# C_2013030EN.01001501.xml

| 1.2.2013 | EN | Official Journal of the European Union | C 30/15 |
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1.2.2013

EN

Official Journal of the European Union

C 30/15

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COMMISSION IMPLEMENTING DECISION

of 30 January 2013

on the purchase and storage of foot-and-mouth disease virus antigens

2013/C 30/09

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Council Directive 2003/85/EC of 29 September 2003 on Community measures for the control of foot-and-mouth disease repealing Directive 85/511/EEC and Decisions 89/531/EEC and 91/665/EEC and amending Directive 92/46/EEC (1), and in particular Article 80(2) thereof,

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Having regard to Council Decision 2009/470/EC of 25 May 2009 on expenditure in the veterinary field (2), and in particular the second paragraph of Article 17 thereof,

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Whereas:

| (1) | Decision 2009/470/EC lays down the procedure governing the Union’s financial contribution towards specific veterinary measures. Those measures are to include the campaign against foot-and-mouth disease. Decision 2009/470/EC provides that Union aid may be granted to set up Union reserves of vaccines against foot-and-mouth disease and requires to determine the level of Union participation and the conditions to which such participation may be subject. |
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(1)

Decision 2009/470/EC lays down the procedure governing the Union’s financial contribution towards specific veterinary measures. Those measures are to include the campaign against foot-and-mouth disease. Decision 2009/470/EC provides that Union aid may be granted to set up Union reserves of vaccines against foot-and-mouth disease and requires to determine the level of Union participation and the conditions to which such participation may be subject.

| (2) | In accordance with Council Decision 91/666/EEC of 11 December 1991 establishing Community reserves of foot-and-mouth disease vaccines (3), stocks of antigens have been established for the express formulation of vaccines against foot-and-mouth disease. |
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(2)

In accordance with Council Decision 91/666/EEC of 11 December 1991 establishing Community reserves of foot-and-mouth disease vaccines (3), stocks of antigens have been established for the express formulation of vaccines against foot-and-mouth disease.

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| (3) | Under Directive 2003/85/EC, the Commission is to ensure that Union reserves of concentrated inactivated antigens for the production of foot-and-mouth disease vaccines are maintained on the premises of the Union antigen and vaccine bank. Those reserves are kept for security reasons at designated sites of the premises of the manufacturer. |
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(3)

Under Directive 2003/85/EC, the Commission is to ensure that Union reserves of concentrated inactivated antigens for the production of foot-and-mouth disease vaccines are maintained on the premises of the Union antigen and vaccine bank. Those reserves are kept for security reasons at designated sites of the premises of the manufacturer.

| (4) | The number of doses and the diversity of strains and subtypes of antigens of foot-and-mouth disease viruses stored in the Union antigen and vaccine bank is to be decided taking into account the needs as estimated in the context of the contingency plans provided for in Directive 2003/85/EC and the epidemiological situation, where appropriate, after consultation with the European Union Reference Laboratory for foot-and-mouth disease (4)
   (5)
   (6). |
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(4)

The number of doses and the diversity of strains and subtypes of antigens of foot-and-mouth disease viruses stored in the Union antigen and vaccine bank is to be decided taking into account the needs as estimated in the context of the contingency plans provided for in Directive 2003/85/EC and the epidemiological situation, where appropriate, after consultation with the European Union Reference Laboratory for foot-and-mouth disease (4)
   (5)
   (6).

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| (5) | In accordance with Commission Decision 2009/486/EC of 22 June 2009 on the purchase of foot-and-mouth disease virus antigens (7) and Commission Decision C(2010) 3913 of 21 June 2010 on the purchase of foot-and-mouth disease virus antigens and on the disposal and replacement of such antigens in the reserves of the Union and amending Decision 2009/486/EC (8), the Commission reorganised the Union antigen and vaccine bank on the basis of new contracts concluded with the manufacturer. |
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(5)

In accordance with Commission Decision 2009/486/EC of 22 June 2009 on the purchase of foot-and-mouth disease virus antigens (7) and Commission Decision C(2010) 3913 of 21 June 2010 on the purchase of foot-and-mouth disease virus antigens and on the disposal and replacement of such antigens in the reserves of the Union and amending Decision 2009/486/EC (8), the Commission reorganised the Union antigen and vaccine bank on the basis of new contracts concluded with the manufacturer.

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| (6) | In accordance with Article 83(3) of Directive 2003/85/EC and Article 15 of Decision 2009/470/EC and where it is in the interest of the Union, vaccines may be supplied to third countries, notably to those with an endemic foot-and-mouth disease situation. Depending on the epidemiological situation in the target third country, such vaccines may need to be polyvalent of varying composition of compatible antigens. |
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(6)

In accordance with Article 83(3) of Directive 2003/85/EC and Article 15 of Decision 2009/470/EC and where it is in the interest of the Union, vaccines may be supplied to third countries, notably to those with an endemic foot-and-mouth disease situation. Depending on the epidemiological situation in the target third country, such vaccines may need to be polyvalent of varying composition of compatible antigens.

| (7) | The foot-and-mouth disease situation in certain parts of North Africa and in West Eurasia deteriorated substantially mainly due to the spread of foot-and-mouth disease viruses exotic to those countries or due to the incursion of new antigenically distinct lineages of previously circulating serotypes. |
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(7)

The foot-and-mouth disease situation in certain parts of North Africa and in West Eurasia deteriorated substantially mainly due to the spread of foot-and-mouth disease viruses exotic to those countries or due to the incursion of new antigenically distinct lineages of previously circulating serotypes.

| (8) | It is therefore necessary to purchase additional quantities of antigens in response to the epidemiological situation in the Union neighbourhood. |
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(8)

It is therefore necessary to purchase additional quantities of antigens in response to the epidemiological situation in the Union neighbourhood.

| (9) | In accordance with Article 75 of Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities (9) (‘Financial Regulation’) and Article 90(1) of Commission Regulation (EC, Euratom) No 2342/2002 of 23 December 2002 laying down detailed rules for the implementation of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities (10) (‘Implementing Rules’), the commitment of expenditure from the Union budget shall be preceded by a financing decision setting out the essential elements of the action involving expenditure and adopted by the institution or the authorities to which powers have been delegated by the institution. |
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(9)

In accordance with Article 75 of Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities (9) (‘Financial Regulation’) and Article 90(1) of Commission Regulation (EC, Euratom) No 2342/2002 of 23 December 2002 laying down detailed rules for the implementation of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities (10) (‘Implementing Rules’), the commitment of expenditure from the Union budget shall be preceded by a financing decision setting out the essential elements of the action involving expenditure and adopted by the institution or the authorities to which powers have been delegated by the institution.

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| (10) | As the global budgetary envelope reserved for the envisaged procurement and the indicative number and type of contracts envisaged and time frame for launching the procurement detailed in this Decision constitute a sufficiently detailed framework in the meaning of Article 90(3) of the Implementing Rules, the present Decision constitutes a financing decision in the meaning of Article 75 of the Financial Regulation. |
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(10)

As the global budgetary envelope reserved for the envisaged procurement and the indicative number and type of contracts envisaged and time frame for launching the procurement detailed in this Decision constitute a sufficiently detailed framework in the meaning of Article 90(3) of the Implementing Rules, the present Decision constitutes a financing decision in the meaning of Article 75 of the Financial Regulation.

| (11) | According to Article 80(4) of Directive 2003/85/EC, the Commission should conclude a supply contract with the manufacturer on the purchase, delivery and storage of the antigens. The contract should provide for a buy-back by the manufacturer of the antigens by the end of their five years guarantee period. |
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(11)

According to Article 80(4) of Directive 2003/85/EC, the Commission should conclude a supply contract with the manufacturer on the purchase, delivery and storage of the antigens. The contract should provide for a buy-back by the manufacturer of the antigens by the end of their five years guarantee period.

| (12) | Directive 2003/85/EC provides that the information on quantities and subtypes of antigens or authorised vaccines stored in the Union antigen and vaccine bank is to be treated as classified information. The information set out in the Annex to this Decision, concerning the quantities and subtypes of foot-and-mouth disease virus antigens to be purchased, should therefore not be published. |
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(12)

Directive 2003/85/EC provides that the information on quantities and subtypes of antigens or authorised vaccines stored in the Union antigen and vaccine bank is to be treated as classified information. The information set out in the Annex to this Decision, concerning the quantities and subtypes of foot-and-mouth disease virus antigens to be purchased, should therefore not be published.

| (13) | The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
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(13)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS DECIDED AS FOLLOWS:

Article 1

1.   The Commission shall, in the first semester of 2013, order concentrated and inactivated foot-and-mouth disease virus antigens in the quantities and subtypes set out in the table in the Annex.

2.   The Commission shall ensure that the antigens referred to in paragraph 1 are distributed to and stored at the two designated sites of the premises of the manufacturer as set out in the table in the Annex.

3.   The measures provided for in paragraphs 1 and 2 shall be carried out by the Commission in cooperation with the manufacturer of the relevant antigens already stored in the Union antigen and vaccine bank.

Article 2

1.   The financial contribution by the Union for the measures provided for in Article 1(1) and (2) shall be at a rate of 100 % of the costs incurred, and shall not exceed EUR 3 000 000,00.

2.   The Commission shall conclude one supply contract with the manufacturer on the purchase, supply to and storage in the Union antigen and vaccine bank and the buy-back by the end of their five years guarantee period of the antigens referred to in Article 1(1).

3.   The Director-General of the Directorate-General for Health and Consumers is authorised to sign the contract provided for in paragraph 2 on behalf of the Commission.

Article 3

This Decision constitutes a financing decision in the meaning of Article 75 of the Financial Regulation.

Article 4

In accordance with Article 80(3) of Directive 2003/85/EC, the Annex to this Decision shall not be published.

Done at Brussels, 30 January 2013.

For the Commission

Tonio BORG

Member of the Commission

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(1)  OJ L 306, 22.11.2003, p. 1.

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(2)  OJ L 155, 18.6.2009, p. 30.

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(3)  OJ L 368, 31.12.1991, p. 21.

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(4)  http://ec.europa.eu/food/animal/diseases/strategy/pillars/antigen-vaccine-banks-task-force_en.htm

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(5)  Report of the 83 Executive Committee meeting of the EuFMD, Bucharest, Romania, 12-13 April 2012, available at: http://www.fao.org/ag/againfo/commissions/eufmd/commissions/eufmd-home/reports/executive-committee/en/

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(6)  http://www.wrlfmd.org/ref_labs/ref_lab_reports/OIE-FAO%20FMD%20Ref%20Lab%20Report%20Jan-Mar%202012.pdf

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(7)  OJ L 160, 23.6.2009, p. 27.

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(8)  Decision not published.

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(9)  OJ L 248, 16.9.2002, p. 1.

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(10)  OJ L 357, 31.12.2002, p. 1.

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