally.
3. Programmes submitted by Member States may be amended or
supplemented under the procedure laid down in Article 26. Under thesame 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 whichthe animals covered by this Directive are susceptible, it shall presentto the Commission appropriate supporting documentation, setting outin particular:
— the nature of the disease and the history of its occurrence in its
territory,
— the results of surveillance testing based on serological, microbiolo-
gical, 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 concernedby 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 deci-sion 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 procedurelaid down in Article 26. They must not exceed those which theMember 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 guaranteesdefined as laid down in paragraph 2 may, in the light of such notifica-tion, be amended or withdrawn under the procedure laid down inArticle 26.1992L0065 — EN — 01.01.1995 — 001.001 — 14
▼B
CHAPTER III
ProvisionsapplicabletoimportsintotheCommunity
Article 16
The conditions applicable to imports of animals, semen, ova and
embryos covered by this Directive must be at least equivalent to thoselaid down in Chapter II.
Article 17
1. For the purposes of uniform application of Article 16, the provi-
sions of the following paragraphs shall apply.
2. Only animals, semen, ova and embryos referred to in Article 1
which satisfy the following requirements may be imported into theCommunity:
(a) they must come from a third country on a list to be drawn upin
accordance with paragraph 3 (a);
(b) they must be accompanied by a health certificate corresponding to
a specimen to be drawn up under the procedure laid down inArticle 26, signed by the competent authority of the exporting
country and certifying that the animals, semen, ova and embryos
meet the additional conditions or offer the equivalent guaranteesreferred to in paragraph 4 and come from approved centres, bodies,institutes or collection centres offering such guarantees.
3. The following shall be established under the procedure laid down
in Article 26:
(a) without prejudice to the list provided for in Article 6 (A) (1) (e), a
provisional list of third countries or parts of third countries able to
provide Member States and the Commission, before the date laiddown in Article 29, with guarantees equivalent to those providedfor in Chapter II and a list of the collection centres for which theyare able to give these guarantees.
This provisional list shall be compiled from the lists of establish-
ments approved and inspected by the competent authorities once
the Commission has checked that these establishments comply
with the principles and general rules laid down in this Directive
(b) updates of that list in the light of the checks provided for in para-
graph 4;
(c) the specific animal health requirements — in particular for the
protection of the Community from certain exotic diseases — orguarantees 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.
4. The list provided for in paragraph 3 may include only third coun-
trys 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(
1) or, in the case of the other animals covered by this
Directive, under a decision taken in accordance with the proce-dure laid down in Article 26 account being taken of their stateof health;1992L0065 — EN — 01.01.1995 — 001.001 — 15
(1) 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).
▼B
b) which, in view of their legislation and the organization of their
veterinary services and inspection services, the powers of suchservices 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 legis-lation in force;
c) the veterinary services of which are able to guarantee that health
requirements at least equivalent to those laid down in Chapter IIare 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 bythe 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 theMember 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 para-
graph 5, national rules applicable to inspection in third countries shall
continue to apply, subject to notification, through the Standing Veter-inary Committee, of any failure to comply with the guarantees offeredin 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
upunder the p rocedure laid down in Article 26,
— have satisfied the checks required by Directives 90/675/EEC and
91/496/EEC(
1),
— have undergone, prior to shipment to Community territory, a check
by an official veterinarian to ensure that the transport conditionsspecified in Directive 91/628/EEC(
2) 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 withdetailed rules to be established under the procedure laid down inArticle 26.
2. Pending the establishment of specific rules for this Article, the
national rules applicable to imports from third countries for whichsuch requirements have not been adopted at Community level shallcontinue to apply, provided they are not more favourable than thoselaid down in Chapter II.1992L0065 — EN — 01.01.1995 — 001.001 — 16
(1) Council Directive 91/496/EEC of 15 July 1991 laying down the principles
governing the organization of veterinary checks on animals entering theCommunity 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).
(
2) 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).
▼B
Article 19
The following shall be decided under the procedure laid down in
Article 26:
(a) specific animal health requirements, for imports into the Commu-
nity, and the nature and content of accompanying documents foranimals intended for zoos, circuses, amusement parks or experi-mental 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 Communityspecies concerned.
Article 20
The principles and rules laid down in Directive 90/675/EEC shall
apply, with particular reference to the organization of and follow-up
to the inspections to be carried out by the Member States and the safe-guard measures to be implemented.
Pending implementation of the decisions provided for in Article 8 (3)
and Article 30 of Directive 91/496/EEC, the relevant national rules forapplying 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
Commonfinalprovisions
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 11shall, where the need arise, be determined under the procedure laiddown 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.
Article 23
Under the procedure laid down in Article 26, special requirements may
be laid down, if appropriate, by way of derogation from Article 6 (A)
(1) (e) and from Chapter II, for the movement of circus and fairground
animals and for trade in animals, semen, ova and embryos intended forzoos.
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 certi-fying 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 MemberStates within the Standing Veterinary Committee.1992L0065 — EN — 01.01.1995 — 001.001 — 17
▼A1
▼B
▼B
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 rulesreferred to in Annex A (1) to Directive 90/425/EEC (OJ No L 268,14. 9. 1992, p. 54).’
Article 26
Where reference is made to the procedure provided for in this Article,
the Standing Veterinary Committee set upby Decision 68/361/EEC(
1)
shall act in accordance with the rules laid down in Article 17 of Direc-tive 89/662/EEC.
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, ovaand embryos which it covers, may grant one another derogations fromArticle 6 (A) (1) (f), Article 8 (b) and Article 11 (1) (d) on a reciprocalbasis.
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 thenew 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 Commissionthereof.
When these measures are adopted by the Member States, they shall
contain a reference to this Directive or shall be accompanied by suchreference on the occasion of their official publication. The methods ofmaking 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 veterinarychecks at frontiers provided for in Directive 89/662/EEC and 90/425/EEC.
Article 30
This Directive is addressed to the Member States.1992L0065 — EN — 01.01.1995 — 001.001 — 18
(1) OJ No L 255, 18. 10. 1968, p. 23.
▼B
ANNEX A
NOTIFIABLEDISEASESINTHECONTEXTOFTHISDIRECTIVE (a)
Diseases Species concerned
Newcastle disease, avian influenza Birds
Psittacosis Psittacidae
American foulbrood Bees
Foot-and-mouth disease Ruminants
Brucellosis (Brucella ssp.)
Tuberculosis
Classical swine fever Suidae
African swine fever
Foot-and-mouth disease
Rabies (b) All susceptible species
(a) Without prejudice to the notifiable diseases provided for in Annex I to Directive 82/
894/EEC.
(b) In accordance with Article 2 of Directive 89/455/EEC.1992L0065 — EN — 01.01.1995 — 001.001 — 19
▼B
ANNEX B
LIST OF DISEASES FOR WHICH NATIONAL PROGRAMMES MAY
BERECOGNIZEDUNDERTHISDIRECTIVE
Mink Viral enteritis
Aleutian disease
Bees European foulbrood
varroasis and acariasis
Apes and felids Tuberculosis
Ruminants Tuberculosis
Lagomorphs Myxomatosis
Viral haemorrhagic disease
Tularaemia1992L0065 — EN — 01.01.1995 — 001.001 — 20
▼B
ANNEX C
CONDITIONSGOVERNINGAPPROVALOFBODIES,INSTITUTESOR
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;
(b) be situated at a reasonable distance from agricultural establishments
whose health status might be jeopardized by the presence of the
approved body, institute or centre;
(c) be under the control of a veterinarian(1) who monitors the animals,
which it must be possible to catch, confine and cage at any time;
(d) have adequate quarantine facilities;
(e) have one or more appropriate premises to practise post-mortem examina-
tion;
(f) be free of the diseases listed in Annex A and, as regards the diseases
covered in the country concerned by a programme pursuant to Article
14, the diseases listed in Annex B;
(g) keepup -to-date records indicating:
— the number of animals of each species present in the establishment,
with information as to their ages,
— the number of animals arriving in the establishment or leaving it,
together with information on their transport and the animals' health,
— observations made during the quarantine period,
— the results of regular examinations of excreta,
— the results of blood tests or any other diagnostic procedures,
— cases of disease and, where appropriate, the treatment administered,
— the results of the dissection of any animals that die in the establish-
ment, including still-born animals;
h) have facilities for appropriate disposal of the bodies of animals which die
of a disease;
i) be monitored by an official veterinarian who must carry out at least two
health checks per year.
Health checks must include at least:— one inspection of all the animals in the establishment,
— representative samples taken from all the species susceptible to the
diseases referred to in Annexes A and B(
2) or detection of these
diseases by other methods. These samples must be analysed by an
approved laboratory to check whether they contain agents of the
diseases for each species in Annex A. Samples may be taken
throughout the year.
The results of the laboratory tests on the samples taken during the
health checks must reveal no evidence of the pathogens in question;
— examination of the records which must be kept.
2. Approval shall be retained where the following requirements are met:
(a) the animals brought into the establishment must come from another
approved centre, institute or body. ►A1However, a Member State
may be authorized by the Commission to allow animals of anotherorigin
to be introduced into a approved body, institute or centre where the
competent authority is unable to find a satisfactory solution for such
animals. The Member State shall submit to the Commission a plan
containing the additional veterinary guarantees applicable in such
cases;◄
(b) if animals covered by Directive 64/432/EEC are held in an approved
centre, institute or body, they may leave the establishment only under
official control;
(c) health checks in the approved centre, institute or body must be carried
out twice a year, in accordance with point 1 (h) of this Annex.1992L0065 — EN — 01.01.1995 — 001.001 — 21
(1) Responsible for day-to-day compliance with the animal health requirements of this
Directive.
(2) Inasmuch as one of these diseases is notifiable in the Member State concerned.
▼B
(d) the results of the laboratory tests on the samples must reveal no trace of
agents of the diseases referred to in Annexes A and B(1);
(e) 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(1) must be notified without delay to the competent
authority.
3. Approval may be suspended, restored or withdrawn in the following circum-
stances:
(a) where notification is given within the meaning of 2 (d) of this Annex, the
competent authority shall temporarily suspend approval of the approved
centre, body or institute;
(b) a sample taken from a suspect animal is forwarded to the approved
laboratory to test for the presence of the pathogens in question. The test
results shall immediately be forwarded to the competent authority;
(c) where the official department has been informed of suspicions as to the
presence of one of the diseases referred to in Annexes A and B (1), it
shall reacts, as regards the laboratory tests, the epizootiological examina-
tion, the measures to be taken against the disease and the withdrawal of
approval, as if the disease had been notified, in accordance with the
Directive governing measures in this field to be taken against the
diseases and trade in animals;
(d) where the test results show no signs of the pathogens concerned, the
offical department shall reinstate approval;
(e) the body, institute or centre shall again be approved only where, after
eradication of the sources of infection, the conditions laid down in point
1 of this Annex, with the exception of point 1 (f), are again fulfilled;
(f) the competent authority shall inform the Commission of the suspension,
restoration or withdrawal of approval.1992L0065 — EN — 01.01.1995 — 001.001 — 22
(1) Inasmuch as one of these diseases is notifiable in the Member State concerned.
▼B
ANNEX D
CHAPTER I
I.Conditions governing the approval of semen collection centres
Semen collection centres must:
1. be placed under the supervision of a ‘centre veterinarian’;
2. have different and physically separate premises for:
— accommodating and isolating animals,
— collecting semen,
— cleaning and disinfecting equipment,
— processing semen,— storing semen;
3. be built or kept separate in such a way as to prevent any contact with
animals outside the centre;
4. have premises such as described at 2 which are easily cleaned and disin-
fected,
II.Conditions for the supervision of semen collection centres
Semen collection centres must:
1. be monitored to ensure that only animals whose semen is to be collected
are kept there. However, other domestic animals may stay in these centres
provided they meet the general conditions set out below,
2. be monitored to ensure that a register is kept showing
— the identity of the animals present in the centre,
— any movements of animas (entering and leaving),
— the health checks made,
— the health history,— the destination of the semen,
— the storage of the semen;
3. be inspected at least twice a year by an official veterinarian to ensure that
the approval and supervision conditions are met;
4. employ competent staff who have received adequate training on disinfec-
tion and hygiene techniques to allow the spread of disease to be avoided;
5. be monitored to ensure that
— 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 properly disinfected or sterilized
before each use,
— any recipient for the storage or transport of semen is disinfected or
sterilized before use;
6. be sure to use:
— products of animal origin used in the processing of the semen (addi-
tive or diluent) which present no health risks or which have
undergone prior processing to preclude such risks,
— a cryogenic agent which has not previously been used for other
products of animal origin;
7. ensure that each quantity of semen is adequately identified in such a way
that the date of collection, the breed and the identity of the donor animal
may be established as well as the name of the approved centre which
made the collection.1992L0065 — EN — 01.01.1995 — 001.001 — 23
▼B
CHAPTER II
Conditionsapplicableincollection centres
Requirements as regards the admission of donor males
A. STALLIONS
Only stallions which, to the satisfaction of the official veterinarian, meet the
following requirements may be used for the collection of semen:
1. they must be in good health at the time of collection
2. they must satisfy the requirements of Directive 90/426/EEC and come
from holdings which also satisfy those requirements;
3. during the 60 days before the first collection they must have undergone
with negative results the following tests:
(a) to detect equine infectious anaemia, an agar-gel immunodiffusion
test, known as the ‘Coggins test’:
(b) to detect viral artheritis, a sero-neutralization test (dilution < ¼)
supplemented, in the event of a positive result, by virological exami-
nation of total semen with a negative result;
(c) to detect contagious equine metritis by isolating the Taylorella equi-
genitalis germ, at least a test of samples taken from the urethra and
the pre-ejaculatory fluid.
The result of these tests must be certified by a laboratory recognized by
the competent authority.
During the period mentioned in the first paragraph of 3 above, and during
the collection period, stallions may not be allowed do serve naturally.
B. SHEEP AND GOATS
1. Only sheepand 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 Direc-
tive 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 guar-
antee 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.
C. If any of the tests referred to in A or B proves positive, the animal must be
isolated and the semen collected from it since the last negative test may not
be placed on the market. The same applies to semen collected from the otheranimals at the holding or collection centre since the date on which the posi-
tive test was carried out. Trade may not resume until the health status of the
centre has been re-established.
CHAPTER III
Requirementsapplicabletosemen,ovaandembryos
Semen, ova and embryos must have been collected, processed, washed and
preserved with a biological product free of living micro-organisms in accor-
dance with the following principles:
(a) the washing of ova and embryos must be carried out in accordance with
Article 11 (3) of this Directive. Their pellucid zone must remain intactbefore and after washing. Only ova and embryos from one and the same
donor may be washed at any one time. After washing, the pellucid zone 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 of any
foreign body adhering to it;1992L0065 — EN — 01.01.1995 — 001.001 — 24
▼B
(b) the medium and solutions used for the collection, freezing and conservation
of ova and embryos must be sterilized in accordance with approved methods
as laid down in Article 11 (3) and handled in such a way that they remain
sterile. Antibiotics must be added to the collection, washing and conserva-
tion mediums in accordance with detailed rules to be determined under the
procedure laid down in Article 26;
(c) all materials used for the collection, handling, washing, freezing and conser-
vation of ova or embryos must be sterilized before use;
(d) they must have been subjected, in accordance with Article 11 (2), to addi-
tional tests to be established under the procedure provided for in Article 26,
in particular of the collection or washing liquids, so as to establish that no
pathogens are present;
(e) they must be kept in sterile recipients (ampoules, straws, duly identified by
a method to be established under the procedure laid down in Article 26):
— containing only products from one male or female donor,
— sealed at the time of freezing in alcohol or fresh liquid nitrogen, and
labelled,
and be placed in sterilized liquid nitrogen containers which present no risk
of contamination to the products;
f) they must be stored in approved conditions for a minimum period of 30
days prior to dispatch;
g) they must be transported in flasks which have been cleaned, disinfected or
sterilized before use.
CHAPTER IV
Donorfemales
Females may be used for the collection of embryos or ova only if they 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 breed concerned, viz. Directive 64/432/EEC for swine, Directive 90/426/
EEC for equids and Directive 91/68/EEC for ovine and caprine animals and
come from herds which also meet the said requirements.1992L0065 — EN — 01.01.1995 — 001.001 — 25
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ANNEX E
CERTIFICATE
1992L0065 — EN — 01.01.1995 — 001.001 — 26