CELEX: 51983PC0512
Language: en
Date: 1983-09-20
Title: PROPOSAL FOR A COUNCIL DIRECTIVE ON ANIMAL HEALTH PROBLEMS AFFECTING INTRA-COMMUNITY TRADE AND IMPORTS FROM THIRD COUNTRIES OF SEMEN OF DOMESTIC ANIMALS OF THE BOVINE AND PORCINE SPECIES

6. 10. 83                              Official Journal of the European Communities                          N o C 267/5
                                                              II
                                                      (Preparatory Acts)
                                                COMMISSION
              Proposal for a Council Directive on animal health problems affecting intra-Community
              trade and imports from third countries of semen of domestic animals of the bovine and
                                                       porcine species
                           (Submitted by the Commission to the Council on 26 September 1983)
THE COUNCIL OF THE EUROPEAN                                       between Member States it is now necessary to achieve
COMMUNITIES,                                                      a harmonized system when semen is traded between
                                                                  Member States and when imported from third
                                                                  countries into the Community;
Having regard to the Treaty establishing the
European Economic Community, and in particular
Article 43 thereof,
                                                                  Whereas in the context of intra-Community trade in
                                                                  semen the Member State where the semen is collected
Having regard to the proposal from the Commission,                should be under an obligation to ensure that such
                                                                  semen has been collected and processed at approved
                                                                  and supervised semen collection centres, has been
Having regard to the opinion of the European
                                                                  obtained from animals whose health status is such as
Parliament,
                                                                  to ensure that the risk of spread of animal disease is
                                                                  eliminated, has been collected, processed, stored and
Having regard to the opinion of the Economic and                  transported in accordance with rules which preserve
Social Committee,                                                 its health status and is accompanied during transport
                                                                  to the country of destination by an animal health
                                                                  certificate;
Whereas rules relative to problems of animal health
concerning intra-Community trade in bovine animals
and swine are already in force pursuant to Council
Directive 64/432/EEC (*), as last amended by                      Whereas, while awaiting harmonized rules for the
Directive 82/61 / E E C ( 2 ); whereas, in addition, rules        control and eradication of foot and mouth disease
exist in relation to problems of animal health when               within the Community, those Member States which
bovine animals and swine are imported from third                  do not practise vaccination against that disease and
countries into the Community pursuant to Council                  which do not allow vaccinated animals on their
Directive 72/462/EEC (3), as last amended by                      territory should be afforded additional safeguards;
Directive 83/91 / E E C ( 4 );                                    whereas in order to protect the Community as a
                                                                  whole from blue tongue disease and African swine
                                                                  fever, specific requirements should be laid down by
Whereas, by means of the aforesaid rules it has been              means of the procedure of the Standing Veterinary
possible to ensure that, in trade in bovine animals and           Committee if and when a Member State becomes
swine between Member States and to Member States                  infected with either of these diseases;
from third countries, animal health criteria have been
certified by the exporting country so that the risk of
spreading animal disease has been virtually
eliminated; whereas a certain risk of spread of animal            Whereas       Community      arrangements     regarding
disease exists when semen is traded;                              veterinary experts should be introduced to provide a
                                                                   means of settling problems between Member States
                                                                   concerning the implementation of this Directive;
Whereas in continuation of the Community policy of                whereas a Community procedure should be provided
harmonizing Member States' national rules on animal                under which Member States may have the possibility
health when animals and their products are traded                  of refusing entry in respect of consignments of semen
                                                                   if the rules of the Directive are not followed or if
C) OJ No   121, 29. 7. 1964, p. 1977/64.                           there is suspicion of the presence of, or of contami-
O OJ No    L 29, 6. 2. 1982, p. 13.                                nation by, infectious animal disease in the
(3) OJ No  L 302, 31. 12. 1972, p. 28.                             consignment or if an outbreak of epizootic disease
(*) OJ No  L 59, 5. 3. 1983, p. 34.                                occurs in the consigning Member State;
 ---pagebreak--- No C 267/6                           Official Journal of the European Communities                              6.10. 83
Whereas for imports of semen into the Community                 (c) 'designated veterinarian' means the veterinarian
from third countries a list of suitable third countries              designated by the competent authority of the
or parts thereof should be drawn up taking into                      Member State or of the third country to be
account certain animal health criteria; whereas                      responsible for the routine observance of the
notwithstanding such a list the Member States should                 provisions of this Directive on a semen collection
authorize importation of semen only from semen                       centre;
collection centres which reach certain standards and
which are officially supervised; whereas, in addition,
in respect of countries or parts thereof on the list,           (d) 'consignment' means a quantity of semen covered
specific animal health conditions should be laid down                by the same certificate;
according to circumstances;
                                                                (e). 'Member State of collection' means the Member
Whereas in order to verify whether the provisions of                 State in which semen is collected and from which
the Directive are being implemented in third countries               it is sent to another Member State;
inspections should be undertaken on the spot;
Whereas safeguards concerning inter alia blue tongue            (f) 'third country of collection' means the third
disease and African swine fever should also be                       country in which semen is collected and from
possible in respect of third countries; whereas official             which it is sent to the Community;
certification should be provided in respect of each
consignment; whereas Member States should subject
each importation to an import control to ensure that            (g) 'Member State of destination' means the Member
the provisions of the Directive have been complied                   State to which semen is sent from another
with; whereas Member States may reject                               Member State or from a third country;
consignments of semen inter alia if epizootic disease
occurs in the third country or part thereof;
                                                                (h) 'officially tuberculosis-free bovine herd' means a
                                                                     bovine herd which satisfies the conditions laid
Whereas provision should be made for the gradual                     down in Annex A (I) to Directive 64/432/EEC;
implementation of this Directive particularly, in
relation to existing stocks of frozen semen; whereas
during this transitional period national animal health          (i) 'officially brucellosis-free bovine herd' means a
rules should continue to apply,                                      bovine herd which satisfies the conditions laid
                                                                     down in Annex A (II) (A) (1) to Directive
                                                                     64/432/EEC;
HAS ADOPTED THIS DIRECTIVE:
                       CHAPTER I                                (j) 'brucellosis-free swine herd' means a swine herd
                                                                     which satisfies the conditions laid down in Annex
                                                                     A (II) (B) (2) to Directive 64/432/EEC;
                   General provisions
                        Article 1                               (k) 'officially swine fever-free holding' means a
                                                                     holding as defined in Article 2 (p) of Directive
                                                                     64/432/EEC;
This Directive shall apply to animal health problems
affecting intra-Community trade and imports from
third countries of semen of domestic animals of the             (1) 'approved laboratory* means a , laboratory
bovine and porcine species.                                           situated in the territory of a Member State or
                                                                      third country designated by the competent
                                                                     veterinary authority to carry out the test or tests
                        Article 2
                                                                      required in this Directive.
 For the purposes of this Directive:
                                                                 (m) 'third country' means any country in which
 (a) 'semen* means the ejaculate of a domestic animal                 Directive 64/432/EEC does not apply;
      of the bovine or porcine species;
 (b) 'semen collection centre' means an officially               (n) 'official veterinarian' means the veterinarian
      approved and supervised establishment situated                  appointed by the competent authority of the
      in the territory of a Member State or in the                    Member State or third country to check the
      territory of a third country in which semen is                  conditions of approval and the supervision of a
      produced for use in artificial insemination;                    semen collection centre.
 ---pagebreak--- 6. 10. 83                           Official Journal of the European Communities                            No C 267/7
                       CHAPTER II                              be permitted to enter intra-Community trade.
                                                               However, according to the procedure laid down in
             Intra-Community trade in semen                    Article 17, it may be decided that under specific
                                                               conditions such semen may enter intra-Community
                         Article 3                             trade. In deciding, consideration shall be given to the
                                                               following points:
1. Each Member State shall ensure that only semen
complying with the following general conditions is             (a) the health status of the area surrounding the
sent from its territory to the territory of another                 semen collection centre and vector survival
Member State:                                                       therein;
(a) it must have been collected and processed for the          (b) the health status of the herd in the semen
     purpose of artificial insemination in a semen                  collection centre, including testing requirements;
     collection centre approved and supervised for the
     purpose of intra-Community trade in accordance            (c) the health status of the donor animal and testing
     with Article 4 (1);                                            requirements; and
(b) it must have been collected from domestic                  (d) testing requirements in relation to semen.
     animals of the bovine or porcine species whose
     health status is in accordance with the provisions
     of Annex B;                                                                        Article 4
(c) it must have been collected, processed, stored and         1. The Member State on whose territory the semen
     transported in accordance with the provisions of          collection centre is situated shall ensure that the
     Annexes A and C;                                          approval provided for in Article 3 (1) (a) is granted
(d) it must be accompanied, during transport to the            only where the provisions of Annex A are observed
     country of destination, by an animal health certi-        and where that semen collection centre is able to
     ficate in accordance with Article 5(1).                   satisfy the other provisions of this Directive. The
                                                               Member State shall also ensure that an official veter-
2. Without prejudice to such provisions as the                 inarian supervises the observance of those provisions
Community may adopt in relation to the control and             and shall withdraw approval when one or more of the
eradication of foot and mouth disease, Member                  provisions is no longer observed.
States which do not practice vaccination against foot
and mouth disease and which by way of derogation               2. All semen collection centres shall be registered
from Directive 64/432/EEC do not allow on their                on a list, each centre having an approval number.
territory animals vaccinated against the said disease          Each Member State shall communicate the list of
may, prior to the introduction of semen into their             semen collection centres and their approval numbers
territory and while complying with the general                 to the other Member States and to the Commission
provisions of the Treaty, require that:                        and notify them without delay of any withdrawal of
                                                               approval.
(a) donor animals are located in semen collection
     centres in which no foot and mouth disease vac-           3. When a Member State considers that the
     cination has taken place within the 30 days               provisions governing approval are not, or are no
     immediately prior to collection of semen for              longer, observed in a semen collection centre in
     intra-Community trade;                                    another Member State, it shall inform the competent
(b) when on the same centre vaccinated and unvac-              authority of that State accordingly. The latter shall
     cinated animals are kept, the latter shall be             take all necessary measures and notify the competent
     housed separately and semen therefrom shall be            authority of the other Member State of the decisions
     certified as having come from unvaccinated                taken and the reasons for such decisions.
     animals;
                                                               If that other Member State fears that the necessary
(c) when the donor animals have been vaccinated                measures have not been taken or are inadequate, it
     within the 12 months immediately prior to                 may so inform the Commission, which shall seek the
     collection, an aliquot of semen from each                 opinion of one or more veterinary experts. In the
     ejaculate shall be subject to a virus isolation test      light of that opinion, Member States may be auth-
     for foot and mouth disease with negative results.         orized under the procedure laid down in Article 18 to
                                                               prohibit provisionally the introduction into their
 3. Semen from semen collection centres situated in             territory of semen coming from that centre.
 Member States in which blue tongue disease, in the
case of bovine semen, and African Swine fever, in the           Such authorization may be withdrawn under the
 case of porcine semen, have been recorded shall not            procedure laid down in Article 18 in the light of a
 ---pagebreak--- N o C 267/8                         Official Journal of the European Communities                              6. 10. 83
new opinion delivered by one or more veterinary                4.     If, after the introduction of semen into the
experts.                                                       territory of the Member State of destination, facts
                                                               come to light which would have justified the
Veterinary experts must be nationals of a Member               application of paragraph 3, the competent veterinary
State other than those involved in the dispute.                authority of the Member State of collection must, at
                                                               the request of the competent veterinary authority of
After consulting the Member States, the Commission             the Member State of destination, make the necessary
shall lay down general rules for applying this                 investigations and notify the latter authority without
paragraph, in particular as regards the appointment of         delay of the outcome of such investigations.
veterinary experts and the procedure to be followed
as regards delivery of opinions by them.                       5.     The decisions taken by the competent veterinary
                                                               authority under paragraphs 2 and 3 must be
                                                               communicated to the consignor or his representative,
                        Article 5
                                                               together with the reasons for such decisions. These
                                                               reasoned       decisions    must,    on  request,     be
1.    Each Member State shall authorize semen of               communicated to him forthwith in writing with an
bovine animals and swine to be imported only on                indication of what appeals against them are open
submission of an animal health certificate in                  under current legislation and the form and time in
accordance with Annex D drawn up by a designated               which they must be commenced. The decisions must
veterinarian of the Member State of collection.                also be communicated to the competent veterinary
                                                               authority of the Member State of collection.
This certificate must:
                                                                                         Article 6
(a) be drawn up in the official languages of the
    Member State of collection and of the Member
    State of destination;                                      1.     A Member State may, if there is a danger of
                                                               animal diseases spreading as a result of the intro-
(b) accompany the consignment to its destination;              duction of semen into its territory from another
                                                               Member State, take the following measures:
(c) be drawn up on a single sheet of paper;
                                                               (a) in the event of an outbreak of an epizootic
(d) be made out to a single consignee.                             disease in the other Member State, temporarily
                                                                   prohibit or restrict the introduction of semen
2. (a) The Member State of destination may prohibit                 from the affected areas of that Member State;
        the introduction of consignments of semen of
        bovine animals or swine into its territory if the      (b) if an epizootic disease becomes widespread or if
        documentary      control   reveals    that    the           there is an outbreak of a new serious naturally
        provisions of Article 3 (1) (d) have not been               transmissible animal disease, temporarily prohibit
        observed.                                                   or restrict the introduction of semen from the
                                                                    entire territory of that State.
   (b) The Member State of destination may take the
        necessary measures, including storage in
                                                               2.     Each Member State must immediately inform
        isolation, to ascertain the position as regards
                                                               the other Member States and the Commission of the
        semen suspected of being affected              or
                                                               outbreak on its territory of any disease referred to in
        contaminated by a contagious or infectious
                                                               paragraph 1, and of the measures taken to control it.
        animal disease.
                                                               It must also notify them immediately of the
                                                               elimination of the disease.
   (c) Decisions taken under points (a) or (b) above
        must, at the request of the consignor or his
        representative, authorize the return of the            3.     Measures taken by the Member States under
        semen provided this is not contrary to                 paragraph 1 and the repeal of such measures must be
        considerations of animal health.                       communicated immediately to the other Member
                                                               States and the Commission together with the reasons
                                                               therefor.
3.    If the introduction of semen has been prohibited
on any of the grounds set out in paragraph 2 (a) and
(b) and the Member State of collection does not                Under the procedure laid down in Article 18 a
within 30 days authorize the return thereof, the               decision may be taken to repeal or amend those
competent veterinary authority of the Member State             measures in particular in order to coordinate them
of destination may order the semen to be destroyed.            with measures adopted by other Member States.
 ---pagebreak--- 6. 10. 83                            Official Journal of the European Communities                             No C 267/9
4.     If the situation envisaged in paragraph 1 arises              adjacent to the country, which might endanger
and if it appears necessary that other Member States                 animal health in the Member States;
also apply the measures taken under that paragraph,
amended, where necessary, pursuant to paragraph 3,              (b) the regularity and rapidity of the information
appropriate measures shall be adopted under the                      supplied by the third country relating to the
procedure laid down in Article 18.                                   existence of contagious animal diseases in its
                                                                     territory, in particular those diseases mentioned in
                         Article 7                                   lists A and B of the International Office of
                                                                     Epizootic Diseases;
1.     Rights of appeal existing under current
                                                                (c) the rules of the country on the prevention and
legislation in the Member States against decisions
                                                                     control of animal diseases;
taken pursuant to this Directive by the competent
authority shall not be affected by this Directive.              (d) the structure of the veterinary services in the
                                                                     country and their powers;
2.     Each Member State shall grant to consignors in
respect of whose consignments of semen such                     (e) the organization and implementation of measures
measures as are provided for in Article 5 (2) have                   to prevent and control contagious animal
been taken, the right to obtain, before other measures               diseases; and
are taken by the competent authority, the opinion of
a veterinary expert to determine whether the                    (f) the guarantees which the third country can give
conditions of Article 5 (2) have been fulfilled.                     with regard to compliance with the provisions of
                                                                     this Directive.
The veterinary expert must be a national of a
Member State other than the Member State of
                                                                                          Article 9
collection or of destination.
The Commission, acting on a proposal from the                   1.     In accordance with the procedure laid down in
Member States, shall draw up a panel of veterinary              Article 17 one or more lists shall be drawn up of
experts who may be instructed to formulate such                 semen collection centres from which Member States
opinions. After consulting the Member States it shall           may authorize the importation of semen from third
lay down general rules which are to be applied, in              countries. The list or lists may be amended or
particular as regards the procedure for formulation of          supplemented according to the same procedure.
these opinions.
                                                                2.     In deciding whether a semen collection centre in
                                                                a third country may appear on the lists referred to in
                       CHAPTER III                              paragraph 1 particular account shall be taken of the
                                                                veterinary control of semen production systems in the
                                                                third country, the powers of the veterinary services
          Imports of semen from third countries                 and the supervision to which semen collection centres
                                                                are subject.
                         Article 8                              3.     A semen collection centre shall appear on the
                                                                list or lists provided for in paragraph 1 only if:
                                                                (a) it is situated in one of the countries on the list
 1.    The Council, acting on a proposal from the
                                                                     referred to in Article 8 (1);
Commission, shall draw up a list of third countries or
parts thereof from which the Member States shall                (b) it has been officially approved for exports to the
 authorize importation of semen of bovine animals and                 Community by the veterinary services of the third
 swine taking into account the health situation in those             country concerned;
 countries or parts thereof. This list may be
 supplemented or amended according to the procedure              (c) it is under the supervision of a designated veteri-
 laid down in Article 17.                                             narian of the third country concerned; and
                                                                (d) it is subject to regular inspection by an official
 2.     In deciding whether a third country or part                  veterinarian of the third country concerned at
 thereof may appear on the list referred to in                        least twice per year.
 paragraph 1 particular account shall be taken of:
                                                                                          Article 10
 (a) the state of health of the livestock, other domestic
      animals and wildlife in the third country,                 1.     Semen of bovine animals and swine must come
      particular attention being paid to exotic animal           from animals which immediately prior to collection of
      diseases, and of the health situation of areas             their semen have remained in the territory of part of
 ---pagebreak--- No C 267/10                          Official Journal of the European Communities                               6. 10. 83
the territory of a third country on the list established        2.    The certificate must correspond to a specimen
in accordance with Article 8 (1) for not less than six          drawn up in accordance with the procedure laid
months.                                                         down in Article 17.
2.     Notwithstanding the provisions of Article 8 (1),                                  Article 12
and paragraph 1 above, the Member States shall
authorize the importation of semen of bovine animals            1.     Member States shall ensure that              each
and swine from a third country or part of a third               consignment of semen entering the georgraphical
country on the list only if the semen complies with             territory of the Community is subjected to an import
the animal health requirements adopted in accordance            control before it is placed under any temporary or
with the procedure set out in Article 17 for imports of         final customs procedure except the procedure for
semen from that country according to the species of             external transit, and shall prohibit the introduction of
animal concerned.                                               such semen into the Community if the import control
                                                                made on arrival reveals that:
In adopting such requirements in relation to blue
tongue disease and African swine fever consideration            — the semen does not come from the territory, or
shall be given to the following points:                             part thereof, of a third country included on the
                                                                    list drawn up in accordance with Article 8 (1),
(a) the health status of the area surrounding the
     semen collection centre and vector survival                — the semen does not come from a semen collection
     therein;                                                       centre included on the list provided for in Article
                                                                    9(1),
(b) the health status of the herd in the semen
     collection centre including testing requirements;          — the semen comes from a territory, or part thereof,
                                                                    of a third country from which imports are
(c) the health status of the donor animal and testing               prohibited in accordance with Article 15,
     requirements; and
                                                                — the animal health certificate which accompanies
(d) testing requirements in relation to semen.                      the semen is not in conformity with the provisions
                                                                    of Article 11.
3.     The reference basis for fixing animal health
conditions in accordance with paragraph 2 for bovine            2.     The Member State of destination may take the
tuberculosis and bovine and swine brucellosis shall be          necessary measures, including storage in isolation, to
the standards laid down in Annex A to Directive                 ascertain the position as regards semen suspected of
64/432/EEC. It may be decided, in accordance with               being affected or contaminated by a contagious or
the procedure laid down in Article 17 on a case-by-             infectious animal disease.
case basis, to waive these conditions where the third
country concerned provides similar animal health                3.     If the introduction of semen has been prohibited
guarantees. In that case, animal health conditions at           on any of the grounds set out in paragraphs 1 and 2
least equivalent to those in Annex A to that Directive          above and the exporting third country does not
shall be laid down in accordance with the same                  within 30 days authorize the return thereof, the
procedure.                                                      competent veterinary authority of the Member State
                                                                of destination may order the semen to be destroyed.
                        Article 11
                                                                                         Article 13
 1.    Member States shall authorize semen of bovine
animals and swine to be imported only on submission             Each consignment of semen authorized for intro-
of an animal health certificate drawn up by a                   duction into the Community by a Member State on
designated veterinarian of the third country of                 the basis of the controls referred to in Article 12 (1)
collection.                                                     must, when sent to the territory of another Member
                                                                State, be accompanied by the original certificate or an
This certificate must:                                          authenticated copy thereof, suitably endorsed, in
                                                                either case, by the competent veterinary authority
 (a) be drawn up in the language of the third country           which was responsible for the examination carried out
     of collection and in at least one of the official          in accordance with Article 12.
      languages of the Member State of destination;
                                                                                         Article 14
 (b) accompany the semen in the original;
 (c) be drawn up on a single sheet of paper;                    All expenditure incurred as a result of the application
                                                                 of Articles 12 and 13 and in particular the cost of
 (d) be made out to a single consignee.                          controlling the semen, storage costs and the cost of
 ---pagebreak--- 6.10.83                             Official Journal of the European Communities                          NoC267/ll
any destruction of semen shall be chargeable to the            accordance with the provisions of Article 5 of
consignor, the consignee or their agent, without               Directive 72/462/EEC has taken place. The
compensation by the State.                                     Commission shall inform the Member States of the
                                                               results of the investigation.
                        Article 15                             A Member State in whose territory a check is being
                                                               carried out shall give all necessary assistance to the
 1.   Notwithstanding the provisions of Article 8, if in       experts in carrying out their duties.
a third country a contagious animal disease which can
                                                               The general provisions for implementing this Article
be carried by semen breaks out or spreads and
                                                               shall be determined in accordance with the procedure
endangers the health of the livestock in one of the
                                                               laid down in Article 17.
Member States or if any other reasons connected with
animal health so justifies, the Member State of                In accordance with the same procedure, a code shall
destination concerned shall prohibit the importation           be established containing the rules to be followed for
of that semen, whether imported directly or indirectly         the purpose of the checks provided for in this
through another Member State, either from the whole            paragraph.
of the third country or from part of its territory.
                                                               2.    Before 1 January 1988, the Council shall review
2.    Measures taken by the Member States under                this Article on the basis of a report from the
paragraph 1 and notice of the withdrawal of such               Commission, which may also submit proposals in this
measures, must be communicated immediately to the              connection.
other Member States and the Commission, together
with the reasons therefor.
                                                                                       Article 17
The Standing Veterinary Committee shall meet as
                                                               1.    Where the procedure laid down in this Article is
soon as possible after such communication and shall
                                                               to be followed, matters shall be referred by the
decide, in accordance with the procedure laid down
                                                               chairman, either on his own initiative or at the
in Article 18, whether these measures should be
                                                               request of a Member State, to the Standing
amended, in particular in order to coordinate them
                                                               Veterinary Committee (hereinafter called 'the
with measures adopted by other Member States, or
                                                               Committee') set up by Council Decision 68/361/
withdrawn.
                                                               EEC 0).
If the situation envisaged in paragraph 1 arises and if
it appears necessary that other Member States also             2.    Within the Committee the votes of Member
apply the measures taken under that paragraph,                 States shall be weighted as provided for in Article 148
amended where necessary in accordance with the                 (2) of the Treaty. The chairman shall not vote.
preceding subparagraph, appropriate measures shall
be adopted under the procedure laid down in Article            3.    The representative of the Commission shall
18.                                                            submit a draft of the measure to be adopted. The
                                                               Committee shall deliver its opinion on such measures
                                                               within two days. Opinions shall be delivered by a
3.    Resumption of importation from the third                 majority of 45 votes.
country concerned shall be authorized in accordance
with the same procedure.
                                                               4.    The Commission shall adopt the measures and
                                                               shall apply them immediately where they are in
                      CHAPTER IV                               accordance with the opinion of the Committee. If
                                                               they are not in accordance with the opinion of the
                                                               Committee or if no opinion is delivered, the
                   Common provisions                           Commission shall immediately submit to the Council
                                                               the measures to be adopted. The Council shall adopt
                        Article 16                             the measures by a qualified majority.
                                                               If, within three months from the date on which the
                                                               proposal was submitted to it, the Council has not
 1.   Veterinary experts from the Commission may,              adopted any measures, the Commission shall adopt
in so far as is necessary to ensure uniform application        the proposed measures and apply them immediately,
of this Directive, make on-the-spot checks; they may           save where the Council has decided by a simple
verify whether approved semen collection centres are           majority against those measures.
actually complying with this Directive, particularly
with Annexes A, B and C. However, verification of
compliance with the provisions of Article 8 (2) shall
not be obligatory where an on-the-spot inspection in           O OJ No L 255, 18. 10. 1968, p. 23.
 ---pagebreak--- NoC267/12                                Official Journal of the European Communities                                  6.10.83
                           Article 18                                  the proposed measures and apply them immediately,
                                                                       save where the Council has decided by a simple
1.    Where the procedure laid down in this Article is                 majority against those measures.
to be followed, matters shall without delay be
referred by the chairman, either on his own initiative                                         Article 19
or at the request of a Member State, to the
Committee.                                                             1.     The provisions of Articles 3, 4, 5, 6 and 7 shall
                                                                       not be applicable to semen collected and processed in
2.    Within the Committee the votes of the Member                     a Member State before 1 January 1985.
States shall be weighted as provided for in Article 148
                                                                       2.     The provisions of Articles 8, 9, 10, 11, 12, 13,
(2) of the Treaty. The chairman shall not vote.
                                                                       14 and 15 shall not be applicable to semen collected
                                                                       and processed in a third country before 1 January
3.    The representative of the Commission shall
                                                                       1985.
submit a draft of the measures to be adopted. The
Committee shall deliver its opinion on such measures                   3.     Until the date of entry into force of the
within two days. Opinions shall be delivered by a                      provisions referred to in Article 9 the Member States
majority of 45 votes.                                                  shall not apply to imports of semen from third
                                                                       countries more favourable conditions than those
4.    The Commission shall adopt the measures and                      resulting from Chapter II concerning intra-
shall apply them immediately where they are in                         Community trade.
accordance with the opinion of the Committee.
Where they are not in accordance with the opinion of                                           Article 20
the Committee or if no opinion is delivered, the
Commission shall immediately submit to the Council                     The Member States shall bring into force the laws,
a proposal regarding the measures to be adopted. The                   regulations and administrative provisions necessary to
Council shall adopt the measures by a qualified                        comply with this Directive on 1 January 1985, and
majority.                                                              shall immediately inform the Commission thereof.
If, within 15 days from the date on which the                                                  Article 21
proposal was submitted to it, the Council has not
adopted any measures, the Commission shall adopt                       This Directive is addressed to the Member States.
                                                              ANNEX A
                                                             CHAPTER I
                                       Conditions for the approval of semen collection centres
              Semen collection centres must:
              (a) have at their disposal at least:
                    (i) animal accommodation including isolation facilities,
                   (ii) semen collection facilities including a separate disinfection room,
                  (iii) a semen processing room,
                  (iv) a semen storage room;
              (b) be so constructed or insulated that contact with outside livestock is prevented;
              (c) be so constructed that the animal housing, and the semen collecting, processing and storing
                  facilities are readily capable of being cleansed and disinfected;
              (d) be so constructed that the health of the animals contained therein is catered for;
              (e) have at their disposal isolation accommodation which shall have no direct communication with
                  the normal animal accommodation;
              (f) be so designed that the animal accommodation is physically separate from the semen processing
                  room and both are separate from the semen storage room.
 ---pagebreak--- 6. 10. 83                             Official Journal of the European Communities                                 N o C 267/13
                                                         CHAPTER II
                               Conditions relating to the supervision of semen collection centres
          The collection centres must:
          (a) be so supervised that only animals of the species whose semen is to be collected are contained
              therein;
          (b) be so supervised that a register is kept of all animals at the centre, giving details of the breed,
              date of birth and identification of each of the animals;
          (c) be subject to regular inspection by an official veterinarian at least twice per year, at which time
              the conditions of approval and supervision shall be checked;
          (d) be so supervised that the entry of unauthorized persons is prevented. However, authorized
              visitors shall be permitted, according to the conditions laid down by the designated veterinarian;
          (e) employ technically competent staff suitably trained in disinfection procedures and hygiene
              techniques relevant to the control of the spread of disease;
          (f) be so supervised that:
                  (i) only semen collected at an approved centre is processed and stored in an approved centre,
                      without coming into contact with any other semen. However, semen not collected in an
                      approved collection centre may be processed at an approved collection centre provided this
                      is done at a separate time and with separate equipment,
                 (ii) collection, processing and storage of semen takes place only in the accommodation set
                      aside for the purpose under conditions of the strictest hygiene,
                (iii) all pieces equipment having contact with the semen or the donor animal during collection
                      and processing are appropriately disinfected prior to use,
                (iv) products of animal origin used in the processing of semen are obtained from sources which
                      present no animal health risk to the species of animal in question or are so treated prior to
                      use that such risk is prevented,
                 (v) storage flasks and transport flasks are appropriately disinfected prior to commencement of
                      filling,
                (vi) the cryogenic agent used has not been previously used for other products of animal origin,
               (vii) each individual dose of semen is clearly marked in such a way that the date of collection,
                      breed and identification of donor animal may be readily established.
                                                           ANNEX B
                                                          CHAPTER I
                     Conditions to be met prior to entry of animals into approved semen collection centres
           1. All animals entering a semen collection centre shall:
              (a) have been subjected to a period of isolation of at least 30 days in accommodation specifically
                    approved for the purpose by the competent authority of the Member State;
 ---pagebreak--- N o C 267/14                              Official Journal of the European Communities                                6.10. 83
                (b) prior to entry into the isolation described in (a) above have been obtained from herds which
                    satisfy the following conditions:
                    — in the case of bovine animals they are:
                           (i) officially tuberculosis free,
                          (ii) officially brucellosis free or brucellosis free,
                        (iii) herds in which no facts have been brought to the notice of the designated veteri-
                               narian which would lead him to conclude that a case of enzootic bovine leukosis has
                               occurred within the three preceding years;
                    — in the case of swine they are brucellosis free.
                    Further in the case of swine they have been obtained from an officially swine fever-free
           ^        holding.
               (c) following at least 30 days in isolation described at (a) above and within 30 days prior to
                    entering the semen collection centre have been subjected to the following tests with negative
                    results:
                    — in the case of bovine animals:
                           (i) an intradermal tuberculin test carried out in accordance with the procedure laid
                               down in Annex B of Council Directive 64/432/EEC,
                         (ii) a serum agglutination test complying with the procedure laid down in Annex C of
                               Council Directive 64/432/EEC and have shown a brucella count of lower than 30
                               international units (iu) of agglutination per millilitre,
                        (iii) a serological test for enzootic bovine leukosis carried out in accordance with the
                               procedure laid down in Annex G of Council Directive 64/432/EEC,
                        (iv) a fluorescent antibody test for Campylobacter fetus infection on a sample of preputial
                               material or vaginal washings or, test mating of maiden heifers. In the case of female
                               animals a vaginal mucus agglutination test shall be carried out,
                         (v) a microscopic and cultural test for Trichomonas foetus on a sample of preputial
                               washings. In the case of females the test shall be done on a sample of
                               vaginal washings;
                    — in the case of swine:
                         (i) a sero-agglutination test in accordance with the provisions of Annex C of Council
                              Directive 64/432/EEC showing a brucella count lower than 30 iu of agglutination
                              per millilitre,
                        (ii) a complement fixation test in accordance with the provision of Annex C of Council
                              Directive 64/432/EEC;
               (d) a serum neutralization test for Aujeszky's disease.
            2. Tests, where appropriate, shall be carried out in a laboratory approved by the Member State.
            3. (i) If an animal intended for entry to a semen collection centre has undergone a period of
                    individual isolation and has reacted positively to:
                    (a) the tests for tuberculosis, brucellosis or enzootic bovine leukosis it shall not be permitted
                         to enter the semen collection centre,
                    (b) the tests for campylobacteriosis, trichomoniasis or Aujeszky's disease it shall not be
                         permitted to enter the semen collection centre but may be subjected to a further period
                         of isolation and if similar tests carried out after this period prove to be negative it may
                         then enter.
               (ii) If an animal entering a semen collection centre has undergone a period of group isolation
                    and has reacted positively to:
                    (a) the tests for tuberculosis, brucellosis, and enzootic bovine leukosis none of the group
                         shall be permitted to enter the semen collection centre. Eligibility of the non-reacting
                         animals in the group may be re-established according to the provisions of Annex B,
                         Chapter I, paragraph 1 (b) and (c) of this Directive,
 ---pagebreak--- 6.10. 83                              Official Journal of the European Communities                               N o C 267/15
                  (b) the test for campyiobacteriosis, trichomoniasis or Aujeszky's disease the procedure at 3
                       (i) (b) above may be applied to any or all of the animals in the group.
         4. Animals entering the semen collection centre shall do so only with the express permission of the
            designated veterinarian. All movements both in and out shall be recorded.
         5. All animals entering the semen collection centre shall show no clinical sign of disease on the day
            of consignment and shall have been obtained from isolation accommodation which on the day of
            consignment officially fulfils the following conditions:
              (i) is situated in the centre of an area 20 km in diameter in which for at least 30 days there has
                   been no incidence of foot and mouth disease and in addition, in the case of swine, are
                   situated in the centre of an area two km in diameter in which for at least 15 days there has
                   been no incidence of swine fever, swine vesicular disease or contagious swine paralysis
                   (Teschen disease);
             (ii) has for at least three months been free from foot and mouth disease and brucellosis in the
                   case of bovine animals and foot and mouth disease, swine vesicular disease, bovine and
                   porcine brucellosis, swine fever and contagious porcine paralysis (Teschen disease) in the
                   case of swine;
            (iii) has for at least 30 days been free from all other compulsorily notifiable diseases which are
                   contagious or infectious for the animal species in question according to Annex E of Council
                   Directive 64/432/EEC.
         6. Provided the conditions of paragraph 5 above are satisfied and the routine tests referred to in
            Chapter II have been carried out during the previous 12 months, animals may move from one
            semen collection centre to another without isolation and test provided the movement is direct,
            the animal in question does not come in contact, direct or indirect, with ruminating animals and
            swine of a lower health status and the means of transport has been desinfected. If the movement
            from one semen collection centre to another takes place between Member States it shall take
            place without prejudice to Council Directive 64/432/EEC.
                                                         CHAPTER II
         1. Routine test to be applied to all bovine animals on an approved semen collection centre.
            All bovine animals kept on an approved semen collection centre shall be subjected at least once
            per year to the following tests or treatments.
               (i) an intradermal tuberculin test for tuberculosis carried out in accordance with the procedure
                   laid down in Annex B of Council Directive 64/432/EEC with negative results;
              (ii) a serum agglutination test for brucellosis giving a count of lower than 30 iu of agglutination
                   per millilitre when carried out in accordance with the procedure laid down in Annex C of
                   Council Directive 64/432/EEC;
             (iii) a serological test for enzootic bovine leukosis with negative results carried out in accordance
                   with the procedure laid down in Annex G of Council Directive 64/432/EEC;
             (iv) a serum neutralization test for infectious bovine rhinotracheitis/infectious pustular vulvo-
                   vaginitis with negative results or, in the case of an animal giving a positive reaction to this
                    test, within 30 days following the test and prior to collection of semen, to a virus isolation
                    test for infectious bovine rhinotracheitis virus with negative results;
              (v) a fluorescent antibody test for Campylobacter fetus on preputial material or vaginal washings
                    with negative results, or in the case of females a vaginal mucus agglutination test or, sheath
                    lavage with an antibiotic suspension active against Campylobacter fetus on each of three
                    consecutive days;
             (vi) a microscopic and cultural test for Trichomonas foetus on a sample of preputial material.
 ---pagebreak--- No C 267/16                           Official Journal of the European Communities                                 6. 10. 83
           2. Routine tests to be applied to all swine on approved semen collection centres.
              All swine kept on an approved semen collection centre shall be subjected at least once per year to
              the following tests:
                (i) a serum agglutination test for brucellosis and show a brucella count of lower than 30 iu of
                    agglutination per millilitre when carried out in accordance with the procedure laid down in
                    Annex C of Council Directive 64/432/EEC;
               (ii) a negative complement fixation reaction when given a serological examination for
                    brucellosis in accordance with the procedure laid down in Annex C of Council Directive
                    64/432/EEC;
              (iii) a serum neutralization test for Aujeszky's disease with negative results;
              (iv) a serum neutralization test for swine fever with negative results, except where swine have
                    been derived from officially swine fever-free holdings.
           3. Tests, where appropriate, shall be carried out in a laboratory approved by the Member State.
           4. Where a donor animal gives a positive reaction to any of the routine tests outlined in paragraphs
              1 and 2 above, semen from that animal collected since the date of the most recent negative test
              of that animal for the disease in question shall not be permitted to enter intra-Community trade.
                                                           ANNEX     C
           Conditions relating to the semen collected at approved semen collecting centres for the purpose of
                                                     intra-Community trade
           1. Semen shall be obtained from animals which:
              (a) show no clinical sign of disease on the day of collection;
              (b) have not been vaccinated against foot and mouth disease within the 30 days immediately
                   prior to collection;
              (c) have been resident on an approved semen collection centre for a continuous period of at
                   least six months in the case of bovine semen and for at least three months in the case of
                   porcine semen immediately prior to collection;
              (d) are not allowed to serve naturally;
              (e) are located in semen collection centres which on the day of collection are situated in the
                   centre of an area of 20 km in diameter in which for at least 30 days there has been no
                   incidence of foot and mouth disease and in addition, in the case of swine, are situated in the
                   centre of an area two km in diameter in which for at least 15 days there has been no
                   incidence of swine fever, swine vesicular disease, or contagious porcine paralysis (Teschen
                   disease);
              (f)    (i) are located in semen collection centres, in the case of frozen semen, which for at least
                         three months prior to collection until 30 days after collection have been free from foot
                         and mouth disease in the case of bovine semen and foot and mouth disease, swine
                         vesicular disease, bovine and porcine brucellosis, swine fever and contagious porcine
                         paralysis (Teschen disease) in the case of porcine semen,
                    (ii) are located in semen collection centres which, in the case of fresh porcine semen for at
                         least three months prior to collection until the day of consignment have been free from
                         foot and mouth disease, swine vesicular disease, bovine and porcine brucellosis, swine
                         fever and contagious swine paralysis (Teschen disease),
                   (iii) are located in semen collection centres where, if all bovine animals are not seronegative
                         for IBR/IPV, the donor bull is seronegative on the day of collection or the semen
                         therefrom has been subjected to a virus isolation test with negative results;
 ---pagebreak--- 6.10. 83                            Official Journal of the European Communities                                  N o C 267/17
            (g) are located in semen collection centres which have been free from all other compulsorily
                 notifiable diseases which are infectious or contagious for the animal species in question
                 according to Annex E of Council Directive 64/432/EEC during the period commencing 30
                 days prior to collection until 30 days after collection.
         2. Semen for intra-Community trade shall:
              (i) be stored in approved accommodation for a minimum period of 30 days prior to dispatch
                  except in the case of fresh porcine semen;
             (ii) be transported to the Member State of destination in flasks which have been cleansed and
                  disinfected before use and which have been suitably sealed prior to dispatch from the
                  approved storage accommodation.
            (iii) be sent direct to the place of loading under the responsibility of the designated veterinarian.
 ---pagebreak--- N o C 267/18                         Official Journal of the European Communities                                          6. 10. 83
                                                          ANNEX D
                                                    Animal Health Certificate
             for trade between Member States of the EEC in semen of animals of the bovine and porcine species
                                                                                               No
            Country of collection:
           Competent authority:
           Competent local authority:
           I. Identification ofsemen:
                Species of donor animal:
                    No of doses        Date(s) of          Identification of
                                       collection           donor animal                      Breed          Date of birth
           II. Origin of semen:
                Address of semen collection centre(s):
                Approval number of semen collection centre(s):
           III. Destination of semen:
                The semen will be sent from
                                                                                   (place of loading)
                                                                          (country and place of destination)
                by
                                                            (means of transport)
                Name and address of consignor:
                Name and address of consignee:
            IV. I, the undersigned designated veterinarian, certify that:
                1. The semen described above was collected, processed and stored under conditions which
                    comply with the standards laid down in Directive . . . / . . ./EEC;
                2. The semen described above was sent to the place of loading in a sealed container under
                    conditions which satisfy the provisions of Directive . . . / . . ./EEC.
            Done at                                                                            on
                                                                              (Signaturet)
                          Seal
                                                                         (Name in block letters)