No C 140/6 Official Journal of the European Communities 28. 5. 84 
APPENDIX 
to the opinion of the Economic and Social Committee 
Rejected amendments 
The following amendments to the draft Committee opinion, tabled in accordance with the Rules 
of Procedure, were rejected in the course of the discussions: 
Paragraph 2.8. 
Delete paragraph 2.8. 
Voting: 
Votes in favour: 37, votes against: 61, abstentions: 6. 
Paragraph 2.8. 
Reword as follows: 
'The Committee is prepared to endorse, for a limited period of five years, a formula based on 
a quota system which, at the same time, through an increase in the co-responsibility levy, 
involves a small reduction in price.' 
Voting: 
Votes in favour: 13, votes against: 46, abstentions: 37. 
Opinion on the proposal for a Council Directive on animal health problems affecting 
intra-Community trade and imports from third countries of semen of domestic animals of 
the bovine and porcine species 
(84/C 140/03) 
The text referred to the Committee has been published in Official Journal of the Euro­
pean Communities No C 267 of 6 October 1983, page 5. 
A. LEGAL BASIS FOR THE OPINION 
On 28 November 1983, the Council of the European Communities asked the Econo­
mic and Social Committee for an opinion on the abovementioned proposal. 
Procedure: 
The Section for Agriculture was entrusted with the preparatory work on this matter, 
and Mr Storie-Pugh was appointed rapporteur. 
However, as the Section for Agriculture had no meeting scheduled during March or 
April 1984, Mr Storie-Pugh was instructed to submit this matter to the plenary session 
of the Economic and Social Committee, as rapporteur-general. 
28. 5. 84 Official Journal of the European Communities No C 140/7 
B. OPINION OF THE ECONOMIC AND SOCIAL COMMITTEE 
The Committee opinion was adopted by a unanimous vote at the meeting on 28 March 
1984 (216th plenary session of 28 and 29 March 1984). 
1. The Economic and Social Committee welcomes 
the proposal and is in general agreement, especially 
since many of the conditions are already common 
practice in Member States and the proposals closely 
follow the general lines of earlier animal health and 
third-country directives. 
2. General comments 
2.1. It should be stated that bovine semen should 
only be used for intra-Community trade in the 
frozen state and imported from third countries in the 
frozen state (self evident since it would not other­
wise be possible to comply, using fresh semen, with 
a 30-day storage period prior to despatch. See 
Annex C 2 (i)). The same condition should be 
applied to porcine semen when techniques become 
sufficiently developed. 
In the meantime, and without in any way detracting 
from the principle of responsibility emanating from 
the point of production, consideration should be 
given by Member States recommending super­
visory/control measures for female porcines insemi­
nated with 'fresh' imported semen. 
2.2. Member States should, in general, only 
appoint as designated veterinarian those who are 
fully conversant with the terms of the Directive, and 
have expertise in the discipline. This should cause 
no difficulty as in the majority of cases the desig­
nated veterinarian will be employed full-time at a 
semen collection centre or have a number of smaller 
units under his supervision. However, in cases 
where this is not so the designated veterinarian's sig­
nature on the Animal Health Certificate (Annex D) 
should be countersigned by the official veterinarian. 
In addition, attention must be drawn to the princi­
ple that a veterinarian should be asked to certify 
only those matters which are within his knowledge 
or can be ascertained by him personally. This point 
applies to the information regarding incidents of 
notifiable disease in Annex C 1 (e) which has to be 
certified in IV I of the Animal Health Certificate. 
Hence an addendum is needed to cover this require­
ment and should be signed by the official veterinar­
ian. Equally when the Animal Health Certificate for 
imports of semen from third countries is drawn up, 
the signature of both the designated veterinarian 
and that of the official veterinarian should be man­
datory. 
2.3. Though it is not the practice for protocols on 
methods to be published in a Council paper, a 
source reference to these (additional to those listed 
in Annex B, Chapter I), as well as to a list of 
approved laboratories would be helpful in a manner 
similar to that used in Directive 83/494/EEC. 
Such a paper should also list: 
2.3.1. Recommended procedures for disinfection 
and sterilization. 
2.3.2. Details of approved treatment of diluents 
(ref. Annex A II (f) (iv)) and of approved diluents. 
2.4. There is a need for a continuing consideration 
of certification of freedom from, or testing for, dis­
eases other than those presently included in this 
draft Directive. 
2.5. Reference should be made to the procedure 
for the importation of semen for special, scientific 
or experimental purposes under circumstances not 
complying with the provisions of this Directive. The 
Standing Veterinary Committee should be empow­
ered to authorize such importations on a case-by-
case basis. 
2.6. Whereas the importation of animals, pregnant 
by artificial insemination or by embryo transfer, is 
permitted, no check is laid down in regard to the 
semen used or the embryo implanted. This loophole 
should be closed. In the meantime, the Standing 
Veterinary Committee should act on a case-by-case 
basis. 
2.7. For the same reason and for purposes of 
infrastructure planning, the Commission should 
draw up a panel of veterinary experts to formulate a 
proposal on animal health problems affecting intra-
No C 140/8 Official Journal of the European Communities 28. 5. 84 
Community trade and imports from third countries 
of embryos for transplantation. 
3. Specific Comments 
3.1. General Provisions 
Article 2 
Insert (m) before (f). 
Add after (i) the definition of a 'brucellosis-free 
herd' (Directive 64/432/EEC). 
Article 3 2 (c) 
Delete and replace by: 
'When donor animals have been vaccinated within 
the 12 months prior to collection, an aliquot of 
semen from each ejaculate intended for export shall 
be subjected to a virus isolation test for foot-and-
mouth disease with negative results. In the case of 
bovine semen, frozen diluted semen may be used for 
the purpose.' 
Article 3 3 
After 'African' add 'or Classical'. 
Articles 19 and 20 
A longer transition period would be appropriate to 
enable buildings to be altered or built to comply 
with the Directive. Nevertheless, the objectives of 
the Directive should not be frustrated by excessive 
delay. It is suggested that the transition period 
should not be longer than for a total period of two 
years. 
3.2. Annex A 
Chapter I (a) (iv) 
Add 'and facilities for the separate storage of semen 
intended for export'. 
Chapter I (b) 
Delete and replace by: 
'be so constructed or isolated that contact with out­
side livestock from which disease could be spread to the species on the semen collection centre, or vice-
versa, is prevented.' 
Chapter I (c) 
After 'disinfected' add 'or sterilized'. 
Chapter I (d) 
After 'health' add 'and welfare'. 
Chapter II (a) 
Delete and replace by: 
'(a) be so supervized that only animals of the spe­
cies from which semen is collected are held. 
Notwithstanding, other domestic animals, 
essential for the normal running of the centre, 
can be brought in so long as there is no risk of 
disease transmission to the species from which 
semen shall be collected. Animals of other spe­
cies than bovines or porcines from which semen 
may be collected may be admitted under condi­
tions determined by the designated veterinar­
ian.' 
Chapter 11(b) 
Replace 'register' by 'record'. 
Add 'together with a record of all disease tests and 
vaccinations performed and details of the health/ 
disease history of each animal'. 
Chapter II (e) 
Delete and replace by: 
'Employ technically competent staff suitably trained 
in disinfection procedures, sterilization procedures 
and hygiene techniques relevant to the control of 
the spread of disease. It is desirable that such staff 
should not have had contact, during the 96 hours 
prior to being on duty, either at their residence or 
elsewhere or in the course of other duties, with any 
cloven-hoofed animals other than those on the 
approved semen collection centre. If staff have had 
such contact during the 96 hours prior to being on 
duty, they should carry out approved disinfectant 
procedures, change clothing and put on suitable 
protective clothing before resuming duty at the 
approved semen collection centre.' 
28. 5. 84 Official Journal of 
Chapter 11(f) (iii) 
After 'disinfected' add 'or sterilized'. 
Chapter II'(f) (iv) 
Line 3 to read '... risk to any species of animal or 
are so treated 
Chapter II (f)(vii) 
Add before 'the date of collection' the words 'the 
official identity of the approved centre'. 
3.3. Annex B 
Chapter 11 (b) (iii) 
Delete and replace by: 
'from herds in which no facts have been brought to 
the notice of the designated verterinarian which 
would lead him to conclude that a clinical case of 
enzootic bovine leukosis had occurred within the 
three preceding years. 
In addition; bulls intended for admission, under 
18 months of age, should originate from dams which 
had a negative serological test for leukosis after the 
birth of the nominated bull. In the event of the dam 
not being available, all eligible animals in the herd 
of origin must undergo a serological test for leukosis 
with negative result.' 
Chapter 11 (c) 
Delete first four lines and replace by: 
'during the 30 days in isolation described at (a) 
above, and prior to entering the semen collection 
centre, have been subjected to the tests set out 
below with negative results (for cattle i-vi and swine 
i-iii). The animals should then go into on-centre 
segregation for 30 days, during which time semen 
may be collected which shall not be used for artifi­
cial insemination until and unless the animals have 
been subjected to a repeat test. In the case of bov-
ines as set out in paragraphs (c) (ii), (c) (v) and 
(c)(vi); and as in (c) (i), (c) (ii) and (c) (iii) in the 
case of swine. 
In addition, bulls should be subjected to, either, pre­
putial lavage with approved antibiotics daily for 
three successive days; or, a cultural test for Campy­
lobacter fetus infection on a sample of preputial 
material. In the case of female animals one vaginal 
mucus agglutination test shall be carried out. European Communities No C 140/9 
All repeat tests should take place after an interval of 
30 days.' 
Chapter 11 (c) (iv) 
Delete the necessity for repeat testing as this has 
been incorporated in Chapter I 1 (c). See above. 
Add after 'fluorescent antibody test' the words 'or a 
cultural test'. 
Chapter 11 (c) (v) 
Delete the necessity for repeat testing as this has 
been incorporated in Chapter I 1 (c). See above. 
Chapter 11 (c) 
Add new paragraph I 1 (c) (VI). 
'For cattle destined to enter an approved semen col­
lection centre (a) without a vaccination programme, 
a serum neutralization test for infectious bovine 
rhinotracheitis/infectious pustular vulvo-vaginitis 
(IBR/IPV) with negative result of (b) with a vaccina­
tion programme, a virus isolation test on a sample 
of preputial material for infectious bovine rhino-
tracheitis and infectious pustular vulvo-vaginitis 
(IBR/IPV) with negative results.' 
Chapter 11(d) 
Delete (d) as a bovine test and change numeration 
to become (iii), so as to be included under the head­
ing 'in the case of swine'. 
Chapter 13 (i) (a) 
Add after leukosis 'or Aujeszky's Disease'. 
Chapter 13 (i) (b) 
Delete 'or Aujeszky's Disease'. 
Chapter 13 (ii) (a) line 3 
Add after 'Semen Collection Centre' the following: 
'In the case in which one member of the group fails 
the test, the brucellosis negative bulls may move 
NoC 140/10 Official Journal of the European Communities 28. 5. 84 
into isolation on an approved centre subject to 
re-test, at 30 days, during which time semen may be 
collected but not issued. If such animals pass the 
re-test, they may enter the centre proper and semen 
collected previously may be issued for use in artifi­
cial insemination. If they fail the re-test, they shall 
be removed and any semen collected shall be des­
troyed.' 
Chapter II1 (iv) 
Delete and replace by: 
'(a) In the case of approved semen collection 
centres without a vaccination programme, a 
serum neutralization test for infectious bovine 
rhinotracheitis/infectious pustular vulvovagini­
tis (IBR/IPV) with negative results. 
(b) In the case of approved semen collection 
centres with a vaccination programme, an 
annual virus isolation test on a sample of prepu­
tial material for infectious bovine rhinotrachei-
tis and infectious pustular vulvo-vaginitis, 
(IBR/IPV) with negative results.' 
Chapter III (V) 
Add after 'fluorescent antibody test' the words 'or a 
cultural test'. 
3.4. Annex C 
1(e) 
Add before 'Swine Fever' the words 'Classical or 
African'. 
1(f)(1) and (ii) 
After 'Swine fever' add the words '... (Classical or 
African), Aujeszky's disease ...'. 
Done at Brussels, 28 March 1984. 1(f) (Hi) 
Delete first line up to '... where' and replace by: 
'(a) Are located in approved semen collection 
centres without a vaccination programme where, 
if all...' 
and add: 
'(b) Are located in approved semen collection 
centres with a vaccination programme where an 
aliquot of frozen diluted semen from the ejacu­
late intended for export has been subjected to a 
virus isolation test with negative results.' 
2(H) 
Replace 'flasks' by 'containers'. 
3.5. Annex D 
I 
Add after the column headed 'No of doses' another 
column headed 'Identification of dose'. 
IV1 
Add after 'Directive .../.. ./EEC the words 
'(excluding the provisions of Annex C 1 (e))'. 
IV2 
Below 'name in block letters' add a line for 'position 
held and address'. 
After IV 2 add a form of certificate, to be signed by 
the official veterinarian covering the information 
required in Annex C 1 (e). 
The Chairman 
of the Economic and Social Committee 
Francois CEYRAC