COMMISSION OF THE EUROPEAN CGAMUNITIES 
COM(91) 340 final 
Brussels, 27 September 1991 
Amendment to the proposal for a 
COUNCIL DECISION 
designating and taying down the functions of a 
Community Coordinating Institute for 
foot-and-mouth disease vaccines 
(presented by the Commission pursuant to Article 149(3) 
of the EEC Treaty) 
EXPLANATORY MEMORANDUM 
On 26 June 1990, the Council adopted Directive 90/423/EEC, amending, 
amongst others, Directive 85/511/EEC introducing Community measures for 
the controi of foot and mouth disease. By this amendment, the Council, 
acting on a proposal from the Commission, was required to designate a 
specialized institute for vaccine and cross-immunity checks, and to 
determine its powers, by 1 April 1991. 
In fact, Article 14 of Directive 85/511/EEC, before its amendment, had 
contained a similar requirement for Council to designate such an 
institute. On the 8 April 1988, the Commission made a proposal for a 
Council Decision designating and laying down the functions of a 
Coordinating Institute for foot and mouth disease vaccines (C0M(87)537 
final). The Institute nominated at the time was the Animal Virus 
Research Institute, Pirbright, UK. This proposal has not been adopted. 
Since the Commission's original proposal, certain changes have 
occurred. Firstly, other amendments to Directive 85/511/EEC made by 
Directive 90/423/EEC require that Member States should cease routine 
vaccination against foot and mouth disease before 1 January 1992, and 
that the Commission should make proposals for the setting up of 
Community reserves of ant I-foot-and-mouth disease vaccines. This latter 
proposal was sent to Council on 26 April 1991 (C0M(91)131 final). This 
new development means that the functions of the Community Coordinating 
Institute (CCI) must now include tests on the quality and safety of 
vaccines in the Community reserves, while reducing the activity 
relating to testing of nationally produced vaccines as previously 
foreseen. 
Secondly, following discussions in Council on the original proposal to 
designate Pirbright as the CCI, the other two candidate laboratories 
were reassessed, this also being done in the light of improvements made 
in those laboratories. As a result, it is now proposed that The 
Central Veterinary Institute, Lelystad, the Netherlands, should be 
appointed as CCI, as the only alternative to Pirbright. Meanwhile, Lyon 
has been proposed as the site of part of the EC vaccine reserve 
[C0l.'.(91)131 Final], thus involving all candidate laboratories in the 
final strategy. 
This amendment to the Commission's proposal is, therefore, made to take 
account of the new situation, and is made pursuant to Article 149(3) of 
the EEC Treaty. 
It should be noted that the CCI may receive Community financial aid 
according to and following the conditions provided for.in Article 28 of 
Council Decision 90/424/EEC of 26 June 1990, on expenditure in the 
veterinary field. 
Amendment to the proposal for a 
COUNCIL DECISION 
designating and laying down the functions of a 
Community Coordinating Institute for 
foot-and-mouth disease vaccines 
The Commission presented the above mentioned proposal to the Council on 
8 ApriI 1988(1). The initial proposal is amended as follows: 
1. The first recital is replaced by the following: 
"Whereas Article 14(1) of Directive 85/511/EEC authorizes Member 
States to retain reserves of antigens and to retain establishments 
for the packaging and storing of ready-to-use vaccines for 
emergency vaccination; 
Whereas Article 14(3) of that Directive requires the Commission to 
make proposals for the setting up of at least two Community 
reserves of anti-foot-and-mouth disease vaccines; 
Whereas Article 14(2) of that Directive requires the designation of 
a specialized institute for vaccine and cross-immunity checks; 
whereas it is also necessary to lay down the functions and duties 
of such an institute, which should include the standardization of 
control of vaccines carried out by national institutes prior to 
authorization for use in Member States, and the necessary checks on 
antigen stored in the Community reserves, to ensure the potency, 
safety and stability of the antigens and vaccines produced 
therefrom;" 
2. The final recital is deleted. 
3. Articles 1 and 2 are replaced by the following: 
(1) COM (87) 537 final 
"Article 1 
Coordination of the control of foot and mouth disease vaccines used 
within the Community shall be carried out by "The Central Veterinary 
institute, Lelystad, Nether lands", hereinafter referred to as the 
Community Coordinating Institute. 
Article 2 
The functions and duties of the Community Coordinating Institute 
designated in Article 1 shall be: 
1. to coordinate the methods of control carried out by the national 
institutes on foot and mouth disease antigens and vaccines intended 
for use in accordance with Articles 13(3) and 14(1) of Directive 
85/511/EEC; 
2. to coordinate the control of foot and mouth disease vaccine by 
national institutes in each Member State specifically by: 
(a) at regular intervals or on the request of the Institute or the 
Commission, receiving representative samples of batches of foot 
and mouth disease vaccine intended for use in the Community 
including that produced in third countries for use either in 
the Community, in Community supported vaccination campaigns or 
for use in animals intended for importation into the Community 
and testing such vaccines for safety and potency; 
(b) carrying out comparative studies to ensure that safety and 
potency testing in each Member State is carried out by 
comparable methodology; 
(c) testing by means of cross immunity assays in live cattle the 
efficacy of existing vaccines against important new field 
strains of foot and mouth disease virus and communicating the 
results of such assays without delay to the Commission and the 
Member States; 
or gzih^r :rg. data ana information on the control procedures an;! 
ih? -'âcch'e tests and the periodic transmission of such 
UrV.*TT:it ion to the Commission and the Member Slatas; 
3. (a; tu i?>si'.s and Implti-nent the necessary arrangements for further 
training of experts In vaccine verification and testing with a 
V"L>VJ 1i,- i ^nnoriz !ng such techniques; 
(b) tc orgcMze an annual meeting where representatives of the 
nation»! institutes may review vaccine control and testing 
techniques and the progress of coordination; 
4. uO tc check antigen submitted for the Community antigen reserves 
as provided for in Article 14 of Directive 85/511/EEC for the 
pol^ncy and safety and compliance with conditions of supply; 
(b) to carry out routine potency testing of antigen in the 
Community antigen reserves; 
(c) to meek the sterility of vaccine produced from the Community 
antigen reserves when needed, in accordance with the European 
Pharmacopoeia; 
5. '=) i«i cooperation with appropriate Community experts, to assist 
and advise the Commission in ensuring that institutes which 
produce foot and mouth disease vaccine are operating to the 
necessary minimum safety requirements; 
(b) to assist the Commission in reviewing the list of institutes 
authorized to manipulate virus in connection with vaccine 
production, in accordance with the provisions of Article 13(2) 
of Directive 85/511/EEC; 
o . in cooperation with the suppliers of antigen and the Community 
Reference Laboratory, to review strains stored in the Community 
reserves, and to select suitable new strains to be adapted to 
icst'e culture for future vaccine production; 
•?• 
7. to store important seed virus strains other than those held In 
the bank; 
8. to carry out research in relevant aspects of vaccine 
production, especially development of technology for virus 
production, cell culture and vaccine manufacture; 
9. to collaborate with the Community Reference Laboratory in all 
relevant aspects of foot and mouth disease, including the 
publishing a regular bulletin on the activities of the two 
Institutes, and the training of field veterinarians in the 
clinical diagnosis and epidemiology of foot and mouth disease." 
4. Articles 4 and 5 are deleted. 
5. In Article 6, the first sentence is replaced by the following: 
"The Community Coordinating Institute shall be appointed for a 
period of 5 years, as from 1 November 1991." 

6 
ISSN 0254-1475 
COM (91) 340 final 
DOCUMENTS 
EN 03 
Catalogue number : CB-CO-91-402-EN-C 
ISBN 92-77-75816-3 
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