COMMISSION OF THE EUROPEAN COMVIUNITIES 
C0M(92) 462 final 
Brussels, 12 November 1992 
Report from the Commission 
on 
the animal health rules to be applied to bovine semen for 
intra-Community trade and imports from the third countries in 
accordance with Article 4 of Directive 88/407/EEC 
and 
proposa I 
for a 
Counc iI D i rect i ve 
amending Council Directive 88/407/EEC of 14 June 1988 
laying down the animal health 
requirements applicable to intraCommunity trade in and imports 
of deep-frozen semen of domestic animals of the bovine 
species and extending it to cover fresh bovine semen 
(presented by the Commission) 
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EXPLANATORY MEMORANDUM 
Council Directive 88/407/EEC lays down the animal health requirements applicable 
to intra-Community trade in and imports of deep-frozen semen of domestic animals 
of the bovine species. At the time of adoption, the situation in Member States 
with respect to the status of infectious bovine rhinotracheitis/infectious 
pustular vulvovaginitis (IBR/IPV) in semen collection centres varied 
considerably. Article 4 therefore required the Commission to report on the 
situation, with appropriate proposals. 
The general IBR/IPV situation in Member States has not changed significantly : 
since the Directive was adopted. There is still a need to allow collection of 
semen from bulls which are positive to a blood test for this disease, because of 
the long term nature of breeding programmes (typically 10 years). It is therefore 
proposed to continue the use of bulls which were positive before vaccination 
until the 10-year cycle comes to an end (1998), and to allow vaccination to 
continue until such time as Member States make progress in eradication in the 
national herd. 
Additionally, proposals are made to 
- clarify the situation with respect to the brucellosis, enzootic bovine leucosis 
(EBL) and tuberculosis status of the bull on entry to a collection centre, 
- discontinue virus isolation testing for foot and mouth disease (FMD) for bulls 
vaccinated more than 12 months prior to collection, and to reduce the number of 
semen straws to be tested from 10 to 5%, 
- discontinue the treatment of bulls with streptomycin against leptospirosis, 
- remove the requirement for a bull to be on a collection centre for 30 days 
before collection for trade purposes, 
- extend the Directive to cover fresh semen and 
- allow future amendments to the annexes by the Commission under the Regulatory 
procedure. 
- A (r^o 
Report from the Commission 
on 
the animal health rules to be applied to bovine semen for 
intra-Community trade and imports from the third countries in 
accordance with Article 4 of Directive 88/407/EEC 
Introduct ion 
Council Directive 88/407/EEC laying down the animal health rules applicable to 
intra-community trade in and imports from third countries of deep-frozen semen of 
domestic animals of the bovine species was adopted by Council on 14 June 
1988d). It was subsequently amended in particular by Council Directive 
90/120/EEC*2) on 5 March 1990, with respect to rules relating to semen derived 
from bulls which were serological I y positive for I BR, either before entry or 
following vaccination on the centre. Special rules were introduced in Article 4 
to allow Member States to continue trade in semen from such bulls, for a 
transitional period until 31 December 1992. These rules were required to be 
reviewed by 1 January 1992. 
The purpose of this report is to made such reviews, and also to identify other 
problems found during the implementation of the Directives, in support of 
proposals for suitable amendments. 
I BR 
IBR is a disease of cattle caused by a Herpes virus. It can manifest itself in 
either a respiratory form or a urogenital form. It is the respiratory form which 
is most commonly recognised in the Community. The disease may appear in the acute 
or sub acute form, but no serological differences have been identified between 
the strains. In the urogenital form, it causes balanoposthitis in the male and 
vulvovaginitis in the female. It may be the cause of infertility, particularly in 
the female. Vaccines may be used to control its effects. However, vaccines 
probably do not prevent infection by field virus. 
(1) OJ No L 194 of 22.07.1988, p. 10 
(2) OJ No L 71 of 17.03.1990, p. 37 
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The presence of virus in the semen is a potential means of spread. This is 
complicated by the problem of latency. This means that, after a clinical or 
subclinical infection, the virus may remain latent for the life of the animal. It 
may also be reactivated and shed at irregular intervals, particularly if the 
animal is stressed or has corticosteroids administered to it. Infected bulls must 
therefore be regarded as potential lifelong shedders of virus. 
Few countries have attempted to eradicate the disease in their national herd. 
Denmark has a national programme, and Ireland has had rules in the past designed 
to prevent the introduction of virulent forms which, it was claimed were absent 
from the island. In the AI industry, as a general rule, attempts are made to 
ensure freedom of the bulls from IBR, in view of its importance as a disease of 
breeding. This is done either by exclusion of any seropositive animal from the 
centres, or by a policy of vaccination after initial testing (with negative 
results). Some countries maintain separate IBR positive and negative studs. In 
positive centres, semen from a clinically affected animal would not be used. 
Furthermore, there are still some centres which contain bulls which were not 
tested prior to entry, and which were vaccinated, before the Directive was 
adopted. Their true status is, therefore, unknown. Trade in semen from the latter 
category of bulls is permitted until 31/12/92, subject to a negative virus 
isolation test being carried out on the semen before export. Trade in semen from 
bulls which were seronegative before vaccination is also permitted, without virus 
isolation. In both cases, Member States in which all centres are seronegative may 
refuse semen from centres which do not have that status. 
A major problem with semen is its long storage time after collection. Because of 
this, and the length of cattle breeding programmes (typically 5 years to prove a 
dairy bull and at least 5 years full use after testing), there will be a great 
deal of semen in stores by the end of the transitional period. A limited survey 
has been carried out in some Member States. This survey shows that an abrupt 
cessation of trade in semen from positive bulls at the end of 1992 wiI be very 
costly and will rob the industry of valuable genetic material. (Table 1). 
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Similarly, there are bulls of great genetic value in centres in some third 
countries. It is important to have access to this genetic material for a further 
limited period. Many breeding programmes started at the time of adoption of the 
Directive, i.e. 1988, and the bulls in these programmes will be used at least 
until 1998. 
It is clear that Council Directive 88/407/EEC gave impetus to the objective of 
finally eradicating this disease from AI centres. While this should continue to 
be the long-term aim, the practicality of maintaining a bull centre free from IBR 
without vaccination in a country where the cattle in the national population are 
infected must be questioned. The airborne route of infection is not normally 
considered to be a major source of infection, especially over long distances. 
However, this route cannot be excluded. Therefore, it is essential to consider 
the possible action to be taken if a centre becomes infected. 
There are three options: 
- slaughter of all stock, 
- vaccination of all stock, 
- testing with removal of infected animals and vaccination of the remainder. 
The first option is unacceptable, in view of the financial and genetic value of 
the bulls. The second option would leave infected bulls on the centre; this would 
present a hazard to incoming animals, and is not consistent with the long-term 
aim. The third option is best, therefore. 
The draft proposal attached to this report proposes to maintain the trade in 
semen from bulls of unknown status until the end of 1998, and to allow 
vaccination of seronegative bulls on the centres where desired by the Member 
State concerned. The virus isolation test would continue to be required for all 
semen from seropositive bulls which had not been found to be seronegative prior 
to vaccination on the centre. Seropositive bulls may not enter a centre at all. 
The protocols for the serological and virological tests and the number of straws 
to be tested will be established by the Commission. 
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Foot and Mouth Disease (FMD) 
Article 4 of the Directive also makes provisions for virus isolation or animal 
innoculation tests on semen from bulls vaccinated against FMD, when going to a 
non-vaccinating country. Council Directive 90/423/EEC^3) banned the use of FMD 
vaccine as and from 1/1/92, and, in practice, all Member States had stopped by 
August 1991. This requirement should therefore be reviewed. The opinion of the 
Scientific Veterinary Committee is that semen produced from bulls vaccinated more 
than 12 months before semen collection presents only a negligible risk, assuming 
that the centre was free from FMD at the time of collection. Therefore it is 
proposed that the testing should apply to trade in semen between all Member 
States, but only on semen collected within 12 months of vaccination. 
Additionally, the Scientific Veterinary Committee has recommended that the number 
of straws to be tested can be reduced to 5% from 10%. 
Furthermore, under a non-vaccination policy, there is no further need to keep 
fresh semen out of the scope of the Directive. Virus isolation tests would limit 
the practicality of trade in fresh semen, but are not needed for all collections 
(see preceding paragraph). This applies equally to IBR. 
Quarantine of bulls and semen 
Annex C requires 
- i) that the bulls are kept on the approved centre for 30 days prior to 
collect ion, and 
- ii) that the semen is stored 30 days prior to dispatch. 
This double quarantine is considered to be unnecessary, and one element could be 
deleted. The quarantine on semen itself gives the best guarantee that the health 
status at the time of collection was satisfactory. Furthermore, the bulls are 
subjected to intensive testing before entry into the centre. 
(3) OJ No L 224 of 18.08.1990, p. 13 
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It is therefore proposed that the requirement for the bull to be in the centre 
for 30 days prior to collection can be revoked. To allow trade in fresh semen, it 
is also necessary to remove the quarantine for this category; this can be 
justified on the basis of the very low volume of trade in fresh compared with 
frozen semen. 
Other problems 
Other difficulties have been highlighted by Member States. Appropriate amendments 
have therefore been proposed. 
a) The double requirement to treat bulls and semen with antibiotics against 
Leptospirosis can be replaced by single treatment of the semen with suitable 
ant ibiot ics. 
b) Currently, a bull must either come from a herd which is free from enzootic 
bovine leucosis or its dam must be tested within 30 days of movement of the 
bull to the centre. This is illogical, as it is the status of the dam at the 
time of weaning which is most relevant. Therefore it is proposed that this 
test on the dam should be done after removal of the bull from its dam. Where 
the bull is born as a result of embryo transfer, the recipient female is 
regarded as the dam. 
c) The current requirement in respect of brucellosis status is that the bull 
must come from an officially free herd and must not have been in any other 
herd of lower status. The latter requirement is automatic, given the rules 
for movement into officially free herds,.and has lead to confusion of 
interpretation. It is therefore proposed that reference is made directly to 
the definition of an officially free herd in Directive 64/432/EEC*4>. 
(4) 0J No L 121 of 29.0».1964, p. 2012/64 
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TABLE 1 
IBR - Positive and negative bulls on centre in 
Belgium and the Netherlands 
Predicted situation on 1 January 1993 
Year of birth 
THE NETHERLANDS 
1981 
1982 
1983 
1984 
1985 
1986 
1987 
1988 
1989 
1990 
1991 
TOTAL 
BELGIUM 
1987 
1988 
1989 
1990 
1991 
TOTAL I BR Pos 
1 
3 
2 
7 
5 
5 
10 
61 
95 
-
-
179 
10 
89 
104 
96 
-
299 I BR Neg 
0 
0 
0 
1 
5 
6 
22 
340 
440 
450 
450 
1714 
1 
27 
28 
37 
128 
221 Total 
1 
3 
2 
8 
10 
11 
32 
401 
535 
450 
450 
1903 
11 
116 
132 
133 
128 
510 
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proposa I 
for a 
CounciI Directive 
amending CounciI Directive 88/407/EEC of 14 June 1988 
laying down the animal health 
requirements applicable to intraCommunity trade in and imports 
of deep-frozen semen of domestic animals of the bovine 
species and extending it to cover fresh bovine semen 
THE COUNCIL OF THE EUROPEAN COMMUNITIES 
Having regard to the Treaty establishing the European Economic Community, and in 
particular Article 43 thereof; 
Having regard to the proposal from the Commission^1), 
Having regard to the opinion of the European Par Iiament^2), 
Having regard to the opinion of the Economic and Social Committee*3^, 
Whereas Council Directive 88/407/EEC^4^, as last amended by 
Directive 90/425/EEC^5^ rays down the animal health requirements applicable to 
intra-Community trade in and imports of deep frozen semen of domestic animals of 
the bov i ne spec i es ; 
Whereas Article 4 of Directive 88/407/EEC defined provisional measures for trade 
in semen from bulIs which are seropositive for Infectious Bovine Rhinotracheitis 
(IBR); whereas these requirements should be reviewed, on the basis of a report 
from the Commission; whereas this report indicates that it is necessary to 
phase out bulls which were seropositive or of unknown status prior to 
vaccination on the centre by 1998, and to maintain the possibility to vaccinate 
on a centre in the future; whereas it is necessary to amend Article 4 in this 
respect ; 
(1) OJ No C 
(2) OJ No C 
(3) OJ No C 
(4) OJ No L 194, 22.07.1988, p. 10 
(5) OJ No L 224, 18.08.1990, p. 29 
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Whereas routine foot and mouth disease vaccination has been discontinued in the 
Community as from August 1991; whereas therefore it is necessary to amend the 
provisions of the Directive to take account of this change in policy; whereas 
this change in policy also permits trade in fresh bovine semen to take place 
under harmonised rules; 
Whereas it is opportune to make further amendments to the Directive to clarify 
certain issues and to take account of changes in technical knowledge, 
particularly in respect of treatment of bulls against leptospirosis, and to align 
the rules with respect to brucellosis, tuberculosis and leucosis with those laid 
down in Council Directive 64/432/EEC^6^; 
Whereas it is appropriate to provide for amendments to the Annexes under a 
procedure establishing close coopérât ion between Member States and the Commission 
within the Standing Veterinary Committee, 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
Directive 88/407/EEC is hereby amended as follows : 
1. In the title, the words "deep frozen" are deleted. 
2. In Article 1, the words "deep frozen" are deleted. 
3. In Article 3, the existing text is prefixed by the number 1, and the 
following paragraph 2 is added: 
"2. Member States which implement an alternative control system providing 
guarantees equivalent to those laid down in this Directive as regards 
movements within their territory of bovine semen, in particular with regard 
to the certificate, may grant one another derogations from the provisions of 
paragraph 1(d) and Article 6, on a reciprocal basis. 
They shall notify the Commission thereof." 
(6) OJ No L 121, 29.09.1964, p. 2012/64 
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4. Article 4 paragraph 1 is replaced by the following: 
"1. Without prejudice to paragraph 2, Member States shall authorize the 
admission of semen from bulls giving a negative reaction to the serum 
neutralization test or the Elisa test for infectious bovine rhino-
tracheit is/infectious pustular vulvo-vaginitis or showing a positive result 
after vaccination in accordance with this Directive. 
Member States may, until 31 December 1998, authorize the admission of semen 
of bulls giving a positive reaction to the serum neutralization test or the 
Elisa test for infectious bovine rhino-tracheitis/infectious pustular vulvo­
vaginitis and not having been vaccinated in accordance with this Directive. 
In that case, each consignment must pass an examination by inoculation into a 
live animal and/or a virus isolation test. 
This requirement shall not apply in respect of the semen of animals which, 
prior to their first vaccination at the insemination centre, reacted 
negatively to the tests referred to in the first paragraph. 
These examinations can, by bilateral agreement, be carried out either in the 
country of collection or in the country of destination. 
Protocols for tests to be used in accordance with this Article, and the' 
number of straws to be tested for each collection, shall be laid down in 
accordance with the procedure in Articie-18." 
5. Article 4 paragraph 3 is replaced by the following: 
"3. Member States may not oppose the admission of semen produced from bulls 
vaccinated against foot and mouth disease. However, where the semen was 
obtained from a bull which had been vaccinated against foot and mouth disease 
during the 12 month period prior to collection, 5% of each collection (with a 
minimum of five straws) intended for sending to another Member State shall be 
subjected to a virus isolation test for foot and mouth disease, with negative 
results." 
6. Article 12 is replaced by the following: 
"Article 12 
The rules laid down in Council Directive 90/675/EEC of 10 December 1990 
laying down the principles governing the organization of veterinary checks on 
products entering the Community from third countries^7) shall apply in 
particular to the organization and follow-up of checks to be carried out by 
the Member States, and the safeguard measures to be applied." 
7. Articles 13 and 14 are deleted. 
8. Article 17 is replaced by the following : 
"Article 17 
Amendments to the annexes to this Directive, in particular to adapt them to 
advances in technology, shall be decided in accordance with the procedure 
laid down in Article 18." 
9. In Article 18 at the end of the 4th paragraph, the words "save where the 
Council has decided against the said measure by a simple majority" are 
deleted. 
10. In Article 19 at the end of the 4th paragraph, the words "save where the 
Council has decided against the said measures by a simple majority" are 
deleted. 
11. In Annex A, chapter ll, the following subparagraph is added at the end : 
"The competent authority may authorize the storage in the approved semen 
storage premises of embryos which meet the requirements of Directive 
89/556/EEC of 25 September 1989 on animal health conditions governing intra-
Community trade in and imports from third countries of embryos of domestic 
animals of the bovine species*8^." 
(7) 0J No L 373 of 31.12.1990, p. 1 
(8) 0J No L 3r2 of 19.10.1989, p. 1 
->M-
12. In Annex B, Chapter I, paragraph 1, (b) is replaced by : 
"(b) prior to their stay in isolation accommodation described in (a), have 
belonged to a herd which is officially tuberculosis free and officially 
brucellosis free, as defined in Annex A.11 of Directive 64/432/EEC." 
13. In Annex B, Chapter I the first sub paragraph of paragraph 1(c) is replaced 
by: 
"have come from an enzootic bovine leucosis free herd as defined in 
Directive 64/432/EEC, or have been produced by dams which have been subjected 
to an Agar Gel Immunodiffusion test, carried out in accordance with Annex G 
of Directive 64/432/EEC, after removal of the animals from their dam. In the 
case of animals derived by embryo transfer, "dam" means the recipient of the 
embr yo." 
14. In Annex B, Chapter I, paragraph 1(e), in the last sentence the words "and 
have treatment against leptospirosis comprising two injections of 
streptomycin at an interval of 14 days (25mg per kilogram of live body 
weight)." are deleted. 
15. In Annex B, Chapter II, paragraph 1, (iii) is replaced by: 
"(iii) a serological test for enzootic bovine leucosis, carried out in 
accordance with Annex C to Directive 64/432/EEC, with a negative result." 
16. In Annex B, Chapter II, paragraph 1(iv) the words "until 31 December 1992" 
are deleted. 
17. In Annex B, Chapter II, paragraph 3 the words "until 31 December 1992" and, 
at the end, the words "under Article 4(1) second, third and fifth 
subparagraphs" are deleted. 
18. In Annex C paragraph 1, (b) is replaced by the following: 
"b) (i) were not vaccinated against foot and mouth disease during the 
12 months prior to collection 
or 
(ii) were vaccinated against foot and mouth disease during the 12 months 
prior to collection, in which case 5% (with a minimum of five straws) of the 
collection shall be submitted to a virus isolation/animal inoculation test 
for foot and mouth disease with negative results," 
19. In Annex C, sub-paragraph 1(d) is deleted and the remaining sub-paragraphs 
are accordingly renumbered. 
20. In Annex C paragraph 3, (i) is replaced by the following: 
"be stored in approved conditions for a minimum period of 30 days prior to 
dispatch. This requirement shall not apply to fresh semen." 
21. In Annex D IV, paragraph 4 (iii), the word "consignment" is replaced by the 
word "collect ion". 
22. In Annex D IV, paragraph 5 is replaced by: 
"5. The semen described above was collected from bulls : 
(i) which have not been vaccinated against foot and mouth disease within 
12 months prior to collection(1); 
or 
(ii) which have been vaccinated against foot and mouth disease within 
12 months prior to collection, in which case the semen comes from a 
collection in which 5% of each collection intended for trade (with a 
minimum of 5 straws) has been subjected, with negative results, to a 
virus isolation test for foot and mouth disease in 
laboratory(2)." . 
23. In Annex D IV the following is added: 
"6. the semen was stored in approved conditions for a minimum period of 
30 days prior to dispatch(3)." 
- A 2, -
24. In Annex D, in footnote (2), the words "the second subparagraph of 
Article 4(1)" are replaced by "Article 4". 
25. In Annex D, the following footnote (3) is added : 
"(3) may be deleted for fresh semen." 
Article 2 
1. Member States shall bring into force the laws, regulations and administrative 
provisions necessary to comply with this Directive by 1 April 1993. They 
shall inform the Commission thereof. 
2. When Member States adopt the measures referred to in paragraph 1, they shall 
contain a reference to this Directive or shall be accompanied by such 
reference on the occasion of their official publication. The methods of 
making such reference shall be laid down by the Member States. 
Art icle 3 
This Directive is addressed to the Member States. 
Done at For the Council 

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ISSN 0254-1475 
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