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"BCOUNCIL 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 17.3.1994
"M2 Commission Decision 94/953/EC of 20 December 1994 L 371 14 31.12.1994
Amended by:
"A1 Act of Accession of Austria, Sweden and Finland C 241 21 29.8.1994
(adapted by Council Decision 95/1/EC, Euratom, ECSC) L 1 1 1.1.19951991L0068 — EN — 01.01.1995 — 002.001 — 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
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 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 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 that those
requirements in no case 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 which
would 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 in Council Directive 90/425/EEC of 26 June 1990 concerning!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 — 01.01.1995 — 002.001 — 2
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;
Whereas a procedure should be introduced which provides for close and
efficient cooperation between the Member States and the Commission
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 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 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 to be
transported to the place of destination, either directly or via an
approved 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 of
Annex 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 as listed under
Sections I and II of Annex B, the suspicion or appearance of which
must be notified to 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/or
assembled 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.!B1991L0068 — EN — 01.01.1995 — 002.001 — 3
However, the competent authorities of Member States of destination may
grant general or limited derogations in respect of movement of 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 with the require-
ments 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) 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 1985 introducing
Community 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
this Directive,
— ovine and caprine animals which cannot be marketed on their own
territory for health or animal health reasons justified by Article 36 of
the Treaty.
3. Ovine and caprine animals must also:— either have been born and reared since birth in the territory of the
Community,!B
(1) OJ No L 315, 26. 11. 1985, p. 11.
(2) OJ No L 224, 18. 8. 1990, p. 13.1991L0068 — EN — 01.01.1995 — 002.001 — 4
— or, if they have been imported, come from a third country included
on the list drawn up in accordance with Article 3 of Council
Directive 72/462/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 (1),
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,
(ii) or, in the absence of such conditions, be subject to compliance
with the conditions laid down in Article 7 (2) second, third and
fourth subparagraphs 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 — in order to be introduced onto an officially brucellosis-free or
brucellosis-free ovine or caprine holding — respectively the require-
ments 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
period shall be reduced to 12 months if the animals infected
with Maedi Visna or caprine viral arthritis/encephalitis have
been slaughtered and the remaining animals have reacted
negatively to two tests 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 abovemen-
tioned diseases, within the framework of a programme approved
in accordance with Articles 7 and 8, health guarantees which are
equivalent 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 for intra-Community trade comply with the criteria laid
down in point (i);!B
(1) OJ No L 302, 31. 12. 1972, p. 28.1991L0068 — EN — 01.01.1995 — 002.001 — 5
(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, except
where 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
requirements;
(ii) have been continuously kept on a holding or holdings complying
with the requirements laid down in (i) since birth or for the last
two years;
(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
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 the
infectious or contagious 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 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.!B1991L0068 — EN — 01.01.1995 — 002.001 — 6
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 exceed those 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 may be 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 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, microbi-
ological, pathological or epidemiological investigation and on the
fact that the disease 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 the procedure laid down in Article 15. Such guarantees must not
exceed those which the Member State implements nationally. Where
supporting documentation 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 light of such notification, be amended or withdrawn in
accordance with the 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
contagious agalactia. Following that examination and if it is justified,
the provisions of paragraph 2 may be applicable. The appropriate
decisions provided for in paragraph 2 shall 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!B
(1) OJ No L 224, 18. 8. 1990, p. 19.!A11991L0068 — EN — 01.01.1995 — 002.001 — 7
national rules in force before that date as regards the abovementioned
diseases. The period of one year may if necessary be extended in
accordance with the 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 examinations
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 entry into 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 a health
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 one of the official
languages of the Member State of destination, and be valid 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
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 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 caprine
animals,
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
all necessary aid to the experts in the accomplishment 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 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.
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 Article 9 on a reciprocal basis. They shall notify the
Commission thereof.!A1
!B1991L0068 — EN — 01.01.1995 — 002.001 — 8
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 its opinion 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 in the case of decisions which the
Council is required to adopt on a proposal 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 the absence 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 — 01.01.1995 — 002.001 — 9
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.!B1991L0068 — EN — 01.01.1995 — 002.001 — 10
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 vaccineor 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, inaccordance 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 whichhave 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 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 territorywhich is recognized as officially brucellosis-free, and in which,
after qualification, the introduction of animals is carried out in
accordance with the requirements of point D, a representativenumber of the ovine and caprine animals over six months oldmust 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 holdingswhere there are fewer than 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 beofficially 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 notofficially brucellosis free are placed under official control orundergo an eradication programme.
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!
B1991L0068 — EN — 01.01.1995 — 002.001 — 11
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 thedisease or an official quashing of the suspicion of thatdisease;
(b) brucellosis (B. melitensis) is confirmed, the provisional
suspension may be lifted by the competent authority only ifall animals infected or all the animals of species susceptibleto infection are slaughtered and two tests, separated by an
interval of at least three months or more, and carried out in
accordance with Annex C on all the animals of the holdingover 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 Commis-sion and 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
Member State concerned must keep the Commission and the
other Member States informed of the development of thesituation;
(b) conduct an epidemiological enquiry, and the herds linked
epidemiologically to the infected herd must undergo the testslaid down in point 1 (b).
3. Should an outbreak of brucellosis be confirmed in accordance
with point 2, the Commission after having assessed the circum-stances 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 fora new qualification shall be specified in accordance with thesame 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 twoyears previously. However, females over two years old whichwere 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 such isolation underwent, with negative
results, two tests separated by an interval of at least six
weeks in accordance with 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,
as being officially brucellosis-free:
1. (a) in which at least 99,8 % of the ovine or caprine holdings are
officially brucellosis-free holdings;
or!
B1991L0068 — EN — 01.01.1995 — 002.001 — 12
(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;
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 showwith a confidence rating of 99 % that less than 0,2 % of theholdings 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 with negativeresults;
— annually, from the second year following recognition of a
Member State or region as brucellosis-free (Br. melitensis) ,
random checks carried out at either holding or slaughter-
house level show with a confidence rating of 95 % that less
than 0,2 % of the holdings were infected, or at least 5 % ofthe ovine and caprine animals over six months of age haveundergone a test carried out in accordance with Annex C
with negative results;
— the provisions laid down in the above two indents may be
amended in accordance with the procedure laid down in
Article 15;
This provision shall be reviewed before the entry into force of the
Accession Treaty with a view toits possible amendment, to becarried out in accordance with the procedure laid down in Article15.
(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 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
procedure laid down in Article 15 of this Directive. The vaccinatedanimals 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, onall 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, with negative results, in accordance with Annex C, on
all non-vaccinated ovine and caprine animals on the holding whichare over six months old at the time of testing; and!
B
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(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
conditions 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 ifthe 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 femalesmust 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 caprine animals
which are suspected of having brucellosis (B. melitensis) . However, that
status may be provisionally suspended if the animal or animals areimmediately destroyed or isolated pending official confirmation of thedisease 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 aninterval of three months or more and carried out in accordance withAnnex C on,
— all vaccinated animals over 18 months old,— all non-vaccinated animals over six months old, andboth 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 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 separated by an interval of at least six weeks inaccordance with Annex C; or!
B
(1) OJ No L 140, 1. 6. 1990, p. 123.1991L0068 — EN — 01.01.1995 — 002.001 — 14
(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 of seven
months and not less than 15 days before entering the holding ofdestination.
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.!
B1991L0068 — EN — 01.01.1995 — 002.001 — 15
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 — 01.01.1995 — 002.001 — 16
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-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 onindividual 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 abortusserum.!
B1991L0068 — EN — 01.01.1995 — 002.001 — 17
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 — 01.01.1995 — 002.001 — 18
ANNEX E
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