1992L0065 — EN — 01.03.2003 — 004.001 — 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
►M1Commission Decision 95/176/EC of 6 April 1995 L 117 23 24.5.1995
►M2Commission Decision 2001/298/EC of 30 March2001 L 102 63 12.4.2001
►M3Commission Regulation (EC) No 1282/2002 of 15 July 2002 L 187 3 16.7.2002
►M4amended by Commission Regulation (EC) No 1802/2002 of 10
October 2002L 274 21 11.10.2002
Amended by:
►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 suchanimals 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, freshmeat, 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 — 01.03.2003 — 004.001 — 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 origin
particular requirements should be specified to be imposed when they
are placed on the market for the purposes of trade, particularly whenintended 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 insularposition of those countries, and the fact that they have been free ofrabies for a considerable period of time, warrants particular provisionsto ensure that the placing on the market in the United Kingdom and
Ireland of dogs and cats which do not originate in those countries
does not involve a risk of introducing rabies into those States, withouthowever affecting the abolition of veterinary checks at the frontiersbetween Member States;
Whereas a health certificate is the most appropriate means of guaran-
teeing and monitoring compliance withth ese 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 withth e 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 of
veterinary checks at the frontiers between Member States.
Article 2
1. For the purposes of this Directive:(a) ‘trade’ trademeans trade as defined by Article 2 (3) of Directive
90/425/EEC;1992L0065 — EN — 01.03.2003 — 004.001 — 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
(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 habituallykept 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 researchor 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 withoutprejudice to Article 13 and to the particular provisions to be adoptedin implementation of Article 24, be the subject of trade only if they
satisfy the conditions laid down in Articles 5 to 10 and come from
the holdings or businesses referred to in Article 12 (1) and (3) of thisDirective 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,1992L0065 — EN — 01.03.2003 — 004.001 — 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
— 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 up a control or moni-
toring programme,
— comply withth e 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 withArticle 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 areas
not subject to any ban on animal health grounds and with respectto animals not accompanied by a health certificate or a commercialdocument 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 of
disease and that his holding is not subject to any animal-health
restrictions,
— comply with the requirements ensuring the welfare of the animals
held.
Article 5
1. Member States shall ensure that trade in apes (simiae and 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 withArticle 13 and th at suchanimalsare 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 approved
body, institute or centre of apes belonging to an individual.
Article 6
A. Without prejudice to Article 14 and 15, Member States shall ensure
that ungulates of species other than those referred to in Directives64/432/EEC, 90/426/EEC and 91/68/EEC may be the subject of
trade only if they meet the following requirements:
1. in general they:
(a) must be identified in accordance withArticle 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 — 01.03.2003 — 004.001 — 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
up in accordance withArticle 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 this
Article;
(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 holding
where 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 the42 days preceding loading of the animals and in which theruminants have, in the 30 days prior to their dispatch, under-
gone withnegative 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 asregards tuberculosis. ►
A1These decisions shall take into
consideration the case of ruminants reared in the Arctic
regions of the Community; ◄
(c) in accordance withth e procedure laid down in Article 26,
provisions may be adoptedregarding leukosis;1992L0065 — EN — 01.03.2003 — 004.001 — 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 freshmeat from th ird 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
▼B
3. in the case of suidae:
(a) they must not have come from an area which is the subject
of prohibition measures associated with the presence ofAfrican swine fever in accordance withArticle 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 aresult of classical swine fever;
(c) they must come from a brucellosis-free holding in accor-
dance withDirective 64/432/EEC and satisfy th e relevant
animal 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 test
designed 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 witha negative resultmust 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 has
occurred. This test will be required for a period of twelvemonths after the occurrence of the last outbreak in thatregion;
(f) as regards classical swine fever and during a transitional
period of three years from thedate of entry into force of the
Accession Treaty, a serological test witha negative result
must be carried out on suidae for consignments for Finlandand Sweden, from a region as defined in Article 2 (o) ofDirective 64/432/EEC in which an outbreak of classicalswine fever has occurred. This test will be required for a
period of twelve months after the occurrence of the last
outbreak 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 date
of entry into force of the Accession Treaty, a serological
test witha 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 outbreakof porcine reproductive and respiratory syndrome has
occurred. This test will be required for a period of twelve
months after the occurrence of the last outbreak in thatregion. Detailed rules for applying this point shall be adoptedin accordance withth e 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 — 01.03.2003 — 004.001 — 7
▼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 withArticle 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 withan 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 — 01.03.2003 — 004.001 — 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 withth e 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-
graph1 (a) h as 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-chip identification system
implanted in accordance withdetailed rules to be laid downunder the procedure provided for in Article 26,
— have after the age of three months, been vaccinated against
rabies withan annual booster injection or, at intervals auth or-
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 — 01.03.2003 — 004.001 — 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 batchnumber (self-adh esive 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 inAnnex E supplemented by the following declaration completedby an official veterinarian or by the veterinarian responsible forthe holding of origin and empowered for this purpose by the
competent 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 (
a) and come from a holding
in which no case of rabies has been recorded in the last sixmonths.
(
a) 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 paragraph2, th e
placing on the market in the United Kingdom and Ireland of cats and
dogs not originating in those countries shall be subject to the followingconditions:
(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 conditions
provided 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 theprocedure laid down in Article 26;
(iv) have been born on the holding and have been maintained in
captivity th ere since birthwithno contact withwild 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 showing
the dates of vaccination, and by a certificate corresponding to
a specimen to be drawn up under the procedure laid down inArticle 26 and completed by an official veterinarian or by theveterinarian 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 withth e 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 dispatchfor th at vaccine.1992L0065 — EN — 01.03.2003 — 004.001 — 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 batchnumber (self-adh esive 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 withWHO specifications. If th e 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-monthperiod ofquarantine.
Until 1 July 1994, national regulations applicable withrespect 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 paragraph3 (b), will be reviewed before 1 January1997 in the light of developments in the rabies situation in the MemberStates.1992L0065 — EN — 01.03.2003 — 004.001 — 11
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Article 10a
As regards rabies and in accordance withth e 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 withfor th e 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 withAnnex D (I), or, in th e 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 withth e 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 — 01.03.2003 — 004.001 — 12
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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 animals
or the quality of the semen, ova and embryos referred to in Article 1,
carry out any checks it deems appropriate.
6. Member States shall take the appropriate administrative or penal
measures to penalize any infringement of this Directive, in particularwhere it is found that the certificates or documents drawn up do not
correspond to the actual state of the animals referred to in Article 1,
that the identification of the animals or the marking of the semen, ovaand embryos in question does not comply with this Directive or thatthe animals or products in question have not undergone the checksprovided 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 Stateof destination applies the guarantee provided for in Articles 14 and 15,and trade in semen, ova or embryos of suchanimals consigned to and
from bodies, institutes or centres approved in accordance withAnnex C
shall be subject to production of a transport document corresponding tothe specimen in Annex E. This document, which must be completed bythe 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 withAnnex C and
must accompany them during transport.
2. (a) To be approved, bodies, institutes or centres shall, as regards
notifiable diseases, submit to the competent authority of theMember State all relevant supporting documents relating to therequirements 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
withpoint 3 of Annex C.
(d) Each Member State shall send the Commission a list of
approved bodies, institutes and centres, together with any
changes 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 up or 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 — 01.03.2003 — 004.001 — 13
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— 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 withrespect 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 withth e 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 paragraph2.
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
paragraph1 and submit to th e 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 — 01.03.2003 — 004.001 — 14
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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 up in
accordance withparagraph3 (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 paragraph4 and come from approved centres, bodies,institutes or collection centres offering suchguarantees.
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, withguarantees equivalent to th ose 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-
graph4;
(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 withth e proce-dure laid down in Article 26 account being taken of their stateof health;1992L0065 — EN — 01.03.2003 — 004.001 — 15
(1) Council Directive 71/118/EEC of 15 February 1971 on health problems
affecting trade in freshpoultrymeat (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 withArticle 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 withth e guarantees offeredin accordance withparagraph3, found during th ese inspections.
Article 18
1. Member States shall ensure that the animals, semen, ova and
embryos covered by this Directive are imported into the Community
only if they:
— are accompanied by a certificate to be drawn up by the official
veterinarian.
The specimen certificate shall, depending on the species, be drawn
up under the procedure laid down in Article 26,
— have satisfied the checks required by Directives 90/675/EEC and
91/496/EEC(
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 — 01.03.2003 — 004.001 — 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, withparticular reference to th e 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 paragraph1 of th is 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 — 01.03.2003 — 004.001 — 17
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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 up by 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 withth is 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 — 01.03.2003 — 004.001 — 18
(1) OJ No L 255, 18. 10. 1968, p. 23.
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ANNEX A
NOTIFIABLEDISEASESINTHECONTEXTOFTHISDIRECTIVE
Disease Order/family/species primarily concerned
Newcastle disease, avian influenza Aves
Psitacosis PsittaciformesAmerican foulbrood ApisBrucella 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 Antiloca-
pridae
Brucella suis Cervidae, Leporidae, Ovibos
moschatus , Suidae and Tayassuidae
Mycobacterium bovis Mammalia, in particular Antiloca-
pridae, Bovidae, Camelidae, Cervidae,
Giraffidae, and Tragulidae
Foot and mouthdisease Artiodactyla and Asian eleph ants
Classical swine fever, African swine
feverSuidae and Tayassuidae
Swine vesicular disease Suidae and Tayassuidae
Rinderpest ArtiodactylaBluetongue Antilocapridae, Bovidae, Cervidae,
Giraffidae, and Rhinocerotidae
Contagious bovine pleuropneumonia Bovines (including zebu, buffalo,
bison and yak)
Vesicular stomatitis Artiodactyla and Equidae
Peste des petits ruminants Bovidae and SuidaeLumpy skin disease Bovidae and Giraffidae
Sheep and goat pox Bovidae
African horse sickness EquidaeRift valley fever Bovidae, Camelus species and Rhino-
cerotidae
Porcine enterovirus encephalomyelitis SuidaeInfectious haematopoeitic necrosis Salmonidae
TSE Bovidae, Cervidae, Felidae and
Mustelidae
Anthrax Bovidae, Camelidae, Cervidae,
Elephantidae, Equidae and Hippopota-
midae1992L0065 — EN — 01.03.2003 — 004.001 — 19
▼M3
Disease Order/family/species primarily concerned
Rabies Carnivora, and Chiroptera1992L0065 — EN — 01.03.2003 — 004.001 — 20
▼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 — 01.03.2003 — 004.001 — 21
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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 or the animals
confined and located so as not to pose a health risk to agricultural hold-
ings 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 collec-
tion are derived from approved establishments;
(d) keep up to date records indicating:
(i) the number and identity (age, sex, species and individual identifica-
tion where practical) of the animals of each species present in the
establishment;
(ii) the number and identity (age, sex, species and individual identifica-
tion 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 eutha-
nised;
(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 withth e 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 withCommunity 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 notifi-
able 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;1992L0065 — EN — 01.03.2003 — 004.001 — 22
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(h) if it keeps animals intended for laboratories carrying out experiments, in
conformity withth e 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 imple-
mentation 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 ( simiaeandprosimiae ) 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 withth e instructions
given by the competent authority before being added to the collection.
For apes (simiaeandprosimiae ) 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 certifica-
tion 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, inaccordance withCommunity 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 disin-
fection, 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.1992L0065 — EN — 01.03.2003 — 004.001 — 23
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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 at least
(a) lockable animal accommodation and if required for equidae an exer-
cise area which are physically separated from the collection facilities,
the processing and storing rooms;
(b) isolation facilities which have no direct communication with the
normal animal accommodation;
(c) semen collection facilities including a separate room for the cleansing
and disinfection or sterilization of equipment;
(d) a semen processing room separated from the collection facilities
which need not necessarily be on the same site;
(e) a semen storage room which need not necessarily be on the same site;
3. be so constructed or isolated that contact with outside livestock is
prevented;
4. be so constructed that the entire centre except the office rooms and, in the
case of equidae, the exercise area can be readily cleaned and disinfected.
II.Conditions for the supervision of semen collection centres
Semen collection centres must:1. be supervised that they contain only animals of the species whose semen
is to be collected;
However, other domestic animals may be admitted, provided that they
present no risk of infection to those species whose semen is to be
collected and they fulfil the conditions laid down by the centre veteri-
narian.
If in the case of equidae the collection centre shares a site with an artifi-
cial insemination or service centre, then mares, teaser stallions and
stallions for natural service are admitted provided they meet the require-
ments 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, treat-
ments 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 disinfec-
tion 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 ster-
ilized prior to use or new, disposable and discarded after use,1992L0065 — EN — 01.03.2003 — 004.001 — 24
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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 insemina-
tion 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 suchas 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 disin-
fected 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.
CHAPTER II
Conditionsapplicableincollection centres
Requirements as regards the admission of donor males
A. STALLIONS
Only a stallion which to the satisfaction of the centre veterinarian meets the
following requirements may be used for the collection of semen:
1. it must not show any sign of an infectious or contagious disease at the
time of admission and on the day the semen is collected;
2. it must come from the territory or, in the case of regionalization, from the
part of the territory of a Member State or a third country and from a
holding under veterinary supervision each of which satisfy the require-
ments 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 paragraph7:
(i) an agar-gel immuno-diffusion test (Coggins test) for equine infec-
tious anaemia withnegative result;
(ii) a serum neutralization test for equine viral arteritis. Unless a nega-
tive result at a serum dilution of 1 in 4 is achieved, a virus
isolation test for equine viral arteritis shall be carried out with nega-
tive result on an aliquot of the entire semen of the donor stallion;
(iii) a test for contagious equine metritis carried out on two occassions
withan interval of seven days by isolation of Taylorella equigen-
italisfrom pre-ejaculatory fluid or a semen sample and from genital
swabs taken at least from the penile sheath, urethra and urethral
fossa withnegative result in eachcase;
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 withequidae of lower h ealth
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.1992L0065 — EN — 01.03.2003 — 004.001 — 25
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— and the donor stallion is not continuously resident on the collec-
tion 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. Further-
more, 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 paragraph7 (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
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 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 withth e 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, that animal must be
isolated and the semen, collected from it since the last negative test shall not
be subject of trade. The same applies to semen collected from the other
animals susceptible to the disease concerned at the holding or collection
centre since the date on which the positive test was carried out. Trade shall
not resume until the health status of the centre has been re-established.
CHAPTER III
Requirementsapplicabletosemen,ovaandembryos
Semen, ova and embryos must have been collected, processed and preserverd in
accordance withth e following principles:
(a) The washing of ova and embryos even in the case of equidae must be
carried out in accordance withconditions 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 exam-
ined 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 necessary1992L0065 — EN — 01.03.2003 — 004.001 — 26
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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 appro-
priate 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 collec-
tion, the species, the breed, the identity of the donor animal and the name
and/or the number of the collection centre/team may be established.
(f) Frozen semen, ova and embryos must be placed in sterile liquid nitrogen
containers which present no risk of contamination to the product.
(g) Frozen semen, ova and embryos must be stored in approved conditions for a
minimum period of 30 days prior to dispatch.
(h) Semen, ova and embryos must be transported in containers which either
have been cleaned, disinfected or sterilized as appropriate before use or are
new, disposable and discarded after use.
CHAPTER IV
Donorfemales
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 veteri-
narian, 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 provi-
sions 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 hold-
ings 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 collec-
tion of ova or embryos.1992L0065 — EN — 01.03.2003 — 004.001 — 27
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ANNEX E
Part1
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Part2
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Part3
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