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Vol. 1985/0 211 
  
 
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COMMISSION OF THE EUROPEAN COMMUNITIES
C0M(85) 578 fin a l  
Brussels, 28 October 1985
Report from the Commission to the Council  
on the application of measures for protection against  
enzootic bovine leukosis (EBL)
Proposal for a  
COUNCIL DIRECTIVE
amending D irective 64/432/EEC as regards the d e fin itiv e  arrangements  
made in relatio n  to enzootic bovine leukosis as laid down by
Directive 80/1102/EEC
(submitted to the Council by the Commission)

EXPLANATORY HOTE
Council Directive 80/1102/EEC, which amends Council Directive 64/432/EEC, lays  
down the health guarantees regarding enzootic bovine leukosis when bovine  
animals are entered into intra-Community trade. These health measures have  
been in effect for nearly five years and, in general, the risk of disease  
spreading has been greatly reduced and the measures themselves do not cause  
difficulties in trade. Article 3 of Directive 80/1102/EEC requires that the  
Commission make a report to the Council on the application of the measures  
accompanied by proposals concerning the definitive arrangements, to take  
effect before 31 December 1985. Attached is the report and the proposals, and  
the definitive measures in the proposals are the same as were contained in the  
original Directive which, in effect, the Member States have been applying for  
the last four and a half years.
It is proposed that the attached report and proposals will be adopted by the  
Commission and then transmitted to the Council.

Report to the Council on the application of measures for
protection against enzootic bovine leukosis (EBL)
1. The measures for protection against enzootic bovine leukosis (EBL) are  
laid down in Council Directive 80/1102/EEC of 11 November 1980. The  
purpose of this Directive was to amend Council Directive 64/432/EEC of  
26 June 1964, which deals with animal health problems affecting  
intra-Community trade in :  ovine animals and swine. Article 3 of  
Directive 80/1102/EEC states that the provisions relating to EBL shall  
be applicable until 31 December 1985 and that the Commission shall  
submit to the Council before 31 December 1984 a report on the  
application of this Directive accompanied by proposals concerning the  
definitive arrangements, and that the Council shall take a decision on  
these proposals before 1 July 1985, The purpose of this report is to  
accomplish that requirement.
2. An analysis of Community law relating to enzootic bovine leukosis in  
intra-Community trade
2.1 Special criteria have now been laid down for EBL guarantees, which may
be demanded and given in relation to movement of different categories of  
cattle from one Member State to another. At the same time, it is  
recognised that the guarantees become more valuable when the EBL and BLV  
(bovine leukosis virus) situation is known in the herd of origin and  
when the status of the region and country of origin is known. This is  
why Directive 80/1102/EEC also contains an obligation for all Member  
States to introduce a minimum disease programme before 1 January 1981.
It is also taken into consideration that some Member States have  
•  operated national eradication programmes for several years, eg, Denmark  
and the German Federal Republic, and have managed to eliminate the  
disease systematically.

vA
-  2 -
2.2 Mandatory requirements
For those Member States in which EBL and BLV are not found, a formal  
procedure is established to permit them to protect themselves  
efficiently by asking maximum guarantees when they import cattle; at the  
same time, it is also possible for them to simplify their testing  
procedures when they issue certificates for export. The rules for the  
trade guarantees are given as follows:
a) EBL must be a compulsorily notifiable disease. All animals intended  
for breeding or production purposes must 1) come from a herd in which  
there has been no evidence of EBL during the preceding 3 years, and  
2) have passed an (individual) serological test, if they are more  
than 12 months of age, during the 30 days before loading.
b) Male bovine animals and castrates are not required to be tested if  
they are intended for meat production and if they are less than 30  
months of age. They must be identified by a special mark when they  
are loaded.
c) Female animals entered into intra-Community trade may or may not be 
followed by a guarantee based on an individual test. This is decided  
by the importing Member State. The same conditions for age, marking 
and use, as specified in b),  must be used.
d) Especially strict rules are introduced for high value pure bred  
bovines solely intended for breeding. The importing/exporting Member  
States must ensure that the animals come from a herd in which:
- no facts have been brought to the notice of the official
veterinarian which would lead him to conclude that a case of EBL  
has occurred within the preceding 3 years

- 3 -
- the owner declares that he has no knowledge of such facts and  
furthermore declares in writing that the animal(s) intended for  
intra-community trade has(have) been born or reared in the herd or  
remained an integral part of it for the previous 12 months.
An importing Member State may additionally require that all bovines  
over 24 months of age on the date of the test have passed a  
serological test for EBL within the previous 12 months in the herd of  
origin. If the herd test has been carried out previous to the 30 day  
loading period, then an extra individual serological test is required  
during the 30 day period if the animal(s) is(are) over 12 months of  
age.
e) Concerning intra-Community trade, there are no requirements
applicable to animals intended for immediate slaughter. Member  
States’  own rules shall apply, relating to intra-Community trade or  
movements concerning animals intended for show purposes or bulls for  
artificial insemination centres, providing that these rules are the  
same as those that are applied internally.
2.3 Special provisions for Member States applying compulsory EBL eradication  
proRrammes
2.3.1 The Federal Republic of Germany and Denmark (because they were applying  
a compulsory EBL eradication programme on 1 January 1981) may  
additionally apply the following requirements in the case of bovine  
animals for breeding or production intended for combining with bovine  
herds not suspected of having leukosis.
They must be accompanied by a certificate signed by a competent official  
veterinarian issued on the date of loading, stating:

(i) that the veterinarian haa no knowledge of facts which would lead  
him to conclude that a case of EBL has occurred within the  
preceding 3 years in the herd from Which they come and that the  
owner of this herd ha9 declared that he has no knowledge of such  
facts and that he has further declared, in writing, that the  
animal(s) intended for intra-Community trade has(have) been bom  
and reared in the said herd or remained an integral part of it for  
the previous 12 months
(ii) that all bovines over 24 months of age on the date of the test have  
passed a serological test for EBL within the previous 12 months in  
the herd of origin.
If the above regime is not applied, the breeding or production animals  
that are imported into the Federal Republic of Germany or Denmark from  
other Member States must pass the serological test within 30 days of  
loading if they are over 12 months of age. Male bovine animals and  
castrates less than 30 months of age, if intended for meat production,  
are not required to be tested. The individual serological test is also  
required if the herd test has taken place outside the 30 day period  
prior to loading.
2.3.2 Minimum EBL eradication programmes
Since 1 January 1981, all Member States who have not Introduced special  
national control and eradication plans must have introduced a so-called  
minimum programme, including at least the following criteria:
Member States other than the Federal Republic of Germany and Denmark  
must introduce a minimum programme for the eradication of EBL, including  
at least the following minimum requirements:
-  all tumours in the organs and lymphatic system of bovines must be 
notified and examined histologically by a State supervised veterinary  
laboratory

T r
-  5 -
- all cattle in herds Which have had contagious contact with an animal  
found to be suffering from leukotic tumours shall be subjected to an  
agar gel immuro diffusion test in a State supervised laboratory
- should EBL be confirmed, then the herd will be supervised by the  
veterinary authorities and infected animals may only be removed for  
slaughter under supervision. The herd will remain under supervision  
uni il such time as it has passed 3 AGID tests carried out at 6 monthly  
intervals on all animals over 24 months of age. The tests must be  
carried out in a State supervised laboratory.
2.3.3 The standing Veterinary Committee procedure may also be utilised to
waive the herd test requirement (though not the individual test) when  
high value pure ored breeding animals are entered into intra-Community  
trade, providing that the Member State concerned is recognised as  
providing adequate guarantees as regards EBL.
The United Kingdom in respect of Northern Ireland may also be authorised  
by way of the same procedure for trade into Northern Ireland to require  
a herd test carried out on all animals over 24 months of age when 
animals for breeding or production are imported from other Member  
States. Additionally, these animals will be accompanied by a  
certificate of 3 year clinical herd freedom and stating that the said  
animals were bora and reared in the herd of origin or remained an  
integral part of it for the previous 12 months. The other Member States  
or regions thereof may also be authorised via the same procedure to  
require the same conditions when importing breeding or production  
animals, providing it can be proved that they have been applying the  
minimum requirements as outlined in the EBL eradication programme for at  
least a 2 year period. Additional unnamed conditions may also be  
imposed.

-  6 -
EBL situation in the Member States
3.1 The Netherlands
EBL is a compulsorily notifiable disease. A minimum eradication 
programme was introduced in 1977 involving tumour notification and  
testing of herds of origin. In 1981 there were 49 tumour cases  
notified, in 1982 there were 67 and in 1983 there were 28. None of  
these tumours were found to have been leukotic. Nevertheless, 30 of  
these herds were serologically tested as a result of tumour  
notification. None were found to contain positive animals.
Two animals gave a positive reaction when a total of 43 874 breeding or  
production bovines over 12 months of age were serologically tested for  
intra-Community trade during the years 1981, 1982 and 1983.
One herd was found to contain positive animals when a total of 30 herds  
of origin were serologically tested, thereby enabling high value pure  
bred animals to be entered into intra-Community trade during the years  
1981, 1982 and 1983.
Results of the national screening programme
1981 1982 1983
Herds 80 900 78 900 76 200
Animals 4 635 366 4 671 179 4 733 120Total cattle population
Herds 13 000 14 706 16 809
Serologically tested Animals 110 953 154 836 157 573
Herds 2 0 4
6*Serologically positive Animals 6 0
* imported animals

-  7 -
As a consequence of the testing programme, all positive animals were  
slaughtered within 30 days of diagnosis. Movement was forbidden out of  
herds containing positive animals, except for bovines intended for  
slaughter, until such time as all positive animals had been removed and  
the remaining animals over 12 months of age had passed 4 consecutive  
tests at 6 month intervals.
No authorisations have been given to other Member States to waive the  
serological test for female bovine animals for meat production less than  
30 months of age intended for intra-Community trade.
It is the Netherlands* intention to apply, via the Standing Veterinary  
Committee procedure, to have a herd test carried out on all imported  
breeding or production animals.
3.2 Luxembourg
EBL is a compulsorily notifiable disease. A minimum eradication  
programme was introduced on 1 January 1981 involving tumour notification  
and testing of herd of origin. To date there have been no tumour cases  
notified.
There were no positive reactions when a total of 12 900 breeding or  
production bovines over 12 months of age were serologically tested for  
intra-Community trade during the years 1981, 1982 and 1983.
No herd was found to contain positive animals when a total of 43 herds  
of origin were serologically tested, thereby enabling high value pure  
bred animals to be entered into intra-Community trade during the years  
1981, 1982 and 1983.

-  8 -
Results of the national screening programme
1981 1982 1983
Total cattle population
Serologically testedHerds 3 509 3 382 3 269
Animals 191 000 194 500 194 300
Herds 13 41 491
AnimalB 10 487 9 262 13 480
None of these herds contained positive animals.
No authorisations have been given to other Member States to waive the  
serological test for female bovine animals for meat production less than  
30 months of age intended for intra-Community trade.
It is Luxembourg's intention to apply, via the Standing Veterinary  
Committee procedure, to have a herd test carried out on all imported  
breeding or production animals.
3.3 Greece
EBL is a compulsorily notifiable disease. Tumour notification and  
testing of herd of origin and other eradication measures are practised.  
In 1982 there were 2 tumour cases which were traced back to their herd  
of origin and in 1983 there were also 2 cases traced back. The herds of  
origin were serologically tested and none were found to contain positive  
animals.
As no cattle exports have taken place from Greece, serological tests  
have not been carried out in relation to intra-Community trade.
However, a certain amount of testing has been carried out as follows:

-  9 -
Results of the screening programme
1981 1982 1983
Herds 123 682 117 284 111 365
Total cattle population Animais 680 829 661 022 650 427
Herds 363 499 '290
Serologically tested Animals 7 516 10 013 6 310
Herds 3 6 13
Serologically positive Animals 5 29 107
All positive animals were slaughtered within 30 days of diagnosis.  
Movement was forbidden out of herds containing positive animals, except  
for bovines intended for slaughter, until such time as all positive  
animals had been removed and the remaining animals over 12 months of age  
had passed 4 consecutive tests at 6 month intervals.
No authorisations have been given to other Member States to waive the  
serological test for female bovine animals for meat production less than  
30 months of age intended for intra-Community trade.
3.4 United Kingdom
3.4.1 Great Britain
EBL is a compulsorily notifiable disease. A voluntary scheme was  
introduced in 1979 whereby herd owners are assisted to establish and  
maintain their herds free of EBL. A herd test is carried out at the  
government’s expense for any herd owner who requests it, providing that  
the herd has already had one clear herd test carried out at the owner s  
expense.

-  10  -
In 1981 there were 192 tumour cases notified, of which 75 were  
leukotic. In 1982 there were 175 notified, of which 84 were leukotic 
and in 1983 there were 184 notified, of which 24 were leukotic. No herd 
testing is done as the result of tumour notification. It is often  
difficult to trace herd of origin. Where it is possible to trace sire,  
dam or siblings, these may be tested.
No information is available as to how many high value pure bred animal  
herds were tested nor the results of such testing in relation to  
intra-Community trade.
Results of the national screening programme
1981 1982 1983
Herds 149 359 148 102 136 953
Total cattle population ^ , ^ 3 n  70o 649 11 812 728 11 734 456
Herds 41 200 225
Serologically tested Animals 11 514 Information not available
Herds 7 14 11
Serologically positive Aniinals 25 25 38
When positive animals are found, they may or may not be slaughtered within  
30 days as it is up to the individual farmer to choose in accordance with  
the rules of the voluntary scheme. Movement is not forbidden out of  
positive herds.
Authorisation has been given to the Republic of Ireland to waive the
serological test for female bovine animals for meat production less than 30
months of age when they are imported.

-  11  -
3.4.2 Northern Ireland
EBL is a compulsorily notifiable disease. A minimum eradication  
programme was introduced in 1975 involving tumour notification and  
testing of herds of origin. In 1981 there were 26 tumour cases  
notified, of which 8 were leukotic. The 8 herds were tested and none  
contained positive animals. In 1982 there were 38 tumour cases  
notified, of which 11 were leukotic. The 11 herds were tested and'none  
contained positive animals. In 1983 there were 18 tumour cases  
notified, of which 8 were leukotic. The 8 herds were tested and none  
contained positive animals. No bovine animals either for breeding or  
production or from high value pure bred herds were tested for  
intra-Community trade in 1981, 1982 or 1983.
Results of the screening programme
1981 1982 1983
Herds 40 000 40 000 40 000
Total cattle population Animals 1 436 200 1 428 900 1 471 900
Herds 15 24 25
Serologically tested Animals 1 605 2 202 2 853
Serologically positive 0 0  0
Should a positive bovine be discovered, however, Northern Ireland has  
the necessary legislative powers to require slaughter, restrict movement  
and test herds.
Authorisation has been given to the Republic of Ireland to waive the
serological test for female bovine animals intended for meat production
less than 30 months of age when they are imported.

-  12  -
It is the intention to apply, via the Standing Veterinary Committee  
procedure, to have a herd test carried out on all imported breeding or  
production animals.
EBL is a compulsorily notifiable disease. A minimum eradication  
programme was introduced on 1 January 1983 involving tumour notification  
and testing of herds of origin. In 1983 there were 500 tumour cases  
notified, of which 370 were leukotic. 365 herds of origin were tested,  
of which 268 contained positive animals. Up to the end of Hay 1984, 350  
tumour cases were notified, of which 250 were leukotic. 236 herds of  
origin were tested, of which 180 contained positive animals.
No information is available at a national level concerning the number of  
herds or animals that were submitted to test for the purpose of  
intra-Community trade or the results of such tests.
Results of the national screening programmeFrance
1983
Herds 671 295
Total cattle populationAnimals 17 999 000
Serologically tested Animals 113 499
Serologically positive 8 678
All positive animals were not slaughtered within 30 days of diagnosis
and movement restrictions were not placed on the positive herds.

- 13 -
No authorisations were given (because none were requested) to other  
Member States to waive the serological test for female bovine animal:  
intended for meat production less than 30 months of age intended for  
production for intra-Community trade.
It is not now the intention of France to apply, via the Standing  
Veterinary Committee procedure, to have a herd test carried out on a  
imported breeding or production animals.
3.6 Denmark
EBL is a compulsorily notifiable disease. A national eradication  
campaign has been in force since 1959 which involved tumour notification  
and testing of all herds of origin and the sequestration of positive  
herds. Parallel to tumour tracing, a nationwide testing scheme was in  
operation involving the testing of all cattle at regular intervals. In  
most cases where EBL was found the complete herd was slaughtered or,  
more rarely, the individual reacting animals were slaughtered and the  
herd was retested a number of times until at least 4 consecutive clear  
tests were achieved. At the moment there are a total of 26 herds in  
Denmark which are infected and these are a hangover from the earlier  
testing campaigns.
In 1981 there were 148 tumour cases notified, of which 84 were  
leukotic. None of these 84 herds contained positives when tested. In  
1982 there were 153 tumour cases notified, of which 70 were leukotic.
Of these 70 herds, only one herd contained positive animals when  
tested. In 1983 there were 177 tumour cases notified, of which 75 were  
leukotic. None of these 75 herds contained positives when tested.
In 1983 there were a total of 388 bovines intended for breeding or  
production over 12 months of age, intended for intra-Community trade,  
serologically tested. None of these were found to be positive. Up to  
the end of May 1984, 168 such animals were tested and none were found to  
be positive.

-  14  -
In 1983 and up to the end of May 1984, there were a total of 136 herds  
of origin serologically tested, thereby enabling pure bred animals to be  
entered into intra-Community trade, of which one herd was found to  
contain positive animals.
Results of the national screening programme
1981 1982 1983
Herds 40 000 40 000 40 000
Total cattle populationAnimals 2 890 000 2 857 000 2 876 000
Herds 2 281 843 744
Serologically tasted 75 382 «0 914* .110 562*
Herds 14 4 4
Serologically positive 47 16 23
* mainly random samples from slaughterhouses
All positive animals were not necessarily slaughtered within 30 days of  
diagnosis. However, movement restrictions were placed on the herds and,  
in some of these herds, testing continued after removal of the reactors  
until such time as all remaining animals over 12 months of age had  
passed 4 consecutive tests at 6 month intervals.
Denmark, under Community law, requires that all imported animals for  
breeding or production come from a herd of origin in which all animals  
have passed a test within the last 12 months.
Authorisations have not been given to waive the serological test for  
female bovine animals intended for production less than 30 months of age  
when imported into Denmark.

Germany
EBL is a compulsorily notifiable disease. A national eradication  
programme has been in force since 1976 which involves testing of all  
herds (except beef units) and the slaughter of the positive animals  
within 30 days followed by at least 3 consecutive clear tests before
release of movement controls. Herds which reach the status of
"non-suspect" are thereafter tested every 2 to 3 years.
In 1981 there were 142 tumours notified, of which 126 were leukotic
1982 there were 182 tumours notified, of which 141 were leukotic and in
1983 there were 237 tumours notified, of which 119 were leukotic.  
Information is not available as to how many of these herds contained  
positive animals when retested.
Results of the national screening programme
1981 1982 1983In
Herds537 482 519 580 544 696
Total cattle population 15 051 205 14 996 175 14 782 535
Herds 164 264 153 026 199 782
Serologically tested Animals 3 461 769 3 241 101 3 936 135
Herds 3 907 2 220 1 556
Serologically positive Animals 6 870 4 564 2 097
Authorisations have not been given to waive the serological test for  
female bovine animals intended for meat production less than 30 months  
of age when imported into Germany.

-  16  -
3.8 The Republic of Ireland
EBL is a compulsorily notifiable disease. A minimum eradication  
programme was introduced in 1977 involving tumour notification and  
testing of herds of origin. In 1981 there were 108 tumour cases  
notified, of which 19 were leukotic. 10 of these herds of origin were  
tested and none were found to contain positive animals. In 1982 there  
were 55 tumour cases notified, of which 17 were leukotic. 11 of these  
herds of origin were tested and none were found to contain positive  
animals. In 1983 there were 74 tumour cases notified, of which 14 were  
leukotic. 12 of these herds of origin were tested and none were found  
to contain positive animals.
In 1982, 4 423 bovines were tested for intra-Community trade. None were  
positive. In 1983, 5 886 bovines were tested for intra-Community  
trade. None were positive. Up to the end of May 1984, 214 bovines were  
tested and again none were found to be positive. Records do not specify  
whether herds were pure bred high value animals or otherwise.
Results of the national screening programme
1981 1982 1983
Herds 193 391 181 814 195 477
Total cattle population Animals 6 695 800 6 688 300 6 771 100
Serologically tested Animals* 24 740 10 285 2 633
Serologically positive 0 0 0
* sampling is confined to breeding stock - full herds are not tested

-  17  -
Should a positive bovine be discovered, however, Ireland has the  
necessary legislative powers to require slaughter, restrict movement and  
test herds.
No authorisations have been given to waive the serological test for  
female bovine animals intended for meat production less than 30 months  
of age when they are imported.
It is the intention to apply, via the Standing Veterinary Committee  
procedure, to have a herd test carried out on all imported breeding or  
production animals.
3.9 Belgium
EBL is a compulsorily notifiable disease. A minimum eradication  
programme was introduced in 1969 involving tumour notification and  
testing of herds of origin. In 1981 there were 31 tumours which were  
leukotic and in 1982 there were 22. No information is available for  
1983 or 1984. The herds of origin were serologically tested but  
information is not available as to whether they were positive or  
negative.
From 1.7.1981 to 30.6.1982, 1 656 breeding or production bovines over 12  
months of age were serologically tested prior to intra-Community trade,  
and 2 906 bovines were tested from 1.7.1982 to 30.6.1983. None of these  
animals reacted positively.
The system in Belgium is that all exporting herds are tested annually.
No distinction is made between herds containing high value pure bred  
animals and those containing other category of animals.  The result of  
such testing is as follows:

- 18 -
Results of the annual testing programmeV
Total cattle  
populationHerds
Animals1981
83 221 
3 095 0461982
81 124 
3 063 9631983
80 043 
3 108 3971984 (end  
September)
79 330 
3 184 871
Serologically
testedHerds
Animals3 463 
109 8703 632 
120 3112 411 
57 695285*
Serologically
positiveHerds
Animals16
20838
57919
268222* 
1 409*
* these herds had already given positive reactions to a separate  
national experimental screening programme using an ELISA test  
(monoclonal antigens) and been resubjected to an immunodiffusion test
Additionally, all bovine animals over one year of age, which have been  
imported, are subjected to a retest using the immunodiffusion test. The  
results are as follows:
1.4.81 - 1.3.82 1.3.82 - 31.3.83 1.4.83 - 31.4.84
Serologically
tested24 430 26 284 23 662
Serologically
positive39 32 42
As a consequence of all testing programmes, all positive animals were  
slaughtered within 30 days of diagnosis. Movement was forbidden out of  
herds containing positive animals, except for bovines intended for  
slaughter, until such time as all positive animals had been removed and  
the remaining animals over 12 months of age had passed 3 consecutive  
tests at 6 month intervals.

-  19  -
No authorisations have been given to other Member States to waive the  
serological test for female bovine animals for meat production less than  
30 months of age intended for intra-Community trade.
It is not the intention of Belgium to apply, via the Standing Veterinary  
Committee procedure, to have a herd test carried out on all imported  
breeding or production animals.
3.10 The statistical information in this section was compiled from a
questionnaire that was sent by the Commission to all Member States in  
July 1984. At the time of compilation of this report (mid-December  
1984) no reply has been received from Italy. However, their national  
legislation makes provisions for a minimum eradication programme.
4. A request has been made for a system whereby a region of a Member State  
or a Member State itself, which was really free from the disease, could 
be declared to be actually free from it, thus obviating the necessity to  
carry out a lot of unnecessary serological testing.
Discussion on this topic has taken place on a variety of occasions over  
the last few years and opinions have varied as to how this should be  
accomplished. Some were of the opinion that for a region or a Member  
State to be declared free of the disease, then all the herds within the  
region would have to be serologically tested with negative results  
whilst others were of the opinion that it would only be necessary to  
carry out a test on a percentage of the herds and, again, there was no  
agreement as to what percentage of the herds it would be necessary to  
test and the selection procedure. Everybody was in agreement that if a  
quick, cheap, accurate test were available that could preferably be  
carried out on milk, then it would be a relatively easy matter to  
declare regional or national freedom.

*
-  20  -
To this end, the Commission (DG/VI/B/4 and DG/VI/F/4) have held a number  
of meetings to investigate the possibility of developing and applying  
the ELISA test for this purpose. Results so far have been encouraging  
and work will continue in this field, particularly in relation to  
developing a monoclonal antibody for the above test. In the meantime,  
the experts have recommended that, as a necessary first step, the  
following harmonised protocols should be applied to the ELISA test.
4.1 Enzyme-linked immunosorbent assay (ELISA) for the diagnosis of enzootic  
bovine leukosis
4.1.1 For the ELISA method, the materials and reagents to be used are as  
follows:
a) solid phase microplates, cuvettes or any other solid phase
b) the antigen is fixed on the walls of the wells of the microplate or  
cuvette with or without the aid of a monoclonal antibody. The  
antigen must contain specific glycoproteins of enzootic bovine  
leukosis virus. This antigen must not contain substances which will  
cause interference
c) the biological fluid to be tested (serum, milk, tissue, fluid or  
extract)
d) a positive and negative control serum. The positive and negative  
control sera must be supplied by the State Veterinary Serum  
Laboratory, Copenhagen
e) an anti-bovine immunoglobulin enzyme conjugate
f) a substrate adapted to the enzyme

g) a stopping solution (facultative)
h) buffered solutions for the dilution of the sera for preparation of  
the reagents and for washing the plate
i) a reading system with appropriate filters corresponding to the enzyme  
system used.
4.1.2 Procedure
The antigen is coated cn the walls of the microplate or cuvette (with or  
without the aid of monoclonal antibody).  At least one well must contain  
all the reagents except the test sera (blank). Up to four wells must  
contain known positive serum and up to roitr wells must contain known  
negative serum. Samples must be run in duplicate on the same plate.
The system is incubated for a period of time. The microplate or cuvette  
is consecutively washed at least three times. The conjugate is added  
and the plate is left at a suitable temperature. The microplate or  
cuvette is again consecutively washed at least three times. The 
substrate is then added and left for a suitable time. The reaction is  
stopped with the stopping solution if one is used.
4.1.3 Interpretation of results
The reaction is considered positive if the optical density value is  
twice the mean of the negative controls or higher.
The reaction is considered negative if the optical density value is  
lower than twice the value of the mean of the negative controls.
If monoclonal antibodies are used as catching antibodies in the test,  
the positive control serum must have an optical density value between  
1.000 and 1.500.

&
-  22  -
If the antigen is absorbed on the solii phase, the positive control  
serum must have an optical density value between 0.500 and 1.500.
The test must be re-run if the optical density value of the positive  
control serum does not reach predetermined values or if it is not  
possible to interpret a result as being negative or positive.
5. Conclusions
The Commission is of the opinion that current Community legislation  
relating to EBL and intra-Community trade is satisfactory and a majority  
of the Member States state that they do not desire any changes to be  
made. The attached Commission proposals, therefore, are to accomplish  
this.
All Member States are implementing an eradication programme.  However,  
in some Member States this programme should be reinforced in order to  
fulfill the minimum criteria.
It would be beneficial if the Member States, when carrying out the ELISA  
test for the detection of EBL, would follow the protocols for the test  
as described in the body of this report. The Commission will continue  
to pursue investigations in this area and will make proposals at the  
appropriate time to include newly developed tests in current legislation.
The Commission will re-examine the situation after three years. This review  
is justified by the need to take account of inherent changes in the development  
of the internal market. It will demonstrate actual progress towards eradication  
of the disease, and will form part of a submission to the Council, accompanied  
by an appropriate proposal.

COMMISSION 4124/VI/84-EN Rev
OF THE
EUROPEAN COMMUNITIES JC/sm (VIPB4/369)
îirectorate-General for Agriculture rile Ho 7,5
VI/B/4
DRAFT PROPOSAL  
for a
Council Directive  
of
amending Directive 80/1102/EEC with regard to enzootic bovine leukos  
and health guarantees affecting intra-Coirmunity trade in bovine anim

PROPOSAL  
for a
Council Directive
amending Directive 64/432/EEC as regards the d e fin itiv e  arrangements made  
in relatio n  to enzootic bovine leukosis as laid down by D irective 80/1102/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,
Having regard to the opinion of the European Parliament,
Having regard to the opinion of the Economic and Social Committee,
- ]
W h ereas Council Directive 80/1102/EEC w hich a m e n d s  Council Directive 64/432/EEC of 26 Ju n e 1964 o n
animal health problems affecting intra-Community trade in bovine animals and
(2) (3)swine ,  as last amended by Directive 84/644/EEC ,  lays down common
health guarantees regarding enzootic bovine leukosis as applicable to bovine
animals intended for intra-Community trade;
Whereas Article 1  of Directive 80/1102/EEC included protective m easures against enzootic  
Oovine leukosis in Directive 64/432/EEC for a transitional period ending on 31 December 1985;
Whereas A rtic le  3 of D irective 80/1102/EEC requires that proposals be made con­
cerning the d e fin itiv e  arrangements relatin g  to enzootic bovine leukosis;
Whereas the said arrangements have functioned s a tis fa c to rily  during the tra n s itio n a l  
period, giving a ll necessary guarantees; whereas the arrangements applied during  
that period should therefore now  be made d e fin itiv e ,
(1) OJ No L 325 of 1.12.1980, p 18
(2) OJ No 121 of 29.7.1964, p 1977/64
(3) OJ No L 339 of 27.12.1984, p 30

HAS ADOPTED THIS DIRECTIVE:
Article 1
A rtic le  3 of D irective 80/1102/EEC is hereby deleted.
Article 2
Member States shall bring into force the laws, regulations and administrative  
provisions necessary to comply with this Directive by 1 January 1986 at the  
latest. They shall forthwith inform the Commission thereof.
Article 3
This Directive is addressed to the Member States.
Done at Brussels,For the Council