COMMISSION OF THE EUROPEAN COMMUNITIES 
C0M(91) 270 final 
Brussels, 19 July 1991 
REPORT FROM THE COMMISSION TO THE COUNCIL 
ON THE CLASSICAL SWINE FEVER SITUATION IN ACCORDANCE 
WITH ARTICLE 4b(2) OF COUNCIL DIRECTIVE 64/432/EEC OF 
26 JUNE 1964 ON ANIMAL HEALTH PROBLEMS AFFECTING 
INTRA-COMMUNITY TRADE IN BOVINE ANIMALS AND SWINE 
Proposal for a 
COUNCIL DIRECTIVE 
amending Directive 80/217/EEC introducing Community measures 
for the control of classical swine fever 
Proposal for a 
COUNCIL DECISION 
amending Directive 80/1095/EEC and Decision 80/1096/EEC as 
regards certain measures relating to classical swine fever 
Proposal for a 
COUNCIL DIRECTIVE 
amending Directives 64/432/EEC, 72/461/EEC and 80/215/EEC as 
regards certain measures relating to classical swine fever 
Proposal for a 
COUNCIL DIRECTIVE 
amending Directive 72/462/EEC on health and veterinary inspection 
problems upon importation of bovine animals and swine and fresh 
meat or meat products from third countries 
(presented by the Commission) 
-2 -
EXPLANATORY MEMORANDUM 
The Council by Decision 80/1096/EEC In 1980 introduced Community 
financial measures for the eradication of classical swine fever. The 
measures were linked with actions to be taken under an accelerated 
eradication plan which had the objective to render and keep the territory 
of the Community free of classical swine fever without the necessity of 
recourse to systematic vaccination. This action was planned to run for a 
period of 5 years. Member States, which were not officially swine fever 
free, were to prepare and present eradication plans which, subject to 
certain conditions, could be implemented on a regional basis. Community 
financial contributions were made available for compensation to owners 
for the slaughter and destruction of animals, emergency vaccination, 
systematic vaccination for up to 2 years and for serological tests. 
The 5 years period initially allowed for disease eradication was later 
extended to 6 years and in 1987 supplementary measures were added for a 
period of 4 years extending the total period for implementation of 
eradication plans to 10 years. 
At the time that these eradication plans were coming into operation, an 
epidemic of classical swine fever occurred in Belgium. The disease 
subsequently appeared in the Netherlands and certain areas of Germany. 
The highest annual number of outbreaks recorded within the Community 
during the implementation of the accelerated eradication plans was in 
1984, when a total of 1272 outbreaks occurred. Since then the situation 
has gradually improved except for a period in 1990, when an epidemic was 
experienced in Belgium. By and large the strategy - the non-vaccination 
and stamping-out policy - has been successful as 8 of 12 Member States 
now fulfill the requirements for recognition as officially swine fever 
free Member States and 4 Member States have large areas which at the 
level of regions comply with the conditions for recognition. The ultimate 
goal of eliminating classical swine fever virus from the Community is in 
sight although the rather recently reported occurrence of the disease in 
the European wild boar in two areas (Hessen, Germany and Tuscany, Italy) 
may have postponed the date. 
Experience gained during the implementation of the eradication plans and 
the completion of the single market justify the modifications of existing 
working procedures and amendments to existing legislation concerning 
disease eradication and trade in live pigs, fresh pigmeat and pigmeat 
products. 
- 3 -
The attached report describes the disease situation, rules for trade and 
measures applied to classical swine fever eradication since 1980, while 
proposals for amending legislation are presented in respect of Council 
Decision 80/1096/EEC and Council Directive 80/217/EEC, 80/1095/EEC, 
64/432/EEC, 72/461/EEC, 80/215/EEC and 72/462/EEC. 
Finally it is the intention by Commission Decision to add classical swine 
fever to the list of diseases in Article 3(1) of Council Decision 
90/424/EEC on expenditure in the veterinary field. 
- 4 -
Report from the Commission to the Council on the 
classical swine fever situation in accordance 
with Article 4b(2) of Council Directive 64/432/EEC 
of 26 June 1964 on animal health problems 
affecting intra-Community trade in bovine 
animals and swine 
INTRODUCTION 
The occurrence of animal diseases has, since the earliest days of the 
Community, been an obstacle to the creation of a common market based on 
freedom of trade in livestock, meat and products of animal origin. 
Disparities between health standards in the Member States, between the 
methods used to control animal diseases and between the prophylactic 
measures applied on the farm have restricted the marketing of such goods. 
It is indeed unreasonable to jeopardize the high standards of health 
achieved by a Member State by obliging it to admit to its territory 
livestock or products which, if not reliably guaranteed as safe, are 
liable to reintroduce diseases which have been eradicated at considerable 
technical and financial cost. 
Classical swine fever is regarded as one of the economically most 
important diseases affecting the pig industry. It often produces a high 
mortality and causes further setbacks in pig farming due to abortions, 
retarded growth, etc. The importance of the disease was taken into 
account at the time of the first enlargement of the Community when, 
because of exceptional circumstances in the acceding Member States, 
authorization was given for them to maintain their national laws on 
imports, namely the ban on imports from countries with outbreaks of 
classical swine fever and a policy of vaccination. 
- 5 -
In order to dismantle these barriers to trade, the Community decided in 
1980 to eradicate classical swine fever from the whole of its territory 
by applying a common policy of slaughter and gradual abolition of 
systematic vaccination for the purposes of prevention. This kind of 
common strategy was the only way of ensuring the liberalization of trade 
and the establishment of a true internal market that might otherwise 
serve as a network for the propagation of this epidemic disease. 
I. DISEASE ERADICATION 
1. Eradication plans in Member States 
Plans for the eradication of classical swine fever were launched in 
the early 1980's to stamp out the disease from those Member States 
where it still existed. Likewise, plans were introduced for Greece, 
Portugal and Spain at the time they joined the Community. 
The final goal of each plan was that the Member State concerned 
should obtain a status as "officially swine fever free" based on the 
following health requirements : 
- no swine fever to be detected during the previous 12 months, 
- vaccination against swine fever had not been authorized for at 
least 12 months, 
- holdings not to contain pigs vaccinated against swine fever during 
the last 12 months. 
Community financial measures to support the eradication of the 
disease, Council Decision 80/1096/EEC, include provisions for payment 
of : 
- compensation for slaughtered and destroyed animals, 
- vaccination (emergency vaccinations and prophylactic vaccinations 
for a limited period only as part of an eradication plan), 
laboratory tests for detecting the disease. 
- 6 -
The measures applied by individual Member States to eradicate 
classical swine fever were in accordance with the provisions laid 
down in Directive 80/217/EEC, Directive 80/1095/EEC and 
Decision 80/1096/EEC, but the application of the measures have varied 
in respect of 
- the period allowed for prophylactic vaccination, 
- the priority given to the eradication of classical swine fever on 
a regional level. 
Table 1 provides information on the operation of national eradication 
plans. 
2. Vaccination 
In the past there have been two main strategies for the control of 
classical swine fever. 
The first was based on a systematic and comprehensive vaccination 
programme which might be continued indefinitely; different 
vaccination programmes were available and if properly implemented 
vaccination would normally prevent acute and subacute disease 
outbreaks. Pig owners knew that they could live with the disease and 
stay in business. The disease was controlled, but not the infection 
causing it. 
The second strategy was a policy based on the eradication of disease 
and elimination of the infection without recourse to vaccination. 
This strategy calls for the slaughter of all infected pigs and the 
tracing of their contacts. An important tool in tracing contacts is 
the serological examination of blood samples for antibodies to 
classical swine fever virus. 
Systematic vaccination is Justified where the disease is endemic as 
vaccination reduces immediate losses. Such situations occurred in 
Member States during the 1960s (there were more than 6 000 outbreaks 
in 1961) and in the 1970s (more than 5 000 outbreaks in 1972). 
- 7 -
Table 1 Implementation of plans for eradication of classical swine fever 
Member 
State 
Belgium 
Denmark 
Germany 
Greece 
Spain 
France 
Ireland 
Italy 
Luxembourg 
The Netherlands 
Portugal 
United Kingdom Eradication 
plan started 
1/1/1982 
1/1/1982 
1/8/1983 
1/6/1982 
1/3/1983 
1/3/1982 
1/7/1987 Vaccination 
stopped 
1/4/1988 
1/1/1989 
1/1/1988 
1/7/1988 
30/4/1983 
1/1/1990(1) 
15/7/1986 
1/7/1989 Status 
obtained 
as O.S.F.(2) 
1981 
1990 
1989 
1981 
1981 
1989 
1991 
1981 No. of regions 
recognised 
as O.S.F. 
8/9(3) 
26/30(4) 
94/96(5) 
0/95(6) 
(1) 
(2) 
(3) 
(4) 
(5) 
(6) Except in Sardinia 
O.S.F. - Officially swine fever free 
Number of O.S.F. recognised regions/total number of regions 
Regions in the territory of Germany which have participated in the 
eradication programme since 1982. The regions included in the programme by 
Commission Decision 90/483/EEC are recognised as swine fever free regions 
by Council Decision 90/678/EEC. 
All regions (94) on the mainland are O.S.F. 
A total of 87 regions are recognised as swine fever free. 
- 8 -
If however, classical swine fever outbreaks are sporadic or rare, 
vaccination is an unnecessary extra cost. 
The simultaneous use of both strategies creates major problems for 
the movement of animals (trade), and the tracing of contact animals 
moved to and from diseased herds (epidemiological investigations). 
A Commission funded study of the epidemiology and economics of swine 
fever eradication within the Community carried out during the mid-
1970s<1), concluded in favour of adopting a non-vaccination policy. 
The decision to cease vaccination was taken in 1985. 
A number of third countries such as Australia, Canada, the 
Scandinavian countries, New Zealand and the USA have successfully 
applied a non-vaccination policy for a number of years. Once 
vaccination was prohibited, it was never thereafter utilised. The ban 
on the use of vaccine in these countries was linked to a ban on the 
importation of pigs, fresh pigmeat and untreated products from 
vaccinating countries. With the establishment of the single market 
it is important to continue with a non-vaccination policy in the 
light of intra-Community trade as well as of trade with third 
countries. 
3. Disease situation 
Outbreaks of classical swine fever during the 1980s have been 
recorded in 10 out of 12 Member States, Annex 1. The recorded 
outbreaks from 1980-1989 totalled 3 745, compared to 13 553 outbreaks 
recorded from 1970-1979. Two Member States, Belgium and Germany, 
have during the 1980s experienced outbreaks every year, while two 
Member States, Denmark and Ireland, did not have any outbreaks. 
(1) Studies on the epidemiology and economics of swine fever eradication, 
Commission of the European Communities, 1977. 
- 9 -
The relative large number of outbreaks recorded in Germany during 
1989 and 1990 is to a great extent due to the occurrence of classical 
swine fever in wild boar; each wild boar, shot or found dead, 
infected by classical swine fever is recorded as an outbreak. 
Information on the number of outbreaks recorded in domestic pigs and 
in the wild boar during 1990 is given in Annex 2. 
An analysis of outbreaks to determine the sources of infections 
during 1990 has revealed that the major sources were : fomites and 
contacts with neighbouring herds, Annex 3. 
The main diagnostic method used to diagnose outbreaks in Member 
States is the demonstration of viral antigen by the direct 
immunofluosescence technique, Annex 4. 
4. Financial consequences 
Community financial aid is made available to the Member States from 
the day when the eradication plans are implemented. In accordance 
with the provisions of Council Decision 80/1096/EEC the aid has been 
aval table to cover : 
- up to 50% of the cost of slaughter and destruction as paid by the 
Member States in compensation to the owners of slaughtered 
animals, 
- up to 0.125 ECU per animal for emergency or prophylactic 
vaccination, provided that it is part of a plan, 
- up to one ECU per sample examined in a laboratory in connection 
with detection tests. 
The Community financial aid provided since the commencement of the 
eradication programmes is listed below : 
- 10 -
Î Year of control ! Payments made of Community I 
! measures ! financial aid (reimbursements) ! 
i 1982 ! 4.6MECU 6.07% I 
| 1983 i 14.4MECU 19.12% ! 
I 1984 | 26.4MECU 34.95% ! 
! 1985 ! 13.7MECU 18.16% i 
I 1986 ', 6.5MECU 8.61% ! 
! 1987 ! 4.1MECU 5.40% 
I 1988 ! 1.9MECU 2.62% ! 
! 1989 ! 3.8MECU 5.05% ! 
! 1990* i ! 
! Total ! 75.4MECU 100.00% 
i i i 
I I ___! 
* Applications for reimbursements not received May 1991 
5. Experience gained - measures for the future 
Outbreaks of classical swine fever caused by highly virulent strains 
of the virus are normally readily recognised as they produce a 
disease which is characterised by rise in body temperature, 
depression, loss of appetite, purulent conjunctivitis, stilted gait, 
incoordination, diarrhoea and a high mortality. During the 1980s a 
number of outbreaks have been caused by strains of low virulence, 
which produce weak or indistinct signs of disease. This type of 
virus strain spreads rather slowly through a herd and the infection 
may be present in a population for some time (weeks) before it is 
detected. Virological and serological testing methods are of 
paramount importance for the confirmation of such infections. 
The use of rapid serological testing methods (EL ISA-test), however, 
have been faced with problems in herds which recently have changed 
from having a vaccination status to a non-vaccination status as 
detected antibodies can be caused by a field virus or a vaccine 
antigen. Verification of the result requires additional laboratory 
tests, unless misinterpretation can be ruled out by individual pig 
identification and vaccination records. 
- 11 -
The repeated epidemics in some Member States can be related to the 
dense population of pigs in the affected areas and it seems likely 
that the introduction of virus strain of low virulence into densely 
populated areas will create major eradication problems; particularly 
if large numbers of animals are being moved between herds. 
The occurrence of classical swine fever in European wild boar as 
recently reported from the areas of Hessen, Germany and Tuscany, 
Italy has added new dimensions to the disease situation; and this 
represents a permanent source of infection that will remain within 
the borders of the Community for some time. The importance of the 
infected wild boar as a source of infection of domestic pigs is 
difficult to assess, but it is evident that special attention must be 
given to this matter in the future. 
Measures for thg future 
On balance, the Commission is of the opinion that the eradication 
programmes have been well designed and by and large well implemented. 
At this moment in time, however, it appears appropriate to draw 
attention to certain topics which in the future deserve special 
attention due to the nature of the disease and the completion of the 
single market. 
1. The non-vaccination policy should continue. If emergency 
vaccination is carried out live animals should remain in the 
vaccinal zone. Meat, subject to appropriate heat-treatment, can 
leave the zone. 
- 12 -
2. Measures for the control of classical swine fever in the European 
wild boar should be established. 
3. The diagnostic methods for the confirmation of classical swine 
fever have been improved in recent years. These improved methods 
should be available and used in all Member States. 
4. All Member States should have contingency plans to ensure rapid 
implementation of adopted legislation on control and eradication 
measures. 
5. The adoption of Council Decision 90/424/EEC of 26 June 1990 on 
expenditure in the veterinary field provides for Community 
financial aid, in the event of the occurrence of classical swine 
fever, within the framework of this decision; thus classical 
swine fever will be treated from a financial point of view like a 
number of the other economically important diseases listed in 
Article 3 of the said Decision. 
I Conditions for trade 
The status "officially swine fever free" and "swine fever free". 
With the aim of dismantling trade barriers prior to the total 
eradication of classical swine fever from the Community, since 1980 
it has been possible for geographical regions to obtain status as 
"officially swine fever free" or as "swine fever free". The 
conditions for obtaining the officially swine fever free status 
include : 
- no detection of swine fever for at least 12 months, 
- no vaccination against swine fever had been authorized for at 
least 12 months, 
- holdings do not contain pigs which have been vaccinated against 
swine fever within the last 12 months 
while the condition for obtaining a "swine fever free status" is no 
detection of swine fever for at least 12 months. 
- 13 -
In principle a Member State can at any time within its territory have 
three different types of regions e.g. "officially swine fever free", 
"swine fever free" and no status regions. Where an outbreak occurs 
in an "officially swine fever free" or "swine fever free" region the 
status shall immediately be suspended by the Member State concerned 
in accordance with the provisions of Directive 64/432/EEC or 
72/461/EEC. Depending on the evolution of the disease the status may 
be reinstated or withdrawn. 
In general live animals, fresh pigmeat and pigmeat products can move 
freely between regions/Member States having the same status. The 
system set up for trade has by and large worked satisfactorily, but 
it has been criticized on a number of occasions for not providing 
sufficient protection to Member States, which have obtained the 
officially swine fever free status for a large number of regions, 
but not the whole territory. 
When applying the regional approach to disease eradication and 
control it is appropriate to impose the measures on the areas 
directly affected. The present system does not follow this approach 
in full as the status of regions is fixed prior to outbreaks; thus a 
pig holding situated 100km away from an outbreak may lose trading 
opportunities, while this may not be the case for a holding situated 
in a neighbouring region only 15km away from an infected holding. 
Measures for the future 
The principle of régionalisation should apply in respect of classical 
swine fever as it applies for foot-and-mouth disease. In the event 
of an outbreak a protection and surveillance zone should immediately 
be established around the outbreak. This will ensure an immediate 
ban on the movement of live pigs and fresh meat out of an area 
covering at least 300km2. Should an epidemic develop additional 
protection measures can be introduced in accordance with the 
provisions of Council Directive 90/425/EEC concerning the veterinary 
and zootechnical checks applicable to intra-Community trade in 
certain live animals and products with a view to the completion of 
the internal market. 
- 14 -
III RELATIONSHIP BETWEEN DISEASE ERADICATION AND CONDITIONS FOR TRADE 
The strategy to eradicate classical swine fever has been reasonably 
successful as 8 out of 12 Member States now fulfil the conditions for 
being recognized as officially swine fever free Member States and 4 
Member States have large areas which at a regional level comply with 
the conditions for recognition as officially swine fever free. 
Certain Member States have encountered difficulties during periods 
following the cessation of vaccination. 
The elimination of classical swine fever from the Community before 
1993 is not likely. But free movement of pigs and their products 
without spread of disease can be established provided restrictions 
are placed on holdings and areas directly affected by the disease. 
The following proposals, annexed to this report : 
a) Draft Proposal for a Council Directive amending Directive 
80/217/EEC introducing Community measures for the control of 
classical swine fever 
b) Draft Proposal for a Council Decision amending Directive 
80/1095/EEC and Decision 80/1096/EEC as regards certain measures 
relating to classical swine fever 
c) Draft Proposal for a Council Directive amending Directives 
64/432/EEC, 72/461/EEC and 80/215/EEC as regards certain measures 
relating to classical swine fever 
d) Draft Proposal for a Council Directive amending Directive 
72/462/EEC on health and veterinary problems upon importation of 
bovine animals and swine and fresh meat or meat products from 
third countries 
have been drawn up for this purpose. 
- 15 -
ANNEX 
Number of outbreaks of Classical Swine Fever In Member States 1980-1990 
Country 
Belgium 
Denmark 
France 
Germany 
Greece 
Spain 
Ireland 
Italy 
Luxembourg 
Netherlands 
Portugal 
United Kingdom 
Total 1980 
7 
0 
19 
18 
40 
0 
0 
0 
0 
0 
84 1981 
37 
0 
6 
4 
20 
84 
0 
5 
8 
11 
171 
0 
346 1982 
102 
0 
8 
19 
4 
24 
0 
34 
1 
65 
43 
0 
300 1983 
26 
0 
13 
535 
2 
7 
0 
48 
1 
161 
16 
0 
809 1984 
9 
0 
17 
1041 
3 
1 
0 
13 
0 
176 
9 
0 
1271 1985 
67 
0 
2 
351 
1 
1 
0 
25 
0 
36 
3 
0 
486 1986 
80 
0 
20 
46 
0 
0 
0 
28 
0 
1 
0 
10 
185 1987 
83 
0 
5 
41 
0 
0 
0 
13 
1 
1 
0 
1 
145 1988 
2 
0 
15 
3 
0 
0 
0 
12 
0 
0 
0 
0 
32 1989 
8 
0 
0 
64 
0 
0 
0 
11 
0 
0 
0 
0 
83 1990 
113 
0 
4 
118 
0 
0 
0 
15 
0 
2 
. 0 
0 
252 
ANNEX 2 
o 
i 
Annex 3 
C-S-F-EUR12 
ORIGINS OF DISEASE! 
1990 
87 
48 
38 
20 
12 23 01.UNK-cont. 
02UNK_ FIN 
03.WASTE FOOD 
04. MARKET 
05.Neighb. C. 
06. Purchase 
08.Transport 
09.Human spr 
lO.Fomite spr 
13. Latent 
88. Other 
'01 '02 '03 '04 '05 '06 '08 '09 '10 '13 '88 
- 18 -
ANNEX 4 
The use of diagnostic methods for confirmation of 
Classical Swine Fever, 1988 - 1990 
Codes for notification (82/894/EEC Disease notification) 
DIAGNOSTIC METHODS 
Direct immunofluorescence 
Virus isolation 
Plaque reduction 
Neutralization test (Ni) 
Virus neutralization and Immunofluorescence test (NIFT) 
CI in i caI d i agnosis on I y 0:1 
0:2 
0:3 
0:4 
0:5 
0:6 
TIME-INTERVAL UNDER REPORT: FROM 1/1-1988 TO 31/12-1990 
DISEASE: 10 CSF 
1 
Country 
Germany 
France 
Italy 
Netherlands 
Be 1g i urn 
Luxembourg 
United Kingdom 
Ireland 
Denmark 
Greece 
Spain 
Portugal 
TOTALS 01 
138 
16 
28 
82 
264 02 
12 
8 
1 
37 
58 03 04 05 
21 
1 
22 I 1 
06 
9 
2 
2 
13 
*) 
- 19 -
Proposal for a 
COUNCIL DIRECTIVE 
amending Directive 80/217/EEC introducing 
Community measures for the control of classical swine fever 
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, 
Whereas Council Directive 80/217/EEC^1), as last amended by Directive 
87/486/EEC^2^, introduced Community measures for the control of 
classical swine fever; 
Whereas during the period covered by Directive 80/217/EEC the disease 
has, thanks to the measures adopted to combat it, been eradicated in most 
Member States; whereas, however, certain serious difficulties have been 
experienced in eradicating the disease in areas with a high density of 
pigs and in areas containing wild boar; 
Whereas, in view of the disease evolution, the availability of improved 
diagnostic methods and of the completion of the internal market for 
1 January 1993, it is necessary to amend the control measures already 
taken at Community level to control classical swine fever; 
Whereas these amendments are related to cleaning and disinfection of 
infected farms, disease in wild boar, the use of crisis units, movement 
controls in protection and surveillance zones, emergency vaccination and 
diagnostic procedures, 
(1) OJ No L 47, 21.02.1980, p. 11. 
(2) OJ No L 280, 03.10.1987, p. 21. 
- 20 -
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
Directive 80/217/EEC is hereby amended as follows: 
1. Article 2 is replaced by the following: 
"Article 2 
For the purposes of this Directive the following definitions shall 
apply: 
(a) "pig": any animal of the family suidae; 
(b) "breeding pig": a pig intended or used for reproduction with a 
view to multiplication of the species; 
(c) "fattening pig": a pig fattened and intended for slaughter at the 
end of the fattening period with a view to meat production; 
(d) "slaughter pig": a pig which is intended for slaughter without 
undue delay in a slaughterhouse; 
(e) "feral pig": a pig which is not kept or bred in a holding; 
(f) "holding": any establishment (agricultural or other) situated in 
the territory of a Member State, in which pigs are kept or bred; 
(g) "pig suspected of being infected with classical swine fever": any 
pig exhibiting clinical symptoms or showing post-mortem lesions 
or reactions to laboratory tests carried out according to 
Article 11, indicating the possible presence of classical swine 
fever ; 
(h) "pig infected with classical swine fever": any pig 
in which clinical symptoms or post-mortem lesions of 
classical swine fever have been officially confirmed, or 
in which the presence of this disease has been officially 
confirmed as the result of a laboratory examination carried 
out in accordance with Article 11; 
(i) "owner or keeper": any person or persons, either natural or 
legal, having ownership of the pigs, or charged with keeping the 
said animals, whether or not for financial reward; 
- 21 -
(k) "competent authority": veterinary authority appointed for the 
purpose by the national administration for the Member State 
concerned, being directly responsible to the national 
administration within the scope of this Directive, and reporting 
through the national administration; 
(I) "official veterinarian": the veterinarian appointed by the 
competent authority of the Member State; 
(m) "rendering": the processing of high-risk material in accordance 
with the provisions as laid down in Council Directive 
90/667/EEC*; 
(n) "swill": wast from kitchens, restaurants or, as the case may be, 
from industries using meat. 
*0J No L 363, 27.12.1990, p. 51." 
2. In Article 5 
(a) the following is added to the seventh indent of paragraph 1: 
"The reintroduction of pigs shall start with the introduction of 
sentinel piglets, which have been checked and found negative for 
the presence of antibodies against classical swine fever virus. 
The sentinel piglets shall be placed in accordance with the 
requirements of the competent authority throughout the infected 
holding and be rechecked after 21 and 42 days after placing on 
the holding for the presence of antibodies. 
If none of the piglets has developed antibodies against classical 
swine fever virus and as soon as the results of the second test 
are available, with a negative result, full repopulation may take 
pI ace." 
(b) paragraph 2 is replaced by the following: 
"2. The competent authority may apply the measures provided for 
in paragraph 1 to other holdings where pigs may have become 
infected as a result of their location and direct or indirect 
contact with the infected holding." 
3. The following Article 6a is inserted: 
- 22 -
"ARTICLE 6a 
1. Immediately after the competent authority has information that 
feral pigs are suspected of being infected, it shall take all 
appropriate measures to confirm the presence of the disease, by 
giving information to the owners or keepers of pigs and the 
hunters, and by investigation of all feral pigs, shot or found 
dead, including laboratory testing. 
2. As soon as confirmation of infection in feral pigs has taken 
place, the competent authority of a Member State shall 
immediately place under official surveillance holdings in the 
defined infected area and shall in particular order that: 
(a) an official census shall be made of all categories of pigs on 
all holdings; the census must be kept up to date by the owner 
or keeper; the information in the census must be produced on 
request and may be checked at each inspection; 
(b) all pigs on the holding be kept in their living quarters or 
some other place where they can be isolated from feral pigs. 
The feral pigs must not have access to any material which may 
subsequently come in contact with the pigs on the holding; 
(c) no pigs shall enter or leave the holdings; 
(d) appropriate means of disinfection be used at the entrances 
and exits of buildings housing pigs and of the holding 
itself; 
(e) all dead or diseased pigs on a holding s:.all be tested for 
the presence of classical swine fever; 
(f) no part of any feral pig (shot or found dead) shall enter a 
ho Id i ng; 
(g) persons engaged in hunting feral pigs shall not enter a pig 
ho Id i ng. 
3. Without prejudice to the measures laid down in paragraph 2 Member 
States shall present as soon as possible a written plan to the 
Commission about the measures taken to eradicate the disease in a 
defined infected area and the measures applied to the holdings 
situated in the said area. 
- 23 -
The Commission shall examine the plan in order to determine 
whether it permits the desired objective to be attained and shall 
approve the plan, if necessary with amendments, in accordance 
with the procedure laid down in Article 16. 
The plan may subsequently be amended or supplemented, in 
accordance with the same procedure, to take account of 
developments in the situation. 
4. After approval has been given for the measures provided for in 
the plan, those measures shall replace the initial measures 
referred to in paragraph 2, on a date which shall be decided upon 
in the course of giving approval. 
5. The plan mentioned in paragraph 3 shall contain information on: 
(a) a defined infected area within the territory of the Member 
State referred to in paragraph 2. When defining the infected 
area the competent authority shall take into account: 
(i) the geographical distribution of the disease, 
(ii) the feral pig population in the area, 
(iii) the availability of natural and man-made borders of 
importance for movements of feral pigs. 
(b) the approximate number of groups of feral pigs and their size 
in the defined area; 
(c) specific efforts made to determine the extent of the 
infection in the feral pig population, by investigation of 
feral pigs shot by hunters or found dead, and by laboratory 
test ing; 
(d) the organization of close cooperation between biologists, 
hunters, hunting organizations, the wild life services and 
veterinary services (animal health and public health); 
(e) the reduction of the feral pig population, and the licensing 
of hunting; the period decided to be used for reduction of 
the feral pig population shall consist of an Initial 
eradication period to be followed by a surveillance period; 
- 24 -
(f) the method of removal of feral pigs, found dead or shot. In 
the first phase (eradication period) the removal shall be 
based on destruction under supervision of the competent 
authority. In the second phase (surveillance period) the 
removal shall be in accordance with the requirements laid 
down by the competent authority; 
(g) the epizootiolog lea I enquiry which is carried out on each 
feral pig (shot or found dead). This enquiry must include the 
completion of a questionnaire which supplies information 
about : 
- the geographical area where the animal was found dead or 
shot, 
- the date when the animal was found (dead or shot), 
- the person who found or shot the animal, 
- the age and sex of the pig, 
- if shot: symptoms before shooting, 
- if found dead: the state of the carcase, 
- laboratory findings; 
(h) disease preventive measures applicable to the holdings 
situated in the defined infected area, including the 
transport and movement of animals within, from and to the 
area*, 
(i) the criteria to be applied for lifting the measures taken to 
eradicate the disease in the defined area and the measures 
applied to holdings in the area." 
4. The following Article 7a is inserted: 
"Article 7a 
In order to provide full coordination of all measures necessary to 
ensure eradication of classical swine fever as quickly as possible 
and for the purpose of carrying out the epizootiological enquiry, a 
crisis unit shall be established. 
The general rules concerning national crisis units and Community 
crisis unit are laid down by EEC Council Regulation ../.../EEC*. 
*0J No L 
- 25 -
5. In Article 8 the second sentence of paragraph 2 is replaced by the 
fol lowing: 
"in the event an authorization Is given to remove pigs for 
slaughter the competent authority concerned shall ensure that the 
conditions for removal and slaughtering of pigs fulfil the 
requirements laid down in Article 9(4)(f)(i) and the meat derived 
from the said pigs shall comply with the conditions laid down in 
Article 9(4)(g).M 
6. Article 9 is replaced by the following: 
"Article 9 
1. Immediately after the diagnosis of classical swine fever has been 
officially confirmed in pigs on a holding, the competent 
authorities shall establish a protection zone with a radius of at 
least 3 kilometres around the outbreak site, which is itself 
included in a surveillance zone of a radius of at least 10 
kiIometres. 
2. The competent authority must during the establishment of zones 
take account of: 
(a) the results of the epidemiological studies carried out in 
accordance with Article 7; 
(b) the available serological evidence; 
(c) the geographical situation particularly natural boundaries; 
(d) the location and proximity of holdings; 
(e) patterns of trade in growing and slaughter pigs and the 
availability of slaughterhouses; 
(f) the facilities for control and the nature of the control 
measures employed, particularly whether or not slaughter is 
carried out on the infected premises. 
3. In the case that a zone or zones include parts of the territory 
of several Member States, the competent authorities of the Member 
States concerned shall collaborate to establish the zones. 
4. The following measures shall be applied in the protection zone: 
- 26 -
(a) a census of all the holdings shall be made as soon as 
possible; after the establishment of the protection zone 
these holdings shall be visited by an official veterinarian 
within at least 7 days; 
(b) the movement and transport of pigs on public or private 
roads, excluding the service roads of holdings, shall be 
prohibited. This prohibition shall not apply to the transit 
of pigs by motorway or rail without unloading or stopping-, 
(c) trucks and other vehicles and equipment, which are involved 
in the transport of pigs, or other livestock and in material 
which may be contaminated (eg. feedingstuff, manure, slurry, 
etc.) and which are used within the protection zone, shall 
not leave: 
(i) a holding situated within the protection zone, 
(ii) the protection zone, 
(iii) a slaughterhouse, 
without having been cleaned and disinfected in accordance 
with the procedures laid down by the competent authority. The 
procedures shall include that no truck or vehicle, which has 
been involved in the transport of pigs, can leave the zone 
without being inspected by the competent authority; 
(d) no other species of animals may enter or leave a holding 
without the authorization of the competent authority; 
(e) all dead or sick pigs on a holding shall be reported to the 
competent authority, who shall carry out any investigations 
necessary to establish the presence of classical swine fever; 
(f) pigs may not be removed from a holding in which they are kept 
until 21 days after the completion of preliminary cleaning 
and disinfecting measures as laid down in Article 10; after 
21 days authorization may be given to remove pigs from the 
said holding: 
(i) directly to a slaughterhouse, designated by the 
competent authority, preferably within the protection 
or surveillance zone, under the following conditions: 
5) 
- 27 -
- an inspection of all the pigs on the holding has been 
carried out; 
- a clinical examination of the pigs to be moved for 
slaughter, including the taking of the body 
temperature of a proportion thereof, has been carried 
out; 
- each pig has been marked by ear marking; 
- the pigs are transported in vehicles which are 
sealed by the competent authority. 
The competent authority responsible for the 
slaughterhouse shall be informed of the intention to 
send pigs to it. 
On arrival at the slaughterhouse these pigs shall be 
kept and slaughtered separately from other pigs. The 
vehicle and equipment which have been involved in the 
transport of pigs shall immediately be cleaned and 
disinfected. 
During ante and post mortem inspection carried out at 
the designated slaughterhouse, the competent authority 
shall take into account the possible signs relating to 
the presence of the classical swine fever virus 
infection. 
(ii) under exceptional circumstances directly to other 
premises located within the protection zone under the 
following conditions: 
- an inspection of all the pigs on the holding has been 
carrled out; 
- a clinical examination of the pigs to be moved, 
including the taking of the body temperature of a 
proportion thereof, has been carried out; 
- each pig has been marked by ear marking. 
(g) Fresh meat derived from pigs, referred to in paragraph 4(f) 
shall be given the mark as described in the Annex of Council 
Directive 72/461/EEC of 12 December 1972, on health problems 
affecting intra-Community trade in fresh meat*, and 
subsequently treated in accordance with rules laid down in 
- 28 -
Article 4(1) of Council Directive 80/215/EEC of 22 January 
1980 on animal health problems affecting intra-Community 
trade in meat products**. This shall be done at an 
establishment designated by the competent authority. 
The meat shall be sent to the said establishment under the 
condition that the consignment is sealed during transport. 
5. The measures in the protection zone shall be maintained at least 
until 
(a) all measures laid down in Article 10 have been carried out, 
(b) pigs on all holdings have undergone 
(i) a clinical examination and have been found to have no 
signs of illness suggesting classical swine fever, and 
(ii) a serological examination in accordance with the 
provisions of Annex I and IV without the detection of 
antibodies to classical swine fever virus. 
The examination referred to in (i) and (ii) shall not take place 
before 30 days have elapsed after the completion of preliminary 
cleaning and disinfection measures on the infected holding. 
6. The following measures shall be applied in the surveillance zone: 
(a) a census shall be taken of all pig holdings; 
(b) the movement and transport of pigs on public roads, excluding 
the service roads of holdings shall be prohibited, unless 
licensed by the competent authority. This prohibition shall 
not apply to the transit of pigs by motorway or rail, without 
unloading or stopping; 
(c) trucks and other vehicles and equipment, which are involved 
in the transport of pigs, or other livestock and in material 
which may be contaminated (eg. feedingstuff, manure, slurry, 
etc.) and which are used within the surveillance zone shall 
not leave the zone without having been cleaned or disinfected 
in accordance with the requirements of the competent 
authority; 
- 29 -
(d) no other species of animals may enter or leave a holding 
during the first 7 days after the establishment of the zone 
without the authorization of the competent authority; 
(e) all dead pigs on a holding shall be reported to the competent 
authorities who shall carry out any investigations necessary 
to establish the presence of classical swine fever-, 
(f) pigs may not be removed from a holding on which they are kept 
until 7 days after the completion of preliminary cleaning and 
disinfection measures as laid down in Article 10; after 7 
days authorization may be given to remove pigs from the said 
ho Id i ng: 
(i) directly to a slaughterhouse, designated by the 
competent authority, preferably within the protection 
or surveillance zone, under the following conditions: 
- an inspection of all the pigs on the holding has been 
carried out; 
- a clinical examination of the pigs to be moved for 
slaughter, including the taking of the body 
temperature of a proportion thereof, has been carried 
out; 
- each pig has been marked by ear marking; 
- the pigs are transported in vehicles which are sealed 
by the competent authority. 
The competent authority responsible for the 
slaughterhouse shall be informed of the intention to 
send pigs to it. 
On arrival at the slaughterhouse these pigs shall be 
kept and slaughtered separately from other pigs. 
During ante and post mortem inspection carried out at 
the designated slaughterhouse, the competent authority 
shall take into account the possible signs relating to 
the presence of the classical swine fever infection. 
(ii) under exceptional circumstances directly to another 
premises located within the protection zone or 
surveillance zone under the following conditions: 
- 30 -
- an inspection of all the pigs on the holding has been 
carried out; 
- a clinical examination of the pigs to be moved, 
including the taking of the body temperature of a 
proportion thereof, has been carried out; 
- each pig has been marked by ear marking. 
Trucks and other vehicles and equipment, which are 
involved in the transport of these pigs, shall be 
cleaned and disinfected after each transport. 
(g) Fresh meat derived from pigs, referred to in paragraph 6(f) 
shall be given the mark as described in the Annex of 
Directive 72/461/EEC, and subsequently treated in accordance 
with rules laid down in Article 4(1) of Directive 80/215/EEC. 
This shall be done at an establishment designated by the 
competent authority. 
The meat shall be sent to the said establishment under the 
condition that the consignment is sealed during transport. 
7. The measures in the surveillance zone shall be maintained at 
least untiI 
(a) all measures laid down in Article 10 have been carried out, 
(b) pigs on all holdings have undergone 
(i) a clinical examination and have been found to have no 
signs of illness suggesting classical swine fever, and 
(ii) a serological examination in accordance with the 
provisions of Annex I and IV without the detection of 
antibodies to classical swine fever virus infection. 
The examination referred to In (i) and (ii) shall not take place 
before 15 days have elapsed after the completion of preliminary 
cleaning and disinfection measures on the infected holding. 
8. By derogation from the provisions in paragraph 4(f) and 6(f), the 
competent authority may authorize that pigs are moved out from 
the holding to be transported to a rendering plant for rendering 
or to a place where the pigs are killed in order to be burned or 
- 31 -
buried. These animals shall be tested at random for the presence 
of the classical swine fever virus and the criteria for 
collecting blood samples given in Annex IV shall be taken into 
account during the random testing. 
All necessary precautions shall be taken to avoid the risk of 
spread of the virus by this transport, such as cleaning and 
disinfecting of the truck after the transport. 
9. Where the prohibitions provided for in paragraph 4(f) and 6(f) 
are maintained beyond 30 days because of the occurrence of 
further cases of disease and as a result problems arise in 
keeping the pigs, the competent authority may, following an 
application by the owner explaining the grounds for such 
application, authorize removal of pigs from a holding within the 
protection zone, respectively the surveillance zone, provided 
that 
(a) the official veterinarian has verified the facts; 
(b) an inspection of all pigs on the holding has been carried 
out ; 
(c) a clinical examination of the pigs to be moved, including the 
taking of the body temperature of a proportion thereof, has 
been carr ied out; 
(d) each pig has been marked by ear marking; 
(e) the holding of destination is located in the protection zone 
or within the surveillance zone. 
All necessary precautions shall be taken to avoid the risk of 
spread of the virus by this transport, such as cleaning and 
disinfecting the truck after the transport. 
10. The competent authority shall take all necessary measures, 
including the use of prominent signposts and warning notices and 
use of media resources such as the press and television to ensure 
- 32 -
that all persons in the protection and surveillance zones are 
fully aware of the restrictions in force, and shall take such 
measures as may be considered appropriate to ensure the adequate 
enforcement of these measures. 
*0J No L 302, 31.12.1972, p. 24. 
**0J No L 47, 21.2.1980, p. 4." 
7. Article 10 is replaced by the following: 
"Article 10 
Member States shall ensure that 
(a) the disinfectants to be used and their concentrations are 
officially approved by the competent authority-, 
(b) the cleaning and disinfection operations are carried out under 
official supervision in accordance with 
(i) the instructions given by the official veterinarian, and 
(ii) the procedure for cleaning and disinfecting of an infected 
holding as laid down in Annex V." 
8. The following Article 10a is inserted: 
"Article 10a 
In the event classical swine fever is confirmed in a slaughterhouse 
the competent authority shall ensure that: 
(a) all pigs in the slaughterhouse are slaughtered without delay; 
(b) the carcases and offals of infected and contaminated pigs are 
destroyed under official supervision in such a way as to avoid 
the risk of classical swine fever virus spreading-, 
(c) cleaning and disinfection of buildings and equipment including 
vehicles take place under the supervision of the official 
veterinarian in accordance with instructions laid down by the 
competent authority; 
- 33 -
(d) an epidemiological enquiry is carried out in accordance with the 
provisions of Article 7; 
(e) the re introduction of pigs for slaughter does not take place 
until at least 24 hours after completion of the cleaning and 
disinfection operations carried out in accordance with (c)." 
9. Article 14 is replaced by the following: 
"Article 14 
1. Member States shall ensure that: 
(a) the use of classical swine fever vaccines is prohibited; 
(b) the manipulation of classical swine fever virus for research, 
diagnosis and/or manufacture of vaccines shall be carried out 
only in approved establishments and laboratories; 
(c) the storage, supply, distribution and sale of classical swine 
fever vaccines on the territory of the Community are carried 
out under official control. 
2. Notwithstanding the provisions of paragraph 1 concerning the use 
of classical swine fever vaccine, it may be decided, when 
classical swine fever has been confirmed and is tending to spread 
alarmingly, that emergency vaccination may be introduced. In this 
case the Member State concerned sha11 submit to the Commission an 
emergency vaccination plan which shall include information on-. 
(a) the disease situation which has resulted in the demand for 
the emergency vaccination, 
(b) the extent of the geographical area in which emergency 
vaccination is to be carried out, 
(c) categories of pigs and approximate number of pigs to be 
vaccinated, 
(d) the vaccine to be used, 
- 34 -
(e) the duration of the vaccination campaign, 
(f) the identification and registration of the vaccinated 
animals, 
(g) measures for the movement of pigs and their products, 
(h) other matters appropriate to the emergency situation. 
The Commission shall immediately examine the plan in 
collaboration with the Member State concerned. In accordance with 
the procedures laid down in Article 16 the emergency vaccination 
plan may be approved or amendments and additions may be requested 
before approval is given. 
3. In the event of emergency vaccination a Member State which 
practices emergency vaccination shall ensure that: 
no live pigs leave the vaccination area except for immediate 
slaughter in a slaughterhouse designated by the competent 
authority and situated within the vaccination area or close 
to this area-, 
all fresh pig meat produced from pigs vaccinated during the 
emergency vaccination shall bear the stamp provided for in 
Article 5a of Directive 72/461/EEC and be stored and 
transported separately from meat not having the said stamp. 
4. The provisions of paragraph 3 shall apply during the emergency 
vaccination period and for a minimum of 12 months following 
completion of the vaccination operations in the affected area. 
5. If necessary, the Commission shall adopt rules relating to the 
production, packaging, distribution and state of the stocks of 
anti classical swine fever vaccines in the Community." 
10. Article 14a is replaced by the following: 
- 35 -
"Article 14a 
Veterinary experts from the Commission may, in collaboration with the 
authorities of the Member State concerned, in so far as is necessary 
to ensure uniform application of this Directive, make on-the-spot 
checks; the Commission shall inform the Member States of the results 
of the investigation. 
A Member State in whose territory a check is being carried out shall 
give all the necessary assistance to the experts in carrying out 
their duties. 
The general provisions for implementing this Article shall be 
determined in accordance with the procedure laid down in Article 16." 
11. Annex I is replaced by the following: 
- 36 -
"ANNEX \ 
DIAGNOSTIC PROCEDURES FOR THE CONFIRMATION 
OF DIFFERENTIAL DIAGNOSIS OF CLASSICAL SWINE FEVER 
The following guidelines, standards and minimum criteria are laid down 
for the diagnostic procedures of Classical Swine Fever (CSF). 
A. COLLECTION OF MATERIALS FOR DIAGNOSIS 
1. For virus isolation and antigen detection, tonsil and spleen 
tissues are considered essential. Preferably at least two other 
lymphatic tissues should be collected, such as the 
retropharyngeal, parotid, mandibular or mesenteric lymph nodes 
together with ileum or kidney. Each sample of the tissue should 
be placed in a separate sealed plastic bag and labelled. The 
samples should be transported and stored in leak-proof 
containers. They should not be frozen but kept cool at 
refrigerator temperature and tested without delay. 
2. Blood samples for virus isolation from leucocytes should be 
collected from pigs showing signs of fever or other signs of 
disease. EDTA or heparin should be used as anticoagulants. The 
samples must be kept cool at refrigerator temperature and 
submitted to laboratory testing without delay. 
3. Blood samples for the detection of antibody as an aid to 
diagnosis of clinical outbreaks and for the purposes of 
surveillance, should be taken from animals which have recovered 
from suspect infection and from pigs known to have been in 
contact with infected or suspect cases. In such suspect holdings 
all of the first 20 suspect or in-contact animals, and 25% of any 
additional animals, should be sampled. In order to ensure a high 
probability of detection of antibody, samples should be collected 
from each unit of the holding at this level. 
- 37 -
B. THE LABORATORY DIAGNOSIS OF CLASSICAL SWINE FEVER 
The principal basis for the laboratory diagnosis of CSF shall be the 
demonstration of viral antigen, virus or antibodies in organs or 
tissue fluids. 
In the case of inconclusive results, the tests shall be repeated on 
the same samples. Additional samples should be collected from the 
same source if clinical suspicion continues. 
Serological tests for the detection of antibodies may be used as an 
adjunct to diagnosis in cases of suspect CSF. If the demonstration 
of viral antigen or virus isolation has not been successful on 
material derived from animals giving rise to suspicion of CSF or with 
material from holdings which have had contact with cases of CSF, then 
tests for the detection of antibody shall be applied to blood samples 
of animals which have recovered from the suspect disease and from 
those known to have been in contact with the disease. 
1. Demonstration of viral antigen 
For the demonstration of viral antigen in organ tissues, a direct 
immune labelling system should be used on thin cryostat sections 
(up to five microns) of tonsils and tissues of other organs as 
specified in A (1). The diagnostic reagent must be a pestivirus-
specific polyclonal antiserum to CSF virus, labelled with a 
fluorochrome, an enzyme, or biotin, according to the following 
criter ia: 
(a) hyperimmune serum shall be prepared from pigs free from 
infections or antibody which could affect the specificity or 
quality of the reaction; 
(b) labelled immunoglobulin prepared from CSF hyperimmune pig 
serum as specified under (a) shall have a minimum working 
titre of 1/20 as determined in CSF virus infected cell 
cultures and confirmed by check tests on tissue sections. 
The working dilution of the conjugate shall combine a maximum 
of signal with a minimum of background staining; 
Any sample showing specific cytoplasmic reaction shall be 
considered positive for pestivirus. In such cases further tests 
must be carried out as described in B(3). 
- 38 -
2. Virus isolation and identification in cell cultures 
(a) Virus isolation from tissue samples is performed on 
susceptible cell cultures of PK15 or other equally 
susceptible cell lines. Organ suspension from a suspected 
animal should be inoculated at a dilution of 1/10. 
(b) Virus isolation from blood samples, collected and handled as 
indicated in paragraph A(2), is performed by the inoculation 
of cell cultures with buffy coat suspension reconstituted to 
the original blood volume. 
(c) For detection of viral antigen in the cytoplasm of Inoculated 
monolayers, ceil cultures shall be treated with labelled 
polyclonal antiserum. The staining should be applied at 
intervals from 24 to 72 hours from the time of inoculation. 
(d) Positive cultures should be subject to differential 
diagnostic tests as specified in B(3). Negative results 
after the first cell culture passage may require second or 
even more passages in order to isolate virus. 
3. Monoclonal antibody typing of pestivirus isolates 
(a) Duplicates of tissue cryostat sections or cell cultures which 
give positive reactions with polyclonal antiserum as 
described in B(1) and (2) shall be further examined by 
labelled monoclonal antibodies to differentiate between CSF 
virus and bovine virus diarrhoea (BVD)/border disease (BD) 
viruses. 
(b) Only monoclonal s which have been officially recommended by 
the EC Reference Laboratory for Classical Swine Fever, 
following extensive characterization, should be used. 
(c) The monoclonal s should be grouped into four panels according 
to the following criteria: 
Panel number Reactivity 
1 All pest iviruses 
2 All CSF viruses 
3 CSF vaccine strains 
4 AI I BVD/BD viruses 
- 39 -
Each panel may be represented either by a single monoclonal 
or by a mixture of the component monoclonal antibodies, 
provided that the spectrum of reactivity corresponds to that 
given above. 
(d) The interpretation of the reaction patterns is summarised as 
fol lows: 
Panel 
12 3 4 Interpretation 
+ + CSF confirmed 
+ + + - CSF vaccine strain 
+ + BVD/BD virus 
+ ) 
+ + - + ) Virus unclassified, 
+ + + + ) further tests 
) required 
C. DETECTION OF ANTIBODY TO CLASSICAL SWINE FEVER VIRUS 
The detection of CSF virus antibody in blood samples is carried out 
to assist in the diagnosis of swine fever in holdings containing pigs 
showing clinical signs of the disease or in pigs believed to have had 
contact with infected pigs. It may also be carried out for the 
purposes of surveillance or for surveys in herds of unknown status. 
For these purposes, blood samples should be subjected to an approved 
test. 
The following tests are approved for use and must be carried out with 
the inclusion of appropriate positive and negative serum controls. 
The virus strains to be used for serological tests should be agreed 
at a meeting of the National Swine Fever Laboratories (NSFL), and 
issued as required by the EC Reference Laboratory for Classical Swine 
Fever to the NSFL, upon request. 
All test procedures used must be shown to give satisfactory results 
with CSF reference sera supplied by the EC Reference Laboratory for 
Classical Swine Fever. 
- 40 -
1. The virus neutralization test 
This test is based on the determination of the 50% endpoint. 
Cultures are inoculated with mixtures of diluted serum and a 
constant amount of virus after a specified incubation period at 
37*C. The results are based on the absence of any viral 
replication detectable by an immune labelling system. Either 
neutralization-immunofluorescence (NIF) or the neutralizing 
peroxidase-1 inked antibody (NPLA) assays may be used. Detailed 
protocols will be supplied by the EC Reference Laboratory for CSF 
as required. 
For screening purposes the sera are initially diluted 1/10. When 
a full titration is necessary two-fold dilutions of serum 
starting at 1/10 are prepared. Each dilution is mixed with an 
equal volume of virus suspension containing 100 (+/- 0.5 log10) 
infectious doses (TCID 50). At least two cultures are used at 
each dilution level. After an appropriate incubation period the 
cell cultures are fixed and viral antigen is detected by an 
immune labelling system. The results are expressed as the 
reciprocal of the initial serum dilution at which half the 
inoculated cell cultures fail to show any specific labelling. An 
end-point between two dilution levels is estimated. 
2. The enzyme-1inked immunosorbent assay (ELISA) 
Competitive, blocking and indirect techniques may be used on any 
suitable support. 
It is recommended that the tests used should minimize cross-
reactions with BVDV and other pestiviruses. However, the test 
system must ensure identification of all CSF infections, and at 
all stages of the immune response to infection. 
Ant i gen : 
The antigen should be derived from or correspond to viral 
proteins of one of the recommended CSF virus strains. Cells used 
to prepare antigen should be free of any other pestivirus 
infection. 
- 41 -
Antisera: 
Polyclonal antisera for competitive or blocking assays should be 
raised in pigs or rabbits by infection with one of the 
recommended CSF virus strains or with the lapinized C strain. 
Monoclonal antibodies should be directed against or correspond to 
an immunodominant viral protein of CSF virus. Indirect assays 
should use an anti-porcine immunoglobulin reagent that detects 
both IgG and IgM. 
The sensitivity of the EL I SA should be high enough to score 
positive any serum recating In the neutralization test, and also 
reference positive sera as issued by the EC Reference Laboratory 
for CSF. 
The EL I SA may only be used with serum or plasma samples derived 
from individual pigs. 
If the EL I SA procedure used is not CSF specific, then positive 
samples should be further examined by differential tests as 
specified in section E. 
D. EVALUATION OF THE RESULTS OF LABORATORY TESTING 
1. The demonstration of CSF virus antigen in organ tissues or cell 
cultures after virus isolation from tissue samples following the 
techniques defined in B (1), (2) and (3) shall form the basis of 
confirmation of the presence of the disease except in the case of 
a reaction demonstrated to be due to vaccinal virus specified 
according to B (3). The demonstration of BVD/BD antigen 
according to B (3) shall rule out suspicion of CSF provided there 
are no other grounds for such suspicion. Following unusual or 
unexpected results of monoclonal typing according to B (3) 
pestivirus isolates shall be considered unclassified and the herd 
of origin regarded as suspect pending further testing. This may 
include submission of the virus to a reference laboratory for 
characterization, and serological investigations on the herd of 
origin. 
2. Following the detection of antibody reactive with CSF virus, the 
herd of origin shall be regarded as suspect. 
- 42 -
(a) In order to rule out the suspicion of CSF raised by the 
detection of antibody, the test described in Section E below 
shall be used to distinguish between CSF-reactive antibody 
that may have been induced by other pestiviruses and such 
antibody due to CSF virus itself. All original samples shall 
be retested by the differential test. 
(b) If suspicion cannot be ruled out on the first differential 
test, a further test shall be carried out at least 30 days 
later to follow up the possible spread of infection. All of 
the first 20 animals on the suspect holding shall be sampled 
and 25% of any additional animals. 
3. Interpretation of serological results 
A virus neutralization titre of >. 1/10 in any pig together with 
clinical or epizootiological evidence giving rise to suspicion of 
disease shall constitute a positive diagnosis. A titre of >. 1/10 
in any pig without clinical or epizootiologiaI evidence gives 
rise to suspicion of disease and should be followed by 
differential diagnostic procedures. 
The same criteria should be applied for any pig giving a positive 
EL I SA result. 
E. SEROLOGICAL PROCEDURES FOR THE DIFFERENTIAL DIAGNOSIS BETWEEN 
CLASSICAL SWINE FEVER AND OTHER PEST IVI RUSES 
1. Tests for the differential diagnosis of CSF and other pestivirus 
infections are based on parallel testing of the sera with both 
CSF and BVD/BD virus strains using fully comparable methods. 
The CSF and BVD/BD virus strains for use should have been 
officially approved (see C above). To rule out the suspicion of 
CSF raised by the detection of antibody, blood samples should be 
examined by comparative end-point titrations for neutralizing 
antibody against CSF virus and BVD/BD virus. 
In blocking ELISA, a comparison of percentage blocking with CSF 
and BVD/BD antigens may be used. 
2. The results of the comparative serological tests using reference 
strains of CSF and other pestiviruses shall be interpreted as 
foI Iows: 
- 43 -
(a) if the comparative tests show that more than one pig has 
antibody to CSF virus with no antibody to other pestiviruses 
the test result is considered positive for CSF. 
(b) if the comparative tests show that the titres to CSF virus 
are equal to or higher than the titres to other pest(viruses 
in more than one of the pigs there shall be suspicion of CSF 
and differentiation shall proceed as follows: 
- those pigs which shown neutralizing titres against CSF 
virus which are higher than or equal to the titres against 
other pestiviruses shall be slaughtered. Their tissues 
and, if pregnant, their fetuses, shall be subjected to 
examination for CSF antigen or virus, following the 
procedure defined in B (1, 2 or 3). 
- if CSF viral antigen or virus is detected, CSF shall be 
conf irmed, 
- if the examination defined in the second indent above fails 
to reveal the presence of CSF antigen or virus, the holding 
shall be considered as suspect until'a further set of blood 
samples collected at least 30 days later has been subjected 
to further comparative tests. 
- if these subsequent comparative tests show all animals to 
have significantly (four-fold or greater) higher titres 
against BVD/BD virus than against CSF virus, suspicion 
shalI be ruled out, 
- if one or more animals show a titre against CSF virus that 
is equal to or higher than its titre to BVD/BD virus, then 
the result is considered positive for CSF. 
(c) if the BVD/BD titres are such as not to exclude the 
possibility of CSF, the holding shall be considered as 
suspect and be retested after at least 30 days. 
THE DIFFERENTIAL DIAGNOSIS OF AFRICAN SWINE FEVER (ASF) 
ASF cannot be differentiated from Classical Swine Fever by either 
clinical or post-mortem examinations and both of these diseases 
should be considered in the differential diagnosis of any acute 
febrile haemorrhagic syndrome of pigs. 
- 44 -
Laboratory tests are essential to distinguish between the two 
diseases. A positive diagnosis in an ASF-free country should be 
based on the isolation and identification of ASF virus. 
The principal basis for the laboratory diagnosis of ASF shall be the 
demonstration of virus, viral antigen or antibodies in organs and 
tissue fluids. 
In case of inconclusive or negative results of at least 2 tests on 
samples from animals giving rise to suspicion of ASF or with material 
from holdings which had contacts with cases of ASF, additional 
material should be collected in the same holding and from animals 
which have been in contact with the disease. 
1. Demonstration of viral antigen. 
For the demonstration of viral antigen the direct 
immunofluorescence technique or other suitable techniques shall 
be applied to thin cryostat sections of organ tissues or smears, 
or on sediments from leucocyte cultures. The procedures used are 
similar to those described for CSF, except that ASF-specific 
reagents are used. 
2. Virus isolation and identification 
(a) Haemadsorption (HAD) test 
The HAD test is carried out by inoculating either prepared 
10% tissue suspensions or blood collected in the field from 
suspect pigs into primary pig leucocyte cultures or by 
preparing leucocyte cultures from the blood of febrile pigs 
inoculated at the laboratory or collected in the field. 
Haemadsorption consists of the attachment of large numbers of 
pig erythrocytes to the surface of infected cells and is 
diagnostic for ASF. 
(b) Pig inoculation 
A pool is made with aliquots of each 10% tissue suspension 
and 2ml inoculated intramuscularly into each of four pigs: 
two of these should be vaccinated against CSF and two 
unvaccinated. Pigs should be examined daily for increase of 
- 45 -
rectal temperature and onset of clinical signs for up to 21 
days. If fever develops blood samples should be collected 
for preparation of leucocyte cultures for the HAD test 
(autorosette and inoculation of primary pig leucocyte 
cultures). If no clinical signs develop blood should be 
taken for detection of antibodies after the 21 day 
observation period. 
DETECTION OF ANTIBODY INDUCED BY ASF-VIRUS IN BLOOD SAMPLES AND 
TISSUE FLUIDS 
The detection of antibody in samples of serum or tissue fluid is 
carried out to assist in the diagnosis of ASF in holdings containing 
pigs showing clinical signs suspicious of disease or in pigs believed 
to have had contact with ASF infected pigs. It may also be carried 
out for the purpose of surveillance or for surveys in herds of 
unknown status. 
For these purposes samples should be subjected to an approved test. 
The following are approved for use and must be carried out with the 
inclusion of appropriate positive and negative serum controls. 
(a) Indirect immunofluorescence (MF) test 
(b) EL ISA" 
12. The following annexes are added after Annex III 
- 46 -
"ANNEX IV 
SEROLOGICAL SCREENING OF PIGS IN THE PROTECTION ZONE 
AND SURVEILLANCE ZONE FOR DETECTION OF ANTIBODIES AGAINST 
CLASSICAL SWiNE FEVER VIRUS 
The programme for serological screening shall take into account the 
transmission of classical swine fever and the way pigs are kept, e.g. a 
reference to whether pigs are kept in groups or not. 
1• Serological screening of pigs kept in a group 
A group is two or more pigs kept in direct contact. 
Samp Iing of groups 
if 20 or less than 
20 pigs in a group - 2 pigs. In the event the groups 
consists of a sow with piglet, only 
the sow shall be sampled; 
if more than 20 2 pigs -i- 5% of the remainder. 
All groups shall be sampled. 
2. Serological screening of pigs kept individually: this Includes pigs 
kept in close proximity to each other but having no direct contact, 
e.g. tethered sows 
Sampling procedure 
No of pigs pigs to be tested 
less than 20 
20 - 100 
more than 100 al I 
20 + 20% of the remainder 
20 + 10% of the remainder 
(at least 36) 
- 47 -
ANNEX V 
PROCEDURE FOR CLEANING AND DISINFECTING 
AN INFECTED HOLDING 
I. Preliminary cleaning and disinfection 
a) As soon as the carcases of the pigs have been removed for 
disposal, those parts of the premises in which the pigs were 
housed and any parts of other buildings, yards etc contaminated 
during slaughter or post-mortem examination should be sprayed 
with disinfectants approved for use in accordance with Article 
10. 
b) Any tissue or blood which may have been spilled during slaughter 
or post-mortem or gross contamination of buildings, yards, 
utensils etc should be carefully collected and disposed of with 
the carcases. 
c) The used disinfectant shall remain on the surface at least 24 
hours. 
II. Final cleaning and disinfection 
a) Grease and dirt should be removed from all surfaces by the 
application of a degreasing agent and washed with cold water. 
b) After washing with cold water as described in a) further spraying 
with disinfectant should be applied. 
c) After 7 days the premises should be treated with a degreasing 
agent, rinsed with cold water, sprayed with disinfectant and 
rinsed again in cold water. 
d) Manure and used bedding should be stacked to heat, sprayed with 
disinfectant and left for 42 days. Slurry should normally be 
stored for 42 days after the last addition of infective material. 
This period may be extended if the slurry has been heavily 
contaminated." 
- 48 -
Article 2 
Member States shall bring into force the laws, regulations and 
administrative provisions necessary to comply with this Directive not 
later than 31 December 1991. They shall forthwith inform the Commission 
thereof. 
When Member States adopt these provisions, these shall contain a 
reference to this Directive or shall be accompanied by such reference at 
the time of their official publication. The procedure for such 
reference shall be adopted by Member States. 
Art icle 3 
This Directive is addressed to the Member States 
Done at Brussels, For the Council 
The President 
- 49 -
Proposal for a 
COUNCIL DECISION 
amending Directive 80/1095/EEC and Decision 80/1096/EEC 
as regards certain measures relating to classical swine fever 
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, 
Whereas Council Directive 80/1095/EEC^1), as last amended by Directive 
87/487/EEC^2^, lays down conditions designed to render and keep the 
territory of the Community free from classical swine fever; 
Whereas Council Decision 80/1096/EEC^3^, as last amended by Decision 
87/488/EEC^4^, introduced Community financial measures for the 
eradication of classical swine fever; 
Whereas the measures applied to eradicate classical swine fever have 
gradually improved the health status of the pig population on the 
territory of the Community; whereas it has been possible due to this 
improved status to recognize areas (regions or Member States) as 
officially swine fever-free or swine fever-free; 
Whereas one of the given objectives to keep the territory of the 
Community free from classical swine fever has been reached in large 
areas; whereas it is necessary to take this situation into account and 
consequently amend Directive 80/1095/EEC and Decision 80/1096/EEC, 
HAS ADOPTED THIS DECISION: 
(1) OJ No L 325, 01.12.1980, p. 1. 
(2) OJ No L 280, 03.10.1987, p. 24. 
(3) 0J No L 325, 01.12.1980, p. 5. 
(4) 0J No L 280, 03.10.1987, p. 26. 
- 50 -
Article 1 
In Article 12(2) of Directive 80/1095/EEC the date 1 July 1993 is 
replaced by 1 January 1992. 
Article 2 
The following sentence is added to Article 2(1) of Decision 80/1096/EEC: 
"Nevertheless, the participation of the Community is limited to measures 
carried out before 1 January 1992". 
Art icle 3 
This Decision is addressed to the Member States 
Done at Brussels, For the Counci 
The President 
- 51 -
Proposal for a 
COUNCIL DIRECTIVE 
amending Directives 64/432/EEC, 72/461/EEC and 80/215/EEC 
as regards certain measures relating to swine fever 
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, 
Whereas Council Directive 64/432/EEC of 26 June 1964 on animal health 
problems affecting intra-Community trade in bovine animals and swine*1*, 
as last amended by Decision 91/13/EEC*2*, defines in particular the 
conditions which must be satisfied as regards classical swine fever by 
live pigs intended for intra-Community trade; 
Whereas Council Directive 72/461/EEC of 12 December 1972 on health 
problems affecting intra-Community trade in fresh meat*3*, as last 
amended by Directive 89/662/EEC*4*, defines the conditions which must be 
satisfied as regards classical swine fever by fresh pig meat intended for 
intra-Community trade; 
Whereas Council Directive 80/215/EEC of 22 January 1980 on animal health 
problems affecting intra-Community trade in meat products*5*, as last 
amended by Directive 89/662/EEC, defines in particular the conditions 
which must be satisfied as regards classical swine fever for meat 
products intended for intra-Community trade; 
Whereas the measures applied to eradicate classical swine fever have 
gradually improved the health status of the pig population on the 
territory of the Community; 
(1) OJ No 121, 29.07.1964, p. 1977/64 
(2) OJ No L 8, 11.01.1991, p. 26. 
(3) OJ No L 302, 31.12.1972, p. 24. 
(4) OJ No L 395, 30.12.1989, p. 13. 
(5) 0J No L 47, 21.2.1980, p. 4. 
- 52 -
Whereas one of the given objectives to keep the territory of the 
Community free from classical swine fever has been reached in large 
areas; whereas it is necessary to take this situation into account and 
consequently amend Directives 64/432/EEC, 72/461/EEC and 80/215/EEC; 
Whereas in this context it is appropriate not to extend the type of 
guarantees laid down in Article 4b of Directive 64/432/EEC and of 
Article 13b of Directive 72/461/EEC and to discontinue the measures laid 
down in Article 10 of Directive 80/215/EEC, 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
Directive 64/432/EEC is hereby amended as follows : 
1. In Art icle 2 : 
(a) the words "swine fever" in the second line of (i) of point (ii) 
are deleted, 
(b) the definitions in (p), (q) and (r) are deleted. 
2. In Artide 3: 
(a) the words "swine fever" in the introducing phrase of paragraph 
2(b) are deleted, 
(b) the words "swine fever or" in paragraph 2(b)(i) are deleted, 
(c) paragraph 2(b)(ii) is deleted, 
(d) the words "swine fever" in paragraph 2(c)(ii) are deleted. 
- 53 -
e) the first sentence of paragraph 4 is replaced by the following : 
"Swine for breeding and production must moreover come from 
brucellosis free stock" 
3. Article 4b is replaced by the following: 
"Article 4b 
In addition to the measures provided for in this Directive concerning 
classical swine fever each Member State shall ensure that pigs sent 
from its territory to that of another Member State shall not come 
from a holding or an area which is subject to restrictions for 
classical swine fever in conformity with the provisions of Council 
Directive 80/217/EEC of 22 January 1980 introducing Community 
measures for the control of classical swine fever*. 
*0J No L 47, 21.2.1980, p. 11." 
4. In Annex F, Form III, V, the point (c) is deleted. The points "(d), 
(e) (f) and (g)" becomes "(c), (d), (e) and (f)". 
Article 2 
Directive 72/461/EEC is hereby amended as follows: 
In Article 3 the following point (e) is added after point (d): 
"(e) The meat shall not be the subject of animal health restrictive 
measures pursuant to the provisions of Council Directive 
80/217/EEC of 22 January 1980 introducing Community measures for 
the control of classical swine fever*. 
*0J No L 47, 21.2.1980, p. 11." 
Art icle 3 
Article 10 of Directive 80/215/EEC is hereby deleted. 
- 54 -
Art icle 4 
Member States shall bring into force the laws, regulations and 
administrative provisions necessary to comply with this Directive not 
later than 1 January 1992. They shall forthwith inform the Commission 
thereof. 
When Member States adopt these provisions, these shall contain a 
reference to this Directive or shall be accompanied by such reference at 
the time of their official publication. The procedure for such 
reference shall be adopted by Member States. 
Art icle 5 
This Directive is addressed to the Member States 
Done at Brussels, For the Council 
The President 
- 55 -
Proposal for a 
COUNCIL DIRECTIVE 
amending Directive 72/462/EEC on health and veterinary inspection 
problems upon importation of bovine animals and swine and 
fresh meat or meat products from third countries 
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, 
Whereas Council Directive 72/462/EEC*1*, as last amended by Directive 
91/69/EEC*2*, defines in particular the conditions which must be 
satisfied as regards classical swine fever upon importation of live pigs, 
fresh pig meat and meat products from third countries; 
Whereas in view of the improved health situation within the Community in 
respect of classical swine fever and the discontinuation of systematic 
vaccination against the said disease, it is necessary to amend the 
conditions laid down for importation of live pigs, fresh pig meat and 
meat products, 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
Directive 72/462/EEC is hereby amended as follows: 
1. The following paragraphs 4, 5 and 6 are added to Article 6: 
"4. In respect of classical swine fever pigs must come from the 
territory of a third country which: 
(1) OJ No L 302, 31.12.1972, p. 28. 
(2) OJ No L 46, 19.02.1991, p. 37. 
- 56 -
has been free from classical swine fever for at least 12 
months, 
has not permitted vaccination for the preceding 12 months 
does not allow on its territory pigs which have been 
vaccinated less than 12 months previously. 
By way of derogation from paragraph 4 it may be decided, in 
accordance with the procedure laid down in Article 29, to 
authorize the importation of pigs coming from a part of the 
territory of a third country provided that vaccination against 
classical swine fever is prohibited throughout the entire 
territory of that country and the part of the territory of the 
third country fuifiIs the conditions laid down in paragraph 4. 
By way of derogation from paragraph 4, in the event classical 
swine fever occurs in a third country which fulfils the 
conditions of paragraph 4, it may be decided, in accordance with 
the procedure laid down in Article 29, that the period of 
12 months referred to in the first Indent of paragraph 4 may be 
reduced to 6 months if: 
(a) an outbreak or a number of epizootiologically interrelated 
outbreaks occur within a geographically limited area, and 
(b) the outbreak or outbreaks have been stamped out, within a 
period of 3 months and without recourse to vaccination." 
2. The following subparagraph (c) is added to Article 14(2): 
"(c) in which no classical swine fever has been detected for at 
least the preceding 12 months, vaccination against 
classical swine fever has not been authorized for at least 
the preceding 12 months and in which no pigs have been 
vaccinated against classical swine fever in the preceding 
12 months." 
The following sentence is added to Article 15: 
"In accordance with the the procedure laid down in Article 29, it may 
be decided to derogate from the provisions laid down in Article 
14(2)(c)." 
- 57 -
Art icle 2 
Member States shall bring into force the laws, regulations and 
administrative provisions necessary to comply with this Directive not 
later than 1 January 1992. They shall forthwith inform the Commission 
thereof. 
When Member States adopt these provisions, these shall contain a 
reference to this Directive or shall be accompanied by such reference at 
the time of their official publication. The procedure for such 
reference shall be adopted by Member States. 
Article 3 
This Directive is addressed to the Member States 
Done at Brussels, For the Council 
The President 

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