1991L0068 — EN — 06.05.2002 — 005.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COUNCILDIRECTIVE
of28January1991
onanimalhealthconditionsgoverningintra-Communitytradeinovineandcaprineanimals
(91/68/EEC)
(OJ L 46, 19.2.1991, p. 19)
Amended by:
Official Journal
No page date
►M1Commission Decision 94/164/EC of 18 February 1994 L 74 42 17.3.1994
►M2Commission Decision 94/953/EC of 20 December 1994 L 371 14 31.12.1994
►M3Directive 2001/10/EC of the European Parliament and of the Council of
22 May 2001L 147 41 31.5.2001
►M4Commission Decision 2001/298/EC of 30 March2001 L 102 63 12.4.2001
►M5Commission Decision 2002/261/EC of 25 March2002 L 91 31 6.4.2002
Amended by:
►A1Act of Accession of Austria, Sweden and Finland C241 21 29.8.1994
(adapted by Council Decision 95/1/EC, Euratom, ECSC) L 1 1 1.1.1995
▼B
COUNCILDIRECTIVE
of28January1991
on animal health conditions governing intra-Community trade in
ovineandcaprineanimals
(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 healthconditions 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 ovine and 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 requirementsdesigned 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 referenceshould therefore be made to ‘regions’ as defined in Council Directive64/432/EEC of 26 June 1964 on animal health problems affecting intra-
Community trade in 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 Member State in eradicating certain diseases, provided thatthose requirements in no case exceed those applied nationally by theMember 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 certi-ficate which would be issued by an official veterinarian and whichwould 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 andas regards the protective measures to be introduced, to the general ruleslaid down in Council Directive 90/425/EEC of 26 June 1990concerning veterinary and zootechnical checks applicable in intra-1991L0068 — EN — 06.05.2002 — 005.001 — 2
(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.
▼B
Community trade in certain live animals and products witha view of
the completion of the internal market;
Whereas provision should be made for allowing the Commission to
conduct its own checks;
Whereas a procedure should be introduced which provides for close
and efficient cooperation between the Member States and the Commis-sion within the Standing Veterinary Committee,
HAS ADOPTED THIS DIRECTIVE:
Article 1
This Directive defines the animal health conditions governing intra-
Community 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 thefollowing:
1. ovine or caprine animals for slaughter means animals of the ovine
or caprine species intended to be taken either directly or via anapproved market or assembly centre to a slaughterhouse in orderto be slaughtered there 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 tobe transported to the place of destination, either directly or via anapproved market or assembly 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 ofAnnex A;
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 ►
M3as listed
under Section I of Annex B ◄, the suspicion or appearance of
which must be notified to the competent authorities of the MemberState;
8. official veterinarian means a veterinarian designated by the compe-
tent 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/or assembled or loaded, and which complies with Article 3 (7) ofDirective 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 Articles4, 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 of1991L0068 — EN — 06.05.2002 — 005.001 — 3
▼B
ovine and caprine animals for breeding and fattening, intended solely
for temporary pasturing near internal borders of the Community.Member States making use of such derogation shall inform the
Commission of the content of the derogations granted.
Article 4
1. Ovine and caprine animals:
(a) must be identified and registered in accordance withth e require-
ments of Article 3 (1) (c) of Directive 90/425/EEC; the time limitfor notifying the national systems for identifying and registeringovine and caprine animals begins running from the date of adoptionof this Directive;
(b) must show no clinical sign of disease when inspected by an official
veterinarian, such inspection must take place during the 48 hourspreceding 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 beat 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 Article3 (2) (b) (ii) of Directive 64/432/EEC;
(d) must not be the subject of animal health restrictions applied
pursuant to Council Directive 85/511/EEC of 18 November 1985introducing Community measures for the control of foot-and-mouthdisease(
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 ofAnnex B to this Directive,
— ovine and caprine animals which cannot be marketed on their own
territory for health or animal health reasons justified by Article 36of the Treaty.
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 Direc-tive 72/462/EEC of 12 December 1972 on health and veterinaryinspection problems upon importation of bovine animals and swine1991L0068 — EN — 06.05.2002 — 005.001 — 4
(1) OJ No L 315, 26. 11. 1985, p. 11.
(2) OJ No L 224, 18. 8. 1990, p. 13.
▼B
and freshmeat and meat products from th ird countries(1), as last
amended by Directive 90/425/EEC, and
(i) either meet the animal health conditions laid down in accor-
dance withArticle 8 of Directive 72/462/EEC,
(ii) or, in the absence of such conditions, be subject to compliance
with the conditions laid down in Article 7 (2) second, third and
fourthsubparagraph s of Directive 90/425/EEC.
Article 5
Without prejudice to the additional guarantees that may be required in
accordance withArticles 7 and 8, ovine and caprine animals for
breeding and fattening must, in addition to the conditions laid downin Article 4, meet — in order to be introduced onto an officiallybrucellosis-free or brucellosis-free ovine or caprine holding — respec-tively 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 withArticles 7 and 8, animals for breeding must furth er-more meet the following requirements:
(a) They must have been obtained from a holding and must only have
been in contact withanimals from sucha h olding:
(i) in which the following diseases have not been clinically diag-
nosed:
— 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 period shall be reduced to 12 months if the
animals infected withMaedi Visna or caprine viralarthritis/encephalitis have been slaughtered and theremaining animals have reacted negatively to two testsrecognized under the procedure set out in Article 15,
or which, without prejudice to compliance with the require-
ments for other diseases, provides, for one or more of theabovementioned diseases, within the framework of a
programme approved in accordance withArticles 7 and 8,
health guarantees which are equivalent for the said disease ordiseases;
(ii) where no facts suggesting that the requirements of point (i)
have not been met, have been brought to the attention of theofficial veterinarian responsible for issuing the health certifi-cate;
(iii) whose owner states that he has no knowledge of any such
facts and, moreover, states in writing that the animal oranimals intended for intra-Community trade comply withth ecriteria laid down in point (i);
(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,1991L0068 — EN — 06.05.2002 — 005.001 — 5
(1) OJ No L 302, 31. 12. 1972, p. 28.▼M3
▼B
▼B
— in the 30 days prior to dispatch have undergone, with negative
results, a serological test carried out in accordance withAnnexD or satisfy equivalent health guarantees to be recognized under
the procedure 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 theinfectious or contagious diseases ►
M3referred to in Annex B,
Section 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 impor-
tance of the disease and the programme's likely benefit in relation
to its cost,
— the geographical area in which the programme will be imple-
mented,
— the various status categories to be applied to the holdings, the stan-
dards which must be attained in each category, and the testprocedures to be used,
— 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 paragraph1 may beapproved, in compliance withth e criteria laid down in paragraph1, inaccordance withth e procedure provided for in Article 15. According tothe 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 theprogrammes. Such guarantees must not exceed those which theMember State implements nationally.
3. Programmes submitted by Member States may be amended or
supplemented in accordance withth e 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 withparagraph2 may be approved under th e 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 ►M3listed in Annex B,
Section III ◄to which ovine 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,
— the results of surveillance testing based on serological, microbiolo-
gical, pathological or epidemiological investigation and on the factthat the disease must by law be notified to the competent authori-ties,
— the period over which the surveillance was carried out,1991L0068 — EN — 06.05.2002 — 005.001 — 6
(1) OJ No L 224, 18. 8. 1990, p. 19.
▼B
— where applicable, the period during which vaccination against the
disease has been prohibited and the geographical area concernedby suchproh ibition,
— 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 withth e procedure laid down in Article 15.Such guarantees must not exceed those which the Member State imple-ments nationally. Where supporting documentation is submitted before1 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 whichrelate to the disease. The guarantees defined as laid down in paragraph2 may, in the light of such notification, be amended or withdrawn inaccordance withth e procedure laid down in Article 15.
4. The Commission shall examine as quickly as possible the grounds
submitted by Sweden asregards ovine paratuberculosis and ovine conta-gious agalactia. Following that examination and if it is justified, theprovisions of paragraph2 may be applicable. Th e appropriate decisionsprovided for in paragraph2 sh all be adopted as quickly as possible.Pending those decisions Sweden may, during a period of one year
from the date of entry into force of the Accession Treaty, apply its
national rules in force before that date as regards the abovementioneddiseases. The period of one year may if necessary be extended inaccordance withth e procedure laid down in Article 15.
Article 8a
As regards Finland, for the purposes of applying Articles 7 and 8 and
at its request, the Commission shall organize the necessary examina-tions for the diseases listed in Annex B, headings II and III, so that
the appropriate decisions may be adopted, if necessary, in accordance
with the procedure laid down in Article 15 before the date of entryinto force of the Accession Treaty.
Article 9
In trade between Member States, ovine and caprine animals must,
during transportation to the place of destination, be accompanied by ahealth certificate, 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 oneof the official languages of the Member State of destination, and bevalid for 10 days. The certificate shall consist of a single sheet.
Article 10
1. The rules laid down in Directive 90/425/EEC shall apply, in parti-
cular to checks at origin, to the organization of, and follow-up to, thechecks to be carried out by the Member State of destination, and to theprotective measures to 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.1991L0068 — EN — 06.05.2002 — 005.001 — 7
▼A1
▼B
▼B
Article 11
1. Veterinary experts from the Commission may, to the extent
necessary to ensure uniform application of this Directive and in coop-eration with the competent national authorities, carry out on-the-spotinspections. The Member State on whose territory inspections arecarried out shall afford all necessary aid to the experts in the accom-
plishment of their task. The Commission 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 withth e 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.
Article 12
Member States which implement an alternative control system
providing guarantees equivalent to those laid down in Article 5 andArticle 6 (a) and (c) as regards movements within their territory ofovine and caprine animals may grant one another derogations fromthe inspection provided for under Article 4 (1) (b) and the obligationto produce a certificate provided for under Article 9 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 ofthe internal market, on which the Council will decide by a qualifiedmajority.
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 proce-
dure 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 Veter-inary Committee set up by Decision 68/361/EEC(
1) hereinafter referred
to as the ‘Committee’, either on his own initiative or at the request ofthe 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 Committeeshall deliver its opinion on the draft within a time limit whichthe 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 in the case of decisionswhich the Council is required to adopt on a proposal from theCommission. The votes of the representatives of the MemberStates within the Committee shall be weighted in the mannerset 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 Commissionshall, without delay, submit to the Council a proposal relating tothe measures to be taken. The Council shall act by a qualifiedmajority.1991L0068 — EN — 06.05.2002 — 005.001 — 8
(1) OJ No L 255, 18. 10. 1968, p. 23.
▼B
If, on the expiry of three months from the date of referral to the
Council, the Council has not acted, the proposed measures shall beadopted 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 transitionalmeasures necessary to facilitate the changeover to the new arrange-ments 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 nationalprovisions shall continue to apply until the approval of theprogrammes and in the absence of programmes until the datereferred to in (ii);
(ii) the other provisions of this Directive not later than 31 December
1992.
2. When Member States adopt these measures, they shall contain a
reference to this Directive or shall be accompanied by such reference
on the occasion of their official publication. The methods of making
such a reference shall be laid down by the Member States.
Article 18
This Directive is addressed to the Member States.1991L0068 — EN — 06.05.2002 — 005.001 — 9
▼B
ANNEX A
CHAPTER 1
I.Officially brucellosis (B. melitensis) -free ovineorcaprineholding
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 vacci-
nated at least two years previously withRev. 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 with
Annex C on all ovine and caprine animals on the holding over
six months 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 have come
from an officially brucellosis-free or brucellosis-free holding
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 withpoint 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, after qualifi-
cation, the introduction of animals is carried out in accordance with
the requirements of point D, a representative number of the ovine
and 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 minimum of
50 per holding — except in holdings where there are fewer than
50 suchfemales, in wh ichcase 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 three
years, provided that the holdings which are not officially brucellosis
free are placed under official control or undergo an eradication
programme.
C.Suspectedor 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, pending official
confirmation of the disease or an official quashing of the suspi-
cion of that disease;
(b) brucellosis (B. melitensis) is confirmed, the provisional suspension
may be lifted by the competent authority only if all animals
infected or all the animals of species susceptible to infection are
slaughtered and two tests, separated by an interval of at least three1991L0068 — EN — 06.05.2002 — 005.001 — 10
▼B
months or more, and carried out in accordance with Annex C 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 recog-
nized as officially free from brucellosis (B. melitensis), the Member
State concerned must immediately inform the Commission and the
other Member States.
The competent authority of the Member State concerned must:
(a) slaughter all infected animals and all animals of species suscep-
tible to infection on the holding concerned. The Member State
concerned must keep the Commission and the other Member
States informed of the development of the situation;
(b) conduct an epidemiological enquiry, and the herds linked epide-
miologically 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, a
decision suspending or withdrawing the status of that region. If the
status is withdrawn, the conditions for a new qualification shall be
specified in accordance withth e 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 withArticle 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 were
vaccinated before the age of seven months may also be brought
onto the holding, and
— were isolated under official supervision on the holding of origin
and, during suchisolation underwent, withnegative results, two
tests separated by an interval of at least six weeks in accordance
withAnnex C.
II.Officially brucellosis-free MemberStateorregion
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,
as being officially brucellosis-free:
1. (a) in which at least 99,8 % of the ovine or caprine holdings are offi-
cially brucellosis-free holdings;
or
(b) which fulfils the following conditions:
(i) ovine or caprine brucellosis is a disease that has been compulso-
rily 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;
2. in which the conditions set out in point 1 have been satisfied; and
(i) — the first year following recognition of a Member State or region
as brucellosis-free (Br. melitensis) , random checks carried out at
either holding or slaughterhouse 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 and caprine animals over six months
of age have undergone a test carried out in accordance with
Annex C withnegative results;
— annually, from the second year following recognition of a
Member State or region as brucellosis-free (Br. melitensis) ,1991L0068 — EN — 06.05.2002 — 005.001 — 11
▼M2
▼M2
random checks carried out at either holding or slaughterhouse
level show with a confidence rating of 95 % that less than 0,2 %
of the holdings were infected, or at least 5 % of the ovine and
caprine animals over six months of age have undergone a test
carried out in accordance withAnnex C withnegative results;
— the provisions laid down in the above two indents may be
amended in accordance withth e procedure laid down in Article
15;
This provision shall be reviewed before the entry into force of the
Accession Treaty witha view toits possible amendment, to be carried
out in accordance withth e procedure laid down in Article 15.
(ii) the conditions for qualification continue to be fulfilled.
CHAPTER 2
Brucellosis (B. melitensis) -free ovineorcaprineholding
A.Grant of status
A. An ovine or caprine holding is considered to be brucellosis (B. meli-
tensis)-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 12 months;
(b) all or some of the ovine or caprine animals have been vaccinated
with Rev. 1 vaccine or any other vaccine approved under the proce-
dure 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, withnegative results, in accordance withAnnex C, on
all vaccinated ovine and caprine animals on the holding which 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, withnegative results, in accordance withAnnex C, on
all non-vaccinated ovine and caprine animals on the holding 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 either
born there or come from a brucellosis-free holding under the condi-
tions 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 status only
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 vacci-
nated,
— 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 where
there are fewer than 50 such females, in which case all these females
must be tested.
C.Suspectedor actual cases of brucellosis
1. The brucellosis-free status of an ovine or caprine holding must be with-
drawn if the holding contains one or more ovine or caprine animals 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 suspicion of 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 the species
susceptible to infection are slaughtered and two tests, separated by an1991L0068 — EN — 06.05.2002 — 005.001 — 12
▼A1
▼B
▼B
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
bothgive 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 withth e eradication plans adopted under Decision 90/242/
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 sepa-
rated 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 withth e procedure laid down in
Article 15 of this Directive before the age of seven months and
not less than 15 days before entering the holding 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 a
negative result.1991L0068 — EN — 06.05.2002 — 005.001 — 13
(1) OJ No L 140, 1. 6. 1990, p. 123.
▼B
ANNEX B
I(1)
— Foot-and-mouthdisease
— Brucellosis (B. melitensis)
— Contagious epidydimitis (B. ovis)
— Anthrax— Rabies
III
— Contagious agalactia
— Paratuberculosis— Caseous lymphadenitis— Pulmonary adenomatosis
— Maedi Visna
— Caprine viral arthritis/encephalitis.1991L0068 — EN — 06.05.2002 — 005.001 — 14
(1) Compulsorily notifiable diseases▼M3
▼B
▼B
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 comple-
ment-fixation method described in the Annex to Decision 90/242/EEC or by any
other method recognized in accordance with the procedure laid down in Article
15 of this Directive. The complement-fixation method is used for tests on indi-
vidual 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 by means 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.1991L0068 — EN — 06.05.2002 — 005.001 — 15
▼B
ANNEX D
Official contagiousepidydimitis (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.1991L0068 — EN — 06.05.2002 — 005.001 — 16
▼M1
ANNEX E
1991L0068 — EN — 06.05.2002 — 005.001 — 17
▼M1
►(1)M41991L0068 — EN — 06.05.2002 — 005.001 — 18
▼M1
1991L0068 — EN — 06.05.2002 — 005.001 — 19
▼M1
1991L0068 — EN — 06.05.2002 — 005.001 — 20
▼M1
►(1)M41991L0068 — EN — 06.05.2002 — 005.001 — 21
▼M5
1991L0068 — EN — 06.05.2002 — 005.001 — 22
▼M5
1991L0068 — EN — 06.05.2002 — 005.001 — 23
▼M5
1991L0068 — EN — 06.05.2002 — 005.001 — 24
▼M5
1991L0068 — EN — 06.05.2002 — 005.001 — 25