# Official Journal L 206/2008

| | ISSN 1725-2555 |
| --- | --- |
| Official Journal
  of the European Union | L 206 |
| | |
| English edition | Legislation | Volume 512 August 2008 |

ISSN 1725-2555

Official Journal

of the European Union

L 206

English edition

Legislation

Volume 512 August 2008

---

| Contents | | I   Acts adopted under the EC Treaty/Euratom Treaty whose publication is obligatory | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | | Commission Regulation (EC) No 769/2008 of 1 August 2008 establishing the standard import values for determining the entry price of certain fruit and vegetables | 1 |
| | * | Commission Regulation (EC) No 770/2008 of 1 August 2008 amending Regulation (EC) No 349/2005 laying down rules on the Community financing of emergency measures and of the campaign to combat certain animal diseases under Council Decision 90/424/EEC | 3 |
| | * | Commission Regulation (EC) No 771/2008 of 1 August 2008 laying down the rules of organisation and procedure of the Board of Appeal of the European Chemicals Agency (
  1
  ) | 5 |
| | | Commission Regulation (EC) No 772/2008 of 1 August 2008 amending the representative prices and additional duties for the import of certain products in the sugar sector fixed by Regulation (EC) No 1109/2007 for the 2007/08 marketing year | 14 |

Contents

I   Acts adopted under the EC Treaty/Euratom Treaty whose publication is obligatory

page

REGULATIONS

Commission Regulation (EC) No 769/2008 of 1 August 2008 establishing the standard import values for determining the entry price of certain fruit and vegetables

1

*

Commission Regulation (EC) No 770/2008 of 1 August 2008 amending Regulation (EC) No 349/2005 laying down rules on the Community financing of emergency measures and of the campaign to combat certain animal diseases under Council Decision 90/424/EEC

3

*

Commission Regulation (EC) No 771/2008 of 1 August 2008 laying down the rules of organisation and procedure of the Board of Appeal of the European Chemicals Agency (
  1
  )

1

5

Commission Regulation (EC) No 772/2008 of 1 August 2008 amending the representative prices and additional duties for the import of certain products in the sugar sector fixed by Regulation (EC) No 1109/2007 for the 2007/08 marketing year

14

| | | II   Acts adopted under the EC Treaty/Euratom Treaty whose publication is not obligatory |
| --- | --- | --- |
| | | DECISIONS |
| | | Conference of the Representatives of the Governments of the Member States |
| | | 2008/634/EC |
| | * | Decision taken by common agreement between the Representatives of the Governments of Member States of 18 June 2008 on the location of the seat of the European Institute for Innovation and Technology (EIT) | 16 |
| | | Commission |
| | | 2008/635/EC |
| | * | Commission Decision of 22 July 2008 on imports of semen, ova and embryos of the ovine and caprine species into the Community as regards lists of third countries and of semen collection centres and embryo collection teams, and certification requirements
  (notified under document number C(2008) 3625)

   (
  1
  ) | 17 |
| | | 2008/636/EC |
| | * | Commission Decision of 22 July 2008 establishing the list of third countries from which Member States authorise imports of ova and embryos of the porcine species
  (notified under document number C(2008) 3671)

   (
  1
  ) | 32 |

II   Acts adopted under the EC Treaty/Euratom Treaty whose publication is not obligatory

DECISIONS

Conference of the Representatives of the Governments of the Member States

2008/634/EC

*

Decision taken by common agreement between the Representatives of the Governments of Member States of 18 June 2008 on the location of the seat of the European Institute for Innovation and Technology (EIT)

16

Commission

2008/635/EC

*

Commission Decision of 22 July 2008 on imports of semen, ova and embryos of the ovine and caprine species into the Community as regards lists of third countries and of semen collection centres and embryo collection teams, and certification requirements
  (notified under document number C(2008) 3625)

   (
  1
  )

(notified under document number C(2008) 3625)

1

17

2008/636/EC

*

Commission Decision of 22 July 2008 establishing the list of third countries from which Member States authorise imports of ova and embryos of the porcine species
  (notified under document number C(2008) 3671)

   (
  1
  )

(notified under document number C(2008) 3671)

1

32

| | | Corrigenda |
| --- | --- | --- |
| | * | Corrigendum to Council Regulation (EC) No 717/2008 of 17 July 2008 establishing a Community procedure for administering quantitative quotas ( OJ L 198, 26.7.2008 ) | 34 |
| | * | Corrigendum to Council Directive 94/28/EC of 23 June 1994 laying down the principles relating to the zootechnical and genealogical conditions applicable to imports from third countries of animals, their semen, ova and embryos, and amending Directive 77/504/EEC on pure-bred breeding animals of the bovine species ( OJ L 178, 12.7.1994 ) | 34 |

Corrigenda

*

Corrigendum to Council Regulation (EC) No 717/2008 of 17 July 2008 establishing a Community procedure for administering quantitative quotas ( OJ L 198, 26.7.2008 )

34

*

Corrigendum to Council Directive 94/28/EC of 23 June 1994 laying down the principles relating to the zootechnical and genealogical conditions applicable to imports from third countries of animals, their semen, ova and embryos, and amending Directive 77/504/EEC on pure-bred breeding animals of the bovine species ( OJ L 178, 12.7.1994 )

34

| | |
| --- | --- |
| | (1)   Text with EEA relevance |

---

(1)   Text with EEA relevance

1

| EN | Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.
  The titles of all other Acts are printed in bold type and preceded by an asterisk. |
| --- | --- |

EN

Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.

The titles of all other Acts are printed in bold type and preceded by an asterisk.

---

I Acts adopted under the EC Treaty/Euratom Treaty whose publication is obligatory

REGULATIONS

| 2.8.2008 | EN | Official Journal of the European Union | L 206/1 |
| --- | --- | --- | --- |

2.8.2008

EN

Official Journal of the European Union

L 206/1

---

COMMISSION REGULATION (EC) No 769/2008

of 1 August 2008

establishing the standard import values for determining the entry price of certain fruit and vegetables

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (1),

Having regard to Commission Regulation (EC) No 1580/2007 of 21 December 2007 laying down implementing rules for Council Regulations (EC) No 2200/96, (EC) No 2201/96 and (EC) No 1182/2007 in the fruit and vegetable sector (2), and in particular Article 138(1) thereof,

Whereas:

Regulation (EC) No 1580/2007 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XV, Part A thereto,

HAS ADOPTED THIS REGULATION:

Article 1

The standard import values referred to in Article 138 of Regulation (EC) No 1580/2007 are fixed in the Annex hereto.

Article 2

This Regulation shall enter into force on 2 August 2008.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 1 August 2008.

For the Commission

Jean-Luc DEMARTY

Director-General for Agriculture and Rural Development

---

(1)  
  OJ L 299, 16.11.2007, p. 1. Regulation as last amended by Commission Regulation (EC) No 510/2008 (OJ L 149, 7.6.2008, p. 61).

1

(2)  
  OJ L 350, 31.12.2007, p. 1. Regulation as last amended by Regulation (EC) No 590/2008 (OJ L 163, 24.6.2008, p. 24).

2

---

ANNEX

Standard import values for determining the entry price of certain fruit and vegetables

| (EUR/100 kg) |
| --- |
| CN code | Third country code (1) | Standard import value |
| 0702 00 00 | MK | 27,8 |
| TR | 74,2 |
| XS | 26,5 |
| ZZ | 42,8 |
| 0709 90 70 | TR | 97,2 |
| ZZ | 97,2 |
| 0805 50 10 | AR | 78,5 |
| US | 95,7 |
| UY | 67,2 |
| ZA | 88,2 |
| ZZ | 82,4 |
| 0806 10 10 | CL | 43,1 |
| EG | 141,1 |
| IL | 145,6 |
| MK | 76,7 |
| TR | 156,0 |
| ZZ | 112,5 |
| 0808 10 80 | AR | 88,5 |
| BR | 103,0 |
| CL | 107,1 |
| CN | 88,5 |
| NZ | 114,8 |
| US | 101,0 |
| ZA | 92,9 |
| ZZ | 99,4 |
| 0808 20 50 | AR | 70,7 |
| CL | 64,8 |
| NZ | 152,7 |
| TR | 153,4 |
| ZA | 97,1 |
| ZZ | 107,7 |
| 0809 20 95 | CA | 285,7 |
| TR | 423,0 |
| US | 394,8 |
| ZZ | 367,8 |
| 0809 30 | TR | 154,2 |
| US | 191,9 |
| ZZ | 173,1 |
| 0809 40 05 | BA | 70,3 |
| IL | 119,0 |
| TR | 111,4 |
| XS | 62,1 |
| ZZ | 90,7 |

(EUR/100 kg)

CN code

Third country code (1)

Standard import value

0702 00 00

MK

27,8

TR

74,2

XS

26,5

ZZ

42,8

0709 90 70

TR

97,2

ZZ

97,2

0805 50 10

AR

78,5

US

95,7

UY

67,2

ZA

88,2

ZZ

82,4

0806 10 10

CL

43,1

EG

141,1

IL

145,6

MK

76,7

TR

156,0

ZZ

112,5

0808 10 80

AR

88,5

BR

103,0

CL

107,1

CN

88,5

NZ

114,8

US

101,0

ZA

92,9

ZZ

99,4

0808 20 50

AR

70,7

CL

64,8

NZ

152,7

TR

153,4

ZA

97,1

ZZ

107,7

0809 20 95

CA

285,7

TR

423,0

US

394,8

ZZ

367,8

0809 30

TR

154,2

US

191,9

ZZ

173,1

0809 40 05

BA

70,3

IL

119,0

TR

111,4

XS

62,1

ZZ

90,7

---

(1)  Nomenclature of countries laid down by Commission Regulation (EC) No 1833/2006 (OJ L 354, 14.12.2006, p. 19). Code ‘
  ZZ
  ’ stands for ‘of other origin’.

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| 2.8.2008 | EN | Official Journal of the European Union | L 206/3 |
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2.8.2008

EN

Official Journal of the European Union

L 206/3

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COMMISSION REGULATION (EC) No 770/2008

of 1 August 2008

amending Regulation (EC) No 349/2005 laying down rules on the Community financing of emergency measures and of the campaign to combat certain animal diseases under Council Decision 90/424/EEC

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EC) No 1290/2005 of 21 June 2005 on the financing of the common agricultural policy (1), and in particular Article 42(8a) thereof,

Whereas:

| (1) | Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field (2) lays down the procedures governing the Community financial contribution towards programmes for the eradication of animal diseases. |
| --- | --- |

(1)

Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field (2) lays down the procedures governing the Community financial contribution towards programmes for the eradication of animal diseases.

| (2) | Commission Regulation (EC) No 349/2005 (3) applies to Community financial contributions granted to Member States in respect of eligible expenditure for animal disease eradication measures. |
| --- | --- |

(2)

Commission Regulation (EC) No 349/2005 (3) applies to Community financial contributions granted to Member States in respect of eligible expenditure for animal disease eradication measures.

| (3) | Council Directive 2005/94/EC of 20 December 2005 on Community measures for the control of avian influenza and repealing Directive 92/40/EEC (4) establishes new measures for controlling this disease even in the case of a virus of low pathogenicity. |
| --- | --- |

(3)

Council Directive 2005/94/EC of 20 December 2005 on Community measures for the control of avian influenza and repealing Directive 92/40/EEC (4) establishes new measures for controlling this disease even in the case of a virus of low pathogenicity.

| (4) | Decision 90/424/EEC, as amended by Decision 2006/53/EC (5), provides for Community funding to be allocated for certain eradication measures implemented by the Member States in order to combat avian influenza. Article 3a of the Decision makes the Community financial contribution for the eradication of avian influenza conditional on implementation of the minimum measures laid down in Directive 2005/94/EC. |
| --- | --- |

(4)

Decision 90/424/EEC, as amended by Decision 2006/53/EC (5), provides for Community funding to be allocated for certain eradication measures implemented by the Member States in order to combat avian influenza. Article 3a of the Decision makes the Community financial contribution for the eradication of avian influenza conditional on implementation of the minimum measures laid down in Directive 2005/94/EC.

| (5) | Regulation (EC) No 349/2005 should therefore be amended accordingly. |
| --- | --- |

(5)

Regulation (EC) No 349/2005 should therefore be amended accordingly.

| (6) | Under Regulation (EC) No 349/2005 the Community financial contribution will be paid particularly on the basis of an application for reimbursement accompanied by a financial report comprising an ‘adequate compensation’ section and an ‘operational expenditure’ section. As is already the case with the submission of the ‘adequate compensation’ section, the submission of the ‘operational expenditure’ section of the financial report should be linked with the notification of the specific decision establishing financial support. |
| --- | --- |

(6)

Under Regulation (EC) No 349/2005 the Community financial contribution will be paid particularly on the basis of an application for reimbursement accompanied by a financial report comprising an ‘adequate compensation’ section and an ‘operational expenditure’ section. As is already the case with the submission of the ‘adequate compensation’ section, the submission of the ‘operational expenditure’ section of the financial report should be linked with the notification of the specific decision establishing financial support.

| (7) | Regulation (EC) No 349/2005 should be amended accordingly. |
| --- | --- |

(7)

Regulation (EC) No 349/2005 should be amended accordingly.

| (8) | The measures provided for in this Regulation are in accordance with the opinion of the Committee on the Agricultural Funds, |
| --- | --- |

(8)

The measures provided for in this Regulation are in accordance with the opinion of the Committee on the Agricultural Funds,

HAS ADOPTED THIS REGULATION:

Article 1

Regulation (EC) No 349/2005 is hereby amended as follows:

| 1. | Article 1(1) is replaced by the following:

  ‘1.   This Regulation applies to Community financial contributions granted to Member States in respect of eligible expenditure as defined in Articles 3, 4 and 5, for disease eradication measures in the situations referred to in:






  (a) | Article 3(1) and Article 3a(1) of Decision 90/424/EEC, with the exception of equidae diseases; and |
| --- | --- | --- |

1.

Article 1(1) is replaced by the following:

‘1.   This Regulation applies to Community financial contributions granted to Member States in respect of eligible expenditure as defined in Articles 3, 4 and 5, for disease eradication measures in the situations referred to in:

(a)

Article 3(1) and Article 3a(1) of Decision 90/424/EEC, with the exception of equidae diseases; and

| (b) | Article 4(1) and (2), Article 6(2) and Article 11(1) of that Decision.’ |
| --- | --- |

(b)

Article 4(1) and (2), Article 6(2) and Article 11(1) of that Decision.’

| 2. | Article 2, first subparagraph, (d) is replaced by the following:






  ‘(d) | “necessary expenditure”: costs incurred in purchasing equipment or services referred to in the first, second and third indents of Article 3(2) of Decision 90/424/EEC, in the second indent of Article 3a(3) of that Decision, and in points (a)(i) to (iv) and point (b) of Article 11(4) thereof, where their nature and direct link with eligible expenditure as defined in Article 3 of this Regulation have been shown;’ |
| --- | --- | --- |

2.

Article 2, first subparagraph, (d) is replaced by the following:

‘(d)

“necessary expenditure”: costs incurred in purchasing equipment or services referred to in the first, second and third indents of Article 3(2) of Decision 90/424/EEC, in the second indent of Article 3a(3) of that Decision, and in points (a)(i) to (iv) and point (b) of Article 11(4) thereof, where their nature and direct link with eligible expenditure as defined in Article 3 of this Regulation have been shown;’

| 3. | Article 3(a) and (b) are replaced by the following:






  ‘(a) | swift and adequate compensation to owners forced to slaughter their animals or, where applicable, destroy eggs, in accordance with the first and seventh indents of Article 3(2), the first indent of Article 3a(3), and point (a)(i) of Article 11(4) of Decision 90/424/EEC; |
| --- | --- | --- |

3.

Article 3(a) and (b) are replaced by the following:

‘(a)

swift and adequate compensation to owners forced to slaughter their animals or, where applicable, destroy eggs, in accordance with the first and seventh indents of Article 3(2), the first indent of Article 3a(3), and point (a)(i) of Article 11(4) of Decision 90/424/EEC;

| (b) | operational expenditure paid out in connection with the compulsory slaughter and destruction of animals and contaminated products, cleaning and disinfecting of buildings, and cleaning and disinfecting or, where necessary, destruction of contaminated equipment, in accordance with the first, second and third indents of Article 3(2), the second indent of Article 3a(3), and points (a)(i) to (iv) and (b) of Article 11(4) of Decision 90/424/EEC;’ |
| --- | --- |

(b)

operational expenditure paid out in connection with the compulsory slaughter and destruction of animals and contaminated products, cleaning and disinfecting of buildings, and cleaning and disinfecting or, where necessary, destruction of contaminated equipment, in accordance with the first, second and third indents of Article 3(2), the second indent of Article 3a(3), and points (a)(i) to (iv) and (b) of Article 11(4) of Decision 90/424/EEC;’

| 4. | Article 7(2), second subparagraph, is replaced by the following:
  ‘The “operational expenditure” section of the financial report referred to in point (a) of paragraph 1 shall be submitted in the form of an electronic file in accordance with Annex IV within 60 calendar days from the date of notification of the specific decision establishing financial support.’ |
| --- | --- |

4.

Article 7(2), second subparagraph, is replaced by the following:

‘The “operational expenditure” section of the financial report referred to in point (a) of paragraph 1 shall be submitted in the form of an electronic file in accordance with Annex IV within 60 calendar days from the date of notification of the specific decision establishing financial support.’

Article 2

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 1 August 2008.

For the Commission

Androulla VASSILIOU

Member of the Commission

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(1)  
  OJ L 209, 11.8.2005, p. 1. Regulation as last amended by Regulation (EC) No 479/2008 (OJ L 148, 6.6.2008, p. 1).

1

(2)  
  OJ L 224, 18.8.1990, p. 19. Decision as last amended by Regulation (EC) No 1791/2006 (OJ L 363, 20.12.2006, p. 1).

2

(3)  
  OJ L 55, 1.3.2005, p. 12.

3

(4)  
  OJ L 10, 14.1.2006, p. 16.

4

(5)  
  OJ L 29, 2.2.2006, p. 37.

5

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| 2.8.2008 | EN | Official Journal of the European Union | L 206/5 |
| --- | --- | --- | --- |

2.8.2008

EN

Official Journal of the European Union

L 206/5

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COMMISSION REGULATION (EC) No 771/2008

of 1 August 2008

laying down the rules of organisation and procedure of the Board of Appeal of the European Chemicals Agency

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (1), and in particular Articles 93(4) and 132 thereof,

Whereas:

| (1) | Regulation (EC) No 1907/2006 empowers the European Chemicals Agency, hereinafter the ‘Agency’, to take individual decisions on the registration and evaluation of chemicals, and establishes a Board of Appeal to decide on appeals against the decisions referred to in Article 91(1) of that Regulation. |
| --- | --- |

(1)

Regulation (EC) No 1907/2006 empowers the European Chemicals Agency, hereinafter the ‘Agency’, to take individual decisions on the registration and evaluation of chemicals, and establishes a Board of Appeal to decide on appeals against the decisions referred to in Article 91(1) of that Regulation.

| (2) | Since Regulation (EC) No 1907/2006 lays down only basic rules regarding appeal procedures, it is necessary to provide for detailed rules on organisation of the Board of Appeal as well as for detailed rules of procedure applicable to appeals before that Board. |
| --- | --- |

(2)

Since Regulation (EC) No 1907/2006 lays down only basic rules regarding appeal procedures, it is necessary to provide for detailed rules on organisation of the Board of Appeal as well as for detailed rules of procedure applicable to appeals before that Board.

| (3) | In order to ensure a balanced evaluation of appeals from a legal and technical point of view, both legally and technically qualified members of the Board of Appeal as defined in Commission Regulation (EC) No 1238/2007 of 23 October 2007 on laying down rules on the qualifications of the members of the Board of Appeal of the European Chemicals Agency (2) should participate in each appeal. |
| --- | --- |

(3)

In order to ensure a balanced evaluation of appeals from a legal and technical point of view, both legally and technically qualified members of the Board of Appeal as defined in Commission Regulation (EC) No 1238/2007 of 23 October 2007 on laying down rules on the qualifications of the members of the Board of Appeal of the European Chemicals Agency (2) should participate in each appeal.

| (4) | According to Article 89 of Regulation (EC) No 1907/2006, the Board of Appeal is to consist of one Chairman and two other members, each of whom shall have alternates. It is essential for the Chairman to ensure the quality and consistency of the decisions of the Board of Appeal. |
| --- | --- |

(4)

According to Article 89 of Regulation (EC) No 1907/2006, the Board of Appeal is to consist of one Chairman and two other members, each of whom shall have alternates. It is essential for the Chairman to ensure the quality and consistency of the decisions of the Board of Appeal.

| (5) | To facilitate the handling of appeals, a rapporteur should be designated for each case and his tasks should be determined. |
| --- | --- |

(5)

To facilitate the handling of appeals, a rapporteur should be designated for each case and his tasks should be determined.

| (6) | To ensure that the Board of Appeal can operate smoothly and efficiently, a Registry should be established under its auspices. |
| --- | --- |

(6)

To ensure that the Board of Appeal can operate smoothly and efficiently, a Registry should be established under its auspices.

| (7) | For the same reasons, the Board of Appeal should be empowered to lay down rules for its own functioning and procedure. |
| --- | --- |

(7)

For the same reasons, the Board of Appeal should be empowered to lay down rules for its own functioning and procedure.

| (8) | In order to enable the Board of Appeal to reach final decisions within a reasonable time, the number of the members of the Board of Appeal may be increased by the Management Board of the Agency in accordance with the second subparagraph of Article 89(3) of Regulation (EC) No 1907/2006. Accordingly, the Board of Appeal should be empowered to lay down criteria for the allocation of cases between its members. |
| --- | --- |

(8)

In order to enable the Board of Appeal to reach final decisions within a reasonable time, the number of the members of the Board of Appeal may be increased by the Management Board of the Agency in accordance with the second subparagraph of Article 89(3) of Regulation (EC) No 1907/2006. Accordingly, the Board of Appeal should be empowered to lay down criteria for the allocation of cases between its members.

| (9) | Proof of payment of the appeal fee which is required for any appeal pursuant to Commission Regulation (EC) No 340/2008 of 16 April 2008 on the fees and charges payable to the European Chemicals Agency pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (3) should be attached to the notice of appeal and should be a condition for the admissibility of the appeal. |
| --- | --- |

(9)

Proof of payment of the appeal fee which is required for any appeal pursuant to Commission Regulation (EC) No 340/2008 of 16 April 2008 on the fees and charges payable to the European Chemicals Agency pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (3) should be attached to the notice of appeal and should be a condition for the admissibility of the appeal.

| (10) | If necessary and on the basis of experience in the application of this Regulation, the Commission should review the effectiveness of its provisions and their operation in practice, and amend them where appropriate. |
| --- | --- |

(10)

If necessary and on the basis of experience in the application of this Regulation, the Commission should review the effectiveness of its provisions and their operation in practice, and amend them where appropriate.

| (11) | The measures provided for in this Regulation are in accordance with the opinion of the Committee established under Article 133 of Regulation (EC) No 1907/2006, |
| --- | --- |

(11)

The measures provided for in this Regulation are in accordance with the opinion of the Committee established under Article 133 of Regulation (EC) No 1907/2006,

HAS ADOPTED THIS REGULATION:

CHAPTER I

Organisation of the Board of Appeal

Section 1

The Board of Appeal

Article 1

Composition

1.   Each appeal shall be decided by three members of the Board of Appeal of the Agency, hereinafter ‘the Board of Appeal’.

At least one member shall be legally qualified and at least one member shall be technically qualified in accordance with Regulation (EC) No 1238/2007.

2.   The Chairman of the Board of Appeal, or one of his alternates, shall preside over all appeals.

3.   The Chairman shall ensure the quality and consistency of the decisions of the Board of Appeal.

Article 2

Exclusion of members

Where the procedure under Article 90(7) of Regulation (EC) No 1907/2006 is applied, the member of the Board of Appeal concerned shall be invited to present his comments regarding the reasons for any objection raised under Article 90(6) of that Regulation before a decision is taken.

Pending a decision under Article 90(7) of that Regulation, the proceedings shall be suspended.

Article 3

Replacement of members

1.   The Board of Appeal shall replace a member by an alternate where it decides to exclude him from the proceedings in accordance with Article 90(7) of Regulation (EC) No 1907/2006.

2.   The Chairman may replace any member of the Board of Appeal, at the request of that member, by an alternate in the event of leave, sickness, unavoidable commitments of that member or where, for other reasons, that member is precluded from participating in the proceedings. The criteria for selection of an alternate shall be prescribed in accordance with the procedure set out in Article 27(3).

If a member is unable to ask for replacement, the Chairman may replace him on his own initiative.

The Chairman may reject a request for a replacement only by a reasoned decision.

If the Chairman is precluded from participating in the proceedings, he shall designate his alternate. If the Chairman is unable to do so, the longer serving of the other members deciding the appeal, or, where those other members have the same length of service on the Board of Appeal, the older member shall designate the alternate.

3.   If a member is replaced before a hearing has been held, the proceedings shall not be suspended and the replacement shall be without prejudice to any procedural steps already taken.

If a member is replaced after a hearing has been held, the hearing shall be held again unless the parties, the alternate and the other two members deciding the appeal agree otherwise.

4.   If a member is replaced, the alternate concerned shall be bound by any interim decision taken prior to that replacement.

5.   The absence of a member after the Board of Appeal has taken a final decision shall not preclude the Board of Appeal from carrying out the remaining procedural steps.

If the Chairman is unable to sign the decision or to carry out other remaining procedural steps, the longer serving of the other members deciding the appeal, or, where those other members have the same length of service on the Board of Appeal, the older member shall carry out those steps on behalf of the Chairman.

Article 4

Rapporteur

1.   The Chairman shall designate one of the other members deciding an appeal as rapporteur for the case or fulfil that function himself, taking into consideration the need to ensure a balanced distribution of workload between all members.

2.   The rapporteur shall carry out a preliminary study of the appeal.

3.   The Board of Appeal may, upon a proposal from the rapporteur, prescribe any of the procedural measures provided for in Article 15.

The implementation of those measures may be entrusted to the rapporteur.

4.   The rapporteur shall prepare a draft decision.

Section 2

The Registry

Article 5

Registry and Registrar

1.   The Registry is hereby established within the Agency under the auspices of the Board of Appeal. The person appointed as Registrar under paragraph 5 shall be the head of the Registry.

2.   The task of the Registry shall be the receipt, transmission and custody of documents, and the effecting of other services as provided for by this Regulation.

3.   A Register of appeals shall be kept in the Registry in which references to all notices of appeal and related documents are entered.

4.   The staff of the Registry, including the Registrar, may not participate in any proceedings of the Agency relating to decisions which may be the subject of appeals under Article 91(1) of Regulation (EC) No 1907/2006.

5.   The Board of Appeal shall be assisted in the exercise of its duties by a Registrar, who shall be appointed by the Executive Director on a proposal by the Chairman.

The Chairman shall have the power to give directions to the Registrar on matters relating to the exercise of the functions of the Board of Appeal.

6.   The Registrar shall verify that the time limits and other formal conditions relating to the lodging of appeals are complied with.

7.   General instructions to the Registrar shall be adopted in accordance with the procedure set out in Article 27(3).

CHAPTER II

The procedure

Article 6

Notice of appeal

1.   The notice of appeal shall contain:

| (a) | the name and address of the appellant; |
| --- | --- |

(a)

the name and address of the appellant;

| (b) | where the appellant has appointed a representative, the name and the business address of the representative; |
| --- | --- |

(b)

where the appellant has appointed a representative, the name and the business address of the representative;

| (c) | an address for service, if different from those under points (a) and (b); |
| --- | --- |

(c)

an address for service, if different from those under points (a) and (b);

| (d) | the reference of the decision which is being contested and the remedy sought by the appellant; |
| --- | --- |

(d)

the reference of the decision which is being contested and the remedy sought by the appellant;

| (e) | the pleas in law and the arguments of fact and law relied on; |
| --- | --- |

(e)

the pleas in law and the arguments of fact and law relied on;

| (f) | where appropriate, the nature of any evidence offered and a statement explaining the facts for which the evidence is offered in support; |
| --- | --- |

(f)

where appropriate, the nature of any evidence offered and a statement explaining the facts for which the evidence is offered in support;

| (g) | where appropriate, an indication as to what information in the notice of appeal is to be regarded as confidential; |
| --- | --- |

(g)

where appropriate, an indication as to what information in the notice of appeal is to be regarded as confidential;

| (h) | an indication whether the appellant agrees that service is to be effected on him or, where appropriate, on his representative by telefax, e-mail or other technical means of communication. |
| --- | --- |

(h)

an indication whether the appellant agrees that service is to be effected on him or, where appropriate, on his representative by telefax, e-mail or other technical means of communication.

2.   Proof of payment of the appeal fee pursuant to Article 10 of Regulation (EC) No 340/2008 shall be attached to the notice of appeal.

Where the appellant is a legal person, the instrument or instruments constituting and regulating that legal person or a recent extract from the register of companies, firms or associations or any other proof of its existence in law shall also be attached.

3.   If a notice of appeal does not comply with the requirements set out in paragraph 1(a) to (d) and paragraph 2, the Registrar shall prescribe a reasonable period within which the appellant is to comply with them. The Registrar may prescribe such period only once.

During that period, time shall not run for the purposes of the time limit set out in Article 93(2) of Regulation (EC) No 1907/2006.

4.   If an irregularity is detected which is liable to make an appeal inadmissible, the Registrar shall, without delay, send a reasoned opinion to the Chairman.

Where the Registrar prescribes a period in accordance with paragraph 3, he shall send such opinion after that period has expired if the irregularity has not been corrected.

5.   The Registrar shall serve the notice of appeal on the Agency without delay.

6.   An announcement shall be published on the website of the Agency, indicating the date of registration of an appeal initiating proceedings, the names and addresses of the parties, the subject matter of the proceedings, the remedy sought by the appellant and a summary of the pleas in law and of the main supporting arguments.

The Chairman shall decide whether information indicated by an appellant pursuant to paragraph 1(g) is to be regarded as confidential and shall ensure that any information which is regarded as confidential is not published in the announcement. The practical details of publication shall be prescribed in accordance with the procedure set out in Article 27(3).

Article 7

Defence

1.   The Agency shall lodge the defence within two months after service of the notice of appeal.

The Chairman may, in exceptional circumstances, extend that time limit on a reasoned application by the Agency.

2.   The defence shall contain:

| (a) | where the Agency has appointed a representative, the name and the business address of the representative; |
| --- | --- |

(a)

where the Agency has appointed a representative, the name and the business address of the representative;

| (b) | the pleas in law and the arguments of fact and law relied on; |
| --- | --- |

(b)

the pleas in law and the arguments of fact and law relied on;

| (c) | where appropriate, the nature of any evidence offered and a statement explaining the facts for which the evidence is offered in support; |
| --- | --- |

(c)

where appropriate, the nature of any evidence offered and a statement explaining the facts for which the evidence is offered in support;

| (d) | where appropriate, an indication as to what information in the defence is to be regarded as confidential; |
| --- | --- |

(d)

where appropriate, an indication as to what information in the defence is to be regarded as confidential;

| (e) | an indication whether the Agency agrees that service is to be effected on it or, where appropriate, on its representative, by telefax, by e-mail or other technical means of communication. |
| --- | --- |

(e)

an indication whether the Agency agrees that service is to be effected on it or, where appropriate, on its representative, by telefax, by e-mail or other technical means of communication.

3.   Where the Agency, despite being duly summoned, fails to lodge a defence, the proceedings shall continue without a defence.

Article 8

Intervention

1.   Any person establishing an interest in the result of the case submitted to the Board of Appeal may intervene in the proceedings before the Board of Appeal.

2.   An application stating the circumstances establishing the right to intervene shall be submitted within two weeks of publication of the announcement referred to in Article 6(6).

3.   The intervention shall be limited to supporting or opposing the remedy sought by one of the parties.

4.   The application to intervene shall contain:

| (a) | the name and address of the intervener; |
| --- | --- |

(a)

the name and address of the intervener;

| (b) | where the intervener has appointed a representative, the name and the business address of the representative; |
| --- | --- |

(b)

where the intervener has appointed a representative, the name and the business address of the representative;

| (c) | an address for service, if different from those under points (a) and (b); |
| --- | --- |

(c)

an address for service, if different from those under points (a) and (b);

| (d) | a statement of the remedy sought by the intervener in support of or opposing, in whole or in part, the remedy sought by one of the parties; |
| --- | --- |

(d)

a statement of the remedy sought by the intervener in support of or opposing, in whole or in part, the remedy sought by one of the parties;

| (e) | the pleas in law and the arguments of fact and law relied on; |
| --- | --- |

(e)

the pleas in law and the arguments of fact and law relied on;

| (f) | where appropriate, the nature of any evidence offered in support; |
| --- | --- |

(f)

where appropriate, the nature of any evidence offered in support;

| (g) | where appropriate, an indication as to what information in the application to intervene is to be regarded as confidential; |
| --- | --- |

(g)

where appropriate, an indication as to what information in the application to intervene is to be regarded as confidential;

| (h) | an indication whether the intervener agrees that service is to be effected on him or, where appropriate, on his representative by telefax, e-mail or other technical means of communication. |
| --- | --- |

(h)

an indication whether the intervener agrees that service is to be effected on him or, where appropriate, on his representative by telefax, e-mail or other technical means of communication.

5.   The Board of Appeal shall decide whether or not to allow the application to intervene.

6.   Interveners shall bear their own costs.

Article 9

Representation

Where a party or intervener has appointed a representative, that representative shall provide a power of attorney.

Article 10

Lodging of procedural documents

1.   All pleadings shall be signed and bear a date.

2.   For the purposes of calculating time limits, a document shall not be considered to have been lodged until it is received at the Registry.

3.   A party or an intervener shall submit documents to the Registry by hand or by post. However, the Board of Appeal may allow documents of a party or an intervener to be lodged by telefax, e-mail or by any other technical means of communication.

The rules governing the use of means of technical communication, including the use of electronic signature, shall be adopted in accordance with the procedure set out in Article 27(3).

Article 11

Admissibility of the appeal

1.   The grounds on which an appeal shall be ruled inadmissible shall include the following:

| (a) | the notice of appeal is not in compliance with the requirements set out in Article 6(1)(a) to (d) and (2) and Article 9 of this Regulation; |
| --- | --- |

(a)

the notice of appeal is not in compliance with the requirements set out in Article 6(1)(a) to (d) and (2) and Article 9 of this Regulation;

| (b) | the appellant has exceeded the time limit for submitting an appeal as set out in Article 92(2) of Regulation (EC) No 1907/2006; |
| --- | --- |

(b)

the appellant has exceeded the time limit for submitting an appeal as set out in Article 92(2) of Regulation (EC) No 1907/2006;

| (c) | the appeal is not brought against a decision referred to in Article 91(1) of Regulation (EC) No 1907/2006; |
| --- | --- |

(c)

the appeal is not brought against a decision referred to in Article 91(1) of Regulation (EC) No 1907/2006;

| (d) | the appellant is neither an addressee of the decision contested by the appeal nor able to establish direct and individual concern according to Article 92(1) of Regulation (EC) No 1907/2006. |
| --- | --- |

(d)

the appellant is neither an addressee of the decision contested by the appeal nor able to establish direct and individual concern according to Article 92(1) of Regulation (EC) No 1907/2006.

2.   If the Chairman does not decide on the admissibility of the appeal within the time limit laid down in Article 93(2) of Regulation (EC) No 1907/2006, the appeal shall be remitted to the Board of Appeal for examination of the grounds and the admissibility. The decision on admissibility shall form part of the final decision.

Article 12

Examination of appeals

1.   No further evidence may be introduced after the first exchange of written pleadings unless the Board of Appeal decides that the delay in offering the evidence is duly justified.

2.   No new plea in law may be introduced after the first exchange of written pleadings unless the Board of Appeal decides that it is based on new matters of law or of fact that come to light in the course of the proceedings.

3.   Where appropriate, the Board of Appeal shall invite the parties to the proceedings to submit observations on notifications issued by the Board of Appeal or on communications from the other party or from the interveners.

The Board of Appeal shall set a reasonable period for submission of the observations.

4.   The Board of Appeal shall notify the parties of the closure of the written part of the proceedings.

Article 13

Hearings

1.   The Board of Appeal shall hold a hearing if it considers this to be necessary or if a party so requests.

The request shall be submitted within two weeks from notification to the party of the closure of the written part of the proceedings. This period may be extended by the Chairman.

2.   The summons to the hearing shall be communicated to the parties by the Registry.

3.   If a party who has been duly summoned to a hearing does not appear as summoned, the proceedings may continue without that party.

4.   Hearings before the Board of Appeal shall be public, unless the Board of Appeal, of its own motion or at the request of a party, decides otherwise, for serious reasons.

5.   The hearing shall be opened and directed by the Chairman, who shall be responsible for its proper conduct.

The Chairman and the other members may put questions to the parties or their representatives.

6.   The Registrar shall be responsible for drawing up minutes for every hearing.

The minutes shall be signed by the Chairman and the Registrar and shall constitute an official record.

Before the minutes are signed, witnesses or experts shall be given an opportunity to verify and confirm the content of the parts of minutes recording their evidence.

7.   The hearing may be held by video-conference or by using other communication technology if the technical means are available.

Article 14

Use of languages

1.   The language in which the notice of appeal has been lodged shall be the language of the case on appeal.

If the appellant is the addressee of the decision against which the appeal is brought, the notice of appeal shall be lodged in the language of the decision or in one of the official languages of the Community appearing in the submission which gave rise to the decision, including in any information submitted pursuant to Article 10(a)(i) of Regulation (EC) No 1907/2006.

2.   The language of the case shall be used in the written and oral proceedings and in the minutes and decisions of the Board of Appeal.

Any supporting documents in another language shall be accompanied by a translation into the language of the case.

In the case of lengthy documents, translations may be confined to extracts. However, the Board of Appeal may, of its own motion or at the request of a party, at any time require a more extensive or complete translation.

3.   At the request of a party, and after the other party has been heard, the Board of Appeal may authorise the use of an official language of the Community other than the language of the case for all or part of the proceedings.

4.   At the request of an intervener, and after the parties have been heard, the Board of Appeal may authorise the intervener to use an official language of the Community other than the language of the case.

5.   Where a witness or expert states that he is unable to express himself adequately in the language of the case, the Board of Appeal may authorise him to use another official language of the Community.

6.   Where the Board of Appeal authorises the use of a language other than the language of the case, the Registry shall arrange for translation or interpretation.

Article 15

Procedural measures

1.   The Board of Appeal may prescribe procedural measures at any point in the proceedings.

2.   The purpose of procedural measures shall, in particular, be:

| (a) | to ensure the efficient conduct of the proceedings and to facilitate the taking of evidence; |
| --- | --- |

(a)

to ensure the efficient conduct of the proceedings and to facilitate the taking of evidence;

| (b) | to determine the points on which the parties must present further arguments; |
| --- | --- |

(b)

to determine the points on which the parties must present further arguments;

| (c) | to clarify the remedies sought by the parties, their pleas in law and arguments and the points at issue between them. |
| --- | --- |

(c)

to clarify the remedies sought by the parties, their pleas in law and arguments and the points at issue between them.

3.   Procedural measures may, in particular, consist of:

| (a) | putting questions to the parties; |
| --- | --- |

(a)

putting questions to the parties;

| (b) | inviting the parties to make written or oral submissions on certain aspects of the proceedings; |
| --- | --- |

(b)

inviting the parties to make written or oral submissions on certain aspects of the proceedings;

| (c) | asking the parties or third parties for information; |
| --- | --- |

(c)

asking the parties or third parties for information;

| (d) | asking for documents relating to the case to be produced; |
| --- | --- |

(d)

asking for documents relating to the case to be produced;

| (e) | summoning the parties or their representatives to meetings; |
| --- | --- |

(e)

summoning the parties or their representatives to meetings;

| (f) | drawing attention to matters which seem to be of special significance, or to the fact that certain questions appear no longer to be contentious; |
| --- | --- |

(f)

drawing attention to matters which seem to be of special significance, or to the fact that certain questions appear no longer to be contentious;

| (g) | making observations that may help to keep the focus on essentials during the proceedings. |
| --- | --- |

(g)

making observations that may help to keep the focus on essentials during the proceedings.

Article 16

Evidence

1.   In proceedings before the Board of Appeal, the means of taking evidence may include:

| (a) | requests for information; |
| --- | --- |

(a)

requests for information;

| (b) | the production of documents and items; |
| --- | --- |

(b)

the production of documents and items;

| (c) | hearing the parties or witnesses; |
| --- | --- |

(c)

hearing the parties or witnesses;

| (d) | opinions by experts. |
| --- | --- |

(d)

opinions by experts.

Detailed rules on the taking of evidence shall be laid down in accordance with the procedure set out in Article 27(3).

2.   If the Board of Appeal considers it necessary for a party, witness or expert to give evidence orally, it shall summon the person concerned to appear before it.

3.   The parties shall be informed where a witness or expert is to be heard before the Board of Appeal. They shall have the right to be present and to put questions to the witness or expert.

The parties may object to an expert or witness on the grounds of lack of competence in relation to the appeal. Where such an objection is raised, the matter shall be resolved by the Board of Appeal.

4.   Prior to giving evidence, each expert or witness shall declare any personal interest which he may have in the case, or if he has previously been involved as a representative of one of the parties, or if he participated in the decision under appeal.

Where the expert or witness fails to make such a declaration himself, the parties may bring the matter to the attention of the Board of Appeal.

5.   An objection to a witness or to an expert shall be raised within two weeks of the parties being given notice of the summoning of the witness or appointing the expert. The party shall present the grounds of its objection and indicate the nature of any evidence offered to support it.

6.   Where a witness or expert has given evidence, that evidence shall be reproduced in the minutes.

Article 17

Costs relating to taking of evidence

1.   Witnesses and experts who are summoned by and who appear before the Board of Appeal shall be entitled to appropriate reimbursement of expenses for travel and subsistence.

Witnesses who are summoned by and who appear before the Board of Appeal shall also be entitled to appropriate compensation for loss of earnings.

Experts who are not members of the staff of the Agency shall be entitled to fees for their work.

2.   Payments shall be made to the witnesses after they have given their evidence and to the experts after they have fulfilled their duties or tasks. However, an advance payment may be made.

3.   The Management Board of the Agency shall lay down rules for calculation of the amounts and advances to be paid.

4.   Detailed rules shall be laid down, in accordance with the procedure set out in Article 27(3) and in agreement with the Management Board, regarding the following:

| (a) | who bears the costs with regard to the taking of evidence; |
| --- | --- |

(a)

who bears the costs with regard to the taking of evidence;

| (b) | the arrangements for any payments for reimbursement, compensation and fees to the witnesses and experts. |
| --- | --- |

(b)

the arrangements for any payments for reimbursement, compensation and fees to the witnesses and experts.

5.   The rules referred to in paragraphs 3 and 4 shall take into account, as appropriate, comparable rules existing in other areas of Community law.

Article 18

Competence

If the Board of Appeal remits the case to the competent body of the Agency in accordance with Article 93(3) of Regulation (EC) No 1907/2006, the latter shall be bound by the reasoning in the decision of the Board of Appeal save in so far as a change in circumstances occurs.

Article 19

Deliberations

1.   Only the three members of the Board of Appeal deciding an appeal shall participate in the deliberations regarding that appeal. Deliberations shall be and shall remain secret.

2.   During the deliberations, each member shall state his opinion and the reasons for it.

The opinion of the rapporteur shall be heard first and, if the rapporteur is not the Chairman, the opinion of the Chairman last.

Article 20

Voting

If voting is necessary, votes shall be cast in the sequence provided for in the second subparagraph of Article 19(2). However, if the Chairman is also the rapporteur, he shall vote last.

Decisions shall be taken by a majority of votes.

Abstentions shall not be permitted.

Article 21

Decisions

1.   The decision shall contain:

| (a) | a statement that the decision is delivered by the Board of Appeal; |
| --- | --- |

(a)

a statement that the decision is delivered by the Board of Appeal;

| (b) | the date when the decision was taken; |
| --- | --- |

(b)

the date when the decision was taken;

| (c) | the names of the members of the Board of Appeal who have taken part in the proceedings; |
| --- | --- |

(c)

the names of the members of the Board of Appeal who have taken part in the proceedings;

| (d) | the names of the parties and the interveners to the appeal and their representatives in the proceedings; |
| --- | --- |

(d)

the names of the parties and the interveners to the appeal and their representatives in the proceedings;

| (e) | a statement of the remedy sought by the parties; |
| --- | --- |

(e)

a statement of the remedy sought by the parties;

| (f) | a summary of the facts; |
| --- | --- |

(f)

a summary of the facts;

| (g) | the grounds on which the decision is based; |
| --- | --- |

(g)

the grounds on which the decision is based;

| (h) | the order of the Board of Appeal, including, where necessary, an award of costs for taking evidence and a decision as to the refund of fees pursuant to Article 10(4) of Regulation (EC) No 340/2008. |
| --- | --- |

(h)

the order of the Board of Appeal, including, where necessary, an award of costs for taking evidence and a decision as to the refund of fees pursuant to Article 10(4) of Regulation (EC) No 340/2008.

2.   The Chairman and the Registrar shall sign the decision. The signatures may be electronic.

The original of the decision shall be deposited at the Registry.

3.   The decision shall be served on the parties in accordance with Article 22.

4.   The decision shall be accompanied by a statement that it may be challenged pursuant to Article 230 of the Treaty and Article 94(1) of Regulation (EC) No 1907/2006. The statement shall include the time limit for commencing that action.

Failure to include that statement shall not render the decision invalid.

5.   Final decisions of the Board of Appeal shall be published in full in an appropriate form, unless the Chairman decides otherwise on the reasoned request of a party.

Article 22

Service of documents

The Registrar shall ensure that the decisions and communications of the Board of Appeal are served on the parties and on the interveners.

Service shall be effected by one of the following means:

| 1. | registered post with a form for acknowledgement of receipt; |
| --- | --- |

1.

registered post with a form for acknowledgement of receipt;

| 2. | personal delivery of the copy against a receipt; |
| --- | --- |

2.

personal delivery of the copy against a receipt;

| 3. | any technical means of communication available to the Board of Appeal which the party or its representative has agreed to accept for such purposes. |
| --- | --- |

3.

any technical means of communication available to the Board of Appeal which the party or its representative has agreed to accept for such purposes.

Article 23

Time limits

1.   Any period prescribed by or set under Regulation (EC) No 1907/2006 or this Regulation for the purposes of appeal proceedings shall be calculated in accordance with paragraphs 2 to 6 of this Article.

2.   Where a period expressed in days, weeks, months or years is to be calculated from a day on which an event occurs or an action takes place, that day shall not fall within that period.

3.   A period expressed in weeks, months or years shall end with the expiry of whichever day in the last week, month or year is the same day of the week, or falls on the same date, as the day during which the event or action from which the period is to be calculated occurred or took place.

If, in a period expressed in months or in years, the day on which it should expire does not occur in the last month, the period shall end with the expiry of the last day of that month.

4.   Where a period is expressed in months and days, it shall first be calculated in whole months, then in days.

5.   Periods shall include official holidays of the Agency, Saturdays and Sundays.

6.   If a period would otherwise end on a Saturday, Sunday or official holiday of the Agency, it shall be extended until the end of the first following working day.

Article 24

Extension and exceeding of time limit

1.   Any time limit prescribed pursuant to this Regulation may be extended by whoever prescribed it.

2.   Exceeding a time limit shall be without prejudice to any right of a party provided that the party concerned proves the existence of unforeseeable circumstances or of force majeure to the satisfaction of the Board of Appeal.

Article 25

Stay of proceedings

At the request of a party or of its own motion, the Board of Appeal may, after hearing the parties, stay the proceedings.

Should any of the parties oppose the stay, that decision shall be taken by reasoned decision.

Article 26

Rectification

The Board of Appeal may, after hearing the parties, of its own motion or on application by a party made within one month after the decision has been served, rectify clerical mistakes, errors in calculation and obvious mistakes in the decision.

CHAPTER III

Final provisions

Article 27

Implementing measures

1.   Additional rules of a procedural nature necessary for the efficient processing of the appeals and rules necessary for the organisation of the work of the Board of Appeal, including rules concerning the allocation of cases between members, may be laid down in accordance with the procedure set out in paragraph 3.

2.   Practice directions to parties and interveners and instructions related to the preparations for and conduct of hearings before the Board of Appeal, and to the lodging and service of written pleadings or observations may be adopted in accordance with the procedure set out in paragraph 3.

3.   The Chairman and the other two members appointed in accordance with the first subparagraph of Article 89(3) of Regulation (EC) No 1907/2006 shall adopt the rules and measures provided for in this Regulation by a majority of votes.

Article 28

Entry into force

This Regulation shall enter into force on the third day following its publication in the Official Journal of the European Union.

Official Journal of the European Union

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 1 August 2008.

For the Commission

Günter VERHEUGEN

Vice-President

---

(1)  
  OJ L 396, 30.12.2006, p. 1, as corrected by OJ L 136, 29.5.2007, p. 3. Regulation as amended by Council Regulation (EC) No 1354/2007 (OJ L 304, 22.11.2007, p. 1).

1

(2)  
  OJ L 280, 24.10.2007, p. 10.

2

(3)  
  OJ L 107, 17.4.2008, p. 6.

3

---

| 2.8.2008 | EN | Official Journal of the European Union | L 206/14 |
| --- | --- | --- | --- |

2.8.2008

EN

Official Journal of the European Union

L 206/14

---

COMMISSION REGULATION (EC) No 772/2008

of 1 August 2008

amending the representative prices and additional duties for the import of certain products in the sugar sector fixed by Regulation (EC) No 1109/2007 for the 2007/08 marketing year

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EC) No 318/2006 of 20 February 2006 on the common organisation of the markets in the sugar sector (1),

Having regard to Commission Regulation (EC) No 951/2006 of 30 June 2006 laying down detailed rules for the implementation of Council Regulation (EC) No 318/2006 as regards trade with third countries in the sugar sector (2), and in particular of the Article 36,

Whereas:

| (1) | The representative prices and additional duties applicable to imports of white sugar, raw sugar and certain syrups for the 2007/08 marketing year are fixed by Commission Regulation (EC) No 1109/2007 (3). These prices and duties have been last amended by Commission Regulation (EC) No 757/2008 (4). |
| --- | --- |

(1)

The representative prices and additional duties applicable to imports of white sugar, raw sugar and certain syrups for the 2007/08 marketing year are fixed by Commission Regulation (EC) No 1109/2007 (3). These prices and duties have been last amended by Commission Regulation (EC) No 757/2008 (4).

| (2) | The data currently available to the Commission indicate that the said amounts should be changed in accordance with the rules and procedures laid down in Regulation (EC) No 951/2006, |
| --- | --- |

(2)

The data currently available to the Commission indicate that the said amounts should be changed in accordance with the rules and procedures laid down in Regulation (EC) No 951/2006,

HAS ADOPTED THIS REGULATION:

Article 1

The representative prices and additional duties on imports of the products referred to in Article 36 of Regulation (EC) No 951/2006, as fixed by Regulation (EC) No 1109/2007 for the 2007/08 marketing year are hereby amended as set out in the Annex to this Regulation.

Article 2

This Regulation shall enter into force on 2 August 2008.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 1 August 2008.

For the Commission

Jean-Luc DEMARTY

Director-General for Agriculture and Rural Development

---

(1)  
  OJ L 58, 28.2.2006, p. 1. Regulation as last amended by Regulation (EC) No 1260/2007 (OJ L 283, 27.10.2007, p. 1). Regulation (EC) No 318/2006 will be replaced by Regulation (EC) No 1234/2007 (OJ L 299, 16.11.2007, p. 1) as from 1 October 2008.

1

(2)  
  OJ L 178, 1.7.2006, p. 24. Regulation as last amended by Regulation (EC) No 514/2008 (OJ L 150, 10.6.2008, p. 7).

2

(3)  
  OJ L 253, 28.9.2007, p. 5.

3

(4)  
  OJ L 205, 1.8.2008, p. 16.

4

---

ANNEX

Amended representative prices and additional duties applicable to imports of white sugar, raw sugar and products covered by CN code 1702 90 95 applicable from 2 August 2008

| (EUR) |
| --- |
| CN code | Representative price per 100 kg of the product concerned | Additional duty per 100 kg of the product concerned |
| 1701 11 10  (1) | 23,55 | 4,52 |
| 1701 11 90  (1) | 23,55 | 9,76 |
| 1701 12 10  (1) | 23,55 | 4,33 |
| 1701 12 90  (1) | 23,55 | 9,33 |
| 1701 91 00  (2) | 23,89 | 13,68 |
| 1701 99 10  (2) | 23,89 | 8,77 |
| 1701 99 90  (2) | 23,89 | 8,77 |
| 1702 90 95  (3) | 0,24 | 0,40 |

(EUR)

CN code

Representative price per 100 kg of the product concerned

Additional duty per 100 kg of the product concerned

1701 11 10  (1)

23,55

4,52

1701 11 90  (1)

23,55

9,76

1701 12 10  (1)

23,55

4,33

1701 12 90  (1)

23,55

9,33

1701 91 00  (2)

23,89

13,68

1701 99 10  (2)

23,89

8,77

1701 99 90  (2)

23,89

8,77

1702 90 95  (3)

0,24

0,40

---

(1)  Fixed for the standard quality defined in Annex I.III to Council Regulation (EC) No 318/2006 (OJ L 58, 28.2.2006, p. 1).

(2)  Fixed for the standard quality defined in Annex I.II to Regulation (EC) No 318/2006.

(3)  Fixed per 1 % sucrose content.

---

II Acts adopted under the EC Treaty/Euratom Treaty whose publication is not obligatory

DECISIONS

Conference of the Representatives of the Governments of the Member States

| 2.8.2008 | EN | Official Journal of the European Union | L 206/16 |
| --- | --- | --- | --- |

2.8.2008

EN

Official Journal of the European Union

L 206/16

---

DECISION TAKEN BY COMMON AGREEMENT BETWEEN THE REPRESENTATIVES OF THE GOVERNMENTS OF MEMBER STATES

of 18 June 2008

on the location of the seat of the European Institute for Innovation and Technology (EIT)

(2008/634/EC)

THE REPRESENTATIVES OF THE GOVERNMENTS OF THE MEMBER STATES,

Having regard to Article 289 of the Treaty establishing the European Community,

Whereas:

| (1) | The establishment of a European Institute for Innovation and Technology was decided by Regulation (EC) No 294/2008 of the European Parliament and of the Council of 11 March 2008 establishing the European Institute for Innovation and Technology (1). |
| --- | --- |

(1)

The establishment of a European Institute for Innovation and Technology was decided by Regulation (EC) No 294/2008 of the European Parliament and of the Council of 11 March 2008 establishing the European Institute for Innovation and Technology (1).

| (2) | The location of the seat of this Institute should be determined, |
| --- | --- |

(2)

The location of the seat of this Institute should be determined,

HAVE DECIDED AS FOLLOWS:

Article 1

The European Institute for Innovation and Technology (EIT) shall have its seat in Budapest.

Article 2

This Decision, which will be published in the Official Journal of the European Union, shall take effect on the date of its publication.

Done at Brussels, 18 June 2008.

The President

M. KUCLER DOLINAR

---

(1)  
  OJ L 97, 9.4.2008, p. 1.

1

---

Commission

| 2.8.2008 | EN | Official Journal of the European Union | L 206/17 |
| --- | --- | --- | --- |

2.8.2008

EN

Official Journal of the European Union

L 206/17

---

COMMISSION DECISION

of 22 July 2008

on imports of semen, ova and embryos of the ovine and caprine species into the Community as regards lists of third countries and of semen collection centres and embryo collection teams, and certification requirements

(notified under document number C(2008) 3625)

(Text with EEA relevance)

(2008/635/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A(I) to Directive 90/425/EEC (1), and in particular Article 17(2)(b), Article 17(3), the first indent of Article 18(1), and the introductory phrase and point (b) of Article 19 thereof,

Whereas:

| (1) | Directive 92/65/EEC lays down the animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to the animal health requirements laid down in the specific Community acts referred to therein. It also provides for the establishment of a list of those third countries or parts of third countries, able to provide guarantees equivalent to those provided for in Chapter II therein, from which Member States may import semen, ova and embryos of the ovine and caprine species. |
| --- | --- |

(1)

Directive 92/65/EEC lays down the animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to the animal health requirements laid down in the specific Community acts referred to therein. It also provides for the establishment of a list of those third countries or parts of third countries, able to provide guarantees equivalent to those provided for in Chapter II therein, from which Member States may import semen, ova and embryos of the ovine and caprine species.

| (2) | Directive 92/65/EEC also provides for the establishment of a list of semen and embryo collection centres in third countries, for which those third countries are able to give the guarantees referred to in Article 11 of that Directive. |
| --- | --- |

(2)

Directive 92/65/EEC also provides for the establishment of a list of semen and embryo collection centres in third countries, for which those third countries are able to give the guarantees referred to in Article 11 of that Directive.

| (3) | However, as regards collection centres for ova and embryos of the ovine and caprine species, for the sake of consistency of Community legislation, and taking into account international nomenclature, it is more appropriate to use the term ‘embryo collection teams’ instead of ‘collection centres’ in that case. |
| --- | --- |

(3)

However, as regards collection centres for ova and embryos of the ovine and caprine species, for the sake of consistency of Community legislation, and taking into account international nomenclature, it is more appropriate to use the term ‘embryo collection teams’ instead of ‘collection centres’ in that case.

| (4) | Directive 92/65/EEC provides that semen, ova and embryos of the ovine and caprine species to be imported into the Community are to be accompanied by health certificates, models of which are to be established in accordance with that Directive. |
| --- | --- |

(4)

Directive 92/65/EEC provides that semen, ova and embryos of the ovine and caprine species to be imported into the Community are to be accompanied by health certificates, models of which are to be established in accordance with that Directive.

| (5) | Directive 92/65/EEC also provides for the establishment of the specific animal health requirements or guarantees equivalent to those provided for in that Directive, for imports into the Community of semen, ova and embryos of the ovine and caprine species. |
| --- | --- |

(5)

Directive 92/65/EEC also provides for the establishment of the specific animal health requirements or guarantees equivalent to those provided for in that Directive, for imports into the Community of semen, ova and embryos of the ovine and caprine species.

| (6) | Commission Decision 94/63/EC of 31 January 1994 drawing up a list of third countries from which Member States authorise imports of semen, ova and embryos of the ovine and caprine species and ova and embryos of the porcine species (2) provides that Member States are to authorise imports of semen, ova and embryos of the ovine and caprine species from the third countries appearing in the list in the Annex to Council Decision 79/542/EEC (3), from which imports of live animals of the ovine and caprine species are authorised. |
| --- | --- |

(6)

Commission Decision 94/63/EC of 31 January 1994 drawing up a list of third countries from which Member States authorise imports of semen, ova and embryos of the ovine and caprine species and ova and embryos of the porcine species (2) provides that Member States are to authorise imports of semen, ova and embryos of the ovine and caprine species from the third countries appearing in the list in the Annex to Council Decision 79/542/EEC (3), from which imports of live animals of the ovine and caprine species are authorised.

| (7) | Decision 94/63/EC has now been repealed by Commission Decision 2008/636/EC (4). |
| --- | --- |

(7)

Decision 94/63/EC has now been repealed by Commission Decision 2008/636/EC (4).

| (8) | Accordingly, a list of third countries from which Member States are to authorise imports of semen, ova and embryos of the ovine and caprine species should be established by this Decision. |
| --- | --- |

(8)

Accordingly, a list of third countries from which Member States are to authorise imports of semen, ova and embryos of the ovine and caprine species should be established by this Decision.

| (9) | The lists of semen collection centres and embryo collection teams from which Member States are to authorise imports of semen, ova and embryos of the ovine and caprine species, originating in third countries, should also be established by this Decision. |
| --- | --- |

(9)

The lists of semen collection centres and embryo collection teams from which Member States are to authorise imports of semen, ova and embryos of the ovine and caprine species, originating in third countries, should also be established by this Decision.

| (10) | Article 17(3) of Directive 92/65/EEC provides for the procedure of amendments to the lists of semen collection centres and embryo collection teams from which Member States are to authorise the imports of semen, ova and embryos of the ovine and caprine species. The amended lists are to be published on the website of the Commission (5). |
| --- | --- |

(10)

Article 17(3) of Directive 92/65/EEC provides for the procedure of amendments to the lists of semen collection centres and embryo collection teams from which Member States are to authorise the imports of semen, ova and embryos of the ovine and caprine species. The amended lists are to be published on the website of the Commission (5).

| (11) | In the interests of consistency of Community legislation, the requirements governing intra-Community trade in ovine and caprine animals for breeding, and the specific test regimes for those animals, set out in Council Directive 91/68/EEC of 28 January 1991 on animal health conditions governing intra-Community trade in ovine and caprine animals (6), should be taken into account in the model health certificate for imports of semen of the ovine and caprine species set out in this Decision. |
| --- | --- |

(11)

In the interests of consistency of Community legislation, the requirements governing intra-Community trade in ovine and caprine animals for breeding, and the specific test regimes for those animals, set out in Council Directive 91/68/EEC of 28 January 1991 on animal health conditions governing intra-Community trade in ovine and caprine animals (6), should be taken into account in the model health certificate for imports of semen of the ovine and caprine species set out in this Decision.

| (12) | The animal health conditions for the importation into the Community of animals of the ovine and caprine species intended for breeding are laid down in Decision 79/542/EEC. Those requirements should also be taken into account in the model health certificate for imports of semen of the ovine and caprine species set out in this Decision. |
| --- | --- |

(12)

The animal health conditions for the importation into the Community of animals of the ovine and caprine species intended for breeding are laid down in Decision 79/542/EEC. Those requirements should also be taken into account in the model health certificate for imports of semen of the ovine and caprine species set out in this Decision.

| (13) | Certain infectious diseases of animals of the ovine and caprine species are transmissible via semen. Therefore, particular animal health tests identifying such diseases must be carried out according to specific test programmes reflecting the movements of the donors prior to, and during, the period of semen collection. Those tests and test programmes should be in line with international standards and therefore indicated in the model health certificate for imports of semen of the ovine and caprine species set out in this Decision. |
| --- | --- |

(13)

Certain infectious diseases of animals of the ovine and caprine species are transmissible via semen. Therefore, particular animal health tests identifying such diseases must be carried out according to specific test programmes reflecting the movements of the donors prior to, and during, the period of semen collection. Those tests and test programmes should be in line with international standards and therefore indicated in the model health certificate for imports of semen of the ovine and caprine species set out in this Decision.

| (14) | Account should also be taken of the provisions of Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (7) and of Commission Regulation (EC) No 546/2006 of 31 March 2006 implementing Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards national scrapie control programmes and additional guarantees and derogating from certain requirements of Decision 2003/100/EC and repealing Regulation (EC) No 1874/2003 (8). |
| --- | --- |

(14)

Account should also be taken of the provisions of Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (7) and of Commission Regulation (EC) No 546/2006 of 31 March 2006 implementing Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards national scrapie control programmes and additional guarantees and derogating from certain requirements of Decision 2003/100/EC and repealing Regulation (EC) No 1874/2003 (8).

| (15) | Sanitary conditions for the collection, processing, storage and transport of ova and embryos and the health conditions applied to donor females are laid down in Chapters III and IV of Annex D to Directive 92/65/EEC. However, it is necessary to provide for additional guarantees, in particular as regards the official veterinary supervision of embryo collection teams in this Decision. |
| --- | --- |

(15)

Sanitary conditions for the collection, processing, storage and transport of ova and embryos and the health conditions applied to donor females are laid down in Chapters III and IV of Annex D to Directive 92/65/EEC. However, it is necessary to provide for additional guarantees, in particular as regards the official veterinary supervision of embryo collection teams in this Decision.

| (16) | In the interests of clarity of Community legislation, it is appropriate to set out in this Decision a list of third countries and approved semen collection centres from which Member States are to authorise imports into the Community of semen of the ovine and caprine species, a list of third countries and approved embryo collection teams from which Member States are to authorise imports into the Community of ova and embryos of those species, and the certification requirements relating to such imports in order to gather all these requirements under a single act. |
| --- | --- |

(16)

In the interests of clarity of Community legislation, it is appropriate to set out in this Decision a list of third countries and approved semen collection centres from which Member States are to authorise imports into the Community of semen of the ovine and caprine species, a list of third countries and approved embryo collection teams from which Member States are to authorise imports into the Community of ova and embryos of those species, and the certification requirements relating to such imports in order to gather all these requirements under a single act.

| (17) | In the application of the present Decision, account should be taken of the specific certification requirements provided for in point 7(b) of Chapter IX(B) of Appendix 2 of Annex 11 to the Agreement between the European Community and the Swiss Confederation on trade in agricultural products (9), as approved by Decision 2002/309/EC, Euratom of the Council, and of the Commission as regards the Agreement on scientific and technological cooperation, of 4 April 2002 on the conclusion of seven Agreements with the Swiss Confederation (10). Therefore, for consignments of semen, ova or embryos of ovine or caprine species from Switzerland to the Community, the certificates provided for in Commission Decision 95/388/EC of 19 September 1995 determining the specimen certificate for intra-Community trade in semen, ova and embryos of the ovine and caprine species (11) should apply, as adopted in accordance with that Decision. |
| --- | --- |

(17)

In the application of the present Decision, account should be taken of the specific certification requirements provided for in point 7(b) of Chapter IX(B) of Appendix 2 of Annex 11 to the Agreement between the European Community and the Swiss Confederation on trade in agricultural products (9), as approved by Decision 2002/309/EC, Euratom of the Council, and of the Commission as regards the Agreement on scientific and technological cooperation, of 4 April 2002 on the conclusion of seven Agreements with the Swiss Confederation (10). Therefore, for consignments of semen, ova or embryos of ovine or caprine species from Switzerland to the Community, the certificates provided for in Commission Decision 95/388/EC of 19 September 1995 determining the specimen certificate for intra-Community trade in semen, ova and embryos of the ovine and caprine species (11) should apply, as adopted in accordance with that Decision.

| (18) | In application of the present Decision, account should be taken of the specific certification requirements and model health attestations which may be laid down in accordance with the Agreement between the European Community and the Government of Canada on sanitary measures to protect public and animal health in respect of trade in live animals and animal products (12), as approved by Council Decision 1999/201/EC (13). |
| --- | --- |

(18)

In application of the present Decision, account should be taken of the specific certification requirements and model health attestations which may be laid down in accordance with the Agreement between the European Community and the Government of Canada on sanitary measures to protect public and animal health in respect of trade in live animals and animal products (12), as approved by Council Decision 1999/201/EC (13).

| (19) | In application of the present Decision, account should also be taken of the specific certification requirements and model health attestations which may be laid down in accordance with the Agreement between the European Community and New Zealand on sanitary measures applicable to trade in live animals and animal products (14), as approved by Council Decision 97/132/EC (15). |
| --- | --- |

(19)

In application of the present Decision, account should also be taken of the specific certification requirements and model health attestations which may be laid down in accordance with the Agreement between the European Community and New Zealand on sanitary measures applicable to trade in live animals and animal products (14), as approved by Council Decision 97/132/EC (15).

| (20) | The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
| --- | --- |

(20)

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 ADOPTED THIS DECISION:

Article 1

Imports of semen

The Member States shall authorise imports of semen of the ovine and caprine species, collected in a third country and in an approved semen collection centre, listed in Annex I, and complying with the animal health requirements set out in the model health certificate in Annex II.

Article 2

Imports of ova and embryos

The Member States shall authorise imports of ova and embryos of the ovine and caprine species, collected in a third country and by an approved embryo collection team, listed in Annex III, and complying with the animal health requirements set out in the model health certificate in Annex IV.

Article 3

Applicability

This Decision shall apply from 1 September 2008.

Article 4

Addressees

This Decision is addressed to the Member States.

Done at Brussels, 22 July 2008.

For the Commission

Androulla VASSILIOU

Member of the Commission

---

(1)  
  OJ L 268, 14.9.1992, p. 54. Directive as last amended by Commission Decision 2007/265/EC (OJ L 114, 1.5.2007, p. 17).

1

(2)  
  OJ L 28, 2.2.1994, p. 47. Decision as last amended by Decision 2004/211/EC (OJ L 73, 11.3.2004, p. 1).

2

(3)  
  OJ L 146, 14.6.1979, p. 15. Decision as last amended by Commission Decision 2008/61/EC (OJ L 15, 18.1.2008, p. 33).

3

(4)  See page 32 of this Official Journal.

4

(5)  http://circa.europa.eu/irc/sanco/vets/info/data/semen/semen.html

5

(6)  
  OJ L 46, 19.2.1991, p. 19. Directive as last amended by Directive 2006/104/EC (OJ L 363, 20.12.2006, p. 352).

6

(7)  
  OJ L 147, 31.5.2001, p. 1. Regulation as last amended by Commission Regulation (EC) No 571/2008 (OJ L 161, 20.6.2008, p. 4).

7

(8)  
  OJ L 94, 1.4.2006, p. 28.

8

(9)  
  OJ L 114, 30.4.2002, p. 132.

9

(10)  
  OJ L 114, 30.4.2002, p. 1.

10

(11)  
  OJ L 234, 3.10.1995, p. 30. Decision as amended by Decision 2005/43/EC (OJ L 20, 22.1.2005, p. 34).

11

(12)  
  OJ L 71, 18.3.1999, p. 3.

12

(13)  
  OJ L 71, 18.3.1999, p. 1.

13

(14)  
  OJ L 57, 26.2.1997, p. 5.

14

(15)  
  OJ L 57, 26.2.1997, p. 4. Decision as amended by Decision 1999/837/EC (OJ L 332, 23.12.1999, p. 1).

15

---

ANNEX I

List of third countries and approved semen collection centres from which Member States are to authorise imports of semen of the ovine and caprine species

| ISO code | Name of the third country | Approval number of the centre | Name of the centre | Address of the centre | Date of approval of the centre | Remarks |
| --- | --- | --- | --- | --- | --- | --- |
| Description of the territory
  (if appropriate) | Additional guarantees |
| AU | Australia | | | | | | The additional guarantees as regards testing set out in points II.4.8 and II.4.9 of the certificate in Annex II are compulsory. |
| CA | Canada | | | | | Territory as described in Part 1 of Annex I to Decision 79/542/EEC (as last amended). | The additional guarantee as regards testing set out in point II.4.8 of the certificate in Annex II is compulsory. |
| CH | Switzerland | | | | | | |
| CL | Chile | | | | | | |
| GL | Greenland | | | | | | |
| HR | Croatia | | | | | | |
| IS | Iceland | | | | | | |
| NZ | New Zealand | | | | | | |
| PM | Saint Pierre and Miquelon | | | | | | |
| US | United States | | | | | | The additional guarantee as regards testing set out in point II.4.8 of the certificate in Annex II is compulsory. |
| Notes






  (a) | Health certificates shall be produced by the exporting country, based on the model appearing in Annex II. They shall contain, in the numbered order that appears in the model, the attestations that are required for any third country and, as the case may be, those supplementary guarantees that are required for the exporting third country as indicated in Annex I.
  If so requested by the EU Member State of destination, the additional certification requirements shall be also incorporated in the original form of the health certificate. |

ISO code

Name of the third country

Approval number of the centre

Name of the centre

Address of the centre

Date of approval of the centre

Remarks

Description of the territory

(if appropriate)

Additional guarantees

AU

Australia

The additional guarantees as regards testing set out in points II.4.8 and II.4.9 of the certificate in Annex II are compulsory.

CA

Canada

Territory as described in Part 1 of Annex I to Decision 79/542/EEC (as last amended).

The additional guarantee as regards testing set out in point II.4.8 of the certificate in Annex II is compulsory.

CH

Switzerland

CL

Chile

GL

Greenland

HR

Croatia

IS

Iceland

NZ

New Zealand

PM

Saint Pierre and Miquelon

US

United States

The additional guarantee as regards testing set out in point II.4.8 of the certificate in Annex II is compulsory.

Notes

(a)

Health certificates shall be produced by the exporting country, based on the model appearing in Annex II. They shall contain, in the numbered order that appears in the model, the attestations that are required for any third country and, as the case may be, those supplementary guarantees that are required for the exporting third country as indicated in Annex I.

If so requested by the EU Member State of destination, the additional certification requirements shall be also incorporated in the original form of the health certificate.

| (b) | The original of each certificate shall consist of a single page, both sides, or, where more text is required; it shall be in such a form that all pages needed are part of an integrated whole and indivisible. |
| --- | --- |

(b)

The original of each certificate shall consist of a single page, both sides, or, where more text is required; it shall be in such a form that all pages needed are part of an integrated whole and indivisible.

| (c) | It shall be drawn up in at least one of the official languages of the EU Member State in which the inspection at the border post shall be carried out and of the EU Member State of destination. However, these Member States may allow another Community language instead of their own, accompanied, if necessary, by an official translation. |
| --- | --- |

(c)

It shall be drawn up in at least one of the official languages of the EU Member State in which the inspection at the border post shall be carried out and of the EU Member State of destination. However, these Member States may allow another Community language instead of their own, accompanied, if necessary, by an official translation.

| (d) | If for reasons of identification of the items of the consignment (schedule in point I.28 of the model of certificate), additional pages are attached to the certificate, these pages shall also be considered as forming part of the original of the certificate by the application of the signature and stamp of the certifying official veterinarian, on each of the pages. |
| --- | --- |

(d)

If for reasons of identification of the items of the consignment (schedule in point I.28 of the model of certificate), additional pages are attached to the certificate, these pages shall also be considered as forming part of the original of the certificate by the application of the signature and stamp of the certifying official veterinarian, on each of the pages.

| (e) | When the certificate, including additional schedules referred to in (d), comprises more than one page, each page shall be numbered — (page number) of (total number of pages) — on its bottom and shall bear the code number of the certificate that has been designated by the competent authority on its top. |
| --- | --- |

(e)

When the certificate, including additional schedules referred to in (d), comprises more than one page, each page shall be numbered — (page number) of (total number of pages) — on its bottom and shall bear the code number of the certificate that has been designated by the competent authority on its top.

| (f) | The original of the certificate must be completed and signed by an official veterinarian the last working day prior to loading of the consignment for exportation to the Community. In doing so, the competent authorities of the exporting country shall ensure that principles of certification equivalent to those laid down in Council Directive 96/93/EC are followed.
  The colour of the signature shall be different to that of the printing. The same rule applies to stamps other than those embossed or watermarked. |
| --- | --- |

(f)

The original of the certificate must be completed and signed by an official veterinarian the last working day prior to loading of the consignment for exportation to the Community. In doing so, the competent authorities of the exporting country shall ensure that principles of certification equivalent to those laid down in Council Directive 96/93/EC are followed.

The colour of the signature shall be different to that of the printing. The same rule applies to stamps other than those embossed or watermarked.

| (g) | The original of the certificate must accompany the consignment until it reaches the EU border inspection post. |
| --- | --- |

(g)

The original of the certificate must accompany the consignment until it reaches the EU border inspection post.

| (h) | The certificate shall be valid for 10 days from the date of issuing. In the case of transport by ship the time of validity is prolonged by the time of the trip in the ship. |
| --- | --- |

(h)

The certificate shall be valid for 10 days from the date of issuing. In the case of transport by ship the time of validity is prolonged by the time of the trip in the ship.

| (i) | Semen and ova/embryos shall not be transported in the same container together with other semen and ova/embryos that, either is/are not destined for the European Community, or is/are of a lower health status. |
| --- | --- |

(i)

Semen and ova/embryos shall not be transported in the same container together with other semen and ova/embryos that, either is/are not destined for the European Community, or is/are of a lower health status.

| (j) | During its transport to the European Community, the container shall remain closed and the seal shall not be broken. |
| --- | --- |

(j)

During its transport to the European Community, the container shall remain closed and the seal shall not be broken.

| (k) | The certificate reference number referred to in Boxes I.2 and II.a. must be issued by the competent authority. |
| --- | --- |

(k)

The certificate reference number referred to in Boxes I.2 and II.a. must be issued by the competent authority.

---

ANNEX II

Model health certificate for import of semen of the ovine and caprine species

Image 1

Part I: Details of dispatched consignment

COUNTRY

Veterinary certificate to EU

I.1. Consignor

Name

Address

Tel.

I.2. Certificate reference number

I.2.a

I.3. Central Competent Authority

I.4. Local Competent Authority

I.5. Consignee

Name

Address

Postal code

Tel.

I.6. Person responsible for the load in EU

Name

Address

Postal code

Tel.

I.7. Country of origin

ISO code

I.8. Region of origin

Code

I.9. Country of destination

ISO code

I.10. Region of destination

Code

I.11. Place of origin

Name

Approval number

Address

Name

Approval number

Address

Name

Approval number

Address

I.12. Place of destination

Name

Address

Postal code

I.13. Place of loading

I.14. Date of departure

I.15. Means of transport

Aeroplane

Ship

Railway wagon

Road vehicle

Other

Identification:

Documentary references:

I.16. Entry BIP in EU

I.17.

I.18. Description of commodity

I.19. Commodity code (HS code)

05 11 99 90

I.20. Quantity

I.21.

I.22. Number of packages

I.23. Identification of container/Seal number

I.24.

I.25. Commodities certified for:

Artificial reproduction

I.26. For transit through EU to third Country

Third country

ISO code

I.27. For import or admission into EU

I.28. Identification of the commodities

Species

(Scientific name)

Identification mark

Approval number of the centre

Quantity

Image 2

Part II: Certification

COUNTRY

Ovine and caprine semen

II. Health information

II.a. Certificate reference number

II.b.

I, the undersigned, official veterinarian, hereby certify that:

II.1. the exporting country ...

(name of exporting country) (2)

II.1.1. has been free from rinderpest, peste des petits ruminants, sheep and goat pox, contagious caprine pleuropneumonia and Rift Valley fever during the 12 months immediately prior to collection of the semen to be exported and up until its date of dispatch and no vaccination against these diseases took place during that period;

II.1.2. has been free from foot-and-mouth disease during the 12 months immediately prior to collection of the semen to be exported and up until its date of dispatch and no vaccination against this disease took place during that period;

II.2. the centre at which the semen to be exported was collected and stored:

II.2.1. meets the conditions laid down in Chapter I(I) of Annex D to Directive 92/65/EEC;

II.2.2. is operated and supervised in accordance with the conditions laid down in Chapter I(II) of Annex D to Directive 92/65/EEC;

II.3. the ovine/caprine (1) animals standing at the semen collection centre:

II.3.1. prior to their stay in the quarantine accommodation described in point II.3.2,

(1)(4) either [II.3.1.1. originate from the territory described under point I.8, which has been recognised as officially brucellosis (B. melitensis)-free, and]

(1) or [II.3.1.1. have belonged to a holding which has obtained and maintained its officially brucellosis (B. melitensis)-free status in accordance with Directive 91/68/EEC, and]

(1) or [II.3.1.1. originate from a holding, where in respect of brucellosis (B. melitensis) all susceptible animals have been free from clinical or any signs of this disease for the last 12 months, none of the ovine and caprine animals have been vaccinated against this disease, save those vaccinated with Rev. 1 vaccine more than two years ago, and all ovine and caprine animals over six months of age have been subjected to at least two tests (3), carried out with negative results on samples taken on ... (date) and on ... (date) at least six months apart, the latter being within 30 days of entry into the quarantine accommodation, and]

have not been kept previously in a holding of a lower status;

II.3.1.2. have been kept continuously for at least 60 days on a holding where no case of contagious epididymitis (Brucella ovis) has been diagnosed in the last 12 months,

(1) and [and ovine animals have undergone during the 60 days prior to their stay in the quarantine accommodation described in point II.3.2 a complement fixation test, or any other test with an equivalent documented sensitivity and specificity, to detect contagious epididymitis with result of less than 50 IU/ml;]

II.3.1.3. to the best of my knowledge and according to the written declaration made by the owner do not come from holdings, and have not been in contact with animals of a holding, in which any of the following diseases have been clinically detected within the stated periods prior to their stay in the quarantine accommodation described in point II.3.2:

(a) contagious agalactia of sheep or goats (Mycoplasma agalactiae, Mycoplasma capricolum, Mycoplasma mycoides var. mycoides ‘large colony’), within the last six months;

(b) paratuberculosis and caseous lymphadenitis, within the last 12 months;

(c) pulmonary adenomatosis, within the last three years; and

(1) either [(d) Maedi/Visna for sheep or caprine viral arthritis/encephalitis for goats, within the last three years;]

(1) or [(d) Maedi/Visna for sheep or caprine viral arthritis/encephalitis for goats, within the last 12 months, and all the infected animals were slaughtered and remaining animals subsequently reacted negatively to two tests carried out at least six months apart;]

II.3.1.4. are included in an official system for notification of diseases mentioned in point II.3.1.3;

Image 3

II.3.2. have satisfied the quarantine isolation period of at least 28 days and within that period, and at least 21 days after being admitted to the quarantine accommodation, have undergone with negative results the tests, carried out by the laboratory approved by the competent authority of the exporting country, for:

brucellosis (B. melitensis) in accordance with Annex C to Directive 91/68/EEC,

ovine epididymitis (Brucella ovis), in the case of sheep only, in accordance with Annex D to Directive 91/68/EEC, or any other test with an equivalent documented sensitivity and specificity,

Border disease virus;

II.3.3. have undergone at least once a year the routine tests with negative results for:

brucellosis (B. melitensis) in accordance with Annex C to Directive 91/68/EEC,

ovine epididymitis (Brucella ovis) in accordance with Annex D to Directive 91/68/EEC, or any other test with an equivalent documented sensitivity and specificity; in the case of sheep only;

II.4. the semen to be exported was obtained from donor rams/bucks (1) which:

II.4.1. show no clinical signs of disease on the day the semen was collected;

(1) either [II.4.2. have not been vaccinated against foot-and-mouth disease during the 12 months prior to collection of the semen;]

(1) or [II.4.2. have been vaccinated against foot-and-mouth disease between 7 and 12 months prior to collection, and 5 % (with a minimum of five straws) of each collection have been submitted to a virus isolation test for foot-and-mouth disease with negative results;]

II.4.3. have been kept at an approved semen collection centre for a continuous period of at least 30 days immediately prior to collection of the semen, in the case of collections of fresh semen;

II.4.4. have not served naturally after their entry to the quarantine accommodation described in point II.3.2 and up to and including the day of semen collection;

II.4.5. have been kept at the approved semen collection centres:

II.4.5.1. which have been free from foot-and-mouth disease for at least three months prior to collection of the semen and 30 days after collection or, in the case of fresh semen, until the date of dispatch, and which are situated in the centre of an area of 10 kilometres radius in which there has been no case of foot-and-mouth disease for at least 30 days prior to collection of the semen;

II.4.5.2. which have been free, during the period commencing 30 days prior to collection and ending 30 days after collection of the semen or, in the case of fresh semen, until the date of dispatch, from brucellosis (B. melitensis), contagious epididymitis (B. ovis), anthrax and rabies;

(1) either [II.4.6. have remained in the exporting country for at least the last six months prior to collection of the semen to be exported;]

(1) or [II.4.6. have remained in the exporting country for at least 30 days prior to collection of the semen since entry and they were imported from ... (2) during the period of less than six months prior to collection of the semen and satisfied the animal health conditions applying to donors of the semen which is intended for export to the Community;]

(1) either [II.4.7. were kept in a bluetongue virus-free country or zone for at least 60 days prior to, and during, collection of the semen;]

(1) or [II.4.7. were kept during a bluetongue virus seasonally-free period in a seasonally-free zone for at least 60 days prior to, and during collection of the semen;]

(1) or [II.4.7. were kept protected from the bluetongue virus competent vector Culicoides for at least 60 days prior to, and during collection of the semen;]

(1) or [II.4.7. underwent a serological test to detect antibodies to the bluetongue virus group, carried out in accordance with the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals with negative results on samples taken between 21 and 60 days after collection of the semen;]

(1) or [II.4.7. underwent an agent identification test for bluetongue virus, carried out in accordance with the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals with negative results on blood samples taken on the day of semen collection and at least every 7 days (virus isolation test) or at least every 28 days (PCR test) during the semen collection and have been protected from the bluetongue virus competent vector Culicoides during collection of the semen;]

Image 4

(1) either [II.4.8. were resident in the exporting country (5) which according to official findings is free from epizootic haemorrhagic disease (EHD);]

(1) or [II.4.8. were resident in the exporting country (5) in which according to official findings the following serotypes of epizootic haemorrhagic disease (EHD) exist: ... and were tested on two occasions in an agar-gel immuno-diffusion test or competitive enzyme-linked immunosorbent assay (6) and in a virus neutralisation test for all above listed serotypes of EHD, carried out with negative results in an approved laboratory on samples of blood taken not more than 12 months apart prior to and not less than 21 days following collection of the semen;]

(1) either [II.4.9. were resident in the exporting country (5) which according to official findings is free from Akabane disease and Aino disease;]

(1) or [II.4.9. were resident in the exporting country (5) and were tested on two occasions in an agar-gel immuno-diffusion test and in a serum neutralisation test for Akabane virus and Aino virus carried out with negative results in an approved laboratory on samples of blood taken not more than 12 months apart prior to and not less than 21 days following collection of the semen;]

II.5. the semen to be exported

II.5.1. was collected after the date on which the centre was approved by the competent authority of the exporting country;

II.5.2. was processed, stored and transported under conditions which satisfy the terms laid down in Chapter III of Annex D to Directive 92/65/EEC;

(1) either [II.5.3. meets the requirements of Chapter A(I) of Annex VIII to Regulation (EC) No 999/2001.]

(1) or [II.5.3. meets the requirements of Chapter A(I) of Annex VIII to Regulation (EC) No 999/2001 and is destined for a Member States which benefits, for all or part of its territory, from the provisions laid down in point (b) or (c) of Chapter A(I) of Annex VIII to Regulation (EC) No 999/2001 and the donor animals comply regarding scrapie with the guarantees provided for by the programmes referred to in that point and with the guarantees (7) requested by the EU Member States of destination.]

Notes

Part I

Box reference I.8: Provide the code of territory as appearing in Annex I to Decision 2008/635/EC.

Box reference I.11: place of origin shall correspond to the semen collection centre of the semen origin listed in the Annex I to Decision 2008/635/EC.

Box reference I.22: number of packages shall correspond to the number of containers.

Box reference I.23: identification of container and seal number shall be indicated.

Box reference I.28: Species: select amongst ‘Ovis aries’ and ‘Capra hircus’ as appropriate.

Identification mark shall correspond to the identification of the donor animals and the date of collection.

Approval number of centre: shall correspond to the semen collection centre of the semen origin listed in the Annex I to Decision 2008/635/EC.

Part II

(1) Delete as necessary.

(2) Countries listed in Annex I to Decision 2008/635/EC.

(3) Tests shall be carried out in accordance with Annex C to Directive 91/68/EEC.

(4) Only for the territory appearing with the entry ‘V’ in column 6 of Part 1 of Annex I to Council Decision 79/542/EEC [OJ L 146, 14.6.1979, p. 15] as last amended.

(5) See remarks for exporting country concerned in Annex I to Decision 2008/635/EC.

(6) Standards for EHD virus diagnostic tests are described in the Bluetongue Chapter of the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals.

(7) Additional guarantees as laid down in Article 2 of Regulation (EC) No 546/2006 [OJ L 94, 1.4.2006, p. 28].

The signature and the stamp must be in a different colour to that of the printing.

Official veterinarian

Name (in capital letters):

Qualification and title:

Date:

Signature:

Stamp

---

ANNEX III

List of third countries and approved embryo collection teams from which Member States are to authorise imports of ova and embryos of the ovine and caprine species

| ISO code | Name of the third country | Approval number of the team | Name of the team | Address of the team | Date of approval of the team | Remarks |
| --- | --- | --- | --- | --- | --- | --- |
| Description of the territory
  (if appropriate) | Additional guarantees |
| AU | Australia | | | | | | The additional guarantees as regards testing set out in points II.5.1 and II.5.2 of the certificate in Annex IV are compulsory. |
| CA | Canada | | | | | Territory as described in Part 1 of Annex I to Decision 79/542/EEC | The additional guarantee as regards testing set out in point II.5.2 of the certificate in Annex IV is compulsory. |
| CH | Switzerland | | | | | | |
| CL | Chile | | | | | | |
| GL | Greenland | | | | | | |
| HR | Croatia | | | | | | |
| IS | Iceland | | | | | | |
| NZ | New Zealand | | | | | | |
| PM | Saint Pierre and Miquelon | | | | | | |
| US | United States | | | | | | The additional guarantee as regards testing set out in point II.5.2 of the certificate in Annex IV is compulsory. |
| Notes






  (a) | Health certificates shall be produced by the exporting country, based on the model appearing in Annex IV. They shall contain, in the numbered order that appears in the model, the attestations that are required for any third country and, as the case may be, those supplementary guarantees that are required for the exporting third country as indicated in Annex III.
  If so requested by the EU Member State of destination, the additional certification requirements shall be also incorporated in the original form of the health certificate. |

ISO code

Name of the third country

Approval number of the team

Name of the team

Address of the team

Date of approval of the team

Remarks

Description of the territory

(if appropriate)

Additional guarantees

AU

Australia

The additional guarantees as regards testing set out in points II.5.1 and II.5.2 of the certificate in Annex IV are compulsory.

CA

Canada

Territory as described in Part 1 of Annex I to Decision 79/542/EEC

The additional guarantee as regards testing set out in point II.5.2 of the certificate in Annex IV is compulsory.

CH

Switzerland

CL

Chile

GL

Greenland

HR

Croatia

IS

Iceland

NZ

New Zealand

PM

Saint Pierre and Miquelon

US

United States

The additional guarantee as regards testing set out in point II.5.2 of the certificate in Annex IV is compulsory.

Notes

(a)

Health certificates shall be produced by the exporting country, based on the model appearing in Annex IV. They shall contain, in the numbered order that appears in the model, the attestations that are required for any third country and, as the case may be, those supplementary guarantees that are required for the exporting third country as indicated in Annex III.

If so requested by the EU Member State of destination, the additional certification requirements shall be also incorporated in the original form of the health certificate.

| (b) | The original of each certificate shall consist of a single page, both sides, or, where more text is required; it shall be in such a form that all pages needed are part of an integrated whole and indivisible. |
| --- | --- |

(b)

The original of each certificate shall consist of a single page, both sides, or, where more text is required; it shall be in such a form that all pages needed are part of an integrated whole and indivisible.

| (c) | It shall be drawn up in at least one of the official languages of the EU Member State in which the inspection at the border post shall be carried out and of the EU Member State of destination. However, these Member States may allow another Community language instead of their own, accompanied, if necessary, by an official translation. |
| --- | --- |

(c)

It shall be drawn up in at least one of the official languages of the EU Member State in which the inspection at the border post shall be carried out and of the EU Member State of destination. However, these Member States may allow another Community language instead of their own, accompanied, if necessary, by an official translation.

| (d) | If for reasons of identification of the items of the consignment (schedule in point I.28 of the model of certificate), additional pages are attached to the certificate, these pages shall also be considered as forming part of the original of the certificate by the application of the signature and stamp of the certifying official veterinarian, on each of the pages. |
| --- | --- |

(d)

If for reasons of identification of the items of the consignment (schedule in point I.28 of the model of certificate), additional pages are attached to the certificate, these pages shall also be considered as forming part of the original of the certificate by the application of the signature and stamp of the certifying official veterinarian, on each of the pages.

| (e) | When the certificate, including additional schedules referred to in (d), comprises more than one page, each page shall be numbered — (page number) of (total number of pages) — on its bottom and shall bear the code number of the certificate that has been designated by the competent authority on its top. |
| --- | --- |

(e)

When the certificate, including additional schedules referred to in (d), comprises more than one page, each page shall be numbered — (page number) of (total number of pages) — on its bottom and shall bear the code number of the certificate that has been designated by the competent authority on its top.

| (f) | The original of the certificate must be completed and signed by an official veterinarian the last working day prior to loading of the consignment for exportation to the Community. In doing so, the competent authorities of the exporting country shall ensure that principles of certification equivalent to those laid down in Council Directive 96/93/EC are followed.
  The colour of the signature shall be different to that of the printing. The same rule applies to stamps other than those embossed or watermarked. |
| --- | --- |

(f)

The original of the certificate must be completed and signed by an official veterinarian the last working day prior to loading of the consignment for exportation to the Community. In doing so, the competent authorities of the exporting country shall ensure that principles of certification equivalent to those laid down in Council Directive 96/93/EC are followed.

The colour of the signature shall be different to that of the printing. The same rule applies to stamps other than those embossed or watermarked.

| (g) | The original of the certificate must accompany the consignment until it reaches the EU border inspection post. |
| --- | --- |

(g)

The original of the certificate must accompany the consignment until it reaches the EU border inspection post.

| (h) | The certificate shall be valid for 10 days from the date of issuing. In the case of transport by ship the time of validity is prolonged by the time of the trip in the ship. |
| --- | --- |

(h)

The certificate shall be valid for 10 days from the date of issuing. In the case of transport by ship the time of validity is prolonged by the time of the trip in the ship.

| (i) | Ova/embryos and semen shall not be transported together in the same container with other ova/embryos and semen that, either are/is not destined for the European Community, or are/is of a lower health status. |
| --- | --- |

(i)

Ova/embryos and semen shall not be transported together in the same container with other ova/embryos and semen that, either are/is not destined for the European Community, or are/is of a lower health status.

| (j) | During its transport to the European Community, the container shall remain closed and the seal shall not be broken. |
| --- | --- |

(j)

During its transport to the European Community, the container shall remain closed and the seal shall not be broken.

| (k) | The certificate reference number referred to in Boxes I.2 and II.a must be issued by the competent authority. |
| --- | --- |

(k)

The certificate reference number referred to in Boxes I.2 and II.a must be issued by the competent authority.

---

ANNEX IV

Model health certificate for import of ova and embryos of the ovine and caprine species

Image 5

Part I: Details of dispatched consignment

COUNTRY

Veterinary certificate to EU

I.1. Consignor

Name

Address

Tel.

I.2. Certificate reference number

I.2.a

I.3. Central Competent Authority

I.4. Local Competent Authority

I.5. Consignee

Name

Address

Postal code

Tel.

I.6. Person responsible for the load in EU

Name

Address

Postal code

Tel.

I.7. Country of origin

ISO code

I.8. Region of origin

Code

I.9. Country of destination

ISO code

I.10. Region of destination

Code

I.11. Place of origin

Name

Approval number

Address

Name

Approval number

Address

Name

Approval number

Address

I.12. Place of destination

Name

Address

Postal code

I.13. Place of loading

I.14. Date of departure

I.15. Means of transport

Aeroplane

Ship

Railway wagon

Road vehicle

Other

Identification:

Documentary references:

I.16. Entry BIP in EU

I.17.

I.18. Description of commodity

I.19. Commodity code (HS code)

05 11 99 90

I.20. Quantity

I.21.

I.22. Number of packages

I.23. Identification of container/Seal number

I.24.

I.25. Commodities certified for:

Artificial reproduction

I.26. For transit through EU to third country

Third country

ISO code

I.27. For import or admission into EU

I.28. Identification of the commodities

Species

(Scientific name)

Category

Identification mark

Approval number of the team

Quantity

Image 6

Part II: Certification

COUNTRY

Ovine and caprine ova/embryos

II. Health information

II.a. Certificate reference number

II.b.

I, the undersigned, official veterinarian, hereby certify that:

II.1. the exporting country ...

(name of exporting country) (2)

II.1.1. has been free from rinderpest, peste des petits ruminants, sheep and goat pox, contagious caprine pleuropneumonia, and Rift Valley fever during the 12 months immediately prior to collection of the ova/embryos (1) to be exported and up until its date of dispatch and no vaccination against these diseases took place during that period;

(1) either [II.1.2. has been free from foot-and-mouth disease during the 12 months immediately prior to collection of the ova/embryos (1) and did not carry out vaccination against foot-and-mouth disease during that period;]

(1) or [II.1.2. has not been free from foot and mouth disease during the 12 months immediately prior to collection of the ova/embryos (1) and/or carried out vaccination against foot-and-mouth disease during that period and the donor females come from holdings on which no animal was vaccinated against foot-and-mouth disease during 30 days prior to collection and no animal of susceptible species showed clinical signs of foot-and-mouth disease during the 30 days prior to, and at least 30 days after, the ova/embryos (1) were collected and the ova/embryos (1) were not subjected to penetration of zona pellucida;]

II.2. the ova/embryos (1) to be exported:

II.2.1. were collected and processed on premises within a 10-km radius of which there was no incidence of foot-and-mouth disease, vesicular stomatitis, Rift Valley fever in the 30 days immediately prior to their collection;

II.2.2. were stored at all times on approved premises within a 10-km radius of which there was no incidence of foot-and-mouth disease, vesicular stomatitis or Rift Valley fever from the time of their collection until 30 days thereafter;

II.3. the embryo collection team described under point I.11:

II.3.1. has been approved by the competent authority for export of ova/embryos (1) of the ovine and caprine species to the European Community;

II.3.2. carried out collection, processing, storing and transport of the ova/embryos (1) to be exported in accordance with Chapter III of Annex D to Directive 92/65/EEC;

II.3.3. is subject to inspection by an official veterinarian at least twice a year;

II.4. the donor females:

(1) either [II.4.1. were kept in a bluetongue virus-free country or zone for at least 60 days prior to, and during collection of the ova/embryos (1);]

(1) or [II.4.1. were kept during a bluetongue virus seasonally free period in a seasonally free zone;]

(1) or [II.4.1. were kept protected from the bluetongue virus competent vector Culicoides for at least 60 days prior to, and during the collection of the ova/embryos (1);]

(1) or [II.4.1. underwent a serological test to detect antibodies to the bluetongue virus group, carried out in accordance with the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals between 21 and 60 days after collection of the ova/embryos (1) and giving negative results;]

(1) or [II.4.1. underwent an agent identification test for bluetongue virus, carried out in accordance with the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals on a blood sample taken on the day of the ova/embryos (1) collection or the day of slaughtering and giving negative results;]

II.4.2. to the best of my knowledge and according to the written declaration made by the owner, do not come from holdings, and have not been in contact with animals of a holding, in which any of the following diseases have been clinically detected within the stated periods prior to collection of the ova/embryos (1) to be exported:

(a) contagious agalactia of sheep or goats (Mycoplasma agalactiae, Mycoplasma capricolum, Mycoplasma mycoides var. mycoides ‘large colony’), within the last six months;

(b) paratuberculosis and caseous lymphadenitis, within the last 12 months;

Image 7

(c) pulmonary adenomatosis, within the last three years; and

(1) either [(d) Maedi/Visna for sheep or caprine viral arthritis/encephalitis for goats, within the last three years;]

(1) or [(d) Maedi/Visna for sheep or caprine viral arthritis/encephalitis for goats, within the last 12 months, and all the infected animals were slaughtered and remaining animals subsequently reacted negatively to two tests carried out at least six months apart;]

II.4.3. are included in an official system for notification of diseases mentioned in point II.4.2;

II.4.4. showed no clinical signs of disease on the day of the ova/embryos (1) collection;

(1) (4) either [II.4.5. originate from the territory described under point I.8, which has been recognised as officially brucellosis (B. melitensis)-free, and]

(1) or [II.4.5. have belonged to a holding which has obtained and maintained its officially brucellosis (B. melitensis)-free status in accordance with Directive 91/68/EEC, and]

(1) or [II.4.5. originate from a holding, where in respect of brucellosis (B. melitensis) all susceptible animals have been free from clinical or any signs of this disease for the last 12 months, none of the ovine and caprine animals have been vaccinated against this disease, save those vaccinated with Rev. 1 vaccine more than two years ago, and all ovine and caprine animals over six months of age have been subjected to at least two tests (3), carried out with negative results on samples taken on ... (date) and on ... (date) at least six months apart, the latter being within 30 days prior to collection of the ova/embryos (1), and]

have not been kept previously in a holding of a lower status;

(1) either [II.4.6. have remained in the exporting country for at least the last six months prior to collection of the ova/embryos (1) to be exported;]

(1) or [II.4.6. have remained in the exporting country for at least 30 days prior to collection of the ova/embryos (1) since entry into which they were imported from ... (2) during the period of less than six months prior to collection of the ova/embryos (1) and satisfied the animal health conditions applying to donors of the ova/embryos (1) which are intended for export to the Community;]

II.5. The ova/embryos (1) to be exported:

(1) either [II.5.1. were collected in the exporting country (5), which according to official findings is free from Akabane disease and Aino disease;]

(1) or [II.5.1. were collected in the exporting country (5) and were not subjected to penetration of the zona pellucida, and the donor females underwent a serum neutralisation test for Akabane virus and Aino virus carried out on a blood sample taken not less than 21 days following their collection and giving negative results;]

(1) either [II.5.2. were collected in the exporting country (5), which according to official findings is free from epizootic haemorrhagic disease (EHD);]

(1) or [II.5.2. were collected in the exporting country (5) in which according to official findings the following serotypes of epizootic haemorrhagic disease (EHD) exist: ... and were tested negative on two occasions not more than 12 months apart in an agar-gel immuno-diffusion test or competitive enzyme-linked immunosorbent assay (6) and a virus neutralisation test for all above-listed serotypes of EHD, carried out in approved laboratory on samples of blood taken prior to and not less than 21 days following collection of the ova/embryos (1);]

(1) either [II.5.3. meet the requirements of Chapter A(I) of Annex VIII to Regulation (EC) No 999/2001;]

(1) or [II.5.3. meet the requirements of Chapter A(I) of Annex VIII to Regulation (EC) No 999/2001and are destined for a Member States which benefits, for all or part of its territory, from the provisions laid down in points (b) or (c) of Chapter A(I) of Annex VIII to Regulation (EC) No 999/2001 and the donor animals comply regarding scrapie with the guarantees provided for by the programmes referred to in that point and with the guarantees (7) requested by the EU Member States of destination;]

II.6. The ova/embryos (1) to be exported

II.6.1. were collected after the date on which the embryo collection team was approved by the competent authority of the exporting country;

II.6.2. were processed and stored under approved conditions for at least 30 days immediately after their collection and transported under conditions which satisfy the terms laid down in Chapter III of Annex D to Directive 92/65/EEC;

II.7. The embryos were conceived by artificial insemination using semen coming from semen collection centres approved in accordance with Articles 11(2) and 17(3) respectively of Directive 92/65/EEC and located in a Member State of the European Community or in a third country listed in Annex I to Decision 2008/635/EC (8).

Image 8

Notes

Part I

Box reference I.8: Provide the code of territory as appearing in Annex III to Decision 2008/635/EC.

Box reference I.11: place of origin shall correspond to the embryo collection team by which the ova/embryos were collected, processed and stored and listed in Annex III to Decision 2008/635/EC.

Box reference I.22: number of packages shall correspond to the number of containers.

Box reference I.23: identification of container and seal number shall be indicated.

Box reference I.28: Species: select amongst ‘Ovis aries’ and ‘Capra hircus’ as appropriate.

Category: specify if (a) penetration or (b) non penetration of zona pellucida.

Identification mark shall correspond to the identification of the donor animals and the date of collection.

Approval number of the team: shall correspond to the embryo collection team of the ova/embryos origin listed in the Annex III to Decision 2008/635/EC.

Part II

(1) Delete as appropriate.

(2) Countries listed in Annex I to Decision 2008/635/EC.

(3) Tests shall be carried out in accordance with Annex C to Directive 91/68/EEC.

(4) Only for the territory appearing with the entry ‘V’ in column 6 of Part 1 of Annex I to Decision 79/542/EEC as last amended.

(5) See remarks for exporting country concerned in Annex III to Decision 2008/635/EC.

(6) Standards for EHD virus diagnostic tests are described in the Bluetongue Chapter of the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals.

(7) Additional guarantees as laid down in Article 2 of Regulation (EC) No 546/2006.

(8) Semen collection centres approved in accordance with EC legislation are listed on the Commission website: http://circa.europa.eu/irc/sanco/vets/info/data/semen/semen.html

The signature and the stamp must be in a different colour to that of the printing.

Official veterinarian

Name (in capital letters):

Qualification and title:

Date:

Signature:

Stamp

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| 2.8.2008 | EN | Official Journal of the European Union | L 206/32 |
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2.8.2008

EN

Official Journal of the European Union

L 206/32

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COMMISSION DECISION

of 22 July 2008

establishing the list of third countries from which Member States authorise imports of ova and embryos of the porcine species

(notified under document number C(2008) 3671)

(Text with EEA relevance)

(2008/636/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A(I) to Directive 90/425/EEC (1), and in particular the introductory phrase and Article 17(3)(a) and Article 28 thereof,

Whereas:

| (1) | Directive 92/65/EEC lays down the animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to the animal health requirements laid down in the specific Community acts referred to therein. It also provides for the establishment of a list of those third countries or parts of third countries, able to provide guarantees equivalent to those referred to therein, and from which Member States may import semen, ova and embryos of the porcine species. |
| --- | --- |

(1)

Directive 92/65/EEC lays down the animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to the animal health requirements laid down in the specific Community acts referred to therein. It also provides for the establishment of a list of those third countries or parts of third countries, able to provide guarantees equivalent to those referred to therein, and from which Member States may import semen, ova and embryos of the porcine species.

| (2) | Part III of the Annex to Commission Decision 94/63/EC of 31 January 1994 drawing up a list of third countries from which Member States authorise imports of semen, ova and embryos of the ovine and caprine species and ova and embryos of the porcine species (2) establishes a list of third countries from which Member States are to authorise imports of ova and embryos of the porcine species, and third countries from which imports of porcine semen are authorised, in accordance with Commission Decision 2002/613/EC of 19 July 2002 laying down the importation conditions of semen of domestic animals of the porcine species (3). |
| --- | --- |

(2)

Part III of the Annex to Commission Decision 94/63/EC of 31 January 1994 drawing up a list of third countries from which Member States authorise imports of semen, ova and embryos of the ovine and caprine species and ova and embryos of the porcine species (2) establishes a list of third countries from which Member States are to authorise imports of ova and embryos of the porcine species, and third countries from which imports of porcine semen are authorised, in accordance with Commission Decision 2002/613/EC of 19 July 2002 laying down the importation conditions of semen of domestic animals of the porcine species (3).

| (3) | Decision 94/63/EC has been amended several times to take account of new scientific and technical developments. At present, it applies to semen, ova and embryos of the ovine and caprine species and ova and embryos of the porcine species. |
| --- | --- |

(3)

Decision 94/63/EC has been amended several times to take account of new scientific and technical developments. At present, it applies to semen, ova and embryos of the ovine and caprine species and ova and embryos of the porcine species.

| (4) | The Commission intends to lay down in a separate act the animal health conditions applicable to imports into the Community of semen, ova and embryos of the ovine and caprine species, including the list of third countries from which Member States are to authorise imports of those commodities. |
| --- | --- |

(4)

The Commission intends to lay down in a separate act the animal health conditions applicable to imports into the Community of semen, ova and embryos of the ovine and caprine species, including the list of third countries from which Member States are to authorise imports of those commodities.

| (5) | Decision 2002/613/EC establishes a list of third countries from which Member States are to authorise imports of porcine semen. That list was set up based on the animal health status of third countries from which Member States are to authorise the imports of live pigs. As there is no scientific evidence suggesting that with regard to major exotic contagious diseases the risks arising from the health status of the donor porcine female and male could be mitigated by treatment of the embryo, it is appropriate and in the interests of consistency and coherency of Community legislation, to refer to that list in the present Decision when laying down a list of third countries from which Member States are to authorise imports of ova and embryos of that species. |
| --- | --- |

(5)

Decision 2002/613/EC establishes a list of third countries from which Member States are to authorise imports of porcine semen. That list was set up based on the animal health status of third countries from which Member States are to authorise the imports of live pigs. As there is no scientific evidence suggesting that with regard to major exotic contagious diseases the risks arising from the health status of the donor porcine female and male could be mitigated by treatment of the embryo, it is appropriate and in the interests of consistency and coherency of Community legislation, to refer to that list in the present Decision when laying down a list of third countries from which Member States are to authorise imports of ova and embryos of that species.

| (6) | For the sake of clarity of Community legislation, it is appropriate to repeal Decision 94/63/EC. |
| --- | --- |

(6)

For the sake of clarity of Community legislation, it is appropriate to repeal Decision 94/63/EC.

| (7) | The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
| --- | --- |

(7)

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 ADOPTED THIS DECISION:

Article 1

Member States shall authorise imports of ova and embryos of the porcine species from the third countries from which imports of porcine semen are authorised in accordance with Article 1 of Decision 2002/613/EC.

Article 2

Decision 94/63/EC is repealed.

Article 3

This Decision shall apply from 1 September 2008.

Article 4

This Decision is addressed to the Member States.

Done at Brussels, 22 July 2008.

For the Commission

Androulla VASSILIOU

Member of the Commission

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(1)  
  OJ L 268, 14.9.1992, p. 54. Directive as last amended by Commission Decision 2007/265/EC (OJ L 114, 1.5.2007, p. 17).

1

(2)  
  OJ L 28, 2.2.1994, p. 47. Decision as last amended by Decision 2004/211/EC (OJ L 73, 11.3.2004, p. 1).

2

(3)  
  OJ L 196, 25.7.2002, p. 45. Decision as last amended by Decision 2007/14/EC (OJ L 7, 12.1.2007, p. 28).

3

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Corrigenda

| 2.8.2008 | EN | Official Journal of the European Union | L 206/34 |
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Official Journal of the European Union

L 206/34

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Corrigendum to Council Regulation (EC) No 717/2008 of 17 July 2008 establishing a Community procedure for administering quantitative quotas

(
  Official Journal of the European Union L 198 of 26 July 2008
  )

On page 1 the cover in the Contents, on page 1 in the title and on page 6 in the closing formula:

for:

‘
  17 July 2008
  ’,

read:

‘
  15 July 2008
  ’.

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| 2.8.2008 | EN | Official Journal of the European Union | L 206/34 |
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2.8.2008

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Official Journal of the European Union

L 206/34

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Corrigendum to Council Directive 94/28/EC of 23 June 1994 laying down the principles relating to the zootechnical and genealogical conditions applicable to imports from third countries of animals, their semen, ova and embryos, and amending Directive 77/504/EEC on pure-bred breeding animals of the bovine species

(
  Official Journal of the European Union L 178 of 12 July 1994
  )

On page 67, in Article 3(2)(c):

for:

| ‘c) | be surprised by an official inspection service of the third country,’, |
| --- | --- |

‘c)

be surprised by an official inspection service of the third country,’,

read:

| ‘(c) | be supervised by an official inspection service of the third country,’; |
| --- | --- |

‘(c)

be supervised by an official inspection service of the third country,’;

on page 67, in Articles 2(1), 3(1), 3(2) in the introductory sentence, 3(2)(b), 3(2)(d), 4 in the first indent, Article 5 in the first indent, and

on page 68 in Articles 6 in the first indent and 7 in the first indent;

for:

‘authority’ and ‘authorities’,

read:

‘body’ and ‘bodies’.

---