This document is meant purely as documentation tool and the institutions do not assume any liability for its contents
"B COUNCIL DIRECTIVE
of 28 January 1991
on animal health conditions governing intra-Community trade in ovine and caprine animals
(91/68/EEC)
(OJ L 46, 19.2.1991, p. 19)
Amended by:
Official Journal
No page date
"M1 Commission Decision 94/164/EC of 18 February 1994 L 74 42 17.3.19941991L0068 — EN — 01.05.1994 — 001.001 — 1
COUNCIL DIRECTIVE
of 28 January 1991
on animal health conditions governing intra-Community trade in ovine
and caprine animals
(91/68/EEC)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic Community,
and in particular Article 43 thereof,
Having regard to the proposal 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 the harmonious operation of the common organization of the market
in ovine and caprine animals will not have the results expected of it as long as
disparities between Member States as regards health conditions act as a
restraint on intra-Community trade;
Whereas in order to encourage such trade it is advisable to remove those
disparities and introduce Community-wide rules on the marketing of ovineand caprine animals in such trade; whereas that objective will also contribute
to the completion of the single market;
Whereas in order to be eligible for intra-Community trade, ovine and caprine
animals should meet certain animal health requirements designed to avoid the
spread of infectious or contagious diseases;
Whereas the animal health requirements applicable should vary depending on
the purpose for which the animals are traded;
Whereas the health situation for ovine and caprine animals is not the same
throughout the territory of the Community; whereas reference should
therefore be made to ‘regions’ as defined in Council Directive 64/432/EEC
of 26 June 1964 on animal health problems affecting intra-Community tradein bovine animals and swine (
4), as last amended by Directive 90/425/EEC (5),
when dealing with parts of that territory;
Whereas there must be no barriers to trade between regions in which the
animal health conditions are equivalent;
Whereas provision should be made for allowing the Commission to approve
certain additional requirements in the light of the progress made by a MemberState in eradicating certain diseases, provided that those requirements in nocase exceed those applied nationally by the Member State concerned;
Whereas in order to avoid the spread of infectious or contagious diseases,
conditions should be laid down as regards the transportation of the animals to
their place of destination;
Whereas in order to ensure that the requirements applicable are complied
with, provision should be made for introducing a health certificate whichwould be issued by an official veterinarian and which would accompany ovine
and caprine animals until they reach their place of destination;
Whereas reference should be made, as regards the organization and follow up
of the checks to be carried out by the Member States and as regards the
protective measures to be introduced, to the general rules laid down inCouncil Directive 90/425/EEC of 26 June 1990 concerning veterinary and
zootechnical checks applicable in intra-Community trade in certain live
animals and products with a view of the completion of the internal market;
Whereas provision should be made for allowing the Commission to conduct
its own checks;!B
(1) OJ No C 48, 27. 2. 1989, p. 21.
(2) OJ No C 96, 17. 4. 1989, p. 187.
(3) OJ No C 194, 31. 7. 1989, p. 9.
(4) OJ No 121, 29. 7. 1964, p. 1977/64.
(5) OJ No L 224, 18. 8. 1990, p. 29.1991L0068 — EN — 01.05.1994 — 001.001 — 2
Whereas a procedure should be introduced which provides for close and
efficient cooperation between the Member States and the Commission withinthe Standing Veterinary Committee,
HAS ADOPTED THIS DIRECTIVE:
Article 1
This Directive defines the animal health conditions governing intra-Commu-
nity trade in ovine and caprine animals.
Article 2
For the purposes of this Directive, the definitions laid down in Article 2 of
Directive 64/432/EEC shall apply, with the addition of the following:
1. ovine or caprine animals for slaughter means animals of the ovine or
caprine species intended to be taken either directly or via an approved
market or assembly centre to a slaughterhouse in order to be slaughteredthere under the conditions laid down in Article 6 of Directive
64/432/EEC;
2. ovine or caprine animals for breeding and fattening: ovine and caprine
animals other than those mentioned in point 1 intended to be transportedto the place of destination, either directly or via an approved market orassembly centre;
3. holding: a holding as defined in Article 2 (4) of Directive 90/425/EEC;
4. officially brucellosis-free ovine or caprine holding means a holding
which satisfies the conditions laid down in heading I, Chapter 1 of AnnexA;
5. brucellosis-free ovine or caprine holding means a holding which satisfies
the conditions laid down in Chapter 2 of Annex A;
6. trade means trade between Member States within the meaning of Article
9 (2) of the Treaty;
7. compulsorily notifiable disease means a disease as listed under Sections I
and II of Annex B, the suspicion or appearance of which must be notifiedto the competent authorities of the Member State;
8. official veterinarian means a veterinarian designated by the competent
central authority of the Member State;
9. approved market or assembly centre means any place, other than the
holding, where ovine or caprine animals are sold, bought and/orassembled or loaded, and which complies with Article 3 (7) of Directive
64/432/EEC and Article 5 (1) (b) (i) of Directive 90/425/EEC for
approved markets or assembly centres;
10. region means a part of the territory of the Community as defined in
Article 2 (o) of Directive 64/432/EEC.
Article 3
1. Ovine and caprine animals for slaughter may be the subject of trade only
if they fulfil the conditions laid down in Article 4.
2. Ovine and caprine animals for breeding and fattening may be the subject
of trade only if they fulfil the conditions laid down in Articles 4, 5 and 6,without prejudice to any additional guarantees which may be required
pursuant to Articles 7 and 8.
However, the competent authorities of Member States of destination may
grant general or limited derogations in respect of movement of ovine andcaprine animals for breeding and fattening, intended solely for temporarypasturing near internal borders of the Community. Member States making use
of such derogation shall inform the Commission of the content of the
derogations granted.!B1991L0068 — EN — 01.05.1994 — 001.001 — 3
Article 4
1. Ovine and caprine animals:
(a) must be identified and registered in accordance with the requirements of
Article 3 (1) (c) of Directive 90/425/EEC; the time limit for notifying the
national systems for identifying and registering ovine and caprine
animals begins running from the date of adoption of this Directive;
(b) must show no clinical sign of disease when inspected by an official
veterinarian, such inspection must take place during the 48 hours
preceding the loading of the ovine and caprine animals;
(c) must not come from a holding which is the subject of a prohibition on
health grounds and must not have been in contact with animals from such
a holding, it being understood that:
(i) such prohibition shall be linked to an outbreak of any of the
following diseases to which the animals are susceptible:
— brucellosis,
— rabies,
— anthrax,
(ii) after slaughter of the last animal suffering from or susceptible to one
of the above diseases, the period of prohibition must be at least:
— 42 days in a case of brucellosis,
— 30 days in a case of rabies,
— 15 days in a case of anthrax,
and must not come from a holding or have been in contact with animals
from a holding situated in an established protection zone and from which
animals are forbidden to leave pursuant to Article 3 (2) (b) (ii) ofDirective 64/432/EEC;
(d) must not be the subject of animal health restrictions applied pursuant to
Council Directive 85/511/EEC of 18 November 1985 introducingCommunity measures for the control of foot-and-mouth disease (
1), as
amended by Directive 90/423/EEC (2).
Furthermore, the provisions of Article 4a of Directive 64/432/EEC shall
apply.
2. Member States shall also ensure that the following are not the subject of
trade:
— ovine and caprine animals which might have to be slaughtered under a
national programme for the eradication of diseases not referred to in
Annex C to Directive 90/425/EEC or in Chapter I of Annex B to thisDirective,
— ovine and caprine animals which cannot be marketed on their own
territory for health or animal health reasons justified by Article 36 of theTreaty.
3. Ovine and caprine animals must also:
— either have been born and reared since birth in the territory of the
Community,
— or, if they have been imported, come from a third country included on the
list drawn up in accordance with Article 3 of Council Directive72/462/EEC of 12 December 1972 on health and veterinary inspection
problems upon importation of bovine animals and swine and fresh meat
and meat products from third countries (
3), as last amended by Directive
90/425/EEC, and
(i) either meet the animal health conditions laid down in accordance
with Article 8 of Directive 72/462/EEC,!B
(1) OJ No L 315, 26. 11. 1985, p. 11.
(2) OJ No L 224, 18. 8. 1990, p. 13.
(3) OJ No L 302, 31. 12. 1972, p. 28.1991L0068 — EN — 01.05.1994 — 001.001 — 4
(ii) or, in the absence of such conditions, be subject to compliance with
the conditions laid down in Article 7 (2) second, third and fourthsubparagraphs of Directive 90/425/EEC.
Article 5
Without prejudice to the additional guarantees that may be required in
accordance with Articles 7 and 8, ovine and caprine animals for breeding and
fattening must, in addition to the conditions laid down in Article 4, meet — inorder to be introduced onto an officially brucellosis-free or brucellosis-freeovine or caprine holding — respectively the requirements of Chapter I.D or
Chapter 2.D of Annex A.
Article 6
Without prejudice to the additional guarantees that may be required in
accordance with Articles 7 and 8, animals for breeding must furthermore meet
the following requirements:
(a) They must have been obtained from a holding and must only have been in
contact with animals from such a holding:
(i) in which the following diseases have not been clinically diagnosed:
— in the previous six months, contagious agalactia of sheep
(Mycoplasma agalactiae) or contagious agalactia of goats
(Mycoplasma agalactiae, M. capricolum, M. Mycoïdes var.
mycoïdes ‘large colony’),
— in the previous 12 months, paratuberculosis or caseous
lymphadenitis,
— in the previous three years, pulmonary adenomatosis, Maedi
Visna or caprine viral arthritis/encephalitis. However, this periodshall be reduced to 12 months if the animals infected with Maedi
Visna or caprine viral arthritis/encephalitis have been slaught-
ered and the remaining animals have reacted negatively to twotests recognized under the procedure set out in Article 15,
or which, without prejudice to compliance with the requirements for
other diseases, provides, for one or more of the abovementioned
diseases, within the framework of a programme approved in
accordance with Articles 7 and 8, health guarantees which areequivalent for the said disease or diseases;
(ii) where no facts suggesting that the requirements of point (i) have not
been met, have been brought to the attention of the official
veterinarian responsible for issuing the health certificate;
(iii) whose owner states that he has no knowledge of any such facts and,
moreover, states in writing that the animal or animals intended forintra-Community trade comply with the criteria laid down in point
(i);
(b) in addition, with regard to scrapie, they must:
(i) come from a holding satisfying the following requirements:
— the holding is subject to official checks in accordance with
Article 3 (1) (b) of Directive 90/425/EEC,
— the animals must be marked,— no case of scrapie has been confirmed for at least two years,— checking by sampling must be carried out at slaughter on old
ewes, intended for culling coming from that holding, exceptwhere that holding is situated in a region or a Member State
benefiting from conditions to be adopted in accordance with
Article 8,
— female animals may only be introduced into that holding if they
come from a holding which complies with the same require-
ments;
(ii) have been continuously kept on a holding or holdings complying
with the requirements laid down in (i) since birth or for the last twoyears;!B1991L0068 — EN — 01.05.1994 — 001.001 — 5
(iii) when they are destined for a Member State which benefits, for all or
part of its territory, from the provisions laid down in Articles 7 or 8,satisfy the guarantees furnished pursuant to those Articles;
(c) whith regard to contagious epidydimitis (B. ovis) , non castrated rams, for
breeding, must:
— come from a holding where no case of contagious epidydimitis (B.
ovis) has been diagnosed in the preceding 12 months,
— have been continuously kept on that holding for 60 days prior to
dispatch,
— in the 30 days prior to dispatch have undergone, with negative
results, a serological test carried out in accordance with Annex D orsatisfy equivalent health guarantees to be recognized under theprocedure laid down in Article 15;
(d) the certificate corresponding to Model III of Annex E states that these
requirements have been met.
Article 7
1. A Member State which has a compulsory or voluntary national control
programme or a national monitoring programme for one of the infectious orcontagious diseases referred to in Annex B, Sections II and III for all or part
of its territory may submit the said programme to the Commission, outlining
in particular:
— the distribution of the disease in the Member State,— the reasons for the programme, taking into consideration the importance
of the disease and the programme’s likely benefit in relation to its cost,
— the geographical area in which the programme will be implemented,— the various status categories to be applied to the holdings, the standards
which must be attained in each category, and the test procedures to beused,
— the programme monitoring procedures,— 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 in
accordance with the provisions of the programme are positive.
2. The Commission shall examine the programmes presented by the
Member States. Programmes as referred to in paragraph 1 may be approved,
in compliance with the criteria laid down in paragraph 1, in accordance with
the procedure provided for in Article 15. According to the same procedure,the additional guarantees, general or limited, which may be required in
intra-Community trade, shall be defined at the same time or at the latest three
months after approval of the programmes. Such guarantees must not exceedthose which the Member State implements nationally.
3. Programmes submitted by Member States may be amended or
supplemented in accordance with the procedure laid down in Article 15.
Amendments or additions to programmes which have already been approved
or to guarantees which have been defined in accordance with paragraph 2 maybe approved under the same procedure.
4. Programmes approved in accordance with this Article shall benefit from
the Community funding provided for in Article 24 of Council Decision
90/424/EEC of 26 June 1990 on expenditure in the veterinary field (
1) for the
diseases and under the conditions laid down therein.
Article 8
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, Sections II and III to whichovine and caprine animals are susceptible, it shall present to the Commission
appropriate supporting documentation, setting out in particular:
— the nature of the disease and the history of its occurrence in its territory,!B
(1) OJ No L 224, 18. 8. 1990, p. 19.1991L0068 — EN — 01.05.1994 — 001.001 — 6
— the results of surveillance testing based on serological, microbiological,
pathological or epidemiological investigation and on the fact that thedisease must by law be notified to the competent authorities,
— the period over which the surveillance was carried out,
— where applicable, the period during which vaccination against the disease
has been prohibited and the geographical area concerned by such
prohibition,
— the arrangements for verifying the absence of the disease.2. The Commission shall examine supporting documentation submitted by
Member States. The additional guarantees, general or limited, which may be
required in intra-Community trade shall be defined in accordance with theprocedure laid down in Article 15. Such guarantees must not exceed thosewhich the Member State implements nationally. Where supporting docu-
mentation is submitted before 1 January 1992, decisions on additional
guarantees shall be taken before 1 July 1992.
3. The Member State concerned shall notify the Commission of any change
in the supporting documentation specified in paragraph 1 which relate to the
disease. The guarantees defined as laid down in paragraph 2 may, in the lightof such notification, be amended or withdrawn in accordance with theprocedure laid down in Article 15.
Article 9
In trade between Member States, ovine and caprine animals must, during
transportation to the place of destination, be accompanied by a healthcertificate, signed by an official veterinarian, which conforms to Annex E(Models I, II and III), and which must be drawn up, on the day of the
inspection provided for in Article 4 (1) (b), in at least one of the official
languages of the Member State of destination, and be valid for 10 days. Thecertificate shall consist of a single sheet.
Article 10
1. The rules laid down in Directive 90/425/EEC shall apply, in particular to
checks at origin, to the organization of, and follow-up to, the checks to be
carried out by the Member State of destination, and to the protective measuresto be implemented.
2. In Annex A, heading I of Directive 90/425/EEC the following reference
is added:
‘Council Directive 91/68/EEC of 28 January 1991 on animal health
conditions governing intra-Community trade in ovine and caprineanimals,
OJ No L 46, 19. 2. 1991, p. 19.’
3. In Annex B point A of Directive 90/425/EEC, the first indent is deleted.
Article 11
1. Veterinary experts from the Commission may, to the extent necessary to
ensure uniform application of this Directive and in cooperation with the
competent national authorities, carry out on-the-spot inspections. The
Member State on whose territory inspections are carried out shall afford allnecessary aid to the experts in the accomplishment of their task. TheCommission shall inform the Member States of the outcome of such
inspections.
2. General arrangements for the application of this Article shall be adopted
in accordance with the procedure laid down in Article 15.
The rules applicable in respect of the inspections referred to in this Article
shall be laid down in accordance with the same procedure.!B1991L0068 — EN — 01.05.1994 — 001.001 — 7
Article 12
Member States which implement an alternative control system providing
guarantees equivalent to those laid down in Article 5 and Article 6 (a) and (c)as regards movements within their territory of ovine and caprine animals may
grant one another derogations from the inspection provided for under Article
4 (1) (b) and the obligation to produce a certificate provided for under Article9 on a reciprocal basis. They shall notify the Commission thereof.
Article 13
The provisions of this Directive shall be re-examined before 1 January 1993 in
the framework of the proposals relating to the completion of the internal
market, on which the Council will decide by a qualified majority.
Article 14
Annex A shall be amended by the Council, acting by a qualified majority on a
proposal from the Commission.
Annexes B, C and D shall be amended in accordance with the procedure laid
down in Article 15.
Article 15
1. Where the procedure laid down in this Article is to be followed, the
chairman shall refer the matter without delay to the Standing Veterinary
Committee set up by Decision 68/361/EEC (
1) hereinafter referred to as the
‘Committee’, either on his own initiative or at the request of the representative
of a Member State.
2. (a) The representative of the Commission shall submit to the Committee
a draft of the measures to be taken. The Committee shall deliver itsopinion on the draft within a time limit which the Chairman may lay
down according to the urgency of the matter. The opinion shall be
delivered by the majority laid down in Article 148 (2) of the Treaty inthe case of decisions which the Council is required to adopt on aproposal from the Commission. The votes of the representatives of
the Member States within the Committee shall be weighted in the
manner set out in that Article. The Chairman shall not vote.
The Commission shall adopt the measures envisaged if they are in
accordance with the opinion of the Committee.
(b) If the measures envisaged are not in accordance with the opinion of
the Committee or if no opinion is delivered, the Commission shall,
without delay, submit to the Council a proposal relating to the
measures to be taken. The Council shall act by a qualified majority.
If, on the expiry of three months from the date of referral to the Council, the
Council has not acted, the proposed measures shall be adopted by the
Commission, save where the Council has decided against the said measures by
a simple majority.
Article 16
The Commission may, in accordance with the procedure laid down in Article
15, adopt — for a period of three years — the transitional measures necessary
to facilitate the changeover to the new arrangements provided for in this
Directive.
Article 17
1. Member States shall bring into force the laws, regulations and
administrative provisions necessary to comply with:
(i) Articles 7 and 8 of this Directive two months after the notification date
thereof, it being understood that the corresponding national provisions
shall continue to apply until the approval of the programmes and in theabsence of programmes until the date referred to in (ii);
(ii) the other provisions of this Directive not later than 31 December 1992.!B
(1) OJ No L 255, 18. 10. 1968, p. 23.1991L0068 — EN — 01.05.1994 — 001.001 — 8
2. When Member States adopt these measures, they shall contain a
reference to this Directive or shall be accompanied by such reference onthe occasion of their official publication. The methods of making such areference shall be laid down by the Member States.
Article 18
This Directive is addressed to the Member States.!B1991L0068 — EN — 01.05.1994 — 001.001 — 9
ANNEX A
CHAPTER 1
I. Officially brucellosis (B. melitensis) -free ovine or caprine holding
A. Grant of status
An officially brucellosis (B. melitensis) -free ovine or caprine holding
means
1. a holding:
(a) in which all the animals which are susceptible to brucellosis (B.
melitensis) have been free from clinical or any other signs of
brucellosis (B. melitensis) for at least 12 months;
(b) which contains no ovine or caprine animals which have been
vaccinated against brucellosis (B. melitensis), save those
vaccinated at least two years previously with Rev. 1 vaccine or
any other vaccine approved under the procedure laid down in
Article 15 of this Directive;
(c) in which two tests separated by an interval of six months or more
have been carried out, with negative results, in accordance withAnnex C on all ovine and caprine animals on the holding over sixmonths of age at the time of testing; and
(d) in which, following the tests referred to in point (c), there are
only ovine or caprine animals born on the holding or which havecome from an officially brucellosis-free or brucellosis-freeholding under the conditions laid down in point D,
and in which, after qualification, the requirements laid down in point
B continue to be fulfilled;
2. a holding situated in an officially recognized brucellosis-free Member
State or region in accordance with point II.
B. Maintenance of status
1. In the case of officially brucellosis (B. melitensis) -free ovine or
caprine holdings which are not situated in a part of the territory which
is recognized as officially brucellosis-free, and in which, afterqualification, the introduction of animals is carried out in accordancewith the requirements of point D, a representative number of the ovineand caprine animals over six months old must be checked annually.The holding may retain its officially brucellosis (B. melitensis) -free
status if the results of the tests are negative.
The representative number of animals to be tested must, for each
holding, consist of the following:
— all non-castrated male animals over six months old,— all animals brought onto the holding since the previous test,
— 25 % of the females which have reached the age of reproduction
(i.e. which are sexually mature) or are in milk, with a minimumof 50 per holding — except in holdings where there are fewerthan 50 such females, in which case all females must be tested.
2. For a region which is not officially brucellosis-free where more than
99 % of the ovine or caprine holdings are declared to be officially
brucellosis (B. melitensis) -free, the frequency of checks of officially
brucellosis-free ovine or caprine holdings may be extended to threeyears, provided that the holdings which are not officially brucellosisfree are placed under official control or undergo an eradicationprogramme.
C. Suspected or actual cases of brucellosis
1. Where, on an officially brucellosis-free ovine or caprine holding,
(a) one or more ovine or caprine animals are suspected of having
brucellosis (B. melitensis), the holding’ s officially brucellosis-
free status must be withdrawn by the competent authority.
However, that status may be provisionally suspended if the
animal or animals are immediately destroyed or isolated, pendingofficial confirmation of the disease or an official quashing of thesuspicion of that disease;!
B1991L0068 — EN — 01.05.1994 — 001.001 — 10
(b) brucellosis (B. melitensis) is confirmed, the provisional suspen-
sion may be lifted by the competent authority only if all animalsinfected or all the animals of species susceptible to infection areslaughtered and two tests, separated by an interval of at leastthree months or more, and carried out in accordance with AnnexC on all the animals of the holding over six months old, give
negative results.
2. If the holding referred to in paragraph 1 is in a region which is
recognized as officially free from brucellosis (B. melitensis), the
Member State concerned must immediately inform the Commissionand the other Member States.
The competent authority of the Member State concerned must:(a) slaughter all infected animals and all animals of species
susceptible to infection on the holding concerned. The MemberState concerned must keep the Commission and the otherMember States informed of the development of the situation;
(b) conduct an epidemiological enquiry, and the herds linked
epidemiologically to the infected herd must undergo the tests
laid down in point 1 (b).
3. Should an outbreak of brucellosis be confirmed in accordance with
point 2, the Commission after having assessed the circumstances of
the renewed outbreak of brucellosis (B. melitensis) shall adopt, if that
assessment so justifies, under the procedure laid down in Article 15, adecision suspending or withdrawing the status of that region. If thestatus is withdrawn, the conditions for a new qualification shall bespecified in accordance with the same procedure.
D. Introduction of animals onto an officially brucellosis (B. melitensis)- free
ovine or caprine holding
Ovine or caprine animals may not be introduced into an ovine or caprine
holding which is officially free from brucellosis unless they either:
1. — come from an officially brucellosis-free ovine or caprine
holding;
2. or:
— come from a brucellosis-free holding and,
— are identified individually in accordance with Article 4 (1) (a) of
this Directive,
— have never been vaccinated against brucellosis or if they have
been vaccinated, were so vaccinated more than two years
previously. However, females over two years old which werevaccinated before the age of seven months may also be broughtonto the holding, and
— were isolated under official supervision on the holding of origin
and, during such isolation underwent, with negative results, twotests separated by an interval of at least six weeks in accordancewith Annex C.
II. Officially brucellosis-free Member State or region
Any Member State or region within the meaning of Article 2 (10) of this
Directive may be recognized, under the procedure laid down in Article 15, asbeing officially brucellosis-free:
1. (a) in which at least 99,8 % of the ovine or caprine holdings are officially
brucellosis-free holdings;
or
(b) which fulfils the following conditions:
(i) ovine or caprine brucellosis is a disease that has been
compulsorily notifiable for at least five years;
(ii) no case of ovine or caprine brucellosis has been officially
confirmed for at least five years;
(iii) vaccination has been prohibited for at least three years; and
(c) for which compliance with these conditions has been established
under the procedure set out in Article 15 of this Directive;!
B1991L0068 — EN — 01.05.1994 — 001.001 — 11
2. in which the conditions set out in point 1 have been satisfied; and
(i) each year, random checks carried out at either holding or slaughter-
house level, show with a confidence rating of 99 % that less than 0,2
% of the holdings were infected, or at least 10 % of the ovine andcaprine animals of over six months of age have undergone a testcarried out in accordance with Annex C with negative results;
(ii) the conditions for qualification continue to be fulfilled.
CHAPTER 2
Brucellosis (B. melitensis) -free ovine or caprine holding
A. Grant of status
A. An ovine or caprine holding is considered to be brucellosis (B.
melitensis) -free:
1. in which:
(a) all the animals susceptible to brucellosis (B. melitensis) have
been free from clinical or other signs of brucellosis for at least 12months;
(b) all or some of the ovine or caprine animals have been vaccinated
with Rev. 1 vaccine or any other vaccine approved under theprocedure laid down in Article 15 of this Directive. The
vaccinated animals must have been vaccinated before the age of
seven months;
(c) two tests separated by an interval of six months or more have
been carried out, with negative results, in accordance with Annex
C, on all vaccinated ovine and caprine animals on the holdingwhich are over 18 months old at the time of testing;
(d) two tests separated by an interval of six months or more have
been carried out, with negative results, in accordance with AnnexC, on all non-vaccinated ovine and caprine animals on theholding which are over six months old at the time of testing; and
(e) after the tests referred to under points (c) or (d) have been carried
out, all the ovine and caprine animals on the holding were eitherborn there or come from a brucellosis-free holding under theconditions laid down in section D; and
2. in which the requirements laid down under B continue to be fulfilled
once it has qualified as brucellosis-free.
B. Maintenance of status
An annual test must be carried out on a representative number of the ovine
and caprine animals on each holding. The holding may retain its statusonly if the tests are negative.
The representative number of animals to be tested must, for each holding,
consist of:
— all non-castrated male animals over six months old which have not
been vaccinated,
— all non-castrated male animals over 18 months which have been
vaccinated,
— all animals brought onto the holding since the previous test,
— 25 % of females which are of reproductive age (sexually mature) or in
milk, with a minimum of 50 per holding — except in holdings wherethere are fewer than 50 such females, in which case all these females
must be tested.
C. Suspected or actual cases of brucellosis
1. The brucellosis-free status of an ovine or caprine holding must be
withdrawn if the holding contains one or more ovine or caprineanimals which are suspected of having brucellosis (B. melitensis) .
However, that status may be provisionally suspended if the animal or
animals are immediately destroyed or isolated pending official
confirmation of the disease or an official quashing of the suspicionof that disease.
2. If brucellosis (B. melitensis) is confirmed, the provisional suspension
may be lifted only if all animals infected or all the animals of thespecies susceptible to infection are slaughtered and two tests,!
B1991L0068 — EN — 01.05.1994 — 001.001 — 12
separated by an interval of three months or more and carried out in
accordance with Annex C on,
— all vaccinated animals over 18 months old,
— all non-vaccinated animals over six months old, and
both give negative results.
D. Introduction of animals into a brucellosis (B. melitensis)- free ovine or
caprine holding
The following animals only may be introduced into an ovine or caprine
holding which is free from brucellosis:
1. ovine or caprine animals which come from an ovine or caprine
holding which is free from or officially free from brucellosis (B.
melitensis);
2. until the date laid down for holdings to qualify as brucellosis-free in
accordance with the eradication plans adopted under Decision90/242/EEC (
1) ovine or caprine animals from holdings other than
those referred to in point 1, provided that they meet the following
conditions:
(a) they must be individually identified in accordance with Article 4
(1) (a) of this Directive;
(b) they must originate in a holding on which all animals belonging
to species which are susceptible to brucellosis (B. melitensis)
have shown no clinical or other signs of brucellosis (B.
melitensis) for at least 12 months;
(c) (i) — they must not have been vaccinated during the
previous two years;
— they must have been kept under isolation under
veterinary supervision on the holding of origin and,during that period, must have undergone, with negative
results, two tests separated by an interval of at least six
weeks in accordance with Annex C; or
(ii) they must have been vaccinated with Rev. 1 vaccine or any
other vaccine approved in accordance with the procedure
laid down in Article 15 of this Directive before the age ofseven months and not less than 15 days before entering theholding of destination.
E. Change of status
A brucellosis (B. melitensis) -free ovine or caprine holding may qualify as
an officially brucellosis (B. melitensis) -free herd after a minimum period
of two years if:
(a) it contains no animal which has been vaccinated against brucellosis
(B. melitensis) during the preceding two years at least;
(b) the conditions laid down in point D.2. have been complied with
throughout that period;
(c) at the end of the second year, a test carried out, in accordance with
Annex C, on all animals aged over six months has in each case given anegative result.!
B
(1) OJ No L 140, 1. 6. 1990, p. 123.1991L0068 — EN — 01.05.1994 — 001.001 — 13
ANNEX B
I(1)
— Foot-and-mouth disease
— Brucellosis (B. melitensis)
— Contagious epidydimitis (B. ovis)
— Anthrax— Rabies
II (
1)
— Scrapie
III
— Contagious agalactia
— Paratuberculosis
— Caseous lymphadenitis— Pulmonary adenomatosis
— Maedi Visna
— Caprine viral arthritis/encephalitis.!
B
(1) Compulsorily notifiable diseases1991L0068 — EN — 01.05.1994 — 001.001 — 14
ANNEX C
Brucellosis (B. melitensis) tests
For a holding to qualify for brucellosis-free status, testing for brucellosis (B. melitensis)
is performed by means of the Rose Bengal method or by the complement-fixationmethod described in the Annex to Decision 90/242/EEC or by any other methodrecognized in accordance with the procedure laid down in Article 15 of this Directive.The complement-fixation method is used for tests on individual animals.
When carrying out the Rose Bengal test, if more than 5 % of the animals on a holding
show a positive reaction, a further test is carried out on every animal on the holding bymeans of the complement-fixation method.
Serum containing 20 or more ICFT units/ml must be regarded as positive in the
complement-fixation test.
The antigens used must be approved by the national laboratory and must be
standardized against the second international standard anti-brucella abortus serum.!
B1991L0068 — EN — 01.05.1994 — 001.001 — 15
ANNEX D
Official contagious epidydimitis (Brucella ovis) test
Complement-fixing test:
The specific antigen used must be approved by the national laboratory and must be
standardized against the international standard anti-brucella ovis serum.
The working serum must be standardized with the international standard anti-brucella
ovis serum prepared by the Central Veterinary Laboratory, Weybridge, Surrey, United
Kingdom.
A serum containing 50 or more International Units per/ml must be regarded as positive.!B1991L0068 — EN — 01.05.1994 — 001.001 — 16
ANNEX E
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