# Official Journal L 333/2008

| | ISSN 1725-2555 |
| --- | --- |
| Official Journal
  of the European Union | L 333 |
| | |
| English edition | Legislation | Volume 5111 December 2008 |

ISSN 1725-2555

Official Journal

of the European Union

L 333

English edition

Legislation

Volume 5111 December 2008

---

| Contents | | I   Acts adopted under the EC Treaty/Euratom Treaty whose publication is obligatory | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | | Commission Regulation (EC) No 1228/2008 of 10 December 2008 establishing the standard import values for determining the entry price of certain fruit and vegetables | 1 |
| | * | Commission Regulation (EC) No 1229/2008 of 10 December 2008 entering certain names in the Register of protected designations of origin and protected geographical indications (San Simón da Costa (PDO), Ail blanc de Lomagne (PGI), Steirischer Kren (PGI)) | 3 |

Contents

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

page

REGULATIONS

Commission Regulation (EC) No 1228/2008 of 10 December 2008 establishing the standard import values for determining the entry price of certain fruit and vegetables

1

*

Commission Regulation (EC) No 1229/2008 of 10 December 2008 entering certain names in the Register of protected designations of origin and protected geographical indications (San Simón da Costa (PDO), Ail blanc de Lomagne (PGI), Steirischer Kren (PGI))

3

| | | II   Acts adopted under the EC Treaty/Euratom Treaty whose publication is not obligatory |
| --- | --- | --- |
| | | DECISIONS |
| | | Commission |
| | | 2008/932/EC |
| | * | Commission Decision of 2 December 2008 on the application of Article 8 of Directive 98/79/EC of the European Parliament and of the Council
  (notified under document number C(2008) 7378) | 5 |
| | | 2008/933/EC |
| | * | Commission Decision of 4 December 2008 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean MON89788 (MON-89788-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council
  (notified under document number C(2008) 7517)

   (
  1
  ) | 7 |
| | | 2008/934/EC |
| | * | Commission Decision of 5 December 2008 concerning the non-inclusion of certain active substances in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing these substances
  (notified under document number C(2008) 7637)

   (
  1
  ) | 11 |
| | | 2008/935/EC |
| | * | Commission Decision of 5 December 2008 concerning a Community financial contribution to the Joint Research Centre of the Commission in Belgium and Italy for certain activities carried out pursuant to Regulation (EC) No 882/2004 of the European Parliament and of the Council for the year 2009
  (notified under document number C(2008) 7702) | 15 |

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

DECISIONS

Commission

2008/932/EC

*

Commission Decision of 2 December 2008 on the application of Article 8 of Directive 98/79/EC of the European Parliament and of the Council
  (notified under document number C(2008) 7378)

(notified under document number C(2008) 7378)

5

2008/933/EC

*

Commission Decision of 4 December 2008 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean MON89788 (MON-89788-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council
  (notified under document number C(2008) 7517)

   (
  1
  )

(notified under document number C(2008) 7517)

1

7

2008/934/EC

*

Commission Decision of 5 December 2008 concerning the non-inclusion of certain active substances in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing these substances
  (notified under document number C(2008) 7637)

   (
  1
  )

(notified under document number C(2008) 7637)

1

11

2008/935/EC

*

Commission Decision of 5 December 2008 concerning a Community financial contribution to the Joint Research Centre of the Commission in Belgium and Italy for certain activities carried out pursuant to Regulation (EC) No 882/2004 of the European Parliament and of the Council for the year 2009
  (notified under document number C(2008) 7702)

(notified under document number C(2008) 7702)

15

| | | |
| --- | --- | --- |
| | * | Note to the reader (see page 3 of the cover) | s3 |

*

Note to the reader (see page 3 of the cover)

Note to the reader

s3

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

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(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.

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

REGULATIONS

| 11.12.2008 | EN | Official Journal of the European Union | L 333/1 |
| --- | --- | --- | --- |

11.12.2008

EN

Official Journal of the European Union

L 333/1

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COMMISSION REGULATION (EC) No 1228/2008

of 10 December 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 11 December 2008.

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

Done at Brussels, 10 December 2008.

For the Commission

Jean-Luc DEMARTY

Director-General for Agriculture and Rural Development

---

(1)  
  OJ L 299, 16.11.2007, p. 1.

1

(2)  
  OJ L 350, 31.12.2007, p. 1.

2

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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 | MA | 81,5 |
| TR | 75,2 |
| ZZ | 78,4 |
| 0707 00 05 | JO | 167,2 |
| MA | 56,7 |
| TR | 84,0 |
| ZZ | 102,6 |
| 0709 90 70 | MA | 128,5 |
| TR | 133,8 |
| ZZ | 131,2 |
| 0805 10 20 | AR | 18,1 |
| BR | 44,6 |
| CL | 36,4 |
| EG | 30,5 |
| MA | 76,3 |
| TR | 62,7 |
| ZA | 43,2 |
| ZW | 43,9 |
| ZZ | 44,5 |
| 0805 20 10 | MA | 72,3 |
| TR | 73,0 |
| ZZ | 72,7 |
| 0805 20 30 , 0805 20 50 , 0805 20 70 , 0805 20 90 | CN | 52,4 |
| HR | 54,6 |
| IL | 71,9 |
| TR | 57,3 |
| ZZ | 59,1 |
| 0805 50 10 | MA | 59,0 |
| TR | 64,6 |
| ZZ | 61,8 |
| 0808 10 80 | CA | 89,2 |
| CL | 43,7 |
| CN | 71,7 |
| MK | 34,8 |
| US | 106,7 |
| ZA | 123,2 |
| ZZ | 78,2 |
| 0808 20 50 | CN | 56,2 |
| TR | 97,0 |
| US | 133,9 |
| ZZ | 95,7 |

(EUR/100 kg)

CN code

Third country code (1)

Standard import value

0702 00 00

MA

81,5

TR

75,2

ZZ

78,4

0707 00 05

JO

167,2

MA

56,7

TR

84,0

ZZ

102,6

0709 90 70

MA

128,5

TR

133,8

ZZ

131,2

0805 10 20

AR

18,1

BR

44,6

CL

36,4

EG

30,5

MA

76,3

TR

62,7

ZA

43,2

ZW

43,9

ZZ

44,5

0805 20 10

MA

72,3

TR

73,0

ZZ

72,7

0805 20 30 , 0805 20 50 , 0805 20 70 , 0805 20 90

CN

52,4

HR

54,6

IL

71,9

TR

57,3

ZZ

59,1

0805 50 10

MA

59,0

TR

64,6

ZZ

61,8

0808 10 80

CA

89,2

CL

43,7

CN

71,7

MK

34,8

US

106,7

ZA

123,2

ZZ

78,2

0808 20 50

CN

56,2

TR

97,0

US

133,9

ZZ

95,7

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(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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| 11.12.2008 | EN | Official Journal of the European Union | L 333/3 |
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11.12.2008

EN

Official Journal of the European Union

L 333/3

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COMMISSION REGULATION (EC) No 1229/2008

of 10 December 2008

entering certain names in the Register of protected designations of origin and protected geographical indications (San Simón da Costa (PDO), Ail blanc de Lomagne (PGI), Steirischer Kren (PGI))

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EC) No 510/2006 of 20 March 2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs (1), and in particular the first subparagraph of Article 7(4) thereof,

Whereas:

| (1) | Pursuant to the first subparagraph of Article 6(2) of Regulation (EC) No 510/2006 and in accordance with Article 17(2) thereof, Spain’s application to register the name ‘San Simón da Costa’, France’s application to register the name ‘Ail blanc de Lomagne’ and Austria’s application to register the name ‘Steirischer Kren’ were published in the Official Journal of the European Union (2). |
| --- | --- |

(1)

Pursuant to the first subparagraph of Article 6(2) of Regulation (EC) No 510/2006 and in accordance with Article 17(2) thereof, Spain’s application to register the name ‘San Simón da Costa’, France’s application to register the name ‘Ail blanc de Lomagne’ and Austria’s application to register the name ‘Steirischer Kren’ were published in the Official Journal of the European Union (2).

| (2) | As no objection under Article 7 of Regulation (EC) No 510/2006 has been received by the Commission, these names should be entered in the Register, |
| --- | --- |

(2)

As no objection under Article 7 of Regulation (EC) No 510/2006 has been received by the Commission, these names should be entered in the Register,

HAS ADOPTED THIS REGULATION:

Article 1

The names in the Annex to this Regulation are hereby entered in the Register of protected designations of origin and protected geographical indications.

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, 10 December 2008.

For the Commission

Mariann FISCHER BOEL

Member of the Commission

---

(1)  
  OJ L 93, 31.3.2006, p. 12.

1

(2)  
  OJ C 85, 4.4.2008, p. 13 (San Simón da Costa), OJ C 87, 8.4.2008, p. 8 (Ail blanc de Lomagne), OJ C 91, 12.4.2008, p. 26 (Steirischer Kren).

2

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ANNEX

Agricultural products intended for human consumption listed in Annex I to the Treaty:

Class 1.3.   Cheeses

SPAIN

San Simón da Costa (AOP)

Class 1.6.   Fruit, vegetables and cereals, fresh or processed

FRANCE

Ail blanc de Lomagne (IGP)

AUSTRIA

Steirischer Kren (IGP)

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

DECISIONS

Commission

| 11.12.2008 | EN | Official Journal of the European Union | L 333/5 |
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11.12.2008

EN

Official Journal of the European Union

L 333/5

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COMMISSION DECISION

of 2 December 2008

on the application of Article 8 of Directive 98/79/EC of the European Parliament and of the Council

(notified under document number C(2008) 7378)

(Only the Portuguese text is authentic)

(2008/932/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in-vitro diagnostic medical devices (1), and in particular Article 8 thereof,

Whereas:

| (1) | The Portuguese medical device authority Infarmed has, by letter of 29 July 2005 (2) addressed to the Italian company Medical Biological Service SRL (hereafter MBS), forbidden the marketing of their HIV in-vitro diagnostic test kit ‘HIV 1 & 2 Ab’ (hereafter the HIV test). Infarmed also obliged the Portuguese distributor Prestifarma Lda to recall the product on behalf of MBS. |
| --- | --- |

(1)

The Portuguese medical device authority Infarmed has, by letter of 29 July 2005 (2) addressed to the Italian company Medical Biological Service SRL (hereafter MBS), forbidden the marketing of their HIV in-vitro diagnostic test kit ‘HIV 1 & 2 Ab’ (hereafter the HIV test). Infarmed also obliged the Portuguese distributor Prestifarma Lda to recall the product on behalf of MBS.

| (2) | By letter of 1 September 2005 (3) Infarmed notified these measures under Article 13 of Directive 98/79/EC. As justification for their measure Portugal referred to the German Paul-Ehrlich-Institut’s health surveillance report ‘NCAR DE-2005-07-30’ (PEI Case No PEI0026/05). A subsequent exchange of letters clarified that the NCAR reference was misquoted and that the correct NCAR report number was DE-2005-07-07-30 and that this report is identical to the NCAR report DE-2005-07-27-30. |
| --- | --- |

(2)

By letter of 1 September 2005 (3) Infarmed notified these measures under Article 13 of Directive 98/79/EC. As justification for their measure Portugal referred to the German Paul-Ehrlich-Institut’s health surveillance report ‘NCAR DE-2005-07-30’ (PEI Case No PEI0026/05). A subsequent exchange of letters clarified that the NCAR reference was misquoted and that the correct NCAR report number was DE-2005-07-07-30 and that this report is identical to the NCAR report DE-2005-07-27-30.

| (3) | The NCAR report DE-2005-07-07-30 states that, shortly after an HIV infection, the HIV test needs 10 to 18 days more than comparable tests to detect the infection (low early sero-conversion sensitivity). For the same reason, the Slovak Medical University had, in its test report of 28 October 2004 (4), recommended the Slovak notified body EVPÚ not to certify the HIV test. The test did thus not fulfil the requirement of being conform to the ‘state of the art’ in the meaning of Annex I (Essential requirements) section A.2 of Directive 98/79/EC and section 3.1.8, third sentence, of the Common technical specifications for in-vitro diagnostic medical devices annexed to Commission Decision 2002/364/EC of 7 May 2002 on common technical specifications for in-vitro diagnostic medical devices (5). |
| --- | --- |

(3)

The NCAR report DE-2005-07-07-30 states that, shortly after an HIV infection, the HIV test needs 10 to 18 days more than comparable tests to detect the infection (low early sero-conversion sensitivity). For the same reason, the Slovak Medical University had, in its test report of 28 October 2004 (4), recommended the Slovak notified body EVPÚ not to certify the HIV test. The test did thus not fulfil the requirement of being conform to the ‘state of the art’ in the meaning of Annex I (Essential requirements) section A.2 of Directive 98/79/EC and section 3.1.8, third sentence, of the Common technical specifications for in-vitro diagnostic medical devices annexed to Commission Decision 2002/364/EC of 7 May 2002 on common technical specifications for in-vitro diagnostic medical devices (5).

| (4) | Moreover, as stated by the Paul-Ehrlich-Institut in its letter to the German Ministry of Health of 12 December 2005 (6), the documentation made available by the manufacturer shows that the HIV test did not detect all true positive samples, as required by 3.1.8, first sentence, of the Common technical specifications. This failure has never been explained by the manufacturer or his notified body as required by paragraph 3.1.5 of the Common technical specifications. Thus the HIV test does not fulfil sections 3.1.8, first sentence, and 3.1.5 of the Common technical specifications. |
| --- | --- |

(4)

Moreover, as stated by the Paul-Ehrlich-Institut in its letter to the German Ministry of Health of 12 December 2005 (6), the documentation made available by the manufacturer shows that the HIV test did not detect all true positive samples, as required by 3.1.8, first sentence, of the Common technical specifications. This failure has never been explained by the manufacturer or his notified body as required by paragraph 3.1.5 of the Common technical specifications. Thus the HIV test does not fulfil sections 3.1.8, first sentence, and 3.1.5 of the Common technical specifications.

| (5) | MBS modified the HIV test after taking note of the NCAR report DE-2005-07-07-30. However, the modification did not improve the early sero-conversion sensitivity of the HIV test, as stated by the Paul-Ehrlich-Institut later in a report of 23 August 2007 (7). As stated on page 10 of this report, the modified test also fails to detect samples already confirmed as true positive by Western blot or immunoblot assays. |
| --- | --- |

(5)

MBS modified the HIV test after taking note of the NCAR report DE-2005-07-07-30. However, the modification did not improve the early sero-conversion sensitivity of the HIV test, as stated by the Paul-Ehrlich-Institut later in a report of 23 August 2007 (7). As stated on page 10 of this report, the modified test also fails to detect samples already confirmed as true positive by Western blot or immunoblot assays.

| (6) | The Commission consulted the Member States by letter of 22 March 2007 (D(2007) 7800), the involved notified bodies and institutes by letter of 21 March 2007 (D(2007) 7817), and MBS by letter of 11 June 2007 (D(2007) 16597). It furthermore consulted experts in the field of in-vitro diagnostic medical devices on various occasions and, inter alia, in a meeting on 31 January 2008. |
| --- | --- |

(6)

The Commission consulted the Member States by letter of 22 March 2007 (D(2007) 7800), the involved notified bodies and institutes by letter of 21 March 2007 (D(2007) 7817), and MBS by letter of 11 June 2007 (D(2007) 16597). It furthermore consulted experts in the field of in-vitro diagnostic medical devices on various occasions and, inter alia, in a meeting on 31 January 2008.

| (7) | Article 13 of Directive 98/79/EC (Particular health monitoring measure) has wider conditions than Article 8 (Safeguard clause) of this Directive. Article 13 of Directive 98/79/EC does not require the same level of certainty of the acting authority with regard to the existence of a risk. |
| --- | --- |

(7)

Article 13 of Directive 98/79/EC (Particular health monitoring measure) has wider conditions than Article 8 (Safeguard clause) of this Directive. Article 13 of Directive 98/79/EC does not require the same level of certainty of the acting authority with regard to the existence of a risk.

| (8) | The analysis of the initial notification and of the later correspondence of Infarmed and the consultation of the parties concerned have shown that that it can be ascertained that the device under examination, when correctly maintained and used for its intended purpose, may compromise the health and/or the safety of patients, users or other persons, in the meaning of Article 8 of Directive 98/79/EC, as the essential requirement of being ‘state of the art’ is not met. |
| --- | --- |

(8)

The analysis of the initial notification and of the later correspondence of Infarmed and the consultation of the parties concerned have shown that that it can be ascertained that the device under examination, when correctly maintained and used for its intended purpose, may compromise the health and/or the safety of patients, users or other persons, in the meaning of Article 8 of Directive 98/79/EC, as the essential requirement of being ‘state of the art’ is not met.

| (9) | As the test is slower and less reliable than other devices, it will detect less HIV infections than the other devices and may delay the start of an adequate anti-retroviral therapy. The test could also contribute to an increased risk of missing HIV infected blood donors. It also compromises health in as much as its late and poor detection of the HIV infection may increase the risk of transmission to third persons, for instance by sexual intercourse. |
| --- | --- |

(9)

As the test is slower and less reliable than other devices, it will detect less HIV infections than the other devices and may delay the start of an adequate anti-retroviral therapy. The test could also contribute to an increased risk of missing HIV infected blood donors. It also compromises health in as much as its late and poor detection of the HIV infection may increase the risk of transmission to third persons, for instance by sexual intercourse.

| (10) | According to the European Court of Justice (8) the view given by the European Commission in accordance with Article 8.2 of Directive 98/79/EC binds the Member State which has taken measures. Accordingly, this legal act is to be qualified as a decision, |
| --- | --- |

(10)

According to the European Court of Justice (8) the view given by the European Commission in accordance with Article 8.2 of Directive 98/79/EC binds the Member State which has taken measures. Accordingly, this legal act is to be qualified as a decision,

HAS ADOPTED THIS DECISION:

Article 1

The measures of the Portuguese authority Infarmed taken by letter of 29 July 2005 (DGREE/VPS/086/05 — Case No 9.5.1 — 329/2005) against the marketing of the in-vitro diagnostic medical device ‘HIV 1 & 2 Ab’ manufactured by the Italian company Medical Biological Service SRL are justified.

Article 2

This Decision is addressed to the Portuguese Republic.

Done at Brussels, 2 December 2008.

For the Commission

Günter VERHEUGEN

Vice-President

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(1)  
  OJ L 331, 7.12.1998, p. 1.

1

(2)  DGREE/VPS/086/05 — Case No 9.5.1 — 329/2005.

2

(3)  DGREE/VPS/094/05.

3

(4)  Test report No E-650/04 208600.

4

(5)  
  OJ L 131, 16.5.2002, p. 17.

5

(6)  Reference No A2.

6

(7)  Austrian authorities had asked the Paul-Ehrlich-Institut for this report after confiscating the modified test on the way from MBS to the Austrian company Dialab GmbH, the latter intending to market the test under its own name.

7

(8)  See, by analogy, Judgment of the Court (First Chamber) of 14 June 2007, Case C-6/05, ECR 2007, p. I-4557 Nos 58, 59.

8

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| 11.12.2008 | EN | Official Journal of the European Union | L 333/7 |
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11.12.2008

EN

Official Journal of the European Union

L 333/7

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COMMISSION DECISION

of 4 December 2008

authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean MON89788 (MON-89788-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council

(notified under document number C(2008) 7517)

(Only the French and Dutch texts are authentic)

(Text with EEA relevance)

(2008/933/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (1), and in particular Articles 7(3) and 19(3) thereof,

Whereas:

| (1) | On 31 October 2006, Monsanto Europe S.A. submitted to the competent authority of the Netherlands an application, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from MON89788 soybean (the application). |
| --- | --- |

(1)

On 31 October 2006, Monsanto Europe S.A. submitted to the competent authority of the Netherlands an application, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from MON89788 soybean (the application).

| (2) | The application also covers the placing on the market of other products containing or consisting of MON89788 soybean for the same uses as any other soybean with the exception of cultivation. Therefore, in accordance with Articles 5(5) and 17(5) of Regulation (EC) No 1829/2003, it includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (2) and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC. |
| --- | --- |

(2)

The application also covers the placing on the market of other products containing or consisting of MON89788 soybean for the same uses as any other soybean with the exception of cultivation. Therefore, in accordance with Articles 5(5) and 17(5) of Regulation (EC) No 1829/2003, it includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (2) and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC.

| (3) | On 11 July 2008, the European Food Safety Authority (EFSA) gave a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003 and concluded that it is unlikely that the placing on the market of the products containing, consisting of, or produced from MON89788 soybean as described in the application (the products) will have any adverse effects on human or animal health or the environment in the context of their intended uses (3). In its opinion, EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Articles 6(4) and 18(4) of that Regulation. |
| --- | --- |

(3)

On 11 July 2008, the European Food Safety Authority (EFSA) gave a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003 and concluded that it is unlikely that the placing on the market of the products containing, consisting of, or produced from MON89788 soybean as described in the application (the products) will have any adverse effects on human or animal health or the environment in the context of their intended uses (3). In its opinion, EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Articles 6(4) and 18(4) of that Regulation.

| (4) | In its opinion, EFSA also concluded that the environmental monitoring plan, consisting of a general surveillance plan, submitted by the applicant is in line with the intended use of the products. |
| --- | --- |

(4)

In its opinion, EFSA also concluded that the environmental monitoring plan, consisting of a general surveillance plan, submitted by the applicant is in line with the intended use of the products.

| (5) | Taking into account those considerations, authorisation should be granted for the products. |
| --- | --- |

(5)

Taking into account those considerations, authorisation should be granted for the products.

| (6) | A unique identifier should be assigned to each GMO as provided for in Commission Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms (4). |
| --- | --- |

(6)

A unique identifier should be assigned to each GMO as provided for in Commission Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms (4).

| (7) | On the basis of the EFSA opinion, no specific labelling requirements other than those provided for in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, appear to be necessary for foods, food ingredients and feed containing, consisting of, or produced from MON89788 soybean. However, in order to ensure the use of the products within the limits of the authorisation provided for by this Decision, the labelling of feed containing or consisting of the GMO and products other than food and feed containing or consisting of the GMO for which authorisation is requested should be complemented by a clear indication that the products in question must not be used for cultivation. |
| --- | --- |

(7)

On the basis of the EFSA opinion, no specific labelling requirements other than those provided for in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, appear to be necessary for foods, food ingredients and feed containing, consisting of, or produced from MON89788 soybean. However, in order to ensure the use of the products within the limits of the authorisation provided for by this Decision, the labelling of feed containing or consisting of the GMO and products other than food and feed containing or consisting of the GMO for which authorisation is requested should be complemented by a clear indication that the products in question must not be used for cultivation.

| (8) | Similarly, the EFSA opinion does not justify the imposition of specific conditions or restrictions for the placing on the market and/or specific conditions or restrictions for the use and handling, including post-market monitoring requirements, or of specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in point (e) of Articles 6(5) and 18(5) of Regulation (EC) No 1829/2003. |
| --- | --- |

(8)

Similarly, the EFSA opinion does not justify the imposition of specific conditions or restrictions for the placing on the market and/or specific conditions or restrictions for the use and handling, including post-market monitoring requirements, or of specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in point (e) of Articles 6(5) and 18(5) of Regulation (EC) No 1829/2003.

| (9) | All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed, as provided for in Regulation (EC) No 1829/2003. |
| --- | --- |

(9)

All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed, as provided for in Regulation (EC) No 1829/2003.

| (10) | Article 4(6) of Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC (5), lays down labelling requirements for products consisting of, or containing GMOs. |
| --- | --- |

(10)

Article 4(6) of Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC (5), lays down labelling requirements for products consisting of, or containing GMOs.

| (11) | This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Articles 9(1) and 15(2)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council of 15 July 2003 on transboundary movements of genetically modified organisms (6). |
| --- | --- |

(11)

This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Articles 9(1) and 15(2)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council of 15 July 2003 on transboundary movements of genetically modified organisms (6).

| (12) | The applicant has been consulted on the measures provided for in this Decision. |
| --- | --- |

(12)

The applicant has been consulted on the measures provided for in this Decision.

| (13) | The Standing Committee on the Food Chain and Animal Health has not delivered an opinion within the time limit laid down by its Chairman. |
| --- | --- |

(13)

The Standing Committee on the Food Chain and Animal Health has not delivered an opinion within the time limit laid down by its Chairman.

| (14) | At its meeting on 19 November 2008, the Council was unable to reach a decision by qualified majority either for or against the proposal. The Council indicated that its proceedings on this file were concluded. It is accordingly for the Commission to adopt the measures, |
| --- | --- |

(14)

At its meeting on 19 November 2008, the Council was unable to reach a decision by qualified majority either for or against the proposal. The Council indicated that its proceedings on this file were concluded. It is accordingly for the Commission to adopt the measures,

HAS ADOPTED THIS DECISION:

Article 1

Genetically modified organism and unique identifier

Genetically modified soybean (Glycine max) MON89788, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON-89788-1, as provided for in Regulation (EC) No 65/2004.

Glycine max

Article 2

Authorisation

The following products are authorised for the purposes of Articles 4(2) and 16(2) of Regulation (EC) No 1829/2003 in accordance with the conditions set out in this Decision:

| (a) | foods and food ingredients containing, consisting of, or produced from MON-89788-1 soybean; |
| --- | --- |

(a)

foods and food ingredients containing, consisting of, or produced from MON-89788-1 soybean;

| (b) | feed containing, consisting of, or produced from MON-89788-1 soybean; |
| --- | --- |

(b)

feed containing, consisting of, or produced from MON-89788-1 soybean;

| (c) | products other than food and feed containing or consisting of MON-89788-1 soybean for the same uses as any other soybean with the exception of cultivation. |
| --- | --- |

(c)

products other than food and feed containing or consisting of MON-89788-1 soybean for the same uses as any other soybean with the exception of cultivation.

Article 3

Labelling

1.   For the purposes of the labelling requirements laid down in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003 and in Article 4(6) of Regulation (EC) No 1830/2003, the ‘name of the organism’ shall be ‘soybean’.

2.   The words ‘not for cultivation’ shall appear on the label of and in documents accompanying products containing or consisting of MON-89788-1 soybean referred to in Article 2(b) and (c).

Article 4

Monitoring for environmental effects

1.   The authorisation holder shall ensure that the monitoring plan for environmental effects, as set out in point (h) of the Annex, is put in place and implemented.

2.   The authorisation holder shall submit to the Commission annual reports on the implementation and the results of the activities set out in the monitoring plan.

Article 5

Community register

The information set out in the Annex to this Decision shall be entered in the Community register of genetically modified food and feed, as provided for in Article 28 of Regulation (EC) No 1829/2003.

Article 6

Authorisation holder

The authorisation holder shall be Monsanto Europe S.A., Belgium, representing Monsanto Company, United States of America.

Article 7

Validity

This Decision shall apply for a period of 10 years from the date of its notification.

Article 8

Addressee

This Decision is addressed to Monsanto Europe S.A., Avenue de Tervuren 270-272, B-1150 Brussels.

Done at Brussels, 4 December 2008.

For the Commission

Androulla VASSILIOU

Member of the Commission

---

(1)  
  OJ L 268, 18.10.2003, p. 1.

1

(2)  
  OJ L 106, 17.4.2001, p. 1.

2

(3)  http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753816_1178620787358.htm

3

(4)  
  OJ L 10, 16.1.2004, p. 5.

4

(5)  
  OJ L 268, 18.10.2003, p. 24.

5

(6)  
  OJ L 287, 5.11.2003, p. 1.

6

---

ANNEX

(a)   Applicant and authorisation holder:

| Name | : | Monsanto Europe S.A. |
| --- | --- | --- |
| Address | : | Avenue de Tervuren 270-272, B-1150 Brussels |

Name

:

Monsanto Europe S.A.

Address

:

Avenue de Tervuren 270-272, B-1150 Brussels

On behalf of Monsanto Company — 800 N. Lindbergh Boulevard — St. Louis, Missouri 63167 — United States of America.

(b)   Designation and specification of the products:

| 1. | foods and food ingredients containing, consisting of, or produced from MON-89788-1 soybean; |
| --- | --- |

1.

foods and food ingredients containing, consisting of, or produced from MON-89788-1 soybean;

| 2. | feed containing, consisting of, or produced from MON-89788-1 soybean; |
| --- | --- |

2.

feed containing, consisting of, or produced from MON-89788-1 soybean;

| 3. | products other than food and feed containing or consisting of MON-89788-1 soybean for the same uses as any other soybean with the exception of cultivation. |
| --- | --- |

3.

products other than food and feed containing or consisting of MON-89788-1 soybean for the same uses as any other soybean with the exception of cultivation.

The genetically modified MON-89788-1 soybean, as described in the application, expresses the CP4 EPSPS protein which confers tolerance to the glyphosate herbicide.

(c)   Labelling:

| 1. | for the purposes of the specific labelling requirements laid down in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, and in Article 4(6) of Regulation (EC) No 1830/2003, the ‘name of the organism’ shall be ‘soybean’; |
| --- | --- |

1.

for the purposes of the specific labelling requirements laid down in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, and in Article 4(6) of Regulation (EC) No 1830/2003, the ‘name of the organism’ shall be ‘soybean’;

| 2. | the words ‘not for cultivation’ shall appear on the label of and in documents accompanying products containing or consisting of MON-89788-1 soybean referred to in Article 2(b) and (c) of this Decision. |
| --- | --- |

2.

the words ‘not for cultivation’ shall appear on the label of and in documents accompanying products containing or consisting of MON-89788-1 soybean referred to in Article 2(b) and (c) of this Decision.

(d)   Method for detection:

| — | event specific real-time PCR based method for the quantification of MON-89788-1 soybean, |
| --- | --- |

—

event specific real-time PCR based method for the quantification of MON-89788-1 soybean,

| — | validated on seeds by the Community reference laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm |
| --- | --- |

—

validated on seeds by the Community reference laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm

| — | reference material: AOCS 0906-A and AOCS 0906-B accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm/soybean.cfm |
| --- | --- |

—

reference material: AOCS 0906-A and AOCS 0906-B accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm/soybean.cfm

(e)   Unique identifier:

MON-89788-1

(f)   Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity:

Biosafety Clearing-House, Record ID: see (to be completed when notified).

(g)   Conditions or restrictions on the placing on the market, use or handling of the products:

Not required.

(h)   Monitoring plan:

Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.

(Link: plan published on the Internet)

(i)   Post market monitoring requirements for the use of the food for human consumption:

Not required.

NB: links to relevant documents may need to be modified over time. Those modifications will be made available to the public via the updating of the Community register of genetically modified food and feed.

---

| 11.12.2008 | EN | Official Journal of the European Union | L 333/11 |
| --- | --- | --- | --- |

11.12.2008

EN

Official Journal of the European Union

L 333/11

---

COMMISSION DECISION

of 5 December 2008

concerning the non-inclusion of certain active substances in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing these substances

(notified under document number C(2008) 7637)

(Text with EEA relevance)

(2008/934/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular the fourth subparagraph of Article 8(2) thereof,

Whereas:

| (1) | Article 8(2) of Directive 91/414/EEC provides that a Member State may, during a period of 12 years following the notification of that Directive, authorise the placing on the market of plant protection products containing active substances not listed in Annex I to that Directive that are already on the market two years after the date of notification, while those substances are gradually being examined within the framework of a programme of work. |
| --- | --- |

(1)

Article 8(2) of Directive 91/414/EEC provides that a Member State may, during a period of 12 years following the notification of that Directive, authorise the placing on the market of plant protection products containing active substances not listed in Annex I to that Directive that are already on the market two years after the date of notification, while those substances are gradually being examined within the framework of a programme of work.

| (2) | Commission Regulations (EC) No 451/2000 (2) and (EC) No 1490/2002 (3) lay down the detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list includes the substances enumerated in the Annex to this Decision. |
| --- | --- |

(2)

Commission Regulations (EC) No 451/2000 (2) and (EC) No 1490/2002 (3) lay down the detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list includes the substances enumerated in the Annex to this Decision.

| (3) | Within two months from receipt of the draft assessment report the notifiers concerned voluntarily withdrew, in accordance with Article 11e of Regulation (EC) No 1490/2002, their support for the inclusion of those substances. |
| --- | --- |

(3)

Within two months from receipt of the draft assessment report the notifiers concerned voluntarily withdrew, in accordance with Article 11e of Regulation (EC) No 1490/2002, their support for the inclusion of those substances.

| (4) | The Commission has examined the draft assessment reports, the recommendations from the rapporteur Member States and the comments from other Member States and has come to the conclusion that Articles 11b and 11f do not apply. Consequently, Article 11e applies. |
| --- | --- |

(4)

The Commission has examined the draft assessment reports, the recommendations from the rapporteur Member States and the comments from other Member States and has come to the conclusion that Articles 11b and 11f do not apply. Consequently, Article 11e applies.

| (5) | The substances listed in the Annex to this Decision should therefore not be included in Annex I to Directive 91/414/EEC. |
| --- | --- |

(5)

The substances listed in the Annex to this Decision should therefore not be included in Annex I to Directive 91/414/EEC.

| (6) | As the non-inclusion of these substances is not based on the presence of clear indications of harmful effects as laid down in Annex VI to Regulation (EC) No 1490/2002, Member States should have the possibility to maintain authorisations until 31 December 2010, in accordance with Article 12(3) of Regulation (EC) No 1490/2002. |
| --- | --- |

(6)

As the non-inclusion of these substances is not based on the presence of clear indications of harmful effects as laid down in Annex VI to Regulation (EC) No 1490/2002, Member States should have the possibility to maintain authorisations until 31 December 2010, in accordance with Article 12(3) of Regulation (EC) No 1490/2002.

| (7) | Any period of grace granted by a Member State for the disposal, storage, placing on the market and use of existing stocks of plant protection products containing the listed substances should be limited to 12 months in order to allow existing stocks to be used in one further growing season. |
| --- | --- |

(7)

Any period of grace granted by a Member State for the disposal, storage, placing on the market and use of existing stocks of plant protection products containing the listed substances should be limited to 12 months in order to allow existing stocks to be used in one further growing season.

| (8) | This Decision does not prejudice the submission of a new application under Article 6(2) of Directive 91/414/EEC and Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Council Directive 91/414/EEC as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but have not been included into its Annex I (4) in accordance with the accelerated procedure provided for in Articles 13 to 22 of that Regulation. |
| --- | --- |

(8)

This Decision does not prejudice the submission of a new application under Article 6(2) of Directive 91/414/EEC and Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Council Directive 91/414/EEC as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but have not been included into its Annex I (4) in accordance with the accelerated procedure provided for in Articles 13 to 22 of that Regulation.

| (9) | That procedure allows notifiers whose substance has not been included based on their withdrawal, to make a new application submitting only the additional data necessary to address the specific issues that led to the adoption of the non-inclusion Decision. The notifier has received the draft assessment report which identifies those data. |
| --- | --- |

(9)

That procedure allows notifiers whose substance has not been included based on their withdrawal, to make a new application submitting only the additional data necessary to address the specific issues that led to the adoption of the non-inclusion Decision. The notifier has received the draft assessment report which identifies those data.

| (10) | The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
| --- | --- |

(10)

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

The substances listed in the Annex to this Decision shall not be included as active substances in Annex I to Directive 91/414/EEC.

Article 2

Member States shall withdraw authorisations for plant protection products containing one or several of the substances listed in the Annex by 31 December 2010 at the latest.

Article 3

Any period of grace granted by Member States in accordance with the provisions of Article 4(6) of Directive 91/414/EEC shall expire on 31 December 2011 at the latest.

Article 4

This Decision is addressed to the Member States.

Done at Brussels, 5 December 2008.

For the Commission

Androulla VASSILIOU

Member of the Commission

---

(1)  
  OJ L 230, 19.8.1991, p. 1.

1

(2)  
  OJ L 55, 29.2.2000, p. 25.

2

(3)  
  OJ L 224, 21.8.2002, p. 23.

3

(4)  
  OJ L 15, 18.1.2008, p. 5.

4

---

ANNEX

List of active substances referred to in Article 1

| Active substance | Draft assessment report communicated to the notifier on |
| --- | --- |
| Acetochlor | 14 December 2005 |
| Acrinathrin | 8 October 2007 |
| Asulam | 28 July 2006 |
| Bitertanol | 23 March 2006 |
| Bupirimate | 7 August 2007 |
| Carbetamide | 31 August 2006 |
| Carboxin | 28 July 2006 |
| Chloropicrin | 19 April 2006 |
| Clethodim | 19 April 2006 |
| Cycloxydim | 28 February 2007 |
| Cyproconazole | 15 September 2006 |
| Dazomet | 8 October 2007 |
| Diclofop-methyl | 10 September 2007 |
| Diethofencarb | 24 October 2007 |
| Dithianon | 5 February 2007 |
| Dodine | 29 March 2007 |
| Ethalfluralin | 4 October 2007 |
| Etridiazole | 7 August 2007 |
| Fenazaquin | 23 June 2006 |
| Fenbuconazole | 12 May 2006 |
| Fenbutatin oxide | 20 April 2007 |
| Fenoxycarb | 4 October 2007 |
| Fluazifop-P | 10 September 2007 |
| Flufenoxuron | 8 November 2007 |
| Fluometuron | 31 August 2007 |
| Fluquinconazole | 22 December 2005 |
| Flurochloridone | 27 October 2006 |
| Flutriafol | 9 November 2006 |
| Guazatine | 8 November 2007 |
| Hexythiazox | 18 May 2006 |
| Hymexazol | 8 October 2007 |
| Isoxaben | 9 November 2006 |
| Metaldehyde | 1 September 2006 |
| Metosulam | 8 October 2007 |
| Myclobutanil | 29 March 2006 |
| Oryzalin | 4 October 2007 |
| Oxyfluorfen | 4 October 2007 |
| Paclobutrazol | 7 December 2006 |
| Pencycuron | 1 June 2006 |
| Prochloraz | 18 June 2007 |
| Propargite | 8 October 2007 |
| Pyridaben | 7 August 2007 |
| Quinmerac | 6 July 2007 |
| Sintofen | 8 November 2007 |
| Tau-fluvalinate | 18 June 2007 |
| Tebufenozide | 9 June 2006 |
| Tefluthrin | 4 May 2007 |
| Terbuthylazine | 8 October 2007 |
| Thiobencarb | 21 July 2006 |

Active substance

Draft assessment report communicated to the notifier on

Acetochlor

14 December 2005

Acrinathrin

8 October 2007

Asulam

28 July 2006

Bitertanol

23 March 2006

Bupirimate

7 August 2007

Carbetamide

31 August 2006

Carboxin

28 July 2006

Chloropicrin

19 April 2006

Clethodim

19 April 2006

Cycloxydim

28 February 2007

Cyproconazole

15 September 2006

Dazomet

8 October 2007

Diclofop-methyl

10 September 2007

Diethofencarb

24 October 2007

Dithianon

5 February 2007

Dodine

29 March 2007

Ethalfluralin

4 October 2007

Etridiazole

7 August 2007

Fenazaquin

23 June 2006

Fenbuconazole

12 May 2006

Fenbutatin oxide

20 April 2007

Fenoxycarb

4 October 2007

Fluazifop-P

10 September 2007

Flufenoxuron

8 November 2007

Fluometuron

31 August 2007

Fluquinconazole

22 December 2005

Flurochloridone

27 October 2006

Flutriafol

9 November 2006

Guazatine

8 November 2007

Hexythiazox

18 May 2006

Hymexazol

8 October 2007

Isoxaben

9 November 2006

Metaldehyde

1 September 2006

Metosulam

8 October 2007

Myclobutanil

29 March 2006

Oryzalin

4 October 2007

Oxyfluorfen

4 October 2007

Paclobutrazol

7 December 2006

Pencycuron

1 June 2006

Prochloraz

18 June 2007

Propargite

8 October 2007

Pyridaben

7 August 2007

Quinmerac

6 July 2007

Sintofen

8 November 2007

Tau-fluvalinate

18 June 2007

Tebufenozide

9 June 2006

Tefluthrin

4 May 2007

Terbuthylazine

8 October 2007

Thiobencarb

21 July 2006

---

| 11.12.2008 | EN | Official Journal of the European Union | L 333/15 |
| --- | --- | --- | --- |

11.12.2008

EN

Official Journal of the European Union

L 333/15

---

COMMISSION DECISION

of 5 December 2008

concerning a Community financial contribution to the Joint Research Centre of the Commission in Belgium and Italy for certain activities carried out pursuant to Regulation (EC) No 882/2004 of the European Parliament and of the Council for the year 2009

(notified under document number C(2008) 7702)

(Only the texts in French, Italian, and Dutch are authentic)

(2008/935/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (1), and in particular Article 32(7) thereof,

Whereas:

| (1) | Community reference laboratories in the food and feed control area may be granted a Community financial contribution in accordance with Article 28 of Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field (2). |
| --- | --- |

(1)

Community reference laboratories in the food and feed control area may be granted a Community financial contribution in accordance with Article 28 of Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field (2).

| (2) | The Joint Research Centre of the European Commission in Ispra, Italy is listed in Annex VII to Regulation (EC) No 882/2004 as the Community reference laboratory for material intended to come into contact with foodstuffs and for genetically modified organisms. The Joint Research Centre of the European Commission in Geel, Belgium is listed in Annex VII to Regulation (EC) No 882/2004 as the Community reference laboratory for heavy metal in feed and food, for mycotoxins and for polycyclic aromatic hydrocarbons (PAH). |
| --- | --- |

(2)

The Joint Research Centre of the European Commission in Ispra, Italy is listed in Annex VII to Regulation (EC) No 882/2004 as the Community reference laboratory for material intended to come into contact with foodstuffs and for genetically modified organisms. The Joint Research Centre of the European Commission in Geel, Belgium is listed in Annex VII to Regulation (EC) No 882/2004 as the Community reference laboratory for heavy metal in feed and food, for mycotoxins and for polycyclic aromatic hydrocarbons (PAH).

| (3) | The Joint Research Centre and the Directorate-General for Health and Consumers are both services of the Commission and their relationship is laid down in an annual administrative arrangement supported by a work programme and its budget. |
| --- | --- |

(3)

The Joint Research Centre and the Directorate-General for Health and Consumers are both services of the Commission and their relationship is laid down in an annual administrative arrangement supported by a work programme and its budget.

| (4) | The work programmes and corresponding budget estimates of the Community reference laboratories within the Joint Research Centre for the year 2009 have been assessed. |
| --- | --- |

(4)

The work programmes and corresponding budget estimates of the Community reference laboratories within the Joint Research Centre for the year 2009 have been assessed.

| (5) | Accordingly, a Community financial contribution should be granted for certain activities of the Joint Research Centre of the European Commission in Geel, Belgium and Ispra, Italy, as provided for in Regulation (EC) No 882/2004. The Community’s financial contribution should be at the rate of 100 % of eligible costs as defined in Commission Regulation (EC) No 1754/2006 (3). |
| --- | --- |

(5)

Accordingly, a Community financial contribution should be granted for certain activities of the Joint Research Centre of the European Commission in Geel, Belgium and Ispra, Italy, as provided for in Regulation (EC) No 882/2004. The Community’s financial contribution should be at the rate of 100 % of eligible costs as defined in Commission Regulation (EC) No 1754/2006 (3).

| (6) | In accordance with Article 3(2)(a) of Council Regulation (EC) No 1290/2005 of 21 June 2005 on the financing of the common agricultural policy (4), animal disease eradication and control programmes (veterinary measures) shall be financed from the European Agricultural Guarantee Fund (EAGF). Furthermore, Article 13, second paragraph of that Regulation foresees that in duly justified exceptional cases, for measures and programmes covered by Decision 90/424/EEC, expenditure relating to administrative and personnel costs incurred by Member States and beneficiaries of aid from the EAGF shall be borne by the Fund. For financial control purposes, Articles 9, 36 and 37 of Regulation (EC) No 1290/2005 are to apply. |
| --- | --- |

(6)

In accordance with Article 3(2)(a) of Council Regulation (EC) No 1290/2005 of 21 June 2005 on the financing of the common agricultural policy (4), animal disease eradication and control programmes (veterinary measures) shall be financed from the European Agricultural Guarantee Fund (EAGF). Furthermore, Article 13, second paragraph of that Regulation foresees that in duly justified exceptional cases, for measures and programmes covered by Decision 90/424/EEC, expenditure relating to administrative and personnel costs incurred by Member States and beneficiaries of aid from the EAGF shall be borne by the Fund. For financial control purposes, Articles 9, 36 and 37 of Regulation (EC) No 1290/2005 are to apply.

| (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

A Community financial contribution shall be granted for the following activities of the Joint Research Centre of the European Commission, Ispra, Italy (the laboratory), carried out pursuant to Article 32(1) of Regulation (EC) No 882/2004, and for the organisation of workshops concerning such activities, for the period from 1 January 2009 to 31 December 2009:

| 1. | the activities related to material in contact with foodstuffs; this contribution shall not exceed EUR 180 003; |
| --- | --- |

1.

the activities related to material in contact with foodstuffs; this contribution shall not exceed EUR 180 003;

| 2. | the organisation of the workshops by that laboratory, concerning the activities referred to in point 1; this contribution shall not exceed EUR 75 947; |
| --- | --- |

2.

the organisation of the workshops by that laboratory, concerning the activities referred to in point 1; this contribution shall not exceed EUR 75 947;

| 3. | the activities related to GMOs; this contribution shall not exceed EUR 13 388; |
| --- | --- |

3.

the activities related to GMOs; this contribution shall not exceed EUR 13 388;

| 4. | the organisation of the workshops by that laboratory, concerning the activities referred to in point 3; this contribution shall not exceed EUR 61 440. |
| --- | --- |

4.

the organisation of the workshops by that laboratory, concerning the activities referred to in point 3; this contribution shall not exceed EUR 61 440.

Article 2

A Community financial contribution shall be granted for the following activities of the Joint Research Centre of the European Commission, Geel, Belgium (the laboratory) carried out pursuant to Article 32(1) of Regulation (EC) No 882/2004, and for the organisation of workshops concerning such activities, for the period from 1 January 2009 to 31 December 2009:

| 1. | the activities related to heavy metals in feed and food; this contribution shall not exceed EUR 250 000; |
| --- | --- |

1.

the activities related to heavy metals in feed and food; this contribution shall not exceed EUR 250 000;

| 2. | the organisation of the workshops by that laboratory, concerning the activities referred to in point 1; this contribution shall not exceed EUR 25 000; |
| --- | --- |

2.

the organisation of the workshops by that laboratory, concerning the activities referred to in point 1; this contribution shall not exceed EUR 25 000;

| 3. | the activities related to mycotoxins; this contribution shall not exceed EUR 230 000; |
| --- | --- |

3.

the activities related to mycotoxins; this contribution shall not exceed EUR 230 000;

| 4. | the organisation of the workshops by that laboratory, concerning the activities referred to in point 3; this contribution shall not exceed EUR 22 000; |
| --- | --- |

4.

the organisation of the workshops by that laboratory, concerning the activities referred to in point 3; this contribution shall not exceed EUR 22 000;

| 5. | the activities related to polycyclic aromatic hydrocarbons (PAH); this contribution shall not exceed EUR 232 000; |
| --- | --- |

5.

the activities related to polycyclic aromatic hydrocarbons (PAH); this contribution shall not exceed EUR 232 000;

| 6. | the organisation of the workshops by that laboratory, concerning the activities referred to in point 5; this contribution shall not exceed EUR 22 000. |
| --- | --- |

6.

the organisation of the workshops by that laboratory, concerning the activities referred to in point 5; this contribution shall not exceed EUR 22 000.

Article 3

The Community’s financial contributions provided for in Articles 1 and 2 shall be at the rate of 100 % of eligible costs as defined in Regulation (EC) No 1754/2006.

Article 4

This Decision is addressed to:

| — | for food contact materials: Joint Research Centre, Institute for Health and Consumer Protection, Physical and Chemical Exposures Unit, TP 260, Via E. Fermi, 1, 21020 Ispra (Italy), |
| --- | --- |

—

for food contact materials: Joint Research Centre, Institute for Health and Consumer Protection, Physical and Chemical Exposures Unit, TP 260, Via E. Fermi, 1, 21020 Ispra (Italy),

| — | for genetically modified organisms: Joint Research Centre, Institute for Health and Consumer Protection, Biotechnology and GMOs Unit, Via E. Fermi, 1, 21020 Ispra (Italy), |
| --- | --- |

—

for genetically modified organisms: Joint Research Centre, Institute for Health and Consumer Protection, Biotechnology and GMOs Unit, Via E. Fermi, 1, 21020 Ispra (Italy),

| — | for heavy metals: Joint Research Centre, Retieseweg 111, 2440 Geel (Belgium), |
| --- | --- |

—

for heavy metals: Joint Research Centre, Retieseweg 111, 2440 Geel (Belgium),

| — | for mycotoxins: Joint Research Centre, Retieseweg 111, 2440 Geel (Belgium), |
| --- | --- |

—

for mycotoxins: Joint Research Centre, Retieseweg 111, 2440 Geel (Belgium),

| — | for PAHs: Joint Research Centre, Retieseweg 111, 2440 Geel (Belgium). |
| --- | --- |

—

for PAHs: Joint Research Centre, Retieseweg 111, 2440 Geel (Belgium).

Done at Brussels, 5 December 2008.

For the Commission

Androulla VASSILIOU

Member of the Commission

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(1)  
  OJ L 165, 30.4.2004, p. 1; corrected by OJ L 191, 28.5.2004, p. 1.

1

(2)  
  OJ L 224, 18.8.1990, p. 19.

2

(3)  
  OJ L 331, 29.11.2006, p. 8.

3

(4)  
  OJ L 209, 11.8.2005, p. 1.

4

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11.12.2008

| 11.12.2008 | EN | Official Journal of the European Union | L 333/s3 |
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EN

Official Journal of the European Union

L 333/s3

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NOTE TO THE READER

The institutions have decided no longer to quote in their texts the last amendment to cited acts.

Unless otherwise indicated, references to acts in the texts published here are to the version of those acts currently in force.

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