1964L0432 — EN — 30.06.1964 — 000.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COUNCILDIRECTIVE
of26June1964
onanimalhealthproblemsaffecting intra-Communitytradeinbovineanimalsandswine
(64/432/EEC)
(OJ P 121, 29.7.1964, p. 1977)
Corrected by:
►C1Corrigendum, OJ L 120, 12.5.1975, p. 13 (64/432/EEC)
►C2Consolidated text of corrigenda to instruments published in Special
Editions 1952-72, p. 10 (64/432/EEC)
▼B
COUNCILDIRECTIVE
of26June1964
on animal health problems affecting intra-Community trade in
bovineanimalsandswine
(64/432/EEC)
THE COUNCIL OF THE EUROPEAN ECONOMIC COMMUNITY,
Having regard to the Treaty establishing the European Economic
Community, and in particular Articles 43 and 100 thereof;
Having regard to the proposal from the Commission;
Having regard to the Opinion of the European Parliament(1);
Having regard to the Opinion of the Economic and Social
Committee(2);
Whereas Council Regulation No 20 on the progressive establishment of
a common organisation of the market in pigmeat(3) is already in force
and a similar regulation is to be adopted for beef and veal and whereasthese regulations also concern trade in live animals;
Whereas Regulation No 20 substitutes for the numerous traditional
means of protection at the frontier a single system designed in parti-cular to facilitate intra-Community trade; whereas the regulation to beadopted for beef and veal is also designed to eliminate obstacles tosuchtrade;
Whereas, so long as intra-Community trade in bovine animals and
swine is hindered by differences between the health requirements ofMember States, the implementation of the above-mentioned regulationswill not have the desired effect;
Whereas, to eliminate those differences, measures must be taken within
the framework of the common agricultural policy and in line with regu-lations already adopted or in preparation on the progressive
establishment of a common organisation of markets; whereas the
animal health provisions of Member States must therefore be approxi-mated;
Whereas the right of Member States under Article 36 of the Treaty to
continue to apply prohibitions or restrictions on imports, exports or
goods in transit justified on grounds of the protection of health andlife of humans and animals nevertheless does not exempt them fromthe obligation to approximate the provisions on which those prohibi-tions and restrictions are based, in so far as the differences between
those provisions hinder the implementation and functioning of the
common agricultural policy;
Whereas, in the context of such approximation, the exporting country
must be required to ensure that bovine animals and swine for breeding,
production or slaughter intended for intra-Community trade, the places
from which those animals come and are shipped and the means oftransport used satisfy certain animal health requirements so as to ensurethat the animals are not a source of contagious or infectious disease;
Whereas, so that Member States may be sure that these requirements
are satisfied, provision must be made for the issue by an official veter-inarian of a health certificate which will accompany the animals totheir destination;
Whereas Member States must have the right to prohibit the introduc-
tion into their territory of bovine animals and swine if they are foundto be suffering or are suspected of suffering from a contagious or infec-tious disease, if they may spread such disease without actually1964L0432 — EN — 30.06.1964 — 000.001 — 2
(1) OJ No 61, 19.4.1963, p. 1254/63.
(2) OJ No 121, 29.7.1964, p. 2009/64.
(3) OJ No 30, 20.4.1962, p. 945/62.
▼B
suffering from it or if they do not comply with Community animal
health provisions;
Whereas there is no reason to allow Member States to prohibit the
introduction of bovine animals and swine into their territory for reasonsother than those of animal health and whereas, therefore, the consignorshould at his own request or upon request of his representative beallowed to return the animals to the country of export unless there are
reasons to the contrary;
Whereas, in case of prohibition or restriction, the reasons therefor
should be made known to the consignor of the animals or his represen-tative and to the competent central authority of the country of export so
that they be aware of the reasons why such measures were imposed;
Whereas in the event of dispute between himself and the authority of
the Member State of destination as to the justification for prohibitionor restriction, the consignor should be enabled to obtain the opinion
of a veterinary expert whom he may select from a panel drawn up by
the Commission;
Whereas in some cases and for certain categories of animals it appears
that the general provisions of this Directive may be relaxed without
involving any health risk, by allowing consignee Member States to
grant general or special derogations;
Whereas, in certain fields presenting special problems, the provisions
in Member States cannot be approximated until a more thorough study
has been made;
Whereas a simplified amendement procedure may be provided for
Annexes B to D since the rules contained in those Annexes are of atechnical nature and liable to change; whereas the Commission should
therefore be entrusted with making such amendments after consulting
the Member States;
HAS ADOPTED THIS DIRECTIVE:
Article 1
This Directive shall apply to intra-Community trade in bovine animals
and swine for breeding, production or slaughter.
Article 2
For the purposes of this Directive:
(a) ‘holding’ means an agricultural establishment or officially super-
vised dealer's premises situated in the territory of a Member
State, in which animals for breeding, production or slaughter areregularly kept or bred;
(b) ‘animal for slaughter’ means a bovine animal or swine intended to
be taken on arrival in the country of destination direct to a slaugh-terhouse, or to a market adjoining a slaughterhouse under whoserules all animals may be removed, in particular after the market,
only to a slaughterhouse approved for this purpose by the compe-
tent central authority. In the latter case, the animals must beslaughtered at that slaughterhouse not later than seventy-two hoursafter arriving at the market;
(c) ‘animals for breeding or production’ means bovine animals and
swine other than those referred to in (b), including those intendedfor breeding, milk or meat production, or draft purposes;
(d) ‘tuberculosis-free bovine animal’ means a bovine animal which
satisfies the conditions laid down in Annex A (I) (1);
(e) ‘officially tuberculosis-free bovine herd’ means a bovine herd
which satisfies the conditions laid down in Annex A (I) (2);
(f) ‘brucellosis-free bovine animal’ means a bovine animal which
satisfies the conditions laid down in Annex A (II) (1);1964L0432 — EN — 30.06.1964 — 000.001 — 3
▼B
(g) ‘officially brucellosis-free bovine herd’ means a bovine herd
which satisfies the conditions laid down in Annex A (II) (A) (2);
(h) ‘brucellosis-free bovine herd’ means a bovine herd which satisfies
the conditions laid down in Annex A (II) (A) (3);
(i) ‘brucellosis-free swine’ means swine which satisfy the conditions
laid down in Annex A (II) (B) (1);
(k) ‘►C2 ◄brucellosis-free swine herd’ means a swine
herd which satisfies the conditions laid down in Annex A (II) (B)(2);
(l) ‘epizootic free area’ means an area 20 km in diameter in which,
according to official findings, for at least thirty days prior to
loading there has been:
(i) no incidence of foot-and-mouthdisease, in th e case of bovine
animals;
(ii) no incidence of foot-and-mouthdisease, swine fever or conta-
gious swine paralysis (Teschen disease) in the case of swine;
(m) ‘compulsorily notifiable diseases’ means the diseases listed in
Annex E;
(n) ‘official veterinarian’ means the veterinarian designated by the
competent central authority of the Member State;
(o) ‘exporting country’ means the Member State from which bovine
animals and swine are sent to another Member State;
(p) ‘country of destination’ means the Member State to which bovine
animals and swine are sent from another Member State.
Article 3
1. Each Member State shall ensure that only bovine animals and
swine which fulfil the general conditions laid down in paragraph 2,account being taken where appropriate of the provisions of paragraph7, and also the special conditions fixed for certain categories of bovineanimals and swine in paragraphs 3 to 6, are sent from its territory tothat of another Member State.
2. Bovine animals and swine covered by this Directive must:
(a) show no clinical sign of disease on the day of loading;
(b) have been obtained from a holding which officially fulfils the
following conditions:
(i) it shall be situated in the centre of an epizootic free area;
(ii) it shall, for at least three months prior to consignment, have
been free from foot-and-mouthdisease and bovine brucellosis
in the case of bovine animals and from foot-and-mouthdisease, bovine and porcine brucellosis, swine fever and conta-gious porcine paralysis (Teschen disease) in the case of swine;
(iii) it shall, for a least thirty days prior to consignment, have been
free from all other compulsorily notifiable diseases which arecontagious or infectious for the animal species in question;
(c) in the case of animals for breeding and production, have remained
on the holding referred to in 2 (b) during the thirty days precedingloading. The official veterinarian may certify that the animals have
remained on the holding during the thirty days preceding loading,
in the case of animals identified in the manner provided in subpar-agraph(d) and placed under official veterinary supervision, it beingthus possible to certify that they belong to the holding;
(d) be identified by an official or officially approved earmark or, in the
case of swine, by a permanent identification stamp;
(e) be sent direct from the holding to the actual place of loading:
(i) without coming into contact with cloven-hoofed animals other
than bovine animals and swine which fulfil the conditions laid
down for intra-Community trade;
(ii) segregated into animals for breeding or production and
animals for slaughter;1964L0432 — EN — 30.06.1964 — 000.001 — 4
▼B
(iii) in transport vehicles or containers which have first been
cleansed and disinfected witha disinfectant officiallyauthorised in the exporting country;
(f) be loaded for transportation to the country of destination in accor-
dance withth e conditions set out in subparagraph(e) at a specificplace at the centre of an epizootic free area;
(g) after loading be sent direct and as quickly as possible to the fron-
tier post of the exporting country;
(h) be accompanied during transportation to the country of destination
by a health certificate conforming to Annex F (Models I to IV)which shall be drawn up on the day of loading, in the language ofthe country of destination at least, and be valid for ten days.
3. Bovine animals for breeding or production must moreover:
(a) have been vaccinated at least fifteen days and not more than four
months before loading against types A, O and C of the foot-and-mouthdisease virus using an inactivated virus vaccine approvedand controlled by the competent authority of the exporting country;
(b) come from an officially tuberculosis-free bovine herd, be tubercu-
losis-free and in particular have reacted negatively to anintradermal tuberculin test carried out in accordance withth e provi-sions of Annexes A and B;
(c) come from an officially brucellosis-free bovine herd, be brucel-
losis-free, and in particular have shown a brucella count lower
than 30 international units of agglutination per millilitre whengiven a sero-agglutination test complying withth e provisions ofAnnexes A and C;
(d) in the case of dairy cows, show no clinical evidence of mastitis; in
addition, upon analysis complying withth e provisions of Annex D
their milk must not have shown any sign of a characteristic inflam-
matory condition or of a specifically pathogenic micro-organism.
4. Swine for breeding or production must moreover come from
brucellosis-free stock, themselves be brucellosis-free, and in particularhave shown a brucella count lower than 30 international units of agglu-tination per millilitre when given a sero-agglutination test complyingwith the provisions of Annexes A and C; the sero-agglutination test is
only required for swine weighing more than 25 kilogrammes.
5. Animals for slaughter must not moreover be bovine animals or
swine which are to be slaughtered under a contagious or inflectious
disease eradication programme of a Member State.
6. Bovine animals for slaughter, if over four months old, must in
addition:
(a) have been vaccinated not less than fifteen days and not more than
four months before loading against types A, O and C of the foot-and-mouthdisease virus, using an inactivated virus vaccineapproved and controlled by the competent authority of theexporting country; however, the period of validity of the vaccina-tion shall be extended to twelve months in the case of bovine
animals revaccinated in Member States where such animals are
vaccinated annually and where they are systematically slaughteredwhen they contract foot-and-mouth disease;
(b) if they do not come from an officially tuberculosis-free bovine
herd, have reacted negatively to an intradermal tuberculin test
carried out in accordance withth e provisions of Annexes A and B;
(c) if they do not come from an officially brucellosis-free bovine herd
nor from a brucellosis-free bovine herd have shown a brucellacount lower than 30 international units of agglutination per milli-litre when given a sero-agglutination test complying with theprovisions of Annexes A and C.
7. The following shall also be approved for intra-Community trade:
animals for breeding or production or animals for slaughter acquired on1964L0432 — EN — 30.06.1964 — 000.001 — 5
▼B
an officially approved market for consignment to another Member
State, provided suchmarket fulfils th e following conditions:
(a) it is supervised by an official veterinarian;
(b) it is situated in the centre of an epizootic free area and in a place
where no other livestock market is held on the same day;
(c) it is used after disinfection either for animals for breeding or
production or for animals for slaughter which meet the require-
ments of intra-Community trade as laid down in paragraphs 2 to 6and in Article 4, provided these conditions apply to the animalspecies in question. The provisions of paragraph 2 (e) must in parti-cular have been complied with when the animals were sent tomarket. Before being taken from the holding or market meeting
the requirements of this paragraph to the place of loading, these
animals may be taken to an officially supervised assembly point ifthe latter satisfies the conditions fixed for markets.
Animals acquired on suchmarkets must be sent direct from th e
market or the assembly point to the actual place of loading in
such manner that the provisions of paragraph 2 (e) and (g) aresatisfied, and be exported to the country of destination.
The period during which the assembling of these animals takes
place outside the holding of origin, in particular at the market,
assembly point or actual place of loading may be counted in the
thirty days prescribed in paragraph 2 (c) but shall not exceed fourdays.
8. The exporting country shall designate those markets referred to in
paragraph7 wh ichare approved for animals for breeding or productionand for animals for slaughter. It shall notify the competent central
authorities of the other Member States and the Commission as to which
markets are approved.
9. The exporting country shall determine the procedure for official
supervision of the markets and assembly points referred to in paragraph7 and shall ensure that this supervision is carried out.
10. In the case provided for in paragraph 7, corresponding entries
must be made on the health certificates, in accordance with Annex F
(Models I to IV).
11. The exporting country shall determine the procedure for official
supervision of dealers' premises and shall ensure that this supervision iscarried out.
12. If a holding or the area in which it is situated is the subject of
official restrictions following the outbreak of a disease which is conta-gious or infectious for the animal species in question, the time limitsset in paragraph2 (b) (ii) and (iii) and Article 2 (e) sh all take effect
from the date on which these prohibition restrictions were officially
lifted.
Article 4
1. All animals intended for intra-Community trade must have
remained in the territory of the exporting Member State before theday of loading:
(a) for not less than six months in the case of animals for breeding or
production;
(b) for not less than three months in the case of animals for slaughter.
If such animals are respectively less than six or three months old they
must have remained in the territory of the exporting Member Statesince birth.
2. In all cases to which paragraph 1 applies, appropriate entries must
be made in the health certificates, as required by Annex F (Models I toIV).1964L0432 — EN — 30.06.1964 — 000.001 — 6
▼B
Article 5
If the vaccines referred to in Article 3 (3) (a) and (6) (a) are not manu-
factured in a Member State, they shall be obtained from anotherMember State, except where new scientific data or the absence ofvaccines which up to that time have been considered suitable makes it
necessary to obtain vaccines from outside the European Economic
Community. In the event of outbreaks of foot-and-mouth disease otherthan types A, O and C or variants of these types, against which thevaccines currently used afford inadequate protection or none at all,eachMember State may take th e necessary emergency measures to
adapt the vaccine formulae and to use them accordingly. At the same
time it shall inform the other Member States and the Commissionthereof. The Commission may arrange for discussions to take placeconcerning the measures taken and to be taken.
Article 6
1. Each Member State shall communicate to the other Member
States and the Commission the list of frontier posts to be used for the
introduction of bovine animals and swine into its territory.
Subject to observance of the provisions relating to animal health,
marketing channels and all means of transport available for use shallbe taken into account in determining which frontier posts are to beused.
2. Each country of destination may require the consignor or his
representative to notify it in advance of the entry into its territory of aconsignment of bovine animals or swine, and of the type, nature andnumber of animals, the frontier post and the anticipated time of arrival.
It may not, however, require this notification to be made more than
forty-eight hours before the arrival of the consignment in its territory.
3. Each country of destination may prohibit the introduction of
bovine animals and swine into its territory if an examination made atthe frontier post by an official veterinarian reveals:
(a) that the animals are affected by, or suspected of being affected by,
or of being contaminated by a compulsorily notifiable disease;
(b) that the provisions of Articles 3 and 4 have not been observed as
regards these animals.
The country of destination may take the necessary measures, including
quarantine, to ascertain the position as regards animals suspected ofbeing affected by or of being contaminated by a compulsorily notifi-
able disease or which might spread such disease.
Decisions taken under the first or second sentence must, at the request
of the consignor or his representative, authorise the return of the
animals, provided this is not contrary to considerations of health.
4. If the introduction of animals has been prohibited on any of the
grounds set out in paragraph 3 (a) and the exporting country or thetransit country, as the case may be, does not within eight hoursauthorise the return of them, the competent authority of the country ofdestination may order the animals to be slaughtered or destroyed.
5. Animals for slaughter must be slaughtered as soon as possible
after their arrival at the slaughterhouse, in accordance with animalhealth requirements. Animals for slaughter which have been sent direct
on arrival in the country of destination to a market adjoining a slaugh-
terhouse under whose rules all animals may be removed, in particularafter the market, only to a slaughterhouse approved for this purpose bythe competent central authority must be slaughtered at that slaughter-house not later than seventy-two hours after arriving at the market.
The competent authority of the country of destination may in the light
of considerations of animal health designate the slaughterhouse towhich these animals must be sent.
6. If, after the introduction into the territory of the country of desti-
nation of animals for breeding or production, facts come to light which1964L0432 — EN — 30.06.1964 — 000.001 — 7
▼B
would have justified the application of the first sentence of paragraph
3, the competent central authority of the exporting country must, at therequest of the competent central authority of the country of destination,
make the necessary investigations and notify that authority without
delay of the outcome of such investigations.
7. The decisions taken by the competent authority under paragraphs
3 to 5 must be communicated to the consignor or his representative,
together with the reasons for such decisions. These reasoned decisionsmust on request, be communicated to him forthwith in writing with anindication of what appeals against them are open under current legisla-tion and the form and time in which they must be commenced. The
decisions must also be communicated to the competent central
authority of the exporting country.
Article 7
1. Countries of destination may grant to one or more exporting
countries general authorisations or authorisations restricted to specificcases for the introduction into their territory ►
C2of◄:
A.Bovine animals for breeding, production or slaughter:
(a) which, by way of derogation from Article 3 (3) (a) or 6 (a),
have not been vaccinated against foot-and-mouth disease, if no
case of foot-and-mouthdisease h as been officially recorded in
the exporting country and in the transit countries concerned forat least six months preceding the date of loading;
(b) which, by way of derogation from Article 3 (3) (a) or (6) (a)
have received anti-foot-and-mouth disease serum treatment, notmore than ten days before loading, with an anti-foot-and-mouthdisease serum approved and controlled by the competent
authority of the exporting country and authorised by the compe-
tent authority of the country of destination.
B.Bovine animals for breeding or production which, by way of dero-
gation from Article 3 (3) (c), come from a brucellosis-free herd.
C.Bovine animals for slaughter:
(a) which, by way of derogation from Article 3 (6) (b), have
reacted positively to an intra-dermal tuberculin test;
(b) which, by way of derogation from Article 3 (6) (c), have shown
a brucella count equal to or higher than 30 international units ofagglutination per millilitre when given a sero-agglutination test.
2. When a country of destination grants a general authorisation
under paragraph 1, it shall forthwith inform the other Member States
and the Commission thereof.
3. When a country of destination grants any authorisation under
paragraph 1, a corresponding authorisation must, in the case of transit
operations, be obtained from the transit countries concerned.
4. The exporting countries shall take all necessary measures to
ensure that the health certificates, specimens of which are given in
Annex F (Models I and II), mention that use has been made of one ofthe possibilities provided in paragraph 1.
Article 8
Until the entry into force of such provisions as may be adopted by the
European Economic Community, this Directive shall not affect theprovisions of Member States relating to:
(a) bovine animals and swine which have been treated with antibiotics,
oestrogens or thyreostatics;
(b) the prevention of trichinosis, on condition that those provisions are
not applied in a discriminatory manner, having regard particularlyto the implementation of systematic research to reveal trichina inexporting Member States.1964L0432 — EN — 30.06.1964 — 000.001 — 8
▼B
Article 9
1. A Member State may take the following measures if there is a
danger of animal diseases spreading as a result of the introduction
into its territory of bovine animals or swine from another Member
State:
(a) in the event of an outbreak of an epizootic disease in the other
Member State, temporarily prohibit or restrict the introduction ofbovine animals or swine from the affected areas of that MemberState;
(b) if an epizootic disease becomes widespread or if there is an
outbreak of another serious contagious or infectious animal disease,temporarily prohibit or restrict the introduction of bovine animalsand swine from any part of the territory of that State.
2. Measures taken by a Member State under paragraph1 must be
communicated within ten working days to the other Member States
and the Commission together with the precise reasons for such
measures.
3. If the Member State concerned considers that the prohibition or
restriction referred to in paragraph1 is unjustified, it may apply to th eCommission for the immediate opening of discussions.
Article 10
1. Rights of appeal existing under current legislation in the Member
States against decisions taken pursuant to this Directive by the compe-tent authorities shall not be affected by this Directive.
2. Each Member State shall grant to consignors in respect of whose
bovine animal and swine suchmeasures as are provided for in Article 6
(3) have been taken, the right to obtain, before other measures aretaken by the competent authority other than the slaughter or destructionof animals if essential for considerations of animal or public health, theopinion of a veterinary expert to determine whether the conditions ofArticle 6 (3) have been fulfilled.
The veterinary expert must be a national of a Member State other than
the exporting country or country of destination.
The Commission, acting on a proposal from the Member States, shall
►
C2draw◄up a panel of veterinary experts who may be instructed
to formulate such opinions. After consulting the Member States it shalllay down general rules which are to be applied, in particular as regardsthe procedure for formulation of these opinions.
Article 11
If the Community provisions relating to importation of bovine animals
and swine from third countries do not apply at the time when this
Directive enters into force, or pending their becoming applicable,
national provisions relating to bovine animals and swine importedfrom those countries shall not be more favourable than those governingintra-Community trade.
Article 12
The Member States shall bring into force the laws, regulations and
administrative provisions necessary to comply withth is Directive andits Annexes within twelve months following its notification and shall
forthwith inform the Commission thereof.
Article 13
This Directive is addressed to the Member States.1964L0432 — EN — 30.06.1964 — 000.001 — 9
▼B
ANNEX A
I.Tuberculosis-freebovineanimalsandherds
1. A bovine animal is considered to be tuberculosis-free if it shows no clinical
signs of tuberculosis nor a reaction to an intradermal tuberculin test carried
out in accordance with Annex B not more than thirty days before loading,
nor any specific reaction, and when it is from an officially tuberculosis-free
bovine herd within the meaning of paragraph 2.
2. A bovine herd is considered to be officially tuberculosis-free if:
(a) all the animals are free from clinical signs of tuberculosis;
(b) all the animals over six weeks old have reacted negatively to at least two
official intradermal tuberculin tests carried out in accordance withAnnex
B, the first one six months after completion of disinfection of the stock,
the second one six months later and the remainder at one- or two-yearly
intervals in the case of Member States whose entire bovine herd is under
official veterinary supervision and has a rate of tubercular infection lower
than 1%;
(c) no bovine animal has been introduced without a certificate from an offi-
cial veterinarian showing that the animal has reacted negatively to an
intra-dermal tuberculin test assessed according to the criteria set out in
Annex B 21 (a) and that it comes from an officially tuberculosis-free
herd.
II.Brucellosis-free bovineanimalsandswineandbovineandswineherds
A.Bovine animals and herds
1. A bovine animal is considered to be brucellosis-free when it shows no
clinical signs of the disease and has shown a brucella count lower than
30 international units of agglutination per millilitre when given a sero-
agglutination test complying withth e provisions of Annex C not more
than thirty days before loading and is from an officially brucellosis-free
bovine herd within the meaning of paragraph 2. In addition, in the case
of bulls, the sperm must not contain brucellic agglutinins.
2. A bovine herd is considered to be officially brucellosis-free if:
(a) it contains no bovine animals which have been vaccinated against
brucellosis by use of a live vaccine;
(b) all the bovine animals have been free from clinical signs of brucel-
losis for at least six months;
(c) all the bovine animals over twelve months old:
(aa) have shown a brucella count lower than 30 international units of
agglutination per millilitre when given at six-monthly intervals
two official sero-agglutination tests complying withAnnex C;
the firstsero-agglutination test may be replaced by three ring-
tests carried out at three-monthly intervals provided, however,
that the second sero-agglutination test is carried out at least six
weeks after the third ring-test;
(bb) are checked annually, to establish that brucellosis is not present
by means of three ring-tests carried out at intervals of at least
three months or two ring-tests and one sero-agglutination test
carried out at intervals of at least three months; when the ring-
test cannot be made, two sero-agglutination tests shall be carried
out each year, at six-monthly intervals; in Member States whose
entire bovine herd is under official veterinary supervision and
has a rate of brucellic infection lower than 1%, only two ring-
tests need be carried out eachyear or, if th is cannot be done,
one sero-agglutination test.
(d) no bovine animal has been introduced without a certificate from an
official veterinarian showing that its brucella count was lower than
30 international units of agglutination per millilitre when given a
sero-agglutination test not more than thirty days before it was taken
into the herd and, in addition, that it is from an officially brucellosis-
free bovine herd.
3. A bovine herd is considered to be brucellosis-free if:
(a) by way of derogation from paragraph2 (a), it contains bovine
animals between five and eight months old which have been vacci-
nated only withlive vaccine Buck 19;1964L0432 — EN — 30.06.1964 — 000.001 — 10
▼B
(b) all the bovine animals fulfil the conditions laid down in paragraph 2
(b), (c) and (d); bovine animals less than thirty months old may
however show a brucella count equal to or higher than 30 interna-
tional units of agglutination per millilitre but lower than 80
international units of agglutination per millilitre, the complement
fixation reaction being negative.
B.Swine and swine herds
1. A swine is considered to be brucellosis-free when it shows no clinical
signs of the disease and shows a brucella count lower than 30 interna-
tional units of agglutination per millilitre and a negative complement
fixation reaction when given a sero-agglutination test complying with
Annex C not more than thirty days before loading and, in addition, it
comes from a brucellosis-free herd within the meaning of paragraph 2;
the sero-agglutination test shall only be made on swine weighing more
than 25 kilogrammes.
2. A swine herd is considered to be brucellosis-free if:
(a) for at least one year no case of swine brucellosis nor any sign indi-
cating that the disease might be present have been recorded in respect
of it. If suchsigns are observed, clinical, bacteriological and, if
necessary, serological tests must be carried out under official super-
vision to establish that the symptoms are non-brucellic;
(b) it is situated in the centre of an area of 20 km diameter in which no
case of swine brucellosis has been officially recorded for at least one
year;
(c) bovine animals kept contemporaneously on the holding are officially
brucellosis-free.1964L0432 — EN — 30.06.1964 — 000.001 — 11
▼B
ANNEX B
Standardsforthemanufactureanduseoftuberculins
1. Officially supervised tuberculin tests must be carried out withPPD (bovine)
tuberculin or a tuberculin prepared on a synthetic medium and heat-concen-
trated.
2. For the control of PPD tuberculin, a standard tuberculin conforming
►C2with◄the international PPD standard of the Staatens Seruminstitut
in Copenhagen must be used.
Such standard tuberculin must be that supplied by the Centraal Diergenees-
kundig Instituut, Afdeling Rotterdam.
3. For the control of tuberculins known as ‘synthetic’ tuberculins, a standard
tuberculin conforming withth e international standard for old tuberculin of
the Staatens Seruminstitut in Copenhagen must be used.
Such standard tuberculin must be that supplied by the Paul-Ehrlich-Institut
in Frankfurt-am-Main.
4. Tuberculins must be prepared with one of the BK stocks of the bovine type
indicated below:
(a) An5
(b) Vallee
(c) Behring.
5. The pH of tuberculins must be between 6·5 and 7.6. Only phenol with a concentration of 0·5% may be used as a preservative in
tuberculins.
7. Provided that tuberculins are preserved at a temperature of about 4 ºC, they
may be used up to the end of the following periods:
(a) Liquid PPD tuberculins: six months
Lyophilized PPD tuberculins: five years;
(b) Tuberculins known as ‘synthetic’, non-diluted: five years
diluted: two years.
8. The state institutes listed below must be made responsible for the official
testing of tuberculins in their respective countries:
(a) Germany: Paul-Ehrlich-Institut, Frankfurt-am-Main
(b) Belgium: Institut national de recherches veterinaires,
Brussels
(c) France: Laboratoire central de recherches veterinaires,
Alfort
►
C2(d)◄Grand
Duchy of Luxembourg: Institute of the supplying country
(e) Italy: Istituto Superiore di Sanità, Rome
(f) Netherlands: Centraal Diergeneeskundig Instituut, Afdeling
Rotterdam.
9. Official testing must be carried out either of bottled tuberculins ready for
use, or of a complete consignment of tuberculin before packaging provided
it is subsequently bottled in the presence of a representative of the compe-
tent authority.
10. PPD tuberculin must be tested by biological methods and by the clinical
method.
11. Tuberculins must be sterile.
12. An innocuity test of the tuberculin, to establish its non-toxicity and the
absence of irritant properties, must be carried out as follows:
(a) Non-toxicity: tests must be carried out on mice and guinea-pigs.
Mice: Injection of 0·5 ml of tuberculin under the skin of two mice
weighing 16 to 20 g each. If, within two hours, there are no
clear signs of intoxication it may be concluded that the product
does not contain excessive phenol.1964L0432 — EN — 30.06.1964 — 000.001 — 12
▼C2
▼B
▼B
Guinea-pigs: The guinea-pigs must weigh between 350 and 500 g. The
amount of tuberculin to be injected must be 1 ml per
100 g live weight. One of the two methods described
below must be used:
(aa) Tuberculin is injected into the abdominal skin of two guinea-pigs.
The tuberculin may be considered to be satisfactory if the guinea-
pigs treated in this way show, for not more than two days, a strong
infiltration which is reabsorbed from the third day without having
produced necrosis and is no longer visible after six days. If there is
necrosis of the abdominal skin, or if the infiltration does not disap-
pear within six days, the tuberculin shall be rejected.
(bb) The tuberculin is injected intraperitoneally into two guinea-pigs.
The animals are observed for six weeks during which there must
be no specific symptom or loss of weight. At the end of six weeks
the animals are killed and a check made that there is no tubercular
lesion;
in particular, histological incisions are made in the spleen, liver
and lungs. The same procedure is followed for any animal which
dies before the end of the time limit.
(b) Absence of irritant properties: an intradermal inoculation of 2500 inter-
national units (IU) of tuberculin in a volume of 0·1 ml is made in the
depilated skin of the flank of two guinea-pigs. There must be no reac-
tion after forty hours.
13. Tuberculins must be chemically analysed in order to determine the exact
amount of phenol and to establish whether any other preservative is present.
14. A test of non-sensitisation to tuberculin must be carried out as follows:
Three guinea-pigs which have never been used for scientific tests are given,
at five day intervals, three intradermal injections of 500 international units
of tuberculin in a volume of 0·1 ml. The guinea-pigs are tested fifteen days
later by an intradermal injection of the same amount of tuberculin. They
must not show a reaction different from that of guinea-pigs of the same
weight which have never been used for scientific tests carried out for
control purposes withth e same amount of tuberculin.
15. An activity test must be carried out by the chemical method and by biolo-
gical methods.
(a) Chemical method: this method can be used for PPD and is based on the
precipitation of tuberculo-protein by trichloracetic acid. The nitrogen
content is determined by Kjeldahl distillation. The conversion factor of
the total nitrogen PPD is 6·25.
(b) Biological methods: these methods can be used for tuberculins prepared
on a synthetic medium and for PPD; they are based on the comparison
withstandard tuberculins of th e tuberculins to be tested.
16. The international standard for old tuberculin contains 100000 international
units of agglutination per millilitre.
17. The international PPD standard is delivered in the ►C2lyophilized ◄
state, one international unit = 0·00002 mg of tuberculo-protein. The
ampoule contains 2 mg of tuberculo-protein.
Tuberculins submitted by manufacturers for testing by the state institutes
listed in paragraph 8 must have the same activity as standard tuberculins,
i.e. they must contain 100000 international units ►C2 ◄
per millilitre.
18. (a)Potency testing on guinea-pigs:
Albino guinea-pigs weighing between 400 and 600 g must be used.
These guinea-pigs must be in good health and checked by palpation to
determine whether, at the time of the tuberculin inoculation, their
muscular tone has remained normal in spite of prior sensitisation.
(aa) Guinea-pigs shall be sensitised by inoculation injection of about
0·5 mg of live tuberculosis bacilli in physiological saline emulsion
under the skin of the thigh or the nape of the neck.
The bovine type strain, supplied on request by the Paul-Ehrlich-
Institut in Frankfurt-am-Main must be used for this purpose. An
excessive dose must be avoided so that the guinea-pigs retain their
weight until used;
(bb) Irrespective of the method of titration used, assessment must
always be based on comparison withstandard tuberculin of th e
tuberculin to be tested; the result must be expressed in interna-
tional units per ml.1964L0432 — EN — 30.06.1964 — 000.001 — 13
▼B
(b)Potency testing on bovine animals
When tests are on bovine animals the reactions obtained on tubercular
bovine animals by the tuberculin to be tested must be identical to those
produced by the same amounts of standard tuberculin.
19. Tuberculin tests must be made by a single intradermal injection into either
the neck or the shoulder.
20. The amount of tuberculin to be injected shall be 5000 international units of
PPD or synthetic tuberculin.
21. The result of the intradermal tuberculin test must be read after seventy-two
hours and assessed according to the following method:
(a) Negative reaction: if only limited swelling is observed, withan increase
of not more than 2 mm in the thickness of the fold of skin without clin-
ical signs suchas pasty consistency, exudation, necrosis, pain or
inflammation of the lymphatic ducts in that region and of the lymph
nodes;
(b) Positive reaction: if clinical signs suchas mentioned in (a) are observed
or if there is an increase of more than 2 mm in the thickness of the skin.1964L0432 — EN — 30.06.1964 — 000.001 — 14
▼B
ANNEX C
Bovinebrucellosis
A.Serum agglutination tests
1. The standard agglutinating serum must conform to the standard serum
prepared by the Veterinary Laboratory, Weybridge, Surrey, England.
The ampoule must contain 1000 international agglutination units (IU)
obtained by lyophilising 1 ml of bovine serum.
2. The standard serum must be that supplied by the Bundesgesundheitsamt,
Berlin.
3. The degree of brucella agglutination in a serum must be expressed in
international units per ml ►C2(i.e. Serum X = 80 IU/ml) ◄.
4. Readings of slow sero-agglutination in tubes must be taken at 50% or at
75% agglutination, the antigen used having been titrated under identical
conditions against the standard serum.
5. The agglutinating value of various antigens in relation to standard serum
must be within the following limits:
— If the reading is made at 50%: between 1/600 and 1/1000;
— If the reading is made at 75%: between 1/500 and 1/750.
6. Weybridge Strain No 99 and USDA 1119 or any other strain of equiva-
lent sensitivity must be used for preparing the antigen for use in tube
agglutination (slow method).
7. The culture media used for keeping the strain in the laboratory and for
producing the antigen must be such that they do not encourage bacterial
dissociation (S minus R); potato agar should preferably be used.
8. The bacterial emulsion must be made from physiological saline (NaCl
8·5%) phenolized at 5%. Formol must not be used.
9. The official institutes indicated below must be made responsible for the
official testing of antigens:
(a) Germany: Bundesgesundheitsamt, Berlin
(b) Belgium: Institut national de recherches vétérinaires, Brussels
(c) France: Laboratoire central de recherches vétérinaires, Alfort(d) Grand
Duchy of
Luxembourg: Institute of the supplying country
(e) Italy: Istituto Superiore di Sanità, Rome(f) Netherlands: Centraal Diergeneeskundig Instituut, Afdeling
Rotterdam.
10. Antigens may be delivered in the concentrated state provided the dilu-
tion factor to be used is indicated on the bottle label.
11. In order to carry out a sero-agglutination test, at least three dilutions
must be prepared for eachserum. Dilutions of suspect serum must be
made in such a way that the reading of the reaction at the infection limit
is made in the median tube. If there is a positive reaction in this tube,
the suspect serum contains at least 30 international units of agglutination
per millilitre.
B.Ring-test
12. The ring-test must be made on the contents of each milk churn from the
farm.
13. The standard antigen to be used must come from one of the institutes
listed in paragraph9 (a) and (f).
14. The antigen may be stained only with hematoxylin or tetrazolium;
hematoxylin should preferably be used.
15. The reaction test must be carried out in 8 to 10 mm diameter tubes.16. The reaction test must be carried out using 1 ml of milk to which
0·05 ml of one of the stained antigens has been added.1964L0432 — EN — 30.06.1964 — 000.001 — 15
▼B
17. The mixture of milk and antigen must be incubated at 37 ºC for not less
than forty-five minutes and not more than sixty minutes.
18. The reaction test must be carried out approximately eighteen hours after
milking and assessed according to the following criteria:
(a) Negative reaction: coloured milk, colourless cream;
(b) Positive reaction: milk and cream identically coloured or colour-
less milk and coloured cream.
19. Formol must not be added to the sample. The only product which may
be added is mercuric chloride in a solution of 0·2% and, in such case,
the ratio between the amount of milk and the solution of mercuric
chloride must be 10 to 1.1964L0432 — EN — 30.06.1964 — 000.001 — 16
▼B
ANNEX D
Milkanalysis
1. All milk analyses must be carried out in official or officially approved
laboratories.
2. Milk samples must be taken in accordance withth e following conditions:
(a) the teats must first be disinfected with 70% alcohol.
(b) tubes must be kept in a sloping position while being filled.
(c) milk samples must be taken at the beginning of milking, after eliminating
the first streams from each teat.
(d) a sample must be taken from each quarter; the milk from these samples
must not be mixed.
(e) eachsample must contain at least 10 ml of milk.
(f) if a preservative is required boric acid at 0·5% must be used.
(g) eachtube must bear a label giving th e following information:
— the number of the earmark or any other means of identifying the
animal;
— the quarter from which the sample was taken;
(h) samples must be accompanied by a document giving the following infor-
mation:
— the name and address of the official veterinarian;
— the name and address of the owner;— the means of identifying the animal;
— the stage of lactation.
3. Milk analysis must be made not more than thirty days before loading and
must always include a bacteriological test and a White Side Test (WST) or
California Mastitis Test (CMT). The result of these two tests must be nega-
tive, subject as follows:
(a) if the result of the bacteriological test is positive— although there is no
characteristic inflammatory conditions but the result of the WST (or the
CMT) is negative, a second bacteriological test must be carried out at
least ten days later, within the thirty-day limit set above. This second
test must establishth at:
(aa) the pathogenic micro-organisms have disappeared;
(bb) there are no antibiotics present.
In addition, the absence of inflammation must be established by a further
WST (or a further CMT) which must be negative.
(b) if the bacteriological test is negative while the WST (or the CMT) is
positive, a complete cytological test must be made which must be nega-
tive.
4. The bacteriological test shall include:
(a) the seeding of milk in a Petri dish on blood agar of bovine animals or
sheep;
(b) the seeding of milk in TKT or Edwards media.
The purpose of the bacteriological test is to identify all pathogenic micro-
organisms and it must not be restricted to detecting specific pathogenic strep-
tococci or staphylococci. For this reason, the identification of suspect
colonies obtained from seeding in the above-mentioned media shall be
carried out by traditional methods of bacteriology differentiation such as the
use of the Chapman medium to identify staphylococci and of various selec-
tive media for the detection of entero-bacteria.
5. The complete cytological test is intended to detect, where necessary, a char-
acteristic inflammatory condition independent of any clinical symptom.
The existence of an inflammatory condition is established when the leucocyte
count taken according to the Breed method attains 1 million leucocytes per
millilitre and the proportion of mononuclear to polynuclear leucocytes is
less than 0·5.1964L0432 — EN — 30.06.1964 — 000.001 — 17
▼B
ANNEX E
Thefollowingdiseasesarecompulsorilynotifiable:
(a) Bovine diseases:
RabiesTuberculosis
Brucellosis
Foot-and-mouthdiseaseAnthrax
Cattle plague
Pleuro-pneumonia
(b) Swine diseases:
Rabies
Brucellosis
AnthraxFoot-and-mouthdisease
Classical and African swine fever
Contagious swine Paralysis (Teschen disease).1964L0432 — EN — 30.06.1964 — 000.001 — 18
▼B
ANNEX F
1964L0432 — EN — 30.06.1964 — 000.001 — 19
▼B
►(1)C21964L0432 — EN — 30.06.1964 — 000.001 — 20
▼B
1964L0432 — EN — 30.06.1964 — 000.001 — 21
▼B
►(1)C21964L0432 — EN — 30.06.1964 — 000.001 — 22
▼B
►(1)C21964L0432 — EN — 30.06.1964 — 000.001 — 23
▼B
1964L0432 — EN — 30.06.1964 — 000.001 — 24
▼B
1964L0432 — EN — 30.06.1964 — 000.001 — 25
▼B
►(1)C21964L0432 — EN — 30.06.1964 — 000.001 — 26
▼B
1964L0432 — EN — 30.06.1964 — 000.001 — 27